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Optimism on OIC After FDA Panel Rejects Call For More Cardiac Data

VTE May Be Misleading Quality Measure Hospitals face penalties for greater vigilance

MI ‘signal’ seen with one drug, but not others

key measure used by the Centers for Medicare & Medicaid Services (CMS) to assess a hospital’s quality performance may not reflect quality at all, according to a new report. Instead, a hospital’s rate of venous thromboembolism (VTE) events directly reflects how frequently the hospital conducts imaging tests to diagnose the condition. In other words, the more a hospital looks for VTEs, the more of them it finds. “Hospitals may be unfairly deemed a poor performer for the outcome VTE measure if they have increased vigilance for VTE by performing more VTE imaging studies,” said

xperts said they hoped a recent FDA advisory panel recommendation against requiring randomized controlled cardiovascular outcomes trials for new drugs to treat constipation associated with use of opioids would unblock the field for more such medications. Opioid-inducedd constipation (OIC) “is a real problem,” said Eugene Viscusi, MD, professor of anesthesiology and director of acute pain management at Thomas Jefferson University, in Philadelphia. Additional drugs in development “are at a critical point that if the FDA required see OIC page 42

see VTE page 46

Does Anesthesia Need Its Own NTSB? San Francisco—When disaster strikes the aviation industry, the National Transportation Safety Board (NTSB)—an independent federal agency—is there to investigate the accident and disseminate subsequent recommendations. Is there room for such an agency in health care? A group of experts discussed the issue during a special symposium at the American Society of Anesthesiologists 2013 annual meeting, concluding that although such an organization would undoubtedly benefit patient care in the long run, logistical issues

make its inception challenging, if not impossible. Although there seems to be little appetite for the creation of another arm of bureaucracy in health care, improvements in the airline industry’s safety record have been due in part to practice changes introduced after NTSB investigations, the panelists agreed. And they agreed that a similar model could benefit the medical community as well. Indeed, the NTSB not only points out errors in process but also provides professionals with

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Anesthesia Business Consultants 18 Grifols 19 B. Braun Medical Inc. 20 Dräger 22 Edwards Lifesciences 24 MAQUET Medical Systems USA 26 Masimo 28 Mindray 30 Pacira Pharmaceuticals, Inc. 32 Teleﬂex 33 Par Sterile Products, LLC 34 Spacelabs Healthcare 36 TeamHealth Anesthesia 38 McMahon Publishing 40

Anesthesiology News Guide to Airway Management Accompanies this issue.

CLINICAL ANESTHESIOLOGY

Inadequate neuromuscular blockade and other things that go bump in the night.

see Safety page 10 A nn ua l

Corporate ANNUAL Profiles

POLICY & MANAGEMENT

Work in an ASC? Seven things to know.

50 2014-2015

COMMENTARY

The Prime Directive.

Introduction by Ashutosh Wali, MD Advancements in Lung Isolation Techniques Congenital Syndromes Associated With Difficult Airway Management in the Pediatric Patient Oxygen Delivery, Use, and Toxicity: Achieving a Rational Balance Secrets of Flexible Fiber-Opt ic Pearls for Success in Unusual Bronchoscopy: Circumstances

Supraglottic Airways As Bridges to Safe Exutabtio n of the Difficult Airway Surgical Management of the Failed Airway: A Guide to Percutaneous Cricothyroidotomy The Video Laryngoscopy Market: Past, Present, and Future

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AUGUST 2014

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CORRESPONDENCE To the Editor: o one has to tell independent anesthesiologists that their practices are being buffeted by higher costs, cuts in compensation, tough regulatory requirements and increased hospital demands (see article, June 2014, page 6). The clinical and business pressures are multiplying—and most of the ways out don’t look all that attractive.

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By joining their professional colleagues, anesthesiologists have greater bargaining power with payors and hospitals alike. Scheduling problems are eased as well, since larger groups have greater flexibility in staffing multiple hospitals at the same time. Perhaps most valuable, given the relentless pressure to increase both operating efficiency and quality of care, is the wealth of data and best practices available to large groups. The size of large practices allows partners to collect,

share and analyze huge amounts of outcome-based clinical information. This is a unique—and uniquely productive—asset that has hugely beneficial implications not only for the partners, but also for the health care field. At Midwest Anesthesia Partners, a large group practice, we’ve proven that it’s possible to decrease costs, reduce risk, achieve superior perioperative morbidity and mortality results, and raise patient satisfaction ratings. It’s clear that large practices

allow anesthesiologists to retain control of their professional lives and practice medicine the way they wish. With practice demands mounting and fewer good alternatives available than ever, independent anesthesiologists should seriously consider group affiliation as the best solution to their current and future challenges. —David Rosen, MD Dr. Rosen is president of Midwest Anesthesia Partners, a group practice in the Chicago area.

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hospitals ycerin sho abating , NYC pa with Bax for months showedrtage that had nel hig ter, som waste hli turers of one of three ma e signs of in syste ghts had retu the drug, announjor manufacm rne allocation d its custom cing that it outine pre ers foll ow restriction ing month to a 100% than $60 anesthetic test s. s of severe s cost mo billion As a resu far few re every er than lt, at leas abnorm Tampa 1% reveal year, but alit t one faci Gen the surger ies relating said it was eral Hospital, pertine lity— to lished in y, according to the anesthetic nt use of the able to ease in Florida— lim crit (1989;36: the Canadian a 1989 study or But no ical cardiac me its on the Jou S13 rna l of Anesthpub For tha -S19). Carilion such relief was dication. esia t reason Roanoke in sight om , me national Memorial at nd guideline Hospital, see nitr in low-ris minimizing o shortag s pre e page surger y. k, stable patien operative test rec10 The Am ts ing erican Socundergoing non -em iety of Anesthesiomergent olog ists

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BUYER’ S GUIDE

Private equity groups, on one hand, are ready and willing to invest in independent practices. Their promises of cash, buying power and administrative support are very attractive. Profit, however, is at the heart of any private investment. Sooner or later, that imperative will affect key decisions. Many anesthesiologists are not comfortable surrendering a part of their operating authority to non-medicall partners. On the other hand are medical centers and health networks offering stability, incentive-based compensation, benefits, established workflows and advanced technology to the specialists who join their systems. Having health care professionals at the helm is a definite plus, but the loss of autonomy that comes with major institutional affiliation can be as limiting as private equity partnerships. Almost by necessity, large group practices are filling the void between these two alternatives. Of critical importance, anesthesiology groups are owned and managed by the physicians themselves. Decisions affecting practice management remain with the partners, yet the economies of scale afforded to practitioners, from volume pricing to greater flexibility in staffing, are on par with health care system affiliation.

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AUGUST 2014

COMMENTARY

The Prime Directive By Steven S. Kron, MD

s anyone with a computer knows, before downloading a new program, you must indicate agreement with the Terms of Service (TOS), a tedious multipage scroll. By checking a box at the bottom of the page, you acknowledge that you have read and accept the TOS. Those crafted by the really expensive lawyers have two check boxes—the first indicating that you agree with and accept the TOS, the other that you indeed have read the words to which you assent. Yeah right! Does anyone without a certifiable DSM-5 [Diagnostic and Statistical Manual] disorder go through the ponderous legalese before checking off the box that says he or she has done so? Furthermore, have there ever been negative consequences to such gross dishonesty? I doubt it. Which brings us to the written consent form that I’m confident we all

obtain before administering anesthesia. Naturally, obtaining consent and obtaining a consent form are different animals entirely. Although few if any anesthesia lawsuits hinge exclusively on the lack of a consent form, the absence of one may hurt a defendant accused of other misbehavior. Should a lawsuit arise for an unrelated cause, those smart, really expensive lawyers certainly will use a poorly written consent to raise doubts about the anesthesiologist’s professionalism or concern for the patient. The anesthesia consent form has come a long way since my residency. Back then, it simply did not exist. Of course, we discussed anesthesia with patients during the preoperative visit. But because the surgical consent included a line that anesthesia would be administered, a separate written consent for the receipt of anesthesia was deemed unnecessary. The surgeon or anesthesiologist pretty much dictated the type of anesthesia, so the

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‘Words! Words! Words! I’m so sick of words.’ —Eliza Doolittle in My Fair Lady conversation tended to be one-sided. Entering private practice, I soon learned that patients’ desires mattered. If my plan conflicted with their preconception, I would need to convince them of the benefits of my approach. Yet I did not need their signature. After a decade or so, in response to some outside review, we decided to add a line signed by the anesthesiologist testifying to the fact that he or she discussed anesthesia, possible complications and alternatives with the patient. There was still no requirement for the patient to sign. The next incarnation added a requirement for the patient’s signature. This was a bit of an adjustment for those of us who were not sure how to discuss complications. Conventional medicolegal wisdom says that you need to mention common but minor and rare but catastrophic ones. So, do you tell them that they may get a little sore throat, a bit of nausea and oh, by the way, you might die (please sign at the X)? Our most recent consent form is by far the most thorough I have ever seen and has been made the standard for all the members of the mega–hospital conglomerate to which we belong. It is similar to but even more complete than the form on the website of the American Society of Anesthesiologists and covers every possible issue that could arise. Of the hundreds of patients I have asked to sign this document, none— not a one—has hesitated. Unfortunately, the problem I have consistently encountered is, despite a willingness to sign, their near 100% unwillingness to

Dr. Kron is an anesthesiologist in Hartford, Conn., and a frequent contributor to Anesthesiology News.

read that to which they are attesting! Some of the reluctance is no doubt due to the same lack of interest I have for reading the TOS discussed above: an understanding that these are lawyer-generated documents designed to, as more than one patient has accurately put it, “cover your ass”! My response is to agree, again offer to tell them the risks, and if and when they refuse make a few lawyer jokes and off to sleep. Often, there is the complaint that the document is too long and wordy and written in an illegibly small font. Perhaps most important, by the time they have gotten to me, they have signed multiple forms—consents, releases of information, HIPAA forms and assignments of benefits and are, like Eliza Doolittle, just so sick of words. In my dealings with genuinely sick patients having major procedures, I have found that they and their families generally do seem to appreciate the potential hazards of anesthesia and a signature at the bottom of the page is a true acknowledgment of that. Ironically, it is the healthier and particularly the morbidly obese patients with sleep apnea who are having moderate sedation for minor procedures such as endoscopies who seem less willing to understand risk. Explaining to these folks that propofol is a great drug that will quickly sedate them and allow for a rapid and nausea-free emergence, but may cause apnea or an obstructed airway, can be tricky. It also violates the prime directive: Don’t scare the customer.

AUGUST 2014

AnesthesiologyNews.com I 7

TECHNOLOGY

Lung Assistant Keeps Patients in Air as Bridge to Transplant

portable device for inducing respiration in badly damaged lungs may offer hope for patients in remote areas who must travel long distances for a lung transplant, according to the results of a case study. The outcome of the case, as well as other cases in which the device has been used, represents the first time the instrument has been used aboard a fixedwingg aircraft. The case further suggests that the device can be used successfully under the stresses of takeoff and landing in fixed-wingg aircraft, and with minimal training, the researchers said. The study, presented at the 2014 annual congress of the Society of Critical Care Medicine, reported the case of a 28-year-old woman in Northern Ireland, weighing roughly 60 kg (132 lb), with end-stage lung disease brought on by cystic fibrosis. She had been awaiting a lung transplant for six years, and had had seven aborted trips to the transplant center. Because extracorporeal membrane oxygenation (ECMO) was not available at the remote treatment center, the doctors procured a device called the Novalung Interventional Lung Assist membrane ventilator from Germany, where it is manufactured. The device supported the patient for nearly 16 days, as she waited for a donor organ to become available. Given the remote location and the weather conditions at the time, doctors determined that the best option was to transport the patient by air from Belfast to Newcastle, a journey of about 200 miles. Once a lung became available, the staff loaded the patient onto an air portable stretcher, and dismantled the device into its constituent parts—including pump, circuit and control units— which they secured using a variety of clamps and ad hoc devices. Flying on a Piper Chieftain fixed-wingg aircraft, the doctors and support staff delivered the patient directly to the operating room in Newcastle without incident. Although the Novalung has been used for helicopter transport, this case represents the first time it was used in a fixed-wingg aircraft, subjected to the forces of takeoff and landing. The case demonstrates that the Novalung is a viable option for supporting patients awaiting a lung transplant in remote areas where ECMO is not an option, according to George Gardiner, MBChB, lead clinician at the Critical Care Network in Northern Ireland, who led the medical team managing this patient. “We found that it was actually easier

to use, and easier to train our people on a novel technology, than we had hitherto believed possible,” he said. The Novalung and similar devices also could offer an indirect psychological benefit to patients in remote areas, by allowing them to remain where they have a support network of friends and family until an organ is available, said Denis Hadjiliadis, MD, MHS,

director of the Adult Cystic Fibrosis Program and member of the Lung Transplantation Program at the Hospital of the University of Pennsylvania, in Philadelphia. “Sometimes it puts a lot of strain on families, to have people move far away,” Dr. Hadjiliadis said. “In this case, maybe they could have transported the patient earlier, but that might mean the

patient would have to be alone at the transplant center, with a lot more difficulty, not having their support system around them. Keeping them in their local place, and then transporting them kind of helps from that perspective,” Dr. Hadjiliadis added. —Ajai Raj

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AUGUST 2014

POLICY & MANAGEMENT

Seven Things Anesthesiologists in ASCs Must Know

etween half and three-fourths of the nation’s 45,000-odd anesthesiologists spend at least part of their workday in an ambulatory surgery center (ASC) or other out-off hospital setting. Those who do should be paying attention to a slew of legislative and economic changes poised to reshape the approximately 5,300 Medicarecertified ASCs in the United States. That was the message emerging from a panel held at the 2014 annual meeting of the Society for Ambulatory Surgery. Arnaldo Valedon, MD, chief of the Ambulatory Division and managing partner at First Colonies Anesthesia Associates, in Baltimore, moderated the panel, which included William Prentice, JD, executive director of the ASC Association (ASCA) and Nap Gary Jr., JD, chief operating officer of Regent Surgical Health, who spoke about the challenges and opportunities in the year ahead.

No Closure on the SGR The cost of fixing the sustainable growth rate (SGR)—a formula established by Congress to keep the federal health spending in check by tying physician payments to projected economic growth—has skyrocketed over the past decade. At one point, estimates from the Congressional Budget Office projected that a fix would cost as much as $350 billion over 10 years. In the past year, however, because of the downturn of the economy and changes in inflation, that estimate dropped to between $140 billion and $145 billion over 10 years, Mr. Prentice said. Yet Congress has failed to come up with a permanent solution to the payment problem, instead passing a 12-month fix to avoid a March 31, 2014, deadline that would have resulted in a 24% cut to physician payments. When Congress tries to solve the SGR problem next year, the costs likely will be higher, Mr. Prentice said. “Congress swung and missed at a wonderful opportunity to finally come up with a long-term fix for the problem of physician reimbursement,” Mr. Prentice said. “They just, once again, kicked that can down the road.” The Affordable Care Act Is Here To Stay The partisan climate in Congress means any significant changes to the Affordable Care Act (ACA) are unlikely until after the next

of Callifornia, Berkeley’s Nicholas C. Petris Center on Health Care Markets aand Consumer Welfare found thaat ASCs saved Medicare and its beneficiaries $7.5 billion between 20008 and 2011. The researchers also projected that ASCs could save Medicare $57.6 billion over the next decadee. By pproviding health care across the entire continuum in a manner that’s more eefficient and less expensive and assuress high-quality outcomes, ASCs will m meet ACA’s core objectives, Mr. Gaaryy said.

‘I tell my friends and colleagues, “if you’re not at the table, you’re on the menu.”’ —Arnaldo Valedon, MD

congressional election. Even if Republicans dominate elections in the House of Representatives and the Senate—an outcome that’s far from certain—President Obama would veto any attempt to derail his signature legislative achievement, Mr. Prentice said. Mr. Prentice predicted, however, that Republicans and Democrats in Congress will soon start to see the many flaws in the law. The employer mandate—the provision that any business with more than 50 employees must purchase health insurance or pay a penalty—is one area in which Mr. Prentice sees potential for bipartisan support for change. The ACA’s Effects on ASCs Remain Murky Eight million people signed up for health insurance under the ACA as of the April 15 deadline. About half of enrollees were deemed eligible for Medicaid. The effect of the plan on ASCs hinges on who has enrolled— whether they are the so-called “young invincibles,” younger men and women who consume relatively few health care resources, or seniors with comorbidities who consume much

more—and which plans they have chosen. Plans on the exchanges range from bronze to platinum. Platinum plans tend to have higher premiums and lower deductibles. If the majority of newly insured individuals signed up for bronze plans, with high deductibles, high copays and low premiums, these higher payments might prevent people from getting outpatient surgery unless it’s an emergency, Mr. Prentice said. “Will it move the needle in terms of volume in the ASC?” Mr. Prentice asked. He’s not optimistic. Nap Gary Jr., JD, is more hopeful. The ACA’s stated goal is to improve the quality of health care while cutting costs at the same time, he told Anesthesiolog y News. “Those are two objectives that are right at the heart and soul of ambulatory service,” Mr. Gary said. Patients could spend $1,000 in a hospital or $560 for the same services in an ASC. “There’s an opportunity for enormous savings to the government and to the patients by having those procedures performed in ASCs.” A recent study by the University

Ad ddressing the Inflation Index Is Critical The average payment rate for cases performed in an ASC declined from 65% too 55% of the hospital payment rate foor the same services between 2008 and 2014, Mr. Prentice said. (Thesee averages are based on payment tables and policies the ASCA analyzed after the Centers for Medicare & Meedicaid Services [CMS] made them available.) One of the bills currently under review in Congress, the Ambulatory Surgical Center Quality and Access Act of 2013, aims to change the inflation index for ASCs to match that of hospitals, which in turn affects reimbursement. The inflation index is an annual measure based on the cost of doing business. A hospital’s inflation index, the “market basket update,” is consistent with the cost of the goods and supplies it purchases, Mr. Garyy said. But an ASC’s inflation update is based on the Consumer Price Index for All Urban Consumers (CPIU). Many of the goods and services associated with the CPIU are unrelated to the goods an ASC needs to function. Cupcakes, beer and gasoline are tallied by the CPIU. These items tend to be less inflationary than the goods medical providers require, Mr. Garyy noted. There is no legislative reason for ASCs to rely on this particular index instead of the market basket update. According to the ASCA, the decision was made by the CMS and earlier attempts to reverse it have been thwarted. Because the hospital’s inflation update increases every year, the payment differential between hospitals and ASCs also continues to increase. This widening gap prompted more than 60 ASCs to end their

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POLICY & MANAGEMENT relationship with Medicare over the past three years, according to the report from the University of California, Berkeley. The CPIU also includes a productivity adjustment, an assumption by economists that businesses will find more efficient ways to operate. This assumption reduces reimbursement rates for ASCs. The ACA also includes a productivity adjustment that applies to ASCs. As a result, centers are doubly penalized. Electronic Health Records: ‘Meaningful Use’ Hurts ASCs When hospitals began integrating electronic health records (EHRs), physicians, in exchange for certain bonuses, were required to show that they were using EHRs for 50% of patient encounters. Because ASCs have been slow to adopt EHRs, they are at a significant disadvantage. “It is now a disincentive for surgeons to bring their cases to the ASCs,” Mr. Prentice said. ASC advocates are looking to create a legislative solution, such as implementing a three-year grace period for centers to develop their EHR systems. The fix also would ensure that cases physicians bring to the ASCs would not count against their meaningful use quota. The ASCA has developed a task force to determine how to build a certified EHR system in the ASC environment that the CMS will endorse. Measuring Quality Is the Best Way To Improve Care and Strengthen ASCs’ Reputation In the past, the public’s perception of ASCs may have been that they were less safe than hospitals. “One of the things that we’ve initiated in the last few years is an effort to measure what’s going on in a surgery center in an effort to establish that patient safety and the quality of care is just as good if not better than what a patient would receive in a hospital setting,” Mr. Garyy said. About a year ago, the Agency for Healthcare Research and Quality developed a project in outpatient settings that focused on establishing safe surgery checklists. Within the next two years, the CMS plans to develop a patient experience of care survey, which patients will complete after each visit. When surveys start to become a standard part of care, ASCs must be ready. “I think projects like this are going to be a wonderful way for us to make sure that all of our centers are really at the top of our game,” Mr. Prentice said.

Physicians Must Talk To Their Legislators ASCs can perform almost all of the same surgeries as hospitals and at a lower cost, Mr. Gary said, and physicians in ASCs must help the government to recognize their role in the health care system under the ACA. Dr. Valedon said it is important to ask who is “at the table” in Washington supporting the interests of ASCs. “I tell my friends and colleagues, ‘if you’re not at the table, you’re on the

menu,’” he said. These include Sen. Ron Wyden (D-Ore.), chair of the Senate Finance Committee; Rep. John Larson (D-Conn.) and Rep. Devin Nunes (R-Calif.). f Mr. Nunes and Mr. Wyden introduced the Ambulatory Surgical Center Quality and Access Act in the House and Senate last June. It now boasts 55 co-sponsors in the House and seven in the Senate. Dr. Valedon, Mr. Gary and Mr. Prentice agreed that physicians

high in botic risk is When throm thrombin deficiency ti hereditary an

need to be more politically engaged for the sake of their livelihood and for their patients. “You all have state lawmakers,” Mr. Prentice said. “They need to know who you are. They need to know your perspective on these things, because if you’re not telling them, trust me, health systems and the insurers are.” —Shannon Firth

To learn more, visit www.thrombate.com

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Thrombate III® (antithrombin III [human])—proven effective for patients with hereditary antithrombin (AT) deficiency during surgery, childbirth, and in the prevention and treatment of thromboembolism1 Thrombate III provides predictable amounts of AT to replace what is normally present in the body t AT concentrate purified from human plasma and pasteurized to inactivate viruses, with no confirmed cases of virus transmission t In clinical studies, no cases of thrombotic complications during surgical and obstetrical procedures were reported

Easy to administer1

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t One dosing formula t Bolus intravenous infusion (not continuous infusion) t Pregnancy category B

t 500 IU vials with sterile water for injection t Filter and transfer needles provided t Room temperature storage

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 with Thrombate III, the most common side effects were dizziness, chest discomfort, nausea, and dysgeusia. The anticoagulant effect of heparin is enhanced by concurrent treatment with Thrombate III in patients with hereditary 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. Please see brief summary of Thrombate III complete Prescribing Information on adjacent page. Reference: 1. Thrombate III® (antithrombin III [human]) [prescribing information]. Research Triangle Park, NC: Grifols Inc; 2012. © 2013 Grifols Inc.

February 2013

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POLICY & MANAGEMENT SAFETY

safety and chief of the Patient Safety Division at the Royal Institute of Techsignificant learning opportunities, nology, in Stockholm, Sweden, diswhich would prove equally helpful cussed the many factors that must be in health care. Such an organization considered before such an investigatory would not only examine the causes of health care agency could practice. bad events, it would also provide useful Three Musts for Success data on what health care practitioners are doing right. Any high-quality independent acciYet when it comes to ideas, imple- dent investigation system requires mentation is often far more compli- three traits for success, Dr. Cook cated than inception. Richard I. Cook, said. The first is recognized indepenMD, professor of health care system dence from stakeholders, including CONTINUED FROM PAGE 1

THROMBATE

III®

Antithrombin III (Human) BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION

FOR INTRAVENOUS USE ONLY DESCRIPTION Antithrombin III (Human), THROMBATE IIIw is a sterile, nonpyrogenic, stable, lyophilized preparation of purified human antithrombin III (ATIII). THROMBATE III is prepared from pooled units of human plasma from normal donors by modifications and refinements of the cold ethanol method of Cohn. When reconstituted with Sterile Water for Injection, USP, THROMBATE III has a pH of 6.0–7.5, a sodium content of 110–210 mEq/L, a chloride content of 110–210 mEq/L, an alanine content of 0.075–0.125 M, and a heparin content of not more than 0.1 IU heparin/IU ATIII. THROMBATE III contains no preservative and must be administered by the intravenous route. Each vial of THROMBATE III contains the labeled amount of antithrombin III in international units (IU) per vial. The potency assignment has been determined with a standard calibrated against a World Health Organization (WHO) antithrombin III reference preparation. The capacity of the THROMBATE III manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model using a wide range of viruses with diverse physicochemical properties. There are two dedicated virus inactivation/removal steps included in the THROMBATE III manufacturing process: a heat treatment step at 60°C ± 0.5°C for not less than 10 hours for virus inactivation and a nanofiltration step for effective removal of viruses as small as 18 nm. The manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. An individual production step in the THROMBATE III manufacturing process has been shown to decrease TSE infectivity of that experimental model agent. The TSE reduction step is the Effluent I to Effluent II + III fractionation step (6.0 log10). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed. CLINICAL PHARMACOLOGY Antithrombin III, an alpha2-glycoprotein of molecular weight 58,000, is normally present in human plasma at a concentration of approximately 12.5 mg/dL and is the major plasma inhibitor of thrombin. Inactivation of thrombin by ATIII occurs by formation of a covalent bond resulting in an inactive 1:1 stoichiometric complex between the two, involving an interaction of the active serine of thrombin and an arginine reactive site on ATIII. ATIII is also capable of inactivating other components of the coagulation cascade including factors IXa, Xa, XIa, and XIIa, as well as plasmin. The neutralization rate of serine proteases by ATIII proceeds slowly in the absence of heparin, but is greatly accelerated in the presence of heparin. As the therapeutic antithrombotic effect in vivo of heparin is mediated by ATIII, heparin is ineffective in the absence or near absence of ATIII. The prevalence of the hereditary deficiency of ATIII is estimated to be one per 500 to 5000 in the general population. The pattern of inheritance is autosomal dominant. In affected individuals, spontaneous episodes of thrombosis and pulmonary embolism may be associated with ATIII levels of 40%–60% of normal. These episodes usually appear after the age of 20, the risk increasing with age and in association with surgery, pregnancy and delivery. The frequency of thromboembolic events in hereditary ATIII deficiency during pregnancy has been reported to be 70%, and several studies of the beneficial use of Antithrombin III (Human) concentrates during pregnancy in women with hereditary deficiency have been reported. In many cases, however, no precipitating factor can be identified for venous thrombosis or pulmonary embolism. Greater than 85% of individuals with hereditary ATIII deficiency have had at least one thrombotic episode by the age of 50 years. In about 60% of patients thrombosis is recurrent. Clinical signs of pulmonary embolism occur in 40% of affected individuals. In some individuals, treatment with oral anticoagulants leads to an increase of the endogenous levels of ATIII, and treatment with oral anticoagulants may be effective in the prevention of thrombosis in such individuals. In clinical studies of THROMBATE III conducted in 10 asymptomatic subjects with hereditary deficiency of ATIII, the mean in vivo recovery of ATIII was 1.6% per unit per kg administered based on immunologic ATIII assays, and 1.4% per unit per kg administered based on functional ATIII assays. The mean 50% disappearance time (the time to fall to 50% of the peak plasma level following an initial administration) was approximately 22 hours and the biologic half-life was 2.5 days based on immunologic assays and 3.8 days based on functional assays of ATIII. These values are similar to the half-life for radiolabeled Antithrombin III (Human) reported in the literature of 2.8–4.8 days. In clinical studies of THROMBATE III, none of the 13 patients with hereditary ATIII deficiency and histories of thromboembolism treated prophylactically on 16 separate occasions with THROMBATE III for high thrombotic risk situations (11 surgical procedures, 5 deliveries) developed a thrombotic complication. Heparin was also administered in 3 of the 11 surgical procedures. Eight patients with hereditary ATIII deficiency were treated therapeutically with THROMBATE III as well as heparin for major thrombotic or thromboembolic complications, with seven patients recovering. Treatment with THROMBATE III reversed heparin resistance in two patients with hereditary ATIII deficiency being treated for thrombosis or thromboembolism. During clinical investigation of THROMBATE III, none of 12 subjects monitored for a median of 8 months (range 2–19 months) after receiving THROMBATE III became antibody positive to human immunodeficiency virus (HIV-1). None of 14 subjects monitored for ⱖ 3 months demonstrated any evidence of hepatitis, either non-A, nonB hepatitis or hepatitis B. INDICATIONS AND USAGE THROMBATE III is indicated for the treatment of patients with hereditary antithrombin III deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism. Subjects with ATIII deficiency should be informed about the risk of thrombosis in connection with pregnancy and surgery and about the inheritance of the disease. The diagnosis of hereditary antithrombin III (ATIII) deficiency should be based on a clear family history of venous thrombosis as well as decreased plasma ATIII levels, and the exclusion of acquired deficiency.

practitioners, the health care facility, governmental and nongovernmental authorities and patient representatives. The second requirement is technical competence among investigators. “That competence is a complex mélange of expertise not generally available in health care settings,” Dr. Cook said. This mix includes forensic examination of the setting, technologies and physical data; skill at interviewing involved parties; critical analysis of complex data;

ATIII in plasma may be measured by amidolytic assays using synthetic chromogenic substrates, by clotting assays, or by immunoassays. The latter does not detect all hereditary ATIII deficiencies. The ATIII level in neonates of parents with hereditary ATIII deficiency should be measured immediately after birth. (Fatal neonatal thromboembolism, such as aortic thrombi in children of women with hereditary antithrombin III deficiency, has been reported.) Plasma levels of ATIII are lower in neonates than adults, averaging approximately 60% in normal term infants. ATIII levels in premature infants may be much lower. Low plasma ATIII levels, especially in a premature infant, therefore, do not necessarily indicate hereditary deficiency. It is recommended that testing and treatment with THROMBATE III of neonates be discussed with an expert on coagulation. CONTRAINDICATIONS None known. WARNINGS Because THROMBATE III is made from human plasma, it may carry a risk of transmitting infectious agents, e.g. 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. Inform patients that THROMBATE III is made from human plasma and may contain infectious agents that can cause disease. While the risk that THROMBATE III can transmit an infectious agent has been reduced by screening plasma donors for prior exposure, testing donated plasma, and by inactivating or removing pathogens during manufacturing, patients should report any symptoms that concern them. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Grifols Therapeutics Inc. [1-800-520-2807]. The anticoagulant effect of heparin is enhanced by concurrent treatment with THROMBATE III in patients with hereditary ATIII deficiency. Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during treatment with THROMBATE III. PRECAUTIONS General 1. Administer within 3 hours after reconstitution. Do not refrigerate after reconstitution. 2. Administer only by the intravenous route. 3. THROMBATE III, once reconstituted, should be given alone, without mixing with other agents or diluting solutions. 4. Product administration and handling of the needles must be done with caution. Percutaneous puncture with a needle contaminated with blood can transmit infectious virus including HIV (AIDS) and hepatitis. Obtain immediate medical attention if injury occurs. Place needles in sharps container after single use. Discard all equipment including any reconstituted THROMBATE III product in accordance with biohazard procedures. The diagnosis of hereditary ATIII deficiency should be based on a clear family history of venous thrombosis as well as decreased plasma ATIII levels, and the exclusion of acquired deficiency. Laboratory Tests It is recommended that ATIII plasma levels be monitored during the treatment period. Functional levels of ATIII in plasma may be measured by amidolytic assays using chromogenic substrates or by clotting assays. Drug Interactions The anticoagulant effect of heparin is enhanced by concurrent treatment with THROMBATE III in patients with hereditary ATIII deficiency. Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during treatment with THROMBATE III. Pregnancy Category B Reproduction studies have been performed in rats and rabbits at doses up to four times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to THROMBATE III. It is not known whether THROMBATE III can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pediatric Use Safety and effectiveness in the pediatric population have not been established. The ATIII level in neonates of parents with hereditary ATIII deficiency should be measured immediately after birth. (Fatal neonatal thromboembolism, such as aortic thrombi in children of women with hereditary antithrombin III deficiency, has been reported.) Plasma levels of ATIII are lower in neonates than adults, averaging approximately 60% in normal term infants. ATIII levels in premature infants may be much lower. Low plasma ATIII levels, especially in a premature infant, therefore, do not necessarily indicate hereditary deficiency. It is recommended that testing and treatment with THROMBATE III of neonates be discussed with an expert on coagulation. ADVERSE REACTIONS In clinical studies involving THROMBATE III, adverse reactions were reported in association with 17 of the 340 infusions during the clinical studies. Included were dizziness (8), chest discomfort (3), nausea (3), dysgeusia (3), chills (2), pain (cramps) (2), dyspnoea (1), chest pain (1), vision blurred (1), intestinal dilatation (1), urticaria (1), pyrexia (1), and wound secretion and hematoma (1). If adverse reactions are experienced, the infusion rate should be decreased, or if indicated, the infusion should be interrupted until symptoms abate. CAUTION

& only U.S. federal law prohibits dispensing without prescription.

Grifols Therapeutics Inc. Research Triangle Park, NC 27709 USA U.S. License No. 1871

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and presentation of findings in clear, unambiguous terms. “The third thing you need is rapid start-up of the investigations,” Dr. Cook added. “If you delay, there are features associated with medical accidents that make it extremely difficult to actually perform the investigation.” Unlike transportation catastrophes, medical accidents can occur in a wide variety of circumstances, leave very little forensic evidence behind and rarely stop work in affected facilities. John H. Eichhorn, MD, professor of anesthesiology at the University of Kentucky, in Lexington, echoed the sentiment that although developing an NTSB-like board for health care might be admirable, it would be fraught with pitfalls. Indeed, Dr. Eichhorn noted that members of the Anesthesia Patient Safety Foundation proposed a similar agency in the early 1990s, but implementation was impeded by a host of financial, logistical and medicolegal constraints. Specifically, Dr. Eichhorn noted that mustering a team of qualified, immediately available experts requires significant financial resources, and questions of ownership surrounding an investigation’s findings and recommendations could become woefully entangled. Mark F. Weiss, JD, an attorney in Dallas and Santa Barbara, Calif., who specializes in anesthesia issues, was more blunt in his assessment of the plausibility of such a board, calling it a “pipe dream.” The primary issue is volume as there are thousands of medical accidents for every airplane

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POLICY & MANAGEMENT ‘There’s no legitimate argument that safety isn’t a great goal. It’s just that the notion of some national task force that goes out and investigates all these things is a dream. There are many other things that can be done, but that isn’t one of them.’ —Mark Weiss, JD going to need a lot of investigators; it will create a giant bureaucracy. Most importantly, who’s going to fund this bureaucracy?” Lack of communication also will hinder any kind of investigatory process. “Everyone is going to clam up, because they’re going to be protecting themselves in terms of liability,” he added.

crash. “It would boggle most minds to learn how many medical malpractice suits are filed in the U.S. each year,” Mr. Weiss said. “So if you’re going to have every medical accident investigated by federal investigators, you’re

Rampant Pitfalls Despite his obvious skepticism, Mr. Weiss was quick to add that learning from health care accidents is possible, although in a much different form. “There are huge stores of health care information in hospitals, physicians’ records and insurance companies,” he

told Anesthesiology News. “And you could probably get to a similar result if this information was de-identified and could be searched for safety issues.” In the end, the panelists agreed that leaders in the anesthesia community will need to decide whether pursuing the creation of a central investigatory agency will improve patient care. Although there is a clear benefit to the dissemination of information surrounding accidents, pitfalls are rampant and the opportunity cost may be prohibitive. “There’s no legitimate argument that safety isn’t a great goal,” Mr. Weiss concluded. “It’s just that the notion of some national task force that goes out and investigates all these things is a dream. There are many other things that can be done, but that isn’t one of them.” Eugene R. Viscusi, MD, professor of anesthesiology and director of acute pain management at Thomas Jefferson University, in Philadelphia, agreed that the concept of a safety board, although laudable, would be difficult to implement universally in the health care setting. But he offered an alternative: “A review

board would be incredibly helpful with those catastrophic events that elude our understanding,” Dr. Viscusi said. “A higher-level review committee would provide expert evaluation of those uncommon events. On the other hand, the majority of incidents can be reviewed at a more local level if the infrastructure is created. For example, I would propose that even administration of naloxone for opioid respiratory depression could be reviewed for rootcause analysis at the hospital level.” Dr. Viscusi, a member of the editorial board of Anesthesiology News, suggested the creation of a mandatory, tiered review system that is linked with reporting of findings, with regular publication. “Implementing a system with tiers of review based on the nature and severity of the event would make the process more accessible and create greater buy-in,” he added. “Voluntary reporting is always the problem with medical misadventures, so in order to make this work, you have to incentivize reporting by creating a blameless review with useful information as the direct benefit.” —Michael Vlessides

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Extended-Release Bupivacaine Holds Own In Pair of Surgery Studies

new formulation of slowrelease bupivacaine reduces both pain intensity and postoperative opioid consumption relative to placebo in patients undergoing shoulder surgery and hernia repair, researchers have found.

The formulation, sucrose acetate isobutyrate extended-release bupivacaine (SABER-bupivacaine), seems to offer several advantages over other therapeutic options, according to the investigators, who presented their findings at the 2014 annual spring meeting of the

American Society of Regional Anesthesia and Pain Medicine. SABER-bupivacaine is a semiviscous mixture of 12% bupivacaine that clinicians apply directly to the incision site. The formulation is designed to provide prolonged pain

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relief, reduce reliance on opioids and improve postoperative recovery by slowly releasing the local anesthetic over several days. In one study, Richard Watts, MD, senior consultant anesthetist at The Queen Elizabeth Hospital in Woodville, Australia, and his colleagues enrolled 124 patients scheduled for inguinal hernia repair into the trial (abstract 1-0231). Of the patients, 120 completed the protocol. Patients were randomized to receive 2.5 (n=42) or 5 mL (n=47) of SABERR bupivacaine or placebo. “We showed that patients who received the SABER-bupivacaine, particularly the 5-mL dose, which releases a total of 660 mg over three days [132 mg/mL], had lower pain scores and used less morphine,” Dr. Watts told Anesthesiology News. Mean pain scores on movement over the first three postoperative days were 3.4 and 2.7 in patients receiving the 2.5 and 5 mL SABER-bupivacaine doses, respectively, compared with 3.9 in patients who received placebo (P=0.2372 and 0.0031 for doses, respectively). The drug also appeared to have a significant opioid-sparingg effect. Patients who received placebo consumed a median of approximately 13 mg of morphine equivalents over the 7 -hour studyy pperiod compared 72 p with 5 and 3 mg for those receiving 2.5 and 5 mL, respectively. The researchers also reported that 71.9% of placebo patients used opioids, compared with 53.2% of those receiving SABER-bupivacaine.

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PRN Dr. Watts said the bupivacaine formulation appeared to be as safe as placebo. “We’ve subsequently done cardiac safety studies, because you’re putting a fairly large dose of bupivacaine into the wound,” he said. “Pharmacokinetics show that there’s no dumping of the drug, and serum levels of bupivacaine remain in the nontoxic range.” Some discoloration at the wound site occurred, however Dr. Watts said it was insignificant. In a second, unrelated trial, researchers at several Eurpean hospitals compared 5 mL of SABER-bupivacaine with standard bupivacaine or placebo in 107 adults undergoing arthroscopic surgery (abstract 1-0228). On completion of surgery, a single dose of the treatment medication was deposited subacromially by arthroscopy. The researchers found that mean pain on movement over the first 72 hours postsurgery was 6.43 for patients who received placebo (n=25), 5.16 for those given SABERbupivacaine (n=53) and 5.16 for those treated with standard bupivacaine (n=29). Patients who received SABER-bupivacaine reported pain that was 26% less intense than that of patients who received placebo, according to the investigators. Use of rescue medication also was significantly reduced in the patients who received SABER-bupivacaine— 4 mg median morphine equivalent compared with standard bupivacaine (8 mg ) and placebo (12 mg ) over the 72-hour study period. Median time to first dose of rescue medication was significantly longer in SABER-bupivacaine (16 hours) than either standard bupivacaine (two hours) or placebo (1.5 hours).. Adverse events were comparable between groups, according to the researchers.

Dr. Watts said he would incorporate the new formulation into his practice, once the FDA grants its approval. “In addition to reduced pain and opioid sparing, the main advantage of this simplified method of wound pain management does not tether a patient to a wound catheter or TAP [transversus abdominis plane] catheter, therefore allowing patient mobility and reducing nursing time.” He acknowledged the necessity of headto-head cost and efficacy comparisons

of SABER-bupivacaine with other techniques. Christopher Wu, MD, professor of anesthesiology and critical care medicine at The Johns Hopkins University, in Baltimore, said that although these types of extended-release formulations show promise, many questions remain. “What we really want to know long term is that they not only provide better pain relief, but can improve outcomes as well.” Outcome is a particularly important

consideration with novel agents that tend to cost more than their alternatives, Dr. Wu added. “People want to know what they’re getting for their money. For example, in the case of outpatients, perhaps we can facilitate recovery, get them back to work faster, and in doing so potentially decrease the overall costs of health care to society as a whole. Those are things that really need to be clarified but haven’t been to this point.” —Michael Vlessides

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Study Addresses Extubation Controversy in Children

or years, anesthesiologists have debated the optimal minimal mechanical ventilator support from which to extubate children. At the 2014 annual meeting of the Society for Critical Care Medicine, researchers who presented a trial involving 171 children said their study provides an answer (abstract 371). “Children in intensive care units

should receive extubation readiness tests on CPAP [continuous positive airway pressure], as this effort is the closest surrogate to post-extubation effort,” said Robinder Khemani, MD, a pediatric intensive care physician at the Children’s Hospital of Los Angeles, who presented the study. “Pediatric practitioners often believe that pressure support needs to be added

to overcome perceived resistance to the endotracheal tube for small children. This would imply that work of breathing on CPAP prior to extubation is perceived to be higher than postextubation work.” But this, he said, is not what the study showed. The prospective observational trial involved 171 children undergoing

American Society for Enhanced Recovery (ASER), Duke Department of Anesthesiology and Department of Surgery PRESENT

2nd US Enhanced Recovery Symposium October 10, 2014 New Orleans Downtown Marriott at the Convention Center New Orleans, LA This activity has been approved for 6.25 AMA PRA Category 1 credits™.

This one day symposium will address issues related to enhanced recovery for colorectal and other surgery from a multidisciplinary perspective.

Topics include: t History and Fundamentals of Enhanced Recovery t Preoperative Education and Optimization t Perioperative Fluid Management. How Little, How Much? t Hemodynamic Management. Is it Cost Effective? t Successful Pain Management Strategy t The Role of Regional Anesthesia in Enhanced Recovery t Enhanced Recovery Strategy in Laparoscopic Colectomy. Should I Adopt it? t How Do You Get Your Team Together and Reaching Consensus? t Enhanced Recovery Beyond Colorectal Surgery t Debate: Performance metrics are an efﬁcient way to promote enhanced recovery t Enhanced Recovery Case Studies

Activity Co-Chairs Tong J Gan, MD, MHS, FRCA Timothy E Miller, MB, ChB Julie K Thacker, MD Conﬁrmed Speakers Solomon Aronson MD, MBA, FACC, FCCP Maxime Cannesson, MD, PhD Lee A. Fleisher, MD Stuart A. Grant, MB ChB Stefan D. Holubar MD, MS, FACS Monty Mythen, MD, FRCA Edward N. Rampersaud Jr., MD Roy G. Soto, MD Robert H. Thiele, MD

In collaboration with

http://anesthesiology.duke.edu To exhibit at this event, please contact via phone: 919-681-4660 or e-mail: info@aserhq.org

endotracheal intubation in the pediatric and ICUs at Children’s Hospital. Clinicians used esophageal manometry to measure the effort of breathing with rate pressure product (RPP; peak-to-trough change in esophageal pressure respiratory rate) under four conditions: pressure support 10/5 cm H2O (PS), CPAP 5 cm H2O, five minutes of spontaneous breathing and 60 minutes after extubation. The median age of patients was 5 months, and 42 children had upper airway obstruction after extubation. Seventy-four patients received noninvasive ventilation after extubation; roughly half of those procedures were planned before extubation. RPP was significantly different under the four conditions, using repeated measures analysis of variance with Scheffe’s test for multiple comparisons (P<0.001). RPP was lower under the PS of 10/5 cm H2O condition than under the others. Values under CPAP condition were lower than the values seen during five minutes of spontaneous breathing (P<0.001). In a subset analysis that included only children without upper airway obstruction (n=129), the RPP during PS was still significantly lower than the other three conditions (P<0.001), and there was no difference between CPAP and post-extubation values (P>0.2). In a subset analysis of children without upper airway obstruction and

AUGUST 2014

AnesthesiologyNews.com I 15

PRN ‘We have demonstrated that effort of breathing on CPAP of 5 cm H2O prior to extubation most closely represents postextubation effort of breathing. The addition of pressure support greatly underestimates post-extubation effort. This holds regardless of the size of endotracheal tube, and after controlling for postextubation upper airway obstruction. Hence, children in intensive care units should receive extubation.’ —Robinder Khemani, MD

endotracheal tubes 4.0 mm or smaller (n=95), the RPP during PS was still significantly lower than the other three conditions (P<0.001), and there again was no difference between CPAP and post-extubation values (P>0.2). “We have demonstrated that effort of breathing on CPAP of 5 cm H2O prior to extubation most closely represents post-extubation effort of breathing,” Dr. Khemani said. “The addition of pressure support greatly underestimates post-extubation effort. This holds regardless of the size of endotracheal tube, and after controlling for post-extubation upper airway obstruction. Hence, children in intensive care units should receive extubation readiness tests on CPAP without pressure support, as this effort is the closest surrogate to post-extubation effort.” Shekhar Venkataraman, MD, medical director of respiratory care services in the Department of Critical Care Medicine at the University of Pittsburgh, said clinicians have three main ways to determine if a patient is suitable for discontinuation of mechanical ventilation. They can put patients on CPAP; they can put patients on minimal PS, with the exact value still under debate; or they can test a patient using a T-piece, essentially an endotracheal tube plus a flow of oxygen air and no ventilator assistance. Although the new study adds

information to the debate about which method is the best, only a randomized trial comparing all three will end the controversy, Dr. Venkataraman said. He pointed out that a randomized trial of 257 pediatric patients concluded that T-piece was equally effective as PS of 10 cm H2O (Intensive Care Medd 2001;27:1649-1654). A study involving 17 children concluded that the assessment of effort of breathing during even minimal mechanical ventilation may underestimate

the post-extubation effort in children and that the effort of breathing in children is best approximated by T piece ventilation (Intensive Care Med T2005;31:1700-1705). “Right now if you asked me, evidencebased, what is the correct technique to use, to do the test before extubation, I think it would be hard for us to say,” Dr. Venkataraman said. “There are three techniques, and those three techniques have not been compared in a randomized controlled study against each other.”

Dr. Venkataraman’s personal preference is the T-piece method. “The current evidence, both in adults and children, shows that the work of breathing with a TT piece circuit is very similar to that during spontaneous breathing after extubation,” he said. “Even though I am biased to TT piece, I have to wear my scientist hat and say the other two techniques are probably equally useful.” —Kate O’Rourke

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REFERENCE 1 4th National Audit Project of the Royal College of Anaesthetists and the Difﬁcult Airway Society: Major Complications of Airway Management in the United Kingdom. Report and ﬁndings: March 2011. Editors: Dr Tim Cook, Dr Nick Woodall and Dr Chris Frerk.

16 I AnesthesiologyNews.com

AUGUST 2014

PAIN MEDICINE

Informatics Shows Pain Leads to Repeated Emergency Department Visits

he primary culprit in postoperative visits to the emergency department is pain, according to a recent analysis by North Carolina researchers who used medical informatics to identify and improve shortcomings in patient care. “There’s a lot in the news lately about improving health care outcomes,” said Dinesh J. Kurian, MD, a resident at Duke University Medical Center, in Durham, N.C. “At our institution, we’ve noticed that some of our patients are high emergency department utilizers—people who keep coming back over and over without ever seeming to get their problems solved. We wanted to try to understand why some postoperative patients turn out to be high utilizers and others don’t.” To that end, Dr. Kurian and his colleagues from Duke Anesthesia—including Thomas J. Hopkins, MD, MBA, and Jason Guercio, MD, MBA—used Duke’s online research tool, the Duke Enterprise Data Unified Content Explorer (DEDUCE), to identify and analyze patient visits to the emergency department occurring within three months of an elective spine surgery. The DEDUCE tool compiles data from many sources, allowing clinicians to search millions of data points for research purposes. “This will help us understand which groups to target for interventions so that we can act on things proactively rather than reactively,” Dr. Kurian explained. As reported at the 2013 annual meeting of the American Society of Anesthesiologists, the investigators identified 5,685 spine surgeries performed on 5,339 patients between 2010 and 2011 (abstract 2260). A total of 643

patients went to the emergency department within 90 days of surgery, making 1,005 visits. A primary complaint was recorded in 204 emergency department encounters, 112 of which were the direct result of either uncontrolled pain or a side effect of pain medication. Extrapolating these data to all 1,005 visits revealed that 55% might have been related to pain. This study helped illustrate the feasibility of leveraging clinical informatics to answer clinical questions, Dr Kurian noted. In this case, the data will be used as a framework to help develop a strategy to manage this high-riskk patient population. “Is there a way to identify the high utilizers before they go into surgery so you can come up with a more comprehensive pain management strategy?” asked Leif Saager, MD, assistant professor of anesthesiology at Cleveland Clinic, in Ohio, who helped moderate the poster session at which the Duke team presented its findings. “There were a couple of patterns that jumped out in this population,” Dr. Kurian said. “Certain types of surgery decreased the risk for having to come back. And some of the infections that people returned with were initially diagnosed as pain but were actually infections. This suggested certain organisms that weren’t necessarily covered with our preoperative antibiotics.” Co-moderator Jie Zhou, MD, MBA, an instructor in anesthesia and pain management at Harvard Medical School, in Boston, noted similar patterns at his institution. “One thing we are planning on doing is implementing a subacute pain service to

make sure patients have adequate pain control before they’re discharged, to prevent these types of things from happening.” Study co-investigatorr Solomon Aronson, MD, MBA, said the study should help anesthesiologists identify opportunities to play a more significant role in the perioperative process. “I think the common thread is that we’ve identified that pain is a significant comorbidity that’s inciting the behavior of readmission,” said Dr. Aronson, executive vice chair of anesthesiology at Duke. “Of course, readmission is an important metric that we’re all being scored on. So, when we speak to the broader context of the value proposition of perioperative physicians and what we can do to affect that much broader pathway of care, it is—in a perverse sort of way—nice to know that there is something that is screaming for our involvement. “We can insert ourselves into that process of management in a way that is much more impactful than we traditionally would have thought,” Dr. Aronson continued. “That’s a huge thing for our specialty and an important challenge for us, as specialists, to achieve. Whether or not methodology A or B or C or D is the right answer is soon to be discovered, but what we are demonstrating here is that at first blush, there is an important comorbidity that is right in the sweet spot of anesthesia providers to impact the process of care.” —Michael Vlessides

Seeking Answers for Postmastectomy Chronic Pain

espite recent advances in management of chronic pain, it continues to afflict a high percentage of women who have undergone mastectomy, researchers have found. The study showed that women of younger age and those undergoing axillary lymph node dissection are at greater risk for developing chronic pain. “As we all know, chronic pain can affect many women undergoing mastectomy,” said Gildasio S. De Oliveira, MD, assistant professor of anesthesiology and associate chair for research in anesthesiology at Northwestern University Feinberg School of Medicine, in Chicago. “Most of the studies looking at this phenomenon have taken place in Europe, however. So we decided to look at our center to get a better handle on rates in the United States. It seemed like the perfect time for such a study because many of our surgeons tell us our patients’ pain isn’t bad at all, and that

we might be overestimating the European data.” Dr. De Oliveira and his colleagues enrolled 300 patients into the prospective, observational cohort study. The women were evaluated within at least six months after surgery and completed the modified short-form Brief Pain Inventory and short-form McGill Pain Questionnaire to identify and characterize their pain. The investigators recorded a variety of data regarding demographics, surgery, cancer treatment and perioperative characteristics. Propensityy matchingg analysis was used to examine risk factors associated with the development of chronic pain. As reported at the 2013 annual meeting of the American Society of Anesthesiologists (abstract 2259), 110 patients (36.7%) identified the presence of chronic pain. Among those reporting chronic pain, the average and median worst pain in the previous 24 hours was

3 and 4, respectively, on an 11-point numeric rating scale. “That pain was not insignificant,” Dr. De Oliveira noted. “So we decided to look at which factors are associated with the development of chronic pain.” Independent risk factors associated with the development of chronic pain were age (odds ratio [OR], 0.95; 95% confidence interval [CI], 0.93-0.98) and axillary lymph node dissection (OR, 7.7; 95% CI, 4.3-13.9). Dr. De Oliveira noted, however, that the association with age was inverse: The greater the patient’s age, the lower the incidence of chronic pain. Interestingly, radiation therapy was not associated with the development of chronic pain (OR, 1.05; 95% CI, 0.56-1.95). “We actually did a propensity-matched analysis to account for confounding covariates,” he said. The analysis revealed that radiation was still not associated with the development of chronic pain.

Leif Saager, MD, assistant professor of anesthesiology at Cleveland Clinic, in Ohio, recognized that undergoing mastectomy seems to put women “at enormous risk of chronic pain. I would like to know if there’s anything we can do in terms of intervention to try to prevent something like that.” “There was actually a very interesting study published last September, in which intravenous lidocaine was shown to be effective in reducing chronic postmastectomy pain,” Dr. De Oliveira said. That trial (Clin J Pain 2012;28:567-572) concluded that, when compared with saline, IV lidocaine anesthesia decreased the incidence of chronic pain after mastectomy and was safe for use in clinical conditions. “We’re trying to replicate that study now, since it only examined 36 patients,” he said. —Michael Vlessides

27th Annual

2014-2015

Available online @ AnesthesiologyNews.com

2014-2015

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Profiles

ANESTHESIA S S BUSINESS US SS CONSULTANTS CO SU S

nesthesia Business Consultants, LLC (ABC) is the largest billing and practice management company dedicated to the complex and intricate specialty of anesthesia and pain management. It is both an Anesthesia Quality Institute Preferred Vendor and a Gold Affiliate with the Medical Group Management Association. Tony Mira, ABC’s founder, president and CEO, has maintained a concentration on providing services exclusively to anesthesia and pain management professionals since the company’s inception more than 30 years ago. ABC distinguishes itself by providing optimal business tools to strengthen business processes and enhance cash flow—all while keeping pace with constant changes in the health care environment. ABC prides itself on the longevity of its client relationships and its ability to customize services to the unique requirements of each practice. ABC offers its clients innovative billing and reimbursement services, as well as valuable practice management tools and solutions that allow them to realize their own particular strategic visions and business plans.

resulting in faster claims resolution and higher levels of reimbursement. Extensive management reporting options allow both management and client to monitor subtle changes in payer mix and reimbursement patterns. Services include: • Front-end edit and claim-scrubber technology • Patient deductible strategies and solutions • Claim underpayment monitoring and reporting

Management Support Services No one company is more qualified to furnish critical management information and proactively advise practice decision makers. ABC stands alone in its ability to provide a full range of management support services: • Strategic management • Practice management • Practice consulting • Financial services • Quality management (PQRS) • Human resources consulting • Contracting services • Compliance and HIPAA • Education and training

AT A GLANCE ADDRESS 255 West Michigan Ave. Jackson, MI 49201 (800) 242-1131

WEBSITES www.anesthesiallc.com www.communiquenews.com

SOCIAL MEDIA http://www.anesthesiallc.com/ easyblog/latest http://twitter.com/AnesthesiaLLC https://www.facebook.com/ anesthesiallc http://www.linkedin.com/company/ anesthesia-business-consultants https://plus.google.com/10046113 4039781832016#100461134039 781832016/posts

The ABC Management Advantage ABC distinguishes itself through its focus, operational approach and management structure: • Unlike many competitors who continually redefine their market focus, ABC has remained true to its core market of anesthesiologists, certified registered nurse anesthetists and pain management specialists, enhancing the credibility of its insight and advice. • ABC believes its relationship with its clients is a true partnership—a partnership in which ABC not only helps improve the billing process, but also helps the group operate more efficiently in the operating room, and more proactively in its relationship with the hospital. • ABC’s centralized approach allows effective management and oversight, ensuring consistent results. • Managing a business based on the input and expectations of shareholders does not always result in the most appropriate business decision making. Because ABC is privately held, it has much greater flexibility in setting its agenda, managing the business and being responsive to its clients’ needs.

The ABC Service Advantage ABC offers a full range of services designed to meet its clients’ needs, from a specific area of service to an allencompassing solution partner.

Billing and Reimbursement Services Because all processing is centralized, ABC maintains its high standards for quality control and efficiency,

Tony Mira, president and CEO

Anesthesiology News • August 2014

The ABC Technology Advantage To ensure flexibility with its clients and their varying level of needs, ABC has carefully crafted a portfolio of products to meet client needs during the entire perioperative process. The most advanced, secure and reliable software designed especially for anesthesia billing and practice management, F1RSTAnesthesia T ™ converts clinical information into claims for reimbursement. This powerful tool supports electronic claims editing to ensure consistently high billing acceptance rates and minimizes manual intervention in payment posting through direct remittance processing. Providers also are able to receive real-time or historical information through F1RSTAnesT thesia’s web-based technology or advanced data warehousing/data-mining technology. OneSourceAnesthesia is a powerhouse platform that offers an à la carte approach to the complete perioperative process—clients choose the features they need now, and have the peace of mind that comes from knowing OneSourceAnesthesia e is adaptable and that they can add increasing functionality as their needs grow and change. The OneSourceAnesthesia e platform offers: • Patient portal • Anesthesia Information Management Systems (AIMS) • Postoperative quality • Call scheduling • Patient satisfaction • Patient monitoring • Meaningful use The primary hardware tool required for ABC’s solution is an Apple iPad. The OneSourceAnesthesia solution requires no interaction with the hospital or surgery center’s servers to host the software. These elements, when combined with the intuitive user experience of OneSourceAnesthesia e , offer an unparalleled platform to

SERVICES Full-service billing and practice management firm dedicated exclusively to anesthesiologists and pain management physicians.

EMPLOYEES 850+

streamline and automatically incorporate best practices and clinical protocols to any practice. • F1RSTUse is the first full-service EMR management platform built exclusively for anesthesiologists and pain management specialists to satisfy stages 1 and 2 of meaningful use that are required to earn the Medicare or Medicaid EHR incentive payment. • F1RSTAnalytics T provides Insight at Your Fingertips. We all know that data helps us make better, more educated decisions. But collecting large amounts of data is ineffective without the proper tools to display those insights. Without understanding the context of a specific metric, it can be easily misunderstood and misrepresented. Physicians and managers alike require a smooth transition from the clinical, administrative and operational data sets to better understand the true messages that the data are trying to tell. Make the Data Work for You. F1RSTAnalytics T is the ultimate in technical sophistication. It offers data prowess, providing the data to aid in operating your anesthesia practice as an effective clinical organization and successful business. The information you need, provided in a way you can use it.

This corporate profile was reviewed and approved by Anesthesia Business Consultants.

2014-2015

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Profiles

G O S GRIFOLS AT A GLANCE

rifols is a global health care company with a 70-year legacy of improving people’s health and well-being through the development of life saving plasma medicines, diagnostics systems and hospital pharmacy products. Caring for people is its commitment that remains unchanged since the company started. Grifols is one of the leading companies in the world in the production of life saving plasma therapies, with a business model based on vertical integration, enabling it to control the entire production cycle, starting with the collection of raw material in the form of plasma through an extensive network of donor centers in the United States, and ending with the finished product.

A Legacy of Innovation At Grifols, a history of innovation defines our modern-day approach to medicine. More than 70 years ago, a Spanish hematologist named Dr. Jose Antonio Grifols Roig pursued a line of research that would set the stage for contemporary use of human plasma to treat disease. Together with his sons, he founded Laboratorios Grifols in 1940. Among their pioneering achievements, they obtained a patent in Spain for the process of plasma lyophilization, or freeze-drying of human plasma, along with the devices needed to inject plasma into patients who required its therapeutic properties. Shortly after, in 1951, Dr. Jose Antonio Grifols Lucas published the first large-scale clinical data describing the plasmapheresis technique of extracting plasma from donors while returning their red blood cells. Combined with the work of Edwin Cohn, Grifols paved the way for the birth of the plasma fractionation industry as we know it today.

Expanding To Meet the Demand From these auspicious beginnings, Grifols has evolved into an industry leader in the collection, manufacture and marketing of plasma-derived therapies. Through recent acquisitions, Grifols is now the third largest global producer of plasma-derived medicines. Grifols operates the world’s largest plasma collection platform, with 150 source plasma donation centers across the United States. Grifols has a current capacity of plasma protein fractionation of more than 9 million liters of plasma per

ADDRESS Grifols 2410 Lillyvale Ave. Los Angeles, CA 90032 (888) GRIFOLS (474-3657) www.grifols.com

DIVISIONS Bioscience: Specializes in the research, development, production and commercialization of high-quality plasma therapies. Edwin J. Cohn & Jose Antonio Grifols at the 4th International Congress of Blood Transfusion, Lisbon, 1951.

year. To accommodate the growing global demand for plasma-derived medicines, Grifols is significantly expanding its three manufacturing sites in Clayton, N.C., Los Angeles and Barcelona, Spain—the company’s global headquarters. The expansions include a new, 185,000-square-foot fractionation facility in Clayton and a new facility in Los Angeles dedicated to the production of immune globulin therapies. The new manufacturing facilities will increase the company’s capacity to fractionate plasma to 12 million liters by 2015. In addition, last year, Grifols opened a new, state-ofthe-art plasma testing laboratory in San Marcos, Texas, where every plasma donation undergoes rigorous scientific analysis before being approved for use in manufacturing. The 72,000-square-foot facility houses the latest technology for conducting sophisticated viral testing, including transcription-mediated amplification to rapidly detect minute levels of viral material in plasma samples. The San Marcos laboratory, together with an existing plasma testing laboratory in Austin, will analyze millions of plasma samples annually. Grifols is firmly committed to giving patients and health care providers broad access to our products. As Grifols grows, it continues to pursue its mission of improving the health and well-being of people around the world.

Hospital: Specializes in operational solutions for compounding areas in pharmacy. Diagnostic: Provides a comprehensive range of transfusion medicine, hemostasis, and immunoassay solutions for clinical laboratories, blood banks and transfusion centers.

PRODUCTS Albumin (Human), marketed as Albutein® 5%, Albutein® 25% and Plasbumin® _ 5 and Plasbumin® _ 25 Alpha1-Proteinase Inhibitor (Human), marketed as Prolastin®-C Antihemophilic Factor/von Willebrand Factor Complex (Human), marketed as Alphanate® Antithrombin III (Human), marketed as Thrombate III® BloodChip® for blood genotyping, Coagulation Factor IX (Human), marketed as AlphaNine® SD DG Gel® cards for blood typing Erytra® and Wadiana® automated blood typing instruments Factor IX Complex, marketed as Profilnine® SD Hyperimmune Globulin Therapy Products: • Rabies Immune Globulin (Human) • Tetanus Immune Globulin (Human) • Rho (D) Immune Globulin (Human) • Hepatitis B Immune Globulin (Human) Immune Globulin Intravenous (Human) or IVIG Immune Globulin Injection (Human) Gri-fill® System 3.0 for compounding sterile preparations Misterium® modular clean room solution Grifols-SencorpWhite inventory management system solutions Phocus® Rx: remote pharmacist validation system for compounding IV preparations Procleix NAT solutions for blood testing Grifols Triturus® Fully Automated EIA Analyzer Interlab G26 Clinical Agarose Gel Electrophoresis Systems A focused selection of reagents for infectious serology, autoimmunity, oncology and celiac disease

IVIG manufacturing plant in Barcelona, Spain, designed by Grifols Engineering.

This corporate profile was reviewed and approved by Grifols.

Anesthesiology News • August 2014

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Profiles

B. BRAUN U MEDICAL C INC. C

Braun Medical Inc. (B.Braun), a leader in infusion therapy and pain management, develops, manufactures and markets innovative medical products and services to the health care industry. B.Braun is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. Guided by its “Sharing Expertise®” philosophy, B.Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. The B.Braun group of companies in the United States includes B.Braun, B.Braun Interventional Systems, Aesculap® and CAPS®. B.Braun’s U.S. headquarters is located in Bethlehem, Pa. The B.Braun Group employs more than 50,000 employees in more than 60 countries worldwide. To learn more about B.Braun, visit www. BBraunUSA.com.

B.Braun Pain Management B.Braun is the global and U.S. market leader in regional anesthesia (RA). Our mission is simple—to help our customers reduce costly adverse outcomes, for patients and the facility itself, as a result of the overuse or sole dependency on opioids and gas anesthesia. B.Braun is here to advocate for, and educate on, the benefits of RA; and provide products and services to help improve patient outcomes, along with your bottom line. Our goal is to continue to be the customer’s first choice for safe and effective infusion therapy by investing in education, innovation and quality improvement initiatives.

Here are four ways B.Braun can help today: 1. Increase awareness for Regional Anesthesia. Are you trying to understand the benefits of an RA program, or sell the advantages to your facility, surgeons or nursing team? www.RAAdvantages.com can help by highlighting the cost of adverse events and the associated advantages of RA. Your choices matter—know how these choices impact your patient’s and facility’s bottom line.

Anesthesiology News • August 2014

2. Learn how to start or expand a program for continuous peripheral nerve blocks. Are you aware of the benefits of RA and seeking to increase use, but need assistance with the process? B.Braun has a team of nationally recognized and published anesthesia and nurse consultants, and centers of excellence that can tailor learning specific to your anesthesia groups’ needs. Be the change—advocate and lead your growth and expansion. 3. Standardize to B.Braun. Are you trying to consolidate your suppliers to help reduce costs, complexity and standardize clinical practice across multiple sites? B.Braun has one of the widest portfolios in the industry to help provide choice. At the same time, we have the knowledge and processes to help guide standardization. Treat every patient the same—why should they expect to be treated differently based solely on where they seek care within your health care system? 4. Innovation through consultation. Working with our network of key opinion leaders, watching you work and listening to your concerns—that’s how we’re developing the products and services you will need in the future to be competitive and deliver a superior level of quality care. Recently, B.Braun launched the Contiplex® C, www.contiplexc.com, a revolutionary catheter-over-needle system to help reduce placement time and leakage; as well as Contiplex Echo, the first echogenic needle and catheter system, to help facilitate quicker and easier visualization under ultrasound. Interested in joining our key opinion leader network or providing feedback? Email KOL.us@bbraunUSA.com along with your area of expertise and suggestions.

More on our product portfolio: Epidural. B.Braun’s market-leading Perifix® epidural line is enhanced by the Perifix FX Springwound

AT A GLANCE ADDRESS 824 Twelfth Ave. Bethlehem, PA 18018 (800) 227-2862 www.bbraunusa.com

PRODUCTS Pain control products; disposable post-op pain pumps; IV solutions in latex-, PVCand DEHP-free bags; needle-free systems; electronic pump delivery systems

CEO, CHAIRMAN OF THE BOARD Caroll H. Neubauer

Epidural Catheter. Designed to reduce paresthesia and vessel puncture rates, the FX is available in open-tip uniport and closed-tip multiport versions. For more information on the Perifix FX, please visit www.perifixfx.bbraunusa.com/AN. Spinal. B.Braun’s Pencan® Pencil Point spinal needle is designed for high flow rates for rapid detection of cerebrospinal fluid. B.Braun’s complete RA portfolio also features a patented combined spinal epidural product line. The Espocan® Docking System enables anesthesia providers to lock the position of the spinal needle during combined-technique procedures. The small, unobtrusive docking system sleeve helps inhibit forward and backward movements of the spinal needle while still permitting needle rotation. Peripheral nerve block. With ultrasound practitioners in mind, Ultraline is designed to enhance needle visibility at steep angles where visualization may be more challenging. Ultraline technology is featured in three configurations: Stimuplex® Ultra, a stimulating single-shot needle; Ultraplex, a nonstimulating single-shot needle; and Contiplex Tuohy Ultra, a stimulating needle for placing catheters under ultrasound. For more information on Ultraline needle markings and applications, please visit www.stimuplexultra.com.

This corporate profile was reviewed and approved by B. Braun Medical Inc.

Kareem M Eltaki, MD Anesthesiologist

Ramapo Anesthesia Group

patient. Comfortable patients lead to quicker recoveries. “Regional Anesthesia is getting patients quickly and more comfortably out of the hospital and reducing the narcotics administered for post-op pain management.” “I can tell you, the orthopedic procedures we’re doing the blocks on, we’re not giving opioids. In most cases when I do a block, I won’t even have a narcotic on me. With Regional Anesthesia, we’ve seen the amount patients need post-op and in recovery is almost none, especially in the best case scenarios”.

Profitability RA AdvantagePr

“Our patients matter most. By minimizing post-op pain and decreasing side effects, we’re improving the patient experience significantly.”

RAadvantages.com

Relationships

where advocates for the best in patient care and controlling healthcare costs come together.

Learn more at RAadvantages.com 14-43 321B_AN_7/14_RTS3

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Profiles

DRÄGER Technology for Life®

räger develops innovative medical solutions trusted by people the world over when lives are on the line. “Technology for Life” means more than merely guaranteeing technical excellence. It means assuming responsibility for the lives of those who use our products and depend on them. Technology for Life is both our guiding principle and the central challenge that we draw on for inspiration and motivation. “We do everything we do with passion—and we do it for life.” —Stefan Dräger, Executive Board chairman

125 Years of Heartfelt Dedication Dräger is a family enterprise, publicly traded in Germany and family co-owned, managed and led by the fifth generation of the company’s founders. In 2014, we are celebrating our 125th anniversary and we are convinced: This is the right time to say “thank you.” Thanks to our customers, who join us in our commitment to life. Thanks to our employees, who develop technology that puts life first and find innovative solutions for our customers. And thanks to our business partners, who help us stay connected and invest in our joint future.

AT A GLANCE Global Leader in Medical Technology As a leader in medical and safety technology, Dräger has approximately 12,500 employees worldwide. The company is present in more than 190 countries to effectively serve customers around the globe. The expertise of our management and employees is crucial to the growing globalization of our company. Our employees are characterized by their customer focus, entrepreneurial attitude, flexibility and global orientation.

Integrated anesthesia solutions that simplify operation so you can focus on your patients Dräger anesthesia workstations can include a number of tightly integrated components, including anesthesia machines, patient monitors, clinical IT applications and volatile gas analysis technology. The seamless integration enables the electronic, automated capture of anesthesia data that help users focus on patients—not paperwork.

Integrated monitoring solutions that make it easier to get the information you need It starts with an open architecture design and an ability to host multiple applications simultaneously. The widescreen format of our Infinity® Omega monitoring solutions puts more data at your fingertips at one time. As an electronic version of the traditional patient folder, they can save you time, facilitate decision making and help reduce the potential for medical errors. Plus, uninterrupted patient monitoring from pre-op to the postanesthesia care unit ensures the most complete patient picture possible.

Platform consistency that protects your investment and your patients Dräger’s consistency of platforms makes training more transparent, helping to minimize training costs and reduce errors. The use of a consistent user interface across Dräger anesthesia product lines can significantly reduce

CORPORATE HEADQUARTERS Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23558 Lübeck, Germany +49-451-882-0 info@draeger.com

NORTH AMERICAN HEADQUARTERS Draeger Medical, Inc. 3135 Quarry Rd. Telford, PA 18969 (800) 4-DRAGER (437-2437) info.usa@draeger.com www.draeger.com

PRODUCTS Anesthesia machines, patient monitors, anesthesia information management system, enterprise monitoring solutions, information technologies, ventilation therapy, warming therapy, architectural systems, accessories, surgical lighting, DrägerService®, education and training

EMPLOYEES Approximately 12,500 worldwide

PRESIDENT AND CEO Stefan Dräger

the time needed to learn all the platforms required to support various care settings, ranging from the operating room to magnetic resonance imaging and mobile environments. More importantly, it enables a familiarity that allows you to react intuitively, confidently and efficiently. To learn more about Dräger anesthesia workstations, please contact your local anesthesia sales representative or visit us online at www.draeger.com.

The Infinity Omega-S brings together patient data from diverse sources—such as vital signs, lab data, DICOM images (x-ray, MRI, CT, US) and access to the patient’s electronic medical record. The Infinity Omega-S solution is part of Dräger’s comprehensive anesthesia workstation.

Anesthesiology News • August 2014

This corporate profile was reviewed and approved by Dräger.

Premium performance at and

low

minimal ﬂows

Deliver low and minimal flow anesthesia with workstations designed for it For more than a century, clinicians have trusted Dräger’s innovative anesthesia solutions to improve the practice and business of anesthesia care. Apollo’s Low Flow Wizard, which has proven to reduce volatile agent costs, provides graphical, actionable insight into fresh gas flow efficiency. Sampled gas can return to the breathing system on workstations to help reduce agent waste and your environmental footprint. And a heated breathing system is designed to prevent condensation build-up, so you can remain focused on your patient, not the technology.

4784

WATCH HOW ONE HOSPITAL REALIZED SIGNIFICANT COST SAVINGS AT WWW.DRAEGER.COM/FLOWLOW

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EDWARDS LIFESCIENCES A choice of hemodynamic monitoring options to meet your clinical needs.

dwards Lifesciences’ advanced hemodynamic monitoring and management systems enable individualized hemodynamic optimization. The systems provide clarity into patient status, helping clinicians to make more informed volume management decisions in their moderate- to high-risk surgery patients. Edwards’ extensive line of hemodynamic management sensors, catheters and monitoring tools support clinicians’ needs in the operating room (OR) and ICU. Hemodynamic instability may increase with more complicated or invasive procedures and with the presence of various comorbidities. As a result, clinicians’ hemodynamic monitoring needs and preferences may vary with the complexity of each procedure and patient. Edwards provides a range of monitoring options that can be used in perioperative goal-directed therapy (PGDT) protocols to optimize fluids in moderate- to high-risk surgery patients. Further, the Edwards Enhanced Surgical Recovery program can help implement hemodynamic optimization through PGDT in moderate- to high-risk surgery procedures. The noninvasive ClearSight system extends the clarity of continuous hemodynamic monitoring to moderateand high-risk surgery patients including elderly or obese patients in whom an arterial catheter would not typically be placed – enabling you to make more informed decisions about volume administration in your patients. Parameters monitored include: Stroke Volume (SV), Stroke Volume Variation (SVV), Cardiac Output (CO), Continuous Blood Pressure (cBP). For more information visit, Edwards.com/ClearSight. The minimally invasive FloTrac sensor connects to an existing arterial line to continuously provide dynamic,

flow-based parameters that can be used in PGDT protocols. It is a practical solution for making informed volume management decisions in your moderate- and high-risk surgery patients. The PreSep oximetry catheter continuously measures a patient’s central venous oxygen saturation, providing an earlier and more global view of tissue oxygenation and consumption. The Swan-Ganz pulmonary artery catheter with advanced monitoring capability provides a single, integrated hemodynamic profile for the most complex patients. The Edwards Swan-Ganz catheter remains the leading pulmonary artery catheter for surgical, critical care and trauma patients worldwide. The EV1000 clinical platform presents the physiologic and hemodynamic status of the patient in an intuitive and meaningful way. Designed to work with the FloTrac sensor and PreSep oximetry catheter, the platform offers the scalability and adaptability for both the OR and ICU. Edwards TruWave pressure transducer can be combined with the VAMP (Venous Arterial blood Management Protection) closed-loop blood sampling system to combine accuracy and reliability with the safety of a single closed system, protecting both patients and clinicians from the risk for infection. Edwards offers an extensive line of education and support tools to facilitate the integration of advanced hemodynamic monitoring in acute care settings. Visit www.Edwards.com/CCeducation to review perioperative patient simulations, simulated case studies, product animations and more. Or, visit youtube.com/ECCE4you for OR- and ICU-specific playlists.

AT A GLANCE ADDRESS One Edwards Way Irvine, CA 92614 (800) 424-3278; (949) 250-2500 CriticalCare@Edwards.com www.Edwards.com/CriticalCare Or www.Edwards.com/CCeducation

PRODUCTS Hemodynamic monitoring systems including the ClearSight system; FloTrac sensor; PreSep oximetry catheter; Swan-Ganz pulmonary artery catheter; TruWave pressure transducer; VAMP (Venous Arterial blood Management Protection) system; and EV1000 clinical platform.

With more than 40 years of collaborating with you to advance patient care, Edwards is committed to developing solutions that provide the clarity and control to make more informed decisions. 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, Edwards Lifesciences, the stylized E logo, Enhanced Surgical Recovery Program, ClearSight, EV1000, FloTrac, PreSep, Swan-Ganz, TruWave and VAMP are trademarks of Edwards Lifesciences Corporation.

The EV1000 clinical platform provides a variety of informative screens from which to choose to provide immediate insight and guide your therapeutic interventions. The platform also allows you to select the parameters most significant for your monitoring requirements, enabling you to make more informed decisions and determine the best course of action.

Anesthesiology News • August 2014

This corporate profile was reviewed and approved by Edwards Lifesciences.

Valuable insight to help you guide volume administration. Clarity gives you the control to make more informed decisions.

ClearSight Noninvasive System CO, SV, SVV, SVR, cBP* FloTrac Minimally-Invasive System CO, SV, SVV, SVR Swan-Ganz System CCO, RVEDV, RVEF, SvO2

Edwards Lifesciencesâ&#x20AC;&#x2122; range of hemodynamic monitoring solutions

The Edwards Enhanced Surgical Recovery Program can help you

provides key flow parameters shown to be more informative in

implement PGDT today. PGDT can help ensure your patients are

determining fluid responsiveness than pressure-based parameters.1

consistently maintained in the optimal volume range.

Each offers continuous information which may be used in

Know more. Know now. <To see how you can individualize therapy under more conditions, download our volume optimization app. URL>

Perioperative Goal-Directed Therapy (PGDT) to hemodynamically optimize your moderate to high-risk surgery patients.

1. Michard F, Biais M. Rational fluid management: dissecting facts from fiction. Br J Anaesth 2012 * Continuous Blood Pressure 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. ÂŠ 2014 Edwards Lifesciences Corporation. All rights reserved. AR11787

Edwards Lifesciences | edwards.com

One Edwards Way | Irvine, California 92614 USA

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MAQUET MEDICAL MEDICAL SYSTEMS USA The Gold Standard

AQUET Medical Systems USA is a market-leading medical device company whose mission is to help improve patient outcomes and quality of life through advanced technology. MAQUET offers comprehensive products and therapeutic solutions for the hybrid operating room (OR), ICU and general OR, as well as for patient transport. MAQUET has a long history of innovation in anesthesia, beginning with the introduction of its first anesthesia machine in 1981. Since then, the company has delivered almost 11,000 units to hospitals worldwide. It also has set market standards with its high-performance SERVO ventilation platform for more than 40 years. The company has a deep understanding of mechanical ventilation and the challenges facing anesthesiologists today. Not only are patient demographics constantly shifting, but surgical procedures are becoming more complex on a daily basis, necessitating advanced technology to ensure optimal patient care. MAQUET invests significantly in research and development to meet the changing needs of hospitals and anesthesiologists, and to ensure that it can provide anesthesia products that offer high-performance ventilation and support capabilities. MAQUET’s flagship anesthesia product, the FLOW-i Anesthesia System® with high-performance SERVO ventilation, offers true ICU ventilator performance and effective anesthesia delivery from the same unit.

AT A GLANCE High-Performance Ventilation Features • Set tidal volume is accurately delivered even under high abdominal and thoracic pressures, helping to avoid hypoventilation. • Fast rise time and high flow rates adapt to varying inspiratory demand in the presence of increasing airway pressure. • Sensitive triggering improves synchrony in pediatric patients and those with decreased respiratory drive. • Consistent and accurate PEEP levels are maintained. • Controlled pressure drop during expiration decreases expiratory resistance and work of breathing, in addition to minimizing auto-PEEP at higher respiratory rates.

Advanced Design and Technology The FLOW-i system’s ergonomically designed, fully electronic platform and touchscreen interface are easy to use and upgrade for enhanced workflow today and in the future. The open architecture allows hospitals to add the patient monitor and data management system of their choice and easily integrate future software and hardware advances into the system—increasing cost efficiency by avoiding the need for costly equipment replacement or upgrades. In addition, clinician ease of use and comfort are engineered into every FLOW-i machine with its height adjustability, movable arms and integrated table light.

U.S. HEADQUARTERS MAQUET Medical Systems USA 45 Barbour Pond Dr. Wayne, NJ 07470 (888) 627-8383 www.maquetusa.com

PRODUCTS Intensive care ventilators and anesthesia machines, suite of cardiovascular products (for intra-aortic balloon counterpulsation, cardiac assist, coronary artery bypass surgery, aortic and peripheral vascular surgery, and extracorporeal circulation), flexible room design for OR and ICU, OR tables, lights and ceiling supply units and OR integration

EMPLOYEES 6,000 MAQUET employees in 50 international sales and service organizations, as well as a network of more than 280 sales representatives

PRESIDENT AND CEO Raoul Quintero

FLOW-i Anesthesia System With High-Performance SERVO Ventilation MAQUET’s FLOW-i Anesthesia System seamlessly combines high-performance SERVO ventilation with precise anesthesia delivery to help meet the needs of all patients. These include the most challenging cases, such as obese patients with high abdominal and thoracic pressures, older patients suffering from multiple medical conditions, the critically ill and the smallest neonates. FLOW-i reacts quickly to changing parameters, as the low internal system volume enables rapid changes in gas concentration when needed, and facilitates fast wash-in and wash-out of the anesthetic agent. This process helps to minimize waste and unnecessary use of the agent through precise delivery technology.

Innovative Volume Reflector™ Re-Breathing Technology The FLOW-i system features the innovative Volume Reflector technology to ensure that the breathing circuit will never be empty and that ventilation will remain uninterrupted regardless of surgical constraints, changing conditions or patient position. The re-breathing technology consists of a rigid reservoir to increase the re-breathing as well as maintain high ventilation performance. It replaces both the traditional bellows and the piston technologies in older systems. Oxygen-driven by design, the Volume Reflector helps to minimize the risk for delivering a potentially dangerous hypoxic mixture in the presence of leaks during low-flow anesthesia. With the new O2Guard, an automatic increase of oxygen will occur if the system detects too-low oxygen at the Y-piece. FLOW-i anesthetic agent injection vaporizers are fully electronic, lightweight and can be refilled while slotted in the machine, even when still in use. The agent delivery is mainly on inspiration, leading to less use of anesthetic agents.

Learn More To learn more about the MAQUET FLOW-i Anesthesia System, visit www.maquetusa.com.

Anesthesiology News • August 2014

This corporate profile was reviewed and approved by MAQUET Medical Systems USA.

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MASIMO AT A GLANCE Taking noninvasive monitoring to new sites and applications

or 25 years, Masimo has focused on a singular mission—helping clinicians improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications.

Continuing to SET the Benchmark for Oxygenation Monitoring During Challenging Conditions Masimo SET® (Signal Extraction Technology®) is the proven leader in pulse oximetry, demonstrated by both clinical research and the real-world success of customers and OEM partners. More than 100 independent and objective studies have shown that Masimo SET® outperforms all other pulse oximetry technologies, providing clinicians with unmatched sensitivity and specificity to make critical patient care decisions—even under the challenging conditions of motion and low perfusion.1 Most importantly, only Masimo SET® pulse oximetry has been shown to improve patient outcomes by helping clinicians reduce retinopathy of prematurity,2 screen newborns for critical congenital heart disease,3,4 reduce ventilator weaning time5 and save lives, while reducing rapid response activations and ICU transfers on medical-surgical floors.6

rainbow® Technology Helps Clinicians Protect Patients From Hidden Dangers Throughout the Hospital rainbow® technology comprises a suite of continuous, noninvasive measurements designed to help clinicians with some of the most common, costly and critical decisions made in health care today. The rainbow® SET® suite includes: • Total Hemoglobin (SpHb®) • Methemoglobin (SpMet®) • Carboxyhemoglobin (SpCO®) • Oxygen Content (SpOC™) • Acoustic Respiration Rate (RRa®) • All Masimo SET® measurements

® features rainbow® SET® measurements, intuitive touchscreen display, standard wireless radio and full-screen trending.

Anesthesiology News • August 2014

ADDRESS 40 Parker Irvine, CA 92618 (949) 297-7000 www.masimo.com

Helping Clinicians Optimize Blood Management Red blood cell (RBC) transfusion is one of the most frequent procedures performed in U.S. hospitals, with one in 10 inpatients receiving one or more blood units.7 However, a growing body of clinical evidence suggests that overuse of RBC transfusion increases both patient risk and the cost of care.8,9,10,11 Masimo’s continuous, noninvasive total hemoglobin monitoring (SpHb) has been shown to help clinicians reduce RBC transfusions in low blood loss surgery12 and high blood loss surgery.13 In addition, by measuring hemoglobin continuously, SpHb may help clinicians identify real-time drops in hemoglobin that may indicate bleeding. Although SpHb monitoring is not intended to replace blood draws, continuous monitoring of hemoglobin levels could allow earlier interventions that may prevent disability or death.

PRODUCTS Masimo SET® pulse oximetry and sensors; rainbow® Pulse CO-Oximetry and sensors; rainbow Acoustic Monitoring™; SedLine® brain function monitoring; Patient SafetyNet™ remote monitoring and notification system.

MISSION STATEMENT Improving patient outcomes and reducing cost of care by taking noninvasive monitoring to new sites and applications.

Protecting More Patients by Monitoring Every Breath

EMPLOYEES

The Anesthesia Patient Safety Foundation (APSF) and the Joint Commission recommend continuous oxygenation and ventilation monitoring in all patients receiving opioid-based pain medications.14 However, current methods for respiration rate monitoring are limited by accuracy and patient tolerance. Although we offer bestin-class capnography solutions, we believe rainbow Acoustic Monitoring™ with Acoustic Respiration Rate (RRa) can help clinicians better monitor patient breathing in postsurgical and conscious sedation situations due to its demonstrated ability to detect respiratory pause.15

3,500

FOUNDER AND CEO Joe Kiani

The use of the trademarks PATIENT SAFETYNET and PSN is under license from University Health System Consortium.

References 1. Shah N, Ragaswamy HB, Govindugari K, Estanol L. J Clin Anesth. 2012:24:385-391.

Helping Improve Outcomes on MedicalSurgical Units with Masimo Patient SafetyNet™a

2. Castillo A, et al. Acta Paediatr. 2011;100:188-192.

In August 2012, the Joint Commission Sentinel Event Alert on the safe use of opioids in hospitals recommended implementation of better dosing along with continuous oxygenation and ventilation monitoring (instead of spot-checks) in postsurgical patients.16 Our Patient SafetyNet system combines Masimo SET® pulse oximetry, breakthrough rainbow® measurements and remote patient monitoring with wireless clinician alerts. After implementing Masimo SET® and Patient SafetyNet on a postsurgical floor where only intermittent spot-checking was used before, Dartmouth-Hitchcock Medical Center reduced rapid response activations by 65% and ICU transfers by 48%,6 and saved $1.48 million annually. In addition, no patients suffered irreversible, severe brain damage or died as a result of respiratory depression from opioids over a five-year period.17

5. Durbin CG Jr, et al. Crit Care Med. 2002;30:1735-1740.

3. de-Wahl Granelli AD, et al. BMJ. 2009;338. 4. Ewer A, et al. Health Technol Assess. 2012;16:1-184.

6. Taenzer AH, et al. Anesthesiology. 2010;112:282-287. 7. AHRQ. Inpatient Sample. 1997-2007. 8. Marik PE, et al. Crit Care Med. 2008;36:2667-2674. 9. Carson JL, et al. Cochrane Database Syst Rev. 2012;4:CD002042. 10. Shander A, et al. Transfusion. 2010;50:753-765. 11. Murphy GJ, et al. Circulation. 2007;116:2544-2552. 12. Ehrenfeld JM, et al. American Society of Anesthesiologists Annual Meeting. 2010:LB05 (abstract). 13. Awada WFN, Maher F. Proceeding of the Society for Technology in Anesthesia Annual Meeting. 2013:51. 14. Stoelting RK, et al. APSF Newsletter. 2011. www.apsf.org. 15. Ramsay M, et al. Anesth Analg. doi: 10.1213/ ANE.0b013e318290c798. 16. The Joint Commission. Sentinel Event Alert! 2012:49. 17. Taenzer AH, et al. APSF Newsletter. 2012;27:1.

This corporate profile was reviewed and approved by Masimo.

New from Masimo

ISA connects to Root via Masimo Open Connect™ (MOC-9™)

™

Nomoline™ (No Moisture sampling line) Reduces disposable costs through extended monitoring and use of non-proprietary cannulas

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MINDRAY “healthcare within reach”

s a leading developer, manufacturer and marketer of anesthesia and life support systems, patient monitors, in vitro diagnostics and medical imaging products, Mindray is dedicated to delivering the highest quality medical instrumentation to a global market. Founded in 1991 and headquartered in Shenzhen, China, Mindray is the third largest manufacturer of anesthesia systems and patient monitors worldwide. In 2008, Mindray acquired Datascope’s patient monitor business, which has been a leader in patient monitoring products since it was founded in 1964. With more than 8,000 employees and R&D centers on three continents, Mindray offers a broad range of innovative solutions designed to contain costs while ensuring the highest quality products for patient care. Today, Mindray’s products and services can be found in health care facilities in more than 190 countries. Inspired by the needs of our customers, we adopt advanced technologies and transform them into accessible innovation, bringing healthcare within reach. Our outstanding sales professionals and clinical education specialists provide your staff with comprehensive, on-site training and in-service. Our dedicated field service and in-house technical support organization is one of the largest direct service teams in the industry. Learn how we can help you maximize your resources with some of the most advanced and accessible medical equipment in the industry.

The A3 Anesthesia System provides many of the features and benefits of an advanced anesthesia delivery system for the outpatient and mid-acuity environment. The A-Series has an industry-leading two-hour backup battery supply and is capable of delivering fresh gas and anesthetic agent in the event of total loss of power.

Anesthesia Delivery Systems

Powerful Technology in Patient Monitoring and Network Solutions

The A-Series platform combines the simplicity of traditional anesthesia delivery with advanced features and evolving technology. The A5’s award-winning design, intuitive user interface and advanced ICU quality ventilation modes support effective care across a wide range of patients. The 15-inch color touchscreen is ergonomically designed for comfortable interaction and visibility, allowing clinicians to easily select ventilation modes and adjust settings. Automatic compliance and fresh gas compensation maintain accurate tidal volumes. The temperature-controlled breathing system is maintained at body temperature and virtually eliminates internal condensation. The A5 Anesthesia System comes standard with comprehensive ventilation modes: volume control ventilation, pressure-controlled ventilation with or without volume guarantee, pressure support and synchronized intermittent mandatory ventilation with either volume or pressure control support. Spirometry, high-pressure O2 port, central locking brake, mounting rails, adjustable workspace lighting and an innovative backup control touch pad also come standard. Optional integrated gas analysis with dual-agent auto-ID, aged-based MAC values and capnography further enhance the A5’s ability to support high-acuity requirements. Safety features include a unique auxiliary oxygen and air-flow meter that delivers blended gas through the nasal cannula, decreasing the potential risk for surgical fire.

AT A GLANCE

Anesthesiology News • August 2014

Anesthesia Connectivity Connectivity or interoperability is at the core of the A-Series Anesthesia System platform. Since the government stimulus programs of ARRA and HITECH passed in 2009, the health care industry has seen the adoption of electronic health record (EHR) and anesthesia information management systems in record numbers. To this point, Mindray has been a leader, developing integrated solutions for seamless data exchange. Serial communication, Ethernet communication or both can be deployed using industry standard HL7 protocols. Through this integration, the A-Series Anesthesia Systems are well equipped to meet the interoperability requirements for integration engines and EHR systems.

Anesthesia Consumables Mindray is now a one-source provider of anesthesia equipment and consumable products, offering a competitive line of quality breathing circuits, anesthesia circuit kits, breathing masks, laryngeal airway masks, filters and gas monitoring accessories.

The DPM6 and DPM7 offer a broad range of patient monitoring capabilities in a rugged, modular design. The DPM7’s large 17-inch touchscreen display is most appealing in the operating room, where visibility and convenience are essential. The DPM6’s flexibility and modularity combine with its 12-inch touchscreen display and matching user interface to offer a complementary monitoring solution for postoperative areas. Supporting up to eight invasive pressures and features such as auto-ID of anesthetic agents, carbon dioxide, nitrous oxide and oxygen, combined with monitored anesthesia care and BIS monitoring, the DPM6 and

NORTH AMERICAN HEADQUARTERS Mindray North America 800 MacArthur Blvd. Mahwah, NJ 07430

MINDRAY GLOBAL HEADQUARTERS Keji 12th Road South High-Tech Industrial Park Nanshan, Shenzhen 518057 P.R. China

PRODUCTS AVAILABLE IN THE UNITED STATES Anesthesia delivery systems, breathing circuits, laryngeal airway masks, ultrasound imaging, full line of patient monitors, central stations, telemetry and networking solutions.

EMPLOYEES 8,000 worldwide

PRESIDENT MINDRAY NORTH AMERICA George Solomon

DPM7 represent a powerful combination of advanced functionality and extraordinary value. The newly introduced T1 Compact Transport Monitor offers a brilliant 5-inch touchscreen display and robust monitoring capabilities—all in a versatile 2-lb package.

Ultrasound Imaging Tools Mindray’s M-Series ultrasound systems are practical and effective procedural tools for anesthesia professionals. They enable visualization of target structures before and during anesthesia procedures. The M5 and M7 ultrasound systems are uniquely designed for the procedural room environment. Notable attributes include compact and durable design, a sealed surface for easy cleaning and infection control, exceptional image quality and simple and intuitive operation. The M-Series offers iNeedle needle visualization software, customizable reports and a complete on-board solution for patient information management and connectivity. Users also can select from a wide range of specialty transducers and optional features to meet clinical needs.

Learn More To learn more about how Mindray can help you realize more value in your anesthesia solutions, contact your local sales specialist at (800) 288-2121, or visit us at www.mindray.com.

This corporate profile was reviewed and approved by Mindray.

itâ&#x20AC;&#x2122;s your world Mindray provides a broad range of solutions across the peri-operative environment to support you in the care of your patients. From advanced A-Series anesthesia delivery systems, a new line of single-use breathing circuits and kits, and versatile patient monitors, to flexible transport solutions and portable ultrasound systems â&#x20AC;&#x201C; Mindray offers a world of quality, easy to use, innovative, yet affordable solutions that help simplify the challenges of your complex world.

Mindray North America, 800 MacArthur Blvd., Mahwah, NJ 07430 800.288.2121 www.mindray.com

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PACIRA PHARMACEUTICALS, INC.

acira Pharmaceuticals, Inc. is an emerging specialty pharmaceutical company focused on the clinical and commercial development of new products to address the needs of acute care practitioners and their patients. Pacira is driven by a dynamic workforce committed to optimizing patient care and satisfaction in the acute care setting, with a special focus on improving outcomes in postsurgical pain management.

A Proprietary Drug Delivery Platform The cornerstone of the Pacira product portfolio is DepoFoam®, a proprietary drug delivery platform designed to extend a medication’s duration of action without altering its molecular structure. The DepoFoam carrier matrix is made up of multivesicular liposomes that encapsulate a drug. Each chamber is separated by lipid membranes that naturally erode to release the drug over a desired period of time.

case for EXPAREL as the foundation of an opioid-sparing multimodal postsurgical pain management regimen. Recently published national and regional retrospective analyses2,3 of more than 350,000 postsurgical patients receiving opioids concluded that those who experienced opioid-related adverse events had both longer hospital lengths of stay and higher hospitalization costs. The company’s efforts are buoyed by a groundswell movement led by government and independent health care organizations to mitigate potentially fatal side effects related to opioid use by recommending a shift toward opioid-sparing pain regimens, especially in highrisk postsurgical patients.

Clinical Utility Across a Broad Range Of Potential Applications EXPAREL has broad applications across multiple surgical specialties, as well as in the anesthesiology arena, including use as an infiltration into the transversus abdominis plane for postsurgical analgesia following abdominal procedures. In May, Pacira submitted a Supplemental New Drug Application to the FDA for a nerve block indication for EXPAREL based on positive data from a Phase III study assessing the safety and efficacy of EXPAREL in femoral nerve block for total knee arthroplasty.

The Pacira Advantage

A First of Its Kind, Single-Dose Local Analgesic In 2012, Pacira successfully launched EXPAREL® (bupivacaine liposome injectable suspension), the first and only DepoFoam-based local analgesic. Indicated for administration into the surgical site to produce postsurgical analgesia, a single dose of EXPAREL provides nonopioid pain control with reduced opioid requirements for up to 72 hours* without the need for catheters or pumps.1

Shifting the Postsurgical Pain Management Paradigm The launch of EXPAREL is bolstered by a robust Phase IV clinical program, which builds a compelling

Anesthesiology News • August 2014

Discovery, innovation and proprietary expertise are the hallmarks of the Pacira competitive advantage. The company not only holds the exclusive rights and expertise to DepoFoam, but owns the unique distinction of being the only company in the world with the ability to manufacture DepoFoam-based products, such as EXPAREL, on a large commercial scale. With steadily increasing demand and a growing list of potential clinical applications, Pacira and EXPAREL are poised to become vital fixtures in the postsurgical pain management arena. For more information about Pacira Pharmaceuticals Inc., visit www.pacira.com. *Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing hemorrhoidectomy and bunionectomy procedures.

AT A GLANCE ADDRESS 5 Sylvan Way Parsippany, NJ 07054 (973) 254-3560 www.Pacira.com For more information on EXPAREL, visit www.EXPAREL.com For medical inquiries related to EXPAREL, contact Medical Information at medinfo@pacira.com or 1-855-RX-EXPAREL (1-855-793-9727)

Important Safety Information For EXPAREL EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non–bupivacainebased 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 after 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 amidetype local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk for developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting. 1. Gorfine SR, et al. Diseases of the Colon & Rectum. 2011;54(12):1552-1559. 2. Oderda GM, et al. Journal of Pain & Palliative Care Pharmacotherapy. 2013;27(1):62-70. 3. Kessler ER, et al. Pharmacotherapy. 2013;33(4):383-391. PP-EX-US-0185

This corporate profile was reviewed and approved by Pacira Pharmaceuticals, Inc.

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TELEFLEX

eleflex believes in improving the health and quality of people’s lives. We apply purpose-driven innovation—a relentless pursuit of identifying unmet clinical needs—in a way that benefits patients, providers and society. We offer practical solutions that build, nurture and strengthen the vital parts at the heart of health care. Our ARROW®, Hudson RCI®, LMA® and Rusch® brands shape our portfolio of proven medical products and technologies. These distinguished brands are united by their common sense of purpose in providing anesthesia and respiratory therapy solutions.

LMA Airway Management™ LMA Better by Design® The LMA Airway Management family of products from Teleflex has a proven track record of safety and efficacy, building on a 20-year history of innovation and trust. Each LMA® airway has been carefully designed and tested to meet exacting standards. LMA airways are included in the American Heart Association Guidelines for Resuscitation and the American Society of Anesthesiologists Difficult Airway Algorithm. The LMA Supreme® Single-Use Airway from Teleflex combines the best features of all previous LMA airways and is designed for safety and ease of use. Whether it’s for a routine procedure or to manage a higher-risk patient, the LMA Supreme Airway’s higher seal pressure and gastric access deliver a higher degree of safety. It provides gastric access to suction or to decompress the stomach if the physician so chooses, and is designed to channel fluids away from the airway in the unlikely event of active or passive regurgitation, while also allowing for diagnostic testing and verifiable positioning.

The Next Generation in One-Lung Ventilation

The Rusch® EZ-Blocker™ endobronchial blocker from Teleflex offers an intuitive, secure solution for clinicians to achieve one-lung ventilation and reduce intraoperative malpositioning. It was designed by anesthesiologists who challenged accepted clinical practices and wanted a better way to treat patients. The unique bifurcated distal end of the Rusch EZ-Blocker endobronchial blocker allows for the intuitive placement of the cuffs in the right and left bronchi. Once the Rusch EZ-Blocker endobronchial blocker is advanced through the distal end of a single-lumen endotracheal tube, the

bifurcated cuffs separate and are naturally directed into the left and right mainstem bronchi. The Rusch EZ-Blocker endobronchial blocker securely saddles the carina. The securement cap allows the catheter to be tightened once properly positioned, which minimizes the need to manipulate it after placement and reduces the potential for the cuffs to become dislodged.

Needle-Free Solutions for Drug Delivery The LMA Atomization® family of products from Teleflex provides a simple-to-use, needle-free solution for use with drugs approved for intranasal and oropharyngeal delivery. The LMA ® MAD Nasal™ intranasal mucosal atomization device is the safe, painless and rapidly effective treatment that offers quick absorption across mucosal membranes to the bloodstream. The LMA® MADgic Airway™ intubating airway with mucosal atomization and oxygen delivery is the most innovative choice to create a temporary airway to facilitate fiber-optic intubation, combining atomized topical anesthetic and oxygen delivery in an innovative and elegantly designed oral airway. The LMA® MADgic® laryngo-tracheal mucosal atomization device is the most versatile choice to administer medication across the entire upper airway and beyond the vocal cords.

Post-Op Pain Management Solutions The ARROW® FlexBlock® echogenic continuous peripheral nerve block (CPNB) catheter and the ARROW® AutoFuser® disposable pain pump from Teleflex allow clinicians to combine efficient and accurate catheter placement with a reliable, unimpeded infusion of medication. The ARROW FlexBlock CPNB catheter is an echogenic, flexible, kink-resistant catheter designed to help clinicians better control patient pain and improve overall block success. The ARROW AutoFuser disposable pain pump delivers medication safely and reliably, helping to improve patient quality of life following a procedure. The ARROW AutoFuser disposable pain pump offers the right pain pump to meet a variety of clinical demands, allowing clinicians to provide individualized patient pain control and adjust therapy as needed.

Reducing Cross-Contamination, Reducing Cost The risk for cross-contamination during intubation of the trachea exists because no perfect procedure for decontamination exists. 1 Single-use devices offer the opportunity to reduce potential for infection associated with reusable devices.

This corporate profile was reviewed and approved by Teleflex.

AT A GLANCE ADDRESS 550 E. Swedesford Rd., Suite 400 Wayne, PA 19087

PRODUCTS LMA® Airways, Rusch® EZ-Blocker™ Endobronchial Blocker, Rusch® ET Tubes and Laryngoscopes, ISO-Gard® Mask with ClearAir™ Technology, ARROW® Pain Management

EMPLOYEES 11,400

CHIEF EXECUTIVE OFFICER Benson Smith

Green Rusch® Lite™ and Rusch® EquipLite™ disposable metal laryngoscope blades are single-use blades that offer users the performance and feel of a reusable metal blade. These blades eliminate the hassles associated with reusable blades, including the time and cost of reprocessing, without sacrificing strength or light quality.

Limiting Waste Anesthetic Gas Exposure In the PACU An invisible risk exists in the postanesthesia care unit (PACU). Patients are exhaling waste anesthetic gas (WAG) into the breathing zone of their attending nurses,2 and although it cannot be detected by sight or odor, PACU clinicians can take action to protect themselves from the potential health effects. The first of its kind, the ISO-Gard® mask with ClearAir™ technology from Teleflex was developed in partnership with clinicians who identified the issue and wanted to take action. As the only solution available for “source control” of waste gases, the specialized ClearAir technology of the ISO-Gard mask simultaneously delivers oxygen to patients and scavenges their exhalation to help limit exposure faced by clinicians and minimizes the cumulative effect of low-level exposure to WAG.

References 1. Disposable laryngoscope blades do not interfere with ease of intubation in scheduled general anesthesia patients. Eur J Anaesthesiol. 2003;20:731-735. 2. Occupational Safety and Health Administration, U.S. Department of Labor. Anesthetic gases: guidelines for workplace exposures. Revised May 18, 2000. http://www.osha.gov/dts/osta/anestheticgases. EquipLite is a trademark of Truphatek International Ltd. AutoFuser is a registered trademark of Ace Medical Co., Ltd. Teleflex, ARROW, ClearAir, EZ-Blocker, FlexBlock, Green Rusch Lite, Hudson RCI, ISO-Gard, LMA, LMA Airway Management, LMA Atomization, LMA Better by Design, LMA Supreme, MAD, MAD Nasal, MADgic, MADgic Airway and Rusch are trademarks or registered trademarks of Teleflex Incorporated or its affiliates.

Anesthesiology News • August 2014

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PAR STERILE PRODUCTS, LLC “Providing patients and customers with uncompromising quality and value.” Quality You Can Depend On

The legacy of Par Sterile Products reaches back to the birth of the American pharmaceutical industry at the turn of the 20th century. With a sterile manufacturing facility located in Rochester, Mich., Par Sterile Products possesses an unparalleled reputation for high-quality products and an impeccable record of regulatory compliance. Our iconic brands, such as Aplisol® and Adrenalin®, have been relied on by physicians and patients for decades. While proud of our heritage, we are even prouder of the great things we are accomplishing today. In an injectables world frequently plagued by compliance issues and product shortages, Par Sterile Products stands as a highly regarded partner with exemplary trade service levels and an impeccable record of regulatory compliance. Every week in America, more than 1 million Par prescriptions are dispensed, including Par Sterile Products. In return for the trust that is placed in us, we are committed to providing products of uncompromising quality. In fulfilling this mission, we deliver value to our customers and the physicians and patients who rely on us.

Partners for Health Care Excellence Par Sterile Products, LLC, a subsidiary of Par Pharmaceutical, Inc., is at the forefront of developing, manufacturing, marketing and distributing safe, innovative and cost-effective branded and generic aseptic injectable pharmaceuticals that help improve patient quality

Anesthesiology News • August 2014

of life. We also provide contract manufacturing services to our partners in the biopharmaceutical and pharmaceutical industry. Today, our company’s sales, together with Par Pharmaceutical, Inc., and its other subsidiaries, place it among the top five largest generic pharmaceutical companies in the United States. At Par Sterile Products, our most important resource is the talent and dedication of our nearly 500 employees, each of whom is part of a culture that values integrity, customer focus, teamwork and performance.

AT A GLANCE ADDRESS Morris Corporate Center 2 One Upper Pond Rd., Building D, 3rd Floor Parsippany, NJ 07054

CUSTOMER SERVICE (877) 547-4547

DRUG SAFETY/MEDICAL INFORMATION (800) 828-9393 Option 3

CHIEF EXECUTIVE OFFICER Paul Campanelli

Promising Product Pipeline Par Sterile Products currently markets a portfolio of 14 specialty injectable products, including Brevital®, Dantrium®, Pitocin® and zoledronic acid. Since 2012, Par Sterile Products has launched nine new products. We possess one of the most promising new product pipelines in the injectable space, having developed a pipeline currently consisting of 34 products, 17 of which have already been submitted for FDA approval. We expect at least a half-dozen more ANDA filings before year end, fueled by our commitment to investment in research and development. At Par Sterile Products, we are large enough to maintain a significant trade presence, yet agile enough to provide maximum attention to our customers, and we remain poised to continue our impressive track record of success. For more information, please visit www.parpharm.com.

PAR—People Achieving Results!

This corporate profile was reviewed and approved by Par Sterile Products, LLC.

Par Sterile Products, LLC O u r R a p i d y G row i n g P ro d u c t L i n e I n c l u de s

Dantrium IV ÂŽ

(dantrolene sodium for injection)

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NDC 42023-123-06

Name DantriumÂŽ IV (dantrolene sodium for injection)

Strength 20 mg

Vial Size 70 mL SDV

Unit of Sales 6

For more information on DantriumÂŽ IV and for Full Prescribing Information please visit www.dantrium.com. DantriumÂŽ is a registered trademark of Par Sterile Products, LLC.

PSPB00 0028

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SPACELABS HEALTHCARE

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

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

Spacelabs Healthcare is dedicated to developing and supporting those tools.

Spacelabs Healthcare Collaborates With Clinicians To Provide Clinically Relevant Products Spacelabs Healthcare values the strong clinical partnerships that we have developed and maintained over the past half-century. Through continuous and effective communication with clinical user groups, we gather a deep understanding of needs and requirements in order to develop solutions to help clinicians achieve their goals. Always a leader in innovation with accessibility, continuity and partnership, Spacelabs Healthcare delivers on our promises to: • Help improve patient care. • Help clinicians achieve their goals. • Demonstrate honesty, reliability and integrity. • Deliver quality products and service, service, service.

Excellence in Customer Service and Support

AT A GLANCE ADDRESS 35301 SE Center St. Snoqualmie, WA 98065 (425) 396-3300 www.spacelabshealthcare.com marketing@spacelabs.com

PRESIDENT AND CEO Nicholas Ong

When selecting a perioperative solutions company, consider Spacelabs’ experience and heritage of innovative and intuitive products developed in partnership with our customers to address real-life clinical needs. Our customer-first philosophy reflects our commitment to superior care for you and your patients as well as product support by our award-winning service team.

At Spacelabs Healthcare, excellence in customer service and support are not just words; they are values, embraced by all our employees, that shape the way that we do business. As a result, IMV ServiceTrak™, one of the most respected surveys in the health care industry, ranked Spacelabs “Best for Overall Service Performance among Industry Peers” in 2011 for the second consecutive year, and three of the last six years. We work cooperatively to develop long-term relationships with our suppliers, our distribution partners and our customers to provide the products, tools and services you need. Spacelabs is a focused, agile organization that is here to serve health care professionals worldwide. Our goal is to provide our customers more time to care. Customer loyalty is our reward.

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

Anesthesiology News • August 2014

This corporate profile was reviewed and approved by Spacelabs Healthcare.

Because You and Your Patients are Worth It. Welcome to ARKON™, our “evolutionary” new anesthesia delivery system that features an expandable clinical console which extends out to enable a wide-angle view of the clinical setting. Get closer to your patients. Get a closer look. Request a demonstration today.

*()+ KhY[]dYZk @]Ydl`[Yj] Kh][aÚ[Ylagfk kmZb][l lg [`Yf_] oal`gml fgla[]&

2014-2015

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TEAMHEALTH ANESTHESIA

eamHealth Anesthesia is a nationally recognized provider of comprehensive anesthesia services. Our proven service platform is specifically designed to optimize quality of care; patient and surgeon satisfaction; and operational efficiency. TeamHealth’s 35 years of success in providing local physician partners is built on supporting our providers so they can concentrate on taking care of every patient they see and supporting success in each department we serve. TeamHealth providers care for more than 12 million patients per year, giving us the expertise to hardwire both clinical and operational best practices. With extensive experience as anesthesia providers, business managers and hospital/medical staff leaders, the TeamHealth Anesthesia leadership team is unsurpassed in helping improve the performance of their anesthesia departments. Whether augmenting an existing anesthesia group or forming a new one, TeamHealth Anesthesia provides customized solutions and first-rate specialists. In fact, we are anesthesia industry leaders in: • Surgeon satisfaction • Quality and metric performance, measurement and reporting • Patient safety • Recruitment and retention of anesthesiologists and certified registered nurse anesthetists (CRNAs) • Operating room (OR) efficiency • Group management and leadership • Billing, collections and credentialing

Your Career Will Thrive With TeamHealth Anesthesia Founded by anesthesiologists, TeamHealth Anesthesia uniquely understands the needs and expectations of anesthesiologists and CRNAs. Our solid reputation in the provider community allows us to partner with the best anesthesia clinicians in the market, creating stable, top-notch groups for our hospital and surgeon partners. To continue our success, we need leading clinicians like you to be part of our team.

Anesthesiology News • August 2014

ADDRESS 7111 Fairway Dr., Ste. 450 Palm Beach Gardens, FL 33418 (877) 799-3552 anesthesiajobs@teamhealth.com www.teamhealth.com

• Nurture your professional interests while advancing your career • Receive a highly competitive salary with benefits and performance incentives • Choose from coast-to-coast nationwide practice opportunities • Practice medicine without the daily burdens of managing a practice • Focus on what matters most to you—patient care

SERVICES TeamHealth Anesthesia is one of the nation’s leading outsourced anesthesia and pain management service organizations—specializing in delivering high-quality, cost-effective and servicefocused patient care.

Best of all, when you’re part of our “team,” we’ll provide unparalleled resources that will help you be one of the best anesthesia professionals in the nation. Through timely risk management and our leadership skills education programs like LEAD™, the TeamHealth Leadership Development Institute™ and others, you’ll discover that we care as much about your career and quality of life as you do.

•

Anesthesia Care Team

•

Anesthesia programs nationwide are moving from the physician-only anesthesia service delivery models to mixed-care team models with both physicians and CRNAs. TeamHealth Anesthesia has extensive experience in the anesthesia care team (ACT) model and has successfully transitioned numerous physician-only models to ACT models. Our experience has shown us that the benefits of the ACT model include improved practice efficiencies, increased revenue and profits, standardization of care, flexibility and increased patient and surgeon satisfaction. Always sensitive to the needs of surgeons and the hospitals we serve, TeamHealth Anesthesia implements the following transition activities with minimal disruption to the existing anesthesia program:

Coast-to-Coast Opportunities Your perfect practice is waiting for you at TeamHealth Anesthesia. We have practices throughout the United States, so whether you’re looking for cities, suburbs, mountains or beaches, we have the practice you want, where you want, just waiting for you to make

AT A GLANCE

it your own. Our partner hospitals range from community hospitals in comfortable bedroom townships to major medical centers and teaching facilities in urban areas. With a wide variety of practice environments and case mixes as well as varying anesthesia delivery models—from direct anesthesia care to anesthesia care teams—you’ll find opportunities to:

• Recruit anesthesia medical directors who possess a strong customer service mindset, support their respective hospital’s vision and goals, communicate with surgeons to ensure mutual understanding of the ACT model to be implemented, have experience

•

• •

working with CRNAs and create positive group cultures. Recruit and retain a core group of physicians and CRNAs. Provide team-building workshops with anesthesia providers, surgical leadership and the hospital executive team. Appoint an internal chief CRNA to help physicians and CRNAs work as a team. Leverage TeamHealth’s national customer service training programs to improve satisfaction scores. Implement daily anesthesia “team huddles” to ensure all processes are properly in place for surgeries and patients scheduled for the next day.

By implementing the ACT model, our client hospitals see faster room turnovers as well as drastically improved efficiency and reduced costs.

The Right Job. The Right Place. The Right Partner. TeamHealth Anesthesia is one of the nation’s leading outsourced anesthesia organizations. Specializing in delivering high-quality, cost-effective and servicefocused patient care, our services maximize OR performance while increasing patient and surgeon satisfaction. For more information, visit us online at www. teamhealth.com, call (877) 799-3552, or email anesthesiajobs@teamhealth.com.

This corporate profile was reviewed and approved by TeamHealth Anesthesia.

“We wanted clinical autonomy, ﬁnancial reward, and a partner with experience and size. TeamHealth gave us the whole package.”

~Alan Gwertzman, M.D. Teaneck, NJ

Is it time to consider a sale or merger? Rich Berube 865.293.5638 or Janette Stephenson 954.377.2924 rich_berube@teamhealth.com

janette_stephenson@teamhealth.com

TeamHealth Anesthesia is the premier partner for anesthesia groups. It is part of TeamHealth, one of the largest providers of outsourced physician services offering integrated clinical solutions to hospitals in the areas of emergency medicine, hospital medicine, specialty hospitalists, anesthesia, urgent care and pediatrics. teamhealthanesthesia.com

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MCMAHON PUBLISHING

cMahon Publishing was founded in 1972 by Raymond E. McMahon and has grown to become one of the nation’s largest family-owned medical publishers. McMahon publishes a broad array of medical newsmagazines in various specialties, including anesthesiology, gastroenterology, general surgery, hospital and specialty pharmacy, infectious diseases, pain medicine and oncology. The combined circulation of McMahon publications is approximately 300,000 doctors and pharmacists. Foremost among McMahon publications is Anesthesiology News. Now in its 40th year, Anesthesiology News has been the best-read publication for the specialty for the past 17 years (according to Kantar Media). Nearly 93% of the 47,524 U.S.-based anesthesiologists read this publication each month. McMahon newsmagazines are accompanied by a full line of digital media, including websites, mobile sites, iPad apps, e-newsletters, digital editions, multimedia, social media and other digital communications.

AT A GLANCE

McMahon publishes: •

ADDRESS

Anesthesiology News • Anesthesiology News Buyer’s Guide • Anesthesiology News Guide to Airway Management • Anesthesiology News Special Edition

545 W. 45th St., 8th Floor New York, NY 10036 (212) 957-5300 www.mcmahonmed.com www.anesthesiologynews.com @anesthesianews

•

Clinical Oncology News

•

Gastroenterology & Endscoscopy News

•

General Surgery News

•

Infectious Disease Special Edition

•

Pain Medicine News

•

Pharmacy Practice News

•

Specialty Pharmacy Continuum

anesthesiologynews

PRODUCTS Medical newsmagazines, custom medical publications, educational reviews, special editions, podcasts, pocket guides and more.

EMPLOYEES 60

PUBLISHER AND MANAGING PARTNER Raymond E. McMahon

GENERAL MANAGER, PARTNER Matthew McMahon

ANESTHESIOLOGY NEWS Editorial Director James Prudden Senior Group Publication Director Richard Tuorto Manager, Publication Sales Angela Labrozzi Production Manager Martin Barbieri Art Director Blake Dennis

BUYER’S GUIDE

Anesthesiology News • August 2014

SPECIAL EDITION

This corporate profile was reviewed and approved by McMahon Publishing.

for iPad Download the iPad app from the best-read anesthesiology publication in the United States

Optimized for mobile devices

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@anesthesianews anesthesiologynews

42 I AnesthesiologyNews.com

AUGUST 2014

PAIN MEDICINE bromide (Relistor, Salix) and alvimopan (Entereg, Cubist), with good results. The advisory committeeâ&#x20AC;&#x2122;s conlong-term studies, the market would clusion â&#x20AC;&#x153;was the outcome I was hopbe very limited.â&#x20AC;? ing for,â&#x20AC;? he said. â&#x20AC;&#x153;Thereâ&#x20AC;&#x2122;s not really Many physicians are unaware that enough evidence that these long-term these drugs are available, while oth- safety trials would be required. Iâ&#x20AC;&#x2122;m ers have been concerned about car- now optimistic that additional drugs diovascular risk, said Dr. Viscusi, who will become available for a very unmet noted he has frequently prescribed need in the chronic pain community.â&#x20AC;? the two FDA-approved peripherDivided Panel ally acting Îź-opioid receptor antagoIn a close decision following a nists (PAMORAs), methylnaltrexone

OIC

CONTINUED FROM PAGE 1

lengthy meeting in June, 12 of thee 24 panelists on the FDAâ&#x20AC;&#x2122;s Anessthetic and Analgesic Drug Productts Advisory Committee voted againsst requiring cardiovascular outcomes trrials; seven recommended the agencyy require trials for all PAMORAs andd five recommended the agency requiree trials for Entereg and similar biologgics. The group largely agreed that carrdiovascular studies can be conductedd as postmarketing surveillance, with h the exception of alvimopan, and theyy

â&#x20AC;&#x2DC;Whether the [cardiovascular] signal is true or not, it is a signal about a major complication for an elective medication, and therefore it must be studied carefully. I do trust that the FDA will come to a fair, equitable decision to this dilemma.â&#x20AC;&#x2122; â&#x20AC;&#x201D;Mitchell Cappell, MD, PhD

Rationale, Reversal, and Recovery Of Neuromuscular Blockade Part 2: Ongoing Challenges and Opportunities Case Study Dennis is a 68-year-old man undergoing open abdominal surgery (colectomy). Current Symptoms Â&#x2021; Dyspnea Vital Signs Â&#x2021; Height: 175 cm Â&#x2021; Weight: 85 kg 6LJQLÂżFDQW 0HGLFDO +LVWRU\ Â&#x2021; Hypertension Â&#x2021; Congestive heart failure Â&#x2021; Obstructive sleep apnea &XUUHQW 0HGLFDWLRQV Â&#x2021; Metoprolol 100 mg PO Â&#x2021; Ramipril 2.5 mg PO Laboratory Results Â&#x2021; Apnea hypopnea index: 26/h Â&#x2021; Left ventricular ejection fraction: 30%-35% Anesthesia is induced with sufentanil, propofol, and 0.6 mg/ kg rocuronium based on total body weight and maintained ZLWK GHVĂ&#x20AC;XUDQH LQ DLU R[\JHQ DQG VXIHQWDQLO 6XUJLFDO FRQGLWLRQV DUH GLIÂżFXOW ZLWK D ODFN RI DEGRPLQDO ZDOO PXVFOH relaxation and poor paralysis. An extra dose of rocuronium is administered for deeper neuromuscular block (NMB), and fewer than 2 train-of-four (TOF) responses are noted.

Global Education Group and Applied Clinical Education are pleased to introduce part 2 of a 3-part interactive CME series featuring challenging cases in NMB. Each activity presents a clinical scenario that you face in your daily practice. After reading the introduction to the case, consider the challenge questions, and then visit ZZZ &0(=RQH FRP QPE WR ÂżQG out how your answers stack up against those of our multidisciplinary faculty panel. Access the activities on your desktop, laptop, or tablet to explore the issues surrounding safe, effective, NMB reversal via a unique multimedia learning experience and earn 1.0 AMA PRA Category 1 Credit.â&#x201E;˘ Complete the whole series and earn a total of 3.0 AMA PRA Category 1 Credits.â&#x201E;˘ This activityâ&#x20AC;&#x2122;s distinguished faculty

6RULQ - %UXOO 0' Professor of Anesthesiology Mayo Clinic College of Medicine Jacksonville, Florida

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Challenge Questions 1. What would you do if, at the end of the case, the TOF count is zero? 2. What would you do if, at the end of the case, the TOF count is 2?

Medical Director, Manager New Medical Center Nancy, France

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should last at least a year to sufficiently assess long-term outcomes. Both alvimopan and methylnaltrexone bromide are approved only for specific situations. Alvimopan is restricted to hospitalized patients with postoperative ileus and capped at 15 doses, and only hospitals that register in the Entereg Access Support and Education (E.A.S.E.) program may offer the drug. Methylnaltrexone bromide is approved for short-term treatment in patients with advanced illness receiving palliative care. Alvimopanâ&#x20AC;&#x2122;s restrictions stem from data from one clinical trial by former manufacturer GlaxoSmithKline, which hinted at an increased risk for myocardial infarction (MI) associated with the drug. In that study, from the mid2000s, seven patients taking alvimopan experienced MIs, compared with none taking placebo. â&#x20AC;&#x153;Whether the [cardiovascular] signal is true or not, it is a signal about a major complication for an elective medication, and therefore it must be studied carefully,â&#x20AC;? said Mitchell Cappell, MD, PhD, section head of gastroenterology and hepatology at William Beaumont Hospital, in Royal Oak, Mich. â&#x20AC;&#x153;I do trust that the FDA will come to a fair, equitable decision to this dilemma.â&#x20AC;? During the meeting, committee members heard from pharmaceutical companies Cubist, Salix, AstraZeneca/Nektar (manufacturer of naloxegol/Movantik, which is under review

AUGUST 2014

AnesthesiologyNews.com I 43

PAIN MEDICINE if the signal had a plausible biological explanation. Overall, the committee felt there was a signal, although moderate at most, from alvimopan and that there was insufficient information to determine the presence or absence of a class effect. Dr. Cappell, who voted in favor of outcomes trials, said at the meeting that his decision would depend on cost. Randomized controlled trials can be “overly aggressive,” he noted, so he advocated for postmarketing

observational studies. But Milton Packer, MD, professor and chair of clinical sciences at the University of Texas Southwestern Medical Center, in Dallas, said trials are always feasible. An estimated 116 million Americans are in chronic pain, he said. Of those 116 million, 16% take opioids—and many of them wind up constipated and in need of treatment. “We routinely ask sponsors for cardiovascular outcomes trials when the consequences are a lot smaller than

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for FDA approval), Theravance (manufacturer of investigational PAMORA axelopran), Develco Pharma Schweiz (manufacturer of naloxone, approved for opioid overdose) and several physician consultants paid by the manufacturers. Manufacturers presented clinical trial data on their respective medications. Only alvimopan was shown to have any link to MI, and only in one trial testing the medication for long-term use. Cubist is not pursuing long-term use of the drug. Bill McCarberg, MD, a consultant and president-elect of the American Academy of Pain Medicine, noted that although opioids are “lifesavers,” OIC is prevalent and laxatives often are not effective. William Mezzanotte, MD, MPH, vice president for global medicines development at AstraZeneca, said the imbalance in MI seen with alvimopan has not been observed in any other trial of alvimopan, in trials of other PAMORAs or in the literature. “PAMORAS that demonstrate a favorable risk–benefit profile in Phase III studies can be safely approved for the treatment of chronic OIC in patients with noncancer pain without the need for cardiovascular outcomes trials,” Dr. Mezzanotte said. For several hours, panelists debated whether the presented data suggested the presence of a cardiovascular safety signal associated with the drugs, whether the signal related to just alvimopan versus all PAMORAs and

this one,” he said. Sonia Hernández-Díaz, MD, DrPH, director of the pharmacoepidemiology program at the Harvard School of Public Health, in Boston, questioned whether the panel would have been convened at all except for the single, unreplicated GlaxoSmithKline trial. There is no word yet on when the FDA will make its decision. “We cannot comment on future rulemaking,” said spokesman Jeff Ventura. —Karen Blum

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44 I AnesthesiologyNews.com

AUGUST 2014

CLINICAL ANESTHESIOLOGY

Database Probe Reveals Fear of Residual Motor Block San Francisco—When it comes to neuromuscular blockade, anesthesiologists often find themselves caught between the desire to provide optimal surgical conditions and the fear of residual paralysis. A study by a group of Merck researchers has concluded that fear might be winning out, as the last administration of neuromuscular blocking agents (NMBAs) seems to be occurring at a point that can result in low levels of neuromuscular blockade toward the end of surgery. “Our goal for this retrospective cohort analysis was to establish some information on nondepolarizing neuromuscular blocking agents and their utilization and timing relative to reversal agents and the end of anesthesia,” said Scott Devine, PhD, an outcomes research scientist at Merck, based in Whitehouse Station, N.J. Merck is hoping to win FDA approval for its NMBA reversal agent, sugammadex, which is available outside the United States, but the agency has repeatedly called for more study of the drug. Dr. Devine and his colleagues studied rocuronium and vecuronium use within the National Anesthesia Clinical Outcomes Registry’s (NACOR) anesthesia information management system subset. As part of the analysis, the researchers determined the mean, standard deviation, and minimum and maximum number of minutes from last NMBA administration to the administration of a reversal agent or the end of anesthesia (Table). Using these time points, the investigators

quality of abdominal wall closure.” Leif Saager, MD, assistant profesPatients, sor of anesthesiology at Cleveland n Clinic, in Ohio, recognized that this is a widespread phenomenon among 106,323 anesthesiologists. “Anesthesiologists are hesitant to 147,724 give muscle relaxants at the end of the case,” Dr. Saager said. “Because everybody knows that once the surgery is done, you need to reverse and extubate the patient. So if you keep the patient completely relaxed until the very last moment—which is what the surgeon wants—it means you have to reverse the patient from a very deep level, and immediately extubate them. And we’ve seen that patients get extubated even though there is still a significant amount of muscle relaxant on board. “I think there are a couple of reasons for this,” Dr. Saager continued. “First, we don’t have an established way of monitoring neuromuscular blockade. Second, the dosing of muscle relaxants is very tricky and not very well defined. So if you don’t have a good way of measuring it, people become hesitant and either underdose or overdose. It is very challenging to get it right.” Dr. Devine reported the findings at the 2013 annual meeting of the American Society of Anesthesiologists (abstract 1050). —Michael Vlessides

Table. Timing of Last Neuromuscular Blocking Agent Mean, min

Standard Minimum/ Deviation, Maximum, min min

Administration of reversal agent

34.37

0-166

Anesthesia end

39.42

0-196

estimated the percentage of patients likely to have had a reappearance of the train-off four count to 2 (T2). If the last administration of NMBA was more than 30 minutes before the time point of interest, the patient was considered at T2 or greater. All procedures were performed between Jan. 1, 2010, and Sept. 2, 2012. Based on the timing of administration of the neuromuscular blocker, the investigators observed that 87% of patients had likely achieved a train-off four state of T2 or greater at the time of reversal agent administration. “We were surprised by both the very large standard deviation and the extensive distribution,” Dr. Devine said. Given the relatively late time that the last NMBA is being administered, Dr. Devine hypothesized that low levels of neuromuscular blockade may be occurring toward the end of many surgical procedures. “Theoretically,” he said, “this could compromise some technical aspects of the surgery, such as the

Remifentanil an Option for Conscious Sedation But risk for respiratory effects warrants closely controlled setting

n increasing number of procedures either do not require general anesthesia or are performed in patients too fragile to tolerate it, opening the door to increased use of conscious sedation, particularly with a fast-onset/fast-offset drug. An observational study by a team of French investigators has concluded that target-controlled infusion with remifentanil is appropriate for conscious sedation, even in fragile patients or for long-duration procedures. They noted, however, that a risk for respiratory depression suggests that the approach be used only in a controlled environment with continuous monitoring. “Conscious sedation using remifentanil makes sense in cases of narrow therapeutic window, especially when administered as a target-controlled infusion,” said Valerie Billard, MD, professor of anesthesiology at Institut Gustave Roussy, in Villejuif. The trial included 91 patients, all

of whom required conscious sedation with spontaneous ventilation for procedures including hepatic embolization or chemoembolization, gastrointestinal endoscopy and skin surgery. The average duration of sedation was 69±53 minutes, and 13 cases lasted longer than 120 minutes. Each patient received a targetcontrolled infusion of remifentanil, with an initial target of 2 ng/mL. “We increased the target if the patient complained of pain or was agitated,” Dr. Billard said. “We decreased the target if we observed low respiratory rate, hypoxemia, bradycardia or hypotension.” Assisted ventilation, atropine, ephedrine and propofol were all kept at hand if adjusting the target did not allow the procedure to be completed. As Dr. Billard reported at the 2013 annual meeting of the American Society of Anesthesiologists (abstract 2127), procedures were successfully completed with remifentanil in 86 patients. Four patients required a bolus

of propofol to quell agitation; one was converted to general anesthesia. “Respiratory depression is a main concern,” Dr. Billard noted, “and 37% of patients had at least one episode of respiratory rate below eight [breaths] per minute. But most of the time it was of very brief duration, and could be reversed by verbal command, light stimulation or by decreasing the target.” Two patients required brief assisted ventilation; SpO2 in one patient dropped below 90%. No patient required atropine or ephedrine. “Remifentanil is really suitable for this kind of conscious sedation in fragile patients,” Dr. Billard said. “Failure of sedation remains possible, however, and respiratory depression is not rare and suggests that this technique should be limited to a controlled environment.” Evan D. Kharasch, MD, PhD, the Russell D. and Mary B. Shelden Professor of Anesthesiology at Washington University in St. Louis, said the

study identified the growing demand for conscious sedation and the desire for drugs with rapid onset and offset, which is most commonly achieved with sedative-hypnotics such as propofol and benzodiazepines. “While remifentanil did achieve sedation, there was also a high incidence of respiratory depression, which, while generally brief and treated with patient stimulation or changing infusion rates, required ventilatory assistance in a few patients, while others needed propofol for agitation or conversion to general anesthesia,” Dr. Kharasch said. “As the authors identified, failure of sedation was a real possibility, a controlled environment is critical and skilled practitioners are needed in attendance at all times. “Thus,” Dr. Kharasch added, “the technique of using [remifentanil] only for conscious sedation would appear to need improvement prior to widespread and safe implementation.” —Michael Vlessides

AUGUST 2014

AnesthesiologyNews.com I 45

CLINICAL ANESTHESIOLOGY

Topical Tranexamic Acid Blunts Blood Loss After TKA

topical application of tranexamic acid (TXA) after surgery is a simple, effective way to reduce blood loss, transfusions and the risk for systemic side effects, researchers have found. Normally given orally or intravenously, TXA has been used successfully in a variety of surgeries to prevent the dissolution of blood clots, but some clinicians are still hesitant about administering the drug. “There was a big fear in the orthopedic community about the side effects of TXA increasing the risk for thromboembolic complications, namely venous thrombosis and pulmonary embolism,” study leader Sattar Alshryda, MBChB, consultant trauma and orthopedic surgeon at Royal Manchester Children’s Hospital, in Manchester, United Kingdom, told Anesthesiology News. Dr. Alshrydaa and his colleagues conducted a double-blind, randomized controlled trial with 157 patients to test for blood loss. According to the study,

approximately one-third of patients undergoing knee replacement procedures in England and Wales in 2008 required one to three units of blood. “Joint replacement necessitates allogeneic blood transfusion, which remains a concern for patients and health care providers due to the potentially serious complications of transfusion and cost implications,” Dr. Alshrydaa said. Patients had either a 50-mL saline solution containing 1 g of TXA or a placebo sprayed into their wounds after surgery. The researchers found that topical TXA reduced the absolute risk for blood transfusion by 15.4%. One patient in the TXA group received two units of blood; 32 units were given to 13 patients in the placebo group. Patients who received TXA lost less blood and had shorter hospital stays— 1.2 days shorter, on average—than those in the placebo group, according to the researchers. Their care cost an average of $561 less, as well. The TXA cost $3.70. Knee replacement surgery is

becoming increasingly common in the United States, with costs mirroring its growth. In 2000, surgeons performed 328,122 total knee procedures, according to data from the Agency for Healthcare Research and Quality. That number jumped to 719,000 in 2010. During that decade, the mean length of stay decreased from 4.2 to 3.3 days, whereas mean costs increased from $23,315 to $49,558. But Stavros G. Memtsoudis, MD, an attending anesthesiologist at the Hospital for Special Surgery, in New York City, said reducing costs should not be the driving factor for increasing the use of topical TXA. He said studies have shown—and some clinicians have bought into the idea—that TXA is effective in reducing blood transfusions, but the drug is not given to all patients due to safety issues. “The big question, really, is why doesn’t everyone get it? And the answer to that would be because the safety data are still really difficult to come by. Because to determine safety,

Celebrating 25 Years Improving Patient Outcomes and Reducing the Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications.

you require much bigger studies,” Dr. Memtsoudis said. He said the Hospital for Special Surgery administers TXA topically and intravenously, and that topical use has become more popular in recent years because it is believed “to reduce the dosage that the patient gets exposed to systemically that could cause clotting compared to giving it through the IV.” Dr. Memtsoudis said while he has not seen any side effects so far, any use of the drug might increase the risk for clotting—bringing into question whether the benefits outweigh the risks. Blood loss is important to consider, he said, because of its associated complications. Use of TXA, despite the potential side effects, can prevent these problems. “While you may have an increase on one side, you’re also going to have a decrease on the other side through a reduction of blood loss,” he said. —Martin Leung

46 I AnesthesiologyNews.com

AUGUST 2014

PRN VTE

CONTINUED FROM PAGE 1

study author Mila H. Ju, MD, MS, a clinical scholar with the American College of Surgeons (ACS) and a vascular surgery resident at Northwestern University, in Chicago, after presenting the study at the 2014 annual meeting of the American Surgical Association. VTE is a controversial quality-off care measure included in many quality improvement programs and public reporting initiatives. The CMS deemed VTE a “never event” that will not be additionally reimbursed after certain operations. Beginning in 2015, VTE occurrence will be tied to financial penalties through the CMS Value-Based Purchasing Initiative. But clinicians have criticized the VTE outcome measure, arguing that these events do not reflect poor hospital care. Some evidence backs up this argument. A previous study from the Surgical Outcomes and Quality Improvement Center at Northwestern University found that hospitals with higher rates of VTE perform more imaging studies than other hospitals (JAMA ( 2013;310:1482-1489). That report, however, was criticized for its use of Medicare administrative data, which provide limited information about preoperative risk factors and exclude VTE events that occur in the post-discharge period. Administrative claims data also have higher falsepositive and false-negative rates. Dr. Ju and her colleagues designed the new study to overcome problems in previous studies. They used ACS National Surgical Quality Improvement Program (NSQIP) data reported by 208 hospitals in 2009 and 2010. Patients in the study underwent 11 major surgical procedures associated with higher VTE rates. The data set included more than 30 patient factors for risk adjustment. The analysis confirmed the previous study’s finding: VTE events in the first 30 days after surgery occurred more often at hospitals that performed more imaging studies. Hospitals in the lowest quartile for imaging reported a VTE rate of 1.13%, whereas those in the highest quartile reported a rate of 1.91% (P<0.001). This trend persisted for VTE events that occurred only during the hospital stay. Samuel R.G. Finlayson, MD, MPH, chair of surgery at the University of Utah, in Salt Lake City, said the study raises important questions about how quality is measured. “While comparing hospitals based on their rates of adverse outcomes appears, on the surface, to be a simple and fair approach, it turns out that quality in health care is much more complicated than that,” Dr. Finlayson said. “The problems that the authors have uncovered related to VTE rates strengthen the argument of those who believe that outcome-based, pay-for-performance programs are not ready for prime time.” He noted that the research leaves some questions unanswered, such as why these hospitals conduct additional imaging tests. VTEs occur too infrequently to be used as a quality measure, said Hiram C. Polk, MD, professor of surgery at the University of Louisville, in Kentucky. He pointed to research from his department and the University Health Consortium, showing that deep

vein thrombosis and pulmonary embolism occur rarely after major elective surgery, around or below 1%. Moreover, VTE rates failed to improve after widespread implementation of the 2004 guidelines calling for more pharmacologic prophylaxis of VTE ((Ann Surg 2011;253:215-220). “Industry has funded studies that overestimate the true VTE rate, and that has put the focus on potential hazardous prophylaxis and less on the clinical

KEY POINTS A previous study from the Surgical Outcomes and Quality Improvement Center at Northwestern University found that hospitals with higher rates of VTE perform more imaging studies than other hospitals (JAMA 2013;310:1482-1489). In the current study, VTE events in the first 30 days after surgery occurred more often at hospitals that performed more imaging studies. Hospitals that used VTE imaging more often were also those most likely to adhere to Surgical Care Improvement Project’s VTE prophylaxis guidelines. This may reflect an assumption that increased imaging intensity is associated with better quality.

significance of VTE. So we’re not focusing on the right thing, and these types of quality measures aren’t going to improve quality in hospitals. This is the wrong target.” This study suggested that certain hospital characteristics are associated with higher rates of VTE imaging. The characteristics included teaching intensity at a hospital and accreditations such as that of the Joint Commission. Other significant drivers included a hospital’s medicolegal risk environment according to the CMS malpractice geographic practice cost index, and greater hospital market competition. Hospitals that used VTE imaging more often were also those most likely to adhere to Surgical Care Improvement Project’s VTE prophylaxis guidelines. This may reflect an assumption that increased imaging intensity is associated with better quality, Dr. Ju said. In this study, VTE imaging use rates were calculated from Medicare claims, and VTE prophylaxis adherence data were obtained from CMS’ Hospital Compare. Hospitals showed considerable variation in VTE imaging, with a threefold increase from the lowest quartile at 5.3%, to 16% in the highest quartile. The authors acknowledged that the study had limitations, because it only examined ACS NSQIP hospitals and inpatient VTE imaging use rates were for Medicare patients. —Christina Frangou

Precedex has a different mechanism of action. The ﬁrst and only alpha2 agonist indicated for sedation.1-3

Precedex exerts sympatholytic effects. Reduces the sympathetic stress response.1 May be used in conjunction with vasopressors.1

Precedex maintains respiratory stability. Maintains consistent respiratory rates and oxygen saturation before, during and after extubation without discontinuing the sedative.4-6 Does not have to be discontinued prior to extubation.1

Patients may be arousable from a sedative state when stimulated. May be able to interact with clinicians and complete cognitive and pulmonary function assessments.1,7,8

Reduces the need for opioids while maintaining patient comfort.1,4,9,10 In a randomized, open-label, multicenter trial of 295 adults undergoing CABG surgery, the mean dose of morphine needed for adequate postoperative analgesia was 4 times less in patients sedated with Precedex than in patients sedated with propofol.4 Only 28% of patients receiving Precedex-based sedation required morphine for postoperative pain compared to 63% of patients receiving propofol-based sedation during assisted ventilation.4

Precedex Indications and Usage Precedex is indicated for: • Sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Administer Precedex by continuous infusion not to exceed 24 hours. • Sedation of non-intubated patients prior to and/or during surgical and other procedures.

Precedex Important Safety Information • Monitoring: Continuously monitor patients while receiving Precedex. • Bradycardia and Sinus Arrest: Have occurred in young healthy volunteers with high vagal tone or with different routes of administration, e.g., rapid intravenous or bolus administration. • Hypotension and Bradycardia: May necessitate medical intervention. May be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension, and in the elderly. Use with caution in patients with advanced heart block or severe ventricular dysfunction. • Co-administration with Other Vasodilators or Negative Chronotropic Agents: Use with caution due to additive pharmacodynamic effects. • Transient Hypertension: Observed primarily during the loading dose. Consider reduction in loading infusion rate. • Arousability: Patients can become aroused/alert with stimulation; this alone should not be considered as lack of efficacy. • Prolonged exposure to dexmedetomidine beyond 24 hours may be associated with tolerance and tachyphylaxis and a dose-related increase in adverse events. • The most common adverse reactions (incidence > 2%) are hypotension, bradycardia, and dry mouth.

Please see adjacent pages for the Brief Summary of Prescribing Information.

Hospira, Inc., 275 North Field Drive, Lake Forest, IL 60045 P14-0252-5, 10.5x13, Jun., 14

1. Precedex [package insert]. Lake Forest, IL: Hospira, Inc; 2013. 2. Richards G, Schock P, Haefely W. Benzodiazepine receptors: new vistas. Sem Neurosci. 1991;3(3):191-203. 3. Vanlersberghe C, Camu F. Propofol. In: Schuttler J, Schwilden H, eds. Modern Anesthetics: Handbook of Experimental Pharmacology 182. Berlin, Germany: Springer-Verlag; 2008:227-252 4. Herr DL, Sum-Ping STJ, England M. ICU sedation after coronary bypass graft surgery: dexmedetomidine-based versus propofol-based sedation regimens. J Cardiothorac Vasc Anesth. 2003:17(5):576-584. 5. Venn RM, Hell J, Grounds RM. Respiratory effects of dexmedetomidine in surgical patient requiring intensive care. Crit Care. 2000;4(5):302-308. 6. Data on ﬁle. Hospira, Inc. Protocol W99-302 7. Hall JE, Uhrich TD, Barney JA, et al. Sedative, amnestic, and analgesic properties of small-dose dexmedetomidine infusions. Anesth Analg. 2000;90(3): 699-705. 8. Data on ﬁle. Hospira, Inc. Protocol DEX-97-028 9. Martin E, Ramsay G, Mantz J, et al. The role of the a2-andrenoceptor agonist dexmedetomidine in postsurgical sedation in the intensive care unit. J Intensive Care Med. 2003;18(1):29-41. 10. Candiotti KA, Bergese SD, Bokesch PM, et al. Monitored anesthesia care with dexmedetomidine: a prospective, randomized, double-blind, multicenter trial. Anesth Analg. 2010;110(1):47-56.

BRIEF SUMMARY OF PRESCRIBING INFORMATION PLEASE SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION.

Precedex™ (dexmedetomidine hydrochloride) Injection For intravenous use.

Precedex

™

(dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection

Rx Only

6 ADVERSE REACTIONS 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reﬂect the rates observed in practice. Use of Precedex has been associated with the following serious adverse reactions: • Hypotension, bradycardia and sinus arrest [see Warnings and Precautions (5.2)] • Transient hypertension [see Warnings and Precautions (5.3)] Most common treatment-emergent adverse reactions, occurring in greater than 2% of patients in both Intensive Care Unit and procedural sedation studies include hypotension, bradycardia and dry mouth. Intensive Care Unit Sedation Adverse reaction information is derived from the continuous infusion trials of Precedex for sedation in the Intensive Care Unit setting in which 1007 adult patients received Precedex. The mean total dose was 7.4 mcg/kg (range: 0.8 to 84.1), mean dose per hour was 0.5 mcg/kg/hr (range: 0.1 to 6.0) and the mean duration of infusion of 15.9 hours (range: 0.2 to 157.2). The population was between 17 to 88 years of age, 43% ≥65 years of age, 77% male and 93% Caucasian. Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 1. The most frequent adverse reactions were hypotension, bradycardia and dry mouth [see Warnings and Precautions (5.2)]. Table 1: Adverse Reactions with an Incidence >2%—Adult Intensive Care Unit Sedation Population <24 hours*

1 INDICATIONS AND USAGE 1.1 Intensive Care Unit Sedation Precedex™ is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Precedex should be administered by continuous infusion not to exceed 24 hours. Precedex has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Precedex prior to extubation.

1.2 Procedural Sedation Precedex is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.

CONTRAINDICATIONS

None

5 WARNINGS AND PRECAUTIONS 5.1 Drug Administration Precedex should be administered only by persons skilled in the management of patients in the intensive care or operating room setting. Due to the known pharmacological eﬀects of Precedex, patients should be continuously monitored while receiving Precedex.

5.2 Hypotension, Bradycardia, and Sinus Arrest Clinically significant episodes of bradycardia and sinus arrest have been reported with Precedex administration in young, healthy adult volunteers with high vagal tone or with different routes of administration including rapid intravenous or bolus administration. Reports of hypotension and bradycardia have been associated with Precedex infusion. If medical intervention is required, treatment may include decreasing or stopping the infusion of Precedex, increasing the rate of intravenous fluid administration, elevation of the lower extremities, and use of pressor agents. Because Precedex has the potential to augment bradycardia induced by vagal stimuli, clinicians should be prepared to intervene. The intravenous administration of anticholinergic agents (e.g., glycopyrrolate, atropine) should be considered to modify vagal tone. In clinical trials, glycopyrrolate or atropine were effective in the treatment of most episodes of Precedex-induced bradycardia. However, in some patients with significant cardiovascular dysfunction, more advanced resuscitative measures were required. Caution should be exercised when administering Precedex to patients with advanced heart block and/or severe ventricular dysfunction. Because Precedex decreases sympathetic nervous system activity, hypotension and/or bradycardia may be expected to be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension and in elderly patients. In clinical trials where other vasodilators or negative chronotropic agents were co-administered with Precedex an additive pharmacodynamic effect was not observed. Nonetheless, caution should be used when such agents are administered concomitantly with Precedex.

5.3 Transient Hypertension Transient hypertension has been observed primarily during the loading dose in association with the initial peripheral vasoconstrictive eﬀects of Precedex. Treatment of the transient hypertension has generally not been necessary, although reduction of the loading infusion rate may be desirable.

5.4 Arousability Some patients receiving Precedex have been observed to be arousable and alert when stimulated. This alone should not be considered as evidence of lack of eﬃcacy in the absence of other clinical signs and symptoms.

5.5 Withdrawal Intensive Care Unit Sedation With administration up to 7 days, regardless of dose, 12 (5%) Precedex adult subjects experienced at least 1 event related to withdrawal within the ﬁrst 24 hours after discontinuing study drug and 7 (3%) Precedex adult subjects experienced at least 1 event 24 to 48 hours after end of study drug. The most common events were nausea, vomiting, and agitation. In adult subjects, tachycardia and hypertension requiring intervention in the 48 hours following study drug discontinuation occurred at frequencies of <5%. If tachycardia and/or hypertension occurs after discontinuation of Precedex supportive therapy is indicated. Procedural Sedation In adult subjects, withdrawal symptoms were not seen after discontinuation of short term infusions of Precedex (<6 hours).

5.6 Tolerance and Tachyphylaxis Use of dexmedetomidine beyond 24 hours has been associated with tolerance and tachyphylaxis and a dose-related increase in adverse reactions [see Adverse Reactions (6.1)].

5.7 Hepatic Impairment Since Precedex clearance decreases with severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function [see Dosage and Administration (2.2) in full prescribing information].

All Precedex Adverse Event

(N = 1007) (%)

Hypotension Hypertension Nausea Bradycardia Atrial Fibrillation Pyrexia Dry Mouth Vomiting Hypovolemia Atelectasis Pleural Eﬀusion Agitation Tachycardia Anemia Hyperthermia Chills Hyperglycemia Hypoxia Post-procedural Hemorrhage Pulmonary Edema Hypocalcemia Acidosis Urine Output Decreased Sinus Tachycardia Ventricular Tachycardia Wheezing Edema Peripheral

25% 12% 9% 5% 4% 4% 4% 3% 3% 3% 2% 2% 2% 2% 2% 2% 2% 2% 2% 1% 1% 1% 1% 1% <1% <1% <1%

Randomized Precedex (N = 798) (%) 24% 13% 9% 5% 5% 4% 3% 3% 3% 3% 2% 2% 2% 2% 2% 2% 2% 2% 2% 1% 1% 1% 1% 1% 1% 1% 0

Placebo

Propofol

(N = 400)

(N = 188)

(%)

12% 19% 9% 3% 3% 4% 1% 5% 2% 3% 1% 3% 4% 2% 3% 3% 2% 2% 3% 1% 0 1% 0 1% 1% 0 1%

13% 4% 11% 0 7% 4% 1% 3% 5% 6% 6% 1% 1% 2% 0 2% 3% 3% 4% 3% 2% 2% 2% 2% 5% 2% 2%

* 26 subjects in the all Precedex group and 10 subjects in the randomized Precedex group had exposure for greater than 24 hours. Adverse reaction information was also derived from the placebo-controlled, continuous infusion trials of Precedex for sedation in the surgical intensive care unit setting in which 387 adult patients received Precedex for less than 24 hours. The most frequently observed treatment-emergent adverse events included hypotension, hypertension, nausea, bradycardia, fever, vomiting, hypoxia, tachycardia and anemia (see Table 2). Table 2: Treatment-Emergent Adverse Events Occurring in >1% Of All Dexmedetomidine-Treated Adult Patients in the Randomized Placebo-Controlled Continuous Infusion <24 Hours ICU Sedation Studies Adverse Event Hypotension Hypertension Nausea Bradycardia Fever Vomiting Atrial Fibrillation Hypoxia Tachycardia Hemorrhage Anemia Dry Mouth Rigors Agitation Hyperpyrexia Pain

Randomized Dexmedetomidine

Placebo

(N = 387) 28% 16% 11% 7% 5% 4% 4% 4% 3% 3% 3% 3% 2% 2% 2% 2%

(N = 379) 13% 18% 9% 3% 4% 6% 3% 4% 5% 4% 2% 1% 3% 3% 3% 2%

Table 2: Treatment-Emergent Adverse Events Occurring in >1% Of All Dexmedetomidine-Treated Adult Patients in the Randomized Placebo-Controlled Continuous Infusion <24 Hours ICU Sedation Studies (continued) Adverse Event Hyperglycemia Acidosis Pleural Eﬀusion Oliguria Thirst

Randomized Dexmedetomidine

Placebo

(N = 387) 2% 2% 2% 2% 2%

(N = 379) 2% 2% 1% <1% <1%

The mean total dose was 1.6 mcg/kg (range: 0.5 to 6.7), mean dose per hour was 1.3 mcg/kg/hr (range: 0.3 to 6.1) and the mean duration of infusion of 1.5 hours (range: 0.1 to 6.2). The population was between 18 to 93 years of age, 30% ≥65 years of age, 52% male and 61% Caucasian. Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 5. The most frequent adverse reactions were hypotension, bradycardia, and dry mouth [see Warnings and Precautions (5.2)]. Pre-speciﬁed criteria for the vital signs to be reported as adverse reactions are footnoted below the table. The decrease in respiratory rate and hypoxia was similar between Precedex and comparator groups in both studies. Table 5: Adverse Reactions With an Incidence > 2%—Procedural Sedation Population

Adverse Event In a controlled clinical trial, Precedex was compared to midazolam for ICU sedation exceeding 24 hours duration in adult patients. Key treatment emergent adverse events occurring in dexmedetomidine or midazolam treated patients in the randomized active comparator continuous infusion long-term intensive care unit sedation study are provided in Table 3. The number (%) of subjects who had a dose-related increase in treatment-emergent adverse events by maintenance adjusted dose rate range in the Precedex group is provided in Table 4.

Hypotension1 Respiratory Depression2 Bradycardia3 Hypertension4 Tachycardia5 Nausea Dry Mouth Hypoxia6 Bradypnea

Table 3: Key Treatment-Emergent Adverse Events Occurring in Dexmedetomidine- or Midazolam-Treated Adult Patients in the Randomized Active Comparator Continuous Infusion Long-Term Intensive Care Unit Sedation Study Adverse Event

Dexmedetomidine

Midazolam

(N = 244)

(N = 122)

56%

28%

27%

42%

19%

28%

42%

Hypotension1 Hypotension Requiring Intervention Bradycardia2 Bradycardia Requiring Intervention Systolic Hypertension3 4

Precedex

Placebo

(N = 318)

(N = 113)

(%)

54% 37% 14% 13% 5% 3% 3% 2% 2%

30% 32% 4% 24% 17% 2% 1% 3% 4%

Hypotension was deﬁned in absolute and relative terms as Systolic blood pressure of <80 mmHg or ≤30% lower than prestudy drug infusion value, or Diastolic blood pressure of <50 mmHg.

Respiratory depression was deﬁned in absolute and relative terms as respiratory rate (RR) <8 beats per minute or > 25% decrease from baseline.

Bradycardia was deﬁned in absolute and relative terms as <40 beats per minute or ≤30% lower than pre-study drug infusion value.

Hypertension was deﬁned in absolute and relative terms as Systolic blood pressure >180 mmHg or ≥30% higher than pre-study drug infusion value or Diastolic blood pressure of >100 mmHg.

Tachycardia was deﬁned in absolute and relative terms as >120 beats per minute or ≥30% greater than pre-study drug infusion value. Hypoxia was deﬁned in absolute and relative terms as SpO2 <90% or 10% decrease from baseline.

25%

44%

10%

12%

15%

11%

15%

19%

30%

Hypokalemia

13%

6.2 Postmarketing Experience

Pyrexia

Agitation

Hyperglycemia

Constipation

The following adverse reactions have been identiﬁed during post approval use of Precedex. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hypotension and bradycardia were the most common adverse reactions associated with the use of Precedex during post approval use of the drug.

Hypoglycemia

Respiratory Failure

Renal Failure Acute

Acute Respiratory Distress Syndrome

Generalized Edema

Hypomagnesemia

Tachycardia

Tachycardia Requiring Intervention Diastolic Hypertension3 Hypertension

Hypertension Requiring Intervention†

Table 6: Adverse Reactions Experienced During Post-approval Use of Precedex Body System

Preferred Term

Body as a Whole

Fever, hyperpyrexia, hypovolemia, light anesthesia, pain, rigors

Cardiovascular Disorders, General

Blood pressure ﬂuctuation, heart disorder, hypertension, hypotension, myocardial infarction

Central and Peripheral Nervous System Disorders

Dizziness, headache, neuralgia, neuritis, speech disorder, convulsion

Gastrointestinal System Disorders

Abdominal pain, diarrhea, vomiting, nausea

Heart Rate and Rhythm Disorders

Arrhythmia, ventricular arrhythmia, bradycardia, hypoxia, atrioventricular block, cardiac arrest, extrasystoles, atrial ﬁbrillation, heart block, t wave inversion, tachycardia, supraventricular tachycardia, ventricular tachycardia

Liver and Biliary System Disorders

Increased gamma-glutamyl transpepsidase, hepatic function abnormal, hyperbilirubinemia, alanine transaminase, aspartate aminotransferase

The following adverse events occurred between 2 and 5% for Precedex and Midazolam, respectively: renal failure acute (2.5%, 0.8%), acute respiratory distress syndrome (2.5%, 0.8%), and respiratory failure (4.5%, 3.3%).

Metabolic and Nutritional Disorders

Acidosis, respiratory acidosis, hyperkalemia, increased alkaline phosphatase, thirst, hypoglycemia

Table 4. Number (%) of Adult Subjects Who Had a Dose-Related Increase in Treatment Emergent Adverse Events by Maintenance Adjusted Dose Rate Range in the Precedex Group

Psychiatric Disorders

Agitation, confusion, delirium, hallucination, illusion

Red Blood Cell Disorders

Anemia

Renal Disorders

Blood urea nitrogen increased, oliguria

Respiratory System Disorders

Apnea, bronchospasm, dyspnea, hypercapnia, hypoventilation, hypoxia, pulmonary congestion

Skin and Appendages Disorders

Increased sweating

Vascular Disorders

Hemorrhage

Vision Disorders

Photopsia, abnormal vision

†

Includes any type of hypertension.

Hypotension was deﬁned in absolute terms as Systolic blood pressure of <80 mmHg or Diastolic blood pressure of <50 mmHg or in relative terms as ≤30% lower than pre-study drug infusion value.

Bradycardia was deﬁned in absolute terms as <40 bpm or in relative terms as ≤30% lower than pre-study drug infusion value.

Hypertension was deﬁned in absolute terms as Systolic blood pressure >180 mmHg or Diastolic blood pressure of >100 mmHg or in relative terms as ≥30% higher than pre-study drug infusion value.

Tachycardia was deﬁned in absolute terms as >120 bpm or in relative terms as ≥30% greater than pre-study drug infusion value.

Precedex mcg/kg/hr Adverse Event Constipation Agitation Anxiety Edema Peripheral Atrial Fibrillation Respiratory Failure Acute Respiratory Distress Syndrome

≤0.7*

>0.7 to ≤1.1*

>1.1*

(N = 95)

(N = 78)

(N = 71)

6% 5% 5% 3% 2% 2% 1%

5% 8% 5% 5% 4% 6% 3%

14% 14% 9% 7% 9% 10% 9%

* Average maintenance dose over the entire study drug administration Procedural Sedation Adverse reaction information is derived from the two trials for procedural sedation in which 318 adult patients received Precedex.

Adapted from: EN-3411; Revised 12/2013 Manufactured and Distributed by: Hospira, Inc., Lake Forest, IL 60045 USA Licensed from: Orion Corporation, Espoo, Finland P14-0164-5-10.5x13-Feb.,14 Printed in USA Hospira, Inc., Lake Forest, IL 60045 USA

50 I AnesthesiologyNews.com

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Continuing Medical Education LESSON 311

PreAnesthetic Assessment Of the Patient With Acute Ischemic Stroke—Part 1

CME WRITTEN BY: Eduardo E. Galeano, MD Assistant Professor of Clinical Anesthesiology Albert Einstein College of Medicine Montefiore Medical Center Bronx, New York

REVIEWED BY: A. Elisabeth Abramowicz, MD Associate Professor of Clinical Anesthesiology and Clinical Neurological Surgery Albert Einstein College of Medicine Montefiore Medical Center Bronx, New York

PROFESSIONAL GAPS Most anesthesiologists are aware that it is essential to treat victims of acute ischemic stroke (AIS) as quickly as possible. The structure of a stroke care center and the involvement of the anesthesiologist in the stroke service is new information. This 2-part series discusses the pathophysiology of AIS and the treatments for stroke. Current guidelines for the accreditation and designation of a stroke center, diagnostic protocols, and treatment options for AIS are reviewed. Literature pertaining to the controversy of using general anesthesia versus sedation for the anesthetic management of AIS patients undergoing endovascular treatment is presented. In Part 1, the 3 levels of stroke hospital designation are described. The signs and early diagnosis of AIS are reviewed, and thrombolysis with fibrinolytic agents explained. Part 2 reviews endovascular therapy, the involvement of the anesthetic care provider, and the controversies surrounding anesthetic management of AIS.

LEARNING OBJECTIVES

troke is currently the fourth leading cause of death in the United States.1 More therapies are being investigated to ameliorate the consequences of stroke. The newer endovascular interventions require immobility—hence either good patient cooperation or general anesthesia is necessary. However, it appears that general anesthesia may worsen outcome after interventional treatment for acute ischemic stroke (AIS).2 Whether this finding is causal or incidental is not yet known. The concern that general anesthesia is harmful complicates the formulation of an anesthetic plan. Should clinicians favor sedation as the anesthetic and convert to general anesthesia if necessary or can they begin with a carefully titrated induction and maintain the patient under general anesthesia? No direct studies have compared head-to-head outcomes for different anesthetic techniques; only retrospective data are thus far available.

Stroke Center The American Stroke Association recognizes 3 levels of stroke hospital designation: primary stroke center (PSC), comprehensive stroke center (CSC), and acute stroke-ready hospital (ASRH). The Joint Commission and individual states accredit stroke centers. A PSC must fulfill 11 criteria to become certified (Table 1). A CSC has 5 components: 1. The CSC has personnel with expertise in vascular neurology, vascular neurosurgery, advanced practice nursing in stroke, vascular surgery, diagnostic radiology/neuroradiology, interventional/endovascular, critical care medicine, physical medicine and rehabilitation, physical therapy, occupational therapy, speech therapy, stroke nursing, respiratory therapy, and swallowing assessment. 2. The CSC has diagnostic techniques including magnetic resonance (MR) imaging with diffusion, MR angiography/MR venography, computed tomography (CT) angiography, cerebral angiography, transcranial Doppler, carotid duplex ultrasound, and transesophageal echocardiography. 3. Surgical treatment, including carotid endarterectomy, clipping of intracranial aneurysm, placement of ventriculostomy, intracranial hematoma removal/draining, placement of intracranial pressure transducer, endovascular ablation of intracranial aneurysms and arteriovenous malformations, intra-arterial reperfusion therapy, and endovascular treatment of vasospasm are available.

At the completion of the activity, the reader will be able to: 1. Define the institutional characteristics that are needed to qualify as a primary stroke center, a comprehensive stroke center, or an acute stroke-ready hospital. 2. Describe the evaluation of a patient with AIS, including indicated diagnostic and laboratory tests. 3. Identify criteria that should be met before administration of IV recombinant tissue plasminogen activator (rtPA). 4. Assess the period from “last seen well” to treatment that governs the administration of fibrinolytic therapy. 5. List the modifiable and nonmodifiable risk factors for AIS. 6. Specify the ideal blood pressure for patients after endovascular treatment of AIS. 7. Differentiate the side effects of IV rtPA treatment. 8. Describe the FAST criteria for identifying AIS. 9. Recognize confounding medical problems that can mimic the symptoms of AIS. 10. Describe the rationale behind the extension of IV rtPA treatment from 3 to 6 hours.

CASE A 79-year-old woman was brought to the emergency department after she was found on the floor of her apartment following activation of an elder protection electronic alert. A relative reported that the patient had a history of high blood pressure, type 2 diabetes mellitus, and chronic obstructive pulmonary disease (COPD). Vital signs included blood pressure 175/87 mm Hg, pulse of 76, respiratory rate of 17, and SpO2 of 93% on 2 L O2 via nasal cannula. In the emergency room, the patient had right-sided hemiplegia and was aphasic. Within 1 hour of arrival, she received IV recombinant tissue plasminogen activator (rtPA). Her neurologic condition did not improve, and after 3 hours from the onset of symptoms repeat computed tomography (CT) revealed no hemorrhage. The neuroradiologist wanted to perform a thrombectomy and called for an anesthetic consult. The patient had become agitated and did not follow commands.

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, New York. She is the author of Clinical Anesthesia in Neurosurgery (Butterworth-Heinemann, Boston) and numerous articles. Dr. Frost is past president of the Anesthesia History Association and former editor of the journal of the New York State Society of Anesthesiologists, Sphere. She is also editor of the book series based on this CME program, Preanesthetic Assessment, Volumes 1 through 3 (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 July 31, 2015. (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: August 1, 2014

Termination Date: July 31, 2015

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. Faculty Disclosure Statement 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, New York.

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Infrastructure is in place that includes a stroke unit, an ICU, a stroke clinic, an operating room staffed around the clock, interventional services 24 hours per day, and a stroke registry to compile patient information. 5. Programs must be established that convey stroke education and prevention to the community, train the professional staff at the center, and educate patients. ASRHs must have written emergency stroke care protocols, written transfer agreements with a center that has neurosurgical services, a director of stroke care to oversee the hospital stroke policies, the ability to administer IV rtPA, the ability to perform emergency brain imaging and conduct emergency laboratory testing, and the maintenance of a stroke patient log. Having a community system in place that has ASRHs and PSCs for basic emergency stroke care and that is associated with CSC that can give more comprehensive care is the current recommendation from the American Heart Association and the American Stroke Association.3

Signs and Early Diagnosis of AIS AIS is an abrupt onset of a neurologic deficit caused by occlusion of the intracerebral artery. Both modifiable and nonmodifiable risk factors exist for AIS. Modifiable risk factors include hypertension, tobacco use, diabetes mellitus, peripheral vascular disease, atrial fibrillation, dilated cardiomyopathy, valvular heart disease, sickle cell disease, high cholesterol, poor diet, and physical immobility. Nonmodifiable risk factors are age (the average age of first AIS is 78

years), family history of stroke, race (blacks are at higher risk), sex (women greater than men), and prior stroke or myocardial infarction (MI).4 Given these demographics, the average patient is an elderly woman with underlying chronic disease who most likely is taking some form of anticoagulation medication. Rapid diagnosis and treatment of AIS improves patient outcome.5 More than 10 years ago a new acronym, FAST for Face, Arm, Speech and Time, was developed for public education on the importance of immediate identification of stroke (Table 2).1 In most cases, delivery of IV rtPA, the only FDA-approved therapy for AIS, is effective only within 3 hours of the onset of symptoms. Therefore, knowing the time of symptom onset affects management and is an important element in the presenting patient history. If the stroke is disabling, reliance on witnesses to determine onset is essential. The last time the patient was seen well serves as the time of stroke onset. If the patient woke up with the deficit, then the time he or she went to sleep constitutes the stroke-onset time. Confounding medical problems such as seizures, hypoglycemia, migraines with aura, encephalopathy, central nervous system abscess or tumor, drug toxicity, and psychogenic or conversion disorders can mimic stroke and must be ruled out.6 The following diagnostic tests should be used routinely in patients suspected of having AIS. A non-contrast head CT can rule out alternate diagnoses such as intracerebral hemorrhage that would be a contraindication to IV rtPA. It also can guide treatment decisions; for example,

Table 1. Criteria for Primary Stroke Center Designation

non窶田ontrast-enhanced CT is being investigated to identify early signs of ischemia or large intracranial vessel occlusion. Early signs of cerebral ischemia correlate with increased risk for hemorrhagic transformation. Patients who have a higher National Institutes of Health Stroke Scale score (NIHSS score), and thus more severe deficits and worse prognosis, have a higher incidence of symptomatic intracerebral hemorrhage transformation.7 Laboratory tests that must be performed in all AIS patients include electrolytes; complete blood count for platelet count, chiefly; electrocardiogram and cardiac markers; and coagulation studies. Hypoglycemia can mimic acute stroke symptoms and also is associated with worse outcomes; hyperglycemia also worsens outcome by increasing the size of infarcted area. A platelet count of less than 100,000 is a contraindication to IV rtPA. Troponin levels can indicate a recent MI, which is a relative contraindication for IV rtPA as it may precipitate myocardial rupture. Finally, elevated activated partial thromboplastin time, prothrombin time, or an international normalized ratio above 1.7 will proscribe the use of fibrinolytic therapy.3 A hemorrhagic complication will severely worsen outcome. Other tests should be considered in selected patients if there is good clinical indication, but this should never delay stroke treatment. These tests may include chest x-ray, toxicology screens, pregnancy tests, arterial blood gas analysis, and electroencephalogram.

Medical Interventions Currently, there are 2 basic interventions for ischemic stroke: thrombolysis with IV rtPA or endovascular treatment, either with rtPA alone or using mechanical devices or clot retrieval systems for vessel recanalization. In 1996, the FDA approved IV rtPA based on data from the NINDS (National Institute of Neurological Disorders and Stroke) rtPA trial.7 The study included 624 patients who were treated with either placebo or IV rtPA within 3 hours of stroke onset; half of those in the trial received treatment within 90 minutes of stroke onset. Treatment with rtPA was associated with an increased odds ratio for a favorable outcome (odds ratio [OR], 1.9; 95% confidence interval [CI], 1.2-2.9). This positive effect extended to individual functional measures of global disability (40% vs 28%), global

Acute stroke team

A dedicated team evaluates any patient who is suspected of having a stroke, within 15 min of presentation. This team should be available 24 h/d, 7 d/wk.

Written care protocols

Protocols should facilitate and decrease time to effective treatment.

EMS

Communication between EMS units and the hospital to rapidly bring patients who are experiencing a stroke must be in place.

Emergency department

Emergency department staff should be trained to identify acute stroke and should be able to communicate effectively with EMS and the acute stroke team.

Stroke unit

An established area where a patient can receive specialized monitoring and care.

Neurosurgical services

Neurosurgical intervention should be available within 2 h of activation.

Support of the medical organization

Facility staff and administration should be committed to delivering quality care to acute stroke patients.

Neuroimaging

The hospital should have the ability to complete brain imaging scans within 25 min of receiving an order. Interpretation of the scan should be made within 20 min.

F = Face

Laboratory studies

The hospital should be able to run standard laboratory tests 24 h/d, 7 d/wk including electrocardiograms and chest x-rays.

Ask the person to smile. Does the face droop?

A = Arm

Ask the person to raise both arms. Does one drift downward?

S = Speech

Ask the person to repeat a simple phrase. Is the speech slurred or strange?

T = Time

If you observe these signs, call 911 immediately.

Outcome/quality There should be a database of patient type, treatment types, timeline to treatment, and meaimprovement measures surement of patient outcomes. Educational programs

EMS, emergency medical services

All staff members should receive 8 h/y of continuing medical education credit. The primary stroke center should implement 2 annual programs to educate the public on stroke treatment, prevention, and diagnosis.

Table 2. FAST

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Table 3. Absolute Contraindications for IV rtPA Administration

Table 4. Relative Contraindications for IV rtPA Administration

Significant head trauma or prior stroke in previous 3 mo Only minor or rapidly improving stroke symptoms (clearing spontaneously)

Symptoms suggest subarachnoid hemorrhage Arterial puncture at noncompressible site in previous 7 d

Pregnancy

History of previous intracranial hemorrhage Intracranial neoplasm, arteriovenous malformation, or aneurysm Recent intracranial or intraspinal surgery

Seizure at onset with postictal residual neurologic impairments Major surgery or serious trauma within previous 14 d

Elevated blood pressure (systolic >185 mm Hg or diastolic >110 mm Hg) Active internal bleeding Acute bleeding diathesis

Recent gastrointestinal or urinary tract hemorrhage (within previous 21 d) Recent acute myocardial infarction (within previous 3 mo)

Platelet count <100,000/mm

Heparin received within 48 h, resulting in abnormally elevated aPTT greater than the upper limit of normal

rtPA, recombinant tissue plasminogen activator

Current use of anticoagulant with INR >1.7 or PT >15 seconds Current use of direct thrombin inhibitors or direct factor Xa inhibitors with elevated sensitive laboratory tests (such as aPTT, INR, platelet count, and ECT; TT; or appropriate factor Xa activity assays) Blood glucose concentration <50 mg/dL (2.7 mmol/L) CT demonstrates multilobar infarction (hypodensity >1/3 cerebral hemisphere) aPTT, activated partial thromboplastin time; CT, computed tomography; ECT, ecarin clotting time; INR, international normalized ratio; rtPA, recombinant tissue plasminogen activator; TT, thrombin time

• Exclusion criteria that apply beyond 3 hours: patients over the age of 80 years, patients taking any oral anticoagulants, baseline NIHSS score greater than 25, patients with ischemic injury exceeding one-third of the blood supply territory of the middle cerebral artery, and any diabetic patient with a prior history of stroke.

Contraindications for IV rtPA Administration outcome (43% vs 32%), activities of daily living (53% vs 38%), and neurologic deficits (34% vs 20%). Side effects of treatment included intracranial hemorrhage (ICH), systemic bleeding, myocardial rupture if given after MI, angioedema, and anaphylaxis. Intracerebral hemorrhage is the most common IV rtPA treatment complication and it vastly worsens outcome. Extended time windows to give IV rtPA have been investigated. Both 3 to 4.5 hours and 4.5 to 6 hours were studied to ascertain the risks and benefits of administering rtPA in these timeframes. The most recent study of the 3- to 4.5-hour window was the ECASS III (European Cooperative Acute Stroke Study III).8 The authors enrolled 821 patients who received either placebo (n=403) or rtPA (n=418). The European inclusion criteria differed from the American Stroke Council guidelines because the study excluded patients over the age of 80 years, patients who had an NIHSS score greater than 25 (the NIHSS score evaluates the severity of the stroke on a scale of 0 to 42; a higher score denotes a worse stroke), those taking anticoagulation even if the laboratory values were normal, and those who had a previous stroke and were diabetic. Excellent 90-day outcome using the modified Rankin Scale (mRS) (ie, a score of 0-2) was 52.4% for rtPA versus 45.2% for placebo (OR, 1.34; 95% CI, 1.02-1.76). There was an increase in ICH in the rtPA group (2.4% vs 0.2%; OR, 9.85; 95% CI, 1.26-77.32). However, the ICH rate was in line with clinical data from other studies and showed rtPA can be given safely to properly selected patients beyond the 3-hour original time limit, up

to 4.5 hours after a stroke. A meta-analysis by Sandercock et al of IV rtPA administration within the interval of 4.5 to 6 hours showed a similar outcome benefit.9 The meta-analysis was comprised of 12 studies that enrolled 7,012 patients up to 6 hours after onset of AIS symptoms. Overall, the excellent outcome of mRS score 0 to 2 was 46.3% in the rtPA group versus 42.1% in the placebo arm (OR, 1.17; 95% CI, 1.06-1.29), but patients treated before 3 hours had a more significant treatment benefit for the mRS score of 0 to 2 (40.7% vs 31.7%; OR, 1.53; 95% CI, 1.26-1.86), reinforcing that earlier treatment is much more efficacious. The meta-analysis showed an increase in ICH in the rtPA group (7.7% vs 1.8%; OR, 3.72; 95% CI, 2.98-4.64) and an increase in death within 7 days (8.9% vs 6.4%; OR, 1.44; 95% CI, 1.18-176). Thus, extension of the treatment interval with IV rtPA beyond 4.5 hours is not beneficial because of the increased incidence of oftenfatal ICH. The European Medicines Agency has extended the timeframe for IV rtPA AIS treatment to 4.5 hours since stroke onset, whereas the FDA has declined to do so.

Indications for Administration of IV rtPA The guidelines for treatment of AIS are as follows: • IV rtPA should be given within the first 3 hours of stroke symptom onset. • Ideally, treatment should start within 1 hour of the patient’s arrival at the hospital. • IV rtPA is recommended up to 4.5 hours after stroke onset.

Both absolute and relative contraindications have been identified for IV rtPA administration (Tables 3 and 4). IV rtPA in patients who are in the 3- to 4.5-hour time window and who have one or more of the exclusion criteria listed above need to be studied further. Blood pressure greater than 185/110 mm Hg must be lowered before starting IV rtPA. Physicians should be prepared to treat any side effects of fibrinolytic therapy, including bleeding complications and angioedema. IV rtPA may be given to patients who have had a seizure at the onset of stroke if there is evidence that the residual deficits are from the stroke and are not a postictal phenomenon. The use of other fibrinolytic agents or defibrinogenating agents is not well established and these agents should only be used in clinical trials. Although controversial, the use of IV fibrinolysis may be considered in patients with mild stroke deficits, rapidly improving stroke symptoms, major surgery in the preceding 3 months, and recent MI as long as the risks for complications are weighed against the potential benefits of treatment. IV streptokinase for stroke treatment is not recommended because trial use of this agent has demonstrated greater rates of ICH. Finally, patients taking direct thrombin inhibitors such as dabigatran or direct factor Xa inhibitors such as rivaroxaban and apixaban may be harmed by IV rtPA, and treatment is not recommended if the patient received a dose within 2 days.3 The potential risks for ICH are thought to be greater in these patients because there are no quick reliable tests to assess anticoagulant levels. A careful history detailing the last dose of anticoagulant is important.

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References 1.

http://www.cdc.gov/stroke/facts.htm. Accessed June 17, 2014.

Davis MJ, Menon BK, Baghirzada LB, et al. Anesthetic management and outcome in patients during endovascular therapy for acute stroke. Anesthesiology. 2012;116(2):396-405.

Jauch EC, Saver JL, Adams HP Jr, et al. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013;44(3):870-947. http://www.strokeassociation.org/STROKEORG/AboutStroke/UnderstandingRisk/Understanding-Stroke-Risk_UCM_308539_SubHomePage.jsp# Accessed June 17, 2014.

Scott PA, Silbergleit R. Misdiagnosis of stroke in tissue plasminogen activator-treated patients: characteristics and outcomes. Ann Emerg Med. 2003;42(5):611-618.

The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995;333(24):1581-1587.

Hacke W, Kaste M, Bluhmki E, et al. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008;359(13):1317-1329.

Sandercock P, Wardlaw JM, Lindley RI, et al. The benefits and harms of intravenous thrombolysis with recombinant tissue plasminogen activator within 6 h of acute ischaemic stroke (the Third International Stroke Trial [IST-3]): a randomized controlled trial. Lancet. 2012;379(9834):2352â&#x20AC;&#x201C;2363.

Hacke W, Donnan G, Fieschi C, et al. Association of outcome with early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials. Lancet. 2004;363(9411):768-774.

Post-Test 1.

Which of the following is a contraindication for IV rtPA treatment in a patient who had a stroke 2 hours ago? a. The patient is taking amiodarone. b. The platelet count is 140,000/mm3. c. The patient has diabetes. d. The patient is taking dabigatran.

Which patient can be expected to gain the best results if given IV rtPA? a. A 70-year-old woman who went to bed at 10 PM and woke up at 7 AM with left-sided weakness b. An 82-year-old man who was last seen well at 5 PM and reaches the emergency room at 10 PM c. A 78-year-old woman on warfarin who is unconscious and whose blood sugar is 45 mg/dL d. A 76-year-old man who developed facial droop 1 hour ago; blood pressure is 170/100 mm Hg

What is the highest systolic blood pressure in which IV rtPA is given? a. 180 mm Hg b. 220 mm Hg c. 150 mm Hg d. 120 mm Hg According to the FDA, the time interval for IV rtPA administration should not exceed ______. a. 3 hours b. 4.5 hours c. 6 hours d. 8 hours Which of the following is not a potentially modifiable risk factor for stroke? a. Hypertension b. Valvular disease c. Tobacco use d. Atrial fibrillation

A modifiable risk factor for stroke includes ______. a. Race b. Family history c. Diabetes mellitus d. Prior stroke

Which of the following is not a component of the FAST acronym? a. Face: Does the patient have a facial droop? b. Arm: Does the patient have any weakness in his or her arms? c. Time: Has it been less than 1 hour since the stroke? d. Speech: Does the patient have slurred speech?

Which of the following is the National Institutes of Health Stroke Scale score exclusion criterion for the ECASS III study? a. There is none. b. >25 c. <30 d. <15

Which of the following confounding medical problems is least likely to mimic stroke? a. Heroin intoxication b. Hypoglycemia c. Seizure d. Brain tumor

10. Which of the following laboratory tests does not need to be performed before urgent treatment with IV rtPA? a. Pregnancy test b. Electrocardiogram c. Complete blood count d. Computed tomography scan

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PRN

Physician Stresses Simulation To Avert Harm to Real Patients Physicians should be selected on skills outside of cognition Salt Lake City—As a young combat pilot in the Israeli Air Force, Amitai Ziv practiced on a simulator for every nightmare scenario his trainers could come up with: ejecting from airplanes, landing planes overcome with flames, managing all sorts of equipment malfunctions. When he started medical school after leaving the air force, he was astonished that medical trainees honed their skills not on simulators, but on real patients. “We expect both health care and aviation to have very low tolerance for errors. But in health care, we are very much behind aviation in that respect,” Dr. Ziv said in a lecture at the 2014 Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) meeting. “Our health care training, despite the simulation movement, is still by and large the old model: See one, teach one, do one, kill one. … The patients are the ones who pay the price,” said Dr. Ziv, v chair of medical education at the Sackler School of Medicine of Tel Aviv University. As deputy director of Sheba Medical Center, he is responsible for patient safety, risk management and medical education. A pediatrician, Dr. Ziv has spent the past 20 years trying to adapt the lessons of flight simulation training to the field of medical training. According to his bio, this idea came to him in medical school when a fellow student committed suicide hours after failing a test. The future Dr. Ziv decided then that the testing system, both to get into medical school and to become a licensed physician, was inadequate. It focused purely on a student’s cognition. The system failed to assess the human side of being a physician. Driven by this realization, Dr. Ziv completed his MD dissertation on peer evaluation. Later, he worked with the Educational Commission for Foreign Medical Graduates on a simulation-based program that certifies foreign immigrant doctors applying to work in the United States. In 2001, Dr. Ziv returned to Israel and founded the Israel Center for Medical Simulation (MSR), now “arguably one of the most effective and influential simulation centers in the world,” said Gerald Fried, MD, immediate past president of SAGES and chair of surgery at McGill University, in Montreal, Canada. Housed in a virtual hospital on the massive Chaim Sheba Medical Center campus just outside Tel Aviv, MSR is home to more than 100 different kinds of simulators and employs more than 150 professional actors for its courses. The nonprofit center, which operates on a fee-for-service model, trains more than 10,000 health professionals in more than 60 courses annually. Almost all health care practitioners in Israel have undergone some training at MSR. The student body ranges from medical school applicants to hospital CEOs. Among the trainees are pharmacists

Trainees perform a simulated case at the Israel Center for Medical Simulation. who learn communication skills that can help with angry patients and reduce errors; surgeons who rehearse complex procedures in a high-tech operating room simulator; and surgical residents who practice on virtual-reality simulators. MSR instructors watch everything through one-wayy mirrors and conduct extensive aviation-style debriefs. Even the country’s medical clowns refine their skills through courses at MSR. MSR trains health care workers for run-off themill scenarios but also for the catastrophic “unimaginable” ones. Israel is known for its extensive mass casualty preparedness; much of that training is conducted at MSR. The training extends also to Palestinians; MSR uses simulation to provide trauma training for Palestinian physicians and paramedics through an affiliation with Physicians for Human Rights. MSR’s simulation model can be used around the world to improve safety and medical training, Dr. Fried said. “This can reshape the way medical care is delivered around the world.” The center is founded on the principle that simulation-based medical training and assessment can revolutionize the safety culture in medicine. For too long, medicine has accepted suboptimal levels of safety, Dr. Ziv said. He likes to compare medicine to aviation. If the deaths attributed to medical errors are put into aviation terms, they amount to four Boeing 747

crashes daily, Dr. Ziv said, citing a recent controversial study in the Journal of Patient Safety (2013;9:122-128). Medical errors disproportionately affect women, children and older patients, he added. “This is not something intentional, but these are groups, perhaps, that we do not communicate as effectively with.” Simulation, which ranges from expensive hightech simulators to low-tech role-playingg with actors, provides an environment for people to learn by hands-on practice but without putting patients’ lives at risk, Dr. Ziv said. “This is a very powerful way of teaching.” Dr. Ziv pointed to data collected by the American nonprofit behavioral psychology center, the National Training Laboratory, which showed that learners who are taught by hands-on practice retain around 75% of information. In contrast, students remember about 5% of what they hear in lectures, 10% of what they read and 30% of what they see. A key advantage of simulation is that it can teach skills needed in emergency situations, the medical equivalents of trying to land a plane with a fire in the cockpit, Dr. Ziv said. These are low-frequency but high-stakes scenarios. MSR runs programs to teach trainees and practicing physicians how to respond in so-called “nightmare scenarios.” There is even a module known as the “nightmare course,” a mandatory five-day program for Israeli interns about to begin their first

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PRN are evaluated on interpersonal communication skills, ability to handle stress, initiative and responsibility, and selff awareness. This program resulted in a change of about 20% in the cohort of accepted students compared with previous admission criteria (Med Educ 2008;42:991-998). The investigators found very low correlation between the candidates’ MOR scores and cognitive scores. “MOR conveys the importance of

maintaining humanistic characteristics in the medical profession to students and faculty staff,” Dr. Zivv noted. He would like to see similarly thorough assessments of physicians throughout their career. Physicians should be evaluated on all aspects of the care they provide, from their ability to deal with high-stress situations to their operative skill, he said. “Surgeons can be operating with Parkinson’s and nobody can ground that surgeon. That’s true today

around the world and it is not right.” Dr. Zivv hoped that simulation-based medical education will spark a revolution in medicine. “We will have to change course. We have some barriers but they are not as high as we think. The end of it, there’s the humility message that if we meet our errors in the simulation environment, we will be better off in the real world,” he said. —Christina Frangou

Amitai Ziv, MD, believes personality traits should count more when evaluating medical students and physicians. hospital rotations. They are challenged with a series of stressful situations such as finding themselves in an elevator alone at night with a patient who stops breathing. “Or it could be the nightmare on the emotional front: telling a family that we have erred and we gave their father the wrong blood, that we are responsible for the loss of a loved one,” Dr. Ziv said. “It’s through this kind of proactive learning, rather than [a] reactive one with our apprentice one, [that] we can enact nightmares.” Dr. Ziv asserted that medical errors occur because of malfunctions built into the health care system from the moment applicants are evaluated as candidates for medical school. At most medical schools, the application committee considers grades and extracurricular activities, but places little emphasis on personality traits. But medical schools need to consider personality traits, Dr. Ziv said. And so, MSR, together with Israeli medical schools and Israel’s National Institute for Testing and Evaluation, developed an assessment program—known as MOR, a Hebrew acronym for “selection for medicine”—to measure candidates’ judgment and decision-making skills. Candidates complete a series of behavioral stations, including encounters with simulated patients and group tasks, an autobiographical questionnaire, and a judgment and decision-makingg questionnaire. They EXP-AP-0020-201301

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Patient-Focused Pain Control That Lasts For Up To 72 Hours The only single-dose local analgesic to s Reduce or eliminate opioids with pain control for up to 3 days s Without the need for catheters or pumps

Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing bunionectomy and hemorrhoidectomy procedures. The clinical benefit of the attendant decrease in opioid consumption was not demonstrated. EXPAREL is a liposome formulation of bupivacaine indicated for administration into the surgical site to produce postsurgical analgesia.

Important Safety Information: EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting. Reference: Gorfine SR, et al. Dis Colon Rectum. Dec 2011;54(12):1552-1559.

EXP-AP-0039-201302