The best-read anesthesiology publication in the United States
THE INDEPENDENT MONTHLY NEWSPAPER FOR ANESTHESIOLOGISTS AnesthesiologyNews.com • A p r i l 2 0 1 5 • Volume 41 Number 4
anesthesiologynews @anesthesianews
VISIT US AT SCA BOOTH #100 AND ERAS BOOTH #6
for iPad
ASA Membership: Some Say No
Closed Claims Airway Injury Analysis Spotlights Problems
Are changes needed?
A
Robert E. Johnstone, MD
I
practice anesthesiology, so I belong to the American Society of Anesthesiologists (ASA). The ASA organizes the specialty, develops standards, unites me with colleagues and represents us to the public. I joined in medical school, and have benefited in myriad ways since. But some anesthesiologists
lthough 15 years have passed since the last airway injury analysis of the American Society for Anesthesiologists (ASA) Closed Claims Project, new research reveals that pharyngeal and esophageal perforations continue to be a significant source of patient morbidity and mortality—as well as liability for anesthesiologists. The investigators noted, however, that practitioner diligence is key to reducing the severity of these sometimes-fatal injuries. “In 1999, Domino et al published a review of airway injuries [Anesthesiology [
see ASA page 46
see airway page 18
Administering Death, Terminating Suffering Baby boomers fuel growing interest in the right to die; physicians’ role still hotly debated
I
n November 2014, Brittany Maynard ended her life in Oregon, availing herself of that state’s right to die law. Young, attractive and willing to speak with candor about her decision, Maynard captured the nation’s attention. A month later, in Baltimore, Lawrence Egbert, MD, an 87-year-old anesthesiologist, trained at Johns Hopkins University and the University of Maryland, lost his
10
CLINICAL ANESTHESIOLOGY
Goal-directed fluid therapy reduces post-op morbidity and health care costs.
medical license for allegedly helping six Maryland residents end their lives. Maynard and Egbert are two faces from the same conversation, grabbing headlines and reinvigorating the debate over physician-assisted suicide—or what proponents call physician aid-in-dying—and what role, if any, doctors should have in helping sick individuals end their lives. see assisted page 36
26
POLICY & MANAGEMENT
Bundled payment arrangements require negotiation armed with data.
42
TECHNOLOGY
Biomedical informatics may revolutionize medical research and patient care.
44
COMMENTARY
A Passover metaphor on the incidence of adverse events.
48
CME: PREANESTHETIC ASSESSMENT
Lesson 315: Assessment of the Neonate With Patent Ductus Arteriosus
EDUCATIONAL REVIEW Perioperative Anesthesia Care for Obese Patients, see insert after page 56.
NEW PRODUCT see pages 7 and 22 A7 Anesthesia Workstation from Mindray
ffor iPad see page 4
REPORT Managing Venous Thromboembolism Risk in Hereditary Antithrombin Deficiency see insert at page 28
Be the Owner of the Perioperative Home in Your Facility Practical Application of an Innovative Initiative
The surgical home is a widely discussed but rarely implemented concept in the healthcare industry. The TelePREOP platform is designed specifically to engage all parties of the perioperative process to promote coordination of care for the patient. TelePREOP leverages an industry leader in the technology platform we selected, ePREOP. TelePREOP can engage all Hospital Information Systems that power your healthcare facilities without the overwhelming burden of implementation. The power of the TelePREOP service and platform is that we screen nearly all of your patients prior to the procedure. This effort ensures coordinated data flow from Labs, H&P, and clearances from Cardiac and Anesthesia. This combined with our employed nurses dramatically reduces your case cancellations and delays while streamlining your bottom line.
www.TelePREOP.com
2
01
5
www.AIAPMConference.com
April 17-19, 2015
The Cosmopolitan of Las Vegas
Advanced Institute for Anesthesia Practice Management Securing the Future for Anesthesia Practices
The Advanced Institute for Anesthesia Practice Management will be held April 17–19, 2015 at The Cosmopolitan of Las Vegas. The 2015 Advanced Institute for Anesthesia Practice Management will focus on practice management issues with the goal of enlightening attendees on broader group strategy issues, including numerous talks on billing, coding and compliance. This live activity has been approved for AMA PRA Category 1 Credit™
For full conference information and to register for the AIAPM Conference, please visit www.AIAPMConference.com or email info@AIAPMConference.com
20 CME Credits
Conference Speakers Frank Rosinia, MD Chairman, Department of Anesthesiology, Tulane University School of Medicine John Di Capua, MD CEO, NAPA Management Services Corp Howard Greenfield, MD Principal, Enhance Healthcare Keith J. Ruskin, MD Professor of Anesthesiology and Neurosurgery, Yale University School of Medicine, Chairman of the Board, National Anesthesia Clinical Outcomes Registry Vincent J. Vilasi, MD, MBA CEO, Mid-Atlantic Division NAPA Stanford R. Plavin, MD Partner/Owner: Ambulatory Anesthesia of Atlanta/Savannah, President; Perioperative Management Services LLC Mark F. Weiss, Esq. The Mark F. Weiss Law Firm Vicki Myckowiak, Esq. Myckowiak Associates, PC
JOINTLY PROVIDED BY:
Jeff B. Swearingen Managing Director, Edgemont Capital Partners, LP Robert Tennant, MA Senior Policy Advisor, Medical Group Management Association Neda Ryan, Esq. Anesthesia Business Consultants, LLC Daniel W. Simile, Jr., CPA Executive Vice President of Practice Management, Zotec Partners Marvel J. Hammer, RN, CPC, CCS-P, PCS, ACS-PM, CPCO MJH Consulting Kelly Dennis, MBA, ACS-AN, CAN-PC, CHCA, CPC, CPC-I Perfect Office Solutions, Inc. Devona Slater, CHA, CHC, CMCP President, Auditing for Compliance and Education Judi Blaszczyk, RN, CPC, ACS-PM Compliance Auditor, Auditing for Compliance and Education
4 I AnesthesiologyNews.com
APRIL 2015
DIGITAL
for iPad
Web Tracker
Last month’s most-viewed iPad article
Read the five most-viewed articles last month on AnesthesiologyNews.com 1.
2.
3.
Survey: Earliest The Anesthesiologists Known Film on ‘Perioperativists’ Think They Should Anesthesia Use Are Coming! (Web Exclusive) Be in Charge
4.
5.
Analysis of Anesthesia Start Times Aims To Create National Benchmarks
Perioperative Surgical Home Promotes Perioperativists
Join the Conversation Tweet @anesthesianews using #anesthesianews
Tweets of Interest James Crichton @jcicrichton Fascinating talk by @traumagasdoc but particular commendation for withstanding the barrage as an anaesthetist in a room full of surgeons!
NIHR Research @OfficialNIHR Looking for new people to #peerreview for #NIHR http://ow.ly/KiaKr
NEJM @NEJM “Has your gender impacted your specialty choice?” Read replies in #NEJMForum on women physicians in leadership roles. http://nej.md/1MqBSh6
Taylor Zhou @canibagthat Stridor is sign of impending complete airway obstruction, shouldn’t be left alone and Anesthesia should be called ASAP @FOAM_Highlights
ROBERT S. LAGASSE, MD, New Haven, CT
ELIZABETH ZHONG, Associate Copy Chief
ALEX MACARIO, MD, MBA, Stanford, CA
RICHARD TUORTO, Senior Group Publication Director richardt@mcmahonmed.com, (212) 957-5300, x 916
PETER J. PAPADAKOS, MD, Rochester, NY THE INDEPENDENT MONTHLY NEWSPAPER FOR ANESTHESIOLOGISTS
AnesthesiologyNews.com • mcmahonmed.com
ADVISORY BOARD JEFFREY L. APFELBAUM, MD, Chicago, IL
MICHAEL F. ROIZEN, MD, Cleveland, OH
All U.S. anesthesiologists should receive Anesthesiology News free of charge. If you are not receiving the publication, or if you are changing your name or address, please follow these instructions:
CRAIG WILSON, Sales Associate, Classifieds cwilson@mcmahonmed.com, (212) 957-5300, x 235
JOAN E. SPIEGEL, MD, Boston, MA
MICHELE MCMAHON VELLE, MAX Graphics/Creative Director
MARJORIE STIEGLER, MD, Chapel Hill, NC
BLAKE DENNIS, MAX Graphics/Art Director
PAUL G. BARASH, MD, New Haven, CT
SUSAN T. VERGHESE, MD, Washington, DC
KEITH CANDIOTTI, MD, Miami, FL
EUGENE R. VISCUSI, MD, Philadelphia, PA
PETER J. DAVIS, MD, Pittsburgh, PA
CHARLES B. WATSON, MD, Bridgeport, CT
D. JOHN DOYLE, MD, PHD, Cleveland, OH
PAUL F. WHITE, PHD, MD, Los Altos, CA
LEE A. FLEISHER, MD, Philadelphia, PA
NOT RECEIVING ANESTHESIOLOGY NEWS?
ANGELA LABROZZI, Manager, Publication Sales alabrozzi@mcmahonmed.com, (212) 957-5300, x 204
LINDA S. POLLEY, MD, Ann Arbor, MI
DAN RADEBAUGH, Director of Production and Technical Operations MARTIN BARBIERI, Production Manager
MCMAHON GROUP
ELIZABETH A.M. FROST, MD, New York, NY CLIFFORD GEVIRTZ, MD, New York, NY JULIAN M. GOLDMAN, MD, Boston, MA ADMIR HADZIC, MD, PHD, New York, NY
RAYMOND E. MCMAHON, Publisher, Managing Partner
MCMAHON PUBLISHING
VAN VELLE, President, Partner
JAMES PRUDDEN, Group Editorial Director, jprudden@mcmahonmed.com
ZEEV N. KAIN, MD, Irvine, CA
DAVID BRONSTEIN, DON PIZZI, Editorial Directors
ALAN KAYE, PHD, MD, New Orleans, LA
ROBIN B. WEISBERG, Manager, Editorial Services
1) Contact the American Medical Association (AMA) at (800) 262-3211 or the American Osteopathic Association (AOA) at (800) 621-1773, and notify them of your name, address and professional specialty. You need not be a member of the AMA or AOA to receive the publication. 2) For added assurance of uninterrupted service, you may also mail or fax a copy of your current mailing label, along with your change of name or address to:
BRANDY WILSON, Circulation Coordinator
DAVID WLODY, MD, Brooklyn, NY
TO RENEW ONLINE Go to AnesthesiologyNews.com/Renew.
MATTHEW MCMAHON, General Manager, Partner LAUREN MCMAHON SMITH, MICHAEL P. MCMAHON, MICHELE MCMAHON VELLE, ROSANNE C. MCMAHON, Partners
Circulation Coordinator, Anesthesiology News 545 West 45th Street, 8th Floor New York, New York 10036 Fax: (212) 664-1242 Email: circulation@mcmahonmed.com Please sign and date all requests. If you are not a U.S. anesthesiologist and would like to subscribe, please send a check payable to Anesthesiology News to the Circulation Coordinator. Annual subscription: $70 (outside U.S.A., $90). Single copies: $7 (outside U.S.A., $10). Please allow 8-12 weeks for delivery of the first issue. McMAHON PUBLISHING, Sales, Production and Editorial Offices: 545 W. 45th St., 8th Floor, New York, NY 10036 Tel. (212) 957-5300 Corporate Office: West Redding, CT
McMahon Publishing is a 43-year-old, family-owned medical publishing and medical education company. McMahon publishes six clinical newspapers, nine annual or semiannual Special Editions, continuing medical education and custom publications.
Copyright © 2015 McMahon Publishing, New York, NY 10036. All rights reserved. Anesthesiology Newss (ISSN 0747-4679) is published monthly for $70 per year by McMahon Publishing. Periodicals postage paid at New York, NY, and at additional mailing offices.
®
® ®
®
®
REPORT
POSTMASTER: Please send address changes to Anesthesiology News, 545 W. 45th St., 8th Floor, New York, NY 10036.
The Root of Brain Function Monitoring A more complete picture starts with more complete data
®
SedLine brain function monitoring for the Root™ patient monitoring platform helps clinicians improve anesthetic management by enabling more individualized titration. > Connects to Root via Masimo Open Connect™ (MOC-9™) > 4 simultaneous EEG channels provide continuous assessment of information about both sides of the brain > A single sophisticated algorithm provides accurate, reliable information about a patient’s response to anesthesia > Instantly interpretable, high-visibility display of Masimo’s breakthrough rainbow and SET measurements from ®
Masimo’s Radical-7 handheld monitor ®
www.masimo.com © 2014 Masimo. All rights reserved. Caution: Federal law restricts this device to sale by or on the order of a physician.
®
6 I AnesthesiologyNews.com
APRIL 2015
CLINICAL ANESTHESIOLOGY
Pre-op Aspirin in Cardiac Patients Lowers Post-op Risk for Stroke and Infectious Endocarditis
N
ew Orleans—Aspirin before cardiac surgery significantly reduced postoperative permanent stroke and infectious endocarditis, a benefit that was not associated with increased risks for other potential adverse events. According to Vwaire J. Orhurhu, MPH, there is scant research in the effect of aspirin administration before cardiac surgery. He and his colleagues at Beth Israel Deaconess Medical Center and Harvard School of Public Health, both in Boston, studied the records of 7,599 patients who had undergone non-emergencyy cardiac surgery at the institution between January 2002 and December 2013; 4,159 patients were included in the final analysis (Table). Mr. Orhurhu is currently a medical student at Mayo Clinic. Aspirin exposure or non-exposure was documented based on a simple yes or no response. “So it’s a binary exposure arm,” Mr. Orhurhu said. A total of 3,161 patients were taking aspirin preoperatively; 998 were not. “We identified 16 preoperative variables that were significantly associated with preoperative aspirin,” he added. These variables were included in a logistic regression model and propensity scores were calculated. Preoperative aspirin exposure and the propensity score covariate were included in an additional logistic regression model to predict mortality and eight postoperative outcomes. After propensity score adjustment, permanent stroke was found to be significantly less common in patients who took preoperative aspirin than in their non-aspirin counterparts (40 patients or 2.58% vs. 29 patients or 6.30%; propensity-adjusted odds ratio [OR], 0.52; 95% confidence interval [CI], 0.28-0.94; P=0.031). Moreover, infectious endocarditis was also found to be significantly less common in aspirin patients than non-aspirin patients (60 patients or 1.90% vs. 79 patients or 7.92%; propensity-adjusted OR, 0.47; 95% CI, 0.30-0.75; P=0.001). In contrast, operative mortality was comparable between groups, affecting 60 patients (1.9%) in the aspirin group and 20 patients (2.0%) in the non-aspirin group (OR, 1.23; 95% CI, 0.57-2.77; P=0.565). This ratio did not change after propensity score adjustment. No significant association was seen between aspirin and other postoperative outcomes. “When we looked at outcomes like operative mortality, transient ischemic attack, bleeding, renal failure, pneumonia, hospital readmission and time on ventilation, we didn’t really find any significant association with aspirin use,” he said. “So the good news here is that we found that permanent stroke and infectious endocarditis were both significantly lower among patients who were on preoperative aspirin,” said Mr. Orhurhu, who reported the findings at the annual meeting of the American Society of Anesthesiologists (abstract A2280). Session moderator Brian S. Rothman, MD, asked if there is any evidence corroborating the study’s
findings. “Obviously, stroke and infective endocarditis are unwelcome complications,” said Dr. Rothman, associate professor of anesthesiology at Vanderbilt University Medical Center, in Nashville, Tenn. “Is this consistent with other studies?” “A recent large, randomized controlled study [N Engl J Medd 2014;370:1494-1503] compared aspirin with placebo in non-cardiac surgery and found no association between preoperative aspirin administration and permanent stroke,” Mr. Orhurhu replied. “Nonetheless, we need to further investigate the temporality of infectious endocarditis to the time of preoperative aspirin administration to ascertain if this may actually be an unwelcome complication.”
Indeed, the 10,010 participants in that trial were stratified according to whether they had not been taking aspirin before the study (n=5,628) or were already on an aspirin regimen (n=4,382). The study’s primary outcome was a composite of death or nonfatal myocardial infarction at 30 days, which occurred in 7.0% of patients in the aspirin group and 7.1% in the placebo group. Despite this comparability, major bleeding was more common in the aspirin group (4.6% vs. 3.8%; P=0.04). —Michael Vlessides There were no relevant financial disclosures.
Table. Relationships Between Patient Characteristics and Aspirin Use Aspirin Use Characteristics
No
Yes
Patients, n (%)
998 (24)
3,161 (76)
Age, y
59.59±15.89
66.52±11.45
<0.0001
Sex (% female)
416 (41.68)
866 (27.40)
<0.0001
BSA <1.7 m2, n (%)
193 (19.34)
372 (11.77)
<0.0001
BMI (kg/m2)
27.58±6.13
28.64±5.49
<0.0001
White race, n (%)
875 (87.68)
2,858 (90.44)
0.1080
Diabetes, n (%)
140 (14.03)
1,105 (34.96)
<0.0001
Current smoker, n (%)
148 (20.41)
503 (19.24)
0.7770
Hypertension, n (%)
584 (58.52)
2,601 (82.28)
<0.0001
Last creatinine level
1.10±1.00
1.15±0.89
0.1270
Diagnosis of PVD, n (%)
80 (8.02)
456 (14.43)
<0.0001
Diagnosis of CHF, n (%)
192 (19.24)
576 (18.22)
0.4710
Chronic lung disease, n (%) None Mild Moderate Severe
867 (86.87) 90 (9.02) 33 (3.31) 8 (0.80)
2,797 (88.48) 286 (9.05) 52 (1.65) 26 (0.82)
Ejection fraction, n (%) <40% ≥40%
72 (7.21) 926 (92.79)
411 (13.0) 2,750 (87.0)
637 (63.83)
2,133 (67.48)
164 (16.43) 834 (83.57)
760 (24.04) 2,401 (75.96)
Preoperative IABP, n (% yes)
10 (1.0)
36 (1.14)
0.719
Perfusion time, min
108.20±48.41
96.15±36.26
<0.0001
Cross-clamp time, min
87.13±37.04
73.87±29.97
<0.0001
β-blocker use, n (%)
461 (46.19)
2,351 (74.38)
<0.0001
ACE inhibitor use, n (%)
296 (34.38)
1,302 (47.28)
<0.0001
CABG, n (%)
235 (23.55)
2,208 (69.85)
<0.0001
Left main disease ≥50%, n (%) Operative status, n (%) Urgent Elective
P Value
0.0150
<0.0001
0.0330 <0.0001
ACE, angiotensin-converting enzyme; BSA, body surface area; CABG, coronary artery bypass graft; CHF, congestive heart failure; IABP, intraaortic balloon pump; PVD, peripheral p p vascular disease
the best of both worlds introducing â&#x201E;˘
A N E S T H E S I A W O R K S TAT I O N
The new A7 Anesthesia Workstation
The A-Series warmed breathing system,
combines the simplicity and familiarity of
ascending bellows, and fully supported back
traditional anesthesia delivery with advanced
up gas delivery system offer the security,
technology, performance, and design.
safety, and reliability that defines traditional
Electronic fresh gas flow control ensures
anesthesia delivery.
precise gas flow dynamics with accurate
The feature-rich A7 maximizes valuable
and responsive support for your clinical and
resources by providing the technology you
cost saving requirements, including low flow
need to enhance workflow and provide
anesthesia delivery.
effective care across a wide range of patients
Agent usage calculation assists in
and clinical challenges.
determining the per case cost of expensive
With the A7 Anesthesia Workstation, tradition
inhalation agents.
and technology come together to give youâ&#x20AC;Ś the best of both worlds.
Mindray North America, 800 MacArthur Blvd., Mahwah, NJ 07430 800.288.2121 www.mindray.com
8 I AnesthesiologyNews.com
APRIL 2015
CLINICAL ANESTHESIOLOGY
Aspirin Pre–Cardiac Surgery Benefits Chronic Kidney Patients New Orleans—Preoperative aspirin administration decreases postoperative acute kidney injury and mortality in patients with chronic kidney disease undergoing cardiac surgery, a study finds. “In previous studies, we found that aspirin pretreatment before surgery reduces perioperative complications and mortality in patients undergoing
cardiac surgery,” said Jian-Zhongg Sun, MD, PhD, professor of anesthesiology at Thomas Jefferson University, in Philadelphia. “Generally speaking, aspirin works for surgical patients presenting with high cardiovascular risk, but whether aspirin also provides the same protection for patients with chronic kidney disease is not clear.” To address this question, Dr. Sun and
his colleagues examined the records of 5,175 consecutive patients undergoing cardiac surgery in two tertiary care hospitals; 3,585 met inclusion criteria. These individuals were divided into two groups: those who did or did not take aspirin within five days of surgery. Baseline estimated glomerular filtration rate (eGFR, mL/min/1.73 m2) was classified as normal, greater than 90;
Love at first sight
PRECISION Enables accurate placement with unparalleled control
CONTINUOUS VIEW Provides visual assurance during intubation
The world's only Lung Isolation System that combines airway ventilation and visualization in a disposable device Visit us during SCA at Washington DC, April 12th - 14th and you too will change the way Lung Isolations are performed
CONFIDENCE Facilitates fast, efficient intubation
mildly decreased, 60 to 89; moderately decreased, 30 to 59; severely decreased, 15 to 29; or kidney failure, less than 15. Chronic kidney disease was defined as eGFR less than 60 mL/min/1.73 m2. Postoperative acute kidney injury was defined by Acute Kidney Injury Network criteria (Crit Caree 2007;11:R31). Major outcomes included acute kidney injury, length of ICU stay, readmission, major adverse cardiovascular events and 30-dayy mortality. Dr. Sun noted that 31.5% of patients had chronic kidney disease at baseline. Outcomes worsened as chronic kidney disease became more severe. Indeed, acute kidney injury, major adverse cardiovascular events, ICU stay, hospital readmission and 30-dayy mortality increased 2.1-, 3.5-, 1.8-, 3.1- and 4.6-fold, respectively, for patients with eGFR 15 to 29 compared with 90 mL/ min/1.73 m2 or greater (P<0.001). “If patients take aspirin before the surgery, postoperative acute kidney injury and mortality are decreased compared with the patients who didn’t take preoperative aspirin,” Dr. Sun said in an interview with Anesthesiology News. Multivariate logistic regression adjusted with propensity scores showed that preoperative aspirin use was associated with a significant decrease in postoperative acute kidney injury, major adverse cardiovascular events and 30-dayy mortality. Dr. Sun reported the findings at the annual meeting of the American Society of Anesthesiologists (abstract A2046). The study has been published in Annals of Surgery (2015;261:207-212). “Interestingly, the survival benefit of aspirin therapy was greater in patients whose baseline kidney function was worse,” Dr. Sun reported. Thirty-day mortality was reduced by 23.3% for patients whose baseline eGFR exceeded 90, compared with a 58.2% mortality reduction in those with baseline eGFR of 30 to 59, and a 79.0% reduction in those with a 15 to 30 baseline eGFR. Determining why aspirin has these effects is more challenging to answer. “It’s a really tricky question,” Dr. Sun said. “I think one is related to aspirin’s antiinflammatoryy effects. Secondly, [it is] antiplatelet and antithrombotic.” These benefits come at the potential cost of excessive bleeding, but Dr. Sun found that this was not significant in the study. —Michael Vlessides The author reported no relevant financial relationships.
www.etview.com
APRIL 2015
AnesthesiologyNews.com I 9
POLICY & MANAGEMENT
Physicians Voice Concerns on ICD-10 Transition
T
he American Medical Association (AMA) and 99 other physician groups—including the American Society of Anesthesiologists—signed a letter to the Centers for Medicare & Medicaid Services (CMS) to voice their concerns over the upcoming deadline to switch over to ICD-10 codes. Many physicians are worried that the transition could significantly affect them financially and the care they provide to Medicare patients. They said recent end-to-end testing results show that the Medicare claims acceptance rate would drop from 97% to 81% if ICD-10 codes were currently effective. The letter called for better contingency plans and for the CMS to consider how the transition will affect quality reporting programs. “The likelihood that Medicare will reject nearly one in five of the millions of claims that go through our complex health care system each day represents an intolerable and unnecessary disruption to physician practices,” said
Robert M. Wah, MD, AMA President, in a press release. “Robust contingency plans must be ready on day one of the ICD-10 switchover to save precious health care dollars and reduce unnecessary administrative tasks that take valuable time and resources away from patient care.” The ICD-10 Medicare Fee-ForService End-to-End Testing survey measured 14,249 test claims received from Jan. 26, 2015 to Feb. 3, 2015. The types of claims included were professional (56%), institutional (38%)
and supplier (6%). There were 12,149 accepted claims (81%). Claims were rejected for the following reasons: • 3% for an invalid ICD-9 diagnosis or procedure code • 3% for an invalid ICD-10 diagnosis or procedure code • 13% for non–ICD-10 related errors (e.g., wrong health insurance claim number, invalid place of service and dates of service outside of testing range) The physician groups said the actual rates could be worse because the testing
represents less than 1% of all Medicare claims and were likely from providers who are more prepared for using the new system. They noted that the Oct. 1 deadline may affect quality reporting programs such as the Physician Quality Measurement System and Meaningful Use, which are based on the calendar year, so measures for 2015 will contain both ICD-9 and ICD-10 codes. “We are concerned the administration is underestimating the impact the transition to ICD-10 will have on the regulatory tsunami that is already burdening physicians and threatening access to quality care,” said Dr. Wah. “Although we appreciate the training, educational tools and other efforts by CMS to prepare physicians for the ICD-10 transition, it is clear that more information is needed about how the shift will impact quality reporting so physicians can avoid penalties.” —AN Staff Based on a press release from the AMA.
It’s nice to be valued. “We’re not just employees; we are an integral part of the team and all work in a collegial and supportive way. I believe TeamHealth is one of the most advanced and integrated among healthcare organizations. This creates strong working relationships between specialties and exceptional patient care. As result, we bring more value to the hospitals. With TeamHealth’s national presence and infrastructure I’ve got more professional opportunities as well as more time to pursue personal interests.” — Jonathan Slonin, MD, MBA Facility Medical Director Martin Health System, Stuart, FL
Featured Opportunities: Covenant Medical Center Saginaw, MI Palm Beach Gardens Medical Center Palm Beach Gardens, FL Lima Memorial Hospital Lima, OH
St. Joseph’s Medical Center Stockton, CA Orlando Regional Medical Center Orlando, FL 888.861.4093 www.teamhealth.com | anesthesiajobs@teamhealth.com
10 I AnesthesiologyNews.com
APRIL 2015
CLINICAL ANESTHESIOLOGY
Goal-Directed Fluid Therapy Reduces Morbidity, Costs
A
n augmented approach to perioperative fluid management of complex surgical patients can lower the risk for postoperative morbidity by up to 29% and reduce health care costs by up to $970 per patient. The projections (Crit Care 2014; 18:566) are based on a combination of actual clinical and cost data from the University HealthSystem Consortium (UHC) and findings from studies of the impact of perioperative goal-directed fluid therapy (GDFT). Lead researcher Gerard Manecke, MD, who is professor in the Department of Anesthesiology at the University of California, San Diego Medical Center, explained that the approach relies on standard vital signs as well as hemodynamic parameters such as stroke volume, cardiac output and oxygen delivery, to monitor and direct administration of bolus fluids. He said prior studies have demonstrated benefits using the approach and GDFT has been widely adopted in some European countries, but the additional cost of hemodynamic
monitoring equipment—which can be up as high as $300 per procedure—has likely been a barrier to its adoption in the United States. “What we found is that, even using conservative estimates, the savings resulting from the reduced need for treatment of complications thanks to GDFT are significantly greater than the cost of this equipment,” he said. The analysis used information from 222 medical centers from the UHC, including clinical and cost data from 75,140 adult surgical patients treated in 2011. The patients had undergone one of 10 noncardiac surgical procedures for which previous findings have found GDFT has the greatest clinical and cost impact, Dr. Manecke said (Table). He and his team examined clinical and cost data for patients with and without postoperative complications and projected the potential impact of GDFT in this population. The projections were based on a recent metaanalysis suggesting the approach can reduce the incidence of postoperative
reopening, acute myocardial infarction and nosocomial pneumonia. Mortality rates were higher among those with complications (12.4% vs. Abdominal aortic aneurysm open 1.4% for complications vs. no complirepair cations, respectively; P<0.001), and Aorto-iliac and peripheral bypass hospital stays were longer (mean 20.5 vs. 8.1 days, respectively; P<0.001). Colectomy Additionally, the average direct cost of Esophagectomy care was $47,284 for those with complications compared with $17,408 Femur and hip fracture repair for patients with no complications Gastrectomy (P<0.001). Hepatectomy Dr. Manecke’s team projected GDFT could have shaved between $43 Pancreatectomy million and $73 million off the $252 Resection of rectum million direct costs of treating patients with perioperative complications, or Total cystectomy between $569 and $970 per patient. “We used conservative estimates and morbidity by 17% to 29% ((JAMA I think savings could be greater in the 2014;311:2181-2190). private sector,” Dr. Manecke said. He noted individual institutions can A review of the data showed 11.2% of the patients developed at least one apply the model he and his colleagues of 13 common postsurgical compli- used in the current analysis to capture cations, such as stroke, gastrointesti- a more tailored picture of the potential nal hemorrhage, catheter-associated effects of implementing GDFT at their urinary tract infection, surgical site institution. Table. Surgical Procedures For Which Goal-Directed Fluid Therapy Has Highest Impact
Prewarming Before Surgery Short-Lived for Outpatients
N
ew Orleans—Redistribution hypothermia is minimal and short-lived in outpatients, regardless of whether they are prewarmed before surgery, a study has found. The investigators theorized that this finding, which is in stark contrast to prior research, may be due to changes in medical practice in recent decades, which sees outpatients arrive shortly before surgery instead of the night before. According to Leif Saager, MD, an associate faculty member in the Outcomes Research Department of the Cleveland Clinic, in Ohio, active prewarming is aimed at curbing the threat of intraoperative hypothermia, which typically occurs because of coreto-peripheral body heat redistribution from the normothermic core to the colder peripheral tissue. “With longer procedures, we have a lot of time to get the patient back into the normothermic range,” Dr. Saager said. “Patients who undergo short procedures, however, typically don’t have the time to recover from the initial drop in temperature, even when active heating devices are used. That might lead to additional patient discomfort and dissatisfaction. So we were interested in seeing if we prewarmed patients to avoid redistribution hypothermia, would they fare better? Would they be more satisfied and in a better thermal comfort zone?” In an attempt to answer these queries, Dr. Saager and his colleagues randomized 102 adult outpatients
‘Typically we would expect a drop of about 1°C in the initial redistribution phase. That did not occur in the prewarmed group. But surprisingly, it also didn’t occur to that extent in the non-prewarmed group.’ —Leif Saager, MD
to receive either preoperative and intraoperative warming or intraoperative warming only. The researchers assessed patient satisfaction and thermal comfort at four different times: arrival at the preoperative holding area, before induction, 15 minutes postoperatively and at discharge from the recovery room. As Dr. Saager reported at the 2014 annual meeting of the American Society of Anesthesiologists (abstract A2017), redistribution hypothermia saw the mean core temperature of both groups of patients drop approximately 0.5°C over the course of the first 30 minutes of surgery, then start climbing back toward preoperative levels. Prewarmed patients had
slightly higher mean core temperatures than their counterparts at every time point; this difference was significant at 0, 15 and 30 minutes. Given these results, it is not particularly surprising to find that the prewarmed patients were significantly more satisfied (P=0.04) than those who were not prewarmed. Thermal comfort was found to be greatest before induction, postoperatively and at discharge from the recovery room (P=0.03). Yet what puzzled the researchers was the relatively small decrease in core temperature in patients who were not actively prewarmed. “We expected to find a significant temperature drop in patients who weren’t prewarmed, and we didn’t find it,” Dr. Saager said. “Typically we would expect a drop of about 1°C in the initial redistribution phase. That did not occur in the prewarmed group. But surprisingly, it also didn’t occur to that extent in the non-prewarmed group. They certainly had more of a drop than the patients in the prewarmed group, but they didn’t experience the same drop as you would expect from [what has been described in] previous publications [Arthro[ plasty 2011;26:1380-1386], which demonstrated quite a significant drop from the initial temperature.” Exactly why redistribution hypothermia did not occur to the expected degree in non-prewarmed patients is unclear, although Dr. Saager did not refrain from hypothesizing. “We speculated that maybe things have changed in recent years,” he said.
APRIL 2015
AnesthesiologyNews.com I 11
CLINICAL ANESTHESIOLOGY “I would think ambulatory surgical centers that conduct fewer complex procedures would probably benefit less from implementing GDFT than tertiary care centers,” Dr. Manecke said. Richard Dutton, MD, MBA, who is chief quality officer of the American Society of Anesthesiologists (ASA) and was not involved in the research, broadly agreed with the study’s conclusions, saying, “Better fluid management will likely improve outcomes, since many patients undergoing major operations actually need less fluid— and a lot less salt—than they usually receive.” However, he said he suspects the magnitude of GDFT may not be as dramatic in “real-world” clinical practice as the current analysis portrayed it to be. “Early trials and early meta-analyses, like those used in this study to generate their assumptions, tend to exaggerate results of new technologies,” he said. He noted the analysis was sponsored by Edwards Lifesciences. “What I have mostly taken away from the GDFT literature is that a multimodal, team-based, startto-finish, systematic protocol for
“Nowadays, patients come into the hospital on the day of surgery, only hours before they get started.” Indeed, previous studies were conducted at a time when patients were almost uniformly admitted the night before surgery, and hospitals were likely kept cooler. Patients are now admitted from home, which means they likely arrive at the hospital effectively prewarmed, with higher body heat content and lower core-toperipheral tissue temperature gradients. “In addition, caregivers are much more aware of the importance of maintaining normothermia,” Dr. Saager added. “So perhaps the pressure of patient satisfaction has led nurses and other health care staff to pay closer attention to patient comfort, including their temperature.” —Michael Vlessides The study was supported by The 37 Company, which manufactures the forced-air warming device used in the study. Dr. Saager also reported that he has received compensation from The 37 Company for his participation in expert panels hosted by the company. All remuneration was donated to charity.
managing complex patients produces better results than our normal haphazard and fragmented system,” said Dr. Dutton. The ASA has developed the Perioperative Surgical Home philosophy to address this type of fragmentation of care, he added.
questions comments story ideas
—David Wild
Contact Editor James Prudden at
Dr. Manecke reported serving as a consultant for Edwards Lifesciences. Dr. Dutton reported no conflicts of interest.
jprudden@mcmahonmed.com
PERSPECTIVES IN ANESTHESIOLOGY For postsurgical pain control
Is regional analgesia being used to its full potential? Regional analgesia allows for pain to be targeted at its source while significantly reducing pharmacologic load, including the use of opioids. It’s also been shown to offer an advantage in reducing postsurgical pain compared with general anesthesia.1,2 As part of the commitment to improving postsurgical patient care, we must remain focused on what can be done to help ensure that regional analgesia is being used to its full potential to manage postsurgical pain.
Broadening the value of regional analgesia So what’s preventing greater use of regional block? Current regional analgesia options continue to have limitations when it comes to postsurgical pain management. As a result, physicians are forced to weigh the pros and cons of single-shot and continuous infusion blocks for each patient.3,4 Single-shot blocks meet the anesthesiologists’ goals of being simple, quick, and reliable, providing assurance that the right dose was administered to the right site and that it will last for the intended amount of time.5 However, even when single-shot blocks are chosen, it is often necessary to supplement with opioids or continuous infusion catheters and pumps to compensate for the limited duration of current short-acting, local analgesics. As a result, associated side effects of these additional agents and modalities may undermine patient recovery.4,6-8
Continuous infusion blocks: longer duration, bigger challenges? While continuous infusion blocks can extend the duration of blocks well into the postsurgical period, they can be burdensome on several fronts. For patients: continuous infusion blocks require the use of catheters, which can impede patient mobility due to cumbersome bags and tubing, and can increase the risk of myotoxicity, infection, and overdosing/underdosing due to device malfunction. Catheters can also migrate, dislodge, or clog, further complicating patient care.3,6-9
For treating physicians: the use of catheters may introduce unintended variability by requiring dose adjustments while necessitating management of transient adverse events, which can contribute to insufficient pain control and interfere with postsurgical recovery.8,10 Significant financial consideration: an associated financial burden exists for the equipment required for administration of continuous infusion blocks and postadministration monitoring, which can amount to more than $600 per patient. One must consider these costs compared with those for single-shot blocks.7,11
What is the next level of postsurgical patient care? Despite numerous advancements in postsurgical pain management, patients have seen little or no improvement in postsurgical pain control over the past 20 years.12 Moving forward, an ideal solution would effectively incorporate the strengths of both single-shot and continuous block options in a single therapy while minimizing their inherent risks and shortcomings: • Maintaining the simplicity of single-shot technique without opioid supplementation • Avoiding use of devices and their inherent limitations • Achieving longer-lasting effects to rival those provided by catheters and infusion devices
Dragan Gastevski, MD Anesthesiology, Pain Medicine Chicago, IL
References: 1. Liu SS, Strodtbeck WM, Richman JM, Wu CL. A comparison of regional versus general anesthesia for ambulatory anesthesia: a meta-analysis of randomized controlled trials. Anesth Analg. 2005;101(6):1634-1642. 2. What is regional anesthesia? Hospital for Special Surgery. http://www.hss.edu/anesthesiology-anesthetic-techniques. asp#.VNk3GC42dVc. Accessed February 9, 2015. 3. Chelly JE, Ghisi D, Fanelli A. Continuous peripheral nerve blocks in acute pain management. Br J Anaesth. 2010;105(suppl 1):i86-i96. 4. Brummett CM, Williams BA. Additives to local anesthetics for peripheral nerve blockade. Int Anesthesiol Clin. 2011;49(4):104-116. 5. Buckenmaier III C, Bleckner L. Military Advanced Regional Anesthesia and Analgesia Handbook. Washington, DC: Broden Institute; 2008. 6. Golf M, Daniels SE, Onel E. A phase 3, randomized, placebocontrolled trial of DepoFoam® bupivacaine (extended-release bupivacaine local analgesic) in bunionectomy. Adv Ther. 2011;28(9):776-788. 7. Bingham AE, Fu R, Horn J-L, Abrahams MS. Continuous peripheral nerve block compared with single-injection peripheral nerve block: a systemic review and meta-analysis of randomized controlled trials. Reg Anesth Pain Med. 2012;37(6):583-594. 8. Medtronic. Important safety information for drug delivery systems. http://www.medtronic.com/patients/cancer/important-safetyinformation/. Updated June 4, 2014. Accessed February 11, 2015. 9. Marhofer D, Marhofer P, Triffterer L, Leonhardt M, Weber M, Zeitlinger M. Dislocation rates of perineural catheters: a volunteer study. Br J Anaesth. 2013;111(5):800-806. 10. Subramaniam R, Sathappan SS. The effects of single shot versus continuous femoral nerve block on postoperative pain and rehabilitation following total knee arthroplasty. Malays Orthop J. 2010;4(1):19-25. 11. Knight KH, Brand FM, Mchaourab AS, Veneziano G. Implantable intrathecal pumps for chronic pain: highlights and updates. Croat Med J. 2007;48:22-34. 12. Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey [published online November 15, 2013]. Curr Med Res Opin. 2014;30(1):149-160. doi:10.1185/03007995.2013.860019.
©2015 Pacira Pharmaceuticals, Inc. Parsippany, NJ 07054 PP-EX-US-0631
02/15
THE BODY OF EVIDENCE SUPPORTS CPAP. IT’S ALL ABOUT OPTIMAL PATIENT CARE IN THE PACU. The consensus is in: Various studies indicate the post-operative efficacy of CPAP therapy for highrisk surgery patients. Benefits include reduced incidence of intubation, infection and pneumonia. Improved gas exchange leads to reduced pulmonary complications, shorter intensive care stays and significant cost savings.(1) (2)
ONLY ONE. FLOW-SAFE® II DISPOSABLE CPAP SYSTEM: THE RIGHT CHOICE. Only one CPAP device gives you the advantages of an all-disposable system with a built-in pressure gauge valve that verifies delivered CPAP pressure and pressure relief valve ensuring patient safety. Flow-Safe II. It’s ready to use. No extra equipment is needed. Simply plug into the oxygen source and it delivers CPAP instantly. Flow-Safe II also transfers easily with the patient and the advanced mask design and head harness provide a better seal and greater comfort. And there’s no cleaning or its associated risks.
USING IS BELIEVING. Call 800-237-6418 to request a free sample or visit our website.
(1) Drs. Kingden - Milles, Müller, Buhl, et. al. Nasal – Continuous Positive Airway Pressure Reduces Pulmonary Morbidity and Length of Hospital Stay Following Thoracoabdominal Aorticc Surgery. Chest/128/2/August, 2005. 821-82 28. (2) Drs. Squadrone, Coha, et. al. Continuous Positive Airway Pressure For Treatment of Postoperative Hypoxe emia. A randomized controlled trial. JAMA, Feb. 2, 2005-Vol 293, No. 5 589-595.
mercurymed.com 800.237.6418
Your Need . . . Our Innovation®
APRIL 2015
AnesthesiologyNews.com I 13
CLINICAL ANESTHESIOLOGY
ERAS Approach in Older Patients Lowers Morbidity and Length of Hospital Stay New York—Enhanced recovery after surgery (ERAS), a multimodal rehabilitation protocol designed to fasttrackk postoperative recovery in patients undergoing major surgical interventions, can be applied to older patients, a study has confirmed. Benefits include lower morbidity, reduced hospital length of stay (LOS) and quicker functional recovery. Since ERAS was first developed by a team of European anesthesia researchers in the 1990, practitioners have been hesitant to implement the protocol in older patients due to concerns regarding comorbid conditions. However, anesthesiologists and surgeon members from Hospital Universitario Infanta Leonor in Madrid found that ERAS can be applied successfully in patients aged 75 years or older undergoing colorectal tumor surgery, shortening recovery times and hospital LOS.
patients studied were classified as American Society of Anesthesiologists Physical Status class III (60.7%); 58.9% had comorbid heart disease; 21.4% had comorbid chronic obstructive pulmonary disease; and 26.8% 56 patients aged 75 years or older complications, hospital LOS, hospi- had comorbid diabetes mellitus. In all, undergoing colorectal tumor surgery tal readmission rate and time to func- 91.1% were operated on laparoscopat their hospital in 2013, in whom tional recovery. The average age of the ically (three were converted to open fast-track ERAS was applied. They patients in the series was 80.12 years, procedures); 39.3% underwent right performed descriptive analyses of the and the study population’s ratio of hemicolectomies; 21.4% underwent series and studied morbidity accord- male to female patients was 1:1. sigmoidectomies; 23.2% had anterior ing to the Clavien scale of surgical According to the authors, most see ERAS page 14
The simplest solution is still the best solution. Voss Medical Products and it’s subsidiaries (VM Positioning, VM Cardio, and VM Specialty) have been manufacturing disposable surgical devices for over 30 years. Our products include the Voss PronePositioner™, The Voss Supine Support, the Voss Cardiac Leg Support and the Disposable V-Scope™. Now, we are introducing a disposable surgical foam line for obese patients.
NEW: DISPOSABLE POSITIONING DEVICES FOR OBESE PATIENTS
‘Elderly patients, and those with higher surgical risk, are patients who will benefit most from multidisciplinary perioperative management. ERAS research should be aimed at this group of fragile patients.’
The Prone XL™ The Supine XL™ The Cardiac Leg Support XL™
—Javier Ripollés Melchor, MD
“ERAS programs can be applied to elderly patients,” said Javier Ripollés Melchor, MD, head of the fluid therapy section at Hospital Universitario Infanta Leonor and part of the Grupo Español de Rehabilitación Multimodal GERM/ERAS Spain. “Indeed, elderly patients, and those with higher surgical risk, are patients who will benefit most from multidisciplinary perioperative management. ERAS research should be aimed at this group of fragile patients.” Dr. Melchor spoke during the 68th New York State Society of Anesthesiologists’ PostGraduate Assembly (PGA). The group retrospectively analyzed
The Disposable V-Scope™ The Best Light System Available in a Disposable Laryngoscope
www.vossmedicalproducts.com www vossmedicalproducts com
VM
POSITIONING
VM Positioning, Inc 4235 Centergate San Antonio, TX 78217 Toll Free: 800-247-6294 Phone: 210-650-3124 www.vossmedicalproducts.com
A DIVISION OF VOSS MEDICAL PRODUCTS PROVIDING SIMPLE MEDICAL SOLUTIONS FOR OVER 30 YEARS ©2015 VM Positioning, Incorporated. All rights reserved.
14 I AnesthesiologyNews.com
APRIL 2015
CLINICAL ANESTHESIOLOGY
ERAS Program for Complex Hernias Yields Improvements Improved pain control, quicker intestinal recovery
A
n enhanced recovery after surgery (ERAS) program improved patient outcomes after abdominal wall reconstruction at one of the country’s largest hernia centers, according to a pilot study. Although prospective evaluations of the ERAS pathway are still needed, “we believe ours or similar ERAS pathways will soon become standard for the vast majority of patients undergoing abdominal wall surgery,” said Yuri W. Novitsky, MD, director of the Case Comprehensive Hernia Center at Case Western Reserve University, Cleveland, and his colleagues in their report, published in the journal Plastic and Reconstructive Surgery (2014;134[4 suppl 2]:151S-159S). ERAS programs are designed to reduce patient morbidity and hospital length of stay (LOS) after surgery by providing optimal pain management and accelerating patients’ intestinal recovery. ERAS have been shown to significantly shorten LOS after colorectal surgery, where they were first implemented, as well as in a growing number of general surgical procedures. This is the first time that ERAS have been reported in abdominal wall reconstruction. In a pilot study of 42 consecutive patients undergoing open incisional hernia repair requiring myofascial release in a clean surgical field compared with historical controls, implementation of the ERAS pathway resulted in a faster return to tolerance of solid food and passage of stool by 1.4 days (5 vs. 3.6; P<0.0001) and a mean reduction in LOS by 1.4 days (5.8 vs. 4.4; P<0.0001). Since the ERAS program was started, 97% of patients have remained on the pathway. Dr. Novitsky said the pathway was designed to achieve two goals: optimal pain management and accelerated intestinal recovery. The team provided multimodal pain control with an emphasis on reduced opiate use and application of a precise intraoperative nerve block with longer-actingg local anesthetic, bupivacaine liposome (Exparel, Pacira). Accelerated intestinal recovery was achieved through use of oral μ-opioid receptor antagonist alvimopan (Entereg, Cubist), early feeding and judicious IV fluid administration.
ERAS
growing trend in hernia surgery. “We see a large portion of patients benefit greatly from this approach. It’s very impressive to see somebody wake up from an operation in little or no pain,” he said. Both multimodal pain control and ERAS require more study, he cautioned. In this report, the authors did not report on important details on costs of care and long-term outcomes. “What about hernia recurrence, chronic pain incidence and other long-term complications? What about the overall costs of care for this care process, including these long-term issues?” The ERAS pathway calls for an intraoperative transversus abdominal pain block with bupivacaine liposome injection (20 mL diluted to 120 mL), followed by hydromorphone patientcontrolled analgesia at 0.2 mg every six minutes as needed and a 1 g dose of IV acetaminophen (Ofirmev, Mallinckrodt) every six hours for 48 hours, with oral oxycodone 5 to 10 mg every four hours as needed for breakthrough pain. Dr. Novitskyy said the team developed the ERAS Patients receive oral gabapentin 300 mg three times a based on work done by colleagues in the Colorec- day as soon as they can tolerate oral intake, which is tal Surgery Department of Case Western Reserve continued until discharge. University who pioneered the use of ERAS. They The authors also recommend gabapentin in adopted the validated colorectal ERAS to make it patients with incisional pain lasting beyond 30 days, applicable for abdominal wall reconstruction. especially for pain related to lateral dissection or fixa“The process does have challenges,” Dr. Novitsky tion sutures in the lateral abdominal course. Nonsteroidal anti-inflammatory drugs are not said, in an interview. “For surgeons, it’s a bit of a leap of faith. All surgeons have individual quirky things given routinely due to the risk for postoperative and that has to be worked out. You make changes acute kidney injury. that go against what you used to do.” Patients receive ice chips and sips of water after But, he added, “having the pathway has made it surgery, followed by limited clear liquids on postoperative day (POD) 1, unlimited clear liquids on better and easier for everyone involved.” In an accompanying editorial, Bruce Ramshaw, POD 2 and a regular diet on POD 3. MD, chairman of the Halifax Health general surSince the publication, the investigators have made gery residency program and co-director of Advanced some adjustments to the pathway, including dropHernia Solutions, Daytona Beach, Fla., said that the ping diazepam from pain management and furauthors should be lauded for their practical approach ther accelerating patients’ return to regular diet, said to “real-world clinical quality improvement. Dr. Novitsky. y “To consider a more complex set of solutions beyond Updated details on the ERAS program will be opioid agonists and strive to make a major abdominal presented in April at the 1st World Conference on operation relatively pain-free and with minimal effects Abdominal Wall Hernia Surgery. on bowel function is a very patient-centeredd goal,” he said, noting that multimodal approaches to pain are a —Christina Frangou
90.7% began oral intake on the day of their surgery (the remainder did resections; 10.7% had segmental resec- on either postoperative day 1 or 2). tions; and 5.4% underwent abdomino- According to the authors, mean hosperineal amputation. pital LOS was 9.15 days in ERAS Half of the studied patients had patients (median of five days) and the no postoperative complications, and readmission rate was only 3.6%. 16.1% classified as Clavien I, 19.6% “Many of the elements within the as Clavien II, 7.1% as Clavien IV and ERAS protocol are focused on high7.1% as Clavien V. All of the patients riskk surgical populations—close hemoto which the ERAS protocol was dynamic monitoring, judicious fluid applied were able to get out of bed management, improved postoperawithin eight hours after surgery, and tive pain control using a multimodal CONTINUED FROM PAGE 13
approach, minimally invasive surgery, early feeding and mobilization leading to shorter length of stay in the hospital,” said Tong Joo Gan, MD, MHS, FRCA, professor and chairman, Department of Anesthesiology, Stony Brook Medicine, Stony Brook, N.Y. “These aspects are particularly pertinent in an elderly population. We are in the process of implementing the ERAS protocol and elderly patients will be the main focus.” Dr. Gan, who was not involved in
the research on ERAS presented at PGA, added, “Future research should focus more on the high-risk surgical patient populations, including the elderly, and more specifically on tracking longer-term outcomes beyond hospital discharge, including when patients resume their normal activities or return to baseline health status. I suspect many elderly patients do not get back to their baseline status at all following major surgery.” —Brian Dunleavy
Proven more effective than Benzocaine alone1
Features a 30–60 second onset
Backed by 40 years of in-vivo evidence
Delivers a 30–60 minute duration
With 6% Less Benzocaine, Rx Only Cetacaine and OTC 20% Benzocaine Sprays Aren't Even Related ®
Only genuine Cetacaine is indicated to control pain and reduce the gag reflex. With a unique combination of ingredients Cetacaine (Benzocaine 14%, Butamben 2.0%, Tetracaine Hydrochloride 2.0%), is also proven more effective than Benzocaine alone. That’s why so many hospitals request the little yellow bottle by name.
Cetacaine
®
TOPICAL ANESTHETIC SPRAY TO
(Benzocaine 14.0%, Butamben 2.0%, Tetracaine Hydrochloride 2.0%) (Ben 1 Adriani J, Mehta D, Naraghi M. Mixtures of local anesthetics: The Efectiveness of Combinations of Benzocaine, Butamben, and Tetracaine Topically. Anesthesiology Review. 1981; 12:15-19. * For complete safety information, prescribing information, warnings and contraindications, see the prescribing insert on the next page.
cetacaine.com
800-257-7740
16 I AnesthesiologyNews.com
APRIL 2015
CLINICAL ANESTHESIOLOGY
Stellate Ganglion Block for PTSD, Anxiety and Depression? “I became interested in this after seeing the case report by Eugene Lipov [Ann Clin Psychiatry 2008;20:227-228] that claimed that a patient had his PTSD symptoms completely relieved for a number of months by a single, right-sided stellate ganglion block,” said Michael T. Alkire, MD, a staff physician at Long Beach VA and professor of
anesthesiology at the University of symptoms. The subjects underwent California, Irvine. “That report—and a single, right-sided stellate ganglion a subsequent study by Mulvaney [Pain block using 2% lidocaine 8 cc and Practt 2010;10:349-365]—prompted 0.25% bupivacaine under fluoroscopic me and my colleagues at the VA into guidance, and then were followed for action.” six months. All of the patients underDr. Alkire and his colleagues went a comprehensive battery of enrolled 15 veterans into the study; examinations, including the Clinicianeach patient had extreme, chronic Administered PTSD Scale (CAPS) (>1 year) PTSD with hyperarousal score, Post-Traumatic Stress Disorder Symptom Scale–Self Report (PSS-SR), Beck Depression Inventory version 2, General Anxiety Scale, State-Trait Anxiety Inventory and Mee-Bunney Psychological Pain Assessment Scale. ® Assessments were conducted at baseAdverse Reactions Hypersensitivity Reactions: Unpredictable adverse reactions (i.e. line, and then at one week and one, hypersensitivity, including anaphylaxis) are extremely rare. Localized three and six months post-block. allergic reactions may occur after prolonged or repeated use of any Among the 12 patients who received TOPICAL ANESTHETIC SPRAY aminobenzoate anesthetic. The most common adverse reaction caused the block, three primary responses by local anesthetics is contact dermatitis characterized by erythema were observed. “A few subjects were Brief Summary of the Prescribing Information and pruritus that may progress to vesiculation and oozing. This occurs immediate nonresponders, and one of most commonly in patients following prolonged self-medication, which is contraindicated. If rash, urticaria, edema, or other manifestations those three subjects actually felt worse Active Ingredients of allergy develop during use, the drug should be discontinued. To because he was anxious about the lump Benzocaine ......................................................................14.0% minimize the possibility of a serious allergic reaction, Cetacaine in his neck,” Dr. Alkire said. “Most Butamben..........................................................................2.0% preparations should not be applied for prolonged periods except under Tetracaine Hydrochloride ..................................................2.0% subjects [n=5] had moderate, genercontinual supervision. Dehydration of the epithelium or an escharotic alized feelings of improvement. Intereffect may also result from prolonged contact. Contains estingly, their scores got even better Precaution: On rare occasions, methemoglobinemia has been reported in Benzalkonium Chloride .....................................................0.5% a week later, and continued to show connection with the use of benzocaine-containing products. Care should Cetyl Dimethyl Ethyl improvement with time. And then be used not to exceed the maximum recommended dosage (see Dosage Ammonium Bromide .....................................................0.005% and Administration). If a patient becomes cyanotic, treat appropriately to there were four subjects that we would In a bland water-soluble base. counteract (such as with methylene blue, if medically indicated). call ‘miracle cures.’ These patients Action essentially returned back to normal Use in Pregnancy: Safe use of Cetacaine has not been established with The onset of Cetacaine-produced anesthesia is rapid (approximately within a few minutes, before they even respect to possible adverse effects upon fetal development. Therefore, 30 seconds) and the duration of anesthesia is typically 30-60 minutes, when used as directed. Indications Cetacaine is a topical anesthetic indicated for the production of anesthesia of all accessible mucous membrane except the eyes. Cetacaine is indicated to control pain and for use for surgical or endoscopic or other procedures in the ear, nose, mouth, pharynx, larynx, trachea, bronchi, and esophagus. Dosage and Administration Cetacaine Spray should be applied for approximately one second or less for normal anesthesia. Only a limited quantity of Cetacaine is required for anesthesia. Spray in excess of two seconds is contraindicted. Average expulsion rate of residue from spray, at normal temperatures, is 200 mg per second.
Cetacaine should not be used during early pregnancy, unless in the judgement of a physician, the potential benefits outweigh the unknown hazards. Routine precaution for the use of any topical anesthetic should be observed when Cetacaine is used. Contraindications Cetacaine is not suitable and should never be used for injection. Do not use on the eyes. To avoid excessive systemic absorption, Cetacaine should not be applied to large areas of denuded or inflamed tissue. Cetacaine should not be administered to patients who are hypersensitive to any of its ingredients or to patients known to have cholinesterase deficiencies. Tolerance may vary with the status of the patient. Cetacaine should not be used under dentures or cotton rolls, as retention of the active ingredients under a denture or cotton roll could possibly cause an escharotic effect. Routine precaution for the use of any topical anesthetic should be observed when using Cetacaine.
An appropriate pediatric dosage has not been established for Cetacaine Spray.
Rx Only. Made in U.S.A.
Dosages should be reduced in the debilitated elderly, acutely ill, and very young patients.
© 2014 Cetylite Industries, Inc. All rights reserved. Information is summary in nature and subject to change. Cetacaine and Cetylite are registered trademarks of Cetylite Industries, Inc. All other copyrights are the property of their respective owners.
Tissue need not be dried prior to application of Cetacaine. Cetacaine Cetacaine should be applied directly to the site where pain control is required. Anesthesia is produced within one minute with an approximate duration of thirty minutes. Each 200 mg dose of Cetacaine Spray residue contains 28 mg of benzocaine, 4 mg of butamben and 4 mg of tetracaine HCl.
cetacaine.com
|
800-257-7740
100
Mean CAPS (PTSD symptom severity)
New Orleans—Stellate ganglion block shows promise in providing prolonged relief of chronic, extreme posttraumatic stress disorder (PTSD). A pilot 12-patient series by researchers from the Long Beach VA Healthcare System, while far from definitive, revealed that stellate ganglion block may also be effective in treating anxiety or depression.
Baseline Post-SGB 80
77
60
40 32 20
0
Responders (n=9) REV 4/2013
Figure. Mean Clinician-Administered PTSD Scale scores at baseline and following treatment in responders and nonresponders CAPS, Clinician-administered PTSD Scale; PTSD, post-traumatic stress disorder; SGB, stellate ganglion block
APRIL 2015
AnesthesiologyNews.com I 17
CLINICAL ANESTHESIOLOGY got off the fluoroscopy table.” The block was effective in helping nine subjects (75%). For those who responded, the positive effects resulted in a sigMichael T. Alkire, MD nificant reduction in scores of both the CAPS and PSS-SR R at one week. “The positive effects lasted for a number of months and are still present in a few people as much as six months later,” Dr. Alkire noted here at the 2014 annual meeting of the American Society of Anesthesiologists (abstract A1046). Anxiety, depression and psychological pain scores were significantly reduced by the block and also trended positively with time. “The improvement in depression ratings was so pronounced and so quick that it may rival electroconvulsive therapy,” Dr. Alkire explained. “So we propose that this block itself might be better for acute treatment of depressed patients.” Successfully treated subjects also demonstrated reduced arousal levels of respiratory sinus arrhythmia, heart rate variability and eye blink electromyographic responses. Proposing a neurophysiologic mechanism of action for the dramatic
response to the block is challenging, but Dr. Alkire offered a hypothesis. “I think based on our work investigating mechanisms of emotional memory that we are actually flipping the same switch that gets activated when someone is startled, but in this case, we are switching it in the opposite direction. So, we’re changing their parasympathetic/ sympathetic tone to a more relaxed state almost instantly with the block. “Our work, coupled with recent reports and ongoing studies, strongly
suggests that a large, randomized controlled trial be undertaken to prove the effectiveness of this in a generalized population,” he said. Session moderator Honorio T. Benzon, MD, saw value in performing a sham procedure as part of such a trial. “We published a case report of two patients in whom we did saline injection into the stellate ganglion as part of their diagnostic blocks. They developed Horner syndrome, increases in skin temperature of their ipsilateral
hand, and partial pain relief,” said Dr. Benzon, professor of anesthesiology at Northwestern University’s Feinberg School of Medicine, in Chicago. “So, unless you do a placebo sham technique, you never really know what’s producing the effect you’re seeing.” The study was supported by a pilot grant from the Southern California Institute for Research and Education. —Michael Vlessides
for iPad Download the app from the best-read anesthesiology publication in the United States
PTSD symptom level 84
88
Extreme
Severe
Moderate
Optimized p for f mobile devices
Mild
Normal
Always available online
Nonresponders (n=9)
@anesthesianews
Register for the free e-Newsletter @ anesthesiologynews.com/enews
anesthesiologynews
+anesthesiologynews
18 I AnesthesiologyNews.com
APRIL 2015
CLINICAL ANESTHESIOLOGY AIRWAY
CONTINUED FROM PAGE 1
1999;91(6):1703-1711] in the Anesthesia Closed Claims Project database and found that 8.5% of general claims had airway injuries as the outcome,” reported Karen L. Posner, PhD, the Laura Cheney Professor in Anesthesia Patient Safety at the University of Washington, in Seattle. “The most common injuries in that analysis were pharyngeal and esophageal perforations, at 23%. That was quite a
while ago, however, so we thought we’d look at airway injuries again, as well as trends over time.” To that end, Dr. Posner and her colleagues analyzed the database of 10,093 malpractice claims that were focused on airway or esophageal injuries associated with general anesthesia between 1980 and 2011. The researchers classified the site of airway injury and used claim narratives to identify perforations of the pharynx or esophagus. An on-site closed claims reviewer
identified difficult intubations. Claims for airway injuries that occurred between 2000 and 2011 (N=116) were compared with the previously published results (N=266). Injuries to teeth or dentures were not included in the analysis. Airway injuries represented 9% to 11% of general anesthesia malpractice claims in each decade between 1980 and 2011. The esophagus was the most common site of injury in the current analysis in comparison to the
1999 report (33% vs. 18%, respectively; P<0.01), with perforations comprising 95% of all recent esophageal injury claims. By comparison, injuries to the larynx dropped significantly between the two analyses, from 33% in 1999 to 22% in the current work (P<0.01). Pharyngeal injuries were also common in the current analysis, accounting for 25% of airway injuries, 59% of which were perforations. All told, perforations of the pharynx or esophagus represented nearly half
Where do you go… … if you recall reading an educational supplement, but no longer have a hard copy? … if you heard about an interesting piece from a colleague, and would like to obtain a copy?
1 Go to the home page. 2 Click on the “Medical Education” button. 3 The drop-down menu gives you access to free educational materials from Anesthesiology News.
APRIL 2015
AnesthesiologyNews.com I 19
CLINICAL ANESTHESIOLOGY (46%) of airway injury claims in 2000 to 2011 versus 23% in the 1999 study (P<0.001). Of the 2000 to 2011 perforations, 17% resulted in death. Interestingly, although mortality associated with all airway injury claims remained fairly constant between periods (10% vs. 8%; P=0.35), there was a trend toward more severe outcomes in 2000 to 2011 (9% vs. 5%; P=0.03). “We’re finding that outcomes are getting worse in these more recent claims,” Dr. Posner explained. “Severe and
disabling injuries are increasing; death is still there.” Three-fourths of airway deaths were perforations of the posterior pharynx or esophagus. When the researchers delved deeper into the data, they found that medical equipment was implicated in 57% of pharyngeal or esophageal perforations. “These were pretty evenly divided,” she noted. “There were some transesophageal echos, but surgical equipment [such as dilators for gastric surgery] was also implicated.” Difficult intubation
continued to be associated with onethirdd of all airway injury claims. “Another change we saw was that claims for TMJ [temporomandibular joint] injuries have declined quite a bit,” Dr. Posner added. “They were quite prominent in the earlier data [10%], but we’re seeing very few of those in the more recent claims” (4%; P=0.04). Dr. Posner reported the results of the claims review at the ASA’s 2014 annual meeting (abstract A4015) in New Orleans.
Medical Education CME From the Bench to the Bedside Procedural Breakthrough Pocket Guides Special Reports
Malpractice Claims Skew Reality Using malpractice claims as a data source comes with its own set of challenges, including the lack of a denominator, which precludes the calculation of incidence or risk. “The American malpractice system is based on a contingency-fee basis, so lawyers get a portion of the settlement,” Dr. Posner explained. “So they tend to only take claims where they think there will be see airway page 20
20 I AnesthesiologyNews.com
APRIL 2015
CLINICAL ANESTHESIOLOGY AIRWAY
Indeed, addressing airway injuries begins in the perioperative period, a settlement, or very big settlement. where anesthesia providers should not Therefore, malpractice claims are only be aware of the early signs and biased toward more severe or perma- symptoms of perforation, but should nent injuries.” also respond appropriately, particularly Using such claims can also prove in patients exposed to esophageal equipadvantageous, however. “It gives you a ment or difficult intubations. “The large collection of relatively rare events,” ongoing theme we see in these cases is she said. “We can identify patterns of that often the patient complains of a injury. And it can promote others to sore throat, but it’s not documented in conduct clinical and lab investigations the record that there was an esophageal to try to address these safety issues. pass or if it was a difficult intubation or CONTINUED FROM PAGE 19
if equipment was used; there’s no note or any other communication with the postoperative care team. “It’s important that if there are complaints from the patient about airway problems that the postoperative team knows there may be a problem,” she added. “The trend we see in these is not just the fact that they’re airway injuries. Many of these were delayed in being diagnosed and treated. So these were really severe injuries that got out of control.”
Get the latest news from the best-read anesthesiology publication in the country, including web-exclusive content, delivered directly to your inbox!
Register @ anesthesiologynews.com/enews
@anesthesianews anesthesiologynews +anesthesiologynews for iPad
‘We’re finding that outcomes are getting worse in these more recent claims. Severe and disabling injuries are increasing; death is still there.’ —Karen L. Posner, PhD
Session co-moderator Joseph R. Ruiz, MD, noted that technological advances might ultimately reduce the incidence of airway-associated injuries. “One of the more noticeable changes in the practice for me has been an increasing utilization of video laryngoscopy, particularly in patients where we think there might be some challenges,” said Dr. Ruiz, who is an associate professor of anesthesiology and perioperative medicine at the University of Texas MD Anderson Cancer Center in Houston. “It does seem that, in general, the risk for airway injury— at least in my experience—is substantially reduced with the use of video laryngoscopy.” “There weren’t any in this set, so we aren’t seeing any injuries from video laryngoscopy,” Dr. Posner replied. “We didn’t pick up any GlideScope [Verathon] injuries, although there are case reports of that happening. In addition, it does generally take five years or so for an injury to result in a closed claim.” —Michael Vlessides
APRIL 2015
AnesthesiologyNews.com I 21
CLINICAL ANESTHESIOLOGY
Plastic Disposable Laryngoscope Blades Short of ISO Standards New Orleans—When it comes to disposable laryngoscope blades, the possibility of breakage is not normally a consideration. A study by a Nova Scotia research team has revealed, however, that although most metal disposable blades meet standards set by the International Organization for Standardization (ISO), their plastic counterparts are not nearly as successful when it comes to deflection and failure load. “The revised ISO standard came out in 2009 and specified mechanical properties for disposable blades,” said Andrew Milne, MD, MSc, P Eng, assistant professor of anesthesia, pain management and perioperative medicine at Dalhousie University in Halifax. “They had to deflect less than 10 mm when subjected to a load of 65 newtons, and they had to be structurally intact after a load of 150 N.” Although there have been case reports in the literature about plastic blades breaking, no study to date has evaluated adult disposable laryngoscope blades in comparison to ISO standards. To that end, Dr. Milne and his colleagues tested nine different models of single-use Macintosh laryngoscope blades, five of which were metal and four plastic. Five samples were tested for each type of blade. Each blade was attached to a “green standard” metal laryngoscope handle, which was rigidly clamped to an engineering materials testing machine. “The machine would apply a vertical load to the tip of the blade at a rate of 25 mm per minute,” Dr. Milne reported here at the 2014 annual meeting of the American Society of Anesthesiologists (ASA; abstract A2056). “The resulting force and displacement data were then captured and analyzed.” Each blade was loaded until structural failure or a maximum load of 200 N; the force-displacement data for each blade was zeroed at an initial blade contact force of 0.5 N for analysis. It was found that blade deflections at a load of 65 N ranged from 5.3±0.3 to 9.5±1.6 mm for the metal blades. By comparison, the plastic blades deflected 15.1±0.4 to 19.9±0.8 mm (P<0.001 for all metal vs. plastic blades). With respect to ultimate failure loads, metal blades again proved far superior, ranging between 146.1±4.8
for all metal vs. plastic blades). “Only one of the plastic blades met the ISO standard,” he added. The study also revealed that the most common mode of blade failure was at the handle-blade connection, which either became grossly deformed
and 200 N. “All but one of the metal blades met that ultimate strength test,” Dr. Milne pointed out, “and the one that didn’t was borderline.” Plastic blades, on the other hand, failed at a mean load ranging between 116.8±0.5 and 163.6±0.7 N (P<0.005
or fractured. “A lot of the metal blades have a plastic component at the hinge,” Dr. Milne said. “The common failure modes were either by deformation of this slot or a crack in the plastic hub. “The other thing we saw with a lot of see blades page 24
Why Compromise? Choose NAROPIN Labor & Delivery Acute Pain Management Surgical Anesthesia
Fresenius Kabi’s NAROPIN sets the standard with an extensive portfolio, proven clinical results, and innovative packaging—all of which make it the brand you and your patients can count on.
Important Safety Information 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. NAROPIN may be associated with adverse reactions
Experience our latest versatile delivery system, the freeflex® bag—an innovative container designed for premixed solutions.
which are characteristic of those associated with other amide-type local anesthetics.1 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
We offer product options in 4 strengths:
of *5%: hypotension, nausea, vomiting, bradycardia, fever, pain, postoperative complications, anemia,
0. 2 %
0. 5 %
0.75 %
1%
paresthesia, headache, pruritus, and back pain. 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.
Reference 1. NAROPIN Prescribing Information.
NAROPIN-US.com 0793-NAR- 05-1/ 15
22 I AnesthesiologyNews.com
APRIL 2015
CLINICAL ANESTHESIOLOGY
Use of Cuffed Tracheal Tubes in Neonates Requires Caution New Orleans—The use of cuffed tracheal tubes is increasingly popular in pediatric anesthesia, but investigators have found that there is a risk for increased trauma without proper diligence. “When I was a fellow, many of my colleagues started using MicroCuff [Halyard] tracheal tubes, especially in neonatal patients, where they proved much easier for us to manage airways and ventilate,” said Madhankumar Sathyamoorthy, MBBS, assistant professor of anesthesiology at University of Mississippi Medical Center, in Jackson. “Yet, when we were talking to our neonatologists, they noted an increased incidence of stridor and wondered what had changed in our practice. “So we decided to look back, and in doing so noticed there is very little data regarding nationwide practice patterns with respect to cuffed tracheal tube use in pediatric populations. Indeed, the last two surveys on the subject were performed in 2001 in France [Paediatr Anesth 2001;11:277-281] and in 2008 in the United Kingdom [[Eur J Anaesth 2008;25:685-688], and the MicroCuff tube was not widely used back then.” To gain more understanding of the subject, Dr. Sathyamoorthyy and his colleagues electronically surveyed members of the Society of Pediatric Anesthesia. Surveys were sent between November 2013 and February 2014. Each member was permitted one response, and 805 of the 2,901 society members (28%) responded. Of these, 88% were from the United States and 83% were fellowship trained; 82% practiced pediatric anesthesia more than 50% of the time; and 65% were in academic practice. Dr. Sathyamoorthyy reported the findings at the 2014 annual meeting of the American Society of Anesthesiologists (abstract A3058).
Advertisement A7 Anesthesia Workstation from Mindray The A7 Anesthesia Workstation combines the simplicity and familiarity of traditional anesthesia with advanced technology, performance, and design. Electronic fresh gas flow with control options and quick keys, integrated gas analysis with capnography and agent usage calculation, advanced ventilation modes, spirometry loops, integrated suction, warmed breathing system, ACGO, and HL7 connectivity are among the many advanced features that come standard with the A7. 800 MacArthur Blvd. Mahwah, NJ 07430 800-288-2121 customerservice@mindray.com www.mindray.com See our ad on page 7.
‘Yes, the cuffed tube offers advantages, but you still have to pay attention to the size of the tube or you are going to cause more trauma.’ —Madhankumar Sathyamoorthy, MBBS
The study found that the use of cuffed tracheal tubes in elective surgery increased with patient age. Fewer than 10% of respondents said they used cuffed tubes “all of the time” in preterm patients; this increased to almost 70% of use in those between ages 2 and 8 years. Nevertheless, when compared with previous research, the study revealed that cuffed tracheal tubes are being used with increasing frequency in children of all ages. While more than 65% of respondents acknowledged that they use cuffed tubes routinely in children at least 2 years old, only 25% of respondents in the 2001 French study and less than 10% of those in the 2008 British study did the same. The researchers also surveyed practitioners’ opinions regarding cuffed tracheal tube use. The most common reason for avoiding cuffed tracheal tubes in infants and children was concern about postextubation stridor (39%). The most common way to determine the appropriate size of a cuffed tracheal tube was Holzman’s formula (57%), although it may be of limited use in neonates and infants. Nearly 70% of practitioners accept the size of the tracheal tube if it passes the subglottis without resistance or has a leak at 15 to 30 cm H2O. “One of the respondents’ biggest concerns was the size of the tube,” Dr. Sathyamoorthyy added. “The manufacturer’s recommendation regarding the smallest available cuff tube [3.0 mm ID] is that it be used in full-term infants [weighing] more than 3 kg. But in practice, they’re being used in preterm babies even smaller than 2 kg.” Indeed, only 8% of respondents follow package recommendations for choosing the size of the cuffed tracheal tube, which drew a warning from Dr. Sathyamoorthy. y “Yes, the cuffed tube offers advantages,” he said, “but you still have to pay
attention to the size of the tube or you’re going to cause more trauma.” Interestingly, more than 60% of respondents said they do not monitor cuff pressure during anesthesia, contrary to recommended practice guidelines. “All the cuffed tube studies recommended measuring the cuff pressure,” he noted. “In real practice, however, it’s not being done. Even if you are using cuffed tubes in older children, you still have to pay attention to the cuff pressure. “So the take-awayy message here is that the cuffed tracheal tubes make our practice easier, but practitioners have to pay attention.” According to D. John Doyle, MD, PhD, the study is an important reminder that tracheal intubation is not always the benign procedure that anesthesiologists often think it is. “This caution is especially true in the pediatric population, whose smaller-diameter airway can make tracheal edema from contact pressure a cause for special concern,” said Dr. Doyle, now the chief of general anesthesiology at the Cleveland Clinic Abu Dhabi, in the United Arab Emirates. “I would suggest that if there was one place where anesthesiologists might easily improve their clinical practice, it would be in formally measuring all tracheal tube cuff pressures and ensuring they are always under 30 cm H2O pressure,” Dr. Doyle added. “It’s worth remembering that excessive tracheal tube cuff pressures can produce airway complications ranging from sore throat and hoarseness to tracheal stenosis, tracheal necrosis and even tracheal rupture.” —Michael Vlessides The investigators reported no relevant financial relationships.
Anesthesia Valet™
Anesthesia Valet is the Key to Easy PQRS QCDR Reporting
PQRS QCDR Reporting is Confusing •
Will providers get financial penalties for not participating?
•
Are there significant incentive opportunities for providers that participate?
•
Can providers keep submitting through their billing company?
•
What if the group practices in a care team model?
•
Can individuals submit through QCDR if they have more than 100 providers in the group?
Avoid the Confusion Get Anesthesia Valet and make PQRS/QCDR reporting easy.
Get Started TODAY!
Collect quality data today and build the foundation toward a Perioperative Surgical Home for tomorrow.
There is still time to qualify in 2015!
Get a 5-Minute Demo at: ePREOP.com/AnesthesiaValet Call: (888) 328-7871 See ePREOP’s Anesthesia Valet listed as a “QCDR Ready” vendor on the AQI website.
24 I AnesthesiologyNews.com
APRIL 2015
CLINICAL ANESTHESIOLOGY
Propofol Safer Than Sevoflurane in Ped Sedation, Study Finds New Orleans—If the experience of a University of Minnesota research team is indicative of institutions across the country, then propofol is not only far more popular than sevoflurane for pediatric sedation in anesthesiologist-run sedation units, but safer as well. The investigators found that although procedure and recovery times were comparable between children receiving both agents, side effects were significantly more common in those receiving sevoflurane. As Kumar Belani, MBBS, discussed, propofol has become commonplace during sedation at his institution, in part because the IV line can be established in most children with the aid of distractive methods. “Nevertheless, in some children, because of the variability of response, we might choose to administer the IV after they’re asleep,” said Dr. Belani, professor of anesthesiology at University of Minnesota, in Minneapolis. “As anesthesiologists we have that option, so we give them sevoflurane first.” Dr. Belani and his colleagues examined the medical records of 761 children (376 girls, 385 boys; mean age 4.48±4.61 years) undergoing sedation at the institution between May and December 2011. Recorded variables included patient demographics, admission and discharge data, diagnoses, procedure, sedation type, anesthetic/analgesic medications, complications and length of time in the sedation unit. “We wanted to see if there was any difference in outcomes,” Dr. Belani said in an interview with Anesthesiology News. As Dr. Belani reported at the 2014 annual meeting of the American Society of Anesthesiologists (abstract A3161), 709 pediatric patients were induced with propofol and 52 with
BLADES
most common adverse event, comprising seven of 14 complications in the propofol group and three of seven in Propofol Group Sevoflurane Group the sevoflurane group. Each group had one airway problem, an obstrucBoys, n 92 23 tion in the propofol group and larynGirls, n 107 29 gospasm in the sevoflurane group. a Despite the greater incidence of Age, y 6.41±5.20 4.6±4.02 adverse events associated with its use, Weight, kg 36.59±32.74 26.6±26a sevoflurane nevertheless can be a worHeight, cm 106.8±42.2 102±43 thy alternative to propofol in certain situations, particularly when adminisa Duration of anesthesia, min 45.59±27.85 56.6±41.6 tered exclusively by anesthesiologists. Duration of procedure, min 33.04±25.54 38.9±32.7 Indeed, Dr. Belani noted that having a sedation unit run exclusively by Duration of recovery, min 62.3±37.7 58.1±35.6 anesthesiologists provides treatment a P<0.05. options not available at the hands of other practitioners. “If you’re going to give a general 1 1 anesthetic, you have to be prepared 1 Apnea Headache to treat laryngospasm and any other Anxiety 1 problems that might relate to inhalaAirway tional agents,” he said. “With respect obstruction 1 3 to sevoflurane we have to be ready Laryngospasm 7 Nausea for a slightly higher risk for problems, Nausea although they’re not major.” 3 And although establishing a sedaDesaturation 2 tion unit run exclusively by anestheAgitation siologists was not necessarily easy, 1 Dr. Belani said it was well worth the Flushing effort. “Once we explained our role and showed the administration what we could accomplish, they were satFigure 1. Complications in Complications in isfied,” he said. “And now we’ve gotpropofol group (7.03%). sevoflurane group (13.46%). ten to the point where they can’t live without us. The surgeons, the refersevoflurane. When standardized for (56.6 minutes) than in those receiving ring physicians and [patients’] families all ask for the sedation unit. procedure type, there were 199 pro- propofol (45.6 minutes; P<0.05). “Patients are extremely happy and pofol patients and 52 sevoflurane “We also found that the rate of patients. It was found that the chil- complications was a little bit higher parents are very satisfied with the dren induced with propofol were in those who received sevoflurane,” care we give,” he added. “So having a older (6.4 vs. 4.6 years) and heavier Dr. Belani explained (Figures 1 and 2). sedation unit run by anesthesiologists (36.6 vs. 26.6 kg) than their counter- Indeed, 13.5% (n=7) of sevoflurane allows us to provide exactly what the parts receiving sevoflurane (Table). patients had complications, compared child needs.” Although procedure and recovery with 7.0% (n=14) for those receiving —Michael Vlessides times did not differ between groups, propofol. “We found that agitation anesthesia time was significantly lon- was more common in the sevoflu- The authors of the study reported no relevant ger in those receiving sevoflurane rane group,” he added. Nausea was the financial relationships. Table. Comparison Between Propofol and Sevoflurane Groups When Standardized for the Same Types of Procedures
standard, and we’re hoping this will get the attention of the manufacturers. One the blades was not only did they deflect other thing we feel is important is the in the vertical plane, they also exhib- hinge design. Because even in some of ited a lot of twisting,” he added. “That the metal blades, the plastic hinge porwasn’t specified in the ISO standard, tion is its Achilles heel.” “I find it very interesting that there’s but it could change where the light is an international standard that’s not being shone as the blade deflects.” “So, despite ISO standards, there are really being followed,” said session significant differences in the mechanical co-moderator Robert “Butch” Loeb, properties of these blades, particularly MD, associate professor of anesthesithe plastic ones,” Dr. Milne said. “Not ology at the University of Arizona in many of them actually meet the ISO Tucson. CONTINUED FROM PAGE 21
Jodi Sherman, MD, had a different perspective on disposable laryngoscopes. “We’ve looked at the environmental impact of various reusable and disposable formats and discovered that if we were to reprocess and house the stainless steel handles we could decrease our carbon dioxide footprint by more than 2.4 times,” said the assistant professor of anesthesiology at Yale University School of Medicine in New Haven, Conn., whose abstract (A2171) at the ASA annual
meeting discussed the topic at greater length. “By comparison, if we didn’t do that and then added in the disposable blade, we increased our carbon footprint by seven times. We also found that if we were to reprocess and house the laryngoscope handles, we could save $1 million over the disposables.” —Michael Vlessides The authors had no relevant financial relationships to disclose.
APRIL 2015
AnesthesiologyNews.com I 25
POLICY & MANAGEMENT
CMMI Bundled Payment Models Improve Care Atlanta—No matter the politics, the Affordable Care Act is a catalyst for change in medical practices across the country. The so-called triple aim— patient-centered health care at a lower cost and with less waste—seems like an obvious goal, but all agree it is also a tall order. The two core concepts, improved care and payment reform, should provide high-quality care to patients while rewarding physicians for doing what’s right. “High-quality care costs less to deliver,” said Mark Froimson, MD, an orthopedic surgeon who recently moved from Cleveland Clinic’s Euclid Hospital to Trinity Health, in Michigan, to explore how an integrated care model could be replicated across a national system with 86 hospitals. As executive vice president and chief clinical officer, he leads Trinity Health’s ini-
“Providers start to pay attention and want to be part of this program,” Dr. Froimson said. “It redesigns the way care is delivered by emphasizing key tenets of shared decision making and resource optimization.” This is an opportunity for physicians to be leaders, build a new culture and take ownership of the redesign, he said. A team approach and complete care
management are keys to a successful new design. “We’re guilty [of ] looking at anesthetic or mortality risk but ignoring the impacts that wound healing and rehabilitation potential have,” he said. “We need to look at anemia or uncontrolled diabetes and manage those medical comorbidities. We also need to assess the social determinants of success.”
Surgical teams must change their workflow. Instead of approving patients for joint replacement, scheduling them and then optimizing them, which often leads to cancellations, the team should put patients into an “indicated” pool. Then the team can create a checklist to review with each patient—diabetes, smoking, body mass see CMMI page 27
LMA Supreme
®
Airway
‘High-quality care costs less to deliver.’ —Mark Froimson, MD
tiatives related to patient safety, quality care improvement and patient experience. At the American Society of Anesthesiologists’ 2015 Practice Management conference, Dr. Froimson talked about one of the four new payment mechanisms under the Center for Medicare & Medicaid Innovation (CMMI) and how providers can already see a positive change. “No matter how well we try to prevent illness and maintain chronic disease, episodes will occur,” he said. “We need to understand how to manage those episodes, such as a fracture or gallbladder surgery.” Euclid’s Pilot Program Euclid Hospital joined a pilot program to try one of the new CMMI bundled payment models to improve coordination, quality of care and efficiency of health care services. Under the model, hospitals offer one product for an episode, which includes all pre- and postsurgical services for the patient. The key for each practice—and anesthesiologists in particular—is to lock in the right target price that Medicare will pay for the procedure. If care is coordinated well and the total procedural cost falls under the target price, providers can share the gain. In some cases, physicians can receive up to a 50% bonus over feefor-service rates.
The innovative, advanced, safe second generation supraglottic airway by Teleflex.
ADVANCED THE
F I R S T.
THE
ORIGINAL.
THE
LMA
SUPREME
A I R W A Y.
Continuing the legacy. The LMA Supreme Airway is making it possible to extend its use to more challenging cases. Backed by data and proven effective in advanced procedures: • Laparoscopic Choloecystectomy1
• PPV6,7,8,9
• Retropubic Radical Prostatectomy2
• Obesity3,10
• Prone Position3,4
• Pediatric11,12
• Gynecological Laparoscopy5
• Difficult Airway13
LMASUPREME.COM REFERENCES FERENCES 1. Belena J.M. et al. Journal of Clinical Anesthesia 2011; 23:456-460. | 2. Roiss M. et al. Poster presented at The American Association of Anesthesiologists Annual Meeting 15th -19th, Oct. 2011, Chicago. | 3. Sharma V. et al. BJA 2010; 105(2): 228-232. | 4. Whitacre W. et al. AANA Journal 2014; 82 (2): 101-107. | 5. Abdi W. et al. Acta Anaethesiol Scand. 2010; 54 (2): 141-146. | 6. Bernardini A. et al. Anesthesia 2009; 64: 1289-1294. | 7. Verghese C. et al. Anesthesia and Analgesia 1996; 82: 129-133. | 8. Tretiak S. Anethesiology News 2009. | 9. Viernes D. et al. Anesthesiology News 2010; 9-13. | 10. Verghese C. et al. BJA 2008; 101 (3): 405-410. | 11. Jagannathan N. et al. Pediatric Anesthesia 2012; 22:759-764. | 12. Jagannathan N. et al Anesthesia 2012; 67(2): 139-144. | 13. Ferson D. et al. Anesthesiology 2007; 107:A592.
Teleflex, LMA and LMA Supreme are trademarks or registered trademarks of Teleflex Incorporated or its affiliates. © 2014 Teleflex Incorporated. All rights reserved. MC-000549 rev.1
26 I AnesthesiologyNews.com
APRIL 2015
POLICY & MANAGEMENT
Bundled Payment Plans Require Data and Negotiation Atlanta—Under new financial models established by the Affordable Care Act, bundled payment arrangements are here to stay. Various models will address shared savings, including those for accountable care organizations, the four Center for Medicare & Medicaid Innovation bundled payment initiatives, and alternative payment models that may include the
so-called perioperative surgical home. Payment for anesthesia services may fall into six categories—fee-for-service without gain sharing, discounted feefor-service with potential gain sharing, percentage of bundled payment, portion of shared savings, bonuses for quality and/or performance metrics, and withholds and risk pool participation.
“You need to know some key pieces of data to determine which model is best for you,” said Marc Leib, MD, an anesthesiologist, health care consultant and chairman of the American Society of Anesthesiologists’ Committee on Economics. He discussed the specific bundled payment arrangements and effective negotiating strategies at the American Society of
SC A BOOTH
221 The Most Accurate Insight into Cerebral Oxygenation
CASMED has taken tissue oximetry to the next level and is making it easier than ever to get the kind of accurate and actionable readings you can trust. Building upon the proven accuracy of the FORE-SIGHT® algorithm, ELITE is the first and only FDA cleared tissue oximeter featuring five wavelengths of near-infrared light for greater accuracy and enhanced tissue recognition. ELITE is next generation technology designed to deliver a level of confidence that other conventional parameters cannot match. Visit CASMED at SCA Booth 221.
StO2 44 East Industrial Road, Branford, CT | 800.227.4414 | www.casmed.com
Anesthesiologists 2015 Practice Management conference. Time To Negotiate Fee-for-service will continue to dominate payment systems for the foreseeable future, he said, as either a direct payment method or for comparison in alternative payment models. Practices must know how much they require to perform each service to set the right rate in a bundled arrangement. “If you don’t know where you’re starting from, how are you going to value where you’re going in the future?” he asked. “Each practice must look at its specific data to calculate these price points.” These shared savings arrangements give providers the ability to share the overall savings generated for services provided. In single-sided models, providers share gains but not losses, and in double-sided models, providers share both gains and losses. To negotiate their slice of the shared savings, anesthesiologists should first establish a basis to evaluate proposals, Dr. Leib said. What is the cost of providing specific services? What are typical fee-for-service payments for similar services? Calculate your minimum acceptable payment— your “bottom line”—for a procedure. Add an expected profit margin for taking risks, plus a potential upside gain based on the likelihood of the care team achieving a savings. Look at the details of the package being offered and consider how much of the share will go to the hospital, surgeons, hospitalists and postoperative care, such as that provided by physical therapists. Don’t forget to adjust for your patient pool and the risk of taking on severely ill patients. “One size fits none. You have to look at your practice, dollars, costs, revenues and individual data or payor mix,” Dr. Leib said. “There’s no way for me to give you the exact number you should be looking for, but you can hire someone to evaluate your data to determine the bottom line number for negotiations.” During negotiations, anesthesiologists may face barriers from reluctant physicians who don’t want to share payments with additional practices. Some providers have little appreciation for what anesthesiologists contribute to the equation and how they can be part of overall savings.
APRIL 2015
AnesthesiologyNews.com I 27
POLICY & MANAGEMENT CMMI
CONTINUED FROM PAGE 25
index, anemia, Staph colonization, narcotic dependence, anticoagulation and lack of a supportive home environment—before scheduling a procedure. “This allows patients and families to own their risks, understand the impact on success and manage themselves so they’re not caught by surprise,” he said. “And the practice has fewer cancelled cases.” Practices can also eliminate sometimes unnecessary but routinely performed interventions, such as daily lab draws, x-rays in the postanesthesia
care unit for knees, patient-controlled IV analgesia, bulky dressings or drains, routine Foley catheters and other habits that surgeons have developed over the years. Providers should also use business intelligence tools to track performance and outcome measures in addition to process measures, such as noting whether a patient was able to return to work rather than merely complete the surgery. “We engage patients and families, sometimes going into the home,”
Dr. Froimson said. “We firmly believe that being in the hospital is not healthpromoting, and it’s better for patients to recover at home. We believe it is our job to enable that.” During the pilot program, Euclid Hospital saw rates for infections, readmissions and inpatient stays decrease. By eliminating Foley catheter use during joint replacements, for instance, urinary tract infections dropped from 5% in the first quarter of 2013 to zero in the first quarter of 2014. In addition,
skilled nursing facility use fell from 56% to 22%. “There really is an opportunity to deliver better care for patients when you get the team together, think comprehensively and do it in a way that reduces the resources used,” Dr. Froimson said. “Our goal was to break even with the Medicare target price, but we’re doing even better than that now and creating value.” —Carolyn Crist
“Unless they understand what we do beyond putting a patient to sleep, they’re not going to see the value in sharing with us,” he said. “Our job is to tell them and show them with real data.”
‘One size fits none. You have to look at your practice, dollars, costs, revenues and individual data or payor mix.’ —Marc Leib, MD
Value includes fewer inpatient days, decreased utilization of blood products, postoperative pain management, fewer cancelled cases, preoperative testing as appropriate and increased patient satisfaction scores. When maneuvering in negotiations, remember that each practice and shared savings arrangement is unique. Learn as much information about your practice and providers as possible before entering negotiations by obtaining data from multiple sources and slicing and dicing the numbers to show where you provide value, Dr. Leib said. Track and trend your group’s data to show how anesthesia can affect the overall success of the shared arrangement. Begin negotiations early. Prepare yourself for long discussions. Set a positive tone. “If your hospital gives any indication that negotiations are starting, don’t be the last to the table,” Dr. Leib said. “If you’re not there playing along, they’ll find someone who will.”
Post-op pain has met its match
Arrow
Arrow
®
®
AutoFuser A u
FlexBlock Block ock
• ERG ERGONOMIC PUMP DESIGN
• DESIGNED TO HELP BETTER CONTROL PATIENT PAIN
®
Disposable Di ispos Pain Pump
• VAR VARIABLE RATE SELECTOR • UNINTERRUPTED UN CO CONTINUOUS INFUSION
®
cPNB Catheter er
• ECHOGENIC • FLEXIBLE • KINK-RESISTANT
Together, these dynamic i pa pain management solutions can provide you with fast, accurate catheter placement with a reliable, unimpeded infusion of medication.
—Carolyn Crist AutoFuser is a trademark or registered trademark of ACE Medical Co., Ltd. Teleflex, Arrow and FlexBlock are trademarks or registered trademarks of Teleflex Incorporated or its affiliates. © 2015 Teleflex Incorporated. All rights reserved. MC-000988
TELEFLEX.COM/PNB
28 I AnesthesiologyNews.com
APRIL 2015
CORRESPONDENCE
Letter to the Editor Get the latest news from the best-read anesthesiology publication in the country, including web-exclusive content, delivered directly to your inbox!
In re “MOCA Push-Back,” by Robert E. Johnstone, MD; January 2015, page 1
I
t is disingenuous to place a puff piece written by and for the American Board of Anesthesiology (ABA) and not disclose Robert E. Johnstone, MD’s long history with that organization. Even more so when Dr. Johnstone continues with the same assertions that are the tired talking points of the ABA. Inciting code words of “uninformed rants” in opposition or “patient demands” that are wholly vague, unsubstantiated and fear mongering are hardly of the scholarly nature expected from leaders in our specialty, especially the selff appointed ones! Forced failure rates, discriminatory and subjective oral exams, lack of transparency and feedback, and outdated or irrelevant exam material are not the foundations of a legitimate organization. Given Johnstone’s distance from actual one-on-one clinical duties, I can guarantee that his passing effort on the MOCA exam is either manufactured by his ABA peers or, worse, proves that a crammed foreknowledge of the topics and questions is all that’s needed to show “competency.” Either way, that’s a sad indictment of how far credentialing has sunk and yet another reason for the long overdue dissolution of the archaic ABA and its processes. It’s time to create modern, Internetbased, crowd-sourced modules of motivational CME learning, created and
overseen by an unbiased third party such as the Anesthesia Quality Institute (AQI), which as a separate arm of the American Society of Anesthesiologists (ASA) is already dedicated to patient safety and clinical forensics. For instance, following the death of Michael Jackson, the ASA/AQI could have rapidly made available a 3-5 CME module of the on- and offf label uses of propofol, dosage guidelines (with volunteered clinician variances and discussion), Propofol Infusion Syndrome, safety precautions in all settings, and a short pre- and post-test for selff grading. A relevant modernization via the ASA can be done but will require collaboration with our most visionary colleagues, many of whom have no Primary Certification and are thus unfairly marginalized by the pretentious Board, before the currently slapdash and expensive BC and MOCA processes get any further into the weeds. So it’s also time for the ASA to get out of the warm cozy bed of Simon Legree and show the will to advocate for the entire guild of anesthesiologists in a manner befitting the responsive physicians’ union they claim to be. Martin Flynn, MD Venice, California Dr. Johnstone declined to comment but noted that even while he was an officer of the ASA, he continued to work full time clinically.
FDA Launches Drug Shortages Mobile App
T Register @ anesthesiologynews.com/enews
@anesthesianews anesthesiologynews +anesthesiologynews for iPad
he FDA launched its first free mobile app specifically designed to speed public access to valuable information about drug shortages. The app identifies current drug shortages, resolved shortages and discontinuations of drug products. Drug shortages are a fact of life for hospital pharmacists, and can lead health care professionals to rely on alternative drug products, which may be less effective or associated with higher risks than the drug in shortage, according to the FDA. “The FDA understands that health care professionals and pharmacists need real-time information about drug shortages to make treatment decisions,” said Valerie Jensen, associate director of the Drug Shortage Staff in the FDA’s Center for Drug Evaluation and Research. “The new mobile app is an innovative tool that will offer easier and faster access to important drug shortage information.” App users can search or browse by a drug’s generic name or active ingredient, and browse by therapeutic category. The app can also be used to report a suspected drug shortage or supply issue to the FDA. The agency developed the drug shortages app to improve access to information about drug shortages, as part of the FDA’s efforts outlined in the Strategic Plan for Preventing and Mitigating Drug Shortages. The app is available for free download on iTunes (for Apple devices) and the Google Play store (for Android devices) by searching “FDA Drug Shortages.” —AN Staff
APRIL 2015
AnesthesiologyNews.com I 29
POLICY & MANAGEMENT
Post–Acute Care Transitions: Time for Improvements Amy P. Myers, PharmD, BCPS Department of Pharmaceutical Services Vanderbilt University Medical Center Nashville, Tennessee
Erin B. Neal, PharmD, BCPS Department of Pharmaceutical Services Vanderbilt University Medical Center Nashville, Tennessee
current list of hospital medications also may be sent to assist the PAC facility in preparing for the patient’s arrival. At the time of transfer, several additional lists will be sent with the formal paperwork including, at minimum, a list within the discharge summary that provides a historical account of the patient’s hospital stay and a list of medications to be ordered at the PAC facility. These
various medication lists often do not match, causing significant confusion, and they rarely include a prospective plan for managing medications.4 The ambiguous information provided forces staff at the PAC facility to work to discern which medications actually should be ordered. To address some of these problems, s Vanderbilt University Medical Center,
Amanda S. Mixon, MD, MS, MSPH Department of Veterans Affairs Tennessee Valley Healthcare System Geriatric Research Education and Clinical Center Section of Hospital Medicine Division of General Internal Medicine and Public Health Department of Medicine Vanderbilt University Nashville, Tennessee
P
reventing hospital readmissions has become a focus for many health care systems trying to improve care. In addition to safety and quality concerns, the impending Medicare penalties for readmissions have made this an important issue. There is room for improvement, in particular with respect to preventing readmissions among patients discharged to post–acute care (PAC) facilities. Many of the interventions that have been shown to reduce readmissions are not employed in this population, despite the fact that patients discharged to PAC facilities experience 30-dayy rehospitalization rates of up to 25%.1 When patients transfer from the hospital to a PAC facility, there is risk for medication discrepancies at many junctures.2,3 Facilities typically receive a patient’s list of active hospital medications during the initial referral. Once the patient is accepted, another more
4.0 Warfarin Held given
Day of Discharge
3.3
2.7
Held
2 mg ordered for tonight
INR, international normalized ratio a
see transitions page 35
Brought to you by
Now Available Digitally and in Print!
REPORT Enhanced Recovery Pathways For Major Abdominal Surgery Based on the 2nd Enhanced Recovery After Surgery (ERAS) USA Symposium held on October 10, 2014 in New Orleans, Louisiana. Faculty Authors Timothy E. Miller, MB, ChB, FRCA
Tong J. Gan, MD, MHS, FRCA
Julie K. M. Thacker, MD
Assistant Professor of Anesthesiology Department of Anesthesiology Duke University Medical Center Durham, North Carolina
Professor and Chair Department of Anesthesiology Stony Brook University Hospital Stony Brook, New York
Assistant Professor of Surgery Department of Surgery Duke University Medical Center Durham, North Carolina
Download a PDF at AnesthesiologyNews.com or GeneralSurgeryNews.com or in the
&
iPad apps.
For free reprints, contact your representative at one of the supporting companies below. Day Before Discharge
2 Days Before Discharge
Table 1. Warfarin to Target INR: 2.0-3.0a
with the support of a Centers for Medicare & Medicaid Services (CMS) innovations grant known as IMPACT (Improved Post-Acute Care Transitions), implemented a transition intervention for Medicare patients transferring to one of 23 PAC facilities in the Nashville area. The intervention involves a nurse transitions advocate meeting
Duration u at o of o therapy: t e apy py indefinite de te
anesthesiologynews
@anesthesianews
@gensurgnews
Supported by
30 I AnesthesiologyNews.com
APRIL 2015
POLICY & MANAGEMENT All about the ‘experience monopoly’:
Do You Make This Mistake Concerning Customer Value? Mark F. Weiss, JD
Although an experience monopoly is a “soft” concept, for the economists in read an op-ed piece in the crowd there’s a way to describe its which a celebrity econstrength in the language of math: omist was stymied by E + Phe + PQenv = strength of the fact that a medical prounique experience cedure, a hip replacement, where E is the actual level of medical expertise and skill; Phe is the strength for example, costs an insurer of the perceived human experience and $X if performed at one facility, yet $X + $Y if done at PQenv is degree of the perceived qualanother. His assumption Mark F. Weiss, JD ity of the environment. was that some providers are Although I said I was writing in just better at negotiating than others— its panel. math, be warned that this is not a forand that that was somehow “unfair.” For physicians, the lesson to be mula like 2+2 = 4. Unlike our econMy guess is that he’d be happy if the drawn is the importance of developing omist friends, I am not pretending government simply deemed the price, what I call an “experience monopoly,” that fluid circumstances and subjecand happier still if he were the czar providing such a valuable experience tive determinations can lead to an appointed to do the deeming. to patients, referral sources and facili- actual equation that can be proven and I’m sure that I’m not the first to ties that they deem you their preferred repeated with scientific accuracy. point out that economics is not a sci- partner, one that they can’t see themence and that celebrity economists are selves doing without. simply a subset of entertainers, but I’m You’ve deemed many businesses left to wonder whether the guy ever with this status yourself—perhaps the thought about why one fast food place dry cleaner who always greets you by sells a mediocre burger for a dollar or name and helps you carry your clothes two, while a few blocks away, Chez to your car, or the restaurant with Whatever prices a slightly larger one at the wonderful outdoor heated patio 13 times that price and sells them like, (heated floor, large wood-burningg firewell, hotcakes. We’re talking the same place and radiant heat lamps), delibeef, too, not some exotic breed that’s cious cuisine and incredibly attentive fed craft beer twice a day and regu- service, that you both frequent and larly attended to by licensed massage recommend to everyone (contact me, therapists. I’ll give you its name).
I
Getting back to hip replacement—certainly, some facilities might deploy better negotiation techniques than a multibilliondollar insurer. But there are several larger, and more likely, things going on here, such as location and reputation—the carrier simply has to have those facilities and its associated providers on
Rather, it’s just the view from another perspective, describing the relationship among the factors that lead to an experience monopoly in your practice. For example, a physician with a very acceptable level of expertise, say, 7 on a scale of 10, who delivers a fantastic experience from a bright, cheery, modern office, may have a far more successful practice in terms of patient satisfaction than an extremely competent physician, a 10 out of 10 in terms of expertise, who delivers a dismally perceived human experience in an unwelcoming atmosphere. Particularly important is an understanding that the environmental factor does not refer simply to the
Marketing 101 for Anesthesiologists: Show Your Value Atlanta—Like all workers, anesthesiologists must determine the best ways to serve their “customers”—the hospital, surgeons, patients and bill payors. Although it is important to make each group happy, the “real” customers are the hospital administrators who renew contracts. Administrators should know your value and how your anesthesia practice is indispensable to the hospital. “This is Marketing 101 for anesthesiologists,” said Amr Abouleish, MD, an anesthesiologist at the University of Texas Medical Branch at Galveston, who speaks nationally about the economics of anesthesiology care. Dr. Abouleish discussed marketing and branding strategies at the American Society of Anesthesiologists (ASA) 2015 Practice Management conference, in Atlanta. He is a past chairman of ASA’s Committee on Practice Management. “Perception is reality. You want to be the one who creates the reality of your practice,” he said. “If you don’t promote what you do, then someone else will create the perception of what you do.”
Anesthesiologists should follow age-old marketing advice: Identify customer needs, develop products to meet those needs and communicate those products to the customer. To do this, anesthesiologists must understand what the hospital needs and wants, Dr. Abouleish said. “Simply giving anesthesia care in the operating room [OR] will not differentiate you from any other provider, and ignores everything else a hospital would like you to do,” he said. “You probably do more than that but might not even realize it. If you don’t, then how will the hospital?” To be successful, anesthesiology groups must understand that hospitals expect anesthesiologists to improve OR throughput by tackling more cases, reducing turnover time and preparing for procedures on schedule. Hospital administrators want highqualityy care that goes beyond the hospital’s quality management program. They will seek practices that save money and decrease cancellations through preoperative assessment, acute pain care and postoperative
planning. Ultimately, hospitals want to avoid problems. Personality counts, and good anesthesiologists must be good communicators and facilitators who work well with both patients and surgeons. “Do you stay at the anesthesia machine or even sit down during the case? Or are you tying the surgeon’s gown while the nurse preps the patient?” Dr. Abouleish asked. “Do you open a suture pack or answer the phone when the nurse is not in the room? Which anesthesiologist is viewed as being more valuable by the surgeon and the OR nurse?” Anesthesiologists should also prepare to step into leadership roles. Internists may not understand surgeons and surgeons may not understand internists, but anesthesiologists are armed with the experience to talk to both. “Show that you can get it done. Be a hard worker, facilitator and collaborator,” he said. “Communicate what you do every day to the hospital to make yourself indispensable.” —Carolyn Crist
APRIL 2015
AnesthesiologyNews.com I 31
POLICY & MANAGEMENT providing the level of experience that your targeted customers value. Chevrolet and Ferrari don’t target the same customer, and neither should you. Mark F. Weiss is an attorney who specializes in business and legal issues affecting physicians and physician groups, and served as clinical assistant professor of anesthesiology at USC Keck School of Medicine. The Mark F. Weiss Law Firm has offices in Dallas, Texas and Los Angeles and Santa Barbara, California, and represents clients across the country. His email: markweiss@ advisorylawgroup.com.
Financial & Legal Services
Career Opportunities
Medical Equipment
Education
See page 52, and available 24/7 at
AnesthesiologyNews.com/classified.aspx
UNWAVERING
physical environment, over which, in some settings, you may have little to no control—it also refers to the relationship environment in which you provide services. Years ago, I developed a bump on my right wrist. I asked several physicianclients to recommend a hand surgeon. They all suggested Dr. X. I made an appointment with Dr. X. When I arrived to see him, I was shown into a small exam room, really only enough space for two simple chairs and a small table in between. After sitting for at least 20 minutes twiddling my thumb (the other one hurt too much to twiddle), with not a single magazine to read in sight, not even a six-month=old issue of Good Housekeeping, g in walked Dr. X. Without introducing himself, he sat down, manipulated my wrist, and said, “Our opinion is that you have a ganglion cyst.” Never one to be shy, I pretended to look all around the minuscule room and then asked him, “Excuse me, but do you see anyone else in here?” I did have the surgery and, although it’s been more than 20 years, I have not had a problem with my wrist since. But have I ever recommended Dr. X to anyone? No way! Professional expertise: excellent. Perceived quality of the environment: low. Perceived human experience factor: dismal. Strength of unique experience: zero, or perhaps even negative. Of course, the goal is for you to increase the level of performance within your medical group across each of the components. Note especially that you must focus on the human experience and environmental factors—all physicians understand the importance of medical expertise, yet that expertise alone, and, certainly, that expertise tamped down by the impact of a poor environment and an even poorer experience is worthless in terms of creating relationships with patients, referral sources and facilities that over a career will prove extremely valuable. And finally, there’s the issue of price, the element that attracted the economist’s comments in the first place. Experience monopolies do not exist in a vacuum. They are dependent on the value that your customer, whether that’s a hospital, a referral source or a patient, places on them. In other words, pricing, or value, is determined at the customer level. Simply put, some customers will not place as much value on your offering as others. The challenge is
WE ARE UNWAVERING IN OUR MISSION TO DEFEND, PROTECT, AND REWARD THE PRACTICE OF GOOD MEDICINE
New healthcare delivery models bring new medical malpractice risks. That’s why you can’t afford to be wrong in your choice of malpractice insurer. The Doctors Company relentlessly defends, protects, and rewards the practice of good medicine. We provide unmatched coverage to 75,000 members nationwide. When your reputation and livelihood are on the line, choose the insurer that stands with doctors. Join your colleagues—become a member of The Doctors Company.
CALL 888.536.5346 OR VISIT WWW.THEDOCTORS.COM
MISSION
32 I AnesthesiologyNews.com
APRIL 2015
PAIN MEDICINE
Burst and Dorsal Root Ganglion Stimulation Show Promise in SCS New York—Interventional pain specialists need new tools and targets for spinal cord stimulation (SCS) to improve the overall efficacy of the care they provide. That was the key message of a lecture on the discipline presented during the 68th New York State Society of Anesthesiologists’ PostGraduate Assembly. Electrical stimulation has been used to treat pain since the 1960s. Approximately 27,000 SCS devices are currently implanted annually in the United States. However, according to Michael L. Weinberger, MD, associate clinical professor of anesthesiology, Columbia University College of Physicians and Surgeons and director, Pain Management Center, NewYorkPresbyterian Hospital/Columbia University Medical Center, in New York City, recent studies suggest that up to 40% of patients who have SCS devices
implanted “do not end up having satisfactory pain relief,” and as many as 50% of patients who experience initial pain relief find that their devices lose efficacy over time. The good news, Dr. Weinberger noted, is that novel approaches already in use in Europe and other parts of the world have shown promise in clinical practice. He presented clinical data on two methods: dorsal root ganglion (DRG) stimulation and burst stimulation. The DRG, a sensory root that sits in the neural foramen and is surrounded by glial cells, has emerged as a therapeutic target for SCS in recent years. The cells that comprise it are actively involved in signaling in both the central and peripheral nervous systems. The satellite glial cells have receptors for various neuroreactive chemicals that might be released
as a result of injury or inflammation, including bradykinin and ATP. It has been demonstrated that the DRG plays an active role in the mechanism of both neuropathic and chronic pain via central sensitization. “It has been suggested that electrical stimulation of the DRG may alter its sodium, potassium and/or calcium channel gene expression,” Dr. Weinberger told the attendees. “If you have changes in the DRG based on neurofiber injury, we can restore the fibers back to normal via electrical stimulation.” The value of the DRG as an analgesic target has been confirmed in a rat model (Neuromodulation 2013;16:304-311) and several clinical trials. The rat model found that field stimulation of the DRG directly suppresses excitability of sensory neurons that play a role in the pathogenesis of
Supraclavicular Brachial Plexus Catheters for Upper Extremity Pain New York—Placement of bilateral supraclavicular brachial plexus catheters is a viable option for the management of bilateral upper extremity pain. A team from Louisiana State University Health Sciences Center (LSUHSC) in Shreveport presented two case reports in which this approach was used to manage enduring pain. “Our patients presented with bilateral upper extremity trauma and, in spite of being on a multimodal pain regimen, their pain was not adequately controlled due to the extensive nature of their injuries,” said Sudipta Sen, MD, assistant professor of anesthesiology at LSUHSC-Shreveport, who presented the cases at the 68th New York State Society of Anesthesiologists’ PostGraduate Assembly (PGA). The first case involved a 52-year-old woman who had sustained bilateral hand injuries due to a workplace blast injury; the second case involved a 29-yearold man who had sustained bilateral electrocution injuries to both forearms. Historically, supraclavicular blocks have been associated with phrenic nerve blockade and diaphragmatic paralysis; pneumothorax is also a known complication linked to the procedure. However, the advent of ultrasound guidance in regional blockade has been shown to reduce the incidence of pleural puncture and diaphragmatic paralysis by enabling direct needle tip and pleural visualization. According to the authors, in the case of the female patient, a bolus of 20 mL of ropivacaine 0.5% was injected through each catheter. Ropivacaine 0.2% was then infused through each catheter at a rate of 6
‘Placement of supraclavicular catheters under ultrasound guidance enabled us to visualize the spread of the local anesthetic around the brachial plexus in real time.’ —Sudipta Sen, MD
mL per hour. The patient’s catheters were removed without any complications on day 8. Similarly, in the case of the male patient, 10 mL of ropivacaine 0.2% was injected through the left supraclavicular catheter and 10 mL of 0.5% ropivacaine was injected through the right supraclavicular catheter. An infusion of 0.2% ropivacaine at a rate of 8 mL per hour was then initiated through each catheter. In this case, the catheters were removed on postprocedure day 3 without any complications. Despite their success with the approach, the authors emphasized that supraclavicular catheters should be used with caution in patients with respiratory insufficiency due to the possibility of phrenic nerve blockade. “Placement of infraclavicular catheters was technically challenging due to their body habitus,” Dr. Sen said. “However, placement of supraclavicular catheters under ultrasound guidance enabled us to
pain. Perhaps the most notable clinical trial of DRG stimulation to date is a one-year follow-up study, published in Neuromodulation (2015;18:41-49), involving human subjects with back, neck or foot pain. The authors concluded that DRG stimulation is comparable to “traditional SCS” in terms of pain relief, and that its benefits “may include the ability to achieve precise pain–paresthesia concordance, including in regions that are typically difficult to target with SCS, and to consistently maintain that coverage over time”—even when patients move. Historically, one of the concerns with SCS is the variability in the amplitude of stimulation resulting from patient movement. Because of the cerebrospinal fluid (CSF) surrounding the spinal cord, any movement by the patient can cause the
visualize the spread of the local anesthetic around the brachial plexus in real time. We could visualize optimal spread after an initial small bolus dose and used lower infusion rates, thus preventing the potential complication of phrenic nerve blockade seen with higher volumes of the drug.” Thomas M. Halaszynski, MD, DMD, MBA, an anesthesiologist who has devoted much of his research work to the use of supraclavicular catheters, agreed with the LSUHSC authors, noting that ultrasound guidance has created new applications for the devices, at least potentially. However, Dr. Halaszynski, associate professor of anesthesiology and director of urologic perioperative and adult anesthesia at the Yale School of Medicine in New Haven, Conn., who was not involved in the PGA report, emphasized that supraclavicular catheters “in single shots, not to mention bilaterally,” must still be used with caution, particularly in patients with “respiratory compromise or dysfunction,” due to the risk for hemidiaphragm. “We are preparing to publish a study with well over 180 supraclavicular single shots and we still had a small incidence of phrenic nerve creating a hemidiaphragm,” he told Anesthesiology News. “This case report included no objective measurements made as to effect on the phrenic nerve causing a hemidiaphragm. Somebody who has respiratory compromise or dysfunction would potentially succumb to negative results if there were hemidiaphragm on one side, let alone both sides. “There are a lot of variables here that prevent [the authors] from coming to any firm conclusions. That being said, their report does highlight the need for further research into the use of supraclavicular catheters bilaterally.” —Brian Dunleavy
APRIL 2015
AnesthesiologyNews.com I 33
PAIN MEDICINE ‘So what are the advantages of burst? No paresthesia, maybe better analgesia.’
placebo stimulation for one week. For “Neurostimulation, as it stands, is is not subject to positional variabilthe burst stimulation treatment group, effective for a small, rather specific ity. DRG stimulation is not subject to mean numeric rating scale and Short- patient population,” said Ebby G. Var- the patient’s positional changes either Form McGill Pain Questionnaire ghese, MD, medical director of the and can be used to target specific scores were significantly decreased Interventional Pain Medicine Clinic, painful dermatomes. These options compared with the other treatment and assistant professor of clinical have never been seen before, and the groups; these scores did not differ physical medicine and rehabilitation, results seen in Europe are promising. —Michael L. Weinberger, MD significantly between 500-Hz tonic University of Missouri-Columbia, If they hold true, [burst and DRG stimulation and placebo stimulation who was not part of the PGA lecture. stimulation] will improve patient outgroups. “Early literature in burst stimulation comes [compared with the options] “So what are the advantages of suggests the quality of the stimulation we currently provide.” SCS device lead to move, altering its proximity to the spinal cord. There burst? No paresthesia, maybe better is improved, a broader area is covered, and the strength of stimulation is no CSF surrounding the DRG, analgesia,” said Dr. Weinberger. —Brian Dunleavy and it is also very difficult to injure or damage the DRG, according to Dr. Weinberger. “[In these studies] paresthesias were well mapped to where the pain was,” he said. Burst stimulation consists of intermittent packets of closely spaced, high-frequency stimuli. De Ridder pioneered the approach in New Zealand, where he experimented with 40-Hz burst mode with five spikes at 500 Hz per burst, with a pulse width of 100 msec. In contrast, traditional SCS is delivered in constant or tonic fashion, at a pulse width of 300 to 500 msec. Furthermore, unlike with traditional SCS or DRG stimulation, patients undergoing burst stimulation treatment do not experience paresthesia. According to Dr. Weinberger, a recent study comparing burst stimulation with traditional SCS in a What is MISP? rat model found that burst stimHow to get started: The mission statement of the Merck Investigator ulation reduced the visceromotor To learn more about the areas of interest for Studies Program (MISP) is to advance science and reflexes more than tonic SCS, and anesthesia and requirements for submission visit that only burst stimulation signifiimprove patient care by supporting, through the http://engagezone.merck.com/anesthesia.html. cantly decreased nociceptive somatic provision of drug/vaccine and total/partial funding, response at low-intensityy SCS (NeuroThere are two review cycles for anesthesia high-quality research that is initiated, designed, modulation 2014;17:143-151). Based submissions: implemented and sponsored by external investigators. on these findings, the researchers con• First cycle deadline is in early cluded that burst stimulation is more Who Can Participate? February 2015. effective than tonic SCS in attenuThe Merck Investigator Studies Program is open ating visceral nociception, and that • Second cycle deadline is in early burst stimulation has a greater inhibto all academic and community-based physicians, April 2015. itory effect on neuronal response to anesthesiologists, surgeons, and researchers noxious somatic stimuli than to noxworldwide who are interested in conducting their ious visceral stimuli. They also noted own research. that the reduced paresthesia associated with burst stimulation might How Does the Program Work? be due in part to the fact that the This program consists of committees of medical and approach does not increase spontaneous activity of neurons in the gracile scientific staff from different therapeutic areas who nucleus. meet regularly to review Merck investigator study Dr. Weinberger then cited a proproposals. Support and funding are provided spective, randomized, double-blind, based on the scientific merit of the proposal as well placebo-controlled study on the as whether it is in alignment with the published areas effectiveness of burst stimulation of interest. in 20 patients with failed back surgery syndrome (Neuromodulation 2014;17:443-450). Participants were randomized to receive 500-Hz tonic stimulation, burst stimulation or
Interested in conducting your own research?
Consider the Merck Investigator Studies Program.
Copyright © 2014 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. Printed in USA ANES-1124773-0000 07/14
34 I AnesthesiologyNews.com
APRIL 2015
PAIN MEDICINE
Adding Dexamethasone to Brachial Plexus Block Extends Duration and Eases Postoperative Pain New Orleans—Adding perineural dexamethasone as an adjunct to traditional brachial plexus block radically extends the duration of the block and improves postoperative pain outcomes, a meta-analysis has found. Additionally, no reports of persistent nerve injury
were attributed to perineural dexamethasone administration in the nine trials comprising the analysis. “Our group has done quite a bit of research with respect to quality of recovery,” said Meghan E. Rodes, MD, assistant professor of anesthesiology at
Northwestern University, Chicago. “But one area where we don’t have any data is the effect of adding dexamethasone to brachial plexus block. Obviously, there are data out there suggesting this may be helpful in prolonging block. We still don’t know whether it actually makes
Misstral-Air by Stryker is the next generation in patient warming g, offering a simple, safe and d efficient temperature management solution. The system fe eatures a quiet, high h-volume blower with HEPA filtration and a broad range of plus p and premium blan nkets – designed to deliver an even, comfortable flow of difffused warm air over the surfface of the patient. Thiss Controlled Diffusion eliminates individual jets of forced air that cause lofting or shiffting, so the blanket stays in position, keeping the warm air on the patient and out of tthe surrounding environment. Witth an extensive line of disposables, including the exclusive Premium P Warming Suit, whiich is ideal for complicated patient positioning in robotic pro ocedures, Mistral-Air by S Stryker optimizes patient warming throughout the periopera ative process.
To learn more about Mistral-Air, contact your Stryker Medical account manager today.
pa atienthandling.stryker.com Mkt Lit - 874 25 JUN 2013 Rev A.2 | © 2015 Stryker
patients feel like they have a better experience. “There are also questions as to whether the addition of dexamethasone has a negative impact as far as nerve injury and other complications like infection and glucose hemostasis,” she said. To help answer these questions, Dr. Rodes and her colleagues performed a systematic search to identify randomized controlled trials evaluating the effects of perineural dexamethasone as a block adjunct on postoperative pain outcomes in patients receiving regional anesthesia. The meta-analysis was performed using a random-effects model; publication bias was evaluated by examining the presence of asymmetric funnel plots using Egger’s regression. As Dr. Rodes told Anesthesiology Newss at the 2014 annual meeting of the American Society of Anesthesiologists (abstract A1304), the search yielded nine trials comprising 760 patients. It was found that the weighted mean difference of the combined effects favored perineural dexamethasone over controls for both the duration of analgesia (473 minutes; 99% confidence interval [CI], 264-682 minutes) and motor block (500 minutes; 99% CI, 154-846 minutes). Patients receiving perineural dexamethasone also had reduced postoperative opioid consumption (–8.5-mgg morphine equivalents; 99% CI, –12.3 to –4.6 mg). Interestingly, the meta-analysis revealed that perineural administration might not be the only way to use dexamethasone for improved postoperative analgesia. “Desmet and colleagues [[Br J Anaesth 2013;111:445-452] examined both perineural and IV dexamethasone administration and found no significant difference in efficacy between those two treatment groups,” Dr. Rodes said. “Those results made me think that in a nondiabetic patient, I’d strongly consider going the IV route.” Although Dr. Rodes acknowledged the efficacy of perineural administration of dexamethasone, she recognized that more research is necessary before any definitive conclusions can be made. “The question is whether we have captured enough patients to determine dexamethasone’s true effect,” she said. “In the end, there’s definitely more room for study. For even though no significant neurologic symptoms were attributed to the use of perineural dexamethasone, you have to use caution anytime you
APRIL 2015
AnesthesiologyNews.com I 3 5
PAIN MEDICINE use a medication that’s offf labell and has potential toxicity,” she said. Jeff Gadsden, MD, applauded the authors for systematically investigating what has become a common question at meetings and workshops, with little apparent consensus among anesthesiologists. “Although these results have shown that dexamethasone extends both motor and sensory blocks, they lead to the question of where these relatively modest gains will fit with respect to clinical decision making,” said the associate professor of anesthesiology at Duke University Medical Center in Durham, N.C. “For example, if a duration of analgesia well beyond the typical 16 to 24 hours is desired, is eight hours of additional blockade acceptable? If not, a catheter
TRANSITIONS
technique may be more appropriate. Newer, long-actingg local anesthetics are also likely to impact the way we think about these choices.” All told, Dr. Gadsden agreed that more research is required, particularly when it comes to potential neurotoxic sequelae for an offf label adjuvant. “Although there are small animal models showing that dexamethasone may not cause damage when combined with local anesthetics, it is very difficult to draw conclusions about toxicity given the relatively small numbers we have to date,” he said. —Michael Vlessides
YOU can reduce post-surgical complications by
32% 1
in your moderate to high-risk patients.
The authors had no relevant financial relationships to disclose.
CONTINUED FROM PAGE 29
with the patient upon referral to a partner facility and assisting with communication of the patient’s care plan among the family, the acute care setting and the PAC facility. A key component of the intervention is transfer-oriented medication reconciliation performed by a clinical pharmacist, which is a practice recently recommended by the Institute for Safe Medication Practices to prevent medication errors in this vulnerable population.5
medications that were temporarily held. Careful attention is paid to prevent errors of omission, which may occur if a medication that should be restarted at the PAC facility is mistakenly omitted from the transfer orders. It is common for antihypertensives, antidepressants and antiplatelets normally taken at home to be held during the hospital stay, and a plan to resume them often is overlooked. Pharmacists also use this as an opportunity to ensure that CMS core
Table 2. Insulin Requirements Day Before Hospital Discharge: 2/12 Breakfast
Lunch
Dinner
Bedtime
Blood glucose
126 mg/dL
145 mg/dL
195 mg/dL
124 mg/dL
Insulin scheduled
n/a
n/a
n/a
n/a
Insulin prn
0
0
6 units ss
0
prn, as needed; ss, slidingg scale prn,
Pharmacists reconcile the transfer orders at discharge and create a medication management plan (MMP) for the PAC providers. The MMP includes the patient’s prehospital medications, the medications to be ordered at the PAC facility, the indications for each medication, any additional comments and the last administration time for medications at the hospital. This side-byy side comparison of the prehospital medications and transfer orders allows for quick review of medications throughout the continuum of care. To complete the MMP, prehospital medications are reconciled with the transfer orders and are clearly marked as continued, changed, held or discontinued, with a rationale for changes. Additionally, the plan includes specific instructions to restart any prehospital
measures are met. If a core measure medication is omitted (ie, no order for an angiotensin-convertingg enzyme inhibitor for a patient with systolic heart failure), the pharmacist explores the reason and communicates a recommendation to the transferring provider and the receiving PAC facility. Selected high-riskk medications that are particularly associated with errors receive special attention. Orders for warfarin are accompanied by at least three days of international normalized ratio (INR) history, dosage history and a plan for follow-up INR (Table 1). The indication for therapy and goal INR also is clearly stated. Insulin orders prompt the inclusion of blood glucose readings with all scheduled and sliding-scale insulin administered (Tables 2 and 3). see transitions page 38
A large body of evidence demonstrates that hemodynamic optimization through Perioperative Goal-Directed Therapy (PGDT), utilizing dynamic parameters which are informative in determining fluid responsiveness, has been shown to reduce post-surgical complications.1–4 randomized controlled trials and meta-analyses confirmed reduction of risk for AKI, anastomotic leaks, pneumonia, SSI and UTI.1–4 When evidence inspires action, Edwards Enhanced Surgical Recovery program is here to help you implement PGDT. Your vision for reducing post-surgical complications can be realized in a single procedure, or as part of a larger initiative like ERAS, Perioperative Surgical Home or a Quality Improvement Program.
Edwards.com/ESR1 References: 1. Grocott et al. Perioperative increase in global blood flow to explicit defined goals and outcomes after surgery: a Cochrane systematic review. Br J Anaesth 2013 2. Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth 2009; 103: 637–46 3. Dalfino L, Giglio MT, Puntillo F, Marucci M, Brienza N. Haemodynamic goal-directed therapy and postoperative infections: earlier is better. A systematic review and meta-analysis. Crit Care 2011; 15: R154 4. Corcoran T et al. Perioperative Fluid Management Strategies in Major Surgery: A Stratified Meta-Analysis. Anesthesia – Analgesia 2012 Edwards, Edwards Lifesciences, the stylized E logo, and Enhanced Surgical Recovery are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. © 2014 Edwards Lifesciences Corporation. All rights reserved. AR11710
Edwards Lifesciences | edwards.com
One Edwards Way | Irvine, California 92614 USA
Switzerland | Japan | China | Brazil | Australia | India
36 I AnesthesiologyNews.com
APRIL 2015
PRN ASSISTED
CONTINUED FROM PAGE 1
The New ‘Dr. Death’ Dr. Egbert has been hailed—and condemned—as the new Jack Kevorkian. The six deaths cited in the Maryland Board of Physicians’ decision for license revocation took place when he was the medical director of Final Exit Network (FEN), an organization that provides education and guidance for people seeking to end their lives. He was the medical director from FEN’s founding in 2004 until his arrest in 2009 on charges stemming from a death in Georgia. During his tenure, Dr. Egbert signed off on about 300 applications for guidance and was present at the deaths of 100 people. He is planning to appeal the State of Maryland’s decision on principle, although he no longer acts as a guide for those seeking death; and the last time he practiced anesthesia in a clinical setting was in Kosovo in 1999, with a team from Doctors Without Borders. Currently, only Oregon, Vermont, Washington, New Mexico and Montana have legal forms of assisted death. People elsewhere must move to a state where it is legal (as Maynard did), go to Switzerland (where citizenship is not needed), or seek alternatives such as FEN. It’s important to note that unlike any of the existing laws, which require that a patient be mentally competent with a terminal condition where death is imminent to qualify for a right-to-die prescription, FEN will consider cases where the patient has an irreversible chronic condition like Alzheimer’s and death may be farther in the future. Dr. Egbert’s interest in doctor-administered death stretches back to 1982, when he was living in Dallas and working at Parkland Memorial Hospital. He read in a newspaper that an anesthetic was used to execute a death row prisoner and that a professor of anesthesia at the University of Oklahoma advised the state on the practice. He was furious. Shortly after, he was asked by a minister from his Unitarian Universalist church if he would consider giving a deadly dose of anesthesia to a fellow parishioner who had terminal cancer. He met the woman, and “I realized I was getting into the mode of helping her,” he said. In an interview with Anesthesiology News, Dr. Egbert stated without irony, “I oppose doctors killing people. If you study the death penalty, you realize it’s totally crazy. It’s racist and doesn’t prevent crime.” Unlike the prisoner, who was killed by the state, the patient was exercising her right to choose death. Dr. Egbert said what distinguished the two cases was simple: “The desire is the difference.” The ‘Guiding’ Principle After the consultation in Texas, Dr. Egbert discovered The Hemlock Society, an early right to die organization founded by Derek Humphry, who authored “Final Exit: The Practicalities of Selff Deliverance and Assisted Suicide for the Dying” in 1991. (The book is in its third edition.) That group eventually split into Compassion & Choices, a nonprofit that presses states to enact death with dignity laws, and FEN, which seeks to help people die while others debated whether they had the right to do so. “Our organization holds that mentally competent adults suffering from a fatal or irreversible physical
‘We always ask the patient, “Are you sure you want to do this?” right up to the end. We can ask so many times, sometimes the person gets irritated.’ —Lawrence Egbert, MD, an anesthesiologist and former medical director of Final Exit Network
illness have a basic human right to end their life when they judge the quality of their life to be unacceptable,” said Frank Kavanaugh, a member of the FEN board of directors since 2007, and a PhD in health care information systems. Dr. Kavanaugh said FEN doesn’t tell anyone anything they can’t find online or in the local library. What FEN does offer is a vetting process to make sure the patient is an appropriate candidate for endoff life guidance and education to ensure the patient does the procedure properly. FEN will also have someone present at the death if the patient wishes it. “We never encourage anyone to end his or her life; we never provide anyone the means to do so; and we never assist them,” Dr. Kavanaugh pointed out adamantly. FEN practitioners use the term “guide” rather than assist, a distinction that is more than mere semantics. As long as the “guide” doesn’t assist the patient in any physical way, their actions pretty much fall under the protection of free speech. “The First Amendment keeps us out of jail, but not out of court,” Dr. Kavanaugh said. Dr. Egbert knows that well enough. In addition to the charges in Georgia for which he was arrested in 2009 (the case was dropped when the Supreme Court struck down the law under which he was being prosecuted), he was acquitted of charges in Arizona and is still facing charges in Minnesota. Dr. Egbert is no stranger to arrest for a cause, and his unassuming, elderly appearance can be deceptive. His home, which he shares with his third wife, has anti-war posters on the wall. The octogenarian still rides a bicycle from his row house in Baltimore’s Hampden neighborhood to the office of Physicians for Social Responsibility, a group that advocates
against nuclear proliferation and for environmental causes. Now that he’s no longer working with FEN, he has stopped guiding and uses his time to review the medical reports of alleged victims of torture for a human rights lawyer based in Philadelphia. Dr. Egbert is a classic activist. “Larry stands on a soapbox and shouts for what he believes,” Dr. Kavanaugh said. “He’s very dedicated, very outspoken and not afraid of going to jail.” The Dying Process Dr. Kavanaugh added that Dr. Egbert’s frankness has jumpstarted the death with dignity conversation. When it comes to talking about dying, Dr. Egbert is not shy. He explains that The Hemlock Society offered a weekend-longg course on how to become a guide. Many guides have no medical background. “Medical school didn’t train me to do this at all— most of that training came from being a student with other guides,” he said. “What I did learn [from medical training] was the willingness and some ability to talk to people about very complicated subjects.” The moral issue of choosing to take one’s own life may be complex, but the process is fairly straightforward. To be considered for end-off life guidance, Dr. Egbert stated, “You have to have a horrible disease that I can verify from paper records that will show that you’ve done everything possible to ameliorate the symptoms of the disease and to make life tolerable.” Like most FEN guides, Dr. Egbert is an advocate of death by helium inhalation. He says they know it’s a peaceful way to go because volunteers inhaled the gas to the point of danger and experienced no choking or discomfort. Helium tanks are readily available at any party store, unlike barbiturates or other
APRIL 2015
AnesthesiologyNews.com I 37
PRN ‘No doctor in the Netherlands kills his or her patient—the law is about terminating suffering not terminating life. This is not wordplay, but the basis of our law. In the Hippocratic Oath, you have the obligation to take away suffering and sometimes that can only be done by taking away life.’
the friend who was to sit with her at the end couldn’t make it. That woman is still alive. In 2012, she told The Washington Post that she still keeps the helium tanks in case she wants to use them someday.
What the Data Say The COPD patient is not alone. Oregon passed its Death with Dignity Act (DWDA) in 1997, allowing doctors to write a lethal prescription for terminally ill patients. The state tracks DWDA’s use in an annual report. While the reporting isn’t flawless, it’s clear —Rob Jonquiere, MD, a retired physician and now communications that year after year more people obtain a DWDA predirector of the World Federation of Right to Die Societies. scription than use it. In 2014, 155 patients obtained a prescription medications that would need to be “I tell the family to wait two hours to call anyone,” DWDA prescription and 105 people died by using it. stored away over time or obtained by questionable said Dr. Egbert, noting that if the paramedics were to Since the law passed, 1,327 people have had DWDA means. In addition to the gas, a durable, 10-liter plas- arrive too soon, the patient might be resuscitated but prescriptions written and 859 patients have died from tic bag with a hose can be obtained online. brain dead. the medication. The same is true in Washington, “We always ask the patient, ‘are you sure you want He has been criticized for facilitating the death of whose law became active in 2008. In 2013, 173 preto do this?’ right up to the end,” he said. “We can ask a woman who was clinically depressed, but he stated scriptions were written and 119 individuals were conthat he vetted every case on which he signed off and firmed to have died by taking the medication. so many times, sometimes the person gets irritated.” Some patients die from their illness before takOnce they’ve agreed, it is supposed to be entirely sometimes found alternate outcomes. He pointed to in the patient’s hands to do what comes next. The a woman in chronic pain who was seeking end-off life ing the medication. But for others, like Dr. Egbert’s patient places the bag on his or her head, turns counseling. When he reviewed her records, it became patient in New Jersey, knowing there is an alternative on the helium and fills the bag to ensure it’s air- clear that her pain medication management was to a painful end or a messy, possibly botched suicide tight. Then the patient must pull the bag over his incorrect. The woman worked with her doctor and attempt may be enough. Ms. Maynardd ultimately used or her face so it is snug around the neck. Dr. Egbert pharmacist to get on the right medication regime her DWDA prescription, but in the short video she explained that the patient usually loses conscious- and she no longer wanted to die. recorded for Compassion & Choices that propelled In another case, a woman with chronic obstructive her into the national limelight, she explained that it ness within 30 to 60 seconds. The guide or another person present checks the patient’s pulse after 10 pulmonary disease (COPD) had arranged her date was “a relief ” to know that she was in possession of an minutes. of death with Dr. Egbert, but when the day arrived, see assisted page 39
Valuable insight to help you guide volume administration. Clarity gives you the control to make more informed decisions. Edwards Lifesciences’ range of hemodynamic monitoring solutions provides key flow parameters shown to be more informative in determining fluid responsiveness than pressure-based parameters.1
Each may be used in Perioperative Goal-Directed Therapy (PGDT) to help ensure patients are consistently maintained in the optimal volume range. The Edwards Enhanced Surgical Recovery Program can help you implement PGDT today.
Know more. Know now. To see how you can individualize therapy under more conditions visit Edwards.com/ESRsolutions 1. Michard F, Biais M. Rational fluid management: dissecting facts from fiction. Br J Anaesth 2012 For professional use. 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. Edwards Lifesciences devices placed on the European market, meet the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC, and bear the CE marking of conformity. Edwards, Edwards Lifesciences, the stylized E logo, ClearSight, Enhanced Surgical Recovery Program, FloTrac, and Swan-Ganz are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. © 2014 Edwards Lifesciences Corporation. All rights reserved. AR11991
Edwards Lifesciences | edwards.com
One Edwards Way | Irvine, California 92614 USA
Switzerland | Japan | China | Brazil | Australia | India
ClearSight Noninvasive System CO, SV, SVV, SVR, cBP* FloTrac Minimally-Invasive System CO, SV, SVV, SVR Swan-Ganz System CCO, RVEDV, RVEF, SvO2 * Continuous Blood Pressure
38 I AnesthesiologyNews.com
APRIL 2015
PRN TRANSITIONS
Table 3. Insulin Requirements Day of Hospital Discharge: 2/13 (patient discharged at 11 AM)
CONTINUED FROM PAGE 35
Special attention also is given to diuretics, which are listed with the corresponding daily serum creatinine level and daily weight (Table 4). Prospective medication plans are included for other drugs as needed. These plans may include guidance such as titration schedules, monitoring plans, stop dates and warnings for potential adverse events that may be problematic for a particular patient. All orders are reviewed for appropriateness (Table 5). Inclusion of the indication in the MMP helps the pharmacist and other providers assess whether medications need to be continued across transitions of care. Medications that are for use only in the hospital, such as protocol orders and maintenance IV fluids, are removed. For example, proton pump inhibitors initiated for stress ulcer prophylaxis that are continued outside of the ICU should be discontinued before transfer, or will likely become a permanent component of a patient’s medication regimen.6 In patients aged 65 and older, the orders are reviewed for potentially inappropriate medications (identified by the Beers Criteria, eg, benzodiazepines, antipsychotics, anticholinergic drugs).7 If any medications are deemed inappropriate, the pharmacist contacts the discharging service to recommend
Table 4. Diuretics for CHF to Target Weight: 63.5 kga 2 Days Before Discharge
Day Before Discharge
Day of Discharge
Breakfast
Creatinine
0.96 mg/dL
1.06 mg/dL
1.1 mg/dL
Blood glucose
135 mg/dL
Weight, kg
63.5
63.5
63.2
Insulin scheduled
n/a
Furosemide dose
40 mg IV bid
40 mg IV bid
40 mg IV given in the AM
Insulin prn
0
prn, as needed prn,
alternative therapy, discontinuation, dose reduction or change to an “as needed” schedule. If a taper is needed for discontinuation, then a weaning schedule is included in the MMP. The pharmacist finalizes the plan when alerted by the nurse transition advocate about a patient’s transfer; this usually occurs after the PAC referral but before discharge orders are finalized. One copy of the plan is faxed to the PAC facility, and another is sent in the transfer packet that accompanies the patient. After transfer, the nurse transition advocate calls the PAC facility to complete a warm handoff. In addition to verifying receipt of the paperwork, the nurse transition advocate can verbally highlight the most pressing medication issues identified by the pharmacist at this time. The pharmacist contact number also is included within the plan in the event he or she needs to be reached by the PAC for questions or clarifications. This project has led to the identification and resolution of significant medication discrepancies, many of which
CHF, congestive heart failure a
Monitor weight g dailyy
could have resulted in patient harm. Additionally, this work has helped ignite a large-scale effort for the medical center to re-evaluate communication during the transfer order process. Currently, Vanderbilt University Medical Center is using a word processing program to create a standardized plan for each patient, with the goal of integrating the components of the MMP into its information and electronic medical record systems. This will help operationalize this approach for all patients transferred to PAC facilities. References
4. Desai R, Williams CE, Greene SB, Pierson S, Hansen RA. Medication errors during patient transitions into nursing homes: characteristics and association with patient harm. Am J Geriatr Pharmacother.r 2011;9:413-422. 5. ISMP Canada. From the hospital to long term care: protecting vulnerable patients during handoff. ISMP Med Safety Alert!! 2013;18:1-3. 6. Zink DA, Pohlman M, Barnes M, Cannon ME. Longterm use of acid suppression started inappropriately during hospitalization. Aliment Pharmacol Ther.r 2005;21:1203-1209. 7. The American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society Updated Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2012;60:616-631.
1. Mor V, Intrator O, Feng Z, Grabowski DC. The revolving door of rehospitalization from skilled nursing facilities. Health Aff.f 2010;29:57-64.
The project described was supported by Grant Number 1C1CMS331006-02-00 from the Department of Health and Human Services, Centers for Medicare & Medicaid Services.
2. Tija J, Bonner A, Briesacher BA, McGee S, Terrill E, Miller K. Medication discrepancies upon hospital to skilled nursing facility transitions. J Gen Intern Med. d 2009;24:630-635.
Dr. Mixon is a VA HSR&D Career Development Award recipient at the Nashville VA.
3. Boockvar K, Fishman E, Kyriacou CK, Monias A, Gavi S, Cortes T. Adverse drug events due to discontinuations in drug use and dose changes in patients transferred between acute and long-term care facilities. Arch Intern Med. d 2004;164:545-550.
The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the U.S. Department of Health and Human Services or any of its agencies, or the Department of Veterans Affairs.
Table 5. Reconciled Medication List for John Smith MR: 00000000a Updated: 2/13/15 Completed by: Jane Pharmacist, PharmD, Contact number: 123-456-7890; Allergies: No Known Allergies
Prehospital Medications
Allopurinol 100 mg by mouth daily
Atorvastatin 80 mg by mouth daily
Action
Hospital Discharge Medications To Be Given at Post-Acute Care
Indication
Comments
Last Dose
New
Acetaminophen 650 mg PO q6h prn
Pain/fever
Do not exceed 4,000 mg/d.
Not required
Continue
Allopurinol 100 mg PO qd
Gout
2/12/13, 10:15 AM
New
Aspirin 81 mg PO q am
CAD
2/12/13, 10:15 AM
Continue
Atorvastatin 80 mg PO q bedtime
Hyperlipidemia
2/12/13, 22:21 PM
Digoxin 0.125 mg PO qTue, Thu, Sat, Sun
Atrial fibrillation
Hold if HR<60; check SCr weekly; monitor digoxin 2/12/13, level if renal function changes (goal digoxin level 10:15 AM is 0.5-1.2 mg/dL).
New
Ertapenem (Invanz, Merck) 1,000 mg IV q24h
Pneumonia
Continue until follow-up in ID clinic in 4-5 weeks; monitor CBC and BMP weekly (next on 2/14).
2/12/13, 16:00 PM
Continue; note change in dosage
Furosemide 40 mg IV q12h
CHF/edema
Continue IV for 3 d, then switch to 40 mg PO q12h; check BMP weekly to monitor for hypokalemia or AKI; check weight daily.
2/13/13, 5:41 AM
New
Insulin regular human SS 4-20 units qid subcutaneously ACHS SS: BG≤60: d50w 50 mL + contact MD; BG=61-160: no action; BG>160: (BG-100)/15
Hyperglycemia
Only required 6 units over last 36 h; 2/12/13, initiate workup for diabetes and start oral therapy 18:24 PM if appropriate. Can likely discontinue when acute infection has resolved.
New
Hydrocodone-acetaminophen 10 mg/325 mg PO q4h prn
Acute pain
Not used, can discontinue at facility.
Digoxin 125 mcg by Continue mouth Sun, Tues, Thurs, Sat
Furosemide 20 mg by mouth each morning
Not required
ACHS, at meals and bedtime; AKI, acute kidney injury; BG, blood glucose; BMP, basal metabolic panel; BP, blood pressure; CAD, coronary artery disease; CBC, complete blood count; CHF, congestive heart failure; HR, heart rate; ID, infectious disease; PO, by mouth; prn, as needed, SCr, serum creatinine a
Partial list only. y
APRIL 2015
AnesthesiologyNews.com I 39
PRN ASSISTED
CONTINUED FROM PAGE 37
alternative to the death she was told to expect if she chose to let her brain cancer take its course. “You get some peace of mind knowing that the end of your life is within your control and not dependent on someone else,” Dr. Kavanaugh said, “or that you won’t end up in a critical care unit with things plugged into every orifice.” Mildred Z. Solomon, EdD, president and CEO of The Hastings Center, an independent, nonpartisan, nonprofit bioethics research institute in New York and a professor in the Department of Anesthesia at Harvard Medical School, in Boston, told Anesthesiology Newss that the physician aid-in-dyingg movement touches the fundamental cultural fabric of our nation. “Support for physician aid-in-dying, or what opponents call assisted suicide, aligns with the American emphasis on choice and autonomy and our desire to enable selff determination,” she said. Critics of physician-assisted suicide fear that the practice will become widespread and disproportionately affect the poor and the disabled. Dr. Solomon had similar concerns, but now says the data show otherwise. In Oregon and Washington, the number of people using DWDA has risen over time (in 1998, only 24 people got a DWDA prescription and 16 died), but the overall number of people who use the act is relatively small. The vast majority are white, well educated and suffering from cancer (although 2014 did show an uptick in those with amyotrophic lateral sclerosis). The median age in Oregon was 72 years, and 93% of those who sought a DWDA prescription were enrolled in hospice care. Dr. Solomon says many of the potential abuses that people originally worried about have not come to pass, and she wouldn’t be surprised if twice as many states have laws on the books in the next 18 months. However, she worries that over the long term, as health care costs rise and more financial burdens are placed on families, people may seek to use legalized death with dignity laws to save their families from the cost of a prolonged illness. “That’s not a reason not to legalize it, but there should be vigilant monitoring to make sure states with legal assisted death adhere to protocols.” She noted that the conversation will become more complex as the number of people living longer with Alzheimer’s and other dementias increases. Current death with dignity laws do not apply to people with dementia because they lack
‘We never encourage anyone to end his or her life; we never provide anyone the means to do so; and we never assist them. The First Amendment keeps us out of jail, but not out of court.’ —Frank Kavanaugh, PhD, member of the board of directors of Final Exit Network
the mental capacity to make such decisions. But people in the early stages of Alzheimer’s, or who are worried that they will develop Alzheimer’s, may want to assert a right to choose assistance with death. A Global Movement Outside the United States, both assisted suicide and euthanasia appear to be gaining some ground. The practices are legal in Switzerland, Germany, see assisted page 40
Securing Airways with a Gentle Touch TaperGuard™ Cuff Technology oid tracheal High-volume, low-pressure (HVLP) cuffs were introduced to help avoid damage.1 But do they go far enough? Compared to traditionall HVLP cuffs, ents and reduce newer, taper-shaped cuffs can both enhance fit* across patients pressure impact on the trachea.2 In other words, these new cuffs help you secure airways with a gentle touch. Learn more at Covidien.com/TaperGuard1
* Compared with traditional HVLP cuffs, taper- shaped cuffs can accommodate more trachea sizes and shapes. 1. Seegobin RD, van Hasselt GL. Endotracheal cuff pressure and tracheal mucosal blood flow: endoscopic study of effects of four large volume cuffs. Br Med J (Clin Res Ed). 1984;288(6422):965–968. 2. Li Bassi G, Ranzani OT, Marti JD, et al.. An in vitro study to assess determinant features associated with fluid sealing in the design of endotracheal tube cuffs and exerted tracheal pressures. Crit Care Med. 2013;41: 518–526. COVIDIEN, COVIDIEN with logo, Covidien logo and positive results for life are U.S. and internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company. ©2015 Covidien. 14-AW-0121
40 I AnesthesiologyNews.com
APRIL 2015
PRN ASSISTED
CONTINUED FROM PAGE 39
Albania, Colombia and Japan. There are more than 50 right-to-die societies in approximately 23 countries. A Swiss organization, Exit, announced in midMarch that its membership has been surging in recent years. In the German- and Italian-speaking parts of Switzerland, the group’s membership rose to 81,015 people, up from 67,602 in 2013. In 2014, Exit helped 583 people to die. Belgium and the Netherlands have some of the most liberal policies, including ones allowing euthanasia. The Dutch, who decriminalized both euthanasia and physician-assisted suicide in 2001, had over 4,000 people die by choice in 2013. Most were older people and about 80% to 90% had cancer, but the Dutch law allows anyone in “hopeless and unbearable suffering” to seek euthanasia, without the requirement of a terminal diagnosis. While the number of people opting for euthanasia is growing, Rob Jonquiere, MD, a retired physician and now communications director of the World Federation of Right to Die Societies, attributed this to greater awareness of the law and more open conversation in Dutch society about death than to the proverbial slippery slope. “If it was a slippery slope, you would see maybe only 60 percent of cases were terminal cancer, for example,” he said. “We can only explain the growth by saying the medical society and the patients are more or less used to the fact that euthanasia is a possibility and it’s now integrated with palliative care.” Dr. Jonquiere has a sweeping perspective on the topic. He is a general practice doctor who has performed euthanasia, was the CEO of the Dutch Right to Die Society until 2008, and has been extensively involved in the development and implementation of the Dutch euthanasia law. He sees the global tide swaying in favor of the right to die movement, something he attributes to the baby boomer generation. “The people who grew up after World War II is the group who has formed their own lives and made choices all their lives for contraception and marriage—that group is now getting to the age when they’re going to die and they want to make the choice there as well,” he said. He added, “By legalizing and protocolizing an act that’s being practiced by doctors, you make it possible to not do things in secret where it can be abused.” ‘Do No Harm’ It is an argument used by advocates for everything from the legalization of abortion to marijuana— that it’s better to put controversial practices into the mainstream where they can be regulated. Some believe that doctors in the United States are already offering physician-assisted suicide, writing out prescriptions for sleeping pills with a wink and a nod. As is often the case with certain hot-button social issues, religious groups object on moral grounds. But what of the ethics issues for doctors? The American Medical Association stated in its opinion 2.211, “Physician-assisted suicide is fundamentally incompatible with the physician’s role as healer, would be difficult or impossible to control, and would pose serious societal risks.” Dr. Egbert stated he doesn’t like what he did as an exit guide, but that he is very proud that he had the
‘Our whole system [was] designed for an era when we died of acute illness or died of infection, not for the baby boomers who will have long-term chronic illnesses. There’s so much we need to do for the vast majority of people, why not get just as passionate about redesigning a system that will help everyone?’ —Mildred Z. Solomon, EdD, president and CEO of The Hastings Center
courage to step out of the mainstream and help those in need. Dr. Jonquiere, who was practicing euthanasia in the Netherlands before it was legal, said, “No doctor in the Netherlands kills his or her patient— the law is about terminating sufferingg not terminating life. This is not wordplay, but the basis of our law. In the Hippocratic Oath, you have the obligation to take away suffering and sometimes that can only be done by taking away life.” Dr. Solomon agreed with this point. “Ending suffering is part of the physician’s role and relief of suffering is just as important, if not more, than cure,” she stated. “But, physician aid-in-dyingg isn’t the only way to alleviate suffering.” She noted that when the issue is looked at on a case-by-case basis, it’s easy to be swayed by compassion. Ms. Maynard used her video to describe the death she planned: “I will die upstairs in my bedroom that I share with my husband, with my mother and my husband by my side, and pass peacefully with some music that I like in the background.” Dr. Solomon pointed out that individual stories are very moving, but focusing on one person’s tragic circumstances gives physician aid-in-dyingg more prominence in the media than it warrants. When she looks at the data coming out of Washington and Oregon, she sees a practice that is very important to a small number of people. “Unfortunately, though, there is far less attention paid to the larger, systemic need to reform and improve palliative care that could benefit so many more people.” “Our whole system is designed for an era when we died of acute illness or died of infection, not for the baby boomers who will have long-term chronic illnesses,” she said. “There’s so much we need to do for the vast majority of people, why not get just as passionate about redesigning a system that will help everyone?”
The AMA opinion continued: “Instead of participating in assisted suicide, physicians must aggressively respond to the needs of patients at the end of life. Patients should not be abandoned once it is determined that cure is impossible. Multidisciplinary interventions should be sought, including specialty consultation, hospice care, pastoral support, family counseling, and other modalities.” Yet it is just this, the feeling of abandonment, that assisted suicide advocates say is often the problem. Dr. Kavanaugh said his years as a professor of medical and public affairs at George Washington University Health Center, in Washington, D.C., were eye-opening. “I came away with the feeling that we did a really great job of intervening in people’s lives and making them better, but when we couldn’t do that, too often we walked away from them at the most critical point in their life.” Dr. Egbert believes that many patients in need of palliative resources get lost in a quagmire of specialists and consults. “[Guides] are there to educate a person about how to do this themselves, but the other key word would be ‘comfort,’” he said. “A lot of people who are suffering and getting ready to die are very lonely and find out that a lot of physicians abandon them.” According to Dr. Egbert, most patients and families thank him for his help in guiding a loved one to a peaceful, dignified death. But what about the woman with terminal cancer in Texas who started him on this path? “Her daughter talked her out of it,” he said. “According to the minister, she lived two months in horrible pain. But she died with the respect of her daughter. So which one is better or worse? I don’t know the answer to that, but I know that she chose.” —Christianna McCausland
42 I AnesthesiologyNews.com
APRIL 2015
TECHNOLOGY
Biomedical Informatics Promises Profound Clinical Advantages Phoenix—The best days are ahead for biomedical informatics, with the fast-growingg field being analogous to aviation before the advent of the jet age, an expert told attendees of the Society for Technology in Anesthesia 2015 annual meeting. Biomedical informatics and the overarching discipline of informatics are fast gaining traction across the nation’s
health care system as more and more clinicians gain expertise in the field, said Edward H. Shortliffe, MD, PhD, a leading informatics expert. The changes have the potential to transform how data are gathered and used in a way that could revolutionize both medical research and patient care, noted Dr. Shortliffe, professor and senior advisor to the executive
vice provost in the College of Health Solutions at Arizona State University, Scottsdale, and an adjunct professor of biomedical informatics at Columbia University, in New York City. Anesthesia, in turn, has been a leader in incorporating informatics into daily treatment and research. Yet challenges remain, with some of the technology still problematic and
DELIVERING INSIGHT.
CAN YOU HELP REDUCE DELIRIUM RISK? Earlier research concluded that univariate factors associated with delirium include age, preexisting cognitive impairment, greater preoperative functional limitations and a history of prior delirium.1 However, in a more recent randomized controlled trial of 1155 patients, it was shown that episodes of deep anesthesia (bispectral index score <20) were independently predictive for postoperative delirium.2 Numerous additional studies have shown an increased risk of institutionalization, dementia and death in patients with delirium2 as well as increases in hospital length of stay by up to six days3. Moreover, total cost estimates attributable to delirium ranged from $16,303 to $64,421 per patient.4 The good news is, you can reduce the likelihood of delirium occurrence. Guiding anesthetic dosing with brain function monitoring may decrease the rate of postoperative delirium in certain patients.2,3,5,6 Brain function monitoring with Bispectral Index™ (BIS™) technology during surgical procedures gives anesthesia providers the ability to
It’s everybody’s BIS 1. Litaker D1, Locala J, Franco K, Bronson DL, Tannous Z. Preoperative risk factors for postoperative delirium. Gen Hosp Psychiatry. 2001 Mar-Apr;23(2):84-9. 2. Radtke, FM et al. Monitoring depth of anaesthesia in a randomized trial decreases the rate of postoperative delirium but not postoperative cognitive dysfunction. British Journal of Anaesthesia. Published ahead of print Mar 2013. 3. Whitlock, EL et al. Postoperative delirium in a substudy of cardiothoracic surgical patients in the BAG-RECALL clinical trial. Anesth Analg. 2014 Apr;118(4):809-17 4. Leslie DL et al. One-year health care costs associated with delirium in the elderly population. Arch Intern Med. 2008 Jan 14;168(1):27-32. 5. Chan MT, Cheng BC, Lee TM, Gin T; CODA Trial Group. BIS-guided anesthesia decreases postoperative delirium and cognitive decline. J Neurosurg Anesthesiol. 2013 Jan;25(1):33-42. 6. Sieber FE, Zakriya KJ, Gottschalk A, Blute MR, Lee HB, Rosenberg PB, Mears SC. Sedation depth during spinal
directly monitor the anesthetic effect on a patient’s brain to optimize the anesthetic dosing for the individual. Peer-reviewed literature has shown BIS-guided anesthetic titration may aid in a reduction in the incidence of delirium in elderly and other patient populations at increased risk. In turn, reducing delirium can positively impact health care economics by lowering total cost of care.4
“The anesthesia practitioner may use processed electroencephalographic monitors of anesthetic depth during IV sedation or general anesthesia of older patients to reduce postoperative delirium.”7 - Postoperative Delirium in Older Adults: Best Practice Statement from the American Geriatrics Society.
BIS brain function monitoring has also been clinically shown to reduce primary anesthetic delivery (as much as 50%) and promote faster wake-up, recovery and discharge from the PACU.8,9,10
Learn more at: www.everybodysBIS.com
7.
8.
9. 10.
anesthesia and the development of postoperative delirium in elderly patients undergoing hip fracture repair. Mayo Clin Proc. 2010 Jan;85(1):18-26. Inouye, Sharon K. et al. Postoperative Delirium in Older Adults: Best Practice Statement from the American Geriatrics Society. Intraoperative Measures to Prevent Delirium. J Am Coll Surg. 2014; 220; 2, 136 - 148.e1. Gan TJ, Glass PS, Windsor A, et al. Bispectral index monitoring allows faster emergence and improved recovery from propofol, alfentanil, and nitrous oxide anesthesia. BIS Utility Study Group. Anesthesiology. 1997;87(4):808-815. Song D, White PF. Titration of volatile anesthestics using bispectral index facilities recovery after ambulatory anesthesia. Anesthesiology. 1997;87:842-848. Luginbühl M, Wüthrich S, Petersen-Felix S, Zbinden AM, Schnider TW. Different benefit of bispectal index (BIS) in desflurane and propofol anesthesia. Acta Anaesthesiol Scand. 2003;47(2).
COVIDIEN, COVIDIEN with logo, Covidien logo and “positive results for life” are U.S. and internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company. ©2015 Covidien. 15-PM-0036
with lingering skepticism among some medical care providers about the utility of “big data” in the medical arena. Decades of Growth “We are basically a couple of decades into a very long process, and getting it right will take decades more,” Dr. Shortliffe said. Biomedical informatics has its roots in the dawn of the computer age. The use of statistics and computers for diagnosis was first recognized in a seminal piece that appeared in Science in 1959, “Reasoning Foundations of Medical Diagnosis” (1959;130[3366]:9-21). Computers were first used in biomedicine in the 1960s, a decade that also saw the first discussion of the possibility of electronic storage of medical records, Dr. Shortliffe noted. Then-president George W. Bush’s 2004 call for universal electronic medical records within 10 years set the stage for the latest surge in innovation. Stimulus legislation passed in 2009 under the Obama administration further fueled the health care technology boom, using carrots and sticks to push providers to adopt electronic record keeping and data collection. A spokeswoman for the Department of Health and Human Services has estimated that 90% of doctors will be using health care information technology (IT) by 2019, Dr. Shortliffe said. There also has been an explosion in “mid-career learning” that is starting to produce more and more clinicians with a deeper understanding of informatics, exemplified by the announcement by the American Board of Medical Specialties (ABMS), in 2011, of plans for a new subspecialty in clinical informatics. A thousand medical practitioners, from surgeons to anesthesiologists, took the board exams in 2013 and 2014, with another large group expected to sit for the boards this fall, Dr. Shortliffe said. Starting in 2018, only physicians who have taken a fellowship in clinical informatics will be able to become board-certified by the ABMS in the new subspecialty, he said. That, in turn, will provide a spur to medical schools to integrate informatics more closely into their teaching. Currently, there are already a growing number of educational programs in biomedical informatics at colleges and universities at the MS and PhD levels, as well as fellowships for working professionals in the field.
APRIL 2015
AnesthesiologyNews.com I 43
TECHNOLOGY The number of training programs in applied health IT is on the rise, while health care organizations are hiring chief medical information officers who increasingly have this kind of training and experience, Dr. Shortliffe said. “I am hoping this will have a salutary effect on how medical schools look at their curricula,” he added. Informatics and Anesthesia As interest in informatics grows, one challenge has been to hammer out a nomenclature for the field that is universally accepted. A variety of terms are now in use, not only “biomedical informatics,” but also “health informatics” and “medical informatics.” Dr. Shortliffe said his solution has been to refer to biomedical informatics, or “BMI,” when speaking of the core science of the field as it relates to biomedicine and health, with the unmodified term “informatics” reserved for the larger domain-independent discipline of information management and data analysis. The characteristics of BMI include: • Developing theories, methods and processes for the generation, storage, retrieval, use and sharing of biomedical data • Building on computing, communication and information sciences and their application in biomedicine • Supporting reasoning, modeling, simulation, experimentation and translation across the spectrum from molecules to populations • Drawing on the social and behavioral sciences to inform the design and evaluation of technical sciences with the recognition that people are the ultimate users of biomedical information. BMI is having profound effects on anesthesiology, Dr. Shortliffe noted. Informatics/health IT is now routinely used in patient monitoring and in anesthesia-specific electronic medical records, and plays an increasing role in anesthesia decision support, with “exceptional” contributions in the areas of simulation, training and testing, he said. To illustrate this point, Dr. Shortliffe included a slide of anesthesiologists practicing various procedures on a high-tech mannequin in his presentation. Anesthesiology has also been out in front in the “recognition of the role of cognitive science and the innovative application of those methods and theories,” Dr. Shortliffe noted. The use of cognitive informatics has enabled anesthesiologists to better understand how health professionals
use “personal heuristics, experience, data and knowledge to arrive at decisions.” It has also provided valuable insights into both clinicians and patients as computer users. This knowledge, in turn, has helped reduce errors, boost patient safety and clinical teaching, and improve decision support systems, Dr. Shortliffe said. Big data—massive data sets culled from social media and other sources— are also starting to play an increasingly important role, with one example
being the analysis of millions of Internet searches to detect negative but previously unknown drug interactions. As an example, researchers in 2011 confirmed a major health problem affecting patients through data mining of the FDA’s Adverse Event Reporting System. Patients who took both pravastatin (Pravachol, Bristol-Myers Squibb) and paroxetine wound up with elevated glucose levels, regardless of whether they had diabetes. Two years later, another group of
researchers published a paper in the Journal of the American Medical Informatics Association (2013;20:404-408) that came to a startling conclusion. A review of Internet search logs revealed a spike in searches by consumers featuring the two drugs in question as well as symptoms associated with hyperglycemia, with 82 million queries in 2010, Dr. Shortliffe said. The report concluded that “logs of the search activities of populations of computer users see BMI page 45
IMPORTANT CORRECTION OF DRUG INFORMATION ABOUT EXPAREL® (BUPIVACAINE LIPOSOME INJECTABLE SUSPENSION) Pacira Pharmaceuticals, Inc., received a warning letter from the US Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) on September 22, 2014 concerning an advertisement for EXPAREL, which you may have seen published in several professional journals. This publication provides important corrective information about the false and misleading claim. The FDA stated that the advertisement was false or misleading because it overstates the efficacy of EXPAREL. The FDA objected to the claims that EXPAREL provides pain control that lasts for up to 72 hours because the claims suggest that EXPAREL has been shown to provide pain control beyond 24 hours. According to the Prescribing Information, “The primary outcome measure was the AUC [area under the curve] of the NRS [numeric rating scale] pain score (cumulative pain scores) collected over the first 72 hour period.…In this clinical study, EXPAREL demonstrated a significant reduction in pain intensity compared to placebo for up to 24 hours. The difference in mean pain intensity between treatment groups occurred only during the first 24 hours following study drug administration. Between 24 and 72 hours after study drug administration, there was minimal to no difference between EXPAREL and placebo treatments on mean pain intensity.” Excerpts from the applicable sections of the FDAapproved package insert for EXPAREL follow. The FDA has reviewed and approved this communication. Indication for EXPAREL EXPAREL is a liposome injection of bupivacaine, an amide-type local anesthetic, indicated for administration into the surgical site to produce postsurgical analgesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Clinical Studies Hemorrhoidectomy The primary outcome measure was the AUC of the NRS pain intensity scores (cumulative pain scores) collected over the first 72 hour period. There was a significant treatment effect for EXPAREL compared to placebo. ©2015 Pacira Pharmaceuticals, Inc. Parsippany, NJ 07054 PP-EX-US-0623
2/15
In this clinical study, EXPAREL demonstrated a significant reduction in pain intensity compared to placebo for up to 24 hours. The difference in mean pain intensity between treatment groups occurred only during the first 24 hours following study drug administration. Between 24 and 72 hours after study drug administration, there was minimal to no difference between EXPAREL and placebo treatments on mean pain intensity; however, there was an attendant decrease in opioid consumption, the clinical benefit of which was not demonstrated. Important Safety Information EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting. Reporting Adverse Events Heath care providers and patients are encouraged to report adverse events in patients taking EXPAREL to Pacira at 1-855-793-9727. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see accompanying brief summary of Prescribing Information.
44 I AnesthesiologyNews.com
APRIL 2015
COMMENTARY A Passover Metaphor
Connecticut hospitals reported record numbers of errors in 2013, with large increases in the number of falls, medication mistakes and perforations during surgical procedures…. These are the highest “Let them go and gather straw for themselves. And you shall lay on them levels since the [data reporting] the quota of bricks which they made before. You shall not reduce it.” was adopted in mid-2004. Exodus 5:7-8, New King James Version Steven S. Kron, MD —“Hospital Reports of Surgical, Medication Errors Climb,” article from Hartford n 2013, the most recent year for Adverse Event Reporting are available, total number of reported critical inciwhich statistics from the Connecti- the incidence of adverse events reported dents rose from 244 in 2012 to over 500; Courant,t January 6, 2015. cut Department of Public Health’s to the state went to new heights. The a shocking increase of more than 100%! There were increases in endoscopic bowel perforations, patient falls, wrong-side operations and retained foreign objects after surgery. Since Connecticut has enthusiastically embraced the concept of creating a “culture of safety,” this information is both strange and disturbing. I would not be surprised to learn that other states have had similar experiences. According to the Hartford Courant, “hospitals have undertaken myriad initiatives to improve patient safety, including strict procedures to prevent wrong-site surgery, medication errors and pressure sores.” Yet, despite these initiatives, the very things targeted for elimination have increased rather than disappeared. Patient falls and decubiti may simply be due to a decreased ratio of nurses and aides to patients, combined with bedside time being increasingly replaced by time inputting data on computer screens. The increasing size of many patients, no doubt, has contributed to both problems as well. Of greater interest to us are operative problems such as retained foreign bodies and wrong-sided surgery. No surgeon, anesthesiologist or nurse wants to be responsible for harming a patient, to acquire a damaged reputation, to attend endless sentinel event meetings or, naturally, be the defendant in the inevitable lawsuit. So how is it possible that an even greater number of serious mistakes continue to be made? Here is a possible explanation: The last few years have seen major efforts to completely change the culture of the operating room. The concept of “captain of the ship” has been replaced by the ethos of airlines and the Japanese auto industry: Anyone detecting a safety issue or other problem is empowered to “stop the line.” The World Health Organization has published guidelines—readily adopted by U.S. health care decision makers—to include “time-outs” before surgery, where all members of the operating team pause to agree about critical things such as patient and participants’ identity, type and location
The Drive for Safety Has Its Potholes
I
EXP-AP-0020-201301
APRIL 2015
AnesthesiologyNews.com I 4 5
COMMENTARY of surgery, instrumentation, antibiotic and β-blockk timing, etc. A complementary time is spent after the operation for the entire team to regroup and discuss what was done well, what was not and what lessons may be carried to the next procedure. Instrument and sponge counts have been part of the surgical routine forever. Every day brings an administrative initiative of some sort reminding us worker bees to be safe. The back of my hospital ID card states in bold print that I should do “the safe thing, the kind thing, the right thing and the best thing every time.” Thanks for that update! Presumably, if I don’t regularly refresh the knowledge of my responsibility as printed, I will choose the wrong, harmful thing instead. All hospital employees must regularly complete computer modules that teach us about safety, corporate compliance, multiculturalism, etc. And yes, there is a test. On and on and on…. It’s all too much, too fast and too irrelevant to do the very things these various dogmatic pronouncements are trying to achieve. No one deliberately tries to subvert institutionally defined safety, but all the emails, tasks and chores can be overwhelming, and stuff falls through the cracks and gets left behind—sometimes in the patient’s abdomen.
BMI
CONTINUED FROM PAGE 43
can contribute to drug safety surveillance,” he noted. Such a search, had it been conducted at the time rather than after the fact, could have provided an early warning of the problem. The ‘Learning Health Care System’ Meanwhile, there are exciting possibilities. For instance, there is potential for more sophisticated decision support that is “aware of complex clinical contexts,” as well as “models of patients and the care process,” Dr. Shortliffe said. Other possibilities mentioned by Dr. Shortliffe: “Identification of context-specific information or knowledge needs; better integration of systems and transferability of decisionsupport capabilities between systems; and user education and engagement.” There’s also the potential to incorporate data from personal devices. Dr. Shortliffe said informatics may eventually make possible a “learning
Evidence-based airway management
While we are being assured that hospitals are all about the patient, it’s time to acknowledge that the bottom line is important, too; everyone is being pushed to be super-maximallyy efficient. Human beings can be safely sped up to a point, but not beyond it. More stuff to do but with fewer people and less time to do them is a recipe for disaster. To an extent, the drive for safety in hospitals is a microcosm of the prevailing danger-phobic attitudes of modern society: If only kids wore helmets, there would be no bike accidents. If only football had more rules, there would be no concussions. If only cars drove themselves, they would never crash. If only we did a good time-out, we wouldn’t have left a clamp. In theory this is wonderful, but there can be unintended consequences in practice; there are in Connecticut operating rooms. Most people who chose to become doctors and nurses see health care as a calling and not merely a job. Doing the right thing is the default position. Unfortunately, as in Exodus, the pharaoh and his taskmasters are pushing us to do more, faster and with less. But unlike the children of Israel, we have no Moses to lead us through the wilderness.
BIBLIOGRAPHY Published studies, case reports and correspondence
Volume 1, Issue 2 September 2013
www.i-gel.com
Dr. Kron is an anesthesiologist in Hartford, Conn., and a frequent contributor to Anesthesiology News.
health care system,” an “envisioned cycle that ties patient care with knowledge creation and dissemination.” In his presentation, Dr. Shortliffe displayed a chart showing a circular flow of data collected from patients as part of their medical care and treatment. The pooled data spurs research, leading to new treatments and standards that benefit patients. “It’s closing the loop—we ought to be learning from what we do,” he said. A number of obstacles stand in the way of a learning health care system, including the tendency of institutions to guard their data jealously, even if they lack plans for using the information, Dr. Shortliffe warned. Even so, biomedical informatics and its application in clinical settings have exhibited dramatic progress and growth. “The changes in the last decade are really remarkable,” Dr. Shortliffe said. “Things are really taking off.” —Scott Van Voorhis Quality, innovation and choice
800-828-9633 www.intersurgical.com
46 I AnesthesiologyNews.com
APRIL 2015
COMMENTARY ASA
CONTINUED FROM PAGE 1
do not belong—formerly a few unusuual individuuals, but now a sizable minority. While most anesthesiologists value their membership and believve it importtant for their future, why do others say no? Nonmembership first arose about 20 yeears ago. Everyone I knew before then bellonged to the ASA. If someone forgot to pay their dues, a sim mple reminder led to their check being sentt, and an apology. That changed in the 1990s, when managed care began. Managed care linked patient caare and finaancing, introduced big government intoo health care, renamed professionals as providers, disrupted practices, divided clinicians, made cost redduction a goal, created ideologues and birthed politicall advocacy. The ASA has 30,000 active memberrs, and 52,0000 members in all when residents, retirrees and others are included—numbers that chan nge daily with recruitments, renewals and retirements.. At any giiven time, however, one-fourth of U.S. aneesthesiologg ists are not ASA members, and some havee not been for years. Nonmembership has grown oveer the yearrs, a fact which has perhaps not attracted much attenttion since overall membership numbers (in ncluding reetirees, residents, etc.) as well as the resultaant dues haave increased during that period. So Why Not Become a Member?, I Aske ed Nonmember anesthesiologists generrally keep low profiles, knowing their free ride on ASA advoccacy, standards development, quality promootion and public relations upsets dues-payingg membbers. Howeever, they can be found. Our state board off medicine, for instance, lists physicians who selff identtifyy as anessthesiologists. Cross-checkingg with the ASA A roster shoows one-fourth of them as not being meembers. Soome practices have even developed nonmeembership cultures, noticeable when they want help from members with recruitment, regulatory compliance, media coverage or clinical consultations. So why do anesthesiologists not belong? Just apathy, akin to why so few people vote today, or perhaps disillusionment with organized anesthesiology, or something else? I asked a few, and listened. Their most common answers involved high costs, disagreements on issues and leader characterizations. Their focus was personal and present, not group or future. ASA active membership costs $665 per year, plus the cost of required state component membership, which adds a few hundred dollars (e.g., California is $545, Florida is $395, and New York is $595). After requested political action committee (PAC) and foundation contributions, members often spend more than $2,000. Those also joining the American Medical Association, a state association and subspecialty society, which ASA leaders encourage, spend more than $3,000. Combining these with meeting, journal, education and other advocacy costs, many active members spend more than $8,000 per year on professional expenses. Nonmember anesthesiologists receiving contract income without benefits and those working part time usually mentioned costs. Several said they would join the ASA if they did not also have to join their state component. Others said they would belong if their
‘Nonmember anesthesiologists generally keep low profiles, knowing their free ride on ASA advocacy, standards development, quality promotion and public relations upsets dues-paying members. However, they can be found.’
employer or group paid their dues. One couple, both anesthesiologists and competent clinicians, nearing 60, who are working half time as locums contractors and were formerly very active in the ASA, wrote: “Most of our reasons for not joining last year (or this) was money. We are trying to cut down on expenses in order to maintain our lifestyles before we really retire. Can’t really explain it, but the other reason is that because we are only part time and not wholly invested in being anesthesiologists as a definition of our lives anymore, the ASA and the annual meeting seem to have less importance to us, and again, not worth the money.” Some cost complaints are more specific. One private-practice cardiac anesthesiologist wrote, “(ASA) continuing medical education costs are too expensive. I can get my required CMEs [continuing medical education] for a much cheaper price.” Several complained about where the funds went (e.g., a new building, “150 employees” and “training sedation nurses”) or where the funds didn’t go (e.g., subspecialty society meeting support). Another frequent complaint, linking both costs and education, was perceived ASA support for the American Board of Anesthesiology Maintenance of Certification program. Education costs of ASA products seem at or below the market. A national guideline for CME pricing is $12 per credit hour. The popular ASA Anesthesiology Continuing Education series costs $360 for 30 hours of credit. Anesthesiology journal CME costs $120 for 12 credit hours. The ASA Practice
‘At any given time, one-fourth of U.S. anesthesiologists are not ASA members, and some have not been for years.’ Management Conference costs $41 per available CME credit, whereas the main alternative conference costs $47. Cost Is Not the Only Issue The issues nonmembers complained about reflected their personal circumstances, political views and ASA perceptions, especially on nurse scope of practice. An anesthesiologist who does his own cases wrote, “The ASA is committed to the care team model. I am not. For the most part, other specialties don’t have the same problem with their extenders that we have. …The ASA does not represent my views.” And another: “For me to rejoin (after many years), you need to take a stronger stand against CRNAs.” However, a critical care anesthesiologist wrote, “The ASA wasted time, energy and money on a battle with the CRNAs. … The correct see ASA page 54
Now protect your hard-earned reputation from cyber-attack. Since 1987, Preferred Physicians Medical (PPM) has exclusivelly insured anesthesiologists and their practices. Our policyholders also own PPM, so helping our physician owners manage their risk is a cornerstone of wh hat makes us unique. One emerging risk for anesthesiologists is the rise in unauth horized disclosure of personal health information (PHI) from high tech data breaches and security lapses in dealing with patient records, both electronic and paper. As of 1/1/2015, all PPM policyholders receive standard Cyber Liability Covverage at no additional charge, with no underwriting required or deducctibles applied.* Additional coverage tailored to your practice is also availab ble. PPM also maintains a substantial database of more than 122,500 adverse anesthesia events and uses this information to identify areas of risk, monitor developing loss trends, and provide cutting-edge, timely an nd practical anesthesiaspecific risk management advice and strategies like: On-site risk management seminars for policyholderrs and staff presented by PPM in-house in house claims attorneys. attorneys Immediate email notification via Anesthesia Alertss of important, time-sensitive issues such as widespread drug contamination and significant changes to ASA Standards. 24/7/365 telephone access to our experienced attorn neys and claims specialists for the expert risk management advice you need. Exclusive access to anesthesia specific practice and risk management resources. Examples include white papers, sample in nformed consent documents, current and archived issues of Anesthesiia & the Law, w and other useful information for your practice.
*In partnership with NAS Insurance, the leading provider of Cyber Liability Coverage to health care professionals in the United States.
Add your good name to our growing list of ASA “standard of care” clinicians. Call us toll free today at 800.562.5589 and join other select anesthesiologists who have already secured ownership in their professional reputations. 9000 West 67th Street
S h a w n e e M i s s i on , K S 6 6 2 0 2 - 3 6 5 6
800-562-5589
p p m r rg . c om
48 I AnesthesiologyNews.com
APRIL 2015
Continuing Medical Education WRITTEN BY: Marco Mikhael, MD Assistant Professor Loyola University Medical Center Chicago Department of Anesthesiology Maywood, Illinois
CME REVIEWED BY:
Karl Takabayashi, MD Resident - CA-2 Loyola University Medical Center Chicago Department of Anesthesiology Maywood, Illinois
Elizabeth A.M. Frost, MD Department of Anesthesiology Icahn School of Medicine at Mount Sinai New York, New York
DISCLOSURES
LESSON 315
Assessment of the Neonate With Patent Ductus Arteriosus
The authors have no relationships with pharmaceutical companies or manufacturers of products to disclose.
PROFESSIONAL GAPS Treatment of symptomatic patent ductus arteriosus (PDA) is commonly successful with medical therapy. Occasionally, surgical intervention is indicated. Although the general anesthesiologist may only rarely be called on to participate in the care of a newborn with PDA, the condition is common enough that all anesthetic care providers should be well versed in neonatal physiology and management of this congenital abnormality.
TARGET AUDIENCE Anesthesiologists
CALL FOR WRITERS If you would like to write a CME lesson for Anesthesiology News, please send an email to Elizabeth A.M. Frost, MD, at elzfrost@aol.com.
LEARNING OBJECTIVES At the end of this lesson, the reader will be able to: 1. Define patent ductus arteriosus (PDA) and its incidence 2. Recognize the risk factors for PDA 3. Discuss how the PDA closes after birth 4. Recognize the factors that lead to the DA reopening after closure 5. Name the morbidities that are associated with PDA 6. Describe the effect of PDA on systemic organs 7. Identify the clinical presentation of a neonate with PDA 8. Discuss the preoperative management of a neonate with PDA 9. Describe an appropriate intraoperative plan for neonates undergoing PDA ligation 10. List postoperative complications of PDA ligation
CASE A 2-week-old, 0.8 kg neonate was scheduled for ligation of a patent ductus arteriosus (PDA) in the neonatal intensive care unit (NICU). The patient was born at 25 weeks by cesarean delivery with an Apgar score of 5-5-8. His trachea was intubated immediately after delivery; an umbilical arterial catheter and an umbilical venous catheter (UVC) were placed. He was extubated the next day, but had multiple apneic episodes with desaturations and bradycardia requiring reintubation for respiratory failure. The hospital course was complicated by intestinal perforation treated with an abdominal drain in the NICU and anemia of prematurity for which he received a blood transfusion. Echocardiography showed a moderate to large PDA. Cerebral ultrasonography was negative for intraventricular hemorrhage (IVH). Indomethacin was not given to treat the PDA because of the intestinal pathology. The patient had a radial arterial line, a peripherally inserted central catheter (PICC), and a 24 G peripheral IV. Vital signs were: blood pressure 50/20 mm Hg, pulse 156, SaO2 89% to 96%, respiratory rate 52 to 60, and temperature 36.4°C. The ventilator settings were: SIMV, rate 40, FiO2 30%, positive end-expiratory pressure 6, peak inspiratory pressure (PIP) 15, pressure support 5. Infusions included fentanyl 2 mcg/kg per hour, total parenteral nutrition, and lipids.
PREANESTHETIC ASSESSMENT Dr. Elizabeth A.M. Frost, who is the editor of this continuing medical education series, is clinical professor of anesthesiology at the Icahn School of Medicine at Mount Sinai in New York City. She is the author of Clinical Anesthesia in Neurosurgeryy (Butterworth-Heinemann, Boston) and numerous articles. Dr. Frost is past president of the Anesthesia History Association and former editor of the journal of the New York State Society of Anesthesiologists, Sphere. She is also editor of the book series based on this CME program, Preanesthetic Assessment, Volumes 1 through 3 (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 March 31, 2016. (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: April 1, 2015
Termination Date: March 31, 2016
Accreditation Statement The Icahn School of Medicine at Mount Sinai is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Credit Designation Statement The Icahn School of Medicine at Mount Sinai designates this enduring material for a maximum of 2.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. It is the policy of the Icahn School of Medicine at Mount Sinai to ensure objectivity, balance, independence, transparency, and scientific rigor in all CME-sponsored educational activities. All faculty participating in the planning or implementation of a sponsored activity are expected to disclose to the audience any relevant financial relationships and to assist in resolving any conflict of interest that may arise from the relationship. Presenters must also make a meaningful disclosure to the audience of their discussions of unlabeled or unapproved drugs or devices. This information will be available as part of the course material. 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 website, call toll-free customer service at (888) 345-6788 or send an email to Customer.Support@ProCEO.com. For inquiries about course content only, send an email to ram.roth@mssm.edu. Ram Roth, MD, is director of PreAnesthetic Assessment Online and assistant professor of anesthesiology at The Icahn School of Medicine at Mount Sinai, New York, NY.
Introduction
A
PDA is the connection between the lesser curvature of the aortic arch and the pulmonary artery (PA).1 It is an acyanotic congenital heart disease (CHD) if it is not accompanied with other complex cardiac defects. An isolated persistent PDA occurs in 1 in 2,000 to 5,000 live births and affects approximately 1 in 3 premature infants.2 The major risk factor is prematurity and the incidence is highest in neonates younger than 28 weeks postconceptual age, weighing less than 1,000 g, or both.3 Other factors include female gender (2:1), genetic disorders (Down syndrome, Carpenter syndrome, Holt-Oram syndrome, X-linked mutations), and intrauterine exposure to rubella.3 Incidental PDA could possibly be as high as 1 in 500 children. Although considered an anomaly, the presence of PDA may be required to maintain systemic circulation and oxygenation in infants with single ventricles and other complex CHD.
Fetal Circulation Fetal circulation is characterized by a high pulmonary vascular resistance (PVR) and a low systemic vascular resistance (SVR). It varies from adult circulation by the existence of several shunts to carry oxygenated blood from the umbilical vein to the systemic circulation. These shunts include the ductus venosus (DV), the foramen ovale (FO), and the ductus arteriosus (DA). Beginning with the placenta, 50% of oxygenated blood passes through the DV to the right atrium (RA).4 RA configuration helps to direct well-oxygenated blood into the left atrium (LA) via the FO. Blood then travels into the left ventricle (LV), ascending aorta and finally to the brain and upper body. Superior and inferior vena cava blood flow returns to the right ventricle (RV) and into the PA. About 90% of this blood is shunted via the DA to the descending aorta to supply the lower body.4 As a result, RV output contribution to the fetal systemic circulation is double that of LV.2 Combined ventricular output to the lungs is only 7% because PVR is high and alveoli are collapsed and filled with amniotic fluid.4 Ductal closure or constriction in utero can cause severe pulmonary hypertension and edema because of increased reactivity of the pulmonary vascular muscular layer. The resulting RV failure can lead to devastating conditions such as fetal hydrops and demise.2
Postnatal Circulation and PDA Closure An increase in SVR and a dramatic decrease in PVR lead to a transitional circulation in the first few days of life.4 These changes and high oxygen tension constrict the DA and reverse its flow, causing a left-to-right shunt. The DA functionally closes within 48 to 72 hours and anatomically by 2 weeks.2 In infants with birth weights greater than 1,000 g, 67% of PDA closure occurs by 7 days and 94% by the time of discharge. In infants with birth weights less than 1,000 g, closure happens in 30% by discharge.1,2,5 Functional closure is mediated by several factors, including oxygen (which results in contraction of smooth muscle fibers via Ca2+-induced constriction leading to intraluminal ischemic hypoxia), decreased circulating prostaglandins, and decreased ductal luminal pressure.2 It has been suggested that activated platelets forming an
APRIL 2015
AnesthesiologyNews.com I 49
Continuing Medical Education initial platelet plug have an important role in the primary closure of the DA.6 Anatomic closure occurs due to infolding of the endothelium and subintimal disruption and fibrosis.2 The resulting tissue persists as the ligamentum arteriosum. The DV and FO also close during the transition to the postnatal circulatory system. The FO may remain patent in 25% of normal infants. Interference of this closure process can result in pulmonary hypertension and reversal to fetal circulation.4 Additional factors that promote and antagonize PDA closure are summarized in Table 1. Some of the factors that lead to persistence of the DA or reopening after closure include low oxygen tension, fluid overload, respiratory distress syndrome, acidosis, lung collapse, and inflammatory mediators as seen in conditions like necrotizing enterocolitis (NEC), severe infections and sepsis.7
Clinical Picture and Diagnosis Small incidental PDAs may be completely asymptomatic. A large PDA may not exhibit its full hemodynamic effects in the first few days of life because of relatively high PVR, which results in a small left-to-right shunt. After this initial phase, PVR continues to decrease, resulting in a larger shunt and deterioration of the neonate’s condition by the “steal phenomenon.”2,4 The severity of PDA primarily depends on its size, but additional factors include shunt direction, duration of patency, extent of the steal phenomenon, and adequacy of compensatory mechanisms.2 The body attempts to adapt with an increased heart rate, stroke volume, cardiac output, lung lymph flow, maintained contractility, and decreased SVR. Initially, redistribution of blood to vital organs decreases blood flow to the skin, bone, and skeletal muscles. When compensatory mechanisms are exhausted, a “hemodynamically significant” PDA develops, resulting in hypoperfusion to the kidneys, gastrointestinal (GI) tract, brain and heart.
Hypoperfusion manifests as systemic hypotension, renal insufficiency and decreased urine output, NEC, IVH, myocardial ischemia, prolonged capillary refills, and metabolic acidosis. PDA is also characterized by increased pulmonary blood flow, pulmonary edema, worsening respiratory mechanics, and a need for increased ventilator support. Premature infants are more subject to the deleterious effects of PDA due to impaired contractility and relaxation, elevated baseline heart rate, and less organized myocardial fibers.2 Additionally, immature lungs are less capable of removing circulating prostaglandins. Classical physical findings of an isolated PDA include acyanosis with normal oxygen saturation, a vigorous peripheral pulse (due to increased pulse pressure), and a continuous machinery-like murmur best heard at the left upper sternal border.1,2 Worsening respiratory function is caused by transudation of fluid through pulmonary capillaries into interstitial and alveolar spaces due to increased pulmonary venous pressure. Preterm neonates also have less well-developed pulmonary lymphatic systems, which impair efficiency to clear excess interstitial fluid.2 However, in mechanically ventilated preterm neonates, PDA evaluation solely by clinical exam is of limited value. Therefore, other modalities are required to diagnose and assess the severity of PDA. Transthoracic echocardiogram (TTE) is the most useful tool.1 Because the neonate may not demonstrate clinical deterioration in the first few days of life, TTE is done after birth and repeated a few days later to assess patency, direction and magnitude. Other TTE-based diagnostic criteria include LA to aortic root dimension ratio greater than 1:1.4, a ductal diameter greater than 1.4 mm/kg, LV enlargement, and diastolic flow reversal.2 Other modalities include electrocardiography that may show signs of LA, LV and RV enlargement, and chest x-rays indicating cardiomegaly and increased lung markings.1 In
Table 1. Factors Affecting DA Patency
older, stable infants, computed tomography angiography, magnetic resonance imaging, cardiac catheterization, or a combination of the 3, may be performed in complex or questionable anatomy, or if coarctation is suspected.1 Helpful laboratory studies may include B-type natriuretic peptide (BNP) and N-terminal pro-BNP.5,8 Morbidities associated with PDA are listed in Table 2.
Treatment of the Isolated PDA Medical Treatment Conservative medical therapy begins with fluid restriction and diuretics (furosemide or thiazides).2,5,8 If these are not effective, drugs that cause nonselective inhibition of prostaglandin synthesis (cyclooxygenase-1 and -2 inhibitors) are used.2,7 The most commonly used medications are indomethacin and ibuprofen. Recent reports suggest that high-dose acetaminophen may also have a role in increasing PDA closure.5,8 Indomethacin can be started prophylactically within 12 hours of birth or 2 to 3 days postnatal when PDA symptoms start to appear. Prophylactic treatment has been shown to reduce the incidence of severe early pulmonary hemorrhage, severe grades of IVH, the risk for developing symptomatic PDA, and the need for surgical ligation.2 Indomethacin is contraindicated in the presence of bleeding diathesis, NEC, renal failure or thrombocytopenia. It is effective in only 60% to 70% of preterm infants younger than 28 weeks of gestation. Before that age, the ductus wall is very thin and less responsive to the vasoconstrictive effect of hypoxia. Overall, its effectiveness is inversely related to the postnatal age at the time of treatment. With advancing postnatal age, dilator prostaglandins may not be the main factor in maintaining ductus patency.2 Indomethacin significantly decreases cerebral, mesenteric, and renal blood flow, whereas ibuprofen has less of an
Table 2. Morbidities Associated With Persistent Postnatal PDA
Factors That Oppose DA Closure
Factors That Promote DA Closure
Low oxygen tension
Oxygen
General
Acidosis
Normal pH
Altered postnatal nutrition
Lung collapse
Normal lung expansion
Altered postnatal growth
High PVR
Ductus vascular ischemia
Pulmonary
High intraluminal pressure
PGI2
Bronchopulmonary dysplasia
PGE2
Inhibition of PGE2 (indomethacin, ibuprofen)
Gastrointestinal
Nitric oxide
Endothelin
NEC
Carbon monoxide
Calcium channel stimulation
Neurology
Presence of KCa2+ channels
Catecholamines
IVH
cAMP
Rho kinase
Decreased cerebral blood flow
cGMP
Periventricular leukomalacia
Thrombocytopenia
Renal
cAMP, cyclic adenosine monophosphate; cGMP, cyclic guanosine monophosphate; DA, ductus arteriosus; PGE2, prostaglandin E2; PGI2, prostacyclin; PVR, pulmonary vascular resistance Adapted from reference 2.
Renal dysfunction IVH, intraventricular hemorrhage; NEC, necrotizing enterocolitis; PDA, patent ductus arteriosus
50 I AnesthesiologyNews.com
APRIL 2015
Continuing Medical Education effect on blood flow to the organs and is associated with a lower incidence of NEC. Ibuprofen, however, does not have the intracranial hemorrhage–sparing effect of indomethacin. Both medications may worsen renal function, inhibit platelet aggregation, and are associated with GI hemorrhage and perforation.2 Symptomatic ductus can recur after the initial successful treatment with indomethacin. The rate is highest in the most immature neonates and correlates with the timing and completeness of ductus closure with the initial treatment.2 A second treatment can be given, but a surgical consult should be sought if it fails. Surgical treatment is also recommended for patients for whom nonsteroidal anti-inflammatory drugs are contraindicated.
Surgical Treatment The chosen technique of surgical closure of PDA depends on the size of the patient, anatomy of the PDA, and institutional practice. Three approaches are described. A left thoracotomy, assuming levocardia is present, is usually reserved for preterm neonates and small infants, patients with a very large and tortuous PDA, or in the presence of aortic coarctation. Video-assisted thoracoscopic surgery is used in larger infants and children. Device closure is done via endovascular techniques in the cardiac catheterization laboratory and is used often for most of the small to moderate PDAs in larger infants and children.1 PDA closure usually takes place in the NICU to avoid any complications that may arise during transport of fragile, ventilated preterm neonates.
Preoperative Management The neonate should be seen and examined in the NICU and a standard anesthesia history gathered from parents and the hospital chart. Vital signs should be noted to determine the patient’s baseline because significant hypertension or hypotension have been associated with IVH and other adverse outcomes. The anesthetic plan should take into consideration the presence of other congenital anomalies including facial, cerebral, renal, skeletal, or GI tract. Labs and other diagnostic studies, ventilator settings, IV lines, and rates of infusions should be reviewed and discussed with the surgeon
and neonatologist. Blood products should be ordered, readily available, and checked before starting the procedure. A team approach and good communication are essential. In the NICU, ventilation management includes minimizing FiO2 to keep SpO2 adjusted to the neonate’s postnatal age (usually between 89% and 95%) and maintaining normocarbia to decrease left-to-right shunting. Low FiO2 also decreases the risk for the steal phenomenon, incidence of retinopathy of prematurity, and bronchopulmonary dysplasia.1
Intraoperative Management Medications Total IV anesthesia is used for PDA ligation in the NICU. Emergency medications should be prepared in an appropriate diluted concentration, usually in small syringes according to the patient’s weight. These medications include, but are not limited to, the following: atropine 10 to 20 mcg/kg, calcium chloride 5 to 10 mg/kg or calcium gluconate 20 to 30 mg/kg, and epinephrine 1 to 5 mcg/kg. Other emergency medications like succinylcholine, phenylephrine, or ephedrine can be prepared at the anesthesiologist’s discretion. Inotropes such as dopamine or epinephrine should be immediately availabile.1 Albumin 5% may be used as a flush fluid. Anesthesia medications include fentanyl (dosing varies widely among practitioners, but a usual starting dose is 5 to 20 mcg/kg, and the total dose may reach 50 mcg/kg), and vecuronium 0.1 to 0.2 mg/kg or rocuronium 1.2 to 1.5 mg/kg, with additional boluses as needed. Small doses of midazolam may be added. Inhalation anesthetics are not typically used in NICU cases because of myocardial depressant and hypotensive effects and because the regular anesthesia ventilator is not used for these very-low-weight neonates. Prophylactic antibiotics should be given before incision.
IV Access Most of the time, the neonate has an indwelling PICC or UVC for infusions and nutrition. Additional access dedicated to anesthesia medications is preferred to avoid bolusing the total parenteral nutrition line. All IV tubing should be clear of air bubbles to avoid paradoxical air embolism to the coronary, cerebral, and peripheral vessels. A small-volume
extension line should be used to obviate the need for large volume flushes after each drug administration. A 4-way stopcock is connected to the end of the extension and secured at the head of the incubator so medications, fluids, or blood can be administered without disrupting the surgery.
Airway Airway management is paramount in these very small preterm neonates. The majority are already intubated for underlying medical conditions, but if no artificial airway is present they may be intubated either awake or postinduction with an appropriately sized uncuffed endotracheal tube (ETT). Alternative plans should be in place if the neonate has associated airway congenital anomalies. Suction and additional sizes of ETTs, laryngoscopes, and oral airways should be readily available. Minimal leak around the ETT is indicated. If a large leak is present, ventilation can be inadequate after lung retraction, resulting in intraoperative desaturation. The ETT should be changed to a half size larger. Uncuffed ETTs are universally used in preterm infants, whereas cuffed ones can be used in larger neonates.
Monitors Standard American Society of Anesthesiologists’ monitors are used with an additional pulse oximeter, one placed preductal (right hand) and the other postductal. The latter serves as an indicator of any blood flow interruption if the surgeon incorrectly test-clamps the aorta or the main pulmonary artery. A peripheral or umbilical arterial line is helpful, but not necessary. It allows real-time blood pressure monitoring when the ductus is being ligated as well as acid–base and electrolyte monitoring. Temperature monitoring is particularly important in these small neonates to detect and prevent hypothermia. ETCO2 monitoring can be technically challenging in preterm neonates, but some NICUs possess appropriate equipment. It is also useful to detect pulmonary artery ligation or compression.7 Near-infrared spectroscopy allows for continuous measurement of tissue oxygenation. It may be used during and after PDA ligation to reflect perfusion status, and monitor fluctuations in real-time.9
Table 3. Complications Associated With PDA Ligation2,4 Intraoperative
Postoperative
Long-Term Complications
Desaturations
Atelectasis
Rib fusion
Blood loss
Profound hypotension and increased ventilator support Chest wall deformity
Ligation of the wrong vessel (aorta or left pulmonary artery)
Chylothorax
Scoliosis
Unilateral RLN injury and vocal cord paralysis (as high as 67% in preterm neonates <1,000 g) Coarctation of aorta
Compromise of pulmonary function
Thoracic duct injury
Infection
Recurrence of patency
Hypothermia
Recurrence of patency
Pulmonary and/or paradoxical air embolism
BPD
Blood transfusion reactions
Possible impedance of lung growth Pneumothorax
BPD, bronchopulmonary dysplasia; PDA, patent ductus arteriosus; RLN, recurrent laryngeal nerve
APRIL 2015
AnesthesiologyNews.com I 51
Continuing Medical Education Anesthetic Induction and Maintenance Anesthesia is typically induced with fentanyl and a muscle relaxant (see doses above) and maintained with additional boluses as necessary. If the neonate is not already intubated, an ETT is inserted and secured at an appropriate depth. A clinical technique to determine sufficient depth is by auscultating breath sounds bilaterally, gently advancing the ETT into the right bronchus, withdrawing the tube slowly while listening on the left side until breath sounds are present, and then extracting the ETT an additional few millimeters. The patient is positioned in the right lateral decubitus by the surgeon while the anesthesiologist holds the head and the ETT. An appropriately sized axillary roll is made from 4x4 sponges or a small towel. Auscultation is repeated to confirm bilateral ventilation after positioning. A precordial stethoscope is beneficial in assuring adequate ventilation intraoperatively. Mechanical ventilation is typically achieved by a NICU ventilator. The anesthesiologist should be familiar with this device because parameters need to be changed frequently for hypoxemia caused by lung retraction. FiO2 and PIP are adjusted to keep SpO2 at baseline. Although high FiO2 leads to an increase in left-to-right shunt, it is frequently necessary intraoperatively. The anesthesiologist should inform the surgeon of any persistent desaturation so that lung retraction may be relieved until SpO2 improves. Normocarbia should be maintained at 40 to 50 mm Hg. Test-clamping of the PDA increases both systolic and diastolic blood pressures with a more pronounced change in diastolic pressures. If the aorta or the main PA is clamped, the arterial line or pulse oximeter waves in the postductal extremity disappear. Inadvertent clamping of one of the PA branches manifests as hypoxemia. The anesthesiologist must alert the surgeon immediately if either of these situations occurs.
Complications Injury to the aorta or the main PA is fatal unless managed quickly by the surgeon; the anesthesiologist should be ready to transfuse blood immediately. Other complications include vagal-mediated bradycardia that may occur during retraction of major vessels or airways. Cessation of the inciting maneuver usually allows the heart rate to recover. Atropine may be required if the rate persists or cardiac output is negatively affected. The left recurrent laryngeal nerve can be injured during retraction, which may lead to the need for prolonged mechanical ventilation, tube feeding, and hospital stay.2 Additional complications are listed in Table 3.
is characterized by severe hypotension requiring vasopressors and/or inotropes and increased ventilator support. The causes of this decompensation are unknown, but the speculated underlying mechanisms are altered loading conditions, increased SVR, decreased LV output and stroke volume, downregulated cardiovascular adrenergic receptors, relative adrenal insufficiency, and altered vascular tone due to anesthesia. PDA size is one of the strongest predictors for decompensation. Other known risk factors include decreased gestational and postnatal age, and increased ventilator support prior to surgical ligation. Extubation should occur when the patient recovers from muscle relaxant and fentanyl effects and meets extubation criteria typically on postoperative day 0 or 1. It should not be attempted until resolution of hemodynamic instability, which can take several days. According to the infective endocarditis guidelines from the American Heart Association, no prophylaxis is required in acyanotic patients with unrepaired or repaired PDA.10
Concluding Statement
Management of the Case Presented
7. Lockman J, Heitmiller E. Patent ductus arteriosus (PDA), ligation of. In Essence of Anesthesia Practice: Expert Consult. Fleisher L, Roizen MF, eds. Elsevier Health Sciences; 2010:513.
A large air leak was present around the uncuffed 2.5 ETT, so it was exchanged for a 3 uncuffed tube after induction of general anesthesia by IV fentanyl and rocuronium. The procedure was uneventful except for a few episodes of desaturations, no lower than 85%, during lung retractions, for which PIP and FiO2 were increased accordingly. At the conclusion of surgery, the ETT was exchanged for a 2.5 uncuffed tube and PIP and FiO2 titrated down. The postoperative course was stable and the patient was extubated 4 days later.
References 1.
Fleisher L. Congenital heart disease. Anesthesia and Uncommon Diseases. 6th ed. Philadelphia, PA: Expert Consult. Elsevier Health Sciences; 2012:75-136.
2. Clyman R, Noori S. The very low birth weight neonate with hemodynamically significant ductus arteriosus during the first postnatal week. In: Kleinmann C, Seri I, ed. Hemodynamics and Cardiology: Neonatology Questions and Controversies. 2nd ed. Philadelphia, PA: Saunders; 2012:269-291. 3. Schneider D, Moore J. Patent ductus arteriosus. Circulation. 2006;114:1873-1882. 4. Andropoulos D, Stayer S, Russell I. Anesthesia for Congenital Heart Disease. 1st ed. Malden, Massachusetts: Blackwell Futura, USA; 2005:30-31,299-300. 5. Mitra S, Rønnestad A, Holmstrøm H. Management of patent ductus arteriosus in preterm infants—where do we stand? Congenit Heart Dis. 2013;8(6):500-512. 6. Hamrick S, Hansmann G. Patent ductus arteriosus of the preterm infant. Pediatrics. 2010;125:1020-1030.
8. Ibrahim TK, Haium AA, Chandran S, et al. Current controversies in the management of patent ductus arteriosus in preterm infants. Indian Pediatrics. 2014;51(4):289-294. 9. Marin T, Moore J. Understanding near-infrared spectroscopy. Adv Neonatal Care. 2011;11(6):382-388. 10. Wilson W, Taubert KA, Gewitz M, et al. Prevention of infective endocarditis: a guideline from the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group. Circulation. 2007;116:1736-1754.
Post-Test 1.
The ductus arteriosus is a connection between the _____. a. pulmonary artery and aorta b. superior vena cava and pulmonary artery c. left and right atriums d. placenta and inferior vena cava
2.
Which of the following is NOT a risk factor for a patent ductus arteriosus (PDA)? a. Female gender b. Prematurity c. Rubeola exposure d. Down syndrome
3.
Postoperative Management At the conclusion of surgery, the anesthesiologist holds the ETT during drape removal. The neonate is positioned supine and bilateral lung auscultation should be performed to ensure appropriate ETT position and lung ventilation. Thoracotomy tubes are not typically left in place. A chest x-ray allows a check of the position of the ETT and excludes pneumothorax. In the early postoperative period, most neonates experience an improvement in blood pressure and SpO2 with lower FiO2 requirements. In 25% to 30% of cases of neonates with a birth weight less than 1,000 g, this period is followed by one of cardiopulmonary deterioration 6 to 14 hours postoperatively before eventual improvement.2 This phase
Surgical management and provision of anesthesia to a neonate may seem frightening to the clinical anesthesiologist who is not a cardiac specialist. However, with a good understanding of the physiology involved and adherence to basic principles of pediatric anesthesia, these infants have a good outcome.
4.
5.
In utero, what is the right ventricle’s contribution to the systemic circulation compared with that of the left ventricle? a. Varies, depending on weight of the baby b. Double c. Equal d. Half Patency of the ductus arteriosus (DA) is maintained by ___. a. high oxygen tension b. low pulmonary vascular resistance c. low intraluminal pressure d. prostaglandin E2 The ductus arteriosus functionally closes between ____ after delivery: a. 6 and 10 h b. 48 and 72 h c. 2 and 4 wk d. 1 and 3 mo
6.
_____ does NOT result in reopening of previously closed DA. a. Oxygen b. Sepsis c. Necrotizing enterocolitis d. Fluid overload
7.
Which extremity is used to monitor preductal blood pressure? a. Right arm b. Left arm c. Right leg d. Left leg
8.
PDA is associated with decreased blood flow to the following organs EXCEPT: a. Brain b. Lungs c. Kidneys d. Intestine
9.
Which of the following will increase after PDA ligation? a. Venous return b. Stroke volume c. Pulmonary blood flow d. Blood pressure
10. _____ is a compensatory mechanism for PDA. a. Low heart rate b. Low stroke volume c. Low systemic vascular resistance d. Low cardiac output
52
CLASSIFIEDS
APRIL 2015
UF ANESTHESIOLOGY ASCENT Are you seeking collegial partners and a supporƟve work environment in an academic seƫng? To T accommodate expansive growth in perioperaƟve, ICU, and pain services, the University Of Florida Department of Anesthesiology seeks 15 commiƩed physician faculty members for tenure and non-tenure track Assistant / Associate / Full Professor ranks to teach and pracƟce at UF Health Shands Hospital, Shands Children’s Hospital, and Shands Cancer Hospital at the University of Florida, a terƟary care teaching facility located in Gainesville, FL (including, terƟary care / Level I Trauma Center / High risk Ob / Comprehensive Stroke Center / Level 4 NICU / Congenital Heart Center / Solid Organ TransplantaƟon / Cancer Center). These posiƟons require skills in clinical care, ABA cerƟĮcaƟon/eligibility, y and credenƟals to obtain a State of Florida physician’s license. Abundant opportuniƟes exist to develop independent and collaboraƟve research as well as innovaƟve educaƟon models. Base salary is negoƟable commensurate with experience and educaƟon. AddiƟonal variable compen sation is available. Department anesthesiologists pracƟce at UF Health hospitals in Gainesville, FL at the University of Florida alongside 62 / University employment beneĮts include 403(b) plan, 457 plan, faculty anesthesiologists, 78 residents, 17 fellows, and 57 CRNA/AAs. individual and family health insurance, professional disability insurance, Baby Gator childcare, domesƟc partner beneĮts, sovereign immunity malpracƟce status, and others. Gainesville is a vibrant, sun drenched, university city with a low cost of living, Division I NCAA sports, and no state income tax. Salary: Commensurate with educaƟon and experience Minimum Requirements: M.D. or equivalent, credenƟals to obtain a State of Florida physician’s license Criminal background and post oīer health assessment required. Interested applicants must apply through gatorjobs at ŚƩp://jobs.uŇ.edu/posƟngs/60184. Please aƩach curriculum vitae and leƩer of interest. The Universi r ty t of Fl F orida is an equal opportunity insƟtuƟon dedicated to building a broadly l diverse r and inclusive fa f culty and staī aī.
CLASSIFIEDS
APRIL 2015
University of PiĆŠsburgh Medical Center We are seeking highly-talented applicants to join our healthcare system and oÄŤer opportuniĆ&#x;es in neuro, cardiac, and general anesthesiology throughout a fourteen hospital system. Fellowship training or substanĆ&#x;al experience is required in these subspecialĆ&#x;es. Successful candidates must be ABA board-eligible or cerĆ&#x;ÄŽed and qualify for an unrestricted Pennsylvania medical license. The ability to work with a highly producĆ&#x;ve team is criĆ&#x;cal to the success of this posiĆ&#x;on. Interested candidates should send their curriculum vitae and three leĆŠers of recommendÄ&#x201A;Ć&#x;on via email to: MARSHALL W. WEBSTER, MD, UNIVERSITY OF PITTSBURGH, DEPARTMENT OF ANESTHESIOLOGY, A-1305 SCAIFE HALL, 3550 TERRACE STREET, PITTSBURGH, PA 15261 Email: tarnejam2@upmc.edu ApplicÄ&#x201A;Ć&#x;ons will be accepted unĆ&#x;l posiĆ&#x;ons are ÄŽlled. The University of WĹ?ĆŠsburgh is an aĸrĹľÄ&#x201A;Ć&#x;ve acĆ&#x;on, equal opportunity employer.
INTEGRITY
|
EXCELLENCE
|
RESPECT
|
INSPIRED LEADERSHIP
Our clinicians have the opportunity to thrive and grow their careers with our diverse, nationwide network of clinical locations. North American Partners in Anesthesia (NAPA), the nationâ&#x20AC;&#x2122;s leading single specialty anesthesia and perioperative management company, LIVES BY ITS MISSION TO DELIVER AN EXCEPTIONAL EXPERIENCE FOR EVERY PATIENT AND EVERY CLIENT EVERY DAY 7HEN YOU JOIN .!0! YOU ARE IMMEDIATELY CONNECTED TO DEDICATED HIGHLY SKILLED CLINICIANS WITH A PATIENT lRST PHILOSOPHY AND A SUCCESSFUL GROWING ORGANIZATION THAT ACTIVELY SUPPORTS YOUR CAREER GOALS
JOIN OUR TEAM TODAY. Contact our clinical recruiters at recruitment@NAPAanesthesia.com or 516.945.3388.
One Exceptional Experience at a Timeâ&#x20AC;ŚEvery Day.
What We Offer Competitive Compensation & BeneďŹ ts &LEXIBLE 3CHEDULING s #AREER -OBILITY Work-life Balance
We Invest in You -ENTORING 0ROFESSIONAL $EVELOPMENT 2EWARDING !TMOSPHERE s #OLLABORATIVE %NVIRONMENT
NAPAanesthesia.com
53
CLASSIFIEDS
54
APRIL 2015
Large, stable, and growing Chicago-area prĂĐƟce is seeking BC/BE anesthesiologists. PosiƟons are available for general pƌĂĐƟĐe, pain and cardiac. CompeƟƟve salary with opportunity for rapid advancement to $350,000 plus. BeneĮts package including 401(k) with match, health and disability insurance, CME allowance, and full malpƌĂĐƟĐe insurance coverage including tail. ͻ Leadership track opportuniƟes leading to addiƟonal compensĂƟon. ͻ Nurturing work environment with mixture of personal cases and care team model. ͻ 6 weeks paid vacĂƟon. ͻ ͻ ͻ
Interested candidates should send inquires to KaƟe Enright at kenright@conƟnentalanesthesia.com. Mailing address: 1301 West 22nd Street, Suite 610, Oakbrook, IL 60523; telephone: 847.772.2293
Cardiothoracic Anesthesiologist
University Hospitals Case Medical Center in Cleveland, OH is seeking a full-Ɵme board eligible/cerƟĮed anesthesiologist who has completed a one year cardiothoracic anesthesia fellowship. NBE Advanced PerioperaƟve TEE Testamur status is necessary if you are not a Diplomate of the NBE. We are strongly encouraging applicaƟons from individuals who will signiĮcantly contribute to the growing academic core of a mid-sized academic anesthesia pracƟce. Our pracƟce involves providing anesthesia for thoracic, coronary, valve, major aorƟc, heart/lung transplant, ventricular assist device implantaƟon surgeries and electrophysiology/catheterizaƟon laboratory based procedures. Provision of some main operaƟng room anesthesia care is expected. MoƟvaƟon to teach residents, medical, nursing and anesthesia assistant students is a requirement. Faculty appointment at Case Western Reserve University School of Medicine will be commensurate with one’s academic record. University Hospitals is an equal opportunity employer. Interested applicants should send a cover lĞƩer along with their curriculum vitae to edwin.avery@uhhospitals.org.
ACADEMIC PEDIATRIC ANESTHESIOLOGIST - COLUMBIA, MO. The University of Missouri (UM) Department of Anesthesiology and PerioperaƟve Medicine is seeking a fellowship-trained pediatric anesthesiologist. Successful candidates will be ABA cerƟĮed or eligible. Academic rank and pay is based upon qualiĮcaƟons in either a tenure or non-tenure track. An interest in teaching is essenƟal; research experience is desirable. The pracƟce is based at the UM Women’s & Children’s Hospital where all pediatric surgical subspecialƟes are represented except solid organ transplant and cardiac surgery. The department supports pediatric emergency services, criƟcal care transport, a PICU and a NICU. Three pediatric anesthesiologists currently share clinical responsibiliƟes and home call for all high risk pediatric cases. During regular duty hours, they provide care for adult paƟents on occasion. UM oīers a generous compensaƟon and beneĮt package. Columbia is a vibrant university community of over 100,000 with a low cost of living. It has been cited by Money Magazine as the 13th most highly educated municipality in the US and by Outside Magazine as one of the 10 Best US communiƟes. For addiƟonal informaƟon about the posiƟon, please contact: B. Craig Weldon, MD at weldonb@health.missouri.edu An Equal Opportunity/Access/AĸrmaƟve AcƟon/Pro Disabled & Veteran Employer To request ADA accommodaƟons, please call Human Resource Services at 573-882-7976.
COMMENTARY ASA
CONTINUED FROM PAGE 46
patient-centered approach is to work with folks to build the best integrated model.” Some complaints seemed bizarre, even fantasized. One long-time nonmember complained his group has not made him a partner, an unethical practice the ASA condones, and “the reason why I am not a member.” Several mentioned how hard they work, whereas ASA officers do not, for example, “all the ASA presidents and officers haven’t seen the inside of an OR in forever.” (This irksome comment drives me to note that I worked full time clinically while I was an ASA officer.) One anesthesiologist perceived the ASA as too conservative and aligned with Republican politics—his reasons for not belonging. Logically, more members would make the ASA more influential, especially if united. In 2010, Art Boudreaux, MD, ASA secretary, wrote, “A membership goal is to make ASA an invaluable part of every anesthesiologists professional practice.”* This is not happening. Is it even possible? From my limited survey, attracting all anesthesiologists into the ASA is currently not possible, and perhaps not desirable. The anesthesiology community is large, numbering approximately 65,000 physicians, and heterogeneous. Some nonmembers distrust authority. Some seem angry, stressed or
loners, undesirable traits for an effective professional society. Two nonmembers, among the highest earners in a group where everyone else belongs, seemed fixated on maximizing their current incomes. One nonmember who gambles most weekends has trouble paying his rent. Many nonmembers seemed detached from the ASA, engaged in other aspects of life, such as research, volunteer work in underserved areas, golfing and raising families. They tuned out the ASA and politics. A few rejoin when their life changes. One anesthesiologist responded, “I only join when looking for work or writing a department manual.”
Should more be done to attract nonmembers? Reducing costs would respond to their most common complaint. Is co-membership in a state component really necessary? Could individuals elect to drop their state memberships by paying $100 more for general state-level activities? Could the ASA take over willing state societies and eliminate redundant administrations? The ASA pays millions of dollars each year to its foundations. Could other ways be found to fund them, and reduce dues? Most not-myy belieff comments mentioned advocacy. Should education be emphasized over advocacy? Could different messaging reach nonmembers, correct misperceptions and engage them in the future? Would discounts for groups with 100% ASA membership encourage intragroup discussions? What To Do? Should non-members be identified publicly for memThe ASA can celebrate a majority membership, bers to interrogate? healthy budget, robust agenda, high-impact journal The answers are unclear, but a start toward fuller and successful programs. Many other societies can- membership would be to recognize the numerous not. American Medical Association membership is nonmembers, understand why, and change. down to 17% of physicians, its PAC a fraction of the * ASA Newsletter, 74(6), 2010. ASA PAC. But is a society built around advocacy, with dues Dr. Johnstone is professor of anesthesiology, West Virginia its primary funding, one that can continue to grow? University, and a frequent contributor to Anesthesiology News. His What if advocacy falters? What if cost resistance comments are personal opinions, not the policies of any group to which he belongs. grows?
Track Hemoglobin Changes in Real Time with Noninvasive and Continuous Hemoglobin (SpHb ) Monitoring ÂŽ
Enhance patient care with real-time visibility to whether hemoglobin is stable, dropping, or rising.
5%
4.5%
4%
87%
Reduction in Blood Transfusion Frequency
3%
2%
1%
0.6%*
0%
SpHb Impact in Higher Blood Loss Surgery2 2.5
Average RBC Units Transfused Per Patient
Frequency of Intraoperative Blood Transfusions
SpHb Impact in Lower Blood Loss Surgery1
1.9 2
0.9
Average RBC Units Reduced Per Patient
1.5
1.0** 1
0.5
0
Standard Care Group
SpHb Group
Randomized controlled trial in 327 orthopedic patients. *p=0.03 vs Standard Care Group
Standard Care Group
SpHb Group
Prospective cohort study in 106 neurosurgery patients. **p<0.001 vs Standard Care Group
In two recent studies, SpHb monitoring used in conjunction with laboratory testing helped clinicians reduce blood transfusion in surgery and helped clinicians initiate more timely transfusions when truly indicated.
To learn more, visit www.masimo.com/hemoglobin Ehrenfeld JM, et al. American Society of Anesthesiologists. 2010;LB05. 2 Awada WFN et al. Proceeding of the Society for Technology in Anesthesia Annual Meeting, 2013: p 51.
1
Caution: Federal law restricts this device to sale by or on the order of a physician.
800-257-3810 | www.masimo.com Š 2015 Masimo. All rights reserved.
PRINTER-FRIENDLY VERSION AVAILABLE AT ANESTHESIOLOGYNEWS.COM
Perioperative Anesthesia Care For Obese Patients ABDULLAH S. TERKAWI, MD Department of Anesthesiology University of Virginia Charlottesville, Virginia, USA
MARCEL E. DURIEUX, MD, PHD Department of Anesthesiology University of Virginia Charlottesville, Virginia, USA
Department of Anesthesiology King Fahad Medical City Riyadh, Saudi Arabia Outcomes Research Consortium Cleveland Clinic Cleveland, Ohio, USA Conflicts of interest: The authors declare no conflicts of interest or financial disclosure es.
T
he marked increase in the prevalence of obesity over the past 20 years has led to an increase in the number of bariatric and nonbariatric surgeries
in this population. This in turn makes every anesthesiologist likely to deal with this challenging population. Perioperative targeted and organized assessment and preparation are important to reduce mortality and morbidity and improve recovery.
The World Health Organization defines obesity as body mass index (BMI) ≥30 kg/m2, and further classifies it into 3 groups: class I (30-34.99 kg/m2), class II (3539.99 kg/m2), and class III (≥40 kg/m2), which is morbid obesity (MO).1 Furthermore, there is a consensus in the literature that BMI 50 to 59.9 kg/m2 is superobese, BMI 60 to 69.9 kg/m2 is super-superobese, and BMI >70 kg/ m2 is hyperobese.1 Obesity is a multisystem, chronic, proinflammatory metabolic disorder.2 It has manifold negative effects on health. Table 1 summarizes the most relevant pathophysiologic changes associated with obesity. (See Key for definitions of all acronyms.) Recently, Terkawi et al3 presented their successful anesthesia experience with the heaviest man in the world (weighing 610 kg), which exemplifies the challenges associated with this patient population. In this review, we discuss the problems most relevant to the anesthesiologists.
Preoperative Assessment and Preparation Preoperative assessment, preparation, and planning are important keys to successful anesthesia in obese patients. The anesthesiologist’s vigilance should help to limit the morbidity and mortality that can be associated with surgery in these patients. The preoperative interview should take place sufficiently in advance of surgery to allow adequate patient preparation. Suggested preoperative assessment and preparations include the following: y Airway assessment: The best way to predict difficult intubation in obese patients is still being debated, and the available studies based their findings on the use of regular laryngoscopes, which may make them irrelevant with the recent introduction of newer intubation tools (eg, the video laryngoscope). However, assessment tools are still important, if only to guide the selection of the most useful intubation tool for
A N E ST H E S I O LO GY N E WS • A P R I L 2 0 1 5
1
Table 1. Pathophysiologic Changes and Disorders Possibly Associated With Obese and Morbidly Obese Patients2,4-9 Changes/Causes
Anesthetic Considerations
Respiratory system MO: results in a typical restrictive pattern; L in FVC (25%-50% of predicted), FRC, and TLC, as well as L in tidal volume and ERV (30%-60% of predicted). FRC L exponentially as BMI K. Tidal volume may or may not be reduced.6
Rapid desaturation during apnea period of intubation; requires effective preoxygenation. Lower abdominal operations further L FRC by 10%-15%; upper abdominal procedures L FRC by 30%, and thoracotomy by 35%.7 With anesthesia, pneumoperitoneum, and supine or Trendelenburg position, further reduction in FRC will occur. Once FRC falls below the closing capacity of the lung, premature airway closure and atelectasis can occur, which subsequently will lead to ventilation/perfusion mismatch and impaired oxygenation.
L Chest wall and lung compliance (especially with truncal obesity). Lung compliance can be reduced ≤40% in MO. Abdominal and peritoneal fat mass cause a cranial shift of the diaphragm (~4 cm in supine position), impairing lung expansion.
Results in rapid, shallow breathing and K work of breathing, with subsequent K in O2 consumption and K in CO2 production. Trendelenburg position exaggerates these effects.
K Airway resistance due to small airway collapse, reduced volumes, and potential airway remodeling secondary to low adiponectin levels.
K Resistance is exaggerated in the supine and Trendelenburg positions.
CO2 levels almost normal (unless OHS present) due to unchanged physiologic dead space and ratio of dead space to tidal volume.
The larger waist-to-hip ratio in android “abdominal” obesity has a more negative impact on gas exchange.
O2 consumption K due to metabolic activity of excess fat, and rises disproportionally with exercise. Mild K of the alveolar-arterial O2 gradient, hypoxemia on room air and K O2 consumption on exercise.
Ventilation/perfusion mismatch leads to hypoxemia.
L Tissue oxygenation.
K Risk for wound infection; can be prevented by optimization of perioperative ventilation and oxygenation, proper antibiotic selection with appropriate dosing to reach adequate tissue concentrations, tight glycemic control, proper fluid and pain management, avoidance of hypothermia.
Higher incidence of pre- and postoperative atelectasis that lasts longer than in nonobese patients.10
Predisposition to hypoxemia/hypoxia during postoperative course. Degree of atelectasis correlates positively with incidence of ARDS. Leads to hypoxemia and hypercapnia, K susceptibility to the respiratory depressant effects of sedatives, opioids, and anesthetics. K Risk for difficult intubation, and postoperative complications; hypoxia, apnea, respiratory arrest, hypertension, arrhythmias, and cardiac arrest.
OSA
K Risk for liver disease, liver fibrosis, and nonalcoholic fatty liver disease.11 K Risk for right heart side HF. OSA in patients undergoing bariatric surgery was independently associated with significantly K ORs of emergent endotracheal intubation, noninvasive ventilation, and AF.12 OHS
High risk for postoperative respiratory complications; more likely to develop opioid-related side effects.2 Patients have compromised central respiratory drive. Main treatment is positive airway pressure therapy, and appropriate sleep referral may be mandated before major surgery.13
Bronchial asthma: obesity K incidence and prevalence of asthma; exact mechanism not known, but possibly related to proinflammatory state in obesity.14
2
A N E ST H E S I O LO GY N E WS .CO M
Obese patients with asthma experience more symptoms, are relatively resistant to steroids, and show K morbidity.14
Table 1. Pathophysiologic Changes and Disorders Possibly Associated With Obese and Morbidly Obese Patients2,4-9 Changes/Causes
Anesthetic Considerations
Cardiovascular system Triad of K CO, elevated circulating blood volume, and enhanced sympathetic activity are characteristic changes in obese patient. Blood volume K proportional to body surface area, which contributes to K preload and CO that may lead to LV hypertrophy and failure.
Anesthesia induction and intubation cause greater reduction in cardiac index in obese patient than in nonobese, which can L 17%-33% in obese patients versus 4%-11% in nonobese. This L can persist into the postoperative period in obese patients.7
Hypertension that may be complicated by concentric LV hypertrophy.
K Risk for intraoperative BP lability.
Coronary artery disease.
Additional perioperative cardiac and hemodynamic monitoring as these patients have a higher risk for perioperative myocardial infarction.
Ventricular remodeling and diastolic dysfunction. Can occur independently of hypertension and become more relevant in those with significant respiratory dysfunction.
Diastolic dysfunction K the risk for postoperative CHF, prolonged hospital stay, and complications in major surgery.
AF; as patient obesity K, risk for LAD K (â&#x2030;¤50% of severely obese patients may have LAD). The higher epicardial fat mass that may be associated with obesity can be associated with atrial arrhythmias.
Arrhythmias may be associated with hypoxia due to sleep apnea.
Pulmonary artery hypertension, as a consequence of prolonged hypoxia and hypercapnia of OSA and OHS. It can be complicated by RV enlargement and hypertrophy that can cause RV failure (cor pulmonale).
Avoid elevated PVR (by preventing hypoxemia, acidosis, hypercarbia, and pain) and avoid myocardial depressants.
Obesity-related cardiomyopathy.
K with the duration of obesity (>10 y) and the severity of obesity. Mostly manifests as diastolic CF.15
CF; the longer the duration of obesity the higher the risk. CF can be due to LV wall stress and elevated filling pressure secondary to the longstanding K in stroke volume and L in SVR to compensate for K CO demands, or as a consequence of leptinrelated hypertrophic changes, or hypertensive changes.
Hemodynamic goals: avoid tachycardia, hypertension, hypotension, hypoxia, and hypercarbia.
Cerebral autoregulation may be altered.
Maintain SVR, preload, and sinus rhythm.
table continues on next page
Key K, increase(s), increased
ERV, expiratory reserve volume
OHS, obesity hypoventilation syndrome
L, decrease(s), decreased, reduces AE, adverse event
FOI, fiber-optic intubation FRC, functional residual capacity
OR, odds ratio OSA, obstructive sleep apnea
AF, atrial fibrillation AHI, apnea-hypopnea index
FVC, forced vital capacity GERD, gastroesophageal reflux disease
PACU, postanesthesia care unit PEEP, positive end-expiratory pressure
AKI, acute kidney injury
HF, heart failure
PONV, postoperative nausea and vomiting
ARDS, acute respiratory distress syndrome AUC, area under the curve
IBW, ideal body weight ICU, intensive care unit
PPV, positive-pressure ventilation PVR, pulmonary vascular resistance
BMI, body mass index
LAD, left atrial dilatation
RSI, rapid sequence induction
BP, blood pressure CBW, corrected body weight
LBW, lean body weight LV, left ventricle
RV, right ventricle SVR, systemic vascular resistance
CF, cardiac failure
MetS, metabolic syndrome
TAP, transversus abdominal plane
CHF, congestive heart failure CO, cardiac output
MO, morbid obesity NC, neck circumference
TBW, total body weight TLC, total lung capacity
CPAP, continuous positive airway pressure
NMB, neuromuscular blockade
TMD, thyromental distance
DMV, difficult mask ventilation
NMBA, neuromuscular blocking agent
TSH, thyroid-stimulating hormone
DVT, deep vein thrombosis
NPO, nothing by mouth
EIT, electrical impedance tomography
NSAID, nonsteroidal anti-inflammatory drug
A N E ST H E S I O LO GY N E WS â&#x20AC;˘ A P R I L 2 0 1 5
3
Table 1. Pathophysiologic Changes and Disorders Possibly Associated With Obese and Morbidly Obese Patients2,4-9 Changes/Causes
Anesthetic Considerations
Miscellaneous MetS; a combination of central obesity, hypertension, dyslipidemia, and insulin resistance or impaired glucose tolerance. Incidence of MetS in patients presenting for bariatric surgery, 12.7%.16
Impaired glucose tolerance even without diabetes mellitus can lead to disturbances of the autonomic nervous system with abnormal adrenergic reflexes in ~25% of patients.5 MetS is an independent predictor of postoperative complications, and K risk for pulmonary (eg, atelectasis, pneumonia, ARDS, and respiratory failure) and cardiac AEs, AKI, as well as composite outcome.16,17 Thus, medical optimization of these patients before surgery is warranted.
Type 2 diabetes, as a result of hepatic steatosis and dysregulation of glucose metabolism.
Optimize glycemic control, a very important factor to reduce infection. Glycosylation of collagen and its deposition in the joints result in stiff joint syndrome that may K risk for difficult intubation. A good indicator of this syndrome is to ask the patient to put hands in a prayer position and look for stiff fingers or joint deformities.
GERD, chronic gastritis, and gastroparesis.
Sufficient NPO time (although there is a lack of specific recommendations for obese patients). Premedications and precautions; consider these patients to have a full stomach.
Hepatic steatosis; results from accumulation of fat in the liver. Hyperglycemia and hyperinsulinemia are associated with accumulation of fat around the islet cell of pancreas.
May affect drugs that are metabolized in the liver.
Renal: glomerular hyperfiltration and K creatinine clearance.
May affect drugs that are cleared by the kidneys.
Obesity-related glomerulopathy can cause end-stage renal disease. Obesity has been considered a state of chronic low-grade systemic inflammation and chronic oxidative stress.18 Hypothyroidism: Positive association between increases in BMI and TSH level. Apparent link between leptin and obesity and alterations of thyroid hormones.19
Subclinical hypothyroidism not uncommon in obese patients and is correlated with K BMI. Drug metabolism may L. Patients may have K sensitivity to respiratory depression from sedatives.
Thiamine deficiency
May present with neurologic symptoms that may be misinterpreted as regional or neuraxial anesthesia side effects.
Iron and vitamin B12 deficiency
Concomitant anemia of different underlying causes.
each individual patient. Importantly, BMI by itself is not a predictor of difficult intubation.20 The following is a summary of the most useful tools: Mallampati score (≥3) and large neck circumference (NC; >40 cm) may increase the chances for difficult laryngoscopy (intubation with the traditional laryngoscope). NC should be measured at the level of the thyroid cartilage. A neck diameter of 50 cm carries a risk for difficult intubation of about 20%. This percentage doubles when neck diameter is 60 cm.20 Thyromental distance (TMD; <6 cm) is another predictor.20 TMD is the distance from the thyroid notch to the mentum in centimeters. A recent study found that the NC to TMD ratio, the Mallampati score, and the Wilson score were independent predictors of difficult intubation.
4
A N E ST H E S I O LO GY N E WS .CO M
Among them, an NC:TMD ratio >5 had the highest accuracy (AUC 0.865).21 Leoni et al22 evaluated different preoperative, commonly used, difficult airway indices as predictors of DMV in obese patients (BMI >30 kg/m2). They found that limited mandible protrusion, Mallampati score (≥3), NC (>46 cm), and male gender were risk predictors, whereas history of OSA and TMD distance were not. They also found that the risk for DMV increases with the association of 2 (OR, 18.3), 3 (OR, 35.2), or 4 (OR, 64.9) of these independent predictors of DMV. y Respiratory and oxygenation status: Pulmonary function tests and a sleep study can help in the management of intraoperative ventilation, planning extubation, and postoperative pulmonary care. Two important clinical entities should be screened for:
OSA has been reported in ≤71% of patients with MO (≥35 kg/m2) undergoing bariatric surgery.23 OSA is typically diagnosed by a sleep assessment study (overnight polysomnography),24 which might be done more selectively in patients who show higher probability of having the disease based on the results of the following screening questionnaires: STOP-BANG questionnaire; Snoring, Tiredness, Observed apnea, and high blood Pressure combined with BMI >35, Age >50, Neck circumference >40 cm, and male Gender. Each item will receive 1 point with a maximum score of 8. Less than 3 points indicates a low risk for OSA; more than 3 points predicts high risk.25 The questionnaire was validated in obese and MO surgical patients; for identifying severe OSA, a score of 4 has a sensitivity of 88%. For confirming severe OSA, a score of 6 is more specific.26 The American Society of Anesthesiologists’ Task Force on Perioperative Management of Patients with Obstructive Sleep Apnea created a scoring system for perioperative risk from OSA.27 They define no OSA as an AHI <5, mild OSA as an AHI of 6 to 20, moderate OSA as an AHI of 21 to 40, and severe OSA as an AHI >40.27 AHI index is represented by the number of apnea and hypopnea events per hour of sleep. Patients with OSA and a hypopnea index >5 can benefit from overnight CPAP or bilevel positive pressure airway for 6 to 12 weeks before surgery,28 although the exact period is not well defined. OHS (also known as Pickwickian syndrome) diagnostic criteria include BMI >30 kg/m2 and awake
PaCO2 >45 mm Hg without other causes of hypoventilation. y Cardiovascular system assessments: Common cardiac complications that might be present in obese patients are summarized in Table 1. Cardiac function evaluation in patients with MO can be very challenging, as these patients have limited ability to perform physical activity to determine their functional capacity (eg, metabolic equivalents) and usually have muffled heart sounds on auscultation due to chest wall fat. y Patient transportation might be challenging and should be planned, particularly in superobese patients. We found that using a lifter helps ensure patient safety and reduces the possibility of injury to health workers (Figure). Respiratory and cardiovascular deterioration and the significant risk for nerve, joint, muscular and soft tissue injuries are important factors that should be kept in mind during patient positioning and transportation for surgery.
Airway Management Preoxygenation is very important in these patients to compensate for their high lability with rapid desaturation during intubation and to ensure enough oxygen reserve during the intubation process, which might be prolonged when intubation is difficult. As these patients are also likely to be difficult to ventilate by mask, proper face mask selection is critical. Preoxygenation for 3 minutes in the 25-degree head-up (“ramped”) position achieves a 23% increase in oxygen tension and a clinically significant increase in the desaturation safety period, in comparison to preoxygenation in the supine position.29 This preoxygenation technique can be further enhanced by augmenting the FRC using 5 to 10 cm H2O CPAP.30
Figure. Using a lifter to transport a patient facilitates patient safety and safeguards medical team members.
A N E ST H E S I O LO GY N E WS • A P R I L 2 0 1 5
5
It also has been found that noninvasive PPV improves oxygenation and end-expiratory lung volume in MO patients compared with conventional preoxygenation when performed for a 5-minute interval.31 A 30-degree reverse Trendelenburg position during anesthesia induction provided the longest safe apnea period compared with the 30-degree back-up Fowler position (ie, only the cephalad half of the operating room table is tilted upward at a 30-degree angle with a break in the table at the level of the patient’s hips) and horizontalsupine positions.32 The incidence of difficult intubation in obese patients has been reported between 13% and 24%; difficult face mask ventilation was as high as 79%.5 To overcome DMV, NMBAs have been suggested, given early in the induction sequence, although this approach is always controversial.1 To overcome challenging intubation in these patients, multiple maneuvers were tested. The most successful are proper patient positioning in ramped position, and the use of video laryngoscopes, intubating laryngeal mask airways or awake FOI equipment.33 A ramped position has been proposed to facilitate ventilation and visualization of the glottis for intubation. The external auditory meatus and sternal notch should align horizontally at the same level.34 Dhonneur et al, in a study with 318 MO patients, found that videoassisted tracheal intubation had a 100% success rate, shorter duration to tracheal intubation, and better arterial oxygenation quality compared with the Macintosh laryngoscope.35 If awake FOI is mandatory, adequate airway topicalization (anesthetizing) and/or remifentanil (0.05– 0.1 mg/kg/min IBW) can be successfully used.34 One of the major airway issues that occurs after anesthesia induction is collapse of the soft tissue of the pharynx as a consequence of loss of muscle tone, which is more pronounced in MO patients,36 especially when they lie supine and when they have associated OSA. This is why OSA is a good predictor for difficult intubation. This fact has caused some experts to believe that intubation should be done awake. We recommend that when awake FOI is required, the patient should be in the semi-sitting position and it might be better if the anesthesiologist approaches the patient from the front. An endoscopic mask is available (eg, VBM, Medizintechnik GmbH) that allows continuous oxygen flow and PPV during the intubation procedure. Recently, a case of successful use of an endoscopic mask to facilitate awake FOI was reported in a MO patient, and it is felt that PPV during the procedure helped to open up the collapsed posterior soft tissue.37 This approach might be prudent in patients dependent on assisted ventilation due to severe OSA. Interestingly, awake video laryngoscopy–assisted intubation under airway topicalization and sedation was found feasible in MO patients.38 The bottom line is that the anesthesiologist’s experience with these different tools, the degree of difficult intubation anticipated, and the patient’s clinical condition should be considered when selecting the appropriate
6
A N E ST H E S I O LO GY N E WS .CO M
tool to use. The role of airway adjuncts, such as the video laryngoscope, is still under evaluation. At present, their use depends on the skills of the individual clinician. RSI is a common practice in obese patients, and is used to avoid the risk for aspiration. Rather than giving a hypnotic (such as propofol) followed by a muscle relaxant (such as rocuronium) after loss of consciousness and the ability to mask-ventilate has been confirmed, both drugs are administered almost simultaneously, to shorten the time span between spontaneous breathing and intubation. Additionally, cricoid pressure is maintained to prevent regurgitation of stomach contents. A comprehensive review by Fried concluded that the risks and benefits of RSI and cricoid pressure should be weighed in fasted obese patients undergoing elective surgery who have no other risk factors for pulmonary aspiration.39 Interestingly, extensive meta-analysis did not find evidence to support or discourage the use of RSI to lower aspiration risk.40 Furthermore, the application of cricoid pressure seems to make intubation more problematic. Thus, a reasonable approach is to use RSI when indicated (eg, a patient with GERD), but not as routine practice in fasted obese patients who come for elective surgery but are at low risk for aspiration.34
Anesthesia Induction and Maintenance The physiologic and anthropometric changes (eg, increased CO, changes in regional blood flow, and increases in both fat and lean body mass) that are associated with obesity have a great influence on drug pharmacokinetics. Moreover, the pharmacodynamics of some anesthetics also may be altered as a result of respiratory pathophysiology (eg, OSA), which may exaggerate side effects of anesthetics and narrow their therapeutic window.41 In obese patients, fat mass and lean body mass are not proportional. As a general rule in obese patients, lipophilic drugs have an increased volume of distribution whereas hydrophilic drugs show only minor changes.5 Anesthesiologists should be knowledgeable about the appropriate dosing and selection of anesthetic and analgesic drugs in obese patients (Table 2). Obesity tends to be an exclusion criterion in many clinical drug trials. There is a lack of pharmacokinetic and pharmacodynamic studies of many drugs in MO patients, and a need for such studies, especially given the increase in the number of these patients who come for surgery. As a rule of thumb, LBW is the most appropriate dosing scalar for the majority of anesthetic medications and opioids, except for the nondepolarizing NMBAs, where IBW is more appropriate.41 However, succinylcholine remains the only drug that should be dosed based on TBW. It is traditionally felt that succinylcholine is the drug of choice for RSI due to its rapid onset of action and short duration.41 Recent evidence suggests sugammadex is a better agent than neostigmine in reversing NMB in obese patients. Carron et al found that sugammadex allowed a safer and faster recovery from profound rocuronium-induced NMB than did neostigmine
Table 2. Summary of Drug Doses Commonly Used During Anesthesia2,41 Drug
Dose
Comments
Acetaminophen IV
15 mg/kg (LBW)
Clearance is K, so dosing may need to be more frequent, max dose 4-6 g/day.1 Check liver function.
Alfentanil
130-245 mcg/kg, and infusion 0.5-1.5 mcg/kg/ min (LBW)
Antibiotics
TBW
Subcutaneous soft tissue penetration looks impaired in obese patients. Cefuroxime 1.5 g IV is sufficient against gram-positive but not gram-negative organisms.42
Cisatracurium
0.15-0.2 mg/kg (IBW)
Duration of action prolonged when given based on TBW.
Dexmedetomidine
0.2 mcg/kg/h (TBW)43
When used as infusion it L opioid use, nausea, and the PACU length of stay. But it does not affect late recovery (eg, bowel function) or improve overall quality of recovery.43,44
Enoxaparin
0.5 mg/kg (TBW)
DVT prophylactic dose, divided into bid doses.
Etomidate
0.2 mg/kg (LBW)
Despite more hemodynamically stable characteristics, etomidate induction is associated with a substantially K risk for 30-day mortality, cardiovascular morbidity, and prolonged hospital stay, in a general population.45 A recent study suggested that etomidate can be dosed according to IBW in MO patients.46
Fentanyl
2-3 mcg/kg (LBW)
Clearance significantly higher, and increases linearly with “pharmacokinetic mass,” which is highly correlated to LBW.
Ketamine
1-2 mg/kg (LBW)
Might be used in hypotensive patient. Adding 1 mcg/kg/min to propofol and remifentanil TIVA mixture was found to provide more hemodynamic stability, satisfactory recovery profile, and adequate postoperative pain relief.47
Lidocaine
1.5 mg/kg bolus, and 2 mg/kg/h infusion both as CBW48
Bolus followed by infusion until end of surgical procedure with indicated doses shows lower opioid consumption and better quality of recovery.48,49
Midazolam
Premedication 0.15-0.35 mg/kg (TBW), max 5 mg. If used as continuous infusion, use IBW
Concomitant use with opioids can potentiate its respiratory AEs.
Morphine
0.05-0.10 mg/kg (LBW)
Better to avoid due to longer duration of action, particularly in patient with OSA or OHS.
Neostigmine
0.05 mg/kg (CBW)50
Or 70 mcg/kg LBW; total dose ≤5 mg.51
Propofol
1.5-2.5 mg/kg for induction (LBW), maintenance infusion (TBW)
The most common induction agent used; its high lipophilicity and rapid distribution profile account for its short duration of action. Volume of distribution and clearance at steady state increases with K TBW.
Remifentanil
1 mcg/kg for endotracheal intubation, and 0.2-2 mcg/kg/min for infusion (LBW)
Its rapid onset of action (1 min) and ultra-short half-life (5-10 min) make it a good option for intraoperative pain management. Aids in maintaining adequate relaxation and reducing volatile anesthetic or propofol requirements.
Rocuronium
0.6-1.2 mg/kg (IBW)
1.2 mg/kg has rapid onset. The use of rocuronium (1 mg/kg) reversed with sugammadex (16 mg/kg) was found superior to succinylcholine as it allows earlier re-establishment of spontaneous ventilation.52
table continues on next page
A N E ST H E S I O LO GY N E WS • A P R I L 2 0 1 5
7
Table 2. Summary of Drug Doses Commonly Used During Anesthesia2,41 Drug
Dose
Comments
Succinylcholine
1-1.5 mg/kg (TBW), ≤150 mg total dose
As in MO patients, the amount of pseudocholinesterase and the extracellular fluid K; doses should be administered based on TBW. Postoperative myalgia seems to be more severe and problematic in obese patients53; pretreatment with low-dose nondepolarizing NMBAs or sodium channel blockers such as lidocaine is highly recommended in this population.54 It is a very useful and effective medication in the treatment of laryngospasm in obese patients.
Sufentanil
1-2 mcg/kg (LBW)
Sugammadexa
A final consensus on optimal sugammadex dosing in obese patients has not been reached. Different dosing scalar have been suggested: 2 mg/kg (IBW + 40%)55 and 2 mg/kg (CBW)50; however, TBW seems to be the most safe and effective dosage regimen for complete reversal from NMB with sugammadex in MO patients.56 Caution: A case report has shown that the use of sugammadex does not guarantee absence of the risk for recurarization.57 Train-of-four still must be checked before extubation.
Thiopental sodium
3-5 mg/kg (LBW)
Very similar to propofol pharmacokinetics.
Vecuronium
0.1-0.12 mg/kg (IBW)
No rapid onset dose, has longer duration of action when given based on TBW.
CBW = IBW + 0.4 × (TBW – IBW) IBW in male = 50 kg + 2.3 kg for each inch over 5 ft; in female = 45.5 kg + 2.3 kg for each inch over 5 ft. LBW in male = (1.10 x weight [kg]) – 128 × (weight2/[100 × height {m}]2); in female = (1.07 x weight [kg]) – 148 × (Weight2/(weight2/[100 × height {m}]2) MO: either BMI >40 kg/m2, or BMI >35 kg/m2 with associated comorbidities such as diabetes mellitus, hypertension, OHS, OSA, pulmonary arterial hypertension, and RV and LV failure. a
At press time, not approved by FDA for use in the United States.
in patients with MO.49 The same conclusion was found by Gaszynski et al.48 Also, sugammadex has better ability to prevent postoperative residual curarization in comparison with neostigmine. (Note that sugammadex is not approved by the FDA at press time.) Continuous quantitative monitoring of neuromuscular function (instead of an empirical approach) should be used to guide the intraoperative administration of NMBAs, and residual NMB should be excluded before extubation as it is an independent risk factor for postoperative respiratory complications.58 It is crucial to correctly use and interpret the neuromuscular monitoring equipment in these patients. For example, in patients with very high levels of adipose tissue at the wrist, the face is the recommended monitoring location. When wrist circumference is >18 cm, ulnar nerve supramaximal stimulation currents of >70 mA can be required, which monitoring devices may be unable to achieve.2 Patients should be extubated fully awake after confirming recovery from NMB by assuring that train-of-four ratio exceeds 90%. Extubation should be in the semi-sitting or ramped position to minimize the risk for aspiration and help ventilation. Among the volatile anesthetics, desflurane appears to be the best option, as it is the least lipophilic and
8
A N E ST H E S I O LO GY N E WS .CO M
least soluble available agent, and theoretically has limited distribution in the adipose tissue, suggesting faster emergence and recovery characteristics. However, clinical studies comparing it with sevoflurane yielded conflicting results in terms of emergence time.41 Although De Baerdemaeker et al did not find any difference between desflurane and sevoflurane use and time to recovery,59 McKay et al found desflurane to be faster.60 The duration of anesthesia exposure (ie, 2-4 hours) and the severity of BMI are factors that were found to determine the clinical significance of this difference. On the other hand, sevoflurane has a potential clinical effect on renal function,61 as it results in inorganic fluoride (compound A) that is nephrotoxic at concentrations >50 mmol/L.41 Kaur et al found similar hemodynamic effects from desflurane and sevoflurane, whereas the immediate and intermediate recovery was significantly faster with desflurane, allowing fast-tracking and early discharge of patients.62 Finally, because isoflurane is more lipophilic than sevoflurane and desflurane, it has fallen out of favor for use in obese patients.41 However, for procedures that last 2 to 4 hours, it shows similar recovery times in obese and nonobese patients when used at 0.6 minimal alveolar concentration.63 Overall, the choice of inhaled anesthetic is likely of limited relevance.
Ventilation and Oxygenation
Vascular Access and Fluid Management
Optimal ventilation and oxygenation helps prevent postoperative respiratory complications. The pulmonary changes associated with obese patients (Table 1) can put the patient at increased risk for ventilator-induced lung injury during general anesthesia. During general anesthesia, the FRC can fall below closing capacity of the lung, inducing a cyclic opening and closing of small airways during mechanical ventilation.5 FRC can fall after induction of anesthesia to ~50% of preanesthesia values.6 PEEP can be optimized based on the assessment of pressure-volume loops and titrated based on PaO2. Ultrasound has been successfully used to optimize PEEP in critical care, but has not yet been used in the intraoperative setting.64 EIT may be a promising clinical approach to lung function monitoring in patients with mechanical ventilation. EIT has been successfully used to assess lung recruitability and to titrate PEEP. Erlandsson et al found that EIT enables rapid assessment of lung volume changes in MO patients and optimization of PEEP.65 High PEEP (15 cm H2O) levels need to be used to maintain a normal FRC and to minimize shunt. Volume loading prevents circulatory depression despite a high PEEP level. Using EIT-based center-of-ventilation index in nonobese patients undergoing laparoscopic cholecystectomy, Karsten et al found that the use of initial recruitment maneuvers and a PEEP of 10 cm H2O preserved homogeneous regional ventilation during laparoscopic surgery in most, but not all, patients and improved oxygenation and respiratory compliance.66 As the lung does not increase with increasing BMI, the tidal volume should always be adjusted to IBW.8 It has been shown that obese patients are at greater risk for postoperative atelectasis than nonobese patients. Intraoperative alveolar recruitment with a vital capacity maneuver maintained for 7 to 8 seconds followed by PEEP 10 cm H2O was effective in preventing lung atelectasis and was associated with better oxygenation, shorter PACU stay, and fewer pulmonary complications in the postoperative period in obese patients undergoing laparoscopic bariatric surgery.67 A lung-protective strategy using low tidal volume (6-10 mL/kg IBW) and a pressure limit <30 cm H2O was suggested, with PEEP ranging between 10 and 15 cm H2O.5 Altering tidal volume and respiratory rate does not improve arterial oxygenation, whereas PEEP did.7 The best ventilation strategy is to optimize gas exchange and pulmonary mechanics and to reduce the risk for respiratory complications. A recent quantitative systematic review and meta-analysis found some evidence that recruitment maneuvers added to PEEP compared with PEEP alone improves intraoperative oxygenation and compliance without AEs. There is no evidence of any difference between pressure- or volumecontrolled ventilation in respiratory outcomes.68 The main focus on mechanical ventilation in obese patients is to “keep the lung open” during the entire respiratory cycle.6 Table 3 summarizes recommended strategies.
Placement of central venous catheters should be avoided as much as possible, as these patients may have concomitant CF and may decompensate if placed in the supine or head-down position to facilitate line insertion. Even in the absence of major cardiac issues, prolonged periods in those positions can cause respiratory decompensation, mainly in the awake patient. Central line placement in the sitting position carries a high risk for air embolism.2 Therefore, anesthesiologists should resist the temptation to embark on central line placement in these high-risk patients, when good peripheral lines can achieve the same result. Ultrasound-guided vascular access can be of great benefit for inserting central lines, if absolutely indicated, peripherally inserted central catheters and peripheral lines. It can help to identify the vessels, measure the depth, assess for anatomical variations, assess for the presence of thrombosis, and rule out complications.64 To avoid overload consequences and maintain good hydration and oxygenation, careful perioperative fluid management is crucial in MO patients. A conservative fluid approach seems best. Traditional parameters (ie,
Table 3. Recommended Ventilation Strategies Based on Available Evidence2,5,6,8,9 • Tidal volume of 6-10 mL/kg (IBW) with respiratory rate that maintains normocapnia (aim: pH 7.3-7.45). • Use of recruitment maneuvers (plateau pressure ~40-55 cm H2O) for 7-8 sec, as long as the patient is hemodynamically stable, after induction and before extubation, and whenever indicated. • Application of PEEP 10 cm H2O until extubation, always after recruitment maneuvers, and whenever possible considering cardiovascular status. Severely obese patients may require ≤15 cm H2O. • Use of reverse Trendelenburg position whenever possible, from the time of preoxygenation to extubation. • FiO2 between 0.4 and 0.8, even during the preextubation period, as higher levels may lead to formation of resorption atelectasis. • Avoid losing PEEP effect by suctioning the tube or by accidental disconnection of the circuit. • Use a ratio of the duration of inspiration to expiration of 1:1-1:3. • Monitor peak airway pressure and airway plateau pressure (≤30 cm H2O). • Extubation should be after ensuring adequate reversal of NMB, with the patient positioned almost upright or in reverse Trendelenburg, and fully awake.
A N E ST H E S I O LO GY N E WS • A P R I L 2 0 1 5
9
Table 4. Possible Complications In Obese Patients After Bariatric Surgery (in order of frequency)76-79
BP, central venous pressure, and urine output) are not accurate in predicting volume status in these patients. Indeed, in patients undergoing laparoscopic bariatric surgery, intraoperative urine output was found to be low regardless of the use of relatively high-volume fluid therapy, which suggests it is not a good measure to guide fluid therapy.28 Other functional parameters have been suggested (eg, stroke volume variation and PPV).69 Fluid therapy should always be administered based on patient IBW.70
Complication
Prevalence, %
Total wound infections
2.57-6a
AKI77
5.8
Urinary tract infection
3.9a
Peripheral nerve injury
0.4-4.6
Perioperative Pain Management
Venous thromboembolism79
0.9a-2.2
Systemic infections
1-1.6a
Ventilator dependence >48 h
0.32-1.8a
Pneumonia
0.5-1.5a
Wound disruption
0.15-1.4a
DVT79
1.3
Pulmonary embolism79
0.9
Cardiac arrest
0.08-0.5a
Myocardial infarction
0.02-0.5a
Stroke
0.02-0.2a
Acute renal failure
0.12
Rhabdomyolysis
Rare/unknown
Perioperative pain management in obese patients is a very important element in reducing the overall morbidity that may complicate surgery. As many obese patients have baseline pulmonary and airway issues (eg, OSA and OHS), an ideal analgesic regimen should not cause further respiratory depression and sedation, and should be robust in improving postoperative recovery (eg, respiratory function). Therefore, multimodal analgesia is a sound approach. According to the ASA Closed Claims database, 48% of respiratory AEs secondary to opioids occurred in obese or MO patients.71 This should make us cautious using opioids in obese patients and suggests considering further adjuvant pain management approaches like dexamethasone, lidocaine, and NSAIDs (Table 2). NSAIDs are not contraindicated in asthmatic patients, and use of drugs like diclofenac and ketorolac seem appropriate.1 Continuous peripheral nerve blocks, local anesthetic wound infiltration, or TAP block also are useful. If opioids are required, they should be used in a minimally effective dose. Ultrasound-guided TAP block after laparoscopic bariatric surgery has been found to be feasible and reduces opioid requirements, improves pain score, decreases sedation, promotes early ambulation, and results in greater patient satisfaction.72,73 If patientcontrolled analgesia with opioids is still to be used, fentanyl might be better than morphine, background infusions should be avoided, and the lockout period should be adjusted to minimize sedation and respiratory depression.2 Recently, Ziemann-Gimmel et al74 found that the use of opioid-free total IV anesthesia (with propofol, ketamine, and dexmedetomidine) was associated with a large reduction in relative risk for PONV compared with balanced anesthesia (volatile anesthetics and opioids).
a
Data from Bamgbade et al76 extracted from different types of operations that were not specified. Numbers from Turner et al78 were recalculated to represent the incidence among the whole study population (32,426 patients).
Table 5. Possible Peripheral Nerve Injuries in Obese Patients • Stretch injury to the brachial plexus and ulnar neuropathy among the most commonly reported.80 • Compression damage to the lateral femoral cutaneous nerve (meralgia paresthetica); patients usually develop pain, paresthesia, or hypersensitivity in the anterolateral aspect of the thigh.81 Lithotomy position and increased intraabdominal pressure from laparoscopic insufflation K risk. • Bilateral sciatic nerve palsy after bariatric surgery was reported in a patient with BMI 78 kg/m2 after prolonged laparoscopic surgery, despite adequate precautions.82 • Vagal nerve injury, especially in gastric banding surgery. Usually presents with nausea and vomiting secondary to decreased gastric motility.80 On the other hand, excessive vagal nerve stimulation that may be associated with an intragastric balloon overstretching the gastric wall may lead to bradyarrhythmia and cardiac arrest.83
10
A N E ST H E S I O LO GY N E WS .CO M
Postoperative Recovery and Care There are no clear guidelines as to where the immediate postoperative care of the obese patient should take place, whether in the PACU or the ICU. The decision rests largely on the judgment of the anesthesiologist and surgeon. To reduce postoperative pulmonary complications, different techniques have been used. The most useful are summarized here: y Frequent chest physiotherapy and use of incentive spirometry.
y Avoid placing the patient in the supine position; head-up position (30-45 degrees) improves respiratory mechanics (increases FRC). y Use of noninvasive CPAP as early as possible when the PaO2 to FiO2 ratio falls to <300.6 It has been found that Boussignac CPAP improved blood oxygenation compared with passive oxygenation with a nasal catheter but had no influence on CO2 elimination in non–CO2-retaining MO patients.75 There is insufficient literature to evaluate the effect of CPAP or noninvasive PPV on the postoperative respiratory status of patients with OSA. y Administer robust PONV and pain control with minimal sedation. Possible postoperative complications in obese patients are summarized in Table 4. Obese patients had a higher mortality rate than nonobese patients.76 AKI after bariatric surgery was reported as high as 5.8% (defined as a postoperative increase in serum creatinine by 0.3 mg/dL within 72 hours).77 Neurologic complications after bariatric surgery can be classified into immediate (mostly mechanical injury) or late (mostly secondary to malnutrition). They include the peripheral, central, and enteric nervous system.80 Possible peripheral nerves injuries in obese patients are summarized in Table 5. Rhabdomyolysis is a rare complication of bariatric surgery. Chakravartty et al performed a systematic review including 145 patients who developed rhabdomyolysis after bariatric surgery.84 Risk factors were male gender, elevated BMI (>50 kg/m2), prolonged operating time, and patient positioning (lithotomy or lateral decubitus). Rhabdomyolysis increases the risk for developing acute renal failure and mortality. Patients usually presented with severe postoperative pain involving areas of contact with the operating table, such as the gluteal, lumbar, and shoulder muscles, thus careful padding of these pressure points is important. If patients who received
epidural or regional analgesia report breakthrough pain, this should raise suspicion for the possibility of underlying rhabdomyolysis, and serum creatine kinase should be checked (>10,000 U/L if rhabdomyolysis is present). Furthermore, when postoperative epidural analgesia is used, it has been suggested that regular postoperative creatine kinase levels be checked to identify rhabdomyolysis early.84 Copious hydration and mannitol have been used successfully.85 However, liberal intraoperative fluids did not prevent rhabdomyolysis.86
Anesthesiology Training in the Morbidly Obese Patient: Present and Future There is no current fellowship in the United States in bariatric anesthesia, nor is a mandatory rotation for residents in dealing with MO patients required by the Accreditation Council for Graduate Medical Education.87 Leykin and Brodsky recently published a comprehensive and unique book about perioperative anesthesia management in obese surgical patients, and they highly support specific training.87 There is also a need for more guidelines and research in this area. A “road map” model toward establishing clinical practice guidelines for anesthesia in MO patients has been suggested.88 In conclusion, the marked increase in the obese population makes it almost certain anesthesiologists will be taking care of this population. Although historically, physicians have been afraid of doing surgery in superobese patients, advances in anesthetic medications, ventilator techniques, and other devices now permit safe anesthesia with better postoperative recovery in heavier patients. Anesthesiologists should be fully knowledgeable of the challenges these patients present and have the skills to attend to them, and they must be continually aware of ongoing research in bariatric surgery. Similarly, primary care providers, internists, and surgeons who operate on these patients should be aware of the considerable perioperative challenges.
Abbreviated References (full citations online) 1.
Bellamy MC, et al. Periop Med. 2013;2:12.
16. Schumann R, et al. ASA Annual Meeting. 2013: abstract BOC05.
2. Cullen A, et al. Can J Anaesth. 2012;59:974-996.
17. Glance LG, et al. Anesthesiology. 2010;113:859-872.
3. Terkawi AS, et al. Saudi J Anaesth. 2014;8(suppl 1):S101-S104.
18. Tang J, et al. Int J Nephrol. 2012;2012:608397.
4. Neligan PJ. Curr Opin Anaesthesiol. 2010;23:375-383.
19. Reinehr T. Mol Cell Endocrinol. 2010;316:165-171.
5. Huschak G, et al. Best Pract Res Clin Endocrinol Metab. 2013;27:247-260.
20. Brodsky JB, et al. Anesth Analg. 2002;94:732-736.
6. Pelosi P, et al. Best Pract Res Clin Anaesthesiol. 2010;24:211-225. 7. Donohoe CL, et al. J Clin Anesth. 2011;23:575-586. 8. Lewandowski K, et al. Best Pract Res Clin Anaesthesiol. 2011;25:95-108.
21. Kim WH, et al. Br J Anaesth. 2011;106:743-748. 22. Leoni A, et al. Minerva Anestesiol. 2014;80:149-157. 23. Lopez PP, et al. Am Surg. 2008;74:834-838. 24. Epstein LJ, et al. J Clin Sleep Med. 2009;5:263-276.
9. Schumann R. Int Anesthesiol Clin. 2013;51:41-51.
25. Chung F, et al. Anesthesiology. 2008;108:812-821.
10. Eichenberger A, et al. Anesth Analg. 2002; 95:1788-1792.
26. Chung F, et al. Obes Surg. 2013;23:2050-2057.
11. Sookoian S, et al. Obes Surg. 2013;23:1815-1825.
14. Farah CS, et al. Respirology. 2012;17:412-421.
27. Practice guidelines for the perioperative management of patients with obstructive sleep apnea: an updated report by the American Society of Anesthesiologists task force on perioperative management of patients with obstructive sleep apnea. Anesthesiology. 2014;120:268-286.
15. Poirier P, et al. Circulation. 2009;120:86-95.
28. O’Neill T, et al. Curr Anaesth Crit Care. 2010;21:16-23.
12. Mokhlesi B, et al. Obes Surg. 2013;23:1842-1851. 13. Kaw RK, et al. Sleep Med Clin. 2014;9:399-407.
A N E ST H E S I O LO GY N E WS • A P R I L 2 0 1 5
11
29. Dixon BJ, et al. Anesthesiology. 2005;102:1110-1115; discussion 5A.
60. McKay RE, et al. Br J Anaesth. 2010;104:175-182.
30. Herriger A, et al. Anaesthesia. 2004;59:243-247.
61. Gerchman F, et al. J Clin Endocrinol Metab. 2009;94:3781-3788.
31. Futier E, et al. Anesthesiology. 2011;114:1354-1363.
62. Kaur A, et al. J Anaesthesiol Clin Pharmacol. 2013;29:36-40.
32. Boyce JR, et al. Obes Surg. 2003;13:4-9.
63. Lemmens HJ, et al. Anesth Analg. 2008;107:1864-1870.
33. Cattano D, et al. Anesthesiology News Guide to Airway Management. 2011:37(8):17-23.
64. Terkawi AS, et al. ScientificWorldJournal. 2013;2013:683685.
34. Aceto P, et al. Surg Obes Relat Dis. 2013;9:809-815. 35. Dhonneur G, et al. Obes Surg. 2009; 19:1096-1101. 36. Hillman DR, et al. Br J Anaesth. 2003;91:31-39. 37. De Jarnett D. AANA J. 2013;81:282-284. 38. Moore AR, et al. Anaesthesia. 2012;67:232-235. 39. Freid EB. Anesthesiol Clin North America. 2005;23:551-564. 40. Neilipovitz DT, et al. Can J Anaesth. 2007;54:748-764. 41. Ingrande J, et al. Br J Anaesth. 2010;105 Suppl 1:i16-i23. 42. Barbour A, et al. Int J Antimicrob Agents. 2009;34:231-235. 43. Tufanogullari B, et al. Anesth Analg. 2008;106:1741-1748. 44. Bakhamees HS, et al. Middle East J Anesthesiol. 2007;19:537-551. 45. Komatsu R, et al. Anesth Analg. 2013;117:1329-1337. 46. Gaszynski TM, et al. Eur J Anaesthesiol. 2014;31:713-714. 47. Hasanein R, et al. Egypt J Anaesth. 2011;27:255-260. 48. De Oliveira GS Jr., et al. Obes Surg. 2014;24:212-218. 49. De Oliveira GS Jr, et al. Anesth Analg. 2012 Aug;115;2:262-7. 50. Gaszynski T, et al. Br J Anaesth. 2012;108:236-239. 51. Carron M, et al. Obes Surg. 2013;23:1558-1563. 52. Sorensen MK, et al. Br J Anaesth. 2012;108:682-689. 53. Tejirian T, et al. Obes Surg. 2009;19:534-536.
65. Erlandsson K, et al. Acta Anaesthesiol Scand. 2006;50:833-839. 66. Karsten J, et al. Acta Anaesthesiol Scand. 2011;55:878-886. 67. Talab HF, et al. Anesth Analg. 2009;109:1511-1516. 68. Aldenkortt M, et al. Br J Anaesth. 2012;109:493-502. 69. Jain AK, et al. Obes Surg. 2010;20:709-715. 70. Poso T, et al. Obes Surg. 2013;23:1799-1805. 71. Bird M. ASA Newsletter. 2007;71:7-9. 72. Sinha A, et al. Obes Surg. 2013;23:548-553. 73. Wassef M, et al. J Pain Res. 2013;6:837-841. 74. Ziemann-Gimmel P, et al. Br J Anaesth. 2014;112:906-911. 75. Gaszynski T, et al. Obes Surg. 2007;17:452-456. 76. Bamgbade OA, et al. World J Surg. 2007;31:556-560. 77. Weingarten TN, et al. Obes Surg. 2013;23:64-70. 78. Turner PL, et al. Obes Surg. 2011;21:655-662. 79. Stein PD, et al. Obes Surg. 2013;23:663-668. 80. Frantz DJ. Curr Gastroenterol Rep. 2012;14:367-372. 81. Macgregor AM, et al. Obes Surg. 1999;9:364-368. 82. Yasin A, et al. Obes Surg. 2007;17:983-985. 83. Cubattoli L, et al. Obes Surg. 2009;19:253-256. 84. Chakravartty S, et al. Obes Surg. 2013;23:1333-1340. 85. Ankichetty S, et al. Can J Anaesth. 2013;60:290-293.
54. Schreiber JU, et al. Obes Surg. 2010;20:134. Comment on: Tejirian T, et al. Obes Surg. 2009;19:534-536.
86. Wool DB, et al. Obes Surg. 2010;20:698-701.
55. Van Lancker P, et al. Anaesthesia. 2011;66:721-725.
87. Leykin Y, Brodsky JB, eds. Controversies in the Anesthetic Management of the Obese Surgical Patient. New York, NY: Springer; 2013.
56. Carron M, et al. Anaesthesia. 2012;67:298-299. 57. Le Corre F, et al. Can J Anaesth. 2011;58:944-947. 58. Murphy GS, et al. Anesth Analg. 2010;111:120-128. 59. De Baerdemaeker LE, et al. Obes Surg. 2006;16:728-733.
12
A N E ST H E S I O LO GY N E WS .CO M
88. Eldawlatly A, et al. Saudi J Anaesth. 2012;6:319-321. Corresponding author: Abdullah S. Terkawi, University of Virginia, Department of Anesthesiology. Charlottesville, Virginia 22903 â&#x20AC;&#x201C; USA. Email: asterkawi@gmail.com
April 2015 April 2015 Brought to You by
REPORT Managing Venous Thromboembolism Risk in Hereditary Antithrombin DeďŹ ciency ďŹ Introduction
fatal complication, many may Faculty be at increased risk for longHereditary antithrombin defiMichael Cordisco, MS, CCP term sequelae, such as pulmociency (HAD) magnifies the risk nary hypertension or venous for venous thromboembolism Chief of Perfusion insufficiency. From 10% to 30% (VTE) in affected patients.1 Its Stamford Hospital may die within a month of diagdisproportionate contribution to Stamford, Connecticut nosis.4,6 Inherited thrombophilVTE, a potentially life-threaten1,2 Medical Writer ing event, supports the value ias are detected in a small but clinically significant proportion of screening in individuals with Theodore Bosworth of patients with VTE, particurisk factors. The estimated lifeMcMahon Publishing larly those with a prior histotime risk for VTE in patients with ry of thrombosis.7,8 A diagnosis HAD ranges from 50% to 85%,3 before or early within the period of risk offers an oppor opporbut many of these individuals, particularly those with mild tunity to modify risk with anticoagulant therapies. forms, may never receive a diagnosis.1 The risk for VTE In the general population, the incidence of HAD is variin patients with HAD can be readily modified with antiably estimated at up to 0.2%.9 Of inherited thrombothrombin replacement during high-risk situations along 1 with other strategies to reduce hypercoagulability. Thus, philias involving defects in endogenous suppression of coagulation factors, which includes deficiencies in proa systematic approach toward evaluating patients for teins S and C, HAD is among the least common and HAD and initiating VTE prophylaxis in patients with HAD most severe.9 Although deficiencies in proteins S and C is potentially beneficial for this population. each increase the thrombotic risk by about 10-fold, HAD Background increases the risk 20-fold (Figure 1).8,9 HAD is less common than many of the inherited thrombophilias assoVTE is defined as deep vein thrombosis (DVT), pulciated with increased levels or function of coagulation monary embolism (PE), or both.4 In the United States, factors, such as factor V Leiden, factors Leiden hyperhomocysteinemia hyperhomocysteinemia, approximately 550,000 550 000 cases of VTE are diagnosed 5 and elevated factor VIII, but its effect on VTE risk is 4- to each year. Of the patients who develop this possibly
Editorial support provided by
Supported by
REPORT 6-fold higher.9 Overall, inherited thrombophilias may play a role in the pathogenesis of approximately 40% of provoked and unprovoked VTE episodes.7 As an endogenous anticoagulant, antithrombin binds to thrombin to prevent its activation, a critical step in the coagulation cascade, while also exerting inhibitory effects on coagulating factors Xa, IXa, XIa, XIIa, and plasmin.9-11 More than 250 genetic mutations have been associated with HAD that fall under 2 major subtypes.10 Type 1 is characterized by a quantitative deficit in functionally active antithrombin. Deficiency is variably defined as 70% to 80% of normal circulating levels.10,12 Type 2, which is more common in the general population,11 is characterized by normal levels of antithrombin but impaired binding activity. Further subdivision of type 2 can be made according to specific protein-binding defects,13 but screening for HAD is based on functional assays that detect deficiency in antithrombin activity regardless of type or subtype.1 Essentially, all patients with HAD have a heterozygous form because homozygous inheritance typically leads to death in utero.11 The risk for VTE in patients with HAD is low in individuals younger than age 20, increasing progressively with older age.14 The degree of impaired antithrombin activity in patients with either type 1 or 2 HAD varies.13 Importantly, even mild deficiency in antithrombin has been shown to increase the risk for VTE.12 In the hospital setting, the risk for VTE can be substantially increased in patients with HAD; the rates of VTE among patients undergoing cardiac, gynecologic, oncologic, or other surgical procedures associated with high VTE risk climb from
Number of Times Relative to General Population
20
less than 5% in patients without HAD15 to approximately 20% in those with the disorder.16 In pregnant women with HAD, the incidence of VTE also has been shown to be greater than 50%.3 Although VTE can occur outside of the hospital and in the absence of other risk factors,17 the first clinical manifestations of HAD often are triggered by surgery or prolonged immobility during hospitalization.11 For this reason, idiopathic VTE in otherwise low-risk hospitalized patients may prompt evaluation for HAD or another inherited thrombophilia. Prior history of VTE provides another consideration for thrombophilia evaluation.7
Diagnosis The diagnosis of HAD involves gathering information including patient and family history and repeated screening assays.1 Kenichi Tanaka, MD, MSc, anesthesiologist and professor at the University of Maryland School of Medicine, noted that without preadmission diagnosis, it can be difficult to differentiate HAD from acquired deficiency in the acute setting. “Medical history is of prime importance here. You can talk to the patient and figure out if there’s any personal or family history of thrombophilia,” Dr. Tanaka said. “Look at recent medical history to determine if the patient had any thrombotic events particularly within 3 months of any type of surgery or if the patient had experienced any complication during or after pregnancy. You really have to know if these patients are at risk for antithrombin deficiency.” Dr. Tanaka added that clinicians should pay attention to all patient factors that may reduce antithrombin levels, particularly when an initial HAD diagnosis cannot be made in the
20
15
10
10
10
5
5
5 3
3
Prothrombin gene mutation
Hyperhomocysteinemia
0 HAD
Protein C deficiency
Protein S deficiency
Factor V Leiden
Elevated factor VIII levels
Coagulation Disorder Figure 1. HAD presents the highest risk for thrombosis among inherited thrombophilias. Patients heterozygous for factor V Leiden have approximately a 5-fold greater risk for venous thrombosis, whereas homozygotes have approximately an 80-fold greater risk. Thrombate III (antithrombin III [human]) is not indicated for the treatment of thrombophilias other than HAD. HAD, hereditary antithrombin deficiency Adapted from reference 9.
In clinical studies of Thrombate III, the most common adverse events were dizziness, chest discomfort, nausea, and dysgeusia.
2
REPORT acute setting. Dr. Tanaka noted that antithrombin levels might be reduced in patients with ongoing major organ infection, disseminated intravascular coagulation (DIC), or sepsis. “Then, I also pay attention to the production of antithrombin. Antithrombin is made in the liver so if the patient has cirrhosis or any end-stage liver dysfunction, that’s an important sign that antithrombin might be low.” Right-side heart failure causing liver congestion as well as heparin exposure for more than 3 to 4 days can reduce antithrombin levels. Overall, testing antithrombin levels can help explain the response to anticoagulation used during surgery, such as heparin, which depends on antithrombin as a cofactor. Thrombophilia screening often is not recommended in an unselected population due to the low prevalence of these disorders. However, thrombophilia evaluation in patients with risk factors, such as personal or family history of VTE,7 and who are facing situations associated with high thrombotic risk, including surgery, pregnancy, trauma, or extended immobilization, may offer an opportunity for significant risk reduction.18 Of the functional tests available for antithrombin activity, the factor Xa inhibition assay is generally preferred over a thrombin inhibition assay because it avoids the confounding effects of heparin cofactor II activity, which may mask HAD.11 When screening is performed, clinicians also should be mindful of other clinical variables and interpret results accordingly. For example, at the time that the blood sample is taken, if patients are receiving anticoagulants, such as heparin or the direct Xa inhibitors, results could be affected by these medications.3 When ordering an antithrombin functional assay, a hematologist consult may be appropriate for considering the result in the context of other clinical factors. Antigenic assays should be reserved for defining HAD type after the initial diagnosis as these would be expected to miss type 2 HAD, which is the more common form.11 Although a functional antithrombin level in the normal range rules out HAD, a single abnormal test does not confirm HAD.11 Once antithrombin deficiency has been confirmed by repeated tests, the opportunity arises to educate patients about its relationship to VTE and the risk it imposes for thrombosis over the lifetime. Testing of family members also may be appropriate.11 Genetic testing also may be useful as the mechanisms for specific antithrombin deficiency can be further investigated by geneticists; however, such testing usually is not performed.1,11
Management Clotting disorders require a comprehensive approach to balance prevention of VTE against risk for bleeding events.12 Anticoagulants already are broadly applied in hospitalized patients at risk for VTE.7 HAD management should be considered within this context. In HAD, replacement of antithrombin in high-risk situations offers the most direct approach to managing the underlying disorder,1 but other steps to modify risk also should be considered. Steps to correct disorders with the potential to contribute to VTE risk, such as malnutrition or anemia,4 should not be overlooked. Discontinuing or reducing exposure to procoagulant therapies, such as oral contraceptives,4 also may be appropriate. Confirming HAD patients are on optimal doses of anticoagulants as indicated is also an important step to consider independent of antithrombin replacement.
Several exogenous therapies are available to increase antithrombin activity. These are the human plasma-derived antithrombin, marketed as Thrombate III® (antithrombin III [human]) (Grifols; Research Triangle Park, NC); the non-human recombinant antithrombin derived from goat’s milk, marketed as ATryn® (antithrombin [recombinant]) (rEVO Biologics; Framingham, MA); and fresh frozen plasma (FFP; Table).19-22 FFP was once the only available source for antithrombin replacement.23 As mentioned above, concentrated antithrombin replacement options are now available. The much lower concentration of antithrombin in FFP compared with antithrombin concentrate necessitates administration of high volumes of FFP to normalize antithrombin in a patient with HAD. Thrombate III is antithrombin concentrate derived from human plasma. It has a half-life (3.8 days) consistent with endogenous antithrombin. Because it is derived from plasma, there is a theoretical risk for transmission of infectious disease including the Creutzfeldt-Jakob disease (CJD) agent, despite steps in the manufacturing process designed to reduce this risk. However, no cases of viral disease or CJD transmission have ever been reported.19 It is indicated for the treatment of HAD in connection with surgical or obstetric procedures or when HAD patients develop a thromboembolism. In clinical studies with Thrombate III, the most common side effects were dizziness, chest discomfort, nausea, and dysgeusia.19 Thrombate III is administered in a bolus intravenous infusion (not continuous infusion) and is dosed according to patient weight to achieve antithrombin function levels between 80% and 120% of normal activity. Maintenance doses equal to 60% of the loading dose are administered as infrequently as once daily, but the interval should be assessed based on the antithrombin level achieved. Thrombate III is stored at room temperature and is readily reconstituted with sterile water.19 The non-human antithrombin concentrate ATryn (antithrombin [recombinant]), which is indicated for the prevention of perioperative and peripartum VTE but not the treatment of VTE in patients with HAD, is produced from the milk of genetically modified goats.20 The most common adverse reactions reported in clinical trials were hemorrhage and infusion site reaction. ATryn has a half-life of approximately 12 to 18 hours and is administered as a loading dose based on patient weight followed by a continuous infusion.20 ATryn requires refrigerated storage and must be brought to room temperature no more than 3 hours prior to reconstitution. ATryn is contraindicated in patients with known hypersensitivity to goat proteins.20 The difference in half-life between the plasma-derived and recombinant antithrombin formulations and the resulting difference in dosing volume and administration requirements are important clinical considerations. The products should not be considered as interchangeable. Protocols for dosing and administration must be tailored to the specific antithrombin concentrate being used. Additionally, Thrombate III is stored at room temperature19 ; therefore, there is no waiting time to bring it up to room temperature if a higher dose is needed beyond what was initially anticipated for a case.
Surgery In HAD patients scheduled for surgery, different paths are defined by the use of systemic anticoagulation with heparin. Antithrombin is essential for anticoagulation with heparin
Please see Important Safety Information on page 6 and refer to accompanying full Prescribing Information for complete prescribing details.
3
REPORT as heparin’s mechanism of action is to bind to and catalyze the effects of antithrombin by 1,000-fold.24,25 Therefore, doses of both heparin and antithrombin must be adjusted to accommodate this effect. Intraoperative monitoring of coagulation factors, such as prothrombin time and partial thromboplastin time, international normalized ratio, and activated clotting time are appropriate. Measurement of antithrombin also is advisable, recognizing that a baseline level in anticipation of surgery may differ from the level at the time of the procedure. The degree of functional antithrombin deficiency before surgery should influence the decision of how much antithrombin concentrate to have available over the period of prophylaxis, but dosing is variable and antithrombin levels may fluctuate over the duration of a case requiring antithrombin replacement. Tengborn and colleagues reported a thrombotic complication rate of 17% in patients with HAD who underwent surgery without any supplemental antithrombin and 22% in those treated with other methods (Figure 2).16 In patients not receiving systemic anticoagulation or those receiving lowdose heparin typical during percutaneous catheterizations,26 greater attention may be applied to repletion of antithrombin to restore normal functional activity. However, management of these patients must be individualized due to variables such as the use of antifibrinolytics, which preserve clots by slowing their breakdown.27
In all patients undergoing surgery, the type and duration of anesthesia is another variable associated with risk for VTE.6 This risk is increased in patients with HAD due to the higher incidence of VTE in this population.1 Steps such as positioning of the body to improve blood flow should be employed to mitigate this risk. A diagnosis of HAD also should intensify attention to blood monitoring during surgical procedures. The goal of close monitoring is not only to reduce clotting risk but also to avoid bleeding events. If a bleeding event occurs, the focus should be to reverse the activity of heparin. “We can neutralize heparin with protamine sulfate28 but adjusting the dose of protamine can be a complex process if the clinician has given a large amount of heparin during surgery,” Dr. Tanaka added.
Immobilized Patients In HAD patients with VTE risk defined by prolonged immobilization, variables that should influence the dose and duration of antithrombin therapy, or whether to initiate antithrombin therapy, include the degree of functional deficiency, the types of other therapies being employed to prevent clot formation, and the frequency and types of blood monitoring. More conservative approaches may be most appropriate for individuals at high risk for bleeding, but sustained antithrombin therapy should be considered in patients with severe forms of HAD with multiple risk factors for VTE and a prolonged period of risk.29
Table. Properties of Thrombate III® (Antithrombin III [Human]), ATryn® (Antithrombin [Recombinant]), and Fresh Frozen Plasma Thrombate III
ATryn
Fresh Frozen Plasma
Source
Human plasma
Milk from transgenic goats
Whole blood or pooled human plasma
How supplied
500 IU vials
525 IU or 1,750 IU vials
250 mL bags
Antithrombin concentration
50 IU/mL a
164 IU/mL or 175 IU/mLb
~1 IU/mLc
Antithrombin dose for example patient: 80 kg, 60% baseline antithrombin activity level, treated for 24 hd
3,429 IUd
8,921 IUd
3,429 IUd
Volume needed for example patient
69 mL administered 54 mL administered via bolus infusion over via continuous infu10-20 min sion over 24 h
3,429 mL administered via continuous infusion over 24 h to achieve equivalent dose
a
After reconstitution with 10 mL sterile water for injection.
b
After reconstitution with 3.2 mL (525 IU vial) or 10 mL (1,750 IU vial) sterile water for injection.
c
Fresh frozen plasma will contain approximately 1 IU/mL of antithrombin.
d
Total dose in 24 h based on an 80 kg surgical patient with 60% baseline antithrombin activity. See complete Prescribing Information for Thrombate III and ATryn for full dosing guidance.
Thrombate III (antithrombin III [human]) is indicated for the treatment of patients with hereditary antithrombin deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism. Adapted from references 19-22.
4
The anticoagulant effect of heparin is enhanced by Thrombate III. Reduced dosage of heparin is recommended during treatment with Thrombate III to avoid bleeding.
REPORT Conclusion
For VTE management in pregnant women with HAD, postpartum prophylaxis is recommended by the American College of Chest Physicians even among those without a previous VTE, but with a positive family history, because of the high rate of events.30 For all women, including those with HAD who have had a previous VTE, heparin is further recommended by the College during the postpartum period, when the risk for VTE also remains elevated. Additional strategies for VTE prophylaxis during the postpartum period, such as the use of compression stockings, may be appropriate in severe cases of HAD.30 The inclusion of antithrombin replacement therapy provides an important opportunity to act directly on the source of elevated VTE risk in patients with HAD. More than 40% of VTE in patients with HAD occurs during defined periods of high risk.17 Although it is important to individualize therapy in the context of the complex and interrelated factors that contribute to VTE risk, antithrombin concentrate can be used in community as well as tertiary health care centers when coagulation activity is appropriately monitored.
VTE is a serious but largely preventable complication of surgery or hospitalization. Individuals with HAD, which poses the greatest risk for VTE among inherited defects in control of the coagulation cascade, are overrepresented in cases of VTE.1,2 Screening for HAD in patients with a prior history of VTE offers an opportunity to identify this disorder in advance of the period of risk. Appropriate application of strategies to lower VTE risk in these patients, including antithrombin replacement, would be expected to favorably affect overall VTE rates and isolate patient groups who could benefit from lifetime risk management.
Long-Term VTE Risk Prevention In patients with HAD, the use of antithrombin replacement therapy typically is confined to periods of acute risk, such as during perioperative or peripartum periods. Longer periods of treatment may be appropriate in nonambulatory hospitalized HAD patients when VTE risk remains elevated. Other situations associated with high risk for VTE, such as the presence of an in-dwelling catheter, also may warrant extended periods of antithrombin therapy, particularly in patients with significant impairment of antithrombin function due to HAD. After the period of acute risk, it is unclear whether patients with HAD require any change in the type or duration of anticoagulants other than antithrombin, such as vitamin K antagonists or low-molecular-weight heparin, relative to those without HAD. Referral to a hematologist for extended follow-up may be appropriate not only for guidance in the post-discharge period but for counseling in regard to modifying and avoiding the lifetime risk for thrombotic events. Despite the potential for screening and risk modification to reduce the risk for VTE in patients with HAD, published guidelines regarding the acute or long-term management of this or other inherited thrombophilias remain limited. In a review of guidelines that addressed clinical strategies for reducing VTE recurrence, some guidelines advocated specifically for tests to determine the cause of VTE, whereas others did not address this question at all.31 One remaining guideline called for testing to be limited to patients who also have a strong family history of recurrent unprovoked VTE.32 One explanation is that the limited number of prospective studies conducted in patients with HAD are an obstacle to evidence-based guidelines. However, the established risk for recurrent VTE in patients with HAD, as well as other inherited thrombophilias, supports proactive efforts to identify populations suitable for prophylaxis.
Prophylaxis Before Surgery
Pregnancy
Antithrombin concentratea,b 0 n=10
No treatment n=29
17.2%
Other treatmentsc n=18
22.2%
0
5
10
15
20
25
Incidence of Thrombotic Complications, %
Figure 2. Antithrombin replacementa helps prevent thromboembolism during surgery in patients with HAD. No patient administered antithrombin concentrate alone or in combination with other methods had signs of thromboembolism. Retrospective study of 57 surgical cases.d a
Not Thrombate III (antithrombin III [human]); plasmaderived antithrombin concentrate used was studied but not marketed.
b
Also combined with other types of prophylaxis.
c
Dextran, low-dose heparin, peroral anticoagulants, and combinations.
d
Twenty-three patients underwent 57 operations of various types. Fourteen of the 23 patients had previous deep vein thromboses. In 29 procedures, patients were not given thromboprophylaxis. In 28 procedures, thromboprophylaxis was used.
HAD, hereditary antithrombin deficiency Adapted from reference 16.
Because Thrombate III is made from human plasma, it may carry a risk of transmitting infectious agents, eg, viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral diseases or CJD have ever been identified for Thrombate III. Please see Important Safety Information on page 6 and refer to accompanying full Prescribing Information for complete prescribing details.
5
REPORT
Case Study Managing Hereditary Antithrombin Deficiency in a Patient Undergoing Cardiac Surgery With Cardiopulmonary Bypass Introduction Outside of a known familial trait for antithrombin deficiency, thrombotic events often are the first indication that a patient may have hereditary antithrombin deficiency (HAD) and can provide clinicians an opportunity to evaluate the underlying cause of thrombosis. The following case report will discuss how the cardiac surgical team evaluated periprocedural risks, anticoagulation technique, and the conduct of cardio-pulmonary bypass (CPB) of a patient after a diagnosis of HAD.
Case Presentation A 44-year-old man was diagnosed with pulmonary embolism (PE) after several days of shortness of breath that he described as more severe than usual. The patient related a family history consistent with a genetic thromboembolic disorder and was found to have HAD based on a functional antithrombin assay result of less than 45%. The acquired form of antithrombin deficiency was ruled out after a thorough history of present illness and lack of recent heparin administration, enteric protein loss, or bleeding history. Additionally, the patient was found to have atrial fibrillation and moderate to severe mitral valve insufficiency discovered during a transesophageal echocardiogram. The patient underwent thrombolytic therapy for the PE and was subsequently referred to and followed by both a hematologist and a cardiologist who recommended elective mitral valve repair (MVR). In preparation for the MVR, the cardiac surgical team identified 3 specific risks that are unique to the patient with HAD who would need to be heparinized in order to be placed on CPB: 1) the inability to adequately and safely heparinize for CPB, 2) postprocedural bleeding due to consumptive coagulopathy from inadequate anticoagulation with heparin, and 3) the risk for thrombotic complication relative to patient positioning while under general anesthesia. To address these risks, presurgical supplemental antithrombin was administered via a commercially available preparation of Thrombate III (antithrombin III [human]) (Grifols; Research Triangle Park, NC). Thrombate III is an FDA-approved, human
plasma–derived therapy for the treatment of HAD.19 In clinical studies with Thrombate III, the most common side effects were dizziness, chest discomfort, nausea, and dysgeusia. Because Thrombate III is made from human plasma, it may carry a risk for transmitting infectious agents, such as viruses or, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of virus or CJD transmission have ever been identified.1 The loading dose of Thrombate III for this patient was calculated based on the patient’s weight and baseline antithrombin level, using the equation presented in Figure 3.19 After invasive monitoring line placement, the patient received approximately 500 additional units of reconstituted Thrombate III over several minutes in the operating room. After the median sternotomy, the patient was administered 3 mg/kg of bovine heparin before cannulation for CPB, which facilitated a safe activated clotting time (ACT) for CPB of more than 450 seconds using the Medtronic Heparin Management System (Medtronic, Minneapolis, MN). The CPB circuit consisted of a Terumo (Terumo, Ann Arbor, MI) custom tubing pack and Capiox SX-18 oxygenator with “X-Coating,” a poly2-methoxyethyl acrylate (PMEA) surface modification. Normothermic CPB, surface-modified circuitry, and Thrombate III were all part of the CPB strategy and were intended to reduce the likelihood of activation of the coagulation cascade and minimize the patient’s risk for bleeding. The surgical repair of the patient’s mitral valve was uneventful and he was weaned from normothermic CPB, transferred to the ICU, and extubated. He did not require a subsequent dose of Thrombate III and was not transfused with allogeneic blood during his surgical course.
Discussion CPB necessitates the total suspension of the coagulation cascade and normal hemostatic mechanisms with systemic unfractionated heparin as the CPB circuit and cardiac surgery will activate the common pathway of the coagulation cascade. Antithrombin deficiency, whether hereditary or acquired, makes anticoagulation with heparin difficult.
Important Safety Information Thrombate III® (antithrombin III [human]) is indicated for the treatment of patients with hereditary antithrombin deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism. In clinical studies, the most common adverse events were dizziness, chest discomfort, nausea, and dysgeusia. The anticoagulant effect of heparin is enhanced by concurrent treatment with Thrombate III in patients with hereditary
6
AT-III deficiency. Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during treatment with Thrombate III. Thrombate III is made from human plasma. Plasma products carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed to reduce this risk. No cases of transmission of viral disease or CJD have ever been identified for Thrombate III.
REPORT
Units required (IU) = [desired – baseline AT activity level] × weight (kg) 1.4 Figure 3. Dosing formula for Thrombate III (antithrombin III [human]). AT, antithrombin Based on reference 19.
It remains unclear whether or not the inability to achieve an “adequate” ACT for CPB in antithrombin-deficient patients represents a true inability to anticoagulate versus current point-of-care testing limitations. For this reason, it has been reported that anticoagulation in antithrombin-deficient patients often necessitates extreme and potentially unsafe doses of unfractionated heparin.33 This is potentially due to the inability to form heparin–ATIII complexes that are necessary to inhibit factors Xa and IIa.34 Thrombate III (antithrombin III [human]) allows for replacement of antithrombin and may avoid the potential overdosing of heparin. General anesthesia by its very nature and intent will increase the risk for thrombotic complication relative to patient positioning through stasis of blood and immobility for long periods of time. This increases the risk for thrombosis in a patient with HAD greater than that of the general population. Our concern for thromboembolism was during the post-anesthetic induction period of the operation: before anticoagulation with heparin and after reversal with protamine. The weight-based
replacement dose of Thrombate III was calculated for supplemental repletion of antithrombin and was given to reduce the risk for thrombosis. Activation of the coagulation cascade and the subsequent stimulation of labile coagulation factors will cause the consumption of those factors regardless of whether or not a fibrin clot is formed. The resultant effect is coagulopathic bleeding via depletion of coagulation factors through their consumption. This degree of coagulation factor depletion is particularly dangerous in the post-cardiac surgical setting.35
Conclusion A deficiency of antithrombin naturally occurring in the plasma whether hereditary or acquired can complicate a surgical procedure increasing risk to the patient and costs to the facility. A complete assessment of risks and development of a multimodal surgical and pharmacologic strategy for the treatment of patients with HAD can help to attenuate the increased risks associated with surgery in these patients.
References 1.
Rodgers GM. Role of antithrombin concentrate in treatment of hereditary antithrombin deficiency. An update. Thromb Haemost. 2009;101(5):806-812.
10. Crowther MA, Kelton JG. Congenital thrombophilic states associated with venous thrombosis: a qualitative overview and proposed classification system. Ann Intern Med. 2003;138(2):128-134.
2.
Yilmaz S, Gunaydin S. Inherited risk factors in low-risk venous thromboembolism in patients under 45 years. Interact Cardiovasc Thorac Surg. 2015;20(1):21-23.
11. Patnaik MM, Moll S. Inherited antithrombin deficiency: a review. Haemophilia. 2008;14(6):1229-1239.
3.
Maclean PS, Tait RC. Hereditary and acquired antithrombin deficiency: epidemiology, pathogenesis and treatment options. Drugs. 2007;67(10):1429-1440.
4.
Beckman MG, Hooper WC, Critchley SE, et al. Venous thromboembolism: a public health concern. Am J Prev Med. 2010;38 (4 suppl):S495-S501.
5.
Centers for Disease Control and Prevention (CDC). Venous thromboembolism in adult hospitalizations - United States, 2007-2009. MMWR Morb Mortal Wkly Rep. 2012;61(22):401-404.
6.
Heit JA, Silverstein MD, Mohr DN, et al. Predictors of survival after deep vein thrombosis and pulmonary embolism: a populationbased, cohort study. Arch Intern Med. 1999;159(5):445-453.
7.
Coppola A, Tufano A, Cerbone AM, et al. Inherited thrombophilia: implications for prevention and treatment of venous thromboembolism. Semin Thromb Hemost. 2009;35(7):683-694.
8.
Rosendaal FR. Risk factors for venous thrombotic disease. Thromb Haemost. 1999;82(2):610-619.
9.
Franchini M, Veneri D, Salvagno GL, et al. Inherited thrombophilia. Crit Rev Clin Lab Sci. 2006;43(3):249-290.
12. Di Minno MN, Dentali F, Lupoli R, et al. Mild antithrombin deficiency and risk of recurrent venous thromboembolism: a prospective cohort study. Circulation. 2014;129(4):497-503. 13. Picard V, Nowak-Gottl U, Biron-Andreani C, et al. Molecular bases of antithrombin deficiency: twenty-two novel mutations in the antithrombin gene. Hum Mutat. 2006;27(6):600. 14. Bucciarelli P, Rosendaal FR, Tripodi A, et al. Risk of venous thromboembolism and clinical manifestations in carriers of antithrombin, protein C, protein S deficiency, or activated protein C resistance: a multicenter collaborative family study. Arterioscler Thromb Vasc Biol. 1999;19(4):1026-1033. 15. White RH, Zhou H, Romano PS. Incidence of symptomatic venous thromboembolism after different elective or urgent surgical procedures. Thromb Haemost. 2003;90(3):446-455. 16. Tengborn L, Bergqvist D. Surgery in patients with congenital antithrombin III deficiency. Acta Chir Scand. 1988;154(3):179-183. 17. Vossen CY, Conard J, Fontcuberta J, et al. Risk of a first venous thrombotic event in carriers of a familial thrombophilic defect. The European Prospective Cohort on Thrombophilia (EPCOT). J Thromb Haemost. 2005;3(3):459-464.
Please see Important Safety Information on page 6 and refer to accompanying full Prescribing Information for complete prescribing details.
7
REPORT 18. Mannucci PM. Genetic hypercoagulability: prevention suggests testing family members. Blood. 2001;98(1):21-22. 19. Thrombate III antithrombin III (human) [package insert]. Research Triangle Park, NC: Grifols. 20. ATryn, antithrombin (recombinant) lyophilized powder for reconstitution [package insert]. Framingham, MA: rEVO Biologics, Inc.; 2013. 21. Food and Drug Administration. Circular of information for the use of human blood and blood components. April 2014. www.fda.gov/ downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM364593.pdf. Accessed February 20, 2015. 22. Scott E, Puca K, Heraly J, et al. Evaluation and comparison of coagulation factor activity in fresh-frozen plasma and 24-hour plasma at thaw and after 120 hours of 1 to 6°C storage. Transfusion. 2009;49(8):1584-1591. 23. Bharadwaj J, Jayaraman C, Shrivastava R. Heparin resistance. Lab Hematol. 2003;9(3):125-131. 24. Kottke-Marchant K, Duncan A. Antithrombin deficiency: issues in laboratory diagnosis. Arch Pathol Lab Med. 2002;126(11): 1326-1336. 25. Chuang YJ, Swanson R, Raja SM, et al. Heparin enhances the specificity of antithrombin for thrombin and factor Xa independent of the reactive center loop sequence. Evidence for an exosite determinant of factor Xa specificity in heparin-activated antithrombin. J Biol Chem. 2001;276(18):14961-14971. 26. Rao SV, Ohman EM. Anticoagulant therapy for percutaneous coronary intervention. Circ Cardiovasc Interv. 2010;3(1):80-88. 27. Ortmann E, Besser MW, Klein AA. Antifibrinolytic agents in current anaesthetic practice. Br J Anaesth. 2013;111(4):549-563.
28. Ni Ainle F, Preston RJ, Jenkins PV, et al. Protamine sulfate downregulates thrombin generation by inhibiting factor V activation. Blood. 2009;114(8):1658-1665. 29. Simioni P, Sanson BJ, Prandoni P, et al. Incidence of venous thromboembolism in families with inherited thrombophilia. Thromb Haemost. 1999;81(2):198-202. 30. Bates SM, Greer IA, Middeldorp S, et al; American College of Chest Physicians. VTE, thrombophilia, antithrombotic therapy, and pregnancy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 suppl):e691S-e736S. 31. De Stefano V, Rossi E. Testing for inherited thrombophilia and consequences for antithrombotic prophylaxis in patients with venous thromboembolism and their relatives. A review of the Guidelines from Scientific Societies and Working Groups. Thromb Haemost. 2013;110(4):697-705. 32. Baglin T, Gray E, Greaves M, et al; British Committee for Standards in Haematology. Clinical guidelines for testing for heritable thrombophilia. Br J Haematol. 2010;149(2):209-220. 33. Finley A, Greenberg C. Review article: heparin sensitivity and resistance: management during cardiopulmonary bypass. Anesth Analg. 2013;116(6):1210-1222. 34. Li W, Johnson DJ, Esmon CT, et al. Structure of the antithrombin-thrombin-heparin ternary complex reveals the antithrombotic mechanism of heparin. Nat Struct Mol Biol. 2004;11(9):857-862. 35. Horvath KA, Acker MA, Chang H, et al. Blood transfusion and infection after cardiac surgery. Ann Thorac Surg. 2013;95(6): 2194-2201.
Editorial support for this piece was provided by McMahon Publishing. Disclosures: Mr. Cordisco reported no relevant financial conflicts of interest.
Copyright Š 2015, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form. US/TH/0215/0002
8
SR147
Disclaimer: This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, Grifols, and the authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature.