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Palliative Care: Another Role For ‘Titrationologists’? New York—Perry Fine, MD, believes anesthesiologists should play a role in the delivery of palliative care. “We as anesthesiologists are perfectly aligned to spend more of our time, knowledge and skills involved with patients who are facing endoff life lif issues or are actively suffeering,” the professor of aneesthesiology at the University of Utah and strateegic advisor to Capital Caring , Washington C D.C., told the audience gathered for the R.W.
Monitor Triglycerides To Avoid Propofol Infusio New Orleans—It is disturbingly common, dangerously lethal and difficult to diagnose, yet propofol-related infusion syndrome (PRIS) may be detected before it happens, given proper vigilance by anesthesiologists. Indeed, research has found a positive correlation between the duration of propofol infusion and increasing triglyceride (TG) levels, which may indicate onset of the deadly complication. “Obviously, propofol has many beneficial properties, including rapid emergence and
see palliative page 6
see PRIS page 37
Bellevue Hospital: A Place for Teaching We reprint here an article about New York City’s iconic Bellevue Hospital that appeared in SPHERE, the quarterly publication of the New York State Society of Anesthesiologists, Inc. (2014;66[3]:13-22).We thank the authors, Drs. Mackersey and Nacht, as well as the editor of SPHERE, Jason Lok, MD.
A
crooked 1919 photograph shows members of the Barnum & Bailey Circus, in the middle of an annual show in Bellevue’s garden courtyard. On an average summer evening, when New York City tempers are stretched and some citizens’ behavior is perhaps not at its best, it is easy to imagine the hijinks of the modern “performers” we treat as part of
a long Bellevue tradition. While the characters have changed and the original site has shifted, one thing has remained steadfast since 1736: “No One Is Turned Away.”1 From the curved iron railings facing First Avenue, to the stone-carved entrance sign “EMPLOYES,”2 history permeates the now-modern buildings. This history is the fascinating draw see Bellevue page 18
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COMMENTARY
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POLICY & MANAGEMENT
The Perioperative Surgical Home envisions anesthesiologists as perioperativists.
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POLICY & MANAGEMENT PALLIATIVE
CONTINUED FROM PAGE 1
Robertazzi Memorial Panel during the 68th New York State Society of Anesthesiologists’ PostGraduate Assembly (PGA). “It is by virtue of our expertise that we are obligated ethically to become involved,” he added. Dr. Fine and Amy Alvarez-Perez, MD, a palliative care physician in the Department of Supportive and Palliative Care, Roswell Park Cancer Institute,
Buffalo, N.Y., discussed the ethical and legal issues surrounding the provision of palliative care—and the potential role for anesthesiology therein—during a unique debate format entitled, “Current Controversies in the Art and Science of Anesthesiology.” Other topics discussed during the event included the role of etomidate in the hemodynamically unstable patient and safety trends in the delivery of anesthesia. According to the Institute of Medicine, palliative care focuses on
providing patients with relief from the symptoms, pain and stress of a serious illness. It is not limited to the terminally ill and can be provided along with curative treatment. The primary goals of palliative care are improving and supporting the best quality of life for both the patient and the patient’s family and preventing and relieving the patient’s suffering. Dr. AlvarezPerez added that hospice care is a type of palliative care for people in the final months of life.
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The Brittany Maynard Case On this latter application for palliative care, Dr. Alvarez-Perez, a former anesthesiologist who retrained in palliative care, said that current approaches by the medical establishment to prevent prolonged and painful dying include do not resuscitate orders; the termination of lifesustaining treatments (sometimes called passive euthanasia, which is a misnomer); and the administration of large doses of opioids (sometimes called indirect euthanasia). All of these treatment paths are accepted legally and ethically. The issue of physician assistance in dying or the “death with dignity” movement made national headlines last year with the case of Brittany Maynard. Ms. Maynard was diagnosed with terminal brain cancer in 2013 and decided that she would end her life when the suffering from her disease became unbearable. She relocated from California to Oregon because of the latter state’s death with dignity provision, which allows for physician-assisted dying in those with a confirmed terminal diagnosis. Ms. Maynard died in November 2014, at the age of 29, after taking a legal, lethal dose of secobarbital prescribed by a physician. “She did not want to have someone else decide how or when she would die and she did not want to suffer to the point of needing palliative sedation,” Dr. Alvarez-Perez told the audience at the PGA. Both speakers said palliative care is an important part of the provision of contemporary health care. Where they differ is on the issue of which specialists should be involved in its delivery. Although Dr. Fine sees a role for anesthesiologists as an important and integral member of palliative care teams—given their expertise in pharmacologic and interventional pain treatment and titrated reduction of consciousness and awareness— Dr. Alvarez-Perez holds strongly to the idea that palliative care is a specialty unto itself. “Palliative care should be the standard of care for all seriously ill patients and their families,” she said. “And that means palliative care should be done by those who practice and preferably are board certified in palliative care, not anesthesiologists.” Dr. Fine, however, argued that there is still room for anesthesiologists to “competently apply their technical skills to provide total analgesia for intractable pain or palliative
FEBRUARY 2015
AnesthesiologyNews.com I 7
POLICY & MANAGEMENT sedation to eliminate existential suffering”; however, those opting to do so must confront potential barriers, including what he described as the “complex” ethical and legal questions surrounding indications for these interventions. He noted that, much like in criminal law, what is permissible often centers on the issue of “intent” in applying potentially lifelimitingg treatments. Often, there is no clear, distinct line between the health care professionals’ moral and ethical obligations to provide relief to patients who are experiencing intolerable suffering and their obligation to “do no harm.” “There is a deeply established ethical standard that the intended action must not be intrinsically wrong, whether we’re talking about a very potent analgesic or palliative sedation—the agent must only intend the ‘good’ effect and not the ‘bad’ effect,” he explained. “And the ‘bad’ effect must not be a means of achieving the ‘good’ effect. In other words, intentionally killing to stop all pain is not viewed as a proportional response
‘Titration is everything, and if there is one thing that can be said of anesthesiologists it is that we are really “titrationologists.” Serious pain is our domain. Preventing and relieving it is what we’re good at, so how can we not take a leadership role?’ —Perry Fine, MD
to the problem since we have other means to address it. Proportionality and intent is key to determining ethical actions in all medical decision making, especially where the possibility of hastening death looms large.” According to Dr. Fine, consensus guidelines for palliative sedation cover everything from categories of agents that can be used as well as indications for when they can be implemented (i.e., in those suffering from severe, intractable pain not responsive to the “usual” pharmacologic options, or regional anesthesia, or surgical/radiotherapeutic
interventions, and in those who suffer emotional anguish or exhaustion that has not responded to reasonable attempts at addressing their underlying causes of existential distress). Dr. Fine also published an updated approach to treating cancer pain that includes palliative sedation as a final step in treating intolerable pain based on the seminal protocol developed by the World Health Organization, which promoted stepwise and progressive use of increasingly more potent (opioid) analgesics to address the worldwide problem of undertreated cancer pain.
The field of anesthesiology has historically been at the forefront, Dr. Fine noted, of developing myriad and novel formulations and approaches for safely and effectively delivering pharmacotherapy to patients in a variety of dire circumstances, including those facing end-off life decisions. He added that many of the treatment decisions made in the palliative care setting mirror those made by anesthesiologists in the critical care and/or surgical settings. Classes and specific drugs available for sedation include barbiturates, benzodiazepines, opioids, neuroleptic agents, etomidate, propofol and, most recently, dexmedetomidine. “You have expertise in these agents, it’s simply a matter of applying it in a different setting,” Dr. Fine said. “Titration is everything, and if there is one thing that can be said of anesthesiologists it is that we are really ‘titrationologists.’ Serious pain is our domain. Preventing and relieving it is what we’re good at, so how can we not take a leadership role?” —Brian Dunleavy
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POLICY & MANAGEMENT
Perioperative Surgical Home Promotes Perioperativists New York—What’s k in a name? Everything to proponents of the American Society of Anesthesiologists’ (ASA) concept of the Perioperative Surgical Home (PSH), which sees the anesthesiologists’ role in the surgical suite morphing into that of a “perioperativist.” Alan E. Curle, MD, associate professor of clinical anesthesiology and director, Center for Perioperative Medicine, University of Rochester Medical Center, Rochester, N.Y., and Jonathan S. Gal, MD, assistant professor of anesthesiology, Icahn School of Medicine at Mount Sinai, New York City, presented their perspectives on the PSH model during the 68th New York State Society of Anesthesiologists’ PostGraduate Assembly (PGA). “No one can escape the drumbeat of concern over the escalation of costs associated with the delivery of health
care in the United States,” Dr. Curle said. “For us, as anesthesiologists, 60% of the health care dollars spent in the United States currently are being spent on procedural care. In addition, our outcomes overall—or the value for the dollars spent—are much worse than those of other countries with similar resources, based on indicators such as infant mortality and life expectancy.” Concerns over the costs—and outcomes—associated with surgery will become even more acute, experts believe, with the continued aging of the American population, particularly as older individuals are at greater risk for complications during surgery, due to increased comorbidities. To address this, the PSH approach was launched by the ASA and modeled after a similar care philosophy—the Patient-Centered Medical Home—developed by and
for primary care physicians. The PSH model is a patient-focused multidisciplinary approach designed to optimize health care value, with anesthesiologists at the head of a multidisciplinary, comprehensive care team. The ‘Triple Aim’ “The goal of the PSH is to enhance value and to help achieve what has been termed the triple aim—a better patient experience, better health care, at a lower cost,” Dr. Curle said. “One can also consider the PSH as one side of a two-sided coin, with an accountable care organization, that takes on the coordination of patient care in a global sense.” Under the PSH model, the anesthesiologist effectively guides the surgical process for individual patients in coordination with their center’s director of anesthesiology and the surgical
team. Once it has been determined that a patient needs surgery, Dr. Curle explained, the anesthesiologist—or perioperativist—will assess the patient within the context of available data with respect to preexisting comorbidities that may lead to complications during a procedure. In addition to crafting the appropriate administration of anesthesia, the perioperativist would guide patients—and/or their families—in the determination of “best practices” and “next steps.” The perioperativist will then coordinate the surgical plan—allocating the necessary resources within the surgical center—and map out the postoperative recovery period. “As important as the gathering of ... outcomes data is on the front end, the system must allow for the easy recall of any outcomes data that can be used to decrease risk for this and future
Academic Anesthesiologists Busy but Content New Orleans—Although academic anesthesiologists often feel overburdened by their professional responsibilities, the majority would choose an academic career again, suggesting they have chosen their preferred career path. According to Rebecca M. Speck, PhD, MPH, academic anesthesiologists often are challenged by balancing the professional demands of research productivity, clinical excellence and quality training. “This is something we don’t have in the literature right now about anesthesiologists,” said Dr. Speck, an instructor in anesthesiology at the University of Pennsylvania, Philadelphia. “There are some data in general medicine, family medicine and surgery. But we were eager to get this information out there specific to this profession.” To help accomplish this goal, Dr. Speckk and her colleagues sent a Web-based survey to 830 people who applied for career development funding from the Foundation for Anesthesia Education and Research (FAER) between January 1973 and February 2013, as well as 143 members of the Association of University Anesthesiologists (AUA) who had not applied for FAER funding. The survey included 59 items on topics raging from research funding to leadership positions, career satisfaction to work–life balance. As Dr. Speckk reported at the American Society of Anesthesiologists (abstract A2279) annual meeting, 38% of FAER applicants (n=318) and 24% of AUA members (n=35) responded. The majority were men (71%) and white (67%). Nearly half (41%) said they were overburdened with work responsibilities. Among those actively participating in research (n=282), 54% felt their work interfered with the quality of research they would like to maintain. This finding did not differ between men and women (55% vs. 52%; P=0.69). On a personal note, 29% of respondents were
department, 77% would choose an academic career again and 7% planned to leave their institution within the next one or two years.
dissatisfied with their level of involvement with their family as well as their own health and well-being (32%). Forty-one percent felt their career affected their family life often or all of the timee and 40% felt it affected their health and well-being often or all of the time. Despite this, very few respondents reported being dissatisfied with their fit in their departments (10%) or level of compensation (12%). Similarly, very few reported frequent thoughts of quitting their position (12%) or intending to leave their current institution within one or two years (13%). The vast majority reported they would choose to pursue an academic career again (85%), which was consistent for men and women (88% vs. 84%, P=0.48). The researchers suggested that these data will help institutions attract and retain staff for these demanding positions. “There’s a presumption in different clinical specialties that women don’t advance as much, are more likely to leave their appointments, and are more likely to be dissatisfied with their careers,” Dr. Speckk said. “We really didn’t see that at all.” These data, she explained, are comparable to those from a 2009 survey by the Association of American Medical Colleges, which found that 64% of anesthesiologists were satisfied with their fit in their
Research Funding Also Surveyed The investigators also examined subsequent research funding among FAER applicants who did and did not receive career development awards. It was found that a significantly greater proportion of FAER recipients had a PhD in addition to their MD (31% vs. 15%; P=0.01) and FAER grant recipients were significantly more likely to apply for funding from the National Institutes of Health (NIH) than those who did not receive such grants (62% vs. 43%; P=0.006); this pattern did not persist with respect to other funding sources, however. With the exception of NIH grants, both FAER recipients and applicants received comparable subsequent research funding. “One of the key things we found is that FAER applicants subsequently did very well, whether they got the FAER grant or not,” added co-investigator Lee A. Fleisher, MD. “So just going through the process appears to have been helpful.” “So that positive feedback you’re getting is actually facilitating some success down the road,” said Brian S. Rothman, MD, the session co-moderator.r “People really valued the opportunity to go through the process, learn how to write a grant, and get feedback,” said Dr. Speck. “Very often, people who apply for grants and get rejected don’t hear much in return,” added Dr. Rothman, associate professor of anesthesiology at Vanderbilt University in Nashville, Tenn. “You submit, you’re rejected, and you don’t get very much feedback. FAER isn’t like that, and that makes a difference.” —Michael Vlessides
FEBRUARY 2015
AnesthesiologyNews.com I 9
POLICY & MANAGEMENT patients and reduce the costs associated with the delivery of that care,” Dr. Curle said. He added that there is potential to reduce avoidable readmissions and unsubstantiated variations in care, costs, satisfaction and hospital length of stay.
“A main driver for their cost savings among anesthesiologists to take a leaderrelative to the benchmark they com- ship role in the management of patient pare themselves to is the lack of post- care in the surgical setting, Frederick L. discharge readmissions and hospital Greene, MD, FACS, former chairman expenses,” explained Dr. Gal. of surgery and residency program direc“There is still a lot of things we don’t tor at Carolinas Medical Center in Charknow, such as how much it truly costs lotte, N.C., told Anesthesiology Newss that to implement PSH,” added Dr. Curle, the “concept of a medical home implies The Perioperativist-Integrator who also acknowledged that anesthesi- full care,” and that this may not be realisAccording to Dr. Gal, the anesthe- ologists may be met with resistance by tic at “all surgical sites, where the roles of siologist in the PSH model acts as an some other specialists who are reluc- anesthesiologists may be vastly different depending on the complexity of the insti“integrator,” coordinating the “path tant to relinquish control. Although he understands the desire tution and its patients. of care from the time the procedure is booked to 30 days postoperatively.” The biggest challenge to the approach, he added, entails the “macro-system integration, which means [the anesthesiologist] getting involved in the pre-op clinic, as well as working with pharmacy, labs, physical therapy, social work and/or visiting nurse aids during the post-op period.” As evidence of the model’s effectiveness, he cited a study published by Raphael et al (Perioper Med [Lond]] 2014;3:6) documenting its implementation in 2012 for Download the app patients undergoing primary elective total knee arthroplasty (TKA) or total from the best-read hip arthroplasty (THA) at the UCIrvine Medical Center, in California. anesthesiology The PSH at UC-Irvine integrates publication in the four perioperative phases: preoperative, intraoperative, postoperative and United States post-discharge. The preoperative process incorporates expectation management, early discharge planning, protocol-driven health risk assessment and medical optimization. Intraoperative management includes standardized anesthetic, nursing and surgical care protocols, as well as goal-directed fluid therapy. Postoperative management provides for multimodal analgesia, a targeted recovery plan, early ambulation, nutrition management and prompt rescue from complications. Post-discharge care begins in the hospital with a coordinated transition to an appropriate rehabilitation setting. Raphael et al found that, under the PSH model, total per-diem costs for TKA and THA were $10,042 and $9,952, respectively, significantly less than literature-reported benchmarks of $17,588 for TKA and $16,267 for Always THA. Costs were reduced by an overavailable all reduction in hospital lengths of stay online (from four days to three). With PSH, implant cost was $7,482 for TKA and $9,869 for THA. In-room to incision time cost was $1,263 for TKA and $1,341 for THA and surgery time cost was $1,558 for TKA and $1,930 for THA. Postanesthesia care unit time cost was $507 for TKA and $557 Register for the free e-Newsletter @ for THA. All of these figures are well anesthesiologynews.com/enews below national benchmarks.
“Anesthesiologists are supposed to know how to give anesthesia and how to give it safely,” said Dr. Greene. “While anesthesiologists should play an important role in the preparation of the surgical patient for an operation, they should not subsume the surgeon’s role in the perioperative setting. I do agree that the management of the surgical patient has to be team-based involving surgeons, anesthesiologists and nurses.” —Brian Dunleavy
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10 I AnesthesiologyNews.com
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POLICY & MANAGEMENT
Experimental Drug May Shield Liver From Ischemia
A
novel complement inhibitor appears to not only protect the liver from injury after surgery but may spur regeneration of the organ, researchers have found. There is presently no approved treatment for ischemia reperfusion injury (IRI), the inflammation that occurs when blood flow is returned to healthy liver tissue after diseased tissue has been surgically removed. IRI results
in part from the deposition of complement, a protein that kills liver cells and impairs regeneration. Complement inhibition therefore has been recognized as a potential way to prevent IRI. However, some complement proteins deposited early signal cells involved in hepatic proliferation and are essential to the regeneration of liver tissue. Researchers from the Medical University of South Carolina, in
Charleston, treated mice with a sitetargeted murine complement inhibitor, CR2-CD59, to investigate the balance between complement-dependent injury and regeneration. They found that the novel agent not only protected against IRI, but also enhanced the proliferation of hepatocytes significantly. Long-term survival in the mice that received the treatment directly after surgery—just before the skin was
closed—reached 70%, even in animals from whom as much as 90% of the liver had been removed, compared with 0% survival in untreated mice. The researchers concluded that
Where do you go… … if you recall reading an educational supplement, but no longer have a hard copy? … if you heard about an interesting piece from a colleague, and would like to obtain a copy?
1 Go to the home page. 2 Click on the “Medical Education” button. 3 The drop-down menu gives you access to free educational materials from Anesthesiology News.
FEBRUARY 2015
AnesthesiologyNews.com I 11
POLICY & MANAGEMENT unlike other available complement inhibitors, which disrupt the early essential component of the complement pathway, CR2-CD59 may offer a nontoxic approach to preventing liver injury and promoting regeneration in a variety of liver injuries in humans. The researchers reported their findings in the Journal of Experimental Medicine (2014;211:1793-1801). —Monica J. Smith
Book on Anesthesiology’s Role in Global Health
S
pringer has just released “The Role of Anesthesiology in Global Health,” the first comprehensive guide on the topic. The editors are Elizabeth Frost, MD, professor of anesthesiology, Icahn Medical Center at Mount Sinai, New York City; Clifford Gevirtz, MD, adjunct associate professor of anesthesiology, Louisiana State University, School of Medicine, New Orleans, LA; Ram Roth, MD assistant professor,
Department of Anesthesiology, Icahn School of Medicine at Mount Sinai; and Carrie Atcheson, MD, MPH PGY4, Department of Anesthesiology, Icahn School of Medicine at Mount Sinai. Drs. Frost and Gevirtz are members of Anesthesiology News’’ advisory board. The book covers surgical diseases endemic to low- and middle-income countries and ways anesthesiologists can improve the safety, efficacy and
Medical Education CME From the Bench to the Bedside Procedural Breakthrough Pocket Guides Special Reports
management of acute and chronic traumatic injuries in a low-resource setting. The 432-page book offers real-life clinical scenarios and underscores the need for collaborative development of a global health strategy. This book is available in both soft cover and eBook. Visit the Springer website (www.springer.com/medicine/anesthesiology) for more details.
—AN Staff
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Preoperative Routines Reduce Post-Op Risks in Obese Patients
D
edicated protocols for obese patients undergoing abdominal surgery can greatly reduce their risk for complications after the procedure, researchers have found. Ensuring that patients are physically fit and knowledgeable about the procedure, combined with steps to minimize the risk for blood clots and other complications, might be key to preventing
adverse outcomes and hastening recovery, the researchers said. “This gives us a good opportunity to have patients go through major surgery and still prevent the more frustrating complications of surgery, like developing a clot, or developing pneumonia after an operation,” said David Shaz, MD, a pulmonary intensivist at the James J. Peters VA Medical Center
in New York City, where the retrospective chart review was conducted. Dr. Shaz and his colleagues presented their findings at the 2014 annual meeting of the Society of Critical Care Medicine (abstract 603). The study included 105 morbidly obese patients (90 men) who had been referred for laparoscopic sleeve gastrectomy surgery by their primary care
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physicians. The average age of the patients was 51, and their average body mass index was 45 kg/m2. To qualify for the surgery, patients first had to undergo a fitness and nutrition regimen that lasted between six and 12 months, to ensure that the regimen did not aid significantly with weight loss. The surgeries were performed over a span of about three years, between January 2010 and June 2013. Once accepted for surgery, patients were required to comply with a strict exercise and dietary program, and were thoroughly educated about the procedure and its risks. Psychologists and psychiatrists also worked with the patients. Before surgery, doctors administered heparin and applied compression boots to prevent blood clots. In addition, 95 patients were given heparin on postoperative day 1. Continuous or bilevel positive airway pressure was applied to 30 patients on the first night postsurgery, to assist with sleep apnea. To prevent lung collapse, 70 patients were encouraged to walk more than 100 feet within five hours of undergoing surgery. On average, the patients were discharged 2.44 days after the procedure. No patients experienced blood clots or collapsed lungs, although a few contracted pneumonia or bronchitis. These results suggest that following dedicated protocols can lead to better patient outcomes, Dr. Shaz said. Patient preparedness is the key factor, he said. The protocols show promise for other types of surgery as well, said Megan Anders, MD, assistant professor of anesthesiology at the University of Maryland Medical Center, in Baltimore. “In the prior literature there are mixed data on the relative rate of complications after bariatric surgery, with some authors noting that an apparent lower rate of [venous thromboembolism] in some studies, for example, may be due to use of stricter protocols in these populations,” Dr. Anders said. “The data from this abstract, although limited in sample size, would support that theory.” —Ajai Raj
FEBRUARY 2015
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POLICY & MANAGEMENT
C. difficilee Infection Takes Bigger Toll in Elderly Philadelphia—One of the challenges in managing patients infected with Clostridium difficilee is identifying those most at risk for dying of the disease and treating them appropriately. New research adds to mounting evidence that advanced age is a significant predictor of death from C. difficilee infection (CDI), tripling an older patients risk for mortality compared with that of a younger patient. “The conundrum of this infection is that treatment is based on severity,” said Sahil Khanna, MD, assistant professor of medicine at Mayo Clinic in Rochester, Minn. “If you have mild or moderate disease, you get treated with metronidazole. If you have severe disease, you get treated with vancomycin.” The American College of Gastroenterology (ACG) defines severe disease as CDI in patients with albumin below 3 g/dL, and either white blood count of at least 15,000 cells/mm3 or abdominal tenderness. “We wanted to see if there were other markers that could [identify] severity, and the first step in doing that was to study an end point for severe infection, which in our study was mortality,” Dr. Khannaa said. “We wanted to evaluate what predicts mortality in patients with CDI, and whether some factors are more predictive than others.” Dr. Khannaa and his colleague, Darrell Pardi, MD, professor of medicine at Mayo, evaluated data from the National Hospital Discharge Survey. The survey included an estimated 162 million adults between 2005 and 2009, of whom 1.26 million had CDI. All-cause mortality of hospitalized patients with CDI was 6.9% compared with 2.2% for hospitalized patients without CDI. “We can’t say they died of CDI, just that they had CDI and also died in the hospital,” Dr. Khannaa noted. “The older people were, the more likely their chance of dying. So we dichotomized people into two age groups: from 18 to 64 and 65 and older,” Dr. Khannaa said. “On univariate analysis, not considering other factors, people who were older had a threefold higher risk for dying of CDI than younger people. That was striking.” Several other factors stood out as well, such as undergoing colectomy, and certain comorbidities—congestive heart failure, pulmonary circulation disorders, metastatic cancer, electrolyte disorders and weight loss—were associated with a significantly higher risk for death. “Our conclusion is that age should be factored into assessment of severity, and
people older than 65 should be considered to have severe disease and possibly managed with vancomycin rather than metronidazole. Of course, future studies will need to investigate this in clinical practice; this was a retrospective study and mostly hypothesis-generating.” Neil Gupta, MD, MPH, assistant professor of medicine and director of interventional endoscopy at Loyola
University Medical Center, in Maywood, Ill., agreed that age should be considered when trying to predict disease severity and therapy. “However, I would be more forward regarding the implications of the study results,” Dr. Guptaa added. “This study actually adds to a growing body of literature showing that older age is associated with higher mortality in patients
with CDI. As a result, this study confirms the results of prior studies, and clinicians should start considering patient age when managing CDI if they are not doing so already.” Dr. Khannaa presented his research at the ACG’s 2014 annual meeting (poster P1644). —Monica J. Smith
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LMASUPREME.COM REFERENCES FERENCES 1. Belena J.M. et al. Journal of Clinical Anesthesia 2011; 23:456-460. | 2. Roiss M. et al. Poster presented at The American Association of Anesthesiologists Annual Meeting 15th -19th, Oct. 2011, Chicago. | 3. Sharma V. et al. BJA 2010; 105(2): 228-232. | 4. Whitacre W. et al. AANA Journal 2014; 82 (2): 101-107. | 5. Abdi W. et al. Acta Anaethesiol Scand. 2010; 54 (2): 141-146. | 6. Bernardini A. et al. Anesthesia 2009; 64: 1289-1294. | 7. Verghese C. et al. Anesthesia and Analgesia 1996; 82: 129-133. | 8. Tretiak S. Anethesiology News 2009. | 9. Viernes D. et al. Anesthesiology News 2010; 9-13. | 10. Verghese C. et al. BJA 2008; 101 (3): 405-410. | 11. Jagannathan N. et al. Pediatric Anesthesia 2012; 22:759-764. | 12. Jagannathan N. et al Anesthesia 2012; 67(2): 139-144. | 13. Ferson D. et al. Anesthesiology 2007; 107:A592.
Teleflex, LMA and LMA Supreme are trademarks or registered trademarks of Teleflex Incorporated or its affiliates. © 2014 Teleflex Incorporated. All rights reserved. MC-000549 rev.1
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Malnutrition ‘Skeleton’ Still Rattling in Hospital Closets Progress report cites awareness gaps among caregivers
O
ne in three Americans enters a hospital malnourished, which increases their risk for adverse events, such as surgical site infections, postoperative pneumonia and the development of pressure ulcers. So with the Centers for Medicare & Medicaid Services (CMS) withholding payment to
hospitals for 11 of these preventable conditions, hospitals and long-term care facilities should be looking at malnutrition as a contributing factor—or so one would think. Recent research shows that many facilities are missing an opportunity to address malnutrition, which
is associated with increased rates of complications and readmission, prolonged hospital stays and greater mortality. In particular, malnourished patients are two to three times more likely to develop a surgical site infection or postoperative pneumonia (Arch Surgg 2010;145: 148-151)
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and twice as likely to develop a pressure ulcer (Nutrition 2010;26:896-901). Nearly half (45%) of patients who fall in the hospital are malnourished (J ( Hum Nutr Diet 2007;20:558-564). “Malnutrition can increase the risk of hospital-acquired infections, increasing the patient’s length of stay and increasing their risk of morbidity and mortality. It can also interfere with the health care practitioner’s ability to adequately and successfully treat the patient while he or she is in the hospital,” explained Carmen Roberts, MS, RD, LDN, a clinical dietitian specialist at Johns Hopkins Bayview Medical Center, in Baltimore. “Of course, there is never one thing that influences a patient’s stay in the hospital, but malnutrition can be a significant factor,” said Melissa Parkhurst, MD, associate professor in the Department of Internal Medicine at the University of Kansas Medical Center, in Kansas City, and medical director of Nutrition Support Services at the University of Kansas Hospital. “The data we have over a number of years consistently show that one in three patients enters the hospital already meeting the criteria for malnourishment,” said Dr. Parkhurst, who is also the clinical representative in the Alliance to Advance Patient Nutrition, an interdisciplinary partnership dedicated to raising awareness about malnutrition in hospitals. “We know that if left unattended, about two-thirds will experience further decline while they are in the hospital.” Also worrisome are the statistics showing that even well-nourished individuals will experience some type of nutritional decline when they enter the hospital because of their illness, poor appetite, dietary restrictions, gastrointestinal problems and other issues, according to Dr. Parkhurst. “There are multiple reasons why malnutrition in the hospital is an issue,” she said. “The hospital care of a patient is a complex system with a lot of moving parts and a lot of things that are competing for the attention of the physician, nurses and administrators. Then on top of that, you add a lack of general understanding of the cost of malnutrition and lack of awareness and inaction.” These factors make it easy for malnutrition to fall under the caregivers’ radar, she explained. Many patients are
FEBRUARY 2015
AnesthesiologyNews.com I 15
PRN
By the Numbers: Fixing Malnutrition Growing evidence associates the effective treatment of malnutrition in the hospital with:
and, if interventions are put into place, they are not always tracked to see if they are working. It happens every day in hospitals and longterm care facilities across the country, Dr. Parkhurst said.
it remains underrecognized and often goes untreated (Nutr Today 1974;9:4-8). Because one in three people enters the hospital already meeting the criteria for malnourishment (Int J Environ Res Public Health 2011;8:514-527), The Skeleton in the Closet and malnutrition has been linked to Malnutrition in the hospital is not increased morbidity and mortality, the a new problem. In a landmark 1984 Joint Commission mandates that a study, Charles E. Butterworth Jr., MD, nutrition assessment be done when a referred to malnutrition as the “skel- person enters the facility. However, the eton in the hospital closet” because group does not provide any guidance
about the management of the patient once he or she is identified, which is how that patient falls through the cracks, Dr. Parkhurst pointed out. If a patient is identified as being malnourished, often he or she is discharged before a full nutritional assessment is performed because the average time for such an evaluation is five days after admission, which is also the average hospital length of stay (J ( Parenter Enteral Nutrr 2011;35:209-216). see skeleton page 16
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placed on NPO (nothing by mouth) orders for long periods, or they are taken for radiographs or other diagnostic tests or procedures during mealtimes and frequently miss meals. Others stop eating because they do not like the food, feel nauseated, are experiencing medication-related changes in taste, are depressed or in pain, or have another issue. Patients’ lack of adequate caloric intake may go unnoticed over time
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16 I AnesthesiologyNews.com
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malnutrition (http://www.malnutrition. com/progressreport). The report high“Dietitians need to do an assess- lights some of the obstacles impeding ment within a timely fashion of progress in recognizing and treating the screening coming back at risk,” malnutrition, as well as recommends a Dr. Parkhurst said. “And the dieti- roadmap for institutions to follow. To change the paradigm will require tian’s recommendations, which are only implemented about 40% of the direct, system-wide and sustained time, need to be followed up by the intervention, according to the report, physician-led team.” released in August 2014. Among the The Alliance to Advance Patient recommendations are: Nutrition recently issued a progress • Hospital administrators and staff report on alleviating hospital-based must view nutrition as a priority for CONTINUED FROM PAGE 15
improving care, quality and cost. • Clinicians’ roles must be redefined to include nutrition, giving them the power to address patient’s nutritional needs. • The electronic health record (EHR) should be leveraged to standardize nutrition documentation and communicate nutrition care plans. • Someone should take responsibility for the patient’s nutritional status. The process begins with the screening, Dr. Parkhurst said. A simple, easyy to-use
Interested in conducting your own research? Consider the Merck Investigator Studies Program. What is MISP? The mission statement of the Merck Investigator Studies Program (MISP) is to advance science and improve patient care by supporting, through the provision of drug/vaccine and total/partial funding, high-quality research that is initiated, designed, implemented and sponsored by external investigators. Who Can Participate? The Merck Investigator Studies Program is open to all academic and community-based physicians, anesthesiologists, surgeons, and researchers worldwide who are interested in conducting their own research. How Does the Program Work? This program consists of committees of medical and scientific staff from different therapeutic areas who meet regularly to review Merck investigator study proposals. Support and funding are provided based on the scientific merit of the proposal as well as whether it is in alignment with the published areas of interest.
Copyright © 2014 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. Printed in USA ANES-1124773-0000 07/14
How to get started: To learn more about the areas of interest for anesthesia and requirements for submission visit http://engagezone.merck.com/anesthesia.html. There are two review cycles for anesthesia submissions:
• First cycle deadline is in early February 2015. • Second cycle deadline is in early April 2015.
tool tied to the EHR should be used. Once a patient is identified as malnourished, the dietitian must quickly perform a full assessment and make recommendations. Someone on the care team must act on these recommendations and periodically check the patient’s nutritional status. Finally, during the huddle, nutritional status should be one of the issues discussed by the health care team. All members of the health care team should be part of the screening and treatment of malnutrition, according to Johns Hopkins’ Ms. Roberts. Nurses and physicians can screen patients on admission and during history taking as well as do a physical for nutritional risk factors and to identify the need for nutritional intervention if needed, as well as educational requirements during the hospital stay. “Dietitians are experts at assessing the patient’s nutritional needs and providing appropriate nutritional interventions,” she said, which could include recommending therapeutic diets, providing education to the patient and caregivers, and making recommendations to the physician for supplemental nutrition if needed during the patient’s hospital stay. Some malnutrition occurs because of nausea, vomiting, diarrhea and altered taste from medications. Pharmacists can conduct a medication reconciliation and side-effect profile, and make recommendations that might foster
FEBRUARY 2015
AnesthesiologyNews.com I 17
PRN “Let’s catch these patients who are already at risk, who are showing signs of malnutrition when they hit the door, and make sure we have a plan in place quickly to intervene and track [their progress],” Dr. Parkhurst said.
questions comments story ideas
—Marie Rosenthal
‘Let’s catch these patients who are already at risk, who are showing signs of malnutrition when they hit the door, and make sure we have a plan in place quickly to intervene and track [their progress].’ —Melissa Parkhurst, MD
calorie intake. They also can assist with IV nutritional support if needed, Ms. Roberts said. Even therapists can help recognize if patients are not eating properly and report that to the health care team. They also can recommend adaptive devices that might make eating easier for patients with handicaps. Social workers can assist the patient in locating community resources if needed. “Providing the patient with community and outpatient resources is an essential part of treating nutritional problems and ultimately avoiding readmission for these conditions,” Ms. Roberts said. “The ultimate goal is to move the patient from the acute environment and to provide them with the resources in the community to ultimately treat any long-term nutritional problems.” These efforts can pay off. Studies show a 25% reduction in the incidence of pressure ulcers (Ageing ( Res Rev 2005;4:422-450), 14% reduction in overall complications (Cochrane Database Syst Rev 2009;CD003288) and a 28% reduction in avoidable hospital readmissions (Arch ( Intern Med 2001;161:1549-1554) when adequate nutrition is maintained in hospitalized patients. Well-nourished patients also experience an average reduction in the hospital length of stay of about two days (Am ( J Med 2006;317:495-501).
The Alliance to Advance Patient Nutrition accepts major funding from Abbott Nutrition, which is a founding partner.
Contact Editor James Prudden at
jprudden@mcmahonmed.com
T O H E A LT H C A R E P R O V I D E R S Waste Anesthetic Gas (WAG) is the small amount of anesthetic gases that leak into the surrounding room during medical procedures. In the PACU, WAG may be exhaled by patients recovering from anesthesia. This gas is not typically harmful to the patient, but the health effects could be cumulative for nurses working in the patient’s breathing zone.1, 2
THE NUMBER OF H E A LT H C A R E P R OV I DE R S I N T HE U . S . P O T E N T I A L LY EXPOSED TO WAG2
WHO IS AT RISK
MORE THAN
250,000
SOURCE CONTROLLED SCAVENGING
HOW EXPOSURE HAPPENS IN THE PACU3
PACU nurses work directly within their patients’ breathing zones.
40 PACU NURSES ANESTHESIOLOGISTS SUPPORT STAFF TECHNICIANS NURSE MGRS SURGEONS NURSING AIDES DENTISTS HYGIENISTS
Patients continue to exhale WAG up to 40 minutes
after leaving the operating room.
An effective method for decreasing PACU clinician exposure to WAG is the use of a source control scavenging system, such as the ® ISO-Gard Mask with ClearAir™ Technology from Teleflex3
LEARN MORE AT THEINVISIBLERISK.ORG REFERENCES:
1. Occupational Safety & Health Administration, U.S. Department of Labor. (Revised 18 May 2000). Anesthetic Gases: Guidelines for Workplace Exposures. Retrieved from: http://www.osha.gov/dts/osta/anestheticgases/. 2. OSHA. Waste Anesthetic Gases. May 2008. Available at: https://www.osha.gov/SLTC/wasteanestheticgases/index.html. 3. McGlothlin JD, Moenning JE, Cole, SS. Evaluation and Control of Waste Anesthetic Gases in the Postanesthesia Care Unit. Journal of PeriAnesthesia NursingVolume 29, Issue 4, Pages 298-312, August 2014. This study was funded in part by a grant from Teleflex
Teleflex, ClearAir and ISO-Gard are trademarks or registered trademarks of Teleflex Incorporated or its affiliates. © 2015 Teleflex Incorporated. All rights reserved. MC-000321 Rev 1
TELEFLEX 3015 Carrington Mill Boulevard, Morrisville, NC 27560 Toll Free: 866.246.6990 Phone: +1.919.544.8000 TELEFLEX.COM
18 I AnesthesiologyNews.com
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CONTINUED FROM PAGE 1
of Bellevue: a nearly unbroken chain3 of profound public service punctuated by a long list of New York and U.S. firsts. Bellevue anesthesia is no exception. Bellevue is among the oldest hospitals in North America. Where City Hall now stands, the “Publick Workhouse and House of Correction of the City of New York” opened as a six-bed infirmary on the second floor in 1736. After a series of yellow fever and smallpox epidemics in the early 1790s, city leaders took action and leased land in Kips Bay Farm known as Belle View. In 1794 they constructed a two-story pest house known as Belle Vue Hospital and treated the predicted influx of seasonal “fevers.” The pest house was not used between 1796 and 1797 but reopened when the land was purchased, in fee simple, by the city in 1798.4 From its inception, Bellevue has been a place for teaching. In 1788, at the cutting edge of controversy, the local militia was required to disperse the “Doctors Mob Riot”—a protest against the teaching of human anatomy. It was not until 1854 that a renowned Bellevue surgeon, Dr. James Wood, managed to have a bill passed in Congress legalizing
1
the dissection of cadavers for teaching. That same year, Bellevue became the site of the first systematic autopsies in New York, and in 1861 the Bellevue Medical College was founded.5 In 1882 Bellevue expanded its role as a teaching hospital by allowing New York medical schools to appoint medical and surgical attendings. A master plan for the Bellevue campus was created in 1896 and, two years later, Bellevue Medical College merged with what is now NYU. The doctors pioneered a true public hospital: managing epidemics, cleaning up public health issues, running clinics and founding outreach programs. Although many illustrious medical and surgical champions emerged from Bellevue, anesthesia was a late arrival on the honor roll. This later appearance is part of the history of U.S. anesthesia as a separate physician-run specialty. After W.T.G. Morton made his famous public demonstration at Massachusetts General Hospital in 1846, ether caught on as an agent in the U.S. As a relatively safe anesthetic, its administration was often delegated to non-physicians. By comparison, in the United Kingdom, chloroform became more popular. As a more difficult drug to titrate, with well-publicized early fatalities,6 chloroform became the domain of physicians.7 As a result, the American field of anesthesiology as a recognized medical specialty
developed relatively gradually. For the early part of the 20th century there was no formal instruction and most practitioners were selff taught. In the early 1930s, the state of anesthesia at Bellevue was unrecognizable by modern standards. Patients had no preoperative workup and no notes in the chart—even after an intraoperative death. Endotracheal intubation was prohibitedd by certain services for non-thoracic cases. Anesthesia was administered by the department of nursing, with four independent and non-cooperative divisions. Nurses were only allowed to provide inhalational anesthesia and did so without the modern luxury of ventilators, pipeline gas or automated monitoring. Spinals were performed by unsupervised surgery residents with a purported immediate fatality of one in 150. Overall, deaths were common and poorly investigated. Most post-mortem records were skeletal, giving a pre-operative diagnosis, the anesthetic used (e.g., “cyclopropane and ether”), followed by a description such as “… the resection was being performed, when his heart stopped ...”8 Then, in 1935, things began to change. As legend has it, that year, a particularly disastrous thoracic see Bellevue page 20
3
2
5 4 1. Ringling Brothers and Barnum & Bailey Circus Day at Bellevue, 1919. 2. Annual performances (Ringling Bros. and Barnum & Bailey) took place from 1908 until 1967. Circus Day, date uncertain. 3. Circus Day at Bellevue, 1965 4. Three Bellevue horsedrawn ambulances, 1895. 5. Horse-drawn ambulance entrance, 1885. Images courtesy of Bellevue Hospital A Archives.
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case prompted the head of surgery, Dr. Arthur Wright, to look for help. He had been about to hire a dentist when he heard through a chance conversation about a post-graduate training program for anesthesia at the University of Wisconsin-Madison. The program, started in 1927 by Dr. Ralph Waters, was the first of its kind. Wright asked Waters to recommend someone to set up an anesthesia department at the New York University medical school and Waters recommended one of his star alumni: Emery Rovenstine. Wright’s support was critical and he even went as far as personally paying part of Rovenstine’s $5,000 salary. This protégé of Waters would transform both Bellevue and the practice of anesthesia. Rovenstine came to New York with a missionary zeal that made him unpopular with many established practitioners. Initially, the majority of Bellevue surgeons were, at best, uninterested and, more often, hostile to any change. They objected to his newfangled ideas: pre-surgical evaluations and testing, pre-anesthetic plans, post-anesthetic visits,
and detailed anesthesia records. However, with great political acumen, Rovenstine had a strategy: he began by rounding with the surgeons; he got to know them and demonstrated that he could also be helpful outside the operating room. Rovenstine’s most lasting contribution was education. He used two assistants: one clinical, who also trained residents, and one research assistant, who was dedicated to experimental work and more difficult cases. Senior Bellevue residents taught the juniors with attending supervision but with an emphasis on resident autonomy and didactic conferences. Critical to education and quality was detailed recording of morbidity and mortality events, using a punch card method for record-keepingg and data analysis that Rovenstine developed with Waters in Wisconsin. Rovenstine also introduced the use of “M&M” conferences (which later attracted citywide attendance) as a venue for learning. Rovenstine insisted on the anesthetist as a professional—a physician and clinician —rather than as a technician. If it was just a technical task there was no need for the specialist training he so firmly believed in.
When Rovenstine joined Bellevue in 1935, there were no anesthesia residents. By 1943, there were a total of 15 in the whole country, seven of them at Bellevue. Just five years later, the Bellevue anesthesia residency included 27 trainees. Residency under the chief was no ether frolic: a rare female resident who had two failed intubations, both leading to deaths, was called into his office. Rovenstine told her that she shouldn’t be a doctor at all so she “packed up her clothes, left the hospital, and got a job far away from medicine …” Rovenstine later reported: “She’s married now and has three children. I suppose she takes pretty good care of them.” Unabashed, he continued: “... I liked her for not making excuses. You know, a lot of surgeons and anesthetists tend to blame a death on the patient.”9 Early trainees received room, board, and $35 to $70 a month—less than nurses were paid, and for longer hours. Rovenstine’s response? “The money is all gravy anyway, I see to it that they don’t get any time to spend it. I believe in working a resident to death. He gets three years of hell from me, and then, if he wants, he can go out and make that fifty thousand a year.”10 Rovenstine’s office was at Bellevue and he see Bellevue page 24
1 2 1. Bellevue Hospital in 1863 as seen from the East River.
3 4
2. Rovenstine (needle in hand) believed that “only millionaires and indigents get decent medical care” and would use Bellevue patients for public demonstrations of technique: “Some of the spectators, though they felt awed, also felt inclined to giggle. Even trained anesthetists sometimes get into this state during nerve-block demonstrations because of the tenseness such feats of magic induce in them. The patient, thin, stark-naked, and an obvious product of poverty and cheap gin mills, was nervous and rather apologetic …” Photo from private collection, quotations from The New Yorker,r October 1947: “PROFILES, Anesthesiologist, 1 – The Cold and Drousy Humour.” A Profile of Dr. Emery Andrew Rovenstine.
3 Copy of a 1938 intra3. operative record for a o pulmonary lobectomy. p (SSource: private collection)
4. Surgical Amphitheater 4 at Bellevue, 1890. Doctors co onduct an operation in th he surgical amphitheater att Bellevue for New York City’s medical students. Th he photo is meticulously sta aged by Bellevue’s official photographer at the time, O.G. Ma ason. (Courtesy of Bellevue Hospital Archives)
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ProCESS Trial May Lead to Sepsis Protocol Tweaks
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hirteen years ago, a seminal study on early, protocoldriven therapy for severe sepsis showed that the aggressive intervention boosted survival in these critically ill patients. Now, a new look at the treatment strategy suggests that such a rigid approach may be no more effective than current bedside treatments.
The original single-center study (N Engl J Medd 2001;345:1368-1377) found that in-hospital mortality was significantly reduced in patients with severe sepsis or septic shock who were treated based on a sixx hour protocol of early goal-directed therapy (EGDT) compared with those who were provided usual care (30.5% vs. 46.5%, respectively). The protocol consisted
primarily of central venous catheterization to monitor central venous pressure and oxygen saturation, along with a targeted resuscitation strategy. To determine if the findings from that study are still generalizable, and to assess whether all of the protocol components are still needed, investigators conducted the ProCESS (Protocolized Care for Early Septic Shock) trial ((N Engl J Med
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2014;370:1683-1693). They enrolled 1,341 patients from 31 emergency departments across the United States. Of these patients, 439 were randomly assigned to EGDT, 446 to protocolbasedd standard therapy and 456 to usual care. Resuscitation approaches varied regarding the observation of central venous pressure and oxygen, and the use of vasopressors, inotropes, IV fluids and blood transfusions. At 60 days, there were 92 deaths in the EGDT group (21%), 81 in the protocol-based standard therapy group (18.2%) and 86 in the usual-care group (18.9%). These differences in mortality were not statistically significant, the investigators reported. There also were no major disparities in 90-dayy mortality, one-yearr mortality and necessity for organ support. As a result, the researchers concluded that there was no substantial advantage, with respect to death or illness, of protocol-based resuscitation over the current standard. The design of the ProCESS trial has several merits compared with the earlier research, according to Ishaq Lat, PharmD, FCCM, clinical coordinator of critical care at University of Chicago Medical Center, who was not involved with either study. He noted, for example, that the randomized controlled trial design of ProCESS was impressive, given the challenge of screening and enrolling patients with severe sepsis in hectic critical care settings. Moreover, “including patients from all over the country makes [the newer study] a better representation of patients with severe sepsis and septic shock than before, and gives it a broader level of relevance.” But he stressed that the ProCESS study results should be interpreted in the context of acknowledging the last decade of improved sepsis management. “The initial NEJM M trial called for early recognition to institute treatment with antimicrobial agents, timely administration of fluids and vasopressor agents, and conservative transfusion thresholds—all of which are now reflective of the care in most institutions today,” Dr. Lat said. That would explain, he added, why survival in the usual-care arm of the ProCESS trial was significantly increased compared with survival in the original goal-directed resuscitation study. “This may well be representative of the dramatic improvement in sepsis treatment that we’ve seen in recent years,” he said.
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Self-Reported Emergent BMI Figures Useful New Orleans—The selff reported weight and height of emergent surgical patients can be valid indicators to determine the body mass index (BMI) during preoperative evaluation, a study has confirmed. Although direct measurements should be taken whenever possible, the data indicate that selff reportingg can be a useful tool in certain situations. Claudia P. Cobos, MD, and Alexandra Chaves, MD, of the Clinica Jorge Piñeros Corpas in Bogota, Colombia, analyzed a sample of 120 patients between the ages of 18 and 87, from November 2013 to January 2014. Patients were asked to selff report their height and weight, unaware that direct measurements would follow. Researchers then used the KruskalWallis test to evaluate the magnitude of the difference between the measured and selff reported data for height, weight and BMI, using age categories. The group correlation between measured and selff reported height was only 0.95. Weight measurements also demonstrated a strong correlation (Spearman index = 0.92). Of all participants in the survey, 26% overestimated their weight and 63% underestimated their weight. In total, the group correlation between selff reported and measured BMI was 0.90. “The findings are important because in some institutions, anesthesiologists program all medications and ventilatory mechanical parameters with selff reported data,” Dr. Cobos said. “Direct measurements should still be taken when possible.” Dr. Cobos said in an interview that although they were surprised to see a fair correlation between the numbers,
To make future studies more relevant to real-world clinical practice, “perhaps we select an end point other than [survival], such as health care resources or patient quality of life,” Dr. Lat suggested. “Or maybe we should design smaller studies that won’t impact a heterogeneous pool of patients with the syndrome, leading to more patientspecific treatment strategies, such as those that have been developed for heart failure or hypertension.” The study was supported by a grant from the National Institute of General Medical Sciences. —Paul Bufano
that correlation decreased with age. “We noticed a strong correlation between measured and selff reported height and weight, but that changed in older patients,” Dr. Cobos said. “That disparity grew as they aged.” The research revealed that as people age, they tend to overestimate their height and underestimate their weight, thus creating a lower selff reported
BMI. Although patients between the ages of 18 and 39 overestimated their height by 1.1 cm, that number rose to 3.4 cm for individuals between the ages of 60 and 87. Older patients may overestimate their height because of reductions in height that come with advancing age. “There is a strong correlation, but it’s better to take to the scale for older patients
or those who you suspect are overweight. There were significant differences among some of them in measured and selff reportedd BMI,” said Dr. Cobos, who noted that overweight patients have a higher probability of perioperative complications and cardiovascular, pulmonary and metabolic morbidity. —Craig Guillot
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Analysis of Anesthesia Start Times Aims To Create National Benchmarks New Orleans—Researchers are creating a set of national benchmarks to estimate times in which anesthesia takes effect for different procedures. Knowing average intraoperative anesthesia ready times could help hospital administrators and anesthesiology departments improve intraoperative efficiency with better scheduling and optimized use of anesthesiologists. Sudheer K. Jain, MD, assistant clinical director of the Department of Anesthesiology, and third-year anesthesiology resident Lori Russo, MD, of NYU Langone Medical Center, New York City, discussed their ongoing research at the annual meeting of the American Society of Anesthesiologists. As hospital administrators are requiring health care providers to
become more cost-effective and efficient, they have begun to take a closer look at anesthesiologists. Anesthesiologists at busy institutions are being encouraged to shorten their anesthesia induction times, but absent national benchmarks health care providers might be pressured into unrealistic expectations, potentially resulting in adverse outcomes. “Our hospital has a lot of pressure to make things move [more] quickly and anesthesia is something they often look at. There’s no real existing data on this and we wanted to see how long things should take,” Dr. Russo told Anesthesiology News. Their research examined the anesthesia induction times for 22,604 cases performed at the institution over the nine-month period from April to
December 2013. Cases were categorized by the hospital’s 74 most common surgical procedure types, ranging from spinal fusion and craniotomy to bowel resection. Average times were recorded from the moment the patients were wheeled into the operating room until the time they were ready for the surgical procedure and positioning. Dr. Jain said the hospital
BELLEVUE
in 1940 served as its president. He also helped found the journal Anesthesiology. In 1943 and 1944, Rovenstine was president of the ASA, and in 1945 he was instrumental in establishing the PostGraduate Assembly. Continuing the tradition of Dr. Gaston Labat, who perfected many regional techniques at Bellevue, Rovenstine set up the first Bellevue nerve block clinic and had patients come in for pain relief procedures. Cadavers (in legal use thanks to Dr. Wood) were used to train residents in needle placement. Rovenstine would demonstrate nerve blocks on “indigents” in front of a host of trainees and other physicians, proudly using an eyeliner pencil to mark the needle insertion site. Eventually, it became obvious that patients were getting better and safer care under Rovenstine’s training system. A New York thoracic surgeon was quoted as saying: “Being a Rovenstine anesthesiologist is being a goddam good doctor… they know clinical medicine, and they know pharmacology. Rovenstine and his mentor, Dr. Ralph Waters, have made anesthesia grow up. Anesthesiology is no longer a sub-branch of surgery but a distinct branch of medicine, and one of the most valuable. Nobody in the world knows more about physiology than a good anesthetist. They spend all
their lives finding out what makes people live.”13 Rovenstine and his peers gradually convinced surgeons and hospital leadership that anesthesia should only be performed by specialists, after years of training. Rovenstine’s success in reducing mortality from wartime chest trauma as he “hammered away at bronchial toilette” earned him a place on the Army’s advisory board. Even more telling was the edict that in any Army general hospital OR, “… the anesthetist should be in charge of the operating room and of keeping the patient alive, and … the surgeon should be in charge of cutting.”14 Reading this quote in 2014, it’s difficult not to wonder: What happened since? Although Rovenstine died in 1960, in many respects, his Bellevue lives on. The department grew to further academic heights under Dr. Herman Turndorf and, more recently, Dr. Thomas Blanck. Our new chairman, Dr. Andrew w Rosenberg, has opened the latest chapter in Bellevue’s ongoing story. Current trainees can still feel “Rovey” looking over their shoulder, not only through many departmental paintings, but also in the ongoing enthusiasm that Bellevue gives to quality patient care and teaching. Dr. Levon Capan arrives early each morning and inspects the OR list for
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had little to do with the more lucrative private practice done at the Postgraduate Hospital.11 What Rovenstine had to offer was indeed far more valuable than money. He wanted to make Bellevue the “anesthesia capital of the world” and he had no shame in advocating for himself, his trainees, and his profession. Prior to leaving for a teaching mission to Central Europe, he dismissed the idea of carrying notes: “I’ve got all there is on this subject in my head.” And when fostering a “talented young man,” Rovenstine was known to say, “Let’s get you some publicity.”12 This was no press-conference; Rovenstine meant publication. His tally of more than 200 articles and the illustrious list of his graduates (Dr. Virginia Apgar, Dr. Louis Orkin and Dr. Perryy Volpitto, just to name a few) indicate that although showmanship was a trademark of Rovenstine’s, it was a show with substance. He encouraged collaboration with scientists to develop the scientific foundation for anesthetic practice, rather than just publishing papers on technique. Rovenstine went on to help formalize professional development. In 1938, he was one of the seven founders of the American Board of Anesthesiology (ABA) and
interesting cases. As he enters the anesthesia library, the room of future anesthesiologists falls silent. Papers are shuffled. Who will be in the hot seat this morning? Then a pause: “Doctor, tell us about your first case in Room 6 today ...” Is that a smirk on Roventine’s portrait? –Kiri Mackersey, MD, and Alexander Nacht, MD Drs. Mackersey and Nacht are anesthesiologists at Bellevue Hospital and NYU Medical Center.
Notes 1. Sandra Opdycke. No One Was Turned Away: The Role of Public Hospitals in New York City since 1900. New York: Oxford University Press, 1999. 2. An alternate spelling of “employees” now obsolete. 3. Until Hurricane Sandy in 2012, Bellevue had been open without interruption since 1798. The flooding afforded us a sudden reminder of our East River Belle View location and, during the blackout, an opportunity to experience historical conditions. It was with great reluctance that we closed our doors, but as the sanitary risk began to threaten the hospital’s very mission, we were reminded of the wisdom of our Bellevue forebears. A Bellevue surgeon who helped give the New York Board of Health “almost autocratic powers” reminisced in 1918: “The unsanitary condition of the city prior to 1866 cannot be described so that an audience of today can fully appreciate the reality ... Large areas were undrained, giving rise to miasmatic fevers in the Autumn. The cobble-stone paved streets were lined and littered with garbage. Small butcher shops were in every section, requiring herds of cattle, sheep and hogs to be driven through the streets … Life in the streets, now made perilous by
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PRN previously based its scheduling models from incision to surgical end time without factoring in anesthesia. Over the course of a day, those incorrect calculations were adding up to significant time delays and putting additional pressure on anesthesiologists. “It’s really important to [factor in] anesthesia ready times because there can be a lot of time involved in it. There can be a significant variability for certain types of cases and it can make a big impact in scheduling,” said Dr. Jain. The researchers studied a large number of cases to get a more detailed analysis in order to differentiate ready times based on the anesthetic procedures performed as well as staffing
the automobile, was then even more endangered by stray cattle made furious by the hooting, chasing mob.” In late 2012, we were again undrained, but thanks to the outstanding staff, no hogs, mobs or miasmatic fevers emerged. And when Bellevue rose again, we just carried on. (New York Times August 27, 1922. Obituary for Dr. Stephen Smith. “Dr. Stephen Smith Dies in 100th Year: Famous Physician was a Pioneer in Sanitary Reforms in New York City,” quoting a previous 1918 NY Times article by Dr. Stephen Smith.) 4. Source: HHC. Retrieved from http://www.nyc.gov/ html/hhc/bellevue/html/about/history.shtml. 5. In 1841 the City of New York Medical School (now NYU) formally affiliated with Bellevue, although medical instruction had started at Bellevue much earlier. 6. In 1848, Hannah Greener from Newcastle, England, is the first widely reported fatality from chloroform anesthesia. History of Anaesthesia Society, UK. 7. Ortega RA, Kelly LR, Yee MK, Lewis KP. Written in Granite: A History of the Ether Monument and Its Significance for Anesthesiology. Anesthesiology 2006; 105: 838-842. 8. “PROFILES, Anesthesiologist, 1 – The Cold and Drousy Humour.” A Profile of Dr. Emery Andrew Rovenstine. The New Yorker, October 1947. 9. Ibid. 10. Ibid. 11. Later “University Hospital” and now NYU Langone Medical Center. 12. “PROFILES, Anesthesiologist, 1–The Cold and Drousy Humour.” A Profile of Dr. Emery Andrew Rovenstine. The New Yorker, October 1947.
considerations. Data will be analyzed based on type of anesthesia and how it was administered, and Dr. Russo said they are also tracking the number and types of health care workers involved in the delivery of the anesthesia. Times might vary if there was a certified registered nurse anesthetist or resident in the room. Dr. Russo said using as many factors as possible could help create more accurate benchmarks for anesthesia start times. She said they’ve already
discovered valuable information that could help determine precise anesthesia times for surgery planning. Surgical schedulers will be able to say, for example, that the anesthesiologist may need up to 44 minutes to get a patient having coronary artery bypass graft surgery ready for incision, whereas an anesthesiologist preparing a patient for total hip arthroplasty may need an average of 18 minutes. “We want to be able to say this is exactly the time we need to start. We
—Craig Guillot
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13. “PROFILES, Anesthesiologist, 3–The Patient is Doing Well.” A Profile of Dr. Emery Andrew Rovenstine. The New Yorker, November 1947. 14. Ibid. Quote from an unnamed ex-army thoracic surgeon.
can try to improve upon that and also create more realistic schedules,” said Dr. Russo. In addition to establishing benchmarks, Dr. Jain said the information could also help identify ways to decrease anesthesia start times or improve efficiencies. S olutions may include shifting some procedures outside of the operating room or adjusting staffing for certain procedures.
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Survey: Compliance for Some SCS Infection Control Pra Lacking for Others San Francisco—A recent international survey on infection control practices for spinal cord stimulation (SCS) implants and trials has helped identify the best practice protocols that were closely followed by interventional pain physicians, as well as several important areas where the researchers saw a need for improvement. The 33-question online survey—based on “an extensive literature review of infection control policies”—was created to help researchers gain insight into current practices and to help in the development of better and more specific neuromodulation infection control policies. According to the researchers, only limited research exists on preventing surgical site infections for SCS, which are reported at a rate of 2% to 8%. There were 506 responses to the survey. Answers were divided into areas of compliance (80% or more participation) and noncompliance (less than 80% participation) when compared with “current evidence-based recommendations.” Areas of compliance included: • Use of preoperative antibiotics for SCS trials (86%). • Use of preoperative antibiotics for SCS implants (96%). • Appropriate preoperative timing of prophylactic antimicrobial administration (97%). • Irrigation of the surgical wound before wound closure (87%). • Application of occlusive dressing after SCS trial (80%). The researchers were surprised to find several practices regarding antibiotic use (e.g., preoperative weightbasedd antibiotic dosing) on the noncompliance list. Advertisement
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“If you’re going to give an antibiotic but you don’t weight-base dose it, it’s useless,” said David Provenzano, MD, who presented the results at the American Society of Regional Anesthesia and Pain Medicine (ASRA) 13th annual pain medicine meeting (e-poster ASRAP-0048). “If you don’t get minimum inhibitory concentrations to your antibiotic, you might as well not give it.” Preoperative weight-based antibiotic dosing for SCS trials and implants was 40% and 48%, respectively. Dr. Provenzano, president of Pain Diagnostics and Interventional Care, in Bridgeville, Pa., noted that the continued use of antibiotics in the postoperative period was another critical area that could have a negative effect. “We don’t have specific data for this for stimulation, but if you adapt antibiotic standards and you look at other implantable devices and you look at spine surgery specifically, continuation of antibiotics beyond 24 hours is counterproductive. It does not help,” he said. “People who continue antibiotics following spine surgery actually have worse outcomes and elevated levels of inflammatory markers.… It is not a recommended practice.” Half of the physicians surveyed said they continued antibiotics in the postoperative period for SCS trials and 43% did so for SCS implants. The survey also highlighted major gaps in physician knowledge of procedures and protocols. For example, only 8% of respondents knew the maximum time criterion for defining a deep surgical site infection of an implantable device. “If you look at the CDC [Centers for Disease Control and Prevention] definition for deep infection, we are responsible for one year after implantable device.
Most people were not cognizant of that. They said 30 days. That’s only for a superficial infection,” said Dr. Provenzano. Other areas of noncompliance included: • Use of chlorhexidine gluconate for preoperative skin antiseptic agent (39%). • Use of double gloving (48%). • Application of an occlusive dressing following an SCS implant (68%). • Hair removal (when required) with electric clippers immediately before the surgical procedure (74%). The survey was distributed through device manufacturers and associations such as the American Academy of Pain Medicine, ASRA and the European Society of Regional Anaesthesia & Pain Therapy. The majority of the responses (410) came from physicians in the United States. Of the total number of respondents, 99 belonged to an academic practice, 105 to a hospital-based practice, 182 to a private group practice and 102 to a private solo practice. The study authors noted that not all health care providers answered all of the questions in the survey. Dr. Provenzano said although the researchers are happy with the number of responses, the response rate could be seen as a downside to the study. He said they are currently working on a statistical analysis of the results to further break down the data in categories such as type of practice, demographics and physicians with high compliance rates. The researchers concluded that “further education is warranted on infection control strategies for physicians performing spinal cord stimulator trials and implants.” —Martin Leung
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Robotic-Assisted Procedures Effective, Time-Saving for Pain Management
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obotic-assisted, computed tomography (CT)-guided interventional pain management procedures are as effective as conventional C-arm, fluoroscopy-guided approaches, according to data presented at the International Spine Intervention Society’s 2014 annual scientific meeting. The prospective observational study included 200 non-pregnant people (80 women; age range, 18-80 years), who were scheduled for clinically indicated procedures for pain. Half of the group underwent a robotic-assisted procedure, and the other half was treated using non-robotic procedures. In each group, 22 patients underwent a lumbar sympathetic block, 16 a celiac plexus block, 12 a dorsal root ganglion block and 11 a thoracic sympathetic block. The remaining 39 patients underwent an array of procedures, ranging from superior hypogastric plexus block to sacroiliac joint injection. Lead researcher Madhan Kumar, MD, MBBS, senior consultant, Department of Pain Management, Global Hospital, Global Health City, in Chennai, Tamil Nadu, India, performed all the procedures. He used standardized approaches, including the same local anesthetic. Dr. Kumar and his team found that there was 99.8% accuracy of needle placement in the robotic-assisted group and 98% in the non–roboticassisted group, with 100% and 98% confirmation by contrast, respectively. The average time from imaging to contrast confirmation was 240 to 420 seconds and 600 to 700 seconds, respectively. Needle placement required, on average, less than 420 seconds and more than 600 seconds, respectively. Patients rated the approaches using the Madhan Position Comfort Scale, which Dr. Kumar created. The robotic approach received a 9 out of 10, compared with a 5 out of 10 for the standard approach. “I presented my scientific paper as an eye-opener in the field of interventional pain management,” Dr. Kumar explained after the meeting in a series of emails. “There is scope beyond fluoroscopy for a robotic approach, which saves time and allows better patient positioning.” However, Zack McCormick, MD, a postgraduate year 4 resident at the
Rehabilitation Institute of Chicago/ Northwestern McGaw Medical Center, who attended the talk, said the study did not address the significant expense of robots, nor whether robotics or CT guidance improves the procedures. He said the inclusion of
both contributed to the reported superior outcomes in the CT guidance/ robot group,” Dr. McCormick, who was not involved in the study, said. “A better study design would have been one group with robot plus CT many different types of procedures, guidance versus another group with some of which are more appropri- human plus CT guidance.” ate for CT guidance than others, also —Rosemary Frei, MSc makes the results difficult to interpret. “One of the challenges in interpreting these preliminary data is the fact that Drs. Kumar and McCormick did not report any it is unclear if CT guidance, robots or relevant conflicts of interest.
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Experts Call for Individualized, Evidence-Based Cancer Pain Treatment Model
T
he biopsychosocial approach to individualizing assessment and treatment of cancer pain should become the mainstream approach and a new model is needed to make it even more widely accessible and implemented. That was the bottom line of a presentation by a Dutch cancer pain professor at the 7th World Congress of the World Institute of Pain (WIP), held recently in Maastricht, Netherlands. The three-step model for pain medicine published by the World Health Organization (WHO) in 1986 for the management of cancer pain (http:// www.who.int/cancer/palliative/painladder/en/) is still being used but does not allow for individualized diagnosis and treatment, said Kris C.P. Vissers, MD, PhD, president-elect of the WIP and research chair, Department of Anesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, Holland. In contrast, the biopsychosocial approach takes into account the psychological state of the patient, the patient’s social support and his or her values and sense of spirituality, he said. It also emphasizes a thorough assessment of the causes of the pain. This holistic view of pain is able to account for the significant variations in the amount of pain, suffering and resulting coping behaviors among patients with the same anatomical abnormalities, or lack thereof, Dr. Vissers said. He proposed a four-pronged framework for assessing and diagnosing each patient with cancer pain. These focus on the pain source/site; how that pain is propagated and processed; and whether the pain processing is altered in some way at some point in the body (Figure). “We have the knowledge to be able to do provide these ‘medical reasoning models’ routinely in clinical practice every day with every pain patient but we’re not implementing them. If a primary care provider refers a patient then he should provide a medical hypothesis for that patient’s pain, including the site, the nerve damage and whether there is central desensitization,” Dr. Vissers said. “This information is necessary to provide the correct therapy, rather than just providing broad, empiric therapy.” He believes that quantitative sensory testing should be used to determine the magnitude of sensory abnormalities in pain patients. He also proposed the
use of centralized databases to collect information on validation of assessment tools, patient diagnoses, treatments and long-term outcomes. This will lead to continuous improvement and standardization in use of assessment tools, increased accuracy, reduced cost of
diagnosis and treatment, and improved education and training of health care professionals who treat pain patients. Two American pain experts contacted by Anesthesiology News agreed it is important to supplant the outdated WHO pain treatment algorithm with
a more nuanced, evidence-based and individualized approach. “The biopsychosocial model Dr. Vissers described and variations of it have been implemented in various cancer institutions, including ours,” said Amitabh Gulati, MD, director of ambulatory pain, Department of Anesthesia and Critical Care, Memorial Sloan-Ketteringg Cancer Center, New York City. “Our palliative, psychiatry, rehabilitation and anesthesiology services meet regularly to discuss patients
Experience the power of predictable control 1- 4
Visit www.aboutULTIVA.com to see how Remi could work for you. *Remifentanil is commonly referred to as Remi by anesthesia providers. † Continuous infusions of Remi should be administered only by an infusion device and continuous monitoring is necessary. Interruption of infusion will result in rapid offset of effect. ‡ Within 5 to 10 minutes after discontinuation of Remi, no residual analgesic activity will be present. However, respiratory depression may occur in some patients up to 30 minutes after termination of infusion due to residual effects of concomitant anesthetics. Other analgesics should be administered prior to discontinuation of Remi where postoperative pain is anticipated. INDICATIONS ULTIVA® (remifentanil HCl) for Injection is indicated for intravenous administration: • As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures • For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting • As an analgesic component of monitored anesthesia care in adult patients
ULTIVA is a registered trademark of Glaxo Group Limited. The Mylan logo is a registered trademark of Mylan Inc.
©2014 Mylan Institutional
IMPORTANT RISK INFORMATION Continuous infusions of ULTIVA should be administered only by an infusion device. IV bolus administration of ULTIVA should be used only during the maintenance of general anesthesia. In nonintubated patients, single doses of ULTIVA should be administered over 30 to 60 seconds. Interruption of an infusion of ULTIVA will result in rapid offset of effect. Rapid clearance and lack of drug accumulation result in rapid dissipation of respiratory depressant and analgesic effects (within 5 to 10 min) upon discontinuation of ULTIVA at recommended doses. Discontinuation of an infusion of ULTIVA should be preceded by the establishment of adequate postoperative analgesia particularly where postoperative pain is anticipated. Vital signs and oxygenation must be continuously monitored during ULTIVA administration. ULTIVA produces adverse events that are characteristic of μ-opioids, such as respiratory depression, apnea, tachycardia, bradycardia, hypotension,
ULT-2014-0052
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AnesthesiologyNews.com I 29
PAIN MEDICINE Diagnosis
Management
Site Aggressiveness
Source
Nerve damage
Transmission Treat nerve damage
Central sensitization Altered saliency Pro-nociceptive modulation
Processing
Autonomy
Altered processing
Eliminate, deafferent
Treatment
Opioids, nerve block
IV lidocaine, mexiletine
Treat central sensitization IV ketamine, Treat altered saliency pregabalin, CBT, Treat pro-nociceptive clonidine, TCAs, modulation tapentadol
Treat altered central processing Deafferentation ineffective
Figure. Proposed biopsychosocial cancer treatment model. CBT, cognitive-behavioral therapy; TCA, tricyclic antidepressant Sou ce Vissers Source: sse s KP. 7th t World o d Co Congress g ess Institute st tute oof Pain. a 2014. 0
who have complex pain symptoms and develop a comprehensive plan similar to that described by Dr. Vissers.” Brian Bruel, MD, an assistant professor of pain medicine, University of Texas MD Anderson Cancer Center, Houston, and president-elect of the Cancer Pain Research Consortium, said his group was formed last year to develop guidelines that “fill the holes” in the care of cancer patients with pain. He added that Dr. Gulati is also a member of the consortium.
Remi* is a potent μ-opioid agonist with rapid analgesic onset and peak effect, and short duration of action.†1
Rapid response†1
Early post-op neurological assessment‡3,4
Rapid recovery‡1
No accumulation1
Established hemodynamic profile1,2 Remi produces adverse events that are characteristic of μ-opioids, such as respiratory depression, apnea, tachycardia, bradycardia, hypotension, hypertension, and skeletal muscle (including chest wall) rigidity. Please see Indications and Important Risk Information below, and accompanying brief summary of Prescribing Information on adjacent page for all precautions, warnings, contraindications, and adverse events. hypertension, and skeletal muscle (including chest wall) rigidity. Because these effects are dose-dependent and can occur rapidly, continuous monitoring is necessary. ULTIVA should not be used as a sole agent because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia. ULTIVA should be used with caution in pediatric, geriatric, and morbidly obese patients due to high variability in pharmacodynamics and dose/response. Intraoperative awareness has been reported with concomitant administration with propofol infusion ≤75 mcg/kg/min. Failure to adequately clear the IV tubing to remove residual ULTIVA has been associated with the appearance of respiratory depression, apnea, and muscle rigidity upon the administration of additional fluids or medications through the same IV tubing.
October 2014
Due to the presence of glycine in the formulation, ULTIVA is contraindicated for epidural or intrathecal administration. ULTIVA is also contraindicated in patients with known hypersensitivity to fentanyl analogs. ULTIVA SHOULD BE USED IN A CAREFULLY MONITORED SETTING BY SPECIFICALLY TRAINED PERSONS NOT INVOLVED IN THE SURGICAL OR DIAGNOSTIC PROCEDURE. OXYGEN SATURATION IS TO BE CONTINUOUSLY MONITORED. RESUSCITATIVE AND INTUBATION EQUIPMENT, OXYGEN, AND AN OPIOID ANTAGONIST MUST BE READILY AVAILABLE. References: 1. ULTIVA [package insert]. Rockford, IL: Mylan Institutional LLC; 2011. 2. Twersky RS, et al. J Clin Anesth. 2001;13(6):407-416. 3. Wilhelm W, et al. Br J Anaesth. 2001;86(1):44-49. 4. Bilotta F, et al. Eur J Anaesth. 2007;24(2):122-127.
“In June 2014,” he said, “we held a multi-institutionall and multidisciplinary meeting involving neurosurgery, anesthesia, physical medicine and rehabilitation, psychology, and medical and radiation oncology, in order to come up with discipline-specific best practices. That’s an important step toward creating new evidence-basedd guidelines for pain management in cancer patients.” —Rosemary Frei, MS No relevant conflicts of interest were reported.
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Novel Compound Yields Long-Acting Anestheti New Orleans—The duration of sensory blockade was significantly prolonged by a novel site 1 sodium channel blocker that belongs to the class of paralytic shellfish toxins. This first-in-human trial was reported at the American Society of Anesthesiologists 2014 annual meeting and was named the “Best Clinical Abstract.”
ULTIVA® for Injection
“Neosaxitoxin has prolonged local anesthesia when given either alone or with bupivacaine or epinephrine, while reducing the risk of systemic toxicity,” said Carolina Donado, MD, of Boston Children’s Hospital and Harvard Medical School. Neosaxitoxin belongs to a class of natural neurotoxic alkaloids known as the paralytic shellfish toxins, explained
(remifentanil hydrochloride) For IV Use Only Rx only Brief Summary: The following is a brief summary only. Before prescribing, see complete ULTIVA prescribing information. CONTRAINDICATIONS Due to the presence of glycine in the formulation, ULTIVA is contraindicated for epidural or intrathecal administration. ULTIVAA is also contraindicated in patients with known hypersensitivity to fentanyl analogs. WARNINGS AND PRECAUTIONS Continuous infusions of ULTIVA should be administered only by an infusion device. IV bolus administration of ULTIVA should be used only during the maintenance of general anesthesia. In nonintubated patients, single doses of ULTIVA should be administered over 30 to 60 seconds. Interruption of an infusion of ULTIVA will result in rapid offset of effect. Rapid clearance and lack of drug accumulation result in rapid dissipation of respiratory depressant and analgesic effects upon discontinuation of ULTIVA at recommended doses. Discontinuation of an infusion of ULTIVA should be preceded by the establishment of adequate postoperative analgesia. Injections of ULTIVA should be made into IV tubing at or close to the venous cannula. Upon discontinuation of ULTIVA, the IV tubing should be cleared to prevent the inadvertent administration of ULTIVA at a later point in time. Failure to adequately clear the IV tubing to remove residual ULTIVA has been associated with the appearance of respiratory depression, apnea, and muscle rigidity upon the administration of additional fluids or medications through the same IV tubing. USE OF ULTIVA IS ASSOCIATED WITH APNEA AND RESPIRATORY DEPRESSION. ULTIVA SHOULD BE ADMINISTERED ONLY BY PERSONS SPECIFICALLY TRAINED IN THE USE OF ANESTHETIC DRUGS AND THE MANAGEMENT OF THE RESPIRATORY EFFECTS OF POTENT OPIOIDS, INCLUDING RESPIRATORY AND CARDIAC RESUSCITATION OF PATIENTS IN THE AGE GROUP BEING TREATED. SUCH TRAINING MUST INCLUDE THE ESTABLISHMENT AND MAINTENANCE OF A PATENT AIRWAY AND ASSISTED VENTILATION. ULTIVA SHOULD NOT BE USED IN DIAGNOSTIC OR THERAPEUTIC PROCEDURES OUTSIDE THE MONITORED ANESTHESIA CARE SETTING. PATIENTS RECEIVING MONITORED ANESTHESIA CARE SHOULD BE CONTINUOUSLY MONITORED BY PERSONS NOT INVOLVED IN THE CONDUCT OF THE SURGICAL OR DIAGNOSTIC PROCEDURE. OXYGEN SATURATION SHOULD BE MONITORED ON A CONTINUOUS BASIS. RESUSCITATIVE AND INTUBATION EQUIPMENT, OXYGEN, AND AN OPIOID ANTAGONIST MUST BE READILY AVAILABLE. Respiratory depression in spontaneously breathing patients is generally managed by decreasing the rate of the infusion of ULTIVA V by 50% or by temporarily discontinuing the infusion. Skeletal muscle rigidity can be caused by ULTIVA and is related to the dose and speed of administration. ULTIVA may cause chest wall rigidity (inability to ventilate) after single doses of >1 mcg/kg administered over 30 to 60 seconds, or after infusion rates >0.1 mcg/kg/min. Single doses <1 mcg/kg may cause chest wall rigidity when given concurrently with a continuous infusion of ULTIVA. Muscle rigidity induced by ULTIVA should be managed in the context of the patient’s clinical condition. Muscle rigidity occurring during the induction of anesthesia should be treated by the administration of a neuromuscular blocking agent and the concurrent induction medications. Muscle rigidity seen during the use of ULTIVA in spontaneously breathing patients may be treated by stopping or decreasing the rate of administration of ULTIVA. Resolution of muscle rigidity after discontinuing the infusion of ULTIVA occurs within minutes. In the case of life-threatening muscle rigidity, a rapid onset neuromuscular blocker or naloxone may be administered. ULTIVA should not be administered into the same IV tubing with blood due to potential inactivation by nonspecific esterases in blood products. PRECAUTIONS Vital signs and oxygenation must be continually monitored during the administration of ULTIVA. General: Bradycardia has been reported with ULTIVA and is responsive to ephedrine or anticholinergic drugs, such as atropine and glycopyrrolate. Hypotension has been reported with ULTIVA and is responsive to decreases in the administration of ULTIVA or to IV fluids or catecholamine (ephedrine, epinephrine, norepinephrine, etc.) administration. Intraoperative awareness has been reported in patients under 55 years of age when ULTIVA has been administered with propofol infusion rates of ≤ 75 mcg/kg/min. Rapid Offset of Action: WITHIN 5 TO 10 MINUTES AFTER THE DISCONTINUATION OF ULTIVA, NO RESIDUAL ANALGESIC ACTIVITY WILL BE PRESENT. However, respiratory depression may occur in some patients up to 30 minutes after termination of infusion due to residual effects of concomitant anesthetics. Standard monitoring should be maintained in the postoperative period to ensure adequate recovery without stimulation. For patients undergoing surgical procedures where postoperative pain is generally anticipated, other analgesics should be administered prior to the discontinuation of ULTIVA. ULTIVA should not be used as a sole agent for induction of anesthesia because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia. Pediatric Use: The efficacy and safety of ULTIVA as an analgesic agent for use in the maintenance of general anesthesia in outpatient and inpatient pediatric surgery have been established in controlled clinical trials in pediatric patients from birth to 12 years. In clinical trials, the clearance rate observed in neonates was highly variable and on average was two times higher than in the young healthy adult population. While a starting infusion rate of 0.4 mcg/kg/min may be appropriate for some neonates, an increased infusion rate may be necessary to maintain adequate surgical anesthesia, and additional bolus doses may be required. The individual dose for each patient should be carefully titrated (see ULTIVA Prescribing Information [PI], DOSAGE AND ADMINISTRATION, Table 11). ULTIVA has not been studied in pediatric patients for use as a postoperative analgesic or as an analgesic component of monitored anesthesia care. Geriatric Use: Of the total number of subjects in clinical studies of ULTIVA, 486 were in the age range 66 to 90 years. While the effective biological half-life of remifentanil is unchanged, elderly patients have been shown to be twice as sensitive as the younger population to the pharmacodynamic effects of remifentanil. The recommended starting dose of ULTIVA should be decreased by 50% in patients over 65 years of age. Use in Morbidly Obese Patients: As for all potent opioids, caution is required with use in morbidly obese patients because of alterations in cardiovascular and respiratory physiology. Long-term Use in the ICU: No data are available on the long-term (> 16 hours) use of ULTIVA as an analgesic in ICU patients. Carcinogenesis, Mutagenesis, Impairment of Fertility: Animal carcinogenicity studies have not been performed with remifentanil. Remifentanil did not induce gene mutation in prokaryotic cells in vitroo and was not genotoxic in an in vivoo rat assay. No clastogenic effect was seen in hamster or mouse studies. In the in vitroo mouse lymphoma assay, mutagenicity was seen only with metabolic activation. Remifentanil has been shown to reduce fertility in male rats when tested after approximately 40 times the maximum recommended human dose (MRHD). The fertility of female rats was not affected at IV doses as high as 1 mg/kg when administered for at least 15 days before mating. Pregnancy Category C: Teratogenic effects were not observed in either rats or rabbits following administration of remifentanil at doses up to 400 times and 125 times the MRHD, respectively. Administration of radiolabeled remifentanil to pregnant rabbits
senior investigator Charles B. Berde, MD, PhD, professor of anesthesia (pediatrics) at Harvard Medical School. In nature, neosaxitoxin is produced by algae blooms, but the compound is now being manufactured from bioreactor-grown algae by the Chilean-based company Proteus SA. Dr. Berde acknowledged the involvement of Dan Kohane, MD, PhD, in
and rats demonstrated significant placental transfer to fetal tissue. There are no adequate and well-controlled studies in pregnant women. ULTIVA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Administration of remifentanil to rats throughout late gestation and lactation at IV doses up to 400 times the MRHD in terms of mg/m2 of body surface area, had no significant effect on the survival, development, or reproductive performance of the F1 generation. Animal Toxicology: Intrathecal administration of the glycine formulation without remifentanil to dogs caused agitation, pain, hind limb dysfunction, and incoordination. These effects are believed to be caused by the glycine. Glycine is a commonly used excipient in IV products and this finding has no relevance for IV administration of ULTIVA. Labor and Delivery: Respiratory depression and other opioid effects may occur in newborns whose mothers are given ULTIVA shortly before delivery. The safety of ULTIVA during labor or delivery has not been demonstrated. Placental transfer studies in rats and rabbits showed that pups are exposed to remifentanil and its metabolites. In a human clinical trial, the average maternal remifentanil concentrations were approximately twice those seen in the fetus. In some cases, however, fetal concentrations were similar to those in the mother. The umbilical arteriovenous ratio of remifentanil concentrations was approximately 30% suggesting metabolism of remifentanil in the neonate. Nursing Mothers: It is not known whether remifentanil is excreted in human milk. After receiving radioactive-labeled remifentanil, the radioactivity was present in the milk of lactating rats. Because fentanyl analogs are excreted in human milk, caution should be exercised when ULTIVA is administered to a nursing woman. ADVERSE EVENTS In controlled clinical trials in approximately 2770 adult patients, ULTIVA produced adverse events characteristic of μ-opioids, such as respiratory depression, bradycardia, hypotension, and skeletal muscle rigidity. These adverse events dissipated within minutes of discontinuing or decreasing the infusion rate of ULTIVA. Table 1: Adverse Events Reported in ≥ 1% of Adult Patients in General Anesthesia Studies* at the Recommended Doses† of ULTIVA Induction/Maintenance Adverse Event Nausea Hypotension Vomiting Muscle rigidity Bradycardia Shivering Fever Dizziness Visual disturbance Headache Respiratory depression Apnea Pruritus Tachycardia Postoperative pain Hypertension Agitation Hypoxia
ULTIVA (n=921)
Alfentanil/ Fentanyl (n=466)
Postoperative Analgesia ULTIVA (n=281)
Morphine (n=98)
After Discontinuation ULTIVA (n=929)
Alfentanil/ Fentanyl (n=466)
8 (<1%) 178 (19%) 4 (<1 % ) 98 (11%)‡ 62 (7%) 3 (<1%) 1 (<1%) 0 0 0
0 30 (6%) 1 (<1%) 37 (8%) 24 (5%) 0 0 0 0 0
61 (22%) 0 22 (8%) 7 (2%) 3 (1%) 15 (5%) 2 (<1%) 1 (<1%) 0 1 (<1%)
15 (15%) 0 5 (5%) 0 3 (3%) 9 (9%) 0 0 0 1 (1%)
339 (36%) 16 (2%) 150 (16%) 2 (<1%) 11 (1%) 49 (5%) 44 (5%) 27 (3%) 24 (3%) 21 (2%)
202 (43%) 9 (2%) 91 (20%) 1 (<1%) 6 (1%) 10 (2%) 9 (2%) 9 (2%) 14 (3%) 8 (2%)
1 (<1%) 0 2 (<1%) 6 (<1%) 0 10 (1%) 2 (<1%) 0
0 1 (<1%) 0 7 (2%) 0 7 (2%) 0 0
19 (7%) 9 (3%) 7 (2%) 0 7 (2%) 5 (2%) 3 (1%) 1 (<1%)
4 (4%) 2 (2%) 1 (1%) 0 0 3 (3%) 1 (1%) 0
17 (2%) 2 (<1%) 22 (2%) 10 (1%) 4 (<1%) 12 (1%) 6 (<1%) 10 (1%)
20 (4%) 1 (<1%) 7 (2%) 8 (2%) 5 (1%) 8 (2%) 1 (<1%) 7 (2%)
*Does not include adverse events from cardiac studies or the neonatal study. See ULTIVA PI, Tables 6, 7, and 8 for cardiac information. † See ULTIVA PI, Table 10 for recommended doses. Not all doses of ULTIVA were equipotent to the comparator opioid. Administration of ULTIVA in excess of the recommended dose (i.e., doses >1 and up to 20 mcg/kg) resulted in a higher incidence of some adverse events: muscle rigidity (37%), bradycardia (12%), hypertension (4%), and tachycardia (4%). ‡ Included in the muscle rigidity incidence is chest wall rigidity (5%). The overall muscle rigidity incidence is <1% when remifentanil is administered concurrently or after a hypnotic induction agent. In the elderly population (> 65 years), the incidence of hypotension is higher, whereas the incidence of nausea and vomiting is lower. DRUG ABUSE AND DEPENDENCE ULTIVA is a Schedule II controlled drug substance that can produce drug dependence of the morphine type and has the potential for being abused. OVERDOSAGE As with all potent opioid analgesics, overdosage would be manifested by an extension of the pharmacological actions of ULTIVA. Expected signs and symptoms of overdosage include: apnea, chest-wall rigidity, seizures, hypoxemia, hypotension, and bradycardia. In case of overdosage or suspected overdosage, discontinue administration of ULTIVA, maintain a patent airway, initiate assisted or controlled ventilation with oxygen, and maintain adequate cardiovascular function. If depressed respiration is associated with muscle rigidity, a neuromuscular blocking agent or a μ-opioid antagonist may be required to facilitate assisted or controlled respiration. Intravenous fluids and vasopressors for the treatment of hypotension and other supportive measures may be employed. Glycopyrrolate or atropine may be useful for the treatment of bradycardia and/or hypotension. Intravenous administration of an opioid antagonist such as naloxone may be employed as a specific antidote to manage severe respiratory depression or muscle rigidity. Respiratory depression from overdosage with ULTIVA is not expected to last longer than the opioid antagonist, naloxone. Reversal of the opioid effects may lead to acute pain and sympathetic hyperactivity. ULTIVA is a registered trademark of Glaxo Group Limited. US Patent Nos. 5,019,583; and 5,866,591 Version C, 07/2011 Manufactured for Mylan Institutional LLC, Rockford, IL 61103 Manufactured by Hospira, Inc. Lake Forest, IL 60045
the compound’s development and in facilitating Boston Children’s Hospital’s collaboration with Proteus SA. In healthy volunteers, neosaxitoxin significantly prolonged the time to partial and complete recovery when administered with the other agents. Duration of effect exceeded 24 hours for some parameters. This characteristic of prolonged blockade should give neosaxitoxin advantages over current anesthetics, especially in settings where high volumes of local anesthetic are required, according to Dr. Berde, who said this would help avoid the adjunctive use of systemic opioids, which can lead to longer hospitalizations, and the need for perineural catheter infusions to prolong the anesthetic effect. “With combination formulations using site 1 sodium channel blockers, we can provide local anesthesia for periods of several days with a single injection before or during surgery,” he predicted. Compound Was Evaluated In Healthy Volunteers Dr. Donado presented the results of a randomized, controlled, doubleblind Phase I trial of neosaxitoxin. The study examined the intensity and duration of cutaneous blockade with combinations of neosaxitoxin plus 0.2% bupivacaine (NB) and with epinephrine (5 mcg/mL) (NBE). Outcomes were compared with those seen with 0.2% bupivacaine alone. In the dose-escalation study (part 1), 66 healthy adult men received two simultaneous 10-mL subcutaneous injections in a 3 x 3-cm square, one on each posterior calf. In the five NB dose cohorts evaluated for safety, no serious adverse events or need for medical intervention were observed. Numbness and tingling, however, did occur in a dose-dependent fashion after injection. At the highest dose
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PAIN MEDICINE block density between bupivacaine and NBE (both doses) were seen in all block parameters for mechanical touch detection and pain threshold (P<0.05). At 24 hours, 100% of the NBE groups reported some degree of block compared with about 60% in the NB group and 25% in the bupivacainealone group, she said.
School of Medicine, and director of the Acute Pain Service at Children’s Hospital Colorado in Aurora, commented for Anesthesiology News. “The [potential] appearance of neosaxitoxin as a local anesthetic adjuvant is an exciting addition to regional anesthesia and science as a whole. In historical terms, our most recent addition to classic local anesthetics was in 1996 Time for a New Compound with the introduction of ropivicaine, Alan R. Bielsky, MD, assistant pro- proving that new compounds are overfessor at the University of Colorado due,” he said.
(40 mcg), all of the participants experienced notable numbness and tingling that lasted at least 30 minutes. In part 2 of the study, epinephrine was added to the regimen, which eliminated the numbness and tingling. The second part of the study aimed at determining the duration and density of the block at 24 (partial recovery) and 48 hours (full recovery), evaluating several parameters. Eighteen individuals received one of three formulations: 10 mcg NBE; 30 mcg NBE; or saline placebo. The comparison of outcomes also included previous patients who received 0.2% bupivacaine alone, neosaxitoxin 10 mcg and 30 mcg alone, or NB. Mechanical touch detection, pain threshold and cool temperature detection threshold were recorded at baseline, at eight time points during the first 24 hours, and then daily for seven days postinjection or until cutaneous sensitivity returned to baseline. “The neosaxitoxin combinations had prolonged time to partial recovery versus bupivacaine or neosaxitoxin alone. The time to partial recovery was almost three times longer in the combinations compared with bupivacaine alone. All the differences were statistically significant,” Dr. Donado reported, noting that similar trends favoring neosaxitoxin were observed across all parameters. NBE (both 10 and 30 mcg) resulted in significantly prolonged block compared with bupivacaine. For the mechanical pain threshold, the complete blockade lasted 5.3 hours with bupivacaine compared with 22 hours for 10 mcg NBE (P<0.01) and 22 hours for 30 mcg NBE (P<0.05). For mechanical touch detection, the complete block duration with bupivacaine was 7.03 hours compared with 33.9 hours for 10 mcg NBE (P<0.05) and 35.14 hours for 30 mcg NBE (P<0.05). At 24 and 48 hours, differences in
“As a daily regional anesthesia practitioner, my ‘wish list’ includes medicines that are long-lasting, have limited toxicity and are motor-sparing,” he said. “Specific questions that will hopefully be addressed by future studies will include the performance of the drug in the perineural space, effect on motor function, ability to administer in the neuraxial space, and utility in targeting ectopic activity in neuropathic pain.”
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Certain Opioids May Raise Likelihood of Androgen Deficiency
O
pioids may increase the risk for androgen deficiency (AD) in men—depending on the type of opioid, dosage and the patient’s physical health—so checking testosterone levels before considering opioid therapy may be beneficial, a new retrospective cohort study suggested. Lead study author Andrea L. Rubinstein, MD, head of the Chronic Pain Department at The Permanente Medical Group in Santa Rosa, Calif., and her team identified 1,121 men on stable doses of a single opioid for daily use to determine whether low testosterone levels are related to opioid dose. The men were found using the Kaiser Permanente Northern California administrative databases. All study participants were taking exactly one of the following opioids in the 100 days before the testosterone test: fentanyl (in transdermal form), hydrocodone, morphine, methadone or oxycodone. The authors used logistic regression to assess the association between individual opioids and AD, controlling for dose, obesity, age, hypertension and hyperlipidemia. Hydrocodone was used as the referent for the regression analysis because it was associated with the lowest incidence of AD among the opioids examined during preliminary analyses. Dr. Rubinstein and her team found that men on fentanyl (odds ratio [OR], 26.40), methadone (OR, 7.39) and oxycodone (OR, 3.17) were more likely to be androgen-deficient than those on
hydrocodone. Morphine was also associated with a significantly higher risk for AD than hydrocodone—the sample included only 48 men taking morphine alone.
merits testing [testosterone levels] in every [male patient] on opioids. When the opioid risks outweigh the benefits, it is time to seek alternative therapy options.”
‘I think the high incidence [of deficiency] merits testing [testosterone levels] in every [male patient] on opioids. When the opioid risks outweigh the benefits, it is time to seek alternative therapy options.’ —Andrea L. Rubinstein, MD
Dose was associated with an increased risk for AD for men on hydrocodone and oxycodone. Higher dose was not associated with an increased risk for AD among men on fentanyl, methadone or morphine. Men 50 years of age or older who had diabetes, hypertension and/ or hyperlipidemia were more likely to be androgen-deficient than men who were younger than 50 years old and did not have these conditions. Obese men were also more likely to be androgendeficient than those who were not obese. “Androgen deficiency needs to be a part of the total equation for each patient when deciding if [an opioid] is good therapy,” said Dr. Rubinstein. “I think the high incidence [of deficiency]
Chong Hwan Kim, MD, who works at the West Virginia University Pain Clinic, Morgantown, and has a research interest in AD among opioid users, agreed that Dr. Rubinstein’s findings highlight the importance of checking androgen levels among men undergoing treatment for chronic pain. However, he said further research is needed before this issue becomes a key driver in pushing practitioners to alternative therapeutic options. “We have little evidence for the mechanism of action or causation of androgen deficiency in opioid use,” said Dr. Kim, who was not involved in Dr. Rubinstein’s research. “Conclusive associations between duration, dosage or even specific risk factors for development of androgen deficiency with
opioid use are also unclear. Additionally, most of the clinical symptoms are commonly seen in the chronic pain population even prior to opioid initiation. For now, prescribers should consider testing based on clinical judgment and continue appropriate monitooring. Further studies are needed before any recommendations can be made such as for baseline testing or screening criteria.” Dr. Rubinstein first became interested in this topic after a patient presented to her clinic complaining of low levels of testosterone. She was initially dismiissive and wondered how anyone could “feel” low levels of testosterone. After test results showed the patient’s levels as undetectable, Dr. Rubinstein searched the medical literature for information on the risk for low testosterone among men on opioid therapy. She found only a handful of articles, most published in the 1970s. According to Dr. Rubinstein, previous studies—including work in her own clinic—have reported that opioids suppress testosterone in men who use them daily for chronic pain. Although this research has identified a dose– response relationship, she added, none of these studies have demonstrated definitively that low testosterone is related to opioid dose. The findings were presented in Las Vegas during PAINWeek. —Brian Dunleavy
Medical Trainees With Less Knowledge of Evidence-Based Prescribing Favor Brand-Name Drugs
P
hysician trainees who are more receptive to pharmaceutical promotion and have less knowledge of evidence-based prescribing are likely to recommend brand-name drugs over generic alternatives, a national survey found. Led by Kirsten E. Austad, MD, researchers from the Brigham and Women’s Hospital–Harvard Medical School, in Boston, asked first- and fourth-year medical students and third-year residents to answer evidencebased and marketed-drug questions to determine if interactions with pharmaceutical sales representatives would affect their medical knowledge and prescription drug preferences. At least 14 trainees at each level per school were randomly selected—1,601 students (49% response rate) and 735 residents (42.9% response rate). All participants were asked how often they used different educational resources to learn about prescription drugs. Fourth-year students and residents were
given multiple-choice knowledge questions regarding appropriate initial therapy for clinical scenarios for patients with diabetes, hyperlipidemia, hypertension and sleeping difficulties. According to the researchers, “evidence-based answers followed widely used clinical guidelines, whereas marketed-drug answers favored brand-name drugs.” Respondents reported commonly using sources such as Google and Wikipedia. Of fourth-year students and residents, 48% to 90% accurately identified evidence-based prescribing choices. The team used survey answers to create an “industry relations index” to gauge each trainee’s level of acceptance of pharmaceutical promotion. They found that a “10-point industry relations index was associated with 15% odds of selecting an evidencebased prescribing choice (odds ratio [OR], 0.85; 95% confidence interval [CI], 0.79-0.92).” They reported a significant association between the industry relations
index and increased odds of prescribing brand-name drugs (OR, 1.08; 95% CI, 1.00-1.16). The findings were published in JAMA Internal Medicine e (2014;174:1283-1290). —Martin Leung
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Obstructive Sleep Apnea Patients Benefit From Perioperative Use of CPAP New Orleans—Cumbersome though it may be, perioperative continuous positive airway pressure (CPAP) is a boon to obstructive sleep apnea (OSA) patients undergoing surgery, according to a meta-analysis. Researchers from Toronto Western Hospital found that CPAP reduces the perioperative Apnea–Hypopnea Index (AHI) and hospital length of stay (LOS) in this at-riskk patient population. “We already know that the prevalence of obstructive sleep apnea in the general population is very high,” said Mahesh Nagappa, MD, DNB, MNAMS, a fellow at the Toronto, Ontario institution. “The prevalence is not only higher in the surgical population than in the general population, but most OSA patients who come for surgery may be undiagnosed, untreated and have many coexisting diseases. All of these may lead to increased perioperative adverse events.” “There are many treatments for OSA,” he continued. “In this study, we evaluated whether the administration of CPAP during the perioperative period, and its effect on the length of hospital stay and the Apnea–Hypopnea Index.” Dr. Nagappaa and his colleagues performed an English-language literature search for OSA studies of adult surgical patients who were either using or not using perioperative CPAP, with reported data on AHI and hospital LOS. A total of five manuscripts were analyzed. As Dr. Nagappa reported at the 2014 annual meeting of the American Society of Anesthesiologists (abstract A4012), two studies provided data on preoperative (n=100) and postoperative (n=51) AHI in patients treated with CPAP. These studies revealed that CPAP significantly reduced the perioperative API. Indeed, the preoperative index of 37±19 events per hour fell to 12±16 events per hour (P<0.001). “So we saw a decrease of about 25 events per hour when using CPAP,” Dr. Nagappa said. “It’s important to remember that 12 events every hour is still on the high side, so the CPAP was not completely effective in resolving sleep-breathingg disorders.” Three studies provided data on hospital LOS, revealing that CPAP patients (n=264) had a significantly shorter stay than their counterparts
who did not receive CPAP (3.9±4.0 vs. 4.3±4 days; P>0.05). “We also examined the data regarding the continued use of CPAP in these patients,” Dr. Nagappa said. “Among the studies, preoperative CPAP was as used by 278 patients, but only
importance of using CPAP in the preoperative and postoperative period,” he said. “As we found, CPAP significantly decreased postoperative Apnea– Hypopnea Index, and significantly shortened length of hospital stay, too.” 117 patients used it in the postoperaNevertheless, he pointed out that furtive period. So the compliance rate was ther research is required with respect to the use of perioperative CPAP. There is very poor, only 42%. “So the two important messages I a need of larger trials with more patients. want to convey is we really need to —Michael Vlessides educate our patients as well as other Dr. Nagappa did not report any relevant financial health care professionals regarding the disclosures.
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Postoperative Benefits Seen With Preoperative IV Ibuprofen Placebo
Ibup
40 35
MFSS (total score)
into the prospective, randomized double-blind study. Each patient Placebo Ibup received a single preoperative IV dose 200 of either ibuprofen 800 mg (n=28) or placebo saline (n=27). A number of 190 parameters were measured—including quality of recovery, fatigue, mood and cognitive capacity—at four time 180 points: preoperatively, in the postanesthesia care unit (PACU) and on post170 operative days (POD) 1 and 3. As Dr. Le reported at the 2014 annual meeting of the American Soci160 ety of Anesthesiologists (abstract A2019), global quality of recovery 150 scores (as measured using the 40-item Pre-op POD1 POD3 Quality of Recovery [QoR40] questionnaire) were higher for patients taking ibuprofen than for controls (P<0.001) on POD 1 (Figure 1). Figure 1. Changes in global Patients in the ibuprofen group also 40-Item Quality of Recovery proved superior in the QoR40 Questionnaire scores over time. domains of comfort, emotion and pain. The global QoR40 scores were analyzed “QoR40 scores were the same for using two-way repeated measure ANOVA both groups preoperatively,” Dr. Le (analysis of variance) with drug group as said. “But on postoperative day 1, there the between-subjects factor and period of testing as the within-subjects factor. The was a significant decline in the placebo main effects of time (P<0.001) P and drug group, whereas there was no change (P=0.003) P were significant. Scores were in the ibuprofen group. By postopera- significantly lower in the ibuprofen treattive day 3, these scores had returned to ment group than in the placebo treatment P group on POD 1 (*P<0.001). baseline for the placebo group.” Ibup, ibuprofen; POD, postoperative day; pre-op, Similarly, analysis of the nine- preoperatively; QoR40, 40-Item Quality of Recovery item Modified Fatigue Severity Scale Questionnaire Global QoR40
New Orleans—To the welldocumented analgesic benefits of IV ibuprofen add this: Preoperative administration of the nonsteroidal anti-inflammatory drug (NSAID) improves the overall quality of recovery. A recent study also revealed that IV ibuprofen also might improve postoperative cognitive recovery. According to Vanny Le, MD, and a team of researchers from Rutgers New Jersey Medical School in Newark, the stress response to surgery may lead to a number of postoperative complications, including diminished quality of recovery. Because NSAIDs may decrease activation of the stress response, the researchers hypothesized that IV ibuprofen might improve recovery characteristics in patients undergoing laparoscopic cholecystectomy. “Our study specifically looks at the optimization of anesthetic management in order to enhance recovery and minimize some postoperative sequelae that occur after surgery,” said Dr. Le, an assistant professor of anesthesiology. “So we looked at IV ibuprofen, which we believed would improve postoperative recovery.” To that end, Dr. Le and her colleagues enrolled 55 individuals undergoing laparoscopic cholecystectomy
30 25 20
** ***
*
15 10 5 0
Pre-op PACU
POD1
POD3
Figure 2. Changes in the Modified Fatigue Severity Scale over time. MFSS total scores were analyzed by two-way repeated measure ANOVA with drug group as the betweensubjects factor and period of testing as the within-subjects factor. The main P and drug effects of time (P<0.001) (P=0.006) P were significant. Scores were significantly lower in the ibuprofentreatment group versus the placeboP treatment group in the PACU (**P=0.01), POD 1 (***P<0.001) P and POD 3 (*P=0.03). P MFSS, Modified Fatigue Severity Scale; PACU, postanesthesia care unit; POD, postoperative day; pre-op, preoperatively
ROTEM More Sensitive for Fragile Liver Transplant Patients New Orleans—Although thromboelastography (TEG) and rotational thromboelastometry (ROTEM) both are accepted means for measuring coagulation parameters, the two have rarely been compared in liver transplantation surgery. A recent study has concluded that although the two modalities provide comparable results, ROTEM corresponded better with partial thromboplastin time (PTT) and was more sensitive in identifying fibrinolysis. “The complex hemostatic changes that occur during liver transplantation are well documented, and patients undergoing liver transplantation are at increased risk of bleeding,” said Ezeldeen Abuelkasem, MD, a member of the research team and a resident at the University of Pittsburgh Medical Center. “The standard laboratorybased tests—including platelet counts,
fibrinogen level, PTT, PT [prothrombin time] and INR [international normalized ratio]—are limited in their clinical value, since obtaining these lab results often takes time. More importantly, these standard laboratory-based tests do not reflect the entire coagulation process.” Given these limitations, both TEG and ROTEM have become widely adopted as point-off care coagulation devices in liver transplantation. TEG offers kaolin TEG, rapid TEG, heparinase TEG and functional fibrinogen TEG. ROTEM, on the other hand, provides five traditional channels, including the INTEM, EXTEM, HEPTEM, FIBTEM and APTEM assays. Yet despite the popularity of these devices, little research has clinically compared the two in this often fragile patient population. To that end, Dr. Abuelkasem and
his colleagues studied the two modalities in 19 consecutive isolated liver transplantation patients (median age, 55 years; 11 men; median Model for End-stage Liver Disease score, 19; six live donors). Both TEG and ROTEM were performed simultaneously, at induction of general anesthesia (baseline) and 30 minutes after graft reperfusion from an existing arterial catheter. Corresponding coagulation indices between TEG and ROTEM—maximum amplitude (MA) versus maximum clot firmness (MCF); reaction time (RT) versus clotting time (CT)— were compared as a percent change from baseline at 30 minutes after graft reperfusion. The incidence of clot lysis (lysis-30 greater than 8% in TEG and maximum lysis greater than 15% in ROTEM) was also compared. The MA in functional fibrinogen TEG
and the MCF in FIBTEM were compared using plasma fibrinogen levels measured at each point as the reference value. As Dr. Abuelkasem reported at the 2014 annual meeting of the American Society of Anesthesiologists (abstract A4006), the only significant difference found between the modalities among the corresponding coagulation indices was between the RT of kaolin TEG and the CT of INTEM. Indeed, the percentage change from baseline was 7.9% for TEG, compared with 48.6% for ROTEM (P=0.0002). When these numbers were reanalyzed with respect to percent changes of PTT, RT was significantly different from PTT (P<0.0001), whereas CT was not (P=0.43). “So how about fibrinolysis?” Dr. Abuelkasem asked. “We did 136 measurements in total for fibrinolysis.
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CLINICAL ANESTHESIOLOGY revealed that patients in the ibuprofen group had significantly lower scores at every postsurgical evaluation point than their counterparts in the placebo group (Figure 2). Perhaps not surprisingly, there was a significant time effect in the placebo group, with significantly higher fatigue scores recorded in the PACU and on POD 1 than before surgery. Global analyses using the Digits Span Forward and Backward (DSF/DSB) tests revealed the significant effects of time and ibuprofen. Indeed, patients taking ibuprofen had higher DSB scores in the PACU than did patients who were given placebo (P<0.05). “There was no significant decline in physical independence in the placebo group on postoperative day 1, but patient support was the same for all time periods after the surgery,” Dr. Le said. “I also think the difference here is that patient support is determined independent of surgical factors and is more dependent on the patient’s social situation.” Andrea Kurz, MD, called the study interesting, important and promising. “In general, I believe that any drug that effects perioperative inflammation might be beneficial … as long as we believe that most ‘bad’ postoperative outcomes are related to inflammation, which I do,” said the professor and vice-chair of anesthesiology at the
And out of those 136 measurements, we identified fibrinolysis at 23 points using ROTEM.” Among these 23 measurements, however, only 11 (47.8%) were detected in kaolin TEG. “So we conclude that both TEG and ROTEM provide comparable results in coagulation evaluation during liver transplantation,” he added. “The TEG and ROTEM indices corresponded well with standard lab tests, except for the RT time of kaolin TEG to PTT. Finally, fibrinolysis was more easily detected with ROTEM.” Both the MA of functional fibrinogen TEG and the MCF of ROTEM showed strong correlation with the plasma fibrinogen level. —Michael Vlessides Dr. Abuelkasem had no relevant financial relationships to disclose.
Cleveland Clinic, in Ohio. “My biggest concern with respect to the study is sample size,” Dr. Kurz continued. “In other words, the results are almost too good to be true. Also, their interaction results are interesting, but again, we usually need many more patients for such analyses.” —Michael Vlessides The study was partly funded by Cumberland Pharmaceuticals. There were no other relevant financial relationships.
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Hypertonic Saline in Subarachnoid Hemorrhage Patients Increases Risk for Acute Kidney Injury
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ontreal–Although hypertonic saline solution helps control intracranial hypertension and symptomatic hyponatremia in critically ill patients with subarachnoid hemorrhage (SAH), such treatment appears to come at a cost: Hypertonic saline,
or high sodium exposure, significantly increases the odds of developing acute kidney injury (AKI) in this alreadyfragile patient population. “When you look at subarachnoid hemorrhage, you see that we’ve gotten a lot better at fixing the actual aneurysm,
so now we’re beginning to pay attention to all the other things that make a difference to patient outcomes,” said Avinash B. Kumar, MD, associate professor of clinical anesthesiology at Vanderbilt University, Nashville, Tenn. “In recent years, hypertonic saline
Maximum Daily Serum Sodium (mEq/L)
180 160 140 120
1 2 3 4 5 6 7 8 9 10 11 12 13 14 180
ICU day (AKI)
160 140 120 1 2 3 4 5 6 7 8 9 10 11 12 13 14
ICU day (no AKI)
Figure. Hypernatremia as risk factor for AKI AKI, acute kidney injury; ICU, intensive care unit
has been shown to be more effective than mannitol in managing intracranial hypertension that often accompanies subarachnoid hemorrhage,” he said. “Nevertheless, we don’t have a lot of data on what this actually does to the non-neurologic aspects of care of these patients.” With that in mind, Dr. Kumarr and his co-investigators retrospectively examined data from a cohort of 736 adults admitted to the institution’s neurosciences ICU between 2006 and 2012. Each patient was at least 18 years of age and had been admitted for at least 72 hours after a SAH. The researchers defined AKI using the Acute Kidney Injury Network serum creatinine criteria between 72 hours and 14 days after admission. Sodium exposure was captured as the running maximum daily serum sodium concentration. Sodium exposure was used as a surrogate for hypertonic saline therapy. As Dr. Kumarr reported at the 2014 annual meeting of the International Anesthesia Research Society (abstract S-138), 64 patients (9%) developed AKI. Not surprisingly, these individuals had longer hospital lengths of stay (15.6±9.4 days) than their counterparts who did not develop AKI (12.5±8.7 days). Furthermore, the chances of dying were more than double in the patients who developed AKI (odds ratio, 2.33). After adjusting for a number of possible confounding factors, sodium exposure was also found to be significantly
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onset, antiemetic properties and neurophysiologic benefits such as decreased cerebral metabolic demand, anticonvulsive properties and possible neuroprotective effects,” said Amit Prabhakar, MD, a resident at Louisiana State University (LSU), in New Orleans. Nevertheless, PRIS—which was first recognized in five 1992 case reports— remains a very real possibility for patients receiving high-dose infusions of the drug for lengthy periods of time. “We all know that propofol is used in short cases and also for infusions, in particular in the ICU,” said Alan D. Kaye, MD, PhD, professor and chairman of anesthesia at LSU. “With propofol infusion syndrome, people who are on the drug for a long period of time can develop it. It’s often lethal, and it is something a lot of people really don’t appreciate.” Clinically, PRIS manifests itself in several ways, including the development of metabolic acidosis, rhabdomyolysis, a
associated with the risk for developing AKI. Indeed, for each 1 mEq/L increase beyond 150 mEq/L in the running maximum daily serum sodium, the hazard of developing AKI was increased by 5.4% (95% confidence interval, 1.4-9.7). “Among all these signals, the one that stood out the most was the maximum daily sodium over a 14-dayy period,” Dr. Kumar said in an interview with Anesthesiology News. “So if you choose to give someone hypertonic saline as a way to control intracranial pressure, it’s worth bearing in mind that hypernatremia is a significant risk factor for developing AKI.” (Figure.) Interestingly, after performing regression analysis, the researchers did not find any significant correlation between contrast exposure and kidney injury. “One possible explanation for this may be the way we manage fluids in these patients,” he added. “In most nonneuro[logic] ICU patients, the plan usually is diuresis after the initial resuscitation. But in subarachnoid hemorrhage patients, hypovolemia worsens vasospasm. So these patients tend to have a more liberal fluid strategy.” Given the relatively low incidence of SAH, conducting a prospective, randomized trial presents significant challenges. “But I think this is new information that’s valuable for intensivists and clinicians who take care of this patient population.” —Michael Vlessides
series of cardiac arrhythmias (including right bundle branch block, Brugada-like syndrome, atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, ventricular fibrillation and electromechanical dissociation), acute renal failure, high lipemic serum, hepatomegaly and fatal cardiac arrest. To help determine the incidence and characteristics of PRIS at their Level 1 Trauma hospital, the investigators reviewed a year’s worth of charts for ICU patients at least 18 years of
age who received continuous propofol for sedation for a period of days. Cases of PRIS were defined as those requiring vasopressor infusions and having recorded increases in both TGs and creatinine. In all, 72 patients met inclusion criteria (61 men and 11 women). “We were looking for biomarkers: abnormalities and lab values that might help us predict whether or not a patient would develop propofol infusion syndrome and whether we should switch to another protocol,” said James H. Diaz,
MD, MPH, DrPH, professor of anesthesiology and public health at LSU. As Dr. Kaye and his colleagues reported here at the 2014 annual meeting of the American Society of Anesthesiologists (abstract A2143), the total average propofol infusion duration for all patients was 6.96 days. Three male patients met the study’s case definition for PRIS, one of whom died. In all, the facility demonstrated a PRIS incidence of 4.1%, and a case fatality rate of 33%. see PRIS page 38
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Malignant Hyperthermia Guidelines Updated by MHAUS New York—Anesthesiology practices are challenged by the rare but life-threateningg disorder of malignant hyperthermia (MH), which is typically triggered by the use of volatile anesthetic gases (e.g., sevoflurane) or depolarizing muscle relaxants (e.g., succinylcholine) in susceptible patients. First described in the early 1960s, there are an estimated 75 reported cases of MH annually in the United States; in most years one or two of these cases prove fatal. Ronald S. Litman, DO, attending anesthesiologist at the Children’s Hospital of Philadelphia (CHOP) and professor of anesthesiology and pediatrics at the Perelman School of Medicine at the University of Pennsylvania, Philadelphia, reviewed recent changes to MH guidelines during the New York State Society of Anesthesiologists’ PostGraduate Assembly. The 2014 Joan Rivers incident has called into question whether anesthesiologists—particularly those working in ambulatory surgery centers (ASCs)—are adequately prepared to manage sudden complications when they occur, Dr. Litman said. The Malignant Hyperthermia Association of the United States (MHAUS) telephone hotline and website for professional questions regarding MH, which Dr. Litman oversees, received more than 400 calls and hundreds of Web-based queries in 2014 as of mid-December; although these numbers represent only a handful of the surgical procedures performed over the course of a typical year in the United States, they do reflect that the complication remains a concern for anesthesia professionals. “Most of the calls we receive are not MH, and result from a febrile response during or following the maintenance of general anesthesia,” said Dr. Litman, who serves as vice president of scientific development for MHAUS. Based on the cases reported to the MHAUS database, he added, “MH remains rare in the PACU [postanesthesia care unit] setting— almost all cases of MH occur before patients leave the OR [operating room].”
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“Our fatality rate is consistent with other smaller studies,” Dr. Diaz said. “However, we feel that our incidence of propofol infusion syndrome may be slightly higher because we’re a trauma center. Therefore, our need to have prolonged sedation protocols for people with traumatic brain injuries and multiple traumatic injuries might be greater than, say, in a suburban hospital.” Interestingly, the study also found a positive correlation between increased TG levels and duration of infusion. “We were able to show an 87% correlation with the duration of therapy and increasing triglyceride levels,” Dr. Diaz told Anesthesiology News. “We also expected to find similar biomarker relationships
Recent research indicates that some people are genetically predisposed to MH because of a defect on the long arm of chromosome 19. There are now 36 known MHcausingg mutations, and genetic testing for susceptibility to the complication is becoming more widely available—and less costly. MHAUS Recommendations Dr. Litman explained that the recent changes to the MHAUS guidelines center on monitoring for MH and how to manage cases when the complication occurs. Some of the key MHAUS recommendations are: • Use core temperature monitoring over the more standard skin temperature monitoring in all surgical cases longer than 30 minutes in duration. Studies have linked the lack of core temperature monitoring with increased mortality in cases of MH. • When administering anesthesia to patients susceptible to MH, use nontriggering techniques (i.e., total IV anesthesia), carefully monitor end-tidal carbon dioxide values and prepare the anesthesia machine by inserting charcoal filters (Vapor-Clean, Dynasthetics) into the anesthesia breathing circuit to remove residual trace amounts of volatile anesthetics. • Immediately treat MH by administering dantrolene. Any ASC that has the potential to use succinylcholine should have an adequate supply of dantrolene on hand. • Any patient suspected to have MH at an ASC should be immediately transferred to the nearest full-service hospital for treatment. MHAUS
with liver function tests—which we didn’t. And although we found slight increases above normal in serum creatinine, there wasn’t a strong correlation between duration of infusion and increasing serum creatinine over time.” As a result of these findings, the researchers recommended that clinicians administering long-term propofol infusions strongly consider early monitoring of TG levels. Should patients begin to demonstrate elevated TG levels, the propofol infusion should be stopped immediately. “You can just stop the drug cold turkey,” Dr. Diaz added. “You don’t have to wean it.” The way Dr. Diaz sees it, monitoring TGs is just the first step in what has the potential to become a highly analytical method for determining which patients
guidelines recommend that ASCs that treat known MH-susceptible patients be located adjacent to hospitals; failing that, however, Dr. Litman indicated that ASCs should have transfer protocols in place with nearby hospitals to ensure immediate treatment should MH arise during a procedure. Finally, Dr. Litman and his colleagues at CHOP have developed a cognitive aid for use in the OR or ASC, which can be uploaded to all computer screens in the surgical suite should an MH-related emergency arise. He suggested that all anesthesiologists develop a similar protocol for use in their practices. Richard P. Dutton, MD, executive director, Anesthesia Quality Institute, and clinical associate in anesthesia at University of Chicago of Medicine, who was not involved in the development of the MHAUS guidelines, said, “It is important to keep talking about MH [despite it being relatively rare] because it keeps everyone informed. The controversy here is that we are doing a lot of outpatient procedures now, in ambulatory surgery centers, and dantrolene is expensive for many of these centers to keep on inventory. Ninety-five percent of all dantrolene in America gets thrown out every year because it dates out before you have to use it, because MH is so rare.” He added that although it is important for all ASCs to prepare for complications such as MH, a transfer protocol such as the one recommended by MHAUS is advisable, as “specialty care for very sick patients is very important.”
may or may not be at risk for developing PRIS. “As we go further, there are going to be molecular biomarkers,” he explained. “We’re not there yet, but we’re already thinking about it. “It looks like the syndrome is a genetic disease of mitochondrial function,” Dr. Diaz added. “The mitochondria are not able to utilize fats in the production of high-energyy phosphates. And we think there are people with existing genomic disturbances who are likely predisposed to this.” Eugene R. Viscusi, MD, professor of anesthesiology at Thomas Jefferson University in Philadelphia, commended the authors for reminding their peers that PRIS is a real and present danger when propofol sedation is provided for an extended
—Brian Dunleavy
period. “Furthermore,” he said, “they nicely quantified the mean time to onset and approximate relative risk.… Their reported findings of the correlation between triglyceride levels and duration of infusion support their recommendation for early triglyceride monitoring to avoid this potentially lethal scenario. “I agree with the authors’ conclusion that this is just the first step in a more analytical method for determining risk profile,” Dr. Viscusi added. “There is still much work to be done before we have molecular biomarkers. For now, their point is well taken: Caution and monitoring for rising triglycerides may give an early warning.” —Michael Vlessides
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Adverse Event Reporting Is Better With Anonymity New York—Implementing adverse event (AE) reporting systems that protect the anonymity of those reporting into them ultimately improves the accuracy of the data collected, leading to overall improvements in the safety, efficacy and efficiency of anesthesia care, a study presented during the 68th New York State Society of Anesthesiologists’ PostGraduate Assembly (PGA) concluded. “Fear of punitive measures may discourage providers from accurately reporting adverse events when quality data is used to evaluate their performance,” said Lindsay Lopata, MD, an anesthesiology resident at Long Island Jewish Medical Center (LIJMC), in New Hyde Park, N.Y., and the lead author of the study. “More confidentiality with the submitted data may alleviate some of these concerns yet still allow providers to identify patterns in their own practices compared to benchmarks to improve quality of care. Accurate reporting is essential to develop best practices and improve patient safety and outcomes.”
Organizations (PSO). The Anesthesia Quality Institute’s (AQI) Anesthesia Incident Reporting System (AIRS) is a PSO, but also allows providers to choose between confidential or anonymous reporting. Given the importance of quality and outcomes metrics in the determination of reimbursements as well as the identification of “best practices,” the authors
sought to assess the viability of an anonymous reporting structure within an AE registry, using data collected from nine “experienced” anesthesiologists at a 184-bed NAPA hospital submitted during the second quarter of 2014. The participating anesthesiologists anonymously completed quality forms detailing intraoperative and postanesthesia care unit complications
for every case. Compliance with the quantity of reporting was measured by comparing the anonymously submitted forms to the billing records for each provider. The number of cases, compliance rate and reported incidence of quality and outcome metrics were compared with those for a similar period in 2013 (which were not see adverse page 43
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‘Exit Criteria’ After Pediatric Cardiac Surgery Reduces Early Reinterventions New Orleans—In the setting of pediatric cardiac surgery, early reinterventions can be prevented by meeting established clinical criteria before leaving the operating room (OR). “We saw a rather startling decrease on early reinterventions, within the first
12 postoperative hours, after we implemented these objective criteria,” said Suanne M. Daves, MD, Children’s Hospital at Vanderbilt, in Nashville, Tenn. “We showed that anesthetic management with predetermined physiologic parameters, requiring intraoperative deci-
sion making and consensus for discharge from the OR, can have a significant impact,” said Dr. Daves, who presented the study at the American Society of Anesthesiologists annual meeting. Surgery to correct congenital heart defects can be associated with
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complications requiring urgent surgical reintervention in the early postoperative period. In an attempt to minimize this risk, personnel in the Pediatric Cardiac Anesthesia Division of Children’s Hospital at Vanderbilt developed a set of clinical criteria that must be met before transport from the OR to the ICU. The criteria included parameters believed to portend a stable early postoperative course for children undergoing surgical procedures involving cardiopulmonary bypass. The team implemented the criteria, then compared the rates of urgent reintervention with those observed before implementation in February 2012 (Figure). The criteria for OR exit were: • Laboratory values: pH >7.30, lactate <10 mM • Inotropes: epinephrine <0.05 mcg/ kg/min, or dopamine <10 mcg/kg/ min, or vasopressin <0.06 U/kg/h • Near-infrared spectroscopy (cerebral and somatic) within 20% of baseline • Chest tube bleeding rate <10 mL/ kg/h Dr. Daves explained how these criteria are implemented. “After the conclusion of surgery, if a patient does not meet any of the criteria, the attending anesthesiologist brings back the surgeon, the cardiologist and the intensivist, and this group arrives at a consensus about what should be done: whether to intervene surgically or medically (i.e., change in inotropes, transfusion), to observe or to proceed to the ICU. We do not leave the OR until we all agree that the patient is adequately stable. “In other words, if a patient does not meet these criteria, the attending anesthesiologist should call for all hands on deck, and facilitate a consensus on a management plan,” she said. She cited some of the following scenarios as questions that might be asked: Should the chest be opened? If opened, is there a residual defect that should be immediately addressed? Can bleeding be corrected medially, or is re-exploration indicated? Should mechanical support be initiated? The primary end point was a composite outcome of mediastinal exploration (ME) and extracorporeal membrane oxygenation (ECMO) placement within the first 12 hours postoperatively.
FEBRUARY 2015
CLINICAL ANESTHESIOLOGY
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AnesthesiologyNews.com I 41
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Figure. Trends in frequency of reinterventions following implementation of reduction strategies Exit Criteria Reduced Interventions In a cohort of 2,210 pediatric patients, use of the exit criteria was associated with a 77% reduction in the composite primary outcome of urgent reintervention and ME, from 7.38% before the protocol to 2.55% after its implementation (P<0.001), Dr. Daves reported. Specifically, the need for ME was reduced from 5.70% to 1.65% (P<0.001), and use of ECMO was reduced from 1.68% to 0.90% (P<0.16). The criteria also appeared to ameliorate the risk for poor outcomes when reintervention was needed. Among patients who underwent urgent reintervention, mortality was significantly decreased, compared with the preimplementation period. Three surgeons were involved in these cases, and one was associated with a 27% reduction in the composite outcome. This surgeon happened to be a recent addition to the staff, young, and dedicated to spending more time in the OR, Dr. Daves pointed out. A Risk Adjustment for Congenital Heart Surgery (RACHS-1) score greater than 3 was associated with a 2.4-fold increased risk for interventions. Factors that were not significant included the transfusion algorithm, ICU double coverage, patient weight and anesthesiologist. “We also looked at secondary outcomes— morbidity and mortality, acute renal injury and stroke, adjusted by RACHS-1 score—and we found that if there is an early intervention, the chance of these increases,” Dr. Daves said. These secondary outcomes, therefore, were prevented through the avoidance of early reintervention.
50
“Dr. Daves’ study shows that ‘hardstop’ criteria can significantly reduce urgent reintervention and mediastinal exploration in children following heart surgery. Perhaps the most important aspect of this study is not so much the criteria themselves but the conversation it facilitates between the teams caring for the patient,” said Mark Twite, MA, MB, BChir, associate professor and director of pediatric cardiac anesthesia at Children’s Hospital Colorado and University of Colorado, Denver.
“The objective standardized criteria help the operating room and ICU teams advocate for the patient by removing any barriers to communication, which facilitates decisions leading to improved outcomes. Initiatives such as this are a step in the right direction and further enhance the role anesthesiologists must play in the perioperative care of patients,” Dr. Twite said in an interview. —Caroline Helwick
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FEBRUARY 2015
CLINICAL ANESTHESIOLOGY
Insufflating Gas Pressures Can Exceed Margin of Safety New Orleansâ&#x20AC;&#x201D;Despite technological advances that have substantially improved the safety of gastrointestinal (GI) endoscopy in recent years, the risk for fatal gas embolism from insufflating gasâ&#x20AC;&#x201D;although extremely rareâ&#x20AC;&#x201D;is still present. In fact, a study by a University of Florida, Gainesville, research team has concluded that when the flush button is depressed on a popular
manufacturerâ&#x20AC;&#x2122;s endoscope, gas is emitted from the tip at pressures capable of exceeding 300 mm Hg, which can cause complete circulatory compromise under the right conditions. According to Jeffrey D. White, MD, the implementation of a new endoscopic technique at the Gainesville institution prompted him and his colleagues to consider how much
insufflating gas pressure was being generated at the distal tip of the endoscope. â&#x20AC;&#x153;A search of the literature revealed no information, which surprised us,â&#x20AC;? said Dr. White, an assistant professor of anesthesiology at the University of Florida. â&#x20AC;&#x153;As such, we chose
to look at all three types of endoscope that we have at our center: one for colonoscopy, one for GI endoscopy, and one for ERCP [endoscopic retrograde cholang iopancreatog raphy].â&#x20AC;? The Olympus endoscopes tested, he said, do not list technical specificaJeffrey D. White, MD tions on the company website for emitted gas flow or maximum pressure at the distal port. Insufflating gas pressure that exceeds local venous pressure raises the specter of potential embolic consequences. Maximum pressure and flow at the distal gas exit port were tested on the Olympus GIF-Q180, CF-Q180 and TJF-Q180. Gas pressure was measured using an overtube with Tegaderm seal at the distal end, and a distal side port connection to an arterial pressure transducer. Each endoscope was seated within the overtube sleeve, with both Global Education Group and Applied Clinical ends completely sealed. Gas flow was Education are pleased to introduce part 3 of a 3-part set to a rate of 2 L per minute and the interactive CME series featuring challenging cases gas flush button depressed. Pressure LQ 10% (DFK DFWLYLW\ SUHVHQWV D FOLQLFDO VFHQDULR was then measured within the sleeve that you face in your daily practice. After reading six times for each endoscope. the introduction to the case, consider the challenge â&#x20AC;&#x153;What we saw is that when you TXHVWLRQV DQG WKHQ YLVLW ZZZ &0(=RQH FRP QPE depressed the flush button you genWR ÂżQG RXW KRZ \RXU DQVZHUV VWDFN XS DJDLQVW WKRVH erate greater than 300 mm Hg presof our multidisciplinary faculty panel. sure every time. Thatâ&#x20AC;&#x2122;s two-and-a-half to three times the normal systolic Access the activities on your desktop, laptop, or tablet blood pressure,â&#x20AC;? said Dr. White, at the WR H[SORUH WKH LVVXHV VXUURXQGLQJ VDIH HIIHFWLYH 10% 2014 annual meeting of the AmerUHYHUVDO YLD D XQLTXH PXOWLPHGLD OHDUQLQJ H[SHULHQFH ican Society of Anesthesiologists and earn 1.0 AMA PRA Category 1 Creditâ&#x201E;˘ or 1.0 (abstract A2058). He noted that, if $$1$ &( FUHGLW IRU HDFK &RPSOHWH WKH ZKROH VHULHV presented near highly vascular tisand earn a total of 3.0 credits. sue, or where blood vessels are dilated or arterializedâ&#x20AC;&#x201D;such as in patients 7KLV DFWLYLW\ÂśV GLVWLQJXLVKHG IDFXOW\ with advanced liver disease and portal -RQ *RXOG 0' hypertensionâ&#x20AC;&#x201D;pressures of this level Chief, Division of General Surgery could produce a gas embolus capable Alonzo P. Walker Chair in Surgery of causing complete circulatory comProfessor of Surgery promise in one minute or less. Medical College of Wisconsin Senior Medical Director of Clinical Affairs â&#x20AC;&#x153;We were surprised by the high presFroedtert Hospital sures generated,â&#x20AC;? he said. â&#x20AC;&#x153;And as we Milwaukee, Wisconsin embark on a new horizon of natural orifice transluminal endoscopic -DQ 3DXO 0XOLHU 0' 3K' surgery, where we leave the endoluBariatric Anesthesiologist St. Janâ&#x20AC;&#x2122;s Hospital men and start dissecting through tisBruges, Belgium sue planes, we need to consider the potential risks along with the benefits 7ULFLD 0H\HU 3KDUP' 06 )$6+3 of these new procedures. If you think Departments of Pharmacy and Anesthesiology about that high [rate of ] pressure Scott and White Memorial Hospital being emitted from the tip of an endoTexas A&M University System HSC College of Medicine Temple, Texas scope with sufficient proximity to transmit that gas into the bloodstream, itâ&#x20AC;&#x2122;s a set up for the development of a Access this activity at fatal gas embolism. And that could ZZZ FPH]RQH FRP QPE happen very quickly at a flow rate of
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2SWLPL]LQJ 6DIHW\ DQG (IÂżFLHQF\ Case Study Brenda is a 78-year-old woman undergoing open abdominal surgery to correct symptomatic pelvic organ prolapse. Current Symptoms Â&#x2021; Pelvic organ prolapse failing conservative therapy Vital Signs Â&#x2021; Height: 175 cm Â&#x2021; Weight: 85 kg 6LJQLÂżFDQW 0HGLFDO +LVWRU\ Â&#x2021; Dyslipidemia Â&#x2021; Type 2 diabetes mellitus Â&#x2021; Glaucoma &XUUHQW 0HGLFDWLRQV Â&#x2021; Ezetimibe Â&#x2021; Glyburide Â&#x2021; Insulin glargine Â&#x2021; Pravastatin Anesthesia is induced with fentanyl 100 mcg, propofol 150 mg, and rocuronium 50 mg and maintained with GHVĂ&#x20AC;XUDQH LQ DLU R[\JHQ $PSLFLOOLQ VXOEDFWDP 3 g is given intravenously as well. At 90 minutes after induction, the surgeon reports tension in the surgical ÂżHOG DQG UHTXHVWV DGGLWLRQDO UHOD[DWLRQ 1R PRQLWRULQJ of neuromuscular function is performed.
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This activity is jointly provided by Global Education Group and Applied Clinical Education. Supported by an educational grant from Merck.
FEBRUARY 2015
AnesthesiologyNews.com I 43
CLINICAL ANESTHESIOLOGY ADVERSE
were higher in 11 categories with anonymous reporting. submitted anonymously) as well as the Richard P. Dutton, MD, executive NAPA benchmark. director, AQI and clinical associate in The authors found that the total anesthesia at University of Chicago of number of AEs increased 2.5 times in Medicine, who was not involved in the the anonymous period compared with NAPA research, noted that the issue the identified period. Significantly of anonymity may be more important higher number of events occurred in for “quality outcomes capture systems” six categories: aspiration, hypotension, such as NAPA’s, which ask anesthehypertension, dysrhythmia, skin injury sia providers to report on every case and difficult intubation. Compared regardless of outcomes and are used to with the NAPA benchmark, incidences assess job performance versus “incident CONTINUED FROM PAGE 39
2 L per minute. This has already been documented in the literature associated with ERCP.” Given these results, the researchers were quick to make recommendations to possibly improve patient safety. “We endorse the use of carbon dioxide [CO2] instead of air as an insufflating gas. There are practices where people still use air, even though it’s 35 to 50 times less soluble in blood than CO2,” Dr. White said. “We also encourage the future design of endoscopes to allow precise regulation of the maximum gas pressure being emitted from the tip. There is currently no failsafe for the Olympus endoscope, and we think this is something that should be noted.” Harriet W. Hopf, MD, reminded her colleagues of the best way to treat gas emboli should they occur. “Most gas emboli will cross the pulmonary circulation because of bronchial vessels,” said the professor of anesthesiology at the University of Utah, in Salt Lake City. “So this is a good opportunity to remind us all that if we start seeing more of these, we should get these patients into a hyperbaric chamber immediately. Patients who survive the initial event and are treated with hyperbaric oxygen within 24 hours usually have close to 100% recovery. “If it’s a CO2 embolism,” she continued, “patients might have an arrest or show some instability, but then they’ll often come right back. They will actually have had endothelial injury and ischemia reperfusion injury, will often wake up fine, and then get worse again. So if they’ve had any kind of a gas embolism, you should consider sending them right to the hyperbaric chamber.” —Michael Vlessides The authors had no relevant financial relationships to disclose.
capture systems” such as AIRS, which are designed to capture “real sentinel events” and, hopefully, prevent them from happening again by identifying them and allowing other professionals to learn from them. Dr. Dutton added that both types of event capturing systems—quality and incident, if you will—should be mainstays in every anesthesia practice. “Anonymity may enhance accuracy in reporting of adverse events in a system like NAPA’s because it is used as a
measure of physician performance,” he explained. “That’s different than what we are trying to do with AIRS. The goal here is to capture all complications and learn something from them. Having an anonymous reporting component probably encourages some people to report [into AIRS] who otherwise wouldn’t, but only 10% of those who submit reports have opted to do so completely anonymously.” —Brian Dunleavy
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44 I AnesthesiologyNews.com
FEBRUARY 2015
COMMENTARY
Reducing Health Care Costs and Improving Quality of Care Are Incongruent Goals By S.J. Slavin, MD
is it that when we have a severely preterm infant born in the United States, we spend millions upon millions Anesthesiologist of dollars to try to prolong the life of these 24-week Smithtown, New York preemies (and we accept high morbidity and mortalam starting to become confused and frustrated ity, despite the money spent)? In many other countries, by the numerous articles in the press, includ- these preemies are allowed to die and are called miscaring in anesthesia journals, that assume as fact that riages. This serves two purposes: It lowers health care our health care system provides poor quality of care, costs and improves infant mortality statistics. Are these and therefore must undergo “fundamental change.” health care systems truly better? Not only must the quality of health care be significantly improved, but this improvement must come at a significantly lower cost than what is currently being spent. I have been a practicing anesthesiologist since I finished residency in 1996, in both New York and Pennsylvania, and I have a number of observations that I feel the need to discuss. First, and most obviously, although I am sure there are certain areas in health care where in the short term we can improve quality and reduce cost, there is no way that in the long term reducing costs can improve quality (of anything). g Is there any other example in any other area of business or life where reducing costs is associated with an improvement in quality on a longterm, consistent basis? Even all the savings we recoup by eliminating “unnecessary” preoperative testing will be out the window once one patient dies due to an unrecognized medical condition that the plaintiff ’s attorney will point out could have been prevented by a $10 lab test. It seems to me that criticisms of our health care system are based on three factors: 1) high expense; 2) presumed low quality of care; and 3) the fact that people with more money have more access than people with less money. None of this occurs in a vacuum, and our health care system must be compared with other systems that currently exist in the world (most particularly government-run health care because I do not To address inequalities in access to health care, it believe that pure fee-for-service will ever come back), must be understood that throughout history individunot to some utopian dream that doesn’t currently exist als with more financial resources (money, wealth, land, etc.) have always had more access to anythingg than (nor has ever, for that matter). What specifically do we look for in quality of health individuals who are less well off. This doesn’t apply care? I have read numerous times in these (and other) only to health care, but to other human needs as well pages that although our health care expenditures are (such as access to healthy food, safe housing, etc.). In very high, we need to improve our quality of care. Can any society, rich people will always be better off than someone give me specificc examples of where our qual- poor people; rightly or wrongly, that will never change. Let’s look at health care systems around the world— ity of care is poor (note that this is a separate issue from access to care, which will be discussed later)? We hear many of these are places where we are told the system that our life expectancy is not up to par with other is more equitable to poor people. parts of the world. Why specifically would that be? England: Rich people who are unsatisfied with the How much of a factor is our high trauma rate? In the government-run health system have the money to purUnited States, trauma is a leading killer of young peo- chase their own private insurance and be cared for ple, thus severely reducing our life expectancy statis- at private hospitals; poorer people do not have this tics; however, our high trauma rate is nott a reflection luxury. of a poor health care system. Our high trauma rate is a Canada: Rich people who don’t like the separate issue that needs to be addressed and discussed government-run health system have the money to get in a different context. Likewise, we hear that our infant their health care in the United States; poorer people mortality rate is higher than other countries that spend do not have the out-off pocket cash to do this. Rememless money than we do. Again, why specifically would ber the prime minister who flew to Miami to have his that be? How much of this is a social issue rather than CABG [coronary artery bypass graft] that was unavaila health care issue? How much of a confounding factor able to him in Canada?
I
Venezuela: Hugo Chavez had his surgeries outside his country. Are the majority of Venezuelans rich enough to afford to do that? Haiti: According to stories I read following the earthquake several years ago, if you are hospitalized in Haiti you need to have family or friends bring you food, otherwise you don’t eat. In all of these countries (plus untold others) we are told that health care is better because it is more equitable to poor people. Is it really? Certainly, we should strive to improve access for poor people, and we are doing that. But don’t throw out our whole system simply because there is some amount of inequality! My group and I routinely provide anesthesia to patients who will not be paying. The idea that poor people have no access to health care is not accurate (at least in my experiences in New York and Pennsylvania). Yet critics like to point to these other countries and say that their poor people have better access to care than our poor people. Would Michael Moore truly have any surgery performed in Cuba? Several comments are in order here regarding the recent VA [Veterans Affairs] “scandal.” To continue the previous thought: I guarantee you that regardless of whatever health care system we put into place in the future, President Obama and any other politician (all rich and connected people) will get better care than the average veteran at a government-run VA hospital. The veteran’s health care won’t change at all; the president will always go to the front of the list, because he is a rich and powerful person. However, I would wager that in our current health care system, more people in the United States have better access to the care they would want than the people who can afford to purchase private insurance in England or the Canadians who can afford to have their care in the United States. Do we really want a system like theirs where only a handful of people can afford private insurance (or have enough out-off pocket cash), instead of the system we currently have where most people are (or at least were) happy with their health care? Remember, although politicians, union leaders and other rich and important people want to “fundamentally change” health care for you and me, many of them were given exemptions from the Affordable Care Act provisions (so that they can continue getting the health care they want, while starting to deny it to the rest of us). As an aside for those wondering why the VA system is currently in the news with scandal, a few points: 1) government bureaucracy; 2) lack of incentive for physicians to work late at night or overtime to see more patients in a day, as is done in private practice, so waiting lists are created; and 3) government fosters incompetence—anyone ever hear the saying, “good enough for government work”? Many of these ailments in the VA system also can be found in other countries with government-run health care. Again, how many people in England can afford
FEBRUARY 2015
AnesthesiologyNews.com I 45
COMMENTARY private insurance to escape their waiting lists? Right now in the United States, these health care failures are limited to a small subset of the population; is this really the model we want for the rest of us? If the government system is so great, why are so many people in Britain and Canada trying to escape it? For that matter, why are our politicians and unions so anxious to be exempt from “Obamacare”? It is because these systems only supply basic health care needs; anything beyond basic care is either not covered or paid for by a long waiting list … unless you are rich enough to circumvent the system. I will wager that in the United States, a large portion of the population gets above basic-levell health care; is that really the case in these other countries where you have to pay out of pocket for the same thing? Yes, health care is expensive. There may be ways to try to reduce some costs, but ultimately the only way to successfully do so would be by denial of care. But I don’t think Americans would want that if they were told this explicitly (think of the horror upon hearing the phrase “death panels”). To Americans, when we think quality of care, we generally think of things that are not documented by statistics: choosing our own doctor, choosing our own hospital (although many hospitals do not accept many of the Obamacare plans because they lose money on them), choosing our own health plan, and not having a waiting list (such as at the VA) or queue. These criteria are not reflected in objective health care statistics such as life expectancy and infant mortality; still, they are important to us as Americans and will be lost if we persist with this charade that we can consistently reduce expenses and simultaneously increase quality. I have yet to hear any calls for “fundamental change” to the food industry, despite the fact that lower-income people are less able to purchase healthy (and more expensive) fresh fruits and vegetables. I have also never heard anyone call for “fundamental change” to the (safe) housing market. Why only health care? The richest among us will always get what they want. The poorest among us will always need help and charity, no matter what type of system we have (remember, many of these ‘Obamacare’ plans have such high deductibles and copayments that health care is still inaccessible to them). I am most concerned with the enormous middle (the vast majority) that weree happy and satisfied with their health care under the old” system, but won’t be happy as we
cut spending and what we as Americans define as quality of care suffers greatly. I conclude with a story from several months ago when I was in a very busy labor and delivery suite. It was 2:45 a.m. and I was asked to place a labor epidural in a woman for her fourth baby (she had insurance, but other women that night did not). She had had an epidural with her first child, but not her second and third, so I asked why not. It seems that she was living in Venice, Italy, for the middle two and things are
different there. She starting describing to me how things work. First, epidurals were scheduled with an anesthesiologist from 8 a.m. to 5 p.m.; if you didn’t plan your delivery right, you were out of luck. There were few fetal monitors. When the nurse decided it was time for you to deliver, she walked you down the hall to the delivery room. A half hour after your delivery, you got up and walked up several flights of stairs to your next room. I am sure that the vast majority of patients do not suffer any increased
morbidity or mortality from this vastly different (and significantly cheaper) style of health care. Therefore, here are my three suggestions for how to significantly reduce health care costs in this country without reducing measurable qualityy off care markers: • Eliminate non-emergent use of anesthesiologists in labor and delivery suites (labor epidurals are purely elective and therefore do not see incongruent page 54
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FEBRUARY 2015
Continuing Medical Education
CME LESSON 314
Preoperative Assessment Of the Patient for Stent Placement
AnesthesiologyNews.com I 47
WRITTEN BY: Gurmukh Sahota, MD, PhD, Resident, Department of Anesthesiology and Critical Care, Perelman School of Medicine, University of Pennsylvania, Philadelphia
REVIEWED BY: Aris Sophocles, MD, Cardiothoracic Anesthesiology Fellow, Department of Anesthesiology and Critical Care, Perelman School of Medicine, University of Pennsylvania, Philadelphia; John G.T. Augoustides, MD, FASE, FAHA, associate professor, Department of Anesthesiology and Critical Care, Perelman School of Medicine, University of Pennsylvania, Philadelphia
DISCLOSURES The author has no relationships with pharmaceutical companies or manufacturers of products to disclosure.
PROFESSIONAL GAPS Stent placement has become common practice in the United States; most anesthesiologists are aware of the need for caution in these patients, who are at higher risk for cardiac complications. Cardiac risk indices have been presented and revised by the American College of Cardiology. Anesthesia providers should be aware of these recommendations.
TARGET AUDIENCE Anesthesiologists
CALL FOR WRITERS If you would like to write a CME lesson for Anesthesiology News, please send an email to Elizabeth A.M. Frost, MD, at elzfrost@aol.com.
LEARNING OBJECTIVES
Introduction
C
At the end of the lesson, the reader will be able to: 1. Understand the basic evolution of stent technology. 2. Describe current guidelines regarding risk/benefit of preoperative percutaneous coronary intervention (PCI) for noncardiac surgery (NCS). 3. Know the patient characteristics that would favor coronary artery bypass grafting (CABG) rather than PCI. 4. Define the main categories of antiplatelet medications and their mechanisms of action. 5. Discuss the management of antiplatelet medications in the perioperative period. 6. Describe proposed bridging strategies for antiplatelet agents. 7. Describe the risk factors for stent thrombosis. 8. Summarize American Society of Anesthesiologists (ASA) Practice Alert guidelines as well as American College of Cardiology recommendations regarding perioperative management of stents. 9. Discuss the American Society of Regional Anesthesia and Pain Medicine (ASRA) guidelines regarding antiplatelet agents and neuraxial techniques. 10. List postoperative considerations for patients with coronary stents.
CASE
oronary artery disease (CAD) is the leading cause of death globally,1 and remains a significant risk factor for perioperative myocardial ischemia. There are 2 main management strategies for CAD: medical (using primarily drugs to manage the disease) or interventional (acting directly on the lesions). Coronary artery bypass grafting has been a mainstay of interventional treatment of CAD, but ongoing advances have also resulted in PCI becoming a mainstream intervention for CAD. Although balloon angioplasty is effective, the high rate of coronary restenosis prompted clinical development of bare metal stents (BMS) in an effort to prolong coronary patency.2 In a further breakthrough, drug-eluting stents (DES) consisting of a stent, carrier, and antiproliferative drug entered clinical practice about 10 years ago after large trials demonstrated that they significantly reduced the risk for coronary restenosis after PCI. Since then, further advances in DES technology have been developed, such as newer antiproliferative agents and use of bioabsorbable materials.2
A 57-year-old woman with a past medical history significant for hypertension, hyperlipidemia, and hypothyroidism presented with chest pain complicated by supraventricular tachycardia to a rate of 140 beats per minute, inferior ST-segment elevation and ST-segment depression in the lateral leads. Urgent cardiac catheterization revealed extensive disease: 80% occlusion of the left anterior descending (LAD) artery, 90% occlusion of the left circumflex (LCx) artery, and a chronically occluded right coronary artery. Further evaluation also documented an asymptomatic 5.1-cm aneurysm of the descending thoracic aorta with extensive mural thrombus. At this point, the patient was considered to be at excessive risk for coronary artery bypass grafting (CABG) due to her severe hypothyroidism, as reflected by her clinical stigmata of myxedema and a serum thyroid-stimulating hormone level more than 10 times the upper limit of normal. Medical management was initiated to render her euthyroid and stabilize her acute coronary syndrome, with plans for possible intervention after this period of medical stabilization. However, she presented 2 weeks later with chest pain and congestive heart failure. She was admitted to hospital and underwent percutaneous coronary intervention (PCI) with bare metal stenting of her known LAD and LCx arterial lesions, with good clinical response. A transthoracic echocardiogram after this successful PCI demonstrated left ventricular hypertrophy, mildly depressed left ventricular systolic function with inferior hypokinesis, and no significant valvular disease.
Perioperative Management of Cardiac Stents in Noncardiac Surgery
Dr. Elizabeth A.M. Frost, who is the editor of this continuing medical education series, is clinical professor of anesthesiology at the Icahn School of Medicine at Mount Sinai in New York City. She is the author of Clinical Anesthesia in Neurosurgeryy (Butterworth-Heinemann, Boston) and numerous articles. Dr. Frost is past president of the Anesthesia History Association and former editor of the journal of the New York State Society of Anesthesiologists, Sphere. She is also editor of the book series based on this CME program, Preanesthetic Assessment, Volumes 1 through 3 (Birkhäuser, Boston) and 4 through 6 (McMahon Publishing, New York City).
Although PCI has revolutionized the management of CAD, it presents new challenges for perioperative physicians. A catastrophic complication of coronary stents is stent thrombosis because it carries a high risk for mortality, including during the perioperative period.3,4 The risk for stent thrombosis is particularly high before the stent is coated with native endothelium (typically about 4-6 weeks after BMS and 12 months after DES).4 During this period of elevated risk, patients are managed with dual-antiplatelet therapy (DAPT), commonly with aspirin and clopidogrel, to prevent clot formation. The surgical stimulus increases the risks for stent thrombosis in the perioperative period by activating platelets and inducing a hypercoagulable state.4 Additionally, surgical procedures that put patients at high risk for bleeding may require cessation of perioperative antiplatelet therapy, further increasing the risk for stent thrombosis.4 Minimizing surgical risk requires balancing the risks for bleeding against stent thrombosis. Patients may benefit from multidisciplinary preoperative planning that includes input from surgeons, anesthesiologists, and cardiologists. Current guidelines discuss the perioperative management of coronary stents.4
Indications for Preoperative PCI The American Heart Association/American College of Cardiology (AHA/ACC) guidelines for PCI and noncardiac surgery (NCS) offer guidance for preoperative PCI (Table 1).2,4 The definitions of the clinical recommendations are as follows: class I (benefits >>> risk), class IIa (benefits >> risk), class IIb (benefits > risk), and class III (risks > benefits). With regard to the level of evidence,
PREANESTHETIC ASSESSMENT
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 January 31, 2016. (CME credit is not valid past this date.) You must achieve a score of 80% or better to earn CME credit. Time to Complete Activity: 2 hours
Release Date: February 1, 2015
Termination Date: January 31, 2016
Accreditation Statement The Icahn School of Medicine at Mount Sinai is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Credit Designation Statement The Icahn School of Medicine at Mount Sinai designates this enduring material for a maximum of 2.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. It is the policy of the Icahn School of Medicine at Mount Sinai to ensure objectivity, balance, independence, transparency, and scientific rigor in all CME-sponsored educational activities. All faculty participating in the planning or implementation of a sponsored activity are expected to disclose to the audience any relevant financial relationships and to assist in resolving any conflict of interest that may arise from the relationship. Presenters must also make a meaningful disclosure to the audience of their discussions of unlabeled or unapproved drugs or devices. This information will be available as part of the course material. Visit www.mssm.procampus.net today for instant online processing of your CME post-test and evaluation form. There is a registration fee of $15 for this non–industry-supported activity. For assistance with technical problems, including questions about navigating the website, call toll-free customer service at (888) 345-6788 or send an email to Customer.Support@ProCEO.com. For inquiries about course content only, send an email to ram.roth@mssm.edu. Ram Roth, MD, is director of PreAnesthetic Assessment Online and assistant professor of anesthesiology at The Icahn School of Medicine at Mount Sinai, New York, NY.
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Continuing Medical Education
Figure 1. Mechanisms of acute coronary syndromes and targets of antiplatelet and antithrombotic agents. Reproduced with permission from the publisher and authors.8
Table 1. AHA/ACC Consensus Guidelines on Preoperative PCI
the definitions are as follows: level A (sufficient: multiple randomized clinical trials [RCT] or meta-analysis), level B (limited: single RCT or multiple nonrandomized studies), and level C (sparse: case studies and/or expert opinion). The recommendation against routine PCI for stable CAD is based on 3 main trials (CARP, DECREASE-II, DECREASE-V).4 In brief, the CARP (Coronary Artery Revascularization Prophylaxis) trial randomly assigned 510 patients with angiographically proven CAD to coronary revascularization or medical management before elective major vascular surgery. Although the risk for perioperative cardiac events can be accurately predicted by the Revised Cardiac Risk Index (Table 2), the CARP data showed that revascularization did not affect the risk for cardiac events both in and beyond the postoperative period. The trial excluded patients with significant left main disease, unstable CAD syndromes, severe aortic stenosis, and/or left ventricular ejection fraction less than 20%. The exclusion of these patients represents a selection bias against high-risk cardiac patients who might have improved outcomes from coronary artery revascularization before surgery. The DECREASE (Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echo Study Group) study also had 2 trials relevant to the recommendation against routine PCI. The DECREASE-II trial showed that in patients undergoing major vascular surgery with intermediate cardiac risk factors and adequate β-blocker therapy, preoperative coronary revascularization of extensive ischemia did not significantly improve 30-day outcome. The DECREASE-V trial randomly assigned 101 vascular surgery patients with extensive myocardial ischemia to preoperative coronary revascularization versus medical therapy. The composite primary outcome of death and myocardial ischemia was similar in both groups.
Consensus Guidelines From AHA/ACC 2014
Benefit vs Risk, Class
Level of Evidence
Delay NCS after PCI for 365 d after DES
I
B
Delay NCS after PCI for 30 d after BMS
I
B
Delay NCS after PCI for 14 d after BA
I
C
PCI before NCS: STEMI (not LM disease)
I
C
PCI before NCS: NSTEMI vs high-risk unstable angina (not LM disease)
I
C
PCI before NCS: sudden cardiac death survivor with presumed ischemia-mediated VT
I
C
Clinician consensus regarding relative risks for NCS and management of antiplatelet therapy
IIa
C
PCI before NCS: unprotected LM disease with: SIHD: if low risk for PCI complications, good long-term PCI outcome, and severely elevated risk for poor CABG outcomes UA/NSTEMI: if not a CABG candidate
IIa
B
PCI before NCS: unprotected LM disease with STEMI: if PCI more rapid/safe alternative to CABG
IIa
C
PCI before NCS: LM disease unable to undergo CABG because of increased risk from comorbidities IIb
B
Elective NCS after DES after 180 d If risk for delay greater than risk for ischemia and stent thrombosis
IIb
B
If DAPT has to be halted, elective surgery within 12 mo after DES
III
B
If DAPT has to be halted, elective surgery within 30 d after BMS
III
B
CABG would not require antiplatelet regimens as extensive as those for PCI and therefore might be more amenable for patients with coronary disease who require urgent surgeries. Although there have been many studies comparing these 2 coronary revascularization modalities, most are not focused specifically on the perioperative period.5,6 The studies have demonstrated that CABG significantly reduces repeat revascularization procedures within the first 5 years compared with PCI, regardless of stent type.5,6 Although the literature suggested that the benefit of CABG versus PCI on cardiovascular outcomes was limited to diabetic subgroups, a more recent meta-analysis showed that in multivessel CAD both mortality and morbidity are decreased with CABG regardless of diabetic status.6 Compared with BMS, first-generation DES had a lower rate of repeat vascularization (although only in diabetics) but a higher rate of adverse cardiac events, including death, myocardial infarction, and cerebrovascular accident.7 With the advent of the newer generations of DES, this comparison with CABG will require further RCTs to guide decisions regarding the relative risks and benefits, with special emphasis on high-risk groups such as patients with diabetes.
Routine PCI for stable CAD
III
B
Management of Antiplatelet Therapies
If aspirin needs to be halted, elective surgeries within 14 d after BA
III
C
Antiplatelet medications are designed to prevent aggregation of platelets targeting an array of different mechanisms (Figure 1).8 Multiple medications from different classes can be used to more effectively block aggregation. Three main classes of medications are commonly employed:
AHA/ACC, American Heart Association/American College of Cardiology; BA, balloon angioplasty; BMS, bare metal stent; CABG, coronary artery bypass grafting; CAD, coronary artery disease; DAPT, dual-antiplatelet therapy; DES, drug-eluting stent; LM, left main coronary artery; NCS, noncardiac surgery; NSTEMI, non-ST-segment elevation myocardial infarction; PCI, percutaneous coronary intervention; SIHD, stable ischemic heart disease; STEMI, ST-segment elevation myocardial infarction; UA, unstable angina; VT, ventricular tachycardia
Management of Coronary Disease: CABG or PCI
FEBRUARY 2015
AnesthesiologyNews.com I 49
Continuing Medical Education Table 2. Revised Cardiac Risk Index Components
Points
High-risk surgery (intraperitoneal, intrathoracic, or suprainguinal vascular procedure)
1
Ischemic heart disease (by any diagnostic criteria)
1
History of congestive heart failure
1
History of cerebrovascular disease
1
Insulin-dependent diabetes mellitus
1
Creatinine >2 mg/dL
1
• thromboxane A2 (TxA2) inhibitors (including aspirin) • thienopyridines (including clopidogrel and ticlopidine) • glycoprotein (GP) IIb/IIIa inhibitors (such as eptifibatide, tirofiban, and abciximab) Aspirin prevents TxA2 synthesis by irreversibly blocking the cyclooxygenase enzyme, thereby inhibiting the plateletactivating and -aggregating effects of TxA2. Thienopyridines are selective P2Y12 inhibitors, as is the closely related ticagrelor. Mechanistically, they prevent the unmasking of the GPIIb/ IIIa receptors, thereby preventing platelet aggregation. Direct GPIIb/IIIa inhibitors also are available and are associated with intense platelet inhibition. They are available as IV formulations. Although they are short acting, recovery of normal platelet function is still measured in hours after these medications have been stopped.2,8 Special consideration is required for perioperative antiplatelet therapy for patients with coronary stents scheduled for NCS.4 A balance between the risk for bleeding and the risk for stent thrombosis must be struck so that the patient is provided with the safest perioperative outcome.4 This risk–benefit ratio should be assessed by the surgeon and anesthesiologist with critical input from a cardiologist. Despite the lack of evidencebased management strategies in this setting, an algorithmic guide has been developed.4,9 If there is low risk for surgical bleeding, patients should typically continue all oral antiplatelet agents. If there is intermediate risk for surgical bleeding, aspirin should typically be continued perioperatively but clopidogrel may be discontinued 5 days before surgery and restarted
as soon as possible postoperatively. If the risks for bleeding are high (eg, from closed-space procedures, such as of the eye, brain, or spinal cord), oral antiplatelet therapy may have to be discontinued. In this setting, if the risk for stent thrombosis is high, bridging therapy with a short-acting IV antiplatelet agent is an option, although the data are uncertain regarding the safety and efficacy of this strategy.4,10 Bridging therapy uses short-acting parenteral platelet blockade to span the interval from cessation of oral antiplatelet medications to the time of surgery. In this fashion, platelet blockade is maintained until the time of surgery to maintain coronary stent patency. At the time of surgery, however, discontinuation of the IV platelet blockade allows surgery to proceed with intact platelet function.4,10,11 Although heparin is an anticoagulant, it has minimal effects on platelet function and thus cannot be relied on to prevent stent thrombosis from platelet activation. Rather, bridging with short-acting GPIIb/IIIa inhibitors, such as tirofiban and eptifibatide, has been reported in this scenario, although the efficacy and safety of this therapy requires further study. An attractive future option for perioperative antiplatelet therapy as a bridging option may be the P2Y12 blocker, cangrelor, as it appears to be a powerful IV platelet inhibitor with a very short half-life.11,12
Risk Factors for Stent Thrombosis Three major categories define the risk for stent thrombosis: coronary anatomy, patient characteristics, and stent indication.4,9-12 Coronary anatomy remains critical to the risk for stent thrombosis as complex PCI may result in stent scenarios that are very thrombogenic. Examples of this high-risk stent morphology include stenting at coronary bifurcations, stenting at coronary ostia, multiple overlapping stents, and stents in very small coronary arteries.9-12 Furthermore, coronary stents placed in the setting of an acute coronary syndrome are also at increased risk for stent thrombosis. Patient comorbidities that typically increase the risk for stent thrombosis are advanced age, low ejection fraction, diabetes, renal impairment, and previous brachytherapy.4,9-12
American Society of Anesthesiologists Practice Alert A 2009 practice alert was released by the American Society of Anesthesiologists to alert the perioperative community about the dangers of inadequate perioperative platelet blockade in patients with coronary stents.13 This document
Table 3. ASRA Guideline for Neuraxial Blockade in the Setting of Platelet Blockade Medications
Recommendation for Neuraxial Blockade
Benefit vs Risk, Class
Level of Evidence
NSAIDs only
No contraindications
1
A
NSAIDS concurrently with oral anticoagulants, UFH, LMWH
Against use
2
C
Ticlopidine
Wait 14 d
1
C
Clopidogrel
1. Wait 7 d 2. Document normalization of platelet function (5-7 d) with assay
1
C
ASRA, American Society of Regional Anesthesia; LMWH, low-molecular-weight heparin; NSAID, nonsteroidal anti-inflammatory drug; UFH, unfractionated heparin
highlighted the finding that premature discontinuation of DAPT was associated with an increased risk for stent thrombosis and that the time to wait for elective surgery was dependent on the type of coronary stent: BMS (4-6 weeks) and DES (12 months).13 This practice alert has been updated and replaced by the 2014 AHA/ACC guideline for NCS that reviews the management of antiplatelet therapy in the perioperative period in detail. The guiding principle in this scenario is to balance the risks for surgical bleeding versus the risks for stent thrombosis in the context of a conversation between the anesthesia providers, the surgical team and, when necessary, a cardiology consultant.
American Society of Regional Anesthesia Guidelines Regarding Antiplatelet Therapies and Neuraxial Techniques The executive summary of the American Society of Regional Anesthesia guidelines on anticoagulation studies has a dedicated section that discusses regional anesthetic management of patients receiving antiplatelet medications.14 This guideline states that these medications have a diversity of effects on platelet function and that there is no wholly accepted laboratory test that can guide therapy. The authors identify bleeding risks as a history of easy bruising/excessive bleeding, female sex, and increased age. The findings are summarized in Table 3 with the caveat that the risk with clopidogrel and ticlopidine is mainly based on labeling precautions and the surgical and interventional cardiology/radiology experience. Class ranges from 1 to 3 and signifies agreement on efficacy (1), conflicting evidence regarding usefulness (2), and probably not useful and possibly harmful (3). The letter A, B, or C defines the level of evidence: RCT/meta-analysis (A), multiple observational/epidemiologic studies (B), and case-report/expert opinion (C).
Postoperative Management of Cardiac Stents Two major problems can arise in patients with cardiac stents in the postoperative period: hemorrhage and/or stent thrombosis. Depending on patient risk factors, these situations may be an indication for a higher level of monitored care such as in an ICU. With regard to postoperative hemorrhage, there is a paucity of evidence regarding the quantitative platelet threshold for adequate hemostasis. Recommendations suggest that platelet transfusion thresholds should typically be 50,000/mcL for major surgery and 100,000/mcL for neurosurgery to minimize the risk for bleeding.15,16 Many of the current oral platelet blockers require transfusion of platelets to provide functional hemostasis due to their prolonged action. Specific platelet-function testing such as thromboelastogram might be helpful in guiding transfusion, but there is a paucity of guidance from the literature. Transfusion of a platelet dose will typically increase the platelet count by 30,000 to 40,000/mcL in the average-size adult.15,16 Additionally, in the context of postoperative hemorrhage, it may become necessary to provide packed red blood cells or fresh frozen plasma to maintain adequate oxygen delivery and replete coagulation factors. Stent thrombosis in general presents as an ST-segment elevation myocardial infarction, and thus the appropriate management is prompt PCI, as outlined in recent ACC/AHA guidelines.2 As a result, patients at risk for stent thrombosis should be cared for in an environment where there is rapid access to primary PCI. Despite the efficacy of PCI, perioperative stent thrombosis
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Continuing Medical Education still carries significant mortality. The best management here is prevention: â&#x20AC;&#x153;An ounce of prevention is worth a pound of cure.â&#x20AC;?
stents: observations from the Registry of Stent Thrombosis for Review and Reevaluation (RESTART). Circulation. 2010;122:52-61. 4.
New Frontiers in Coronary Stents Drug-eluting stents were developed to combat the problem of in-stent stenosis due to intimal hyperplasia. They elute antiproliferative medications that prevent intimal growth but remain uncoated with intima as a consequence and so are at risk for late thrombosis. Bioabsorbable stents may provide a solution to ameliorate this late stent thrombosis risk.17 A further benefit of bioabsorbable stents would be in pediatric populations, as they allow for vessel growth without requiring removal. There are different types of stents with differing absorption products, elution, radio-opacity, deployment, and duration of support.17 For the first 6 months, a scaffold with associated drug can limit negative remodeling, but after that it provides no useful function and could potentially have the disadvantage of being a nidus for late thrombosis and possibly limiting luminal enlargement and return of vasomotor/endothelial function.17 Further trials are required to explore whether bioabsorbable stents offer the safety and efficacy in PCI to minimize both the risks for intimal growth and stent thrombosis.
Management of Case Presented Although CABG would have been preferable for the patient, the patient underwent medical management and PCI, given her active comorbidities. After consideration of the risks, the decision was made to continue her DAPT throughout her surgical procedures. The patient underwent carotid-subclavian bypass 3 days after stenting and then 8 days after stenting underwent thoracic endovascular aortic aneurysm repair (TEVAR). For both cases, the patient received uneventful balanced general endotracheal anesthesia with careful monitoring of her blood pressure by arterial cannulation. A spinal drain was not placed as it was contraindicated given her continued antiplatelet therapy with aspirin and clopidogrel. She was discharged 7 days after the TEVAR to a skilled nursing facility for physical rehabilitation.
5.
6.
7.
8.
References 1.
2.
3.
Kimura T, Morimoto T, Kozuma K, et al. Comparisons of baseline demographics, clinical presentation, and long-term outcome among patients with early, late, and very late stent thrombosis of sirolimus-eluting
Sipahi I, Akay MH, Dagdelen S, et al. Coronary artery bypass grafting vs percutaneous coronary intervention and long-term mortality and morbidity in multivessel disease: meta-analysis of randomized clinical trials of the arterial grafting and stenting era. JAMA Intern Med. 2014;174:223-230. Holmvang L, Kelbaek H, Kaltoft A, et al. Long-term outcome after drug-eluting versus bare-metal stent implantation in patients with STsegment elevation myocardial infarction: 5 years follow-up from the randomized DEDICATION trial (Drug Elution and Distal Protection in Acute Myocardial Infarction). JACC: Cardiovasc Interv. 2013;6:548-553. Lilly SM, Wilensky RL. Emerging therapies for acute coronary syndromes. Front Pharmacol. 2011;2:61.
11. 12. 13.
14.
15. 16. 17.
1.
Percutaneous coronary intervention (PCI) includes all of the following adjuncts, except: a. Balloon angioplasty b. Bare metal stents c. Drug-eluting stents (DES) d. Coronary endarterectomy
6.
Which of the following does not affect the risk for stent thrombosis? a. Coronary anatomy b. Age c. Sex d. Placement during acute coronary syndrome
2.
Based on the 2014 American Heart Association/American College of Cardiology guidelines, choose the answer that has the best evidence for the benefits outweighing the risks. a. Delay noncardiac surgery (NCS) for 365 days after DES implantation. b. PCI before NCS in patients with left main coronary artery disease resulting in an ST-segment elevation myocardial infarction and distal coronary flow of thrombolysis in myocardial infarction less than 3 who are good candidates for coronary artery bypass grafting (CABG) but PCI could be faster/safer. c. PCI before NCS in patients with stable coronary artery disease. d. Elective surgery 1 week after balloon angioplasty.
7.
Based on the American Society of Anesthesiologists practice guidelines, which is a correct statement? a. Continue dual-antiplatelet therapy (DAPT) during an elective surgical procedure. b. Wait 4 to 6 months after a DES for elective surgery. c. Always discontinue DAPT after the recommended guidelines. d. Restart thienopyridine therapy as soon as possible if stopped for an emergency surgery.
8.
Based on the American Society of Regional Anesthesia 2010 anticoagulation guidelines, which of the following is not supported by class 1 evidence (agreement that the intervention is beneficial)? a. No contraindications to neuraxial techniques for patients on nonsteroidal anti-inflammatory drug (NSAID)-only therapy b. Warning against neuraxial techniques for patients on combination NSAID/warfarin therapy c. Stopping clopidogrel 7 days before a neuraxial technique d. Stopping clopidogrel 5 days before a neuraxial technique and verifying platelet function
9.
For a postoperative hemorrhage in a patient on antiplatelet therapy, which of the following therapies is unlikely to have benefit? a. Protamine b. Packed red blood cells c. Platelets d. Fresh frozen plasma
3.
4.
Lozano R, Naghavi M, Foreman K, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380:2095-2128. Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circulation. 2011;124:2574-2609.
Rodriguez AE, Arismendi L, Romero G, et al. Randomized trials of PCIs versus CABG surgery: why coronary stenting should remain the first choice of revascularization in non-diabetic patients and why the controversy is still present in diabetics. Exper Rev Cardiovasc Ther. 2014;12:297-309.
10.
Bell B, Layland J, Poon K, Spaulding C, et al. Focused clinical review: periprocedural management of antiplatelet therapy in patients with coronary stents. Heart Lung Circ. 2011;20:438-445. Capodanno D, Angiolillo DJ. Management of antiplatelet therapy in patients with coronary artery disease requiring cardiac and noncardiac surgery. Circulation. 2013;128:2785-2798. Oprea AD, Popescu WM. Perioperative management of antiplatelet therapy. Br J Anaesth. 2013;111 (suppl 1):i3-i17. Brilakis ES, Patel VG, Banerjee S. Medical management after coronary stent implantation: a review. JAMA. 2013;310:189-198. Caplan RA, Connis RT, Nickinovich DG, et al. Practice alert for the perioperative management of patients with coronary artery stents: a report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Anesthesiology. 2009;110:22-23. Horlocker TT, Wedel DJ, Rowlingson JC, et al. Executive summary: regional anesthesia in the patient receiving antithrombotic or thrombolytic therapy: American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Third Edition). Reg Anesth Pain Med. 2010;35:102-105. McCullough J. Overview of platelet transfusion. Semin Hematol. 2010;47:235-242. Slichter SJ. New thoughts on the correct dosing of prophylactic platelet transfusions to prevent bleeding. Curr Opin Hematol. 2011;18:427-435. Igbal J, Gunn J, Serruys PW. Coronary stents: historical development, current status, and future directions. Br Med Bull. 2013;108:193-211.
Post-Test
Conclusion Management of patients with recent coronary stents who require NCS remains an evolving field due to ongoing advances. The guidelines suggest that it is safest to avoid surgery during the critical initial period after revascularization, but if absolutely necessary surgery can proceed, recognizing the risks for stent thrombosis. Given the lack of a gold standard measurement of antiplatelet function, there is no definitive metric to assist in perioperative medication management. The current guidelines provide a framework for management in the context of current limitations.
Fleisher LA, Fleischmann KE, Auerbach AD, et al. 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014. [Epub ahead of print.]
9.
5.
Which of the following statements is correct regarding CABG and PCI? a. In diabetics, PCI with DES has a lower rate of repeat revascularization procedures than CABG in the first 5 years. b. The death rate for CABG is lower than that for PCI in patients without diabetes. c. The death rate for CABG is lower than that for PCI in patients with diabetes. d. In patients with diabetes, the risk for stroke and death is increased with CABG rather than with PCI with DES. Which of the following is least likely to inhibit platelet aggregation? a. Aspirin b. Heparin c. Clopidogrel d. Tirofiban Which of the following medications is likely ineffective in bridging antiplatelet therapy? a. Tirofiban b. Heparin c. Epifibatide d. All of the above
10. Pick the optimal timing for a DES to remain present in a bioabsorbable stent: a. 1 month b. 3 month c. 6 months d. 12 months
Jo ntlyy P Joint Provide Provid id de ded ed by ed
SAMBA
Annual Meeting 30 3 0th A ANNIVERSARY NNIVE V RSARY RY
SAMBA 30th Annual Meeting April 23-25, 2015 Hyatt Regency Scottsdale Resort & Spa at Gainey Ranch Scottsdale, AZ
Attend and earn up to
23.5 CMEs
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COMMENTARY
No Amnesty for the Affordable Care Act By David V. Cossman, MD
I
was watching President Obama’s “amnesty” speech the other night and I began to understand the Affordable Care Act (ACA). The goals of health care reform, setting aside cost control, always seemed straightforward to me: Provide care and coverage for the uninsured, end the practice of cancelling insurance for those who need it the most because they were sick and consumed a lot of resources, and provide coverage for people with “preexistingg conditions.” Addressing these issues that affect maybe 40 million people could have been accomplished in a bipartisan way without disturbing the other 300 million Americans, which was the pledge. The reasons for the lack of clarity in the massive actual law are starting to come into focus through a coalescence of events. Nancy Pelosi’s famous observation after the bill’s passage that we would all have to “wait to see what was in it” before deciding if we liked it or not now seems more cunning than accidental. One got the sense of a purposeful intent to deceive, or a failure to disclose. Jonathan Gruber’s recent comments verify this. Mr. Gruberr is a professor at Massachusetts Institute of Technology, the architect of the ACA and speaker of the stunning admission that the bill was written “opaquely” to disguise the fact that, in essence, health care reform was a huge redistribution scheme that no one would support if it explicitly stated that the intent was to subsidize care for the poor by forcing others to buy expensive policies with bells and whistles that few needed. Could anything be worse than to hear the Speaker of the House say, “I don’t know what’s in the bill,” or one of its authors say, “You can’t tell what’s in the bill” because it was intentionally written to confuse? Yes. “It doesn’t matter what’s in the bill.” That’s worse. Much worse. “It doesn’t matter what’s in the bill” is the same thing as saying “the law is what we say it is.” If that isn’t scary enough, just add the words, “what we say it is can change at any time.” One can argue whether or not President Obama acted within the Constitution and the scope of his executive authority the other
night when he lifted the threat of deportation against people illegally in this country, but what matters is that he repeatedly told us he had no legal or Constitutional authority to do so. But he did it anyway. and appeared quite pleased with himself for doing a noble thing. Moral authority trumped legal authority that can be manipulated. Was it this same dismissive attitude toward the law that informed the writing of the ACA and its circuitous movement through the legislative process? Had the president and his agents intended all along to get anything passed and then worry about what was in it later, knowing full well that implementation could always be reshaped by broad interpretation or selective enforcement of its provisions? Are we living in an age where the black letter of the law is nothing more than license to act independently, arbitrarily, or worse, for political gain? That’s what TSVBMC [the still very beautiful Mrs. Cossman] says, and she’s got the law degree, not me. Mr. Gruber admitted that when the bill was being written, the framers were instructed to put everything in it (hence its length), but disguise its true purpose of wealth redistribution from the voter and its cost from the Congressional Budget Office. More cynically, it appears the law was intentionally deceptively written as a center-right document designed to embarrass Republicans who would inevitably vote against it along strict partisan lines. The personal mandate and the insurance exchanges to enhance competition in the marketplace are both conservative ideas lifted directly from the Hoover Institute, a conservative think tank that advised none other than Massachusetts Governor Mitt Romney in his implementation of the state plan, upon which the ACA was modeled. Odd that Gov. Romney ran against his own plan, but politics poisons principles every time. To embarrass themselves further, conservatives asked the U.S. Supreme Court to strike down the personal mandate, the symbol of personal responsibility and accountability endorsed by conservatives. Chief Justice John Roberts, one of their own, saw the paradox and struck them down. If the Republicans were stupid for voting against it, what can we say about the Democrats who all
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voted for it? Where was all the promised reform? What about a single payor and univer- David V. Cossman, MD sal coverage? Wasn’t the purpose of “health care reform” in the first place to rein in the insurance industry that was extracting billions from health care through managed care products like health maintenance organizations that coined money by rationing care? Not only is there nothing in the ACA to constrain the insurance companies, they are making out like bandits. Far from being a federal reform of health care, the ACA has resulted in a virtual takeover of health care by the insurance industry. Look at the numbers since ACA went live. The four major players—Aetna, Humana, United Healthcare and Cigna—have seen their profits double in two years and their market caps rise nearly 70% on the New York Stock Exchange. Some of the profits have come from millions of new enrollees in managed Medicaid plans, in which profits are high and reliable because the premiums are 100% subsidized by the U.S. Treasury. A second massive wave of new enrollees into the exchanges came from people who lost their cheaper nonconforming plans despite the president’s pledge that this would not happen. They were greeted with sticker shock. Mr. Gruber has stated the president knew this when he told Americans that the average family of four would see $2,500 in savings the first year. The insurance companies saw this coming and got on board early. The Harry and Louise ads that they sponsored to kill off the Clinton health care plan in the 1990s stayed in storage. Besides, Harry and Louise are now on Medicare enjoying free federally sponsored health care. But wait, there’s more! As an added bonus, the ACA would create a virtual monopoly for the five or six largest insurance companies by forcing the small to mid-sized firms selling unqualified products out of business. How great was that, the federal government creating instead of prosecuting monopolies! Other big businesses are taking note and reevaluatingg their traditional antigovernment postures. There’s a lot of money to be made from big see amnesty page 54
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CLASSIFIEDS ACADEMIC PEDIATRIC ANESTHESIOLOGIST - COLUMBIA, MO. The University of Missouri (UM) Department of Anesthesiology and PerioperaƟve Medicine is seeking a fellowship-trained pediatric anesthesiologist. Successful candidates will be ABA cerƟĮed or eligible. Academic rank and pay is based upon qualiĮcaƟons in either a tenure or non-tenure track. An interest in teaching is essenƟal; research experience is desirable. The pracƟce is based at the UM Women’s & Children’s Hospital where all pediatric surgical subspecialƟes are represented except solid organ transplant and cardiac surgery. The department supports pediatric emergency services, criƟcal care transport, a PICU and a NICU. Three pediatric anesthesiologists currently share clinical responsibiliƟes and home call for all high risk pediatric cases. During regular duty hours, they provide care for adult paƟents on occasion. UM oīers a generous compensaƟon and beneĮt package. Columbia is a vibrant university community of over 100,000 with a low cost of living. It has been cited by Money Magazine as the 13th most highly educated municipality in the US and by Outside Magazine as one of the 10 Best US communiƟes. For addiƟonal informaƟon about the posiƟon, please contact: B. Craig Weldon, MD at weldonb@health.missouri.edu An Equal Opportunity/Access/AĸrmaƟve AcƟon/Pro Disabled & Veteran Employer To request ADA accommodaƟons, please call Human Resource Services at 573-882-7976.
ANESTHESIOLOGIST: Tired of air polluƟon, traĸc jams, crowds, and crime? Then GarreƩ County is for YOU! GarreƩ County Memorial Hospital, nestled in the scenic mountains of beauƟĨƵů western Maryland, currently has an opening for an Anesthesiologist. Varied caseload - 2300 surgeries per year which include orthopedics, general, ophthalmology, pediatrics, obstetrics, gyn, and vascular. High degree of autonomy. Contract 1099 employment. Call required. Must be proĮcient in regional and blocks. Supervision off Įve CRNA's and assistance with regulatory standards required. Live and work in a mountain playground with good schools, low crime and a stable economy. GCMH is located just minutes away from Deep Creek Lake, Wisp Ski Resort including the new Adventure Sport Center, and numerous state parks. Enjoy hunƟng, Įshing, hiking, boaƟng, skiing (water and snow), swimming, snowshoeing, mountain biking, etc. Visit www.deepcreekƟmes.com and www.gcmh.com for more informaƟon on our area and hospital, and www.garreƩcountyschools.org for informaƟon on our school system. At GarreƩ County Memorial Hospital, our moƩo is "Excellent Care Close to Home." This exempliĮes the atmosphere of caring, commitment, respect and professionalism that is felt throughout the hospital. Interested applicants may send a resume to:
GarreƩ County Memorial Hospital Human Resources Department 251 North Fourth Street Oakland, MD 21550 or FAX your resume to us at 301-533-4328 or contact Kendra Thayer, Vice President for PaƟĞŶt Care Services/CNO at 301-533-4169. EOE H/V/M/F
UNIVERSITY OF FLORIDA SEEKING 15 PHYSICIAN FACULTY MEMBERS UF Anesthesiology Ascent. Are you seeking collegial partners and a suppoƌƟve work environment in an academic seƫng? To accommodate expansive growth in periopĞƌĂƟve, ICU, and pain services, the University Of Florida Department of Anesthesiology seeks 15 commiƩed physician faculty members for tenure and non-tenure track Assistant / Associate / Full Professor ranks to teach and pƌĂĐƟĐĞ at UF Health Shands Hospital, Shands Children’s Hospital, and Shands Cancer Hospital at the University of Florida, a tĞƌƟĂƌLJ care teaching facility located in Gainesville, FL (including, teƌƟĂƌLJ care / Level I Trauma Center / High risk Ob / Comprehensive Stroke Center / Level 4 NICU / Congenital Heart Center / Solid Organ TransplantaƟon / Cancer Center). These poƐŝƟons require skills in clinical care, ABA cerƟĮĐĂƟon/eligibility, and credĞŶƟĂls to obtain a State of Florida physician’s license. Abundant opportuniƟes exist to develop independent and collaboraƟve research as well as innovaƟve eduĐĂƟon models. Base salary is negoƟĂble commensurate with experience and eduĐĂƟon. AddŝƟonal variable compensaƟon is available. Department anesthesiologists pƌĂĐƟĐĞ at UF Health hospitals in Gainesville, FL at the University of Florida alongside 62 faculty anesthesiologists, 78 residents, 17 fellows, and 57 CRNA/AAs. University employment benĞĮƚƐ include 403(b) plan, 457 plan, individual and family health insurance, professional disability insurance, Baby Gator childcare, domesƟc partner bĞŶĞĮƚƐ͕ sovereign immunity malpƌĂĐƟce status, and others. Gainesville is a vibrant, sun drenched, university city with a low cost of living, Division I NCAA sports, and no state income tax. Salary: Commensurate with eduĐĂƟon and experience Minimum Requirements: M.D. or equivalent, ĐƌĞĚĞŶƟals to obtain a State of Florida physician’s license Criminal background and post oīĞƌ health assessment required. Interested applicants must apply through gatorjobs at hƩp://jobs.uŇ.edu/posƟngs/60184. Please ĂƩach curriculum vitae and leƩer of interest . Final candidate will provide oĸcial transcript to the hiring department upon hire. A transcript will not be considered "oĸcial" if a designĂƟon of "Issued to Student" is visible. Degrees earned from an eduĐĂƟon inƐƟƚƵƟon outside of the United States are required to be evaluated by a professional ĐƌĞĚĞŶƟaling service provider approved by the NĂƟonal AssociaƟon of CredenƟĂů EvaluĂƟon Services (NACES), which can be found at hƩp://www.naces.org/. The University of Florida is an equal opportunity inƐƟƚƵƟon dedicated to building a broadly diverse and inclusive faculty and ƐƚĂī͘
54 I AnesthesiologyNews.com
FEBRUARY 2015
COMMENTARY AMNESTY
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government with big plans that it can’t execute. Saving face gets expensive. Warren Buffett is no dummy: He’s doing quite nicely with the anti–Big Business crowd in power. Even excessive government regulation is being revisited as ultimately being pro–Big Business because it poses hopelessly complex and expensive barriers to entry for smaller competitors. Politicians love regulations because of all the campaign contributions this brings in to get around them. Big Business is starting to love them because smaller competitors can’t afford compliance or lobbying for a variance. The monumental government failure on opening day was an unexpected bonanza for the insurance companies. What was running through the minds of the CEOs of the Big Four when the president, Department of Health and Human Services (HHS) Secretary Sebelius and the hapless technocrats came crawling on hands and knees, begging for help to launch healthcare. gov that was four years and $2 billion in the making? Apparently, the federal labor pool of 25 million was insufficient to launch a website, so the insurance industry graciously supplied executive and technical personnel. An obvious conflict of interest was waived by the government, so the insurance industry is now basically running HHS. But wait, there’s even more! Health care reform was supposed to move to a single-party payor; ACA didn’t do that. It was supposed to insure everyone; it didn’t do that. It was supposed to control costs so that health care didn’t consume 16% of the gross domestic product; it didn’t do that either, but there is one provision of the ACA that was supposed to be a step in that direction, but when all is said and done, it will more likely than not just be another huge profit engine for the insurance industry. The ACA provides for a little-known $3 billion “pilot project” to fund
INCONGRUENT
“outcome studies.” Outcome studies in the context of the ACA are studies that compare the relative effectiveness of different treatments for diseases and conditions. It’s not an exact science in that effectiveness takes into account the “therapeutic index” or the length of time that a treatment, when successful, is beneficial. Let me translate that for you: If you’re an old person, say over 75,
with action deemed necessary to serve a higher purpose. If the president can act in a way he repeatedly described as illegal to end deportations, Humana should have little trouble telling me I’m not getting covered for a carotid thromboendarterectomy because maximum medical therapy works as well, or well enough, or sufficiently well given the price difference.
ACA Not only is there nothing in the ACA to constrain the insurance companies, they are making out like bandits. Far from being a federal reform of health care, the ACA has resulted in a virtual takeover of health care by the insurance industry. don’t expect to get a total hip because you won’t be alive long enough to enjoy it. Take Advil instead. Total hips are for younger people who don’t need them. That’s outcome analysis and the therapeutic index in a nutshell. Of course, the ACA explicitly states that outcome studies cannot be used for payment decisions. Enter once again our good friend and tour guide Mr. Gruber, who explains with a wink and a nod that it would be a mistake to think that the law would interfere
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improve quality of care; yet, they are very expensive to provide). • Significantly curtail use of expensive electronic monitoring of laboring patients. • Severely reduce hospital ancillary staff. Is this really what we want?
If providers (formerly known as doctors) aren’t getting paid, they will change their behavior in the same way that tax preferences influence investment, saving and spending decisions. Throw in accountable care organizations (ACOs) so everyone’s financial interests are aligned and surgeons will be getting year-end bonuses for doing the fewest cases. We’ll see if the ortho guy from the ACO who still does a lot of total hips gets invited to the Christmas party.
PS (written on the day of Joan Rivers’ death): I was watching CNN and their medical correspondent pointed out that people are having procedures in ambulatory facilities that really would be more safely done in the hospital; he said that this is done in order to reduce health care costs. I couldn’t help thinking: Perhaps if we spent more money on health care instead of less, Joan Rivers
And who benefits from using outcome analysis to deny payment? Not the patient; not the doctor; the insurance companies pocket the savings. If underwriting losses go up, they disproportionately raise premiums. If they go down, they claim the money is adding to “reserves.” When is the last time you saw your premium go down for insurance of any kind? The ACA is going back to the Supreme Court in King v. Burwell over whether or not a person who enrolls through a federal exchange is entitled to the same federal subsidy as one who enrolls through a state exchange, even though the law does not provide for it. The defenders of the law say it was a mere oversight, and the legislative intent of the entire law was to provide coverage for everyone. Exhibit A for plaintiff King will be none other than Mr. Gruber, who let the cat out of the bag when he told a group of students that the subsidy was intentionally denied to those enrolling through the federal exchanges to force states to construct their own. Only 13 states did so. We’ll see how the Supreme Court, and specifically Chief Justice Roberts, reacts to the “law really doesn’t matter” crowd this time around. I agreed with him when he denied conservatives victory the first time around over the mandate issue. My guess is that he, alarmed by the president’s apparent lawlessness in the immigration issue, will use this case to make the point that laws matter, they’re not fluid, and they can’t be ignored to serve political objectives. He will reject the notion that in a nation held together by the rule of law, breaking the law is permissible, even if one asserts commitment to a perceived higher moral imperative like religion, conscience or social justice. Political expediency won’t make the list. Those who do not respect existing law will not get a pass for writing one they had no intention of obeying. It might just be that the price of amnesty will be the ACA.
(and countless others who aren’t famous enough to be featured on CNN) would still be alive. Furthermore, it seems the gastroenterologist involved in her care has written articles (easily available on-line) stating that using anesthesiologists to administer propofol for endoscopies costs the US health industry $5 billion annually and is unnecessary. Please draw your own conclusions from this.
THE BODY OF EVIDENCE SUPPORTS CPAP. IT’S ALL ABOUT OPTIMAL PATIENT CARE IN THE PACU. The consensus is in: Various studies indicate the post-operative efficacy of CPAP therapy for highrisk surgery patients. Benefits include reduced incidence of intubation, infection and pneumonia. Improved gas exchange leads to reduced pulmonary complications, shorter intensive care stays and significant cost savings.(1) (2)
ONLY ONE. FLOW-SAFE® II DISPOSABLE CPAP SYSTEM: THE RIGHT CHOICE. Only one CPAP device gives you the advantages of an all-disposable system with a built-in pressure gauge valve that verifies delivered CPAP pressure and pressure relief valve ensuring patient safety. Flow-Safe II. It’s ready to use. No extra equipment is needed. Simply plug into the oxygen source and it delivers CPAP instantly. Flow-Safe II also transfers easily with the patient and the advanced mask design and head harness provide a better seal and greater comfort. And there’s no cleaning or its associated risks.
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(1) Drs. Kingden - Milles, Müller, Buhl, et. al. Nasal – Continuous Positive Airway Pressure Reduces Pulmonary Morbidity and Length of Hospital Stay Following Thoracoabdominal Aorticc Surgery. Chest/128/2/August, 2005. 821-82 28. (2) Drs. Squadrone, Coha, et. al. Continuous Positive Airway Pressure For Treatment of Postoperative Hypoxe emia. A randomized controlled trial. JAMA, Feb. 2, 2005-Vol 293, No. 5 589-595.
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