40th Anniversary 1972-2012
GENERALSURGERYNEWS.COM
October 2012 • Volume 39 • Number 10
The Independent Monthly Newspaper for the General Surgeon
Opinion
NASH Spikes as Reason For Liver Transplant
Who Shot J.R.? D AVID V. C OSSMAN , MD
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or those of you in your first few years of practice as an MD, you were being breast-fed in 1980 when “who shot J.R.?” was the burning question on the prime-time evening soap, “Dallas.” Almost half a billion people worldwide tuned in to find out who shot J.R. Ewing, the patriarch of an oil-rich family played by Larry Hagman (who obviously wasn’t mortally wounded since he’s back, with a new liver, on a “Dallas” remake). A jilted mistress, of course, with family ties to the Barnes, the archenemy of the Ewings, pulled the trigger. How predictable. And disappointing.
This time, J.R. turned out to be the shooter. Early this summer, J.R. took center stage again in the form of Chief Justice John G. Roberts, only this time it was “J.R. and the Supremes” who captivated the nation’s attention with the pending decision on the constitutionality of the mandate provision of the Patient Protection and Affordable Care Act (PPACA) that requires all Americans to buy health insurance. For intrigue and drama, this was true theater. Audience see PPACA page 34
FROM THE BENCH TO THE BEDSIDE Incorporating a Novel Local Analgesic Into an Opioid-Sparing Strategy for Postsurgical Pain see page 8
Obesity Faulted; Study Shows Transp nsplant Helps Nonalcoholic Steatohepatitis Patients Pat
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merica’s stretched donorr pool and limited resources for transplant will come under further stresss in the next decade as nonalcoholic steatohepatitis (NASH) supplantss hepatitis C as the primary indiccation for liver transplant, experts saay. According to a study presented at the American Sur urgical Association’s annual meetin ing, NASH is now the fastest-growin ing indicator for liver transplant at th he University of California, Los Angeeles (UCLA), which has one of the he country’s largest transplant programs.
drawn fire from the medical device industry, which predicts, despite some counterclaims, that the tax will result in lost profits, vanishing jobs, relocation overseas and a decline in innovation. There is even a Web site, no2point3.com, supported by Cook Medical, with the message, “Kill the med device tax!” In June, the House passed a bill (H.R. 436) to repeal the tax. The bill is
SAN N DIEGO—One in every two bariatric surgeons will be h hit with a medical malpracttice claim during their careerr, a new study shows, but nearlyy 70% of those claims are dropped, dismissed or found in favor of o the surgeon. “Th his survey indicates that malprac actice claims are common eve vents but lawsuits occur most frequently in cases where no negfre ligence is found to have occurred,” li said study author Ramsey Dallal, sa MD, director of bariatric surgery, EinM stein Healthcare Network, Philadelphia. adelphia. Dr. Dallal, chair of the Am merican Society for Metabolic and Bariatric Surgery (ASMBS)’s patientt safety committee, presented the stu udy at the organization’s annual meetin ng. The study is based on a survvey of members of the ASMBS praccticing in the United States. Of 1,6672 eligible members asked to com mplete an email survey detailingg their medicolegal experience,, 330 responded, for a responsee rate of 20%. Surgeons who completed the survey had been in practice for a mean of 15.3 years, representing 5,042 years of bariatric surgery experience. Nearly 40% practiced in a hospital or
see DEVICE TAX page 14
see CLAIMS page 18
see LIVER page 4
Excise Tax Looms ffor Medical Device Industry Manufacturers Argue Tax Will Cause Layoffs, Stifle Innovation
B
arring a major political shift, medical device manufacturers will face a new 2.3% excise tax on their products beginning in 2013, which is expected to raise $29 billion over 10 years. Enacted in 2010 as part of the Affordable Care Act (ACA) that is reforming health care, the tax has
Claims Common In Bariatrics, But Outcomes Often Favor Surgeons Exper ert Witnesses a Particularly Conten entious Issue in Bariatrics
B Y C HRISTINA F RANGOU
B Y G EORGE O CHOA
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INSIDE Opinion Physicians’ Thoughts on the 2012 Presidential Election and Its Effect on Health Care .................... 12
Surgeons’ Lounge Experts Debate the Use of Sentinel Lymph Node Biopsy in Melanoma ...................... 20
A Patient With a Large, Malodorous, Fungating Right Breast Mass ...... 28
GSN Editorial
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2012
A Way With Words Frederick L. Greene, MD, FACS Clinical Professor of Surgery UNC School of Medicine Chapel Hill, North Carolina
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ne of the main reasons that I enjoy writing these monthly editorials for General Surgery Newss is to develop a story using a variety of words that intertwine to convey a mood, a vision, an emotion or a concept that might be of interest to my surgical brethren. Frequently, I turn to a thesaurus or dictionary to help find the right word or phrase that best reflects the aura that I am trying to convey. Our language is so rich and encompassing that there is always room for improving a meaning or a phrase. The beauty of language is that it continues to change as generations use new words and phrases that describe new technologies, communication maneuvers, social networking or quasi-medical conditions. Words tend to creep into usage and reflect ideas that were not even thought about a decade or less ago. Our dictionaries are truly dynamic in the sense that these new words and phrases
must be considered for inclusion in these official repoositories of our lexicon n. The insertion of these linguistic “newcomersâ€? is decided by language experts who carefully l consider id each h possible addition and their appropriate definition and usage before inclusion. Recently, the overseers of the MerriamWebster’s Collegiate Dictionaryy announced their annual update that reflects the increased use of approximately 100 new words or terms. Several of these new inclusions piqued my interest. There are now official definitions for “earworm,â€? “aha moment,â€? “man cave,â€? “brain crampâ€? and “bucket list.â€? For those who are wondering about “earworm,â€? this word refers to a tune that you cannot get out of your mind, that keeps playing and playing and playing and ‌ well, you get the picture. We all have experienced this malady, but never had a term for it. Rather than just a blight on an ear of corn, now we have a good alternative and an official definition. Three new additions to the officialMerriam-Websterr lexicon were “flexitarian,â€?
Senior Medical Adviser Frederick L. Greene, MD Charlotte, NC General Surgery, Laparoscopy, Surgical Oncology
Editorial Advisory Board Maurice E. Arregui, MD Indianapolis, IN General Surgery, Laparoscopy, Surgical Oncology, Ultrasound, Endoscopy
Kay Ball, RN, CNOR, FAAN Lewis Center, OH Nursing
Philip S. Barie, MD, MBA New York, NY Critical Care/Trauma, Surgical Infection
L.D. Britt, MD, MPH Norfolk, VA General Surgery, Trauma/Critical Care
David Earle, MD Springfield, MA General Surgery, Laparoscopy
James Forrest Calland, MD Philadelphia, PA General Surgery, Trauma Surgery
Edward Felix, MD Fresno, CA General Surgery, Laparoscopy
Robert J. Fitzgibbons Jr., MD Omaha, NE General Surgery, Laparoscopy, Surgical Oncology
David R. Flum, MD, MPH Seattle, WA General Surgery, Outcomes Research
Michael Goldfarb, MD
Leo A. Gordon, MD Los Angeles, CA General Surgery, Laparoscopy, Surgical Education
Gary Hoffman, MD Los Angeles, CA Colorectal Surgery
Namir Katkhouda, MD Los Angeles, CA Laparoscopy
We have all experienced [an earworm], but never had a term for it. Rather than just a blight on an ear of corn, now we have a good alternative and an official definition. “obesoogenic� and “energy drink,� words or o phrases that have something thi tto d do with eating patterns or dietary decisions. “Flexitarian,� which was traced back to a 1998 introduction, is defined as “one whose normally meatless diet occasionally includes meat or fish.� I am sure in certain circles this word will be quite beneficial. I am confident that “flexitarian� could relate to many types of “detours� from a planned course and I am sure that we all can think of examples that occur in our own surgical worlds. Being flexible is generally a good thing, whereas the state of being a “flexitarian� somehow denotes wishy-washiness with religious overtones. The second addition having a dietary bent is the word “obesogenic,� an adjective for “promoting excessive weight gain: producing obesity.� Now this is truly a useful word! This really transcends our bariatric terms and can be interjected so smoothly and effortlessly into so many discussions with patients, colleagues and
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friends. The word, presumably introduced around 1986, now has been anointed with official sanction by our lexicographers, and unfortunately pertains to so many of us and our patients today. Despite the efforts of those who have attempted to curtail the imbibing of sugar-laden sodas and high-fat fast foods, the obesity epidemic continues to spiral out of control and the consequences of “obesogenic� lifestyles contribute to excess morbidity, mortality and continued draining of our health care budget. It will be my pleasure to continue to have an opportunity to introduce these new words and phrases into this column over the next several years as they are “officially� welcomed into our language. It would be nice to avoid the inclusion of words that describe inappropriate or risky behavior. But, alas, that is the beauty of words and language that help to describe everything around us—both good and bad.
Mission Statement It is the mission of General Surgery News to be an independent and reliable source of news and analysis about the current state of surgery. It strives to provide a venue for discussion and opinions, from all viewpoints, on the issues most important to surgeons.
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INFECTIOUS DISEASE SPECIAL EDITION
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In the News LIVER
jContinued from page 1 In 2002, NASH was thee primary p indication for liver transplant nt in about 3% of all liver transplants att UCLA. By 2011, it accounted for fo 19% of all liver transplants and d was the second most common indication for liver transplantt at the center, representing a fivefold increase over ninee years. “NASH willl soon become the leading indication for liver transplantation in the United Stat ates,” said Vatche Agoopian, MD, a transpla lant surgeon at the Davi vid Geffen School of Med dicine at UCLA. The situation in Loss Angeles is similar to that at transplant centers across the country, said John P. Roberts, MD, professor of surgery and chief of transplantation at the University of California, San Francisco. NASH is rising dramatically in the United States, yet another consequence of the sky-high obesity rate. Populationbased studies suggest about 12% of Americans may have fat and inflammation
AT A GLANCE Population-based studies suggest about 12% of Americans may have fat and inflammation present in the liver. The epidemic of hepatitis C, which currently accounts for about half of liver transplants in the United States, appears to have peaked and the numbers are expected to slide downward. Analysis showed that NASH patients required more resources during their surgery and postoperatively, but that long-term survival of NASH patients matches those of other transplant patients. Researchers identified two predictors of lower survival in NASH patients: obesity and pretransplant hemodialysis.
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2012
‘This is where the future is going and it has the potential to overwhelm the system. We’re already short of organs now.’ —John P. Roberts,
present in the liver. At the same time, the epidemic of hepatitis C, which currently accounts for about half of liver transplants in the United States, appears to have peaked and the numbers are expected to slide downward. Even at its peak, hepatitis C affected about 1% of the U.S. population. The growing prevalence of NASH suggests that a much larger proportion of the population could one day be candidates for liver transplant, said Dr. Roberts. “It’s changing very fast. My sense is that you are going to see a big switch in indication for liver transplant from hepatitis C to NASH within the next decades,” said Dr. Roberts. “This is where the future is going and it has the potential to overwhelm the system. We’re already short of organs now.” A study presented at the American Association for the Study of Liver Diseases meeting this fall showed that NASH accounts for an increasing proportion of liver transplants nationally and liver transplant recipients with NASH have poorer survival compared with non-NASH recipients without hepatitis C (Brandman D et al. Temporal trends in liver transplantation [LT] for nonalcoholic steatohepatitis [NASH]; abstract). The UCLA study is the largest singleinstitution experience of liver transplant for NASH. Unlike previous research, it demonstrates that NASH patients can have outcomes that are comparable to other patients undergoing liver transplants. Even so, NASH patients place increased demand on hospital resources, the study showed. Between 1997 and 2011, 144 patients
underwent liver transplant for NASH, representing 12% of all liver transplants at UCLA during that time. Before 2002, only eight patients in total underwent liver transplantation MD for NASH. Since then, the number has leaped upw ward annually. Patients with NASH had more preP tran nsplant comorbidities and higher prettransplant acuity than patients who und derwent liver transplants for other cau uses. Two-thirds of NASH patients had d a body mass index (BMI) of 30 kg/ m2 or greater and/or diabetes; 50% of patients had hypertension and 30% had pa metabolic syndrome—all significantly m higher than in other transplant patients. NASH patients had an average Model for End-Stage Liver Disease score of 33, 45% were on hemodialysis and 17% were receiving vasopressors. Analysis showed that patients with NASH required more resources during their surgery and postoperatively. They had significantly longer operative times, reaching a median of 6.9 hours
compared with 5.3 hours for other patients (P<0.001); they had greater operative blood loss (18 vs. 14 units of packed red blood cells; P=0.004) and a longer total hospital length of stay (35 vs 29 days; P=0.046). But long-term, the survival of patients with NASH matches those of other transplant patients. One- and threeyear graft survival reached 80% and 70%, respectively, and one- and threeyear patient survival was 84% and 75%, respectively. The survival rates were similar to those for all other patients undergoing liver transplant except for patients with hepatitis C. Patients with hepatitis C who received liver transplants had much poorer outcomes: a 62% survival and 57% graft survival after three years. Two factors appear to be important predictors of survival in patients with NASH: namely, patients who had a BMI greater than 35 kg/m2 and patients requiring pretransplant hemodialysis had worse outcomes after transplant. The authors said these factors might help guide the selection of patients who may benefit most from liver transplant.
Chad Hoover, Ephemera #4, 48" x 36", oil on canvas. The surgeon and patient alone are captured in a dramatic moment during the procedure. For more information contact chad@chadhooverart.com.
In the News
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2012
Drug a ‘Potential Breakthrough’ for Preventing Liver Cancer B Y C HRISTINA F RANGOU SAN DIEGO—One of the most widely used diabetes drugs in the world appears to have an unexpected secondary benefit: reducing the risk for hepatocellular carcinoma (HCC) by more than 50%, according to two new studies. At the 2012 Digestive Disease Week (DDW) meeting, results from an American case–control study and a nationwide study from Taiwan showed HCC
incidence plummeted in patients with diabetes who were taking metformin compared with diabetic patients who were not receiving the therapy. The reports represent a major step in prevention of liver cancer. “The results are astonishing. If you put it together these two papers, we have potentially a breakthrough in the prevention of liver cancer,” said Jacques Devière, MD, PhD, professor of medicine at Erasme University Hospital in Brussels, Belgium, after hearing the
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studies press ented. Previous epidemiologic studies have suggested that metformin may be protectivve against many cancerrs, and a recent study published in Cancer Prevention Researchh showed that metform min slowed tumor actt ivity in mice givee n chemically-induceed liver tumors (2012;5:544-5552).
But the two studies prresented at the DDW W meeting mark an important step in und derstanding a relationship p between metformin an nd HCC. The studies are unique in size and scope, and the results leave little doubt that metfformin has a statistically significant and d clinically significant protective effect. The Taiwanese study was conducted in two parts: a population-baased study that started with almost all of the country’s 23 million people and an in vitro study that looked at metformin’s effects in humans and mice (abstract 596). In the first part, investigators used the Taiwanese national health insurance database to identify patients diagnosed with HCC. Between 1997 and 2008, investigators recruited all the newly diagnosed HCC cases, totaling nearly 97,430 patients, and compared them with nearly 200,000 age-, gender- and first-visit-tophysician–matched controls. As expected, people diagnosed with diabetes had much higher risk for developing HCC—an increase of nearly 2.5fold (odds ratio [OR], 2.29) compared with people without diabetes, a rate similar to that in previous large epidemiologic studies. But for the first time, the study showed that in patients with diabetes taking metformin, HCC occurred significantly less often compared with other individuals with diabetes. HCC occurred most often in patients with diabetes who were not using metformin (OR, 1.95; 95% confidence interval [CI], 1.88-2.03), followed by patients with diabetes who rarely used metformin (OR, 1.74; 95% CI, 1.67-1.82) and least often in patients with diabetes who regularly used metformin (OR, 1.56; 95% CI, 1.49-1.64). Moreover, metformin’s effect was shown to be dose-dependent: For every year of metformin use, patients with diabetes had a 7% decrease in HCC risk, after controlling for other factors. The investigators then performed cell line studies to look at the in vitro effects of metformin on cell proliferation and cell cycle. Studies of HepG2 and Hep3B hepatoma cell lines showed that metformin inhibited hepatocyte proliferation and induced cell cycle arrest at G0/G1 in two ways: by upregulating p21/Cip1 and p27/Kip1 and by downregulating cyclin D1 in a dosedependent manner. The effect was independent of p53, a protein strongly associated with tumor suppression. “I think this is an exceptional piece see METFORMIN PAGE 37
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In the News
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2012
Sleeve Improves Transplant Candidacy in Morbidly Obese Weight Loss Puts Patients in Accpetable BMI Range; Procedure Seems Safe in This HighRisk Group B Y C HRISTINA F RANGOU
transplants on obese patients and has performed d transplants on post-bariatric patientts. He said adhesions can be problemattic after bariatric surgery but this shoulld not deter transplant surgeons from operating on these patieents. Nationaally, 15% to 20% of paatients on the transplantt list are morbidly obese with a BMI grreater than 35 kg/m2. Many of these patiients will be denied a transplant if they cannot losse weight. At UCS SF, all patients who undergo liiver transplant must have a BM MI less than 40 kg/m2; those whoo undergo kidney transplant mustt have a BMI less than 38 kg/m2; and d diabetic patients needing a kidney transplant l must h have a BMI less than 34 kg/m2. It is hoped that bariatric surgery will enable more obese or overweight patients to undergo transplant, said Dr. Lin. Pre-transplant bariatric surgery is a good option for patients who are languishing on the wait list and are likely to wait five to seven years for an organ, said Dr. Oberholzer. But for many of those patients, bariatric surgery is not an option, particularly patients with kidney disease. They may be too sick to undergo bariatric surgery, or could die undergoing dialysis in the year or two after bariatric surgery while they are losing weight. Only 50% of dialysis patients are still alive three years after the start of therapy for end-stage renal disease, according to figures from the United States Renal Data System. “If it takes, that means you are going to tell the patient that he has probably—depending on how you do the math and other risk factors—only a 60% to 70% chance to be alive when he has lost the weight, two years after bariatric surgery, but is still undergoing dialysis,” said Dr. Oberholzer.
’We have to get away from this statistical thinking where we refuse to do transplants on patients who are obese because we don’t want to report poor outcomes.’
SAN DIEGO—Obese or overweight adults with endstage organ failure can safely undergo laparoscopic sleeve gastrectomy, resulting in significant weight loss —Jose Oberholzer, MD and improving their candidacy for transplant, a new study shows. Without weight loss, many of these patients would An obese patient with renal disnot be considered as candidates for transplant at some ease would havve better odds of survivtransplant centers. al if he or she has a living donor transplant In the pilot study of 26 obese or overweight liver as soon as possiblee and has a minimally transplant candidates, all patients safely underwent lapinvasive transplant. aroscopic sleeve gastrectomy. They experienced more In this study, the inveestigators set out to test nonfatal complications than the regular bariatric patient the hypothesis that laparooscopic sleeve gastrectopopulation, but no deaths within 30 days were reported. my can be safely performeed in high-risk patients Importantly, all patients lost enough weight to place with liver or kidney failure.. It is the first study to them in the acceptable body mass index threshold for examine laparoscopic sleeve gastrectomy in a transsolid organ transplantation. plant l population. l “Bariatric surgery is technically feasible, even in Investigators chose sleeve gastrectomy because they patients with cirrhosis or portal hypertension. It prowanted to avoid the foreign-body implantation of a gasvides excellent sustained weight loss and improves tric band. Unlike gastric bypass, the sleeve gastrectomy candidacy for liver transplantation,” said study author allows surgeons to maintain access to the biliary system Matthew Yi-Chih Lin, MD, a fellow in minimally and has reduced surgical complexity. invasive surgery at the University of California, San The study group consisted of six patients with endFrancisco (UCSF). Dr. Lin presented the study at stage kidney disease (including five patients requiring the 2012 annual meeting of the American Society for dialysis) and 20 patients with severely compromised liver Metabolic and Bariatric Surgery. function and a mean MELD score of 11. Patients had an At the time the study was reported, eight patients average BMI of 48.3 kg/m2 before bariatric surgery and underwent successful solid organ transplants: Six needed a kidney or liver transplant or both. Their mean patients underwent liver transplants, one patient had a age was 57 years. combined liver and kidney transplant and one patient Twenty-six percent of patients developed complicareceived a kidney transplant. Transplant patients had a tions, a rate that is on the upper end of the range for mean body mass index (BMI) of 46 kg/m2 prior to barcomplications. Previous studies reported complication iatric surgery. By the time of their transplant, their mean rates ranging from 0 to 24%. BMI had dropped to 31 kg/m2. Six patients developed complications within 30 days Transplant patients did not experience negative of bariatric surgery. Two patients had superficial wound effects from the bariatric surgery. There were no cases infections that required antibiotics and one patient develof acute rejection, and no patient had difficulty mainoped transient encephalopathy, required admission to taining immunosuppression. All patients maintained the ICU and eventually recovered. Another patient was their weight loss for at least six months after transplant admitted to the ICU as a precaution after a rise in credespite being immunosuppressed. atinine levels. One patient developed postAn additional 14 patients are currentoperative bleeding and required blood ly on the transplant list and have lost transfusion, and another was diagnosed AT A GLANCE with a staple-line leak. enough weight to qualify for transplantation at UCSF. Two patients died while waiting for All 26 liver transplant candidates in this study achieved The study demonstrates that obese an organ and another died of progressive eligibility for solid organ transplants. adults who need a transplant have “excelliver failure four years after bariatric surlent” treatment options and should not be gery. All deaths occurred more than 30 More complications, but no deaths at 30 days. ruled out as candidates, said Jose Oberholdays after surgery. zer, MD, C&B Frese and G. Moss ProfesThe study cohort lost weight at a rate All patients maintained their weight loss for at least six months sor of transplant surgery, bioengineering similar to that reported for a standard barafter transplant despite being immunosuppressed. and endocrinology, and chief of transplaniatric procedure. After surgery, the patients tation at the University of Chicago. lost 17% of excess weight by one month, Nationally, 15% to 20% of patients on the transplant list are “There is huge discrimination toward 26% by three months, 50% at 12 months morbidly obese with a BMI greater than 35 kg/m2. Many of obese patients who are in need of transand 66% at 24 months. these patients will be denied a transplant if they cannot lose plantation and I really think that, as a “This study suggests sleeve gastrectoweight. physician, we have to get away from this my may be performed safely in carefulstatistical thinking where we refuse to ly selected morbidly obese patients with After surgery, patients in the study lost 17% of excess weight do transplants on patients who are obese impending organ failure, and the signifby one month, 26% by three months, 50% at 12 months and because we don’t want to report poor outicant weight loss they achieve may make 66% at 24 months. comes,” he said. them more suitable candidates for transDr. Oberholzer regularly performs plantation,” said Dr. Lin.
You’ll see. Introducing the world’s first OLED surgical monitor. Imagine response time more than 10 times faster than LCD, for superb suppression of motion blur. Envision colors that remain true and saturated, even deep into the shadows. Get ready for contrast that renders anatomic features with eye opening clarity. Welcome to Sony TRIMASTER™ EL OLED technology. When a pixel is off, it’s completely off with a deep black that will astound you. And when a pixel is on, it emits light directly with no backlight to wash out the true colors. So take a careful look at Sony’s PVM-2551MD monitor. You’ve never seen surgical imaging like this before. See the difference at sony.com/HDforsurgery. © 2012 Sony Electronics Inc. All rights reserved. Reproduction in whole or in part without written permission is prohibited. Features and specifications are subject to change without notice. Sony, TRIMASTER and the make.believe logo are trademarks of Sony. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician or other appropriately licensed medical professional. CAUTION: See product labeling for indications, contraindications, warnings, cautions, and directions for use.
THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES
Incorporating a Novel Local Analgesic Into an Opioid-Sparing Strategy for Postsurgical Pain Tong-Joo Gan, MD, MHS Vice Chair, Department of Anesthesiology Duke University Health System Durham, North Carolina
Introduction Despite increased understanding of the mechanisms of pain and the introduction of new analgesics, poor postsurgical pain management continues to be a significant problem facing health care providers. The literature indicates that more than 85% of postsurgical patients report moderate, severe, or extreme pain during recovery. Hospital reimbursements increasingly are based on patient outcomes and patient satisfaction, making improvements in the management of postsurgical pain crucial. Recent data from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) confirm that there is room for improvement, as hospitals nationXJEF TDPSFE BO BWFSBHF PG JO QBJO NBO agement, according to the national survey, which examined factors from the patient perspective. The specific, negative clinical outcomes that may result from suboptimal management of postsurgical pain include deep vein thrombosis, pulmonary embolism, coronary ischemia, myocardial infarction, pneumonia, poor wound healing, insomnia, and demoralization.3 Additionally, there are economic and patient-related implications associated with these complications including extended hospital length of stay (LOS), readmission, and patient dissatisfaction with medical care.4 It has been shown that effective management of acute postsurgical pain may improve clinical outcomes and quality of life and emerging data suggest that aggressive treatment of acute postsurgical pain may prevent the risk for chronic pain development.5 Because the mechanism of pain is complex and involves multiple receptor systems in the peripheral and central nervous system, effective management of acute pain can benefit from a multimodal approach.4 Multimodal techniques for pain manageNFOU JODMVEF UIF BENJOJTUSBUJPO PG PS more drugs that act by different mechanisms to provide analgesia, thereby reducing the amount needed of any one agent.4 Although opioids are widely used as monotherapy for the management of postsurgical pain, they are accompanied by significant side effects that can result in patient discomfort, delayed recovery, and prolonged hospital LOS.6 When a multimodal approach is implemented, there may be a reduction in opioid requirements, which may lead
Inpatient Case Study: A 62-Year-Old Obese Man Undergoes an Open Right Hemicolectomy Stephen M. Cohen, MD, FACS, FASCRS Atlanta Colon and Rectal Surgery, P.A. Atlanta, Georgia
T
his case will describe a method of using a multimodal analgesic regimen to control pain in a patient undergoing an open colectomy procedure. The patient had a biopsy-proven adenocarcinoma of the cecum. His past medical history is significant for nonâ&#x20AC;&#x201C;insulindependent diabetes, mild chronic obstructive pulmonary disease, and hypertension, making this a desirable candidate for an opioid-reducing pain management strategy. "T SPVUJOF QSBDUJDF UIF QBUJFOU XBT BENJOJTUFSFE NH PG BDFUBNJOPQIFO JOKFDUJPO NJOVUFT QSJPS UP UIF JODJTJPO
BOE NH PG LFUPSPMBD JOKFDUJPO JNNFEJBUFMZ GPMMPXJOH JOEVD tion of anesthesia. Prior to closing the incision, EXPAREL was injected directly into the wound. The dose of EXPAREL is based on the surgical site and the volume required to cover the area. *O UIF QJWPUBM TPGU UJTTVF USJBM B EPTF PG NH PG &91"3&- POF N- WJBM XBT EJMVUFE XJUI N- PG QSFTFSWBUJWF GSFF OPSNBM TBMJOF 6TJOH UIBU EBUB BT B CFODINBSL NH &91"3&- POF N- WJBM XBT EJMVUFE XJUI N- PG QSFTFSWBUJWF GSFF OPSNBM TBMJOF GPS B UPUBM WPMVNF PG N- FOPVHI WPMVNF UP DPWFS UIF area. Ten mL of the mixture was infiltrated above and below the fascia and the remainder of the EXPAREL was infiltrated directly into the subcutaneous tissue (Figure). The patient received a UPUBM PG NDH PG GFOUBOZM EVSJOH TVSHFSZ BOE XBT BXBLF BOE BMFSU NJOVUFT BGUFS UIF QSPDFEVSF That evening, the patient tolerated sips of clear liquids and started oral acetaminophen and ibuprofen every 6 hours. He XBT BENJOJTUFSFE NH *7 PG IZESPNPSQIPOF JO EJWJEFE EPTFT EVSJOH UIF GJSTU IPVST BGUFS TVSHFSZ 0O QPTUPQFSBUJWF EBZ the patient rated his pain as a 3 on a pain rating scale (range, CFJOH no pain) and was ambulating in the hallway. He did not report nausea, vomiting, or itching. Bowel function SFUVSOFE PO EBZ BOE UIF QBUJFOU XBT EJTDIBSHFE MBUFS UIBU EBZ )F SFQPSUFE B QBJO TDPSF PG BOE TBJE IF GFMU DPOUFOU TBU isfied, and happy.
Discussion This case depicts how a multimodal analgesic approach that incorporates an agent such as EXPAREL may be beneficial for a QBUJFOU VOEFSHPJOH JOQBUJFOU TVSHFSZ XIFSF VQ UP IPVST PG local analgesia would be desirable. Multimodal therapy allows the physician to use several different medications, each with its own mechanism of action, to treat postsurgical pain, thereby decreasing the need for any single agent such as an opioid. This is an important goal in patients such as this one with a complicated medical history. Using a multimodal approach, the patient did not report any opioid-related adverse events 03"&T FH OBVTFB DPOTUJQBUJPO BOE JUDIJOH *O TVNNBSZ multimodal therapy incorporating EXPAREL can be used with the goal of decreasing opioid use, subsequent ORAEs, and minimizing the hospital LOS.
Commentary by Tong-Joo Gan, MD, MHS
Figure. Infiltration depth in tissue. Adapted with permission from Guideline Central.
to fewer opioid-related side effects and reduced morbidity.7 This can be achieved by administering non-opioid adjuncts such as acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase inhibitors, calcium channel antagonists such as gabapentin and pregabalin, Îą BHPOJTUT
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This case illustrates the excellent outcome following an open colectomy procedure when postsurgical pain is well controlled. The patient received a multimodal technique, incorporating acetaminophen, an NSAID, and a local analgesic. EXPAREL together with scheduled doses of acetaminophen and ibuprofen ensure continuous analgesic effects throughout the recovery period. This strategy has been shown to reduce opioid requirements, potentially leading to other positive outcomes. In this case, the use of an opioid-reducing multimodal approach resulted in the timely recovery of bowel functioning and a rapid postsurgical recuperation.
such as clonidine and dexmedetomidine, and local anesthetics.4 The role of nonopioid analgesics for postsurgical pain management is discussed in a review article by White and colleagues.8 The authors state that effective pain control with local anesthetics in the early
postsurgical period facilitates recovery by enabling early ambulation and discharge, potentially achieving opioid-sparing effects and a decrease in the incidence of postoperative nausea and vomiting.8 Although traditional local analgesics provide effective pain management at the wound site, they have
Supported by
a 6- to 8-hour duration of efficacy, which has limited their use to treat postsurgical QBJO MBTUJOH UP IPVST 9 The addition of EXPARELp (bupivacaine liposome injectable suspension), a novel local analgesic that proWJEFT B UIFSBQFVUJD CFOFGJU GPS VQ UP IPVST by reducing pain and decreasing opioids, may provide a new platform for an opioidsparing multimodal strategy. According to the Joint Commission in a new Alert dated "VH VTF PG BO JOEJWJEVBMJ[FE NVMtimodal plan to manage postsurgical pain is recommended, of which the best approach may be to start with a non-narcotic.
Conclusion Pain management in the inpatient and outpatient surgical settings is an important clinical area for health care providers, patients, insurance companies, and society as a whole. Effective postsurgical pain management can potentially have positive patient and economic implications including affecting HCAHPS outcomes. The Joint Commission strongly advocates the use of a multimodal approach to postsurgical pain management. A multimodal approach including local pain management at the surgical site, along with acetaminophen, and NSAIDs, may serve as the cornerstone of a pain management technique that reduces the need for opioid medications in the postsurgical recovery period.4 The advances in novel drug development and new formulations of local analgesics can further enhance the effectiveness of multimodal therapy for postsurgical pain management. EXPAREL is indicated for single-dose administration into the surgical site to produce postsurgical analgesia. The maximum dose of EXPAREL should not exceed 266 mg (20 mL, 1.3%) of undiluted drug. The approval of EXPAREL was based on two pivotal clinical trials that demonstrated the efficacy and safety of EXPAREL in excisional hemorrhoidectomy (soft tissue model) and bunionectomy (orthopedic model). Dosing and administration in other surgical models will be influenced by the methodology used to administer the local anesthetic, as well as, individual patient considerations, which need to be determined by individual prescribers. The accompanying case studies represent the individual clinical experience of Drs. Stephen M. Cohen and Jennifer Ayscue, and are not to be construed as prescriptive dosing and administration recommendations for how to treat similar patients. Please see brief summary of Prescribing Information on the following page.
References Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg
Outpatient Case Study: A 92-Year-Old Man Undergoes a Hemorrhoidectomy Jennifer Ayscue, MD, FACS, FASCRS Assistant Professor, Department of Surgery Georgetown University School of Medicine Washington Hospital Center Washington, DC
T
Discussion
his case will describe a method of using multimodal postsurgical analgesia in an ambulatory setting. The patient has B NPOUI IJTUPSZ PG BMNPTU EBJMZ SFDUBM CMFFEJOH XJUI CPXFM movements sometimes filling the toilet. He has undergone several transfusions for anemia and evaluation revealed bleeding hemorrhoids. He has mild Alzheimerâ&#x20AC;&#x2122;s disease but is otherwise relatively healthy. A hemorrhoidectomy was requested to control the bleeding. Although the main goal was to definitively control the bleeding, the patient was very nervous about pain control after surgery. Because the patient had mild Alzheimerâ&#x20AC;&#x2122;s disease and because opioids had historically caused pronounced altered mental clarity in this patient, there was concern on the part of the patient, as well as his family, about taking opioids. It was clear that this patient could benefit from a multimodal approach to manage his postsurgical pain. Prior to starting the procedure and under moderate sedaUJPO DD PG CVQJWBDBJOF IZESPDIMPSJEF BOE FQJOFQISJOF XBT JOKFDUFE JO UIF JOUFSTQIJODUFSJD TQBDF and subcutaneous tissue circumferentially, laterally near the ischial spines, and bilaterally in the direction of the pudendal nerves. At the conclusion of the procedure, one vial containJOH NH DD PG &91"3&1 XBT JOKFDUFE VTJOH B HBVHF needle in the same distribution as was previously described. In UIF QJWPUBM TPGU UJTTVF USJBM B EPTF PG NH PG &91"3&1 POF N- WJBM XBT EJMVUFE XJUI N- PG QSFTFSWBUJWF GSFF OPSNBM saline. Based on the dosing in this trial, the older age and overBMM IFBMUI PG UIF QBUJFOU BOE NZ TUBOEBSE QSPUPDPM PG DD UP DD PG CVQJWBDBJOF IZESPDIMPSJEF XJUI FQJOFQISJOF * DIPTF B TJNJMBS EPTF GPS UIJT DBTF EJMVUJOH UIF NH DD WJBM XJUI DD PG QSFTFSWBUJWF GSFF OPSNBM TBMJOF GPS B UPUBM WPMVNF PG DD In the postanesthesia care unit, the patient quickly awakFOFE GSPN BOFTUIFTJB BOE SFQPSUFE PVU PG PO B QBJO TDBMF Because he was able to void urine early, he was discharged quickly and without issue. He was released home with prescripUJPOT GPS IZESPDPEPOF BDFUBNJOPQIFO UBCMFUT PSBMMZ FWFSZ 6 hours as needed) and lidocaine 5% ointment (to be used as OFFEFE )F XBT JOTUSVDUFE UP UBLF EPDVTBUF NH FWFSZ hours for constipation. The patient did not report any pain for approximately 48 IPVST )F SFQPSUFE UBLJOH BQQSPYJNBUFMZ UP IZESPDPEPOF
Hospital Care Quality Information from the Consumer Perspective. http://www.hcahpsonline.org. "DDFTTFE "VHVTU 3. Carr DB, Goudas LC. Acute pain. Lancet. 4. American Society of Anesthesiologists. Practice guidelines for acute pain management in the perioperative setting. An updated report by the American Society of Anesthesiologists task force on acute pain management. Anesthesiology 5. Voscopoulos C, Lema M. When does acute pain become chronic? Br J Anaesth. TVQQM i69-i85. 6. Loftus RW, Yeager MP, Clark JA, et al. Intraoperative ketamine reduces perioperative opiate consumption in opiate-dependent patients with chronic back pain undergoing back surgery. Anesthesiology 7. Zhao SZ, Chung F, Hanna DB, Raymundo AL, Cheung RY, Chen C. Dose-response relationship between
acetaminophen tablets per day for several days and then switched to standard acetaminophen until stopping all pain NFEJDBUJPOT CZ QPTUPQFSBUJWF EBZ 5IF QBUJFOU IBE OP QPTUoperative complications and reported feeling well, without QBJO BU NPOUI QPTUPQFSBUJWFMZ Historically, postsurgical pain control options have consisted mainly of systemic pain medications (primarily opioids), lidocaine 5% ointment, and bupivacaine hydrochloride by elastomeric infusion pump at the site of pain. Opioids are well known to cause several ORAEs including nausea, constipation, altered mental status, and urinary retention. Elastomeric pumps work well when implanted, but they may be difficult to manage during activities of daily living and may have risks associated with catheters and delivery rates. EXPAREL, an agent that combines the benefits of a wellknown medication, bupivacaine, with a proven delivery technology and the convenience of a simple intraoperative JOKFDUJPO DBO QSPWJEF TJHOJGJDBOU QBJO DPOUSPM GPS VQ UP hours. While individual results will vary, this particular case demonstrates how incorporating EXPAREL in a multimodal strategy can delay and diminish the need for systemic opioid therapy. A multimodal approach to postsurgical pain management can be particularly effective in the ambulatory setting.
Commentary by Tong-Joo Gan, MD, MHS Outpatient surgery has increased tremendously during the past decade and it is estimated that more than PG BMM TVSHJDBM QSPDFEVSFT JO UIF 6OJUFE 4UBUFT BSF performed as day surgery. This percentage is estimated to increase further. One of the major challenges in day surgery is providing adequate pain control after discharge from an outpatient facility. Multimodal analgesic techniques are recommended and have been shown to be superior to opioid-based analgesia.8 Appropriate analgesic selection with minimal side effects is important and especially relevant in an elderly patient population, as illustrated in this case study. Acetaminophen and EXPAREL may decrease the use of opioids and therefore opioid-related side effects when used in appropriate doses. This approach may be particularly suited for elderly patients undergoing painful surgical procedures in an outpatient setting. In patients with decreased renal function, care should be taken with dose selection.
opioid use and adverse effects after ambulatory surgery. J Pain Symptom Manage 8. White PF, Kehlet H, Neal JM, et al. The role of the anesthesiologist in fast-track surgery: from multimodal analgesia to perioperative medical care. Anesth Analg. 9. Beauregard L, Pomp A, Choiniere M. Severity and impact of pain after day-surgery. Can J Anaesth. Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum The Joint Commission Sentinel Event Alert. Safe use of opioids in hospitals. http://www.pwrnewmedia. DPN KPJOU@DPNNJTTJPO PQJPJET EPXOMPBET 4&"@ @PQJPJET QEG "DDFTTFE "VHVTU
Best infiltration practices. Local analgesic infiltration techniques for abdominal surgery. The Best Infiltration Practices Working Group. http:// FHVJEFMJOF HVJEFMJOFDFOUSBM DPN J "DDFTTFE "VHVTU $%$ "NCVMBUPSZ TVSHFSZ JO UIF 6OJUFE 4UBUFT IUUQ XXX DED HPW ODIT EBUB OITS OITS QEG "DDFTTFE "VHVTU
Disclosures Dr. Ayscue has received honorarium from Pacira Pharmaceuticals, Inc. Dr. Cohen is a consultant and on the speakersâ&#x20AC;&#x2122; bureau for Baxter, Covidien, novoGI, Pacira Pharmaceuticals, Inc, and Sanofi. Dr. Cohen has received honorarium from Pacira Pharmaceuticals, Inc. Dr. Gan has received research funding from AcelRx Pharmaceuticals, Inc, Covidien, Cumberland Pharmaceuticals Inc, Fresenius Kabi, and Pacira Pharmaceuticals, Inc. He has received honorarium from Baxter and Cheetah Medical, Inc.
(&/&3"- 463(&3: /&84 t 0$50#&3
##
Disclaimer: This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, Pacira Pharmaceuticals, Inc., and the authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature. $PQZSJHIU ÂŞ .D.BIPO 1VCMJTIJOH 8FTU UI 4USFFU /FX :PSL : /: 1SJOUFE JO UIF 64" "MM SJHIUT SFTFSWFE JODMVEJOH UIF SJHIU PG SFQSPEVDUJPO JO XIPMF PS JO QBSU JO BOZ GPSN
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10
In the News
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2012
Interior Vena Cava Filters Are Risk in Bariatric Surgery, Study Shows Some Experts Argue Filters Still Useful in Some Patients B Y C HRISTINA F RANGOU SAN DIEGO—Inferior vena cava (IVC) filters should be discouraged in bariatric surgery patients because the risks associated with filters exceed the benefits, surgeons reported at the 29th annual meeting of the American Society for
Metabolic and Bariatric Surgery. “What’s clear is that, in a large group of patients, there certainly is no benefit to the IVC filters and there may be harm as well,” said Jonathan F. Finks, MD, assistant professor of surgery, University of Michigan Health Systems, Ann Arbor. Dr. Finks presented the study on behalf of investigators, led by Nancy Birkmeyer, PhD, from the Center for Healthcare Outcomes and Policy and the University of Michigan, Ann Arbor.
In 1,018 patients who underwent preoperative IVC filter placement since 2006, the adjusted rate of venous thromboembolism (VTE) was 1.8%—4.5 times that for propensity-matched patients who did not have a filter (odds ratio [OR], 4.30; 95% confidence interval [CI], 1.55-11.9; P=0.005). Patients without a filter had a P VTE rate of 0.4%. Patients who received IVC filters also were at significantly higher risk for deep vein thrombosis (DVT) than matched
controls. DVT occurred in 1.2% of IVC patients compared with 0.3% of matched controls (OR, 4.66; 95% CI, 1.24-4.48; P=0.023). Pulmonary embolism (PE) rates were not significantly increased in patients with IVC filters; 0.7% developed a PE versus 0.2% among controls (OR, 3.42; 95% CI, 0.84-13.9; P=0.085). The findings come from an analysis of data collected by the Michigan Bariatric Surgery Collaborative, a
EX-AP-0020-201111 EX-AP-0039-201201
In the News
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2012
prospective statewide clinical registry that contains data on more than 30,000 bariatric procedures. In August 2010, investigators from this collaborative published a study that showed prophylactic IVC filters for gastric bypass surgery did not reduce the risk for PE for procedures completed between 2006 and 2008 (Ann ( Surgg 2010; 252:313-318). Also in August 2010, the FDA issued a warning about IVC filters based on more than 920 reports of adverse events, of which 328 involved device migration, 146 involved embolizations, 70 involved
perforation of the IVC and 56 involved filter fracture. “The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE subsides,” according to the FDA report. After the FDA’s warning, Dr. Finks and colleagues decided to update their study, this time focusing on outcomes for patients treated between 2006 and 2011. They hoped the study would include enough patients to demonstrate any potential harm, which their previous study was not powered to do.
‘The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE subsides.’ —FDA report In the new analysis, the study population consisted of 29,326 bariatric surgery patients from 32 hospitals, representing 95% of bariatric procedures performed in
postsurgical pain control for u s e d i v p to 7 pro e s 2 ho o d urs * e On
EXPAREL is the only single-dose local analgesic that… • Provides up to 72 hours1* of analgesia with • Reduced opioid requirements1† • Without the need for catheters or pumps
EXPAREL is a liposome formulation of bupivacaine indicated for administration into the surgical site to produce postsurgical analgesia.
Important Safety Information: EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting. *Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing bunionectomy or hemorrhoidectomy procedures; additional studies are underway to further demonstrate the safety and efficacy in other procedures. † The clinical benefit of the attendant decrease in opioid consumption was not demonstrated. Reference: 1. Gorfine SR, Onel E, Patou G, et al. Bupivacaine Extended-Release Liposome Injection for Prolonged Postsurgical Analgesia in Patients Undergoing Hemorrhoidectomy: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial. Dis Colon Rectum. Dec 2011;54(12):1552-1559.
Please see brief summary of Prescribing Information on back page. For more information, visit www.EXPAREL.com
the state. About 3.5% of patients underwent preoperative IVC filter placement. The investigators identified a propensity-matched cohort of 1,045 patients for comparison from the group of patients who did not receive filters. Of the patients in the filter group, 39% had previous VTE, as did 36% of matched controls. When compared with matched controls, IVC filter patients had higher rates of serious complications (5.7% vs. 3.7%; OR, 1.66; 95% CI, 1.07-2.57; P=0.022) P and statistically nonsignificant increases in mortality (0.7% vs. 0.2%; OR, 3.43; 95% CI, 0.70-16.9; P P=0.130), any complication (15.3% vs. 11%; OR, 1.32; 95% CI, 0.97-1.78; P P=0.075) and permanently disabling complications (1.1% vs. 0.5%; OR, 3.08; 95% CI, 0.98-9.66; P=0.054). P Seven patients who received IVC filters died over the study period. Of these, four had PEs and two had IVC thrombosis/occlusion. Other serious IVC filter-specific complications included IVC filter migration in two patients. About 40% of IVC filters were retrievable, 45% were permanent and 15% were unknown. Investigators could not detect any difference in rates of mortality or serious complications with the various filters. They noted a slight but nonsignificant trend toward higher VTE rates with retrievable filters. The study also demonstrated a marked drop in IVC filter use following the FDA warning. Between 2008 and 2011, the use of IVC filters in Michigan plummeted, dropping from 8% to less than 1% use in bariatric patients. “This really has changed my practice of care,” said Matthew Hutter, MD, assistant professor in surgery at Harvard Medical School in Boston, speaking after the study was presented. But IVC filters still may have a role for some bariatric patients, several surgeons said in the discussion after Dr. Finks’ presentation. John Kellum, MD, professor of surgery, Virginia Commonwealth University (VCU) in Richmond, said patients at his institution have benefited from IVC filters. “As a single center, we performed 175 prophylactic filters, mainly Greenfield filters. We found there were no deaths from pulmonary emboli in the filter group but there were several pulmonary emboli in the no-filter group.” Greenfield filters were initially recommended for obese hypoventilated patients, and these patients could still benefit from filters, said Harvey J. Sugerman, MD, emeritus professor of surgery at VCU, and editor-in-chief of Surgery for Obesity and Related Diseases. “I know that overall, patients didn’t benefit but there still may be some subgroups of patients who really could benefit from this.”
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Opinion
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2012
Thoughts on the 2012 Election and Beyond We asked physicians for their thoughts on the impact of the 2012 presidential election on health care. Here are two responses:
D
uring an interview in August 2012, President Obama reflected that a mistake he made during his first term was thinking “that this job was about getting the policy right. And that’s important. But the nature of this office is also to tell a story to the American people that gives them a sense of unity and purpose and optimism, especially during tough times.” Perhaps during a second term as president, when running for re-election is no longer a concern, Barack Obama will incorporate valuable feedback regarding the weakness of the Affordable Care Act to make necessary improvements to strengthen the law. After doing so, the president should have the wisdom to set policy aside for the moment, and take the time to listen to the frontline stories of patients and physicians that illuminate the central challenges with the healthcare system that the Affordable Care Act did not address, and highlight new challenges that emerged after passage of the law. The overarching intent should be for President Obama to unify the collective
intelligence, energy, and passion of dedicated physicians across America, to restore hope and inspire a new generation of leaders to solve the pressing healthcare needs of Americans. —John Maa, MD, assistant professor — of surgery, UCSF, member of the General Surgery News advisory board.
T
he most dramatic changes to practice during the next presidential term will be largely unaffected by the results of the election. The momentum behind the abandonment of fee-for-service practice is so strong in the purchaser community and insurance industry that, irrespective of a new administration’s Medicare policy, anesthesiologists will need to find our way in the global payment world as private health plans persist in this transition. The complexity of managing a capitated payment will drive some to employment by a health system; others will devise ingenious alternate arrangements to preserve practice autonomy. We will be making the argument for the value of our services more locally than before,
as our “transaction” will move from the health plan to our local care delivery organization. If Gov. Romney is elected, his ability to actually repeal the Affordable Care Act (ACA) will depend on the composition of the Senate. Even in the absence of majorities in both houses and an outright repeal, there are executive opportunities to derail implementation. Piecemeal interference could lead to poorrly managed implementation of the law with w resultant uncertainty and chaos. If reepeal is accomplished,, unless a viable rreplacement law is enacted—no smaall task as we learned in 2009— —the ranks of the uninsured will nott be substantially diminished. Forr those delivering anesthesia care too indigent communities, the relieef from coverage expansion will be missed. President Obam ma’s re-election will virtually guarantee that h the h law l remains on the books even if implementation funding is a battle. Hundreds of billions of cuts to providers in the ACA—not to mention the retention of the cuts to the sustainable growth rate for Medicare— will make expanding provider capacity to serve the newly covered a real challenge.
A Surgeon Soothsayer? Surgeon Daniel Jones, MD, on Mitt Romney and mandatory health care coverage in 2006: “The current system’s broken, we have to fix it, and this is a new idea that—if it works—may be a blessing for the country,” commented Daniel B. Jones, MD, Chief of Minimally Invasive Surgery at Beth Israel Deaconess Medical Center and an Associate Professor at Harvard Medical School, Boston. Bo “With 45 million people uninsureed in the United States, if Gov. [M Mitt] Romney gets this right, he neeeds to be running for president.” From: “Massach husetts Pilots Mandatory y Healthcare Coverage Plan,” G General Surgery News, Ju uly 2006.
One need only look as far as M d d to understand Medicaid d dh how underfunding leads to diminished access. While it’s true that some practices will offset these cuts with new coverage for the previously uninsured, many others will sustain the cuts without this benefit. —Alexander A. Hannenberg, MD Anesthesiologist in Newton, Mass.
In the News
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2012
GI Lymph Node Retrieval Falls Short of Recommended Guidelines Improvement Is Seen, But Not to Sufficient Level, Researchers Say B Y C HRISTINA F RANGOU SAN DIEGo—Surgeons today remove more lymph nodes than ever before during surgery for gastrointestinal (GI) cancer, but lymph node retrieval still falls far short of recommended guidelines for most types of cancers, according to a recent study. Overall, only colon and rectal cancer resections meet the lymph node dissection (LND) rates recommended by the American College of Surgeons and the National Comprehensive Cancer Network (NCCN), according to an analysis of the Surveillance, Epidemology and End Results (SEER) database. All other cancer types remain well below the recommendations for lymph node retrieval, with less than 50% of patients having an adequate dissection. “Lymph node dissection for cancer remains inadequate, even at the present time in the United States, although the number of dissected nodes is increasing in all cancer types,” said lead author Attila Dubecz, MD, a surgeon in the Department of General and Thoracic Surgery, Klinikum Nurnberg Nord in Nuremberg, Germany. The study was presented at the 53rd annual meeting of the Society for Surgery of the Alimentary Tract, a part of Digestive Disease Week 2012. Over the past decade, the NCCN, the American Joint Committee on Cancer (AJCC) and physician groups have targeted LND as a performance measure. These organizations maintain that if too few lymph nodes are retrieved, clinicians and patients lack sufficient information to make decisions about adjuvant chemotherapy. “There are skeptical voices about [LND] and its effect on overall survival, but its effect and its use on the prognosis and the need for adjuvant chemotherapy are undisputed,” said Dr. Dubecz. Dr. Dubecz and colleagues studied the rate of LND during surgery for GI cancer, using SEER data from 1998 to 2009. The investigators included all patients with potentially resectable GI cancer and compared the number of lymph nodes dissected to NCCN recommendations. Investigators defined adequate lymphadenectomy as removing at least 15 nodes in esophagus, stomach and pancreatic cancers and at least 12 nodes in colon, rectum and small bowel cancers. Over the study period, LND improved for all cancers. The median number of excised nodes rose from seven to 13 in esophageal cancer, nine to 12 in stomach
cancer, three to six for small bowel cancer, nine to 15 in colon cancer, eight to 13 in rectal cancer and seven to 11 in pancreatic cancer. Despite the improvements, for all cancer types other than colon cancer, less than 50% of patients received an adequate LND. About four in 10 patients with esophageal, pancreatic and gastric cancers had the recommended number of nodes dissected. By 2008, the percentage of patients
with adequate lymphadenectomy was 16.4% for esophagus, 37.4% for stomach, 31.4% for small intestine, 72.7% for colon, 58.2% for rectum and 49.9% for pancreas. Men, non-whites, patients aged 65 years or older, those undergoing surgical therapy earlier in the study period and living in areas with high poverty rates were significantly less likely to receive adequate lymphadenectomy (all P<0.0001). Thomas A. Aloia, MD, attending surgeon at The Methodist Hospital,
Houston, said the study highlights an important topic in the field of surgical oncology. “On one hand, the data suggest that we are making progress over time on this issue. Yet on the other, the 2009 data appear to be inadequate in terms of the recovery rates for lymph nodes.” He noted that the study has limitations because it was based on administrative data, and the statistical differences related to socioeconomic status are small and not likely to be clinically relevant.
SIGNIFICANTLY
REDUCES SSI Rate of Superf icial Incisional SSI Alexis® Wound Protector/Retractor
22.7% (15/66)
Standard Retractors
P = 0.004
14.6%
P = 0.02
(7/48)
79%
P = 0.0021
89%
RRR*
RRR*
8.1%
100% RRR*
(9/110)
1.6%
4.69%
(1/61)
(3/64)
Reid, et al. 1
0%
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Lee, et al. 2
For more information, please visit
Horiuchi, et al. 3
Scan to request a clinical study booklet
www.appliedmedical.com or call 800.282.2212
or contact from a representative.
Alexis O ®
WOUND PROTECTOR/RETRACTOR
©2012 Applied Medical, the Applied Medical logo and Alexis are U.S. registered trademarks of Applied Medical Resources Corporation. 1917AL0912
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In the News DEVICE TAX
jcontinued from page 1 not generally expected to pass the Senate or survive a threatened presidential veto, but the future of the medical device tax may be decided on Election Day. “The overall fate of health [care] reform will hinge on the results of the November election,” Paul N. Van de Water, PhD, senior fellow, Center on Budget and Policy Priorities (CBPP), in Washington, D.C., said in an interview. “If the Republicans take control of both the White House and Congress, there is a good chance they will
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2012
overturn health reform.” “The medical device tax is just bad policy,” Wanda Moebius, spokeswoman for AdvaMed, a medical device industry trade association in Washington, D.C., said in an interview. “It will have a very damaging effect on our industry’s ability to hire and advance medical innovation, and it does nothing to make health care more accessible.” The industry widely expects the tax to have a disproportionate effect on small to mid-sized companies. Because the tax equals 2.3% of total revenues, not profits, even a company that is not profitable or
has relatively low profits will have to pay. According to literature from the Medical Device Manufacturers Association (MDMA), another industry trade association, the medical device industry makes a profit of 3.4% on sales. Therefore, says MDMA, the tax of 2.3% could consume more than 65% of a typical company’s profits. But not everyone agrees. “That sounds like a pretty big exaggeration,” said Jeff Jonas, CFA, research analyst, Gabelli & Co., in Rye, N.Y, in an interview. “For large companies like Medtronic and Stryker, there may be a 3% or 4% hit to
profit. For small companies that are barely profitable, 65% could be correct.” To pay the tax, many companies are expected to cut jobs, although here again there is dispute. A study financed by AdvaMed found that more than 43,000 jobs in the medical device industry would be lost as a result of the new tax. “That seems on the high side,” said Mr. Jonas. “There will definitely be layoffs and other cost cuts, but I don’t have a total number for the industry.” But according to Stephen L. Ferguson, JD, chairman of the Board of Directors, Cook Group Inc., in Bloomington, Ind., “Forty-three thousand is a minimal figure. I think it’ll be much larger than that,” he said in an interview. “You have to put the tax in the context of the overall federal budget,” Dr. Van de Water said. “If the tax is repealed, the loss in tax revenues will have to be made up from another tax or from cutting federal spending. Either alternative would offset whatever effect on jobs the tax repeal would have. From a macroeconomic perspective, there wouldn’t be much of an effect on jobs at all.” Other criticisms of the tax concern global competitiveness and innovation. Mr. Ferguson said the main reason the tax should be repealed “is the industrial impact on one of the strongest industries we have, in terms of balance of payments and innovation.” Whether at the level of start-ups, growing companies like Cook, or very large companies, the tax, he said, “is driving jobs outside the United States.” Cook is already an example. Although not contemplating layoffs, the company has shelved plans to build five new manufacturing plants over five years in the Midwest. John Eckberg, director of media relations, Cook Group Inc., wrote by email, “that action is directly related to the imposition of the medical device tax.” Kem Hawkins, president of Cook Medical, said that as a result of the medical device tax, “we have plans to grow our production overseas; that is, our growth will be overseas but we have decided not to put our employees at risk. That is one of the benefits of being a private company: We can sacrifice a little of the bottom line to do the right thing.” The tax also will hurt innovation, said Mr. Ferguson. “If you take development outside the United States, venture capitalists will take the good ideas of inventors overseas.” Dr. Van de Water countered, “The argument on competitiveness is off base because the tax is carefully structured so it in no way disadvantages American firms. Both U.S. and foreign firms pay the tax on devices sold in this country—it’s evensteven. And it doesn’t apply to U.S. products sold overseas. “The tax will also have little effect on innovation in the medical device industry,”
In the News
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2012
He Said, She Said How the device tax will affect the medical device industry depends on whom you ask. ‘It will have a very damaging effect on our industry’s ability to hire and advance medical innovation, and it does nothing to make health care more accessible.’ —Wanda Moebius, spokeswoman for AdvaMed
‘If you take development outside the United States, venture capitalists will take the good ideas of inventors overseas.’ —Stephen L. Ferguson,
Dr. Maa voiced his views at the AdvaMed meeting in Washington, D.C., in 2010, where he said, “I believe that the medical device industry has been misunderstood in the crafting of the ACA. I think this is most clearly reflected in the imposition of a blunt, flat tax of medical devices.” In his interview with General Surgery News, he argued that a progressive tax would likely have been fairer, and that it might have been preferable to distribute the tax across the supply chain. Charles T. McHugh, MD, FACS, a retired general surgeon now in family practice in Baileyville, Me., commented
by email, “I find the arguments of device manufacturers that the tax will raise health care costs, reduce sales and push manufacturing out of the United States, thus costing jobs, not meritorious.” Although he acknowledged that the tax would probably raise the costs of medical devices, he said, “In some cases, the discouragement to purchase with its attendant pressure for hyper-utilization may be a very good and effective means to reduce overall health care costs.” Lev Melinyshyn knows firsthand what the cost of the medical device tax is. As president of a small medical device firm,
UreSil, LLC, in Skokie, Ill., he said in an interview, “We did go through a layoff, beginning at 52 employees and going down to 46. Six people were laid off. The layoff was predominantly related to preparation for the tax.” As for the effect on innovation, “before we spent on new product development. Now all technical resources are directed to cost reduction,” Mr. Melinyshyn said. “We’re quite concerned about the impact of the medical device tax. Based on future projected sales and actual net income of 2011, it will increase our tax by 26% of net income.”
JD, chairman of the Board of Directors, Cook Group Incorporated
‘The tax will also have little effect on innovation in the medical device industry. To the contrary, health reform may well spur medical device innovation by promoting more cost-effective ways of delivering care.’ —Paul N. Van de Water, PhD
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‘I find the arguments of device manufacturers that the tax will raise health care costs, reduce sales and push manufacturing out of the United States, thus costing jobs, not meritorious.’ —Charles T. McHugh, MD, retired general surgeon
Dr. Van de Water added. “To the contrary, health [care] reform may well spur medical device innovation by promoting more cost-effective ways of delivering care.” In a CBPP publication that he authored, Dr. Van de Water argued that health care reform, on balance, may benefit the medical device industry by extending coverage to 33 million more Americans, thus boosting demand for medical devices. Mr. Ferguson responded, “I have seen absolutely no evidence to support that statement. … Most of the new patients will be voluntarily uninsured, basically healthy people who don’t need medical devices. This doesn’t generate more device usage.” Asked for a general surgeon’s perspective, John Maa, MD, assistant professor, Division of General Surgery, University of California, San Francisco, said, “Most surgeons are likely unaware of this tax, but should educate themselves about [its] implication. … The general surgeon is interested in innovation. Front-line surgeons are often the first to design new devices. The way the tax is constructed, it may provide a barrier to introducing new technologies. It will likely stifle innovation.”
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In the News CLAIMS
jcontinued from page 1 academic group, 26% in a single-specialty group, 20% in solo practice, 13% in a multispecialty group and 3% in other settings. Half of surgeons surveyed reported that they had been sued at least once in their career; 18% had been sued once; 14% sued twice and the remainder more than twice. On average, 1.5 medical malpractice liability claims were filed against each responding surgeon. Article by Christina Frangou
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS S / OCTOBER 2012
But the majority of those claims were either dropped, dismissed or found in favor of the surgeon, according to the survey, a finding that supports the argument that many claims filed against doctors are unwarranted and do not reflect negligence. Of the 464 lawsuits involving 156 surgeons, 54% were dropped or dismissed, 27% were settled out of court, 19% went to trial or arbitration. In cases that went to trial, 72% were found in favor of the surgeon defendant. “Lawsuits occur most frequently when no negligence is found to have occurred,” said Dr. Dallal.
Claims that resulted in n a finding of non-negligence were more likely to be brought by plaintiffss who used experts without bariatric qu ualifications. In more than 90% of casess, the prime expert witness used to deetermine if the standards of bariatric surgery care were upheld was a bariatrric surgeon. But when the expert witnesss was not a bariatric surgeon, surgeons reported an 11-fold risk for going to triial. However, the use of so-called nonexxpert expert witnesses was not associated d with a ruling against the surgeon in a case going to trial.
AT A GLANCE 52% of bariatric surgeons report having been sued at some point in their careers, but the majority of the claims are dropped, dismissed or found in favor of the surgeon. When the expert witness was not a bariatric surgeon, surgeons reported an 11-fold risk for going to trial. Last spring, the ASMBS released a statement on the qualifications of expert witnesses in bariatric surgery medicolegal matters.
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Surgeons who were insured reported a mean yearly cost of malpractice insurance of $59,200 with the highest reported in the range of $300,000. Analysis showed that a surgeon’s risk for being sued increased independently the more years that he or she was in practice and the more cases he or she performed.
In the News
GENERALSURGEERYNEWS.COM M / GENERAL SURGERY NEWS / OCTOBER 2012
Expeert witneesses have been a conttentious iissue in the field of baariatric su urgery where, for the llast severral years, bariatric ssurgeons h have been calling forr a halt on n use of nonbariattric expertts in cases involvin ng weightt loss surgery. The isssue is com mmon across surgiccal speciallties but has been particu ularly con ntentious in bariatricc surgery. Last sprring, the ASMBS releaseed a statement on th he qualifications of eexpert witnesses in n bariatric surgery medicolegal matters. The ASMBS called for expert witnesses to hold the n sam me specialization aas the deffendant and said the expert witn ness in a bariatric surgery legal meeting should ho hold or have held privileges of thee specific procedure at issue when the alleeged malpractice occurred (Surg Obes Relaated Dis 2012;8:e9-e10). Experts cauttion that the survey results only reflect onee-fifth of eligible surgeons, who may not b be representative of bariatric surgeons th hroughout the country. Even so, so the findings provide a picture of the medicolegal climate for bariatric surgeons within the United States. Marina Kurian, MD, assistant professor of surgery, medical director, Program for Surgical Weight Loss, NYU School of Medicine, New York City, said she was not surprised by the study findings, but the results highlight the high rate of frivolous suits. â&#x20AC;&#x153;The suits take an emotional toll on the provider. Even when a surgeon knows he or she hasnâ&#x20AC;&#x2122;t done anything wrong, the language that is used in the complaints is such that itâ&#x20AC;&#x2122;s hard not to be disheartened. You go out there and you do your best every day and then you get a lawsuit for a complication that youâ&#x20AC;&#x2122;ve discussed with the patient already.â&#x20AC;? â&#x20AC;&#x153;Itâ&#x20AC;&#x2122;s critical to do whatever we can to cut down on frivolous lawsuits.â&#x20AC;? Some surgeons chose not to report their malpractice premiums or did not know the cost of their premiums. Those who were insured reported a mean yearly cost of malpractice insurance of $59,200 with the highest reported in the range of $300,000. The mean lifetime amount paid in lawsuits was $250,000, and the highest reported settlement reached $7 million. The total amount paid by the respondents was $70,871,998. Multivariate logistic regression analysis showed that a surgeonâ&#x20AC;&#x2122;s risk for being sued increased independently the more years that he or she was in practice
â&#x20AC;&#x2DC;The suits take an emotional toll on the provider. Even when a surgeon knows he or she hasnâ&#x20AC;&#x2122;t done anything wrong, the language that is used in the complaints is such that itâ&#x20AC;&#x2122;s hard not to be disheartened.â&#x20AC;&#x2122; â&#x20AC;&#x201D;Marina Kurian, MD
[odds ratio 1.03; P=0.03) and the more cases he or she performed. â&#x20AC;&#x153;In essence, our most experienced surgeons are the ones being sued the most,â&#x20AC;? said Dr. Dallal. The odds of having a lawsuit that resulted in monetary compensation independently increased with the number of years in practice, the number of lawsuits experienced, the type of practice and the lack of a bariatric surgery expert witness. The cost of malpractice insurance premiums was independently predicted by the amount paid in prior lawsuits
and the number of cases the surgeon performed, but not the number of negligent claims. Most lawsuits were filed about two years after the alleged injury, and one to two years may pass before the suit is resolved, the survey showed. Because it takes several years for lawsuits to pass, surgeons who have only been in practice for a few years are significantly less likely to report being sued.
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Expert Editorial Forum
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2012
Melanoma and Sentinel Lymph Node Biopsy Even With Level 1 Evidence, Controversies Surround the Technique in This Type of Cancer WRITTEN AND COMPLIED BY
R OSEMARY
F REI , MS C
S
entinel lymph node biopsy remains a controversial topic in the diagnosis and treatment of melanoma. The most significant landmark trial—the MSLT (Multicenter Selective Lymphadenectomy Trial)-I—made a stir in the oncology community when it demonstrated that wide excision of intermediate-thickness primary melanoma and sentinel lymph node biopsy (SLNB) followed immediately by completion lymphadenectomy (CL) produces
similar rates of melanoma-specific survival as wide excision and observation of regional lymph nodes with CL performed only if nodal relapse occurred (N Engl J Med d 2006;355:1307-1317). Additionally, the mean estimated five-year disease-free survival (DFS) rate was higher in the SLNB group. The investigators also reported that the five-year survival rate in patients with micrometastases found by SLNB was significantly higher than in observation patients who later developed clinically palpable nodal metastases.
Question
Do you feel MSLT-1 results clearly support routine SLNB in intermediate-thickness melanoma?
Matthew H. Kanzler, MD: MSLT1 was designed and appropriately powered to answer only one question: Does performing SLNB increase overall survival of melanoma patients compared with removing clinically detected LN if and when they appear during follow-up? The results do not support routine SLNB as a therapeutic procedure in intermediate-thickness melanoma. The fact that the authors completely failed to mention the primary outcome results in the abstract of the
A follow-up randomized trial, MSLT-II, is under way and may help to solve some of the remaining questions (http://clinicaltrials.gov/ct2/show/NCT00297895). The investigators will focus on whether completion lymph node dissection (CLND) should be performed immediately in patients with intermediate-thickness melanoma who have positive nodes on SLNB, or whether patients should first be observed and undergo CLND only if and when nodal ultrasound detects more positive nodes. The primary outcome is
paper, but instead chose to emphasize the results of inappropriate subset analyses of MSLT-1 data, clearly shows the authors’ bias regarding this procedure. Subsequent publications have shown that the small improvements in DFS found on subset analyses were in fact entirely attributable to lead-time bias and lack of appropriate handling of both false-positive and falsenegative patients in the study.
Daniel G. Coit, MD: MSLT-1 is probably the highest-quality data defining the role of SLNB in melanoma. I don’t care how the investigators analyzed the results, I care that the trial has provided top-quality data: The interpretation is up to the readers, clinicians and patients. And it very clearly confirmed that sentinel node status is the most important prognostic factor in
10-year melanoma-specific survival, with secondary outcomes including 10-year DFS and 10-year recurrence rate. However, the first set of interim results are not expected until at least 2017 and the full 10-year results won’t be reported until at least 2024. In the meantime, General Surgery News s asked experts from across the country how they use this controversial procedure in their patients based on the currently available evidence. Once you’ve read their opinions, we’d like to hear yours. You can email editor Kevin Horty at khorty@ mcmahonmed.com.
intermediate-thickness melanoma. This is what has kept SLNB in the forefront of management of patients with intermediate-thickness melanoma. The other thing it showed us is that it is probable that positive sentinel nodes will evolve into clinical disease. Additionally, it said that SLNB detects about 25% of the nodes that will develop into regional disease—that is, the false-negative rate is about 25%. And also, if you take all comers, SLNB is a staging procedure and not clearly a treatment, because the study could not demonstrate an improvement in melanoma-specific survival. The distant DFS curve is an extremely important curve that has never been shown. The point that people really struggle with is that the study didn’t show an improvement in melanoma-specific survival even though DFS and nodal recurrence did improve. I believe it’s because the study was under-powered to show a statistically significant difference in melanoma-specific survival. see MELANOMA page 22
P ARTICIPANTS Daniel G. Coit, MD, is professor of surgery at Weill Cornell Medical College, attending surgeon at Memorial Sloan-Kettering Cancer Center, New York City, and chair of the National Comprehensive Cancer Network (NCCN) Melanoma Guidelines Panel.
Martin S. Karpeh Jr., MD, is chairman of the Department of Surgery at Beth Israel Medical Center, and director of surgical oncology and associate director, Continuum Cancer Centers of New York.
Anna Pavlick, MD, is associate professor, co-director of the Melanoma Program and assistant director for Clinical Research Education in the Departments of Medicine and Dermatology at the NYU Cancer Institute, New York City.
Matthew H. Kanzler, MD, is clinical professor in the Department of Dermatology at Stanford University’s School of Medicine, in California.
Stanley Leong, MD, is president of the Sentinel Node Oncology Foundation, chief of cutaneous oncology and associate director of the Center for Melanoma Research and Treatment, California Pacific Medical Center, and professor emeritus of surgery at the University of California, San Francisco School of Medicine.
Jennifer A. Wargo, MD, is assistant surgeon in the Division of Surgical Oncology at Massachusetts General Hospital and an instructor of surgery at Harvard Medical School, Boston.
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Expert Editorial Forum
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2012
MELANOMA
Question
jcontinued from page 20 Stanley Leong, MD: I agree that the study showed SLN status is irrefutable as a prognostic indicator. And for that reason SLNB is the standard of staging in melanoma. People who criticize MSLT-1 do not even do SLNB. Nothing is perfect, for every study there are always unanswered questions, but the study provided level I evidence that sentinel node status is a very strong prognostic indicator.
Jennifer A. Wargo, MD: I do believe MSLT-1 supports the use of SLNB in intermediate-thickness melanoma for prognostic reasons and for durable regional control, but I do not believe it provides evidence of any survival benefit. In MSLT-1 there were patients in the SLNB group with microscopic deposits of melanoma that would be unlikely to progress to a palpable nodal recurrence, and these patients were compared with patients who presented with bulky nodal metastases. Additionally, the groups were selected for comparison after randomization, making statistical considerations invalid. Furthermore, the authors did not include patients in the analysis who had a false-negative SLNB result and later presented with nodal recurrence.
care in melanoma in the United States. SLNB clearly has prognostic benefit as well as potential benefit with durable regional control.
Should SLNB be the standard of care in melanoma in the United States?
Dr. Kanzler: From a therapeutic perspective, the answer is fairly clear: There is no role for SLNB in the standard care of patients with melanoma. And although it clearly has been shown that as a single prognostic factor, the status of the SLN is the strongest predictor of outcomes, the procedure is expensive, invasive and leads to complications in 10% of patients undergoing the procedure. What has not been investigated to date is whether or not a combination of other important noninvasive prognostic factors would result in prognostic information comparable to SLNB data. In fact, predicted survival rates can currently be obtained by inputting specific known prognostic
data for a particular patient into a large computer database containing known outcomes for patients with similar demographic information (http://cancer.lifemath.net/melanoma/outcome/). The accuracy of this mathematical database has been confirmed with data on hundreds of thousands of patients in Surveillance, Epidemiology and End Results (SEER) national data sets. Use of such a database can provide excellent prognostic information to melanoma patients and should be offered to patients as an alternative to invasive SLNB procedures.
Dr. Coit: I can’t answer that question because “standard of care” is a legal term. I think it’s more appropriate to say that for patients with invasive melanoma, you should have a discussion about the pros and cons of SLNB. The NCCN guidelines include phrases like “discuss SLNB” and “offer SLNB,” but nowhere is SLNB mandated. Because the information gleaned from it is primarily prognostic, and I don’t think you can mandate a prognostic test, it depends on whether the patient wants the information.
Dr. Wargo: As of 2012, SLNB should be offered as standard of
‘I do not believe all disease detected is clinically significant, especially micromets.’ —Anna Pavlick, MD
Question
Is all disease detected by SLNB, including micrometastases, clinically relevant?
Dr. Coit: It clearly is. The patients with even micrometastases in their lymph nodes do worse than patients with negative lymph nodes. That’s well documented. And that’s the basis of the American Joint Committee on Cancer (AJCC) staging—that even isolated tumor cells in a lymph node are clinically significant. It’s not as clinically significant as macro disease, but when it is actionable is a different question.
Dr. Leong: We know that cancer is an aggressive disease. We published a paper a year ago showing that different levels of tumor burden in melanoma SLNs are associated with different levels of survival. So that confirms it’s a spectrum, and hence early diagnosis and early eradication of growing cells in the SLN are intuitively beneficial. The only problem is we can’t demonstrate yet that they’re therapeutically beneficial.
‘It clearly is. The patients with even micrometastases in their lymph nodes do worse than patients with negative lymph nodes.’
Anna Pavlick, MD: I do not believe all disease detected is clinically significant, especially micromets. The amount of disease and location of the disease is more clinically meaningful. Many retrospective trials in the past five years have tried to answer that question and most of the data suggest that the amount and location are the most clinically relevant.
—Daniel G. Coit, MD
Dr. Wargo: I disagree that all disease detected by SLNB including micrometastases is clinically significant. There is clearly heterogeneity within stage III patients that contributes to the widely variable survival rates seen in this group. At one extreme are patients with a single melanoma cell identified within one sentinel node and at the other are patients who present with bulky nodal metastases. Based on survival rates, it is fairly clear that there are patients with minimal microscopic disease who will never have a recurrence.
Dr. Kanzler: MSLT-1 authors imply that all microscopically involved nodes will progress to macroscopic disease. If such an assumption were correct, 19.4% of the patients randomized to the SLNB intervention arm of the study would have been expected to develop clinically palpable nodes by the end of the study—that is, the sum of the 16% of patients with positive SLNB results plus the 3.4% of patients who initially had a negative SLNB result but who later developed nodal disease during follow-up. This incidence
is 24% higher than the actual incidence of 15.6% found during follow-up for patients assigned to the observation arm. The discrepancy can only be explained if one-fourth of patients with positive sentinel nodes in the SLNB arm would never have developed palpable nodes if followed by observation.
Dr. Karpeh: My preference is to perform SLNB in patients with intermediate-thickness melanomas or those with thin melanomas between 0.75 and 1 mm that show evidence of ulceration or increased mitotic rate. There is as high as a 10% chance off having positive nodes in that subgroup of thin melanomas and I do recommend SLN mapping. The morbidity is fairly low and the information gained is clearly prognostic and may be helpful as new therapies for melanoma are developed. Having said that, I feel each patient has to be counseled individually and that comorbidities, age and the patients’ informed decision also factor heavily into making the final decision.
see MELANOMA page 22
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Expert Editorial Forum Question
Under what conditions should clinicians counsel patients that it’s advisable to go ahead with SLNB?
Dr. Pavlick: Patients need to be educated about the negative risk factors associated with melanoma, the percentage of risks such as infection and lymphedema versus benefit of this procedure and how this procedure would increase the patients’ access to adjuvant clinical trials. There should be an informed decision made by the patient and his or her melanoma team after all of the pros and cons have been discussed.
Dr. Coit: Probably the single most controversial issue in SLNB is where the cutoff of probability of having a positive SLN [is] for going ahead with SLNB. Right now it seems to be somewhere between 5% and 10%, but where it is in that spectrum depends enormously on a number of factors, including patient age. In an editorial we wrote for the
Question
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2012
Annals of Surgical Oncology—and the NCCN guidelines—SLNB is generally not recommended for patients with melanoma under 0.75 mm in thickness. For many patients with a thickness of 0.75 to 1 mm, SLNB should be discussed and offered, and most patients with melanoma greater than 1 mm thick will end up having SLNB because the probability of positive sentinel nodes is significantly higher in this group.
Dr. Kanzler: Since publication of the MSLT-1 data, several physicians have advocated including patients with increasingly thinner melanomas into the appropriate candidate pool, including patients with melanomas thinner than 1 mm if they are found to have other negative prognostic characteristics such as increased mitotic rates. This has been done despite the lack of evidence that
‘The fact that the authors completely failed to mention the primary outcome results in the abstract of the paper, but instead chose to emphasize the results of inappropriate subset analyses of MSLT-1 data, clearly shows the authors’ bias regarding this procedure.’ —Matthew H. Kanzler, MD SLNB has clinically significant prognostic benefits in these groups of people. A recent meta-analysis of 3,651 patients enrolled in 34 studies involving patients with melanomas of no more than 1 mm was performed. The SN positivity rate in these patients was only 5.6%, well below the cutoff suggested by an expert panel headed by Charles Balch, MD, from Johns Hopkins in Baltimore, who suggested that SLNB should be discussed with patients whose risk for harboring clinically occult nodal disease is 10% or greater. More importantly, analysis of survival data from these patients with thin melanomas showed an equal number of melanoma-related
Should SLNB plus completion lymphadenectomy of biopsy-positive patients be the standard of care in melanoma in the United States?
Dr. Kanzler: No. A recent 16-center comparative study involving 298 melanoma patients with positive SLNB found that patients had similar survival rates whether a CL was performed immediately after SLNB or was delayed until clinically palpable nodes developed. Thus, while the SLNB does provide prognostic information, to date there is no evidence that performing a CL of biopsy-proven SLNs improves survival. Additionally, although the SLNB procedure is associated with only [a] 10% complication [rate], adding a CL procedure increases the complication rate to 37%, and these complications are typically much more significant, including permanent lymphedema. Until MSLT-II is completed, the best data available to date shows that lymphadenectomies in the absence of palpable disease—either with or without SNB procedures—do not improve the survival of melanoma patients, and should be avoided outside of the MSLTII setting.
Dr. Coit: Increasingly, as patients with positive sentinel nodes hear this discussion, they are choosing not to have a CLND. It becomes a patient choice, and right now we’re in a bit of a conundrum. We have enormous experience with CLND, so that’s our standard recommendation for any patients with positive sentinel nodes including micromets. The problem is it’s a morbid procedure and we don’t know whether it makes any difference. So we are very much encouraging patients with positive sentinel nodes to enter into MSLT-II, because it will be the holy grail of this question.
Dr. Pavlick: SLNB and CL of biopsy-positive patients should not be the standard of care anywhere. Clinical judgment is vital in helping patients make that decision. I believe the extent of tumor within the SLNB and its location must play a role in this decision making.
Dr. Wargo: As of 2012, CL following a positive SLNB should be discussed with and offered as standard of care in melanoma in the United States. However, this clearly has less strength than the arguments made for SLNB alone. The majority of patients will not have an additional positive node, and will be subjected to potential morbidity of a CL. The key in the future will be to determine who is most likely to benefit from CL and to do it selectively for high-risk patients. In addition, as we get better adjuvant therapy and biomarker data, the role of CL is likely to diminish significantly. The results of MSLT-II should be helpful in guiding us.
‘From a therapeutic perspective, the answer is fairly clear: There is no role for SLNB in the standard care of melanoma patients.’ —Matthew H. Kanzler, MD
deaths in the SNB-positive and SNBnegative groups, making the prognostic utility of this procedure doubtful in this group. These patients all had at least one additional risk factor, including ulceration, regression or invasion to Clark level 4 or 5. Also, the utility of SLNB in patients under age 20 and over age 60 years has been questioned as it appears that the accuracy of predicting outcomes in these patients by SLNB status is poor— for example, young patients have higher rates of SLNB positivity yet excellent prognosis, whereas elderly patients, whose prognosis is poorer, have a low rate of SLNB positivity.
Dr. Leong: I do support CL. Because prognostically you can identify the patients who would do much worse if their CLND is positive. As a surgeon, it is critical that we intervene in the early stages, before the disease spreads from the sentinel nodes to nonsentinel nodes and then beyond.
Dr. Karpeh: I think it should be presented to patients as a common practice that will probably benefit 16% to 20% of patients. The fact that MLST-1 patients undergoing delayed CL had a greater volume of disease than those having early CL for positive SLNB is further evidence that the residual disease does progress over time. The argument against doing the early CL is that there is no survival benefit, but the study was not powered to answer the question of survival benefit in the subset of SLNB-positive patients. This question is being addressed in MSLT-II and I think all patients should be encouraged to enter the trial. My practice is to discuss all the pros and cons of CL with my patients but I do recommend CL in the subset of patients with H&E [hematoxylin and eosin] stain– positive sentinel nodes since we continue to struggle with successfully treating recurrent disease. However, in patients who have immunohistochemistry-positive sentinel nodes only, the data suggests that CL may be over-treatment because the vast majority of the residual nodes are negative.
Daniel G. Coit, MD, Matthew H. Kanzler, MD, Martin S. Karpeh Jr., MD, Stanley Leong, MD, Anna Pavlick, MD, and Jennifer A. Wargo, MD, each report that they have no relevant disclosures.
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In the News
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2012
The Top Breast Cancer Papers of 2011: A Surgeon’s Perspective 1. B Y M ONICA J. S MITH
PHOENIX—For the past nine consecutive years, Helen Pass, MD, assistant professor of clinical surgery at Columbia University, New York City, co-director of the Women’s Breast Center and chief of breast surgery at The Stamford Hospital, in Stamford, Conn., has prepared for the annual American Society of Breast Surgeons
meeting by combing the literature for what she considers the best breast cancer papers of the previous year—papers that are landmark studies, have practice-changing implications or elicit comments and questions from patients. In her 2011 search, Dr. Pass found more than 16,000 English-language studies, and highlighted or mentioned 20 of them. Here is a summary of her presentation.
Axillary Dissection vs No Axillary Dissection in Women With Invasive Breast Cancer and Sentinel Node Metastasis (Guiliano A et al. JAMA 2011;305:569-575) The Z0011 trial sought to determine whether completion axillary lymph node dissection (CALND) is necessary in patients with positive sentinel lymph nodes (SLN). The trial included 891 women with breast cancer (T ≤5 cm), clinically negative ALN and
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pathologically proven metastatic disease. Patients were ineligible if they had three or more positive lymph nodes (LN), if the LNs were matted at presentation or if the patients received neoadjuvant therapy. At five years, overall survival (OS) and disease-free survival were about the same whether patients underwent SLND or CALND. The researchers concluded that in patients with limited SLN metastatic disease, one to two positive SLN, who are treated with breast-conserving therapy (BCT) and receive systemic therapy, SLND alone was not inferior to ALND. They also suggested that SLN micromets found by immunohistochemical staining are probably insignificant and that immunohistochemical staining of SLND may be unnecessary.
Dr. Pass: It is not clear if SLND alone would be sufficient for patients with three or more positive nodes, those with clinically evident or matted nodes, those treated with mastectomy, those who undergo partial breast irradiation and those who decline systemic therapy. Also, longer follow-up might skew the results. Nevertheless, patients who have only one to two involved nodes, who are receiving BCT with whole breast radiation and appropriate systemic treatment do not need to be subjected to CALND. Of all the studies I’m going to discuss, this one is the most practice changing. It’s hard to get away from doing immunohistochemical routinely and it’s hard to omit doing completion dissection, but I think the data are pretty robust in appropriately selected patients.
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Oncologic Safety of Breast Conserving Surgery After Tumor Downsizing by Neoadjuvant Therapy: A Retrospective Single Centre Cohort Study (Fitzal F et al. Breast Cancer Res Treatt 2011;127:121-128) A big concern in breast cancer care is how much surgical treatment patients receiving neoadjuvant therapy require. This retrospective review, with a median follow-up of about five years, evaluated 308 patients who received neoadjuvant therapy and were downstaged from mastectomy to BCT. They found local recurrence–free survival and OS of 81% and 92% of patients who were downstaged from mastectomy to BCT, compared with 91% and 72%, respectively, of patients who were not downstaged. The difference in OS persisted even after the data were censored for nonresponders. Favorable prognostic factors included the ability to have BCT, negative nodes and low- to
In the News
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2012
medium-grade tumors; patients who fared the worst were nonresponders who received BCT. The researchers concluded that BCT is oncologically safe after tumor downstaging by neoadjuvant chemotherapy.
Dr. Pass: We have to remember there has been no prospective randomized study to date that demonstrates a survival advantage with neoadjuvant treatment. Nonetheless, neoadjuvant chemotherapy can successfully convert patients to candidates for BCT; it can give you information about tumor biology; it is always relevant on the clinical trial; and if response occurs, it is safe.
3.
Accuracy of Sentinel Lymph Node Biopsy After Neo-Adjuvant Chemotherapy in Patients With Locally Advanced Breast Cancer and Clinically Positive Axillary Nodes (Canavese G et al. Eur J Surg Oncoll 2011;37:688-694) Another question that arises in the context of neoadjuvant chemotherapy is whether sentinel lymph node biopsy (SLNBx) is feasible and accurate in patients who undergo neoadjuvant therapy. In this study, researchers compared the status of the SLN with that of the ALN in 64 consecutive patients who received neoadjuvant chemotherapy and underwent SLNBx followed by CALND. Their identification rate was 94%, with 37 of 60 patients (61.7%) having at least one positive SLN, and two of 23 patients with negative SLN having positive ALNs. There was a false-negative rate of 5%, a negative predictive value of 91% and an overall accuracy of 97%. The researchers concluded that SLNBx can be done in patients who receive neoadjuvant chemotherapy.
Dr. Pass: We know that neoadjuvant therapy successfully eradicates disease in about 40% of patients with clinically positive nodes, so in those patients it would be nice to avoid a completion dissection. These are the patients who really benefit from presentation at a multidisciplinary tumor board and establishing a treatment plan prospectively, so that every treating physician knows exactly how he or she is going to incorporate the findings into treatment decisions.
4.
Comparison of Treatment Outcome Between Breast-Conservation Surgery With Radiation and Total Mastectomy Without Radiation In Patients With One to Three Positive Axillary Lymph Nodes (Kim S et al. Int J Radiat Oncol Biol Phys 2011;80:1446-1452) In this retrospective review, researchers compared BCT and mastectomy
without locoregional radiotherapy in 125 and 365 patients, respectively, all of whom had one to three positive ALN. At a median follow-up of 10 years, OS was significantly better in patients who underwent BCT. The researchers concluded that adjuvant locoregional radiotherapy reduced local recurrence, distant recurrence and mortality in patients with one to three positive nodes, and suggested expanding the indications to include mastectomy patients with one to three positive nodes.
Dr. Pass: The cutoff points in
staging are arbitrary—5 cm is bad, 4.8 cm is OK; that doesn’t really speak to biology. I’ve started to make sure all LNpositive patients who have a mastectomy get referral to radiation oncologists for a discussion of the risks and benefits of post-mastectomy radiation. This also changes recommendations for immediate reconstruction for these patients; you may change your sequencing based on the likelihood that locoregional radiotherapy will be needed.
5.
Increased Risk of Locoregional Recurrence for Women With
T1-2N0 Triple-Negative Breast Cancer Treated With Modified Radical Mastectomy Without Adjuvant Radiation Therapy Compared With BreastConserving Therapy (Abdulkarim B et al. J Clin Oncoll 2011;29:2852-2858) In this retrospective review, researchers compared local recurrence–free survival in women with T1 and T2 triple-negative breast cancer (TNBC) who underwent BCT, mastectomy or mastectomy with radiation. They found a local recurrence–free survival rate of 94% in patients who had BCT, 85% in see BREAST CANCER page 32
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28
Surgeons’ Lounge
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2012
Dear Readers, Welcome W l to the h O October b issue i off Th The S Surgeons’’ Lounge. L This issue Thi i feaf tures Dr. Cassann Blake, MPH, FACS, head, Section of Surgical Breast Oncology, Cleveland Clinic Florida, Weston, who discusses the case of a large, malodorous, fungating right breast mass. And, back by popular demand, we invite you to take the Surgeon’s Challenge! We greatly value our readers’ opinions and encourage all feedback. Sincerely, Samuel Szomstein, MD, FACS Editor, The Surgeons’ Lounge Szomsts@ccf.org
Question for Dr. Cassan Blake
Dr. Szomstein n is associate director, Bariatric Institute, Section of Minimally Invasive Surgery, Department of General and Vascular Surgery, Cleveland Clinic Florida, Weston.
Dr. Blake’s
Reply
From Hira Ahmad, MD, PGY1 surgery Cleveland Clinic Florida, Weston
68-year-old woman presented to the emergency room with a large, malodorous, fungating right breast mass (Figure). She was informed she had an inflammatory breast cancer, or a recurrence, and was referred to the breast clinic for an appointment the following day. The patient described the mass as having the initial appearance of an insect or spider bite and progressing over a three-month period. Her history is significant for a diagnosis of a stage 1 ovarian cancer in 1995 and a stage 1 left breast invasive ductal carcinoma in 2004. She underwent a lumpectomy and a sentinel lymph node biopsy followed by radiation therapy and anastrozole for five years. She also was diagnosed with a right breast ductal carcinoma in situ in 2005. A comprehensive BRCA A test did not identify a known mutation and she proceeded to have a lumpectomy and a sentinel lymph node biopsy. This was then followed by radiation therapy for her stage 0 breast cancer. On physical examination, the necrotic, right breast mass occupied the entire lower outer quadrant of the breast and had surrounding erythema (Figure). Upper-extremity lymphedema was not observed. A core biopsy was performed and the diagnosis was a high-grade sarcoma with extensive necrosis consistent with an angiosarcoma involving breast parenchyma and skin. What are the surgical options for this patient? What are the recommended margins? Additionally, what is the prognosis and the follow-up plan for this patient?
A
Breast cancer remains a prevalent disease in women and carries a lifetime risk of 12.4%. Since the 1980s, breast conservation followed by radiation therapy has been offered as treatment for breast cancer with an equivalent survival to mastectomy. The number of women being diagnosed with in-field angiosarcoma after radiation therapy has slowly increased as more patients opted for breast conservation therapy. Angiosarcomas are rare, malignant, high-grade soft tissue tumors of endothelial-like cells that line vascular
A large malodorous, fungating right breast mass.
channels. They may occur as a primary breast malignancy, a late complication of upper-extremity lymphedema following mastectomy and axillary clearance (Stewart–Treves syndrome), or secondary to radiation therapy to the breast or chest wall. The median age of diagnosis is in the third decade for primary angiosarcoma, whereas it is the seventh decade for patients with a history of breast cancer with or without radiation therapy. The clinical presentation of angiosarcoma varies depending on the setting from which it arises. Primary angiosarcoma presents as a rapidly growing mass within the breast parenchyma with an average median size of 5 to 6 cm. Lymphedemaassociated angiosarcoma commonly occurs in the skin of the upper or medial arm, but may present along the chest wall as painless pink-to-purple colored lesions that progress to multiple dermal nodules measuring 5 mm or less. Angiosarcoma associated with radiation therapy similarly may present in the skin of the breast or chest wall as pink-to-purple colored skin lesions and may or may not be associated with a mass. The median size of these tumors is 5 cm. The estimated risk for radiation therapy–associated angiosarcoma is 0.06% to 1%, and the tumor has an average latency period of seven years. However, the latency period remains elevated for 20 years after radiation therapy before beginning to decline. This is in contrast to the 11-year latency period of lymphedema-associated angiosarcoma. A benefit has not been found in the use of neoadjuvant chemotherapy and is questionable in the adjuvant setting. As a result, the primary therapy for radiation therapy–associated angiosarcoma is surgery. Recommended margins range from 3 to 5 cm with or without resection of the pectoralis major fascia or muscle. Breast conservation is not routinely offered for angiosarcoma of the breast. The most commonly found involved margin is the deep margin. The impact of close or involved margins cannot be understated. The median time to local recurrence for margins less than 1 cm is three months versus 23 months for larger margins. Additionally, the median survival time for incompletely excised tumors is four to six months versus 42 months for adequate excisions. These cases frequently require the see SURGEONS’ LOUNGE page 30
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Surgeons’ Lounge jcontinued from page 28 involvement of plastic surgery to manage the resulting chest wall defect after resection. Axillary nodal involvement is a rarity and axillary clearance is only indicated for clinically involved lymph nodes or in an effort to obtain a negative margin. The overall five-year survival rate for these patients is 38%. Follow-up recommendations for these patients have yet to be established. Review of this patient’s last mammogram in 2009 showed post-radiation therapy edema of the breast: The prior lumpectomy site was the upper outer
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2012
quadrant and upper-extremity lymphedema was not observed. A positron emission tomography/computed tomography (PET/CT) scan was obtained for staging. Axillary nodal involvement and distant metastasis were not identified. The computed tomography component of this study did show tumor extension into the pectoralis major muscle but a bone scan came up clear. A breast magnetic resonance imaging (MRI) scan was requested to better define the extent of the tumor and to evaluate the contralateral breast; however, this patient had a history of social issues and further imaging was deferred. Clinically,
Axillary nodal involvement is a rarity and axillary clearance is only indicated for clinically involved lymph nodes or in an effort to obtain a negative margin. The overall fiveyear survival rate for these patients is 38%.
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the tumor was affixed to the chest wall, fungating, necrotic and foul-smelling. The surrounding skin had characteristic pink lesions extending to below her costal margin. A mastectomy was planned with resection of the pectoralis major muscle based on the imaging obtained preoperatively. In the operating room, a marking pen was used to outline the extent of the skin lesions, followed by outlining a 5- to 6-cm margin beyond these lesions. A skin incision was made and due to the extent of the planned resection, minimal flaps were raised. The clavicular head of the pectoralis major and pectoralis lis minor was preserved. The sternocostal head of the pectoralis major was freed near its attachment to the humerus and pulled downward. The origin of the pectoralis major was transected using cautery, and perforating vessels in the intercostal space near the sternum were clamped and tied. Palpation of the axilla did not identify any clinically suspicious lymph nodes. The tumor was found to abut and possibly extend to the chest wall, and a chest wall resection of the underlying area to obtain negative margins was performed. The defect was repaired by plastic surgery using Parietex, titanium mesh, methylmethacrylate (MMA), right pedicled latissimus muscle flap, serratus muscle flap and a split-thickness skin graft. Final pathology confirmed an 8.2 cm, high-grade sarcoma with tumor ulcerating the overlying skin and nipple. The tumor invaded into the pectoralis muscle with a deep margin of 0.5 mm. The chest wall resection of ribs, soft tissue and muscle was found to be benign. The patient was transferred for rehabilitation on the ninth postoperative day and subsequently discharged. A follow-up PET/CT every three to six months for one to two years and then annually to year 5 was recommended. Additionally, high-risk breast MRI alternating with mammography of the contralateral breast was recommended. It was acknowledged that the benefit of this plan is unknown. Because of the patient’s history of bilateral breast cancer, ovarian cancer and a maternal history of breast cancer, BART genetic testing was requested but was denied by her health insurance company.
Erratum: We inadvertently neglected to give credit to Daniel Szkolnik, MD, from the University of Florida, Tampa, for his collaboration on the section “History and Other Facts About Zenker’s Diverticulum,” in the August 2012 issue of The Surgeons’ Lounge.
Surgeonsâ&#x20AC;&#x2122; Lounge
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2012
Next Month: The Surgeonâ&#x20AC;&#x2122;s Challenge (Co-collaborator: Adam Bauermeister, PGY1, Cleveland Clinic Florida, Weston)
MD,
49-year-old man underwent laparoscopic longitudinal gastrectomy (sleeve) for morbid obesity (body mass index [BMI]: 40 kg/m2). On postoperative day (POD) 1, the patient is recovering well
A
and complaining only of mild abdominal tenderness. Upper gastrointestinal evaluation with Gastrografin demonstrates no obstruction or leak, and duplex ultrasonography of the lower extremities indicates no deep vein thrombosis. The patient has mild hypotension and normal labs (complete blood cell count [CBC] and comprehensive metabolic panel [CMP]).
31
The patient is advanced to a Phase I diet and a Foley catheter is discontinued. On POD 2, the patient is tolerating a diet and hypotension has resolved, but he comments that he has unusual mild to moderate right buttock pain. On examination, the buttock is without erythema, induration or signs of infection. The rectal exam is normal; the urine output is adequate; and labs (CBC and CMP) are still within normal limits. What work-up and further management should be performed at this stage of the patientâ&#x20AC;&#x2122;s hospital course?
Suggested Reading Jallali N, et al. Surgical management of radiation-induced angiosarcoma after breast conservation therapy. Am J Surg. 2012;203:156-161. Linford A, et al. Surgical management of radiation-associated cutaneous breast angiosarcoma. J Plast Reconstr Aesthet Surg. 2011;64:1036-1042. Mery CM, et al. Secondary sarcomas after radiotherapy for breast cancer: sustained risk and poor survival. Cancer. r 2009;115:4055-4063. Rosen PP, et al. Mammary angiosarcoma: the prognostic significance of tumor differentiation. Cancer. 1988;62:2145-2151. Sher T, et al. Primary angiosarcomas of the breast. Cancer. r 2007;110:173-178. Strobbe LJ, et al. Angiosarcoma of the breast after conservation therapy for invasive cancer, the incidence and outcome. An unforeseen sequela. Breast Cancer Res Treat. 1998;47:101-109. Styring E, et al. Changing clinical presentation of angiosarcomas after breast cancer: from late tumors in edematous arms to earlier tumors on the thoracic wall. Breast Cancer Res Treat. t 2010;122:883-887.
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Vorburger SA, et al. Angiosarcoma of the breast. Cancer. 2005;104:2682-2688.
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In the News BREAST CANCER jcontinued from page 27
those who had mastectomy and 87% in those who had mastectomy plus radiation. They concluded that women with this breast cancer subtype who undergo mastectomy without radiation have a significantly increased risk for local regional relapse compared with those who have BCT. Dr. Pass: This shows us that breast cancer subtypes matter, and the paradigm that BCT is equivalent to mastectomy
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2012
may not apply in all subtypes. More aggressive surgery might not be the right answer, and post-mastectomy radiation therapy for these patients may not end up being limited to patients with tumors greater than 5 cm. Again, I think as we are getting more savvy looking at the subtypes of aggressive breast cancers, we realize that one treatment does not apply to all types. We can clearly see that BCT is not contraindicated in the TNBC subtype.
6.
Positron Emission Tomography (PET) for Assessment of Axillary
Lymph Node Status in Early Breast Cancer: A Systematic Review and Meta-analysis (Cooper KL et al. Eur J Surg Oncoll 2011;37:187-198) In this meta-analysis, researchers evaluated 26 studies with 2,591 patients to investigate the effectiveness of PET/CT (computed tomography) in the assessment of the axilla in early breast cancer. They found PET or PET/CT had a sensitivity of 63% and a specificity of 94%, and the larger the metastatic foci were, the more sensitive PET was. But PET had a lower sensitivity and specificity than sentinel lymph node biopsy, so
the researchers concluded that PET/CT should not replace sentinel lymph node biopsy for assessment of the axilla.
Dr. Pass: Current guidelines do not support the use of PET/CT for the evaluation of early-stage breast cancer, but that does not mean PET/CT has no use. It is still useful for patients with locally advanced breast cancer and patients with recurrent or metastatic breast cancer. Its usefulness in T2 and IIIA breast cancer is yet to be determined.
7.
The Safety of Multiple Re-Excisions after Lumpectomy for Breast Cancer (Coopey S et al. Ann Surg Oncol 2011;18:3797-3801) The most important risk factor for local recurrence after BCT is involvement of the margins; researchers behind this retrospective review of 3,737 patients sought to determine the local recurrence rates in patients undergoing two or more excisions, and to identify factors associated with achieving negative margins. They found 70 patients required multiple re-excisions; 49 of them were able to achieve negative margins. In the median follow-up of 64 months, one patient had a local recurrence and one patient had distant recurrence. Factors predicting persistently positive margins were multifocality and positive LN. The researchers concluded that multiple re-excisions are a safe alternative to mastectomy as long as negative margins are achieved and the cosmetic outcome is acceptable.
Dr. Pass: This study is important because re-excision rate is increasingly being evaluated as a potential quality measure. I always argue that I can get nice negative margins with one surgery, but my cosmetic outcome may not be great. This tells us that assessment of cosmetic result needs to become a routine measure that we document in our follow-up visit. We need to start looking at that, not just disease status and the results of the patient’s most recent mammogram.
8. Get concise medical education videos at your fingertips.
Triple Negative Breast Cancer Is Not a Contraindication for Breast Conservation (Adkins F et al. Ann Surg Oncoll 2011;18:3164-3173) In this retrospective analysis, researchers evaluated the impact of surgery type—BCT versus mastectomy— in 1,325 patients with TNBC, all of whom received neoadjuvant chemotherapy. They found a local recurrence rate of 26% in patients receiving BCT and 30% in those who underwent mastectomy, a difference that was not statistically significant. But in every other measure, BCT did achieve statistically significantly better outcomes, most importantly for OS, in 74% versus 63% of patients who
In the News
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2012
underwent mastectomy. The researchers concluded that BCT is not associated with increased local relapse, and is a reasonable option for women with TNBC.
Dr. Pass: When you see a TNBC patient aged 60 or younger, consider referral for genetic testing, because those results may influence your and the patient’s surgical decision making. But the presence of TNBC itself does not mandate mastectomy; selection should be based on the usual criteria. Some data suggest that the multimodal approach, i.e., the addition of radiation to these patients, improves their outcome.
Dr. Pass: Patients have to individualize their treatment decisions. Is the effect on quality of life worth the benefit of preventing something you may or may not ever get? For women who are anxious about breast cancer and less concerned about side effects, yes. But should we put it in our water source so that it’s available to every woman at risk? No.
10.
Effect of the GonadotropinReleasing Hormone Analogue Triptorelin on the Occurrence of Chemotherapy-Induced Early Menopause
in Premenopausal Women With Breast Cancer (Mastro L et al. JAMA 2011;306:269-276) In the PROMISE-GIM6, researchers studied the effect of temporary ovarian suppression on the incidence of early menopause in young women with breast cancer. They administered the gonadotropin-releasing hormone analog triptorelin in 281 women prior to and during chemotherapy and waited to see if menses returned. If it did, they continued triptorelin for at least two years. They found triptorelin decreased the rate of early menopause to 9%,
compared with 26% in women who did not receive the treatment. Dr. Pass: This is not just for fertility preservation, but also for management of menopausal symptoms—some patients may be done with child planning but don’t want to go through early menopause. The optimal duration of suppression is unknown because chemotherapy-induced amenorrhea is associated with an improved prognosis in women with early-stage breast cancer.
9.
Exemestane for Breast-Cancer Prevention in Postmenopausal Women (Goss P et al. N Engl J Med 2011;364:2381-2391) The NSABP-P1 and P2 trials showed that tamoxifen and raloxifene are effective for the primary prevention of breast cancer, but only 4% of women take tamoxifen for chemoprevention. In this randomized, placebo-controlled trial, researchers investigated the impact of exemestane on invasive breast cancer in 4,560 postmenopausal women at increased risk for breast cancer. Early discontinuation was observed in 5% of both the exemestane and placebo groups, and the former group reported more hot flashes and arthritis than the latter. Exemestane decreased the risk for all cancers and decreased the incidence of invasive breast cancer to 0.19%, compared with 0.55% in the placebo group.
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34
Opinion PPACA
jcontinued from page 1 participation through blogs, petitions and talk radio was at a fever pitch. Liberals and conservatives believed everything was on the line, and braced for validation or defeat when decision day came. This time, however, J.R. turned out to be the shooter and now that his opinion has been read and the smoke is starting to clear, it’s hard to figure out who won and who lost. Everyone, it seems, got winged. Let me explain. Conservatives believed for a variety of reasons that J.R. (Chief Justice John Roberts) and his four reliable conservative allies in the court would shoot the whole law down becausse there was no precedent for regulating inactivity, such as not buying health insurance. Although Congress could regulate just about anything under the expanded interpretation of the Commerce Clause of the Constitution, it could not compel anyone to engage in commerce. Because PPACA lacked the usual severability clause that protected other provisions of the bill if one was declared unconstitutional, l the whole law was vulnerable, unless the court ruled otherwise. In handicapping the decision, conservatives argued that Mr. Roberts and the other conservative justices of the court still held a grudge against President Obama for humiliating them in front of the nation during his State of the Union speech for its decision on corporate campaign financing. No politician had ever reprimanded the court, especially a constitutional lawyer expected to have a profound respect for the separation of powers. In criminal terminology, this very public rebuke was the motivation. Constitutional justification, one way or the other, can always be found by the creative mind. Oral arguments for the government by the stammering Solicitor General Donald Verrilli Jr., had conservatives high-fiving like it was all over. He looked like he was taking a dive, whiffing on over-the-plate lobs by the liberal justices who seemed to be coaching more than interrogating. When asked by Justice Antonin Scalia if there were any constitutional limitations on the prerogatives of the legislative and executive branches in addressing public policy issues, like forcing people to eat broccoli to promote good health, Mr. Verrilli froze. He couldn’t think of any. It was the “if the glove doesn’t fit you must acquit” moment for the anti-mandate side. New York’s Mayor Michael Bloomberg’s assault on 32-ounce colas was still months away, so there was still a belief among rational people in the gallery that
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2012
somewhere, boundaries separating our private lives from the expanding domain of the nanny state would be found and enforced by the court’s decision in this case when the mandate was overturned. Then the president weighed in with his now infamous warning that it would be “unprecedented” for the court to strike down a law duly passed by an elected majority of both houses of Congress. The characterization of Obamacare as a bipartisan bill aside,
Even a strict constructionist with a grudge couldn't force himself to rule it was the court's buinsess to run health care. Good for him.
th only the l thing thi unprecedented d t d about b t the th president’s statement was the failure by a constitutional lawyer to recognize that striking down bills passed by elected officials is in fact the only business the court is in. Surely the president, even though he was in fact not a constitutional law professor at the University of Chicago Law School as advertised, but a paid “senior lecturer,” knew that. The only way to make sense of his comment was that he expected defeat, and was setting the stage for a full frontal attack on the conservative court for judicial activism in thwarting the will of the people and depriving them of all the benefits of PPACA. Given the disastrous results of the 2010 interim elections for Democrats who had to run on the newly minted health care law, many pundits thought that the politically savvy president secretly preferred to run as a victim of the conservative court’s misanthropy rather than as a defender of a bill that was becoming increasing unpopular as voters were beginning to understand the president’s quaint pledge that no one happy with their current insurance would be affected by this bill. It also didn’t help that Europe was imploding; crushed by entitlements they couldn’t afford and California was doing a credible imitation of Greece. The markets were queasy, and the Office of Management and Budget had revised upward the cost of the bill, and reminded everyone it could be even worse if the assumptions provided by the current administration proved inaccurate.
For a president who seems to value getting re-elected above all else, getting out from beneath this bill by a court decision he could vilify didn’t seem like a bad way to go. For their part, liberals yearning for the fulfillment of the 100-year quest for socialized medicine believed that at least one conservative justice, probably Anthony Kennedy, would split from the pack and rule that the prohibition against regulating “inactivity” was too soft an argument to thwart Congress’ will. ill Al Although h h the h concept off there h b being i
no constitutional basis to compel activity was clever, the court would not recognize “inactivity” as a constitutionally tit ti ll protected t t d right i ht like freedom of speech, religion and congregation. Liberals also pointed to legal precedent for regulating inactivity under the Commerce Clause. In the famous Wickard v. Filburn (1942) case, the court ruled that Congress had jurisdiction over a Kansas corn farmer who grew corn only for his own consumption under the theory that anything that affects the supply of corn by dumping or withholding, affects the price and is therefore interstate commerce, even if a single ear never left the farm, no less crossed the state line. Because the price of insurance is affected by the number of policy holders, not buying insurance affects the price and not buying it, is therefore, “commerce” and therefore is subject to regulation by Congress. Clear as a bell, no? With a 5-4 conservative majority in the court, handicappers were predicting that, short of a defection, PPACA would be struck down. When the decision was announced you could hear the agonized ululations of conservatives everywhere from Fox News to Rush Limbaugh to the Drudge Report and Breitbart. Almost as divesting as the decision was the unexpected betrayal of the dependable conservative chief justice, who not only sided with the liberal majority, but also wrote the opinion that simply stated, it’s the job of Congress and not the Supreme Court to manage health care. When stated this way, it seems so irrefutable and makes one wonder why the president had
framed his statement in a manner sure to antagonize, unless for political reasons he was trying to snatch defeat from the jaws of victory. Whatever. The intrigue was over. Even a strict constructionist with a grudge couldn’t force himself to rule that it was the court’s business to run health care. Good for him. The postmortem began and we learned that Mr. Roberts initially sided with the other four conservative justices to strike down the mandate, but then changed his mind. We don’t know why and it certainly wasn’t because the solicitor general dazzled him. His conservative colleagues were sliding him messages under his door inquiring if he really believed Congress should regulate a Kansas farmer who grew corn for his own consumption. Despite the cajoling, the chief justice was immovable in his basic premise that government has a duty to tend to the nation’s business. Perhaps Mr. Roberts saw this as an opportunity to restore the nonpartisan reputation of a court that had been injured by the Bush v. Goree (2000) decision that left a big ideological cleavage in the country. My own belief that although the issue of the mandate was brought to the court by conservatives, the chief justice could never convince himself that being compelled to buy health insurance violated any true sensibility of conservative doctrine that purports to put a premium on personal responsibility and accountability for one’s actions. I think he believed that the mandate issue was merely the best legal pretext for overturning a law that conservatives found objectionable for a host of other reasons and a legal challenge is always the quickest way to expedite repeal. Full disclosure. I’m also conservative by nature, but in my very first column for General Surgery News seven years ago entitled “5 Simple Steps to Control Health Care Costs,” I advocated forcing everyone to buy health insurance, especially young adults who were making BMW payments instead of paying for premiums. I found nothing about mandatory health insurance that violated any of my conservative beliefs. I saw not buying health insurance as unrealistic and irresponsible, and not a noble expression of one’s commitment to the concepts of personal freedom and liberty. I got angry letters from people who said it was like forcing people who don’t own a car to buy auto insurance. The analogy does not hold because people who do not drive do not need auto insurance. People without health insurance get sick. When I see a guy on TV with the “Live Free or Die” t-shirt saying he doesn’t want the government telling him he has see PPACA PAGE 38
GSN Bulletin Board
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METFORMIN
jContinued from page 5 of information because it shows that the decrease in HCC may not only be due to prevention but also by a therapeutic action of some sort,” said Mario Chojkier, MD, professor of medicine at the University of California, San Diego, in summarizing the paper during a “Best of DDW” session at the DDW meeting. Dr. Chojkier said the findings have significant clinical implications. Although no experts called for patients to receive metformin prophylactically, investigators said more studies might lead to different prescribing patterns. Dr. Chojkier said that for now, physicians should “be stringent” in assessing insulin resistance according to the guidelines from the American Diabetes Association. The second study on metformin compared 612 patients with histologically proven intrahepatic carcinoma who were seen at Mayo Clinic with 594 patients without a history of cancer matched for age, gender, ethnicity and residential area (abstract 597). Sensitivity analysis showed that metformin use was associated with a 60% reduced risk for intrahepatic carcinoma in diabetics compared with diabetic patients who did not take metformin. The finding is novel but will require further investigation and validation in
another cohort, said lead author Roongruedee Chaiteerakij, MD, of Mayo Clinic, Rochester, Minn. The same study also showed no significant association between statin use and decreased risk for intrahepatic carcinoma. Experts say more work on this subject is needed. Hashem B. El-Serag, MD, MPH, chief of gastroenterology and hepatology, Baylor College of Medicine, Houston, said the Mayo study involved too few patients to be conclusive, and the findings may reflect a bias on the part of treating physicians. “Physicians don’t like to give statin or metformin to people with cirrhosis, so it looks like those who develop cancer are using them less, not because of a biological phenomenon but because of an avoidance phenomenon,” said Dr. El-Serag. But Chun-Ying Wu, MD, PhD, MPH, of the faculty of medicine at National Yang-Ming University in Taipei, Taiwan, and lead author of the Taiwanese study, believes that metformin should be recommended in patients with diabetes. “We can say metformin is actually chemopreventive for HCC development.”
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38
Opinion PPACA
jcontinued from page 34 to buy health insurance (or wear a helmet) because it’s an infringement on his liberty, I know he knows that when his Harley skids off the road and hits a tree, he’s not going to be left for road kill. He’s going to be scooped up and helicoptered to a Level 1 trauma center where $1 million are going to be spent putting Humpty Dumpty back together again. I’ll take these Don’t-Tread-on-Me types seriously when I see a signed advance directive pinned to their shirts declining any care at the public’s expense when they get sick or injured. Those people don’t have to buy insurance. If there are a dozen of them, I’d be surprised. The problem with all these bold proclamations about not buying insurance is that everyone knows despite all the rhetoric about the “uninsured,” that everyone is covered. Go to any hospital with an emergency room and at least 10% of the beds will be filled with the homeless, the indigent and the uninsured. EMTALA [Emergency Medical Treatment & Labor Act ] is the name of their insurance company. Those “conservatives” who refuse to recognize that they might get sick or hurt and that when they do they’ll get free care at their neighbor’s expense are really camouflaged liberals who expect and demand free treatment as a “right.” Strip off the philosophical varnish of the conservative about “freedom” and the net result to society is the same. They are all “takers” who will never understand that they are taking from people, not the government. The government doesn’t come in the middle of the night to sew them up; a person does. The government doesn’t appear in court as a defendant when they’re not happy with how their scar looks; a person does. It’s not even the government that pays for them. The government is a conduit from our pockets to theirs. Loud anti-government rhetoric should not be permitted to disguise the real intentions of people who are takers, regardless of whom they vote for and what side of the aisle they sit on. My guess is that Mr. Roberts never believed the mandate was a fundamental conservative issue, and that the court didn’t need to extend itself to protect the phony prerogatives of people too dense to understand and provide for the vagaries and inevitabilities of the human condition. The chief justice’s opinion could have stopped with the affirmation of the right of Congress to deal with health care. President Obama and the Democrats would have been a lot happier if it did. But Mr. Roberts, knowing he would face violent criticism from the right, went on to opine that the reason why the mandate was constitutional was because it was a tax and not a penalty for inactivity, despite what Minority Speaker Nancy Pelosi and Majority Speaker Harry Reid called it during the legislative process. OMG. A TAX. And not even on the 1-percenters, because they’ve all got health insurance. No one disputes the right of Congress to tax, and that is exactly what it’s doing. A tax on the middle class doesn’t play well in Peoria on the campaign trail. And Mr. Roberts didn’t stop there. The mandate derived its authority from the power to tax and not from the Commerce Clause, that infinitely elastic regulator of interstate commerce that provided the pretext for virtually everything Congress wanted to do for the past 50 years. The Wickard v. Filburn decision allowed Congress to bulldoze its way into every nook and cranny of American life, including onto the private cornfields of a Kansas farmer minding his own business. By shunning this decision that liberals wanted to use as the pretext to
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2012
regulate inactivity, the chief justice put a gigantic stop the carriers that the increase was in anticipation of sign in front of the bulldozer. When Mayor Bloomberg underwriting losses due to 30 million new customers with comes into court claiming he killed the 32-ouncer unmet health needs flooding the system. Someone also because it is increasing the city’s borrowing costs (because was going to have to pay the expense of insuring those the city employs people who drink colas and get fat and with preexisting illnesses who had been denied coverage. then get diabetes that increases the cost of their health And all those wonderful “free” benefits mandated by the insurance premiums so they have to move to Connecticut law? Turns out they are actually not free. They too will to get cheaper insurance, that causes the New York real be paid for. The insurance companies are not in business estate prices to shrink, that decreases the tax base that to lose money. affects the city’s merchants At least the premium notices didn’t As a doctor, a taxpayer, a and therefore interstate say at the bottom, “If you’re happy patient and voter, the lack of with your insurance and care, nothing commerce), he’s going to see that big stop sign the even a semblance of intelligent will change.” That would be cruel. court imposed with this Little wonder the president chose ruling. He’s going to be sent discussion on what we’re going not to go there, sticking with the home with a note from the 26-year-olds who can now continue to do with health care from teacher: No more meddling to sponge off Mommy and Daddy in the name of regulating either candidate has been deeply until they find a real job, as if that is interstate commerce. something that they might be able to distressing. And Mr. Roberts coulld do in today’s economy. have stopped there. But he Who shot J.R.? That was easy. The didn’t. He further opin ned misstress, who else? Who won the mandate that members of Congreess warr? Well, that’s about as clear and easy to had every right to impoose und derstand as our two candidates’ current socialized medicine on the posittions on health care issues when either people for exactly the reason n stated by can pull themselves th away from discussing Bain President Obama when he allegedly was jawboning the Capital and Barack Obama’s Columbia and Harvard court to uphold the mandate. Congress is a duly elected transcripts. body voted into office for the purpose of representing In a nutshell, President Obama supports the mandate the people and giving them what they want and need. that he violently opposed and called unconstitutional If for any reason people don’t like how the president or when he ran against Hillary Clinton in the 2008 Congress interprets exactly what it is they need, then presidential Democratic primary. Now that it passed, he’s they should use, as Justice Ruth Bader Ginsberg stated, really happy. Not. “deferred settlement of the issue.” Translation: Vote for Mitt Romney is against the same mandate that he someone else. imposed in Massachusetts that nearly ate the state No wonder that although President Obama “won,” he treasury and demoralized the medical profession. He was looked like he had lost all 32 games in the opening bracket proud of it then and disavows it now. He claims that that of the NCAA tournament. Although conservatives were mandate was different from the one he currently opposes, wailing in self-pity and rancor, apparently incapable of but other than one was state and the other federal, understanding that they had truly won, the president they’re identical twins. When you ask the candidates seemed to immediately understand the court was doing about health care, they both squirm and look like you’re him no favors. He tried to pretend he was happy, but about to produce an embarrassing picture from a college really was at a loss for words to express his joy. He knew frat party. For the tumult that led up to decision day, Mr. Roberts had yoked him with PPACA for the coming health care fell off the public’s radar like an expensive campaign season and by this time he probably rues the Hollywood blockbuster that gets bad word of mouth on day he didn’t take former president Bill Clinton’s advice opening weekend and winds up on DVD in two weeks. to stay away from health care. It’s a monster that will As a doctor, taxpayer, patient and voter, the lack of even consume those that try to control it. Better to nibble a semblance of intelligent discussion on what we’re going around the edges with incremental reforms that are to do with health care from either candidate has been affordable. He looked dour and thin-lipped when he deeply distressing. We just spent one full year on an idiotic, gave his usual perfunctory salute to the 2 million young meaningless debate about whether or not compelling adults now able to enjoy extended adolescence by staying someone to buy health insurance is constitutional. J.R. on their parents’ insurance policy until 26 years of age, says it is, so it is. We should have just called him a year thanks to the law; as if extending dependency nearly into ago and saved ourselves all the trouble. We could have middle age were a good thing. He seemed disinclined spent the time and energy picking over the 3,500 pages to discuss much of anything else in the 3,500-page law of PPACA to find some stuff worth salvaging that most that the court had salvaged, especially the mandate that could agree on, and unloading all the crap that really was now officially a new tax on the middle class. There needs to go, like the Independent Payment Advisory was the obligatory mention of the 30 million uninsured Board and worthless bureaucracies that will have the and those with preexisting conditions, but people were entire medical profession as card-carrying members of on to the fact that their care was going to be paid for the Service Employees International Union within a by new taxes on the middle class. The uninsured hoard decade, which I’m sure is the ultimate intent of the law. of 30 million faceless people who had been the abstract The great health care debate with the denouement in representation of the liberals love for mankind was the Supreme Court had the original “Who Shot J.R.” suddenly coming to life and competing with them for beat by a mile for complexity and intrigue. So muich so their doctor’s attention. that now that the smoke has cleared, you can’t even tell The decision could not have come at a worse time. the winners from the losers. How great is that? One hundred and thirty million people with employerAnd they said “who shot J.R.?” was much ado sponsored insurance had just received premium increases about nothing. of between 10% and 25% with explanations from —Dr. Cossman is a vascular surgeon from Los Angeles, Califf —
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Aphorisms & Quotations for the Surgeon Moische Schein
September 1, 2002 This book presents a medley of more than 1,500 aphorisms, quotations and rules—by surgeons and nonsurgeons—about surgery, surgeons and anything relevant to the practice of surgery. Readers will use this book to decorate their lectures or manuscripts with relevant smart or enterr taining entries. Most of all, this book simply will be read or browsed for pleasure.
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Atlas of Advanced Operative Surgery: Expert Consult—Online and Print
Vijay P. Khatri November 9, 2012
ORDER ONLINE For pricing, a more complete review and easy ordering with a credit card, go to McMahonMedicalBooks.com. We can supply any medical book in print, so if you don’t find the book you want, email your request with billing information to RMcMahon@McMahonMed.com. If you are an author and would like your medical book featured in this book section, contact Ray McMahon, Publisher, at RMcMahon@McMahonMed.com.
This new resource picks up where other surgical references leave off, providing highly visual, step-by-step guidance on more than 100 advanced and complex procedures in both general and subspecialty areas.
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Atlas of Surgical Techniques for Colon, Rectum, and Anus
James W. Fleshman Jr. October 15, 2012 In this volume in the Surgical Techniques Atlas Series, top authorities provide expert, step-by-step guidance on surgery of the large bowel, rectum and anus—including both open and closed approaches for many procedures—to help you expand your repertoire and hone your clinical skills.
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Bariatric Surgery I: Revisional Bariatric Surgery Cine-Med
January 1, 2011 Ciné-Med, Inc. presents the ACS Video Anthology Collections: Bariatric Surgery I: Revisional Bariatric Surgery. Sixteen videos from the Amerr ican College of Surgeons Video Library have been assembled into this DVD set. set
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Complete Self Assessment for Medical and Surgical Finals: Second Edition
Kinesh Patel; Neil Patel July 1, 2012 You have read your textbook and your course notes; now you need to test your knowledge and practise your exam technique. This handbook is the ideal tool, examining all the core information medical students must know by the end of their final year via the most popular question formats.
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Day Case Surgery
Douglas McWhinnie; Ian Jackson; Ian Smith February 20, 2012 The current interest and focus on day surgery is a result of public demand and government-imposed targets. This concise handbook provides the practising day surgery professional with a modern overview of current practice to act as both a reference and a practical guide to every-day challenges.
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Surgical Oncology
David L. Bartlett, Pragatheeshwar Thirunavukarasu, Matthew D. Neal May 4, 2012 Surgical Oncology y is a full-color text that incorporates the basic tenets of surgical practice with the innovations of modern technology in an evidence-based fashion.The goal of the book is to present the opinions of experts in the field alongside an analytical and unbiased review of the evidence.
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Year Book of Vascular Surgery 2012
Gregory L. Moneta November 15, 2012 The Year Book of Vascular Surgery y brings you abstracts of the articles that reported the year’s breakthrough developments in vascular surgery, carefully selected from more than 500 journals worldwide. Expert commentaries evaluate the clinical importance of each article and discuss its application to your practice. There’s no faster or easier way to stay informed! GSN1012
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