The October 2011 digital edition of Anesthesiology News by McMahon Group

P Ane lease sth Vis Boo esiolo it us a th # gy 2 t 102 011 3

Anesthesiology 2011 meeting issue

The Independent Monthly Newspaper for Anesthesiologists AnesthesiologyNews.com • O c t o b e r 2 0 1 1 • Volume 37 Number 10

Fast-tracking TKA Patients Viable Las Vegas—As the number of total knee replacement surgeries is predicted to skyrocket in the near future, health care institutions continually seek ways to reduce associated costs and decrease hospital length of stay. A proof-ofconcept trial by investigators at the University of Pittsburgh Medical Center may have addressed both issues, having found that the surgery can be performed on an ambulatory basis in a meaningful percentage of patients.

Mounting Board Demands Foster Growing Unease

nesthesiologists and other physicians are becoming increasingly concerned that conditions for maintaining board certification may also become unofficial requirements for maintaining state licensure, turning what has been voluntary into something that is mandatory to practice medicine. Many physicians also worry that they may have to duplicate the expensive and timeconsuming board maintenance of certification requirements to retain their medical licenses. Physicians who became board-certified during the past decade must pass a closed-book written examination and provide medical practice performance evaluations in addition to obtaining traditional continuing medical

see tka page 68

see demands page 28

Anesthesiologists and Pharmacists Partner To Improve OR Outcomes Denver—By teaming up with pharmaCenter, had recognized cists, anesthesiologists can enhance their the challenges in discapacity to protect patient safety and tribution, persontheir hospital’s bottom line. nel accountability That was the common conclusion of and patient safety two posters presented at the American with controlled Society for Health-System Pharmasubstances—parcists Summer Meeting—one proposing ticularly in the a new tool to track the use, and waste, of fast-paced operatanesthetic agents and another comparing ing room (OR). With the effectiveness of two popular inhaled such a wide range of difanesthetics. ferent anesthesia kits and reports, it was “difficult to reconcile what anesthesioloSafety Through Standardization gists said they were using with what they Michael Chappell, RPh, operations actually used,” he said. see partner page 44 supervisor at Methodist Dallas Medical

INside

52 | CLinical Anesthesiology Special section on bloodstream infections.

06 | COMMENTARY A new way to lose a bundle—life under CMS’ new payment system.

50 | technology Why the iPad is changing anesthesia training.

84 | PRN How nitrous oxide fueled the fortunes of two 19th-century titans.

86 | PAIN MEDICINE Taking aim at opioid overprescribing.

24 |

Benefits of Extending the Duration of a Local Analgesic as Part of a Multimodal Regimen For Postsurgical Pain

42 |

Guiding Fluid Management in the Surgical Setting (Part 2 of a 2-Part Series)

91 | CME—PreAnesthetic Assessment Lesson 294: PreAnesthetic Assessment of the Patient With Hereditary Angioedema

Newproducts

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see page 34.

FLOW-i® Anesthesia Delivery System from Maquet, see page 68.

GlideScope AVL Reusable Video Laryngoscopes from Verathon Medical, see page 86.

Is Fiberoptic Intubation separately billable for an anesthetic? Find the answer at: www.anesthesiallc.com/an-oct11

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4 I A n e s t h e s i o l o g y N e w s . c o m Octo b e r 2 0 1 1

Discuss these and other articles @ AnesthesiologyNews.com.

Heard Here First: When you get patients this large,

there’s no study, no pharmacy [guidelines],

no recommendations.

October 2011

The five most-accessed articles last month on AnesthesiologyNews.com 1. Program Encourages Reporting Accidents Waiting To Happen 2. Interview With Dr. Elizabeth Behringer (Podcast)

You have to rely on your training and you have to

be prepared.

3. Multimodal Analgesia With TAP Block Aids Post-op Recovery

See article on page 114.

4. More Biomarker Data Add to Insights On Postanesthesia Cognition 5. Fiber-optic Intubation: Advanced Combinations for More Success and Less Morbidity (Educational Review)

Robert S. Lagasse, MD, New Haven, CT Alex Macario, MD, MBA, Stanford, CA ALIX MATHIEU, MD, MBA, MS, Cincinnati, OH The Independent monthly Newspaper for Anesthesiologists

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6 I A n e s t h e s i o l o g y N e w s . c o m Octo b e r 2 0 1 1

C OMM E NT A R Y CMS Innovation:

A New Way To Lose a Bundle

atch out! The Centers for For example, an anesthesiology Medicare & Medicaid Ser- group and hospital could partner and vices is innovating again, propose a bundled payment for total proposing a new way to pay physicians hip replacement. To find a discounted less. The agency calls this creation payment to propose to CMS for their “bundled payments for care innovation.” bundled package, they could just elimiIt means physicians provide the care, nate lab work and x-rays as unnecessary. and CMS makes a bundle. Without these items anesBut if CMS could underthesiologists could decide stand perioperative homes, when to transfuse blood it could stop innovating— by noting when the conand have its bundle. In junctival veins of patients perioperative homes, aneslook pale and surgeons thesiologists coordinate could decide which hips to the care of surgical patients replace by having patients across the pre-, intra- and walk to the operating room postoperative continuum. and observing their limps. Media officials for CMS This is obviously dangerous and its parent agency, the Robert E. Johnstone, MD territory, because surgeons Department of Health and and radiologists might Human Services (HHS), announced counter-propose surgery without anesthis bundled-payment scheme with a thesia, just using local anesthetics and flurry of press releases in late August. mouth gags. Of course, before even examining the Bundled payments have some ratiodetails of this scheme, one might ques- nale behind them—the elimination tion why government centers should of unnecessary services and improved have offices for press releases. A decent coordination of care, both of which proposal for saving taxpayer money could reduce spending on medical and reducing government bureaucracy care. Of course, the big money to be is to just eliminate these offices. saved nationally lies primarily in more The reason given for this “improve- efficiently treating chronic conditions, ment initiative” is “to improve patient such as depression, hypertension and care through payment innovation that obesity. Nevertheless, some observers fosters improved coordination and feel savings could be wrung from hosquality through a patient-centered pitalizations and acute treatments by approach.” At least the government improving efficiencies. press offices have learned to use mulHealth care reformers variously identiple forms of “improvement” in their tify bundled payments as episode-ofeuphonic buzzword statements. Unfor- care, global and packaged pricing. All tunately, their initiative announce- would pay the clinicians and the instiments will confuse the physicians who tution typically involved in the acute provide the patient care, and sow dis- care of a patient a single sum of money sension over payments. for their services during treatment— A bundled-payment program gen- for example, the work-up, surgery erally would work as follows: A and postoperative rehabilitation of a group of physicians and a hospital get patient with breast cancer or a severely together, propose a lump-sum pay- arthritic knee joint. ment for some episode of care and Reformers identify bundled-paydivide the payment (or the savings ment plans as a financial strategy from a target amount) according to falling between fee-for-service and capan internal formula. CMS innovators itation. Reformers view fee-for-service, are one step ahead of any colluders the current payment model for aneswho might propose too big a pay- thesiologists and other physicians, as ment. They advise: “The target price driving the increase in health care costs … would be set by applying a discount today. After all, more services lead to to total costs for a similar episode of more payments. care as determined from historical Under capitation, clinicians receive data.” Bundled payments are similar a set sum per patient per year regardto the game of musical chairs where less of how many services any patient everyone tries to find a chair when receives, which removes the financial the music stops but the music maker incentive to provide more services. The see bundle page 9 has removed some chairs.

Spacelabs Healthcare The following advertorial is provided as a service to our valued advertisers. It is designed to support the advertisement presented to the right.

Spacelabs Healthcare Q: Who is Spacelabs Healthcare? A: Spacelabs Healthcare is a comprehensive perioperative solutions provider. We are a global developer, manufacturer and distributor of medical equipment and services, including solutions for patient monitoring and connectivity, anesthesia delivery and ventilation, diagnostic cardiology, and supplies and accessories selling to hospitals, clinics and physician offices.

Q: What perioperative solutions does Spacelabs Healthcare offer? A: Spacelabs provides various perioperative solutions—from low to high acuity, simple to complex cases, pediatric to geriatric patients—that offer the choices you need in anesthesia delivery, patient monitoring, and supplies and accessories. What’s more, you can configure solutions to suit your individual practices and preferences.

Q: What is “The Spacelabs Advantage”? A: For more than 50 years, health care professionals have experienced the company’s proven commitment to connecting innovation with care; stability for a strong future; collaboration with clinical and technological partners; effective implementation of real-world solutions; and service wherever, whenever and however it’s needed. The most important factor in patient care is a knowledgeable medical professional with the right tools. Spacelabs Healthcare is dedicated to developing and supporting those tools.

Q: How 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 that includes meetings and user groups, we gather a deep understanding of clinical needs 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: Where does Spacelabs manufacture perioperative solutions that are sold in the United States? A: These products are manufactured by Spacelabs Healthcare at our world headquarters in Issaquah, Wash.

Q: Is Spacelabs Healthcare known for customer service? A: At Spacelabs Healthcare, excellence in customer service and support are not just words. They are values, embraced by all of our employees, that shape the way we do business. As a result, IMV ServiceTrak, one of the most respected surveys in the health care industry, has ranked Spacelabs Healthcare “Best for Overall Service Performance among Industry Peers” for the second consecutive year, and for three of the last four years. We work cooperatively to develop long-term relationships with our suppliers, our distribution partners and our customers to provide the products, tools and services you need. Spacelabs Healthcare is a focused, agile organization that is here to serve health care professionals worldwide. Our goal is to provide our customers with more time to care. Customer loyalty is our reward. When selecting a perioperative solutions company, consider Spacelabs Healthcare’s experience and our heritage of innovative and intuitive products that have been 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.

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8 I A n e s t h e s i o l o g y N e w s . c o m Octo b e r 2 0 1 1

Havel’s® Inc.

The following advertorial is provided as a service to our valued advertisers. It 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?

hips and shoulders. Finally, the EchoTuohy is used for epidural catheter placement or PNBs by those using ultrasound guidance.

Both features create multiple angled surfaces near the tip to reflect the sound waves back to the transducer, even at steep insertion angles.

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,

Q: What special surface features make Havel’s ultrasound needles echogenic?

Q: What new improvement has been made to the EchoStim, EchoBlock and EchoBlock MSK needles?

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.

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 29 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 heat-anneals 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 Phone: (800) 638-4770 Email: jbarrett@havels.com Web site: www.havels.com

Octo b e r 2 0 1 1

AnesthesiologyNews.com I 9

COMME N TA R Y Bundle continued from page 6 financial risk for patient care falls on clinicians or whoever holds the capitation contract. Bundled payments would shift considerable financial risks from payers to physicians, although perhaps not as much as under capitation. President Obama laid out this financial motivation in his 2009 address to delegates of the American Medical Association. “The cost of our health care is a threat to our economy,” he said. “We need to bundle payments so you aren’t paid for every single treatment you offer a patient.” HHS secretary Kathleen Sebelius, in announcing the bundled-payment plan, echoed that notion. The initiative, she said, “is a key part of our efforts to … lower costs.” Thus, Section 2704 of the Affordable Care Act requires a demonstration project “to evaluate the use of bundled payments for the provision of integrated care (for) an episode of care that includes … an episode of care that includes a hospitalization and concurrent physician services.” But Do They Work? Bundled payments for medical care have reduced costs modestly in some trials. The Rand Corporation, however, rates the evidence supporting bundled payments as limited and mixed. The research group has cautioned that implementing bundled payments would require fundamental changes in the way physicians provide care and bill for their services. Physicians undertaking bundled payments are likely to discover many difficulties, such as deciding when an episode of care begins and ends, who is responsible when care does not fall into a neat episode, how to handle overlapping bundles with concurrent episodes of care, and who pays when a patient experiences a catastrophic event during an episode of care. At present, bundled payments seem like just another payment scheme that will be tried, find few supporters and never see wide adoption. Anesthesiologists practicing in settings that want to try bundled payments should understand how to fully price their services— or risk financial losses. It is critical to reject Medicare charges as a basis for payment division because Medicare greatly undervalues anesthesiology relative to other specialties. (Stead and Merrick recently stepped through a possible bundled-payment allocation calculation.)

Good options for reducing costs for acute care exist, particularly those involving surgery. The perioperative, or surgical, home is one. In this model, anesthesiologists who run surgical suites, preoperative clinics and postoperative pain services coordinate patient care throughout the perioperative period. Anesthesiologists already coordinate schedules for surgical suites in most institutions. Doing so improves efficiency and reduces costs. Simply expanding suite coordination

to include preoperative and postoperative care would improve institutional efficiency overall and decrease hospital length of stay. In perioperative homes, anesthesiologists are paid to coordinate care, in addition to providing their professional services. That’s the model for primary care physicians, who now are paid to coordinate chronic care. Perioperative homes would not disrupt established payment mechanisms as the proposed bundled-payment

schemes would, yet they would help CMS reduce costs. CMS could even establish perioperative homes and eliminate press releases, improving life for everyone. —Robert E. Johnstone, MD Dr. Johnstone is professor of anesthesiology at West Virginia University, in Morgantown, and vice president for professional affairs of the American Society of Anesthesiologists. This commentary represents his personal views.

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1 0 I A n e s t h e s i o l o g y N e w s . c o m Octo b e r 2 0 1 1

C OMM E NT A R Y

The Hard Reality of Soft Despotism

n 1831, 26-year-old Alexis de Tocqueville disembarked a steamer in New York City with the official charge of studying the U.S. penal system, but with the ulterior motive of assessing the nascent democracy in the new world. Following the revolution of 1789, France had been experimenting with several types of republics and monarchies, and de Tocqueville was a member of the newly formed July Monarchy, which he despised. His observations over the following two years provided the source material for his remarkably prescient and oft-quoted work, “Democracy in America.” It is part paean to the industriousness and resourcefulness of Americans and part warning to Americans of the pitfalls of democracy as seen through the eyes of a disaffected Frenchman. One of the themes of the book is “soft despotism,” which is the term De Tocqueville uses to describe the voluntary surrendering of individual rights and independence to the government in exchange for protection and entitlements. He remarked that people in the new world, who had risked all to get away from the despots of Europe, were too accepting of government regulation of their lives that would erode their personal independence and cede control of their lives back to a central power. De Tocqueville wrote, “Such a power does not destroy, but it prevents existence; it does not tyrannize, but it compresses, enervates, extinguishes, and stupefies a people.” As I read his words, his warning seems to relate to the situation we have with health care today. Providers and consumers have been seduced into ceding some of their individual rights to the government in exchange for either remuneration or entitlements. Consumers In a passage that seems to describe today’s consumers of health care, de Tocqueville wrote, “People will voluntarily surrender their liberty and habitually look to the state for their needs.” When Americans sign up for health insurance, they give up some of their independence and join large groups, which then use their numbers for collective bargaining or pooling of resources for use by their members in times of need. This system has evolved into one in which people’s health care is provided to them without their direct financial participation. The rules of moral hazard dictate that people who are not financially involved in their own health care do not seek out the least expensive options and have no financial incentive to make healthy lifestyle choices. When a third party (health insurance companies or government) is picking up the tab, the consumers partially abrogate responsibility for their own health care. In exchange, the third party dictates how they must live their lives: It can limit the physicians

Hard Reality they see or the treatments they receive; it may influence where they work; and some people even enviThe U.S. health care system is fully engaged in the sion a system that dictates what eating, smoking and soft despotism that de Tocqueville warned about, but lifestyle habits they must choose. there is a hard reality that we must both recognize and accept. Compromising consumers’ personal freeProviders doms and providers’ professional autonomy started De Tocqueville warned that people who were con- at the dawn of modern medicine and has become a trolled by too many rules and regulations would necessary, even desirable part of our professional and become a “flock of timid and industrious animals, of personal lives. which the government is the shepherd.” The first good example of surrendering personal freedoms was the adoption of the Flexner Report of 1910. At the time, the practice of medicine was unregulated. Medical schools were trade schools that were run by physicians who determined their own curriculum and taught whatever they wished. Treatments and medications were largely anecdotal, mostly ineffective and too often detrimental. All of this was documented in the report that went on to recommend drastic changes in the way medicine was taught, and consequently how it would be practiced. The plan was fully endorsed by both the American Medical Association and the federal government, and training for physicians in the United States became highly regulated. Anecdotal practice was largely proscribed and physicians were forced to give up their personal independence for the good of the profession. They were starting to become “timid and industrious animals,” and soft despotism started its creep into medicine. When hospital insurance, Blue Cross, was begun in Texas in 1929, many physicians were concerned that the collective bargaining and contracts between employers and hospitals would erode their independence as practitioners. Blue Cross was so financially beneficial for the hospitals, however, that 10 Although this may apply to the consumer, it is years later physicians eagerly signed on to Blue Shield certainly true for providers. As I consider the regi- and accepted the same contractual arrangements mented nature of performance measures, best prac- with insurers. Since that time, the insurance industry tices, quality management criteria, safety goals, has had a progressively more intrusive role in setting pay-for-performance, etc., I can appreciate what de our rates and regulating our practices, but we still Tocqueville warned of 200 years ago. He predicted voluntarily surrender our independence for financial that government agencies would “cover the surface security. Although we are becoming timid animals, of society with a network of small complicated rules, we are certainly better-paid timid animals. minute and uniform, through which the most origiIn 1965, with the advent of Medicare and Medicaid, nal minds and the most energetic characters cannot physicians gave up still more independence and this penetrate, to rise above the crowd.” time it was to the government, which was ever more In reading this passage from de Tocqueville, I monolithic in regulating practice and setting rates than was reminded that the other day I was engaged in a the private insurance industry had been. Since their heated debate about whether we had failed a perfor- rather modest beginnings, there have been numerous mance measure because a frankly septic patient was modifications to both Medicare and Medicaid that given antibiotics for more than 24 hours after surgery further regulate payment and therefore the behavior of without documentation of the reason that the antibi- providers. The Centers for Medicare & Medicaid Serotics must be continued. I’m not sure I would char- vices (CMS), their administrative arm, directly conacterize my mind as original but I do consider myself trols more than 30% of all health care spending in the energetic, and I could not penetrate this network of United States and indirectly controls the remaining see soft despotism page 13 small complicated rules.

HEALTH CARE

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AnesthesiologyNews.com I 13

COMME N TA R Y

Soft Despotism continued from page 10

Tocqueville had a surprising insight into the development of this financial problem. In one of the most perplexing passages in his book, he wrote that Americans have a “depraved taste for equality.” Equality is one of those totem words contained in many of our national documents and printed on our money that automatically conjures an image of something good, but one wonders if equality is always desirable. Health care is often said to be a right and not a privilege. I would add that food, shelter and edu-

70%. The intrusiveness of the CMS into our professional lives has been increasing since its inception. Whether it is by diagnosis-related groups, resourcebased relative value scales, or sustainable growth rates, the industry is highly regulated and professional autonomy is almost nonexistent. In this environment, I find it ironic that some critics of government health care initiatives have become soft-despotism alarmists. When a panel of experts, such as the FDA, determines what treatments should Basic health care, like the other be covered by insurance, this is called “rationing.” essential needs of life, needs When the utility of treatment at the end of life is questioned, this is the government designating “death to be universally accessible panels.” The implication of these alarmists is that up to now we have been independent, and we risk losbut not equal. De Tocqueville ing our autonomy with these intrusions into our personal and professional lives. The truth is that we have was suggesting that legislated been readily giving up our autonomy since Abraham Flexner wrote his scathing report that forced the govequality leads to something more ernment to step in and regulate medical education. This trend has continued for the past 100 years and it despotic because there is nothing is interesting that with every successive refinement of ‘soft’ about forced equality. the system—whether it was health insurance, Medicare and Medicaid, managed care, mandated care and so forth—there were always alarmists who consid- cation, to name a few, should also be rights and not ered each new development to be intrusive and even privileges. By this I mean that everyone should have despotic. access to food, shelter and education but not that everyone should eat the same food, live in the same Depraved Equality suburban sprawl or get the same education. It is The health care issue that has become most impor- accepted that people should be allowed to choose tant in the past 10 years is how much health care can how they want to distribute their resources between we as a nation afford. Because the federal govern- housing, food, and education as well as entertainment is the agent that controls the purse strings for ment and transportation. By the same token, they most health care expenditures, it is again in the cross- should be able to spend what they want on health hairs of the alarmists, but here I think the alarm- care. All people should have access to what is deterists have a valid concern. Two hundred years ago, de mined to be adequate health care, and for those who

truly can’t afford it, it should be provided. But those who want to purchase more health care, such as treatments of unproven benefits (eg, Avastin for breast cancer), unproven prevention (eg, colonoscopies after 75 years of age), cosmetic surgery, boutique care, etc, should be allowed to do so at their own expense. Basic health care, like the other essential needs of life, needs to be universally accessible but not equal. De Tocqueville was suggesting that legislated equality leads to something more despotic because there is nothing “soft” about forced equality. I hope we recognize the wisdom of his words before we crash the whole enterprise. A Hobgoblin Although soft despotism has been a hobgoblin for health care alarmists since the dawn of modern medicine, it is the way in which we have solved our major problems. Early in the 20th century, it addressed the problem of ineffective and anecdotal health care; later, it provided adequate reimbursement for providers; and more recently, it has improved access to care for the consumers. Our problem now is not in the softly despotic practices of governmental controls and regulations; the more urgent matter is the risk associated with over-indulging our “depraved taste for equality.” An insistence on equal delivery of health care rather than adequate delivery of health care for all is a step beyond soft despotism that makes it look and feel a lot like hard despotism. That is the option chosen by the Communist world at about the same time we started down our path of soft despotism. It didn’t seem to work very well for them and I don’t think it will work for us. —Jon C. White, MD Dr. White is professor of surgery at George Washington University, in Washington, D.C.

1 4 I A n e s t h e s i o l o g y N e w s . c o m Octo b e r 2 0 1 1

C OMM E NT A R Y

Resident Burnout—You’re Not Alone

ere’s an exercise for incoming anesthesia residents: Take a look at the resident next to you. Chances are, one of you will experience burnout—possibly quite severe—during your training. The problem will be bad enough that it could threaten not only your health but also that of your patients through inattention, drug errors and other avoidable lapses of care. How do we know this? A group of researchers at Northwestern University in Chicago has been studying burnout and depression among anesthesia providers for some time. Their findings, both published and unpublished, paint a concerning picture. Their most recent survey data, presented at this year’s annual meeting of the Association of University Anesthesiologists, found that 56% of the 1,400 respondents suffered from moderate to high burnout. Risk factors included younger age, female sex, early stage of training and being unmarried (so much for Hollywood).

Residents suffering from burnout reported less attention to patients and a higher incidence of drug errors. Burnout, the researchers concluded, is “extremely prevalent” in anesthesiology and represents “a potential threat to resident health and the safety of patients.” If that sounds troubling, consider this: A study published in the August

issue of Academic Medicine found an even higher rate of burnout among internal medicine residents—ranging from 50% to 75%, depending on how burnout was defined. So, what is burnout, and how does it differ from simple fatigue? In a review of resident burnout from 1983 to 2004, Niku Thomas, MD, defined the problem as “a pathological syndrome

in which emotional depletion and maladaptive detachment develop in response to prolonged occupational stress.” The Maslach Burnout Inventory, the gold standard for diagnosing burnout, adds a lack of personal achievement to these two indicators. Dr. Thomas argued that burnout often occurs during residency because most training programs are demanding,

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AnesthesiologyNews.com I 15

COMME N TA R Y

interfere with work–home balance and put trainees in subordinate positions. Her work also echoes the conclusions of the Northwestern survey that residents suffering from burnout believe they commit more medical errors. In 2003, when the Accreditation Council on Graduate Medical Education (ACGME) restricted resident work hours to an average of 80 hours

per week, most people assumed resident fatiguerelated burnout and error would decrease. Researchers from Boston and Chapel Hill, N.C., looked at the psychological well- Kristin Adams Forner, MD being of surgical residents around the country before and after the 80-hour

workweek. They found a decrease in psychological distress, but no difference in perceived stress or academic performance among residents. Indeed, Dr. Thomas agreed that “although resident work hours and sleep deprivation are associated

To read more on burnout, try: • J Am Coll Surg 2004;198: 633-640. • Surgery 2005;138:150-157. • Anesthesiology 2011;114:194-204. • J Clin Anesth 2011;23:176-182. • JAMA 2011;305:2009-2010. • Acad Med 2011;24.

with stress and medical errors,” they alone were not associated with burnout. Moreover, she showed that decreasing work hours was not associated with a reduction in burnout. Instead, the intensity of the resident’s workday, and the degree to which it interrupts home life, were repeatedly cited as critical factors in resident burnout. But our residents are not alone in their struggle. The studies examining burnout among our chairpersons and program directors found similar results: More than 50% of the respondents from around the country were at risk for, or already suffering from, this same affliction. Risk factors for chairpersons included low job satisfaction and poor significant other support. Program directors also included those two risk factors but added to them disputes with their chairpersons and the ACGME. So how do we begin to address a pathology that threatens patient care and is so widespread in our community? Given the results of these studies, perhaps we need to look at providing more opportunities for social interaction and support system strengthening, both within and outside of our departments. Perhaps we need to find ways to help our chairpersons, program directors and residents introduce more control over their work demands and homelife demands while promoting better separation of the two spheres. Perhaps we could occasionally remind those around us of the things they do well, instead of focusing on the things they could do better. And perhaps we could remember, after all, that each of us is playing for the same team. —Kristin Adams Forner, MD Dr. Forner is staff anesthesiologist and medical director for the Department of Anesthesiology at Wright-Patterson Air Force Base, in Dayton, Ohio. You can read more of her writing at www.doc behindthedrapes.com.

1 6 I A n e s t h e s i o l o g y N e w s . c o m Octo b e r 2 0 1 1

P OLI C Y & M A NAGEMENT

Medicare Pay Cuts Return to the Brink Once Again A 30% pay reduction looms: what will happen this time?

hysicians in the United States are anxiously watching the clock tick down to Jan. 1, 2012, when, barring another last-minute Congressional override, their pay for caring for Medicare patients will drop by an estimated 29.5%. The cut is mandated under the sustainable growth rate (SGR) formula that determines physician pay. Since 2002, the formula, which is based on the economy and Medicare spending, has calculated declines in physician pay. All declines have repeatedly been averted by eleventh-hour legislation. The ongoing threat of cuts harms physician morale and is causing many providers to re-evaluate their practices, said Kathryn Wagner, MD, a private practice breast surgeon in San Antonio. “If the cuts go through, it may very well put me out of business,” she said. After this summer’s tumult surrounding the raising of the federal debt ceiling, it’s difficult to predict whether the Congressional debt committee will again come through with legislation to spare doctors from a massive pay cut. Will it be the same old songand-dance halted by a last-minute stopgap measure? Or will the cuts, perhaps a portion of them, finally go through? And if that happens, what then? Some analysts and physicians have argued that it may be best for the pay reduction to happen. Perhaps then, Congress will be forced to come up with a permanent replacement for the SGR because of a sudden disappearance of physicians participating in Medicare. A 2010 nationwide survey by the Surgical Coalition, which includes the American College of Surgeons and 22 other medical organizations representing 240,000 anesthesiologists and surgeons, showed that only one-third of respondents planned to continue participating in Medicare after a 21% pay cut goes through. Anesthesiology News asked several clinicians for their thoughts on the current payment crisis.

only 33 cents on the dollar, as compared to private payment rates—according to a report from the Government Accountability Office. Anesthesiologists provide Medicare patients the best possible care at below market rates. This is unsustainable. The American Society of Anesthesiologists supports full repeal of the SGR, with replacement by a mechanism that accurately reflects the costs of providing care. The current SGR system is equally as damaging as the Independent Payment Advisory Board (IPAB). ASA supports full repeal of IPAB as well. Dr. Carmel: The AMA [American Medical Association] is making sure Congress knows that the result of allowing this drastic cut to take effect would be catastrophic. Not only must this massive cut be stopped, but the failed formula must be repealed to end this dangerous cycle of scheduled cuts and frequent short-term delays that causes disruptions for patients and physicians. In 2010 alone, Congress acted five times to pass short-term measures to stop scheduled Medicare physician payment cuts. Frequent short-term fixes have increased both the size of the scheduled Medicare cuts and the cost of fixing the problem. The fiscally responsible action for the Congressional debt committee is to repeal the broken Medicare physician payment formula. The debt committee’s deadline comes just before the 30% cut is scheduled to occur, providing an opportunity to stabilize Medicare and stop increasing the cost of repeal. The AMA will engage patients, physicians and the public to communicate to Congress that the time to fix this problem is now.

years? I don’t see a permanent solution coming out of Washington until after the 2012 presidential elections, unfortunately. Dr. Snider: My wife, who is a clinical psychologist, tells me that the best predictor of future behavior is relevant past behavior. Since we have been through this many times before, one would certainly predict, based on past behavior, that Congress will go right to the brink of implementing the draconian cuts, then come up with a temporary fix to avoid them. The problem with that approach, in addition to the anxiety and turmoil the uncertainty brings to physicians, is that each time Congress uses it, the permanent solution gets more expensive and less likely to be possible. The real question is whether we have already reached the point where it is no longer a solvable problem.

Dr. Rubin: I don’t think the cuts in their current form could possibly go through. I don’t think that anyone in any business could sustain a 30% cut at one time. I do think that there is going to be some kind of reduction and negotiation of the entire SGR fix in the process. I suspect it’s going to be a bit of a give-and-take between medicine and Congress as to Dr. Nicastri: As you are aware, SGR is a flawed sys- how we end up with a new formula. To answer your tem that links physician reimbursement rates to the question, I don’t think the entire cut will go through gross domestic product (GDP). Because spending but some of it will. on physician services has outpaced increases in GDP, AN: Do you expect that these cuts will the mandated formula has called for cuts in reim- AN: What repercussions do you expect go through? What’s your prediction for bursements each year for most of the past eight to what will happen in January 2012? nine years. In all but one of those years, Congress has if the physician payment cut goes acted to temporarily postpone those cuts. The cumu- through? Dr. Cohen: The current SGR system is broken. lative cuts have now added up to the 29.5% cut about Long recognized as the leaders in patient safety, anes- to go into effect in January. It seems very likely Con- Dr. Carmel: A 30% cut in Medicare for physicians thesiologists are unfairly paid through Medicare at gress will act, once again, to temporarily postpone would be devastating to physicians’ ability to mainthe lowest rate among all health professionals—at those cuts for a period of time—perhaps one or two tain their practices and to seniors’ access to health see pay cuts page 18

T he E x pert P anel Jerry A. Cohen, MD

President-Elect American Society of Anesthesiologists University of Florida College of Medicine Gainesville, Fla.

Peter W. Carmel, MD

President of the American Medical Association Chair of Department of Neurological Surgery New Jersey Medical School Newark, New Jersey

Guy Nicastri, MD

President of the American Society of General Surgeons Private Practice Surgeon Pawtucket, Rhode Island

Howard C. Snider, MD

President of the American Society of Breast Surgeons Private Practice Breast Surgeon Montgomery, Alabama

Chad Rubin, MD

Chair of General Surgery Coding and Reimbursement Committee of the American College of Surgeons General and Vascular Surgeon Columbia, South Carolina

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1 8 I A n e s t h e s i o l o g y N e w s . c o m Octo b e r 2 0 1 1

P OLI C Y & M A NAGEMENT Pay Cuts continued from page 16 care. According to a 2010 AMA survey, about one in five physicians overall and nearly one-third of primary care physicians say they are already being forced to limit the number of Medicare patients in their practice due to the threat of future cuts and inadequate Medicare rates. The Medicare physician payment formula must be repealed. Dr. Nicastri: These cuts, if allowed to go into effect, would have a devastating effect on Medicare patients. The already low reimbursement rates make it very difficult for physicians to cover the cost of providing care to the Medicare patient. Cutting these already low reimbursements means physicians would actually see Medicare patients at a financial loss. To make up for this, providers would clearly have to limit, or even reduce, the number of Medicare patients they can see. This comes at a time when the Medicare ranks are beginning to swell due to the aging baby boomers. Dr. Snider: I think there are many physicians who are within a few years of retirement, and the drastic cut would tip them over the edge and cause them to retire earlier than planned. Many physicians already refuse to see Medicare patients, and it is already difficult to get anyone to take on a new Medicare patient. That problem would become much worse and would lead to what I think would be a real crisis in access to care for senior citizens.

is concerned so any cut, regardless of how small, could be the difference in whether someone is able to stay in practice or be forced to close. A specialty that currently has higher reimbursement will still feel the pain of a cut but might be able to absorb it better. Obviously, overhead costs keep going up and physicians have no way of passing those costs on to the consumer, or the patient, like most businesses do. So when the profit margin is already low, a small cut can be devastating.

the road. Clearly, any new system must pay physicians fairly and be value-based. Any new system should be phased in over time. Quality should be emphasized and an objective, peer-reviewed process should be set up. Perhaps physicians should be given the opportunity, and legal right, to contract directly with their Medicare patients for their services.

Dr. Snider: The SGR was a flawed and ultimately unsuccessful attempt to control costs. In order to continue to have quality care available to all MediDr. Rubin: Obviously, there are some other fields— care recipients, there must be a guarantee that, going geriatrics, in particular—that will feel it even more forward, appropriate care will be reimbursed at reabecause they have a higher percentage of Medicare sonable rates. The formula to adjust rates annually patients. Anyone who does vascular surgery is going must take into consideration not only inflation, but to be almost exclusively Medicare, so that will hit also increases in overhead that are specific to medDr. Rubin: If a 29.5% reduction went through, general surgeons. Then again, general surgeons may ical practices, such as high rates for malpractice prethere would be dire consequences in terms of access be a bit better [off ] because we can shift our focus miums and increased costs for new equipment and for Medicare patients. I suspect there will be prac- somewhat, but it’s still going to hurt. technology upgrades. Physician payment accounts tices that will completely shift the focus of their care. for only about 8% of Medicare costs, so if Medicare There will be, probably, practices that will either AN: What would you like to see as an stopped paying doctors altogether, it would still have close or have to change what they do. That’s a 30% a major solvency problem. Most of the savings must, cut overnight. I don’t know that any business can sus- alternative to the SGR? of necessity, come from the other 92% of the Meditain that. It would have a huge impact on my own Dr. Carmel: A replacement for the Medicare phy- care dollar. A revenue-neutral approach to future practice. I do about 50% vascular, 50% general sur- sician payment formula, known as the sustainable physician reimbursement will ultimately fail as overgery, and I see a lot of Medicare patients. I would growth rate, should not be another one-size-fits-all head costs eventually take away what little profit is have to reduce significantly the number of Medicare formula. It should allow physicians to choose from a left. Unfortunately, that day has already come for patients that I take into the practice. I’d have to limit menu of new payment models that reward physicians some physicians who can no longer see Medicare and hospitals for keeping patients healthy and man- patients without losing money. it very, very significantly. aging chronic conditions. The AMA’s three-pronged approach, which we Dr. Rubin: I would like to see the end to the SGR. AN: How do or will general surgeons have presented to Congress, includes repeal of the We’ve got to get rid of it. It’s a flawed formula that fare compared with other specialties with SGR, enacting a five-year period of stable Medicare cannot work. Obviously, we can’t just demand that regard to the proposed payment cuts? physician payments and the testing of care delivery Congress come up with $450 billion in this curmodels that would form the basis for a new Medicare rent economic setting. I would like to see a rebasing Dr. Carmel: This cut would impact all physicians physician payment system. with something based on a more realistic measure who accept Medicare or TRICARE [a federal proThe AMA is working with specialty and state such as Medicare economic index and more realisgram for Medicare-eligible retired uniformed services medical societies to form a new Physician Payment tic quality measures. We’ve got to come up with a members] patients. Of course, we know that general Reform and Delivery Leadership Group. This group system that reduces the volume and the use. Call it surgery is one of the specialties confronting a work- will include physicians who are currently participat- rationing if you will, but there has got to be some force shortage, so no doubt the prospects of such ing in payment and delivery innovations and other sort of stop to the rampant increases in cost and enormous payment cuts forcing some colleagues to experts. By sharing expertise and resources, physi- volume. Whether that’s evidence-based, qualitysee fewer Medicare patients must heighten the sense cians can assess the models that will improve patient based or value-based, that stop has to occur. I don’t of unease among general surgeons. care, learn how to get programs off the ground, think we’re going to just have Congress come along address challenges and determine the impact of these and say, “We’ll fix the SGR. Here’s the $450 billion Dr. Snider: I limit my practice to breast surgery reforms on patient care and practice economics. that’s already been spent that we’ll pay for.” That’s now, so I have more knowledge in that area than in not going to happen. other general surgery procedures. Breast surgery is Dr. Nicastri: The SGR needs to be completely already at or near the bottom as far as reimbursement repealed. Congress must stop kicking the can down —Compiled by Christina Frangou

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P OLI C Y & M A NAGEMENT

Competition, Quality Diverge for Common Hospital Treatments Patients often pay more for inferior care

ith a gas station on every corner, consumers can expect to pay less at the pump. Not so when it comes to hospital care. For patients, more competition does not necessarily mean lower prices or better quality of care. In fact, a new study has found that the prices of some medical and surgical interventions spike in areas where competition is fiercest. And in some cases, patients regularly pay more for worse outcomes. In two related studies presented at the 2011 annual meeting of the International Anesthesia Research Society, a team from the University of Chicago probed the relationships between competition, cost and quality (abstracts S-107 and S-108). The group examined data on the treatment of four diagnoses covering a range of electiveness and complexity—heart failure, acute myocardial infarction (AMI), heart valve replacement and cholecystectomy—at hundreds of hospitals.

‘Competition really only

more companies offer the same service, attempt to deliver quality, but the pricyou would expect this to lower the ing jump at the very top end suggested price. But in fact, it didn’t.” that other factors are also at play. An institution’s reputation, for example, Arms-Race Mentality might be one such influence. Among Dr. Glick said his group’s data con- the hospitals at which costs and comfirm the theory that hospitals tend to petition were the highest, significompete in an arms-race style in an cantly more facilities were named “Top

Hospital” for the four studied diagnoses by US News & World Report, which publishes influential lists ranking hospitals, universities and other institutions. But does competition really drive quality for surgery? The answer, according to the Chicago researchers, is no.

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works to lower prices when the people who are paying are the ones who are making the decisions. Insurance companies can separate consumers from the financial consequences of their health care choices.’ —David Glick, MD The researchers found that with rising competition, determined by the number of hospitals offering the same treatment within 20 miles, cost for procedures also increased. But the link was not linear; mean cost shot up at the highest levels of competition. “We have shown that the cost for these four procedures was directly related to the competition,” said David Glick, MD, associate professor of anesthesia and critical care at Chicago, senior co-investigator of the studies. “Normally in the business world, if

Current solutions are available but not ideal. As sedation relaxes the tongue and soft tissues around the airway, this commonly leads to upper airway obstruction. Oral airway and nasal trumpets are frequently utilized options. These devices can be helpful, but they often require a deeper level of anesthetic and can cause patient coughing, gagging or bleeding.

Performing a manual jaw thrust or a chin lift is probably the most frequently used option to secure an airway. Manual manipulation of the patient may be intermittent or continuous, and while the maneuver is not difficult for the anesthesia provider to perform, it can fully occupy a clinician’s hands, making other tasks difficult or impossible to do. JED™ helps providers manage the patient’s airway, allowing them to induce a deeper level of anesthesia because the airway is patent and obstruction is not an issue. JED™ is fast and easy to use. A memory foam head support comfortably secures the head in a forward position. The patient is next placed in a sniffing position and disposable foam mandible cups are placed under the angle of the mandible to obtain a jaw thrust. The three-way adjustable apparatus allows you to position your patient anywhere from a sniffing position to a full jaw thrust, if required. Once placed, intervention is rarely necessary.

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AnesthesiologyNews.com I 21

POLICY & M A N A G E ME N T

Speedy help in recovery rooms. Recovery rooms can rapidly become a place of chaos. Often a single recovery room nurse is overseeing multiple patients who may each have individual airway needs. When faced with a patient experiencing difficulty, the PACU nurse needs to act swiftly and often independently. A jaw thrust maneuver is commonly performed to help the patient regain a patent airway. Not only will the nurse have to be cautious not to hyperextend the neck, but several other steps are required for a successful jaw thrust. Complications caused by other factors, such as pre-existing medical conditions, patients with difficult airways, obese or sleep apnea patients, add to the difficulty of maintaining an open airway. JED™ eliminates the need for a recovery room nurse to perform any external manipulation (jaw thrust) or revert to using an internal airway method on recovering patients; when left in place after a procedure, JED™ helps provide an open airway until sedation wears off.

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Difference in Mean Cost ($ Thousands)

Mean Cost ($ Thousands)

Procedure

Degree of Competition

JED’s™ helping hand extends into applications outside of the OR too.

Quartile

BEYOND THE OR

Heart valve replacement

In difﬁcult-to-intubate patients, ﬁberoptic intubation is a reliable and common method. But it often requires a second pair of hands to improve laryngeal exposure via a manual jaw thrust. JED™ can maintain a patient in a jaw thrust position, thus alleviating the need for an assistant or an extra set of hands during the procedure.

Table. Competition Quartiles For Medical and Surgical Diagnoses

Cholecystectomy

Additional Help for Fiberoptic Intubations

Although a positive relationship seemed to exist between cost and quality in heart valve replacement, with seven metrics correlating positively with Medicare reimbursement, heart failure and cholecystectomy showed no such correlation between cost and quality (Figure). Treatment of AMI showed a slightly negative correlation between quality metrics and reimbursement, indicating decreasing quality with bigger bills.

Heart failure treatment

ventricular function and discharge instructions. Metrics for cholecystectomy were complications, appropriate antibiotics (three metrics), prophylaxis for deep vein thrombosis (DVT; two metrics) and safe hair removal. Metrics for heart valve replacement were mortality, complications, appropriate antibiotics (three metrics), DVT prophylaxis (two metrics) and controlled blood sugar after surgery (Table). Higher competition—and cost— did not always lead to better outcomes.

AMI treatment

The researchers drew on cessation advice, aspirin on Medicare data to determine arrival and at discharge, and price via reimbursement whether patients were takrates, and records from ing a β-blocker at discharge, Blue Cross Blue Shield to percutaneous translumidetermine competition nal coronary angioplasty and to verify quality using within 90 minutes of arrival given set of metrics. The David Glick, MD at the hospital, and fibriquality metrics for AMI nolytic medication within were mortality, complications, use of 30 minutes of arrival. Metrics for an angiotensin-converting enzyme heart failure were mortality, complica(ACE) inhibitor for left ventricular tions, ACE inhibitor for LVSD, smoksystolic dysfunction (LVSD), smoking ing cessation advice, assessment of left

0-1

37.7 ± 8.3

2-4

40.8 ± 8.6

3.1

5-10

43.4 ± 12.2

2.6

11-31

46.6 ± 11.6

3.2

0-1

6.2 ± 1.4

2-5

6.4 ± 1.4

0.2

6-17

6.9 ± 2.0

0.5

18-101

8.0 ± 2.1

1.1

0-3

6.4 ± 0.9

4-9

6.5 ± 1.1

0.1

10-24

7.1 ± 1.7

0.6

25-105

8.0 ± 1.8

0.9

0-1

5.2 ± 1.0

2-5

5.5 ± 1.1

0.3

6-16

6.0 ± 1.6

0.5

17-98

7.3 ± 1.9

1.3

Dr. Glick noted that the heart valve replacement surgery is a procedure for which an informed decision is most likely, reflecting the fact that it is both complex and highly elective. That is in sharp contrast to the treatment of heart attacks, for which a patient has almost no say in where the procedure takes place. Heart attack care had the greatest degree of competition, the lowest quality—and the greatest jump in price, from $6,000 in the third quartile to $7,300 in the fourth, most competitive, quartile, the researchers found. The 22% increase was substantially more than the rise between either the first and second quartiles (5.8%) or the second and third quartiles (9%). “Hospitals that treat heart attack patients are basically going to get them see quality page 36

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Nexfin™ From BMEYE

Q: Why measure cardiac output noninvasively and continuously? A: Cardiac output is the main determinant of oxygen delivery to tissue. Yet today, parameters that are routinely monitored during surgery, like blood pressure and heart rate, are neither sensitive nor specific enough for the timely identification of hemodynamic deterioration. Moreover, cardiac output monitoring has traditionally relied on invasive, costly, intermittent or unreliable methods. This is

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Q: How does ccNexfin measure cardiac output noninvasively? A: ccNexfin connects to the patient by simply wrapping an inflatable cuff around the

Care fully making a difference

middle phalanx of the finger. The pulsating finger artery is “clamped” by applying equivalent counter pressure that results in a blood pressure (BP) waveform. The resulting BP waveform serves as the basis for continuous cardiac output, obtained by a novel and validated pulse contour method (Nexfin CO-Trek™). In addition, ccNexfin has integrated pulse CO-oximetry measurements with Masimo Rainbow® SET technology, allowing clinicians to get real-time, continuous values of oxygen saturation and hemoglobin concentration. These values, in combination with cardiac output, allow ccNexfin to also provide noninvasive and continuous oxygen delivery.

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Octo b e r 2 0 1 1

AnesthesiologyNews.com I 23

POLICY & M A N A G E ME N T

How Scenario Surveys Strengthen Strategy

our hospital opens a new clinic directed solely at charity care and almost overnight 25% of your cases become “no pay” or, at best, very low pay. Your hospital closes. You have worked hard to establish a good working relationship with the hospital’s CEO. She is fired and her replacement has a reputation of being “anti-anesthesia.” These may or may not be real issues for your practice, but each problem, and many others like them, has impacted my clients over the years. What changes are in store for you and your practice? As Niels Bohr, Nobel laureate said, prediction is very difficult, especially about the future. But just because it’s difficult doesn’t excuse you from attempting to predict

the possible bumps that are in store for your practice, or from protecting your profits and guarding against significant business setbacks. This process of identifying potential events and trends, conducting what I call the Scenario Survey Process, is a necessary part of establishing a vibrant overall strategy for your success.

This process of identifying potential events and trends, conducting what I call the Scenario Survey Process, is a necessary part of establishing a vibrant overall strategy for your success. Please visit us at the ASA Booth #2224

A Bit of Background

present situation will remain the same. For example, you may assume that the Before going further, it’s essential hospital will never close, that the payer that you understand the important dis- mix cannot change overnight or that tinction between planning and strate- new regulations won’t instantly gut gic thinking. Planning is a process of $1.2 million from this year’s bottom projection from the present. However, line because these things are not occurextrapolating future problems based on ring at the present time. But life isn’t your present situation is not effective; that simple, and all potential future see scenarios page 26 this tactic presumes the facts of your

THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

Benefits of Extending the Duration of a Local Analgesic as Part of a Multimodal Regimen for Postsurgical Pain Faculty Harold Minkowitz, MD Staff Anesthesiologist Memorial Hermann Memorial City Medical Center Houston, Texas

Sonia Ramamoorthy, MD, FACS, FASCRS Associate Professor of Surgery Rebecca and John Moores Cancer Center UC San Diego Medical Center La Jolla, California

Introduction Poorly managed pain in the postoperative period is common and can be associated with worsened outcomes, higher costs of care, reduced patient satisfaction, and an increased risk for developing chronic pain syndromes.1-6 Over the past 2 decades, multimodal and preemptive analgesia strategies have been developed in an effort to facilitate improved pain control for postsurgical patients.3,7-11 Among the various techniques and pharmacologic agents employed within these strategies are several classes of local anesthetics/analgesics, which can be quite effective in reducing postsurgical pain.12 This review will provide a brief overview of postsurgical pain, discuss the concepts of multimodal analgesia and preemptive analgesia, and present the potential role of current and emerging local anesthetics in improving the control of postsurgical pain.

Epidemiology and Consequences of Postsurgical Pain Acute pain is common after many types of surgeries. In a telephone survey of adults who had surgical procedures, Apfelbaum and colleagues reported that approximately 80% (n=250) of patients experienced acute postsurgical pain, and of these patients,

86% had moderate, severe, or extreme pain.1 The time course of postsurgical pain can be protracted. Lynch and colleagues assessed pain after elective noncardiac surgery through the use of questionnaires and a visual analog scale in 276 patients. They reported that the mean maximum pain score on postsurgical day 1 was 6.3 (moderate pain) and decreased only slightly to 5.6 by postsurgical day 3.13 Beauregard and colleagues assessed pain using questionnaires in 89 patients who underwent ambulatory surgery. They found that 40% of patients reported moderate to severe pain during the first 24 hours after discharge and that pain decreased over time but was severe enough to interfere with daily activities, even several days after surgery.14 Inadequate management of acute postsurgical pain often results in decreased mobilization, which can increase the probability of pneumonia and venous thromboembolic disease.2,15,16 The psychological effects of uncontrolled pain, including depression and anxiety can also contribute to poor patient outcomes and decreased patient satisfaction. 3 Furthermore, Perkins reported that uncontrolled postsurgical pain was the main predictor for development of chronic pain syndromes and that improved postsurgical analgesia reduced the incidence of this complication.4 Postsurgical pain also is associated with decreased long-term function as well as increased resource utilization and health care costs. For example, Morrison and colleagues studied 411 patients undergoing surgical repair of a hip fracture and reported that patients with higher postsurgical pain scores had significantly longer hospital length of stay (LOS), were significantly less likely to be ambulating by postsurgical day 3, took significantly longer to ambulate further than a bedside chair, and had significantly lower locomotion scores at 6 months.2

Table. Effect of Opioid-related ADEs on LOS and Cost Per Patient ADE

LOS increase (days)

Estimated cost increase ($)

Gastrointestinal (nausea/vomiting)

0.47

510

Cutaneous (rash/hives/itching)

0.26

209

CNS (confusion/lethargy)

1.97

942

Respiratory (respiratory depression)

1.35

626

Urinary (urinary retention)

4.41

777

ADE, adverse drug event; CNS, central nervous system; LOS, length of stay Adapted from reference 24.

ANESTHESIOLOGY NEWS â&#x20AC;˘ OCTOBER 2011

Coley and colleagues reported that postsurgical pain was the most frequent reason for hospital readmission after discharge.5

Strategies To Improve Postsurgical Pain Management Opioid monotherapy remains a widely used mode of postsurgical analgesia. Patient-controlled analgesia (PCA) pumps have improved the delivery of opioids in the inpatient setting; however, they can be subject to programming errors, device malfunctions, and patient tampering.17-20 Although this strategy can be effective in some cases, opioids have various adverse effects (AEs) that curtail their practical efficacy as well as expose patients to dangerous complications.21,22 For example, central nervous system effects associated with opioids, such as sedation and respiratory depression, are particularly dangerous.21,22 Other AEs are common even at low doses, such as nausea, vomiting, and ileus, which can result in significant discomfort and longer hospital LOS.21,23 Still other opioid-related AEs, such as urinary retention, can necessitate further procedures or treatments (such as urinary catheters) and their associated discomforts and costs. In one study of hospitalized patients, urinary retention was associated with an increase in cost of $777 per patient, correlating with a percentage increase in cost of 14.5% (Table).21,24 Over a 10-year period of surveillance, more than 60,000 patients were observed who received opioids following surgery. More than 4,000 adverse drug events (ADEs) were observed in this cohort. It was determined that 59% of these ADEs involved an opioid, accounting for an adjusted increase in LOS of 0.53 days.24 Other drug classes, such as nonsteroidal anti-inflammatory drugs (NSAIDs) administered orally or intravenously, have been shown to reduce overall use of narcotics postsurgery, thereby reducing the frequency of AEs related to bowel function and narcotic use.25,26 Recent initiatives to improve management of postsurgical pain cite the potential effectiveness of multimodal analgesia and preemptive analgesia. Multimodal analgesia is defined as the simultaneous use of different classes or modes of analgesics that modulate different pathways and receptors in order to provide superior pain control (Figure).10,27 Multimodal analgesia provides several types of benefits to postsurgical patients. First, use of agents with different analgesic mechanisms can result in synergistic effects and thereby produce greater efficacy. Second, the synergism between these agents may allow for the use of lower doses of each respective agent, thereby

limiting dose-related AEs, particularly when these regimens allow lower doses of opioids.10,28 These actions, in turn, may facilitate earlier mobilization and rehabilitation after surgery, earlier transition to the outpatient setting, and decreased costs of care.9

Local Anesthetics as a Component of Multimodal Analgesia Local anesthetics, which impede the transmission of nociceptive signals by blocking sodium channels in neurons, are used in a variety of ways for postsurgical pain control.12,29,30 Strategies include the use of local anesthetics in epidural anesthesia as well as for various types of peripheral nerve blocks, as well as via continuous infusion using either elastomeric or electronic pumps.12,31,32 However, continuous infusion of local anesthetics via indwelling catheters can be associated with complications (eg, bleeding, accidental dislodgement or migration, infection, paresthesias, dysesthesias, pain not related to surgery) and is not particularly suited to use in the ambulatory setting.12,33 Another method of using local anesthetics is via infiltration of the wound during the final stages of the surgical procedure, which can be used alone or in combination with other analgesic regimens.30,31 Because the mode of delivery does not require an indwelling catheter, it may be better suited to facilitating earlier discharge from the hospital or for effective pain control following surgical procedures. The use of local anesthetics/analgesics instead of opioids obviates the chance of opioid-induced AEs and reduces nursing workload, while the analgesic action of the drug can still control resting pain and pain on motion, thereby fostering patient mobility.30 Almost all local anesthetics can be effectively used for wound infiltration, but local anesthetics with longer duration of action are preferred. The high lipid solubility of bupivacaine lends itself to the treatment of postsurgical pain.34 In particular, bupivacaine offers a rapid onset and provides one of the longer durations of activity of the commonly used extended duration analgesics.35 New formulations of bupivacaine that can extend its duration of action are being developed. A multivesicular liposomal formulation, DepoFoamÂŽ bupivacaine, can extend the duration of action from 6 to 9 hours to up to 72 hours and is therefore better suited to the natural time course of postsurgical pain. Studies of this agent in a variety of surgical contexts, including hernia, hemorrhoidectomy, breast augmentation, bunionectomy, and total knee arthroplasty, demonstrated a statistically

Supported by

Conclusion The use of a multimodal regimen can improve postoperative pain control; infiltration with a long-acting local anesthetic/ analgesic has the potential to become a foundation of multimodal pain control. New formulations of local anesthetics/ analgesics with an extended duration of action are under development and may better match the time course of postsurgical pain. Thus, these new agents may help reduce health care expenditures through reduction in hospital LOS, facilitation of pain control following surgery, avoidance of opioid-related costs and AEs, and improved patient satisfaction.

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. 2. Morrison RS, Magaziner J, McLaughlin MA, et al. The impact of post-operative pain on outcomes following hip fracture. Pain. 2003;103(3):303-311. 3. Joshi GP, Ogunnaike BO. Consequences of inadequate postoperative pain relief and chronic persistent postoperative pain. Anesthesiol Clin North America. 2005;23(1):21-36. 4. Perkins FM, Kehlet H. Chronic pain as an outcome of surgery: a review of predictive factors. Anesthesiology. 2000;93(4):1123-1133. 5. Coley KC, Williams BA, DaPos SV, Chen C, Smith RB. Retrospective evaluation of unanticipated admissions and readmissions after same day surgery and associated costs. J Clin Anesth. 2002;14(5):349-353.

Opioids α2-agonists Centrally acting analgesics Anti-inflammatory agents (COX-2–specific inhibitors, nonselective NSAIDs)

Pain

Ascending input

Descending modulation Spinothalamic tract

Local anesthetics Opioids α2-agonists COX-2–specific inhibitors

Dorsal horn

Dorsal root ganglion

Local anesthetics Peripheral nerve Peripheral nociceptors

Trauma

Opioids Local anesthetics Anti-inflammatory agents (COX-2–specific inhibitors, nonselective NSAIDs)

Figure. Site of action for agents used in multimodal analgesia. COX, cyclooxygenase; NSAID, nonsteroidal anti-inflammatory drug Reprinted from Kehlet H, et al. The value of “multimodal” or “balanced analgesia” in postoperative pain treatment. Anesth Analg. 1993;77(5):1048-1056.

6. Svensson I, Sjöström B, Haljamäe H. Assessment of pain experiences after elective surgery. J Pain Symptom Manage. 2000;20(3):193-201. 7. Duellman TJ, Gaffigan C, Milbrandt JC, Allan DG. Multi-modal, preemptive analgesia decreases the length of hospital stay following total joint arthroplasty. Orthopedics. 2009;32(3):167. 8. Richmond CE, Bromley LM, Woolf CJ. Preoperative morphine pre-empts postoperative pain. Lancet. 1993;342(8863):73-75. 9. White PF. Multimodal analgesia: its role in preventing postoperative pain. Curr Opin Investig Drugs. 2008;9(1):76-82. 10. Kehlet H, Dahl JB. The value of “multimodal” or “balanced analgesia” in postoperative pain treatment. Anesth Analg. 1993;77(5):1048-1056. 11. Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002; 183(6):630-641. 12. Gupta A. Wound infiltration with local anaesthetics in ambulatory surgery. Curr Opin Anaesthesiol. 2010;23(6):708-713. 13. Lynch EP, Lazor MA, Gellis JE, Orav J, Goldman L, Marcantonio ER. Patient experience of pain after elective noncardiac surgery. Anesth Analg. 1997;85(1):117-123. 14. Beauregard L, Pomp A, Choinière M. Severity and impact of pain after day-surgery. Can J Anaesth. 1998;45(4):304-311. 15. Geerts WH, Bergqvist D, Pineo GF, et al. American College of Chest Physicians. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. 8th ed. Chest. 2008;133(6 suppl):381S-453S. 16. Culp WC Jr, Beyer EA. Preoperative inspiratory muscle training and postoperative complications. JAMA. 2007;297(7):697-698; author reply 698-699. 17. Rathmell JP, Wu CL, Sinatra RS, et al. Acute postsurgical pain management: a critical appraisal of current practice, December 2-4, 2005. Reg Anesth Pain Med. 2006;31(4 suppl 1):1-42.

18. Grass JA. Patient-controlled analgesia. Anesth Analg. 2005;101(5 suppl):S44-S61. 19. White PF. Mishaps with patient-controlled analgesia. Anesthesiology. 1987;66(1):81-83. 20. Walkerlin G, Larson CP. Spouse-controlled analgesia. Anesth Analg. 1990;70(1):115-128. 21. Oderda GM, Said Q, Evans RS, et al. Opioidrelated adverse drug events in surgical hospitalizations: impact on costs and length of stay. Ann Pharmacother. 2007;41(3):400-406.

29. Gordon SM, Mischenko AV, Dionne RA. Longacting local anesthetics and perioperative pain management. Dent Clin North Am. 2010;54(4):611-620. 30. White PF. The changing role of non-opioid analgesic techniques in the management of postoperative pain. Anesth Analg. 2005; 101(5 suppl):S5-S22. 31. Morisaki H, Fukushima K, Suzuki K. Wound infiltration with lidocaine prolongs postoperative analgesia with spinal anaesthesia. Can J Anaesth. 1996;43(9):914-918.

22. Wheeler M, Oderda GM, Ashburn MA, Lipman AG. Adverse events associated with postoperative opioid analgesia: a systemic review. J Pain. 2002;3(3):159-180.

32. Kristek J, Kvolik S, Sakic K, Has B, Prlic L. Intercostal catheter analgesia is more efficient vs intercostal nerve blockade for post-thoracotomy pain relief. Coll Antropol. 2007;31(2):561-566.

23. Trabulsi EJ, Patel J, Viscusi ER, Gomella LG, Lallas CD. Preemptive multimodal pain regimen reduces opioid analgesia for patients undergoing robotic-assisted laparoscopic radical prostatectomy. Urology. 2010;76(5):1122-1124.

33. Borgeat A, Dullenkopf A, Ekatodramis G, Nagy L. Evaluation of the lateral modified approach for continuous interscalene block after shoulder surgery. Anesthesiology. 2003;99(2):436-442.

24. Oderda GM, Evans RS, Lloyd J, et al. Cost of opioid-related adverse drug events in surgical patients. J Pain Symptom Manage. 2003; 25(3):276-283. 25. Sim R, Cheong DM, Wong KS, Lee BM, Liew QY. Prospective randomized, double-blind, placebo-controlled study of pre- and postoperative administration of a COX-2-specific inhibitor as opioid-sparing analgesia in major colorectal surgery. Colorectal Dis. 2007;9(1):52-60. 26. Southworth S, Peters J, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen 400 and 800 mg every 6 hours in the management of postoperative pain. Clin Ther. 2009;31(9):1922-1935. 27. Joshi GP. Multimodal analgesia techniques and postoperative rehabilitation. Anesthesiol Clin North America. 2005;23(1):185-202. 28. Pyrati S, Gan TJ. Postoperative pain management. CNS Drugs. 2007;21(3):185-211.

34. Klimscha W, Chiari A, Michalek-Sauberer A, et al. The efficacy and safety of a clonidine/bupivacaine combination in caudal blockade for pediatric hernia repair. Anesth Analg. 1998;86(1):54-61. 35. Palmer CM, Van Maren G, Nogami WM, Alves D. Bupivacaine augments intrathecal fentanyl for labor analgesia. Anesthesiology. 1999;91(1):84-89. 36. Bergese S, Candiotti K, Gorfine S. The efficacy of EXPAREL, a multivesicular liposomal extendedrelease bupivacaine. Poster presented at: the 2011 International Anesthesia Research Society (IARS) Annual Meeting; May 21-24, 2011; Vancouver, British Columbia. 37. Denepitiya-Balicki T, Punjala M. New and emerging analgesics: extended duration bupivacaine. In: Sinatra RS, Jahr JS, Watkins-Pitchford JM, eds. The Essence of Analgesia and Analgesics. 1st ed. New York, NY: Cambridge University Press; 2011:473. 38. Golf MG, Daniels SE, Onel E. A phase 3 randomized, placebo-controlled trial of DepoFoam bupivacaine (extended-release bupivacaine local anesthetic) in bunionectomy. Adv Ther. 2011; Epub ahead of print.

ANESTHESIOLOGY NEWS • OCTOBER 2011

BB1157

significant decrease in pain and/or opioid requirements for up to 3 days.36,37 For instance, DepoFoam bupivacaine was studied in 2 pivotal Phase III randomized, placebo-controlled trials in patients undergoing hemorrhoidectomy and bunionectomy. In the trial of 189 patients undergoing Milligan-Morgan hemorrhoidectomy, a significant decrease in total opioid use was noted in the DepoFoam bupivacaine group. In addition, the time to first opioid use following surgery was significantly extended compared with the placebo group (14.3 vs 1.1 hours, respectively). Similar results were demonstrated in the bunionectomy study. Reducing opioid use after surgery may be clinically beneficial in the management of postsurgical pain.38 In addition to improving patient outcomes and satisfaction, improved pain management has the potential to lead to early ambulation and reduced health care costs by decreasing hospital LOS, as well as minimizing the need for patient admission/ readmission. Other multimodal strategies regarding the use of local anesthetics/analgesics as part of the multimodal armamentarium usually include continuous infusion and may be associated with complications.30,32 Some of these issues could be addressed by a local analgesic with an extended duration.

2 6 I A n e s t h e s i o l o g y N e w s . c o m Octo b e r 2 0 1 1

P OLI C Y & M A NAGEMENT Scenarios continued from page 23

In essence, a Scenario Survey involves identifying scenarios must be considered when as many potential scenardeveloping your practice’s overall busi- ios, or conceivable futures, ness strategy. as possible. The survey is, in Unlike planning, strategic thinking effect, a hunt for your own is based on envisioning a future and black swans: events that, no then strategizing to have that future matter how low their probpull you toward its accomplishment. A ability, pack the potential Mark F. Weiss, JD strategy involves an ongoing, changing for high impact. process that, if done properly, allows For example, if your pain the creators to regularly revisit and practice was centered at one alter the approach. facility, the odds that the

facility will be physically destroyed by a natural disaster are low, but the impact of that event would be disastrous to your practice. The purpose of the Scenario Survey is not to identify potential scenarios, judge the odds they might occur and estimate the damage that would result. No matter how expert you are at strategizing, it is

impossible to identify and value all potential risks. Instead, the purpose of the Scenario Survey is to identify classes of underlying trends, issues and questions and to develop a strategy that accounts for as many possible future classes as possible. For example, a facility’s closure due to bankruptcy is a possible scenario that could belong in the same class as a facility going under. The more scenarios a strategy incorporates, the more robust that strategy is, and, therefore, the more likely that the strategy will serve you well. Alternatively, if a strategy survives only in one possible future, the more fragile and prone to failure it likely will be. The Scenario Survey is a valuable tool in the development of strategy. Using it strengthens strategies and therefore strengthens the odds of your practice’s success. —Mark F. Weiss, JD Mark F. Weiss, JD, is an attorney who specializes in the business and legal issues affecting physicians and physician groups on a national basis. He holds an appointment as clinical assistant professor of anesthesiology at USC’s Keck School of Medicine and practices with Advisory Law Group, a firm with offices in Los Angeles and Santa Barbara, Calif., representing clients across the country. He can be reached by email at markweiss@advisorylawgroup.com.

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AnesthesiologyNews.com I 27

The following advertorial is provided as a service to our valued advertisers. It is designed to support the advertisement presented below.

Teleflex

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Q: What research was used to develop the ErgoPack System? A: The new bundle was developed using anthropomorphic research. Our team of engineers worked with a consulting firm specializing in human factors research and product usability. Their goal was to better understand how our first-generation maximal barrier precautions trays were being used and where gaps in sterile procedure existed. They recorded hours of procedures and interviewed dozens of clinicians about their use of the product. The team’s goal was to use a systems engineering approach to improve compliance with CLABSI prevention guidelines and sharps safety techniques. The team also assessed the layout and flow of the tray’s components for faster insertion times and a better insertion experience. The engineers found that a lot of time was spent setting up for an insertion. They also found that if clinicians did not always have the right procedural components in their kits, they had difficulty following recommended CLABSI prevention guidelines.

A: The outcome was clinician-focused ergonomic packaging for Arrow’s central-line bundles. The ergonomic packaging uses a systems engineering approach to protect against infection. The component design makes it easier to do the right thing by following the procedure’s sequential flow. Because each recommended item is laid out in the order in which it should be used during the procedure, the clinician has an easier time following the recommended standards. The ErgoPack System is laid out in sequential layers: The first layer contains the sterile procedure stop sign, alcohol hand gel and a checklist on the exterior of the package. The second layer contains the ChloraPrep®, cap and mask, and the third layer contains the sterile hand towel and gown. The final and fourth layer contains a full body drape, insertion components, an

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SonoLong – The new revolutionary echogenic catheter kit equipped with “3D Cornerstone” reflectors PAJUNK® has, as the first and only manufacturer, initiated a system, by which the catheter is introduced under sterile conditions directly from a cassette through the TRUE echogenic SonoPlex cannula. The SonoPlex cannula is equipped with “3D Cornerstone” reflectors, which render optimal reflection properties at steep and shallow puncture angles. This SonoLong kit is perfectly suitable for the optimal ultrasound guided continuous nerve block.

Visibility – regardless of the puncture angle

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Maximum stability and improved echogenicity – through steel stylet

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Optimal ﬂow and localization – through central opening and depth graduations

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2 8 I A n e s t h e s i o l o g y N e w s . c o m Octo b e r 2 0 1 1

POLICY & MA NA G E M E N T Demands continued from page 1

boards to test various approaches to maintenance of licensure, said Drew Carlson, communications director for the group. New standards would be enacted sometime after that. The maintenance of licensure framework tracks so closely to the maintenance of certification requirements that FSMB “strongly supports having physicians who are already engaged in maintenance of certification [be] recognized as being in compliance with any state’s MOL [maintenance of licensure] program,” said Humayun J. Chaudhry, DO, president and chief executive, in a statement posted on the organization’s Web site. Although the American Medical Association (AMA) supports lifelong learning, delegates at the AMA’s annual meeting in June expressed concern that new rules for maintenance of licensure would force them to duplicate CME and other maintenance of certification requirements. The delegates voted to ask the ABMS not to require physicians to pass numerous examinations in order to maintain their certifications. “There is widespread concern about these multiple certifications and licensure examinations that are starting to chew up more and more expense,” said Gregory Threatte, MD, professor and chair of pathology at the State University of New York, Syracuse, according to American Medical News.

education (CME) credits in order to maintain certification, generally every seven to 10 years. The enhanced requirements, enacted in 2000 by the 24 medical and surgical specialty boards belonging to the American Board of Medical Specialties (ABMS), have garnered mixed reviews, ranging from grudging acceptance to vehement opposition. Supporters claim the process keeps physicians up to date in knowledge and practice and improves patient safety. Critics complain that the testing methodology does not represent current practice because it prohibits access to reference materials and forces doctors to spend unnecessary time and money cramming for tests in specialty areas that they do not practice and have no intention of doing so. “The last thing we need is to have our primary care physicians retire rather than take on the board recertifications that are being forced on them,” said Stanley H. Block, MD, medical director of Providence Community Health Centers, in Rhode Island. Critics also say there is no objective evidence to support claims of improved patient outcomes. “I’m a champion test-taker. I’ve taken all kinds of tests throughout my medical career and I can tell you that a test does not measure whether you are any good or not. It merely tells you whether you are good at taking a test,” said Jane Orient, MD, an internist in Tucson, Ariz., and executive director of the Association of American Show Them the Money Physicians and Surgeons, which represents doctors in private practice. “MainSome physicians believe maintetenance of certification is a waste of nance of certification has less to do with time and money.” improving quality of care than with collecting additional fees for examination From MOC to MOL and other services on the part of speIn April 2010, the Federation of State cialty medical boards and their related Medical Boards (FSMB), which rep- societies and associations. Contributing resents the approximately 70 medical to this perception is the fact that some and osteopathic boards in the United of the larger boards collect millions of States and its territories, enacted a new dollars in annual testing fees, have assets framework for maintenance of licensure. totaling tens of millions of dollars, and Currently, most state boards require pay their officers and executives high renewing doctors to merely update salaries. Individual physicians can expect information about their certifications, to pay several thousand dollars to comtraining and malpractice claims, pro- plete the maintenance of certification vide proof of their CMEs and pay a fee. process. The new framework would require phyThe medical boards, all not-forsicians to also pass periodic knowledge profit corporations, deny having a profit and skills tests, and to demonstrate per- motive and maintain that the new formance standards using patient data requirements encourage lifelong learnfrom their own practices. Their results ing, support physician competence, might then be compared with local and and improve clinical outcomes and national statistics. patient safety. In addition to the AMA, Early next year, the FSMB will initi- many organizations including the Joint ate pilot projects with 11 state medical Commission and the Accreditation

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AnesthesiologyNews.com I 29

PO LI CY & MA NA GEMENT Council for Continuing Medical Education, endorse professional assessment, continuous learning and lifelong practice improvement. Nevertheless, financial conflicts of interest, or at least their appearance, can arise because medical boards and their affiliated societies are financially intertwined in the recertification process. “For some of the other boards, a significant amount of their revenue comes from maintenance of certification because they’ve created products that fit some of those requirements,” said David L. Brown, MD, secretary of the American Board of Anesthesiology (ABA). “Unlike some of the boards that have developed products to sell to their physicians, we made a very conscious decision not to do that so it wouldn’t be perceived that we were somehow trying to increase revenues with products,” Dr. Brown said. “We purposely tried to stay away from having that conflict.” The ABA last year collected $912,000 in maintenance of certification fees, less than 10% of the organization’s $9.5 million annual revenue, he said. Mark A. Warner, MD, president of the American Society of Anesthesiologists (ASA), said the ASA is not the exclusive provider of educational materials and activities for the maintenance of certification in anesthesiology (MOCA) process. “Any other organization may develop materials and activities for the MOCA process, presumably working with the ABA to ensure that these meet their guidelines,” Dr. Warner said. Thus far, however, only the ASA has sought approval to supply these materials. “It seems likely that this will change in coming years, as I know of at least one anesthesiology subspecialty organization that is discussing the possibility of doing so,” said ABA President Glenn P. Gravlee, MD. The ABA has been implementing MOCA over the past decade. Anesthesiologists who were originally certified prior to 2000 are “grandfathered” or exempted from the process, but they are encouraged to participate in it. In addition to CMEs, diplomates must submit a four-step case evaluation and complete an anesthesia simulation course

at an ASA-certified simulation center. The “cognitive examination” consists of 200 multiple-choice questions, 150 of which are general and the remaining 50 are specific to pediatrics, cardiothoracic medicine, neuroanesthesia, critical care, obstetrics/gynecology and pain medicine. Forcing all anesthesiologists to study for these subspecialties is wasteful, said Paul Kempen, MD, PhD, a general anesthesiologist at the Cleveland Clinic, in Ohio. “They want us to test every 10 years in all areas of anesthesia, including chronic pain management, which is a whole new specialty in itself. It’s a waste of time and money.” The ABA’s Dr. Brown explained that preparing separate specialty examinations would have been too costly. “So we’re trying to bridge it to make it pretty commonsense stuff that actually has applicability for most people,” he said. But so far, it appears that nearly all anesthesiologists who are required to undergo MOCA are in the process of doing so. According to Dr. Brown, 99.6% of the 2000 cohort of ABA diplomates is expected to complete the MOCA program by 2013. Dr. Warner added, “The ASA is not aware of any information on anesthesiologists who are critics of the MOCA process. Some individuals have expressed concern to ASA that the MOCA process is either not clear to them or is an activity that they do not wish to pursue. However, there are no survey data, to our knowledge, on the interest or disinterest of anesthesiologists in the MOCA process.” Widespread Criticism Yet, although some physicians say maintenance of certification is worthwhile, this sentiment does not appear to be widespread. In March 2010, the New England Journal of Medicine asked readers to vote on whether they thought a physician who holds certificates of unlimited duration from the American Board of Internal Medicine (ABIM) should voluntarily enroll in maintenance of certification (N Engl J Med 2010;362:948-952). The results were overwhelming: 63% of more than 2,500 respondents recommended against enrolling. Strikingly, more than 80% of the respondents were themselves board-certified physicians (N Engl J Med 2010;362:e54-e55). Many of them commented that the cost outweighed the benefit, and that the program was a money-generating activity for ABIM. Many respondents who reported having gone through the see demands page 30

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3 0 I A n e s t h e s i o l o g y N e w s . c o m Octo b e r 2 0 1 1

P OLI C Y & M A NAGEMENT Demands continued from page 29

Simulation Centers Get Boost From MOCA

ne of the requirements of maintenance of certification in anesthesiology (MOCA) is to attend an approved anesthesia simulation course. The American Society of Anesthesiologists (ASA) has endorsed 27 simulation centers nationwide, including at such major institutions as Mount Sinai, Stanford University and Vanderbilt University. ASA president Mark Warner, MD, said the centers were selected based on their educational programs, facilities, and instructor experience. Participants work as part of a small team but take turns being the primary anesthesiologist. Scenarios recreate challenging clinical

cases, including “the management of hypoxemia and hemodynamic derangement and to emphasize teamwork skills in resolving such events,” Dr. Warner said. Each participant’s performance is videotaped and reviewed afterward, but is neither graded nor scored. “This is not a pass/fail exam, but an experiential learning opportunity that is designed to stimulate practice improvement,” the ASA says. According to David Brown, MD, president of the American Board of Anesthesiologists, past participants viewed the experience as positive, with 92% indicating it would change their practice.

Paul Kempen, MD, PhD, a general anesthesiologist at the Cleveland Clinic, in Ohio, remains critical. “The installation of simulators in university settings requires the investment of tremendous amounts of money. Now they want to create repeat and paying customers to use this equipment at preferred sites and finance it,” he said. “There is no protocol (yet) as to what should be simulated in terms of recertification, nor validation that it is effective in this setting,” Dr. Kempen added. “There are no tests required for simulation. It’s almost as if they are saying, ‘Just come, pay for it, and you’ll have a good time.’” —T.A.

15 16

5 23

13 18

2 25 8 6

26 4

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1 Cooper Simulation Laboratory, Cooper University Hospital, Camden, N.J. 2 Center for Medical Simulation, Cambridge, Mass. 3 Duke University Human Simulation and Patient Safety Center, Duke University Medical Center, Durham, N.C. 4 Texas Tech University Health Sciences Center, Lubbock, Texas 5 Stanford School of Medicine Center for Immersive and Simulation-based Learning, Stanford, Calif. 6 Stony Brook University Medical Center Clinical Skills Center, Stony Brook, N.Y. 7 University of Utah Anesthesiology Department Center for Patient Simulation, Salt Lake City 8 The Mount Sinai School of Medicine Human Emulation, Evaluation, and Education Lab for Patient Safety, New York City 9 Patient Simulation Center, University of Texas Medical Branch at Galveston

10 University of Virginia Health System Medical Simulation Center, Charlottesville 11 Howard and Joyce Wood Simulation Center, Washington University in St. Louis School of Medicine 12 Anesthesia Simulation Center, San Francisco General Hospital, University of California, San Francisco Department of Anesthesia and Perioperative Care 13 Northwestern Center for Clinical Simulation, Northwestern University Feinberg School of Medicine, Chicago 14 Peter M. Winter Institute For Simulation Education and Research, University of Pittsburgh 15 Institute for Simulation and Interprofessional Studies, University of Washington, Seattle 16 Oregon Health & Science University Anesthesia Simulation Services, Portland 17 Penn State Hershey Clinical Simulation Center, Hershey 18 University of Chicago Center for Simulation

19 University of Miami – Jackson Memorial Hospital Center for Patient Safety 20 UCLA Simulation Center, Los Angeles 21 Mayo Clinic Multidisciplinary Simulation Center, Rochester, Minn. 22 Vanderbilt University Simulation Technologies Program, Nashville, Tenn. 23 University of New Mexico School of Medicine, Anesthesiology Simulation Education Program, Albuquerque 24 Wake Forest University Baptist Medical Center Patient Simulation Laboratory, Winston Salem, N.C. 25 Beth Israel Deaconess Medical Center, Simulation and Skills Center, Boston 26 Medical University of South Carolina Healthcare Simulation Center, Charleston 27 University of Kentucky Department of Anesthesiology, Lexington

process said it was only marginally beneficial and took time away from caring for patients and other learning activities. Others argued for keeping the requirement but revising the process to make it less burdensome. Martin S. Dubravec, MD, an allergist in Cadillac, Mich., completed his maintenance of certification with the American Board of Allergy and Immunology in 2008. “The material did not reflect my practice,” Dr. Dubravec said. “It was unduly burdensome and made it harder for me to provide high-quality care to patients, since I had to spend many hours and thousands of dollars preparing for clinically irrelevant tests.” Ron Benbassat, MD, an internist in Beverly Hills, Calif., said he is hoping to be a catalyst for change. “We are all for staying current with medical changes,” he said, “but the onerous [maintenance of certification] program is no way to achieve this.” Dr. Benbassat runs a Web site (www. changeboardrecert.com) in an effort to mobilize physicians to petition their boards, hospitals and state medical organizations to reform or abolish maintenance of certification requirements. “Doctors are collectively apathetic and afraid to make waves,” he said. “Doctors need to take their heads out of the sand, unify and take control back of our profession.” The controversy over maintenance of certification is not limited to physicians. The National Board on Certification and Recertification of Nurse Anesthetists (NBCRNA), in August, announced proposed new rules for continued certification, including a standardized examination every eight years. The response has been vocal and about evenly split, said Wanda Wilson, PhD, CRNA, executive director of the American Association of Nurse Anesthetists. Karen Plaus, PhD, CRNA, executive director of the NBCRNA, said her organization would consider the feedback and comments before making a final recommendation to its board. When it comes to anesthesiologists, Dr. Brown said the ABA has tried to make MOCA “the least onerous we can for our docs, with as much clarity and transparency as we can for society.” “It’s a balance to try to get it right,” Dr. Brown continued. “Do we get it right for everybody? I would guess that we don’t. But the worst thing would be to have some group that doesn’t know anything about medicine trying to make these rules instead of us.” —Ted Agres

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Scott Augustine, MD, Anesthesiologist and Inventor Scott Augustine, MD, invented Bair Hugger® forced-air warming (FAW) 24 years ago. His latest invention, air-free, reusable HotDog® conductive fabric warming, challenges forced-air warming products on safety, effectiveness and cost. Dr. Augustine responded to the following questions.

Q: Why did you develop HotDog warming? A: We wanted to address the shortcomings of FAW products as well as provide lower-cost, clinically superior warming and be friendly to the environment.

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for preventable infections, the hospital is stuck with the bill. A 1% reduction at a hospital doing 1,000 total joint replacements per year results in 10 avoided infections—a savings of $1 million, not to mention averting the pain and suffering of the patients.

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safely treated millions of patients. However, like many other medical devices and drugs, it has been found to have an adverse effect in certain subgroups of patients. In these situations, the device or drug is not necessarily withdrawn from the market. Instead, new warnings and contraindications are issued about which patients should not receive the therapy. It seems that contraindicating the use of FAW during implant surgery is only prudent.

Q: You say HotDog warming is “clinically superior” to FAW. What does that mean? A: Published research shows equal effectiveness blanket-for-blanket, but HotDog frequently warms better in customer trials because multiple blankets and a mattress can be used simultaneously. HotDog, being air-free, is also safer—especially for orthopedics and cardiac—because the sterile field is not disrupted by contaminated waste heat.

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Q&A With Carin Hagberg, MD Q: What are the most critical challenges influencing airway management? A: Management of the difficult airway remains one of the most relevant and challenging tasks for anesthesia care providers. Insurance claims involving airway management continue to comprise an important aspect of the American Society of

Anesthesiologists Closed Claims Project, which tracks all anesthesia-related claims. In addition, a variety of airway techniques and devices are currently available for clinical use. Selection of equipment should be based on evidence, principles of accepted guidelines and proper judgment. Familiarity and confidence with the chosen equipment are key factors contributing to a successful outcome.

Q: How does video technology facilitate the management of difficult airway cases? A: A common factor preventing successful tracheal intubation is the inability to visualize the vocal cords when performing direct laryngoscopy. Video laryngoscopes are a relatively new addition to the armamentarium of devices for the airway manager. In

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Q: In your experience, how has the adoption of video technology improved training? A: Video laryngoscopy allows the instructor to see what the trainee is visualizing in “real time” and allows for instruction and demonstration to multiple viewers. An assistant can visualize the effects of laryngeal manipulation, if needed, and the procedure can be recorded and reviewed later in presentations or discussions. Video laryngoscopy also can facilitate the teaching of alternative techniques, such as flexible fiber-optic endoscopy. Direct laryngoscopy can also be taught with certain video laryngoscopes, such as the Berci DCI®, C-MAC®, GlideScope (Verathon Medical) and McGrath (LMA North America).

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A: There is really not one optimum technology solution for management of the difficult airway. Each airway device has unique properties that may be advantageous in certain situations, yet limiting in others. Specific airway management techniques are greatly influenced by individual disease and anatomy, and successful management requires combinations of devices and techniques. Nonetheless, clinical judgment born from experience is crucial to their application.

Octo b e r 2 0 1 1

AnesthesiologyNews.com I 33

POLICY & M A N A G E ME N T

Preventing Nosocomial Infections Saves Lives, Money Analysis of Michigan hospitals makes business case for Keystone ICU patient safety program

he use of an evidence-based prevention program for nosocomial infections can generate significant cost savings for hospitals, according to new data. Previous analyses of the Keystone ICU Project have shown its efficacy in preventing hospital-acquired infections (HAIs). But to implement a new intervention or program, hospitals require proof that the investment will yield a positive economic return within a certain period of time. “It seems strange to say, ‘well you’re saving lives, but how much does it cost us?’ but at some point in the health care system that’s an important consideration,” said Hugh Waters, PhD, adjunct associate professor at Johns Hopkins Bloomberg School of Public Health, in Baltimore, and lead author of the economic analysis. Dr. Waters and colleagues sought to make a business case for the Keystone ICU Project by comparing its cost ($161,584 per year, which includes initial implementation) with the average cost of treating a catheter-related bloodstream infection (CRBSI) or case of ventilator-associated pneumonia (VAP)—$36,500 and $10,000, respectively. The intervention costs an estimated $3,375 per infection averted, leading to $1.1 million in annual savings for the typical hospital (Am J Med Qual 2011;26:333-339). The savings were derived from a 2010 observational study of the Keystone ICU Project in 106 ICUs across 67 hospitals (BMJ 2010;340:c309). The authors found that the intervention reduced the rate of CRBSIs from 7.7

to 1.1 per 1,000 catheter-days, preventing 29.9 infections annually. A separate, unpublished analysis by Berenholtz and colleagues found the program prevented 18 cases of VAP per year. “In the bigger picture, I hope this helps open the door for more commonsense economic arguments for

why good health practices should be adopted in the United States,” Dr. Waters said. The economic analysis was conducted on a subsample of the original Keystone ICU Project and used six Michigan hospitals that averaged 4,532 catheter lines per year. The hospitals

varied in size, staffing and setting. The researchers used activity-based costing techniques to quantify indirect costs attributed to the intervention, such as staff salaries, time allocated to train and educate hospital personnel and equipment purchases. Staff see business page 34

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P OLI C Y & M A NAGEMENT

Costly ICU Transfer Delays Addressed by Simple Measures

elays transferring patients into and out of the intensive care unit after surgery can cost hospitals as much as $30,000 per week, researchers have found. However, ICU staff can reduce these lags by as much as 80% by instituting simple and cost-effective interventions that add structure to the often diffuse process of transferring patients, according to the researchers, who presented their findings at the 2011 annual meeting of the Society of Critical Care Medicine (abstract 114). Not surprisingly, hospitals are taking a closer look at ways to make “throughput” more efficient by removing obstacles to smooth and timely transfers. “Simple things, such as prolonged waits for discharge orders to be written or for test results to come in, can cause significant transfer delays and lead to a shortage of beds both in the ICU and upstream of the ICU,” said Richard Savel, MD, associate professor of critical care at Albert Einstein College of Medicine, in New York City. “In the meantime, a patient may be medically stable and otherwise ready for transfer,” said Dr. Savel, who was not involved in the research. The costs of these delays indeed add up, as Richard Pino, MD, associate professor of anesthesia, critical care and pain medicine at Massachusetts General Hospital, in Boston, and colleagues documented. They prospectively examined data from 731 patients treated at their 20-bed surgical ICU between January and July 2010, who were subsequently transferred to surgical hospital wards. Of the study group, 22% (160 of 731) were delayed in transfer out of the ICU by at least one, and as many as six, days. The most common reasons were a lack of available surgical floor beds and rooms appropriate to prevent infections, Dr. Pino reported (Table). Significantly, 21% of the patients delayed in transfer were to be moved overnight, compared with 12% who were to be transferred during the day (P=0.005). Advertisement

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The higher rate of overnight transfer delays “is purely a timing issue,” Dr. Pino said, and might not be the best place to try to attack the problem. “Once a procedure is completed and a patient is stable for discharge from the postanesthesia care unit, it can be quite late at night,” Dr. Pino said. “A patient admitted to the floor at 10 p.m. might have his morning labs drawn at 6 a.m., only eight hours after the procedure. This patient may need an additional laboratory test several hours later and may be discharged later in the day when results are available.” According to Dr. Pino, the weekly price tag for these delays—the difference between the average cost of an ICU bed and the average cost of a surgical floor bed as billed to insurers—amounted to $29,319. Despite significant and costly outbound delays, Dr. Pino said his institution has managed to curtail delays in ICU admission by tasking a trio of staff, including an ICU charge nurse, a critical care triage nursing supervisor and an operating room anesthesia administrator, with monitoring the process. “They communicate throughout the day to place patients scheduled for admission to the ICU or those who may unexpectedly need an ICU admission,” Dr. Pino told Anesthesiology News. “At times, this is a difficult task when one considers the large number of high-acuity patients that we see, but we manage to place all patients who require ICU care in an expedient manner.”

The experience of the Johns Hopkins Medical Institutions also is instructive. A 2008 analysis at the Baltimore facility revealed that postponed transfers out of the ICU were partly accounted for by lengthy waits for transfer orders and test results. Theresa Hartsell, MD, PhD, assistant professor of anesthesiology and critical care medicine at Johns Hopkins, and her colleagues found that delays in transfers from the ICU led to 3.5% of inbound patients winding up in a holding pattern after surgery (abstract 100). These patients required either prolonged stays in the operating room or temporary diversion to a recovery room while an ICU bed was made available. Project Green Light In an effort to shorten these wait times, the Hopkins team began marking so-called “green light” patients—those outbound patients expected to be clinically stable and ready for transfer the next day— on a dedicated bulletin board near the nursing station each night. The early designation, they reasoned, would provide the ICU team enough time to collect data and test results from downstream, and deliver data upstream to surgical floors. The advance notice also would give primary surgical teams a chance to write transfer orders before the start of the next day. Concurrently, the unit adopted a “2´10” protocol, with the goal of transferring two patients out of the ICU by 10 a.m., in time to accept all but the earliest of OR admissions. Staff were offered pizza as incentive to meet this goal, gathering “points” every time they met the 2´10 target. “The program is just a structured way of getting physicians to triage their discharges as well as their admissions—it helps them hustle a bit more and really take pride in their work,” Dr. Hartsell said. Soon after implementing the intervention in December 2008, inbound transfer delays from surgery or the postanesthesia care unit fell by 83%, to 0.6% of patients, the researchers found. The improved efficiency has translated to a 5% increase in the absolute number of patients transferred into the ICU during the 18-month data collection period. —David Wild

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Business continued from page 33 members were interviewed to assess how much of their time was spent on activities associated with the program, such as checking patients’ intubation or assisting with the placement of central lines. “We made sure we covered all sizes and types of hospitals in terms of specialization,” Dr. Waters said. “I think there is no question that the results are statistically solid and Michigan is not very different from other states, so the data can be applied to hospitals in different states.” The current hospital reimbursement landscape is increasingly placing the economic burden of nosocomial infections on the hospital itself; the Centers for Medicare & Medicaid Services and many

commercial insurers no longer pay institutions to treat many HAIs. As a result, it has become imperative for hospitals to engage in evidence-based prevention methods. Although this type of incentive paradigm encourages hospitals to reduce their rates of HAIs through negative reinforcement, the reality is that eliminating every infection may be impossible. “This is an issue with performance-based payment; some hospitals have a much larger number of cases coming in that are at risk for these infections,” Dr. Waters said. “So there’s an argument for some kind of risk adjustment to these rates along with positive incentives for those showing improvements.” —Seth Kandel

3 6 I A n e s t h e s i o l o g y N e w s . c o m Octo b e r 2 0 1 1

P OLI C Y & M A NAGEMENT Quality continued from page 21

bid down,” he said. But of course, it depends on the amount of competition no matter what,” Dr. Glick told Anesthe- in the health insurance market and siology News. “If you have a heart attack power that they have—not that of the when you are eating your ice cream at consumer, because it’s not the patient the mall, you don’t have time to make who determines the price of service— choices. They put you in an ambulance it’s the negotiation between the insurand take you to the nearest hospital.” ance company and provider.” Stuart Guterman, vice president Lack of Transparency for payment and system reform at the Commonwealth Fund, in New York Dr. Glick argued that since patients City, noted that there are many poten- are not aware of prices and quality tial explanations for the unclear rela- metrics, it is not surprising that quality tionship between competition, price and quality. “The fact that cost and quality don’t go together indicates that something else is at play,” Mr. Guterman said. “It could depend on where those high-cost hospitals were located. For example, are those hospitals in areas where there is higher income, because higher income could drive what prices a hospital is able to charge, regardless of the competition.” Other factors include whether people are better insured in an area, or whether insurers are simply willing to pay more in an area, he added, noting that this in itself can attract physicians to a hospital. “All things being equal, more competitors should allow prices to be 18

by Medicare, but Mr. Guterman said more must be done. “The issue of transparency is fundamental,” he said. “You find an amazing amount of variation between what different payers pay for the same service at the same hospital and what the same payer pays at different hospitals. It leads you to believe something is not functioning right in this market and people don’t generally know what others are paying.” —Jennifer Hanawald

r = –0.11 P = 0.0047

Cost (Thousands)

and competition do not have the same relationship in hospital care that they do in other areas of business. “Competition really only works to lower prices when the people who are paying are the ones who are making the decisions,” he said. “Insurance companies can separate consumers from the financial consequences of their health care choices.” The last decade has seen strides in health care transparency, especially thanks to data recorded and published

14 12 10 8 6 4 2 0

10%

Mortality Rate Figure (a). The mortality rate for heart failure fell as costs of care rose ... 18

r = –0.086 P = 0.033

Cost (Thousands)

Recent studies have concluded proper techniques, protocol and bundling can successfully prevent Central Line Associated Bloodstream Infections (CLABSIs).

14 12 10 8 6 4 2

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Adult Smoking Cessation Counseling Figure (b). ... but hospitals that received higher reimbursement were less likely to offer smoking cessation counseling to adults—a quality metric for the treatment of heart failure.

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AnesthesiologyNews.com I 37

POLICY & M A N A G E ME N T

Top Five Employment Issues for Pain Management Centers Dear Arizona Pain Specialists, Our pain management center has grown significantly. With additional employees come increased challenges in management. How should a pain practice address human resource issues proactively? Thank you, Growing Practice Seeking Fewer HR Headaches

Dear GPSFHRH, our practice isn’t unique. As the specialty of pain management has grown, practices have seen an increase in business, number of employees and related human resource issues. As your practice grows, compensation, recruitment, staffing, communication, employee relations and employee development should be on

your mind. Although solutions must be tailored to meet each practice, the following advice is appropriate for any practice in the pain management specialty.

compensation must be competitive and fair for all employees, yet still cost-effective and compatible with the mission and culture of the pain management center. Compensation programs are Compensation important to employers because they A smart compensation program affect the hire and retention rate of the should be designed to attract, moti- organization. vate and retain employees. In general, The two ways to design and structure a compensation program are direct and indirect compensation. Direct compensation includes wages such as base pay, bonus and direct cash that organizations offer their employees. Indirect compensation includes nonwages with indirect monetary value, such as unpaid leave, disability insurance, life insurance, working titles and medical benefits programs. Indirect compensation allows a practice to compensate employees for their experience, knowledge and skills. Often the value is equal to or more than direct wages. Indirect compensation also gives pain management centers additional leverage during recruitment.

When developing a compensation package, there are several factors to consider. First, ensure the package is competitive. An organization can lead its competition by paying higher wages and having a better compensation program to attract more qualified employees. When lagging behind competitors in this arena, employers pay more for recruitment and training. The turnover rate of employees and related expenses will be considerable. Some organizations choose to deliberately pay below the market average because of economic necessity; this will always limit the hiring pool. Furthermore, centers must make sure that they have a clear salary structure and all employees understand how the program is designed. This structure should be based on labor market conditions, which will greatly influence

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P OLI C Y & M A NAGEMENT Employ continued from page 37 how organizations design and pay employees for their job, knowledge and skills. Organizations should be proactive, not reactive, to trends. Unfortunately, the reality for many pain management physicians is that reimbursements have declined significantly. Because of declining reimbursements, most practitioners are forced to see more patients, but receive the same income. This

Afford Reli Avail Deploy

environment of declining reimbursements occurs while regulatory and personnel costs increase, creating a difficult scenario for employee recruitment and retention.

benefit the practice. A new employee’s success or lack thereof depends on an analysis of the center’s goals. Organizations must make sure that they have the right person for the right job. Does the employee have the creRecruitment and Staffing dentials and training required for the Recruitment is the process of identi- position? Or is the employee simfying potential employees and encour- ply likeable and one the organization aging them to apply for a position wants to keep on staff ? Employers within a practice. The process starts must not fall into the personality trap. with a job-need analysis, including Job descriptions should be written details on how the position will fit and without specific employees in mind.

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Employers will save themselves, their clients and their employees countless headaches associated with unprepared and underqualified employees who they thought could simply “figure it out.” Whether recruiting for a position internally or externally, the job description should drive the selection of the employee. If an internal candidate meets all hiring requirements, the pain practice can capitalize on its investment, by posting the job internally first and selecting and developing the current employee. Another great source for recruitment is former employees who are eligible for rehire. Rehire status should be listed on exit interviews and kept in employee files for ready access and review. Former employees often have advantages over new employees because they are familiar with the company’s mission, business culture and systems. The biggest mistake most practices make is rehiring employees with performance, attitude or attendance issues. It does not make sense to rehire a previous employee who lacks skills required for the job simply because he or she is familiar with the organization. Job skills should outweigh personality and familiarity in decision making.

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877-6-Airway or visit Airtraq.com

Communication Open, effective and clear communication is the No. 1 priority for most employees in all organizations, regardless of size. There is a right and a wrong way to communicate with staff to achieve the results that the organization wants. An effective communication style helps employers build trust and respect, and fosters an environment where learning can occur for both employees and patients. Active listening helps improve

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AnesthesiologyNews.com I 39

POLICY & M A N A G E ME N T communication. This advice may seem simple, but listening without distraction or interruption is paramount to effective communication. Face-to-face communication, spoken conversation or dialogues are influenced by voice modulations, pitch, volume and even speed and clarity. Nonverbal communication sends an even stronger message to staff members. Nonverbal communication includes everything from how executive and health care staff members dress and use body language to the furniture in the waiting room. Communication styles influence how employees respond to employers, too. For example, when speaking with the executive who comes to work in faded scrubs, employees may use an inappropriately casual tone. When the same executive arrives early, keeps a tidy desk and wears a pressed shirt and tie, employees will sit up a bit straighter. They can recognize a leader who demands their attention and respect. Written communication with employees and patients is also key. Most practices struggle with unclear, undefined policies and procedures. This makes human resources far more complicated when special employees are able to bend the generally understood rules to their liking. Instead, clearly written and distributed policies and procedures set the rules for all staff. Employees often receive a brief overview of the policies during orientation and then are expected to know them and the consequences of violating them. Employees should be given ample time to review policies and procedures, and the consequences of violations should be clearly communicated to them. If every practice had the perfect staff, there would be no employment headaches. How can pain management centers decrease

employee-related issues and meet the needs of their staff ? Practice management must understand employees are not perfect. It is the responsibility of the practice to help and train employees to understand the importance of policies (especially as they evolve), how they can apply in the workplace and why they are necessary. Policies and procedures are fluid. Regularly, management should communicate any changes to policy and how these updates influence workflow.

The sooner the organization can communicate change and allow for question-and-answer time with staff, the better.

team on employee issues and create an environment in which the staff feels respected. Listening to the needs and concerns of staff—and taking action to address these issues—will keep a pracEmployee Relations tice’s workforce happier and maintain For pain management centers to be a higher retention rate. What makes a successful, they must meet the needs good employee relation program? Simof their patients by offering great cus- ply put: feedback—employees want to tomer service and patient care. The be heard. goal for all pain management cenIf there is no solution, be honest. ters should be to treat employees fairly, Actively listen, recognize the issue and see employ page 40 train and educate the management

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4 0 I A n e s t h e s i o l o g y N e w s . c o m Octo b e r 2 0 1 1

P OLI C Y & M A NAGEMENT

Prefilled Syringes Cut Waste—and Bottom Line on Drugs

witching from vials to prefilled syringes may save hospitals thousands of dollars each year by reducing drug waste, according to new findings presented at the 2011 annual meeting of the International Anesthesia Research Society. Researchers at the Medical University of South Carolina, in Charleston, compared the amount of unused drugs before and after clinicians began using prefilled syringes in a 10-room operating room (OR) suite. They found that the switch cut both the likelihood for and the volume of unused drug drawn into a syringe that would need to be discarded after the procedure. Comparing two time periods covering fewer than 200 surgeries each, the researchers found that this reduction in waste saved $126 per day (abstract S-124). Prefilled syringes likely reduce waste because they are sealed containers, ready to be used and able to be returned to the shelves if unused, explained study co-author Christopher Fortier, PharmD, manager of pharmacy support and OR services and clinical assistant professor at the institution. Often, anesthesiologists will draw up medications into vials in the OR “just in case they may need it,” Dr. Fortier noted. But if that medication is not used, it must be discarded. In contrast,

if a prefilled syringe is not used, clinicians can return it, unopened, he said. “In that way, you’re only using the product you need, when you need it.” The system also cuts waste by reducing the amount of leftover medication in syringes, he added. For instance, an anesthesiologist may prepare 10 mL of a medication but use only 5 mL during surgery; the rest is discarded. But a 5-mL, prefilled syringe would obviate the waste, Dr. Fortier said.

alone is hard to estimate, as clinicians who draw their own must purchase the syringes, labels and needles—and add overhead costs by asking technicians or doctors to draw up medications out of vials prior to surgery. To investigate whether prefilled syringes cut back specifically on drug costs by curbing waste, Dr. Fortier and his team measured the amount of discarded drugs—either unused or left over in used containers—from 154 surgeries (Phase I). They then compared that amount with what was wasted from 171 surgeries (Phase II) in which doctors used prefilled syringes. The research was funded by an educational grant from PharMEDium, which sells prefilled syringes. Fewer cases in Phase II had drug waste (38%) than did Phase I cases, in which 71% had discarded medications. When there were drugs to discard, the total volume decreased by 61%, going from 3,284 mL in Phase I to 1,266 mL in Phase II. As a result, the cost of drug waste fell from $3,106 in Phase I to $1,849 in Phase II, according to the researchers. Prefilled syringes from PharMEDium, which The drugs that had the greatest sponsored the research. decreases in waste included lidocaine Prefilled syringes are more expen- (90%), followed by succinylcholine sive upfront, Dr. Fortier said. However, and glycopyrrolate. the actual cost difference in materials The current study did not look

Employ continued from page 39 try to act to resolve the issue. If there still is no solution, be honest. The organization must create a teamoriented environment where employees understand they have a voice when it comes to change or recommendations. The old adage, “don’t make promises you can’t keep,” remains sound advice to follow. Training and Development Different types of training programs exist to address performance deficiencies and developmental needs at all levels of employment. Creating or providing a training program first requires a precise and accurate job description, and knowing the abilities of all employees. The right training should provide knowledge, skills and abilities to fill a deficiency in skill. An assessment of employees’ needs will help identify gaps in

actual versus desired organizational performance. In this gap, appropriate training is designed. The objective of the training should be to teach employees how to meet expected organizational performance. Creating effective training requires design, implementation and evaluation. Materials should clearly state and teach organizational objectives. Next, it’s important to implement the training to employees and then evaluate whether the employees understand the training and have used the information to improve their job performance. With the right design, implementation and evaluation, practices should see improvements in employee performance immediately. To determine an appropriate schedule for training, management should consider who they want

at safety with prefilled syringes, Dr. Fortier noted, but they have some important advantages over conventional syringes. Prefilled syringes are color-coded and have the name of the drug noted in different locations and angles on the syringe. They also contain bar codes that clinicians can scan to ensure they have the right drug. When clinicians draw up medications from vials, they also must label the syringe, and mistakes can happen, Dr. Fortier said. By using prefilled syringes, “you’re improving safety in how it’s labeled. There’s no question what you’re picking up.” Indeed, the Anesthesia Patient Safety Foundation has recommended that clinicians rely on prefilled or premixed solutions whenever possible, said Robert Stoelting, MD, president of the group, which has received support from PharMEDium. The increased upfront cost may cause some clinicians to hesitate before adopting prefilled syringes, Dr. Stoelting said. “This research addresses this issue and thus will be helpful to other institutions when they consider cost versus benefit—considering safety, less risk for contamination and the ability of an anesthesia professional to do other tasks,” he said. —Alison McCook

their workforce to consist of and where they want their workforce to be in a year, in five years or even 10 years. Continuing education and training are essential to achieve a smart, well-trained workforce. Having the right skills and knowledge helps employees perform better; investing in employees’ education makes them feel more valued and should positively influence the business as a whole. There is no simple formula to create a happy, healthy workforce. However, these suggestions come with experience. All practices will have human resource issues; the advice provided should help minimize workforce headaches. —Tory McJunkin, MD, Paul Lynch, MD, Omor Okagbare, MBA, and Ryan Tapscott, 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.

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THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

Part 2 of a 2-Part Series

Guiding Fluid Management in the Surgical Setting Faculty

Case Study 1: A 60-Year-Old Man Admitted for Radical Cystectomy and Ileal Conduit

Joshua Bloomstone, MD

Chairman, Anesthesiology and Perioperative Medicine Banner Thunderbird Medical Center Glendale, Arizona Anesthesiologist Valley Anesthesiology Consultants, Ltd. Phoenix, Arizona

Neal W. Fleming, MD, PhD Professor of Clinical Anesthesia Director, Cardiovascular and Thoracic Anesthesia UC Davis School of Medicine Sacramento, California

Introduction Recently, Dr. Maxime Cannesson demonstrated the basic concept that morbidity is reduced when operative patients receive the correct amount of volume therapy (volume optimization)—as opposed to too much (volume maximization) or not enough (volume minimization).1 Several studies also have demonstrated that perioperative goaldirected volume therapy has been associated with significant reductions in the operative stress response and enhanced microcirculatory flow in various tissue beds.2 Studies using esophageal Doppler also have shown that morbidity and hospital length of stay (LOS) were reduced when volume therapy was individualized by placing each patient at the top of his or her individual Frank-Starling curve.3-5 Other studies have demonstrated that pre- and immediate postoptimization of the high-risk surgical patient also reduces morbidity,6,7 as well as short- and long-term (15-year) mortality.8,9

Arterial Pressure Variations and Volume Status Measurement The relationship between arterial pressure variations and volume status is easily quantified by the dynamic indices of volume responsiveness, including systolic pressure variation, pulse pressure variation, and stroke volume variation (SVV). These indices—defined only in patients who are mechanically ventilated with tidal volumes of 8 to 10 cc/kg and who have regular rhythms—are highly predictive of volume responsiveness. Traditional static measures such as central venous pressure, pulmonary artery occlusion pressures, and urine output are not predictive.10-13 Numerous researchers have demonstrated the incredible sensitivity and specificity of both pulse pressure and SVV. Variations of 13% to 15% in either pulse pressure or stroke volume represents the dividing line between responders and nonresponders to volume therapy. Variations greater than 15% are associated with volume responsiveness;

he patient’s history includes tobacco use, gross hematuria, and a new diagnosis of high-grade diffuse transitional cell carcinoma of the bladder. The patient was admitted for radical cystectomy and ileal conduit. The patient reported no allergies and was not taking any medications. There was no significant anesthetic history. Upon admission, the patient’s height was 179 cm, weight was 58.8 kg, blood pressure (BP) was 120/70 mm Hg, with a regular heart rhythm of 70 beats per minute. Respiratory rate of 14 breaths per minute with an oxygen saturation of 98% on room air was measured. The patient was afebrile and edentulous with a modified Mallampati Class I airway. The rest of the physical exam was unremarkable. The patient had an 18-g IV in the left forearm. The patient was brought to the operating room having been sedated with midazolam; standard monitors were applied followed by induction with lidocaine and propofol. Muscle relaxation was achieved with rocuronium, after which the patient was intubated. Mechanical ventilation was initiated with 8 cc/kg tidal volume at a rate of 10 breaths per minute. Maintenance was achieved with isoflurane in air and oxygen. A 20-g right radial arterial catheter was placed and connected to a FloTrac sensor. Dynamic response testing was performed to assure optimal damping. Three attempts with ultrasound guidance were made at obtaining central venous access for volume therapy, medication therapy, and central venous pressure (CVP) measurement, but attempts to pass a wire into the superior vena cava were unsuccessful. Two 14-g peripheral IV catheters then were placed for volume therapy as needed, and stroke volume variation (SVV) via the FloTrac system was

considered as the primary preload dependence tool rather than measures of “volume status” via CVP. Surgery began at 7:47 AM. A baseline arterial blood gas at 9:26 AM demonstrated a base excess of 0.2 (Figure 1, point A, SVV 6-9). Shortly after 9:30 AM, 3 prolonged periods of massive hemorrhage occurred, which can be seen by immediate and significant increases in SVV above 13% indicating significant periods of volume loss and preload dependence (Figure 1, points B, D, and F). Each of these periods was met with volume therapy including crystalloids, colloids, and blood products as indicated by point-of-care testing. The appropriate volume was rapidly given until the SVV returned to a point (<13%) at which the patient was likely no longer volume-responsive (Figure 1, points C, E, G, and H). During the period of resuscitation, there was a significant base deficit as expected. However, once the hemorrhage stopped and the patient was made volume-replete (ie, no longer volumeresponsive [SVV <13%]), the base deficit rapidly improved. Neither presser nor bicarbonate therapy was administered. At 1:40 PM, the patient was admitted to the intensive care unit. He was intubated with no base deficit (base ≥1.5; Figure 2), stable BP and heart rate, and was extubated on postoperative day 1. It was obvious that the patient needed volume resuscitation. Tools, such as the FloTrac sensor, generally inform clinicians of when additional fluid administration is no longer warranted. Thus, the patient’s resuscitation, although dramatic, ended without a base deficit (Figure 2). Cases such as this highlight the relationship between intraoperative volume optimization and the central role it plays in assuring the adequacy of perfusion. 4 Generalized Normal High

2 0

A G

–2

Generalized Normal Low –4 –6 –8

Figure 1. Stroke volume variation (%) in magenta; cardiac output (L/min/m2) in yellow.

variations less than 13% are not responsive.11-14 It has been shown in mechanically ventilated operative patients that an SVV of 13% literally can divide operative patients into 2 groups: those who are likely and those who are unlikely to respond to a fluid challenge.15 The FloTrac system automatically provides measures of SVV every 20 seconds after connecting it to either a new or existing arterial catheter. Small-scale trials have demonstrated that the use of these dynamic indices in high-risk surgical patients decreases time on mechanical ventilation, time in the intensive care unit, and hospital LOS.16 Volume responsiveness as measured by

ANESTHESIOLOGY NEWS • OCTOBER 2011

Figure 2. Change in arterial blood gas base excess (mmol/L) during surgery.

SVV has not only been validated in the supine position, but also in the prone position,17 during neurosurgery,13 liver transplantation,15 cardiac surgery,18 and thoracic surgery.19 Additionally, when operative volume management is performed using SVV, not only do perfusion indicators such as lactate remain within normal limits, but morbidity and rehospitalization rates are decreased.20 Recently, the FloTrac system was used to deliver goal-directed therapy in spontaneously ventilating patients undergoing elective total hip arthroplasty. Although volume responsiveness could not be assessed by SVV as these patients were spontaneously

ventilating, volume therapy was administered until the stroke volume was optimized. Results from this pilot trial showed significant reductions in perioperative morbidity.21 Pinsky described a fundamental truth about hemodynamic monitoring and patient outcomes in the following way: Hemodynamic monitoring devices do not improve outcome unless paired with treatment protocols that are known to improve outcomes.22 The use of SVV and a monitoring tool such as the FloTrac system provides a practical and accurate method of individualizing and optimizing volume therapy and delivering goaldirected therapy to operative patients.

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Intraoperative fluid management is a component of patient care with occasional differing priorities between clinicians. The placement of a pulmonary artery catheter has the potential to comprehensively characterize cardiovascular function and guide fluid administration, but carries with it risk and cost. The FloTrac sensor along with the PreSep oximetry catheter (see Case Study 2, this page) provide information that may better characterize the cardiovascular physiology and guide patient management. The cardiac output (CO) derived from the arterial pressure waveform provides a continuous measurement of total blood flow. If CO is not adequate, the dynamic monitor of SVV provides a guide for potential therapeutic interventions. The cardiac index/CO and SVV measurements also provide clear demonstration of the patients who require inotropic support rather than additional fluids to optimize CO. With the growing body of evidence that perioperative goal-directed fluid management decreases the incidence of complications, the FloTrac sensor and PreSep oximetry catheter provide the common language for clinicians to coordinate and optimize patient management in the perioperative setting.

References 1. Cannesson M. Arterial pressure variation and goaldirected fluid therapy. J Cardiothorac Vasc Anesth. 2010;24(3):487-497. 2. Kehlet H, Bundgaard-Nielsen M. Goal-directed perioperative fluid management: why, when, and how? Anesthesiology. 2009;110(3):453-455. 3. Sinclair S, James S, Singer M. Intraoperative intravascular volume optimisation and length of hospital stay after repair of proximal femoral fracture: randomised controlled trial. BMJ. 1997;315(7113): 909-912. 4. Venn R, Steele A, Richardson P, Poloniecki J, Grounds M, Newman P. Randomized controlled trial to investigate influence of the fluid challenge on duration of hospital stay and perioperative morbidity in patients with hip fractures. Br J Anaesth. 2002;88(1):65-71. 5. Gan TJ, Soppitt A, Maroof M, et al. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002;97(4):820-826. 6. 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. 7. Shoemaker WC, Appel PL, Kram HB, Waxman K, Lee TS. Prospective trial of supranormal values of survivors as therapeutic goals in high-risk surgical patients. Chest. 1988;94(6):1176-1186. 8. Boyd O, Grounds RM, Bennett ED. A randomized clinical trial of the effect of deliberate perioperative increase of oxygen delivery on mortality in high-risk surgical patients. JAMA. 1993;270(22):2699-2707. 9. Rhodes A, Cecconi M, Hamilton M, et al. Goaldirected therapy in high-risk surgical patients: a 15-year follow-up study. Intensive Care Med. 2010;36(8):1327-1332. 10. Marik PE, Baram M, Vahid B. Does central venous pressure predict fluid responsiveness? A systematic review of the literature and the tale of seven mares. Chest. 2008;134(1):172-178. 11. Michard F. Changes in arterial pressure during mechanical ventilation. Anesthesiology. 2005;103(2): 419-428.

Case Study 2: A 73-Year-Old Man Scheduled for Spinal Decompression With Instrumentation

73-year-old man (weight, 80 kg; height, 182 cm) with symptomatic spinal stenosis was scheduled for a T12 to S1 decompression with instrumentation. Past surgical history included a total hip replacement at age 69 years and a 2-level lumbar laminectomy 4 years prior. His past medical history was notable for hypertension and coronary artery disease. At age 72, the patient had 2 drug-eluting stents placed (left anterior descending artery and circumflex). Preoperative medications included metoprolol extended release (25 mg twice daily), simvastatin (10 mg daily), clopidogrel (75 mg daily, discontinued 3 days prior), aspirin (325 mg daily), and olmesartan-hydrochlorthiazide (40 mg/12.5 mg daily). Additional preoperative evaluation included a transthoracic echo that demonstrated mild anterior wall hypokinesis and an ejection fraction of 40%. General anesthesia was initiated with midazolam (2 mg), fentanyl (2 mcg/kg), propofol (2 mg/kg), and rocuronium (0.5 mg/kg), and then maintained with oxygen/air/sevoflurane (1/1/0.8) and a dexmedetomidine infusion (0.007 mcg/kg per minute). A radial arterial catheter with a FloTrac sensor was placed to provide continuous cardiac output (CO) and dynamic monitors of cardiac function. The PreSep oximetry catheter was placed for intra- and postoperative monitoring of central venous oxygen saturation (ScvO2). Following induction, vital signs were recorded: heart rate 75, blood pressure (BP) 110/80 mm Hg, cardiac index (CI) 1.4 L/min/ m2, stroke volume index (SVI) 20 mL/m2, stroke volume variation (SVV) 13%, and ScvO2 63% (Table). Despite normal heart rate and BP, newer supplemental monitors of cardiovascular function demonstrated the CI was well below the minimum target of 2.4 L/min/m2. Extended periods of hypoperfusion may increase the incidence of perioperative complications. Therefore, the dynamic functional parameters, such as SVI and SVV, were used to guide and monitor interventions to improve the CO. As SVI was below

the normal range (35-45 mL), and SVV was outside my target range of less than 12%, the patient was given a bolus of 500 mL of 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection. The CI and ScvO2 both increased, but remained below the targets of 2.4 L/min/m2 and 70%, respectively. Because the SVV and SVI were now within target ranges, additional fluid was less likely to improve the cardiac function. Thus, an infusion of dopamine (4 mcg/kg per minute) was initiated. The measured parameters improved and remained within their target ranges until the cumulative estimated blood loss (EBL) approached 900 mL, when the SVV began to increase and the ScvO2 began to decrease (Table). The suspected anemia was confirmed with a measured hematocrit of 25. The patient received 2 units of packed red blood cells with an improvement again in all measured hemodynamic parameters. Following completion of the 7-hour procedure, the patient was extubated in the operating room. Continuous ScvO 2 monitoring with the PreSep catheter was continued during the immediate postoperative period as a monitor of both global perfusion and tissue oxygen supply in this patient, who was at increased risk for continued postoperative blood loss. The patient was weaned off dopamine shortly after arrival in the surgical ICU. The surgical wound drains continued to fill slowly with an additional EBL of 500 mL over the first 6 hours, but the ScvO2 remained greater than 70%. No further blood transfusions were required. The patient was transferred to the ward the following morning as drainage slowly ceased. The FloTrac sensor is useful as a guide for the perioperative management of patients with co-existing diseases and decreased margin for error. In this case, the PreSep oximetry catheter served as an early guide to the need for transfusion, and was then continued into the ICU for monitoring of a patient at risk for continued postoperative blood loss.

Table. Vital Signs During Surgery Event

Heart Rate

Blood Pressure Cardiac Index Stroke Volume Stroke Volume Central Venous (mm Hg) (L/min/m2) Index (mL/m2) Variation Oxygen Saturation

After induction

110/80

1.4

13%

63%

After fluids

125/80

2.1

65%

After dopamine

130/85

2.5

70%

After estimated blood loss, 900 mL

120/75

2.4

14%

60%

After transfusion

130/80

2.6

75%

12. Cannesson M, Musard H, Desebbe O, et al. The ability of stroke volume variations obtained with Vigileo/FloTrac system to monitor fluid responsiveness in mechanically ventilated patients. Anesth Analg. 2009;108(2):513-517.

16. Lopes MR, Oliveira MA, Pereira VO, Lemos IP, Auler JO Jr, Michard F. Goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery: a pilot randomized controlled trial. Crit Care. 2007;11(5):R100.

13. Berkenstadt H, Margalit N, Hadani M, et al. Stroke volume variation as a predictor of fluid responsiveness in patients undergoing brain surgery. Anesth Analg. 2001;92(4):984-989.

17. Biais M, Bernard O, Ha JC, Degryse C, Sztark F. Abilities of pulse pressure variations and stroke volume variations to predict fluid responsiveness in prone position during scoliosis surgery. Br J Anaesth. 2010;104(4):407-413.

14. Reuter DA, Kirchner A, Felbinger TW, et al. Usefulness of left ventricular stroke volume variation to assess fluid responsiveness in patients with reduced cardiac function. Crit Care Med. 2003;31(5):1399-1404. 15. Biais M, Nouette-Gaulain K, Cottenceau V, Revel P, Sztark F. Uncalibrated pulse contour-derived stroke volume variation predicts fluid responsiveness in mechanically ventilated patients undergoing liver transplantation. Br J Anaesth. 2008;101(6):761-768.

18. Reuter DA, Goepfert MS, Goresch T, Schmoeckel M, Kilger E, Goetz AE. Assessing fluid responsiveness during open chest conditions. Br J Anaesth. 2005;94(3):318-323. 19. Suehiro K, Okutani R. Stroke volume variation as a predictor of fluid responsiveness in patients undergoing one-lung ventilation. J Cardiothorac Vasc Anesth. 2010;24(5):772-775.

20. Benes J, Chytra I, Altmann P, et al. Intraoperative fluid optimization using stroke volume variation in high risk surgical patients: results of prospective randomized study. Crit Care. 2010;14(3):R118. 21. Cecconi M, Fasano N, Langiano N, et al. Goaldirected haemodynamic therapy during elective total hip arthroplasty under regional anaesthesia. Crit Care. 2011;15(3):R132. 22. Pinsky MR. Hemodynamic evaluation and monitoring in the ICU. Chest. 2007;132(6):2020-2029.

This 2-part series is sponsored and funded by Edwards Lifesciences. CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See Instructions for use for full prescribing information, including indications, contraindications, warnings, precautions, and adverse events.

ANESTHESIOLOGY NEWS â&#x20AC;˘ OCTOBER 2011

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Conclusion

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P OLI C Y & M A NAGEMENT 10

Partner continued from page 44

‘We’re spending an awful lot of money [on desflurane], but we’re not getting any benefit.’ —Eric L. Chernin, RPh

between the pre- and post-periods: $250.78 and $253.24, respectively.

Research findings demonstrate that pharmacists in the OR ‘can take a lead as the medication safety expert, whether officially or unofficially.’ —Tricia Meyer, MS, PharmD One year after the kits’ implementation, the team has no intention of slowing down the effort. Mr. Chappell suggested that they might even create more specialized kits; for example, kits for minor cases don’t need all the pieces included in the original. Asked to comment, Tricia Meyer, MS, PharmD, assistant professor of anesthesiology at the Texas A&M College of Medicine, in College Station, said the Methodist Dallas Medical Center findings demonstrate that pharmacists in the OR “can take a lead as medication safety experts, whether officially or unofficially.” Dr. Meyer suggested that pharmacists also can promote medication safety by preparing IV medication kits to be used after hours, complete with admixture instructions, IV bag, labels and filter needles, as well as by placing a bulletin board outside of the OR pharmacy with current information on drugs, dosing charts for pediatric dosages, drug shortage updates and information on black box warnings.

Rate of Discrepancies, %

So Mr. Chappell and his pharmacy colleagues decided to collaborate with the center’s anesthesiology and surgery departments to create a universal kit that would cover 95% of their surgery patients. Inside were various dosages of fentanyl, hydromorphone, midazolam and morphine. “We put everything in one place,” said Mr. Chappell, lead researcher (poster 3-M), noting that anesthesia providers, pharmacists and pharmacy technicians each had clear responsibilities. “The kits would come back to us from the provider along with the anesthesia record,” he added, “so pharmacists could look at them and see what they used, what they put on the record and then reconcile any waste.” Technicians would then validate and refill the kits’ contents. The team analyzed billing and financial data from two months before and after the kits were implemented in June 2010. Sure enough, they found that medication tracking became much more accurate with the introduction of the kits. The rate of discrepancies dropped from 6.8% during week 1 to 2.7% at week 13 (Figure). Mr. Chappell’s team linked most of the discrepancies to drug waste procedures, such as the mislabeling of waste syringes or lack of documentation. Total medication charges for both inpatient and outpatient anesthesia, however, remained similar

6.8 6

4 2.7 2

Week 1

Week 13

Figure. Anesthesia medication discrepancies, pre- and post-implementation.

bariatric surgery and using one of two available desflurane vaporizers, until anesthesiologists began a push to turn rooms over faster and lobbied to use the more expensive agent. They argued that the recovery characteristics of desflurane would indeed hasten room turnovers, and desflurane vaporizers were subsequently placed in every OR suite. Mr. Chernin and his colleagues responded by conducting a retrospective review to determine if the agent sped up emergence time from general anesthesia and improved overall efficiency of the OR. After reviewing 100 charts in both September 2009 and September 2010—matching the surgeon, procedure and agents whenever possible—preliminary results suggested that there was no clinically significant difference in emergence times between the two inhaled anesthetics. The finding remained even after analyzing differences in emergence times and differences in surgical procedure duration. Mr. Chernin questioned whether the switch to desflurane was worthwhile. “We’re spending an awful lot of money, but we’re not getting any benefit,” he said. “A couple of minutes here or there are meaningless. You can’t capture those minutes from a financial perspective. You’re not going to do an extra case in that room that day or send recovery personnel home early.” Still, he noted that there are some patients, such as those who have a bad airway or need to be awakened and recover reflexes as quickly as possible, for which the pricier anesthetic might make sense. “But it doesn’t pay to use it exclusively in this setting.” Dr. Meyer said the poster “is a solid example of how operating room pharmacists can play a pivotal role in the evaluation of drugs used in the OR through collaboration with anesthesiologists.”

Is Pricier Always Better? Inhaled anesthetic agents also contribute significantly to the overall cost and safety of anesthesia, each differing to some degree in their potency, minimum alveolar concentration, lipid solubility, induction characteristics and recovery time. Two of the newest agents, desflurane (Suprane, Baxter) and sevoflurane, are prized for their low solubility and, therefore, more rapid recovery time compared with older inhaled anesthetics, such as isoflurane. Due to its particularly low solubility, some anesthesiologists suggested that desflurane could nudge out sevoflurane in effectiveness. However, it also costs significantly more: $19.61 per minimal alveolar concentration (MAC) hour compared with $5.76. “If this rapid recovery allows for the completion of additional surgical cases by decreasing operating suite turnover time, or reduction in personnel overtime expenses, then it could yield a cost savings,” said Eric L. Chernin, RPh, pharmaceutical care specialist in OR pharmacy at Sarasota —Lynne Peeples Memorial Hospital, in Florida. Sarasota Memorial used both agents, with Dr. Meyer, Mr. Chappell and Mr. Chernin reported no relevant condesflurane limited to patients undergoing flicts of interest.

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T ec h nol o g y

Clinical Engineers Expand Role in Anesthesia Settings

linical engineers are taking on broader functions in anesthesiology departments by vetting equipment purchases, training users, integrating biomedical devices and improving patient safety—areas that are beyond their usual duties of inspecting, maintaining and repairing. Increasingly, clinical engineering (CE) departments are reporting to a chief information officer or information technology (IT) director rather than to the facilities department. However, according to the Emergency Care Research Institute (ECRI), many CE teams may not have mastered yet the new skills required for their expanded collaborative roles. Whether in the surgical environment or participating on capital planning committees, anesthesiologists can expect the role of CE to grow. At Inova Health System, in Falls Church, Va., a team of four clinical engineers serving five hospitals appears to have earned the confidence of senior management. “Any technology to be

bought has to come through CE. This can be more difficult with anesthesia because one machine doesn’t suit all kinds of patients,” said Joe Fernandes, a clinical engineer on the team. CE Vets Anesthesia Machine Purchases At Inova, the anesthesia committee states the function and performance it seeks in new technology; CE helps separate the nice to have from the must have, and narrows choices using several outside sources: equipment test reports from ECRI; insights from hospitals (sometimes coupled with site visits) already using vendors and medical devices under consideration; discount information from MedAssets, a group purchasing organization; and the FDA’s Web site Manufacturer and User Facility Device Experience (MAUDE) (http://www.accessdata. fda.gov/scripts/cdrh/cfdocs/cfmaude/ search.cfm) to explore adverse-event histories of medical devices of interest. The CE team then typically requests

a month-long trial of a machine being considered so that physicians can evaluate it. “Doctors make the choice, but they look to us for guidance,” Mr. Fernandes said. Inova’s financial committee also must approve the purchases.

being used elsewhere and learn from those experiences. They also know the patient safety issues with each device, and how easy or hard each is to maintain.”

Maintaining, Training And Negotiating With Vendors: CE Roles ‘It’s often better to have Manufacturer service contracts might be the most expensive way to in-house engineers trained maintain equipment, Mr. Maliff said, speaking with Anesthesiology News by manufacturers, so recently after ECRI issued a white paper entitled “I’m Going To Ignore you can end or reduce Clinical Engineering Until … Not in My Hospital!” “It’s often betservice contracts.’ ter,” he said, “to have in-house engineers trained by manufacturers, so —Rob Maliff you can end or reduce service contracts.” He added that in hospitals Clinical engineers and biomedi- with a CE staff dedicated to the opercal technicians helping to select and ating room, an immediate response is analyze anesthesia equipment is a possible when issues of life and safety best practice, according to Rob Mal- arise. Also, compared with the saviff, director of the applied solutions ings promised by third-party providers, see engineers page 48 group at ECRI. “They know what’s

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Dräger

AnesthesiologyNews.com I 47

The following advertorial is provided as a service to our valued advertisers. It is designed to support the advertisement presented below.

Innovian® Anesthesia, From Dräger Q: What is Innovian® Anesthesia? A: Innovian Anesthesia is Dräger’s next-generation anesthesia information management system. It’s designed to optimize and address the specific challenges of the perioperative process, from preop to intra-op and post-op/recovery, while simultaneously increasing throughput, accuracy and completeness, to help you sustain a distinct competitive advantage. Innovian Anesthesia provides a comprehensive overview of a patient’s medical story, enabling patient-centric care; improved staff and patient satisfaction; and the ability to track, measure and manage outcomes intended to improve clinical and financial benefits.

dependent on them to remain in operation. During adverse events such as hospital information system and clinical network shutdowns, Innovian Anesthesia will continue to capture and record crucial clinical information that could take months to recover if missed. Innovian’s fault tolerance capability enables it to run while disconnected from the network and still allow a user to complete a case. All clinical data captured while disconnected is replicated to the central database once a network connection is reestablished.

Q: How can Innovian Anesthesia 4.0 enhance your information management process? A: Innovian Anesthesia 4.0 supports the use of bar-code scanners to simplify the patient identification and verification process. It’s one way the system supports the “right patient, right procedure” patient information management process. Our new Innovian Anesthesia E-Forms is a clinical information platform which facilitates the capture and flow of essential anesthesia information

across the perioperative environment. Its intuitive, Web-based user interface effectively supports the capture of admission and preoperative assessment information from remote locations such as pre-admission testing facilities, preoperative holding areas and inpatient care units. E-Forms’ versatile platform also allows it to be conveniently configured to support documentation of other processes along the anesthesia care path.

Q: How does Innovian Anesthesia impact your workload and that of your staff? A: Generating and managing paper-based records is time-consuming and inefficient. They are also subject to human error such as missed—or misread—information. Innovian Anesthesia supports the automated capture of vital signs data, thereby reducing staff workload and freeing time for increased patient vigilance and direct patient care. Innovian Anesthesia provides user-definable alerts and reminders to help care providers complete their records quickly and more completely.

Hitting the spotlight in October . . .

Q: Can Innovian Anesthesia be customized to fit any practice? A: Flexibility is key to workflow support. Although anesthesia providers across the country have similar core workflows and data capture requirements, there are important variations in what, where and how information needs to be entered, tracked and acted on. Innovian Anesthesia’s configurable tools allow anesthesia providers to tailor Innovian Anesthesia to meet their specific practice—from an enterprise, workstation or user level, which means faster clinical adoption and long-term satisfaction.

Q: What types of institutions have implemented Innovian Anesthesia? A: Innovian Anesthesia has a proven track record of successful implementations across a wide variety of hospitals—from large, multicampus academic medical centers to community hospitals. In 2009, the Assistant Secretary of Defense for Health Affairs announced the Innovian Anesthesia platform as the Department of Defense’s (DoD) solution of choice.

Q: Are commercial customers able to take advantage of the DoD data security enhancements? A: Yes. Innovian Anesthesia’s latest release allows all users to take advantage of our implementation of the FIPS (Federal Information Processing Standard) 140-2 U.S. government security standard.

Innovian Anesthesia 4.0 ®

Taking anesthesia information management to the next level

Q: How does Innovian Anesthesia’s fault-tolerant design protect data?

For more than a quarter of a century, clinicians have trusted Dräger for complete, accurate, automated charting of patient vitals and anesthesia data. Today, Innovian® Anesthesia has proven success with more than 130 hospitals and 3,000 users worldwide. Stop by our booth at ASA in Chicago to check out how our newly released Innovian Anesthesia 4.0 makes it even easier to capture all the information you need at the point of care.

A: Although Innovian Anesthesia routinely communicates with servers, it’s not completely

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4 8 I A n e s t h e s i o l o g y N e w s . c o m Octo b e r 2 0 1 1

T ec h nol o g y machines with automatically populated fields “so doctors can see everything in one place,” Mr. Fernandes said. Anesthesiology is “a step ahead of other clinical services in reporting because of integrated anesthesia and data management systems already in use,” Mr. Maliff said. “But, what happens to that anesthesia data? If hospitals want the data to automatically populate an electronic health record, clinical engineers can help make this happen.” He said ideally CE and

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Engineers continued from page 46 “in-house engineers will often go the extra mile aiming to maximize patient safety, equipment up-time and clinician satisfaction.” By mid-2012, Inova plans to begin repairing anesthesia machines in-house, after 15 years with a service vendor that offered group pricing to the health system’s five hospitals. “We constantly re-evaluate,” Mr. Fernandes said. “We’ll have to hire more technicians, including two or three just for anesthesia machines, and do preventive maintenance during nighttime hours. But, we think the cost equation will now work in our favor.” Inova’s flagship hospital in Fairfax, Va., has 75 anesthesia machines and 135 users, including anesthesiologists and nurse anesthetists who required training. Mr. Fernandes said the CE team tells vendors during negotiations to “train us [clinical engineers and biomedical technicians] and we’ll make your equipment look good by training everyone else.” The CE team is able to negotiate the cost and amount of training received, and whether the vendor will train on-site. Integrating Medical Devices The federal push for electronic health records is one motivator behind Inova’s plan to acquire the Epic electronic medical records system (Epic Systems Corporation). The health system plans to integrate all medical devices—including real-time data recordings of surgeries and anesthesia

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e-Newsletters and e-Alerts Get the latest news from the best-read anesthesiology publication in the country delivered directly to your computer or mobile device for free!

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IT work together to integrate medical devices. As the ECRI white paper stated, “With today’s new patient safety imperatives, the Joint Commission’s updated guidelines on the ‘environment of care,’ greater scrutiny of services and pressure to find cost savings where possible, it is important to involve CE in discussions and decisions that affect the use of technology.”

onmed.com mah c m @

5 0 I A n e s t h e s i o l o g y N e w s . c o m Octo b e r 2 0 1 1

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Tablet Devices Get Thumbs-up From Anesthesia Residents New York—This past July, 100 anesthesiology residents and fellows at Mount Sinai School of Medicine switched from paper to plastic. That is, the department’s administrators reallocated the textbook allowance given to their residents and fellows and purchased Apple iPads instead. Adam Levine, MD, director of the anesthesiology residency training

program at Mount Sinai, initially pitched the idea to the chair of the anesthesiology department. “It took exactly two seconds” to win administration approval for the concept, he said. The switch, which cost the department $700 per iPad, including a protective cover and additional warranty, means the department has “gone green.”

More importantly, Dr. Levine said, residents can now access electronic medical records and an entire library of e-textbooks, medical journals and guidelines at the point of care. “This one device has multiple functions at every stage of the perioperative process, and it’s something residents can use both for their education and for patient care,” he told Anesthesiology News.

Daniel Katz, MD, anesthesiology resident at Mount Sinai, said he uses the iPad to read through textbooks and guidelines during breaks and at lunch, and as a reference tool in the operating room. He also said the iPad has helped

http://video.webcasts.com/events/apce001/39551 There are no prerequisites

Current and Emerging Therapies in Chronic Pain This fall, join national experts in chronic pain management for a series of live, complimentary, interactive webinars

Supported by educational grants from Covidien, Millennium Laboratories, and Pfizer Presented by the Johns Hopkins School of Medicine, in collaboration with Applied Clinical Education

Course Director Michael R. Clark, MD, MPH, MBA Associate Professor and Director Chronic Pain Treatment Programs Department of Psychiatry and Behavioral Sciences The Johns Hopkins Medical Institutions Baltimore, Maryland

Statement of Need Four key areas in which clinicians have significant knowledge gaps are: • The knowledge of pain mechanisms and of the mechanisms of action of therapies • Recently approved therapies for chronic pain • Recently published or revised chronic pain treatment guidelines • Novel pain therapies in late-stage development that may be available soon

Schedule

All Sessions 2:00

Faculty Presenter Charles E. Argoff, MD

Professor of Neurology Albany Medical College Director, Comprehensive Pain Center Albany Medical Center Albany, New York

Sponsorship Statement Presented by the Johns Hopkins University School of Medicine

Statement of Responsibility The Johns Hopkins University School of Medicine takes responsibility for the content, quality, and scientific integrity of this CME activity.

Intended Audiences Primary care physicians, physician pain specialists, neurologists, and other health care professionals with an interest in improving their professional skills relative to the treatment and management of chronic pain. The audience also may include nurses, nurse practitioners, physician assistants, and pharmacists.

Accreditation Statement The Johns Hopkins University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Credit Designation Statement The Johns Hopkins University School of Medicine designates this live activity for a maximum of 7 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Policy on Faculty and Provider Disclosure It is the policy of the Johns Hopkins University School of Medicine that the faculty and provider disclose real or apparent conflicts of interest relating to the topics of this educational activity, and also disclose discussions of unlabeled/ unapproved uses of drugs or devices during their presentations. The Johns Hopkins University School of Medicine Office of Continuing Medical Education has established policies in place that will identify and resolve all conflicts of interest prior to this educational activity. Detailed disclosure will be made in the course handout materials.

- 3:00

EST

Article

Multimodal Analgesia for Chronic Pain: Rationale and Future Directions

Figure 1. Andrew Schwartz, MD, searched the literature for recent articles and practice advisories about a rare condition in one of his patients.

Argoff CE, Albrecht P, Irving G, Rice F. Pain Med. 2009;10(suppl 2):S53-S66.

October 12, 2011 • Psychosocial comorbidities Faculty Presenter Dennis Turk, PhD

John and Emma Bonica Professor of Anesthesiology and Pain Research University of Washington School of Medicine Seattle, Washington

Article

Assessment and Treatment of Psychosocial Comorbidities in Patients With Neuropathic Pain Turk DC, Audette J, Levy RM, et al. Mayo Clin Proc. 2010;85(3 suppl):S42-S50.

October 19, 2011 • Pain management in older patients Faculty Presenter Perry G. Fine, MD

Professor of Anesthesiology University of Utah School of Medicine Salt Lake City, Utah

Learning Objectives After completing this activity, the participant will demonstrate the ability to: • Elucidate the pathophysiology of chronic pain and how treatment approaches can target chronic pain appropriately by mechanism of action. • Review currently available therapies, particularly recently approved treatments, for common chronic pain conditions (eg, rheumatologic disorders such as osteoarthritis and other musculoskeletal conditions; neuropathic pain and fibromyalgia; chronic low back pain; and chronic pain associated with other medical conditions). • Apply recommendations from recent evidence-based guidelines to inform the treatment of chronic pain. • Describe emerging therapies for chronic pain that are in late-stage development.

October 5, 2011 • Multimodal therapy

Article

Pharmacological Management of Persistent Pain in Older Persons: American Geriatrics Society Panel on the Pharmacological Management of Persistent Pain in Older Persons Ferrell B, Argoff CE, Epplin J, et al. Pain Med. 2009;10(6):1062-1083.

October 26, 2011 • Interventional therapies Faculty Presenter Richard Rosenquist, MD

Clinical Professor Director, Center for Pain Medicine and Regional Anesthesia University of Iowa Carver College of Medicine Iowa City, Iowa

Article

Interventional Therapies, Surgery, and Interdisciplinary Rehabilitation for Low Back Pain: An Evidence-Based Clinical Practice Guideline From the American Pain Society Chou R, Loeser JD, Owens DK, et al. Spine (Phila Pa 1976). 2009;34(10):1066-1077.

November 2, 2011 • Topical analgesics Faculty Presenter Roy D. Altman, MD

Professor of Medicine David Geffen School of Medicine University of California, Los Angeles Los Angeles, California

Article

Topical therapies for osteoarthritis. Altman RD, Barthel HR. Drugs. 2011;71(10): 1259-1279.

November 9, 2011 • Neuropathic pain Faculty Presenter Vera Bril, MD

Professor of Medicine Department of Neurology University Health Network Toronto General Hospital Toronto, Ontario, Canada

Article

Evidence-Based Guideline: Treatment of Painful Diabetic Neuropathy Bril V, England J, Franklin GM, et al. Neurology. 2011;76(20):1758-1765.

November 16, 2011 • Opioid therapy Faculty Presenter David A. Fishbain, MD

Professor, Department of Psychiatry & Behavioral Sciences Adjunct Professor, Neurological Surgery and Anesthesiology Miller School of Medicine Miami, Florida

Article Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain. Chou R, Fanciullo GJ, Fine RG, et al. J Pain. 2009; 10(2):113-130.

Figure 2. Lucas Bejar, MD, discussed cardiac physiology and hemodynamics with fellow residents, Ralph DiLisio, MD, Natalie Barnett, MD, and Cindy Wang, MD.

him make better-informed decisions at the patient’s bedside. “Accessing electronic medical records at the point of care is a step up from reading paper records, which can be unintelligible or have missing information,” he said. The iPad also has enhanced information flow within the hospital,

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Tec h no l o g y Dr. Levine said. For example, one resident volunteered to post video summaries of the department’s morning conferences on the hospital’s intranet that students can access through their iPads. Residents also can conduct a video conference with their attendings anywhere in the hospital, between iPads or from an iPad to an iPhone (Apple Inc.). “If they also have an iPad or iPhone, faculty can look into an operating room via video and see what’s happening in another clinical environment,” Dr. Levine said. “If a picture is worth a thousand words, one can only imagine the value of live video, which allows you to provide remote feedback on a real-time event.” Whereas Mount Sinai has the first anesthesia department that Dr. Levine knows of that uses the tablet technology on such a scale, a similar project for internal medicine residents was spearheaded at the University of Chicago Medical Center. Bhakti Patel, MD, a fellow in the Section of Pulmonary Critical Care, coordinated the distribution of 115 iPads to the residents in August 2010. Dr. Patel said being able to access medical records, radiology reports and images, and to place electronic orders directly at the patient’s bedside substantially increased the residents’ efficiency. “We surveyed our residents to find out how much time the devices were saving them,” she said. “They said they had added about an hour a day by not having to search for an available desktop or laptop [computer].” C. Peter Waegemann, president of mHealth Initiative, in Boston, an organization that examines how technology is adopted in the health care setting,

said the switch to iPads is a growing trend. “I’m hearing from more and more hospitals and clinics that they’re beginning to use iPads—sometimes in the hundreds, sometimes in the thousands,” Mr. Waegemann told Anesthesiology News. “This is going to become a major tool in medicine and something that also can be tremendously helpful to residents.” Although he could not gauge the number of anesthesia-specific applications that are available, Mr. Waegemann

said there are currently 5,000 to 7,000 health care–related iPad applications and hundreds more are being released every month. “Tablets are here to stay,” he said. The clinical and pedagogic applications of the device are limited only by the amount of time residents and faculty are willing to devote to creating new uses for it, according to Dr. Katz. “One of my peers is developing an application that tracks resource usage, so that at the end of the day when there’s a real

crunch, we can see in real time which rooms are available,” he said. Dr. Katz and his fellow residents also are working on assembling a video library of expert-conducted anesthesia procedures, as well as a procedure simulator specifically designed for the unique attributes and features of the iPad. “The only real issue with the iPad is that it’s one more thing we have to keep track of in the operating room,” Dr. Katz said. “But it’s well worth it.” —David Wild

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C LIN I C A L A N ESTHESI O LO GY

Catheter-related Bloodstream Infections Cybele L. Abad, MD

Nasia Safdar, MD, PhD

Section of Infectious Diseases University of Wisconsin Madison, Wisconsin

Assistant Professor Section of Infectious Diseases Department of Medicine University of Wisconsin Madison, Wisconsin

ealth care–associated infections (HAIs)

are an important cause of morbidity and mortality and place a significant economic

burden on the health care system.1-3 An estimated

1.7 million HAIs (4.5 infections per 100 hospital admissions) occurred in the United States in 2002, resulting in nearly 100,000 deaths.4

Catheter-related bloodstream infections (CRBSIs), most of which are associated with central venous catheters (CVCs), account for 11% CMS mandated that hospitals report of all HAIs.4-6 Agencies such as the CRBSI rates through the NHSN. This National Healthcare Safety Network new CMS regulation makes CRBSI (NHSN; formerly the National Nos- reporting a national requirement to ocomial Infections Surveillance Sys- receive full Medicare inpatient paytem) of the Centers for Disease ments; facilities that fail to report Control and Prevention (CDC) were will not receive the annual 2% Mediformed in response to the growing care payment increase. Intravascular catheters play a awareness that HAIs are urgent public health and patient safety issues.1 central role in the care of critiThe recent action plan proposed cally and chronically ill patients; by the Department of Health and an estimated 5 million CVCs are Human Services identified CRBSIs as inserted in patients each year. However, more than 250,000 central a priority area for prevention.7 In 2002, the National Quality line–associated bloodstream infecForum created and endorsed a list tions (CLABSIs) also occur annuof Serious Reportable Events (SREs) ally, with an estimated mortality to increase public accountability and rate of 12% to 25%.3 A recent metaconsumer access to critical infor- analysis of patients in the intensive mation about health care perfor- care unit (ICU) found that mortality mance. These SREs soon became rates were significantly higher when known as “never events.” Follow- a CRBSI occurred (random effects ing this lead, in 2007 the Centers for model: odds ratio [OR], 1.96; 95% Medicare & Medicaid Services (CMS) confidence interval [CI], 1.25-3.09).9 declared it would no longer reim- Each episode significantly increases burse HAIs such as CRBSIs, increas- hospital length of stay, with addiing the urgency for rational and tional health care costs ranging from effective prevention and treatment $4,000 to $56,000 per episode.6,10,11 strategies to reduce the morbid- The NHSN has published surveility, mortality, and costs associated lance criteria for defining CRBSIs. with them.8 The policy, which went The criteria for patients older than 1 into effect in late 2008, was created year of age are the following: isolato help improve the care of patients tion of a recognized pathogen from by incentivizing hospitals to prevent blood culture(s), the presence of serious hospital-associated adverse clinical signs of sepsis and/or shock events. Beginning in January 2011, (eg, fever, chills, or hypotension), a

determination that the infection is A large prospective surveillance not from other sources, and confir- study using data from SCOPE (Surmation that the organism is not a veillance and Control of Pathogens contaminant.1 of Epidemiological Importance) that Intravascular devices (IVDs) included 24,179 cases of CRBSIs include peripheral vascular cathe- from a 7-year period at 49 hospitals ters (venous and arterial), pulmonary found that the rates of MRSA isolates artery catheters, midline catheters, increased from 22% in 1995 to 57% peripherally inserted central cath- in 2001 (P<0.001). Rates of ceftazieters (PICCs), and various CVCs, dime-resistant Pseudomonas aerugiincluding tunneled(usually long-term nosa isolates increased from 12% in devices) and nontunneled catheters 1995 to 29% in 2001 (P<0.001), and (percutaneously placed CVCs com- 60% of isolates contained vancomymonly used in ICUs).3,5,6,12 This review cin-resistant Enterococcus faecium.15 covers the pathogenesis, microbiology, and treatment of CRBSIs, high- Pathogenesis lighting advances in the areas of The pathogenesis of CRBSIs can prevention and government policy. be attributed to 2 primary causes: bacterial colonization of the device Microbiology and contamination of the fluid Antimicrobial resistance, now con- being administered.16 Contamisidered a global crisis, continues to nated infusate leads to the majorloom large, and the organisms that ity of epidemic IVD-related BSIs, cause CRBSIs are no exception. In but it is rare.16,17 Colonization of the the past 2 decades, the propor- device may be either extraluminal tion of CRBSIs caused by antimi- (from surrounding skin or hematogcrobial-resistant organisms, such as enous seeding of the catheter tip) or methicillin-resistant Staphylococcus intraluminal (caused by an organism aureus (MRSA), multidrug-resistant adhering to the device followed by gram-negative bacilli, and fluco- the creation of a biofilm, a process nazole-resistant Candida species, responsible for persistent infections has been increasing at an alarming and hematogenous spread).3,16,17 In rate.3,13-15 Overall, the organisms most short-term devices, the extralumifrequently responsible for nosoco- nal route is more frequent, whereas mial CLABSIs are coagulase-nega- the intraluminal route is more comtive staphylococci (CoNS) (31%), mon in long-term devices (≥10 days) S. aureus (20%), enterococci (9%), or short-term devices left in longer Escherichia coli (6%), Klebsiella spe- than 4 to 7 days.16,18 cies (5%), and Candida species (9%). see BSI page 54

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C LIN I C A L A N ESTHESI O LO GY BSI continued from page 52

Table 1. Diagnosis of CRBSIs

Diagnosis

Methods requiring CVC removal

Methods not requiring CVC removal

Diagnostic Method

The clinical diagnosis of CRBSIs is difficult because both the sensitivity for clinical signs of inflammation at the catheter site and the specificity for signs of systemic infection are low.19,20 Blood culture specimens from the catheter should be drawn from all available lumens to avoid missed infections. In a recent retrospective analysis of CRBSIs at a single institution, 27.2% would have been missed if only one lumen of the double-lumen catheter had been sampled.21 A number of techniques for the diagnosis of CRBSIs have been studied, including catheter-sparing and non–catheter-sparing methods (Table 1). A recent meta-analysis found that paired quantitative blood cultures were the most accurate diagnostic test, followed by quantitative blood cultures through the CVC and quantitative or semiquantitative catheter segment cultures.22 Paired quantitative blood cultures are labor-intensive and cost almost twice as much as standard blood cultures. The widespread availability of radiometric blood culture systems (eg, BACTEC, Becton Dickinson)— in which blood cultures are continuously monitored for microbial growth (approximately every 20 minutes)— has led to their use in detecting CRBSIs.23 The differential time to positivity (the detection of positivity in a culture of blood drawn from an IVD 2 hours or more before the detection of

Description

Qualitative blood cul- One or more blood cultures ture through device drawn through CVC

Criteria for Positivity

Sensitivity, %

Specificity, %

Any growth

Quantitative blood culture through device

Blood culture drawn through CVC, processed by pour-plate methods or a lysis-centrifugation technique

≥100 CFU/mL

Paired quantitative blood cultures

Simultaneous cultures drawn through CVC and percutaneously

Both cultures positive with CVC culture yielding 5-fold higher or more than peripherally drawn culture

Differential time to positivity

Simultaneous blood cultures drawn through CVC and percutaneously, and monitored continuously

Both cultures positive with CVC positive ≥2 h earlierthan peripherally drawn culture

Qualitative catheter segment culture

Segment from removed CVC is Any growth immersed in broth media and incubated for 24-72 h

Semiquantitative catheter segment culture

A 5-cm segment from removed CVC is rolled 4 times across a blood agar plate and incubated

≥15 CFU

Quantitative catheter segment culture

Segment from removed CVC is flushed or sonicated with broth, serially diluted, plated on blood agar, and incubated

≥1,000 CFU

CFU, colony-forming units; CRBSI, catheter-related bloodstream infection; CVC, central venous catheter Adapted from reference 22.

Management

causative agents in accordance with The management of CRBSIs relies published guidelines and resources.19 on 2 major clinical decisions: 1) the The decision to remove the cathappropriate and timely administra- eter is based on the type of cathetion of systemic antimicrobial treat- ter being used and the organism in ment (SAT) and 2) catheter removal question. This decision becomes or catheter salvage treatment. SAT more complex when specific patient should be selected based on the characteristics are considered, such suspected or proven presence of as the type of device required (tunneled or implanted) and the ease of venous access. Guidelines from the Infectious Diseases Society of America (IDSA) recommend the removal of nontunneled catheters in all complicated infections (eg, thrombosis, endocarditis, osteomyelitis) and in all infections caused by S. aureus, gram-negative bacilli, Enterococcus species, and Candida species. The catheter may be retained with CoNS if systemic antibiotics are given in conjunction with antibiotic lock therapy (ALT).19 In CRBSIs associated 9001:2008 with tunneled or implantable devices, the catheters also require removal for any complicated infections (eg, thrombosis, endocarditis, osteomyelitis), tunnel or pocket infections and port abscesses, and all infections caused by S. aureus and Candida species. According to the recent guidelines, catheter salvage regimens—including For information call 800-717-5955 see BSI page 56 www.gas-worldwide.us lynneﬁsher@gas-worldwide.us

positivity in a cultureof blood drawn simultaneously from a peripheral site) was an accurate predictor for CRBSIs in studies of short- and longterm devices.12,23-25 Newer diagnostic techniques, including acridine orange leucocyte cytospin and endoluminal brush, are currently being investigated and have shown promise.12,26-30

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Improving Needle Image Quality By: Ralf Gebhard, MD, professor of anesthesiology, associate professor of orthopedics and rehabilitation; director, Division of RA and Acute Perioperative Pain Management, University of Miami Miller School of Medicine, Miami, Florida

Q: What are the applications of echogenic needles and who will benefit?

hands-on repetition. This may be the major reason why many “experts” in the field do not rely on echogenic needles or US needle enhancements.

A: A common misconception is that echogenic needles help facilitate shortcuts to learning and applying the fundamental principles of ultrasound (US) and anatomy. Setting the right expectations and use scenarios is critical. First, there is very little to no difference in needle visibility between echogenic and nonechogenic needles at shallow angles, where the vast majority of US-guided blocks are performed. Femoral, axillary and interscalene blocks illustrate this. Second, echogenic needles only really help the clinician when they are fully in plane to help differentiate the tip from the rest of the needle. There is no substitute for hand–eye coordination and maintaining the needle within the 1-mm US beam. There are, however, block applications and user groups that may benefit. Visualizing the needle tip at steeper angles can be more of a challenge for novices and new residents. In this case, echogenic needles may have a more useful role in blocks such as sciatic and infraclavicular or in patients with a higher body mass index. In addition, echogenic needles can help improve hand–eye coordination during training on a phantom. Ultimately, needle choice is determined by personal preference, the type of US machine employed, skill level, needle cost and whether echogenic needles impact critical success factors like block time, safety and success rates.

Q: What characteristics are important to consider before choosing an echogenic needle?

Q: What other techniques or technologies help improve needle visibility? A: A simple acronym, PART, can help improve scanning technique. Push. Is your needle in-plane, but you can’t see it well because of a steep angle between the transducer and needle? Pushing or rocking the heel or toe of the transducer can help reduce the angle. Alignment. Have you lost the needle? Sliding the transducer from side to side parallel to the needle is the easiest way to relocate it. Rotation. Are you really looking at the needle tip? Rotating the probe left and right very slightly can help determine whether the whole needle shaft and tip are in alignment. Tilt. Want to refine the needle image or scan anatomy in proximity to the needle without moving the probe off the patient? Once the needle is located, tilting the probe from side to side can help scan additional anatomy without moving the needle. New technologies and software algorithms from US manufacturers also help to improve needle visualization. When all is said and done, there is no substitute for knowledge of applied anatomy, US physics and

A: Clinicians who begin performing US-guided regional anesthesia often perceive needle brightness to be of paramount importance. However, needle clarity and crispness may be equally—if not more—important because of an important safety trade-off. The brighter or more “effective” it is at bouncing the US beam, the greater the impact on acoustic shadowing under the needle. Acoustic shadowing occurs when an object returns the vast majority of the US beam, effectively allowing nothing to pass underneath. This phenomenon may hide or inhibit important

Under the microscope.1 Echogenic pattern under coating helps reduce impact on feel.

E BL A AIL OW V A N

structures under the needle during advancement. Needle feel and resistance also are of primary concern. Clinicians rely on a consistent tactile feel when traversing facial planes. A repeatable, perceived “pop” helps verify advancement through a plane on the US screen. This is critical to putting the anesthetic in the right place and having a successful block. Although the debate continues, most clinicians also believe that blunt-tip, 30-degree bevels may help reduce the probability of accidental intraneural advancement.

Under ultrasound.2 Echogenic pattern produces clear, crisp image with reduced artifacts and acoustic shadowing.

Stimuplex® Ultra. Echogenicity without Compromise. Improved visibility without negatively impacting tactile feel and acoustic needle shadowing. Same tactile feedback, needle feel and overall handling as B. Braun’s clinically-proven3 Stimuplex A needle. Reduced acoustic shadowing and artifacts under the needle may facilitate safer needle advancement during Supraclavicular and Popliteal nerve blocks. 30 degree, short bevel. Most experts agree that short bevel needles (30-45°) carry less risk of causing nerve injuries during PNB than sharp needles with longer beveled tips.4

Visit us at ASA booth #2007 in Chicago October 15-17, 2011 to see & feel the difference for yourself. 1. Microscope image at 25x from Uni of Hanover, Stimuplex Ultra 22G. 2. Stimuplex Ultra 22G, animal model, 45 degrees. 3. A. Sardesai, N. Denny., M. Herrick, A. Lynch, A. W. HarropGriffiths, “A study of the characteristics of single-injection insulated block needles in a biologic model.” RAPM Vol. 29 No. 5, (Sept- Oct, 2004.) 4. Admir Hadzic, Peripheral Nerve Blocks: Principles and practices. 2004. The McGraw-Hill Companies Inc.

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C LIN I C A L A N ESTHESI O LO GY BSI continued from page 54 the use of ALT—may be attempted when necessary for infections caused by organisms other than S. aureus, fungi, P. aeruginosa, Bacillus species, Micrococcus species, propionibacteria, and mycobacteria.19 Although device-sparing regimens with longer treatment durations and using antibiotic lock solutions have been attempted for uncomplicated S. aureus, gram-negative bacilli, and

even fungal pathogens, the data supporting its efficacy are scant— we do not recommend catheter salvage for S. aureus and other virulent organisms.12,19,31-42 The duration of therapy varies based on the organism and whether or not the device has been removed. Systemic therapy for CoNS infections ranges from 5 to 7 days when the catheter is removed and from 10 to 14 days when it is retained in conjunction with ALT. With catheter removal and

Participate in cutting-edge educational sessions, hands-on workshops and interactive debates.

Collaborate with members of the multiprofessional team to solve complex problems, reduce barriers and improve standards.

uncomplicated infections, the dura- screening all patients who had a clintion of systemic therapy for CRBSIs ically uncomplicated CRBSI caused caused by S. aureus is greater than 14 by S. aureus with TEE was a costdays, 7 to 14 days for gram-negative effective way to determine duration bacilli infections, and 14 days from the of therapy—as short as 2 weeks if the first negative blood culture for Can- TEE result was negative.43 dida infections (Figure).12,19 Transesophageal echocardiog- Catheter Salvage Strategies raphy (TEE) should be performed When the need to retain an existin all patients with a CRBSI caused ing long-term catheter in a patient by S. aureus because of the propen- with a CRBSI is significant, salvage sity of this organism to cause endo- can be attempted by using ALT as carditis. Rosen et al determined that an adjunct to systemic therapy.12,19,44 Approximately 2 mL of solution is infused into the lumen of the catheter and remains there for a certain amount of time per day during the course of treatment.12,44 Solutions consist of the appropriately selected antibiotic combined with heparin (if compatible). In the lock, antibiotic concentrations range from 100 to 1,000 times the usual systemic concentrations. This increased concentration has a greater likelihood for killing organisms embedded in biofilm.44 Current guidelines recommend that antibiotic lock solution be used for 10 to 14 days in conjunction with SAT.19 Vancomycin, cefazolin, — John F. Kennedy and ticarcillin-clavulanic acid (Timentin, GlaxoSmithKline)—all in combiFebruary 4-8, 2012 Houston, Texas, USA nation with heparin—have excellent stability when used in ALTs, retaining George R. Brown Convention Center 90% of their activity after 10 days of dwell time in the presence of suscepDISCOVER NEW FRONTIERS tible organisms.45 CRBSIs caused by Candida speIN CRITICAL CARE cies necessitate prompt removal of Revolutionize the future of critical care medicine with over the catheter; however, this may not 4,000 of the brightest minds from across the globe. In always be immediately possible. A February, the movement towards excellence and consistency solution of ethylenediamine tetin critical care will be ignited by a collision of new perspectives raacetic acid (EDTA) with amphotericin B lipid complex showed promise and innovative solutions that will dramatically improve the during an in vitro model of a Candida outcomes and lives of critically ill and injured patients. biofilm formation, but more research The Society of Critical Care Medicine’s (SCCM) 41st Critical is urgently needed.46 We do not recCare Congress will propel your clinical knowledge to new ommend catheter salvage in the setheights with a diverse lineup of educational programs that ting of S. aureus CRBSIs because of reﬂect the latest discoveries and research in critical care: the high risk for metastatic infection and the slim likelihood of cure with• Participate in cutting-edge educational sessions, hands-on out removal of the catheter.

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Prevention The Healthcare Infection Control Practices Advisory Committee (HICPAC) of the CDC has published extensive guidelines for the prevention of CRBSIs, with a recent update released in 2011 (Table 2).2,3 They emphasize the following: 1) educating and training all health care personnel who insert and maintain catheters; 2) using maximal sterile barrier precautions during CVC insertion; 3) using a greater than 0.5% chlorhexidine skin preparation with alcohol for

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CLIN I CA L A N E S TH E SIOL OG Y antisepsis; 4) avoiding routine replace- or creams at the catheter insertion showed a 63% reduction (95% CI, ment of CVCs as a strategy to prevent site (except in the case of hemodi- 50%-73%) in the rate of overall S. infection; and 5) using antiseptic/ alysis catheters) to avoid promotion aureus infections.52 The study popantibiotic-impregnated short-term of fungal infections and antimicrobial ulation included both hemodialyCVCs and chlorhexidine-impregnated resistance (rating IA).2,3 The guide- sis and peritoneal dialysis patients. sponge dressings if the rate of infec- lines also discourage the adminis- Of the 10 studies, 6 used intranation is not decreasing despite adher- tration of intranasal antimicrobials sal mupirocin 2 to 3 times per day ence to prior strategies. The guidelines before insertion or during the use for 5 to 14 days with various maintealso emphasize performance improve- of a catheter as a means to prevent nance schedules, and 4 used mupiments by implementing bundle strat- colonization or CRBSIs (rating IA).3 rocin applied to the catheter exit site. egies and documenting and reporting A meta-analysis of mupirocin pro- Among patients undergoing hemothe compliance rates for all compo- phylaxis to prevent S. aureus infec- dialysis, S. aureus bacteremia was nents of the bundle as benchmarks for tions in patients undergoing dialysis reduced by 78% (relative risk [RR], quality assurance and performance improvement.2 Novel strategies for the prevention of CRBSIs are summarized in Table 3.2,47-54 Highlighted in Table 2 are important topics for the prevention of CRBSIs. The recommendations are rated based on the strength of evidence supporting them as follows: IA, strongly recommended for implementation and strongly supported by well-designed experimental, clinical, or epidemiologic studies; IB, strongly recommended for implementation and supported by some experimental, clinical, or epidemiologic studies and a strong theoretical rationale; IC, required by state or federal regulations, rules, or standards; and II, suggested for implementation and supported by suggestive clinical, or epidemiologic studies or a theoretical rationale.3

0.22; 95% CI, 0.11-0.42). However, the differences in site, frequency, and duration of mupirocin treatment in these studies and the resulting clinical heterogeneity make it difficult to draw robust conclusions. A randomized, double-blind, placebocontrolled trial evaluating mupirocin prophylaxis for nosocomial S. aureus infections in nonsurgical patients found that routine cultures for S. aureus nasal carriage at admission see BSI page 58

Cutaneous Antisepsis Historically, iodophors, such as 10% povidone-iodine, have been the most widely used skin antisepsis agents in the United States.5,55,56 However, recent studies demonstrate that a 2% chlorhexidine preparation is the superior agent for preventing CRBSIs. A meta-analysisof 4,143 catheters found that chlorhexidine preparations reduced the risk for CRBSIs by 49% (95% CI, 0.28-0.88) compared with povidone-iodine.47 Also, an economic decision analysis based on available evidence suggested that the use of chlorhexidine rather than povidone-iodine for CVCs would result in a 1.6% decrease in the incidence of CRBSIs, a 0.23% decrease in the incidence of mortalities, and cost savings of $113 per catheter used.57 Currently, the CDC recommends a 2% chlorhexidine preparation as the first-choice agent for cutaneous antisepsis (rating IA).2

Topical Antimicrobials The HICPAC/CDC guidelines specifically recommend against the use of topical antibiotic ointments Please visit us at the ASA Booth #613

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C LIN I C A L A N ESTHESI O LO GY BSI continued from page 57 and subsequent intranasal mupirocin use did not prevent nosocomial S. aureus infections.58 Additionally, reports of emerging mupirocin resistance are becoming commonplace.59-64 Routine use of topical or intranasal mupirocin for prophylaxis against CRBSIs is not recommended. The limitations of mupirocin suggest that other topical approaches for the prevention of CRBSIs should be studied. One such agent is honey. The antibacterial properties of some types of honey have made this a promising agent to study. The effect of 3-times-weekly Medihoney (commercially available; pooled antibacterial honey including Leptospermum species honey; Medihoney Pty Ltd) on infection rates in 101 patients receiving hemodialysis via tunneled, cuffed CVCs was compared with topical mupirocin in a randomized controlled trial (RCT). The investigators found similar catheter-associated bacteremia rates in the 2 arms (0.97 vs 0.85 episodes per 1,000 catheter-days, respectively; P>0.05). 65 Although the preliminary results are promising, a larger trial powered to show equivalence or superiority is needed to establish the utility of Medihoney for the prevention of CRBSIs in patients receiving hemodialysis through tunneled, cuffed catheters.

Maximal Barrier Precautions Maximal barrier precautions, including cap, sterile gown, mask, large sterile drape, and sterile gloves, significantly reduce the rate of CRBSIs when used during catheter insertion.3,66 In a study comparing maximalbarrier precautions with control precautions (eg, sterile gloves and small drape), the rate of CRBSIs was 6.3 times higher in the control group (P=0.06).66 The HICPAC/CDC guidelines recommend that maximal barrier precautions be used for all CVC insertions (rating IB).2,3

Insertion Site According to the HICPAC/CDC guidelines, the preferred insertion site of nontunneled CVCs for adult patients is the subclavian vein (rating 1B).2,3 The femoral site is associated with higher rates of catheter colonization as well as increased risk for deep vein thrombosis.3,67-70 In an RCT comparing the femoral and subclavian sites, use of the femoral site was associated with a higher

Uncomplicated

Complicated

Endocarditis, septic thrombosis, osteomyelitis, etc.

Coagulase negative Staphylococcus

Staphylococcus aureus

Short-term CVC/AC and long-term CVC/port:

Short-term CVC/AC:

Remove, SAT for 5-7 d

Remove, SATa for 4-6 wk or 6-8 wk for osteomyelitis

Remove, SAT for minimum of 14 d

Retain,b SAT + ALT for 10-14 d

Long-term CVC/port:

Remove,c SAT for 4-6 wk

Tunnel infection or port abscess: Remove, SAT for 7-10 d

Gram-negative bacilli

Candida species

Short-term CVC/AC:

Remove, SAT for 7-14 d

Short-term CVC/AC and long-term CVC/port:

Tunneled CVC/ port:

Long-term CVC/port:

Retain,b SAT + ALT for 7-14 d

Remove, SAT for 10-14 d

Enterococci

Remove, SAT for 14 d after first negative blood culture

OR Retain, SAT + ALT for

Retain,b SAT + ALT for 10-14 d

10-14 d, remove if no response

Figure. Management of CRBSIs. AC, arterial catheter; ALT, antibiotic lock therapy; CRBSIs, catheter-related bloodstream infections; CVC, central venous catheter; SAT, systemic antimicrobial therapy a Choose most appropriate systemic antimicrobial therapy based on current published guidelines. b Remove retained catheter if there is clinical worsening, relapsing, or persisting infection. c Current guidelines recommend considering catheter salvage therapy; however, outcomes may be poor. Adapted from reference 19.

overall rate of infectious complications (19.8% vs 4.5%, respectively; P<0.001).70 The internal jugular site has been associated with higher rates of CRBSIs than the femoral and subclavian sites in several studies.3,69,71 However, a recent RCT comparing the jugular and femoral sites found no difference in the rate of CRBSIs between the 2 sites (2.3 vs 1.5 per 1,000 catheter-days, respectively; P=0.42).72 A prospective, observational study comparing the subclavian, internal jugular, and femoral insertion sites found colonization lowest at the subclavian site but found no difference in rates of infection between sites.73 Using real-time ultrasound guidance for catheter insertion decreases associated mechanical complications and infection.2,74 In a randomized study comparing real-time ultrasound guidance with the landmark technique for catheter placement in the internal jugular vein, the latter resulted in significantly fewer complications, including fewer CRBSIs (P<0.001).74 A meta-analysis revealed that the use of ultrasound for insertion at the internal jugular and subclavian vein sites decreased

failure (RR, 0.32; 95% CI, 0.18-0.55), complications during catheter placement (RR, 0.22; 95% CI, 0.10-0.45), and the need for multiple placement attempts (RR, 0.60; 95% CI, 0.450.79) in comparison with the landmark technique.75 Although no RCT to date has compared the 3 insertion sites, based on available data, we recommend the subclavian site as the preferred site for CVC insertion along with the use of real-time ultrasound to minimize mechanical complications.

Simulation-based Training A recent observational study at an urban teaching hospital evaluated the impact of a simulation-based educational intervention on the rates of CRBSIs in the medical ICU.76 Ninetytwo second- and third-year internal medicine and emergency medicine residents completed the education program, which included a pretest, an instructional video on proper CVC insertion techniques, ultrasound training, hands-on practice with the simulator device, and a post-test with a minimum score requirement. There were 3.2 infections per 1,000 catheter-days in the 16 months prior to the

intervention in the hospital’s medical ICU. There were 4.86 infections per 1,000 catheter-days in the hospital’s surgical ICU during this preintervention period. The rate of CRBSIs in the medical ICU during the 16-month intervention period, when all secondand third-year residents had completed the training, decreased to 0.5 per 1,000 catheter-days. The rate in the surgical ICU, where no rotating residents completed the simulation training, remained stable at 5.26 per 1,000 catheter-days during the same 16-month time period.76 The cost savings attributed to simulation training recently were evaluated using data from both the year before and the year after training.77 The annual net savings from the simulation-based training, after accounting for the cost of the program, was more than $700,000 (2008 dollars), which translated into a 7 to 1 rate of return on investment for the training program (based on the training cost of $112,000). The use of simulation-based training exemplifies cutting-edge methods for the successful education of health care personnel regarding proper CVC insertion, which fulfills an important

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AnesthesiologyNews.com I 59

CLIN I CA L A N E S TH E SIOL OG Y recommendation of the recently updated HICPAC/CDC guidelines.2

Chlorhexidine-Impregnated Dressings The placement of a chlorhexidineimpregnated sponge dressing (BioPatch, Ethicon, Inc.) over the CVC insertion site has been shown to decrease CRBSIs in several randomized trials.5,78-80 A large, open RCT compared chlorhexidine dressings with standard sterile dressings in 601 chemotherapy patients (9,731 total catheter-days). The study found a significant reduction in CRBSIs in the intervention group (6.35%; 19 of 300) compared with the control group (11.3%; 34 of 301; P=0.016; RR, 0.54; 95% CI, 0.31-0.94).79 Similarly, an RCT conducted in the ICU found that the use of chlorhexidine-impregnated dressings led to significantly fewer CRBSIs than the use of standard sterile dressings (hazard ratio, 0.024; 95% CI, 0.09-0.65; P=0.005).80 The recent HICPAC/CDC guidelines for the prevention of CRBSIs recommend the use of chlorhexidineimpregnated sponge dressings with short-term CVCs in patients older than 2 months when institutional rates of CRBSIs are higher than the institutional goal, despite the consistent use of now-standard prevention measures (using well-trained personnel, chlorhexidine skin antisepsis, and maximal barrier precautions; rating 1B).2

A meta-analysis of externally CH-SS–coated catheters found that they decreased the incidence of both catheter colonization (OR, 0.44; 95% CI, 0.36-0.54) and CRBSIs (OR, 0.56; 95% CI, 0.37-0.84) compared with uncoated catheters.53 A recent meta-analysis found a reduced risk for CRBSIs when first-generation CH-SS–coated catheters (RR, 0.66; 95% CI, 0.47-0.93) were compared with uncoated catheters, but no significant risk reduction among

patients in the ICU (RR, 0.77; 95% CI, 0.53-1.13).50 The second-generation CH-SS–coated catheters significantly reduced CRBSIs in ICU patients (RR, 0.70; 95% CI, 0.30-1.62). Minocycline- and rifampicin-coated catheters were significantly more effective than chlorhexidine gluconate/silver sulfadiazine (CHG/SSD) catheters (RR, 0.12; 95% CI, 0.02-0.67).50 The most recent meta-analysis of 27 trials evaluating anti-infective catheters found a significant

reduction in CRBSIs with their use when all types were analyzed (OR, 0.49; 95% CI, 0.37-0.64).81 Subgroup analysis based on catheter type revealed reductions in CRBSIs for nearly all types compared with standard catheters: CH-SS–impregnated (5 trials; OR, 0.51; 95% CI, 0.261.0), silver-impregnated (6 trials; OR, 0.55; 95% CI, 0.33-0.92), minocycline-rifampin (5 trials; OR, 0.26; 95% CI, 0.15-0.47), miconazole-rifampin see BSI page 60

Antimicrobial-Impregnated Catheters The HICPAC/CDC guidelines recommend the use of antimicrobialcoated catheters if the device is expected to remain in place longer than 5 days if, despite use of a comprehensive CRBSI reduction strategy, the rate of infections is not decreasing (rating IA).2,3 However, the majority of the studies have focused on the use of antimicrobial-coated CVCs used as short-term devices; few data are available on their use as long-term devices.18,50 Several types of antimicrobial-impregnated catheters are available: catheters coated either externally (first generation) or externally and internally (second generation) with chlorhexidine and sulfadiazine silver (CH-SS), catheters coated with minocycline or rifampin, and silver-impregnated catheters.12 Silver-coated catheters include silver-, platinum-, and carbon-coated catheters and silver ion/ alloy catheters.5

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 than bupivacaine (P<0.05).1 To learn more about the clinical beneﬁts of NAROPIN, visit www.naropin-us.com.

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. 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. 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. 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 registered trademarks of APP Pharmaceuticals, LLC. and APP ® are registered trademarks of APP Pharmaceuticals, LLC. ©2011, APP Pharmaceuticals, LLC. All Rights Reserved. 0155-NAR-05-2/11

WHY COMPROMISE?

6 0 I A n e s t h e s i o l o g y N e w s . c o m Octo b e r 2 0 1 1

C LIN I C A L A N ESTHESI O LO GY BSI continued from page 59 (1 trial; OR, 0.12; 95% CI, 0-6.07), benzalkonium chloride–impregnated (1 trial; OR, 1; 95% CI, 0.06-16.45), and CH-SS–coated (9 trials; OR, 0.62; 95% CI, 0.4-0.98).81 The choice of which catheter to use is governed by many factors, including efficacy, cost, cost-effectiveness, and risk for promoting drug resistance. A 2008 analysis found an estimated cost savings of approximately

$227 for every anti-infective catheter inserted.82 Antibiotic resistance is a particular concern with antibioticimpregnated catheters, although trials assessing the efficacy of minocycline-rifampin–coated catheters found no evidence of the emergence of drug resistance.50

Antibiotic Lock Solutions The major mechanism for CRBSIs in patients with long-term devices is intraluminal colonization. For this

Naropin

(ropivacaine HCl) Injection

reason, antibiotic lock solutions have been considered as a logical step to prevent colonization of the intraluminal surfaces of long-term devices and thereby reduce the rate of CRBSIs. A small amount of the antibiotic solution is instilled into the lumen of the catheter and allowed to remain for a specific amount of time, after which it is either flushed or removed. A meta-analysis of 7 randomized trials (primarily involving cancer patients) demonstrated a significantly reduced

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 following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in pediatric and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods are not associated with these findings. The time of onset of symptoms, such as joint pain, stiffness and loss of motion can be variable, but may begin as early as the 2nd month after surgery. Currently, there is no effective treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement. 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 not 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-vivo 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

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

(%) (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

(%) (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

(%) (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

(%) (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.

APP Pharmaceuticals, LLC

0155-NAR-05-2/11

Rev. 11/08

risk for CRBSIs (RR, 0.49; 95% CI, 0.26-0.95) when vancomycin-containing lock solutions were used.51 A recent systematic review and metaanalysis of patients undergoing hemodialysis included data on several lock solutions: various antibiotic combinations, minocycline with EDTA, and nonantibiotic antiseptic solutions including citrate and citrate with taurolidine. All lock solutions included in this meta-analysis showed benefit for the prevention of CRBSIs.54 Ethanol also has been shown to be safe and effective as an antibiotic lock solution.49,83,84 A recently published prospective, double-blind, randomized trial comparing ethanol with heparinized saline in immunosuppressed hematology patients showed a 4-fold decrease in the number of CRBSIs in the ethanol group compared with controls (OR, 0.18; 95% CI, 0.05-0.65).84 Although a number of new antibiotics have shown promise as lock solutions during in vitro studies, more research on their efficacy is needed.85 In general, antiseptic lock solutions are preferred over antibiotic lock solutions because of their greater spectrum of activity and smaller risk for promoting antibiotic resistance. The HICPAC/CDC guidelines include a recommendation for the use of antibiotic/antiseptic lock solutions in patients with long-term catheters who have had multiple CRBSIs despite good aseptic technique (rating II).2 The use of antibiotic lock solutions is also recommended for the prevention of CRBSIs in long-term devices for patients with episodes of CRBSIs and a high risk for recurrence, such as those on hemodialysis. Chlorhexidine bathing has been proposed and evaluated as a strategy for reducing rates of CRBSIs.86-89 Bleasdale and colleagues compared daily chlorhexidine bathing (n=391; 2,210 patient-days) with soap and water bathing (n=445; 2,119 patientdays) among patients in 2 medical ICUs in a 2-arm crossover trial.86 There was a significant reduction in the risk for CRBSIs associated with the use of chlorhexidine bathing compared with the control group (4.1 vs 10.4 infections per 1,000 patientdays; incidence difference, 6.3; 95% CI, 1.2-11.0). A recent meta-analysis of RCTs and quasi-experimental studies evaluating chlorhexidine bathing versus a control bathing method (soap and water) demonstrated a significant reduction in the risk for CRBSIs with chlorhexidine bathing

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CLI NICAL ANESTHESI OLOGY (pooled RR, 0.32; 95% CI, 0.22-0.46; P<0.0001, I2=17%).90 However, a separate retrospective analysis evaluating the effect of switching from soap and water bathing to daily chlorhexidine cleansing in a surgical ICU found no difference in the rates of CRBSIs when the different periods were compared.91 The HICPAC/CDC guidelines recommend daily chlorhexidine bathing as a strategy for reducing the rates of CRBSIs (rating II); however, the conflicting results of recent studies warrant further research in this area.2

Coated Luer-activated Devices In addition to the previously described protection measures, the role of needleless connectors warrants attention. Needleless connectors were developed in response to demands for the improved safety of health care workers (to prevent needlestick injuries) and are integral components of infusion systems across North America. Although needleless connectors, when properly used, clearly reduce the risk for needlestick injuries during access of an IVD or injection port,92-95 reports published over the past decade have raised concerns about their potential to increase the risk for iatrogenic BSIs.96-101 Most of these studies have been retrospective and uncontrolled; suboptimal manipulation of the device, rather than the device itself, may have been responsible for the increased incidence of CRBSIs in some settings. Typically, health care personnel disinfect the connector with 70% (v/v) isopropyl alcohol before IV administration. Although needleless connectors appeared to reduce contamination compared with standard caps,102 a recent study by Menyhay et al found that conventional methods of disinfection may not prevent microbial entry if the luer-activated device (LAD) is heavily contaminated, which may account for the increased risk for CRBSIs observed in some reports.103 The HICPAC/CDC guidelines made no recommendation for or against LADs, given the lack of RCTs on this device. However, chlorhexidine may be the preferred agent for cleaning the ports of needleless devices.2 A recent study evaluated the effect of switching to chlorhexidine for this purpose in a pre-post intervention design on a pediatric hemopoietic stem cell transplant ward.104 In this study, switching from 70% isopropyl

alcohol alone to 2% chlorhexidine in 70% isopropyl alcohol for catheter connector antisepsis was associated with a reduction in the rates of CRBSIs from 12 to 3 per 1,000 catheter-days (P=0.004). Novel technologies have been developed to address the association of these devices with increased rates of CRBSIs. The V-Link with VitalShield (Baxter Healthcare), which recently received FDA approval, is LAD protected, with an interior and exterior antimicrobial coating (silver). Recent in vitro studies compared the V-link with VitalShield with control devices. The studies demonstrated that the antimicrobial coating is more than 99.99% effective in killing the most common organisms responsible for CRBSIs. It also prevented downstream spread and intra-device biofilm formation when Enterobacter cloacae was inoculated and allowed to dry on the septal membrane, followed by the infusion of Lactated Ringer’s running solution at 0.5 mL per minute for 72 hours through the connected device.105 Another promising device, the Saralex-CL (Menyhay Healthcare Systems), is an antimicrobial-barrier cap that threads onto the end of a needleless LAD system. A recent prospective, in vitro study compared standard disinfection techniques for common LADs using 70% isopropyl alcohol with the SaralexCL.106 The Saralex-CL, which uses a solution of 0.25 mL of 2% chlorhexidine gluconate in 70% isopropyl alcohol to bathe the connector septum, was effective in preventing transmission of pathogens across the membranes of precontaminated LADs compared with standard techniques (positive control = 100% transmission, standard technique = 20 of 30; 67% transmission; Saralex-CL = 1 of 60; 1.6% transmission; P<0.001). Data on the clinical efficacy of antimicrobialcoated LADs and antimicrobial-barrier caps are awaited.

Catheter Securement Sutureless securement devices avoid disruption around the catheter entry site and may decrease the degree of bacterial colonization.107 Catheter stabilization also helps decrease the risk for phlebitis and catheter migration/dislodgement while diminishing the risk for needlestick injury to the health care provider.2 see BSI page 62

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C LIN I C A L A N ESTHESI O LO GY BSI continued from page 61

Table 2. Recommendations for the Prevention of CRBSIs • Educate all relevant health care personnel regarding indications for IV catheter use, proper procedures for insertion and maintenance, and infection control measures

• Conduct institutional surveillance for rates of CRBSIs, monitor trends, identify lapses in infection control practices • Express ICU data as number of CRBSIs per 1,000 catheter-days

IA IB

Antisepsis

• Maximal sterile barrier precautions during catheter insertion: cap, mask, sterile gown, sterile gloves, and large sterile full body drape • Hand hygiene: Wash hands with antiseptic-containing soap and water or waterless alcohol-based product before insertion or any manipulation of any IV catheter • Maintain aseptic technique with insertion of IV catheters • Sterile gloves required for arterial, central, and midline catheters, changed during guidewire exchange before handling new sterile catheter • Cutaneous antisepsis: Use 2% chlorhexidine before insertion and during dressing changes (if contraindicated, an iodophor or 70% alcohol are alternatives)

IB IB IB IA IA

Insertion

• When possible, use subclavian site when using a nontunneled CVC • Use jugular or femoral vein site for hemodialysis and pheresis catheters • Insertion and maintenance of IV catheters only by designated, trained personnel with known competence • Use ultrasound guidance when available • Use sterile gauze or sterile, transparent semipermeable dressing • Do not give prophylactic antibiotics to prevent catheter colonization or BSI

IB IA IA IB IA IB

Maintenance

• Dressings: Replace on short-term CVCs every 2 d for gauze and every 7 d for transparent, no more than weekly for tunneled or implanted CVC sites until site is healed • Monitor site visually or by palpation through intact dressing on regular basis and remove dressing for full exam if tender, fever without obvious source, or other manifestations suggesting local infection or BSI • Do not routinely culture catheter tips • Do not use topical antibiotic ointments or creams (except dialysis catheters) • Antimicrobial/antiseptic catheters: Use in adults if catheter is expected to remain >5 d if institutional CRBSI rates are above benchmarks despite comprehensive prevention strategies • Remove IV catheters as soon as no longer necessary • Do not routinely replace CVCs, PICCs, HD catheters, or pulmonary artery catheters to prevent CRBSIs • Replace administration sets no more frequently than 96 h but at least every 7 d, unless infection or unless infusing blood, blood products, or lipid emulsions

IB IB IA IB IA IA IB IA

Novel strategies not addressed in current guidelines

• Antibiotic lock solutions for use in patients with history of multiple CRBSIs • Use chlorhexidine-impregnated sponge dressing for short-term CVCs in patients over 2 mo of age if CRBSI rate is higher than institutional goal despite other standard measures • A sutureless catheter securement device for PICCs • Use a 2% chlorhexidine daily bath to reduce CRBSIs • Needleless devices: chlorhexidine preferred for cleaning access ports • Use “bundle” strategies to improve compliance with evidence-based guidelines for reducing CRBSIs

II IB II II IA IB

Education

Surveillance

Intensive Insulin Therapy The appropriate level of glycemic control for critically ill patients is controversial. A large RCT of 1,548 critically ill patients in a surgical ICU compared intensive insulin therapy (maintenance of blood glucose level between 80 and 110 mg/dL) with conventional insulin therapy (insulin given only for blood glucose levels >215 mg/dL and maintenance of levels between 180 and 200 mg/ dL).110 The study found that intensive treatment reduced overall mortality rates (8% with conventional treatment vs 4.6% with intensive treatment; P<0.04); the greatest mortality reduction was observed in patients with multi-organ failure caused by a septic focus. A similar study in medical ICU patients found no reduction in mortality or difference in rates of bacteremia using intensive therapy.111 A meta-analysis that included 29 RCTs and 8,432 patients found no difference in hospital mortality rates with tight glucose control (21.6% vs 23.3%; RR, 0.93; 95% CI, 0.85-1.03), and the results did not change when patients were stratified by ICU type: surgical, medical, or medical-surgical. However, tight glucose control was associated with a reduced risk for septicemia (10.9% vs 13.4%; RR, 0.76; 95% CI, 0.59-0.97).112 In the NICE-SUGAR (Normoglycaemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation) study, a large RCT of 6,104 adult ICU patients, intensive glycemic control (goal, 81-108 mg/dL) caused increased mortality

Ratinga

Recommendation

Device securement options include sutures, tape, and catheterspecific devices such as the StatLock (Venetec International, Inc., a subsidiary of CR Bard). Sutures may be uncomfortable for the patient, pose a risk for needlestick injury to the provider, and foster inflammation at the catheter insertion site, increasing the risk for infection. StatLock, a sutureless catheter securement device, reduces catheter-related complications, including CRBSIs.107-109 A randomized trial comparing sutures with StatLock for PICC securement found significantly fewer CRBSIs in the StatLock group than in the suture group (2 vs 10, respectively; P=0.032).107 The HICPAC/CDC guidelines recommend the use of a securement device for all intravascular catheters (rating II).2

BSI, bloodstream infection; CRBSIs, catheter-related bloodstream infections; CVC, central venous catheter; HD, hemodialysis; ICU, intensive care unit; IV, intravenous; PICC, peripherally inserted central catheter a

CDC categories of evidence: IA, strongly recommended for implementation and strongly supported by well-designed experimental, clinical, or epidemiologic studies; IB, strongly recommended for implementation and supported by some experimental, clinical, or epidemiologic studies and a strong theoretical rationale; II, suggested for implementation and supported by suggestive clinical or epidemiologic studies or a theoretical rationale.2

Adapted from references 2 and 3.

compared with conventional control (goal, ≤180 mg/dL; OR, 1.14; 95% CI, 1.02-1.28; P=0.02).113 The study population included more medical than surgical ICU patients (intensive group: 36.9% surgical, 63.1% medical; conventional group: 37.2% surgical, 62.8% medical). Severe hypoglycemia (≤40 mg/dL) was significantly more common in the intensive control group (6.8% vs 0.5%; P<0.001).113 A meta-analysis of 26 trials including 13,567 patients—with data from the NICE-SUGAR trial—found no reduction in mortality using

intensive insulin therapy for critically ill patients (pooled RR of death with intensive vs conventional therapy, 0.93; 95% CI, 0.83-1.04).114 However, when analyzed separately, surgical ICU patients did have a benefit, whereas patients in nonsurgical ICUs did not (RR, 0.63; 95% CI, 0.44-0.91).114 A recent meta-analysis of 20 RCTs evaluated the effect of intensive insulin therapy on the incidence of infections in medical and surgical ICU patients. The analysis revealed an overall reduction in the incidence of

infections among all pooled studies (RR, 0.80; 95% CI, 0.71-0.90; P=0.0002; I2=53.5%).115 Subgroup analysis revealed significantly fewer infections in surgical ICU patients in the intensive insulin therapy group compared with standard therapy (11 studies; pooled RR, 0.66; 95% CI, 0.57-0.76; P<0.001). However, no difference in infection rates among medical ICU patients was observed. Pending the results of ongoing and future research, the use of intensive glycemic control for surgical ICU see BSI page 64

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C LIN I C A L A N ESTHESI O LO GY BSI continued from page 62 patients to reduce the risk for HAIs, particularly CRBSIs, is recommended. However, avoiding severe hypoglycemia is crucial, and a glycemic target that can be safely achieved should be used.

Multifaceted Approach Using a Checklist A multifaceted approach must be used to effectively reduce the risk for CRBSIs. The Institute for Healthcare Improvement (IHI) developed the concept of “bundles” to aid risk reduction. According to the IHI, a bundle is a structured way of improving the processes of care and patient outcomes using a checklist of 3 to 5 practices that, when performed collectively and reliably, have led to improved patient outcomes.116 The IHI-recommended evidence-based bundle for CVC care includes the following: 1) hand hygiene; 2) maximal barrier precautions upon insertion; 3) chlorhexidine skin antisepsis; 4) optimal catheter site selection, with the subclavian vein as the preferred site for nontunneled catheters; and 5) daily review of line necessity with prompt removal of unnecessary lines.116 A large multicenter study by Pronovost et al that used evidencebased interventions nearly identical to the IHI CVC bundle for 18 months found a significant reduction in CRBSIs from baseline. The incidence rate of CRBSIs at 0 to 3 months was 0.62 (95% CI, 0.47-0.81) and 0.34 at 16 to 18 months (95% CI, 0.23-0.5).117

These numbers represented up to a 66% reduction in the rates of CRBSIs, a reduction that also was maintained 18 months after the intervention period. The intervention was incorporated into standard practice at the individual centers, as described in a recent follow-up publication.118 Bhutta et al undertook a prospective quasi-experimental study in a children’s hospital, which included the stepwise introduction of interventions over a 5-year period.119 The interventions included maximal barrier precautions, a transition to antibiotic-impregnated CVCs, annual hand-washing campaigns, and the use of chlorhexidine in lieu of povidone-iodine. Significant reductions in CRBSI rates occurred over the intervention period. These were sustained over the 3-year follow-up. Annual rates decreased from 9.7 per 1,000 catheter-days in 1997 to 3 per 1,000 days in 2005 (RR reduction, 0.75; 95% CI, 0.35-1.26). The investigators agreed that multifaceted interventions of this nature reduce the rates of CRBSIs but require a multidisciplinary team and institutional support. The recent implementation of a multifaceted approach in a pediatric cardiac ICU, which included CVC insertion and maintenance bundles, chlorhexidine-impregnated dressings, nurse and physician education, and the addition of a unit-based infection control nurse, resulted in a reduction in the rates of CRBSIs from 7.8 to 2.3 infections per 1,000 catheter-days in less than 2 years.120

The HICPAC/CDC guidelines recommend that multifaceted performance improvement strategies be “bundled” to enhance compliance with evidence-based best practices (rating IB).2

“Getting to Zero”: The CRBSI Mandate The concept of “Getting to Zero” was first applied by the IHI for ventilator-associated pneumonia. Since then, the concept has been used for other HAIs, including CRBSIs. In the effort to “get to zero,” the CMS recently partnered with the NHSN and listed CRBSIs as a “never event.” This partnership creates greater transparency, builds accountability within the health care system, and promotes support for infection control programs and professionals.121 Certainly, by making CRBSI rates available, the public has the opportunity to make informed decisions regarding health care. However, there are both concerns and controversy surrounding the concept of getting to zero and the CRBSI mandate. Infection control experts have shared concerns that getting to zero is an oversimplification of the complexity of HAIs and does not convey the important message that although the majority of HAIs are preventable, some are not.122 A commentary by Victoria Fraser, MD, Washington University School of Medicine in St. Louis, MO, pointed out that this slogan is controversial because it seems scientifically unrealistic. Moreover,

patients and the general public may misinterpret the message to mean that any HAI is the result of an error or a suboptimal process.123 The concern regarding the CRBSI mandate stems mainly from the CDC’s definition of a CRBSI itself. The definition is highly sensitive but poorly specific. The high sensitivity allows it to capture all cases of CRBSIs, but the low specificity causes it to suffer from the inclusion of infections that may not be CRBSIs. In a thoughtful commentary by Sexton et al,124 this limitation of the surveillance definition is highlighted by specific examples where it seemed that the assignation of cases as CRBSIs was done by default (ie, simply because of the absence of proof for a secondary source of infection). The low specificity also greatly undermines the reliability of the publicly reported data on CRBSI rates. The authors then emphasize the need to change and validate the existing definition. They propose the inclusion of an “indeterminate source” category for some CRBSIs, which is “more epidemiologically and clinically useful than data derived from current definitions, which are inconsistent with common clinical practice.”124 Similarly, in a recent retrospective cohort study involving 4 medical institutions, Lin et al125 assessed whether or not surveillance data are consistent across institutions, contending that public reporting and interhospital comparisons of infection rates are only valid if the surveillance methods are uniform. The authors compared a computer algorithm reference standard for CRBSI rates with reported rates from the institution’s infection preventionists. The expected rate varied significantly by medical center, suggesting that there is indeed local variation among medical centers. This then raises doubt as to the validity of comparing published rates of CRBSIs among various institutions.125 The getting to zero initiative has many advantages. It has spurred dialogue about CRBSI prevention, propelled institutions to devote more resources to CRBSI prevention, and increased awareness of these severe infections. However, the campaign to publicly report CRBSIs should incorporate a uniform application of standardized definitions in institutions and a greater emphasis on process measures known to reduce the overall incidence of CRBSI.

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CLIN I CA L A N E S TH E SIOL OG Y References Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008;36(5):309-332. 2. O’Grady NP, Alexander M, Burns LA, et al. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011;39(4 suppl 1):S1-S34. 3. O’Grady NP, Alexander M, Dellinger EP, et al. Guidelines for the prevention of intravascular catheter-related infections. Infect Control Hosp Epidemiol. 2002;23(12):759-769. 4. Klevens RM, Edwards JR, Richards CL, et al. Estimating health care-associated infections and deaths in U.S. hospitals, 2002. Public Health Rep. 2007;122(2):160-166. 5. Crnich CJ, Maki DG. The promise of novel technology for the prevention of intravascular device-related bloodstream infection. I. Pathogenesis and short-term devices. Clin Infect Dis. 2002;34(9):1232-1242. 6. Maki DG, Kluger DM, Crnich CJ. The risk of bloodstream infectionin adults with different intravascular devices: a systematic review of 200 published prospective studies. Mayo Clin Proc. 2006; 81(9):1159-1171. 7. DHHS. Action plan to prevent healthcare-associated infections. 2009. http://www.hhs.gov/ ophs/initiatives/hai/draft-hai-plan- 01062009. pdf. Accessed July 11, 2011. 8. Pear R. Medicare says it won’t cover hospital errors. New York Times. August 18, 2007. 9. Siempos II, Kopterides P, Tsangaris I, Dimopoulou I, ArmaganidisAE. Impact of catheter-related bloodstream infections on the mortality of critically ill patients: a meta-analysis. Crit Care Med. 2009;37(7):2283-2289. 10. Pittet D, Tarara D, Wenzel RP. Nosocomial bloodstream infection in critically ill patients. Excess length of stay, extra costs, and attributable mortality. JAMA. 1994;271(20):1598-1601. 11. Smith MJ. Catheter-related bloodstream infections in children. Am J Infect Control. 2008;36(10):S173.e1-S173.e3. 12. Raad I, Hanna H, Maki D. Intravascular catheter-related infections: advances in diagnosis, prevention, and management. Lancet Infect Dis. 2007;7(10):645-657. 13. Lorente L, Jimenez A, Santana M, et al. Microorganisms responsible for intravascular catheter-related bloodstream infection according to the catheter site. Crit Care Med. 2007;35(10):2424-2427. 14. Trick WE, Fridkin SK, Edwards JR, Hajjeh RA, Gaynes RP. Secular trend of hospital-acquired candidemia among intensive care unit patients in the United States during 1989-1999. Clin Infect Dis. 2002;35(5):627-630. 15. Wisplinghoff H, Bischoff T, Tallent SM, Seifert H, Wenzel RP, Edmond MB. Nosocomial bloodstream infections in US hospitals: analysis of 24,179 cases from a prospective nationwide surveillance study. Clin Infect Dis. 2004;39(3):309-317. 16. Safdar N, Maki DG. The pathogenesis of catheter-related bloodstream infection with noncuffed short-term central venous catheters. Intensive Care Med. 2004;30(1):62-67. 17. Linares J, Sitges-Serra A, Garau J, Perez JL, Martin R. Pathogenesis of catheter sepsis: a prospective study with quantitative and semiquantitative cultures of catheter hub and segments. J Clin Microbiol. 1985;21(3):357-360. 18. Crnich CJ, Maki DG. The promise of novel technology for the prevention of intravascular device-related bloodstream infection. II. Long-term devices. Clin Infect Dis. 2002;34(10):1362-1368. 19. Mermel LA, Allon M, Bouza E, et al. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009;49(1):1-45. 20. Safdar N, Maki DG. Inflammation at the insertion site is not predictive of catheter-related bloodstream infection with short-term, noncuffed central venous catheters. Crit Care Med. 2002;30(12):2632-2635. 21. Guembe M, Rodriguez-Creixems M, SanchezCarrillo C, Perez-Parra A, Martin-Rabadan P, Bouza E. How many lumens should be cultured in the conservative diagnosis of

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30. Tighe MJ, Kite P, Thomas D, Fawley WN, McMahon MJ. Rapid diagnosis of catheter-related sepsis using the acridine orange leukocyte cytospin test and an endoluminal brush. JPEN J Parenter Enteral Nutr. 1996;20(3):215-218. 31. Arnow PM, Kushner R. Malassezia furfur catheter infection cured with antibiotic lock therapy. Am J Med. 1991;90(1):128-130. 32. Capdevila JA, Segarra A, Planes AM, et al. Successful treatment of haemodialysis catheter-related sepsis without catheter removal. Nephrol Dial Transplant. 1993;8(3):231-234. 33. Fowler VG Jr, Sanders LL, Sexton DJ, et al. Outcome of Staphylococcus aureus bacteremia according to compliance with recommendations of infectious diseases specialists:

see BSI page 66

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C LIN I C A L A N ESTHESI O LO GY BSI continued from page 65 experience with 244 patients. Clin Infect Dis. 1998;27(3):478-486. 34. Gosbell IB. Diagnosis and management of catheter-related bloodstream infections due to Staphylococcus aureus. Intern Med J. 2005;35(suppl 2):S45-S62. 35. Hachem R, Raad I. Prevention and management of long-term catheter related infections in cancer patients. Cancer Invest. 2002;20(7-8):1105-1113. 36. Hanna H, Afif C, Alakech B, et al. Central venous catheter-related bacteremia due to gram-negative bacilli: significance of catheterremoval in preventing relapse. Infect Control Hosp Epidemiol. 2004;25(8):646-649. 37. Johnson DC, Johnson FL, Goldman S. Preliminary results treatingpersistent central venous catheter infections with the antibioticlock technique in pediatric patients. Pediatr Infect Dis J. 1994;13(10):930-931. 38. Kassar R, Hachem R, Jiang Y, Chaftari AM, Raad I. Management of Bacillus bacteremia: the need for catheter removal. Medicine (Baltimore). 2009;88(5):279-283. 39. Nguyen MH, Peacock JE Jr, Tanner DC, et al. Therapeuticapproaches in patients with candidemia. Evaluation in a multicenter, prospective, observational study. Arch Intern Med. 1995;155(22):2429-2435. 40. Nucci M, Colombo AL, Silveira F, et al. Risk factors for death in patients with candidemia. Infect Control Hosp Epidemiol. 1998;19(11):846-850. 41. Rubin LG, Shih S, Shende A, Karayalcin G, Lanzkowsky P. Cure of implantable venous port-associated bloodstream infections in pediatric hematology-oncology patients without catheter removal. Clin Infect Dis. 1999;29(1):102-105. 42. Ruiz-Valverde MP, Barbera JR, Segarra A, Capdevila JA, Evangelista A, Piera L. Successful treatment of catheter-related sepsis and extraluminal catheter thrombosis with vancomycin and fraxiparin without catheter removal. Nephron. 1997;75(3):354-355. 43. Rosen AB, Fowler VG Jr, Corey GR, et al. Cost-effectiveness of transesophageal echocardiography to determine the duration of therapy for intravascular catheter-associated Staphylococcus aureus bacteremia. Ann Intern Med. 1999;130(10):810-820. 44. Segarra-Newnham M, Martin-Cooper EM. Antibiotic lock technique: a review of the literature. Ann Pharmacother. 2005;39(2):311-318. 45. Anthony TU, Rubin LG. Stability of antibiotics used for antibiotic-lock treatment of infections of implantable venous devices (ports). Antimicrob Agents Chemother. 1999;43(8):2074-2076. 46. Raad II, Hachem RY, Hanna HA, et al. Role of ethylene diamine tetra-acetic acid (EDTA) in catheter lock solutions: EDTA enhances the antifungal activity of amphotericin B lipid complex against Candida embedded in biofilm. Int J Antimicrob Agents. 2008;32(6):515-518. 47. Chaiyakunapruk N, Veenstra DL, Lipsky BA, Saint S. Chlorhexidine compared with povidoneiodine solution for vascular catheter-site care: a meta-analysis. Ann Intern Med. 2002;136(11): 792-801. 48. Ho KM, Litton E. Use of chlorhexidine-impregnated dressing to prevent vascular and epidural catheter colonization and infection: a meta-analysis. J Antimicrob Chemother. 2006;58(2):281-287. 49. Opilla MT, Kirby DF, Edmond MB. Use of ethanol lock therapy to reduce the incidence of catheter-related bloodstream infections in home parenteral nutrition patients. JPEN J Parenter Enteral Nutr. 2007;31(4):302-305. 50. Ramritu P, Halton K, Collignon P, et al. A systematic review comparing the relative effectiveness of antimicrobial-coated catheters in intensive care units. Am J Infect Control. 2008;36(2):104-117. 51. Safdar N, Maki DG. Use of vancomycin-containing lock or flush solutions for prevention of bloodstream infection associated with central venous access devices: a meta-analysis of prospective, randomized trials. Clin Infect Dis. 2006;43(4):474-484. 52. Tacconelli E, Carmeli Y, Aizer A, Ferreira G, Foreman MG, D’Agata EM. Mupirocin prophylaxis to prevent Staphylococcus aureus

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infection in patients undergoing dialysis: a meta-analysis. Clin Infect Dis. 2003;37(12):1629-1638. Veenstra DL, Saint S, Saha S, Lumley T, Sullivan SD. Efficacy of antiseptic-impregnated central venous catheters in preventing catheter-related bloodstream infection: a metaanalysis. JAMA. 1999;281(3):261-267. Yahav D, Rozen-Zvi B, Gafter-Gvili A, Leibovici L, Gafter U, Paul M. Antimicrobial lock solutions for the prevention of infections associated with intravascular catheters in patients undergoing hemodialysis: systematic review and metaanalysis of randomized, controlled trials. Clin Infect Dis. 2008;47(1):83-93. Clemence MA, Walker D, Farr BM. Central venous catheter practices: results of a survey. Am J Infect Control. 1995;23(1):5-12. Maki DG, Ringer M, Alvarado CJ. Prospective randomised trial of povidone-iodine, alcohol, and chlorhexidine for prevention of infection associated with central venous and arterial catheters. Lancet. 1991;338(8763):339-343. Chaiyakunapruk N, Veenstra DL, Lipsky BA, Sullivan SD, Saint S. Vascular catheter site care: the clinical and economic benefits of chlorhexidine gluconate compared with povidone iodine. Clin Infect Dis. 2003;37(6):764-771. Wertheim HF, Vos MC, Ott A, et al. Mupirocin prophylaxisagainst nosocomial Staphylococcus aureus infections in nonsurgical patients: a randomized study. Ann Intern Med. 2004; 140(6):419-425. Babu T, Rekasius V, Parada JP, Schreckenberger P, Challapalli M. Mupirocin resistance among methicillin-resistant Staphylococcus aureus-colonized patients at admission to a tertiary care medical center. J Clin Microbiol. 2009;47(7):2279-2280. Cavdar C, Saglam F, Sifil A, et al. Effect of once-a-week vs thrice-a-week application of mupirocin on methicillin and mupirocin resistance in peritoneal dialysis patients: three years of experience. Ren Fail. 2008;30(4):417-422. Graber CJ, Schwartz BS. Failure of decolonization in patients with infections due to mupirocin-resistant strains of community-associated methicillin-resistant Staphylococcus aureus. Infect Control Hosp Epidemiol. 2008;29(3):284; author reply 284-285. Orrett FA. The emergence of mupirocin resistance among clinical isolates of methicillinresistant Staphylococcus aureus in Trinidad: a first report. Jpn J Infect Dis. 2008;61(2):107-110. Perkins D, Hogue JS, Fairchok M, Braun L, Viscount HB. Mupirocinresistance screening of methicillin-resistant Staphylococcus aureus isolates at Madigan Army Medical Center. Mil Med. 2008; 173(6):604-608. Rossney A, O’Connell S. Emerging high-level mupirocin resistance among MRSA isolates in Ireland. Euro Surveill. 2008;13(14):pii=8084. Johnson DW, van Eps C, Mudge DW, et al. Randomized, controlled trial of topical exit-site application of honey (Medihoney) versus mupirocin for the prevention of catheter-associated infections in hemodialysis patients. J Am Soc Nephrol. 2005;16(5):1456-1462. Raad II, Hohn DC, Gilbreath BJ, et al. Prevention of central venous catheter-related infections by using maximal sterile barrier precautions during insertion. Infect Control Hosp Epidemiol. 1994; 15(4 pt 1):231-238. Goetz AM, Wagener MM, Miller JM, Muder RR. Risk of infection due to central venous catheters: effect of site of placement and catheter type. Infect Control Hosp Epidemiol. 1998;19(11):842-845. Joynt GM, Kew J, Gomersall CD, Leung VY, Liu EK. Deep venous thrombosis caused by femoral venous catheters in critically ill adult patients. Chest. 2000;117(1):178-183. Mermel LA, McCormick RD, Springman SR, Maki DG. The pathogenesis and epidemiology of catheter-related infection with pulmonary artery Swan-Ganz catheters: a prospective study utilizing molecular subtyping. Am J Med. 1991;91(3B):197S-205S. Merrer J, De Jonghe B, Golliot F, et al. Complications of femoral and subclavian venous catheterization in critically ill patients: a randomized controlled trial. JAMA. 2001;286(6):700-707. Richet H, Hubert B, Nitemberg G, et al. Prospective multicenter study of

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vascular-catheter-related complications and risk factors for positive central-catheter cultures in intensive care unit patients. J Clin Microbiol. 1990;28(11):2520-2525. Parienti JJ, Thirion M, Megarbane B, et al. Femoral vs jugular venous catheterization and risk of nosocomial events in adults requiring acute renal replacement therapy: a randomized controlled trial. JAMA. 2008;299(20):2413-2422. Gowardman JR, Robertson IK, Parkes S, Rickard CM. Influence of insertion site on central venous catheter colonization and bloodstream infection rates. Intensive Care Med. 2008;34(6):1038-1045. Karakitsos D, Labropoulos N, De Groot E, et al. Real-time ultrasound-guided catheterisation of the internal jugular vein: a prospective comparison with the landmark technique in critical care patients. Crit Care. 2006;10(6):R162. Randolph AG, Cook DJ, Gonzales CA, Pribble CG. Ultrasound guidance for placement of central venous catheters: a meta-analysis of the literature. Crit Care Med. 1996;24(12):2053-2058. Barsuk JH, Cohen ER, Feinglass J, McGaghie WC, Wayne DB. Use of simulation-based education to reduce catheter-related bloodstream infections. Arch Intern Med. 2009;169(15):1420-1423. Cohen ER, Feinglass J, Barsuk JH, et al. Cost savings from reduced catheter-related bloodstream infection after simulation-based education for residents in a medical intensive care unit. Simul Healthc. 2010;5(2):98-102. Maki D, Mermel LA, Kluger DM. The efficacy of a chlorhexidine-impregnated sponge (Biopatch) for the prevention of intravascular catheter-related infection—a prospective, randomized, controlled, multicenter study. Presented at: 40th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 17-20, 2000; Toronto, Ontario. Ruschulte H, Franke M, Gastmeier P, et al. Prevention of central venous catheter related infections with chlorhexidine gluconate impregnated wound dressings: a randomized controlled trial. Ann Hematol. 2009;88(3): 267-272. Timsit JF, Schwebel C, Bouadma L, et al. Chlorhexidine-impregnated sponges and less frequent dressing changes for prevention of catheter-related infections in critically ill adults: a randomized controlled trial. JAMA. 2009;301(12):1231-1241. Hockenhull JC, Dwan KM, Smith GW, et al. The clinical effectiveness of central venous catheters treated with anti-infective agents in preventing catheter-related bloodstream infections: a systematicreview. Crit Care Med. 2009;37(2):702-712. Hockenhull JC, Dwan K, Boland A, et al. The clinical effectiveness and cost-effectiveness of central venous catheters treated with anti-infective agents in preventing bloodstream infections: a systematicreview and economic evaluation. Health Technol Assess. 2008;12(12):iii-iv, xi-xii, 1-154. Crnich CJ, Halfmann JA, Crone WC, Maki DG. The effects of prolonged ethanol exposure on

the mechanical properties of polyurethane and silicone catheters used for intravascular access. Infect Control Hosp Epidemiol. 2005;26(8):708-714. 84. Sanders J, Pithie A, Ganly P, et al. A prospective double-blind randomized trial comparing intraluminal ethanol with heparinized saline for the prevention of catheter-associated bloodstream infection in immunosuppressed haematology patients. J Antimicrob Chemother. 2008;62(4):809-815. 85. Bookstaver PB, Williamson JC, Tucker BK, Raad II, Sherertz RJ. Activity of novel antibiotic lock solutions in a model against isolates of catheter-related bloodstream infections. Ann Pharmacother. 2009;43(2):210-219. 86. Bleasdale SC, Trick WE, Gonzalez IM, Lyles RD, Hayden MK, Weinstein RA. Effectiveness of chlorhexidine bathing to reduce catheterassociated bloodstream infections in medical intensive care unit patients. Arch Intern Med. 2007;167(19):2073-2079. 87. Climo MW, Sepkowitz KA, Zuccotti G, et al. The effect of daily bathing with chlorhexidine on the acquisition of methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus, and healthcare-associated bloodstream infections: results of a quasiexperimental multicenter trial. Crit Care Med. 2009;37(6):1858-1865. 88. Munoz-Price LS, Hota B, Stemer A, Weinstein RA. Prevention of bloodstream infections by use of daily chlorhexidine baths for patients at a long-term acute care hospital. Infect Control Hosp Epidemiol. 2009;30(11):1031-1035. 89. Popovich KJ, Hota B, Hayes R, Weinstein RA, Hayden MK. Effectiveness of routine patient cleansing with chlorhexidine gluconate for infection prevention in the medical intensive care unit. Infect Control Hosp Epidemiol. 2009;30(10):959-963. 90. Silva GLM, Safdar N. The efficacy of chlorhexidine baths for reducing healthcare-associated bloodstream infection. Presented at: Fifth Decennial International Conference on Healthcare-Associated Infections; March 18-22, 2010; Atlanta, GA. 91. Popovich KJ, Hota B, Hayes R, Weinstein RA, Hayden MK. Daily skin cleansing with chlorhexidine did not reduce the rate of central-line associated bloodstream infection in a surgical intensive care unit. Intensive Care Med. 2010;36(5):854-858. 92. Gartner K. Impact of a needleless intravenous system in a university hospital. J Healthc Mater Manage. 1993;11(8):44-46, 48-49. 93. Lawrence LW, Delclos GL, Felknor SA, et al. The effectiveness of a needleless intravenous connection system: an assessment by injury rate and user satisfaction. Infect Control Hosp Epidemiol. 1997;18(3):175-182. 94. Mendelson MH, Short LJ, Schechter CB, et al. Study of a needleless intermittent intravenous-access system for peripheral infusions: analysis of staff, patient, and institutional outcomes. Infect Control Hosp Epidemiol. 1998;19(6):401-406.

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CLIN I CA L A N E S TH E SIOL OG Y 95. Skolnick R, LaRocca J, Barba D, Paicius L. Evaluation and implementation of a needleless intravenous system: makingneedlesticks a needless problem. Am J Infect Control. 1993; 21(1):39-41. 96. Cookson ST, Ihrig M, O’Mara EM, et al. Increased bloodstream infection rates in surgical patients associated with variation from recommended use and care following implementationof a needleless device. Infect Control Hosp Epidemiol. 1998; 19(1):23-27. 97. Do AN, Ray BJ, Banerjee SN, et al. Bloodstream infection associatedwith needleless device use and the importance of infection-control practices in the home health care setting. J Infect Dis. 1999;179(2):442-448. 98. Kellerman S, Shay DK, Howard J, et al. Bloodstream infections in home infusion patients: the influence of race and needleless intravascular access devices. J Pediatr. 1996;129(5):711-717.

including NICE-SUGAR study data. CMAJ. 2009;180(8):821-827. 115. Safdar N, Ziegler M, Abad C, Silva G. Intensive insulin therapy for the prevention of infection in the critically ill: a meta-analysis of prospective, randomized trials. Presented at: Fifth Decennial International Conference on Healthcare-Associated Infections; March 18-22, 2010; Atlanta, GA. 116. Haraden C. What is a bundle? http://www.ihi. org/IHI/Topics/CriticalCare/IntensiveCare/ ImprovementStories/WhatIsaBundle.htm. Accessed July 7, 2011. 117. Pronovost P, Needham D, Berenholtz S, et al. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med. 2006;355(26):2725-2732. 118. Pronovost PJ, Goeschel CA, Colantuoni E, et al. Sustaining reductions in catheter related

bloodstream infections in Michigan intensive care units: observational study. BMJ. 2010;340:c309. 119. Bhutta A, Gilliam C, Honeycutt M, et al. Reduction of bloodstream infections associated with catheters in paediatric intensive care unit: stepwise approach. BMJ. 2007;334(7589):362-365. 120. Costello JM, Morrow DF, Graham DA, PotterBynoe G, Sandora TJ, Laussen PC. Systematic intervention to reduce central line-associated bloodstream infection rates in a pediatric cardiac intensive care unit. Pediatrics. 2008;121(5):915-923. 121. Pyrek K. Zero tolerance for infections: A winning strategy. Infection Control Today. January 2008. http://www.infectioncontroltoday.com/ articles/zero-tolerance.html. Accessed July 10, 2011.

99. McDonald LC, Banerjee SN, Jarvis WR. Lineassociated bloodstream infections in pediatric intensive-care-unit patients associated with a needleless device and intermittent intravenous therapy. Infect Control Hosp Epidemiol. 1998;19(10):772-777.

101. Salgado CD, Chinnes L, Paczesny TH, Cantey JR. Increased rate of catheter-related bloodstream infection associated with use of a needleless mechanical valve device at a longterm acute care hospital. Infect Control Hosp Epidemiol. 2007;28(6):684-688. 102. Casey AL, Worthington T, Lambert PA, Quinn D, Faroqui MH, Elliott TS. A randomized, prospective clinical trial to assess the potential infection risk associated with the PosiFlow needleless connector. J Hosp Infect. 2003;54(4):288-293. 103. Menyhay SZ, Maki DG. Disinfection of needleless catheter connectors and access ports with alcohol may not prevent microbial entry: the promise of a novel antiseptic-barrier cap. Infect Control Hosp Epidemiol. 2006;27(1):23-27. 104. Soothill JS, Bravery K, Ho A, Macqueen S, Collins J, Lock P. A fall in bloodstream infections followed a change to 2% chlorhexidine in 70% isopropanol for catheter connection antisepsis: a pediatric single center before/after study on a hemopoietic stem cell transplant ward. Am J Infect Control. 2009;37(8):626-630. 105. Maki DG. In vitro studies of a novel antimicrobial luer-activated needleless connector for prevention of catheter-related bloodstream infection. Clin Infect Dis. 2010;50(12):1580-1587.

107. Yamamoto AJ, Solomon JA, Soulen MC, et al. Sutureless securement device reduces complications of peripherally inserted central venous catheters. J Vasc Interv Radiol. 2002;13(1):77-81. 108. Frey AM, Schears GJ. Why are we stuck on tape and suture? A review of catheter securement devices. J Infus Nurs. 2006; 29(1):34-38. 109. Schears GJ. Summary of product trials for 10,164 patients: comparing an intravenous stabilizing device to tape. J Infus Nurs. 2006;29(4):225-231. 110. van den Berghe G, Wouters P, Weekers F, et al. Intensive insulin therapy in the critically ill patients. N Engl J Med. 2001;345(19): 1359-1367. 111. van den Berghe G, Wilmer A, Hermans G, et al. Intensive insulin therapy in the medical ICU. N Engl J Med. 2006;354(5):449-461. 112. Wiener RS, Wiener DC, Larson RJ. Benefits and risks of tight glucose control in critically ill adults: a meta-analysis. JAMA. 2008;300(8): 933-944. 113. Finfer S, Chittock DR, Su SY, et al. Intensive versus conventionalglucose control in critically ill patients. N Engl J Med. 2009; 360(13):1283-1297. 114. Griesdale DE, de Souza RJ, van Dam RM, et al. Intensive insulin therapy and mortality among critically ill patients: a meta-analysis

Drs. Abad and Safdar reported no relevant conflicts of interest.

We reward loyalty. We applaud dedication. We believe doctors deserve more than a little gratitude. We do what no other insurer does. We proudly present the Tribute® Plan. We go way beyond dividends. We reward years spent practicing good medicine. We salute a great career. We give a standing ovation. We are your biggest fans. We are The Doctors Company.

100. Rupp ME, Sholtz LA, Jourdan DR, et al. Outbreak of bloodstream infection temporally associated with the use of an intravascular needleless valve. Clin Infect Dis. 2007;44(11):1408-1414.

106. Menyhay SZ, Maki DG. Preventing central venous catheter- associated bloodstream infections: development of an antisepticbarrier cap for needleless connectors. Am J Infect Control. 2008; 36(10):S174.e1-S174.e5.

122. Richards C. Getting to zero: an emerging policy framework for the elimination of hospital-associated infections. Infect Control Hosp Epidemiol. 2009;30(1):71-73. 123. Fraser V. Zero: what is it, and how do we get there? Infect Control Hosp Epidemiol. 2009;30(1):67-70. 124. Sexton DJ, Chen LF, Anderson DJ. Current definitions of central line-associated bloodstream infection: is the emperor wearing clothes? Infect Control Hosp Epidemiol. 2010;31(12):1286-1289. 125. Lin MY, Hota B, Khan YM, et al. Quality of traditional surveillance for public reporting of nosocomial bloodstream infection rates. JAMA. 2010;304(18):2035-2041.

Richard E. Anderson, MD, FACP Chairman and CEO, The Doctors Company

You deserve more than a little gratitude for a career spent practicing good medicine. That’s why The Doctors Company created the Tribute Plan. This one-of-a-kind benefit provides our long-term members with a significant financial reward when they leave medicine. How significant? Think “new car.” Or maybe “vacation home.” Now that’s a fitting tribute. To learn more about our medical professional liability program and the benefits that have made us the nation’s leading writer of anesthesiologists, call (800) 352-0320 or go to www.thedoctors.com/tribute.

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C LIN I C A L A N ESTHESI O LO GY TKA continued from page 1 “It has been reported previously that a percentage of total knee replacement patients could be discharged within 24 hours; but, that study used a preselected population that had received preoperative physical therapy and training with the expectation that they would go home within a day,” said Andrew P. Lucic, MD, one of nine regional fellows in the Department of Anesthesiology at Pittsburgh. “The difference with our study is that our patients were not preselected.” The results were presented at the 2011 annual spring meeting of the American Society of Regional Anesthesia and Pain Medicine (abstract 71). Fifty-one minimally invasive total knee replacements using a quad-sparing technique were performed at the institution over a three-month period earlier this year. Preoperatively, each patient received femoral and sciatic nerve blocks with 17 mL of ropivacaine 0.2% (femoral; Naropin, APP Pharmaceuticals) and saline (sciatic). A perineural catheter was then placed for local anesthetic infusion postoperatively. After the patient arrived in the recovery room, the perineural catheter was infused with either bupivacaine 0.0625% at 5 mL per hour (femoral) or bupivacaine 0.0325% at 3 mL per hour (sciatic). Nurses also were allowed to administer boluses (3 mL/h) via catheter before the patient received opioids. In addition, Advertisement

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‘As much as people talk about minimally invasive surgery, the [total knee replacement] procedure really has limited contribution to our ability to discharge the patient. Pain management seems to be more important.’ —Jacques E. Chelly, MD, PhD, MBA each patient was given access to 5 to 10 mg of oxycodone for postoperative breakthrough pain. After surgery, patients were assessed for pain relief and physical ability to determine discharge readiness. “From our standpoint, the biggest thing was their pain scores,” Dr. Lucic said. “However, all patients also had to meet physical therapy discharge criteria and had to have someone at home who could stay with them to prevent falls and assist them with subsequent physical therapy.” Six of the 51 patients (11.8%) were discharged within 24 hours; 21 (41%) were discharged within two days. The aerage hospital length of stay for all 51 patients was 2.48 days. “Participants in this study tended to be younger (average age, 64.2 years) as most were getting total knee replacements for the first time,” Dr. Lucic told Anesthesiology News. “Their BMIs [body mass indices] tended to be on the lower side, too.” Some may view an early discharge rate of 11% as low; the investigators, however, were encouraged by their results and anticipated more improvement. “Obviously this is a newer program,” Dr. Lucic said. “We should be able to improve on the numbers we’ve presented here.” The senior investigator Jacques E. Chelly, MD, PhD, MBA, professor of anesthesiology and orthopedic surgery at the institution, echoed these sentiments. “When we started this program with hip replacements, we reported after three years that 44% of patients went home within 24 hours [Clin Orthop Relat Res 2009;467:1412-1417]. Now, we are at over

60% with hip replacements. And I think we can do better with the knee, without any doubt.” Interestingly, Dr. Chelly pointed more to the success of the analgesic regimen than the surgery in contributing to the possibility of early discharge. “As much as people talk about minimally invasive surgery, the procedure really has limited contribution to our ability to discharge the patient,” he told Anesthesiology News. “Pain management seems to be more important. “We have patients who undergo hip replacement surgery with a classic approach who now go home within a day of the surgery,” Dr. Chelly said. “And surgeons are finally starting to recognize the contribution that regional anesthesia can make in the recovery of these patients.” Kenneth Drasner, MD, professor of clinical anesthesia and perioperative care at the University of California, San Francisco School of Medicine, noted that financial pressures not only continue to generate interest in cost-cutting strategies, but also are major factors in shaping clinical practice. “This is a well-conducted study demonstrating the feasibility of performing these procedures on an ambulatory basis,” Dr. Drasner said. “While these data serve to present proof of concept, frequent comorbidities in this patient population, suboptimal pain control and the need for substantial in-home assistance represent significant barriers to expansion beyond the small percentage of patients who were discharged within 24 hours in this study.” —Michael Vlessides

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C LIN I C A L A N ESTHESI O LO GY

Clinical Images

1,250

rom C. diff to airway education, a trio of short items for which pictures tell the story best.

he prototype for the MRI-safe GlideScope (Verathon Medical) is being trialed at Montefiore Medical Center, in New York City. The device has been used successfully in both adult and pediatric patients. The top image shows the MRI-safe blade lying on the gurney at the mouth of a 3 Tesla MRI without any movement. The bottom image shows the GlideScope console mounted on the wall of the MRI suite. This advancement could significantly improve airway management in the MRI suite and the delivery of MRI-related anesthetics. (Images courtesy of Tracey Straker, MD.)

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NYC Hospital Testing MRI-safe Video Laryngoscope

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Elderly Pts Have Highest Rate of Clostridium difficile Infections

he rate of C. difficile among hospitalized patients aged 65 years or older rose more than 200% since the mid-1990s, data from the National Hospital Discharge Survey show. C. difficile infections can lead to diarrhea, sepsis

and even death, according to the Centers for Disease Control and Prevention (http://www. cdc.gov/nchs/nhds.htm). Most cases occur among patients in hospitals, nursing homes and other health care facilities.

MRI-safe blade

T GlideScope console

The Airway Log

he electronic airway log is being used in 10 academic institutions nationally and internationally. The log allows anesthesia departments to track competency and confidence in airway management. Filled out by residents, it provides a real-time look at the status of their airway

management experience. The log also can be used to implement continuing medical education in airway management for faculty. The log was funded by a grant from the Society for Airway Management.

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Adding Gabapentin Does Not Decrease Post-TKA Pain Toronto—Gabapentin does not decrease pain before and after patients undergo primary total knee arthroplasty (TKA), according to a new study. The study showed no statistically significant differences after surgery in the use of morphine, pain scores or length of stay in the hospital between patients randomized to gabapentin (Neurontin, Pfizer) or placebo. The new results stand in contrast to those from an earlier meta-analysis conducted by the same researchers that looked at the effects of gabapentin after patients received a range of surgeries, from mastectomy to laparoscopic cholecystectomy (Can J Anesth 2006;53:461-469). In the meta-analysis, the investigators found gabapentin was associated with lower postoperative pain scores and use of analgesia. “Our new study shows that there is not a strong indication for using gabapentin in total knee arthroplasty, although it still may be useful in other patient populations,” said James E. Paul, MD, MSc, associate clinical professor and research chair in anesthesiology, and director of the acute pain service at McMaster University, in Hamilton, Canada. “Perhaps in the context of multimodal analgesia, it has less incremental benefit.” In the current study, 101 patients (age range, 19 to 90 years) were randomized to gabapentin (n=52) or a placebo (n=49) before and after TKA. The study was conducted at Henderson General Hospital, in Hamilton, from May 2008 to March 2010, where surgeons annually perform more than 700 TKAs. Patients were excluded if they had a range of conditions, including chronic pain, allergy or intolerance to nonsteroidal anti-inflammatory drugs, acetaminophen, morphine, gabapentin or spinal anesthesia. Perioperatively, the patients received the study medication orally, either 600 mg of gabapentin or placebo, as well as a standard spinal anesthesia with hyperbaric bupivacaine combined with fentanyl. Postoperatively, the patients were given IV morphine for three days and 200 mg of gabapentin or placebo orally every eight hours. The researchers found no significant differences between the gabapentin and placebo groups in morphine consumption after surgery. They also did not find significant differences in

pain scores at rest, patient satisfaction or hospital length of stay. The team reported a high incidence of nausea and vomiting in both treatment groups. However, the rate of mild to severe nausea or vomiting was significantly lower in the gabapentin group than in the placebo group (63% vs. 82%, respectively). The rate of moderate to severe pruritus was also

significantly lower in the gabapentin group than in the placebo group (0% vs. 12%, respectively). Naveen Eipe, MBBS, MD, who was not involved in the study, speculated that excluding chronic pain patients in the TKA study may have affected the results. “Gabapentinoids are very likely to improve pain management in

patients undergoing surgery at a site of chronic pain,” said Dr. Eipe, staff anesthesiologist at The Ottawa Hospital and assistant professor at the University of Ottawa, Canada. “If these patients are specifically studied, you’d probably see significantly better outcomes with drugs like gabapentin and pregabalin [Lyrica, Pfizer].” —Rosemary Frei, MSc

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Lesson 294: PreAnesthetic Assessment of the Patient With Hereditary Angioedema WRITTEN BY:

TARGET AUDIENCE

Natalie F. Holt, MD, MPH Staff anesthesiologist, West Haven Veterans Affairs Medical Center, West Haven, Connecticut; assistant professor, Department of Anesthesiology, Yale School of Medicine, New Haven, Connecticut

Anesthesiologists

REVIEWED BY: Katherine E. Marschall, MD Assistant professor, Department of Anesthesiology, Yale School of Medicine, New Haven, Connecticut

DATE REVIEWED: September 2011 DISCLOSURES The author and the reviewer have no relationships with pharmaceutical companies or manufacturers of products to disclose. This educational activity may contain discussion of published and/or investigational uses of agents for the treatment of disease. The FDA has not approved some uses of these agents. Please refer to the official prescribing information for each product for approved indications, contraindications, and warnings.

NEEDS STATEMENT Hereditary angioedema (HAE) is a condition with important anesthetic consequences; surgery and airway manipulation are recognized triggers, and attacks involving laryngeal edema may lead to a compromised airway that is life-threatening. Recent drug developments have expanded the modalities available for acute treatment and long-term management of these patients. Clinical experience with these agents has been described in journals not generally read by anesthesiologists.

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

LEARNING OBJECTIVES At the end of this activity, the participant should be able to: 1. Summarize the epidemiology and pathophysiology of HAE. 2. Recognize signs and symptoms that support the diagnosis of HAE. 3. List laboratory tests that can be used to confirm the diagnosis of HAE. 4. Manage the symptoms in patients presenting with acute HAE attacks. 5. Tabulate common triggers for HAE attacks and indications for short-term prophylaxis. 6. Identify medications used for short-term prophylaxis against HAE attacks and explain their respective mechanisms of action. 7. Review the side effects and contraindications associated with commonly used HAE prophylactic therapies. 8. Discuss options available for long-term management of patients with HAE. 9. Describe how to monitor patients with HAE who are receiving long-term prophylactic drug therapy. 10. Name new drugs currently available for HAE acute therapy and prophylaxis.

CASE HISTORY A 13-year-old girl was brought to the emergency department by her parents after developing progressive swelling of the face, lips, and tongue. Her parents explained that over the course of the afternoon, the child’s voice had become increasingly hoarse, and she began to complain of difficulty in swallowing. Earlier that day, she had been to the dentist for routine dental cleaning. She had been well at the time, and the visit itself was uneventful. On physical examination, there was marked edema of the perioral region. Her tongue was severely enlarged such that she had difficulty keeping her mouth closed and controlling her saliva. She resisted lying down, preferring to sit in a forward-leaning position. No other constitutional symptoms, including rash or urticaria, were apparent. Vital signs included blood pressure, 100/60 mm Hg; heart rate, 88 beats per minute; oxygen saturation, 96%; and temperature, 97.2°F.

ngioedema is a general term defined as localized, self-limited swelling of subcutaneous and submucosal tissue caused by the release of vasoactive mediators that temporarily increase capillary permeability. Many etiologies—both acquired and inherited—are associated with angioedema, and different mediators are responsible for edema formation depending on the underlying diagnosis. Two main types of angioedema are distinguished: mast cell–mediated, which involves histamine and other vasoactive substances released from mast cells, and bradykinin-mediated.1 Hereditary angioedema (HAE) is a genetic disorder that results in deficiency in functional C1 inhibitor (C1-INH) due to mutations of its gene (SERPING1) on chromosome 11.1,2 The absence of functional C1-INH leads to excess bradykinin, a potent vasodilator that causes edema formation. The main mode of inheritance is autosomal dominant.

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 of Clinical Anesthesia in Neurosurgery (ButterworthHeinemann, 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 (Birkhäuser, 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 post-test and course evaluation before October 31, 2012. (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 2011 TERMINATION DATE: October 31, 2012 ACCREDITATION STATEMENT The Mount Sinai School of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT The Mount Sinai School of Medicine designates this educational activity for a maximum of 2 AMA PRA Category 1 Credits.™ Physicians should only claim 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, 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.

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oCToBer 2011

Tranexamic acid

0.5-1.5 g PO QOD to TID

ε-Aminocaproic acid

4-8 g/d PO, divided into 2 or 3 doses

C1-INH is a serine protease enzyme (serpin) that was discovered and named for its ability to inactivate the complement factor C1. It has since been discovered to play a role in the regulation of coagulation and fibrinolysis and to be the main downregulator of the kinin-generating cascade.8 In addition to inactivating C1, C1-INH also is responsible for inactivating factors XIa and XIIa, plasmin, tissue plasminogen, and kallikrein. The absence of functional C1-INH leads to excess kallikrein, which in turn results in excess bradykinin. A series of proteins degrade bradykinin, including angiotensin-converting enzymes (ACE). Thus, symptoms of HAE are often exacerbated when patients are prescribed ACE inhibitors. There are 2 main subtypes of HAE.2,4 Nearly 85% of patients have type I HAE, which is caused by a genetic mutation that results in absent or very low levels of C1-INH. Type II HAE, which represents about 15% of cases, is characterized by a mutation in the same gene that results in production of a C1-INH protein in a normal quantity, but a nonfunctional form. A third variety of HAE (sometimes called type III HAE) is a very rare subtype originally thought to occur only in women but subsequently diagnosed also in men. Patients with this type of HAE have normal C1-INH levels and function. In a subset of cases, this form of HAE results from a functional mutation in the factor XII gene that leads to excess kallikrein enzyme activation and subsequent bradykinin formation. Very little is known about the management of patients with this rare form of HAE. However, estrogen therapy seems to promote attacks, and the initiation of estrogen-containing medication is sometimes a precipitant to diagnosis.2,4 The remainder of this lesson pertains to the care of patients with HAE types I and II.

1,000 U IV up to twice per week (or self-administered by patient at first sign of an attack)

Diagnosis

Table. Treatments for HAEa Medicationb

Usual Adult Dose

Acute attacks C1-INH concentrate

20 U/kg IV

Kallikrein INH (ecallantide)

30 mg SC, divided into 3 separate 1-mL injections; may be repeated within 24 h if required

Bradykinin-receptor antagonist (icatibant)

30 mg SC

Short-term prophylaxis C1-INH concentrate

1,000 U IV, given as close to procedure as possible (1-6 h); additional doses should be available

17-α Alkylated androgens Danazol

2.5-10 mg/kg/d (maximum, 600 mg/d) started 5 d before and continued for 2 d after procedure date

Stanozolol

4-6 mg/d started 5 d before and continued for 2 d after procedure date

Fresh frozen plasma

10 mL/kg (2-4 U) IV given as close to procedure as possible

Maintenance therapy 17-α Alkylated androgens Danazol

50-200 mg PO QOD to BID (goal, ≤200 mg/d)

Stanozolol

1-5 mg PO QOD to BID (goal, ≤2 mg/d)

Oxandrolone

2.5-10 mg/d PO (goal, ≤5 mg/d)

Antifibrinolytics

C1-INH concentrate

BID, twice daily; HAE, hereditary angioedema; INH, inhibitor; IV, intravenous; PO, by mouth; QOD, every other day; SC, subcutaneous; TID, 3 times daily; U, units a Adapted from references 4, 10, and 12. b Several medications are now available for the treatment of patients with HAE. C1-INH and ecallantide are the 2 drugs currently available in the United States for the treatment of acute HAE attacks. Icatibant is currently available only in Europe. For short-term, preprocedural prophylaxis, C1-INH concentrate is the drug of choice. Androgens may be used but must be started several days in advance of a procedure because of their delayed onset of action. Fresh frozen plasma can be administered if C1-INH concentrate is not available and contraindications or time constraints do not permit the use of androgens. Before the development of C1-INH concentrate, patients with HAE requiring long-term prophylaxis were usually treated with androgens. Antifibrinolytics were less frequently used because of their reduced efficacy and associated risks. Home self-infusion with C1-INH concentrate is now an additional option for long-term maintenance therapy.

The prevalence of HAE is estimated to be 1 in 10,000 to 1 in 50,000. Symptoms usually begin within the first 2 decades of life, but a definitive diagnosis often is delayed because clinical suspicion is lacking. The average time from symptom onset to diagnosis is estimated to be nearly a decade.3,4 Clinical manifestations of HAE include recurrent, spontaneous attacks of subcutaneous and submucosal nonpitting edema without pruritus or urticaria. The severity and frequency of HAE attacks vary dramatically, even among those who share the same genetic mutation.4 Attacks can occur anywhere on the body but usually involve the skin— particularly the face and extremities—or the bowel wall. Abdominal attacks are associated with diffuse pain, vomiting, and diarrhea and may result in significant hypovolemia or shock. In most cases, symptoms develop gradually over a period of 12 to 36 hours and subside without intervention in 48 to 72 hours.4 Some patients experience a prodrome of tingling in the extremities and a flat, nonpruritic serpiginous rash (erythema marginatum).5 Attacks affecting laryngeal tissue are uncommon (estimated at 0.9% of all HAE

attacks), but up to 50% of patients with HAE experience at least 1 episode in their life that involves globus sensation, throat tightness, or dysphagia.4,6 Before the advent of therapy, mortality from HAE attacks with laryngeal edema was as high as 30%, primarily caused by airway compromise.6 Even with therapeutic intervention, temporary airway protection including intubation or tracheostomy may be required until edema resolves.

Pathophysiology HAE is a disorder caused by dysregulation of the kiningenerating system.5,7 Kinins are a poorly understood group of polypeptides that circulate in the bloodstream and play a role in inflammation, blood pressure regulation, and coagulation. The most important kinins are kallidin and bradykinin, potent vasodilators that act on many cell types including the vascular endothelium. Kinins circulate in precursor forms called kininogens, which are activated by the serine protease enzyme kallikrein. Kallikrein itself exists in a dormant form called prekallikrein and is activated by factor XIIa (Hageman factor).

HAE should be suspected in any patient with a history of recurrent edema of the face and extremities without urticaria who is nonresponsive to antihistamine or corticosteroid therapy. HAE also should be considered in patients who present with acute abdominal pain or upper airway obstruction when no other underlying pathology is identified. A positive family history is suggestive, but its absence should not rule out consideration of the diagnosis; in approximately 25% of HAE cases, the genetic defect occurs de novo.6 The short half-life of bradykinin makes its measurement as a diagnostic aid impractical. The most costeffective method to screen for HAE is by measurement of C4 levels.9,10 Although C4 is not directly involved in the pathology of HAE, it serves as a marker of C1-INH activity because C4 is normally cleaved by C1. In patients with HAE, the absence of functional C1-INH leads to excess C1, which in turn results in increased degradation of C4 and characteristically low C4 levels. Normal C4 levels virtually rule out the diagnosis of HAE, although in some patients (about 2%), C4 levels are near normal between attacks. Further diagnostic evaluation of suspected cases includes quantification of C1-INH antigen and functional C1-INH assay results. Low levels of C4, C1-INH antigen, and functional C1-INH are indicative of type I HAE. Low levels of C4 and functional C1-INH with normal or elevated C1-INH antigen support the diagnosis of type II HAE. Measuring C1q complement factor levels can help distinguish hereditary from acquired C1-INH deficiency. The latter is a rare condition marked by increased protease inhibitor consumption usually related to autoantibodies against C1-INH and C1q. C1q levels are low in 75% of patients with acquired forms of C1-INH deficiency but only in 25%

CONTINUING MEDICAL EDUCATION

oCToBer 2011

Suspected HAE

Measure C4 and C1-INH

C4 low; C1-INH low

No family history of HAE

Family history of HAE

Type I HAE

C4 normal; C1-INH normal

Measure C1-INH function

Confirm levels during acute attack

C1-INH function normal

Measure C1q

Low C1q

C4 low; C1-INH normal or elevated

Normal C1q

Consider acquired angioedema

Consider other non-HAE diagnosis

C1-INH function decreased

Consider type III HAE or medicationinduced angioedema

Type II HAE

Type I HAE

Figure. Diagnostic algorithm for HAE. HAE should be suspected in any patient with a history of recurrent episodes of subcutaneous or submucosal edema, abdominal pain, or laryngeal swelling that is unresponsive to corticosteroids and antihistamines. Begin by measuring C4 and quantitative C1-INH. Patients with type I HAE (approximately 85% of cases) characteristically exhibit low levels of C4 and C1-INH. A normal C1q level confirms the diagnosis. If the C1q level is low, the diagnosis of acquired angioedema should be considered. If C4 is low but C1-INH is normal or elevated, a C1-INH functional assay should be performed. Low C1-INH function with low C4 is consistent with the diagnosis of type II HAE. If C4 and C1-INH are both normal and the diagnosis of HAE is still suspected, the measurements should be repeated during an acute attack. If confirmed, the diagnosis may be type III HAE or medication-induced angioedema (eg, from use of angiotensin-converting enzyme inhibitor). Further diagnosis depends on clinical history. Adapted from reference 10. C, complement factor; C1-INH, C1 esterase inhibitor; HAE, hereditary angioedema

of patients with a hereditary deficiency. Using this algorithmic approach, genetic testing is not necessary to confirm the diagnosis of type I or type II HAE (Figure).9,10 Although HAE is an autosomal dominant disorder, patients with the condition usually have C1-INH levels significantly below 50% normal; laboratory biomarkers are useful for diagnosis but do not correlate well with symptom severity.2,3 Similarly, although many treatments for HAE are intended to increase C1-INH levels, C1-INH assays are not helpful in monitoring treatment efficacy.

Short-term Prophylaxis Short-term prophylactics were the first drugs approved to treat patients with HAE, and prevention remains the mainstay of management (Table). Prophylaxis is indicated in anticipation of any event that may trigger an HAE attack. Such procedures include surgery, dental manipulations, endoscopic procedures, and particularly stressful

events or severe illnesses. Intubation and oral and dental surgeries are especially strong triggers. Although there is no way to gauge treatment adequacy, C1-INH levels of at least 40% of normal appear to confer effective prevention against serious attacks.2 Attenuated androgens, specifically 17-α–alkylated agents such as danazol, stanozolol, and oxandrolone, were the first drugs approved for HAE prophylaxis. The mechanism of action of androgens is not fully understood but is presumed to result from enhanced liver synthesis of C1-INH.6 In some studies, androgens have been shown to increase the levels of enzymes responsible for bradykinin degradation, including aminopeptidase P, which also may account for their effectiveness. For short-term prophylaxis, androgens must be started several days before a procedure, as the onset of action is delayed. Current guidelines recommend initiating therapy 5 days prior to the procedure and continuing for 2 to 5 days after.9,10 Androgens are not advised in prepubescent

children, as the drugs may cause premature closure of the epiphyseal plates. Androgens also are contraindicated in pregnancy because they can interfere with fetal sexual development.4,6,9,10 Despite these cautions, short courses of androgen therapy have been used safely in pediatric patients and in women in the last trimester of pregnancy. The most commonly used drug is danazol, administered orally in a dose of 2.5 to 10 mg/kg per day (maximum, 600 mg per day). An alternative drug is stanozolol, 4 to 6 mg per day.9,10 Despite the availability in Europe for several years of a human plasma–derived, nanofiltered C1-INH concentrate for prevention of HAE attacks, it was not until 2008 that the FDA approved the first formulation in the United States.5,11 C1-INH is now the drug of choice for short-term prophylaxis.9,10 C1-INH infusions tend to be well tolerated. The most common adverse side effects are sinusitis, rash, headache, and upper respiratory infection. Although thrombotic

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events have been reported, treatment does not appear to systematically increase thrombotic risk.5 Rigorous donor screening, pasteurization, and nanofiltration virtually eliminate the possibility of infectious transmission. However, the drug is a blood product; therefore, in theory its use carries a risk for bloodborne disease transmission.6 The recommended dose of C1-INH is 1,000 U administered IV 1 to 6 hours before the start of a procedure, with additional doses available intraoperatively or postoperatively if needed.9,10 Before the availability of C1-INH concentrate and in cases when androgen therapy was contraindicated or considered impractical, the administration of fresh frozen plasma (FFP) 1 to 12 hours before the start of a procedure was a frequent treatment strategy. The usual dose was 2 U (400 mL) for adults and 0.05 U/kg (10 mL/kg) in children.3,4 Plasma administration restores C1-INH levels and therefore helps to reduce bradykinin generation. Antifibrinolytics such as tranexamic acid (TA) and ε-aminocaproic acid (EACA) also have been used in shortterm prophylaxis, although they are not FDA-approved for this use and are effective in only about 30% of patients with HAE.12 Antifibrinolytics presumably act to spare C1-INH by inhibiting plasmin activity, thereby blocking complement activation and C1-INH consumption. For adults, the suggested oral dose of TA is 20 to 50 mg/kg per day split into 2 or 3 doses (maximum, 3-6 g per day). The suggested oral dose of EACA is 6 to 12 g per day in 3 or 4 divided doses.2,6,10 Because of reduced efficacy and side effects, these agents are rarely employed today. In cases of minor manipulation (eg, routine dental cleaning) and when C1-INH concentrate is immediately available, the decision to withhold prophylaxis may be considered.9,10 Nevertheless, because attacks are unpredictable, patients with HAE should undergo any procedures in monitored settings where appropriate emergency care is available.

Management of Acute Attacks Until recently, the only way to manage acute attacks of HAE was with supportive care, primarily pain control and hydration for abdominal attacks with hypovolemia. Corticosteroids, antihistamines, and epinephrine—although frequently administered—are of no value (except to exclude other diagnoses). Androgens and antifibrinolytics are not effective during acute attacks because of their delayed onset of action.3 Successful use of FFP was at times reported in the literature; however, its utility remains controversial because in addition to increasing C1-INH levels, FFP also increases concentrations of other complement factors and kinins that may potentiate edema formation.8 Nevertheless, when newer effective therapies are not available, FFP is still administered. In 2009, the first human plasma–derived C1-INH concentrate was approved for acute treatment of HAE abdominal or facial attacks.1,2,5,11 Although not approved for use in children, experience supports the efficacy and safety of C1-INH concentrates in this population. The FDA-approved dose is 20 U/kg. Ecallantide (DX-88) is a kallikrein inhibitor that blocks release of bradykinin. In 2009, it was approved by the FDA for use in moderate to severe HAE attacks in patients aged 16 years or older.11,13 Ecallantide is a recombinant protein produced in yeast. A significant benefit of ecallantide is its ability to be administered either subcutaneously or IV. It is generally well tolerated, but hypersensitivity reactions have occurred. For the treatment of acute HAE attacks, the recommended dose of ecallantide is 30 mg administered subcutaneously in 3 separate 1-mL injections. If symptoms

persist, an additional dose may be administered within 24 hours.9,10,13 Ecallantide has a short half-life and is therefore not expected to be useful as a prophylactic agent.

Maintenance Therapy Among patients with significant quality-of-life issues, frequent HAE attacks (generally considered to be more than 1 severe attack per month), or a history of laryngeal edema, maintenance drug therapy should be considered.5,9,10 Three options are available: androgens, antifibrinolytics, and C1-INH concentrates. In addition to the short-term, preprocedural use of androgens, they also have been used for decades as longterm prophylactics in patients with HAE. Approximately 95% of these patients improve with androgen therapy, but only about one-fourth become symptom free.6 Danazol is the most effective and readily available of the androgens and is therefore the drug most commonly used. Stanozolol is an alternative but must be specially compounded. In addition, because of its strength as an anabolic agent, it has been abused by athletes and as a result is considered illegal in competitive sports. Oxandrolone has minimal virilizing effects; although it is less effective than danazol, it is often chosen when androgens are used in pediatric patients.3 Because laboratory assessment of C1-INH levels does not correlate with symptom relief, dosing is empirical. Several dosing titrations have been advised. For danazol, therapy is often initiated at 400 to 600 mg per day taken in divided doses, with gradual titration to the minimum dose believed to be effective in attack prevention (goal, ≤200 mg per day). A similar approach is advised with stanozolol (starting dose, 4-6 mg per day; goal, ≤2 mg per day).9,10 Long-term androgen use is associated with significant side effects, such as menstrual irregularities, myalgias, and weight gain that may result in self-discontinuation of therapy in as many as 25% of patients.6 In addition, long-term androgen therapy has several negative consequences, such as hypertension, hyperlipidemia, accelerated atherosclerosis, and increased thromboembolic risk. Hepatotoxicity and liver neoplasms also have been reported, and because androgens are metabolized in the liver, they are not recommended in patients with preexisting liver disease. Androgens also exhibit multiple interactions with other drugs, including potentiating the effects of anticoagulants and decreasing insulin requirements. It is advised that all patients on long-term androgen therapy be monitored with liver function tests, complete blood count, lipid profile, and urinalysis every 6 months. An annual liver-spleen ultrasound also is recommended. For patients receiving daily doses of more than 200 mg of danazol and those of prepubescent age, liver-spleen ultrasound is advised every 6 months along with annual measurement of α-fetoprotein levels.6,9,10 Although less reliable than androgens, antifibrinolytics have been used since the 1970s on an off-label basis, especially in patients with contraindications or intolerance to androgens.1 Both EACA and TA are available as oral preparations. The typical oral dose of EACA is 6 to 12 g per day given in 3 or 4 divided doses. The recommended oral dose of TA is 20 to 50 mg/kg per day split into 2 or 3 doses.2,6,10 Antifibrinolytics should be used with caution in patients with a history of thromboembolic disease and are not advised in patients with preexisting glaucoma. Side effects include myalgias, fatigue, hypotension, and visual disturbances.10 Since the advent of newer drug therapies, antifibrinolytics are used infrequently today.

oCToBer 2011

Clinical trials in which C1-INH concentrate was used in long-term prophylaxis found that most patients experienced at least a 50% reduction in attack rates compared with placebo therapy.14 Home self-infusion programs in which patients learn to self-administer drug at the first sign of an attack have been successful. If episodic treatment fails, a standing dose of 1,000 U administered every 3 to 7 days is advised.1,14 As expected, the cost of prophylaxis with C1-INH concentrate is far higher than that of androgens (approximately $150,000 vs approximately $1,000 per year).9 To date, only the human plasma– derived C1-INH product is approved for HAE prophylaxis.

Emerging Therapeutic Options Several clinical trials are under way investigating new agents for treating HAE and are destined to change the management paradigm of these patients. Icatibant is a competitive synthetic bradykinin β2-receptor antagonist that mitigates the effect of excess bradykinin released during HAE attacks.1,10,11 Overall, the drug is well tolerated; in 2 Phase II trials, approximately 90% of patients required a single dose to achieve symptomatic relief. Hypersensitivity reactions have not been reported, even in patients who have been subjected to multiple exposures of the drug. In 2008, icatibant was approved in Europe for treatment of acute attacks of HAE, and received FDA approval in August 2011 for use in the United States.5,9,11 More recently, a recombinant human C1-INH derived from rabbit milk (rh-C1-INH) has been formulated. Phase II and III trials supported the drug’s efficacy and safety at doses of 50 U/kg and 100 U/kg IV.9,10,11 The European Union recently approved its use for acute treatment; it is currently under FDA review in the United States. The half-life of recombinant C1-INH is shorter than that of the plasma-derived protein; therefore, it is expected to be more useful in the treatment of acute attacks than as prophylaxis. The only definite contraindication is in patients with a clear history of rabbit allergy.11 The benefits of rhC1-INH include eliminating the risk for bloodborne pathogen transmission and controlling drug production.

Management of the Case Presented IV access was established in the patient. Hydrocortisone 100 mg IV, diphenhydramine 12.5 mg IV, and nebulized albuterol were administered to her on the presumptive diagnosis of anaphylaxis—although the girl’s parents reported no recent ingestions of new foods or medications and no environmental exposures to potential allergens. After 20 minutes without therapeutic response, the patient began to exhibit inspiratory stridor. The emergency department physician paged the on-call anesthesiology team based on a concern about impending airway compromise. The decision was made to transport the patient to the operating room for urgent intubation in a controlled setting with an otolaryngologist available to establish a surgical airway if endotracheal intubation was unsuccessful. Midazolam 1 mg was administered IV, and standard monitors were applied. Inhalational induction with sevoflurane was performed, maintaining spontaneous ventilation. Fiberoptic laryngoscopy revealed significant swelling of the pharyngeal tissue and a severely narrowed glottic opening; however, a 7.0-mm endotracheal tube was successfully placed under direct visualization. Meanwhile, an immunologist was consulted who suggested the possible diagnosis of HAE, although there was no family history of the disorder. Blood was drawn

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and sent for measurement of C4, C1-INH, and C1q. The immunology laboratory informed the primary team that these specialty tests were performed at an outside facility, and results would not be known for at least 2 to 3 business days. Consequently, the pharmacy was solicited to help procure C1-INH concentrate on an emergency basis, because this medication was nonformulary and would have to be obtained from the hospital’s distributor or the drug manufacturer. Within 18 hours, C1-INH was located and delivered to the hospital, and the patient was treated with an IV dose of 20 U/kg. After 40 minutes, significant improvement in facial and oropharyngeal edema was evident. Within 2 hours, the patient’s symptoms had almost completely resolved. Her trachea was electively extubated while an anesthesiologist and otolaryngologist were at the bedside. The patient exhibited no signs of respiratory distress after extubation.

The laboratory tests ultimately revealed a quantitative deficiency in C1-INH and normal levels of C1q. The diagnosis of type I HAE was established. The family was counseled about the diagnosis and referred to a pediatric allergist for outpatient consultation. The patient was discharged home and had no negative sequelae from the incident.

2. 3. 4. 5.

Maurer M, Magerl M. Hereditary angioedema: an update on available therapeutic options. J Dtsch Dermatol Ges. 2010;8(9):663-672. Levy JH, Freiberger DJ, Roback J. Hereditary angioedema: current and emerging treatment options. Anesth Analg. 2010;110(5):1271-1280. Ebo DG, Verweij MM, De Knop KJ, et al. Hereditary angioedema in childhood: an approach to management. Paediatr Drugs. 2010;12(4):257-268. Zuraw BL. Clinical practice: hereditary angioedema. N Engl J Med. 2008;359(10):1027-1036. Banerji A. Current treatment of hereditary angioedema: an update on clinical studies. Allergy Asthma Proc. 2010;31(5):398-406.

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 e-mail to Customer.Support@ProCEO.com.

7. 8. 9.

References 1.

10.

11. 12. 13. 14.

Gower RG, Busse PJ, Aygören-Pürsün E, et al. Hereditary angioedema caused by C1-esterase inhibitor deficiency: a literature-based analysis and clinical commentary on prophylaxis treatment strategies. World Allergy Organ J. 2011;4(2):S9-S21. Firszt R, Frank MM. An overview of novel therapies for acute hereditary angioedema. Am J Clin Dermatol. 2010;11(6):383-388. Papadopoulou-Alataki E. Upper airway considerations in hereditary angioedema. Curr Opin Allergy Clin Immunol. 2010;10(1):20-25. Bowen T. Hereditary angioedema: beyond international consensus, circa December 2010, the Canadian Society of Allergy and Clinical Immunology Dr. David McCourtie lecture. Allergy Asthma Clin Immunol. 2011;7(1):1-14. Bowen T, Cicardi M, Farkas H, et al. 2010 International consensus algorithm for the diagnosis, therapy, and management of hereditary angioedema. Allergy Asthma Clin Immunol. 2010;6(1):24. Kalra N, Craig T. Update on recent trials in the treatment of hereditary angioedema. Clin Invest. 2011;1(3):439-445. Craig T, Riedl M, Dykewicz MS, et al. When is prophylaxis for hereditary angioedema necessary? Ann Allergy Asthma Immunol. 2009;102(5):366-372. Cicardi M, Levy RJ, McNeil DL, et al. Ecallantide for the treatment of acute attacks in hereditary angioedema. N Engl J Med. 2010;363(6):523-531. Zuraw BL, Busse PJ, White M, et al. Nanofiltered C1 Inhibitor concentrate for treatment of hereditary angioedema. N Engl J Med. 2010;363(6):513-522.

For inquiries about course content only, send an e-mail 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. Edema formation in patients with hereditary angioedema (HAE) is mediated primarily by: a. bradykinin b. histamine c. kallikrein d. plasmin

2. Low levels of which complement protein are often used as a screening test for HAE? a. C1 b. C2 c. C3 d. C4

3. Which drugs are of most benefit in the treatment of acute HAE attacks? a. α-Adrenergic antagonists b. Bradykinin-receptor antagonists c. Histamine-receptor antagonists d. Plasmin inhibitors

4. A common side effect of androgen therapy that leads to patient selfdiscontinuation is: a. nausea b. hypotension c. rash d. weight gain

5. The preferred therapy for prophylaxis against HAE attacks during pregnancy is: a. androgens b. antifibrinolytics c. C1-inhibitor (INH) concentrate d. fresh frozen plasma

6. Transmission of HAE occurs primarily via which genetic pattern? a. Autosomal dominant b. Autosomal recessive c. X-linked recessive d. Spontaneous mutation

7. Which of the following laboratory findings best support the diagnosis of type I HAE? a. Low C4 and low C1-INH b. Low C4 and normal C1-INH c. Low C4 and low C1q d. High C4 and low C1-INH

8. Cases of HAE in which C1-INH level and function are normal are often found to be caused by a defect in which serum protein? a. Factor II b. Factor X c. Factor XII d. Kallikrein

9. One of the presumed mechanisms of action responsible for the effectiveness of androgens as a long-term prophylactic against HAE attacks is: a. bradykinin receptor blockade b. increased C1-INH synthesis c. kallikrein inhibition d. reduced plasminogen activation

10. Ecallantide is FDA-approved for which HAE indications? a. Treatment of acute attacks b. Short-term prophylaxis c. Long-term prophylaxis d. All of the above

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Anesthesiology Board Review: Second Edition Kerri Robertson; David J. Lubarsky; Sudharma Ranasinghe

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Basics of Anesthesia: Expert Consult Online and Print, Sixth Edition

Ronald D. Miller; Manuel C. Pardo Jr.

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This book is as an excellent primer on the scope and practice of anesthesiology. The new edition has been thoroughly updated to reflect new and rapidly changing areas in anesthesia practice including new chapters on awareness under anesthesia, quality and patient safety, orthopedics and expanded coverage of new ultrasound techniques in regional anesthesiology with detailed illustrated guidance.

Beyond Pain: A Comprehensive Pain Board Review for the Pain Management Physician

Thomas Moshiri, MD A detailed and intensive review of the core knowledge needed to pass the pain boards. Containing the essential information you must know and condensing complex subjects into easy-to-understand topics. No other book contains all the information you need in an easy-to-understand manner in one single location.

Clinical Anesthesia Procedures of the Massachusetts General Hospital: Eighth Edition

William C. Levine; Rae M. Allain; Theodore A. Alston; Peter F. Dunn; Jean Kwo; Carl E. Roscow This best-selling pocket reference is now in its eighth edition. In an easyto-scan outline format, it provides current, comprehensive, concise, consistent and clinically relevant guidelines for anesthesia, perioperative care, critical care and pain management. The book has been written, reviewed, updated and field-tested by the Department of Anesthesia, Critical Care and Pain Medicine at the Massachusetts General Hospital.

For Doctors Only: A Guide to Working Less & Building More, Third Edition

Christopher R. Jarvis; David B. Mandell; Jason M. O’Dell This volume helps physicians move beyond theory and into practice by outlining how to find quality advisors and construct a collaborative, multidisciplinary planning team.

Stoelting’s Anesthesia and Co-Existing Disease: Expert Consult: Online and Print: Fifth Edition

Roberta L. Hines; Katherine E. Marschall Today’s leading authorities present the succinct, yet thorough guidance you need to successfully avoid or manage complications stemming from preexisting medical conditions. Organized by disease, the new edition of this popular guide has been completely revised and updated to reflect the latest information on definition, current pathophysiology, significant pre-, intra-, and postoperative factors of the disease process, anesthetic judgment and management.

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Jean-Louis Vincent; Edward Abraham; Patrick Kochanek This textbook remains your best source on effective management of critically ill patients. This trusted reference—acclaimed for its success in bridging the gap between medical and surgical critical care—now features an even stronger focus on patient outcomes, equipping you with the proven, evidence-based guidance you need to successfully overcome a full range of practice challenges.

The Essence of Analgesia and Analgesics Raymond S. Sinatra; Jonathan S. Jahr; J. Michael Watkins-Pitchford

The Essence of Analgesia and Analgesics is an invaluable, practical resource for clinicians giving pain relief in any clinical setting. It describes the pharmacologic principles and clinical use of all available pain medications. It provides detailed overviews of pain processing and analgesic theory, and includes sections dedicated to oral and panteral opioid analgesics, neuraxial opioids, NSAIDs, local anesthetics and more. AN1011

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Pioneering Pain Medicine Department Continues Exemplary Care

n 1970, anesthesiologist Harold Carron, MD, a pioneer in pain management, came to the University of Virginia (UVa) in Charlottesville and established its Pain Management Center, one of the first multidisciplinary clinics for treating pain. “He realized that physicians couldn’t address pain problems, but anesthesiologists could,” said John Rowlingson, MD, who has been with UVa for more than 20 years and is director of the Acute Pain Service. “Dr. Carron had a vision then that pain management was going to become an area of remarkable growth within the anesthesiology specialty.” Today, the Division of Pain Medicine and its Pain Management Center, under the auspices of UVa’s Department of Anesthesiology, continue to carry out Dr. Carron’s vision, treating patients of all ages for acute, chronic and cancer pain and tailoring treatment plans to meet their individual needs. In 2009, the institution received the American Pain Society’s Center of Excellence Award for outstanding patient care for pain.

Beyond the Physical UVa’s Division of Pain Medicine uses a psychosocial approach to treating pain, taking into account physical, psychological and social factors. “We don’t just look at anatomy, but all the things that might be contributing to someone’s pain,” said Kevin Vorenkamp, MD, director of the Pain Management Center. “On MRI, two out of three patients can have a bulging or herniated disc, yet they don’t have pain. So, genetics and social environment definitely play a role in pain, even though we don’t know the exact reasons why. It is indicative that there is more to pain than just the physical, and it’s why a psychosocial approach is necessary.” The Division of Pain Medicine’s multidisciplinary team, trained in anesthesiology, pain management, neurology, psychology, physical rehabilitation, social work and nursing, has more than 100 years of cumulative clinical experience. “Our team’s combined efforts ensure that each patient receives the highest-quality, most advanced treatments possible,” Dr. Vorenkamp said. “Our practitioners are especially focused on finding more efficacious, non-narcotic

modalities.” The division tackles pain problems using an array of techniques and technologies, including medications, nerve blocks, physical therapy, exercise, counseling, behavior modification and surgery. According to Robert Goldstein, MD, director of pain implant therapies, only about 2% to 3% of UVa’s pain patients require invasive surgical neuromodulation treatments. “The majority can be managed with basic and intermediate techniques, such as medication,” he said. If patients need surgery, such as those with cancer-related pain or those who have had multiple back surgeries, the division excels in surgically implanting pain pumps and spinal cord stimulators. “An exciting aspect of pumps is that newer technologies now allow patients to control pain medications, administering extra doses when needed,” Dr. Goldstein said. “Technology also has improved for stimulators. We can now use them to do a much better job helping patients with back and sciatic pain.” UVa’s Division of Pain Medicine is one of the few places in Virginia engaged in peripheral nerve stimulation. “Instead of putting a lead into the spinal canal, it is placed into or near a peripheral nerve, such as at the base of the skull, offering relief to patients suffering from such things as headaches,” Dr. Goldstein said. “Over the past 10 years, it has been an exciting area that continues to grow.” The hub of the pain medicine division is the Pain Management Center, which has approximately 9,000 patient visits per year. The Pain Management Center is located on the third floor of the Fontaine Medical Office Building in Fontaine Research Park, a 54-acre complex on the university’s campus. Its clinicians treat referred patients with acute, chronic and cancer pain problems, including cervical nerve damage, pelvic and abdominal pain, neck injuries, chronic headaches, lower back and nerve pain. The physicians employ a range of modalities, including pharmacologic treatments, transcutaneous electrical nerve stimulation and other complementary therapies, analgesic nerve blocks, exercise physiology and a full gamut of psychology techniques. The center also works closely with UVa’s

Pain Management Center at Fontaine Research Park.

spine center, orthopedic clinic, sports medicine clinic, imaging, physical and occupational therapy, hand therapy and physical medicine and rehabilitation, which are located in Fontaine Research Park. The division’s Acute Pain Service, which treats approximately 2,000

patients annually, consists of an attending physician, a pain fellow, an anesthesia resident and a nurse coordinator. This service manages patients with acute and postoperative pain by using epidurals, subarachnoid or peripheral nerve blocks, local anesthetics and opioids. see UVA page 98

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P A I N M E D I C I NE UVA continued from page 97 “We can get on acute/post-op pain problems faster than primary teams might be able to,” Dr. Rowlingson said. “Thus, we can diminish chronic pain from developing by being more aggressive when addressing acute pain. Our goal is to make the transitions in patient care seamless, and with the same effective quality throughout the process.” In the past few years, UVa has increased efforts to treat cancer pain. The pain division works with UVa oncologists and other palliative supportive care personnel to devise treatment plans that reduce pain for cancer patients and improve their quality of life. “We felt the cancer pain population was underserved from a pain management standpoint,” said Dr. Goldstein, who is also board-certified in hospice and palliative medicine. Pain Medicine U The UVa is consistently rated among the best public institutions in the country for teaching, and the Division of Pain Medicine contributes to the effort by educating patients and primary care physicians about pain and by training tomorrow’s pain specialists. “Education is key to improving pain management in the broadest way possible,” said Robin HamillRuth, MD, director of clinical research. “Our educational efforts are conducted on the regional, national and international levels.” When patients present, UVa’s pain physicians make concerted efforts to inform them of all the factors contributing to their pain physically and psychologically, even discussing lifestyle changes that help alleviate pain, such as quitting smoking or taking up an exercise program. “For primary care physicians, we educate them on pain management, so they can initiate the first wave of treatment right away, rather than have a patient wait four to six weeks to see a pain specialist,” Dr. Vorenkamp said. In developing tomorrow’s pain specialists, the division trains five fellows each year who work with the multidisciplinary team at the Pain Management Center. “We had a long-standing tradition of training pain medicine physicians, even before it became a recognized subspecialty,” Dr. Vorenkamp continued. “We are [Accreditation Council for Graduate Medical Education]–certified and train physicians whose primary fields are anesthesiology, physiatry, psychiatry, neurology and family medicine. We also train residents and fourth-year medical students from UVa and other institutions.”

Robert Goldstein, MD, reviewing a patient’s MRI with the pain fellows at the Pain Management Center.

Pain Management Center physicians outside of the center at Fontaine Research Park.

nerve blocks, the use of opioids in pain management and pain management protocols for patients with obstructive sleep apnea. Recently, Dr. Hamill-Ruth directed a quality research initiative investigating whether clinically available patient information could help identify people at risk for aberrant drug-taking behavior. She examined point-of-care urine drug screening data, patient reports, referring physician records and the state’s prescription monitoring program to determine if this information could help physicians in preProbing Pain’s Origins scribing controlled substances. In fact, in examining UVa’s Department of Anesthesiology maintains point-of-care urine drug screening, she uncovered a program of basic research that explores the mech- the startling fact that nearly 40% of the patients misanisms of anesthetics, such as how anesthetic drugs reported their medication use. interact with neurotransmitter systems in the central “These studies hopefully will help us develop a sysnervous system to produce both pharmacologic and tem that will allow physicians to have credible data at toxicologic effects. the clinic before prescribing, and allow them to make The Division of Pain Medicine’s research activi- better decisions about safely prescribing controlled ties delve into outcomes related to interventional substances,” Dr. Hamill-Ruth said. pain management, gait and low back pain, the necesAnother research project that the division is consary use of anticoagulant therapy in patients receiving ducting, along with the university’s Biomedical

Engineering Department, is determining if “virtual reality” technologies can make mirror therapy for patients with post-amputation phantom limb pain and complex regional pain syndrome more effective. Going Forward UVa’s Division of Pain Medicine hopes to remain at the forefront of pain medicine through innovative clinical care and research endeavors. “We have national leaders in the field who continuously work to improve our education and clinical care,” Dr. Vorenkamp said. “This mandates that we keep up to date with innovations outside of our center, with the goal of improving clinical care moving forward.” Dr. Rowlingson added that the next evolution in clinical care might be pain management at home. “Because people are leaving supervised care venues sooner, the anesthesiologist is going to have to follow patients home,” he said. “That means we are going to have to make our techniques more portable.” —Tom McDonough

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In Tough Financial Times, Pain Clinic Reinvents Itself Austin, Texas—In 2008, the Fairview Pain Management Center (FPMC) in Minneapolis faced imminent closure. The financial crisis had hit its parent company’s corporate coffers and executives were looking for ways to eliminate costs. FPMC, a 10-year-old operation that, according to medical director Miles Belgrade, MD, had been losing money during even the best of times, was a natural target for these cuts. “We had previously been recognized by the American Pain Society with a Clinical Center of Excellence award,” Dr. Belgrade said. “We were quite disappointed to be facing this situation.” Three years later, however, FPMC has managed to reinvent itself and stay afloat. Through the urgency created by necessity, staff and executives have managed to recreate the clinic in several ways. In popular parlance, the FPMC was given an extreme makeover. ‘Waiting in Line’ “We no longer have a central pain center,” Dr. Belgrade said. “We have a small office space, and we now extend our services out by sending multidisciplinary teams to primary care clinics that do not offer in-house pain management services.” These small interdisciplinary teams include a pain physician or nurse practitioner, a psychologist, a physical therapist and sometimes a nurse coordinator with expertise in pain management. The primary care clinics supply FPMC staff with office space and reimburse FPMC for its services. This rearrangement has significantly lowered the clinic’s overhead and allowed it to unload a portion of salary costs while staying true to its multidisciplinary mandate. In fact, according to Dr. Belgrade, FPMC’s staff size has grown since the overhaul, adding four physicians, two psychologists and one physical therapist. Furthermore, rather than limiting itself to a central location, FPMC now has the advantage of an expanded client base, Dr. Belgrade said. “Primary care clinics are waiting in line for our services.” Dr. Belgrade noted that although the recent revitalization has improved the clinic’s financial health, FPMC is still only approaching a break-even point. But results from a survey of FPMC clinicians, administrators and executives presented at the American

Take Charge of Your Life. Ensure Your Future.

Pain Society’s 2011 annual scientific meeting indicate that FPMC staff do not expect the clinic to yield profits; the clinic’s approach is admittedly too labor-intensive and it costs more per patient than the traditional medical model “of a doctor or nurse practitioner with a prescription pad,” Dr. Belgrade said. Surveyed executives suggested the lack of profits is offset by the added value multidisciplinary care offers to clients, a finding Dr. Belgrade said was “kind of refreshing.” “Ideally, as long as the clinic is breaking even, it seems executives would like to have it be a part of the system,” he said. Sticking With the Essentials Some pain clinics have managed to stay profitable throughout the recession, Dr. Belgrade noted, but they mostly do interventional procedures. Only about 20% of FPMC’s services are interventional, he estimated. Despite the allure of doing more profitable procedures, he said clinic staff and executives have no plans to move away from a multidisciplinary approach. “We did face some pressure a few years ago to do more interventional procedures, but we are now focused on improving our financial health by reducing the total cost of care per patient,” he said. “There is a perception among management that the reimbursement structure is set to change as President Obama’s health care reform is rolled out, and Fairview is trying to get ahead of the curve.” Eduardo Fraifeld, MD, an expert in reimbursement and coding issues, applauded FPMC for being creative in difficult times. Dr. Fraifeld believes bill-related cuts to spending will further burden already-stressed pain clinics. “This is sad news not only for pain clinics but for every health professional,” said Dr. Fraifeld, of Southside Pain Solutions, in Danville, Va. “I think we’ll see Medicare reimbursement reduced further so we’re all going to have to find ways of lowering our overhead, and we’ll probably have to suffer some profit reductions as well. What FPMC has done is exactly right. We’ll need to reinvent ourselves.” —David Wild

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P A I N M E D I C I NE

Roll the DICE: Streamline the Workflow in Your Pain Practice Dear Arizona Pain Specialists, My partner and I run a growing interventional pain practice. During the past three months, we hired a new physician and soon will be opening a new location. During this time of rapid growth, our staff has become increasingly overwhelmed. Despite their hard work, their ability to handle the ancillary elements of patient care has suffered. I’m worried that as we continue to grow we will not be able to provide the same level of care for our patients. Do you have any suggestions that can help us continue to provide top-quality patient care while increasing our patient volume? Thank you, Growing Pains Dear Growing Pains, his issue affects all growing pain management practices nationwide. One of the solutions involves a process called “streamlining.” Your workflow needs to be examined and re-evaluated as your practice grows. Growing practices often find that employees become inefficient as they begin to perform many tasks that are unnecessary and/or redundant. One method to avoid this, and create a scalable system for growth, is called the DICE process: Define current workflow Identify key steps Consolidate tasks Execution One principal tenet should guide these elements: Funnel all critical thinking to a single entity. To help illustrate, we describe how Arizona Pain Specialists (APS) changed its workflow for obtaining procedure authorizations based on the DICE method.

The DICE Method in Action Define Current Workflow The first step in streamlining is to define a practice’s current workflow. Often, this step is skipped, and a utopian workflow is simply forced on staff. Current workflow needs to be assessed so that employees can be given clear instruction on how to transition the work they’re doing now into a different model, and still feel comfortable and secure that all aspects of their responsibilities will continue to be handled. Pain management clinics tend to have complicated processes completed by individuals who do a vast amount of critical thinking to determine the appropriate course of action. For example, ordering a radiofrequency ablation (RFA) procedure might include this workflow: • Document a successful trial with medial branch blocks; • Educate the patient about RFA; • Order the RFA procedure; • Schedule the patient for the procedure if authorization is not required; and • Obtain authorization if required. If authorization is required and is obtained, call and schedule the patient. In smaller pain clinics, this process can be managed

by one or only a few employees, all of whom are capable of completing the ancillary tasks at each stage required for a patient’s plan of care to continue. As a practice grows, however, this becomes increasingly difficult and inefficient. With each stage of the patient’s care, the staff member must switch everything he or she is doing, begin a new train of thought and a different set of steps. Handling patient calls, calling insurance companies to follow up on authorizations and calling patients to get more information are all very different processes; when handling all at once there are constant interruptions, distractions and tangents that occur. Focusing on one part of this process and working on it consistently without distraction will ensure maximum quality, consistency and efficiency in completing the task. Identify Key Steps This is an important step that occurs from the time an order for a procedure is written to when the patient is scheduled for that procedure. In this case the key steps are: • Obtain authorization; • Obtain clearance; and • Schedule the patient. Because these can occur in almost any order, we need to identify another step: • Determine the order of operations. The process has now been distilled to four key components. Each of these is a complicated endeavor; however, we have broken the larger nebulous process of scheduling patients for procedures into more manageable steps. This is important for designing an improved workflow, and an excellent way to discover unnecessary steps in current workflow. Consolidate Tasks In order to consolidate each of the key steps, roles for each department must be identified. Departments required to complete the process for this example include provider, authorizations, clearance, scheduler and the front desk. Each of these departments has a clearly defined role within the process of scheduling a procedure. When an order for an RFA is written in clinic, a defined set of processes must occur every time a patient is to be scheduled. First, the front desk staff must determine if the patient needs authorization/clearance, or is ready to schedule immediately; this department is critical in directing the process. Front desk staff must create a marker to track the patient’s authorization process. A marker can be something as simple as a piece of paper, and is used to track the process from when an item is ordered (e.g., a procedure) to when it is scheduled and completed. APS uses a task message in its electronic medical record (EMR) system. The initial information recorded in a task message for an RFA are a patient’s name, insurance, relevant blood thinner information, procedure, side, levels, quantity, prescribing doctor and clinic location. As this information will be used by many different people in multiple departments, it is very important to establish a rigid format for how

this should be written so that interpretation from person to person does not vary. An example of a message at APS would look like this: Doe, John MED *BT* RFA LT L2-L5 PL SC This tells us that patient “John Doe” has Medicare, is on a blood thinner and has been written for a left L2-L5 RFA by Dr. Lynch at the Scottsdale location. The task message should also be used as a log on which any work that is done on a task is recorded. This ensures the task has a history; whoever is working on it can follow a patient’s scheduling progress. For example, if the patient called to check on the status of the authorization, the staff member who took the call would document this interaction in the task. In addition, if an authorization team member contacted the clinic to ensure a peer-to-peer was completed, this information would also go into the task message. This becomes particularly important for the scheduler, who needs to make sense of each stage of the task’s history. When the task arrives in the authorization department, it is imperative that staff knows the task cannot leave the department until

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Pa in M ed ic ine typically a challenge, and simply defining each department’s roles and responsibilities is not enough. One individual should be designated as project manager for execution of the change. This person, more than departmental managers, should act as the ultimate authority on “correct practice” in the new workflow. During the transition, many employees will make mistakes; the expectation that this will occur should be communicated. Nevertheless, the project manager must be

meticulous about following up on each step of the revised workflow and notifying staff members of inconsistencies when they happen. Repetition builds habit, and after enough time and practice, the responsibilities for ensuring that correct workflow is being followed can be offloaded from the project manager back to the departmental managers. During the transition period, however, the guidelines for “correct practice” should stem from a single source. When a plan is drafted, often the wording is

not well written and is subject to interpretation. As long as one person has a vision of correct practice, documentation can be revised during transition so that no misunderstanding is possible and all employees are following a single set of guidelines. Cross-Training And Critical Thinking Smaller practices that handle patients on a case-by-case basis tend to see DICE page 102

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the procedure has been either authorized or denied. The same holds for the clearance department, the task is not to leave the department until blood thinner clearance for the patient has been obtained or denied. The clearance department would then send the task to scheduling to complete the final stages of the process. Now, the marker details the task’s entire history including all necessary information for scheduling. This will include answers to questions such as: “Did the patient want to schedule the procedure? Did the patient obtain authorization? Was the patient denied clearance?” Now, all critical thinking required to successfully resolve the authorization process has been funneled to scheduling, whose main responsibility is to establish patient contact and move forward with scheduling. Execution This last stage in streamlining may be the most difficult because it requires transitioning from the status quo. The transition to a new workflow is

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P A I N M E D I C I NE DICE continued from page 101 produce valuable employees who have been cross-trained in many departments and are capable of handling many situations. Shifting these employees into a single and isolated area can be a frightening prospect for a smaller practice that relies on such employees’ flexibility and skill. The fear is twofold: a decrease in the capabilities of future employees and the development of a disconnect between staff and patients that decreases quality of patient care and satisfaction. The fear that employees may become less capable of handling duties outside of their departmental responsibilities is reasonable. However, compartmentalizing departments and funneling critical thinking should not discourage crosstraining of employees. Cross-training is enormously useful and is an important practice for employees working in a complicated and multifaceted environment like pain management. Such employee training also can benefit the DICE process. The most obvious benefit is apparent when an employee is absent from work. If another employee is cross-trained in the absent employee’s role, work will not be missed during the absence. Second, during unexpected employee turnover, multiple knowledgeable staff will expedite

on-boarding of a new employee, with significantly less negative impact to the organization’s daily workflow. The indirect benefit to cross-training employees in a compartmentalized organization is an increase in an employee’s ability to think critically. It becomes easy when repeatedly performing the same task to lose sight of the bigger picture—quality patient care—and not understand how actions at point A affect actions at point Z in

Simply defining each department’s roles and responsibilities is not enough. One individual should be designated as project manager for execution of the change. an organization. Having employees cross-train, or at least shadow those with whom they cannot cross-train, helps provide context to their work and ensures that when something unexpected occurs during the course of patient care, appropriate action is taken within each department. This should lead all staff to be aware of how their

work is part of the organization’s ultimate goal: excellent patient care. The second fear is that patient satisfaction and care will decrease with compartmentalization due to a disconnect between patients and staff. Although this is reasonable, it is one issue that an EMR has the capacity to handle. The nation is rapidly transitioning to more frequent use of EMR systems on the wave of federal incentives and the ability for these systems to provide improved health care is being observed. For example, since the implementation of an EMR system at APS, the practice has developed a patient concierge group (PCG)—a team exclusively dedicated to interacting with patients regarding treatments, procedures, appointments and nonmedical issues or emergencies. APS uses task messaging to record all of the various processes that occur related to a patient. This allows the PCG to answer patient questions accurately, and in real time, while avoiding the disruption of workflow in other operational departments, like authorization, billing or the clinic. Now, when patients call in to the clinic, they no longer need to speak with an authorization specialist to determine their authorization status. This information is listed in each patient’s chart and is immediately accessible to members of the PCG and other departments.

Conclusion In January 2011, APS used the DICE process to streamline the workflow of its authorization process. APS began with magnetic resonance imaging authorizations, followed by procedure authorizations. Productivity has increased dramatically and more authorizations are being submitted and obtained per month than ever before. Streamlining workflow is tough but necessary for growth. The DICE process provides a framework for how an organization can accomplish shifts in workflow while minimizing negative consequences and maximizing positive outcomes. If done properly, the DICE process will also help pain practices achieve two important goals: increase the quality of patient care and increase practice profitability. —Tory McJunkin, MD, Paul Lynch, MD, Sagar Gondalia and Ryan Tapscott, PhD Drs. Tory McJunkin and Paul Lynch founded Arizona Pain Specialists, a comprehensive pain management practice with three locations, seven pain physicians, 10 midlevel 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.

Massage Reduces Chronic Low Back Pain

assage therapy helps ease chronic low back pain and improve function, according to a randomized controlled trial published in the July issue of Annals of Internal Medicine. This study, the first to compare structural and relaxation (Swedish) massage, revealed that both types of massage worked well, with benefits lasting for six months (2011;155:1-9). “We found that massage helps people with back pain to function,” trial leader Daniel C. Cherkin, PhD, senior investigator at Group Health Research Institute, said in a statement, adding that better function means these individuals are more able to work, take care of themselves and be active. “This is important because chronic back pain is among the most common reasons people see doctors and alternative practitioners.” The study investigators enrolled 401 Group Health Cooperative patients, aged 20 to 65 years, who had

reported having low back pain for at least three months. The patients had “nonspecific” pain and were randomly assigned to one of three treatments: structural massage (n=132), relaxation massage (n=136) or standard care (n=133), the care these

patients would have received anyway. The hour-long massage treatments were given weekly for 10 weeks. At 10 weeks, more than one-third of patients who received either type of massage—but only 4% of patients who received usual care—said their back pain was much better or gone. The Roland Disability Questionnaire also showed that nearly twice as many massage patients as usual-care patients were functioning significantly better than at the beginning of the trial. Patients in the massage groups spent fewer days in bed, were more active and used less anti-inflammatory medications than did those who received usual care. After one year, however, the benefits of massage were no longer significant. Overall, the researchers concluded that massage is a good alternative treatment for patients experiencing chronic low back pain. —AN Staff

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Dynasthetics

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Vapor-Clean, From Dynasthetics Q: What is Vapor-Clean? A: Vapor-Clean is a set of activated charcoal filters placed on the anesthesia machine that block trace amounts of volatile anesthetics from reaching patients susceptible to malignant hyperthermia (MH).

Q: How is Vapor-Clean used? A: Each filter is connected to the breathing circuit and the anesthesia machine inspiratory and expiratory ports. The anesthesia machine is ready to deliver a completely vapor-free (fewer than 5 parts per million) anesthetic in less than 90 seconds.

Q: Without Vapor-Clean, how long do modern anesthesia machines need to be flushed at high fresh gas flow before they are safe to use with an MH-susceptible patient? A: That depends on the machine. Recent studies show that each machine must be flushed for as long as 104 minutes before it can be used safely with an MH-susceptible patient. Even after extended flushing, the concentration of vapor can rise to unsafe levels if the fresh gas flow is inadvertently lowered to normal levels.

Q: How quickly can an anesthesia machine be ready for use with a susceptible patient using Vapor-Clean? A: Studies have shown that the machine is ready within 90 seconds after installing the Vapor-Clean.

Q: What are the advantages of using Vapor-Clean over flushing? A: There are several: No waiting for a machine to be ready, saving costly operating room (OR) time; unlike flushing, because the filters are left in place during the case, the patient is protected for up to 12 hours; and, an OR schedule does not have to be thrown off by an unanticipated MHsusceptible patient.

Q: Have published studies shown that Vapor-Clean removes residual volatile anesthetics? A: Birgenheier et al in Anesthesia and Analgesia (June 2011) showed that Vapor-Clean effectively removes anesthetic to below 5 parts per million in less than 90 seconds when tested with isoflurane, sevoflurane and desflurane in DrĂ¤ger Apollo and Ohmeda Aestiva anesthesia machines. This study also showed that these machines require flushing at 10 L per minute for as long as 84 minutes before they are ready without Vapor-Clean.

Q: Is Vapor-Clean compatible with all anesthesia machines? A: Yes.

Q: Do I need to remove the vaporizers and soda lime before delivering anesthesia to an MH-susceptible patient? A: No. Vapor-Clean captures trace vapor released by all components of the anesthesia machine including the vaporizer and the soda lime.

Q: Do I need a new breathing circuit and bag when using Vapor-Clean? A: Yes.

Q: Does Vapor-Clean work with coaxial breathing circuits? A: Yes. Vapor-Clean filters are placed between the anesthesia machine and the coaxial circuit manifold.

Q: How does Vapor-Clean remove anesthetic vapors? A: The Vapor-Clean filter canisters contain granules of medical-grade activated charcoal, which captures volatile anesthetic vapor molecules.

Q: Can Vapor-Clean be reused? A: No. Vapor-Clean is a single-patient use device.

Q: Can Vapor-Clean be used if MH is detected intraoperatively? A: Yes. When installed intraoperatively, VaporClean removes residual anesthetic vapors emitted by the anesthesia gas machine as well as vapors exhaled by the patient.

Q: What is the source of residual anesthetic vapor in the anesthesia gas machine? A: Plastic and rubber components within the anesthesia machine (valves, tubing, bellows, etc) absorb anesthetic vapor. These absorbed gases are then slowly released when the machine is used for a new patient during a subsequent anesthetic procedure.

Q: Where is Vapor-Clean being used? A: Vapor-Clean is currently in use at many of the leading pediatric and adult hospitals in the United States and Canada.

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P A I N M E D I C I NE

Transient Neuropathic Pain Seen With Spinal Cord Stim

n approximately 1.4% of lumbar spinal cord stimulation (SCS) trials or permanent placements, patients experience transient, focal neuropathic pain, according to a presenter at the 2011 annual meeting of the American Pain Society. This adverse event has not been documented in the literature, the researchers said.

Linqiu Zhou, MD, of Woodbury Spine in Woodbury, N.J., reported on four cases of this phenomenon among 285 SCS procedures (165 patients) over five years. He said it is important to recognize this adverse event early, reassuring the patient that it is temporary and that the SCS is working. “Physicians should encourage their patients to continue using the

stimulator to treat their usual pain and to not discontinue stimulator therapy because they may think the treatment is not working,” said Dr. Zhou, whoalso is assistant professor of rehabilitation medicine at Jefferson Medical College, in Philadelphia. Dr. Zhou said the cause of the transient neuropathy could be irritation by the spinal needle or SCS lead insertion

of a single nerve fiber or a small group of fibers. Michael Whitworth, MD, a principal at Advanced Pain Management Surgery in Columbus, Ind., said he has seen this phenomenon in “a couple” of his own patients and that it resolved spontaneously in all cases. The majority of physicians placing round-lead neural arrays enter at a level lying directly over the cord, thereby exposing the cord to potential trauma from the needle or from the anterior-superior trajectory of the leads, Dr. Whitworth said. “At times, the leads produce a notinsignificant degree of compression of the dura during initial entry through the Tuohy needle, or if the lead buckles laterally during lead advancement,” he said. “Some impediments to advancement may include ligamentum flavum hypertrophy or asymmetry, bony canal stenosis, significant scoliosis, epidural lipomatosis or other causes for difficult advancement.” Thoracic magnetic resonance images are not usually taken before lead placement, he said. Therefore, the first sign of obstruction to advancement often occurs during attempted advancement of the lead. “It is possible this may cause some of the ‘hot spots’ as described by [Dr. Zhou], but this is entirely speculative at this point,” Dr. Whitworth said. Two of the four cases of transient neuropathic pain that Dr. Zhou uncovered in his retrospective chart review occurred after an SCS trial. Another occurred after implantation, while the fourth took place after both a trial and implantation. The patients all experienced pain localized to a small area of a lower extremity; in three patients this was in the dorsum of the first metatarsophalangeal joint; other locations were the median knee and the dorsal foot in the fourth patient. Dr. Zhou thoroughly examined each patient and found allodynia at the painful area, despite SCS being effective in relieving the primary pain. He treated each patient with methylprednisolone tapered over five to 10 days coupled with close follow-up; this completely resolved the pain without residual neurologic complications. None of the patients required removal of their SCS leads or stopped using SCS because of the transient neuropathic pain. —Rosemary Frei, MSc

Octo b e r 2 0 1 1

Disposcope

AnesthesiologyNews.com I 105

The following advertorial is provided as a service to our valued advertisers. It is designed to support the advertisement presented below.

Disposcope Q: What is Disposcope?

Q: How is the Disposcope cleaned?

A: Disposcope is an intubating stylet with a camera on the tip that transmits real-time video images wirelessly to a full-color display. It is a lightweight and portable system with the combined functionality of all other intubating devices.

A: We recommend using cold sterilization to clean the Disposcope. Every institution has its own method and chemical to do cold sterilization. Gas sterilization with ethylene oxide also can be used.

Q: What are the advantages of Disposcope?

Q: How much does Disposcope cost?

A: The Disposcope is an all-in-one device. When Disposcope is used with a laryngoscope, it has a video image similar to that of a video-assisted laryngoscope in the laryngeal area. Disposcope can be bent to any desired angle to have the same view as any optical laryngoscope. With a built-in light and video functionality, Disposcope can be used to intubate easily without a laryngoscope. Passing through the vocal cords, Disposcope serves the same function as a fiber-optic scope. In the trachea, Disposcope can be used as a simple bronchoscope. For detailed comparisons of Disposcope with other tools, please visit www.disposcope.us.

Q: Is learning how to use Disposcope difficult?

A: The cost of a complete Disposcope set is less than one-third the cost of other similar difficult-airway devices. With proper cleaning, each

The innovative Disposcope is a lighted stylet with cutting edge endoscopic technology that will revolutionize endotracheal intubation.

Disposcope can be used 20 times. For each use, it costs slightly more than regular disposable stylets, but is much safer and easier to use.

Q: Why will Disposcope revolutionize endotracheal intubation? A: With its all-in-one functionality and ease of use, Disposcope can be used alone for endotracheal intubation and has the potential to replace the laryngoscope completely in the near future. It will be the biggest change and improvement

All-in-one device provides the functions of a laryngoscope, lighted stylet, videoassisted laryngoscope, fiberoptic scope and simple bronchoscope.

since the beginning of endotracheal intubation.

Q: When is Disposcope available? A: Disposcope has been available in China and parts of Europe for almost a year. We are planning to begin distribution in the United States in October 2011. We will have a booth at the ASA and NYSSA annual conference this year, so please come and try the device. For more information, visit www.disposcope.us or email us at info@disposcope.us.

A lightweight, costeffective & portable system that includes a wireless handset, video-assisted stylet, full-color LCD display and a battery charger.

A: Using Disposcope with a laryngoscope is similar to using any other video-assisted laryngoscope. But the extra functionality enables the experienced clinician to use it easily. Using Disposcope without a laryngoscope is similar to using a lighted stylet, with the added option of real-time video guidance.

Q: Are there other clinical applications for Disposcope? A: Disposcope can be used for double-lumen insertion and nasal intubation, and it can also help to switch a supraglottic airway to tracheal intubation. Because Disposcope can function as a simple bronchoscope, it can confirm the correct location of an endotracheal tube more reliably than a stethoscope, a disposable CO2 detector or a chest x-ray. Disposcope also can be used to assist the insertion of a chest tube, placement of a nasogastric tube and more.

Q: Is Disposcope the ideal device for emergency situations and ambulatory surgical centers? A: Disposcope is a lightweight and portable system with the combined functionality of other intubating devices. Every surgical center has its own setup for difficult airway management, and clinicians cannot always find the tool that they are familiar with in an emergency situation. Disposcope’s portability and all-in-one functionality makes it ideal as the standard device for emergency situations and difficult airway management.

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P A I N M E D I C I NE

RF Neurotomy Found To Resolve Neck, Back Pain Chicago—More than half of patients treated with radiofrequency neurotomy (RFN) for back pain and more than two-thirds treated with RFN for neck pain experienced complete pain relief for at least six months, according to a study presented at the International Spine Intervention Society’s 2011 annual scientific meeting. The series comprised 210 consecutive

patients treated between June 2004 and December 2009 at two clinics in New Zealand. In addition to experiencing complete relief from pain, patients had to be able to complete all routine activities of daily living and return to work, and could not use analgesics or other health care. “The success criteria were overly strict, but the data corroborate what I

see in my own clinic practice: These procedures work in correctly selected patients,” said Manoj Bobby Wunnava, MD, assistant professor of anesthesiology at the University of North Carolina, in Chapel Hill. Lead investigator John MacVicar, MB ChB, medical director of the Southern Rehabilitation Institute, in Christchurch, New Zealand, said

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the outcomes are consistent with the results from benchmark studies on cervical and lumbar RFN and the study used the same techniques. “Our results show what can be achieved if patients are correctly selected and the correct technique is assiduously followed,” Dr. MacVicar said. “RF neurotomy is a precise technique and patients must first have complete relief from initial and confirmatory medial branch blocks. Success is also dependent on the use of larger-gauge needles and placing the electrode in a correct anatomical position, parallel to the nerves being treated.” Dr. MacVicar added that “carrying out additional confirmatory diagnostic blocks does take extra time and performing RFN in an anatomically accurate fashion is more time-consuming than other methods that are used, but the extra effort is well worth it when the result is better outcomes for the patients.” The researchers compared patient outcomes from two practices, A and B. Overall, the outcomes at the two practices were statistically similar. Nearly 60% of patients achieved complete relief of back pain and 68% had complete relief of neck pain for at least six months. Most were treated at the L3/4, L4/5, C2/3 or C5/6 levels. The median numerical pain rating (scale, 0-100) prior to treatment was 60 in practice A and 50 to 55 in practice B. The median duration of relief from a first procedure for cervical pain was 17 months in practice A and 20 months in practice B. With respect to lumbar pain, the median duration of relief from the first procedure was 15 months in each practice. When adding repeat treatments, the median duration of relief was 15 months (cervical) and 13 months (lumbar) in both practices, with ongoing relief in more than 60% of patients. The bulk of patients who did not benefit from RFN experienced no relief, Dr. MacVicar reported. “This latter finding was the most remarkable to me, as I expected a larger number of patients in the ‘unsuccessful’ group to have at least partial results,” Dr. Wunnava said. “Yet it seems that the nonresponders, for the most part, were true nonresponders in that they did not have any result from the radiofrequency procedure. This speaks to the effectiveness of the criteria for defining treatment success.” —Rosemary Frei, MSc

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Digital Revolution Comes to Anesthesia Library The Wood Library-Museum of Anesthesiology (WLM), in the Chicago suburb of Park Ridge, outbreaks in the collection since 1999, is the nation’s premier collection of manuscripts and other archival materials related to anesthesia and anesthesiology. The library has been undergoing a major push to digitize its holdings, and has revamped its Web site (http://www.woodlibrarymuseum.org). Anesthesiology News recently spoke with Mary Ellen Warner, MD, president of the WLM, about these and other changes occurring at the institution. AN: What’s the status of the digitization project for the rare book collection? How many titles— and of what nature—have been digitized so far? Dr. Warner: The WLM has the largest anesthesia rare book collection in the world, with more than 2,000 electronically catalogued books and papers in our collection. We have currently digitized more than 200 of our rare book items for ease of access and preservation. We will be digitizing at least an additional 100 rare book items in 2011 through our vendor, Northern Micrographics. Our initial goal was to continue digitizing items in the collection that haven’t already been digitized by other vendors, such as Google books and/ or Internet Archive. We will now duplicate some of Google’s efforts on our site, on a case-by-case basis, for improved ease of access. Our final goal is to have all our rare book holdings available in a digitized format. We have an extensive selection related to the ether controversy, mesmerism and blood transfusion. Other categories of our rare book collection include obstetrical anesthesia and techniques of intubation. The books that are online are easy to read and have the “turn the page” capability. This digitization will ensure that this valuable collection will be available for all to use far into the future for scholarly and research activity.

AN: When do you expect the project to be finished? Dr. Warner: The rare book project is one of many WLM digitization projects that are currently under way. We began to digitize our rare book items in July 2008 for access and preservation. After experiencing two mold

treating and preserving the rare items has become one of our highest priorities. Our rare book room was renovated in 2006 and now includes its own air filtration, HVAC and fire-suppressant systems. Due to the fragile nature of the rare book collection, our items are scanned see WLM page 108

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1 ASA Standards for Basic Anesthetic Monitoring, Committee of Origin: Standards and Practice Parameters (Approved by the ASA House of Del egates 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%20 Guidelines%20Stmts/Basic%20Anesthetic%20Monitor ing%202011.ashx 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

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A D LI B WLM continued from page 108 bound using a variety of scanners. The bound-book scanners use book cradles to help support the book spine to reduce stress on the binding. Undergoing many steps in the digitization process, from TIFF image files to PDF files, the final product is a searchable PDF file. This process is quite laborintensive and time-consuming. Therefore, the timeline for completion will be over the next decade.

AN: Will these materials be open to the general public or only to members of the American Society of Anesthesiologists?

professionals in medicine and the public in general who have an interest in the history of our specialty, to have the ability to access these remarkable materials.

other libraries, hospitals, etc.?

Dr. Warner: Many of our rare book items, including manuscripts, come from private donations and purchases Dr. Warner: These treasures are AN: Where do the made from antiquarian book Mary Ellen Warner, MD available to anyone who wishes to dealers. Our honorary curaaccess our Web site or arrange a visit rare manuscripts tor, George Bause, MD, MPH, is always in person. We want our ASA members, come from: private collections, on the lookout for rare treasures. He is also one of WLM’s most valuable treasures. Another WLM treasure is Charles Tandy, MD, who has an extreme passion for collecting rare books. He remains very committed to WLM’s collection and preservation of our rare books. We also have a very large archive collection, which is in its early stages of digitization. The purpose of our archive collection is to document events in anesthesia history, provide a resource for scholars and to illustrate the development of anesthesia. The collection includes but is not limited Get the latest news from the best-read to letters, photographs, manuscripts, anesthesiology publication in the country delivered membership lists, minutes, organization records, scrapbooks, newspaper directly to your computer or mobile device for free! clippings, newsletters and other items relevant to anesthesia and the medical specialty of anesthesiology.

e-Newsletters and e-Alerts

AN: What other digitization efforts are under way?

Each installment contains articles from the current month’s issue ahead of print, as well as links to podcasts and other Web-exclusive content

anesthesianews

Dr. Warner: The WLM is embarking on a major digitization project of our museum, library and other holdings. Over a relatively short time period, we will digitize our museum pieces, rare book collections, living history videos and our archival collections. In essence, we are developing a virtual museum and anesthesiology library with this digitization project. More than 100 artifacts in the WLM gallery collections have recently undergone digital image capture. Both virtual “3-D” images (which require more than 100 separate photos of each object) and two-dimensional images are being acquired for these artifacts. These images will form the basis of a digital exhibition. Plans are under way to link the digitized objects to other areas of the WLM collection, including our Living History interviews, archives and rare book collections, thus enhancing access by online pairing of artifacts with interpretive data. In addition, original artistic sketches of these treasures are prominently displayed on our Web site alongside the photographic images. We have a very large collection of

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oral history interviews. This oral history collection provides insight and historical perspectives from pioneers and leaders who experienced and contributed to the history of our specialty. These interviews constitute an authentic record of the contemporary history of anesthesiology. The WLM also archives hundreds of related audiotapes. We began to convert our oral history and educational film collection to a digital format in 2005. Using local vendors, our VHS tapes and 16-mm films were converted to DVD, and the digital files were backed up on portable hard drives. One of our biggest challenges is keeping up with ever-evolving technology. Other collections that we have begun to digitize include art, photographs and archives. Again, our longrange plans include the digitization of all our collections for preservation, ease of access, research and education. As we continue these digitization efforts and Web site development, retaining actual space for our library and museum is a must. Our artifacts, rare books, art, photographs, videos, archives and other holdings still need to be stored in the proper environment for preservation and for research and educational purposes.

AN: The library has endured recent budget cuts. How is it able to pay for this initiative? Dr. Warner: The WLM relies on several sources for funding to continue our mission of preserving the past to promote the future of the specialty of anesthesiology. The major financial sources of support are our parent organization, the ASA, individual donors, anesthesiology component (state) society donations and anesthesiology subspecialty society donations. Support of the WLM by the ASA has been variable depending on their annual budget needs as support of its foundations is just one of its budgetary considerations. While the WLM did receive a significant donation reduction from the ASA in 2010, in 2011 the ASA was very generous in its donation to support our digitization and Web site efforts. This was a collaborative effort, as much of our gallery space was needed by ASA to support their increasing staff needs. In order to reduce our gallery space, increasing the speed of our digitization efforts was essential. This collaboration has been a win-win for both the ASA and the WLM. The ASA has

gained some much-needed space for its staff. The WLM has been allowed to showcase some of its collections throughout ASA headquarters space. We have recently repopulated our new gallery space in our smaller footprint. Individual, state component society and subspecialty society donations are also vital to supporting our efforts. We presently have a special donation activity, the Patrick Sim MLS Memorial

Fund, to honor Patrick Sim, our esteemed librarian who passed away in October 2010. Patrick dedicated more than 39 years of continuous service to the WLM, ASA and the profession of anesthesiology. He was a friend, colleague and mentor to many individuals over the years. Donations to this fund will be used to endow the librarian’s position, The Patrick Sim, MLS Librarian. 

anesthesianews

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A D LI B

Super-obese Patient Presents Airlift, Airway Challenges

n his previous career as a firefighter, Steven Powell, MD, twice rented a U-Haul truck to transport patients who were too obese to fit inside a standard ambulance. Now that he was a physician, Dr. Powell faced the ultimate challenge: the transportation and treatment of a patient weighing half a ton. This patient survived—thanks not only to Dr. Powell’s improvisational skills but also to the generosity of the U.S. Air Force, which bent the rules by allowing a massive Chinook helicopter to fly in from another state to transport him from a small hospital to the largest one in northern New England. Dr. Powell said the patient was an extreme example of the difficulties that anesthesiologists face when confronted with profoundly obese patients. Besides the transportation problem, these patients also present considerable challenges in airway management and finding a central line for drug therapy. “There’s no real guidance,” said Dr. Powell, who discussed the episode at the 2011 annual meeting of the Canadian Anesthesiologists’ Society (abstract 1054094). “When you get patients this large, there’s no study, no pharmacy [guidelines], no recommendations. You have to rely on your training and you have to be prepared.” Dr. Powell said he expected that the problem will become less rare because of America’s obesity epidemic. According to the Centers for Disease Control and Prevention, the rate of morbid obesity (body mass index [BMI] of 40 kg/m2 or greater) rose from 4.7% in 2000 to 5.7% in 2008. Treating the super-obese population—let alone transferring them from one hospital to another—is “an enormous challenge, and I don’t mean to make this a pun,” said Jon Benumof, MD, an anesthesiologist at the University of California, San Diego School of Medicine and chief architect of the difficult airway algorithm for the American Society of Anesthesiologists. The episode began on Dec. 30, 2008, when a 32-year-old man arrived at New London Hospital in New London, N.H., complaining of breathing difficulty. His last known weight had been 580 pounds, but this time the scale registered 1,018 pounds. His BMI was 134. Intubation Impossible The patient was stable for three days, but his condition deteriorated quickly on the fourth day, when he went into what Dr. Powell called “full-fledged respiratory arrest.” At this point, the patient’s size became a literal barrier to his treatment. “It was remarkable that his oropharynx was so small,” Dr. Powell said, adding that his large tongue made it worse. “We could not intubate him.” Dr. Powell, the emergency room physician and a paramedic all tried without success, before they finally managed to insert a supraglottic airway sized for a child. After sedating the patient with propofol and midazolam, the team inserted an endotracheal tube with the help of a GlideScope (Verathon Medical). “You really need to optimize the conditions under which you tackle the airway,” Dr. Benumof said.

Morbidly obese people deposit excess fat inside their bodies as well as nearer the skin. The fat around their necks poses an additional hurdle because it restricts the ability of clinicians to position the head correctly. One study found difficulty with intubating 15.5% of obese patients compared with 2.2% of lean ones (Anesth Analg 2003;97:595-600). “The large tongue is very problematic to get out of the way so you can visualize the vocal cords,” Dr. Benumof said. Another obstacle was gaining IV access. “We didn’t have long-enough tools to access his veins,” Dr. Powell said. This is a common problem, said Dr. Benumof, because even in a comparably lighter but still morbidly obese patient weighing 600 pounds, “finding and accessing the veins is much more difficult because they’re hidden.” Dr. Powell said he finally inserted a four-inch-long intraosseous needle into the patient’s left humerus and kept it there with a snug elastic bandage.

have lift systems, but none was available. Dartmouth’s medical helicopter couldn’t take more than 1,300 pounds total (the patient’s bed alone weighed several hundred pounds), and its stretcher had a limit of 350 pounds. Black Hawk helicopters were deployed to Iraq, but also would have had a problem. A Coast Guard unit in Massachusetts told Dr. Powell that it had a chopper that could handle the patient’s weight but not his volume. A last resort was the Air Force Rescue Center in Washington, D.C. The Air Force sent a 100-foot-long, Army Reserve CH-47 Chinook helicopter from Connecticut. The twin blade hubs create hurricane-force winds near the ground, so takeoff and landing were tricky—especially in a small landing area. Dr. Powell and his team winched the patient’s bed to a tow truck to get him to a landing zone and into the chopper for the brief flight. Even at Dartmouth-Hitchcock, the patient’s weight presented problems for IV and intramuscular injection of drugs, radiology and ultrasound, and also the risk Special Resources Required for bedsores. But finally, the patient was stabilized. A major medical center is the best place for super“People have to take a measure of themselves and obese patients because they require special equipment their environment and say, ‘Am I properly equipped to and imaging devices, Dr. Benumof said. Operating- deal with these patients?’” Dr. Benumof said. “If not, room tables for extremely obese people are not widely don’t be macho about it. I think this guy who did all distributed, and smaller hospitals have been known this transporting deserves great commendation.” to strap two tables together. Even routine equipment “I felt that if I didn’t get him out, he’d be dead,” like appropriately sized blood pressure cuffs can be Dr. Powell said. But “the effort it took for me to transproblematic. fer him from a small hospital to a large hospital was Dr. Powell knew he had to take the patient imme- very difficult.” diately to Dartmouth-Hitchcock Medical Center in The story does have a lighter side. The patient, sufLebanon, N.H., the most advanced facility in the area ficiently frightened by his experience, decided to and a half-hour drive away. It also happened to be change his lifestyle. Within a year, he was down to 655 where Dr. Powell worked. He again considered renting pounds. And for inspiration, he needs to look no fara U-Haul, but the temperature was only 2 F outside ther than his arm. It now bears a tattoo of the number and the cold posed a danger to both the patient and of the Chinook that saved his life. the workers. Bariatric ambulances can take on heavier loads and —John Dillon

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