The October 2012 Digital Edition of Anesthesiology News by McMahon Group

Vis

it u

Always Available Online @ AnesthesiologyNews.com

t An Boo esthe th 2 siolo 605 gy 2

012

THE INDEPENDENT MONTHLY NEWSPAPER FOR ANESTHESIOLOGISTS AnesthesiologyNews.com • O c t o b e r 2 0 1 2 • Volume 38 Number 10

40th Anniversary 1972-2012

ighter anesthesia does not reduce the incidence of postoperative morbidity and short-term mortality in patients undergoing noncardiac surgery, researchers have found. The randomized controlled study, which undercuts previous reports, also failed to reveal higher inflammatory levels among more deeply anesthetized patients. The researchers presented their results at the 2012 annual meeting of the American Society of Anesthesiologists (abstract 1200).

As Liposuction Deaths Mount, Study Exposes Cracks in Safety

quarter-centuryy after the nation’s plastic surgeons received what amounted to carte blanche to per-form liposuction, a new analysis suggests that the procedure is no safer than it was back then. Making matters worse, the researchers said, the surgery has been oversimplified in the popular media, while Americans,, who continue to become obese at an alarming pace, are hungry for a quick solu-tion to their weight problem. Throw into the mix an ample supply of seeminglyy unscrupulous physicians and state regu-lators who do not appear ready to crackk

see depth page 78

see liposuction page 84

INSIDE

Long Past the Schoolyard, Anesthesiologists Still Face Bullying on the Job

ullying is not simply a childhood power struggle that ends with the transition from the playground to adulthood. Social scientists have come to recognize that the “aggressive behavior intended to cause distress or harm that involves an imbalance of power between the aggressor and the victim” can persist long after graduates trade in their backpacks for briefcases— or stethoscopes. New research shows that bullying is a significant problem among

Girish Menon / Shutterstock.com

Anesthesia Depth Not Linked to Post-op Outcomes

anesthesia providers, with the potential for putting patients in danger. In a study presented at the International Anesthesia Research Society’s annual meeting in May, a research team at the University of Medicine and Dentistry of New Jersey (UMDNJ), in Newark, found that 54% of anesthesia providers surveyed there felt that they had been bullied in the past two years, with 70% reporting

12 | COMMENTARY

92 | CLINICAL ANESTHESIOLOGY

A SCIPpery Slope: Philosophical shift takes the individual out of medicine.

Local anesthetic overkill?

98 | POLICY & MANAGEMENT

60 | PAIN MEDICINE

Sexual misconduct and the practicing physician.

New York I-STOP law targets painkiller abuse.

106 | AD LIB The history of anesthesia’s future.

CME: PREANESTHETIC ASSESSMENT Lesson 300: Preanesthetic Assessment of the Patient With Hepatitis C, see page 73.

24 |

86 |

see bully page 50

Incorporating a Novel Local Analgesic Into an Opioid-Sparing Strategy for Postsurgical Pain (Part 1 of a 3-Part Series) Perioperative Patient Monitoring: Case Studies in Major Abdominal Surgery

NEW PRODUCTS

F1RSTUse from Anesthesia Business Consultants, see pages 2, 3 and 31.

BritePro Solo from Flexicare Inc., see pages 50 and 65.

Pyxis® Anesthesia system with Codonics™ SLS 500i™ Safe Label System™ from CareFusion, see pages 6 and 58.

Visit us at Booth #812 at the ASA Annual Convention to see

Use ABC’s new technology to attest to Meaningful Use

to see a complete listing of our afﬁliations, visit www.anesthesiallc.com/about-abc/afﬁliates

gn u in eA p fo fo le r @ rts ou an b r es y e fre th m e es ai we ia lin e llc g kl y .co m

Let our passion be your solution. ABC is your perfect partner. No one company is more qualified to provide comprehensive practice management solutions to anesthesia and pain management practices. We offer extensive resources, single-minded focus and sophisticated technology. Our Billing and Practice Management services offer a full range of services—choose what services you need—don’t pay for those you don’t need. Our technology suite of products features the exclusive and powerful OneSourceAnesthesia system and tracks quality measures and ensures compliance with EMR. We are dedicated exclusively to the anesthesia and pain management markets.

800.242.1131 info@anesthesiallc.com www.anesthesiallc.com

4 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

Comment on these and other articles @ AnesthesiologyNews.com.

Heard Here First: If industry does not

pay

research and education for medical for the necessaryy

October 2012

professionals and patients,

The five most-viewed articles last month on AnesthesiologyNews.com 1. Review of Avoidable Regional Errors Exposes Shocking Lapses 2. Automation Shines Light on ‘Black Hole’ of OR Drugs 3. Ultrasound Proves Good Means of ID-ing Pneumothorax

who will? We cannot, as physicians,

4. Inspector General Weighs In on Fee Sharing

abandon people

5. Fully Robotic Nerve Blocks on the Horizon

with pain—that is unethical. SEE ARTICLE ON PAGE 10.

ACT NOW! Renew your

free subscription to

today at

ALAN KAYE, PHD, MD, New Orleans, LA

ELIZABETH ZHONG, Associate Copy Chief

ROBERT S. LAGASSE, MD, New Haven, CT

RICHARD TUORTO, Senior Group Publication Director richardt@mcmahonmed.com, (212) 957-5300, x 916

ALEX MACARIO, MD, MBA, Stanford, CA THE INDEPENDENT MONTHLY NEWSPAPER FOR ANESTHESIOLOGISTS

AnesthesiologyNews.com • mcmahonmed.com

ADVISORY BOARD

ALIX MATHIEU, MD, MBA, MS, Cincinnati, OH PETER J. PAPADAKOS, MD, Rochester, NY

PAUL G. BARASH, MD, New Haven, CT CHRISTOPHER W. BRYAN-BROWN, MD, Bronx, NY KEITH CANDIOTTI, MD, Miami, FL

TO RENEW ONLINE Go to AnesthesiologyNews.com/Renew. NOT RECEIVING ANESTHESIOLOGY NEWS?

ANGELA LABROZZI, Manager, Publication Sales alabrozzi@mcmahonmed.com, (212) 957-5300, x 204

All U.S. anesthesiologists should receive Anesthesiology News free of charge. If you are not receiving the publication, or if you are changing your name or address, please follow these instructions:

DAVID NATHANSON, Account Manager dnathanason@mcmahonmed.com, (212) 957-5300, x 227

LINDA S. POLLEY, MD, Ann Arbor, MI

ALINA DASGUPTA, Junior Sales Associate, Classified Advertising adasgupta@mcmahonmed.com, (212) 957-5300, x 338

MICHAEL F. ROIZEN, MD, Cleveland, OH JEFFREY L. APFELBAUM, MD, Chicago, IL

AnesthesiologyNews.com/Renew

1) Contact the American Medical Association (AMA) at (800) 262-3211 or the American Osteopathic Association (AOA) at (800) 621-1773, and notify them of your name, address and professional specialty. You need not be a member of the AMA or AOA to receive the publication.

JOAN E. SPIEGEL, MD, Boston, MA MICHELE MCMAHON VELLE, MAX Graphics/Creative Director SUSAN T. VERGHESE, MD, Washington, DC BLAKE DENNIS, MAX Graphics/Art Director EUGENE R. VISCUSI, MD, Philadelphia, PA

DAN RADEBAUGH, Director of Production and Technical Operations

CHARLES B. WATSON, MD, Bridgeport, CT

2) For added assurance of uninterrupted service, you may also mail or fax a copy of your current mailing label, along with your change of name or address to:

MARTIN BARBIERI, Production Manager

PETER J. DAVIS, MD, Pittsburgh, PA PAUL F. WHITE, PHD, MD, Los Altos, CA

BRANDY WILSON, Circulation Coordinator

D. JOHN DOYLE, MD, PHD, Cleveland, OH

Circulation Coordinator, Anesthesiology News 545 West 45th Street, 8th Floor New York, New York 10036 Fax: (212) 664-1242 Email: circulation@mcmahonmed.com Please sign and date all requests.

DAVID WLODY, MD, Brooklyn, NY LEE A. FLEISHER, MD, Philadelphia, PA ELIZABETH A.M. FROST, MD, New York, NY CLIFFORD GEVIRTZ, MD, New York, NY

MCMAHON GROUP

MCMAHON PUBLISHING

RAYMOND E. MCMAHON, Publisher & CEO, Managing Partner

JULIAN M. GOLDMAN, MD, Boston, MA

ADAM MARCUS, Managing Editor amarcus@mcmahonmed.com

CHRISTOPHER M. GRANDE, MD, MPH, Baltimore, MD

JAMES PRUDDEN, Group Editorial Director

VAN VELLE, President, Partner

If you are not a U.S. anesthesiologist and would like to subscribe, please send a check payable to Anesthesiology News to the Circulation Coordinator. Annual subscription: $70 (outside U.S.A., $90). Single copies: $7 (outside U.S.A., $10). Please allow 8-12 weeks for delivery of the first issue.

MATTHEW MCMAHON, General Manager, Partner

ADMIR HADZIC, MD, PHD, New York, NY

DAVID BRONSTEIN, Editorial Director

ZEEV N. KAIN, MD, Irvine, CA

ROBIN B. WEISBERG, Manager, Editorial Services

LAUREN SMITH, MICHAEL P. MCMAHON, MICHELE MCMAHON VELLE, ROSANNE C. MCMAHON, Partners

McMAHON PUBLISHING, Sales, Production and Editorial Offices: 545 W. 45th St., 8th Floor, New York, NY 10036, Tel. (212) 957-5300. Corporate Office: 83 Peaceable St. West Redding, CT 06896. ®

® ®

McMahon Publishing is a 40-year-old, family-owned medical publishing and medical education company. McMahon publishes six clinical newspapers, nine annual or semiannual Special Editions, continuing medical education and custom publications.

® ®

Copyright © 2012 McMahon Publishing, New York, NY 10036. All rights reserved. Anesthesiology Newss (ISSN 0747-4679) is published monthly for $70 per year by McMahon Publishing. Periodicals postage paid at New York, NY, and at additional mailing offices. POSTMASTER: Please send address changes to Anesthesiology News, 545 W. 45th St., 8th Floor, New York, NY 10036.

® ®

End-tidal CO2 Cap-ONE

Safeguard your post-surgical patients

NTX

Introducing Prefense™+ EtCO2 Prefense™

Our 5th-generation system provides comprehensive surveillance for your opioid drip patients. completely—including EtCO2—with one comprehensive yet simple solution. Now you can. The Nihon Kohden Prefense + EtCO2 system enables you to provide end-to-end monitoring that more fully protects patients, while delivering immediate ﬁnancial beneﬁts. We’ve combined our Cap-ONE CO2 monitoring technology with our newest Prefense system, enabling you to monitor opioid-drip patients for: • EtCO2

• Heart rate

• SpO2

• Non-invasive blood pressure

The Beneﬁts: • Higher patient safety and better patient outcomes • Improved economics, with better bed utilization and reduced stays • Fewer unplanned, costly ICU and telemetry admissions

• Respiration rate

Visit us at booth #804 at ASA 2012, October 13–15, to learn more. www.nkusa.com/monitoring 800-325-0283

6 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

The following advertorial has been provided by CareFusion and is designed to support the advertisement presented below.

™

CareFusion Pyxis Anesthesia System With Codonics Safe Label System SLS 500i Q: Who is CareFusion? A: CareFusion, a global medical device company, delivers proven products and services that help measurably improve the medication safety and cost of health care. Used in more than 120 countries around the world, CareFusion supports some of the most widely recognized brand names in the industry, including Pyxis® for medication and supply management. ®

Q: What is the Pyxis Anesthesia system?

A: The Pyxis Anesthesia system helps save time and effort by eliminating the need for manual documentation of dispensed medications in the OR—allowing more time for patient care. Where manually operated work carts are traditionally used, the system can automatically document stored or dispensed drugs. The Pyxis Anesthesia system was created specifically for use within the operating room and other specialty procedure areas to help create a more efficient OR environment.

Q: How can the Codonics™ Safe Label System™ SLS 500i™ be used in conjunction with the Pyxis Anesthesia system? A: The Codonics SLS 500i prints easily identifiable labels for syringes, which can be labeled at the Pyxis Anesthesia system when dispensing controlled substances. Both systems help in simplifying complex OR processes, providing close access to medication and helping streamline the administration process. With the bar

code scanner, the Codonics SLS 500i prints 2D bar codes on labels that can be scanned for additional identification and security.

Q: How does the Pyxis Anesthesia system and Codonics SLS 500i system add value to the anesthesia provider’s workflow? A: Through electronic tracking, the Pyxis Anesthesia system helps ensure medications and supplies are stocked and easily accessible when and where they are needed. In addition, the SLS 500i helps provide convenient access to a system for identifying controlled substances in syringes. Medications can be easily tracked and labeled, helping save time and reducing waste. With options such as bar coding and kit selection, Pyxis Anesthesia system supports personalized workflow and practices, while SLS 500i assists in syringe labeling that complies with The Joint Commission standard and meets the intent of ISO, ASTM standards and ASA guidelines.1

Q: How does the Pyxis Anesthesia system and Codonics SLS 500i support regulatory requirements? A: Pyxis Anesthesia system supports regulatory agency requirements by providing secure storage of controlled substances and an accurate database of all dispensed medications. Pyxis Anesthesia system helps improve narcotics security with the inclusion of a BioID fingerprint or unique password identification system. An optional password re-verification is also available, if the controlled substances drawer is not opened within a set period of time. Codonics SLS 500i prints labels that comply with The Joint Commission standards and meet the intent of ISO, ASTM standards and ASA Guidelines.1

Q: Does the Pyxis Anesthesia system provide reporting capabilities? A: Reports unique to the Pyxis Anesthesia system include My Items reports, Patient Case Information reports and Transfer Item reports. These reports assist with utilization and cost management data.

Q: Can the transaction information from the Pyxis Anesthesia system be accessed from room to room (system to system)?

Help me build a less complex system . In the dynamic and complex operating room, you must make critical decisions while making every second count. ®

Pyxis Anesthesia system automates processes to save time and help anesthesia providers conveniently access ™

™

the medications and supplies they need. When used with Codonics Safe Label System SLS 500i , Pyxis Anesthesia system streamlines complex OR medication preparation and administration processes, providing ASA and The Joint Commission-compliant medication labeling anywhere syringes are prepared. Working together towards quality care—that’s the CareFusion difference. Join us at ASA booth 413 or visit carefusion.com/asystem to learn more.

Pyxis

© 2012 CareFusion Corporation or one of its subsidiaries. All rights reserved. Pyxis, CareFusion and the CareFusion logo are trademarks or registered trademarks of CareFusion Corporation or one of its subsidiaries. Codonics is a trademark or registered trademark of Codonics, Inc. or one of its subsidiaries. DI624

A: Yes, assuming the Pyxis Anesthesia systems are communicating and the Areas table is properly defined in the console, the information from one Pyxis Anesthesia system is communicated to other Pyxis Anesthesia systems, in real time, in the same designated area.

Q: Who do I contact for more information on the Pyxis Anesthesia system and other CareFusion offerings? A: For more information, visit carefusion.com/ anesthesia or carefusion.com. You may also email CareFusion Pyxis technologies at communications@carefusion.com. 1. Joint Commission NPSG 03.04.01, ISO 26825, ASTM 4774 Standards and ASA guidelines.

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 7

IN BR IE F

Obesity by the Numbers: Prevalence of self-reported obesity among U.S. adults.

15-<20% 20-<25% 25-<30% 30-<35% ≥35%

Source: Centers for Disease Control and Prevention

Hypertension by the Numbers: Prevalence of uncontrolled high blood pressure* by selected characteristics.

3M Ranger Blood/Fluid Warming System ™

™

Now proudly part of 3M Infection Prevention

Age group (y) 18-44 45-64 ≥65 65-79 ≥80

Race/Ethnicity White, non-Hispanic Black, non-Hispanic Hispanic Mexican American Other Hispanic

Education (among those aged ≥25 y) <High school diploma High school diploma Some college ≥College degree

Health insurance status Any health insurance Medicare Private Public Uninsured

Water a e in the OR:

What are the ririsks? The 3M Ranger System with dry heat technology for smart patient care ™

™

• Eliminates water as a potential source of nosocomial pathogens from the O.R. • Eliminates ongoing maintenance associated with waterbath-based IV ﬂuid warmers • Hassle-free set up and quick, simple maintenance • Economical, easy-to-use disposable sets including the high ﬂow set (6,000 - 30,000 mL/hr) with an auto-venting bubble trap

Source: National Health and Nutrition Examination Survey (NHANES), United States, 2003-2010 * Uncontrolled hypertension was defined as an average systolic blood pressure ≥140 mm Hg or an average diastolic blood pressure ≥90 mm Hg. Calculated among those with hypertension. Pregnant women were excluded. For information call Arizant Healthcare at 1-800-733-7775 or visit www.rangerﬂuidwarming.com 3M is a trademark of 3M Company, used under license in Canada. RANGER and the RANGER logo are trademarks of Arizant Healthcare Inc., used under license in Canada. ©2011 Arizant Healthcare Inc. All rights reserved. 602442G 6/11

8 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

C OMM E NT A R Y Editor’s Note:: With the presidential election less than a month away, how should anesthesiologists be feeling about the next administration? Will a second term for President Obama or four years for Gov. Mitt Romney make a difference to physicians? Alexander A. Hannenberg, MD, who led the American Society of Anesthesiologists during the debates over health care reform in Mr. Obama’s first term, offers his perspective.

Election 2012: A Physician’s Outlook

he most dramatic changes to anesthesiology practice during the next presidential term will be largely unaffected by the results of the election. The momentum behind the abandonment of feefor-service practice is so strong in the purchaser community and insurance industry that, irrespective of a new administration’s Medicare policy,

anesthesiologists will need to find our way in the global payment world as private health plans persist in this transition. The complexity of managing a capitated payment will drive some to employment by a health system; others will devise ingenious alternate arrangements to preserve practice autonomy. We will be making the argument for the value of our services more

locally than before, as our “transaction” will move from the health plan to our local care delivery Alexander A. organization. If Gov. Romney is Hannenberg, MD elected, his ability to actually repeal the Affordable Care Act (ACA) will depend on the composition of the Senate. Even in the absence of majorities in both houses and an outright repeal, there are executive opportunities to derail implementation. Piecemeal interference could lead to poorly managed implementation of the law with resultant uncertainty and chaos. If repeal is accomplished, unless a viable replacement law is enacted— no small task as we learned in 2009— the ranks of the uninsured will not be substantially diminished. For those delivering anesthesia care to indigent communities, the relief from coverage expansion will be missed. President Obama’s re-election will virtually guarantee that the law remains on the books even if implementation funding is a battle. Hundreds of billions of cuts to providers in the ACA—not to mention the retention of the cuts to the sustainable growth rate for Medicare—will make expanding provider capacity to serve the newly covered a real challenge. One need only look as far as Medicaid to understand how underfunding leads to diminished access. While it’s true that some practices will offset these cuts with new coverage for the previously uninsured, many others will sustain the cuts without this benefit. —Alexander A. Hannenberg, MD Newton, Mass.

Congratulations to Jeffrey L. Apfelbaum, MD, winner of the 2012 Distinguished Service Jeffrey L. Award from Apfelbaum, MD the American Society of Anesthesiologists. Dr. Apfelbaum—a member of the Anesthesiology News s editorial board—is professor of anesthesia and critical care, and chair of the department, at the University of Chicago Medical Center and the Pritzker School of Medicine.

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 9

The following advertorial has been provided by B. Braun Medical Inc. and is designed to support the advertisement presented below.

ULTRAPORT zer0 From B. Braun Medical Inc. Q: What is ULTRAPORT™ zer0? A: ULTRAPORT zer0 is the next generation in four-way stopcock technology, with an incorporated swabable valve and channel-type fluid path versus a traditional stopcock with intersecting boreholes.

Q: How does this channel-type fluid path improve stopcock performance? A: Traditional stopcocks have a side port intersecting the main fluid path creating dead space in the side port where air or residual drug may be trapped, or where infection-causing bacteria may begin colonizing. ULTRAPORT zer0 is a unique stopcock incorporating the side port into the main fluid path. When the handle is turned to the all-open position (handle opposite the side port), ULTRAPORT zer0’s channel fluid path simplifies the priming process and provides for continual flushing of the side port, eliminating dead space.

Q: How does ULTRAPORT zer0 simplify the priming processes?

Q: How does ULTRAPORT zer0 help prevent infections? A: A recent study conducted at DartmouthHitchcock Medical Center by Randy Loftus, MD, et al.,1 concluded, “The ULTRAPORT zer0 stopcock with hub disinfection prior to injection was associated with significant reduction in the risk of inadvertent bacterial injection as compared to the conventional open lumen stopcock.” Study results showed

0% (none of 152) effluent contamination with ULTRAPORT zer0 when disinfected.

Q: How does ULTRAPORT zer0 prevent leaks? A: Many stopcock users may not turn the handle to the off position for the side port (handle over the side port) only to later find that fluid has leaked from the stopcock side port. Because ULTRAPORT zer0 has a

luer-activated swabable valve, the side port is automatically closed when not in use. In addition, the incorporated valve eliminates the need for sterile replacement caps after every access.

Reference 1. Loftus RW, et al. Intraoperative infection control: a paradigm shift. Presented at: Association for Professionals in Infection Control Annual Conference; June 4-6, 2012; San Antonio, TX.

Raise your standards for stopcock performance to ZERO

A: The best way to ensure air is removed during priming of a traditional stopcock is to use an empty syringe to draw the air bubble out of the side port. This is not only an extra step, it is also an opportunity for introducing contamination. However, when the handle of ULTRAPORT zer0 is in the all-open position, the side port is part of the fluid path and air in the side port is pushed out automatically during priming.

Q: What are the benefits of continually flushing the side port? A: In a traditional stopcock, residual drug may be trapped in the side port, resulting in an inadvertent dose the next time the stopcock is accessed or possible mixing of incompatible drugs. ULTRAPORT zer0, with the handle in the all-open position, is designed to continuously flush the side port to eliminate the potential for any residual drug. For drugs without compatibility restrictions this function may eliminate the need to flush, reducing the need and cost for prefilled flush syringes. Continuous flushing of the side port is designed to help prevent the colonization of possible infection-causing bacteria, especially after a blood draw through the stopcock. To avoid mixing incompatible drugs, B. Braun recommends flushing the side port between administrations as well as keeping the stopcock in the all-open position to continuously flush the side port. A demonstration video may be viewed at www.AnesthesiaIV.com.

ULTRAPORT ™ zer0 Luer Activated, Closed-System Stopcocks ULTRAPORT zer0 is a unique, closed-system stopcock designed to eliminate dead space and residual drug, and reduce the chance of catheter-related bloodstream infections, simplifying IV fluid or drug administrations. zer0 zer0 sterile replacement caps needed zer0 leaks. Does not leak if handle is inadvertently left open

For more information, visit www.bbraunusa.com or call your B. Braun representative at 1-800-227-2862.

12-3422_AN_8/12_BB

10 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

C OMM E NT A R Y

Industry-Supported CME and Firewalls

he U.S. Senate Finance Committee is set to investigate the extent and implications of financial ties between the manufacturers of pain-relievingg opioid drugs and professional pain societies, including the American Academy of Pain Medicine (AAPM). At issue is the amount of money provided to professional societies to create and deliver educational content on how to prescribe and consume opioid medications. The two senators leading the probe, Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa), seek to establish if industry support for educational content has led to misleading information that minimizes opioid harm. As president-elect of the AAPM, the principal U.S. organization for the specialty of pain medicine, I both welcome the opportunity to shed light on these issues and fear the potential for distortion. Although profit seeking drives much of American society, as specialists in pain medicine our primary responsibility is to the welfare of our patients. Therefore, we cannot deny the potential for problems in the creation of educational content that is underwritten by industry. Problems could include allowing marketing priorities to direct educational content, exaggerating benefits of a medication or medical device while downplaying its risks, omitting mention of significant but inconvenient data or failing to cite head-to-head comparisons of competing products, particularly conventional treatments. Pain professionals absolutely have a responsibility to ensure pharmaceutical companies do not push marketing messages into educational programs. Established firewalls, already in place, must be used to prevent undue influence. Several such firewalls are used by AAPM. One firewall is unrestricted grants. Educational content at AAPM meetings is supported, in part, by unrestricted grants from pharmaceutical or medical device companies. These grants specify that the grantor have no control over the content of the presentation. A second firewall is the AAPM disclosure policy. Speakers and session leaders must fully disclose relevant financial relationships, including research grants; honoraria or other payments; and advisory board or speakers’ bureau commitments. These relationships are published openly and are available for scrutiny by session attendees. The nationally recognized Accreditation Council for Continuing Medical Education (ACCME), which directs continuing medical education (CME), has set these standards. In 2011, the ACCME reaccredited the Academy with its highest distinction: “accreditation with commendation.” The Senate Finance Committee has begun a process of inquiry into industry funding sources and amounts. Respectfully, I would ask that the committee complete the process by investigating whether and to what extent the educational content has been influenced by dollars. To know the answer, senators should examine not only the dollar amounts or percentages of budgets but also the educational content itself for evidence of bias or misinformation. They can only do this by seeking counsel from unbiased professionals with appropriate credentials in the

‘If industry does not pay for the necessary research and education for medical professionals and patients, who will? I would welcome governmental and other sources of funding for this vital research. Unfortunately, no such support is forthcoming.’

field of pain medicine—not by parties with a history of bias for or against a particular form of therapy, nor by individuals without “real-life” clinical experience caring for patients with intractable pain. Counsel should come from those who can understand the need for measured thought, critical thinking and modulated judgment in clinical decision making, given the paucity of high-qualityy effectiveness research and evidence-based outcomes in this burgeoning field. As medical professionals, we affirm that corporate marketing priorities must never direct CME content. However, not all industry involvement is harmful. Although it is good journalistic form to “follow the money,” taint does not naturally and inevitably follow. New and existing drugs need lots of complicated research to answer important questions. Questions like: Who should get the drug and at what dosage and time points? What are the risks and how do they change for different study populations? How effective is the medication when compared with placebo or other available therapies? The best science takes time and it takes significant resources. A frank approach to these questions would acknowledge that industry supports alll facets of American health care delivery. The pain medicine field is not unique in this regard. If industry does not pay for the necessary research and education for medical professionals and patients, who will? We cannot, as physicians, abandon people with pain—that is unethical. I conduct research on newer pain therapies created with the goal of having less potential for harm than currently available opioid formulations. My former company took money from industry to conduct this research as a precursor to the company’s possible marketing of a new product. I would welcome governmental and other sources of funding for this vital research. Unfortunately, no such support is forthcoming.

Currently, the National Institutes of Health (NIH) devotes only around 1% of its budget to pain research, despite the overwhelming need of 100 million Americans in chronic pain, as reported by the Institute of Medicine and supported by a recent Gallup poll. Given that the government and industry are the only two viable funding sources available, I encourage the NIH and concerned senators to dig into government coffers to facilitate the pain research that is so desperately needed. Furthermore, we should not pretend that other sources of funding bring no possible conflicts. As reported in The Seattle Times, a rise in overdose deaths among Medicaid enrollees in Washington state accompanied a government foray into medical decision making in which methadone was pushed as the preferred analgesic. Methadone is cheaper than other opioids, but at what cost did this cost cutting take place? If following the money is good journalistic and legislative practice—and, in general, it is—let us keep our eyes open to other sources of influence that could cause harm. The reality is, at present, that industry supports the educational initiatives that spread information about appropriate and safe use of its products. Indeed, the FDA mandates that it do so as part of Risk Evaluation and Mitigation Strategies for opioids. Other companies that manufacture and market drugs to treat all types of diseases and conditions do the same. Would producers of drugs to treat diabetes or cancer be forbidden to compile and disseminate information on the risks and benefits of their products? Again, from where, instead, should that information come? —Lynn Webster, MD Dr. Webster is the medical director of CRILifetree Research, in Salt Lake City, Utah, and the incoming president of the American Academy of Pain Medicine.

Preferred Physicians Medical (PPM) formed in 1987 to exclusively insure anesthesiologists and their practices. From day one, each new policyholder also became an owner of PPM, so it’s no surprise thatt protecting our physicians’ professional reputation is at the core of evverything we do. Our substantial database of more than 11,000 adversse anesthesia events collected over the last quarter of a century arms our physician owners with practical, anesthesia-specifi fic strategies to effectively identify and manage risk, including: On-site, anesthesia-specific fi risk management seeminars Exclusive online access to timely and useful risk management resources A subscription b i ti to t Anesthesia A th i & the th Law, L our indu i dustry-respected risk management newsletter In-house Claims Attorneys and Claims Specialistts skilled in using this data to effectively develop defense strategiess and resolve claims without indemnity payment Don’t wait another year. Take ownership of your own reputation by calling PPM today.

Add your good name to our growing list of ASA “standard of care” clinicians. Call us toll free today at 800.562.5589 and join other select anesthesiologists who have already secured ownership in their professional reputations.

12 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

C OMM E NT A R Y

A SCIPpery Slope A philosophical shift takes the individual out of medicine

“Essentially, we’re moving from a Jeffersonian ideal of small

“It is seldom that liberty of

“There is no longer a place forr the

guilds and independent craftsmen to a Hamiltonian recognition

any kind is lost all at once.”

Lone Ranger in health care …”

of the advantages that size and centralized control can bring.”

—David Hume

—Personal communication with th he chairman of the board of a major health care system

—Atul Gawande, MD, The New Yorker, August 11, 2012

t began almost imperceptibly with a small regulation here, a comment there. Slowly at first and then with relentless speed and force it grew, and like a tsunami overwhelms anything in its path. By now, every physician who has practiced for more than a few years has noticed the dramatic shifts in the relationship of doctors to the society in which we practice our profession. From relative independence, we are being forced further into group think. Hardly a day goes by without some new directive from above instructing what and how to perform a task to benefit our patient. Examples abound: The Surgical Care Improvement Project (SCIP) commands us to give a β-blocker and an antibiotic. Woe to the anesthesiologist who misses the magic hour before incision or without explanation holds metoprolol in a bradycardic patient. Then there is the mandatory computer-based education that instructs us to be caring, do the right thing and dump garbage in the appropriate color-coded bins—followed by a test. Why bother with medical school and residency? You can’t make this stuff up! Some centuries ago, Alexis de Tocqueville (or was it Machiavelli) explained how control of a population can be simply achieved by forcing compliance with many relatively small and innocuous requirements. Sounds a lot like the multiplicity of rules and expected behaviors coming down daily from the hospital, insurers, the government and even our own colleagues. A doctor could once choose from multiple diagnostic and therapeutic pathways, like a driver motoring down a wide interstate picking a lane. Now that same physician must navigate a narrowing European cobblestone alley. In a recent issue of The New Yorker magazine, Atul Gawande, a Harvard surgeon, wrote about the efficiencies, quality and cost control of the Cheesecake Factory restaurant chain as a model for improvements in medical

O C TO B E R 2 0 1 2

liberall Enlightenment thin nking, the American n Declaration of Inddependence and the U.S. Constitution. In its place was an ill-defined “reconstructeed post-cultural entityy,” whatever that meanss. The poostmodern generation is obsessed with the idea that we are all in this care delivery. Airline pilots no longer, our new role models deliver crab cakes and teriyaki chicken … but, oh so efficiently. A Postmodern Infection We have all heard about the advantages of replacing the individualistic physician making clinical decisions based on his judgment, education and experience with uniform algorithmdriven medicine. Minimizing variation and increasing predictability, we are told, will improve care and decrease costs. But, in addition to those practical reasons, I believe deep structural changes must have occurred to allow this viewpoint, unthinkable a generation ago, to become an everyday reality. I believe the answer lies in the migration of postmodern continental philosophy to the elite bastions of American education. Today’s medicopolitical-educational opinion leaders, Boomers and Gen Xers, alumni of Ivy League schools—the best of the “best of the best”—came of age in an atmosphere seeped in the words of Derrida, Lyotard, Foucault, Baudrillard and other intellectuals whose thoughts and writings became voguish in the 1970s. These ideas subsequently penetrated state universities and community colleges, became part of the standard curriculum and spread mimetically throughout the culture. Today art, architecture, critical theory, science, medicine, psychiatry and, in many ways life in general, are viewed through the postmodern lens. A cornerstone concept of postmodern philosophy is the importance of the collective over the individual. (Incidentally, this is curious since postmodernism developed out of existentialism, in which individual responsibility was paramount). As reported by Roger Kimball in his book, “Tenured Radicals: How Politics Has Corrupted Our Higher Education” (Ivan R. Dee), a 1984 Stanford University conference of “formidable scholars” essentially declared the death of the concept of the individual as defined by classic

AnesthesiologyNews.com I 13

together. This is so obviOur leaders may not ous a truism as to be banal, deliberately have decided but do they take it too far? to deconstruct MarDoes this approach transcus Welby, M.D. and late to remote control of his weekly TV struggles medical decision making against medical conforby anonymous experts, far mity. But trapped in their postmodern Weltanschauremoved from a particular doctor–patient interaction? Steven S. Kron, MD ung, they simply could not In Dr. Gawande’s view, at help themselves. least, such a system deserves —Steve Kron, MD a chance—indeed, he argues, it’s the Dr. Kron is a semi-retired anesthesiologist in future for many hospitals. Hartford, Conn.

Revealing a more complete picture.

Covidien puts the e powe er of C Cap apno nogr grap aphy hy and Pulse Oximetry with Resp Reespir irat atio ion n Ra Rate te int nto o your hands d. Monitoring a wide range of critical respiratory parameters, the Sensing Systems of Covidien help caregivers provide faster, more informed interventions for their patients.

Oridion® Microstream® Capnography delivers:

Nellcor™ Pulse Oximetry with OxiMax™ Technology provides:

respiratory compromise. ers clinical setting.

sensor design. TO GET A BETTER SENSE OF OUR RESPIRATORY FUNCTION CAPABILITIES, VISIT COVIDIEN.COM/RMS

THE SENSING SYSTEMS OF COVIDIEN Oridion® Microstream® Capnography | Nellcor™ Pulse Oximetry with OxiMax™ Technology BIS™ Brain Monitoring | INVOS™ Cerebral/Somatic Oximetry | LiDCO™ Hemodynamic Monitoring

COVIDIEN, COVIDIEN with logo, Covidien logo and positive results for life are U.S. and internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company. Covidien is the exclusive distributor of LiDCOrapid products in the United States. LiDCO is the manufacturer of record for the LiDCO™ product line and is responsible for maintaining all governmental and regulatory authorizations for the LiDCOrapid product. LiDCO and LiDCOrapid are trademarks of LiDCO Ltd. *FDA 510(k) Clearance of the Nellcor™ Bedside Respiratory Patient Monitoring System is pending. The Nellcor™ Bedside Respiratory Patient Monitoring System is not commercially available in the United States. ©2012 Covidien. All rights reserved. 12-PM-0227

14 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

C OMM E NT A R Y

The following advertorial has been provided by Spacelabs Healthcare and is designed to support the advertisement presented to the right.

Health Care Fraud and the FBI Tracking a small minority of providers who cost the system billions [Editor’s note: The following article was originally published in Missouri Medicine (March/April 2012. 109:2:102-105). Mr. Trousdale is a staff operations specialist from the FBI’s Kansas City Division. The opinions expressed in this article are those of the author and not the FBI.]

he FBI is the primary agency for exposing and investigating health care fraud, with jurisdiction over federal and private insurance programs as well as non-insurance health care fraud matters. The FBI uses its analytic expertise to identify key trends and tap into its investigative partnership with federal, state and local agencies, as well as our relationships with national groups and associations, to uncover fraud. Health care fraud investigations are among the highest priority investigations within the FBI’s White-Collar Crime Program, ranking behind only public corruption and corporate fraud. The FBI works closely with its federal, state and local law enforcement partners, the Centers for Medicare & Medicaid Services (CMS) and other government and privately sponsored program participants to address vulnerabilities, fraud and abuse in the health care system. The FBI’s 56 field offices proactively target fraud through coordinated t d iinitiatives, iti ti ttaskk fforces, strike t ikk teams and undercover operations. Throughout the country, FBI field offices participate in Health Care Fraud Working Groups that involve law enforcement agencies, prosecutors, regulatory agencies and health insurance industry professionals to identify the various crime

problems involving health care fraud. FBI offices establish state and local initiatives to meet the needs of the community. In the United States, various field offices have conducted their own initiatives targeting clinics, pharmacies, durable medical equipment providers, home health agencies and other possible sources of fraud that are a concern within communities. The FBI also develops national and local initiatives when large-scale fraud is detected; this may involve participation by several FBI field offices and other law enforcement agencies. One example of these initiatives is the Department of Justice/Department of Health and Human Services Health Care Fraud Prevention and Enforcement Action Team (HEAT), which now operates in seven cities across the country. As part of its strategy to address health care fraud, the FBI cooperates with the Department of Justice and U.S. Attorney Offices throughout the country to pursue offenders through parallel criminal and civil remedies. These cases typically target largescale medical providers, such as hospitals and corporations, that engage in criminal activity to commit fraud against the government that h undermines d the h credibility of thee health care system m. As a result, much h emphasis is placedd on recovv ering thee

Spacelabs Healthcare Q: Who is Spacelabs Healthcare? A: Spacelabs Healthcare is a comprehensive perioperative solutions provider developing, manufacturing and distributing medical equipment and services throughout the world. We provide solutions for patient monitoring and connectivity, anesthesia delivery and ventilation, diagnostic cardiology and supplies and accessories, selling to hospitals, clinics and physician offices. Spacelabs’ world headquarters is in Issaquah, Wash., where we develop and manufacture anesthesia, patient monitoring and cardiology products. Spacelabs provides various perioperative solutions from low to high acuity, covering simple to complex cases and pediatric to geriatric patients—offering you the choices you need in anesthesia delivery, patient monitoring and supplies and accessories. What’s more, you can configure solutions to satisfy your individual practices and preferences. Our product line is continually developing and expanding with some exciting new additions coming in the near future. Spacelabs Healthcare has more than 50 years of innovation and service and began as the innovator of life-support systems for the Gemini and Apollo space missions. Always endeavoring to meet our customers’ unmet needs, the result is the complete rethinking of the anesthesia delivery system experience.

Q: What is ARKON? A: Until today, anesthesia delivery systems were designed with functionality and reliability as the priority. Although important, we saw these as our starting point. ARKON™ is our “evolutionary” new anesthesia delivery system that pushes the boundaries to provide advanced flexibility and ergonomics for you, the people who use these machines. ARKON puts your patient front and center—offering anesthesiologists the maximum in functionality, comfort and control. Through a combination of an expandable clinical console, which extends out to enable a wide-angle view of your clinical setting, and enhancements not previously available in the perioperative environment, we focused ARKON on youu so you can focus on your patient. Although other machines concentrate on the technology of anesthesia delivery, we believe you will find ARKON unique in its attention to the details of how you work. Providing you with an improved workplace was our priority, with flexibility our focus. Designed to improve the user experience, ARKON is part of our mission to inspire the world to bring the best care to patients as well as their families.

Q: Does Spacelabs Healthcare collaborate with clinicians to provide clinically relevant products? A: Spacelabs Healthcare values the strong clinical partnerships that we have developed and maintained over the past half century. Through continuous and effective communication with clinical user groups, we gather a deep understanding of needs and requirements in order to develop solutions to help clinicians achieve their goals. Always a leader in innovation with Accessibility, Continuity and Partnership, Spacelabs Healthcare delivers on our promises to: • Help improve patient care. • Help clinicians achieve their goals. • Demonstrate honesty, reliability and integrity. • Deliver quality products and service, service, service.

Q: Is Spacelabs Healthcare known for excellence in customer service? A: At Spacelabs Healthcare, excellence in customer service and support are not just words but they are values embraced by all our employees which shape the way that we do business. As a result, IMV ServiceTrak, one of the most respected surveys in the health care industry, has ranked Spacelabs “Best for Overall Service Performance among Industry Peers” for the second consecutive year in 2011, and three of the last five years. When selecting a perioperative solutions company, consider Spacelabs’ experience and heritage of innovative and intuitive products developed in partnership with our customers to address real-life clinical needs. Our Customer-First philosophy reflects our commitment to superior care for you and your patients as well as product support by our award-winning service team.

see FBI page 17 7

Spacelabs Healthcare 5150–220th Ave. SE Issaquah, WA 98029 (425) 657-7200 www.spacelabshealthcare.com

16 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

The following advertorial has been provided by CODAN and is designed to support the advertisement presented below.

Walrus® by CODAN® Q: Can CODAN supply high-quality custom anesthesia, blood, administration and extension sets configured to unique requirements? A: CODAN offers Walrus® by CODAN®, a complete specialty anesthesia set, blood set and accessories product line that includes custom products configured to specific clinician needs. We stock and supply the products when you need them.

Q: Does CODAN offer anesthesia products with both bonded and mechanical connections to streamline the stages of surgery preparation, operating room and recovery room processes as related to patient movement? A: CODAN offers large, completely assembled and sterilized sets, including specialty items such as extension sets, stopcocks, low-profile valves and needleless injection ports that save setup time and lower inventory levels.

pre-pierced) and Y injection sites that help prevent needlesticks and infection. CODAN has custom IV tubing, blood and extension sets that are all in one package (coiled, taped and sterilized) to prevent piecing together multiple components that can lead to line infections.

Q: Does CODAN offer specialty cardiac IV tubing products and accessories? A: CODAN offers a wide range of high-flow cardiac anesthesia IV sets, blood sets and stopcock and one-way valve manifolds, as well as low priming volume tubing for special delivery of certain cardiac drugs.

Q: Does CODAN offer specialty pediatric IV tubing and low priming volume IV tubing sets? A: CODAN offers a wide range of pediatric IV sets, 60-drop mini drip sets, custom burette sets as well as low priming volume syringe pump tubing sets in various lengths (12, 36, 60 and 72 inches) as well as low priming volumes (0.035, 1.0, 1.4 and 1.8 mL).

Q: How do CODAN’s anesthesia products (IV tubing, stopcocks, manifolds, blood sets) help reduce infection? A: CODAN offers many ways of reducing infections caused by and linked to IV tubing such as needle-free (swabable valves and

Q: Are all CODAN anesthesia products latex-free, non-DEHP–free and high-flow? A: CODAN has all of these features and more.

Q: Does CODAN offer inline IV filters on IV and pediatric extension sets? A: CODAN has various sizes of inline filters for IV, epidural, pediatric and cardiac procedures. The filters vary in shapes and sizes, with 1.2 micron and 0.2 micron the most popular.

Q: Does CODAN offer colored striped tubing and kink-resistant tubing? A: CODAN has many different colors and striped tubing for various anesthesia

applications as well as kink-resistant tubing to meet the needs of the clinician.

Q: What is CODAN’s standard delivery time for custom IV tubing products? A: CODAN can manufacture and deliver sterile products in four weeks from receipt of order. We can produce sterile samples in two to three weeks and non-sterile samples in two to three days. Next-day delivery is available upon request (certain conditions may apply).

Q: I am looking for a dead-end cap or a filter cap that won’t allow fluid to leak out the end of the set during or after priming. Does CODAN have a product to meet this need? A: CODAN offers the CODAN Flow Stop Cap™ for bacteria-free and drip-free prepriming for up to 24 hours prior to use and up to seven days pre-priming with refrigeration. Walrus® by CODAN® products are “Made in USA” to ensure the highest product quality and consistent delivery schedules.

Walrus is Back! The Gold Standard of Speciality Anesthesia Sets and Blood Setts IV Administration Sets An array of non-DEHP tubing and latex free components including needlefree access ports, pressure and luer-activated valves, pre-pierced se eptums and

Blood Administration Sets Extension Sets

Stopcocks and One-Way Valves

10, 15, 20 and 60 Drop, Vented, Non-Vented and Valve-Vented Drip Chambers Complete All-In-One Sets Bifurcated and Trifurcated Extension Sets Latex Free and Non-DEHP Tubing Specialty Pediatric, Cardiac and Trauma High Flow Sets The Walrus® name has long been associated with high quality specialty for

Custom Sets, Sterile and Non-Sterile Samples Quality Sets Manufactured in the United States

on the Walrus product line and continues its legacy offering guaranteed

Infusion Therapy Made Clean, Safe and Simple For additional information about Walrus® by CODAN and other CODAN products, call us at (800) 332-6326 or visit www.codanuscorp.com ®

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 17

COMMENTA RY FBI

CONTINUED FROM PAGE 14

illegal proceeds through seizure and forfeiture proceedings, as well as substantial civil settlements. Upon successful conviction of offenders, the FBI provides assistance to various regulatory and state agencies, which may seek exclusion of convicted medical providers from further participation in the Medicare and Medicaid health care systems. Currently, the FBI is working on more than 2,600 pending health care fraud investigations. During fiscal year (FY) 2010, cooperative efforts with its law enforcement partners led to charges against approximately 930 individuals and convictions of close to 750 subjects. Additionally, the investigations led to the dismantling of dozens of criminal enterprises engaged in widespread health care fraud. In FY 2009, FBI investigations resulted in $1.6 billion in restitutions, $853 million in recoveries, $68 million in fines and $54 million in seized assets. The FBI remains committed to working additional health care fraud investigations with its partners at the Department of Health and Human Services (HHS) Office of Inspector General, individual state Medicare fraud offices and Special Investigative Units from private insurance companies. The FBI also works jointly with the Drug Enforcement Administration, the FDA and the Department of Homeland Security to address drug diversion, Internet pharmacy fraud, prescription drug abuse and other health care fraud threats. Those seeking to perpetrate health care fraud take advantage of the confidence that the public, and especially their patients, places in health care system professionals. All health plans heavily rely on the fundamental premise that providers are, for the most part, honest. Relatively few claims are ever reviewed by a human or subjected to electronic quality assurance audits. In fact, 95% of all claims are processed electronically, and as long as the patient is eligible and the diagnosis is not inconsistent with the service billed, the claim is paid. Most insurers seek to make it as convenient as possible for providers

to bill the plan and keep documentation to minimum levels. Consequently, fraudulent claims frequently look exactly like legitimate claims and are easily concealed among the billions of claims, bills and cost reports filed by over a million providers. Some contractors are required to process claims within a specified time limit, increasing the likelihood that a claim initially will be paid, only to be found to be fraudulent after the fact. The actual amount of money lost to fraud is unknown, but it is estimated that anywhere between 3% and 10% of all health care expenditures, both public and private, can be attributed to fraud. One of the most significant and troubling trends observed in recent fraud cases is the willingness of medical professionals to risk patient harm in their schemes. FBI investigations in several offices are focusing on subjects who conduct unnecessary operations, prescribe dangerous drugs without medical necessity and engage in abusive or substandard care practices, such as withholding necessary treatment or medication to cause patients to qualify for a higher level of home health care or hospice care. Recent trends also suggest that advances in technology and electronic medical data have caused fraud schemes to evolve. The FBI has developed expertise in investigating technical schemes involving medical data theft and other fraud schemes facilitated through the use of computers. Of course, fraud schemes continue to consist of traditional schemes that involve fraudulent billing, such as billing for services not rendered and deliberate upcoding of charges for services provided. Some of the common types of health care fraud occur in the areas of home health care, hospice care, durable medical equipment, Internet pharmacies and infusion therapy. One of the predominant emerging areas of health care fraud is in the area of home health care. Home Healthcare Agencies (HHAs) make see FBI page 18

18 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

C OMM E NT A R Y FBI

CONTINUED FROM PAGE 17

up approximately $15.1 billion of the health care market and HHAs continue to grow. This rapidly expanding market is a good target for perpetrators who are seeking to acquire illicit proceeds by exploiting expensive HHA services. In the most common HHA fraud scheme, dishonest providers inflate HHA diabetic episodes to create outlier payments that are in excess of the national 60-day episode

In fiscal year 2009, FBI investigations resulted in $1.6 billion in restitutions, $853 million in recoveries, $68 million in fines and $54 million in seized assets. payments. This scheme alone is projected to cost Medicare more than $1 billion a year. Other HHA fraud schemes include billing for services not rendered, billing for medically unnecessary services, kickbacks to physicians to sign plans of care or to patients for their participation, forging physician signatures in order to bill Medicare, billing for unqualified patients, fabricating or altering visit notes and billing for housekeeping and unskilled services as skilled nursing care. The March 2009 Government Accountability Office (GAO) Medicare report stated that at least part of the 44% increase in home health care spending between 2002 and 2006 could be attributed to fraud. With so much at risk to patients, legitimate health care providers and the health care system, the federal crime of health care fraud is enforced with serious penalties. The basic crime carries a federal prison term of up to 10 years in addition to large financial penalties (18 USC, Section 1347). The federal law also provides that if a perpetrator’s fraud results in injury to a patient, that prison term can double up to 20 years; and if the fraud results in the patient’s death, an individual can be sentenced to life in federal prison. In addition to criminal penalties, health care fraud perpetrators also may be subject to civil penalties under the federal False Claims Act (FCA). The FCA imposes civil

The following advertorial has been provided by Mercury Medical and is designed to support the advertisement presented to the right.

liability on persons who knowingly submit a false or fraudulent claim or engage in various types of misconduct involving federal government money or property. Penalties under the FCA include treble damages, plus an additional penalty of up to $11,000 for each false claim filed. In order to assist physicians in better protecting their practices from the potential for erroneous or fraudulent conduct, the HHS, Office of Inspector General has published a list of recommendations designed to help physicians create a voluntary compliance program. The following summarizes those recommendations: 1. Conduct internal monitoring and auditing through the performance of periodic audits. 2. Implement compliance and practice standards through the development of written standards and procedures. 3. Designate a compliance officer to monitor compliance efforts and enforce practice standards. 4. Conduct staff training on practice standards and procedures. 5. Respond appropriately to detect violations by investigating allegations and the disclosure of incidents to appropriate government entities. 6. Develop open lines of communication, such as discussions at staff meetings on how to avoid erroneous or fraudulent conduct and the use of community bulletin boards to keep employees updated on compliance. 7. Enforce disciplinary standards through well-publicized guidelines. For more information about compliance program guidelines from the HHS, visit www.hhs.oig.gov/oig. The FBI and its law enforcement partners recognize that patient care is the first priority of any physician’s practice and that the majority of health care fraud is committed by a small minority of dishonest providers. Unfortunately, the fraud perpetrated by these individuals ultimately serves to tarnish the reputation of the most trusted and respected members of our society, our physicians. Keeping America’s health care system free from fraud requires active participation from each of us. Those who have knowledge of possible health care fraud schemes are encouraged to contact their local FBI field office, state’s Medicare Fraud Office or the HHS, Office of Inspector General. —Thad Trousdale

Mercury Medical Face-Cradle® Q: Who is Mercury Medical® and what is the Face-Cradle®? A: Mercury Medical is a health care specialty organization. Keeping ahead of the curve with the latest anesthesia innovations is our specialty. In 2013, Mercury celebrates 50 years of providing airway management solutions to clinicians worldwide. Now Mercury Medical has successfully designed the only fully adjustable Face-Cradle prone support system. The Face-Cradle is intended for surgical procedures that require the patient to be in the prone position. It permits the caregiver to see an open view of the patient’s face and endotracheal (ET) tube. The two pieces of cushion fit comfortably over the face and the adjustable base fits most adult head sizes. This device allows greater space for the ET tube and greater visibility of the ET tube and patient’s face.

Q: What are the advantages of the open design? A: There are five major clinical advantages of the open design: • Greater visibility of patient’s eyes and ET tube • Greater accessibility of the ET tube • The open cushion design allows temperature strip • Trending allows use of temporal nerve stimulation during a case • Helps to eliminate concerns of patient’s face or shoulders coming in contact with plastic foam cushion support device.

Q: Is the Face-Cradle easy to position? A: It is the only commercially available prone positioning device that is fully adjustable, both horizontally and vertically. This assists to better position the patient. Handles on the base also allow for easy positioning.

Q: Is there prep time for the Face-Cradle foam cushion set? A: No, the cushion set is fully expanded and ready to use.

Q: Is the Face-Cradle completely disposable? A: No, only the cushion set is disposable and is for single-patient use. Reuse of the cushion set may pose a risk of cross-contamination and the device may not perform as intended. The base and the mirror are reusable.

Q: Can clinicians autoclave and/or sterilize the base and mirror? A: No, do not autoclave or sterilize the base and mirror. Clean the base and mirror using a compatible enzymatic solution.

Q: Can clinicians use other foam or cushion material with the Face-Cradle base and mirror? A: The Face-Cradle base, mirror platform and cushion set are to be used together and should never be used individually.

Q: Can clinicians use the Face-Cradle on children? A: No, this device is intended for adult patients deemed suitable for prone position procedures per clinical judgment.

Q: Is Face-Cradle CE-marked? A: Yes.

Your Need . . . Our Innovation®

20 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

C OMM E NT A R Y

Preventing CLABSIs Through a Multidisciplinary Team Effort Matthew C. Exline, MD, FCCP Assistant Professor Associate Medical Director, MICU Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine Davis Heart & Lung Research Institute The Ohio State University Columbus, Ohio

Madhuri M. Sopirala, MD, MPH Associate Professor Medical Director, Infection Control Division of Infectious Diseases University of Cincinnati Cincinnati, Ohio

administration must embrace this goal, which can help institutions obtain the resources needed for procedural and cultural changes and also makes hospital administration more visible to the unit staff (and vice versa). This will provide incentive to improve at the unit level, especially if the process involves positive reinforcement strategies. The role of hospital administrators in quality improvement projects has been scarcely described in the literature, but the involvement of high-levell hospital or health-system executives in eliminating HAIs can have far-reachingg effects.6,7 The financial constraints being placed on hospitals by the governing bodies of health care, such as the Centers for Medicare & Medicaid Services, may actually help encourage administrative leaders to become excited about the prospect of reducing these infections. Goal setting may best be introduced through a gradual introduction of each benchmark and, upon achieving each goal, ICU staff and other key players in the process should be offered positive reinforcement. The second step is to identify particular key players and then to form a team and assign them well-defined responsibilities related to process improvements, particularly in the ICU. Multiple disciplines are intimately involved in the care of patients in the ICU, so a methodical, multidisciplinary approach that addresses systemic issues may work better than an approach where multiple disciplines operate independently within silos.8,9 This is true regardless of the fact that they are working toward a common goal. Hospital leadership must coalesce the team through setting goals and encouraging all of the key players to buy into the idea that it is a critical step in the process. A typical multidisciplinary team of key players for process improvements may include the ICU medical director or the physician in

uring his visit to NASA in 1962, President Kennedy reportedly stopped a janitor carrying a broom and said, “Hi, I’m Jack Kennedy. What are you doing?” The janitor’s profound response—“I’m helping put a man on the moon, Mr. President”—captures the essence of what it truly means to be part of a team devoted to achieving a mutual goal. Achieving bold objectives requires a multidisciplinary team approach with commitment from leadership and grassroots staff alike. The entire hierarchy of an organization must work toward a common goal. Whether it is manning a space flight or optimizing care for patients in the intensive care unit (ICU), a strategic approach that starts with goal setting and engages the whole team in the process of achieving these goals is likely to result in success. In health care, eliminating central line–associated bloodstream infections (CLABSIs) is one such objective that will significantly affect patient care in the ICU. CLABSIs cause significant morbidity and mortality,1 with increased health care costs.2 Fortunately, the recent trend in health care has been that of near-zero tolerance toward health care–associated infections (HAIs), including CLABSIs. Regardless of whether this trend resulted from or was caused by increased vigilance by various governing agencies in health care toward these infections, evidence suggests that near-zero tolerance is a reasonable expectation. Consideration must be given to the fact that the majority of CLABSIs are preventable, but a minority of them are identified as infections solely because of the highly sensitive surveillance definition used by the Centers for Disease Control and Prevention. These infections may not be preventable unless the contributing factors simultaneously are addressed, such as blood culture contamination or the inappropriate ordering of blood cultures. Multiple studies in a variety of patient populations have offered guidance on the prevention of CLABSIs.3 The methods used by these institutions vary, from focusing on a central line insertion checklist or bundle4 to environmental decontamination or hand hygiene5; however, the commonality of all these studies—whether implicitly stated or not—is the inclusion of a multidisciplinary team with a defined goal of preventing CLABSIs. Introducing a Team Approach Eliminating CLABSIs requires hospitals to take several fundamental steps. First and foremost, the hospital and unit

charge of the unit, along with the nurse manager, the clinical nurse educator, and the clinical pharmacist. A physician can serve as both an educator and a portal to disseminate information about infections and performing process measures to all medical staff working on the unit. The nurse manager can serve a similar role for the nursing staff. A clinical nurse educator, if available, can monitor staff performance by auditing bundle elements and investigating the primary cause for each CLABSI, subsequently educating nursing and medical staff as needed. The critical care pharmacist may emphasize the conversion of IV medications to enteric forms, or at least conversions to less sclerotic forms that do not require central access, which reduces the need for central lines on a daily basis.10 As a result, y in from grassroots staff and unit leaders achieving buyy in from hospital is equally important to obtaining buyadministrators for a performance improvement project. Strength in Numbers A team approach in ICUs is not a new concept, however. In fact, many hospitals feature daily multidisciplinary team rounds in the ICU. Multidisciplinary approaches for fundamental areas of ICU care, such as sedation management and ventilator weaning, consistently have been shown to outperform those of individual disciplines or practitionerbased protocols.11 Although there have not been elaborate descriptions of such an approach in the literature on CLABSIs, the efficacy of multidisciplinary leadership at the unit level has been proven.12 One striking shortcoming—even in studies that describe team approaches—is the integration of infection preventionists and/or epidemiologists into ICU teams. The integration of clinical epidemiology into the ICU team offers several advantages. First and foremost is maintaining enthusiasm toward the goal among executives and unit staff by providing realtime data and timely feedback about CLABSIs.13 This allows for the identification of missed opportunities shortly after an infection is detected, which promotes improved recall or the ability to correct factors that may have contributed to the event. Leveraging the expertise of clinical epidemiologists also may prove useful in building process improvement strategies for CLABSIs and other HAIs. Clinical epidemiologists may have a role as moderators to facilitate smooth team functioning during difficult decision-makingg sessions that arise during process improvements. Organizational data transparency is equally important to goal setting during this process. This transparency is essential to promote the organizational culture shifts necessary to sustain success with CLABSIs. Sustaining “near-zero” is more challenging than getting to “zero,” unless a culture of safety is integrated into the system. Transparency is an important component of this journey toward success; real-time feedback is a critical process to maintain the drive to carry on with performance improvements. see CLABSI page 22

Rapid sleep induction.

Rapid recovery.

Think you don’t have options for an ultrashortacting anesthetic? Here’s your wake-up call. Brevital® Sodium is the alternative you’ve been looking for. For an updated Preparation and Dosing Guide, visit www.brevital.com/brevitaldosing.pdf Brevital® Sodium is an ultrashort-acting anesthetic indicated in adult and pediatric (>1 month) patients as: An induction agent of anesthesia prior to the use of other general anesthetics Anesthesia for short surgical, diagnostic or therapeutic procedures associated with minimal painful stimuli An adjunct to subpotent inhalational anesthetic agents for short surgical procedures

In adults, when administering intravenously, the onset of action occurs within 30 seconds resulting in rapid sleep induction. The induction dose usually provides anesthesia for 5 to 7 minutes In children, when administering intramuscularly, the onset of action occurs within 2 to 10 minutes; when administered rectally, the onset of action occurs within 5 to 15 minutes Chemically stable for 24 hours at room temperature post reconstitution1 Latex-free, preservative-free and sulfur-free1 formulation Robust Supply

SAFETY INFORMATION

Brevital ® should be used only in hospital or ambulatory care settings that provide for continuous monitoring of respiratory (e.g. pulse oximetry) and cardiac function. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for bag/valve/mask ventilation and intubation, and personnel trained in their use and skilled in airway management should be assured. For deeply sedated patients, a designated individual other than the practitioner performing the procedure should be present to continuously monitor the patient. Brevital ® Sodium S is contraindicated in patients in whom general anesthesia is contraindicated, in those with latent or manifest f porphyria, or in patients with a known hypersensitivity to barbiturates. Intra-arterial injection of barbiturate solutions can result in necrosis, which may lead to gangrene and possible amputation and thereby should be avoided. Caution should be exercised in debilitated patients or patients with impaired function of respiratory, circulatory, renal, hepatic or endocrine systems and in those with severe anemia or those who are extremely obese. Side effects include but are not limited to circulatory depression, hypotension, respiratory depression (including apnea), skeletal muscle hyperactivity (twitching), seizures, emergence delirium, restlessness, anxiety, nausea, hiccups, emesis, coughing and pain at the injection site. Following massive exposure to any barbiturate, pulmonary edema, circulatory collapse with loss of peripheral vascular tone, and cardiac arrest may occur. How Supplied NDC 42023-105-01 42023-106-01

Name

Strength

Brevital® Sodium 500 mg (methohexital sodium for injection, USP) ®

Brevital Sodium 2.5 gm (methohexital sodium for injection, USP)

References: 1. JHP Pharmaceuticals, Brevital Sodium Prescribing Information. Rochester, MI. January 2009.

Vial Size

Pack Size

50 mL MDV

See Full Prescribing Information

For more information about Brevital, please visit www.brevital.com, or call JHP Customer Service at 877-JHP-4JHP (877-547-4547). MK354A

22 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

C OMM E NT A R Y CLABSI

CONTINUED FROM PAGE 20

Ass a unit approaches predetermined milestones or continues on extended CLABSI--free streaks, it is easy to imagCLABSI ine that individuals will develop an attitude where they do not want to be the person who ends that streak. Interventions such as ““time time--from from-- event event”” signs, which are common in the manufacturing sector, now are becoming commonplace in the health care sector as hospitals encourage both staff and

patients to become more aware of the goals set forth for CLABSIs. There may be factors unrelated to bundle elements that play a role in the incidence of CLABSIs. Although many studies have shown that physician and nurse compliance with line bundles can greatly reduce infection rates,144 few studies have documented the complete eradication of line infections using only this intervention. The strength of the multidisciplinary approach is its ability to intervene on issues that may be

contributing to the development of CLABSIs and that are not addressed by adherence to the central line insertion and maintenance bundle. The inclusion of infection prevention experts once again provides the ability to investigate and intervene on other factors contributing to CLABSIs. This will enable the team to identify and correct ancillary factors that may be contributing to infections. For example, hospital rooms have been implicated as a potential reservoir for the transmission of resistant

organisms from one patient to another. An investigation may offer opportunities to identify areas of improvement regarding environmental cleaning processes, which subsequently can lead to the inclusion of environmental services into process improvements.15 Discussion The multidisciplinary approach is, in essence, about changing the culture of a unit. Culture change is vital to sustain success, rather than temporarily targeting process measures to achieve a desirable outcome. Similar to landing a man on the moon, the elimination of CLABSIs and other HAIs is a difficult struggle in health care, but it is possible with the persistence of each individual team member. It also requires constant focus to sustain success once the benchmark of near near--zero CLABSIs has been achieved. As tempting as it may be to transition on to the next problem once this milestone has been reached, it will become the team’s responsibility to ensure that measures are in place to maintain the best practices that were optimized during the process improvement project. Such an effort should be viewed as a program that will last indefinitely with minimal resources, since the process already has been integrated into the system. Without this assurance, it is feasible that rates of CLABSIs and HAIs may revert to pre pre--project baseline levels once the project is completed. Thus, it is extremely important to change the culture toward retaining these improvements by making sure that best practices become second nature to the unit’s medical and nursing staff before letting go of the reins. In institutions where there is frequent turnover of medical and/or nursing staff, a plan for periodic assessments of activities related to bundle elements, along with periodic education, may help retain the project’s success. In summary, a multidisciplinary leadership team that includes unusual yet critical players—such as clinical epidemiologists/infection preventionists and hospital administration—in addition to ICU physicians, nurses, and pharmacy staff, will provide a well well--rounded and resourceful approach to reducing CLABSIs and other HAIs in the ICU. It is important to focus on processes aimed at sustaining the desirable outcomes rather than merely achieving them. Drs. Exline and Sopirala reported no relevant conflicts of interest. References for this article are available at www.AnesthesiologyNews.com.

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 23

The following advertorial has been provided by Teleflex and is designed to support the advertisement presented below.

FlexTip Plus® Multi-Port Epidural Catheter From ARROW® Q: How is the ARROW® FlexTip Plus® Multi-Port epidural catheter different from other multiport catheters that are available on the market today? A: The FlexTip Plus Multi-Port epidural catheter features four lateral holes for multiport drug dispersion with the proximal hole location positioned approximately 0.5 cm closer to the catheter tip compared with the average proximal-hole location of our leading competitor’s two top-selling1 multiport epidural catheters.

Q: What types of configurations are available with the FlexTip Plus Multi-Port epidural catheter? A: The FlexTip Plus Multi-Port epidural catheter is available in a variety of kit and set configurations to meet the specific needs of anesthesia providers. Visit www. flextipplus.com for a full listing of product codes and tray components.

Q: How does the FlexTip Plus Multi-Port Epidural Catheter help to reduce inadvertent penetration? A: The soft, flexible tip is designed to deflect when it contacts the dura or blood vessels, which significantly reduces the risk for vessel puncture and the incidence of paresthesia.2

Q: What other advantages does the FlexTip Plus Multi-Port epidural catheter offer? A: Another advantage of the FlexTip Plus Multi-Port epidural catheter is reliable patency. The coil reinforcement makes the catheter kink-resistant to better maintain patency, even in some situations that might cause ordinary nylon catheters to fail.

Q: Why is Teleflex offering a closed tip, multiport epidural catheter in addition to the wellproven open-tip FlexTip Plus epidural catheter? A: Teleflex is now providing the FlexTip Plus technology in both an open-tip and closed-tip, multiport catheter to enable anesthesia providers to achieve the drug dispersion they prefer with the quality of care they demand for their patients.

Q: What type of adapter is included with the FlexTip Plus Multi-Port epidural catheter? A: The FlexTip Plus Multi-Port epidural catheter includes the exclusive ARROW® SnapLock™ Adapter. This unique, singlesnap adapter fastens securely to the catheter without lumen collapse and reduces catheter disconnects.

Q: How do I request a sample? A: Visit www.flextipplus.com to request a sample of the FlexTip Plus Multi-Port epidural catheter.

Q: How can the FlexTip Plus Multi-Port epidural catheter help my practice? A: The FlexTip Plus Multi-Port epidural catheter is designed from the proven

technology of the market-leading1 opentip FlexTip Plus catheter, which is clinically proven to provide a significant reduction in complications commonly associated with epidural catheters.2-3 Visit www.flextipplus.com to download the clinical bibliography, which includes a listing of other major studies in this area. Note: For a list of the references cited in this Q&A, see the Teleflex FlexTip Plus Multi-Port advertisement on this page.

THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

Incorporating a Novel Local Analgesic Into an Opioid-Sparing Strategy for Postsurgical Pain Tong-Joo Gan, MD, MHS Vice Chair, Department of Anesthesiology Duke University Health System Durham, North Carolina

Introduction Despite increased understanding of the mechanisms of pain and the introduction of new analgesics, poor postsurgical pain management continues to be a significant problem facing health care providers. The literature indicates that more than 85% of postsurgical patients report moderate, severe, or extreme pain during recovery.1 Hospital reimbursements increasingly are based on patient outcomes and patient satisfaction, making improvements in the management of postsurgical pain crucial. Recent data from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) confirm that there is room for improvement, as hospitals nationwide scored an average of 70% in pain management, according to the national survey, which examined factors from the patient perspective.2 The specific, negative clinical outcomes that may result from suboptimal management of postsurgical pain include deep vein thrombosis, pulmonary embolism, coronary ischemia, myocardial infarction, pneumonia, poor wound healing, insomnia, and demoralization.3 Additionally, there are economic and patient-related implications associated with these complications including extended hospital length of stay (LOS), readmission, and patient dissatisfaction with medical care.4 It has been shown that effective management of acute postsurgical pain may improve clinical outcomes and quality of life1 and emerging data suggest that aggressive treatment of acute postsurgical pain may prevent the risk for chronic pain development.5 Because the mechanism of pain is complex and involves multiple receptor systems in the peripheral and central nervous system, effective management of acute pain can benefit from a multimodal approach.4 Multimodal techniques for pain management include the administration of 2 or more drugs that act by different mechanisms to provide analgesia, thereby reducing the amount needed of any one agent.4 Although opioids are widely used as monotherapy for the management of postsurgical pain, they are accompanied by significant side effects that can result in patient discomfort, delayed recovery, and prolonged hospital LOS.6 When a multimodal approach is implemented, there may be a reduction in opioid requirements, which may lead

Inpatient Case Study: A 62-Year-Old Obese Man Undergoes an Open Right Hemicolectomy Stephen M. Cohen, MD, FACS, FASCRS Atlanta Colon and Rectal Surgery, P.A. Atlanta, Georgia

his case will describe a method of using a multimodal analgesic regimen to control pain in a patient undergoing an open colectomy procedure. The patient had a biopsy-proven adenocarcinoma of the cecum. His past medical history is significant for non–insulindependent diabetes, mild chronic obstructive pulmonary disease, and hypertension, making this a desirable candidate for an opioid-reducing pain management strategy. As routine practice, the patient was administered 1,000 mg of acetaminophen injection 30 minutes prior to the incision

and 30 mg of ketorolac injection immediately following induction of anesthesia. Prior to closing the incision, EXPAREL was injected directly into the wound. The dose of EXPAREL is based on the surgical site and the volume required to cover the area. In the pivotal soft tissue trial, a dose of 266 mg of EXPAREL (one 20-mL vial) was diluted with 10 mL of preservative-free normal saline. Using that data as a benchmark, 266 mg EXPAREL (one 20-mL vial) was diluted with 20 mL of preservative-free normal saline for a total volume of 40 mL; enough volume to cover the area. Ten mL of the mixture was infiltrated above and below the fascia and the remainder of the EXPAREL was infiltrated directly into the subcutaneous tissue (Figure).12 The patient received a total of 150 mcg of fentanyl during surgery and was awake and alert 20 minutes after the procedure. That evening, the patient tolerated sips of clear liquids and started oral acetaminophen and ibuprofen every 6 hours. He was administered 2 mg IV of hydromorphone in divided doses during the first 24 hours after surgery. On postoperative day 1, the patient rated his pain as a 3 on a pain rating scale (range, 0-10; 0 being no pain) and was ambulating in the hallway. He did not report nausea, vomiting, or itching. Bowel function returned on day 2 and the patient was discharged later that day. He reported a pain score of 2 and said he felt content, satisfied, and happy.

Discussion This case depicts how a multimodal analgesic approach that incorporates an agent such as EXPAREL may be beneficial for a patient undergoing inpatient surgery where up to 72 hours of local analgesia would be desirable. Multimodal therapy allows the physician to use several different medications, each with its own mechanism of action, to treat postsurgical pain, thereby decreasing the need for any single agent such as an opioid. This is an important goal in patients such as this one with a complicated medical history. Using a multimodal approach, the patient did not report any opioid-related adverse events (ORAEs; eg, nausea, constipation, and itching). In summary, multimodal therapy incorporating EXPAREL can be used with the goal of decreasing opioid use, subsequent ORAEs, and minimizing the hospital LOS.10

Commentary by Tong-Joo Gan, MD, MHS

Figure. Infiltration depth in tissue.12 Adapted with permission from Guideline Central.

to fewer opioid-related side effects and reduced morbidity.7 This can be achieved by administering non-opioid adjuncts such as acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase inhibitors, calcium channel antagonists such as gabapentin and pregabalin, α2 agonists

ANESTHESIOLOGY NEWS • OCTOBER 2012

This case illustrates the excellent outcome following an open colectomy procedure when postsurgical pain is well controlled. The patient received a multimodal technique, incorporating acetaminophen, an NSAID, and a local analgesic. EXPAREL together with scheduled doses of acetaminophen and ibuprofen ensure continuous analgesic effects throughout the recovery period. This strategy has been shown to reduce opioid requirements, potentially leading to other positive outcomes. In this case, the use of an opioid-reducing multimodal approach resulted in the timely recovery of bowel functioning and a rapid postsurgical recuperation.

such as clonidine and dexmedetomidine, and local anesthetics.4 The role of nonopioid analgesics for postsurgical pain management is discussed in a review article by White and colleagues.8 The authors state that effective pain control with local anesthetics in the early

postsurgical period facilitates recovery by enabling early ambulation and discharge, potentially achieving opioid-sparing effects and a decrease in the incidence of postoperative nausea and vomiting.8 Although traditional local analgesics provide effective pain management at the wound site, they have

Supported by

Conclusion Pain management in the inpatient and outpatient surgical settings is an important clinical area for health care providers, patients, insurance companies, and society as a whole. Effective postsurgical pain management can potentially have positive patient and economic implications including affecting HCAHPS outcomes. The Joint Commission strongly advocates the use of a multimodal approach to postsurgical pain management.11 A multimodal approach including local pain management at the surgical site, along with acetaminophen, and NSAIDs, may serve as the cornerstone of a pain management technique that reduces the need for opioid medications in the postsurgical recovery period.4 The advances in novel drug development and new formulations of local analgesics can further enhance the effectiveness of multimodal therapy for postsurgical pain management. EXPAREL is indicated for single-dose administration into the surgical site to produce postsurgical analgesia. The maximum dose of EXPAREL should not exceed 266 mg (20 mL, 1.3%) of undiluted drug. The approval of EXPAREL was based on two pivotal clinical trials that demonstrated the efficacy and safety of EXPAREL in excisional hemorrhoidectomy (soft tissue model) and bunionectomy (orthopedic model). Dosing and administration in other surgical models will be influenced by the methodology used to administer the local anesthetic, as well as, individual patient considerations, which need to be determined by individual prescribers. The accompanying case studies represent the individual clinical experience of Drs. Stephen M. Cohen and Jennifer Ayscue, and are not to be construed as prescriptive dosing and administration recommendations for how to treat similar patients. Please see brief summary of Prescribing Information on the following page.

References 1. Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003;97(2):534-540.

Outpatient Case Study: A 92-Year-Old Man Undergoes a Hemorrhoidectomy Jennifer Ayscue, MD, FACS, FASCRS Assistant Professor, Department of Surgery Georgetown University School of Medicine Washington Hospital Center Washington, DC

Discussion

his case will describe a method of using multimodal postsurgical analgesia in an ambulatory setting. The patient has a 15-month history of almost daily rectal bleeding with bowel movements sometimes filling the toilet. He has undergone several transfusions for anemia and evaluation revealed bleeding hemorrhoids. He has mild Alzheimer’s disease but is otherwise relatively healthy. A hemorrhoidectomy was requested to control the bleeding. Although the main goal was to definitively control the bleeding, the patient was very nervous about pain control after surgery. Because the patient had mild Alzheimer’s disease and because opioids had historically caused pronounced altered mental clarity in this patient, there was concern on the part of the patient, as well as his family, about taking opioids. It was clear that this patient could benefit from a multimodal approach to manage his postsurgical pain. Prior to starting the procedure and under moderate sedation, 20 cc of 0.25% bupivacaine hydrochloride and epinephrine (1:200,000) was injected in the intersphincteric space and subcutaneous tissue circumferentially, laterally near the ischial spines, and bilaterally in the direction of the pudendal nerves. At the conclusion of the procedure, one vial containing 266 mg (20 cc) of EXPAREL was injected using a 25-gauge needle in the same distribution as was previously described. In the pivotal soft tissue trial, a dose of 266 mg of EXPAREL (one 20-mL vial) was diluted with 10 mL of preservative-free normal saline. Based on the dosing in this trial, the older age and overall health of the patient, and my standard protocol of 10 cc to 20 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine, I chose a similar dose for this case, diluting the 266 mg/20 cc vial with 20 cc of preservative-free normal saline for a total volume of 40 cc. In the postanesthesia care unit, the patient quickly awakened from anesthesia and reported 0 out of 10 on a pain scale. Because he was able to void urine early, he was discharged quickly and without issue. He was released home with prescriptions for hydrocodone/acetaminophen (1-2 tablets orally every 6 hours as needed) and lidocaine 5% ointment (to be used as needed). He was instructed to take docusate 100 mg every 12 hours for constipation. The patient did not report any pain for approximately 48 hours. He reported taking approximately 1 to 3 hydrocodone/

2. Hospital Care Quality Information from the Consumer Perspective. http://www.hcahpsonline.org. Accessed August 22, 2012. 3. Carr DB, Goudas LC. Acute pain. Lancet. 1999; 353(9169):2051-2058. 4. American Society of Anesthesiologists. Practice guidelines for acute pain management in the perioperative setting. An updated report by the American Society of Anesthesiologists task force on acute pain management. Anesthesiology. 2012;116(2): 248-273. 5. Voscopoulos C, Lema M. When does acute pain become chronic? Br J Anaesth. 2010;105(suppl 1): i69-i85. 6. Loftus RW, Yeager MP, Clark JA, et al. Intraoperative ketamine reduces perioperative opiate consumption in opiate-dependent patients with chronic back pain undergoing back surgery. Anesthesiology. 2010; 113(3):639-646. 7. Zhao SZ, Chung F, Hanna DB, Raymundo AL, Cheung RY, Chen C. Dose-response relationship between

acetaminophen tablets per day for several days and then switched to standard acetaminophen until stopping all pain medications by postoperative day 10. The patient had no postoperative complications and reported feeling well, without pain at 1 month postoperatively. Historically, postsurgical pain control options have consisted mainly of systemic pain medications (primarily opioids), lidocaine 5% ointment, and bupivacaine hydrochloride by elastomeric infusion pump at the site of pain. Opioids are well known to cause several ORAEs including nausea, constipation, altered mental status, and urinary retention. Elastomeric pumps work well when implanted, but they may be difficult to manage during activities of daily living and may have risks associated with catheters and delivery rates. EXPAREL, an agent that combines the benefits of a wellknown medication, bupivacaine, with a proven delivery technology and the convenience of a simple intraoperative injection, can provide significant pain control for up to 72 hours.10 While individual results will vary, this particular case demonstrates how incorporating EXPAREL in a multimodal strategy can delay and diminish the need for systemic opioid therapy. A multimodal approach to postsurgical pain management can be particularly effective in the ambulatory setting.

Commentary by Tong-Joo Gan, MD, MHS Outpatient surgery has increased tremendously during the past decade and it is estimated that more than 60% of all surgical procedures in the United States are performed as day surgery.13 This percentage is estimated to increase further. One of the major challenges in day surgery is providing adequate pain control after discharge from an outpatient facility. Multimodal analgesic techniques are recommended and have been shown to be superior to opioid-based analgesia.8 Appropriate analgesic selection with minimal side effects is important and especially relevant in an elderly patient population, as illustrated in this case study. Acetaminophen and EXPAREL may decrease the use of opioids and therefore opioid-related side effects when used in appropriate doses. This approach may be particularly suited for elderly patients undergoing painful surgical procedures in an outpatient setting. In patients with decreased renal function, care should be taken with dose selection.

opioid use and adverse effects after ambulatory surgery. J Pain Symptom Manage. 2004;28(1):35-46. 8. White PF, Kehlet H, Neal JM, et al. The role of the anesthesiologist in fast-track surgery: from multimodal analgesia to perioperative medical care. Anesth Analg. 2007;104(6):1380-1396. 9. Beauregard L, Pomp A, Choiniere M. Severity and impact of pain after day-surgery. Can J Anaesth. 1998;45(4):304-311. 10. Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011;54(12):1552-1559. 11. The Joint Commission Sentinel Event Alert. Safe use of opioids in hospitals. http://www.pwrnewmedia. com/2012/joint_commission/opioids/downloads/ SEA_49_opioids.pdf. Accessed August 13, 2012.

12. Best infiltration practices. Local analgesic infiltration techniques for abdominal surgery. The Best Infiltration Practices Working Group. http:// eguideline.guidelinecentral.com/i/73209. Accessed August 7, 2012. 13. CDC. Ambulatory surgery in the United States, 2006. http://www.cdc.gov/nchs/data/nhsr/nhsr011.pdf. Accessed August 22, 2012.

Disclosures Dr. Ayscue has received honorarium from Pacira Pharmaceuticals, Inc. Dr. Cohen is a consultant and on the speakers’ bureau for Baxter, Covidien, novoGI, Pacira Pharmaceuticals, Inc, and Sanofi. Dr. Cohen has received honorarium from Pacira Pharmaceuticals, Inc. Dr. Gan has received research funding from AcelRx Pharmaceuticals, Inc, Covidien, Cumberland Pharmaceuticals Inc, Fresenius Kabi, and Pacira Pharmaceuticals, Inc. He has received honorarium from Baxter and Cheetah Medical, Inc.

Disclaimer: This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, Pacira Pharmaceuticals, Inc., and the authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature. Copyright © 2012, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.

ANESTHESIOLOGY NEWS • OCTOBER 2012

BB128

a 6- to 8-hour duration of efficacy, which has limited their use to treat postsurgical pain lasting 24 to 48 hours.9 The addition of EXPAREL® (bupivacaine liposome injectable suspension), a novel local analgesic that provides a therapeutic benefit for up to 72 hours by reducing pain and decreasing opioids, may provide a new platform for an opioidsparing multimodal strategy.10 According to the Joint Commission in a new Alert dated Aug. 8, 2012, use of an individualized, multimodal plan to manage postsurgical pain is recommended, of which the best approach may be to start with a non-narcotic.11

26 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

PRN

Mild Surgical Complications Increase When Residents Participate

esident involvement in surgical cases is associated with a small increase in mild surgical complications, mostly caused by superficial wound infections, according to a new study that included more than 60,000 procedures.

The risk for mild surgical complications increases if the residents are in their later years of training when they take on a greater role in the operating room, the study showed; however, the investigators stressed that the risk remains very small and may not be

clinically relevant. â&#x20AC;&#x153;Resident involvement in surgical procedures is safe. There is a small overall increase in mild surgical complications but we are unsure if it is clinically relevant. The difference may be marginal,â&#x20AC;? said lead author Ravi P.

Kiran, MD, staff surgeon and head of the research section of colorectal surgery at Cleveland Clinic, in Ohio, who presented the study at the 2012 annual meeting of the American Surgical Association (abstract 9). The study is the largest and strongest

EX-AP-0020-201111 EX-AP-0039-201201

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 27

PR N to date to measure the effect of surgical trainees on patient outcomes. An earlier study showed that the intraoperative participation of residents is associated with slightly higher morbidity but slightly decreased mortality across a variety of procedures, which is minimized further after taking into account hospital-level variation (JACS ( 2011;212:889-898). All studies prior to this one were restricted to the experiences of a single hospital or geographic region.

Dr. Kiran and colleagues studied data collected by the National Surgical Quality Improvement Program between 2005 and 2007. They performed a matched comparative study comparing outcomes for 40,474 patients who underwent surgery with resident participation and 20,237 whose operations did not involve resident participation. Analysis showed that resident involvement did not affect 30-day mortality, severe complications or

medical complications. But overall complications did increase from 6.7% to 7.5%, surgical complications rose from 6.2% to 7.0% and mild complications went up from 3.5% to 4.4% when residents participated in an operative case (P<0.001). The increases stem from a spike in superficial surgical site infections (SSIs). Superficial SSIs rose from 2.2% in cases without residents to 3.0% when residents participated. SSIs were the only surgical complication

tsurgical pain control fo s o p s e d r up to provi e 72 ho s o d urs * e On

EXPAREL is the only single-dose local analgesic that… • Provides up to 72 hours1* of analgesia with • Reduced opioid requirements1† • Without the need for catheters or pumps

EXPAREL is a liposome formulation of bupivacaine indicated for administration into the surgical site to produce postsurgical analgesia.

Important Safety Information: EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting. *Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing bunionectomy or hemorrhoidectomy procedures; additional studies are underway to further demonstrate the safety and efficacy in other procedures. † The clinical benefit of the attendant decrease in opioid consumption was not demonstrated. Reference: 1. Gorfine SR, Onel E, Patou G, et al. Bupivacaine Extended-Release Liposome Injection for Prolonged Postsurgical Analgesia in Patients Undergoing Hemorrhoidectomy: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial. Dis Colon Rectum. Dec 2011;54(12):1552-1559.

Please see brief summary of Prescribing Information on back page. For more information, visit www.EXPAREL.com

associated with a statistically significant increase when residents were involved. Deep SSIs, wound disruptions, peripheral nerve injuries, bleeds requiring transfusion, graft failures and reoperations remained the same regardless of resident participation. Surgical trainees did prolong operative time, with the mean procedure time lasting 122 minutes compared with 97 for cases without residents. Length of surgical and hospital stay was unaffected. There are likely multiple reasons for the spike in SSIs, but a major driver appears to be prolonged operative time, said investigators. Operative time is a known to be associated with SSIs. The investigators said they could not confirm whether resident involvement led to the increased infections or if sicker patients with increased complexity underwent surgery at teaching hospitals with resident participation. “Resident participation may by itself be a surrogate for complexity and disease severity despite any attempts at controlling for all potential patient-, disease- and operation-related factors in a matched study,” Dr. Kiran said. The study also showed an association between year of training and rate of complications. Complication rates rose incrementally with year of training. When postgraduate year (PGY) 1 and 2 residents participated in care, 5.9% of patients developed complications. That number rose to 8.2% for PGY 3, 4 and 5 residents and, again, to 8.7% for PGY 6 residents. The investigators suggested that enhanced supervision of residents in PGY 3 or beyond might improve their surgical skills and promote patient outcomes. “The overarching issue seems to be how we might achieve high-quality patient care (and outcomes) in the context of training, and how we might do both well,” said Clifford Y. Ko, MD, professor of surgery and health services at the David Geffen School of Medicine at the University of California, Los Angeles. “With increasingly used metrics, high-qualityy care and training remain the responsibility of every surgical training program.” —Christina Frangou

28 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

PRN

Cheap, Effective Solutions in Trauma Care Born in Africa San Francisco—Surgical trauma care, by definition, is about managing the unanticipated. So, if you want to improve trauma care, start in unexpected places, said Doruk Ozgediz, MD, a pediatric surgeon at the University of Buffalo, in Buffalo, N.Y., and co-founderr of Global Partners in Anesthesia and Surgery (GPAS), an international group that seeks to improve quality of perioperative care in the developing world. That’s what happened in Uganda, where a pivotal change in trauma care over the past three years evolved in the backseats of police cars and taxis. Uganda lacks a designated ambulance service. For years, police cars and taxis have served as the de facto ambulance service to get trauma victims to the hospital in the capital city of Kampala. Onlookers would load an injured person into the back of the vehicles and the driver would careen off to the hospital with the victim. Many patients lost their airways en route or had an uncontrolled hemorrhage, significantly increasing their risk for dying before they reached a trauma center. “We thought that we could improve the situation by training the first responders—the non-medics, police, taxi drivers. Basically, it’s a modified scoop-and-run,” said Dr. Ozgediz. Three years ago, GPAS, in collaboration with other providers, launched a program to train these first responders to transport injured individuals more safely and offer first aid. Following the course, trainees’ scores in basic first-aid knowledge g nearly doubled from 45.3% to 86% (World J Surg 2009;33:2512-2521). Figures from GPAS suggesst the program would cost about 12 cents per capita if this were rolled out across the city, and would resuult in approximately $25 to $150 per life-yearr saved. This is just one example of the way that suurgery and trauma care is changing in Africa, saidd Dr. Ozgediz, speaking at a special session at the American College of Surgeons Clinical Congress, which focused on extreme affordability in surgery. Similar programs have been successful in conflict settings in Iraq, Cambodia and Ghana. The idea is to build on existing, informal mechanisms rather than introduce new systems that may not fit the local context. For years, surgery has not been on the radar in global public health efforts. Compared with HIV, tuberculosis and malaria, surgery pales in term ms of funding and public awareness in developing coun ntries. Surgical services are perceived as too expensivee, too high-tech and too unique to be practical in coun ntries where people die from lack of basic nourishment. Yet, the poorest regions of the world have the laargest surgical-disease burden on earth, mostly from injjuries. Injuries account for an estimated 38% of the diisease burden attributed to surgical conditions. That’s t followed by malignancies at 19%, obstetric com mplications at 9%, and congenital anomalies, cataractss and glaucoma, and perinatal conditions at 6%, 5% % and 4%, respectively, according to figures from the World Health Organization (WHO). Now, a growing movement is calling for a larger role for surgery in poorer regions of the world. Advocates argue that funds dedicated to improving surgical r

care are dollars well spent. What’s more, an emerging body of evidence indicates that funding for basic surgical services is more cost-effective than other broadly supported health projects. For instance, the Disease Control Priorities in Developing Countries Project found surgery is more cost-effective than distributing antiretroviral drugs in countries with a high prevalence of HIV. Surgery costs an estimated $7 to $200 per disability-adjusted life-year (DALY) averted. (DALY is a single measure of disease burden, commonly used by the WHO.) In comparison, antiretroviral drugs cost about $300 to $500 per DALY averted; the measles vaccine costs about $1 to $5 (Lancet 2006;367:1193-1208). Other research has shown that inguinal hernia repair is cost-effective compared with no treatment when repairs are done with inexpensive mosquito netting. Researchers found an incremental costeffectiveness ratio of $12.88 per DALY averted, as described in the book Global Surgery and Public Health. Many problems contribute to the lack of surgical care in low-income countries: a shortage of surgeons and anesthesiologists (in Uganda, an estimated 100 surgeons look after a population of about 25 million), a lack of basic equipment and training and inadequate infrastructure, such as a transportation system to get patients to hospital. But the problems are not insurmountable, g said. He believes that clinicians in the Dr. Ozgediz United States can help. For one, they can help train surgical health

care providers, Dr. Ozgediz said. His team has taught a version of advanced trauma care in Uganda for about $500 total. “We didn’t fly in any people. We helped the Ugandans do their own course. What we did was organize it.” This venture marks a change in thinking about health care delivery in the developing world. In the past, many North American and European surgeons traveled

overseas to train physicians and treat populations in the developing world, said Philip L. Glick, MD, MBA, vice chairman of surgery at the University of Buffalo. “These trips don’t make sense because when you leave, there’s no one there to take care of the population anymore. I think we’re shifting to a belief that our best management of resources is to teach Third-World health care workers how to take care of their own people in a resource-constrainedd way.” Dr. Ozgediz also advocates training nonsurgical personnel to provide surgical services. In many countries, health care practitioners and nonphysicians do surgery, he said. Former fistula patients now treat fistulas in Addis Ababa, Ethiopia. In Mozambique, Malawi and Tanzania, governments have explicit policies to train non-surgeons to perform surgery. The health care workers live and work in rural areas and are trained over a shorter period of time than a typical surgeon. A new study under way in Malawi and Zambia will look at surgical training in these countries. In a cluster-randomized trial, the research aims to produce a new cadre of surgically trained health care professionals who are likely to remain in Africa, particularly rural areas. American-based clinicians along with nongovernmental organizations also can set up scholarships for surgeons abroad. For example, it costs about $1,500 per year to become a specialist surgeon in East Africa byy trainingg through g a three-year postgraduate program, such as that offffered in Uganda. GPAS has been setting upp scholarships for four years, said Dr. Ozgediz . “W We’ve had a significant W increase, over fourfold, in thee number of trainees in anesthesia and surgery.” Even if poorer countries train enough surgeons, surgery can’t happen withooout anesthesia. Anesthesiologists, anesthetic equipppment and drugs are in short supply. Many countttries still rely on EpsteinMacintosh-Oxford eth her anesthesia, which h dates back 50 years, or spinal anesthesia. Some groups try to combaat the anesthesia problem by bringiing in equipment from other cooountries. Often, equipment arriives v that is useless or not compatiblee with the environment. To changgge this, the WHO has issued health ccare equipment donation guidelines, availaaable online. The goal is to reduce donation ns that do not achieve n their intended objectivvves or further burden the recipient health care syyystem. Dr. Ozgediz called for global standards for equity in surgery to help reduce the dispariiities in care between the United Stttates and the developing world. ““We should advocate to level globall surgical disparities. We need to meeeasure disparities and we need to com me up with solutions.” m More infoormation on GPAS is available at www.globalpas.orgg. —Christina Frangou

e-Newsletters and e-Alerts Get the latest news from the best-read anesthesiology hesiology publication in th he country delivered directlly to yourr computer or mo obile de device for free! Eacch installment i con ntains a articles from m the currrent re monthâ&#x20AC;&#x2122;s issu ue e ahead of pr print, as well as liin nks to podcasts and d other o Web-exclusive content Scan this QR code to register for free

Read the latest issue on your iPad! Download it for free from the App Store

@anesthesianews

e-Newsletters and e-Alerts

Links Links to Other to Other TherTherapeutic apeutic Areas Areas

Medical Education

Most Popular Articles & Reader Comments

Buyerâ&#x20AC;&#x2122;s Guides

Podcast Library Tabbed Navigation Digital Editions

Free CME

Most-read Most-read Articles Articles From From Sister Publications Sister Publications

@anesthesianews

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 31

PR N

Anesthesiologist Takes Helm of U.S. Branch Of Doctors Without Borders

ot on my watch. The thought flashed through the mind of anesthesiologist Deane Marchbein, MD, on assignment for Doctors Without Borders, as a Congolese mother of seven suddenly coded on the table in front of her. The newly anointed head of the U.S. branch of the international charity, known around the world as Médecins Sans Frontières (MSF), recalled the events leading up to that moment in the Congo. The woman had just lost her third baby in a row in childbirth. “She was bleeding, bleeding, bleeding. The packing wasn’t working and she needed reoperation,” Dr. Marchbein said. “This was something that carried huge risks in that environment, but we had no choice. So I put her to sleep and the doctor opened her abdomen.” Then the patient had no blood pressure and no carotid pulse. No ventilator was available, so the anesthesiologist said, “I handed the Ambu bag to someone and I jumped up on the table and started doing chest compressions. I was like a crazy woman.” The mother survived, but what happened after that, Dr. Marchbein said, was even more remarkable. The nurses kept the patient in the recovery room for the next two weeks, buying her nutritious food and taking care of her. “This lady survived because the whole team decided that she was going to survive. We’re talking about a team of Congolese nurses who were already struggling to support their families, who worked other jobs as well to make ends meet. It showed me the humanity of people for each other. That was really very moving, and that’s MSF.” Stories like this one pour from Dr. Marchbein, whose more than 30 years of practice have been balanced with fieldwork for MSF since 2006. In those six years, she has packed in working trips to Ivory Coast, Haiti, Libya, Nigeria, South Sudan and Lebanon. Three-Year Term In her three-yearr tenure as head of Doctors Without Borders, which began in June, she will serve as a representative on the French board, while recruiting volunteers and donors. But the new responsibilities will not root her at home. “This is something I made clear to my board: I am willing and eager to take on the role as president, but I was not interested if I couldn’t go to the field. My work in the field informs my work on the board.” Fortunately, Dr. Marchbein’s day job is supportive of the arrangement, which involves her leaving for annual trips of six to eight weeks alongside engagements in her new role as president. A spokesman for Cambridge Health Alliance, Dr. Marchbein’s Bostonbased employer, said that although the group has no formal program for staff pursuing medical missions, “the nature of the institution attracts physicians and staff who are mission-driven and dedicated to improving community health both here and abroad.” Dr. Marchbein also is affiliated with Massachusetts General Hospital, from whom the alliance contracts anesthesiology services.

Doctors Without Borders programs around the world.

A Seller’s Market for Medical Missionaries Dr. Marchbein said that the national shortage of anesthesiologists means clinicians who would like to volunteer are in a good position to negotiate similar arrangements. “If you work for a large hospital, it’s possible they will want to keep you; they would rather give you a leave of absence than lose you.” And the personal rewards will be great. “You will be needed and valued. You will get so much more than you give.” Her own experience supports that view. After more than two decades in private practice, Dr. Marchbein decided to fulfill a long-standingg desire to do fieldwork. “You get to a point in your life and you say, ‘Oh my goodness, I have this long list of things I want to do.’ If these are really things that you believe in, that you want to do, then you need to do something about it—not dream about it anymore, make it reality.” At her previous employer, she had carefully planned a one-time, three-month sabbatical, only to be told at the last minute that she could no longer go. She resigned the next day, and had an epiphany in the process. “I realized I didn’t want this to be a once-in-alifetime event. I applied to Cambridge Health Alliance with that in mind. I sent CVs around with the requirement that I would be able to take four months off annually. I was surprised at how open people were in their responses.” Moving back and forth between the two environments has some added benefits, which include an expanded role for anesthesiologists. “You have the experience of knowing how important your work is, of working with the team in the field, which is just an awesome experience,” she said. “At home, we joke about the blood–brain barrier between anesthesiologists and surgeons, but this is not the case in the field. Some of my most important relationships are those with surgeons.” And there is less to complain about when you return. “You come back and you were taking care of sick patients, and now you are still taking care of sick patients but you have everything you need. There’s always a second pair of hands, there’s the equipment, the tests. You really appreciate what you have at home, and you come back grounded.” Dr. Marchbein emphasized that MSF, like any modern organization, needs diverse people, although she acknowledged that being American and being female

are both facts that must be considered in assignments. “There are places that Americans can’t Deane Marchbein, MD be sent, places where the U.S. military is active, and the presence of U.S. staff would put the team in danger. In places like Afghanistan and Pakistan, it would be a problem. “Being female, on the other hand, makes me desirable in certain contexts, for example in countries where women cannot be examined by men,” she added. “There are times when my gender is a disadvantage, too, especially in conservative, male-dominated societies. For instance, I was in Libya. There was a local doctor who was problematic and my predecessor had also been female and had confrontations with him. His behavior was very upsetting to the patients, so my supervisor offered to handle him if we had differences of opinion.” Although her interest in humanitarian work and MSF specifically was sparked more than 30 years ago, when she was studying art history and French in France and witnessed the birth of MSF during the time of the Biafran War (an internal struggle in Nigeria that left as many as 2 million civilians dead from starvation), she found her greatest inspiration from her own son. “He confronted a life-threateningg illness that ultimately took his life, but he lived every day with grace and spirit,” she said. “He was scared, but he never let it stop him from living fully and doing what he wanted to do. Sometimes when I’m afraid and I think I can’t possibly do this, I think ‘he could, you can.’” —Jennifer Hanawald Advertisement

NEW PRODUCT

F1RSTUse, from Anesthesia Business Consultants Anesthesia Business Consultants introduces F1RSTUse, the first complete electronic health record (EHR) system built exclusively for anesthesiologists and pain management specialists to satisfy stage 1 of Meaningful Use to earn the Medicare EHR incentive payment. F1RSTUse is a Web-based service tailored for anesthesiologists to enter, track and report data needed for CMS guidelines. Anesthesia Business Consultants 255 West Michigan Ave. Jackson, MI 49201 Phone: (517) 787-6440 Fax: (517) 787-0529 Meaningful.Use@AnesthesiaLLC.com http://www.anesthesiallc.com/clinical-technology/meaningful-use See our ad on pages 2 and 3.

32 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

T E C H NO L O G Y

Homeland Security Warns About Medical Device Threats But experts call immediate risk overblown

n May, the U.S. Department of Homeland Security (DHS) issued a bulletin about the security risks associated with using medical devices on an IT network. According to the bulletin, “Attack Surface: Healthcare and Public Health Sector,” the potential vulnerabilities of medical

devices on IT networks include risks to patient safety and the theft or loss of medical information. Implantable, external and portable devices— everything from a pacemaker to an iPad—are potential targets for malicious intrusion and malware, such as viruses. Although deliberate attacks on

implantable devices are not known to have occurred, common malware has infected other kinds of medical devices. Produced by DHS’s National Cybersecurity and Communications Integration Center, the bulletin warns that “failure to implement a robust security program will impact the organization’s

Advance Your Anesthesia Career TeamHealth Anesthesia has ideal practices for anesthesiologists and CRNAs all across the country.

Our team-oriented approach stresses service and quality patient outcomes in professional practice environments. If you’re looking for an attractive income and beneﬁts package, performance incentives, a variety of practice choices and career advancement, then visit teamhealth.com today.

The right job. The right place. The right partner.

www.teamhealth.com 877.799.3552 | anesthesiajobs@teamhealth.com

ability to protect patients and their medical information from intentional and unintentional loss or damage.” Hysterics, Not Information? Julian M. Goldman, MD, medical director of biomedical engineering at Partners HealthCare, in Boston, said the bulletin was so simplistic that it might increase confusion rather than clarity. “For example, the bulletin implies that it is limited to medical devices that ‘are designed to monitor changes to a patient’s health.’ Their scope of how they categorize medical device capabilities, risk and function is incorrect. Medical devices monitor but also deliver fluid, medication or energy. And with these higher-acuityy functions, the risks may be greater,” he said. “I was concerned with the way the issues were conveyed,” added Dr. Goldman, an attending anesthesiologist at Massachusetts General Hospital and an editorial board member of Anesthesiology News. “It’s hysterics instead of information based on rigorous engineering and a scientific basis. It may be indirectly helpful in making people ask questions, but it’s not helpful in providing accurate information.” However, the general issue raised by the bulletin—cybersecurity as an increasingly important aspect of health care—is of concern, said Dale Nordenberg, MD, executive director of the Medical Device Innovation, Safety, and Security Consortium (MDISS), in New York City. “Medical device security vulnerabilities represent a major public health risk,” Dr. Nordenberg told Anesthesiology News. Axel Wirth, national health care solutions architect at Symantec Corp., in Waltham, Mass., said that an informal survey of 56 chief information officers found that 36% had had one or more medical device malware infections in the past 12 months, with 13% reporting multiple instances and 17% stating an increase during that period. There are two main scenarios of medical device attacks, Mr. Wirth said. One involves more complex systems, such as imaging or diagnostic devices, which are built on standard operating system platforms, such as Windows or Linux, and are vulnerable to the same malware as any other computer. Simpler compact devices built on a proprietary platform, such as pacemakers and insulin pumps, are not susceptible

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 33

TE CH N OL OG Y to common malware, Mr. Wirth said. But targeted attacks against them have been demonstrated in security research. So far, none has been reported in a patient, Mr. Wirth added. Nevertheless, he called such targeted attacks “scary” because they affect implantable and life-sustainingg devices.

increase the risk for cyber attacks within the hospital; but when the application is used in the less controlled environment of the home, “appropriate technology mitigations” will be required to “prevent data security issues from occurring,” he said. For example, if an MBAN system were to connect to a home PC and store data there, the data could be encrypted Anesthesia Devices at Risk so that even if the home PC were comIn anesthesiology, the biggest secu- promised, the data could not be read by rity risks are infusion pumps, ven- a hacker. tilators, anesthesia machines and Philips Healthcare also is developing glucometers, Dr. Goldman said. “We don’t know what a malware attack could do. With an infusion pump, even if a malware attack just occupies bandwidth, making the system run slow, that could interfere with patient care.”

MBANs. According to Delroy Smith, MSEE, principal scientist at Philips, in Andover, Mass., a cyber attack on MBANs “would be much more difficult than one upon most other wireless networks because of the proprietary nature of the device software and because such devices communicate only over short distances.” To improve cybersecurity in the health care setting, Dr. Nordenbergg proposed the following measures: integration of IT and biomedical engineering

services, improved surveillance of security vulnerabilities of medical devices, and next-generation devices designed by medical device manufacturers to have improved security profiles. —George Ochoa Dr. Goldman, Mr. Grubis, Mr. Smith and Mr. Wirth reported no relevant financial conflicts of interest. Dr. Nordenberg reported that MDISS receives funding from technology companies and medical device manufacturers in the form of membership dues.

NO O MORE O

‘I was concerned with the way the issues were conveyed. It’s hysterics instead of information based on rigorous engineering and a scientific basis. It may be indirectly helpful in making people ask questions, but it’s not helpful in providing accurate information.’

WHEEL WH W L obstructions o bstructttiions bs s

—Julian M. Goldman, MD Compared with conventional computers, medical devices are especially vulnerable to attack because they have a long useful product life and operate under regulatory approval from the FDA, and so cannot be updated or patched as frequently, according to Dr. Nordenbergg and Mr. Wirth. However, “medical devices are specialpurpose devices, which allows vendors to significantly limit the opportunities and OS components cyber attacks typically exploit,” said Matt Grubis, chief engineer for communications and informatics at GE Healthcare, in Milwaukee. The Federal Communications Commission recently allocated spectrum to a new category of wireless medical devices, medical body area networks (MBANs), which consist of multiple body-worn sensors transmitting patient data to a control device for monitoring by clinicians. According to Mr. Grubis, whose company is among the firms developing MBANs, the new application will not

Move Anesthesia Machines & OR Carts Safely Innovative Research Labs, Inc. Call us toll free at 888.551.9700 for more information www.castrgard.com • sales@castrgard.com • 7316 21st Ave NE, Seattle WA 98115 • fax: 206.525.1490

34 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

T E C H NO L O G Y

Air Emboli During Brain Stim Surgery More Common Than Previously Thought

s many as 10% of patients undergoing awake surgery to implant electrodes for deep brain stimulation experience a venous air embolism, according to a new study by Mayo Clinic researchers. The investigators recommended that, in light of

the findings, all patients who undergo the procedure be monitored with precordial Doppler ultrasound. The findings contrast with prior studies that have found venous air emboli occur in 1.3% to 4.8% of the stimulator implantations (Stereotact

Funct Neurosurg 2011;89:76-82; Stereotact Funct Neurosurg 2009;87:25-30). The researchers presented their findings at the 2012 annual meeting of the American Society of Anesthesiologists (abstract 469). Michael L. “Luke” James, MD,

assistant professor of anesthesiology and neurology at Duke University Medical College in Durham, N.C., who was not involved in the study, said the new results show that emboli during brain stimulator implantation “is a significant problem and prospective study is required to determine whether closer monitoring improves patient care. “I know we have averaged over 100 [brain stimulator] electrode placements or revisions annually over the past five years and I can’t remember a single episode” of venous air embolism, Dr. James added. “That being said, we don’t monitor every single case with Doppler. Thus, it is quite possible we are missing some of these subclinical events. Our outcomes are great, but the data suggest the potential need for more monitoring.” In the current study, lead investigator Michael Johnson, MD, PhD, assistant professor of anesthesiology at the Mayo Clinic College of Medicine in Rochester, Minn., and his colleagues examined data from 140 consecutive patients (mean age, 63; 62% male) who underwent the brain procedure between 2007 and 2011 and were monitored with precordial Doppler. Most had Parkinson’s disease or essential tremor and most often were sedated with dexmedetomidine (Precedex, Hospira) and supplemental lowdose fentanyl. Venous air emboli were defined as air heard on precordial Doppler or the presence of at least three vital sign

Physicians

We’re a whole different animal Our anesthesia and pain management revenue cycle management solutions are like nothing else in the industry. Origin Healthcare Solutions can help you increase collections and improve your bottom line. We offer a dedicated, anesthesia-only billing team, real time practice analytics, and fee schedule optimization, all supported by top-notch customer service and over 20 years of insight and experience. It’s a unique combination nobody else can match. If your net collection rate is under 97%, contact us for a free feasibility study. Stop by booth 1241 at ASA to learn why thousands of anesthesia providers have chosen to partner with Origin l originhs.com

Medical Billing l Analytics l Quality Outcomes Reporting l Coding l Credentialing l Compliance Updates and Training l Managed Care Contracting l Provider Enrollment

40%

Advanced Practice RNs

Registered Nurses

Physician Assistants

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 35

TE CH N OL OG Y ‘I had expected that in an awake patient with exhaled air sampled by a nasal cannula there would be too much noise and baseline variability for ETCO2 to be helpful. However, the ETCO2 data that we obtained in most patients was reasonably stable.’ — Michael Johnson, MD, PhD changes, including a sudden decrease in end-tidal carbon dioxide (ETCO2; ≥2 mm Hg), oxygen saturation or blood pressure, or intraoperative cough or dyspnea. According to the researchers, 10% of patients met criteria for an embolism (95% confidence interval [CI], 4.9%-17%). These included 5.7% (eight of 140) who had a “definite” embolism with air heard on precordial Doppler, and 4.3% (six of 140) who experienced a “probable” event, meeting three of the four vital sign criteria. Although precordial Doppler detected more cases of embolism than vital signs alone, Dr. Johnson emphasized that ETCO2 also was useful in

Percentage of Health Care Providers Using Smartphones During Patient Consultations

60% 67% 74%

Source: Manhattan Reserach, “Taking the Pulse: Nurses 2012”

identifying the complication. “I had expected that in an awake patient with exhaled air sampled by a nasal cannula there would be too much noise and baseline variability for ETCO2 to be helpful. However, the ETCO2 data that we obtained in most patients was reasonably stable,” he said. “Therefore, I believe ETCO2 monitoring should be utilized along with precordial Doppler.” Only two cases of embolism required head repositioning and a

pause in surgery, but the other cases had the potential to cause significant morbidity or mortality, Dr. Johnson said. “It may be that some of the [embolic] episodes we detected stayed at the innocuous stage precisely because we had early detection for venous air embolism set up, and intervened immediately when a embolism was detected,” he said. “The median decrease in ETCO2 in our population was 18 mm Hg,”

Dr. Johnson noted. “To appreciate the significance of this change, consider that a decrease in ETCO2 of 2 mm Hg implies a venous air embolism and a decrease in ETCO2 of 10 mm Hg in a swine model indicates a cumulative injection of 100 mL of air. A total of 200 to 300 mL of air, which is approximately what 18 mm Hg represents, is a fatal embolism dose in humans if it enters the bloodstream rapidly.” —David Wild

36 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

T E C H NO L O G Y

Smart Pumps Get Better Grades After QI Initiatives Revamping drug libraries at heart of the quality improvement efforts e o s Baltimore—A five-year quality improvement effort at a California children’s hospital aimed at revamping the facility’s “smart” programmable infusion pump drug libraries has significantly bolstered the technology’s impact on patient safety. A 40% reduction in potentially severe adverse drug events, a nearly 50% reduction in nonclinically significant alerts and a doubling of drug library usage are among the improved outcomes documented, according to Katie Tu, PharmD, a pharmacy educator at Children’s Hospital of Orange County (CHOC). The efforts have resulted in millions of dollars in avoided costs annually, Dr. Tu noted during a poster presentation at the American Society of Health-System Pharmacists (ASHP) 2012 Summer Meeting. Rita Jew, PharmD, the executive director of pharmacy and clinical nutrition services at CHOC, and a co-author of the poster, said that hospitals that don’t make similar efforts to maximize the effectiveness of their smart pumps are missing out on the benefits of the medication safety technology. “You spend a lot of money on these smart pumps and if you’re using it as just a regular pump, you’re wasting your money,” Dr. Jew w said. “The pump is only smart when you’re using it the smart way. Buying the pump is just the beginning of the investment.” CHOC made its initial investment in smart pumps in 2004. But a year later, when Dr. Jew w joined the hospital as its pharmacy director, she soon

noticed that the staff wasn’t analyzing data that were being collected. When they started to look at the data on a quarterly basis, the numbers pointed to a problem: People were ignoring a lot of pump alerts. “We saw that nurses were not compliant with using the guardrails and were not using the pump appropriately. That’s when we started doing a lot of data mining and [instituted] nursing compliance rounds,” Dr. Jew w said, adding that efforts also were made to make the data from the pumps more user-friendly. y A smart pump oversight committee of pharmacists, nurse educators and representatives from the hospital’s biomedical, information technology, and quality and safety groups was the prime mover in the quality improvement effort. Pharmacists prioritized about 250 drugs in their standardized smart pump software library and set the system so alerts would be generated when an IV medication was programmed outside the institutiondefined drug limits, or guardrails. They monitored to ensure appropriate use of smart pumps and modified programmed limits for several drugs to reduce the number of nonclinically significant alerts and prevent alert fatigue. Nursing educators were actively involved in ongoing compliance surveys. The team found that drug library use increased from 41% to 91% during the last three years (Figure 1); modifications to eliminate nonclinically significant alerts led to a 38% reduction

in guardrail-related alerts; and alert overrides were reduced by nearly 26% over five years (Figure 2). As a result of the system improvements in CHOC, alerts overridden in less than two seconds decreased from an initial 40% in 2008 to consistently less than 20% in following years. Generally, nurses who see an alert and override it in less than two seconds are not evaluating the alert properly, Dr. Tu noted. “Now, our nurses actually pay attention to the alerts,” she said. “I know that because I hear from them if they see an alert that doesn’t make sense, through an email or through their nurse manager.” The CHOC initiative also has succeeded in averting approximately 70 potential adverse drug events each year, at a resulting cumulative cost avoidance estimate of more than $3 million, the team reported. The system has detected and prevented numerous potentially serious medication errors, such as a dopamine infusion programmed for 596 mcg/kg per minute

100 90 80 70 60

1st major data set change based on continuous quality improvement analysis

Partnering with vendor for nursing education

50 40 30 20 10

Compliance rounds

Wireless implementation and complete rebuild of data set

▲

Guardrails usage

Better

0 Jan-June 2005

Jul-Dec 2006

Jan-May 2007

Dec 2008

Apr 2009

Jan-Mar 2010

Apr-June 2010

Figure 1. Guardrailsa usage and nursing compliance rounds (%). a

Includes drug library and other medication safety software.

Jul-Sep S 2010

Oct-Dec O 2010

Jan-Mar 2011

Apr-June 2011

Jul-Sep S 2011

that was then re-programmed to the correct rate of 5.96 mcg/kg per minute. Documenting these “good catches” helps the team re-educate the nurses about why guardrails are in place, Dr. Jew w noted. (For more catches, see Table.) “I know it’s not always about the money—our ultimate goal is to w said. improve patient safety,” Dr. Jew “But at the end of the day, we also have to be good stewards of our investment in medication safety technology. And if you’re not doing everything in your power to data-mine these systems and make sure they are operating at peak efficiency, with spot-on alerts and high staff compliance, then you’re really doing a disservice to your patients and to your hospital’s bottom line.” Another Tack—Central Drug Libraries Larger health systems with multiple hospitals are taking a slightly different approach to getting the most out of their smart pumps: Several of them are moving toward consolidating drug libraries to one standard to be used system-wide, so that every hospital can benefit equally from software updates and other key enhancements. North Shore-Longg Island Jewish Health System, which has facilities on Long Island, N.Y., and New York City, implemented a master library for its 15 hospitals and infusion and dialysis centers last year. Health-system leaders had been considering this initiative for some time, according to Lee Fiebert, PharmD, a medication safety specialist at the health system’s Long Island Jewish Medical Center (LIJ), in New Hyde Park, N.Y., who spoke about his system’s consolidation efforts at a session of the ASHP Summer Meeting. But it was an FDA recall of one of the see smart pumps page 38

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 37

The following advertorial has been provided by I-FLow, LLC and is designed to support the advertisement presented below.

The ON-Q* T-bloc*, from I-Flow Q. Who is I-Flow, and what do they offer anesthesiologists? A. I-Flow, LLC, a Kimberly-Clark Health Care Company, is a global market leader in acute pain and ambulatory medication delivery, driving innovative clinical applications for surgical procedures and regional anesthesia that improve outcomes and advance patient care. Building on I-Flow’s industry leadership in postsurgical pain relief systems, I-Flow provides to customers ongoing, in-depth training, education, consultation and clinical support on its products—a total solution. I-Flow has long been recognized as an innovator in pain management and drug delivery technology and has expanded its offerings to become the trusted total solution provider for pain management and nerve block procedures.

A set of needles, catheters and accessories completes the ON-Q* nerve block solution, meeting the varying needs of physicians by providing them with a comprehensive suite of tools for use in most regional nerve block procedures.

Q. How can customers purchase the ON-Q* T-bloc* trays and kits and additional line of needles, catheters and accessories? A. The ON-Q* T-bloc* trays and kits and additional line of needles, catheters and accessories are available

You’re

for purchase and evaluation samples. Interested customers can contact I-Flow at (800) 448-3569 to place an order or for full product listings. * Registered trademark of Kimberly-Clark Worldwide, Inc.

INVITED

I-Flow, LLC, the manufacturer of the market leading ON-Q* Pain Relief System is hosting an ASA Corporate Non-CME Educational Update Event.

Q. What are some of I-Flow’s most recent innovations? A. I-Flow recently announced the expansion of its portfolio with the launch of our new ON-Q* T-bloc* comprehensive kits and trays for the preparation for and delivery of peripheral nerve blocks. In addition, a line of needles, catheters and accessories is also now available through I-Flow. With I-Flow’s introduction of these new product suites and lines, one trusted provider now offers anesthesiologists a total solution for their product needs for performing nerve blocks.

Saturday, October 13, 2012 7 PM Renaissance Washington, DC Downtown Hotel 999 Ninth Street NW, Washington, DC 20001

Grand Ballroom South

SPEAKER & MODERATOR

PLEASE JOIN US FOR DINNER AND AN EXPER T PANEL DISCUSSION:

Brian Vaughan, MD The Christ Hospital

Developing a continuous peripheral nerve block program

Cincinnati, OH

from outpatient to academia – getting your stakeholders

Q. What do these new product suites include?

SPEAKERS

onboard and overcoming roadblocks.

A. Specifically, the newest additions to the I-Flow product suite include: The ON-Q* T-bloc* product suite, designed to meet the product needs for performing most continuous upper- and lower-extremity and truncal blocks. The product suite will help to streamline the process of adequately stocking the block room. The ON-Q* T-bloc* trays and kits contain everything needed for use in delivering ultrasound-guided nerve blocks.

Stamford, CT

What’s the value of a post-surgical pain management program to your facility?

Ross Cotton, MD Norton Brownsboro

Overcoming barriers and getting stakeholders onboard

Theresa Bowling, MD Stamford Hospital

Louisville, KY

Ralf Gebhard, MD University of Miami Miami, FL

ASA ANNUAL MEETING SUPPOR TER

Driving better patient outcomes and patient satisfaction

Space is limited. Register at myON-Q.com/ASAregistration. Ask your I-Flow* rep for more details.

A K I M B E R LY- C L A R K H E A L T H C A R E C O M PA N Y

Better Recovery. Better Outcomes.

BE SURE TO VISIT US AT BOOTH #1713 AT ANESTHESIOLOGY 2012

38 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

T E C H NO L O G Y SMART PUMPS

CONTINUED FROM PAGE 36

infusion pumps used at North Shore that launched the health system into action. In just 41 business days last spring, a team of more than 600 pharmacists, physicians, nurses and others devised a master library of more than 550 drugs, now listed as more than 2,400 unique line items. The smart pumps were rolled out to LIJ on June 28, and other sites shortly after. Only one community hospital that had purchased new pumps just before the launch is not using the master library. The single library makes sense in a large system such as North Shore, Dr. Fiebert said, because when medical residents, nurses and in-house emergency medical technicians move from site to site within the system, there’s uniformity in pump programming and function. As additional perks, the strategy enables leaders to enforce compliance, have a set point-person overseeing the system and leverages buying power with vendors. “Creating central drug libraries has become a huge push among larger health systems,” Dr. Fiebert said. “If they didn’t already do it, they’re regretting it and trying to figure out how they can do it now.” North Shore just hired a full-time employee to mine data for outcomes, Dr. Fiebert said, although “there’s no doubt there have been some radical catches on both the pediatrics and adult sides.” The Cleveland Clinic also has created a master drug library. Thomas Stanek Jr., a pharmacy student at Northeast Ohio Medical University who interns at the Cleveland Clinic’s main campus, helped with the initiative last summer by consolidating drug information from three of the system’s

A Primer on Smart Pumps

early 68% of U.S. hospitals use software to prevent errors like oversmart pumps, according to a 2011 dosing. Users may easily override a ASHP survey. The devices include soft- “soft” limit, and infuse the medication ware allowing hospitals to create a without changing the pump settings. library of medications providing dosBut a “hard” limit won’t allow the user ing guidelines by establishing drug con- to administer the infusion unless the centrations and hospital-defined upper pump is re-programmed within the and lower dosing limits. Alerts and acceptable range. clinical advisories can be built into the —K.B.

Table. “Good Catches” of Potentially Serious Medication Errors Medication

Programmed

Re-Programmed

Dopamine drip

596 mcg/kg/min

5.96 mcg/kg/min

Midazolam drip

0.5 mg/kg/h

0.05 mg/kg/h

Propofol drip

100 mL/h (1,022 mcg/kg/min)

100 mcg/kg/min

Total parenteral nutrition

32 mL/h (for 2.6-kg neonate)

8.5 mL/h

‘The use of a single medication list for smart pumps only allows for one deployment or push of a medication, resulting in better consistency of care for the patient across the entire health system.’ —Thomas Stanek Jr. 10 hospitals. Although each hospital used the same pumps, each had its own practice, formulary and standard concentration for IV medications. Developing one library for their flagship hospital and two others provided a starting point in working toward a single library for the entire system, Mr. Stanekk noted. He and his colleagues obtained IV drug file library reports from the three hospitals to create a rough-draft master drug library. The team re-organized the drugs by general medication class into a new database. They then

compared each hospital’s IV formulary with the others and the master, noting discrepancies and discussing them with management and clinical pharmacists. This resulted in the smart pump team having an overall master library for all three hospitals. “The biggest challenge was the amount of data,” Mr. Stanek said. “Even though it was only three hospitals, it was quite a bit of [information] to go through to get the draft.” But the results should be worth it, he said, when it comes to improving the quality of patient care. “Not only will

100 97

95 90

84 80 82

80 77

▲

Better 70 July 2006May 2007

2008

2009

Jan-Mar 2010

Apr-June 2010

Jul-Sep S 2010

Oct-Dec O 2010

Jan-Mar 2011

Apr-Jun 2011

Jul-Sep S 2011

it allow for optimal decisions regarding the health system’s formulary, but more importantly, it will improve medication safety. The use of a single medication list for smart pumps only allows for one deployment or push of a medication, resulting in better consistency of care for the patient across the entire health system. At the local level, it accounts for consistent care despite possible staffing changes due to floating.” Smart Pump Guidelines In Works ASHP is working with the Association for the Advancement of Medical Instrumentation (AAMI) and the FDA to help develop guidelines and recommendations for the management of programmable pumps. The AAMI Foundation’s Healthcare Technology Safety Institute is now investigating assorted smart pump issues, including why workarounds happen with drug libraries, who owns drug libraries and how to manage updates, according to Karl Gumpper, RPh, a member of AAMI’s Infusion Systems Steering Committee and the director of ASHP’s Section of Pharmacy Informatics & Technology. He said the committee also is looking at error reporting, noting that it’s sometimes tough to determine if an error resulted from a problem with a drug itself or with a malfunction of the smart pump using that drug. Mr. Gumpper and Bona Benjamin, RPh, the ASHP’s director of medication-use quality improvement, are compiling a resource of standard concentrations and standard drug libraries that could be used as a starter library for hospitals to adopt and build into their use of the technology, or offered through a vendor. In addition, Mr. Gumpper said, “We’re all interested in the wireless integration between electronic health records and smart pumps.” To maximize the use of technology, he said, a physician could enter a prescription through computerized provider order entry, which a pharmacist then could verify and transmit to the device. A nurse then could use bar-code technology to scan the drug and the patient and program the pump. So far, only about 10 hospitals are using this integrated technology, he noted. “It could save a lot of time for the nurses, but we have to make sure everything is working appropriately.” —Karen Blum

Figure 2. Change in alert overrides (%).

40 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

PRN

Variation in Hand-Washing Technique May Up Risk For Bacterial Infection From Epidural Anesthesia Study finds higher rates of colonization with soap

lthough infection associated with neuraxial anesthesia is rare, it can cause devastating adverse events. A new study has found that anesthesiologists who scrub up

The researchers, from Mount Sinai Hospital in Toronto, Canada, found by washing their hands with soap and that including alcohol gel in the handapplying alcohol gel may be more washingg regimen makes a significant likely to spread bacteria when perform- difference in bacterial colonization ing labor epidurals than those who use rates. They stressed the need for guidealcohol gel alone. lines to help standardize and improve

hand-sanitizingg practices among epidural practitioners. “This study was part of a series of research projects that started with a survey to determine best aseptictechnique practices for epidural analgesia at our institution and across Ontario,” said Naveed T. Siddiqui, MD, assistant professor of anesthesia and pain medicine at the University of Toronto in Ontario. “We found that practice varies tremendously between institutions, and wanted to see where that difference comes from.” Using a sample size of 300 randomly selected practitioners, the research team examined the three most common techniques of hand washing (up to the elbows) for labor epidurals in their institution and compared the growth of microbial organisms for each method. Participants in group A used alcohol gel alone; group B handwashed with soap and used a sterile towel to dry and group C hand-washed with soap, used a nonsterile towel to dry and then used alcohol gel. Swabs were obtained from the inside forearms of each participant, cultures were immediately performed by a blinded microbiologist and bacterial growth was studied for up to 72 hours. Group B had the highest colonization rate at 25%, whereas group A had the lowest at 4%. Group C, which used a combination of soap and alcohol, had a bacterial growth rate of 16%. “So the most effective way of reducing any bacterial colonization ization w was to use at least 5 mL of aalcohol,” said Dr. Siddiqui, wh who reported the see technique page 43

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 41

PR N

Caught Dirty-Handed: Surveillance Study Finds Low Rates Of Proper Hand Hygiene Among Anesthesiologists

ever pristine, hand washing compliance among anesthesia providers may be lower than previously reported, according to researchers who took video of clinicians in action to confirm the lapses. The study found that anesthesiologists and nurse anesthetists almost never fully met recommendations by the World Health Organization (WHO) for proper hand hygiene—although they did so more often when they felt they were at risk for contracting an infection from a patient. “Hand hygiene has proven to be a problem again and again,” said John Rowlands, MD, anesthesiology resident at Dartmouth-Hitchcockk Medical Center, in Lebanon, N.H., who led the study. “The purpose of this study was to get an idea of how often opportunities for hand hygiene occurred under WHO guidelines.” Health care–acquired infections affect 10% of hospitalized patients, according to the American Journal of Infection Controll (2002;30:145-152), a figure explained in part by suboptimal hand hygiene. Dr. Rowlands and his colleagues recorded surgical cases with a small video camera mounted behind the anesthesia work area in five randomly selected operating rooms at a large academic medical center. The recordings were coded for hourly hand washing opportunities based on WHO guidelines, including prior to patient contact, prior or to aan aseptic task, after potential exposure to bo body fluids, after glove removal, after patient ent contact c and after contact with immediate ate patient surroundings. Investigators also assessed how compliance progressed thro hroughout the administration of general anesth esthesia. The researchers saw 323 hand hygi ygiene opportunities per hour of anesthes esia

time. Most opportunities arose at the start of a case or after contact with immediate patient surroundings. Overall compliance with WHO hand hygiene guidelines was 2.9%. Anesthesia providers were most likely to follow the WHO guidelines for hand decontamination

following a potential exposure to body fluid, and least likely to follow guidelines pertaining to hand decontamination prior to patient contact. The findings, which Dr. Rowlands presented at the 2012 annual meeting of the International Anesthesia Research

Society (S-226), are consistent with those of prior studies. Carlos Vaamonde, MD, infectious disease specialist at Weill Cornell Medical College, in New York City, who was not involved in the project, said that bottom-up redesign of see hands page 43

Less pain. Less opioids. From the start. OFIRMEV® provides significant pain relief*1 • OFIRMEV 1 g (Q6h) + patient-controlled analgesia (PCA) morphine demonstrated significant pain relief vs placebo + PCA morphine (P<0.05 over 6 h)1 • OFIRMEV 1 g (Q6h) + PCA morphine showed greater reduction in pain intensity over 24 h (SPID24)† compared to placebo + PCA morphine (P<0.001)2

OFIRMEV reduces opioid consumption*1 • OFIRMEV 1 g (Q6h) + PCA morphine significantly reduced morphine consumption vs placebo + PCA morphine (–46% over 6 h, P<0.01; –33% over 24 h, P<0.01)1 • The clinical benefit of reduced opioid consumption was not demonstrated

OFIRMEV from the start • Consider administering the first dose of OFIRMEV PreOp or post-induction • Schedule OFIRMEV Q6h for first 24 h and continue as clinically warranted

Indiccation OFIRMEV is indicated for the management of mild to moderate pain; the management of moderate to severe pain with adjunctive opioid analgesics; and the reduction of fever. Important Safety Information OFIRMEV is contraindicated in patients with severe hepatic impairment, severe active liver disease or with known hypersensitivity to acetaminophen or to any of the excipients in the formulation. Acetaminophen should be used with caution in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment. Do not exceed the maximum recommended daily dose of acetaminophen. Administration of acetaminophen by any route in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death.

Discontinue OFIRMEV immediately if symptoms associated with allergy or o hypersensitivity occur. Do not use in patients with acetaminophen allergy. The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients. OFIRMEV is approved for use in patients ≥2 years of age. The antipyretic effects of OFIRMEV may mask fever in patients treated for postsurgical pain. To report SUSPECTED ADVERSE REACTIONS, contact Cadence Pharmaceuticals, Inc. at 1-877-647-2239 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.com. Please see Brief Summary of Prescribing Information on adjacent page or full Prescribing Information at OFIRMEV.com.

OFIRMEV should be administered only as a 15-minute intravenous infusion. *Randomized, double-blind, placebo-controlled, single- and repeated-dose 24-h study (n=101). Patients received OFIRMEV 1 g + PCA morphine or placebo + PCA morphine the morning following total hip or knee replacement surgery. Primary endpoint: pain relief measured on a 5-point verbal scale over 6 h. Morphine rescue was administered as needed. †SPID24=sum of pain intensity differences, based on VAS score, from baseline, at 0 to 24 h.

References: 1. Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. y 2005;102:822-831. 2. Data on file. Cadence Pharmaceuticals, Inc.

OFIRMEV and the OFIRMEV dot design are trademarks of Cadence Pharmaceuticals, Inc.

OFV11330112

OFIRMEV.com

42 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

PRN

Anesthesia-Led Effort To Promote Smoking Cessation Produces Durable Results

n anesthesiologist-directed intervention to help patients stop smoking that combines counseling and the drug varenicline (Chantix, Pfizer) could help some people undergoing elective surgery break their habit, Canadian researchers report.

More than one-third of patients who enrolled in the intervention program for smoking cessation at the University of Toronto said they were abstaining from cigarette use a year later. The researchers presented their findings at the 2012 annual meeting of the Society

for Ambulatory Anesthesia. Pfizer funded the study. The preoperative anesthesiology visit presents a “teachable moment” for tobacco cessation interventions, said senior study author Frances Chung, MBBS, professor of anesthesiology at

the University of Toronto and medical director of the Ambulatory Surgical Unit and Combined Surgical Unit at Toronto Western Hospital. About 15% of patients coming for their preoperative clinic visit smoke, Dr. Chungg said. Most “are very motivated to stop smoking.” In the latest study, patients started varenicline therapy one to two weeks before surgery. “These people may already want to stop smoking but they lack the knowledge or the tools to do so,” Dr. Chung said. “When we speak about the adverse effects of smoking, they are responsive. They cannot smoke in the hospital anyway, so they’re essentially forced to stop.” Anesthesiologists should advise patients about smoking-related surgical complications, she said: Smoking increases the chance of infections, poor bone healing, sepsis and myocardial ischemia. Counseling in a preoperative assessment prompts patients “to think a bit more” about quitting, Dr. Chungg said. Focus of the Specialty In 2008, the American Society of Anesthesiologists launched a program, Ask-Advise-Refer, to encourage the specialty to play a greater role in promoting smoking cessation among hospital patients. For the study, researchers screened 17,765 patients in two preoperative clinics from June 2008 to October 2010. Of the 2,383 patients (13.4%) who smoked, 286 who were eligible scheduled noncardiac elective surgeries and were randomized to receive either varenicline (n=151) or a placebo (n=135). Both study groups received in-hospital and telephone counseling, which was initiated in the preoperative visit and continued for 12 months. Three months into the intervention, the smoking abstinence rate was 44% for the group prescribed varenicline and 32% for those who received a placebo (P<0.05). Six months into the intervention, the abstinence rate was 36% for the varenicline group and 26% for the placebo group (P<0.05). At the one-yearr end follow-up, abstinence rates were 36% for the varenicline group and 25% for the placebo group (P<0.05). About 13% of patients taking varenicline experienced nausea, versus 4% for those taking placebo (P<0.01). see smoking page 50

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 43

PR N TECHNIQUE

are suspected, the bacteria on the skin of the anesthesiologist are not findings at the 2012 annual meeting of always the culprits. the Canadian Anesthesiologists’ Soci“I believe the investigators have ety (abstract 1344599). done an excellent job of estabInterestingly, hand washing followed lishing the best way to cleanse the by the use of sterile towels and alcohol skin prior to epidural or spinal progel proved less effective than the use cedures,” he said. “But they have of alcohol alone. This, the research- not yet demonstrated a change in ers hypothesized, likely reflects a less- patient risk.” stringent sterilization technique when —Michael Vlessides and alcohol gel was used after hand washing than when it was used alone. Maureen Sullivan “Although the incidence of infection in this population is low, it is increasing, and breaches in aseptic practice could be one of the contributing factors,” Dr. Siddiqui said. “There is also ample evidence to suggest that superficial colonization may result in deeper infection.” With that in mind, Dr. Siddiqui stressed the importance of washing to the elbows, especially for those anesthesiologists who don’t wear gowns during these procedures. “There’s a possibility of contamination if your forearms are not clean and the epidural catheter touches it,” he said. “So if you are not wearing a gown, you should be meticulous about using the best technique of hand washing, which should include at least 60% alcohol.” “It seems clear that attention to hand-washingg technique is at least as important as the cleansing substances used,” said Scott Segal, MD, professor and chair of anesthesiology at Tufts University School of Medicine, in Boston. “Nevertheless, my principal concern with drawing conclusions from the study is the extrapolation from positive skin cultures on anesthesiologists’ forearms to putting patients at risk for infection.” Neuraxial infection after placement of epidural or spinal anesthetic is exceedingly rare, he added. Even when breaches in sterile technique CONTINUED FROM PAGE 40

HANDS

using a new protocol whether there will be a reduction in stopcock contaminaoperating rooms, including the materi- tion—a proven surrogate for patient als from which equipment is made, will infection and increased mortality. Also, be necessary if conditions are to improve. eventually we will conduct a study “You’re never going to get a person which attempts to address improveto wash their hands 300 times in an ments in hand hygiene.” hour,” Dr. Vaamonde said. “This is a This fall, his group will be using systems issue that will require a systems data from the current study in a pracapproach to solve.” tice improvement effort focused on the Dr. Rowlands said he is planning to anesthesia work area and hand hygiene conduct a follow-up study “to see if we in the operating room. clean the contaminated objects better —Ajai Raj CONTINUED FROM PAGE 41

“It made the surgical procedure

much,much more fun, if it can be called as such!”

–Lynn S.

Table. The Method Matters! HandWashing Protocol

OR for Colonization (95% CI) P-value

Nonsterile towel alone

12.36 (4.19-36.49)

<0.001

Nonsterile towel plus alcohol

4.57 (1.43-14.20)

0.009

Sterile towel alone

8.00 (2.67-23.98)

<0.001

Sterile towel plus alcohol

1.53 (0.42-5.60)

0.519

Alcohol alone 1.00 (reference)

Another 3M™ Bair Paws™ ﬂex gown love story Warm patients are happy patients. The Bair Paws ﬂex gown offers clinical and comfort warming throughout the surgical journey. And it transforms patient satisfaction and quality of care while maintaining normothermia to help prevent surgical site infections. See more patient stories at ILoveBairPaws.com.

—

CI, confidence in interval; nterval;; OR, odds ratio 3M is a trademark of 3M Company, used under license in Canada. BAIR PAWS and the BAIR PAWS logo are trademarks of Arizant Healthcare Inc., used under license in Canada. ©2012 Arizant Healthcare Inc. All rights reserved. 603453H 8/12

44 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

PRN

The Emergence of CarbapenemaseProducing Enterobacteriaceae BRIAN CURRIE, MD, MPH Professor of Clinical Medicine Division of Infectious Diseases Albert Einstein College of Medicine Assistant Dean for Clinical Research Montefiore Medical Center New York, New York

This process has been facilitated by the fact that genes that encoded antibiotic-resistance determinants were often located on plasmids that were transferred with high frequency between K. pneumoniae strains and other genera of Enterobacteriaceae. This process is best epitomized by the worldwide emergence of extended-spectrum β-lactamases (ESBLs) and their rapid dissemination among Enterobacteriaceae— especially K. pneumoniae strains. Although ESBLs are often referred

nterobacteriaceae encompass a large group of commensal bacteria in the human bowel, including Klebsiella pneumoniae and Escherichia coli, which are common etiologies of both community- and hospital-acquired infections. Nosocomial Klebsiella isolates have exhibited increasing levels of antibiotic resistance over the past

20 years. to as a single entity, they actually are a complex group of enzymes capable of hydrolyzing a wide variety of β-lactam substrates. Each ESBL has some degree of unique regional distribution across the world. For instance, TEM- and SHV-type ESBLs are common in the United States, whereas CTX-M–type ESBLs are more common throughout Asia, Europe, Canada, and South America. The β-lactamase genes that encode for each ESBL (eg, blaTEM, blaSHV) often are linked on plasmids

with genes that produce aminoglycoside- or quinolone-resistance factors. Plasmid transfer (as depicted in Figure 1) can result in extensive antibiotic resistance,1,2 and this phenomenon has led to an increased reliance on carbapenems in clinical practice.3 By 1995, ESBLs commonly were encountered among Klebsiella isolates, but carbapenem resistance was relatively uncommon and primarily was the result of the combined activity of a weak AmpC β-lactamase and porin mutations; less frequently,

it could be attributed to speciesspecific, chromosomally-encoded β-lactamases that could hydrolyze carbapenems.1 In 1995, there was an ominous report from Japan about a plasmid-borne gene recovered from a Serratia isolate that encoded for a metallo–β-lactamase gene called IMP-1, which was capable of hydrolyzing carbapenems.4 In 2001, a similar report from North Carolina documented the identification of a plasmid-borne gene, KPC-1, encoding for a non-metallo–β-lactamase capable

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 45

PR N of hydrolyzing carbapenems that was recovered from a K. pneumoniae isolate.5 Since then, the number of newly recognized plasmid-borne carbapenemases has proliferated and they have rapidly disseminated to become a global problem. Although referred to as carbapenemases, they possess the ability to hydrolyze a broad variety of β-lactams, including carbapenems, cephalosporins, penicillins, and sometimes, aztreonam. When linked to other resistance factors on the same plasmid, they can present a significant therapeutic challenge to clinicians.

Classification and Epidemiology of Carbapenemases Carbapenemases identified in Enterobacteriaceae belong to 3 classes of β-lactamases based on molecular characteristics: Ambler class A, B, and D.3 A brief discussion of each class follows, with a focus on the plasmid-borne carbapenemase genes. Class A carbapenemases include K. pneumoniae carbapenemases (KPC), IMI-2, and GES (Guiana extendedspectrum β-lactamases)—all of which effectively hydrolyze carbapenems and all other β-lactams, have serine active sites, and are partially inhibited by clavulanic acid.3 Plasmidencoded KPCs have emerged as the most clinically dominant member of the class. First described in 2001 in North Carolina, KPC subsequently was detected in 2004 during multiple hospital outbreaks in New York City; by 2007, it had emerged in multiple hospitals on the East Coast.5-7 KPC became endemic in New York City and areas of New Jersey and now has been reported in 38 states across the country.2 Similarly, KPC rapidly disseminated to France, Israel, Greece, Colombia, and China, and reported outbreaks of KPC have occurred in many European countries, South America, and India.2,3 KPCs are encoded by the blaKPC gene, which is located within a Tn3-type transposon, Tn4401, and is capable of inserting into diverse plasmids of gram-negative bacteria.2 There are now 11 known variants of the KPC gene, blaKPC-1/2 through blaKPC-12, although the global dissemination of KPC is largely associated with KPC-2 and KPC-3—KPC-1 and KPC-2 subsequently were shown to be genetically identical.2,8 KPCs have largely emerged among nosocomial K. pneumoniae isolates, but

they have been reported with some across the world and appears to be IMP was first reported in 1991 in a frequency among nosocomial iso- associated with the global dissemi- Pseudomonas isolate from Japan. VIM was first reported in 1997 in a lates of E. coli, Enterobacter species, nation of KPCs.3 S. marcescens, Citrobacter freundi, Class B carbapenemases include Pseudomonas isolate from Italy. Suband rarely, Pseudomonas and Aci- Verona integron–encoded metallo–β- sequently, both enzymes gradually netobacter.2,3 KPC isolation has been lactamases (VIM), imipenem-hydro- moved into a number of Enterobacassociated with both acute- and lyzing β-lactamases (IMP), and New teriaceae genera.1 Both VIM and IMP long-term care facilities; commu- Delhi metallo–β-lactamase (NDM-1). now are endemic in Greece, Italy, nity isolates rarely are reported.2,3,9-11 These enzymes hydrolyze all β-lac- Spain, Taiwan, and Japan, although KPCs have demonstrated a close tams except aztreonam, have zinc- outbreaks and increasing reports of association with individual K. pneu- active sites, and are inhibited by the isolates have come from Europe. moniae clones. Sequence type (ST)- ethylenediaminetetraacetic acid Cases of both IMP and VIM have 258 has been extensively identified (EDTA), but not by clavulanic acid.3 see ESBLs page 46

When it comes to brain protection and patient safety during surgery, hindsight is never good enough. FORE-SIGHT® empowers clinicians to protect the brain Provides unparalleled non-invasive actionable accuracy

Eliminates the need for pre-induction baseline reading Detects otherwise unnoticed cerebral desaturation events

Absolute Cerebral Oximeter

Accurate insight into brain oxygenation Visit CASMED at ASA Booth #2405 - or www.cerebraloximetry.com

44 East Industrial Road Branford CT, 06405 800.227.4414

46 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

PRN ESBLS

CONTINUED FROM PAGE 45

Susceptible E. coli been noted in many other countries, but they are only occasionally reported in the United States.3 VIM and IMP carbapenemases now are largely reported from nosocomial Klebsiella isolates that exhibit multiple antibiotic resistance patterns— both are associated with integron elements that facilitate their insertion into plasmids.3,12 There are 21 known variants of IMP and 24 variants of VIM have been described. VIM has been clustered into 3 lineages: VIM-1, VIM-2, and VIM-7.12,13 The most prominent and problematic member of this class is NDM-1, which is encoded by the carbapenemase gene blaNDM-1 (Figure 2).13 This enzyme Figure 2. A 3D structural model was first described in 2008 in a Klebsiella isolate of NDM-1. obtained from a patient in Sweden who previously had been hospitalized in New Delhi, India.15 By Reprinted from: Wang JF, Chou KC. Insights from modeling the 3D structure of New Delhi metallo–β-lactamase 2010, blaNDM-1–containing Enterobacteriaceae had and its binding interactions with antibiotic drugs. PLoS been reported in every continent except Central One. 2011;6(4):e18414. and South America, and a direct link to the Indian subcontinent (ie, India, Pakistan, and Bangladesh) was established for most of these cases.3 Sub- samples within a 12-km radius of New Delhi, they sequent investigations revealed that the blaNDM-1 identified NDM-1–positive strains of K. pneumoniae, gene was present on the plasmids of numerous E. coli, and C. freundi, as well as Shigella boydii, clinical isolates from both nosocomial- and com- Vibrio cholera, and a variety of nonfermentative munity-acquired K. pneumoniae and E. colii infec- gram-negative bacteria.17 It is now believed that tions that were obtained from a wide geographic the Balkan countries, the Middle East, and possiarea of the Indian subcontinent.16 NDM-1 carriage bly, the United Kingdom, also are endemic reseralso was documented among numerous other spe- voirs for NDM-1.3 cies of Enterobacteriaceae. Both community and Class D carbapenemases include oxacillinnosocomial isolates exhibited multiple antibiotic hydrolyzing metallo–β-lactamases (OXA), of which resistance patterns and NDM-1 carriage was iden- OXA-48 is the most common.1,3 These enzymes tified in multiple bacterial clones.16 After investiga- are somewhat unique because they exhibit only tors evaluated seepage water and public tap water a weak ability to hydrolyze carbapenems, broadspectrum cephalosporins, and aztreonam. Highlevel carbapenem resistance occurs only when OXA enzymes are coexpressed with ESBLs and porin resistance factors.1,3 Class D carbapenemases have active serine sites and are not inhibited by clavulanic acid or EDTA. β-lactamase genes that encode for blaOXA-48 most often are recovered from nosocomial isolates of K. pneumoniae and E. coli.1,3 OXA-48 was first identified in a K. pneumoniae isolate from Turkey in 2003; since then, it has become endemic there and also has disseminated across Europe, the Southeast Mediterranean region, and Africa.3 A second variant, OXA-181, has been reported in India. OXA genes have not been reported in the United States,3 but the epidemiology of OXA carbapenemases continues to evolve. Carbapenemases are a complex group of β-lacFigure 1. Process of bacterial tamases that display significant genetic diversity, but they all share several troubling characteristics. conjugation. First, Enterobacteriaceae strains that carry mobile A) Donor cell produces a sex pilus. carbapenemases often express multiple antibioticB) Pilus attaches to recipient cell, brings the resistance patterns, thus creating a therapeutic 2 cells together. challenge. Second, they all exhibit high variability C) The mobile plasmid is nicked and a single regarding which carbapenems they hydrolyze, a strand of DNA is transferred to the recipient cell. trait that makes it difficult to identify them with D) Both cells recircularize their plasmids, synthephenotypic testing.3,18-20 Similarly, the extensive size second strands, and reproduce pili. Both genetic diversity among the types of carbapencells are now viable donors. emases—and the diversity within each type—can Image courtesy of Adenosine and Science Professor Online present a significant challenge to identify them (www.scienceprofonline.com). with available molecular techniques.

Test isolates streaked away from disk

Figure 3. The modified Hodge test for carbapenemase production. Image courtesy of Kenneth S. Thomson, PhD.

Laboratory Identification Of Carbapenemases Current methods for identifying carbapenemase-producing bacteria are based on disk diffusion or, increasingly, automated microdilution susceptibility testing.3 Although the Clinical and Laboratory Standards Institute reduced the break points for carbapenems in 2010 to improve carbapenemase detection in the United States, these approaches still will not reliably detect all instances of whichever carbapenemase may be present.3 Specific tests have been used to supplement disk diffusion and automated microdilution when high-level resistance is not noted. The modified Hodge test has been used to screen for carbapenemase production in this setting (Figure 3), especially for KPC19; however, it lacks specificity (false-positives from AmpC producers) and sensitivity. Additionally, it does not reliably identify NDM-1. A variety of other tests using EDTA and boronic acid inhibition have been investigated, but they have not reliably demonstrated the requisite sensitivity and specificity.21 Similarly, selective disclosing media have been developed to screen isolates for carbapenemase production in both clinical and infection-control settings. Several methods have been commercialized, including CHROMagar KPC, Brilliance CRE (Oxiod, Ltd.), and HardyCHROM carbapenemase (Hardy Diagnostics). These approaches also have documented issues with sensitivity and specificity.21-23 Additionally, these secondary tests are labor-intensive, expensive, not well suited for high-throughput testing, and add at least an additional 18 hours to specimen turnaround time.21,22 Currently, there is no phenotypic-based diagnostic test that has demonstrated the required sensitivity, specificity, and ease of adaptability to the clinical laboratory that can rapidly identify all known types of carbapenemases.3,20,21 In contrast, molecular diagnostic approaches rapidly are becoming the gold standard for the detection of carbapenemases. Initial efforts were directed at the creation of assays that could be see ESBLs page 48

Please join us for an

ASA Industry Theater Presentation Sunday, October 14th from 11:30am – 12:00pm Booth #554 in the exhibit hall MEDICATION SAFETY IN THE OPERATING ROOM: CHALLENGES AND SOLUTIONS

PharMEDium Services is pleased to sponsor an educational presentation outlining the current state of medication safety in the operating room and a potential program to address the needs of the anesthesia provider and the patient.

Given by:

Steven B. Edelstein M.D. Professor of Anesthesia

All participants will receive a complimentary Bistro Lunch voucher upon completion of the presentation.

Vice Chair for Education and Compliance Department of Anesthesia Loyola University Medical Center Maywood, IL

Example of PharMEDium services.

Please visit us at In a complex O.R. environment, a new medication veriﬁcation documentation system coupled with PharMEDium’s ready-to-use O.R. anesthesia syringe portfolio can provide peace of mind.

Booth #2413

48 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

PRN ESBLS

CONTINUED FROM PAGE 46

used in support of active surveillance programs that drive infection control interventions. They primarily consisted of a variety of “home-grown” real-time multiplex polymerase chain reaction (PCR) assays that were optimized for rectal swab KPC detection.7,23,24 The use of an experimental prototype real-time multiplex PCR assay (Becton, Dickinson and Company) with primers for all known variants of KPCs was recently described.25 A single commercial product is available, Hy-KPC PCR (Hy Laboratories, Ltd). These assays were shown to be highly sensitive and specific with 2-hour turnaround times and, when combined with intensive bundled infection-control interventions, they have proven to successfully limit the prevalence of KPCs on an institutional, regional, and national basis.26-30 This approach is very promising for areas of the world where KPCs currently are the predominant carbapenemase, such as in the United States. Similarly, both real-time PCR assays and a

loop-mediated isothermal amplifi- diagnostic use. Additional issues their widespread use has not been cation assay have targeted NDM-1 include the need for automation with associated with significant nephrodetection.31 Only a handful of these minimal sample processing, high toxicity or neurotoxicity. Although assays have been commercialized throughput, cost, and a flexibility that they often are used in combination and none of them currently are FDA will accommodate the ever-increas- with other antibiotics, this approach ing genetic diversity of carbapen- seems to offer little advantage over approved. Recognition of the continuing emases.3 Both the treatment and the use of high-dose polymyxin trend toward the globalization of containment of carbapenemase-pro- alone.2,36 However, combination thercarbapenemases and the need to ducing Enterobacteriaceae depend apy with tigecycline may be imporaddress regions where several types on the resolution of these diagnos- tant in preventing the development of polymixin resistance, which has already are in circulation (eg, India, tic issues. Greece, and Europe) have driven the been reported to arise during therdevelopment of a variety of molecu- Treatment of Carbapenemases apy (and has increasingly been lar diagnostic assays that can detect C a r b a p e n e m a s e - p r o d u c i n g reported in general).36 all types of carbapenemases. These Enterobacteriaceae routinely exhibit Tigecycline is a glycylcycline antiinclude DNA microarray and multi- resistance to multiple antibiotics and biotic that frequently is reported to plex real-time PCR assays that can generally have only a reported sus- have activity against carbapenedetect the genetic elements of KPC, ceptibility to polymyxins (colistin mase-producing bacteria. However, NDM-1, IMP, VIM, and OXA-48.32-35 and polymyxin-B), tigecycline, and the drug does not reliably achieve The Check-MDR CT102 DNA microar- sometimes, fosfomycin.3,15 adequate levels in urine or blood ray (Check-Points BV) has been comPolymyxins are cyclic polypeptide and, hence, is not indicated for the mercialized, but currently is not FDA antibiotics that achieve concentra- treatment of urinary tract infections, approved. Despite the great promise tion-dependent bactericidal activity, serious bacteremias, pneumonia, or that current molecular assays have and they are the only antibiotics that central nervous system infections.36 demonstrated regarding sensitivity, can be used to treat serious blood- A recent FDA alert recommended specificity, detection of multiple car- stream infections caused by car- the use of alternative agents to tigebapenemase types, and rapid turn- bapenemase-producing organisms. cycline in the face of serious infecaround time, it remains to be seen Polymyxins also have been used tions following evidence of increased if they can be adapted to meet the for the majority of other infections mortality associated with tigecydemands required for routine clinical caused by these organisms,36 and cline treatment in this setting.36

NEW!

Infiniti™ just got better, introducing the all-new Infiniti Plus™. Visit CIVCO at ASA booth #2313 to learn how to make ultrasound needle guidance the standard of care in your facility.

WWW.CIVCO.COM | 800.445.6741 Sterile Infiniti Plus procedure kit.

Now Available in additional gauge sizes!

COPYR COPYRIGHT RIGH HT © 2012 2012. CIVCO IS A REGI REGISTERED ISTEERED TRADEMARK OF CIVCO CO M MEDICAL SOLUTIONS SOLUTIONS. INFINITI INIT AND INFINITI PLUS ARE TRADEMARKS OF CIVCO. ALL PRODUCTS MAY NOT BE LICENSED IN ACCORDANCE WITH CANADIAN LAW. 2012A-2594

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 49

CLINICAL CAREERS

PRN Tigecycline increasingly is being relegated to the role of a last-resort treatment option. Fosfomycin susceptibility is observed in more than 50% of carbapen emase-producing Enterobacteriaceae.36 The drug acts by inhibiting early stages of cell wall synthesis and is available in granular form for use as an orally administered liquid. Fosfomycin is useful for the treatment of urinary tract infections, and further investigations are required to determine if there is any other role for this antibiotic.36 Fosfomycin resistance frequently emerges during treatment and it has been suggested that it should always be used in combination with another drug.36 Given the limited number of drugs in the gram-negative development pipeline, it is important to focus on interventions that reduce the prevalence of infections caused by carbapenemase-producing Enterobacteriaceae. Additional efforts will need to focus on the prudent use of what limited antibiotics currently are available. Both strategies may prove useful in preventing the development of resistance to current treatment options.

Conclusion The carbapenemase- producing Entero bacteriaceae rapidly have emerged as a significant threat to global health. There is an urgent need to develop effective diagnostic testing strategies to guide both timely clinical treatment and to maximize infection control interventions. Failure to address these issues is likely to be associated with an intensification of the problem. Current treatment options are limited and without effective control of the prevalence of these organisms and the prudent use of the limited antibiotics available, widespread resistance could develop.

References 1.

Quennan AM, Bush K. Carbapenemases: the versatile β-lactamases. Clin Microbiol Rev. 2007;20(3):440-458.

2. Arnold R, Thom K, Sharma S, et al. Emergence of Klebsiella pneumoniae carbapenemase-producing bacteria. Southern Med J. 2011;104(1):40-45. 3. Nordmann P, Naas T, Poirel L. Global spread of carbapenamase-producing Enterobacteriaceae. Emerg Infect Dis. 2011;17(10):1791-1798. 4. Ito H, Arakawa S, Ohsuka R, et al. Plasmidmediated dissemination of the metallo-β-lactamase gene blaIMP among clinically isolated strains of Serratia marcescens. Antimicrob Agents Chemother. 1995;39(4):824-829.

5. Yigit H, Queenan AM, Anderson GJ, et al. Novel carbapenem-hydrolyzing β-lactamase, KPC-1, from a carbapenemresistant strain of Klebsiella pneumoniae. Antimicrob Agents Chemother. 2001;45(4): 1151-1161. 6. Bratu S, Mooty M, Nichani S, et al. Emergence of KPC-possessing Klebsiella pneumoniae in Brooklyn, New York: epidemiology and recommendations for detection. Antimicrob Agents Chemother. 2005;49(7):3018-3020.

TAKE CHARGE

of your Life. ENSURE YOUR FUTURE

7. Endimiani A, Hujer A, Perez F, et al. Characterization of blaKPC containing Klebsiella pneumoniae isolates detected in different institutions in the Eastern USA. J Antimicrob Chemother. 2009; 63(3):427-437. 8. Richter S, Frasson I, Biasolo M, et al. Ultrarapid detection of blaKPC1/2-12 from perirectal and nasal swabs by use of real-time PCR. J Clin Microbiol. 2012;50(5):1718-1719. 9. Won SY, Munoz-Price LS, Lolans K, et al; Centers for Disease Control and Prevention Epicenter Program. Emergence and rapid regional spread of Klebsiella pneumoniae carbapenemase-producing Enterobacteriaceae. Clin Infect Dis. 2011;53(6):532-540. 10. Gaviria DA, Greenfield V, Bixler D, et al. Carbapenem-resistant Klebsiella pneumoniae associated with a long-term-care facility— West Virginia, 2009-2011. MMWR. 2011; 60(41):1418-1420. 11. Endimiani A, DePasquale J, Forero S, et al. Emergence of blaKPC–containing Klebsiella pneumoniae in a long-term acute care hospital: a new challenge to our healthcare system. J Antimicrob Chemother. 2009; 64(5):1102-1110. 12. Pournaras S, Poulou A, Voulgari E, et al. Detection of the new metallo-β-lactamase VIM-19 along with KPC-2, CMY-2 and CTXM-15 in Klebsiella pneumoniae. J Antimicrob Chemother. 2010; 65(8):1604-1607. 13. Wang JF, Chou KC. Insights from modeling the 3D structure of New Delhi metallo-βlactamase and its binding interactions with antibiotic drugs. PLoS One. 2011;6(4): e18414. 14. Dong F, Song X, Ping L, et al. Characterization of multidrug-resistant and metallo-β-lactamase producing Pseudomonas aeruginosa isolates from a pediatric clinic in China. Chin Med J. 2008; 121(17): 1611-1616. 15. Yong D, Toleman M, Giske C, et al. Characterization of a new metallo-β-lactamase gene, blaNDM-1, and a novel erythromycin esterase gene carried on a unique genetic structure in Klebsiella pneumoniae sequence type 14 from India. Antimicrob Agents Chemother. 2009;53(12):2046-5054. 16. Kumarasamy K, Toleman MA, Walsh TR, et al. Emergence of a new antibiotic resistance mechanism in India, Pakistan and the UK: a molecular, biological, and epidemiological study. Lancet Infect Dis. 2010;10(9): 597-602.

Be part of a powerful group of best-in-class clinicians, unified by common goals and empowered to realize their potential. Join an industry leader that fosters the highest level of quality and first-rate patient care, while enabling clinicians to develop and maintain superior working relationships. Thrive in an environment that consistently appeals to dedicated anesthesia professionals across the U.S. Somnia boasts an exceptional clinician retention rate and offers flexible work schedules that accommodate the busiest of lifestyles. Our opportunities provide geographic and clinical diversity, stability and competitive compensation packages. Choose a national organization recognized as a world-class leader in anesthesia management services—choose Somnia. For more information about career opportunities, contact us at recruitment@somniainc.com.

17. Walsh TR, Weeks J, Livermore DM, Toleman MA. Dissemination of NDM-1 positive bacteria in the New Delhi environment and its implications for human health: an environmental point prevalence study. Lancet Infect Dis. 2011;11(5):355-362. 18. Nordmann P, Gniadkowski M, Giske CG, et al; European Network on Carbapenemases. Identification and screening of carbapenemase- producing Enterobacteriaceae. Clin Microbiol Infect. 2012;18(5): 432-438. 19. Girlich D, Poirel L, Nordmann P. Value of the modified Hodge test for detection of emerging carbapenemases in Enterobacteriaceae. J Clin Microbiol. 2012;50(2): 477-479.

see ESBLs page 51

www.somniainc.com/takecharge

50 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

PRN BULLY

CONTINUED FROM PAGE 1

experiences that were consistent with being bullied. Participants in the survey reported enduring ridicule relating to their professional abilities, namecallingg and negative rumors, as well as being excluded from group discussions about professional issues. All of the clinicians surveyed said they had been involved in a bullying event, as witness, victim or perpetrator. And 16% identified themselves as the bully. The survey was designed by and targeted to all levels of anesthesia providers, including faculty, residents and nurse anesthetists. Potential Effect on Patients “People who are bullies early in life who are not educated about the harm it causes bring that behavior into professional life,” said Sergey V. Pisklakov, MD, assistant professor of anesthesiology and director of the neuroanesthesia service at UMDNJ, who led the study. “Such behavior among health care professionals really puts patients in danger—that’s why it’s so important to educate and remediate,” v who also is chair said Dr. Pisklakov, of the school’s clinical competence committee. “Bullying disturbs other members of the team, distracts them from concentrating on patient care, and takes their attention away from the patient,” he

Shutting down can lead to trouble. “There have been cases reported where a patient is brought into surgery, draped and ready for an operation on the left knee, and someone is thinking, ‘But I thought it was the right knee,’ but because of that inhibition doesn’t speak up. Sure enough the operation takes place on the incorrect knee,” Dr. Schyve said. The Joint Commission published a Sentinel Event Alert, titled “Behaviors that undermine a culture of safety,” in July 2008 to raise awareness about the potential harm of intimidating behavior and lay out new standards to address it. “One of the keys to a culture of safety is that people throughout the organization feel comfortable telling others when they see something that’s unsafe, whether it happened and harmed or whether nothing’s happened but might,” he said. Although Dr. Pisklakov’s work focused specifically on the culture among anesthesia providers, Dr. Schyve said similar results could be seen across the health care industry among all levels and types of staff. “Surveys have been said. “All of this increases possibility of is a concern. “When people respond done that involved multiple health care medication or diagnostic errors.” to others speaking up with bully- organizations and found this pattern in Paul M. Schyve, MD, senior advi- ing behavior, whether it’s being vis- most institutions. These results are consor for health care improvement at ibly angry or nonresponsiveness, it sistent with that and this organization the Joint Commission, which accred- doesn’t take too many occasions before should be praised for having the courits hospitals and health care organiza- someone feels it isn’t worth it to take age to look into this.” tions across the country, agreed that the risk to talk about these things,” the effect of bullying on patient safety Dr. Schyve said. —Jennifer Hanawald

NEW PRODUCT BritePro Solo From Flexicare Inc. Flexicare BritePro Solo is the complete single-use laryngoscope system as it should be. Combining a single-use blade with a single-use LED handle, BritePro Solo offers the following advantages: • No risk for cross-contamination mination • Quality feel without compromise • One size fits all • Excellent tissue visualization • Saving life economicallyy BritePro Solo ... As It Should Be Flexicare Inc. 15281 Barranca Pkwy., Unit D Irvine, CA 92618 Phone: (949) 450-9999 Fax: (949) 450-9992 brant.nave@flexicare.com www.flexicare.com See our ad on page 65.

SMOKING

CONTINUED FROM PAGE 42

Although people might think the one-year abstinence figures are low, “actually that’s very high,” Dr. Chungg said. Most people who try to quit smoking on their own have a success rate of only between 3% and 5%, she said. In general, if people have not smoked for a year, “it means they really have stopped.” Varenicline, a partial agonist of the nicotinic receptor, received FDA approval in 2006. The drug has been linked to an increased risk for heart attacks and irregular heartbeats, as well as changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts or actions, according to various patient reports, lawsuits and studies. It carries a black box warning from the FDA for its link to psychological events. Chung said she and her colleagues informed patients of the risks before administering varenicline but none experienced those symptoms. Sadeq Quraishi, MD, MHA, assistant professor of anaesthesia at Harvard Medical School and a staff anesthetist at Massachusetts General Hospital, both in Boston, called the study “a very encouraging report.” But Dr. Quraishi cautioned that the relatively small clinical trial has not yet undergone peer review. He also expressed concern that because both

varenicline and exposure to anesthetics can trigger nausea, it might be advisable to wait until after surgery to start the medication. Dr. Chungg said the nausea effect from varenicline was mild in her patients. Dr. Quraishi, who co-authored a 2006 paper on the anesthesia preoperative assessment as an ideal opportunity for smoking cessation intervention, published in the Journal of Clinical Anesthesia (2006;18:635-640), said anesthesiologists should take the lead on smoking cessation during presurgical visits. Primary care physicians see patients in the community, and surgeons are focused on surgical issues, he said. “We have the luxury and the time to sit down and talk to patients and have a meaningful discussion.” The preoperative visit provides an ideal time and place, he said, as patients are already in the hospital and it is easy to set up a meeting with a cessation counselor. Abstaining from cigarettes 24 hours before surgery may have a substantial effect on patients’ cardiovascular risk, while pulmonary function starts to improve about 72 hours after tobacco cessation, he said. The best outcomes for wound healing occur from quitting smoking eight to 12 weeks before surgery. —Karen Blum

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 51

PR N 23 rd Co A A nv en S nnu tio A al n Is su e

GHQW

7KH ,QGHSHQ

er 10 23 Nu mb Vo lum e WREHU

VWKHVLRORJLV

LQH IRU $QH

V 0DJD] 0RQWKO\ 1HZ

What Were You Reading Then?

ow-Flow icity From L dies Show x to ro h p e t Stu No N ,Two Recen Sevoflurane arkers...

e Renal M Using Sensitiv

erimental iety of exp ices of s in a var ind no difference established clinical ) and found clinical markers and ted sidebar, page 84. n of posent atic rec ym enz wo rela to the questio , page 1 ction. (See evidence , JAPAN—T ANE HAMAMATSU oflurane report no esiology kidney fun data add information see SEVOFLUR sev SEATTLE & ( esth The new low-flow dies (An studies of icity. The two stu ed low-flow sevoflu tox e of nephro -7, 1238-53) compar h-flow sevofluran hig 1997;86:1231 -flow isoflurane and rane with low

ere’s a look at three covers spanning a decade of October issues of Anesthesiology News.

Multimodal Approach ve Will Improive Care que at er gle techni p io hile no sin to completely Per , D —Wbee a n shown ENMARK

HVIDOVRE rtality, imen has yet ity and mo g mulor drug reg toperative morbid t adoptin pos othesized tha lead to signifieliminate geon has hyp may ces of Danish sur rvention techniques e consequen ucing abl inte l esir oda und tim red ions in the recovery, cant reduct ry, thus improving e costs. The key car inju lthal hea gic g sur hophysiand lowerin postoperative pat trolling morbidity ing , is con ely manag to effectiv rehabilitation, he saidich places heavy ology and stress response, wh al er it be the surgic organ function. ntion, wheth demands on e unimodal interve it will only have rik ertreatment “If you hav rition or antibiotics, s for und noted Dr. Hen gy utory reason Pantle-Fisher noted, n relief, nut specific outcome,” rolo trib pai nte con troe al one al Gas n, Dr. There are al and medic st an effect on Department of Surgic e. “But it will not chronic pai clinics mu gical and straints on busy surgic ered analgesic let, of the Hospital her c compplications sive pain must man- of sur Keh y ord con hen rsit rs e of pre ive tim as ion Un cifi h including oday’s com n clinic administrat effects suc at Hvidovre effect on other nonspe c complicati CHICAGO—T n treat pain; a pai es patients’ ability nurses that delay overdosing and side r of addiction. dia avee a major nary infections, car tha hav ion; and fea receive only that improv and professional medication; fear of do more mo ial ory depress ts in a way uchh as pul suc family, soc tle-Fisher, Assistant sedation and respirat pital surveys, patien age pain dication l n in their ann to hos analgesic me Fisher g of din t to functio ing to Dr. Friedl Pan esthesia and Critica cor oun “Ac the am Pantleb lives, accordthe Department of An and Director of both about one-quarter of for these reasons,” Dr. because of a in of Chicago nic and the hospi- prescribed for them undertreatment occurs e range and Professor Cli University most of all effective dos and where Care at the t Pain Management said. “But arding the wledge reg lgesic agents, and how invasive the Outpatien n Center here. lack of kno undergoing ana Pai tal’s Acute percent of patients n prior to surgery duration of action of ir action. “About 50 fer uncontrolled pai ef following sur nts exert the pain pathage se the suf reli l about surgery wil nce inadequate pain “Many patients with “Knowledge as for pain . and experie Pan tle- Fisher said of despair, not only ways and target are an unders , er with ger y,” Dr. syndromes live live e or terminal illness relief, togeththe mode of action n chronic pai ir underlying diseas m untreated pain. ding of stan used, will the fro of suf fer especially of the analgesics because provider aus e the y surgery and health-care patients but also bec trol in patients after mes remains a sig enable the e ely manag “Pain con chronic pain syndro n though pain can to effectiv and chronic pain,” h eve wit ts. e, se ien car in tho m in health up to 90 percent of patagents with acute her said. ble pro t Fis in sic nifican Dr. Pantle- bination of knowleffectively ctive analge be managed is not a lack of effe m is undertreatment This com hophysiology of m ble pat ment of The proble modalities. The pro undertreat edge of the dge of pharmacont period and or treatme pain, knowle pharmacodynampostoperative n.” o the cag ing Chi and of dur pai kinetics nts, and the h chronic University patients wit grand rounds in the across the USA and ics of analgesic age ion of those Whether at medical meetings of proper practical administrat managesiologists ety of Anesthe s this mission or at patient American Soci Hospitals Pantle-Fisher pursue tient nts fuels ting of the treat- age activities at the Outpa the Annual Mee the d Europe, Dr. ent: lare at site of the 1997 has dec em t ment San Diego, ement Clinic nag pain manag Health Organization a basic human righ Ma n Pai o. “The World c pain to be singly refined tech- University of Chicag CLINIC, C page 1 rea te and chroni see PAIN ment of acu demand. Today’s inc logy, can meet the aco and a priority er with polypharm individual patient.” DE h eth INSI niques, tog changing needs of eac E specific and GE PAIN MANA 4. ON PAGE L INS NAL S BEG EDUCATIO l UCT . . SECTION NESTHESIA PROD R TIVE A —3-Step Ana PERIOPERA NEW Patient The : 153 n from A esso ts E 8. SMENT—L EDUCATIONA S ON PAG tion on produc rma TIC ASSES . . BEGIN . . . info THE . p . e . . Step . NES ..... PREA For mor —Three osis . . . . . . . . . . . l, Medwave, With Osteopor Step 1: Choicc Maya Medica EKE/S ©GENE WARN

U RS BUREA N & VISITO CONVENTIO AN DIEGO

Reclaims icago Clinic nic Pain h C f o y it m Chro Univers espair’ Fro ‘Lives of D

Circon, ics and others, Inc., Radion and 97. see pages 96

H 25 T

REVIEW EDUCATIONALfor the Management of theBEGINS ON PAGE 16. . —Guidelines sia Patient . . . . . . . . . . . . . . sthe Geriatric Ane

Y SAR VER ANNI

MCM

TRICKS OF T

AHO

PUBL

ISHI

GROU

lm Pa a 9 n e9 i w g o pa rt e te se

THE INDEPEND ENT

Acc ord ing to an Inte rna tion al

MONTHLY NEW SPAPER

OCTOBER

PAIN

luded that curr y high ent approach this type of regi onal block are es to of lato and suggested flawed, that anesthes n ve ner consider alter iologists nativ e due “The success e routes. rate of the later inciatic nerve bloc k has been descal sciffurcaas anywhere ribed from 45% to rrve at reported Fran k Rosemeier, MD,100%,” than (UK), a CA-1 Resident in Ane MRCP magm ology at the Washington Univsthesitrial School of Med ersity icine m has are various appr , St. Louis. “There oaches, and diffe ttors rent see scia tic page 1

20. Birgy A, Bidet P, Genel N, et al. Phenotypic screening of carbapenemases and associated β-lactamases in carbapenem resistant Enterobacteriaceae. J Clin Microbiol. 2012;50(4):1295-1301.

Pain Medicine

News—

Cardiac Anesthesiology —

Regional Anesthesiology —

PreAnesthetic Assessment—

CME

21. Gazin M, Paasch F, Goossens H, et al. Current trends in culture- based and molecular detection of extended-spectrum β-lactamase-harboring and carbapenem-resistant Enterobacteriaceae. J Clin Microbiol. 2012; 50(4):1140-1146. 22. Samra Z, Bahar J, Mada-Shapiro L, et al. Evaluation of CHROMagar KPC for a rapid detection of carbapenem-resistant Enterobacteriaceae. J Clin Microbiol. 2008;46(9):3110-3111. 23. Hindiyeh M, Smollen G, Grossman Z, et al. Rapid detection of blaKPC carbapenemase genes by real-time PCR. J Clin Microbiol. 2008;46(9):2879-2883. 24. Cole JM, Schuetz AN, Hill CE, Nolte FS. Development and evaluation of a real-time PCR assay for detection of Klebsiella

25. Simkins J, Pokharel R, Dogra S, Gialanella P, Ravishankar S, Currie BP. Prevalence of carbapenemase producing Klebsiella pneumoniae colonization at an academic medical center in New York City. Presented at: 49th Annual Meeting of the Infectious Diseases Society of America; October 20-23, 2011; Boston, MA. 26. Borer A, Eskira S, Nativ R, et al. A multifaceted intervention strategy for eradication of a hospital-wide outbreak caused by carbapenem-resistant Klebsiella pneumoniae in Southern Israel. Inf Control Hosp Epidemiol. 2011;32(12):1158-1165. 27. Ben-David D, Maor Y, Keller N, et al. Potential role of active surveillance in the control of a hospital-wide outbreak of carbapenem-resistant Klebsiella pneumoniae infection. Infect Control Hosp Epidemiol. 2010;31(6):620-626. 28. Munoz-Price L, De La Cuesta C, Adams S, et al. Successful eradication of a monoclonal strain of Klebsiella pneumoniae during a K pneumoniae carbapenemase-producing K. K. pneumoniae outbreak in a surgical

2 0 0 2 / Volu me 28 Num ber 10 siol ogy new s.co m

www .ane sthe

Imp rov ing Ana lge sia , Red

ucin g Tox icit y … Implantable Int rat Treats Refracto hecal Analgesic Pump ry Cancer Pa in O ,

DO FLA.—A n implantable that delivers Thomas J. Smit pain medicati pump on in a slow-release h, MD, Pete Staats, MD, and fash colleagues pres r S. the spinal fluid ion directly into evidence from ented this improve pain has been shown to cal trial suggestin randomized cliniicontrol and dimi g drug toxicity, that an imp nish able intrathec according to resu t al drug delivery lanta trial presente lts of (IDDS) outperfo system d rme meeting of the at the 2002 annual d com prehensive medical man Ame Clinical Oncolog rican Society of several notable agement (CMM) in categories. was also linke y. The technique Dr. Smith is Asso d with increase vival for canc ciate Professo r Medicine and er patients with d surr of Hea tory pain. refracat the Medical lth Administration College of Virg inia see RLAN

impl anta ble

pneumoniae carbapenemase genes. J Clin Microbiol. 2009;47(2):322-326.

GISTS

Lateral Sciatic Block Linked d to an Anatom Failure Rate ic Variation S — conc

PRODU CTS

CONTINUED FROM PAGE 49

ANESTHESIOLO

MR I Tria l …

page 1

At a Lar ge Can adi an Inst itut ion …

Blood Conserv a Open Referra tion Program l Found Ineffic ient

VICTORIA, BRITISH at one large Can COLUMBIA—If conditions adia resentative, open n institution are rep-referral blood v vatio consern programs r donation prog —especially autologous rams—could cantly enhanced be sign by either prescree ifipatients before ning acceptance or educating refe by rring physician further Alberta research A s. As an out, while cert team recently pointed ain surgical serv appropriately ices refer to program, othe the blood-conservation rs grossly over their need in estimate this regard. “About five year an open referral s ago, we established were voluntar policy whereby patients w ily geons who wan referred to us from surralternatives,” ted blood conservation commented Barr egan, FRCPC, y A. FinProfessor and Cha Department of Anesthesiology ir of the Medicine at and Pain the Faculty of Med University of Alberta F Edmonton. “Weicine and Dentistry, in E never adve program exte p nsively, except rtised the to targeted see

Daniel & Yea ger, EMS S, and Pfizer

ESBLS

FOR

intensive care unit in Miami, Florida. Infect Control Hosp Epidemiol. 2010; 31(10):1074-1077. 29. Munoz-Price L, Hayden M, Lolans K, et al. Successful control of an outbreak of acute Klebsiella pneumoniae carbapenemaseproducing K. pneumonia at a long-term acute care hospital. Infect Control Hosp Epidemiol. 2010;31(4):341-347. 30. Schwaber M, Lev B, Israel A, et al; Israel Carbapenem-Resistant Enterobacteriaceae Working Group. Containment of a countrywide outbreak of carbapenem-resistant Klebsiella pneumoniae in Israeli hospitals via a nationally implemented intervention. Clin Infect Dis. 2011;52(7):848-855. 31. Liu W, Zou D, Li Y, et al. Sensitive and rapid detection of the New Delhi metallo-βlactamase gene by loop-mediated isothermal amplification. J Clin Microbiol. 2012;50(5):1580-1585. 32. Monteiro J, Widen R, Pignatari AC, Kubasek C, Silbert S. Rapid detection of carbapenemase genes by multiplex real-time PCR. J Antimicrob Chemother. 2012;67(4): 906-909. 33. Cohen S, Voets G, Scharringa J, et al. Detection of carbapenemase-producing

bloo d page p 1

ILLUSTRATION BY RENE

CARSON

Enterobacteriaceae with a commercial DNA microarray. J Med Microbiol. 2012;61(6): 809-812. 34. Naas T, Cuzon G, Bogaerts P, Glupczynski Y, Nordmann P. Evaluation of a DNA microarray (Check-MDR CT102) for rapid detection of TEM, SHV and CTX-M extended-spectrum β-lactamases and of KPC, OXA-48, VIM, IMP, and NDM-1 carbapenemases. J Clin Microbiol. 2011;49(4): 1608-1613. 35. Cuzon G, Naas T, Bogaerts P, Glupczynski Y, Nordmann P. Evaluation of a DNA microarray for the rapid detection of extended-spectrum β-lactamases (TEM, SHV and CTX-M), plasmid-mediated cephalosporinases (CMY-2-like, DHA, FOX, ACC-1, ACT/MIR and CMY-1-like/MOX) and carbapenemases (KPC, OXA-48, VIM, IMP and NDM). J Antimicrob Chemother. 2012;67(8): 1865-1869. 36. Falagas ME, Karageorgopoulos DE, Nordmann P. Therapeutic options for infections with Enterobacteriaceae producing carbapenem-hydrolyzing enzymes. Future Microbiol. 2011;6(6):653-666. Dr. Currie reported no relevant conflicts of interest.

52 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

P A IN M E D I C I NE

Pain Physicians Petition FDA for Improved Opioid Labeling

group of leaders within the pain medicine community is appealing to the FDA to do something about the growing problem of prescription drug misuse and abuse, by amending the language on opioid analgesic labeling. Not everyone, however, thinks the group is going about obtaining its objective in the right manner, with at least one expert arguing that a label change now would do harm as well as good. A group calling itself Physicians for Responsible Opioid Prescribing (PROP) has joined forces with the consumer advocacy organization Public Citizen to file a petition with the FDA calling for changes to the labeling of and marketing practices associated with opioid analgesics. Those signing the petition—including pain specialists, anesthesiologists, neurologists, psychiatrists, primary care physicians and other health specialists—argue that the current labeling creates the “false impression that chronic opioid therapy is an evidence-based [long-term] treatment” for chronic noncancer pain (CNCP). At press time, the FDA had yet to respond to the group’s petition. Although many pain specialists agree with PROP’s stated goals of reducing the morbidity and mortality associated with prescription opioid misuse and abuse, not all agree with the organization’s proposed methods for doing so. Charles Argoff, MD, professor of neurology and director of Albany Medical Center’s pain management program, in Albany, N.Y., said: “Given the millions of people who have truly benefited on a longterm basis from the use of opioid analgesics for CNCP and who could suffer as a consequence of such a label change and that there is no evidence that a label change alonee would alter misuse and abuse and given that the FDA, when developing an indication for a particular medication, uses the highest-qualityy evidence to do so, it is not clear that at this time this is indeed the best way to approach this very real health care crisis.” “A lot of doctors have been misinformed about opioids because a lot of the education has minimized the risks and exaggerated the benefits,” said Andrew Kolodny, MD, president and founding member of PROP. “Our hope is that if the FDA were to implement what we’re requesting that it would reduce overprescribing by physicians who are influenced by marketing and educational programs that send an implied message that opioids are safe and effective for long-term use in chronic pain even though we have an expert consensus that that evidence doesn’t exist.” y chairman of psychiatry at MaiDr. Kolodny, monides Medical Center in New York City, became involved in the efforts to establish PROP after his experiences as medical director for special projects

in the Office of the Executive Deputy Commissioner for the New York City Department of Health and Mental Hygiene in the early 2000s. While there, he led initiatives designed to reduce drug deaths related to overdose. Initially, he said, these programs targeted heroin addicts; however, he and his colleagues soon found that there was an increasing need to address addiction and overdose deaths among those addicted to prescription opioids. PROP’s primary mission has been to educate physicians about what its members and supporters believe constitutes safe and reasonable opioid prescribing by providing “counterdetailing” information on the risks associated with their long-term use.

In recent years, the Centers for Disease Control and Prevention (CDC) has somewhat controversially described the problem of opioid abuse and misuse as an “epidemic.” Critics of this stance have accused the CDC of exaggerating the problem, and the federal government in general of taking out its frustrations over past failed drug policies on physicians and patients. Agency statistics, in fact, indicate that accidental deaths from prescription opioids in the United States now far outnumber those associated with so-called “street” drugs such as cocaine and heroin. A CDC report on the issue concluded that a fourfold increase in opioid prescriptions between 1999 and 2008 led to a fourfold increase in prescription opioid overdose deaths over the same period. “Based on a 12-week trial, you can’t say someone is going to do well on opioids three years later,” Dr. Kolodnyy said. Recent efforts on the part of manufacturers to develop opioid formulations designed to reduce potential abuse and misuse (by making them more difficult to inject or snort) are a step in the right direction, he added, but the majority of patients who

are addicted to pain medications swallow them in pill form. (He emphasized that this latter position is his own, and not representative of PROP.) Specific Actions Requested To address the issue more proactively, according to Dr. Kolodny, y the PROP petition asks the FDA to: • strike the term moderatee from the indications for CNCP for all approved opioid analgesics; • add a maximum daily dose, equivalent to 100 mg of morphine, for CNCP; and • add a maximum duration of 90 days for continuous (daily) use for CNCP. A letter submitted to the FDA along with the petition included the following statement: “The Federal Food, Drug and Cosmetic Act established that a drug intended to treat a condition must be proven safe and effective for use as labeled. The current label on opioid analgesics does not comply with this law.” Notable signers of the petition and the accompanying letter include Edward C. Covington, MD, director of the Neurological Center for Pain at Cleveland Clinic; Robert W. Day, MD, PhD, president emeritus of the Fred Hutchinson Cancer Research Center in Seattle; Thomas A. Farley, MD, MPH, commissioner of the New York City Department of Health; Stuart Gitlow, MD, MBA, MPH, acting president of the American Society of Addiction Medicine; Kurt C. Stange, MD, PhD, professor of family medicine and community health at Case Western Reserve University in Cleveland; and Roger Rosenblatt, MD, MPH, professor and vice chair, of family medicine at the University of Washington School of Medicine, in Seattle. In all, 37 health care professionals signed the petition. “The views laid out in the letter are concordant with the sense that I have based on the existing literature and my clinical experience regarding the prescribing of opioids for long-term noncancer pain,” said Richard A. Deyo, MD, MPH, director of the Oregon Clinical and Translational Research Institute Community and Practice Research Program at Oregon Health & Science University, in Portland. “It’s a complex story. Many physicians believe that opioids are safe and effective for long-term use, even though this is not supported by the literature we have,” said Dr. Deyo, whose name is on the petition. A representative of the FDA said the agency has not yet determined its response to the PROP petition or offered a timetable for when a response would be announced. ‘As the primary association for pain physicians, we believe that the adoption of the recommendations in the PROP petition to lower doses or duration would provide a false sense of security for patients and practitioners,” said Lynn Webster, MD, President-Elect of the American Academy of Pain Medicine, in a press release. “In our view, a more effective means to address this problem would be enhanced prescriber education and adherence to principles of practice, including ongoing monitoring for aberrant behaviors and early signs of addiction.” —Brian Dunleavy See related article on page 60.

54 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

P A IN M E D I C I NE

Interventional Pain Fellowship in Brazil Has Global Hopes

o help physicians train in interventional pain medicine techniques and prepare for the World Institute of Pain (WIP) exam, several Brazilian and American pain specialists have pioneered an interventional pain fellowship for Brazilian doctors that they hope will be a game changer. Before the course was conceived, travel to the United States or

Europe was necessary to learn interventional pain medicine techniques. The goal of this new fellowship is to provide physicians with a streamlined alternative to a full-time fellowship. Classes are scheduled one Saturday a month for seven months, and include both classroom and procedure room education, including a weekend of cadaver work in the United States. The

course concludes with written, oral and practical exams patterned on the interventional pain fellowship exams offered by the WIP. The first group of 15 anesthesiologists, orthopedic surgeons and neurosurgeons completed the course near Sao Paolo in late April, and the next group started immediately after. “It matters to us and our patients

that we take the steps toward the WIP exam,” said Lia Belloso, MD, an anesthesiologist and pain physician based in Cuiaba, Brazil, who was in the first group of students. “Our patients know that we are doing better with this level of expertise, and we also get better outcomes.” Andrea Trescot, MD, president of the American Society of Interventional Pain Physicians and coordinator of the program in the United States, agreed: “This training sets them up well to do the actual WIP exam.” Dr. Trescot became involved in the interventional pain fellowship after meeting Fabricio Dias Assis, MD, immediate past chair of the WIP’s Latin American section, during his frequent trips to the United States to supervise the advanced training of Brazilian pain physicians. Dr. Assis wanted to give Brazilian physicians easier access to learn these interventional pain medicine techniques and asked Dr. Trescot to help. Dr. Assis coordinates the WIPendorsed course and hosts it at his private clinic, the Singular Pain Management Center in Campinas, Brazil,

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 55

PA IN M E D ICIN E about an hour’s drive from the coun- Dr. Trescot said she enjoys teaching the course because the students’ “enthusitry’s capital. asm is just visceral.” A Full Course Load Hoping To Go Global During the first six Saturdays of instruction, the students learn through Charles Oliveira, MD, Dr. Assis’s observation in the mornings, which partner at Singular who has helped includes watching Dr. Assis perform organize the course, affirmed that the procedures in real time. In the after- Brazilian physicians think highly of it. noons, the students get hands-on “All of the students are very happy with experience, learning how to do the pro- the lectures and with the opportunities cedures they observed in the morning to do procedures that they have never been able to do before. In a few years, using a Spine Phantom. “The Spine Phantom is a dummy that has the look and feel of the spine, and helps the students become familiar with the anatomic landmarks,” said Dr. Trescot. “It can be used over and over again and also fits into a suitcase—‘have body, will travel.’”

we will have a lot of pain physicians in Brazil doing the right procedures in the right way.” The program has gained corporate and institutional support from Vortex Medical, Micromar, Bramsys, Unis and the Brazilian Society for the Study of Pain. The success of this course so far has convinced Drs. Assis, Oliveira and Trescot to start exploring the idea of bringing the program to other countries.

“The nice thing,” Dr. Trescot said, “is that, theoretically, now that we have all the modules in place, as well as the roster of hundreds of articles that the physicians read over the seven months, the program could be put into virtually any country in which there are some practicing pain physicians who are willing to be the in-countryy coordinators and some other physicians who can get it rolling.” —Rosemary Frei, MSc

NAROPIN® delivers a faster return of motor function than bupivacaine.1,2 A Block Well Done. NAROPIN provides 8 to 10 hours faster return of motor function following total knee replacement 1 than bupivacaine (P<0.05). P

Using NAROPIN beyond recommended doses to increase motor block or duration of sensory block may negate its favorable cardiovascular advantages, in the event that an inadvertent intravascular injection occurs.

To learn more about the clinical beneﬁts of NAROPIN, visit www.naropin-us.com.

Important Safety Information There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. NAROPIN is not approved for this use. Please see dosage and administration details in Prescribing Information at www.naropin-us.com.

Like all amide-type local anesthetics, NAROPIN may be associated with adverse reactions. In clinical trials, side effects were mild and transient and may reflect the procedures, patient health status, and/or other medications used. Adverse events reported at a rate of ≥5%: hypotension, nausea, vomiting, bradycardia, fever, pain, postoperative complications, anemia, paresthesia, headache, pruritus, and back pain.

Please see accompanying brief summary of Prescribing Information. www.naropin-us.com NAROPIN is indicated for the production of regional or local anesthesia for surgery and for acute pain management. References: 1. Beaulieu P, Babin D, Hemmerling T. The pharmacodynamics of ropivacaine and bupivacaine in combined sciatic and femoral nerve blocks for total knee arthroplasty. Anesth Analg. 2006;103:768-774. 2. Morrison LM, Emanuelsson BM, McClure JH, et al. Efficacy and kinetics of extradural ropivacaine: comparison with bupivacaine. Br J Anaesth. 1994;72:164-169. Naropin® and logo are trademarks of Fresenius Kabi USA, LLC. APP ® and are trademarks of Fresenius Kabi USA, LLC. ©2012, Fresenius Kabi USA, LLC. All Rights Reserved. 0155-NAR-05-2/11

WHY COMPROMISE?

56 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

P A IN M E D I C I NE

Massachusetts Pain Center’s ‘Balanced Approach’ Helps Reach Pain Patients

or clinicians at Brigham and Women’s Hospital Pain Management Center (BWHPMC), “the fight against chronic pain is all about balance—excellent clinical care, innovative technology, cutting-edge research and comprehensive training,

all applied to help patients overcome pain and improve the quality of their lives,” said medical director Edgar L. Ross, MD. “We strive for excellence in all of these areas because we know pain affects people in myriad ways. Our patient population isn’t homogeneous

Naropin

(ropivacaine HCl) Injection BRIEF SUMMARY INDICATIONS AND USAGE Naropin is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration. CONTRAINDICATIONS Naropin is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type. WARNINGS In performing Naropin blocks, unintended intravenous injection is possible and may result in cardiac arrhythmia or cardiac arrest. The potential for successful resuscitation has not been studied in humans. There have been rare reports of cardiac arrest during the use of Naropin for epidural anesthesia or peripheral nerve blockade, the majority of which occurred after unintentional accidental intravascular administration in elderly patients and in patients with concomitant heart disease. In some instances, resuscitation has been difficult. Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the probability of a successful outcome. Naropin should be administered in incremental doses. It is not recommended for emergency situations, where a fast onset of surgical anesthesia is necessary. Historically, pregnant patients were reported to have a high risk for cardiac arrhythmias, cardiac/ circulatory arrest and death when 0.75% bupivacaine (another member of the amino amide class of local anesthetics) was inadvertently rapidly injected intravenously. Prior to receiving major blocks the general condition of the patient should be optimized and the patient should have an i.v. line inserted. All necessary precautions should be taken to avoid intravascular injection. Local anesthetics should only be administered by clinicians who are well versed in the diagnosis and management of dose-related toxicity and other acute emergencies that may arise from the block to be employed, and then only after ensuring the immediate (without delay) availability of oxygen, other resuscitative drugs, cardiopulmonary resuscitative equipment, and the personnel resources needed for proper management of toxic reactions and related emergencies (See also ADVERSE REACTIONS, PRECAUTIONS, and MANAGEMENT OF LOCAL ANESTHETIC EMERGENCIES). Delay in proper management of dose-related toxicity, underventilation from any cause, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death. Solutions of Naropin should not be used for the production of obstetrical paracervical block anesthesia, retrobulbar block, or spinal anesthesia (subarachnoid block) due to insufficient data to support such use. Intravenous regional anesthesia (bier block) should not be performed due to a lack of clinical experience and the risk of attaining toxic blood levels of ropivacaine. Intra-articular infusions of local anesthetics followingg arthroscopic p and other surgical g procedures p is an unapproved pp use,, and there have been post-marketing p g reports p of chondrolysis y in patients p receivingg such infusions. The majority j y of reported p cases of chondrolysis y have involved the shoulder jjoint;; cases of ggleno-humeral chondrolysis y have been described in ppediatric and adult ppatients followingg intra-articular infusions of local anesthetics with and without eppinephrine p for pperiods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods p are not associated with these findings. g The time of onset of symptoms, y p , g y Currently,y, there is no effective treatment such as jjoint ppain,, stiffness and loss of motion can be variable,, but mayy begin g as earlyy as the 2nd month after surgery. for chondrolysis; y ; ppatients who experienced p chondrolysis y have required q additional diagnostic g and therapeutic p pprocedures and some required q arthroplasty p y or shoulder replacement. p It is essential that aspiration for blood, or cerebrospinal fluid (where applicable), be done prior to injecting any local anesthetic, both the original dose and all subsequent doses, to avoid intravascular or subarachnoid injection. However, a negative aspiration does nott ensure against an intravascular or subarachnoid injection. A well-known risk of epidural anesthesia may be an unintentional subarachnoid injection of local anesthetic. Two clinical studies have been performed to verify the safety of Naropin at a volume of 3 mL injected into the subarachnoid space since this dose represents an incremental epidural volume that could be unintentionally injected. The 15 and 22.5 mg doses injected resulted in sensory levels as high as T5 and T4, respectively. Anesthesia to pinprick started in the sacral dermatomes in 2-3 minutes, extended to the T10 level in 10-13 minutes and lasted for approximately 2 hours. The results of these two clinical studies showed that a 3 mL dose did not produce any serious adverse events when spinal anesthesia blockade was achieved. Naropin should be used with caution in patients receiving other local anesthetics or agents structurally related to amide-type local anesthetics, since the toxic effects of these drugs are additive. Patients treated with class III antiarrhythmic drugs (e.g., amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive. PRECAUTIONS: General: The safe and effective use of local anesthetics depends on proper dosage, correct technique, adequate precautions and readiness for emergencies. Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use. (See WARNINGS and ADVERSE REACTIONS.) The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse events. Injections should be made slowly and incrementally, with frequent aspirations before and during the injection to avoid intravascular injection. When a continuous catheter technique is used, syringe aspirations should also be performed before and during each supplemental injection. During the administration of epidural anesthesia, it is recommended that a test dose of a local anesthetic with a fast onset be administered initially and that the patient be monitored for central nervous system and cardiovascular toxicity, as well as for signs of unintended intrathecal administration before proceeding. When clinical conditions permit, consideration should be given to employing local anesthetic solutions, which contain epinephrine for the test dose because circulatory changes compatible with epinephrine may also serve as a warning sign of unintended intravascular injection. An intravascular injection is still possible even if aspirations for blood are negative. Administration of higher than recommended doses of Naropin to achieve greater motor blockade or increased duration of sensory blockade may result in cardiovascular depression, particularly in the event of inadvertent intravascular injection. Tolerance to elevated blood levels varies with the physical condition of the patient. Debilitated, elderly patients and acutely ill patients should be given reduced doses commensurate with their age and physical condition. Local anesthetics should also be used with caution in patients with hypotension, hypovolemia or heart block. Careful and constant monitoring of cardiovascular and respiratory vital signs (adequacy of ventilation) and the patient’s state of consciousness should be performed after each local anesthetic injection. It should be kept in mind at such times that restlessness, anxiety, incoherent speech, light-headedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, depression, or drowsiness may be early warning signs of central nervous system toxicity. Because amide-type local anesthetics such as ropivacaine are metabolized by the liver, these drugs, especially repeat doses, should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. Local anesthetics should also be used with caution in patients with impaired cardiovascular function because they may be less able to compensate for functional changes associated with the prolongation of A-V conduction produced by these drugs. Many drugs used during the conduct of anesthesia are considered potential triggering agents for malignant hyperthermia (MH). Amide-type local anesthetics are not known to trigger this reaction. However, since the need for supplemental general anesthesia cannot be predicted in advance, it is suggested that a standard protocol for MH management should be available. Epidural Anesthesia: During epidural administration, Naropin should be administered in incremental doses of 3 to 5 mL with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. Syringe aspirations should also be performed before and during each supplemental injection in continuous (intermittent) catheter techniques. An intravascular injection is still possible even if aspirations for blood are negative. During the administration of epidural anesthesia, it is recommended that a test dose be administered initially and the effects monitored before the full dose is given. When clinical conditions permit, the test dose should contain an appropriate dose of epinephrine to serve as a warning of unintentional intravascular injection. If injected into a blood vessel, this amount of epinephrine is likely to produce a transient “epinephrine response” within 45 seconds, consisting of an increase in heart rate and systolic blood pressure, circumoral pallor, palpitations and nervousness in the unsedated patient. The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or more seconds. Therefore, following the test dose, the heart should be continuously monitored for a heart rate increase. Patients on beta-blockers may not manifest changes in heart rate, but blood pressure monitoring can detect a rise in systolic blood pressure. A test dose of a shortacting amide anesthetic such as lidocaine is recommended to detect an unintentional intrathecal administration. This will be manifested within a few minutes by signs of spinal block (e.g., decreased sensation of the buttocks, paresis of the legs, or, in the sedated patient, absent knee jerk). An intravascular or subarachnoid injection is still possible even if results of the test dose are negative. The test dose itself may produce a systemic toxic reaction, high spinal or epinephrine-induced cardiovascular effects. Use in Brachial Plexus Block: Ropivacine plasma concentrations may approach the threshold for central nervous system toxicity after the administration of 300 mg of ropivacaine for brachial plexus block. Caution should be exercised when using the 300 mg dose. (See OVERDOSAGE.) The dose for a major nerve block must be adjusted according to the site of administration and patient status. Supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions, regardless of the local anesthetic used. Use in Peripheral Nerve Block: Major peripheral nerve blocks may result in the administration of a large volume of local anesthetic in highly vascularized areas, often close to large vessels where there is an increased risk of intravascular injection and/or rapid systemic absorption, which can lead to high plasma concentrations. Use in Head and Neck Area: Small doses of local anesthetics injected into the head and neck area may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses. The injection procedures require the utmost care. Confusion, convulsions, respiratory depression, and/or respiratory arrest, and cardiovascular stimulation or depression have been reported. These reactions may be due to intra-arterial injection of the local anesthetic with retrograde flow to the cerebral circulation. Patients receiving these blocks should have their circulation and respiration monitored and be constantly observed. Resuscitative equipment and personnel for treating adverse reactions should be immediately available. Dosage recommendations should not be exceeded. (See DOSAGE AND ADMINISTRATION.) Use in Ophthalmic Surgery: The use of Naropin in retrobulbar blocks for ophthalmic surgery has not been studied. Until appropriate experience is gained, the use of Naropin for such surgery is not recommended. Drug Interactions: Specific trials studying the interaction between ropivacaine and class III antiarrhythmic drugs (e.g., amiodarone) have not been performed, but caution is advised (see WARNINGS). Naropin should be used with caution in patients receiving other local anesthetics or agents structurally related to amide-type local anesthetics, since the toxic effects of these drugs are additive. Cytochrome P4501A2 is involved in the formation of 3-hydroxy ropivacaine, the major metabolite. In vivo, the plasma clearance of ropivacaine was reduced by 70% during coadministration of fluvoxamine (25 mg bid for 2 days), a selective and potent CYP1A2 inhibitor. Thus strong inhibitors of cytochrome P4501A2, such as fluvoxamine, given concomitantly during administration of Naropin, can interact with Naropin leading to increased ropivacaine plasma levels. Caution should be exercised when CYP1A2 inhibitors are coadministered. Possible interactions with drugs known to be metabolized by CYP1A2 via competitive inhibition such as theophylline and imipramine may also occur. Coadministration of a selective and potent inhibitor of CYP3A4, ketoconazole (100 mg bid for 2 days with ropivacaine infusion administered 1 hour after ketoconazole) caused a 15% reduction in in-vivoo plasma clearance of ropivacaine. Pregnancy Category B: There are no adequate or well-controlled studies in pregnant women of the effects of Naropin on the developing fetus. Naropin should only be used during pregnancy if the benefits outweigh the risk. Labor and Delivery: Local anesthetics, including ropivacaine, rapidly cross the placenta, and when used for epidural block can cause varying degrees of maternal, fetal and neonatal toxicity (see CLINICAL PHARMACOLOGY and PHARMACOKINETICS). The incidence and degree of toxicity depend upon the procedure performed, the type and amount of drug used, and the technique of drug administration. Adverse reactions in the parturient, fetus and neonate involve alterations of the central nervous system, peripheral vascular tone and cardiac function. Maternal hypotension has resulted from regional anesthesia with Naropin for obstetrical pain relief. Local anesthetics produce vasodilation by blocking sympathetic nerves. Elevating the patient’s legs and positioning her on her left side will help prevent decreases in blood pressure. The fetal heart rate also should be monitored continuously, and electronic fetal monitoring is highly advisable. Epidural anesthesia has been reported to prolong the second stage of labor by removing the patient’s reflex urge to bear down or by interfering with motor function. Spontaneous vertex delivery occurred more frequently in patients receiving Naropin than in those receiving

but heterogeneous, with different needs for different people.” Diversity Rules BWHPMC staff believe there is no quick fix when dealing with pain, Dr. Ross said. No single pill or

bupivacaine. Nursing Mothers: Some local anesthetic drugs are excreted in human milk and caution should be exercised when they are administered to a nursing woman. The excretion of ropivacaine or its metabolites in human milk has not been studied. Based on the milk/plasma concentration ratio in rats, the estimated daily dose to a pup will be about 4% of the dose given to the mother. Assuming that the milk/plasma concentration in humans is of the same order, the total Naropin dose to which the baby is exposed by breast-feeding is far lower than by exposure in utero in pregnant women at term (see Precautions). Pediatric Use: The safety and efficacy of Naropin in pediatric patients have not been established. Geriatric Use: Of the 2,978 subjects that were administered Naropin Injection in 71 controlled and uncontrolled clinical studies, 803 patients (27%) were 65 years of age or older, which includes 127 patients (4%) 75 years of age and over. Naropin Injection was found to be safe and effective in the patients in these studies. Clinical data in one published article indicate that differences in various pharmacodynamic measures were observed with increasing age. In one study, the upper level of analgesia increased with age, the maximum decrease of mean arterial pressure (MAP) declined with age during the first hour after epidural administration, and the intensity of motor blockade increased with age. This drug and its metabolites are known to be excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Elderly patients are more likely to have decreased hepatic, renal, or cardiac function, as well as concomitant disease. Therefore, care should be taken in dose selection, starting at the low end of the dosage range, and it may be useful to monitor renal function. (See PHARMACOKINETICS, Elimination.) ADVERSE REACTIONS Reactions to ropivacaine are characteristic of those associated with other amidetype local anesthetics. A major cause of adverse reactions to this group of drugs may be associated with excessive plasma levels, which may be due to overdosage, unintentional intravascular injection or slow metabolic degradation. The reported adverse events are derived from clinical studies conducted in the U.S. and other countries. The reference drug was usually bupivacaine. The studies used a variety of premedications, sedatives, and surgical procedures of varying length. A total of 3,988 patients have been exposed to Naropin at concentrations up to 1.0% in clinical trials. Each patient was counted once for each type of adverse event. Incidence ≥5%: For the indications of epidural administration in surgery, cesarean section, postoperative pain management, peripheral nerve block, and local infiltration, the following treatment-emergent adverse events were reported with an incidence of ≥5% in all clinical studies (N=3988): hypotension (37.0%), nausea (24.8%), vomiting (11.6%), bradycardia (9.3%), fever (9.2%), pain (8.0%), postoperative complications (7.1%), anemia (6.1%), paresthesia (5.6%), headache (5.1%), pruritus (5.1%), and back pain (5.0%). Incidence 1-5%: Urinary retention, dizziness, rigors, hypertension, tachycardia, anxiety, oliguria, hypoesthesia, chest pain, hypokalemia, dyspnea, cramps, and urinary tract infection. Incidence in Controlled Clinical Trials: The reported adverse events are derived from controlled clinical studies with Naropin (concentrations ranged from 0.125% to 1.0% for Naropin and 0.25% to 0.75% for bupivacaine) in the U.S. and other countries involving 3,094 patients. Tables 3A and 3B list adverse events (number and percentage) that occurred in at least 1% of Naropin-treated patients in these studies. The majority of patients receiving concentrations higher than 5.0 mg/mL (0.5%) were treated with Naropin. Table 3A Adverse Events Reported in ≥1% of Adult Patients Receiving Regional or Local Anesthesia (Surgery, Labor, Cesarean Section, Post-Operative Pain Management, Peripheral Nerve Block and Local Infiltration)

Adverse Reaction Hypotension Nausea Vomiting Bradycardia Headache Paresthesia Back pain Pain Pruritus Fever Dizziness Rigors (Chills) Postoperative complications Hypoesthesia Urinary retention Progression of labor poor/failed Anxiety Breast disorder, breast-feeding Rhinitis

N 536 283 117 96 84 82 73 71 63 61 42 42 41 27 23 23 21 21 18

Naropin total N=1661 N 1661

(%) (32.3) (17.0) (7.0) (5.8) (5.1) (4.9) (4.4) (4.3) (3.8) (3.7) (2.5) (2.5) (2.5) (1.6) (1.4) (1.4) (1.3) (1.3) (1.1)

N 408 207 88 73 68 57 75 71 40 37 23 24 44 24 20 22 11 12 13

Bupivacaine total N=1433 N 1433

(%) (28.5) (14.4) (6.1) (5.1) (4.7) (4.0) (5.2) (5.0) (2.8) (2.6) (1.6) (1.7) (3.1) (1.7) (1.4) (1.5) (0.8) (0.8) (0.9)

Table 3B Adverse Events Reported in ≥1% of Fetuses or Neonates of Mothers Who Received Regional Anesthesia (Cesarean Section and Labor Studies)

Adverse Reaction Fetal bradycardia Neonatal jaundice Neonatal complication-NOS Apgar score low Neonatal respiratory disorder Neonatal tachypnea Neonatal fever Fetal tachycardia Fetal distress Neonatal infection Neonatal hypoglycemia

N 77 49 42 18 17 14 13 13 11 10 8

Naropin total N=1661 N 1661

(%) (12.1) (7.7) (6.6) (2.8) (2.7) (2.2) (2.0) (2.0) (1.7) (1.6) (1.3)

N 68 47 38 14 18 15 14 12 10 8 16

Bupivacaine total N=1433 N 1433

(%) (11.9) (8.2) (6.6) (2.4) (3.1) (2.6) (2.4) (2.1) (1.7) (1.4) (2.8)

OVERDOSAGE Acute emergencies from local anesthetics are generally related to high plasma levels encountered, or large doses administered, during therapeutic use of local anesthetics or to unintended subarachnoid or intravascular injection of local anesthetic solution. (See ADVERSE REACTIONS, WARNINGS, and PRECAUTIONS.) MANAGEMENT OF LOCAL ANESTHETIC EMERGENCIES: Therapy with Naropin should be discontinued at the first sign of toxicity. No specific information is available for the treatment of toxicity with Naropin; therefore, treatment should be symptomatic and supportive. The first consideration is prevention, best accomplished by incremental injection of Naropin, careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic and during continuous infusion. At the first sign of change in mental status, oxygen should be administered. The first step in the management of systemic toxic reactions, as well as underventilation or apnea due to unintentional subarachnoid injection of drug solution, consists of immediate attention to the establishment and maintenance of a patent airway and effective assisted or controlled ventilation with 100% oxygen with a delivery system capable of permitting immediate positive airway pressure by mask. Circulation should be assisted as necessary. This may prevent convulsions if they have not already occurred. If necessary, use drugs to control convulsions. Intravenous barbiturates, anticonvulsant agents, or muscle relaxants should only be administered by those familiar with their use. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated. Supportive treatment of circulatory depression may require administration of intravenous fluids, and, when appropriate, a vasopressor dictated by the clinical situation (such as ephedrine or epinephrine to enhance myocardial contractile force). Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the probability of a successful outcome. The mean dosages of ropivacaine producing seizures, after intravenous infusion in dogs, nonpregnant and pregnant sheep were 4.9, 6.1 and 5.9 mg/kg, respectively. These doses were associated with peak arterial total plasma concentrations of 11.4, 4.3 and 5.0 μg/mL, respectively. In human volunteers given intravenous Naropin, the mean (min-max) maximum tolerated total and free arterial plasma concentrations were 4.3 (3.4-5.3) and 0.6 (0.3-0.9) μg/mL respectively, at which time moderate CNS symptoms (muscle twitching) were noted. Clinical data from patients experiencing local anesthetic induced convulsions demonstrated rapid development of hypoxia, hypercarbia and acidosis within a minute of the onset of convulsions. These observations suggest that oxygen consumption and carbon dioxide production are greatly increased during local anesthetic convulsions and emphasize the importance of immediate and effective ventilation with oxygen, which may avoid cardiac arrest. If difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated, endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated after initial administration of oxygen by mask. The supine position is dangerous in pregnant women at term because of aortocaval compression by the gravid uterus. Therefore, during treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels should be accomplished. Resuscitation of obstetrical patients may take longer than resuscitation of nonpregnant patients and closed-chest cardiac compression may be ineffective. Rapid delivery of the fetus may improve the response to resuscitative efforts.

Fresenius Kabi USA, LLC

0155-NAR-05-2/11

Rev. 11/08

treatment stops all pain; it must be attacked on multiple fronts. “We’ve developed this multidisciplinary clinic with many different specialties to address that reality,” Dr. Ross said. Founded in 1975, BWHPMC is the only two-time American Pain Society Center of Excellence winner, having received the award in 2007 and 2011. Located in the Boston suburb of Chestnut Hill, it began with a single physician handling pain issues at Brigham and Women’s Hospital. Today, its staff of 35 treats approximately 6,500 inpatients and more than 25,000 outpatients annually. BWHPMC’s patient-centered care for most acute and chronic pain conditions, including cancer pain, uses state-off the-art pharmacologic, interventional, behavioral and complementary treatment approaches. The staff performs nearly 8,000 procedures annually, from neural blocks to nucleoplasty to implanting spinal cord stimulators to intrathecal pumps. Its full range of cognitive-behavioral therapies includes biofeedback, relaxation training, coping skills, psychotherapy and vocational counseling, while complementary medicine treatments incorporate such techniques as hypnosis, acupuncture, massage and herbal medicine. The center’s multidisciplinary/multicultural team consists of board-certified physicians in anesthesiology, neurology, orthopedics, internal medicine, physiatry and psychiatry—supported by advanced practice nurses, physician assistants, psychologists, physical and occupational therapists, pharmacists, acupuncturists, massage therapists, and dental and facial pain specialists. Case managers coordinate care for each patient, and the center employs language interpreters, patient advocates, financial counselors and domestic violence counselors when necessary. According to Dr. Ross, the team’s multiculturalism is a key asset. “You have to take into account a patient’s personal beliefs regarding culture and religion in order to reach them,” he said. “Especially at end of life, when religious beliefs become paramount.” High-Tech Tools Information technology (IT) has proven to be one of the most important tools in BWHPMC’s toolbox,

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 57

PA IN M E D ICIN E Exploring the Nature of Pain Research at BWHPMC into the basic mechanisms of pain, as well as new therapies, is conducted at its Pain Research Center in Boston. Established in 1980, the center engages in both basic science and clinical research, using a variety of methods: molecular biology, cellular physiology, biochemistry, pharmacology, animal behavioral studies and clinical observations. It receives approximately $10 million in funding from the National Institutes of Health

see Brigham page 58

AdaptiveStim

EXCLUSIVELY AVAILABLE WITH

RestoreSensor ® Listens and senses when your patient changes position. Learns from previous experience and remembers your patient’s last comfortable setting. Responds and automatically adjusts stimulation to your patient’s optimal setting. Records your patient’s objective activity data.

The Choice of

Continuous Motion Learn more by visiting www.adaptivestim.com. or contact us via email at RS.adaptivestim@medtronic.com. Neurostimulation Systems for Pain Therapy Brief Summary: Product Technical Manuals and Programming Guides must be reviewed prior to use for detailed disclosure. Indication for Use - Chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain. Contraindications: Diathermy. Warnings: Defibrillation, diathermy, electrocautery, MRI, RF ablation, & therapeutic ultrasound can result in unexpected changes in stimulation, serious patient injury or death. Rupture/piercing of neurostimulator can result in severe burns. Electrical pulses from the neurostimulator may result in an inappropriate response of the cardiac device. Precautions: The safety and effectiveness of this therapy has not been established for: pediatric use, pregnancy, unborn fetus, or delivery. Follow programming guidelines & precautions in product manuals. Avoid activities that stress the implanted neurostimulation system. EMI, postural changes, & other activities may cause shocking/jolting. Adverse Events: Undesirable change in stimulation; hematoma, epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief, chest wall stimulation, & surgical risks. For full prescribing information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com. USA Rx Only Rev 0209

UC220012 112050 50073d 5073d 733d d EN

improving the quality, safety and effectiveness of assessing and treating patients in pain. “We have a very active clinical practice,” said Robert Jamison, PhD, professor, Department of Anesthesiology, Perioperative and Pain Medicine and Psychiatry at BWHPMC. “Technologies such as electronic medical records, computerized provider order entry, note scanning and medication tracking programs help us determine if we are providing the safest and most effective care to these patients. We also educate our physicians on the newest developments in the field, and technology helps us do that.” Patients compile pain experiences on electronic diaries. “Electronic diaries allow patients to track pain much more accurately, and they give us a better understanding of what is happening,” Dr. Jamison said. “If you can monitor what’s happening on a daily basis, you get much more detailed information. It’s a huge benefit versus paper records.” BWHPMC takes advantage of three-dimensional (3D) pain mapping software to better identify the sources and intensity of a patient’s pain. Patients use the software on their home computers to zoom in or rotate 3D body images to locate their pain and classify it (e.g., burning, aching, stabbing). The information is uploaded to a center pain specialist who can graphically see the patient’s pain. “Technology improves communication and enriches the clinician–patient relationship,” said Dr. Jamison. “Additionally, it allows us to collect more accurate data, helping us develop better outcomes information. The future should prove very exciting. We’re currently working with an electronic device located on the side of a patient’s stomach that tracks his or her movements. That kind of information has been a weak link in pain management—what activities do people do on a daily basis.”

and industryy sponsoredd grants, allowing its 13 PhDs and 20 research fellows and assistants to conduct more than 50 clinical trials and observational studies. A current study involves using nanotechnologies to treat chronic pain. BWHPMC’s Laboratory of Nanomedicine and Biomaterials seeks to develop nanoparticle systems capable of delivering therapeutic molecules to targeted disease cells. These particles also might be equipped to signal when the drug is

58 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

P A IN M E D I C I NE BRIGHAM

CONTINUED FROM PAGE 57

delivered and how effectively it is working. “This methodology could have far-reachingg implications for treating many diseases,” said Omid Farokhzad, MD, director of the lab. “In the long run, the real impact for pain, and related fields like oncology, will come when systemically administered nanoparticles not only image and treat, but also sense and detect very early disease changes when they can be most readily treated.” Other studies the center is involved with deal with the molecular and cellular mechanisms of pain, how anesthetics and analgesics affect the body, sensory pain testing, the role of catastrophizing, opioid therapy for noncancer pain, and better tools for selecting and assessing patients for opioid therapy. Training Aids Innovation Completing BWHPMC’s balanced approach is its training capabilities, which have made it one of the leading centers in the United States for developing tomorrow’s pain specialists. “Training helps us keep on the cusp of innovation,” said Srdjan Nedeljkovic, MD, director of the pain medicine fellowship program. “Our fellows expect and anticipate that we will be involving them in the latest [methods] for managing pain.” The fellowship program, accredited by the Accreditation Council for Graduate Medical Education, graduates eight fellows each year. The International Association for the Study of Pain–based curriculum covers approximately 50 topics—from acute to cancer and HIV pain, as well as most treatments (e.g., pharmacologic management, interventional procedures). Advertisement

NEW PRODUCT Pyxis® Anesthesia system with Codonics™ SLS 500i™ Safe Label System™ from CareFusion Pyxis® Anesthesia system and Codonics™ SLS 500i™ Safe Label System™ help simplify complex OR medication processes. Pyxis Anesthesia system helps provide secure, convenient access to OR meds, while automatically documenting stored and dispensed drugs. The SLS 500i™ helps improve medication safety and support labeling requirements by providing electronic safety checks wherever syringes are prepared. 3750 Torrey View Ct. San Diego, CA 92130 Phone: (858) 617-2000 communications@carefusion.com www.carefusion.com See our ad on page 6.

Brigham and Women’s Pain Management Center‘s multidisciplinary/multicultural team enables it to treat the complex issues associated with chronic and acute pain.

BWHPMC training also extends to residents at Brigham and Women’s Hospital, and the center has worked with the Controlled Risk Insurance Company, a leader in evidence-basedd risk management, to develop an interactive Web site to educate primary care clinicians on assessing and treating pain. More than 5,000 primary care physicians currently log on to the Web site’s continuing medical education course. Hand in hand with training, the center’s public policy/public awareness initiatives have brought its clinicians before a variety of legislative hearings on pain management issues. Dr. Nedeljkovic was part of the legislative committee that created the Massachusetts Pain Initiative, which took effect Feb. 1. It requires any physician obtaining or renewing his or her professional license to complete at least 10 hours of training in effective pain management. BWHPMC also has been involved in developing a prescription monitoring system for Massachusetts, and creating Federation of State Medical Boards policies on prescribing opioids. “We have to reach out not only to our own local community of doctors and patients, but beyond that in order to provide the best care,” Dr. Nedeljkovic said.

BWHPMC researchers study the molecular structure of brain receptors and ion channels to uncover their roles in pain and the drugs used to treat it.

referral base and significantly increase our service radius.” The center also is about to launch an initiative to help primary care physicians better assess patients who need opioids. It will provide them with treatment protocols, such as opioid risk management and outcomes tools, and pre-visit online questionnaires Maintaining the Equilibrium to track how the drugs affect patients, including their Despite its full plate, BWHPMC has been expand- activity levels and other measures, such as sleep. “It ing clinical services, such as psychology, social work will let us more effectively participate with accountand pharmacy, and its palliative care and pelvic able care organizations,” Dr. Ross said. pain programs to better meet the changing needs “Medicine is changing very quickly; the final form of patients. It is looking to develop more high-tech of what these changes will look like is still far from interventional tools, such as improved radiofre- being defined,” he continued. “What is clear is that quency ablation and spinal percutaneous procedures. pain management will need to develop meaningful “We also are developing online collaboration tools outcome measures, understand the true cost of treatto allow us to better communicate with primary care ment and provide more cost-effective approaches that doctors for initial pain management approaches bring specialized knowledge to the front lines of care.” and speed referrals when specialty care is required,” Dr. Ross said. “This will allow us to expand our —Thomas McDonough

www.dantrium.com *JHP’s Dantrium® IV has a 36 month shelf life at manufacturing point. Compare the dating between the brand Dantrium® IV and the generic Dantrolene Injection/Revonto™ before placing your order. There is always some lag period between manufacturing date and when the product ships to the end user, which varies based on when the order is placed. Please note thatt Dantrium® IV shipping now expires in 2015, allowing you the most savings in the event the product sits in your inventory until it expires. Management of Malignant Hyperthermia (MH) crises requires various supportive measures individualized for the patient’s condition. Administration of Dantrium® IV is one component of therapy and should not be considered a substitute for these measures. Even when properly treated, an MH crisis can result in death. Adverse events with Dantrium® IV include loss of grip strength, weakness in the legs, drowsiness, and dizziness, thrombophlebitis, and tissue necrosis/injection site reactions secondary to extravasation. There have been rare reports of pulmonary edema, urticaria and erythema. Symptomatic hepatitis (fatal and non-fatal) has been reported at various dose levels of the drug. Fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur with Dantrium® therapy. In case of overdose, symptoms include, but are not limited to, muscular weakness, lethargy, coma, vomiting, diarrhea, and crystalluria. For acute overdosage, general supportive measures should be employed. Please visit www.dantrium.com for full prescribing information for Dantrium® IV. MK268A

60 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

P A IN M E D I C I NE

New York Law Targets Painkiller Abuse Advocates call it a national model, but critics call program unwieldy, unhelpful

VT n Aug. 27, New York Gov. Andrew ME Cuomo signed into law a bill intended WA MT ND to curb the state’s “epidemic” of preMN scription drug abuse and diversion. NY OR WI SD ID MI The Internet System for Tracking OverWY PA IA Prescribingg Act (I-STOP) calls for a modNE OH IL IN NV WV VA ernization of New York’s online prescription UT V CO KS KY drug monitoring program (PDMP), a regCA MO NC istry that prescribers or their designees must TN OK SC AZ NM AR consult before writing prescriptions for conGA MS AL trolled substances. Pharmacists filling those TX prescriptions will be required not only to LA AK FL check the registry but also to update it in real time. Lawmakers hope the law will discourage doctor shopping. Operational PDMPs Eric Schneiderman, the state’s attorney HI Enacted PDMP legislation, but general, called I-STOP “a national model for smart, program not yet operational coordinated communication between health care Legislation pending GU providers and law enforcement to better serve patients, stop prescription drug trafficking, and provide treatment to those who need help.” The law faces strong opposition from several physi- Figure. Status of prescription drug monitoring cian and patient advocacy groups, including the Med- programs (PDMPs). ical Society of the State of New York (MSSNY), that Map is current as of June 13, 2012 have expressed concern that it will restrict access to care. Operational ‘Nightmare’? The legislation takes effect on Aug. 27, 2013, New York is not the only state to use a PDMP, nor although practitioners writing prescriptions in the is the registry strategy new. Every state except Misemergency department or dispensing in-house med- souri has enacted legislation for state-run PDMPs, and ications will be among those exempted. I-STOP also the system is operational in 41 of them (Figure). New will require the state to adopt electronic prescribing York’s program has existed for decades, but physicians by the end of 2014, a move expected to curb fraud were not previously required to check it and many selfrom stolen prescriptions and prescription pads. In dom did so. addition, I-STOP reschedules hydrocodone as Sched“It’s operationally a nightmare. It’s cumbersome. It’s ule II and tramadol as Schedule III substances. slow,” said Daniel Murphy, MD, MBA, president of An early proposal for I-STOP included cost esti- the New York chapter of the American College of mates of $10 million to overhaul the state’s PDMP. Emergency Physicians. Another concern, he said: The However, the law is not expected to have a fiscal database is updated by pharmacies only by the 15th impact, according to state budget officials. “Initial day of the following month—and even then, only preinvestments can be covered within existing resources,” scriptions meeting multiple red-flagg criteria show up. said Morris Peters, a spokesman for the State Division “If I’m worried about some guy in front of me hopof Budget, in an email. The division expected cost ping from drugstore to drugstore perhaps this weeksavings from fewer paper prescriptions and inappro- end,” Dr. Murphyy said, “what good is data from 12 priate prescriptions. weeks ago?” I-STOP garnered unanimous support in the New Keeping Pace With Florida York Senate and Assembly, which sent the bill to The Centers for Disease Control and Preven- Gov. Cuomo’s desk in June, just a week after the FDA tion calls prescription drug abuse the nation’s fastest- announced its Risk Evaluation and Mitigation Stratgrowingg substance use problem. In step with the rest egy (REMS) for long-actingg and slow-release opiof the nation, New York’s narcotics prescriptions have oids. An initiative three years in the making, REMS skyrocketed in recent years. More than 22 million requires drug companies to fund optional educational were written in 2010—a number exceeding the state’s programs for physicians who prescribe the painkillers. population, and a 36% rise since 2007. In 2010, unin- That disappointed some stakeholders, including Physitentional overdose deaths involving prescription anal- cians for Responsible Opioid Prescribing (PROP; see gesics numbered 171 in New York City alone. article, page 52), as the agency’s own advisory commitCrime is another grim consequence of the epi- tee had urged it to make education mandatory and to demic. In New York, a dealer was jailed for selling educate doctors about shorter-actingg forms of opioids oxycodone from his Staten Island ice cream truck, as well. An early version of I-STOP also included manwhile last summer, David Laffer, an unemployed Army veteran, killed four people at a Long Island datory prescriber training. According to Lawrence pharmacy in a theft of more than 10,000 pills of Epstein, MD, vice president of the New York State hydrocodone. Society of Anesthesiologists (NYSSA), the group

asked that the requirement be removed. NYSSA feared that some physicians would forgo training NH aand opt out of prescribing. That would leave MA ppain specialists with a heavier patient burRI CT den d and potentially decrease access to care for NJ patients who require these medications. DE MD Frank Dowling, MD, clinical associate proDC fessor of psychiatry at Stony Brook Univerfe sity Medical Center, in Stony Brook, N.Y., and Commissioner for Science and Public Health for MSSNY, said the risk that doctors will stop prescribing opioids is a real concern. Being required to check the database—and I-STOP’s potential new layer of liability—will discourage many nonspecialists from prescribing controlled substances, he said. It also will damage doctor–patient relationships and may lead to increased complication rates from use of other pain medications like nonsteroidal anti-inflammatoryy drugs. “What the state did, in my view, is they faulted doctors for not using a database that most didn’t know existed or how to use it, and does not work,” Dr. Dowlingg said. “Doctors are human. You give us a tool that works and we are going to use it.” But a mandate, he said, is “heavyy handed and overreaching. To have to look up every single patient every single time is a huge waste of resources.” Upgrading the database, integrating it with electronic medical records, and adding an array of voluntary measures like improved law enforcement and better patient and physician education would have accomplished similar ends, he said. “I would hope that other states could learn from New York and avoid the unintended consequences that it chose not to avoid.” On the other hand, Andrew Kolodny, MD, chair of psychiatry at Maimonides Medical Center in New York City, and president of PROP, expressed cautious support for I-STOP’s mandate. “Otherwise, the only docs that are going to really look at it are going to be the ones we are least worried about,” Dr. Kolodnyy said. Indeed, CDC medical epidemiologist Leonard Paulozzi, MD, MPH, said a small subset of prescribers—mostly primary care physicians—writes the vast majority of opioid prescriptions in the United States. “There may be 100 patients for every one doctor,” Dr. Paulozzi said. “It makes more sense to focus on physician practices than try to modify the behavior of those 100 patients.” Among anesthesiologists, those most likely to be affected by the new law are pain specialists, Dr. Epstein said. “I think for the average anesthesiologist who is not practicing pain management, it won’t change anything,” he said. “So long as the database access is streamlined and the results timely and comprehensive, it’s very reasonable for physicians to be querying the database, so I do not have a problem with that.” Regardless of how I-STOP works out in practice, it seems certain that doctors in New York will continue to see patients who are abusing or diverting opioids. y “is a very “Learning how to say no,” said Dr. Murphy, important part of the future.” —Jenny Blair

62 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

P A IN M E D I C I NE

Nerve Handling Tied to Chronic Pain After Hernia Surgery New York—One k in six patients who reported chronic pain six months after an open inguinal hernia repair still suffers from chronic pain 10 years later, according to a prospective German study reported at the Fifth International Hernia Congress. Others develop late-onset pain, even after five years. “Patients reporting chronic pain vary with time. This is a very important message,” said lead author Wolfgang Reinpold, MD, director of the Department of Surgery of Gross-Sand Hospital and director of the Hernia Center, in Hamburg. The study was initially published in Annals of Surgery in 2011, at which point, only five-yearr data were available. At this spring’s international hernia meeting, Dr. Reinpoldd presented updated results after conducting a 10-year follow-up of the two-phase study. The prospective cohort study followed 736 patients who underwent 781 elective primary inguinal hernia operations at the Hernia Centre of Reinbek Hospital, Germany, from April 2000 to April 2002. Patients underwent pain assessments on the day of surgery; the first, second and seventh day postsurgery; and at six months and five years after surgery. After six months, the rate of chronic pain was

16.4%, while 15.9% of patients reported sensory disorder. At the five-yearr mark, 16.1% of patients reported chronic pain and 20.3% had sensory disorder of the groin. Independent significant predictors of chronic pain were preoperative pain, chronic pain after six months, sensory disorder after five years and ilioinguinal nerve neurolysis in Lichtenstein repair due to mobilization of the nerve from its natural bed and nerve preservation. Based on the results of the study, Dr. Reinpold and colleagues called on surgeons to avoid ilioinguinal nerve mobilization in the Lichtenstein technique. “The inguinal nerves should either be left untouched in their natural bed or, if this is not possible, a neurectomy and proximal end implantation … should be performed,” they said. At the meeting, the investigators presented their 10-yearr outcomes data. They had sent a questionnaire to 736 patients, and received responses from 55%. Eight patients in the cohort died over the course of the study. Among the respondents, 13.6% reported chronic pain 10 years after surgery. Most patients with pain classified it as mild without an effect on daily activities or quality of life. However, eight patients (1.8%) had

relevant pain, defined as a score greater than 3 on a visual analog scale. No patient described the sensation as very strong. Five of the eight reported a slight interference with daily activities. Among the eight patients with relevant pain, five had undergone a Lichtenstein repair and three had a Shouldice repair. Seven of the eight patients had neurolysis of the ilioinguinal nerve with preservation of the nerve. Significant predictors of chronic pain were younger than age 50 years, sensory disorder of the groin after five years and chronic pain after six months. Dr. Reinpold said the 10-yearr results confirm their earlier recommendations. They called on surgeons to visualize the nerves and handle with care; to leave the inguinal nerves untouched in their natural bed or, if this is not possible, to perform a neurectomy and proximal end implantation; to leave the cremasteric muscle and spermatic fascia intact; and to avoid mesh suture fixation to the internal oblique muscle. The investigators believe that a chronic inflammatory reaction occurs between the conventional polypropylene mesh and mobilized nerve, leading to long-term post-herniorrhaphyy chronic pain. Another hypothesis is that chronic scar formation with fibrotic nerve traction leads to chronic pain. Dr. Reinpold’s study comes on the heels of international guidelines published in 2011. Both reports see nerve page 65

Obesity and Pain Associated in Large-Scale Study

bese individuals are more prone to daily pain, new data show. In a study of more than 1 million randomly selected individuals in the United States, a clear association between body mass index (BMI) and pain was seen, even after controlling for demographic variables (Obesity [Silver Spring]; 2012 Jan 19. [Epub ahead of print]). Previous studies have suggested an association between obesity and pain, but “with data on over 1 million participants, this is likely the largest epidemiological examination of the pain–obesity relationship,” wrote Niloofar Afari, PhD, associate professor in the Department of Psychiatry, University of California, San Diego, in an email. Dr. Afari, senior author of a previous study (Pain 2010;11:628-635) that analyzed twin data to determine the relationship between chronic pain and overweight and obesity, said: “Like our own paper, this [new one] is a population-based study, meaning that the findings are likely not due to health care seeking.” However, Dr. Afari added, “Their finding of a

modest relationship between pain and obesity, which is not accounted for by specific pain conditions, contributes to the literature [on the topic].” The new study analyzed telephone survey data on 1,062,271 adults collected from 2008 to 2010 by the Gallup Organization. Survey questions included height and weight, allowing researchers to calculate BMI; questions about pain conditions in the past year; and a query about pain experience in the past day. The participants were categorized by escalating BMI: low-normal group (BMI <25 kg/m2); overweight group (BMI 25-30); obese I group (BMI 30-35 kg/m2); obese II group (BMI 35-40 kg/m2); and obese III group (BMI >40 kg/m2). The researchers found that 19.2% of the participants were in the lownormal BMI range, 21.4% were classified as overweight and the remaining 59.4% were in the three obese categories. Compared with the low-normal BMI group, the overweight group reported 20% more pain, and the obese I, II and III groups reported 68%, 136% and 254% more pain, respectively. The association held for both men and women

and was stronger in older age groups. Women presented a steeper trend as BMI increased compared with the trend for men. The authors concluded that “BMI and daily pain are positively correlated in the United States,” adding that the association is “robust” and exists after controlling for several pain conditions and across gender and age. Study leader Arthur A. Stone, PhD, vice-chair of psychiatry and behavioral science at Stony Brook University, in Stony Brook, N.Y., said the article marks an advance in at least two ways. “First, prior studies demonstrating this association were limited by their small sample sizes and, often, by their restriction to certain geographic areas. This study is representative of the entire United States and has a very large sample size. Second, pain was measured with a relatively new technique of asking respondents about their pain ‘yesterday.’ This measurement technique avoids distortion in the results due to biases associated with imperfect recall.” Much remains unclear about the relationship between obesity and pain, Dr. Afari noted. “There’s been some

investigation of the link between obesity and pain, but there’s still lots to be known in terms of the mechanisms that underlie the relationship.” Dr. Stone said, “[We] speculate that certain hormones associated with body fat could impact inflammatory processes, which themselves are associated with increased pain. [F]uture research will have to confirm that speculation.” Michael Nusbaum, MD, president of the New Jersey chapter of the American Society for Metabolic and Bariatric Surgery, noted the role of musculoskeletal pain. “Morbidly obese patients carry much more weight, and are subject to joint pain and back pain,” Dr. Nusbaum said. “Morbidly obese people also suffer from a chronic inflammatory response as a result of being obese.” —George Ochoa Drs. Afari and Nusbaum reported no relevant financial disclosures. Dr. Stone reported the following relevant financial disclosures: senior scientist with the Gallup Organization, senior consultant with PRO Consulting and member of the Scientific Advisory Board of Wellness & Prevention, Inc.

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 63

The following advertorial has been provided by Havel’s® Inc. and is designed to support the advertisement presented below.

Ultrasound Needles From Havel’s® Inc. Q: What are ultrasound needles? A: Ultrasound needles have special surface features that make them echogenic or hyperechoic during ultrasound-guided procedures. They show up brighter under ultrasound than regular needles. Havel’s offers several ultrasound needles for anesthesia and pain management, including the new improved EchoStim® Insulated, EchoBlock® Non-Insulated, EchoBlock®PTC30, EchoBlock®MSK, EchoBlock®PTC and the EchoTuohy™.

Q: What do anesthesiologists and certified registered nurse anesthetists use each ultrasound needle for? A: The EchoStim Insulated needle is used for ultrasound-guided peripheral nerve blocks (PNBs), by those using ultrasound and nerve stimulation together. The EchoBlock Non-Insulated and EchoBlock PTC30 are used for ultrasound-guided PNBs by those using ultrasound only. The sharper EchoBlock MSK and EchoBlock PTC are used for ultrasound-guided pain injections, typically in knees, hips and shoulders. Finally, the EchoTuohy is used for epidural catheter placement or PNBs by those using ultrasound guidance.

Q: What special surface features make Havel’s ultrasound needles echogenic? A: Havel’s new improved EchoStim, EchoBlock and EchoBlock MSK have patent-pending Corner Cube Reflectors (CCR®) near the tip, while the EchoBlock PTC, PTC30 and the new EchoTuohy have Micro Laser Etching (MLE™) near the tip. Both features create multiple angled surfaces near the tip to reflect the sound waves back to the transducer, even at steep insertion angles.

Q: What new improvement has been made to the EchoStim, EchoBlock and EchoBlock MSK needles? A: Originally, the needles had nine Corner Cube Reflectors near the tip arranged in three rows of three. This worked well, but some practitioners had to rotate the needle slightly to see the reflectors under ultrasound. By increasing the reflector pattern to four rows of four, they are recognized quicker and need to be rotated less often. We still focus on the tip with 16 reflectors in the first 5.5 mm of the needle.

Q: Are Havel’s insulated ultrasound needles more expensive than regular insulated needles? A: No. Most customers say Havel’s insulated EchoStim needles are the same price or cost less than regular insulated needles. Some were so impressed by the low price they wrote about it on Havel’s Web site. See their testimonials at http://blog.havels.com/testimonials/.

Q: Why should I consider needles from Havel’s? A: For more than 30 years, Havel’s Inc. has known the importance practitioners place on having the proper needle to ensure the safety of each patient. This is why, from the beginning, Havel’s

forged relationships with some of the finest manufacturers in the world. These relationships have allowed Havel’s to develop specialty needles for regional anesthesia and pain management in a variety of sizes and styles to help provide “safer, more effective blocks.”

Q: What is so special about Havel’s Hakko® needles? A: Hakko Medical, in Japan, is the world-class manufacturer of Havel’s needles. All feature two small bevels on the backside of the tip in addition

to the front-bevel geometry. These two small “back” bevels reduce lateral deviation and insertion pressure for smoother punctures and more control, which ensures more accurate injections and aspirations. Because this manufacturing process requires some handcrafting, you will not find back bevels on other brands. Hakko also manufactures its own cannula to guarantee the stainless steel has been purged of impurities. Hakko heatanneals each tube to get the exact combination of strength and flexibility, which reduces the “bowing” effect experienced with other

needles. Every Hakko needle is also inspected before it ships, and Havel’s is the exclusive U.S. distributor of Hakko needles.

For more information, please contact: Havel’s Inc. 3726 Lonsdale St. Cincinnati, Ohio 45227 (800) 638-4770 jbarrett@havels.com www.havels.com

64 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

P A IN M E D I C I NE

Up to One in Six Patients Report Pain 12 Months Postsurgery

significant percentage of patients who undergo herniorrhaphy, hysterectomy or thoracotomy experience chronic pain for several months afterward; up to 17% report pain 12 months after their procedures. Henrik Kehlet, MD, PhD, an expert in postsurgical pain, said he hoped the findings would “increase attention

to the clinical problem of long-term pain after surgery—a shared interest between anaesthesiologists and surgeons.” Dr. Kehlet, head of surgical pathophysiology at the Rigshospitalet in Denmark, was not involved in the latest research. Some patients develop chronic pain after surgery, but the rate of chronic postsurgical pain (CPSP) is always

higher in research studies than in patients presenting to pain units, said Antonio Montes Pérez, MD, PhD, chief of the pain clinic at the Hospital del Mar in Barcelona, Spain. One explanation, Dr. Montes said, is that many patients initially experience pain that lasts a few months, and then improves, so they do not raise the problem with their doctor.

You know ONLY capnography measures real-time adequacy of ventilation.

But did you know Oridion Capnography protects your non-intubated patients in the ICU and General Floor too?

To get a better sense of how many patients experience CPSP over the long term, Dr. Montes and his colleagues at the Catalan Society of Anesthesiology called patients three months after surgery. Anyone who said they had pain was referred to the hospital for a physical examination and more detailed questions about the level of pain. These patients also received treatment from the hospital’s pain unit. The investigators then called patients 12 months later to see if their pain had changed. Dr. Montes’ group initially called 2,399 patients who underwent herniorraphy, 1,013 after hysterectomy and 535 who had undergone a thoracotomy. Approximately 25% were lost to follow-up. The researchers found that 14% and 18% of patients said they were still in pain three months after a herniorraphy and hysterectomy, respectively. Of those who had undergone thoracotomy, nearly 38% were experiencing pain, most of whom also were taking analgesics, and experienced pain that exceeded a 3 on a 10-point scale in a 24-hour period (numerical rating scale; Table). After three months, the rate of CPSP dropped, but persisted in nearly 5% and 6% of patients who underwent herniorraphy and hysterectomy, respectively, and 17% of those who had undergone a thoracotomy. It is not surprising that thoracotomy is associated with a higher risk for long-term pain, explained Dr. Kehlet, as the procedure carries a high Table. Thoracotomy Patients Reported the Highest Rates of Lingering Pain After Surgery

Only capnography measures adequacy of ventilation as recommended by patient safety standards (ASA, APSF, Joint Commission)1,2,3. No matter how you measure respiratory rate, it gives you only a partial picture of ventilation. 1 ASA Standards for Basic Anesthetic Monitoring, Committee of Origin: Standards and Practice Parameters (Approved by the ASA House of Delegates on October 21, 1986, and last amended on October 20, 2010 with an effective date of July 1, 2011) - Viewed 3-21-11 at ww.asahq. org/.../Standards%20Guidelines%20Stmts/Basic%20Anesthetic%20Monitor ing%202011.ashx

Protect all your patients with Oridion Capnography: Crisp, accurate waveforms Simple to use Comfortable for your patients Learn more at www.oridion.com.

2 Stoelting R and Overdyk F. Anesthesia Patient Safety Foundation, Conclusions and Recommendations from June 08, 2011 Conference on Electronic Monitoring Strategies to Detect Drug-Induced Postoperative Respiratory Depression. Accessed August 25, 2011 at http://www. apsf.org/announcements.php?id=7. 3 Standards for Basic Anesthetic Monitoring. American Society of Anesthesiologists. Accessed 6/20/11 at http://www.asahq.org/For-Healthcare-Professionals/~/media/For%20Members/documents/Standards%20Guidelines%20Stmts/Basic%20Anesthetic%20Monitoring%202005.ashx

Patients enrolled, n Patients lost to follow-up, n (%) Median age (10th-90th percentile) CPSP at 3 mo, % NRS >3, % Patients taking analgesics, % Patients with neuropathic pain, % CPSP at 12 mo, % CPSP, chronic postsurgical p g pain; p NRS, numerical ratingg scale

Come see us in the Covidien booth #1416 at ASA

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 65

PA IN M E D ICIN E likelihood of damaging the intercostal nerve. Overall, the findings are consistent with previous research, Dr. Kehlet added, but they do not advance the understanding of what causes CPSP—or how to treat it. So far, every procedure appears to carry some risk for chronic pain, which increases in patients with preoperative psychosocial factors such as anxiety and concern about pain, those who experience nerve injury during surgery and possibly in patients who do not receive enough postoperative pain management. In the meantime, the new findings suggest that doctors need to be more proactive in preventing and managing postsurgical pain, Dr. Montes said. If patients are experiencing pain in the first few months after surgery, he recommended, they should be referred to experts in pain management. “We need to be more aggressive in the perioperative management of pain, above all, in the patients with more risk,” Dr. Montes said. In patients with risk factors for developing CPSP, “it is important to diminish intensity of pain during the whole perioperative period.” These results are part of a multivariate analysis that identified several variables that appear to increase the risk for developing CPSP, including some genetic polymorphisms. Although CPSP seems to disappear in some patients, for too many, the pain lingers, Dr. Montes said. “Many of these patients are never referred to pain units because many surgeons consider that if there is not surgical treatment needed, the pain expressed by the patients, it is not justified, that is why patients continue suffering in silence.”

NERVE

CONTINUED FROM PAGE 62

stress what some specialists have argued for years: A mesh repair is not the same as a traditional tissue repair with the addition of mesh. Mesh repairs are a completely different operation and the nerves need to be treated carefully, left in their natural beds and not exposed to contact with the mesh. “Mesh repair has its own principles that have to be followed. For

many years, surgeons had a mindset that was otherwise,” said Parviz K. Amid, MD, clinical professor of surgery at the David Geffen School of Medicine at the University of California, Los Angeles. Dr. Amid said surgeons persistently hung onto three “cardinal mistakes from the past”: removing the ilioinguinal nerve from its natural bed, roughly mobilizing the spermatic cord by finger instead of doing it gently under direct vision and removing the cremasteric layers that protect the genital branch

of the genitofemoral nerve and the vas deferens. Based on the current evidence, the rate of chronic pain can be reduced to less than 1% by careful nerve handling, Dr. Amid said, and surgeons are growing more cognizant of nerve management. “Surgeons are beginning to understand that they have to deprogram their memory bank and not rely on teachings of the past,” Dr. Amidd said. —Christina Frangou

The complete single-use laryngoscope system

No Risk of Cross-Contamination Designed for single use only, BritePro Solo laryngoscopes are 100% sterile and packaged individually, thus eliminating the risk of cross-contamination.

Thoracotomy

Herniorraphy

Hysterectomy

—Alison McCook

2,399

1,013

535

638 (26.6)

247 (24.4)

133 (24.9)

- No risk of cross-contamination

60 (39-76)

54 (42-74)

64 (49-76)

- Quality Feel without Compromise

13.6

17.9

37.6

- One Size Fits All

38.6

48.3

52.5

- Excellent Tissue Visualization from Advanced LED light

24.9

47.4

60.5

- Saving Life Economically

38.7

37.4

55.1

4.5

5.9

17.0

www.briteproSolo.com 1 800 985 3314

inquiries@flexicare.com

66 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

P A IN M E D I C I NE

Caudal Epidurals Show Benefit for Chronic Low Back Pain

axmaiah Manchikanti, MD, CEO and board chair of the American Society of Interventional Pain Physicians (ASIPP) and several other experts have found good evidence for use of caudal epidural injection and steroids to relieve chronic low back pain caused by disk herniation or radiculitis (Pain Physician 2012;15:E159-E98). The review found only fair evidence for

caudal injections in managing chronic axial or diskogenic pain, spinal stenosis and post-surgeryy syndrome. “This was an extremely rigorous evaluation with assessment of the quality of the studies without injecting personal bias as is done in many cases,” Dr. Manchikanti observed. Dr. Manchikanti, ASIPP Past President Allan Parr, MD, and seven

others examined 73 studies published between 1966 and December 2011. The team assessed the clinical relevance and quality of the 11 randomized trials and five observational or cohort studies that met their inclusion criteria. Overall they found few studies of reasonable quality, particularly for chronic low back pain without disk herniation.

FRIDAY - TUESDAY DECEMBER 14 -18, 2012 MARRIOTT MARQUIS NEW YORK

66th Annual

PostGraduate Assembly in Anesthesiology PROGRAM & REGISTRATION MATERIALS:

Sponsored by:

The New York State Society of Anesthesiologists, Inc.

Up to 46.5 AMA PRA Category 1 CreditsTM

m Internationally Renowned Speakers m Scientific Panels & Focus Sessions m Hands-on & Interactive Workshops m Mini Workshops m Medically Challenging Case Reports m Problem-Based Learning Discussions m Scientific Exhibits m Poster Presentations m Technical Exhibits m Resident Research Contest m Pre-PGA Hospital Visits m 3,500 Anesthesiologists in Attendance m More than 6,000 Registrants m New York City Tours m Holiday Shopping m Jazz Clubs m Broadway Shows m Opera

Featuring programs in conjunction with:

ONLINE REGISTRATION:

www.nyssa-pga.org

Six of the randomized trials and two of the non-randomized studies examined disk herniation and radiculitis. Four of the six randomized trials included long-term follow-up, and three of these—two of which were found to be high-quality—had positive results. The two studies with short-term follow-up had positive results. Both non-randomized studies had long-term follow-up. One yielded positive results and the other demonstrated what the reviewers considered unclear results. The review of the studies for chronic axial or diskogenic pain, spinal stenosis and post-surgeryy syndrome showed fair evidence for use of caudal epidural injections for these indications. “This paper reactivates the interest in this old technique, which is both simple and can be useful in some selected patients,” said Michel Dubois, MD, professor of anesthesiology and pain medicine at New York University Medical School, in New York City. “Unfortunately though, it didn’t address improvements to needle injection technique that have been made, such as giving the injections using a catheter directed closely toward the site of the pathology. This is particularly useful in patients who had previous back surgeries.” Lawrence Kamhi, MD, a pain specialist at Beth Israel Medical Center, in New York City, called the review helpful. “For clinicians preferring this approach over lumbar interlaminar or transforaminal epidural injections, as well as for post-laminectomyy and fusion surgery patients being treated for chronic pain and for whom the caudal epidural approach is anatomically simpler to execute, the authors’ systematic literature analysis is reassuring.” In separate systematic literature reviews published in Pain Physician, Dr. Manchikanti and several others found good evidence backing the effectiveness of therapeutic lumbar transforaminal epidural steroid injections (2012;15:E199-E245) and lumbar interlaminar epidural injections (2012;15:E363-E404) in radiculitis secondary to disk herniation in the back or lower extremities. They also found good evidence for the effectiveness of cervical epidural injections for the management of chronic neck and upper-extremity pain caused by radiculitis secondary to disk herniation (Pain Physician 2012;15:E405-E434). —Rosemary Frei, MSc

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 67

PA IN M E D ICIN E

Interventionalist Group Releases Updated Opioid Guidelines

ractitioners of interventional pain management typically consider strategies such as epidural injections and nerve blocks before initiating more “conventional” pharmacotherapeutic approaches, so it should come as no surprise that a professional society representing the specialty advocates for a conservative philosophy regarding the use of opioid analgesics in the setting of chronic noncancer pain. The American Society of Interventional Pain Physicians (ASIPP) first developed its “Guidelines for Responsible Opioid Prescribing in Chronic NonCancerr Pain” in 2005 with the goal of “curtail[ing] the abuse of opioids without jeopardizing noncancer pain management with opioids.” In July, the group released an updated version of the document, which was published in two parts in the journal Pain Physician (2012;15[3 suppl]:S1-S116). “Because of the changing body of evidence, this document is not intended to be a ‘standard of care’ [but is meant] to provide guidance for the use of opioids for the treatment of chronic noncancer pain, to bring consistency in opioid philosophy among the many diverse groups involved, to improve the treatment of chronic noncancer pain, and to reduce the incidence of drug diversion,” said Laxmaiah Manchikanti, MD, ASIPP’s CEO and chair of the group’s board. The authors of the guidelines found “good evidence” that nonmedical use of opioids is “extensive,” citing for example that as many as one-thirdd of chronic pain patients “may not use prescribed opioids as prescribed or may abuse them” and that a significant proportion (roughly 40%) of the fatalities associated with opioids may stem from this improper use. They also wrote that evidence supporting the short-term use of opioids for chronic noncancer pain is “fair” but that evidence supporting their long-term use in this setting is “limited” due to a lack of “long-term (>3 months), high-quality” studies. Although ASIPP does not recommend entirely against long-term use of opioids, the group does urge physicians considering opioid therapy for longer than 90 days in chronic pain patients to first perform “comprehensive assessment and documentation” of the patient focusing on, among other aspects, “psychosocial history, psychiatric status and substance abuse history.” And despite what it described as “limited evidence” of its reliability and accuracy, the panel

also supports screening for opioid use as well as urine drug testing and prescription monitoring (according to existing laws in the physicians’ home state, if applicable). The use of both of these latter strategies is supported by stronger evidence, according to ASIPP. Based on recommendations such as these, “noninterventionalists” such as Michael W. Loes, MD, director of

Sierra Pain Consulting in Scottsdale, Ariz., believe ASIPP is “leaning toward ‘political correctness’ in a social environment where opioids for chronic pain are now increasingly frowned upon.” Dr. Loes said ASIPP has “largely separated itself ” from professional societies such as the American Academy of Pain Medicine and the American Pain Society “with a selective” point of view.

“Notably, most ‘interventionists’ have entrenched ideas that blocks of various sorts, stimulators of various types and pumps with various combinations of cocktails are better than a sensitive patient–physician relationship where appropriate medication is prescribed, opioid or nonopioid.” —Brian Dunleavy

e-Newsletters and e-Alerts Get the latest news from the best-read anesthesiology hesiology publication in th he country delivered directlly to yourr computer or mo obile dev device for free! Eacch iinstallment con ntains a articles from m the currrent re month’s issu ue e ahead of pr print, as well as liin nks to podcasts and do other Web-exclusive content Scan this QR code to register for free

Read the latest issue on your iPad! Download it for free from the App Store

@anesthesianews

68 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

P A IN M E D I C I NE

Exceeding Patient Expectations Dear Arizona Pain Specialists, I am a physician-owner of a pain practice in Mississippi, and have begun to hear complaints from several patients about my practice. These complaints primarily center on the staff on the phones being in a hurry, rude and generally unhelpful. None of these complaints are directed at the medical care that we deliver, but I find myself struggling daily to address these needs. What is the missing piece that is preventing my practice from satisfying my patient’s needs? Sincerely, Dr. Tele-path Dear Dr. Tele-path, common misconception in medicine is that a patient’s experience, positive or negative, is defined by his or her experience with a medical provider. In reality, what happens before or after the patient visit is just as important as what occurs in the exam room. A great example of this is how your staff interacts with and treats patients on phone calls. Providing excellent patient care involves making excellent clinical decisions and supporting patients’ needs in and outside of the office. Understanding C.A.R.E. and how it can be applied to your practice will improve the patients’ perception of your practice and of the medical community. So what is C.A.R.E.? C.A.R.E. stands for: Showing Compassion for patients, Acknowledging their individual needs, setting Reasonable expectations and providing Excellent customer service. C.A.R.E. is about understanding yourr patient, whether this interaction is in the exam room or over the phone. It is important to recognize that your phone staff ’s contribution to patient care is no less important than the care they receive from medical staff in the exam room, and may dictate the success or failure of their treatment.

this week.” This reaction may be appropriate, but this answer lacks compassion. So what’s another option that may be a more compassionate response? “Ms. Smith, I’m so sorry to hear that you are in so much pain. Unfortunately, we don’t have any available appointments until the day after tomorrow, but we are putting you on our call list if we have any lastminute cancellations. Please tell me a little bit more about your pain though, and I will see if there is anything that we can do for you in the meantime.” Notice that, in this instance, a compassionate response doesn’t necessarily mean that Mary is going to be able to get an appointment any sooner. But this response shows that you care about her pain and are validating her condition. It also lets her know that you are working on her behalf and trying to seek an earlier solution to her problem. Providing Compassion in Action this level of service shows that the patient isn’t “just Compassion is an important attribute for all prac- another number” with your practice—even if you titioners of medicine to have, and it is a virtue found aren’t always able to meet each person’s immediate throughout the most successful pain management demands. practices. Compassion in pain management starts Acknowledging Individual Needs with understanding that patients often are experiencing severe and debilitating pain along with psyYou can establish guidelines or script how a call chological comorbidities. As a result, pain patients should go, but one of the keys to excelling in cusalready may be upset or irritable when they interact tomer service is to acknowledge the unique needs with your office staff. It is important that every staff of each patient. Although you can’t “know” every member is sympathetic to patients’ pain and makes patient, you can become an expert at recognizing difan effort to work with them so they can receive excel- ferent tones of voice and allowing the patient to diclent patient care. tate the flow of conversation. Most patients can be divided into three categoLet’s take this common example. The patient Mary Smith contacts your practice regarding what she ries. The first type, the “easy patient,” is going to rely describes as “horrible pain,” and demands to be seen on you to dictate the flow of the conversation. They immediately. Ideally, Mary Smith would be accom- typically will not ask a lot of questions and will allow modated, yet in this example there are no avail- you to walk them through the process. Handling this able appointments for at least two days. Without a type of patient should be easy—you simply follow all quick option for solving this problem, the response of the normal steps to schedule an appointment and often is simply to tell the patient, “Sorry, there are offer them any necessary information. Review imporno appointments and you will have to be seen later tant information with this type of patient even if you

believe that they already know it, as they probably will not inquire. The second type, the “busy patient,” wants his or her needs met quickly and is looking for quick and concise answers to questions. They are identified by an impatient tone in their voice, a tendency to talk over you and talk fast. The best thing that you can do for these patients is to rapidly identify their needs, address them, confirm that you have fully assisted them and allow them to proceed with their day. The last thing that you want to do is to keep them on the phone longer than they want to be. The final type of patient, the “inquisitive patient,” is looking for either extensive information or somebody to talk to. These patients do not come along frequently. Still, it remains important that you address their needs. Some of them are looking for a lot of information and are likely to ask many questions. This can be frustrating, but conveying information is important and they should not be faulted for being detail-oriented. Information relayed to any patient should be accurate, and it is especially important with these patients, as they may be taking notes and would remember your name if you say anything incorrect. Other patients are simply looking for somebody to talk to about unrelated matters. You should listen and participate in this conversation, but only up to a point. It is your responsibility to tactfully guide the conversation to a conclusion to avoid potentially jeopardizing other patients’ care by assisting just one person. For example, patient John Stevens, a 78-year-old widower, regularly contacts your practice to “confirm appointments” and to discuss his care plan, but routinely steers the conversation to stories about his life. It is important that you do not simply disregard Mr. Stevens, but also that you steer the conversation to a conclusion. For example: “That sounds see expectations page 70

PONV prevention that covers the entire at-risk period from post-op to PACU discharge Priming dose starts early Unique transdermal delivery system provides a priming dose of scopolamine upon application Statistically signiﬁcant reduction in nausea, vomiting, and retching 2 to 4 hours post-op1

Continuous release keeps working Extended release delivers a near constant dose over 24 hours2 66% of Transderm Scop® patch patients vs. 46% for placebo reported no retching/vomiting within the 24-hour period postadministration

1. Kootelko DM, Rottman RL, Wright WC, et al. Transdermal scopolamine decreases nausea and vomiting following cesarean section in patients receiving epidural morphine. Anesthesiology. 19899;71:675-678. 2. Transderm Scop® [package insert]. New Providence, NJ: Baxter Healthcare Corporation; 2006. Corp

Indications and Important Risk Information for the Transderm Scop® patch (scopolamine 1.5 mg) Transdermal Therapeutic System

Indications The Transderm Scop® patch is indicated in adults for prevention of nausea and vomiting associated with recovery from anesthesia and surgery. The patch should be applied only to skin in the postauricular area. Important Risk Information The Transderm Scop® patch is contraindicated in: Persons who are hypersensitive to the drug scopolamine or to other belladonna alkaloids or to any ingredient or component in the formulation or delivery system. Patients with angle-closure (narrow-angle) glaucoma. The Transderm Scop® patch should not be used in children. The Transderm Scop® patch should be used with caution in the elderly or in individuals with impaired liver or kidney function; patients with pyloric obstruction, urinary bladder neck obstruction, or in patients suspected of having intestinal obstruction. Also use with caution in patients with a history of seizures or psychosis.

Since drowsiness, disorientation and confusion may occur, patients should not drive, operate dangerous machinery, or participate in activities that require alertness. Patients should not use alcohol. Use with caution in patients taking other drugs that can cause CNS effects, such as sedatives or tranquilizers. Rarely, idiosyncratic reactions have occurred. The most serious that have been reported include acute toxic psychosis, confusion, agitation, rambling speech, hallucinations, paranoid behavior and delusions. Since scopolamine can cause dilation of pupils and blurred vision upon direct eye contact, patients should be strongly advised to wash hands thoroughly with soap and water immediately after handling the patch. Because of an aluminized layer in the delivery system, it is recommended to remove The Transderm Scop® patch prior to undergoing an MRI. Skin burns have been reported at the patch site during an MRI.

Monitor glaucoma therapy in patients with chronic open-angle (wide-angle) glaucoma.

In ﬁve postoperative nausea and vomiting clinical studies, the most commonly reported adverse events were dry mouth (29%) and dizziness (12%).

Please see full prescribing information on the following page.

09/12 720295

Baxter is a registered trademark of Baxter International Inc. Transderm Scop is a registered trademark of Novartis AG.

70 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

P A IN M E D I C I NE EXPECTATIONS

CONTINUED FROM PAGE 68

very interesting, Mr. Stevens. You have lived a very interesting life. It’s unfortunate that we don’t have more time to discuss that in depth, but is there anything else that I can help you with?” You are acknowledging that you are interested in his life, but are also reminding him that you are there to assist him and other patients with very specific purposes.

No person or practice will always successfully address every patient’s specific needs, but taking steps to recognize and accommodate individual needs will result in a higher level of satisfaction and, ultimately, more kept appointments.

within one week.” If this is going to be one of your selling points, you must ensure that patients actually receive scheduling within one week. Such a statement becomes a requirement both for patients and referring providers. Failing to meet this standard may lead to dissatisfied patients and fewer Don’t Set the Bar Too High referrals. Therefore, do proper research and Many medical practices set expectations that turn out to be unrealis- avoid setting unrealistic goals. You tic. For example, you might state that could have employees gauge and report your practice “always schedules patients back on the average time patients must

wait for an appointment. You should only make the claim that patients are able to get an appointment within one week after verifying that this is indeed possible. Even when you set realistic expectations, sometimes they will not be met. When this happens, it is important to identify the reason for the discrepancy. If the cause is something temporary, such as a physician being ill or on vacation, carefully explain this to the patient. If the cause is something more long-term—for instance, patient growth outpacing your ability to accommodate patients—the solution may be to temporarily revise expectations. Either way, communication with patients and referring offices is critical. Making Excellence The Standard Meeting patients’ expectations for care is important, but exceeding patient and industry expectations can give your practice an advantage. It helps to recognize existing trends in pain management and go beyond the standard. For example, pain management offices generally take patient calls between 8 a.m. and 5 p.m. daily. Although this standard meets most patients’ needs, keeping phones open from 7 a.m. to 7 p.m. provides a service that may accommodate patients whose work hours prevent them from reaching your practice. Finding such niches will set you apart and drive patient satisfaction and referrals. Despite efforts to provide excellent customer service, mistakes will occur. Recovering from a mistake provides an opportunity for demonstrating excellent customer service. An example of this might be the following: Patient Emily Stone is ordered to receive an interventional pain procedure to treat her chronic low back pain. Ms. Stone is told this in her office visit and that she will be receiving a call to schedule after her insurance has been consulted and she is authorized to proceed. Three weeks pass, and Ms. Stone contacts the office inquiring about her procedure and complaining that she has not heard from the office. After looking into the patient’s chart, it is determined that the information was not properly communicated after her office visit and nothing has been done. Ms. Stone is likely to be upset and steps must be taken to rectify the situation. Explain the situation to the patient, but also make sure to follow this information with a solution: “Ms. Stone, in reviewing your chart it appears as though we failed to follow through

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 71

PA IN M E D ICIN E with communicating your procedure order to your insurance for authorization. Now that this has been recognized, we have alerted our authorizations staff and they are going to begin working on this immediately. We will do our best to make certain that this is expedited as much as it can be and will follow up with you regularly during the process.”

Compassion is an important attribute for all practitioners of medicine to have, and it is a virtue found throughout the most successful pain management practices. Honesty will go a long way with patients, especially if you follow it with a solution that shows that you are going to work to swiftly resolve errors. The person identifying this error should work quickly to communicate the situation to management so that the patient’s needs are met, and hopefully the error is not repeated. If the situation is quickly resolved and the patient is taken care of, he or she will be more likely to view the mistake as a rare occurrence and see the response to the situation as excellent customer service. Keys to Implementation And Training Providing adequate training and support for those members of the staff actively implementing the C.A.R.E model is critical to the success of this program. It is important to select staff with strong communication skills for roles involving direct interaction with patients. People filling these roles should complete role-playy sessions in order to gauge their response to common situations prior to receiving additional training. A strong candidate should already possess the ability to come up with creative solutions to situations that may occur. Team members should become well versed in the company’s expectations for dealing with patients. Throughout the training process, you should be clear that individuals will be held accountable for maintaining these expectations. For areas that are measurable, begin to track and measure performance.

Establish guidelines to reward those who promote excellent customer service by exceeding your expectations and consequences for those not meeting their goals. This will drive them to go above and beyond when dealing with all your patients. Finally, you must be prepared to follow through with monitoring and enforcing those rules and guidelines. This means monitoring calls and interactions with patients to ensure that the messages relayed by staff are consistent

with the standards and values of your practice. Providing proper resources to your team members and following the basics outlined in the C.A.R.E. model will improve patient care outside the exam room, and should return the patient focus in the exam room to treating pain effectively. —Tory McJunkin, MD, Paul Lynch, MD, Brian De Martino, BA, and Edward Swing, PhD

Drs. McJunkin and Lynch founded Arizona Pain Specialists, a comprehensive pain management practice with three locations, seven pain physicians, 10 mid-level providers, three chiropractors, on-site research and behavioral therapy. They teach nationally and are consultants for St. Jude Medical and Stryker Interventional Spine. Through their partner company, Boost Medical, they provide practice management and consulting services to other pain doctors throughout the country. For more information, visit ArizonaPain. com and BoostMedical.com.

72 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

C LIN I C A L A N ES THES IO LO G Y

General Endotracheal Anesthesia Makes Radiofrequency Ablation for A-fib More Efficient Boston—The use of general endotracheal anesthesia rather than moderate sedation for patients undergoing radiofrequency ablation (RF) for atrial fibrillation reduces the length of the procedure and cuts recovery time, researchers have found. The new study challenges the common thinking among cardiologists that general anesthesia for RF ablation is an obstacle to speedy care. “I am hoping that this study can serve as a little bit of ammunition for the anesthesiologist to say, ‘There are data out there saying I am not going to slow you down, and if I provide a general anesthetic, not only your satisfaction but your efficiency is going to improve,’” said Devin Roberts, MD, a fellow in the Department of Anesthesiology, Perioperative and Pain Medicine at Brigham and Women’s Hospital, in Boston, who led the study. Dr. Roberts presented the findings at the annual meeting of the

Society of Cardiovascular Anesthesiologists (SCA; abstract 46). General anesthesia increasingly is used for RF ablation, both because the procedures themselves are longer and the patient population is more complex. “We have a lot of patients who are coming in now to have second- and thirdtime ablations and those patients are more complicated,” said Wendy Gross, MD, director of the Cardiac Anesthesia Liaison Service at Brigham, and senior author of the study. She pointed out that patients living long-term with atrial fibrillation might develop tachycardiarelated cardiomyopathy and other comorbidities. In addition, Dr. Gross said, more sophisticated catheters and ablation techniques allow physicians to perform more precise procedures that may take longer in patients undergoing repeat treatment. Two years ago at Brigham, nurses primarily provided moderate sedation for

PRACTICE MANAGEMENT GROUP, LLC SM

TARGETING THE “BUSINESS” OF MEDICINE

ANESTHESIA BILLING SPECIALISTS COMPLETE BILLING SOLUTIONS PROFESSIONAL AND EXPERIENCED STAFF COMPREHENSIVE MANAGEMENT REPORTING PROVIDER CREDENTIALING CONTRACT NEGOTIATION AND CONSULTATION CONTINUOUS COMPLIANCE AUDITING CERTIFIED CODERS

5127 Ocean Highway / P.O. Box 2429 Murrells Inlet, SC 29576 P: 800.951.7850 / F: 843.357.4940 WWW.PMGMEDICALBILLING.COM

‘I think this helps explain why we are seeing such a

Table. Comparison of GETA and Sedation for Persistent Atrial Fibrillation Procedure Recovery Time Time (min) (min)

reduction in the procedure times: The cardiologists were actually able to perform some of the technical aspects of the procedure more quickly when the patient was under general anesthesia managed by an anesthesiologist.’ —Devin Roberts, MD

Sedation

296

168

GETA

216

123

GETA predicted time reduction

83.1 min (P<0.0001) P

38.4 min (P=0.004) P

GETA, general g endotracheal an anesthesia nesthesia

analysis using data from the EP Lab Data System revealed that the time to transeptal puncture was significantly shorter in the patients who received general anesthesia—53 (±22 minutes) versus 94 (±34 minutes; P<0.001). “I think this helps explain why we are seeing such a reduction in the procedure times: The cardiologists were actually able to perform some of the technical aspects of the procedure more quickly when the patient was under general anesthesia managed by an anesthesiologist,” he said. He added that the data did not indicate any significant difference in the number of RF burns, the total RF burn time or the need for repeat procedure between the two groups. Menachem Weiner, MD, assistant professor of anesthesiology at Mount Sinai School of Medicine, in New York City, said the study was significant in that it showed anesthesia could make RF ablation more efficient, but it also has a broader message. “As more and more procedures are taken out of the operating room, in favor of less invasive techniques, anesthesiologists are going to have to start moving out of the operating room and start to take part in satellite areas such as the cath lab and the electrophysiology suite,” Dr. Weinerr said. “We will be able to start becoming leaders in those areas, in the same way that anesthesiologists have become leaders in the operating room.” He pointed out that even cardiac valve surgery is now being performed in some catheterization labs. “Minimally invasive procedures are the future,” Dr. Weinerr said.

RF ablation of atrial fibrillation. But as the approach became inadequate for many of these cases, Dr. Gross and colleagues were asked to provide general anesthesia more frequently. Now, all ablations for atrial fibrillation at the hospital are performed with general anesthesia. In the study presented at the SCA meeting, the Boston team used data from the hospital electronic scheduling system and analyzed procedure length and recovery time for 40 patients who received sedation and 36 patients who received general anesthesia administered by anesthesiologists. The average age of patients in the two groups was similar, 60 years for sedation and 59 years in the group that received general. Average procedure time was significantly shorter with general anesthesia (216 vs. 296 minutes; P<0.001). Mean recovery time in the postanesthesia care unit (PACU) also was significantly shorter with general anesthesia (123 vs. 168 minutes; P<0.001; Table). Dr. Roberts pointed out that the PACU difference is even more significant because of an institutional policy that allows patients receiving sedation to leave the unit after 30 minutes. Patients who receive general anesthesia, however, must wait at least 90 minutes before they are discharged. He said the research group plans to analyze the data further to determine if general anesthesia also improved patient satisfaction, in terms of causing less nausea and vomit—Kate O’Rourke ing or increasing satisfaction with the Drs. Gross Roberts, and Weiner reported no reloverall procedure experience. According to Dr. Roberts, additional evant disclosures.

CONTINUING MEDICAL EDUCATION

OCTOBER 2012

Lesson 300: Preanesthetic Assessment of the Patient With Hepatitis C WRITTEN BY

LEARNING OBJECTIVES

Natalie F. Holt, MD, MPH Staff Anesthesiologist, West Haven Veterans Affairs Medical Center West Haven, Connecticut Assistant Professor, Department of Anesthesiology Yale University School of Medicine New Haven, Connecticut

At the end of this activity, the participant should be able to: 1. Understand the epidemiology and pathophysiology of HCV infection. 2. Identify patients who should be screened for the infection. 3. List the appropriate tests to perform once a patient has been diagnosed with HCV infection. 4. Identify candidates for HCV treatment. 5. Describe the preferred drug treatment regimen for patients infected with the HCV and the side effects and contraindications to therapy. 6. List complications of the infection. 7. Describe appropriate precautions to prevent HCV transmission. 8. Outline means to prevent postoperative complications in patients with HCV infection. 9. Identify new developments in drug therapies to treat the infection in patients who fail initial treatment. 10. Present an anesthetic plan suitable for patients with HCV infection.

REVIEWED BY Robert Lagasse, MD Professor, Department of Anesthesiology Yale University School of Medicine New Haven, Connecticut

DISCLOSURES The author and reviewer have no relationships with pharmaceutical companies or manufacturers of products to disclose.

PROFESSIONAL GAPS Most anesthesiologists are unaware of the effects of hepatitis C virus (HCV) transmission and the potentially severe consequences associated with the infection. The committee has deemed anesthetic implications of HCV infection and methods to prevent disease transmission to be essential information.

TARGET AUDIENCE Anesthesiologists

CALL FOR WRITERS If you would like to write a CME lesson for Anesthesiology News, please send an email to Elizabeth A.M. Frost, MD, at ElzFrost@aol.com.

CASE HISTORY A 62-year-old man presented for open repair of a ventral hernia that had developed as a consequence of an emergency exploratory laparotomy he had undergone 30 years previously following a motor vehicle accident. Medical history included gout, for which he took allopurinol, and obesity (body mass index [BMI], 33 kg/m2). He was a lifelong nonsmoker and consumed no more than 2 alcoholic beverages per night. Routine preoperative lab tests demonstrated mildly elevated aspartate aminotransferase (AST) and alanine aminotransferase (ALT), at 66 and 88 IU/L, respectively. Other chemistries, hematocrit, white blood cell, and platelet counts were normal, but the international normalized ratio (INR) was 1.2. In light of elevated AST and ALT levels, a hepatitis panel was drawn. The enzyme immunoassay test for hepatitis C antibodies was positive. Recombinant immunoblot assay confirmed the diagnosis, and quantitative polymerase chain reaction (PCR) for hepatitis C RNA revealed a viral load of 885,000 IU/mL, genotype 1a.

Epidemiology

CV is a blood-borne infection caused by a singlestranded RNA flavivirus.1 The worldwide prevalence of HCV infection is about 3% (130 million to 180 million individuals).2,3 In the United States, approximately 1.3% (3.2 million people) of the adult population is infected with HCV. HCV infection is the leading cause of death from liver disease and the main indication for liver transplant in the United States.3 HCV infection is most prevalent among current or former users of injection drugs, resulting from the sharing of needles and other drug paraphernalia. In adults with a history of injection drug abuse, the prevalence of HCV infection is more than 45% and may be as high as 90% in older drug abusers.3,4 The prevalence of HCV infection also is considerably elevated among patients on hemodialysis,

PREANESTHETIC ASSESSMENT Dr. Elizabeth A.M. Frost, who is the editor of this continuing medical education series, is clinical professor of anesthesiology at the Mount Sinai School of Medicine in New York City. She is the author off Clinical Anesthesia in Neurosurgery (Butterworth-Heinemann, Boston) and numerous articles. Dr. Frost is past president of the Anesthesia History Association and former editor of the journal of the New York State Society of Anesthesiologists, Sphere. She is also editor of the book series based on this CME program, Preanesthetic Assessment, Volumes 1 through 3 (BirkhĂ¤user, Boston) and 4 through 6 (McMahon Publishing, New York City).

A COURSE OF STUDY FOR AMA/PRA CATEGORY 1 CREDIT Read this article, reflect on the information presented, then go online (www.mssm.procampus.net) and complete the lesson posttest and course evaluation before October 31, 2013. (CME credit is not valid past this date.) You must achieve a score of 80% or better to earn CME credit. TIME TO COMPLETE ACTIVITY: 2 hours RELEASE DATE: October 1, 2012 TERMINATION DATE: September 30, 2013 ACCREDITATION STATEMENT The Mount Sinai School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT The Mount Sinai School of Medicine designates this enduring material for a maximum of 2.0 AMA PRA Category 1 Creditsâ&#x201E;˘. Physicians should claim only the credit commensurate with the extent of their participation in the activity. It is the policy of Mount Sinai School of Medicine to ensure objectivity, balance, independence, transparency, and scientific rigor in all CME-sponsored educational activities. All faculty participating in the planning or implementation of a sponsored activity are expected to disclose to the audience any relevant financial relationships and to assist in resolving any conflict of interest that may arise from the relationship. Presenters must also make a meaningful disclosure to the audience of their discussions of unlabeled or unapproved drugs or devices. This information will be available as part of the course material.

CONTINUING MEDICAL EDUCATION

This lesson is available online at www.mssm.procampus.net

estimated at 8.9% to 14.9% in the United States.3,5 Individuals who received blood transfusions or solid organ transplants prior to 1992 are at increased risk for HCV infection because routine testing for the virus of donated blood products did not occur before that time.6,7 Given current testing methods, blood transfusion in the United States has a very low risk for HCV transmission—less than 1 case per 2 million units transfused.8 Sexual intercourse is an inefficient means of HCV transmission, but the presence of HCV infection is significantly higher in people with multiple sexual partners. People who are infected with HCV are advised to use condoms during sex and to not share razors, toothbrushes, or other devices that may become contaminated with blood. Maternal-tofetal HCV transmission also is uncommon, estimated to account for approximately 5% of cases.5,8 Although most infants with vertically acquired HCV remain chronically infected, their disease progression tends to be mild. HCV is not transmitted in breast milk or saliva.3

Pathophysiology Acute infection with HCV is asymptomatic in 60% to 70% of patients.8 In the remainder, symptoms are nonspecific and include fatigue, nausea, abdominal pain, and anorexia. HCV RNA typically can be identified as early as 2 weeks after acute exposure, and onset of symptoms generally occurs within 4 to 12 weeks.8 Antibodies to HCV typically appear 8 to 12 weeks after infection.9 Approximately 15% to 35% of persons who acquire HCV are able to clear the infection spontaneously. The remaining 55% to 85% develop chronic infection.3,10 Spontaneous resolution is more common among infected women and infants.3 Among patients with chronic HCV infection, 5% to 25% will develop cirrhosis over a period of 20 to 30 years.3,10 Risk factors for disease progression include male sex, age greater than 40 years at the time of infection, co-infection with HIV or hepatitis B, and daily alcohol use of more than 50 g (about 3 drinks) per day.1 Among patients with cirrhosis, the risk for hepatocellular carcinoma is 1% to 3% per year.3,11 An estimated 1% to 5% of HCV-infected patients will die as a consequence of some complication related to their infection (liver disease or cancer).5,8,10,12 Each year, HCV infection accounts for approximately 8,000 to 10,000 deaths in the United States.8 In addition to liver disease, 10% to 40% of patients with HCV infection develop at least 1 extrahepatic disease manifestation.13,14 These comorbidities include arthralgia, cutaneous manifestations, xerostomia, xerophthalmia, sensory neuropathy, and cryoglobulinemia.3,14,15 In its most severe form, cryoglobulinemia may present with systemic vasculitis and glomerulonephritis. Furthermore, an association between HCV infection and an increased risk for insulin resistance and type 2 diabetes recently has been identified.16 There are 6 major genotypes of HCV.3 In the United States, approximately 72% of HCV-infected patients have genotype 1 and 16% to 19% have genotype 2.1 It is possible for a person who has become infected with one HCV genotype of HCV to become re-infected with another.

Diagnosis and Evaluation The United States Preventive Services Task Force recommends against routine screening for HCV infection.1 Table

1 lists the persons for whom HCV screening is recommended. The screening test of choice for identifying HCV infection is an enzyme immunoassay for HCV antibodies. The specificity of this test is about 99%.3 False-positives do occur, especially when the test is applied in a low-risk population, such as healthy blood donors. False-positives also may occur in patients with certain autoimmune diseases and hypergammaglobulinemia. Conversely, falsenegatives may be seen in patients with immunodeficiency disorders, hypogammaglobulinemia, or immediately following HCV exposure and prior to the development of antibodies. A positive HCV antibody test warrants confirmatory testing, usually through PCR testing for the presence of HCV RNA. If the result is confirmed, quantitation of viral load and genotyping should take place.3,5,12 Both provide useful information for prognostication and diagnostic decision making. Response to treatment is significantly higher in patients infected with genotype 2 HCV (70% to 80%) than in those with genotype 1 HCV infection (40% to 50%).3,8,10 The role of liver biopsy in the assessment of patients with HCV infection is controversial.3,5 Liver biopsy is the gold standard for determining the degree of liver fibrosis. However, the procedure is not without risk; an estimated 1% to 5% people who undergo liver biopsy require hospitalization. Therefore, some practitioners argue against its routine use.10 The results of liver biopsy are especially helpful when weighing the risks and benefits of treatment in patients with HCV infection and significant comorbid diseases. Alternative noninvasive techniques by which to grade the extent of liver fibrosis such as transient elastography are in development but are not in widespread use.3

Treatment HCV infection has no cure, but certain therapies have been shown to significantly reduce the progression of

Table 1. Persons for Whom HCV Screening Is Recommended Current or former IV drug users Recipients of solid organ transplants or blood or blood product transfusions prior to 1992 Children born to HCV-infected mothers Health care workers, emergency medical personnel, and other public safety workers after sharps injury or other mucosal exposure from an HCVinfected individual

OCTOBER 2012

liver disease. The current treatment of choice is pegylated interferon-α (PEG/IFN-α) plus ribavirin. The recommended duration of therapy is 24 weeks for patients with HCV genotypes 2 and 3 and 48 weeks for patients with HCV genotypes 1 and 4.3 Treatment should be considered for all HCV patients who are at least 18 years old and are willing to comply with therapy. 3 Therapy is widely accepted for HCVpositive patients with abnormal AST/ALT levels and/or evidence of liver fibrosis on biopsy. Treatment also may be considered for patients with either no or mild liver fibrosis, normal AST/ALT levels, and for those who have failed prior treatment with IFN or PEG/IFN only. In patients taking IFN, flu-like symptoms are common, especially early in the course of treatment.3,15 Psychiatric disorders including depression, confusion, and irritability occur in 30% of patients on IFN therapy.1 Anemia, leukopenia, and thrombocytopenia are reported in as many as 50% of patients.3,12,15 IFN also may induce or exacerbate autoimmune conditions, such as thyroiditis or hepatitis.3 Ribavirin therapy is associated with hemolytic anemia, pruritus, nasal congestion, and elevated uric acid levels.15 Ribavirin is cleared renally; therefore, dose adjustments are required when given to patients with preexisting renal disease. Ribavirin also is teratogenic in animals.15 For some patients, the side effects of HCV treatment outweigh its benefits. Treatment is generally contraindicated in patients with significant concurrent heart, kidney, or lung disease, uncontrolled depression, untreated thyroid disease, or autoimmune hepatitis. Therapy is not recommended for recipients of solid organ transplants, pregnant women, women who refuse contraceptive therapy, and children under the age of 2 years.3,5 The best predictor of long-term treatment efficacy is a sustained virologic response (SVR), defined as the absence of HCV RNA by PCR assay 24 weeks following cessation of treatment.3 In addition to viral genotype, certain other factors are associated with a lower probability of treatment response and include high pretreatment viral load, black race, age greater than 40 years, male sex, BMI greater than 25 kg/m2, and greater degree of liver fibrosis at the initiation of treatment.1,3,10 Approximately 30% of patients treated with PEG/ IFN-α and ribavirin do not achieve a virologic response. Another group of patients experience virologic relapse, which usually occurs within the first 12 weeks of treatment. In nonresponders, retreatment with the same regimen is rarely effective and therefore not recommended. Recent trials suggest that some of these patients may achieve an SVR using a combination of direct-acting antiviral agents such as asunaprevir and daclatasvir with or without PEG/IFN and ribavirin.10,17 For patients who relapse, retreatment with PEG/IFN-α and ribavirin may be considered, particularly for those with significant liver fibrosis or cirrhosis.3

Current sex partners of HCV-positive individuals Individuals with HIV infection Individuals with unexplained abnormal AST or ALT levels Current or former hemodialysis patients AST, aspartate aminotransferase; ALT, alanine aminotransferase; HCV, hepatitis C virus; IV, intravenous Adapted from reference 3.

Anesthetic Considerations Elective surgery is not advisable in patients with acute hepatitis of any kind because of increased perioperative morbidity and mortality. For patients with stable chronic HCV infection, general principles of care include attention to prexisting liver insufficiency and avoidance of drugs, such as acetaminophen, isoniazid, methyldopa, and phenytoin. Laboratory assessment should include measurement of serum chemistries, AST/ALT levels,

CONTINUING MEDICAL EDUCATION

OCTOBER 2012

Table 2. Calculation of the MELD Score

Nosocomial Transmission

Nosocomial transmission of HCV MELD Score = 10 {0.957 n(scr) + 0.378 n(Tbil) + 1.12 n(INR) + 0.643} infection has been documented to occur only through contact with Score 3-Mo Mortality, % blood, blood products, or bodily fluids containing blood.3 The odds ≥40 71.3 of transmission of HCV infection 30-39 52.6 from an HCV-infected needlestick or sharps injury are approximately 20-29 19.6 1% to 2% per incident.1,8,9,19 Over a 10-19 6.0 career, it has been estimated that the lifetime HCV seroconversion risk for a 0-9 1.9 surgeon may be as high as 5%.20 Following any exposure, an employee INR, international normalized ratio; MELD, Model for End-Stage Liver Disease; SCR, serum creatinine; Tbil, total bilirubin should report to occupational health a If the patient has been dialyzed within the last 7 d, use 4.0 as the serum creatinine value. or the emergency department as Any value <1 should be rounded to 1. soon as possible. The wound should Adapted from reference 18. be thoroughly washed with antimicrobial solution. Current guidelines recommend monitoring for HCV antibody seroconversion at 3 and 6 bilirubins, complete blood count, and coagulation promonths. Initiation of HCV drug treatment is not recomfile. Serum albumin also is useful in patients with modmended unless seroconversion occurs.15 erate to severe fibrosis or cirrhosis. Signs and symptoms Patient-to-patient transmission of HCV has been known of asterixis, ascites, and gastroesophageal varices should to occur through the improper use of multidose vials in be sought. which used syringes or needles resulted in drug contamThe Model for End-Stage Liver Disease (MELD) score ination.21-26 Reusable parts of a breathing apparatus also is used to estimate the probability of survival in patients have been implicated, probably also as a result of occult with liver disease based on 3 variables: INR, serum creatiblood contamination.27 A study conducted in the Nethernine, and total bilirubin. MELD is the scoring system used lands showed that one-third of operating room surfaces by the United Network for Organ Sharing to prioritize had evidence of occult blood contamination. These areas patients on the waiting list for liver transplant and to preincluded laryngoscope blades, pulse oximeters, and other dict survival after transplantation.18 It also is useful in estireusable medical equipment.28 The use of IV tubing with mating preoperative risk (Table 2). 1-way valves to prevent blood contact and transition to There is no preferred anesthetic technique for patients single-use medical devices aid in the prevention of nosowith chronic HCV infection. Drug pharmacokinetics may comial HCV transmission. be altered as a result of end-organ dysfunction, reduced Although rare, there also are reports of anesthetist-toserum proteins, high cardiac output, or altered liver perpatient transmission of HCV.29-32 In some cases, no obvifusion. Regional anesthesia is appropriate if the platelet ous breaches of standard precautions were identified. The count and coagulation profile are within normal limmost likely source of infection is thought to be contact its. There is no evidence that HCV is found in appreciable with exposed skin lacerations. The practice of introducing quantities in cerebrospinal fluid or causes damage to the a finger into the patient’s mouth during intubation may central nervous system. be a source of exposure for the patient. Even if gloves are Patients with liver disease tend to have a hyperdynamic worn, undetected perforations may be present.32 circulation, marked by increased cardiac output and low No recommendations call for restricting the professystemic vascular resistance. Splanchnic vasodilation consional activities of HCV-positive health care workers.8,9 tributes to the formation of ascites and reduced effective In all cases, standard precautions and strict adherence circulating volume. Vasopressors may be required in the to aseptic technique are paramount. It has been esticontext of anesthetic induction or with the use of volatile mated that the risk for HCV transmission from an infected agents. The goal of fluid management in these patients is surgeon to a patient would occur in approximately 1 in to maintain adequate organ perfusion. Vasopressin and 10,000 cases; the risk would be expected to be lower for vasopressin analogues may be particularly useful, as they anesthesiologists, given that they perform less exposurehave been shown to increase splanchnic resistance and prone procedures.33 3 improve renal blood flow and glomerular filtration rate. Invasive hemodynamic monitoring may facilitate the Management of the Case Presented management of these patients. Patients with cirrhosis are at increased risk for infection. Therefore, the timely adminGiven the absence of acute liver dysfunction, the deciistration of pre-incision antibiotics and close attention to sion was made to proceed with the case. On the day of the sterile technique are crucial. surgery, an epidural catheter was inserted prior to inducNarcotics are appropriate for postoperative pain contion of general anesthesia. While cleaning up sharps after trol; however, dosage should be carefully titrated. Acetcompletion of the procedure, the anesthesia resident aminophen and nonsteroidal anti-inflammatory drugs stuck her finger with the contaminated epidural needle. should not be administered to patients with advanced Permission was obtained from the patient’s wife to perliver disease, although they may be used in patients with form a full hepatitis panel and testing for HIV. Aside from mild liver dysfunction in normal doses. HCV, no other infection was identified. a

HCV antibody and liver enzymes were performed on the anesthesia resident at the time of the event and at 3 and 6 months after.15 She remained HCV antibody–negative and no treatment was recommended.

Concluding Statement HCV infection is an often asymptomatic but potentially fatal disease. Although progression of the illness usually can be slowed, there is no cure. Due to exposure to blood in the operating room, hepatitis C poses a work-related risk for anesthesiologists. Extreme care must be taken to avoid needlestick contamination, especially from patients identified as high risk for hepatitis infection.

References 1.

Wilkins T, Malcolm JK, Raina D, Schade RR. Hepatitis C: diagnosis and treatment. Am Fam Physician. 2010;81(11):1351-1357.

World Health Organization. Hepatitis Fact Sheet No. 164. June 2011. www.who.int/mediacentre/factsheets/fs164/en/. Accessed February 27, 2012.

Ghany MG, Strader DB, Thomas DL, Seeff LB. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009;49(4):1335-1374.

Armstrong GL, Wasley A, Simard EP, McQuillan GM, Kuhnert WL, Alter MJ. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med. 2006;144(10):705-714.

Jou JH, Muir AJ. In the clinic. Hepatitis C. Ann Intern Med. 2008;148(11):ITC6-1-ITC6-16.

Alter MJ, Kruszon-Moran D, Nainan OV, et al. The prevalence of hepatitis C virus infection in the United States, 1988 through 1994. N Engl J Med. 1999;341(8):556-562.

Wang CC, Krantz E, Klarquist J, et al. Acute hepatitis C in a contemporary US cohort: modes of acquisition and factors influencing viral clearance. J Infect Dis. 2007;196(10):1474-1482.

Centers for Disease Control and Prevention. Hepatitis C FAQs for Health Professionals. http://www.cdc.gov/hepatitis/hcv/hcvfaq. htm. Accessed February 27, 2012.

Thurston RS. Acute hepatitis C virus and cardiac surgeons. J Thorac Cardiovasc Surg. 2009;137(3):519-520.

10. Rosen HR. Clinical practice. Chronic hepatitis C infection. N Engl J Med. 2011;364(25):2429-2438. 11. Fattovich G, Giustina G, Degos F, et al. Morbidity and mortality in compensated cirrhosis type C: a retrospective follow-up study of 384 patients. Gastroenterology. 1997;112(2):463-472. 12. Nash KL, Bentley I, Hirschfield GM. Managing hepatitis C virus infection. BMJ. 2009;338:b2366. 13. Mehta S, Levey JM, Bonkovsky HL. Extrahepatic manifestations of infection with hepatitis C virus. Clin Liver Dis. 2001;5(4):979-1008. 14. Cacoub P, Renou C, Rosenthal E, et al. Extrahepatic manifestations associated with hepatitis C virus infection. A prospective multicenter study of 321 patients. The GERMIVIC. Groupe d’Etude et de Recherche en Medecine Interne et Maladies Infectieuses sur le Virus de l’Hepatite C. Medicine (Baltimore). 2000;79(1):47-56. 15. Lentschener C, Ozier Y. What anaesthetists need to know about viral hepatitis. Acta Anaesthesiol Scand. 2003;47(7):794-803. 16. Mehta SH, Brancati FL, Sulkowski MS, Strathdee SA, Szklo M, Thomas DL. Prevalence of type 2 diabetes mellitus among persons with hepatitis C virus infection in the United States. Ann Intern Med. 2000;133(8):592-599. 17. Lok A, Gardiner D, Lawitz E, Martorell C, Everson G, Ghalib R, et al. Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med. 2012;366(3):216-224. 18. Wiesner R, Edwards E, Freeman R, et al. Model for end-stage liver disease (MELD) and allocation of donor livers. Gastroenterology. 2003;124(1):91-96. 19. De Carli G, Puro V, Ippolito G. Risk of hepatitis C virus transmission following percutaneous exposure in healthcare workers. Infection. 2003;31(suppl 2):22-27.

CONTINUING MEDICAL EDUCATION

This lesson is available online at www.mssm.procampus.net

20. Kuo YH, Fabiani JN, Mohamed AS, et al. Decreasing occupational risk related to blood-borne viruses in cardiovascular surgery in Paris, France. Ann Thorac Surg. 1999;68(6):2267-2272. 21. Germain JM, Carbonne A, Thiers V, et al. Patient-to-patient transmission of hepatitis C virus through the use of multidose vials during general anesthesia. Infect Control Hosp Epidemiol. 2005;26(9):789-792. 22. Tallis GF, Ryan GM, Lambert SB, et al. Evidence of patientto-patient transmission of hepatitis C virus through contaminated intravenous anaesthetic ampoules. J Viral Hepat. 2003;10(3):234-239. 23. Gutelius B, Perz JF, Parker MM, et al. Multiple clusters of hepatitis virus infections associated with anesthesia for outpatient endoscopy procedures. Gastroenterology. 2010;139(1):163-170.

OCTOBER 2012

24. Krause G, Trepka MJ, Whisenhunt RS, et al. Nosocomial transmission of hepatitis C virus associated with the use of multidose saline vials. Infect Control Hosp Epidemiol. 2003;24(2):122-127.

29. Cody SH, Nainan OV, Garfein RS, et al. Hepatitis C virus transmission from an anesthesiologist to a patient. Arch Intern Med. 2002;162(3):345-350.

25. Comstock RD, Mallonee S, Fox JL, et al. A large nosocomial outbreak of hepatitis C and hepatitis B among patients receiving pain remediation treatments. Infect Control Hosp Epidemiol. 2004;25(7):576-583.

30. Mawdsley J, Teo CG, Kyi M, Anderson M. Anesthetist to patient transmission of hepatitis C virus associated with non exposureprone procedures. J Med Virol. 2005;75(3):399-401.

26. Widell A, Christensson B, Wiebe T, et al. Epidemiologic and molecular investigation of outbreaks of hepatitis C virus infection on a pediatric oncology service. Ann Intern Med. 1999;130(2):130-134. 27. Chant K, Kociuba K, Munro R. Investigation of possible patientto-patient transmission of hepatitis C in a hospital. NSW Public Health Bull. 1994;5:47-51. 28. Hall J. Blood contamination of anesthesia equipment and monitoring equipment. Anesth Analg. 1994;78(6):1136-1139.

Visit www.mssm.procampus.net today for instant online processing of your CME post-test and evaluation form. There is a registration fee of $15 for this non–industry-supported activity. For assistance with technical problems, including questions about navigating the Web site, call toll-free customer service at (888) 345-6788 or send an email to Customer.Support@ProCEO.com.

31. Ross RS, Viazov S, Gross T, Hofmann F, Seipp HM, Roggendorf M. Transmission of hepatitis C virus from a patient to an anesthesiology assistant to five patients. N Engl J Med. 2000;343(25):1851-1854. 32. Kopka A. Anesthetist to patient transmission of hepatitis C virus associated with non exposure-prone procedures. J Med Virol. 2005;77(4):500; discussion 1. 33. Ross RS, Viazov S, Roggendorf M. Risk of hepatitis C transmission from infected medical staff to patients: model-based calculations for surgical settings. Arch Intern Med. 2000;160(15):2313-2316.

For inquiries about course content only, send an email to ram.roth@mssm.edu. Ram Roth, MD, is director of PreAnesthetic Assessment Online and assistant professor of anesthesiology at The Mount Sinai School of Medicine, New York, NY.

Post-Test 1.

The prevalence of HCV infection in the adult population of the United States is approximately_____. a. 1.3% b. 4.1% c. 8.9% d. 13.9%

The risk for neonatal transmission of HCV from an infected mother is_____. a. <10% b. 10%-20% c. 25%-35% d. 50%-60%

The pharmacologic treatment regimen of choice for patients with HCV infection is_____. a. Ribavirin and asunaprevir b. Hepatitis C immunoglobulin c. Pegylated interferon-α only d. Pegylated interferon-α plus ribavirin

The risk for transmission of HCV from a needlestick injury involving a known hepatitis C-positive patient is approximately_____. a. 1%-5% b. 5%-10% c. 10%-15% d. 15%-20%

Following acute infection, when are antibodies to HCV most likely to appear in the blood? a. 1-4 wk b. 4-8 wk c. 8-12 wk d. 12-16 wk

What is the most common HCV genotype in the United States? a. 1 b. 2 c. 3 d. 4

What HCV genotype is most responsive to pharmacologic treatment? a. 1 b. 2 c. 3 d. 4

Which of the following patient characteristics is associated with a favorable response to pharmacologic HCV treatment? a. Black race b. Body mass index >25 kg/m2 c. Male gender d. Age <40 y

What percentage of people with HCV will develop cirrhosis in the decades following infection? a. 5%-10% b. 15%-25% c. 25%-40% d. 60%-70%

10. In what percentage of people is acute HCV infection asymptomatic? a. 10%-20% b. 30%-40% c. 60%-70% d. 80%-90%

Breakthrough Measurements. Radical Monitor.

Introducing the 2012

Radical-7

Once again raising the technology bar, the 2012 Radical-7 leverages Masimo’s breakthrough noninvasive measurements with a radical departure from traditional monitoring for breakthrough functionality designed to automate the process of care and enable clinicians to instantly adapt to changing monitoring needs in individual patients and care areas. > Breakthrough noninvasive measurements: ā Total Hemoglobin (SpHb®) ā Pleth Variability Index (PVI®) ā Oxygen Content (SpOC™) ā Acoustic Respiration Rate (RRa™) ® ā Methemoglobin (SpMet ) ā Carboxyhemglobin (SpCO®) > Instantly adaptable functionality > Intuitive touchscreen operation > Integrated wireless connectivity > Easy customization

78 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

C LIN I C A L A N ES THES IO LO G Y DEPTH

CONTINUED FROM PAGE 1

“While previous work suggests that maintaining a lighter plane of anesthesia provides short-term benefits such as faster recovery, better hemodynamic control and reduced respiratory complications, nausea and vomiting and duration of hospitalization, it does not appear to prevent major morbidity,” said lead investigator Basem Abdelmalak, MD, associate professor in the Department of General Anesthesiology and Outcomes Research at the Cleveland Clinic, in Ohio. The results are part of the DeLiT (Design and

Table. Studies of Survival in BIS-Monitored Patients Monk et ala

Lindholm et alb Leslie et alc

Patients (N)

1,064

4,087

2,463

Mean age, y

Patients with ASA score ≥3, %

Cardiac surgery patients, %

42%

BIS-monitored patients

100

Average BIS

49±9

37±7

45±7

Organization g of the Dexamethasone, Light Anesthesia and Tight Glucose Control) trial, a

Increased risk for 1 y mortality with BIS <45

24.4% for each additional hour

randomized, single-center analysis of the effects that dexamethasone, glucose control and, in this case, depth of anesthesia have on perioperative inflammation and complications in surgery patients. In examining the effects of anesthesia depth, Dr. Abdelmalakk and his colleagues compared a composite of more than one dozen serious outcomes— including myocardial infarction, stroke, sepsis and 30-dayy mortality—in 194 patients given light anesthesia and 187 given deeper anesthesia. Anesthetic depth was evaluated by bispectral index monitoring (BIS, Covidien). Dr. Abdelmalakk and his team also compared plasma concentrations of the inflammatory marker high-sensitivity C-reactive protein (hsCRP). Patients randomized to light and deep anesthesia had median BIS values of 51 (range: 47-54) and 43 (40-48), respectively (P<0.001). Those assigned to lighter anesthesia spent a median of 16% (4%-40%) of their time under sedation with BIS values below 45, compared with 66% (36%-86%) of the time for patients who received deeper anesthesia (P<0.001). Dr. Abdelmalak’s group found no significant differences in the incidence of morbidity and mortality between the two groups. There also was no correlation between median BIS values, time spent under anesthesia with a BIS value less than 45 and morbidity or mortality. Concentrations of hsCRP were similar in the two groups, according to the researchers. Dr. Abdelmalakk said earlier studies that found an increased incidence of poor outcomes with deeper anesthesia have examined those with other clinical risk factors, including a “triple low” of low BIS, low mean arterial pressure and low mean arterial concentration of volatile anesthesia ((Anesthesiology News, November 2009, page 1). However, his group did not look at this combination of possible risk factors. Kate Leslie, MD, professor of anesthesia and pain management at Royal Melbourne Hospital in Victoria, Australia, led a long-term follow-up study of the B-Aware trial, which also examined the effects of sedation depth in nearly 2,500 surgical patients at high risk for intraoperative awareness (Anesth ( Analg 2010;110:816-822). Her team found an increased risk for all-cause long-term mortality, myocardial infarction and stroke if patients were sedated at BIS values below 40 for more than five minutes. Dr. Leslie suggested that one reason Dr. Abdelmalak’s team found no increase in complications and deaths with deeper sedation may have been that differences in sedation depth between the two groups were too narrow.

Increased risk for 2-y mortality with BIS <45

—

18% for each additional hour

Increased risk for long-term mortality with BIS <40 for >5 min

—

41%d

ASA, American Society of Anesthesiologists; BIS, bispectral index monitoring a

Anesth est Analg a g 2005;100:4-10 005; 00 0 b Anesth est Analg a g 2009;108:508-512 009; 08 508 5 c Anesth est Analg a g 2010;110:816-822 0 0; 0 8 6 8 d Median ed a follow-up: o o upp 4.1 years yea y s

“Median BIS values were 43 and 51 and the median percentage of time spent at BIS below 45 was only 66% in the deep sedation group,” Dr. Leslie emphasized. “Future investigators should seek greater separation in depth of anesthesia between the two groups. Furthermore, many of the observational studies on the topic have reported excess mortality in the years following surgery, so a long-term follow-up is desirable.” However, she added, “Dr. Abdelmalak and colleagues have used a very efficient and elegant methodology to address an intriguing and a difficult area to study.” Daniel Sessler, MD, the Michael Cudahy Professor and Chair of the Department of Outcomes Research at the Cleveland Clinic, and a co-investigator of the current study, said that although the mean BIS difference in the deep and light anesthesia groups was only 8, patients randomized to deep anesthesia spent four times longer with a BIS value less than 45. “Despite this substantial difference, our primary outcome—a composite of serious complications— did not differ between the groups,” Dr. Sessler said. “While this result appears to contradict the recent report from Leslie et al, that analysis was observational. The underlying B-Aware study was randomized, but the depth-off anesthesia analysis was not. In contrast, we conducted a randomized trial which provides the strongest protection against bias and confounding.” The results of the current study may have implications that go beyond important patient safety concerns, said Marc E. Koch, MD, MBA, president and CEO of Somnia, Inc., a national anesthesia management consulting organization in New Rochelle, N.Y.

“With changes in health care before us, tens of millions of new patients— many with surgical needs—will be entering the health care system without the requisite personnel or facility capacity to fully address this new-found volume,” said Dr. Koch, who was not involved in either study. “It is likely that the swath of surgical patients migrating to nonhospital facilities that have more fluidity— and discretion on whom they serve—may offer shorter wait times and lines for surgical bookings and better throughput due to their ability to mitigate the patient congestion many hospitals will see. Because of this, over time, volumes ending up in private ambulatory facilities will be of broader scope and greater acuity. “Studies have already shown that case duration, in and of itself, is not necessarily associated with higher rates of and major morbidity,” Dr. Koch continued. “This study goes one step further by demonstrating that anesthesia depth does not impact the level of hsCRP or lead to an increase in major morbidity. “Thus, with longer surgical times, and now deeper planes of anesthesia not necessarily being associated with major morbidity,” he said, “non-hospital facilities may choose to evaluate the sorts of cases they undertake and not necessarily turn away longer cases or those associated with higher planes of anesthesia.” —David Wild Drs. Abdelmalak and Sessler received research funding from Coviden. The B-Aware Trial was partly supported by an unrestricted educational grant and loan of monitors, which were returned at the end of the trial. Dr. Koch reported no relevant disclosures.

80 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

C LIN I C A L A N ES THES IO LO G Y

Insurance Status Linked to Type of Anesthesia in C-Section Study probes factors associated with anesthetic method for labor surgery

lthough the use of general anesthesia during cesarean delivery appears to be declining, new research indicates that rates of administration still vary widely between hospitals. The probability that a woman will receive general anesthesia during a

cesarean surgery depends largely on whether she is scheduled for an additional procedure, such as a hysterectomy, and the makeup of the hospital’s payer mix, according to investigators at the University of Michigan Health System, in Ann Arbor. Women delivering at hospitals where about half of

patients are insured are 6.5 times more likely to receive general anesthesia as those delivering at hospitals where a majority of patients have private coverage. “The fact that the delivering hospital’s payer mix is among the most important predictors of whether a

The Better Flow to Improve Your Bottom Line Simply follow this flow chart...

Pre-fi filled Pain Pumps from CAPS®, a B. Braun Company

It illustrates B. Braun’s path to improved operational efficiency in Regional Anesthesia. Half of all US Hospitals operate in the RED. A trend B. Braun, the market leader in RA, is helping to reverse. One Company. One RA integrated System. One more opportunity to improve your Bottom Line.

Learn More at ASA, Booth #2227

25 B. Braun/C CAPS Facilitiess in the US

woman would receive general anesthesia for cesarean delivery suggests that institutional resources, socioeconomic differences in patients and/or the availability of epidural anesthesia exert a powerful influence over anesthetic selection,” said Jill Mhyre, MD, director of research and of quality improvement in obstetric anesthesiology at the University of Michigan, who led the study. Dr. Mhyre presented her group’s findings at the 2012 annual meeting of the Society for Obstetric Anesthesia and Perinatology (abstract OP 2-2). The Michigan researchers studied inpatient data from the New York State Department of Health’s SPARCS (Statewide Planning and Research Cooperative System) data reporting system, which includes a variable for anesthesia to identify trends and predictors of the use of general anesthesia during cesarean surgery. They pulled information from 258,886 cesarean deliveries at 95 hospitals between 1998 and 2008. Across all years, general anesthesia was used in 8.7% of all cesarean deliveries; the rate decreased from 15.5% in 1998 to 4.7% in 2008 (P<0.001). This trend persisted after adjusting for patient age and race and obstetric see general page 82

B. Braun Field Suppo Support

the he B. BRAUN System

B. Braun PNB Needles, Catheters, Ca Trays

GOPump® & GOBlock®

To schedule an evaluation and see for yourself the advantages of the B. Braun System visit us at PainPumpAdvantage.com or call 800-227-2862.

CAPS is a registered trademark of Central Admixture Pharmacy Services, Inc. GOPump and GOBlock are registered trademarks of Symbios Medical Products, LLC. Rx Only. © 2012 B. Braun Medical Inc. Bethlehem, PA. All Rights Reserved.

12-3424_8/12_KE

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 81

CL IN ICA L A N E STH E SIOL OG Y

Analgesia Needs Similar for First, Repeat C-Section

omen undergoing a repeat elective cesarean delivery appear to experience similar levels of pain and require the same amount of analgesia after surgery as those recovering from their first such procedure, a recent study has found. Each year, 1.4 million American women undergo cesarean deliveries. Of those, roughly one-third are elective repeat deliveries ((Am J Obstet Gynecol 2010;203:326 e1-10). Because cesarean deliveries are performed repeatedly in the same manner, the procedure is an ideal model for studying pain processing and excitatory pathways that may lead to postoperative hyperalgesia, according to experts. However, experts do not agree about whether central sensitization, with or without scar hyperalgesia, after surgery will result in increased pain when the surgery is repeated, or if different postoperative analgesic regimens are needed for first or repeat surgeries. The latest findings suggest such alterations might not be necessary for subsequent cesarean deliveries, according to the study. The researchers presented their findings at the 2012 annual meeting of the Society for Obstetric Anesthesia and Perinatology (abstract OP 2-1). Investigators collected outcomes data from 451 healthy women scheduled for elective primary or repeat cesarean deliveries at two study sites, the University of Washington, in Seattle (n=91), and St. Joana Hospital, in Sao Paulo, Brazil (n=360). Each woman received a standardized spinal anesthetic (12 mg of bupivacaine,

25 mcg of fentanyl and 100 mcg of morphine) with a multimodal regimen of postoperative analgesia that included acetaminophen and diclofenac, IV morphine in the postanesthesia care unit and oxycodone or tramadol for breakthrough pain. The researchers assessed pain scores for patients at rest and upon moving into the sitting position, as well as

pain from uterine cramping at 12, 24 and 48 hours after cesarean delivery. Women in the study also were asked in follow-up phone calls to report their pain—average pain and the worst pain in past week—eight weeks and six months after the procedure. Although there was a trend toward more intense pain in women undergoing a repeat cesarean delivery, with up

to 7% of these women reporting moderate pain at six months, only pain at rest 48 hours after surgery was shown to be statistically significant (P=0.05). Wound hyperanalgesia and opioid use at 48 hours did not differ between the two groups. “When all other things are equal— spinal anesthesia and the obstetric see cesarean pain page 82

82 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

C LIN I C A L A N ES THES IO LO G Y CESAREAN PAIN

CONTINUED FROM PAGE 81

context, meaning these women were not in labor prior to requiring the cesarean delivery and did not require an urgent surgical procedure—having a repeat cesarean delivery did not increase the likelihood of having more severe postoperative pain in this cohort of healthy women,” said co-investigator Ruth Landau, MD, director of obstetric anesthesia and clinical genetics research in the Department of Anesthesiology and Pain Medicine at the University of Washington Medical Center, in Seattle. Dr. Landau said hers was the first study to compare elective primary and elective repeat cesarean deliveries. The results are in line with those from an earlier retrospective study that found no difference in pain scores or analgesic requirements after an elective cesarean under spinal anesthesia or an unplanned cesarean delivery (IJOA 2010;19:10-15). However, the anesthetic protocol used in that study varied, with some women undergoing an emergency cesarean delivery receiving an indwelling epidural catheter used for anesthesia. Because most of the women recruited for the study were from Brazil, where the rate of elective planned cesarean delivery is much higher than in the United States, the results may not necessarily apply to U.S.-based obstetric practice. “Any interpretation of these results needs to take into account cultural and medical differences in pain management and opioid use and may not reflect true differences in analgesic ‘need’,” Dr. Landau said. In addition, the data should not be generalized to women at high risk for pain or who have been in labor first and then deliver by cesarean. David Wlody, MD, chair of anesthesiology at Long Island College Hospital, in Brooklyn, N.Y., noted that although the research is intriguing, additional studies with more patients are needed to tease out whether the trend toward higher pain scores in the repeat section group might reach statistical significance. The present study looked at 304 primary and 147 repeat deliveries. “In practice, we are going to individualize pain treatment based on the patient and her symptoms,” said Dr. Wlody, y a member of the editorial board of Anesthesiology News, who was not involved with the study. —Amanda Crowe

GENERAL

CONTINUED FROM PAGE 80

complications, as well as hospitallevel variables including annual delivery volume, the rate of cesarean delivery and the proportion of patients covered by private insurance. Women scheduled for an additional surgery, particularly exploratory laparotomy, were most likely to receive general anesthesia during their cesarean delivery, with an

adjusted odds ratio of 7.7 over women undergoing labor alone, the researchers found. Women at hospitals where fewer than 48% of patients had private insurance were nearly five times more likely to receive general anesthesia as those who gave birth at hospitals where more than 72% of patients were covered privately. A better payer mix may indicate the availability of more resources within a hospital, including deeper anesthesia staffing and use of epidurals,

Dr. Mhyre told Anesthesiology News. In facilities where anesthesiologists are responsible for the main operating rooms and take calls from home, they often arrive at delivery rooms after a delay. And by the time they arrive, anesthetic choices may be fewer, she said. The results also could reflect the availability of around-the-clock epidural services or differences in patient preferences. Minority patients or those with less education are less likely to

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 83

CL IN ICA L A N E STH E SIOL OG Y want an epidural, she said (Anesthesiol( ogy 2007;106:19-25). As a rule, Dr. Mhyre said, patients and physicians prefer regional anesthesia. Most patients wish to be awake for the birth of their child, and nerve blocks carry far fewer risks for uterine relaxation, exposure of the fetus to anesthetics and airway mishaps. But even in the final years of the study, she said, as many as 20% of women in certain hospitals in the database were receiving general anesthesia.

“We don’t know what the ideal rate is, but it’s certainly less than 20%,” she said. Joy Hawkins, MD, director of obstetric anesthesia at the University of Colorado Hospital in Aurora, agreed that general anesthesia is becoming less common in cesarean deliveries. “We used to think it was about safety, but more and more it’s because women want to be awake” during delivery and to spend time with their babies, Dr. Hawkins said. In addition,

obstetricians feel more comfortable with regional anesthetic techniques. With general anesthesia, they must hurry through the first part of surgery because the fetus can absorb anesthetic and come out sleepy. But clinicians should avoid thinking that everyone is a candidate for regional anesthesia, Dr. Hawkins added. “We don’t want to delay initiation of [delivery] because we are taking so long to place a spinal or epidural.” General anesthesia is necessary in

some cases, such as emergency deliveries or if the woman has significant health issues like coagulation or cardiac lesions, she said. “My take is, I agree we all are seeing a decrease in general anesthesia, but I don’t think we’ve rightsized yet.” Researchers from Northwestern University in Chicago and Massachusetts General Hospital in Boston contributed to the study. —Karen Blum

84 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

C LIN I C A L A N ES THES IO LO G Y LIPOSUCTION

American Society of Anesthesiologists (ASA; abstract 144) that numerous down on them, and the result is a rec- deaths due to liposuction have been ipe for a national disaster. reported since Klein and Lillis popSelma Calmes, MD, consultant in ularized the notion of high-volume anesthesiology for the Los Angeles tumescent anesthesia in the United County Coroner/Medical Examiner, States in their seminal 1985 paper in has begun to dig behind the details of the Journal of the American Academy patient death during liposuction—and of Cosmetic Surgery (1987;4:263-267). she does not like what she’s finding. Twenty states established regulations Along with colleague J. Daniel in response. But people are still dying, Augustine, MD, Dr. Calmes reported and the researchers said much more at the 2012 annual meeting of the could be done to save them. CONTINUED FROM PAGE 1

ULTIVA® for Injection

(remifentanil hydrochloride) For IV Use Only Rx only Brief Summary: The following is a brief summary only. Before prescribing, see complete ULTIVA prescribing information. CONTRAINDICATIONS Due to the presence of glycine in the formulation, ULTIVA is contraindicated for epidural or intrathecal administration. ULTIVA is also contraindicated in patients with known hypersensitivity to fentanyl analogs. WARNINGS AND PRECAUTIONS Continuous infusions of ULTIVA should be administered only by an infusion device. IV bolus administration of ULTIVA should be used only during the maintenance of general anesthesia. In nonintubated patients, single doses of ULTIVA should be administered over 30 to 60 seconds. Interruption of an infusion of ULTIVA will result in rapid offset of effect. Rapid clearance and lack of drug accumulation result in rapid dissipation of respiratory depressant and analgesic effects upon discontinuation of ULTIVA at recommended doses. Discontinuation of an infusion of ULTIVA should be preceded by the establishment of adequate postoperative analgesia. Injections of ULTIVA should be made into IV tubing at or close to the venous cannula. Upon discontinuation of ULTIVA, the IV tubing should be cleared to prevent the inadvertent administration of ULTIVA at a later point in time. Failure to adequately clear the IV tubing to remove residual ULTIVA has been associated with the appearance of respiratory depression, apnea, and muscle rigidity upon the administration of additional fluids or medications through the same IV tubing. USE OF ULTIVA IS ASSOCIATED WITH APNEA AND RESPIRATORY DEPRESSION. ULTIVA SHOULD BE ADMINISTERED ONLY BY PERSONS SPECIFICALLY TRAINED IN THE USE OF ANESTHETIC DRUGS AND THE MANAGEMENT OF THE RESPIRATORY EFFECTS OF POTENT OPIOIDS, INCLUDING RESPIRATORY AND CARDIAC RESUSCITATION OF PATIENTS IN THE AGE GROUP BEING TREATED. SUCH TRAINING MUST INCLUDE THE ESTABLISHMENT AND MAINTENANCE OF A PATENT AIRWAY AND ASSISTED VENTILATION. ULTIVA SHOULD NOT BE USED IN DIAGNOSTIC OR THERAPEUTIC PROCEDURES OUTSIDE THE MONITORED ANESTHESIA CARE SETTING. PATIENTS RECEIVING MONITORED ANESTHESIA CARE SHOULD BE CONTINUOUSLY MONITORED BY PERSONS NOT INVOLVED IN THE CONDUCT OF THE SURGICAL OR DIAGNOSTIC PROCEDURE. OXYGEN SATURATION SHOULD BE MONITORED ON A CONTINUOUS BASIS. RESUSCITATIVE AND INTUBATION EQUIPMENT, OXYGEN, AND AN OPIOID ANTAGONIST MUST BE READILY AVAILABLE. Respiratory depression in spontaneously breathing patients is generally managed by decreasing the rate of the infusion of ULTIVA by 50% or by temporarily discontinuing the infusion. Skeletal muscle rigidity can be caused by ULTIVA and is related to the dose and speed of administration. ULTIVA may cause chest wall rigidity (inability to ventilate) after single doses of >1 mcg/kg administered over 30 to 60 seconds, or after infusion rates >0.1 mcg/kg/min. Single doses <1 mcg/kg may cause chest wall rigidity when given concurrently with a continuous infusion of ULTIVA. Muscle rigidity induced by ULTIVA should be managed in the context of the patient’s clinical condition. Muscle rigidity occurring during the induction of anesthesia should be treated by the administration of a neuromuscular blocking agent and the concurrent induction medications. Muscle rigidity seen during the use of ULTIVA in spontaneously breathing patients may be treated by stopping or decreasing the rate of administration of ULTIVA. Resolution of muscle rigidity after discontinuing the infusion of ULTIVA occurs within minutes. In the case of life-threatening muscle rigidity, a rapid onset neuromuscular blocker or naloxone may be administered. ULTIVA should not be administered into the same IV tubing with blood due to potential inactivation by nonspecific esterases in blood products. PRECAUTIONS Vital signs and oxygenation must be continually monitored during the administration of ULTIVA. General: Bradycardia has been reported with ULTIVA and is responsive to ephedrine or anticholinergic drugs, such as atropine and glycopyrrolate. Hypotension has been reported with ULTIVA and is responsive to decreases in the administration of ULTIVA or to IV fluids or catecholamine (ephedrine, epinephrine, norepinephrine, etc.) administration. Intraoperative awareness has been reported in patients under 55 years of age when ULTIVA has been administered with propofol infusion rates of ≤ 75 mcg/kg/min. Rapid Offset of Action: WITHIN 5 TO 10 MINUTES AFTER THE DISCONTINUATION OF ULTIVA, NO RESIDUAL ANALGESIC ACTIVITY WILL BE PRESENT. However, respiratory depression may occur in some patients up to 30 minutes after termination of infusion due to residual effects of concomitant anesthetics. Standard monitoring should be maintained in the postoperative period to ensure adequate recovery without stimulation. For patients undergoing surgical procedures where postoperative pain is generally anticipated, other analgesics should be administered prior to the discontinuation of ULTIVA. ULTIVA should not be used as a sole agent for induction of anesthesia because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia. Pediatric Use: The efficacy and safety of ULTIVA as an analgesic agent for use in the maintenance of general anesthesia in outpatient and inpatient pediatric surgery have been established in controlled clinical trials in pediatric patients from birth to 12 years. In clinical trials, the clearance rate observed in neonates was highly variable and on average was two times higher than in the young healthy adult population. While a starting infusion rate of 0.4 mcg/ kg/min may be appropriate for some neonates, an increased infusion rate may be necessary to maintain adequate surgical anesthesia, and additional bolus doses may be required. The individual dose for each patient should be carefully titrated (see ULTIVA Prescribing Information [PI], DOSAGE AND ADMINISTRATION, Table 11). ULTIVA has not been studied in pediatric patients for use as a postoperative analgesic or as an analgesic component of monitored anesthesia care. Geriatric Use: Of the total number of subjects in clinical studies of ULTIVA, 486 were in the age range 66 to 90 years. While the effective biological half-life of remifentanil is unchanged, elderly patients have been shown to be twice as sensitive as the younger population to the pharmacodynamic effects of remifentanil. The recommended starting dose of ULTIVA should be decreased by 50% in patients over 65 years of age. Use in Morbidly Obese Patients: As for all potent opioids, caution is required with use in morbidly obese patients because of alterations in cardiovascular and respiratory physiology. Long-term Use in the ICU: No data are available on the longterm (> 16 hours) use of ULTIVA as an analgesic in ICU patients. Carcinogenesis, Mutagenesis, Impairment of Fertility: Animal carcinogenicity studies have not been performed with remifentanil. Remifentanil did not induce gene mutation in prokaryotic cells in vitroo and was not genotoxic in an in vivo rat assay. No clastogenic effect was seen in hamster or mouse studies. In the in vitroo mouse lymphoma assay, mutagenicity was seen only with metabolic activation. Remifentanil has been shown to reduce fertility in male rats when tested after approximately 40 times the maximum recommended human dose (MRHD). The fertility of female rats was not affected at IV doses as high as 1 mg/kg when administered for at least 15 days before mating. Pregnancy Category C: Teratogenic effects were not observed in either rats or rabbits following administration of remifentanil at doses up to 400 times and 125 times the MRHD, respectively. Administration of radiolabeled remifentanil to pregnant rabbits and rats demonstrated significant placental transfer to fetal tissue. There are no adequate and well-controlled studies in pregnant

Drs. Calmes and Augustine, a forensic pathologist, analyzed liposuction death records from the coroner’s database, collecting a variety of procedurerelated information. They also analyzed autopsy and toxicology findings from the cases. “There are hazards to liposuction that most people do not even realize,” Dr. Calmes said. “Fat cells are held together by a fine network of fibrous tissue. During liposuction, this tissue is traumatized by a trocar, and fat cells

women. ULTIVA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Administration of remifentanil to rats throughout late gestation and lactation at IV doses up to 400 times the MRHD in terms of mg/m2 of body surface area, had no significant effect on the survival, development, or reproductive performance of the F1 generation. Animal Toxicology: Intrathecal administration of the glycine formulation without remifentanil to dogs caused agitation, pain, hind limb dysfunction, and incoordination. These effects are believed to be caused by the glycine. Glycine is a commonly used excipient in IV products and this finding has no relevance for IV administration of ULTIVA. Labor and Delivery: Respiratory depression and other opioid effects may occur in newborns whose mothers are given ULTIVA shortly before delivery. The safety of ULTIVA during labor or delivery has not been demonstrated. Placental transfer studies in rats and rabbits showed that pups are exposed to remifentanil and its metabolites. In a human clinical trial, the average maternal remifentanil concentrations were approximately twice those seen in the fetus. In some cases, however, fetal concentrations were similar to those in the mother. The umbilical arteriovenous ratio of remifentanil concentrations was approximately 30% suggesting metabolism of remifentanil in the neonate. Nursing Mothers: It is not known whether remifentanil is excreted in human milk. After receiving radioactive-labeled remifentanil, the radioactivity was present in the milk of lactating rats. Because fentanyl analogs are excreted in human milk, caution should be exercised when ULTIVA is administered to a nursing woman. ADVERSE EVENTS In controlled clinical trials in approximately 2770 adult patients, ULTIVA produced adverse events characteristic of μ-opioids, such as respiratory depression, bradycardia, hypotension, and skeletal muscle rigidity. These adverse events dissipated within minutes of discontinuing or decreasing the infusion rate of ULTIVA. Table 1: Adverse Events Reported in ≥ 1% of Adult Patients in General Anesthesia Studies* at the Recommended Doses† of ULTIVA Induction/Maintenance

Postoperative Analgesia

After Discontinuation

Adverse Event

ULTIVA (n=921)

Alfentanil/ Fentanyl (n=466)

ULTIVA (n=281)

Morphine (n=98)

ULTIVA (n=929)

Alfentanil/ Fentanyl (n=466)

Nausea Hypotension Vomiting Muscle rigidity Bradycardia Shivering Fever Dizziness Visual disturbance Headache Respiratory depression Apnea Pruritus Tachycardia Postoperative pain Hypertension Agitation Hypoxia

8 (<1%) 178 (19%) 4 (<1 % ) 98 (11%)‡ 62 (7%) 3 (<1%) 1 (<1%) 0 0 0

0 30 (6%) 1 (<1%) 37 (8%) 24 (5%) 0 0 0 0 0

61 (22%) 0 22 (8%) 7 (2%) 3 (1%) 15 (5%) 2 (<1%) 1 (<1%) 0 1 (<1%)

15 (15%) 0 5 (5%) 0 3 (3%) 9 (9%) 0 0 0 1 (1%)

339 (36%) 16 (2%) 150 (16%) 2 (<1%) 11 (1%) 49 (5%) 44 (5%) 27 (3%) 24 (3%) 21 (2%)

202 (43%) 9 (2%) 91 (20%) 1 (<1%) 6 (1%) 10 (2%) 9 (2%) 9 (2%) 14 (3%) 8 (2%)

1 (<1%) 0 2 (<1%) 6 (<1%) 0 10 (1%) 2 (<1%) 0

0 1 (<1%) 0 7 (2%) 0 7 (2%) 0 0

19 (7%) 9 (3%) 7 (2%) 0 7 (2%) 5 (2%) 3 (1%) 1 (<1%)

4 (4%) 2 (2%) 1 (1%) 0 0 3 (3%) 1 (1%) 0

17 (2%) 2 (<1%) 22 (2%) 10 (1%) 4 (<1%) 12 (1%) 6 (<1%) 10 (1%)

20 (4%) 1 (<1%) 7 (2%) 8 (2%) 5 (1%) 8 (2%) 1 (<1%) 7 (2%)

*Does not include adverse events from cardiac studies or the neonatal study. See ULTIVA PI, Tables 6, 7, and 8 for cardiac information. † See ULTIVA PI, Table 10 for recommended doses. Not all doses of ULTIVA were equipotent to the comparator opioid. Administration of ULTIVA in excess of the recommended dose (i.e., doses >1 and up to 20 mcg/kg) resulted in a higher incidence of some adverse events: muscle rigidity (37%), bradycardia (12%), hypertension (4%), and tachycardia (4%). ‡ Included in the muscle rigidity incidence is chest wall rigidity (5%). The overall muscle rigidity incidence is <1% when remifentanil is administered concurrently or after a hypnotic induction agent. In the elderly population (> 65 years), the incidence of hypotension is higher, whereas the incidence of nausea and vomiting is lower. DRUG ABUSE AND DEPENDENCE ULTIVA is a Schedule II controlled drug substance that can produce drug dependence of the morphine type and has the potential for being abused. OVERDOSAGE As with all potent opioid analgesics, overdosage would be manifested by an extension of the pharmacological actions of ULTIVA. Expected signs and symptoms of overdosage include: apnea, chest-wall rigidity, seizures, hypoxemia, hypotension, and bradycardia. In case of overdosage or suspected overdosage, discontinue administration of ULTIVA, maintain a patent airway, initiate assisted or controlled ventilation with oxygen, and maintain adequate cardiovascular function. If depressed respiration is associated with muscle rigidity, a neuromuscular blocking agent or a μ-opioid antagonist may be required to facilitate assisted or controlled respiration. Intravenous ﬂuids and vasopressors for the treatment of hypotension and other supportive measures may be employed. Glycopyrrolate or atropine may be useful for the treatment of bradycardia and/or hypotension. Intravenous administration of an opioid antagonist such as naloxone may be employed as a speciﬁc antidote to manage severe respiratory depression or muscle rigidity. Respiratory depression from overdosage with ULTIVA is not expected to last longer than the opioid antagonist, naloxone. Reversal of the opioid effects may lead to acute pain and sympathetic hyperactivity. ULTIVA is a registered trademark of Glaxo Group Limited. US Patent Nos. 5,019,583; and 5,866,591 Version B, 06/08/2011 Manufactured for Bioniche Pharma USA LLC, Lake Forest, IL 60045 Manufactured by Hospira, Inc. Lake Forest IL 60045

can be picked up by open blood vessels and carried to the heart and lungs.” Fat emboli are just one hazard faced by liposuction patients. Local anesthetic toxicity also is a real risk factor, as surgeons typically infuse dilute local anesthetic agents while the fat cells are being disrupted and sucked from the patient’s body. Infection also is a concern during liposuction. In September, Maryland officials shut down a Baltimore-area clinic after three women undergoing liposuction developed serious streptococcus infections. One of the patients died as a result of the infection. The risks do not end there. “The amount of local anesthetic that the surgeons inject is very high,” Dr. Calmes said. “So most of our patients had a high blood level of lidocaine.” Sedatives are administered intravenously during the procedure, another area of risk given that trained anesthesia personnel are rarely present for officebased liposuction. Yet liposuction can be risky even when anesthesiologists are providing care. Karen B. Domino, MD, professor of anesthesiology and adjunct professor of neurological surgery at the University of Washington, in Seattle, analyzed the ASA Closed Claims database for Anesthesiology News, looking for malpractice claims involving anesthesiologists who provided care for liposuction. Of the 9,536 claims in the database, 18 were associated with liposuction as the primary procedure. Of those, eight patients died, whereas another sustained permanent brain damage. Payment to the plaintiff was made in 12 of the 18 claims, with a median award of more than $400,000. Causes of injuries were mostly anesthetic complications, including difficult intubation, inadequate oxygenation/ventilation, airway obstruction, burns from use of hot water bottles to warm the patient, medication errors and slow recognition/ treatment of anaphylaxis. There were three cases of problems with fluid management and one case of local anesthetic toxicity related to liposuction. Look Out for Local Guy Weinberg, MD, professor of anesthesiology at the University of Illinois College of Medicine in Chicago, said the same standards of care should be used for local anesthetic administration during liposuction as for regional anesthesia. “Moreover, it is necessary that any physician using local anesthetics be aware of the current recommendations for managing local anesthetic

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 85

CL IN ICA L A N E STH E SIOL OG Y ‘In my opinion, they should be more stringently regulating these procedures, because physicians are abusing this method and patients are dying.’ —Selma Calmes, MD systemic toxicity, including its prevention, diagnosis and treatment,” Dr. Weinbergg said. Dr. Weinbergg had created a Web site, www.lipidrescue. org, addressing local anesthetic toxicity. In the Los Angeles study, the researchers identified nine liposuction deaths; records were unavailable for two patients, both of whom died in 1996. The remaining seven deaths occurred in 1999 (one), 2003 (one), 2004 (one), 2007 (one) and 2010 (three). Patients ranged in age from 29 to 61 years (mean 46.4 years), in weight from 150 to 206 pounds (mean 179 pounds), and in body mass index from 25 to 36 kg/m2 (mean 29.5 kg/m2). Six of the seven patients who died and for whom records were available were women. Perhaps not surprisingly, none of the cases was performed in a hospital. Four were in office-based settings, three in outpatient surgical units. General anesthesia was used in two cases, one by an anesthesiologist (the other practitioner could not be determined). The doctor performing the procedure or assisting with it sedated the other five patients. Fewer than half of the patients in the study had all the required monitors. All had blood pressure monitors; two also had an electrocardiogram and three also had pulse oximeters. The only patient who received end-tidal carbon dioxide

monitoring was the one who received general anesthesia from an anesthesiologist. Every patient who died underwent tumescent liposuction. Solution volume ranged from 0.8 to 7 L (mean 4.4 L); the volume of fat removed was 1.4 to 5.5 L (mean 3.7 L). Two patients were discharged home and died there on the day of the procedure. One patient died in the doctor’s office. The other four were transferred to a hospital, where they died. The interval until death ranged from one to seven days. Blood levels of lidocaine after death averaged 6.4 mcg/mL, but reached as high as 13 mcg/mL. Official causes of death included drug intoxication (lidocaine and sedatives), fat emboli, venous emboli and coronary artery disease. ‘Periphery of Medicine’ As Dr. Calmes pointed out, the inherent risks associated with liposuction are compounded by the fact that sometimes unscrupulous physicians might view the procedure as a cash cow. “Technically, liposuction is easy to do and there’s really no control over who’s doing this at this point in time,” she said. “We’ve found that doctors who fail in other specialties start doing liposuction in their office. The investment is minimal and there are

lots of patients who pay cash up front because insurance does not cover this procedure. So I see it as the periphery of medicine done by people who aren’t well observed and who want to make a relatively easy living.” Anne Taylor, MD, a plastic surgeon in Columbus, Ohio, agreed that patient safety needs to be of primary concern. “A fully trained, boardcertified plastic surgeon has six years of training in surgery. So the patient needs to know what kind of training the surgeon has had, or if [he or she is] even a surgeon.” The hazards of liposuction often are exacerbated by the fact that patients are undergoing multiple procedures, a phenomenon that Dr. Calmes observed in the cases she reviewed: one woman was undergoing a mammoplasty; two had “buttock lifts.” Although some states have enacted legislation aimed at protecting liposuction patients, so-called “cosmetic surgeons” (who are not board-certified plastic surgeons) have not gone down without a fight. To make matters worse, Dr. Calmes said, few physicians performing these procedures are being monitored by regulatory agencies. “I discovered to my horror that nobody is actually tracking these things,” she said. “In my opinion, they should be more stringently regulating these procedures,” Dr. Calmes said, “because physicians are abusing this method and patients are dying.” She recommended that medical boards enable strict reporting systems for liposuction deaths, and enact stricter regulations around the

Death Rates From Complications of Medical and Surgical Care—an Improving Picture

—AN Staff Source: Centers for Disease Control and Prevention.

140 ≥85 yrs 75-84 yrs 65-74 yrs 45-64 yrs

120

Deaths per 100,000 population

urgery is getting safer. Between 1999 and 2009, deaths from complications of medical and surgical care among Americans aged 45 and older fell among all age groups, according to the Centers for Disease Contrrol and Prevention. Deaths per 100,000 population declined 39%, to 71.3 deaths for people aged 85 and older; 37%, to 51.4 deaths for those aged 75-84; 38%, to 27.9 deaths for those aged 65-74; and 28%, to 8.9 deaths for people aged 45-64. The decline was smallest for Americans between the ages of 45 and 64.

1000 800 60 40 20 0 1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

procedure. Limiting surgeons to one cosmetic procedure at a time would also improve patient safety. Having a trained anesthesia practitioner present during the procedure would also go a long way toward improving patient safety as well, as would enforcing monitoring requirements. Limited Oversight Leads To Patient ‘Lottery’ Dr. Taylor, former editor of Plastic Surgery News, a publication of the American Society of Plastic Surgeons, agreed that anesthesiologists have an important role to play during these procedures. “I like to collaborate with anesthesia,” she noted. “I think it’s safer to have an anesthesiologist as part of the operating room team versus trying to do liposuction in an office setting, where you are by yourself.” Dr. Calmes also recommended much stricter requirements in terms of who can perform liposuction. “Right now in California, I think you can watch a video and then perform the procedure and advertise yourself as a cosmetic surgeon,” she said. Professional plastic surgery associations have pushed for this kind of tighter control, but as Dr. Calmes noted, “it seems like nobody is paying attention to them. “The problem is not the boardcertified plastic surgeons,” she said. “The problem is the lower-level physician who wants to make a quick buck and the gullible patient who wants to go on a quick diet.” Elizabeth Frost, MD, professor of anesthesiology at Mount Sinai Medical Center, in New York City, pointed out that when it comes to a procedure like liposuction, consumers must be wary of how and where they spend their money. “Dr. Calmes decries the practice of tumescent liposuction by untrained or greedy physicians,” Dr. Frost said. “I could not agree more. Certainly if states have provided guidelines based on best practice, they should be followed.” However, added Dr. Frost, a member of the editorial board of Anesthesiology News, “no evidence is presented that these deaths actually occurred at the hand of ‘lower-level’ individuals. As far as I know, most plastic surgeons are paid in advance and not by insurance. This is their practice and they can hardly be condemned for it. As for the patient who wants a quick fix? How different is that from buying a lottery ticket? And as with so much in life, caveat emptor!”

Year

—Michael Vlessides

THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

Part 1 of a 3-Part Series

Perioperative Patient Monitoring: Case Studies in Major Abdominal Surgery David W. Green, MB, FRCA, MBA Consultant Anaesthetist and Honorary Senior Lecturer Department of Anaesthetics, Intensive Care and Pain Relief King’s College Hospital NHS Foundation Trust London, United Kingdom

Maxime Cannesson, MD, PhD Department of Anesthesiology & Perioperative Care School of Medicine University of California, Irvine Irvine, California

Introduction During major abdominal surgery, incidence of major blood loss (MBL) as well as fluid loss is an acute risk factor, particularly for patients aged at least 65 years and those undergoing complex surgeries.1 If fluid is not replenished during the perioperative period, fluid loss and MBL can lead to an increased risk for complications, including cardiac and respiratory failure, impaired cognitive function, and physiologic reactions to infections due to the lack of oxygenation and organ perfusion.2 Underlying disease and comorbidities, anesthetic use, and nature and duration of surgery also are associated with the development of these complications, which often lead to poor patient outcomes.3 Complications greatly increase the risk for morbidity and mortality, as well as time spent in the intensive care unit (ICU), overall hospital length of stay (LOS), and potential need for further postoperative follow-up.4 Consequently, negative outcomes may incur increased costs related to staffing, medication, and equipment use.5 Efficient strategies to detect and treat potential triggers of organ failure, both intraoperatively and postoperatively, are particularly important for patients at high risk for complications.2

Case Study 1: A 58-Year-Old Man Scheduled for Partial Right Nephrectomy and Resection Of a Tumor Infiltrating the Inferior Vena Cava

he patient’s medical history included a previous left nephrectomy, myocardial infarction, and hypertension (treated with β-blockers and calcium antagonists). His American Society of Anesthesiologists classification was 3 (patient with severe systemic disease). Resection of right kidney tumor infiltrating the inferior vena cava (IVC) with IVC clamp and IVC replacement with prosthesis was planned. Anesthetic management included general anesthesia induction and maintenance with a target-controlled infusion of propofol and remifentanil. Cerebral regional oxygen saturation (rSO2), nominal cardiac output (CO), and other hemodynamic vitals were monitored using the INVOS and LiDCO systems.

During surgery, the IVC was clamped and prosthesis placed following the removal of liver metastases and two-thirds of the right kidney. After IVC clamp, the LiDCOrapid d monitor displayed the fall in blood pressure (BP) and stroke volume (SV), as well as a sudden rise in stroke volume variation (SVV). Although the exact amount for a fluid challenge is controversial, our practice uses the ratio of 5 mL per 1 kg of weight over a few minutes (ie, 5 times patient weight 95 kg, or 500 mL). The patient was administered 500 mL of 6% hydroxyethyl starch 130/0.4 and BP and SV recovered. The LiDCOrapid d monitor displayed the effect of this fluid challenge in the event-response screen with an increase in SV of 92%. SVV returned to the normal range of 11%. Loss of venous return for any reason, such as sudden or continuing major blood loss (MBL), can similarly result in an increase in SVV, which may be the first sign that MBL is occurring. During the period of IVC clamping, nominal CO, SV, and BP each decreased (Figure); rSO2 also fell after clamping. Maintaining preinduction values of these parameters during surgery minimizes the build up of oxygen debt. In abdominal surgery, maintenance of rSO2 is important to prevent occult cerebral hypoxia as well as hypoxia in other organs. Following fluid administration, SVV decreased together with recovery of rSO2 and BP, as well as a gradual rise of nominal CO and SV. Using the INVOS system, LiDCOrapid monitor, and other assessment tools, monitoring aided in the maintenance of rSO2 and nominal CO after the initial period of clamping and fluid challenge. When the IVC clamp was removed, nominal CO increased. The LiDCOrapid d monitor tracked results of the fluid challenge in terms of fall in SVV and increase in nominal SV, BP, and CO. Appropriate fluid challenge resulted in a gradual rise in rSO2 suggesting restoration of oxygen delivery. Figure. Case review screen of the LiDCOrapid monitor. After removal of two-thirds of the remaining right kidney, creatinine levels peaked at approxCase review screen showing the effect of clamping on SVV increase (top row) imately 900 mg/dL at postoperative day 7, and and reduction in nCO (second row), nSV (third row), and BP (bottom row). then decreased to 250 mg/dL, reflecting the Recovery follows fluid challenge. patient’s limited kidney function. Despite the BP, blood pressure; HR, heart rate; HRV, heart rate variability; nCO, nominal cardiac output; nSV, fact that the patient had roughly one-sixth of nominal stroke volume; SVV, stroke volume variation total renal mass postoperatively, his renal funcCourtesy of David W. Green, MB, FRCA, MBA. tion recovered and he did not require dialysis.

Perioperative Hemodynamic Monitoring To potentially improve outcomes and reduce complications, monitoring modalities that reflect the patient’s dynamic intravascular physiology in real time should be employed. Increasingly, clinicians have turned to hemodynamic assessment to measure cardiac output to guide vasopressor support for oxygen delivery, organ perfusion, and blood pressure (BP), as well as the use of appropriate anesthetics. Data has shown that using hemodynamic assessments to guide fluid management leads to reduced hypovolemia and hypoperfusion.6

Using the measurement of stroke volume (SV), stroke volume variation, and pulse pressure variation,6 over other volume indicators like central venous pressure (CVP),7 have been effective in reducing complications and improving outcomes via goaldirected protocols.6 Evidence suggests that goal-directed hemodynamic optimization of high-risk patients initiated in the operating room and continued in the ICU improves short-term outcomes as well as long-term survival.8

ANESTHESIOLOGY NEWS • OCTOBER 2012

Pearse and colleagues studied the difference between goal-directed therapy—evaluating fluid response by change in SV and oxygen delivery using the LiDCO™ plus advanced hemodynamic monitoring system—versus fluid administration guided by CVP in 122 patients undergoing major vascular, upper and lower gastrointestinal, hepatobiliary, and urologic surgeries.9 The authors found that patients receiving goal-directed therapy developed fewer complications and had reduced hospital LOS.9

Cerebral Oximetry Maintenance of adequate cerebral oxygenation and blood flow—potentially preventing neurocognitive morbidities—is critical in the management of surgical patients. The INVOS™ cerebral/somatic oximeter uses near-infrared spectroscopy to noninvasively monitor regional or cerebral blood oxygen saturation, and recent studies have shown its benefit in major abdominal surgery. Casati and colleagues randomized 122 elderly patients to intraoperative cerebral

Supported by

oxygen saturation monitoring with a treatment intervention protocol using the INVOS system or to routine monitoring of arterial BP and heart rate maintained within 20% of baseline values.10 Results showed that patients in the INVOS cerebral/somatic oximetry group experienced less cognitive decline postoperatively and had shorter LOS than patients in the control group.10 According to the authors, potentially inadequate blood oxygen supply to the brain was minimized using the INVOS system (oxygen saturation maintained at ≥75% of preinduction levels).10

Monitoring Level of Consciousness Developing a goal-directed approach regarding anesthetic use also has been shown to reduce overall anesthetic consumption and lead to improved recovery times.11 The BIS™ (Bispectral Index) Level of Consciousness (LOC) system monitors brain function by analyzing electroencephalographic data using a proprietary algorithm that calculates a value between 0 (the absence of brain activity) and 100 (fully awake). Validation studies have demonstrated that a BIS value between 40 and 60 is considered suitable for surgical anesthesia and reflects a decreased cerebral metabolic rate and a low probability of awareness.12 In a retrospective analysis of 24,120 cases, Sessler and colleagues found that patients who simultaneously experience low-normal BIS values, mean arterial pressure (MAP), and minimum alveolar concentration have nearly triple the risk for 30-day mortality compared with those whose numbers are higher.13

Case Study 2: A 73-Year-Old Man Referred for Abdominal Aortic Aneurysm Repair

his patient’s medical history included type 2 diabetes, hypertension, and smoking (1 pack a day for 40 years, discontinued 15 years ago). His American Society of Anesthesiologists classification was 3; his weight was 72 kg. He had a surgical history of transurethral prostate resection 10 years ago. He reported being able to walk 4 flights of stairs and described no chest pain. A preoperative echocardiography (EKG) demonstrated a left ventricular ejection fraction of 55% to 60%; there was no right ventricular failure. The patient had a recent stress EKG that did not demonstrate any abnormalities; the heart was in sinus rhythm. A preoperative carotid Doppler showed a bilateral carotid stenosis (about 60% stenosis). The preoperative creatinine was normal. Aspirin was discontinued 6 days prior to surgery. Anesthetic management included general anesthesia induction with propofol and sufentanil, maintenance with sevoflurane and sufentanil, and neuromuscular blockade with cisatracurium. Vascular access was obtained via 2 large bore IVs (16 gauge). Minimally invasive cardiac output, stroke volume (SV), and stroke volume variation (SVV) monitoring were determined using the LiDCOrapid advanced hemodynamic monitor. Depth of anesthesia was assessed using the BIS™ (Bispectral Index) monitor with the goal of maintaining values between 40 and 60 and to optimize SV based on an SV optimization protocol. Fluid management consisted of a baseline crystalloid infusion (3-4 mL/kg per hour), associated to a titration of 6% hydroxyethyl starch based on the SV optimization protocol.

A significant decrease in mean arterial pressure (MAP) was observed immediately after the induction of general anesthesia. It was treated with a bolus of phenylephrine 100 mcg although SVV was high (20%). When such an acute change in MAP occurs, it is important to correct it quickly in order to avoid adverse effects on postoperative cognitive function. This hypotensive episode lasted less than 3 minutes and MAP was stable afterward. Once hemodynamic variables are stabilized, SV optimization is key. In this case, SV was 53 mL and SVV was 18% after stabilization (Table). Following the SV optimization protocol, a bolus of 6% hydroxyethyl starch was given. This bolus decreased SVV to 10% and increased SV from 53 to 61 mL (15% increase). According to the SV optimization protocol, another bolus of fluid (200 mL) was given. SVV decreased to 7% and SV increased to 66 mL (<10% increase). At this time, it was determined that SV was optimized. The BIS monitor was used to facilitate dosing of the primary anesthetic agent in this patient. Sevoflurane was titrated in order to maintain the BIS range between 40 and 60. Sevoflurane was kept between 0.8 and 1.1 minimum alveolar concentration, and BIS values oscillated between 42 and 62. Information from the BIS monitor aided in the assessment of adequate depth of anesthesia. Titration of the anesthetic agent was useful in achieving the goal of maintaining stable MAP during the procedure. Two units of blood were given during the case. He spent 1 night in the ICU and was discharged on postoperative day 5. No complications were observed.

Table. Key Monitoring Parameters During Surgery Immediately After Induction of General Baseline Anesthesia

15 Min After After 200 mL Induction Of 6% HES

After Additional 200 mL of 6% HES

MAP, mm Hg

SVV, %

SV, mL

Conclusion

BIS value

These case studies illustrate the benefits of hemodynamic assessment and fluid management throughout surgery in helping clinicians provide improved outcomes and reduce the risk for complications. As demonstrated by these cases, as well as in literature, monitoring cerebral oxygenation allows for clearer and earlier indication of oxygen deficits. Monitoring LOC provides an additional layer of understanding on appropriate anesthetic levels preserving MAP and reducing possible adverse events following surgery. These systems have the advantage of potential application in the postanesthesia care unit and the ICU, and can provide objective data to help clinicians improve patient outcomes in these acute care settings as well.

Left cerebral oximetry, %

Right cerebral oximetry, %

Sevoflurane MAC

0.6

0.9

References

BIS, Bispectral Index; bpm, beats per minute; HES, hydroxyethyl starch; MAC, minimum alveolar concentration; MAP, mean arterial pressure; NA, not applicable; SV, stroke volume; SVV, stroke volume variation Courtesy of Maxime Cannesson, MD, PhD.

replacement strategy in major abdominal surgery: A prospective randomized trial. Arch Surg. 2010; 145(12):1193-1200. 3. Brooks-Brunn JA. Predictors of postoperative pulmonary complications following abdominal surgery. Chest. 1997;111(3):564-571. 4. Jhanji S, Lee C, Watson D, Hinds C, Pearse RM. Microvascular flow and tissue oxygenation after major abdominal surgery: association with postoperative complications. Intensive Care Med. 2009; 35(4):671-677.

1. Olin K, Eriksdotter-Jönhagen M, Jansson A, Herrington MK, Kristiansson M, Permert J. Postoperative delirium in elderly patients after major abdominal surgery. Br J Surg. 2005;92(12):1559-1564.

5. Donati A, Loggi S, Preiser JC, et al. Goal-directed intraoperative therapy reduces morbidity and length of hospital stay in high-risk surgical patients. Chest. 2007;132(6):1817-1824.

2. Futier E, Constantin JM, Petit A, et al. Conservative vs restrictive individualized goal-directed fluid

6. Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and

fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009;37(9):2642-2647. 7. Marik PE, Monnet X, Teboul JL. Hemodynamic parameters to guide fluid therapy. Ann Intensive Care. 2011;1(1):1. 8. Hamilton MA, Cecconi M, Rhodes A. A systematic review and meta-analysis on the use of preemptive hemodynamic intervention to improve postoperative outcomes in moderate and high-risk surgical patients. Anesth Analg. 2011;112(6):1392-1402. 9. Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett ED. Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445]. Crit Care. 2005;9(6):R687-R693.

10. Casati A, Fanelli G, Pietropaoli P, et al. Continuous monitoring of cerebral oxygen saturation in elderly patients undergoing major abdominal surgery minimizes brain exposure to potential hypoxia. Anesth Analg. 2005;101(3):740-747. 11. Punjasawadwong Y, Boonjeungmonkol N, Phongchiewboon A. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2007;(4):CD003843. 12. Bowdle TA. Depth of anesthesia monitoring. Anesthesiol Clin. 2006;24(4):793-822. 13. Sessler DI, Sigl JC, Kelley SD, et al. Hospital stay and mortality are increased in patients having a “triple low” of low blood pressure, low bispectral index, and low minimum alveolar concentration of volatile anesthesia. Anesthesiology. 2012;116(6):1195-1203.

Disclaimer: This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, Covidien, and the authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature. Copyright © 2012, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.

ANESTHESIOLOGY NEWS • OCTOBER 2012

BB1233

Disclosures: Dr. Green reported receiving honoraria from Covidien and GlaxoSmithKline, and receiving grant/research funding from Covidien, Deltex Medical, and LiDCO Group Plc. Dr. Cannesson reported that he is a consultant for Covidien, Dräger, Edwards Lifesciences, Masimo, and Philips.

88 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

C L I N I C AL ANES THES IO LO GY Editor’s note: We try to bring you all the news in a timely manner, but sometimes things slip through the cracks. Here are a few stories from last year’s annual meeting of the American Society of Anesthesiologists that caught our eye but never made the pages of the magazine.

Nebulized or Atomized (Shaken or Stirred?), Bupivacaine Provides Equivalent Analgesia In Peds Study

approach because there’s very little need for IV rescue medication,” said study leader Petra M. Meier, MD, senior associate in perioperative aneslthough the intraperitoneal thesia at Children’s Hospital Boston administration of bupivacaine and assistant professor of anaesthesia with a nebulizer results in lower at Harvard Medical School. “So we are peak plasma levels and less systemic thinking about using this for day surabsorption of the local anesthetic than gery as well. We have been very lucky with a mucosal atomizer, the difference with our surgeons. They have no comdoes not appear to affect postoperative plaints about it.” analgesia, researchers have found. Dr. Meier’s group had two goals for The investigators found no differ- the study, she said. “One was to deterence between the two approaches in mine the pharmacokinetic parameterms of total morphine requirements ters and plasma levels for aerosolized at two, 12 and 24 hours after surgery. intraperitoneal bupivacaine. The sec“Our surgeons like the nebulizer ond was to confirm the relatively low

analgesic requirements that we found in a previous retrospective study [J Pediatr Urol 2008;4:337-340; Meier PM et al; 2010 ASA; A338].” In the 2010 pilot study, the Boston researchers examined the pharmacokinetic parameters of aerosolized intraperitoneal bupivacaine in 30 children ranging in age from 6 months to 6 years. The children received 1.25 mg/kg of bupivacaine, diluted with saline to a total volume of 30 mL, by aerosolization. Plasma concentrations of bupivacaine ranged from 0.0 to 2.44 mcg/ mL. Concentrations fell quickly and were within the generally accepted

safe range for conscious adult patients, leading the investigators to conclude that intraperitoneal aerosolized bupivacaine is safe and rapidly absorbed systemically. Yet several patients had peak plasma levels above 2 mcg/mL. As a result, the investigators wanted to compare that study’s results with a newer technique to administer bupivacaine: the micropump nebulizer. The latest trial also enrolled children aged 6 months to 6 years (N=49), all undergoing robot-assisted laparoscopic urologic surgery. One group (n=30) received 1.25 mg/kg of bupivacaine, diluted with saline, using a mucosal

Novel Clot Preserver Passes Early Clinical Tests In Cardiac Surgery Cases

MDCO-2010 Plasma Concentration, nM

he first study in intended patients of an exper- sternotomy using minimized extracorporeal circula- infusion, eliminated with a half-life of one hour and imental drug to prevent blood loss during tion (priming volume of 600 mL). abated by 85% within four hours of the end of infucardiac surgery found that the drug demonMDCO-2010 was administered immediately sion (Figure). strates predictable pharmacokinetics and an accept- after heparin bolus, with a loading dose followed by The investigators also found that MDCO-2010 able safety profile, researchers reported. continuous infusion until sternal closure. Patients exhibited dose-dependent antifibrinolytic and antiThe drug, MDCO-2010 (The Medicines Com- received one of five doses of MDCO-2010 by con- coagulant effects. “Pharmacokinetics were quite pany), is a synthetic, small-molecule serine protease tinuous infusion (n=24)—ranging between 12.5 and fine, with stable conditions throughout intraoperainhibitor designed to reduce blood loss, transfusion 219 mcg/kg per hour—or saline (n=8). tive infusion,” Dr. Englberger said. “We found antifirequirements and associated morbidity in cardiac Plasma levels of the drug were stable during brinolytic effects in patients treated with study drug. surgical patients. Until now, the antiInterestingly—and perhaps challengHeparin Protamin Dose, mg/kg/h fibrinolytic compound has been tested ing for the future—the drug also demCPB 219 in animals and some healthy volunonstrates moderate anticoagulative 109 Loading Continuous infusion teers, said Lars Englberger, MD, assoeffects.” 62.5 dose ciate professor of cardiac surgery at Although eight patients (four of 24 25 12.5 University Hospital Berne, in Berne, in MDCO groups; four of eight in 1500 Switzerland, who led the trial. the placebo group) received perioper“This is the first study in surgiative allogeneic blood products, none cal patients, and we showed a good required surgery for the bleeding or safety profile for this new drug and pericardial tamponade. 1000 good pharmacokinetics with preAdverse events were compadictable plasma concentrations,” rable between the study groups, Dr. Englberger said. “And from what Dr. Englberger said. Two of the 24 500 we know in animal studies, there are patients in the treatment group experirelevant anticoagulative and antifibrienced adverse events that were considnolytic effects; these may be clinically ered to be unrelated to the study drug: important.” a myocardial infarction and a graft 0 Pre Pre 15 min 30 min 60 min Sternal 15 min 30 min 4h The Phase IIa, double-blind, thrombosis. Two of the eight patients heparin closure placebo-controlled dose escalation in the placebo group had postoperative CPB Post sternal closure Timepoint study comprised 32 patients undergohemorrhages. ing elective, primary coronary artery Figure. Plasma levels of the clot-preserving drug nearly abated within four “And even though we had relatively bypass grafting through midline hours after infusion. small numbers of patients, the 12-hour

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 89

CL IN ICA L A N E STH E SIOL OG Y atomization device in a single with the nebulizer. “This bolus. indicates a reduced extent of The second group (n=19) systemic absorption in the received undiluted 0.5% micropump nebulizer group,” bupivacaine with a microDr. Meier explained. pump nebulizer (Aeroneb No arrhythmias or clinical Pro, Philips Respironics) into signs of neurotoxicity were the carbon dioxide insufobserved in the study. flation tubing over a 15- to Dr. Meier reported the 30-minute period. At the end off sur- findings fi di at the 2011 annual meeting of gery, 1.25 mg/kg of 0.25% bupivacaine the American Society of Anesthesiolo(maximum, 10 mL) was injected sub- gists (abstract 828). cutaneously into the trocar incisions. —Michael Vlessides Plasma bupivacaine levels were measured by high-performance liquid chromatography. Maximum plasma concentrations of bupivacaine were significantly lower in patients receiving the drug with the nebulizer. Absorption of bupivacaine was nearly instantaneous in both groups, the researchers said. Maximum measured bupivacaine plasma concentrations were 2.44 mcg/mL in the group treated with the atomizer and 0.83 mcg/mL in the patients treated

chest drainage was significantly lower in patients who were treated with the drug,” he said. Daniel Bainbridge, MD, associate professor of anesthesia at The University of Western Ontario in London, Canada, said new methods of preventing blood transfusion in cardiac surgery are warranted. “Transfusion rates range from 20% to 60%,” Dr. Bainbridge said. “This wide range not only indicates a lack of consensus on when to transfuse, but also the high rate at which we transfuse, and these transfusions are generally associated with more adverse outcomes.” Dr. Bainbridge cautioned that although no adverse events were observed in the study, the new drug may not be safe. “We need larger trials for that,” he said. The researchers presented their findings at the 2011 annual meeting of the American Society of Anesthesiologists (abstract 053). The Medicines Company is scheduled to begin a study to compare MDCO-2010 with another blood-loss drug, tranexamic acid, as well as placebo, in roughly 270 patients undergoing cardiac surgery. That trial, which Dr. Englberger is leading, was to begin enrollment in March and end in June 2013, according to information on the Web site, ClinicalTrials.gov. —Michael Vlessides

Contact

the editor of Anesthesiology News

amarcus@mcmahonmed.com

90 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

CLI NI CA L A NESTH E SIOL OG Y

New Clotting Product Sets Sights on Drier Surgical Field

novel polysacchaassess clot formation because ride powder might of the irregular curves it crehelp reduce patients’ ated. “With this dose we risk for bleeding from small found immediate clotting vessels during surgery. The and very high clot firmness,” compound was found to Dr. Hanke said. “The test significantly increase coagwas not able to give proper ulation speed and clot firminformation about how the ness, even when diluted to clot expanded, so that’s why mimic coagulopathy caused Alexander A. Hanke, MD we took that dose out of the by massive transfusion, according to the statistical analysis.” Nevertheless, at this researchers, who acknowledged that fur- dose, even in diluted blood the clot was ther clinical trials are necessary to prove firm, leading the researchers to believe in vivo efficacy of the powder. that it may be capable of sealing micro“Microvascular bleeding appears very vascular bleeding areas. frequently in the operating room,” said Although 4DryField is still early in Alexander A. Hanke, MD, staff anesthe- development, the investigators said siologist and chief of the perioperative it has many potential applications. hemostasis section at Hannover Medi- “This can be useful for surgical procecal School in Hannover, Germany. “It’s dures in the trauma department, where a really big problem. The idea behind you have liver or splenic ruptures. It putting a hemostatic polysaccharide can also be used in cardiac surgery, powder directly onto a bleeding surface where diffuse bleeding often occurs,” is that it increases the speed of coag- Dr. Hanke explained. ulation and clot firmness by building In the meantime, other options are a tight viscous mesh of gel and blood available. Arista absorbable hemostatic components. So you have a stable clot particles (Medafor, Inc.) are approved within a short period of time.” by the FDA, as are QuikClot hemoTo test the viability of the new agent, static dressings (Z-Medica CorporaDr. Hanke and his co-investigators took tion). “But this new product likely has blood samples from 10 healthy volun- more power in accelerating clot forteers. The samples were then treated mation because it draws more water,” with three different doses of the poly- Dr. Hanke said. “And once you take saccharide powder (4DryField, Plant- the water out of the blood, you have Tec Medical): 5, 10 or 20 mg. EXTEM a concentration of coagulation factesting was used to measure coagulation tors and platelets. That’s why the effect time and maximum clot firmness. To should be a little more pronounced determine the effect of 4DryField under with this agent.” dilution, all tests also were performed The researchers are now turnwith 50% diluted samples. ing their attention to animal models. The 10-mgg dose significantly reduced “Until now, the agent was only used clotting time (P=0.011) and increased in ex vivo and experimental models,” mean clot firmness (P<0.001) in native Dr. Hanke said. “Next we have to go blood, according to the researchers, who into animal models, and then human presented their findings at the 2011 patients. So there is a lot of work to do, annual meeting of the American Society but it looks good for now.” of Anesthesiologists (abstract 051). Both Bruce D. Spiess, MD, professor of parameters improved. anesthesiology at Virginia CommonThese results persisted in diluted wealth University in Richmond, said blood (clotting time: P=0.002; mean he was encouraged by the early results. clot firmness: P<0.0001), although “The bottom line is I think there’s a the values were improved from severely place for all kinds of these products,” reduced to slightly below normal Dr. Spiess said. “If this group from Gerrange. The 5-mgg dose had little effect many can make even small changes to on these parameters, either in native or the current products available, then diluted blood. there’s absolutely a place for it in the The 20-mgg dose (considered the nor- clinical arena, especially if they use it as a mal dose by the agent’s manufacturer) platform and then support it with addihad such a profound effect on clot firm- tives and other things you can put in it.” ness and mean clotting time that rota—Michael Vlessides tion thrombelastometry was not able to ■

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 91

CL IN ICA L A N E STH E SIOL OG Y

More, Earlier, Anemia Screening Needed Before Surgery and 61.5% were classified as urgent. The researchers found that only 21.2% of the overall study group had received early anemia screening, whereas the remainder had their hemoglobin tested one to 13 days prior to surgery. They found that 28.5% of elective cases and 16.6% of urgent cases had received early anemia screening.

Almost half of all patients in the study (42.7%) had preoperative anemia which, using the World Health Organization definition, was a hemoglobin concentration below 13 mmol/L for men and 12 mmol/L for nonpregnant women. As expected, anemia was more prevalent in women than men (50.2% vs. 38.4%, respectively; P<0.0001).

Anemic patients were more likely to receive a red blood cell transfusion than non-anemic patients (87.6% vs. 47.9%, respectively; P<0.0001). Aryeh Shander, MD, chief of anesthesiology, critical care medicine, pain management and hyperbaric medicine at Englewood Hospital and Medical Center in Englewood, N.J., said the see anemia page 97

3M™ Bair Huggerr™ Therapy

E EV

Now proudly part of 3M Infection Prevention

f-1 In

AL GO

Boston—Few patients receive early preoperative anemia screening for cardiac surgery, according to a large retrospective study by North Carolina researchers. Investigators found that only 29% of patients undergoing nonemergent cardiac surgery at their institution underwent early screening for anemia over a two-year period. “We have a significant number of patients going to surgery who are anemic. There is a large population that could benefit from some controlled screening,” said Nicole Guinn, MD, cardiac anesthesia fellow at Duke University School of Medicine, in Durham. Dr. Guinn presented the findings in a poster at the recent annual meeting of the Society of Cardiovascular Anesthesiologists (poster SCA38). “There would be some cost to setting up a preoperative anemia screening clinic, but there are also significant costs associated with blood transfusions and the associated increase in morbidity and mortality.” Early screening for anemia, defined as a hemoglobin check 14 to 45 days prior to surgery, provides physicians with sufficient time to treat anemic patients before surgery, by, for example, addressing an iron or nutritional deficiency. Clinicians have long known that preoperative anemia can increase rates of blood transfusions in the perioperative period as well as increase morbidity and mortality (New Engl J Med 2001;345:1230-1236; JAMA 2007;297:2481-2488). Transfusions of red blood cells carry risks, including pulmonary edema, renal failure, multiorgan failure, myocardial infarction and infection. Transfusions also increase hospital length of stay, health care costs and the risk for death. In their study, Dr. Guinn and colleagues set out to determine how many cardiac surgery patients at their facility were receiving early anemia screening. They conducted a review of all adult patients who had undergone coronary artery bypass graft surgery (CABG) or CABG plus valve repair or replacement between January 2008 and December 2009. “We excluded all emergent surgery cases and Jehovah’s Witness patients,” said Dr. Guinn, noting that because Jehovah’s Witness patients do not receive blood transfusions they often are monitored and treated preoperatively for anemia. Of the 1,545 patients in the study, 38.5% were elective cases

Warm From Underbody Series

™

The 3M Bair Huggerr underbody blanket series offers warming for virtually any surgery, routine to complex without the risk of heating pressure points. Our seven underbody series blankets deliver all the beneﬁts of forced-air warming with the convenience of unrestricted patient access and smart design features like unique surface outlets that prevent ﬂuid pooling.

Adult Underbody

Large Pediatric Underbody

Model 545

Model 550

Spinal Underbody

Lithotomy Underbody

Model 575

Model 585

Pediatric Underbody Model 555

Full Access Underbody Models 635/637

Call 800-733-7775 to schedule an evaluation or visit www.bairhugger.com for more information.

3M is a trademark of 3M Company, used under license in Canada. BAIR HUGGER and the BAIR HUGGER logo are trademarks of Arizant Healthcare Inc., used under license in Canada. ©2011 Arizant Healthcare Inc. All rights reserved. 602737N 7/11

92 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

C LIN I C A L A N ES THES IO LO G Y

Local Anesthetic Overkill Seen in Some Blocks Palm Springs, Calif.—The concentration of ropivacaine typically used in ultrasound-guided supraclavicular blocks is much greater than necessary, a recent study has found. The investigators concluded that 40 mL of 0.138% ropivacaine will produce surgical anesthesia in 95% of such patients. Excessive dosing of the drug increases the risk for toxic reactions that, in rare

cases, can be fatal. “Local anesthetic toxicity continues to be a problem in regional anesthesia, and we anesthesiologists often wonder about the ideal concentration of agents such as ropivacaine,” said Elizabeth Baker, MD, assistant professor of anesthesiology at the University of New Mexico, in Albuquerque, who helped conduct the study.

“Since pediatric anesthesiologists use much lower ropivacaine concentrations in children—with very good success—we may not need to use such high concentrations in adults. So we started with a fairly standard concentration of 0.5% and wanted to see if we could still get effective surgical anesthesia for the arm as we lowered the drug concentration.”

Dr. Bakerr and her colleagues enrolled 13 patients over age 18 years into the trial; each was undergoing upper limb surgery not involving the shoulder. Blocks were performed by attending regional anesthesiologists with expertise in ultrasound guidance and who were blinded to the concentration of the local anesthetic. After patients were sedated with midazolam and fentanyl, the block was performed with a 22-gauge, 80-mm Tuohy needle. The needle was inserted at the lateral border of the probe using an in-plane technique toward the corner pocket. A total of 40 mL local anesthetic was injected to achieve a comprehensive spread around the brachial plexus. “A previously published article found the minimum effective volume for supraclavicular blocks, when using a mixture of 2% lidocaine and 0.5% ropivacaine, to be 40 mL,” Dr. Baker explained (Reg Anesth Pain Medd 2009; 34:215-218). “So we held that volume constant and looked at reducing the concentration.” For ropivacaine, the starting concentration was 0.5%. “With every successful block, we decreased the concentration of ropivacaine by 0.05%, until we got a failure,” added Dr. Baker,r who reported her group’s findings at the 2012 annual spring meeting of the American Society of Regional Anesthesia and Pain Medicine (abstract P15). “Once we had a failure, we increased the concentration again by 0.05%.” Sensation to ice exposure in the median, ulnar, radial and musculocutaneous nerve distributions was tested every five minutes by a blinded assessor. Block success was defined as complete loss of sensation to ice in all four nerve distributions within 30 minutes. These patients proceeded with surgery under monitored anesthesia care. Patients with sensation of cold in any of the four distributions within 30 minutes were deemed unsuccessful. Similarly, blocks also were considered unsuccessful if the surgeon needed to inject local anesthesia during the procedure or if patients complained of pain in the operating room. The study was stopped after 13 patients had participated. The researchers concluded that the ED50 of ropivacaine in this patient population was 0.107% (95% confidence interval, 0.081%-0.132%); the ED95 was 0.138%. John F. Butterworth, MD, professor and chair of anesthesiology at Virginia see excess page 96

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 93

CL IN ICA L A N E STH E SIOL OG Y

Pregabalin Stumbles for Analgesia in Cosmetic Surgery Trial

he use of pregabalin as a component of a multimodal analgesic strategy does not reduce pain levels in women following cosmetic surgery, an international team of researchers has found. “This was a pragmatic trial,” said Luis E. Chaparro, MD, clinical research fellow in anesthesiology and perioperative medicine at Queen’s University in Kingston, Ontario, Canada, who helped conduct the study. “We did everything in a real-world clinical situation. So we were combining pregabalin with the real analgesic regimen that patients would normally receive after this type of surgery. And when we added pregabalin to this multimodal analgesic strategy, we did not see any analgesic benefit.” Dr. Chaparro’s group presented its findings at the 2012 annual meeting of the Canadian Anesthesiologists’ Society (abstract 1315569). “We started the trial in early 2006, when research about the ability of gabapentin to decrease postoperative pain was becoming very popular. At the time there was very little data on pregabalin, so we decided to look more closely at its effects.” Dr. Chaparro collected the data while practicing in his native Colombia, where cosmetic surgery among women is fairly common. A randomized, double-blind clinical trial from three surgical centers in Medellin, Colombia, was conducted. Of 110 women undergoing ambulatory cosmetic surgery, 99 completed the trial. Patients were randomized to receive either 75 mg of oral pregabalin every 12 hours for five consecutive days beginning the night before surgery, or a placebo. Each participant also received 8 mg of IV dexamethasone (either dipyrone or diclofenac) and 0.5 mg/kg of IV morphine. Upon discharge, patients were prescribed a weak opioid plus acetaminophen capsules, and an anti-inflammatory drug, as needed. “Initially, we were only collecting data for lipectomy,” Dr. Chaparro told Anesthesiology News. “However, our plastic surgeons were happy to combine procedures, such as lipectomy plus breast augmentation or lipectomy plus abdominoplasty.” These combinations, he added, may affect the validity of the trial. The trial’s primary end point was movement-evoked pain scores at two, 24, 48, 72 and 96 hours after surgery. Despite the addition of pregabalin to

the multimodal regimen, the researchers found no differences between the two groups of patients at any point throughout the trial. On the fourth day after surgery, the median movement-evoked pain score was less than 4 out of 10 in each group. Similarly, no differences were found between the groups in consumption of opioids and anti-inflammatoryy drugs

or adverse events. These results persisted after several post-hoc analyses for potential confounders, such as age, body mass index and type of surgery. Given the preponderance of research demonstrating the analgesic efficacy of pregabalin, Dr. Chaparro suggested using the agent in other patient populations. “I’m not saying that pregabalin

doesn’t have an analgesic effect; the drug works,” he noted. “There is, for instance, strong information that pregabalin has an analgesic effect in chronic pain. For me, the secret lies in deciding when to use pregabalin and when not to use pregabalin. I think a good target population is one that has a contraindication to narcotics and see cosmetic page 96

We do what no other medical liability insurer does. We reward loyalty at a level that is entirely unmatched. We honor years spent practicing good medicine with the Tribute® Plan. We salute a great career with an unrivaled monetary award. We give a standing ovation. We are your biggest fans. We are The Doctors Company. We created the Tribute Plan to provide doctors with more than just a little gratitude for a career spent practicing good medicine. Now, the Tribute Plan has reached its five-year anniversary, and over 22,700 member physicians have qualified for a monetary award when they retire from the practice of medicine. More than 1,300 Tribute awards have already been distributed. So if you want an insurer that’s just as committed to honoring your career as it is to relentlessly defending your reputation, request more information today. To learn more about our medical professional liability program and the benefits that have made us the nation’s leading writer of anesthesiologists, including the Tribute Plan, call (800) 352-0320 or visit us at www.thedoctors.com/tribute.

www.thedoctors.com

Tribute Plan projections are not a forecast of future events or a guarantee of future balance amounts. For additional details, see www.thedoctors.com/tribute.

94 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

C LIN I C A L A N ES THES IO LO G Y

For TKA, Clinician Preference a Reasonable Guide To Femoral Block Options San Diego—Regional anesthesiologists debating the relative merits of continuous or single-shot femoral nerve blocks after knee replacement surgery might take comfort in a recent study that suggests that the two approaches appear to have equal effect

on early and long-term outcomes. The findings, from researchers at the University of Toronto, in Canada, suggest that the choice for a continuous infusion versus the less invasive single shot is a matter of clinician preference. “Two European studies published

- T. S. Elliot

Outside the city of San Juan, far from the sandy Caribbean beaches that lure most visitors to Puerto Rico, a world seldom seen awaits. Underground caves of immense beauty and mystery stretch below the bustle of the island’s heavily trafﬁcked thoroughfares. In these caves you will discover hidden landscapes and species distinct to this environment. At the Society of Critical Care Medicine’s (SCCM) 42nd Critical Care Congress, to be held January 19 to 23, 2013, in San Juan, Puerto Rico, we invite you to explore deep below the surface and uncover powerful advances that will forever change critical care medicine. Open your mind to disciplinary convergences and unique but effective models of operation and behavior. The Society’s annual ﬁve-day Congress is one of the largest multiprofessional critical care events in the world, providing opportunities to make valuable connections and develop diverse perspectives.

some 15 years ago showed that continuous femoral nerve block improves the functional-related outcomes after total knee arthroplasty,” said Eric Albrecht, MD, clinical fellow in anesthesia at the institution, who led the latest work. “The problem is these studies are now

outdated. So we wanted to find the ideal local anesthetic regimen that would provide good balance between pain relief and mobility.” Dr. Albrecht’s group enrolled 69 patients who were scheduled for total knee arthroplasty. The patients, all American Society of Anesthesiologists physical status I to III, were randomized to three groups. Patients in group 1 received a 20-mL bolus of 0.2% ropivacaine with epinephrine, followed by an infusion of 0.1% ropivacaine at 10 mL per hour, along with a patient-controlled bolus of 10 mL every 30 minutes. Those in group 2 received a 20 mL bolus of 0.2% ropivacaine with epinephrine, followed by an infusion of 0.2% ropivacaine at 5 mL per hour, along with a patient-controlled bolus of 5 mL every 30 minutes. “We maintained the same total dose, but only varied the concentration and volume,” Dr. Albrecht said. The infusion was discontinued on the morning of postoperative day 2. The single-shot block consisted of a 30-mL bolus of 0.375% ropivacaine with epinephrine, followed by an infusion of saline and a patientcontrolled bolus. “We chose this dose because it has been shown to be clinically relevant in terms of functionalrelated outcomes in previous studies,” Dr. Albrecht explained. Surgery was performed under spinal anesthesia; all patients received a standardized multimodal analgesia regimen consisting of intrathecal morphine and a single-shot sciatic nerve block. The primary outcome was distance walked on the second morning after surgery. Other outcomes included opioid consumption, pain at rest and during physiotherapy, active and passive knee flexion, quadriceps strength and long-term functional recovery. As Dr. Albrecht reported at the 2012 annual spring meeting of the American Society of Regional Anesthesia and Pain Medicine (abstract P19), patients in group 1 walked an average of 37 m on the second day after surgery, whereas patients in groups 2 and 3 walked 41 m—a statistically insignificant difference. Indeed, the only statistically significant difference found between groups was passive flexion on the first postoperative day. “However see femoral page 97

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 95

CL IN ICA L A N E STH E SIOL OG Y

Maternal Deaths From Sepsis on the Rise

epsis affects more than one in 3,300 women during hospitalization for delivery, according to new research, and rates of severe sepsis and sepsis-related death increased markedly between 1998 and 2008. Investigators at the University of Michigan Health System and Massachusetts General Hospital, in Boston, found that chronic renal insufficiency, chronic liver disease, stillbirth, retained products of conception and cesarean delivery were among the strongest predictors of severe sepsis during hospitalization for delivery. The researchers presented their findings at the 2012 annual meeting of the Society for Obstetric Anesthesia and Perinatology (abstract GM-4). For the study, Melissa Bauer, DO, clinical lecturer in anesthesiology at the University of Michigan, in Ann Arbor, and colleagues pulled delivery information for 1998-2008 from the Nationwide Inpatient Sample, the largest administrative data set of admissions available in the United States. They studied records from more than 9 million admissions for delivery in women aged 12 to 55 years, looking for diagnostic codes for sepsis, severe sepsis (defined as sepsis and organ dysfunction) and death. Sepsis was a complication in 2,758 deliveries—or about one in 3,300. Of those, 855 cases (24%) were severe and 87 cases (3.2%) resulted in death. While the overall incidence of sepsis did not appear to have changed during the study period, the rate of severe sepsis increased from 17% in 1998-2000 to 30% in 2007-2008 (P<0.001). The death rate among patients with sepsis increased during the same period, from 2.2% to 4.9% (P=0.03). The researchers found nine factors to be associated with severe sepsis in the patient population, including premature delivery, chronic illness and retained elements of delivery (Table).

Why severe sepsis rates are on the rise is unclear, Dr. Bauer said. The numbers could reflect a higher-riskk patient population, with more women having comorbidities such as chronic renal disease, chronic liver disease, diabetes or congestive heart failure; there may be an increase in the cesarean delivery rate; and there could be an increase in microbial resistance.

Identifying sepsis in laboring patients is tougher, Dr. Bauerr says, because criteria for Systemic Inflammatory Response Syndrome, such as tachypnea, a white blood cell count over 12,000 and a pulse higher than 90 beats per minute all can be masked by physiologic changes in pregnancy. In the United Kingdom, which also has seen an increase in death rates from

sepsis, Dr. Bauer said hospital nurses use the Modified Early Warning Score to monitor changes in vital signs, urine output and neurologic status. If enough changes are detected, an attending anesthesiologist and an obstetrician are called to the bedside to monitor the patient. “I think that’s a good model and it should be done here,” she said. see sepsis page 96

Introducing the Uniblocker™ by LMA™ designed for endobronchial bro bronchial blockade of the e left le or right lung in procedures ced cedures requiring g ventilation. v one-lung

Ideal for difficult airways, the Uniblocker™ incorporates a flexible high torque control blocker shaft, which is easy to direct and malleable for smooth manipulation. This flexible blocker shaft with a soft, open lumen tip allows repositioning without causing trauma to the anatomy.

The Uniblocker™ is easily removed without disconnecting the swivel connector from the anesthesia circuit. Simply remove all of the air from the cuff and disconnect the quick release connector. Uniblocker shaft incorpor incorporates rpor a metallic, radio-opaq radio-opaque opaq mesh allowing for or smoother sm manipulation.

For more information, visit our website at www.LMANA.com or call 1-800-788-7999.

Table. Factors Associated With Severe Sepsis in Laboring Mothers

High volume, GB (Gas Barrier) cuff is made of silicone with gas barrier properties to reduce diffusion of gas into or out of the cuff.

Cerclage during pregnancy Cesarean delivery Chronic heart failure Chronic liver disease Chronic renal insufficiency Hypertensive diseases of pregnancy

LM FAMILY OF PRO LMA PRODUCTS RO

Preterm delivery (<37 wk of gestation) Retained products of conception Stillbirth

™ LMA A Airway Management Man | LMA EMS™ | LMA Visualization™ | LMA Atomization™ | LMA Pain Management™

Exclusively ddistributed in the U.S. by: LMA North America, Inc., 4660 La Jolla Village Dr., Suite 900 San Diego, CA 92122 P: 800-788-7999 F: 858-622-4130 Copyright © 2012, The Laryngeal Mask Company Limited LMA. LMA and LMA Better by Design are trademarks of the LMA Group of companies. The Uniblocker logo and its component parts are trademarks of the Fuji Systems Corporation, manufacturers of the Uniblocker product. Uniblocker is distributed exclusively in the U.S. by LMA North America, Inc. LMA 661-09/12

96 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

C LIN I C A L A N ES THES IO LO G Y EXCESS

CONTINUED FROM PAGE 92

Commonwealth University, in Richmond, questioned the utility of administering such a non-standard dose. “Is there any difference in using 0.138% instead of, say, 0.2%, which is conveniently packaged that way by the manufacturer?” “We’re trying to show that you can definitely use a much lower concentration than 0.5% to produce a surgical block,” Dr. Baker said. “Whether that

affects the onset or duration of action is another study” that she and her colleagues, led by Nicholas Lam, MD, are starting. Yet Dr. Butterworth saw fartherreachingg possibilities with the trial. “Now that [this study was] done with ropivacaine, one of the most valuable things is to do the same thing with the other local anesthetics to compare their relative potency in a standardized way,” he explained. —Michael Vlessides

COSMETIC

CONTINUED FROM PAGE 93

anti-inflammatories, such as the elderly. But in cosmetic surgery— which can sometimes be very painful—you are better off combining drugs that you know will have a better effect.” Girish P. Joshi, MD, professor of anesthesiology and pain management at the University of Texas Southwestern Medical School, in Dallas, said gabapentin,

pregabalin and similar drugs may have a role in managing the perioperative pain of patients at high risk for persistent postoperative pain. “The study by Dr. Chaparro is well designed and provides clinically relevant information,” he said. “The analgesic technique they used appears to be adequate for the procedures included. Thus, it makes it difficult to prove benefit from adding another medication, such as pregabalin.” “Although drugs such as gabapentin and pregabalin have been used for several types of surgical procedures and have been shown to reduce opioid requirements, they are not for routine use,” Dr. Joshi continued. “These drugs are probably most beneficial in situations associated with high incidence of persistent postoperative pain, which have been shown to have neuropathic mechanisms. Currently, there is significant controversy regarding the optimal dose and duration of administration of these drugs.” —Michael Vlessides

SEPSIS

Providers choose Anesthesia-Rx for a fast, intuitive workﬂow. ™

McKesson’s Anesthesia-RxTM is the automated medication cart that offers fast, easy, and reliable access to the medications you need. Anesthesia-Rx keeps medications close to patients, supports preparation for upcoming cases, and minimizes interaction with the cart by providing fast dispensing. And the automated color syringe label printer saves time in the OR by replacing manual medication labeling processes. Anesthesia-Rx was designed in conjunction with anesthesia providers so that the cart complements existing OR workﬂows, ﬂ making it easy to learn and use. There is simply no better cart for providing Anesthesiologists with fast, easy and reliable access to medication, while fostering better collaboration between anesthesia providers and the pharmacy to effectively manage inventory and charge capture.

For more information, visit www.Anesthesia-Rx.com

Anesthesia-Rx matches OR workﬂow, providing fast, easy access to medications.

CONTINUED FROM PAGE 95

Nurses should be encouraged to alert physicians at the beginning of sepsis-related physiologic changes and not wait until the patient is obviously ill, added study co-author Jill Mhyre, MD, director of research and of quality improvement in obstetric anesthesiology at the University of Michigan. Samuel Galvagno Jr., DO, PhD, a trauma anesthesiologist at the University of Maryland Shock Trauma Center, in Baltimore, who has written about sepsis in pregnancy, said elevated sepsis rates could in part reflect adoption of the Surviving Sepsis Campaign. Guidelines for the program, launched by the Society of Critical Care Medicine and the European Society of Critical Care Medicine in 2004, provide protocols for identifying and managing sepsis. The study period also covered a “landmark trial” by Rivers and colleagues on early goal-directed therapy for the treatment of severe sepsis and septic shock, published in The New England Journal of Medicinee in 2001. “Both may contribute to a surveillance bias, where we may be picking up more cases,” Dr. Galvagno said. Still, he said, “It’s an extremely important study highlighting a very important cause of mortality. We need to be very vigilant in understanding symptoms of sepsis in this population, especially in view of this data.” —Karen Blum

O C TO B E R 2 0 1 2

AnesthesiologyNews.com I 97

CL IN ICA L A N E STH E SIOL OG Y FEMORAL

CONTINUED FROM PAGE 94

this difference did not have any clinical significance,” Dr. Albrecht said. Michael Buys, MD, assistant clinical professor of anesthesiology at the University of Utah in Salt Lake City, noted that pain scores on the first day after surgery were “fairly high,” perhaps as a result of sciatic enervation. “It would be important to know if it was femoral distribution or sciatic distribution,” Dr. Buys said. “There have been a couple of papers to show that you need the sciatic block for good pain control with total knee arthroplasty. So maybe instead of not having a femoral nerve catheter, the answer is that you need a sciatic catheter as well.”

Table. Early Functional and Pain-Related Outcomes, Postoperative Day 2, a.m. Group 1

Group 2

Group 3

P Value

37±32

41±31

41±28

0.91

Active flexion, degrees

61±17

73±20

66±18

0.2

Passive flexion, degrees

82±11

89±14

79±12

0.06

Quadriceps strength, lb

6±4

6±3

5±5

0.71

Pain at rest

3±2

5±3

3±3

0.12

Pain during physiotherapy

6±2

7±3

7±2

0.71

Patient satisfaction

7±3

6±3

8±2

0.14

Enhanced Humbles LapWrap p Positioning Pad ®

Now even more secure with two-way performance!

—Michael Vlessides

ANEMIA

Anesthesiologist Frank Humbles, M.D. knows the importance of patient positioning. CONTINUED FROM PAGE 91

low screening rate was not surprising. “Clinicians still regard anemia as not being a big issue,” Dr. Shander said. In 2011, the Joint Commission released blood management performance measures that included a provision that patients should have their hemoglobin checked 14 to 45 days prior to a surgery that has a high potential for blood loss. Dr. Shander, who was a member of the technical advisory panel that developed the guidelines, said clinicians have been slow to adopt the recommendation for anemia screening, in part because the National Quality Forum (NQF) has not endorsed them. “For a lot of the surgeons who sit on the NQF committee, the measure would delay the patient getting into the operating room,” Dr. Shanderr said. “In addition, there is still pushback among physicians that anemia is not important.” Dr. Guinn said that her hospital still does not mandate early anemia screening for cardiac surgery patients. At Englewood, however, all elective and urgent cardiac surgery patients have been undergoing early anemia screening for the past two years. “Every patient going for a complex surgery or a surgery where there is potential for significant blood loss should be screened for anemia 14 to 45 days prior to surgery,” Dr. Shander said. “Screening and identifying anemia prior to surgery in cardiac and noncardiac patients is only better care. It is time we stop ignoring anemia.” —Kate O’Rourke

The Enhanced Humbles LapWrap®. • Positions patients arms while allowing easy access for leads and IV’s • Secures patient to OR table • Is dual sided for increased flexibility • Optional extensions can be attached for the extremely obese

Designed to meet

The operative word in patient positioning.

AORN recommendations

www.impmedical.com

Now you can secure your patient in place. Loop the LapWrap® tab around the side rail of the OR table.

Bariatric Patients are no problem. The LapWrap’s® tab configuration also makes positioning bariatric patients easier.

Keep arms securely positioned. Designed to prevent tissue injury. Arms stay where you put them during the procedure.

Adaptable to all size patients. Use the optional extensions to secure the extremely obese.

The LapWrap® was designed to meet AORN recommendations in “Recommended practices for positioning the patient in the perioperative practice setting” to prevent tissue injury and ischemia that may be caused by tucking a patient’s arms at his or her side.

For more info or to order call 1-800-467-4944

Drs. Guinn and Shander reported no relevant financial conflicts.

Visit us at Booth 1346 at Anesthesiology 2012 sponsored by the American Society of Anesthesiologists US Patent No. 8,001,635

98 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

P OLI C Y & M A NAGEMENT

Sexual Misconduct by Professionals: A New Model of Understanding [Editor’s Note: The following articles (see also page 100) were originally published in Missouri Medicine, May/June 2012].

Illustrations The following are but a few fictional examples drawn from compilations of real cases: • An overworked married pediatrician was attracted to a single mom in his practice. They became friendly and one day he offered to help if she ever needed anything fixed around the house. Eventually she called and asked him to come over to fix a leaky faucet. This started an affair that lasted several months. When his wife discovered the affair, he broke it off. The mother became angry, felt exploited and retained an attorney. Comment It’s important to realize that the family of patients can be considered patients too, especially in pediatrics, where the parents are considered patients along with their children. ---------• A general surgeon kissed an employee, who also was his patient, when she came to him crying about a problem she was having. Word got out in the office and a formal complaint was made to the medical board. Comment Treating an employee, neighbor or anyone else, means that the person then becomes a patient. ---------• A family practitioner finally gave in to a seductive patient who brazenly seduced him. Comment Claiming that an affair was the patient’s fault doesn’t work. It’s the doctor’s sole responsibility to set limits and act professionally. If you are uncomfortable with a seductive patient, refer him or her to another doctor. Professional Sexual Misconduct Betrayal and exploitation are among the most egregious of human offenses, and when they involve a health professional preying on a vulnerable patient, the most basic of ethical principles are violated. When the patient–physician relationship is exploited and professional sexual misconduct (PSM) occurs, it is particularly problematic because it strikes at the core spirit of the profession. The breach of trust associated with PSM is damaging to the patient, the health professional and the medical profession at large. It’s damaging to the patient, who is exploited and may never trust another health professional. It’s damaging to health professionals, who often lose their reputations, find their finances plundered and their licenses revoked and in more than two dozen states, find themselves subject to criminal charges and imprisonment. Finally, it’s damaging to the medical profession at large because of degradation in the perceived legitimacy of the profession each time this happens.

Physician sexual misconduct is behavior that exploits the physician–patient relationship in a sexual way, whether verbal or physical, or expressions of thoughts and feelings or gestures that are sexual or that reasonably may be construed by a patient as sexual. Unfortunately, claims of PSM are not rare. A confidential survey1 found that 8% of physicians admitted committing some degree of PSM with one or more patients, and most physicians acknowledge they’ve been tempted. Despite this, there is a generalized denial in the health professions regarding the risks and/or existence of PSM and a taboo regarding discussing it. Even with the “sexual” nature of the offense, it turns out that health professionals who’ve committed PSM rarely have any type of sexual disorder. Very few are true sociopaths. Most of the time, in fact, these physicians simply lose good judgment and believe they’ve “fallen in love” with the patient. Most physicians who commit PSM do so in times of personal trauma or professional crisis, when judgment is diminished. Unresolved vulnerabilities may

arise associated with overwork or professional dissatisfaction. The turbulent times of midlife often trigger PSM. To flee the pain of parental death, a failing marriage or empty nest issues with the departure of children to college are times when physicians may “act out” inappropriately. All this becomes more relevant by the fact that PSM is preventable. Educating physicians about good boundaries and helping them become more aware of their vulnerabilities and risks and ways of setting up their practice to protect patients and themselves is critical. Not only is PSM preventable, but doctors who commit PSM usually are treatable, and relapses are rare when good treatment and education occurs and precautions are taken. Considering the very damaging real-life consequences of PSM, it is surprising how casually it is depicted on TV and in movies. The discordance between how professional boards and criminal agencies view PSM versus its media portrayal is troubling, and may contribute to the risk for PSM because it creates a false sense of acceptability for inappropriate relationships with patients. Additionally, there are many stories about relationships between doctors and their patients leading to successful marriage, without any apparent harm. These, however, are the exceptions. More typically, the patient eventually becomes aware of a sense of exploitation and becomes very angry. Not uncommon are cases in which a physician–patient marriage ends in divorce, at which time the ex-spouse files a complaint and lawsuit—and wins. It’s tragic that as terrible and devastating as PSM is, it is essentially a taboo subject; little or nothing is taught regarding PSM in medical schools, and it’s rarely a subject for postgraduate training. To help prevent PSM, it’s important to have a basic understanding of boundary theory and the dynamics that underlie boundary violations, to develop vigilance for early warning signs of potential boundary problems with patients, and to gain insight into professional and personal vulnerabilities and risk factors. Excellent continuing medical education–based courses are available for further in-depth training. PSM (synonymous with “sexual boundary violation”) can be defined as any action of a sexual nature that oversteps or disregards ethical or legal limits of professional behavior. For our purposes, sexual refers to any erotic physical contact, and also may include sexual behavior involving language or gesture. Even the use of sexual humor or informal speech can be deemed misconduct. The somewhat vague concept of “boundary” is made more explicit by reference to professional ethical and legal norms. Ethical prohibition against sexual relations with patients dates back at least as far as the Hippocratic oath of ancient Greece. An abbreviated version of the passage states: “[I] will abstain from every voluntary act of mischief and corruption; and, further see misconduct page 100

The bookstore division of

MCMAHONMEDICALBOOKS.COM An Online Bookstore

ORDER BOOKS ONLINE

THE BOOK PAGE PUBLISHER’S TOP PICKS OF THE MONTH ON MCMAHONMEDICALBOOKS.COM These books and thousands more...

Anesthesia Unplugged: Second Edition

Christopher Gallagher; Michael C. Lewis; Christine Park; Deborah Schwengel July 6, 2012 Featuring an easy-to-navigate atlas-style design, this skill-sharpening book delivers step-by-step instruction on the entire spectrum of perioperative, ambulatory, regional and general procedures to disarmingly demystify anesthesiology.

Scan here for our complete catalog of medical books.

ORDER ONLINE For pricing, a more complete review and easy ordering with a credit card, go to McMahonMedicalBooks.com. We can supply any medical book in print, so if you don’t find the book you want, email your request with billing information to RMcMahon@McMahonMed.com. If you are an author and would like your medical book featured in this book section, contact Ray McMahon, Publisher, at RMcMahon@McMahonMed.com.

Anesthesiology Board Review Pearls of Wisdom: Third Edition

Sudharma Ranasinghe; Kerri Wahl; Eric Harris; David Lubarsky July 17, 2012 With content following the anesthesiology board exam blueprint, emphasis is placed on distilling key facts and clinical pearls essential for exam success. This high-yield review is the perfect complement to larger texts and delivers an intense, streamlined review in the days and weeks before the exam.

Anesthetic Management of the Obese Surgical Patient

Jay B. Brodsky; Hendrikus J. M. Lemmens January 16, 2012 Every day, anesthesiologists are presented with obese and morbidly obese patients undergoing every type of surgical procedure; the management of these patients differs significantly from that of normal weight patients undergoing the same procedure. This book discusses these specific management issues within each surgical specialty area.

Benumof and Hagberg’s Airway Management

Carin A. Hagberg October 15, 2012 This book will enhance your airway management skills and equip you for clinical challenges. Trusted by anesthesiologists, residents and nurse anesthetists, this one-of-a-kind anesthesiology reference offers expert, full-color guidance on pre- and post-intubation techniques and protocols, from o equipment equ p e t selection se ect o through t oug management a age e t of o complications. co p cat o s

Case Studies of Near Misses in Clinical Anesthesia

John G. Brock-Utne, MD, PhD, FFA August 9, 2011 All anesthesiologists eventually face the fear of a “near miss,” when a patient’s life has been put at risk. Learning from the experience is crucial to professionalism and the ongoing development of expertise. Drawing on 40-plus years of practice in major metropolitan hospitals around the world, this book presents 80 carefully selected cases that provide the basis for lessons and tips to prevent potential disaster.

Handbook for Stoelting’s Anesthesia and Co-Existing Disease: Expert Consult: Online and Print: Fourth Edition

Roberta L. Hines October 15, 2012 In this handbook, the authors discuss the most critical, clinically relevant topics from Stoelting’s Anesthesia and Co-Existing Disease e in a concise, compact, portable format. You’ll have convenient access to dependable guidance on a full range of pre-existing conditions that may impact the perioperative management of surgical patients.

Pocket Pain Medicine (Pocket Notebook Series)

Richard Urman; Nalini Vadivelu June 8, 2011 This handbook is an invaluable tool for every resident and practicing physician who needs to understand the essentials of acute and chronic pain management, including all current guidelines and standards of care.

Thoracic Anesthesia, An Issue of Anesthesiology Clinics

Peter D. Slinger October 12, 2012 This issue of Anesthesiology Clinics covers the latest updates in thoracic anesthesia written by the world-leading experts on the topic. Procedurr ally focused articles cover best practices in anesthestic management of one-lung ventilation, airway stenting, esophagectomy, mediastinal biopsies,, postthoracotomy p y atrial fibrillation and more. AN1012

100 I AnesthesiologyNews.com

O C TO B E R 2 0 1 2

P OLI C Y & M A NAGEMENT MISCONDUCT

CONTINUED FROM PAGE 98

from the seduction of females or males, of free men or slaves.” Most professional societies have a code of ethics that contains clear statements regarding what constitutes appropriate sexual boundaries. The major area in which these codes differ is regarding how long, if ever, it is necessary following termination of the patient–physician relationship before a relationship can be pursued. On the subject of where the lines are drawn inside the professional relationship, they are essentially identical. The Federation of State Medical Boards, in a policy statement in 2007, clearly defines what it considers sexual boundaries, and states that disciplinary action should be taken against any physician who violates them. Here are some salient excerpts from that document: “Physician sexual misconduct is behavior that exploits the physician–patient relationship in a sexual way. This behavior ... may be verbal or physical, and may include expressions of thoughts and feelings or gestures that are sexual or that reasonably may be construed by a patient as sexual. … There are primarily two levels of sexual misconduct: sexual violation and sexual impropriety. Behavior listed in both levels may be the basis for disciplinary action by a state medical board. ... Sexual violation may include physician–patient sex, whether or not initiated by the patient, and engaging in any conduct with a patient that is sexual or may be reasonably interpreted as sexual. Sexual impropriety may comprise behavior, gestures or expressions that are

seductive, sexually suggestive or sexually demeaning to a patient.” The document goes on to state, “Findings of sexual misconduct are often sufficiently egregious as to warrant revocation of a physician’s medical license, although a lesser action may be considered for cases of sexual impropriety.” It is important to know that most acts of PSM occur following progressive problems with boundaries that precede the PSM. Often these steps are referred to as “boundary crossings,” which may be initiated with the best of intentions, but progressively tumble down a “slippery slope” of professional destruction. Although these precedent behaviors are not necessarily unethical in and of themselves, they are major warning signs. In order to prevent sexual boundary violations, it is important to understand this progression and the precedent boundary disturbances. Sometimes these boundary disturbances are limited to one patient or one particular type of patient, and in other cases they may characterize the clinician’s general practice style. In the context of rehabilitation from sexual boundary violation(s), it is incumbent on the professional to address all of these boundary issues. Precedent boundary problems can include time issues, such as extending the time of office visits (often by scheduling at the end of the day), conducting the visit during non-office hours or by extending the visit from the last appointment of the day into non-office hours (after the staff leave the office). Another category of precedent behaviors includes

“concepts of place and space,” for example, making home visits (except when clearly part of regular practice), meeting a patient at a social occasion or agreeing to share a meal with a patient at a restaurant. Another area, giving or receiving gifts, can be a problem if it tends to “deprofessionalize” the relationship, encourage romanticizing of the relationship or interferes with therapeutic aims. In general, it is a good idea to have an office policy that gifts from patients are not accepted (except to the office as a whole). Physical contact is another area of concern. There are times in the course of clinical practice where touching the patient outside of a physical examination is accepted, such as a handshake at the beginning or end of an appointment, or the placing of a hand on the shoulder as a comforting gesture. Some practitioners also feel it is permissible to hug patients at times, although, depending on the characteristics of the patient, this can be very dangerous. Context clearly is important in determining the extent that a hug may be thought of in this way. Hugging can cause serious confusion in the professional relationship, can be interpreted or experienced in a romantic way by the patient and can lead to greater intimacy. An important adage to remember is that when it comes to boundaries, “perception is everything.” The misinterpretation of a therapeutic hug as romantic may be impossible to defend. Boundary issues involving money can precede PSM. Examples include lending or borrowing of money from patients, business activities with patients see misconduct page 102

Safeguarding Yourself Against Allegations Of Sexual Abuse or Patient Impropriety

y drawing boundaries between their personal and professional lives, physicians can protect their practices and themselves while also still achieving their true goal: providing quality care to their patients. As an attorney, I know that lawyers and doctors are frequently strange bedfellows. However, the two professions have one thing squarely in common, and likely always will. No matter where we are or who we’re surrounded by, be it at a church, synagogue or mosque, at a dinner party, having a drink at a pub, or even when simply spending time with extended family over the holidays, the same question always comes up, “Hey, can I ask you something?” The lines between patient and professional are frequently blurred, especially in rural areas, where “the family doctor” can, after knowing a particular family of the common good is still bound by ethical requirements, and it can be tough to tell where the line between the two begins or ends. With allegations of

physician sexual abuse of patients continuing to be in the headlines, doctors need to be alert to prevent even the appearance of impropriety. Physicians can safeguard themselves with a few simple suggestions that will ensure that quality care is being provided with a minimum of issues. 1. Use Your Office The simplest line to draw is to always insist that patients be seen inoffice whenever possible. This rule frequently can be used to politely brush aside random inquiries that doctors (and I, as a lawyer) frequently get at social occasions. The person saying, “Hey, can I ask you something? I’ve got this issue with my back...” should be politely redirected by merely saying, “Of course you can. Here’s my card.

Why don’t you call my office and we can set up an appointment for next week.” By directing patients to your office whenever possible, you help to maintain the line between friendship and professional practice. 2. Redirect When Necessary If a patie patient or potential patient behaves in a way that gives you pause or you otherwise feel as though you cannot remain professionally objective with respect to that person’s care, refer the individual to another physician immediately. If someone asks you for your advice on an informal basis, providing that person with the contact information of a doctor who is a specialist in the area of inquiry will help to redirect the conversation away from your own medical expertise. Physicians who field

phone calls from their patients at all hours of the day and night are advised in nonemergent situations to politely ask the patient to call again in the morning or refer the individual to the on-calll physician (e.g., “You need me at my best and asking me to give an opinion late at night does not fully benefit either of us”). 3. Charge for Your Services Although it may seem difficult to charge friends or family for your services, remember your expertise and knowledge are all you have to sell. Giving away your time devalues your skills. You deserve to be compensated for your services. If you charge for your services, it helps to remove any doubt that your advice and treatment were made in your full capacity as a physician, not “just as a friend.” Finally, in some instances, this practice will likely dissuade some people from coming to you during offf hours with trivial complaints. see abuse page 102

anesthesianews

Links Links to Other to Other TherTherapeutic apeutic Areas Areas

e-Newsletters and e-Alerts

Medical Education

Buyerâ&#x20AC;&#x2122;s Guides