The June 2012 Digital Edition of General Surgery News by McMahon Group

Convention Issue:

American Society for Metabolic and Bariatric Surgery 40 th ANNIVE R SARY ®

June 2012 • Volume 39 • Number 6

GeneralSurgeryNews.com

The Independent Monthly Newspaper for the General Surgeon

Opinion

Lap Chole-ERCP Combo May Result in Better Care, Lower Costs

A Keynesian View Of Health Care B y J on C. W hite , MD

One-step Procedure; Surgeon Experience With ERCP Is Linchpin

hen people ask me my thoughts on health care, I tell them I am a Keynesian. John Maynard Keynes (1883-1946), a British economist, was the most influential economist in the United States in the early to mid20th century when, coincidentally, medicine began its ascent from the Dark Ages. Most importantly, his philosophy of economics comports with my observations of the practice

Government has always been an important partner to the health care industry and it has intervened in times of crisis. of medicine. Keynes wrote that “the theory of economics does not furnish a body of settled conclusions immediately applicable to policy. It is a method rather than a doctrine, an apparatus of the mind, a technique of thinking, which helps its possessors to draw correct conclusions.” During my 30-year career in medicine, I have come to think about medicine in the same way. Medicine has very see Keynesian page 53

clinical Experience Minimally Invasive Surgery in Thoracic Procedures Using Advanced Technologies

see page 10

Endocrine Therapy Halts Need for Mastectomy in 51% Randomized Trial of Aromatase Inhibitors; U.S. Lags Behind Europe in Their Use

B y M onica J. S mith

B y C hristina F rangou

San Diego—Combining laparoscopic cholecystectomy with endoscopic retrograde cholangiopancreatography (ERCP) may result in better patient care and substantially reduced cost compared with the traditional two-step procedure, according to research presented at the Society of American Gastrointestinal and Endoscopic Surgeons’ (SAGES) annual meeting. “We set out to combine laparoscopic cholecystectomy with

Orlando, Fla.—One in every two women scheduled to undergo mastectomy for large, estrogen receptor (ER)–rich breast cancer were downgraded after receiving a course of neoadjuvant aromatase inhibitor (AI) therapy, which allowed them to undergo breast-conserving surgery instead, according to a Phase II open-label, randomized trial presented at the Society of Surgical Oncology’s 65th Annual Cancer Symposium (abstract 3). Clinicians say the study demonstrates that preoperative endocrine therapy can play a strong role in treating this group of patients and could, perhaps, replace chemotherapy. “Conversion from mastectomy to breast-conserving surgery in 51% of women who were initially classified as

see ECRP page 42

Survey Shows Surgeon Salary and Job Satisfaction Down in 2011 B y V ictoria S tern

verall, general surgeons reported earning less in 2011 than the previous year, and almost half said they were dissatisfied with their job, according to the results of an online survey conducted by Medscape. In February, Medscape polled U.S.

physicians in 25 different specialties, including general surgery, to determine changes in income and job satisfaction. Medscape collected responses from 24,216 physicians, of whom 2% were general surgeons. Of the survey respondents, 83% were men, 33% were under the age of 45 years, and about 84% were

see Endocrine page 20

clinical Experience Advances in Vessel Sealing for Laparoscopic Bariatric Surgery see page 26

REPORT Techniques for Using Biologics in Ventral Hernia Repair

see Survey page 38

see insert at page 28

INSIDE In the News

Surgeons’ Lounge

Obesity Care

In Michigan, Collaborative Coverage of the 11th Annual Bariatric Options for GERD Programs Improve Quality, Surgery of the Foregut and Hiatal Hernias; Sleeve Save Money . �� 4 Symposium ....................... 8 Gastrectomy Guidelines �� 22

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Cut and Paste Frederick L. Greene, MD Chairman, Department of General Surgery Carolinas Medical Center Charlotte, N.C.

y June editorial is stimulated by the rollout of the computerized physician order entry (CPOE) portion of our electronic medical records (EMR) system this week at my institution. I am sure that discussions of the role of the EMR and CPOE have been ongoing at your location. Obviously, a great deal of work and planning has gone into this next phase of the “meaningful use” of the EMR and all attending physicians, trainees, nurses, mid-level providers and so on, have spent hours getting ready for this evolution. It is unclear to many whether the EMR will, in fact, increase the overall quality of care and reduce the opportunities for misadventure. I also have concerns about the unintended consequences of the computer-generated and template-driven approach to medicine. Think back to when you were a medical student. You rotated on a service as

GSN Editorial Sadly, I have a feeling that this

a third-year clinical clerk and began to use some of important rite of passage for students the principles you learned may be lost in the template-driven, in physical diagnosis class. We all were excited about cut-and-paste world of electronic putting on that white coat records keeping. and showing up on the inpatient floor with the idea that now we could be part of the team that takes care of symptoms and other meaningful critepatients and could feel what it was like to ria into a progress note. It gave us the be a doctor. One of our duties was to take opportunity to feel that we were part of a good history and physical on a patient the team. Sadly, I have a feeling that this and provide that write-up to our menimportant rite of passage for students tors who were directing the outpatient may be lost in the template-driven, cutand inpatient care. The other important and-paste world of electronic records issue was to follow a patient on a daily basis in order to see the positive pro- keeping. In teaching institutions, one of the gression of someone who was benefiting from good medical care and, on the sur- byproducts of introducing the EMR gical service, recuperating from an opera- is that the medical student has been tion that we had the privilege to witness. marginalized from the record-keeping We were taught to write progress notes queue. The template-driven progress in the patient’s chart, and these were notes are now, in many teaching institudutifully countersigned by our residents tions, solely in the purview of the attendand ultimately perhaps by the attending physician, mid-level providers and ing physician. This routine also allowed the residents caring for the patient. At us to learn how to function as physicians many institutions, the medical student and incorporate laboratory data, intake does not play a role in developing a progand output information, patient-related ress note or placing a written history and

Joseph J. Pietrafitta, MD Minneapolis, MN General Surgery, Laparoscopy, Colon and Rectal Surgery, Laser Surgery

Frederick L. Greene, MD

Los Angeles, CA General Surgery, Laparoscopy, Surgical Education

Gary Hoffman, MD

Barry A. Salky, MD

Editorial Advisory Board

Los Angeles, CA Colorectal Surgery

New York, NY Laparoscopy

Maurice E. Arregui, MD

Namir Katkhouda, MD

Paul Alan Wetter, MD

Indianapolis, IN General Surgery, Laparoscopy, Surgical Oncology, Ultrasound, Endoscopy

Kay Ball, RN, CNOR, FAAN

Los Angeles, CA Laparoscopy

Miami, FL Ob/Gyn, Laparoscopy

Youngstown, OH General Surgery, Laparoscopy

Editorial Staff

Philip S. Barie, MD, MBA

Peter K. Kim, MD Bronx, NY Emergency General Surgery

Kevin Horty

New York, NY Critical Care/Trauma, Surgical Infection

L.D. Britt, MD, MPH

Raymond J. Lanzafame, MD

David Earle, MD

Rochester, NY General Surgery, Laparoscopy, Surgical Oncology, Laser Surgery, New Technology

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 Long Branch, NJ Laparoscopy, Telemedicine

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Victoria Stern Associate Editor (vstern@mcmahonmed.com)

James Prudden

Manager, Editorial Services

San Francisco, CA Surgical Hospitalist

Elizabeth Zhong

Gerald Marks, MD Wynnewood, PA Colon and Rectal Surgery, Colonoscopy

J. Barry McKernan, MD Marietta, GA Laparoscopy

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© 2012 by McMahon Publishing, New York, NY 10036. All rights reserved. General Surgery News (ISSN 1099-4122) is published monthly by McMahon Publishing, 545 West 45th Street, New York, NY 10036. Corp. Office, 83 Peaceable Street, Redding CT 00896. POSTMASTER: Please send address changes to General Surgery News, 545 W. 45th St., 8th Floor, New York, NY 10036.

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physical into the chart. The more serious consequence of this EMR system is that students cannot develop their own methods of creating documents because they are not allowed to participate in the activity. The repercussions of this revolution in documentation are not limited to medical students; they involve all physicians who now are exposed only to template-driven documentation, which

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.

Disclaimer Opinions and statements published in General Surgery News are those of the individual author or speaker and do not necessarily represent the views of the editorial advisory board, editorial staff or reporters.

All U.S. general surgeons, colorectal surgeons, vascular surgeons, surgical oncologists and trauma/critical care surgeons should receive General Surgery News free of charge. If you are changing your address or name, you must notify the AMA at (800) 262-3211 or the AOA (if appropriate) at (800) 621-1773 to continue receiving GSN. You need not be a member; however, they maintain the ultimate source of our mailing addresses. If you are not a general surgeon or other specialist listed above and would like to subscribe, please send a check payable to General Surgery News. Please allow 8-12 weeks for the first issue. Subscription, $70 per year (outside U.S.A., $90). Single copies, $7 (outside U.S.A., $10). Send checks and queries to: Circulation Coordinator, General Surgery News, 545 West 45th Street, 8th Floor, New York, NY 10036. Fax: (212) 664-1242.

INFECTIOUS DISEASE SPECIAL EDITION

In the News

GeneralSurgeryNews.com / General Surgery News / June 2012

In Michigan, Collaborative Programs Improve Quality, Save Money Insurance Company Teams Up With More Than 70 Hospitals; General Surgery and Bariatric Outcomes Improve B y G eorge O choa

ver a three-year period, four collaborative programs sponsored by Blue Cross Blue Shield of Michigan (BCBSM) saved $232.8 million in health care costs and lowered complication and mortality rates, BCBSM and physician leaders of the programs announced in April. An actuarial analysis found that about two-thirds of the savings from the programs—which include general surgery, bariatric surgery, cardiac surgery and angioplasty—benefited hospital patients throughout Michigan, including those with other private insurance plans, Medicare, Medicaid or no insurance, not BCBSM patients. “[W]e want to offer better value to our customers: lower costs and improved outcomes of care,” Thomas L. Simmer, MD, senior vice president, Health Care Value and Provider Affiliation, and chief medical officer, BCBSM, Detroit, said in an interview. “This has been a great way to do that. We have a big social mission: benefiting all patients, not just Blue Cross patients.” Known as Collaborative Quality Initiatives (CQIs), the programs sponsored by BCBSM involve hospitals collaborating to improve care and reduce costs. More than 70 hospitals across Michigan participate in at least one CQI; 12 CQIs are now in operation. The CQIs meet regularly (every three to four months) to share data to find links between medical or surgical processes and patient outcomes, and also to learn from each other to improve outcomes. One CQI, the Michigan Surgical Quality Collaborative (general surgery), saved $85.9 million from 2009 to 2010, and achieved an 18% reduction in surgical site infection and a 15% reduction in patient hospital length of stay. Its project director, Darrell A. Campbell Jr., MD, chief medical officer, University of Michigan Health System, and Henry King Ransom Professor of Surgery, Department of Surgery, Ann Arbor, said in an interview: “I was gratified to see such a substantial savings. Hospital complications are expensive. If you can avoid them, you

EMR

continued from page 3 may circumvent the “thought process” that is so important in developing one’s approach to patient care. Rather than spend time at the bedside analyzing the actual patient, the temptation will be to rely on inputting clinical information to satisfy templates that have been created to populate the cyber-chart. It will be a great temptation to “cut and paste” rather than “inquire and examine”! I recognize all of the positive attributes of having good documentation, especially in a computerized format. I also recognize that it would make the collection of data much easier and reduce the time

will save a lot of money for somebody.” The Michigan Bariatric Surgery Collaborative (MBSC; bariatric surgery) achieved a savings of $14.6 million between 2008 and 2010. The death rate following bariatric surgery fell from 0.21% in 2007 to 0.02% in 2009. The director of this CQI, Nancy Birkmeyer, PhD, associate professor of surgery, University of Michigan Health System, Ann Arbor, said in an interview: “I knew that we’d been effective in reducing rates of complications, and to hear confirmation of cost savings was great.” An example of a cost-saving change in practice, she said, is decreased use of the inferior vena cava filter. “We found they’re not beneficial, they’re harmful. … They’re very expensive—they cost $14,000.” The other programs whose results were measured in the actuarial analysis are the Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative (cardiac and thoracic surgery), which saved $30.3 million between 2009 and 2010, and the BCBSM Cardiovascular Consortium (angioplasty), which saved $102 million between 2008 and 2010. Asked for the essential ingredients for a successful

that many of us spend in the futile exercise of searching for laboratory information, I’s and O’s, drain output, pathology reports and so forth. My concern is that perhaps we have not given enough thought to the consequences of this electronic revolution on medical education and the personal daily involvement with the patient. Hopefully, we can overcome this by discovering ways to integrate the needs of our students into these formats. The greater challenge is to avoid the temptation to let record keeping become the goal of our medical care. The use of templates and static outlines could potentially minimize the traditional need to assess patients, answer

collaborative in general surgery, Dr. Campbell said, “You have to develop the right culture, one where you trust each other and share ideas. How do you develop it? First, financial support is important. Second, the payer needs to be agnostic to the results—we don’t share who’s the best or worst hospital. Third, we use a pay-for-participation model. Everybody gets money, not just those with the best results. This fosters participation.” A participant in the MBSC, Wayne J. English, MD, FACS, clinical assistant professor, Department of Surgery, Michigan State University College of Human Medicine, and medical director, Bariatric & Metabolic Institute, Marquette General Hospital, Marquette, Mich., said a system of bonus incentive payments is used, although there is no penalty regarding agreed-on compensation. “When the collaborative was first developed, surgeons were skeptical about sharing their data. It is not easy to be sitting in the same room as your competitor across town,” Dr. English wrote in an email. “The atmosphere can be very exciting, but also tense, when MBSC participants receive the envelopes containing the data comparing all peers within the state. The blinded data prevents anyone from knowing who anyone else is. The participants all realize that this is not a contest to see who makes it on top of the list and that the process is necessary for programs to improve the quality of care provided for patients.” The most important obstacle to the success of a collaborative, said Dr. Campbell, is the “financial aspect.” “Blue Cross Blue Shield defrayed the cost of the collaborative. That aspect has to be solved, or it becomes more difficult.” Efforts are under way to spread the Michigan model to other parts of the nation, said Dr. Simmer. “We are working with other Blues plans to try to foster it throughout the country.” A significant barrier, he noted, is that “you have to be willing to put your money in a place that doesn’t offer a unique competitive advantage.” Dr. Birkmeyer said: “[Insurance] plans tend to be dominated by business people. Blue Cross Blue Shield of Michigan has realized that collaborative quality improvement doesn’t just save lives but also saves money.” Drs. Birkmeyer, Campbell, English and Simmer reported no relevant financial disclosures.

I think we are at a great tipping point in medicine as a consequence of the technical advances in monitoring patient care. their questions and provide physical diagnostic confirmation of findings on rounds. One could propose a future scenario in which “the team” could sit around a table some distance from the in-patient venue, manipulate a robot with video and audio capability (already marketed!) to visit our patient and then have all of the data transcribed to us on our electronic tablet, allowing us to

create a note that could go seamlessly into the EMR—all of this obviating any need to ever go into the patient room or lay hands on anyone. I think we are at a great tipping point in medicine as a consequence of the technical advances in monitoring patient care. For those who have been involved in medical student and resident education, the EMR and newer methods of data collection must not be a barrier to involvement with patients. Only time will tell how all of this will affect the interface between patients and their physicians. We all need to avoid a “cutand-paste” mentality and the potential that this would lead to high tech, but low touch.

In the News

GeneralSurgeryNews.com / General Surgery News / June 2012

Elderly Derive Same Benefits From Lap Appendectomy as Young B y M onica J. S mith San Diego—Elderly patients who undergo laparoscopic appendectomy appear to experience the same benefits, including less morbidity, fewer surgical site infections and shorter hospital length of stay, as younger patients, according to research presented at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

Although laparoscopic appendectomy is becoming the standard of care for patients with appendicitis, most research on this approach in the elderly population has been limited by small sample size and a lack of subgroup analyses. So Ashkan Moazzez, MD, FACS, lead physician, outpatient surgery and chair, Infection Prevention and Control Committee, H. Claude Hudson Comprehensive Health Center, Los Angeles, and his colleagues at the University of Southern California,

conducted a carefully matched retrospective review of 2005 to 2009 American College of Surgeons National Surgical Quality Improvement Program (ACS/ NSQIP) databases to compare outcomes between elderly patients undergoing laparoscopic or open appendectomy. The researchers analyzed two cohorts of patients aged 65 years and older: an aggregate cohort of 3,674 patients, of whom 2,644 (72%) underwent laparoscopic appendectomy and 1,030 (28%)

underwent open procedures, and a matched cohort based on preoperative risk factors with 1,030 patients in each arm. They also did subgroup analyses of

GeneralSurgeryNews.com / General Surgery News / June 2012

complicated and uncomplicated appendicitis and of patients with high and low American Society of Anesthesiologists (ASA) scores. “NSQIP data is not randomized to treatment trend, which can introduce a selection bias that can affect outcomes. So we used propensity score matching, which is the probability of having a treatment—in this case, open appendectomy—given preoperative risk factors, and matched each patient in the open group with a patient in the laparoscopic group who had the closest propensity score,” Dr. Moazzez said.

In the aggregate cohort, 12 of 27 preor intraoperative risk factors were significantly different between the laparoscopic and open groups. For instance, patients in the open group were more likely to smoke and had a higher rate of pulmonary disease, preoperative wound infection, preoperative sepsis, bleeding disorders and other risk factors. After matching, no statistical differences remained. In the aggregate cohort, patients in the open group experienced a higher rate of minor morbidity than the laparoscopic group, at 9.3% versus 4.5%, which was statistically significant. They also had

In the News a higher rate of overall morbidity and a higher rate of mortality (13.4% vs. 8.2%; P<0.001; and 2% vs. 0.9%; P=0.003, respectively). In the matched group, the laparoscopic group still had a statistically significant edge over the open group in terms of overall and minor morbidity, but mortality difference was no longer significant. “This shows that when patients are matched based on preoperative risk factors, laparoscopic surgery does not have a survival benefit over open appendectomy,” Dr. Moazzez said. Patients in the laparoscopic arm had a lower risk for superficial site infection,

‘I think as our experience matures ... the data will demonstrate that there are benefits to laparoscopy in different subgroups of patients, including older patients.’ —W. Scott Melvin, MD deep incision infection and wound disruption. But they did have a higher rate of organ space infection. “This is a very controversial issue,” Dr. Moazzez said. “Some literature showed this effect, that laparoscopy is associated with a higher rate of intra-abdominal infection. However, a meta-analysis of randomized controlled trials has shown there is no difference, but our study again shows that this is something we see with laparoscopic surgery.” Findings in the subgroup analysis of uncomplicated and complicated appendicitis were similar, with patients in the laparoscopic group generally experiencing less morbidity and fewer surgical site infections, but more organ space infections than those in the open group. The same held true for patients in the subgroup of patients with higher ASA scores. “In almost all groups, patients in the laparoscopic group had a one-day shorter hospital stay and no difference in operating time,” Dr. Moazzez said. In sum, laparoscopic appendectomy is safe in elderly patients, and is associated with less morbidity, lower surgical site infection and shorter hospital stay, but also with a higher rate of intra-abdominal infection. During the commentary following Dr. Moazzez’s presentation, one surgeon noted that despite the rigorous matching, there was still a possibility for selection bias: Surgeons may prefer to do one type of procedure over another and have different pathways, and outcomes could vary depending on the site where the operations were performed. Dr. Moazzez replied that the study did not control for those biases, which was a limitation. “We do have to recognize the limitations of existing bias when we look retrospectively at this data,” said W. Scott Melvin, MD, professor of surgery, The Ohio State University and director, Center for Minimally Invasive Surgery/director, Division GenGI Surgery, The Ohio State University Medical Center. “But this data and modern experience demonstrate that laparoscopy improves outcomes for appendectomy across most groups and populations. I think as our experience matures and we become more comfortable performing laparoscopic cases, the data will demonstrate that there are benefits to laparoscopy in different subgroups of patients, including older patients.”

Surgeons’ Lounge

GeneralSurgeryNews.com / General Surgery News / June 2012

Coverage of the 11th Annual Surgery of the Foregut Symposium All stories written by Jonathan Sloane, MD, from Cleveland Clinic Florida

Dear Reader, Welcome to the June issue of The Surgeons’ Lounge. In this second of our two-part series, we present highlights from the 11th Annual Surgery of the Foregut Symposium, which took place at the Biltmore Hotel, Coral Gables, Fla., February 19-22, 2012, and was hosted by Raul Rosenthal, MD, from Cleveland Clinic Florida. The July issue will resume our regular format and will feature David Hazzan, MD, director of Minimally Invasive Surgery, Carmel Medical Center, in Haifa, Israel. Sincerely, Samuel Szomstein, MD, FACS Editor, The Surgeons’ Lounge Szomsts@ccf.org

A Message From the Symposium Director Dear Readers, I am pleased to share highlights from the recent 11th Surgery of the Foregut meeting. As is our tradition, we had more than 50 faculty members participating from around the globe, who drew an audience of close to 280 surgeons. For the first time this year, and hopefully for many years to come, the Surgery of the Foregut meeting was hosted jointly with the Digestive Disease Institute at the Cleveland Clinic, in Cleveland, which joined forces with the Digestive Disease Institute at Cleveland Clinic Florida, in Weston. In recognition of his devotion and contribution to the field of surgery, Robert E. Hermann, MD, was honored. Dr. Hermann has served as a surgeon and educator and past chairman of the Department of Surgery at the Cleveland Clinic, in Cleveland. Edward H. Phillips, MD, from the Department of General Surgery at Cedars-Sinai Medical Center, in Los Angeles, delivered the inaugural Robert E. Hermann lecture. The highlights of Dr. Phillips’ presentation are among those featured in this issue. For the past 10 years, I have been involved in the research and treatment of gastroparesis, a silent, unrecognized and dreadful disease. In an expert panel from our Gastroparesis Unit, and the presentation of Tom Abell, MD, this disease was discussed at length, and the proceeding is provided in summary for this issue. I hope you will find all the featured articles interesting and thought-provoking, and I look forward to welcoming the readers to our 12th Annual Surgery of the Foregut Symposium in February 2013, in Coral Gables, Fla. Sincerely, Raul J. Rosenthal, MD, FACS, FASMBS Chairman, Department of General Surgery Cleveland Clinic Florida in Weston Ed Phillips, MD (Robert Hermann Honorable Lecture) at right, and Robert Hermann, MD (honoree)

Surgical Management of Gastroparesis At the meeting, symposium director Raul Rosenthal, MD, FACS, spoke about the surgical management of gastroparesis. Gastroparesis is defined as abnormal neuromuscular activity of the stomach, which can lead to antral hypomotility and disordered contractions, resulting in delayed emptying of solids in the absence of mechanical obstruction. The symptoms of gastroparesis include abnormal fullness, abdominal pain, early satiety, heartburn, nausea and vomiting. The causes include diabetes, Parkinson’s disease, intestinal pseudo-obstruction and connective tissue disorders. The disease is diagnosed by upper gastrointestinal (GI) contrast series, upper GI endoscopy, electrogastrography and a stomach-emptying scan. The treatments include dietary modifications, such as small frequent meals; low-fiber, low-fat diet; and high-calorie liquid supplements. Physicians should encourage patients to quit smoking and to maintain good blood sugar control. If lifestyle changes fail, Dr. Rosenthal and his colleagues turn to motility medications such as domperidone (Motilium, Janssen Pharmaceutica), erythromycin (E-mycin or Erythrocin, Eli Lilly) and metoclopramide (Reglan, A.H. Robins). However, 50% to 75% of patients do not tolerate or respond to stomach motility medications. If the disease proves refractory to the medications, gastric electrical stimulation is a safe and effective option that consists of lowenergy pulse stimulation to the stomach. The Enterra device, developed by Medtronic, is implanted laparoscopically under general anesthesia. The procedure takes one to two hours. Patients often go home the next morning and patients can see

benefits two to three months after the procedure. The initial parameters, after implantation of the device, are: • Current=5 mA • Pulse width=330 microsec • Frequency=14 Hz • Cycle-on time=0.1 sec • Cycle-off time=5.0 sec • Impedance=200 to 800 ohms The risks of the procedure include gastric mucosal perforation, electrode displacement, peristimulator seroma, peristimulator skin erosion, insulation break, device infection and lack of response. Investigators from the Cleveland Clinic Florida conducted a study, which included 52 patients with grade 3 gastroparesis, from 2003 to 2011 (Expert Rev Gastroenterol Hepatol 2012 [Epub ahead of print]). Forty-four patients underwent a laparoscopic placement of the gastric stimulator and eight underwent a laparoscopic gastric bypass. In the stimulator group, only 5.8% (n=2) had episodes of vomiting initially, which resolved at six months. At two years, the use of narcotics, prokinetics and antiemetics, and episodes of nausea and vomiting were reduced to less than 25%. Dr. Rosenthal concluded that when medical therapy fails, surgical approaches like the gastric electrical stimulator and gastric bypass procedures are valid treatment options. The stimulator and the gastric bypass procedure can ameliorate the debilitating symptoms of endstage gastric disease, decrease narcotics requirements, return patients to normal oral nutritional intake and offer general improvements in life satisfaction.

Temporary Gastric Stimulation for Gastroparesis At the 11th Annual Surgery of the Foregut Symposium, Thomas L. Abell, MD, professor of medicine, division director and fellowship program director, University of Mississippi Medical Center, in Jackson, presented on the efficacy of using temporary gastric stimulation to treat gastroparesis. Patients with severe symptoms of gastroparesis experience intense pain and represent a cost burden because of frequent hospitalizations for intractable nausea and vomiting. The five-year mortality of patients with gastroparesis is similar to that of patients with congestive heart failure. One study,

for instance, estimated five-year survival to be 67% in 431 patients with gastroparesis (Gastroenterology 2009;136:1225-1233). After medications have failed, the options for treatment are limited to total parenteral nutrition (TPN), feeding jejunostomy tubes, gastric bypass and the gastric neurostimulator. Specifically, Dr. Abell recommended the use of gastric neurostimulator. He noted that between 40 and 50 studies examining the effectiveness of gastric neurostimulators all have shown positive results (Table 1-4). When considering permanent gastric electrical stimulation, the

following factors are taken into consideration: symptoms, gastric emptying test (GET), quality of life (QoL), survival and safety. Dr. Abell conducted a study of more than 600 patients with gastroparesis who successfully received temporary stimulator implants (presentation ASGE 2012). Dr. Abell concluded that temporary gastric neurostimulation may be a useful treatment for patients. However, more research is needed to gain a better understanding of gastroparesis-like illnesses, and more trials should be done to evaluate new applications and technologies to treat it.

GeneralSurgeryNews.com / General Surgery News / June 2012

Surgeons’ Lounge

Understanding Gastroparesis as indicated by observations that gastric pH is higher and pancreatic polypeptide responses to sham feeding are selectively impaired in patients with diabetic gastroparesis. In a preliminary study from a large multicenter database, erythrocyte sedimentation rates and C-reactive protein levels increased more in patients with severe idiopathic gastroparesis than in those with less severe disease. Additionally, the investigators showed that increased levels of antinuclear antibodies were related to presence of nausea, raising the possibility that inflammatory factors may contribute to the pathogenesis of this condition. Delayed emptying of solid food in diabetic gastroparesis generally is believed to result from impaired phasic antral contractions, but other factors contribute. Increased postprandial antral diameter is demonstrable on ultrasound, suggesting tonic motor defects. Increased liquid retention in the fundus and prolonged solid food retention in both the proximal and distal stomach occur in diabetic patients with gastroparesis, demonstrating altered intragastric distribution. Emptying also may be delayed from increased

Alison Schneider, MD, from the Cleveland Clinic in Florida, discussed our current and evolving understanding of gastroparesis. Gastroparesis is a chronic, symptomatic disorder characterized by abnormal neuromuscular activity of the stomach, resulting in delayed gastric emptying in the absence of mechanical obstruction. Basic gastric physiology is shown in the diagram (Figure). Pathophysiologic studies in patients with idiopathic gastroparesis have identified several abnormalities. One investigation observed hypersensitivity to gastric balloon inflation in 29% of patients, which related to increases in upper abdominal pain, early satiety and weight loss compared with those without hypersensitivity (Gut 2007;56:29-36). Impaired fundic accommodation, reported in 43% of patients, was more often associated with increased early satiety and loss of weight than in those with normal accommodation. Vagus nerve integrity can be measured by assessing gastric acid output or pancreatic polypeptide responses to sham feeding. Vagal neuropathy is more severe in diabetic than idiopathic gastroparesis,

Table 1. Effect on Vomiting and Nausea Study or Subgroup

Nat Clin Pract Gastroenterol Hepatol. 2005;2:454.

outflow resistance in the pylorus or the small intestine. The age-adjusted incidence of gastroparesis per 100,000 person-years, from 1996 to 2006, was 9.8 (95% confidence interval [CI], 7.5-12.1) among women and 2.4 (95% CI, 1.2-3.8) among men (Gastroenterology 2009;136:1225-1233). Of patients with diabetes mellitus, 30% to 50% have delayed gastric emptying; 5% to 12% have symptoms associated with delayed gastric emptying; and gastroparesis typically develops more than 10

years after the onset of diabetes. In the idiopathic gastroparesis population, 90% are women, and the mean age at diagnosis is 33.7 years. The Gastroparesis Cardinal Symptom Index (GCSI) is a validated patientassessed gastroparesis symptom severity measure, in which a score is given for each symptom: None=0, Very Mild=1, Mild=2, Moderate=3, Severe=4 and Very Severe=5. The symptoms in the measure see Pathophysiology page 12

Table 3. SF-36 Score Improvements

Mean Difference, Post- to Pre-GES (95% CI) Vomiting Severity Score

Figure. Basic gastric physiology.

Nausea Severity Score

Abell T et al, Gastroenterology 2003;125:421–428

1.30 (0.67-1.93) 1.10 (0.47-1.73)

Forster J et al, Am J Surg 2001;182:676-681

1.20 (0.36-2.04) 1.70 (0.72-2.68)

Lin Z et al, Diabetes Care 2004;27:1071-1076

2.00 (1.38-2.62) 1.90 (1.28-2.52)

McCallum R et al, Clin Gastroenterol Hepatol 2005;3:49-54

0.90 (–0.24-2.04) 2.00 (1.45-2.55)

Total

1.45 (0.99-1.91) 1.69 (1.26-2.12)

Study or Subgroup

Mean Difference, Post- to Pre-GES (95% CI) SF-36 Physical Composite Score

SF-36 Mental Composite Score

Abell T et al, 2003

6.60 (1.38-11.82)

9.00 (3.05-14.95)

Jones MP. Am J Gastroenterol 2003;98:2122-2129

4.10 (–6.39-14.59)

2.50 (–5.92-10.92)

Lin Z et al, 2004

9.70 (4.71-14.69)

9.10 (3.82-14.38)

McCallum et al, 2005

9.10 (2.40-15.80)

9.90 (1.17-18.63)

Total

8.05 (5.01-11.10)

8.16 (4.85-11.47)

Table 4. Requirement for Enteral or Parental Nutritional Support Study or Subgroup

Odds Ratio, Post- to Pre-GES (95% CI)

Abell T et al, 2003

2.58 (0.85-7.86)

de Csepel J et al, Surg Endosc 2006;20:302-306

5.00 (0.49-50.83)

Mean Difference, Post- to Pre-GES (95% CI)

Forster et al, 2001

8.91 (2.10-37.78)

Change in Two-Hour GE

Change in Four-Hour GE

22.00 (18.90-25.10)

12.00 (8.10-15.90)

Gray J. Neurogastroenterol Motil 2006;18:493

65.00 (2.24-1887.35)

Abell T et al, 2003 Lin Z et al, 2004

1.50 (–2.11-5.11)

12.00 (6.00-18.00)

Lin Z et al, 2004

3.89 (1.27-11.95)

McCallum R et al, 2005

15.00 (9.51-20.49)

12.00 (3.69-20.31)

58.00 (46.57-69.43)

21.00 (10.46-31.54)

Mason R et al, Arch Surg 2005;140:841-848

102.14 (5.64-1848.52)

van der Voort IR et al, Exp Clin Endocrinol Diabetes 2005;113:38-42

McCallum R et al, 2005

3.00 (0.67-13.40)

10.50 (–17.56-38.56)

Velanovich V. J Gastrointest Surg 2008;12:1656-1662

6.83 (0.79-59.48)

12.67 (9.76-15.58)

Total

5.53 (2.75-11.13)

CI, confidence interval; GES, gastric electrical stimulation World J Surg 2009;33:1693-1701.

Table 2. Change in Two- and Four-Hour Gastric Emptying (BE) Study or Subgroup

Forster J et al, 2001 Total

23.15 (7.93, 38.37)

the Science Behind PoSitive Patient outcomeS

Minimally Invasive Surgery in Thoracic Procedures Using Advanced Technologies Surgical Treatment and the Advancement of VATS

An Interview With: Shanda H. Blackmon, MD, MPH, FACS

Head, Section of Thoracic Surgery The Methodist Hospital Houston, Texas Assistant Professor of Surgery Weill Cornell Medical College

Thomas Fabian, MD, FCCP Chief, Section of Thoracic Surgery Associate Professor of Surgery Program Director Cardiothoracic Surgery Residency Albany Medical College Albany, New York

Background Lung cancer is the leading cause of cancerrelated mortality among both men and women in the United States.1 With a prevalence rate reaching more than 370,000 people, 6.94% of men and women born today (1 in 14 people) will be diagnosed with lung cancer at some point in their lifetime, according to recent estimates.2 The incidence of lung cancer does appear to be declining in US men, although the rate is rising in women.3 Age also is a critical factor in lung cancer diagnosis: A majority of individuals diagnosed are age 65 or older.1 Nonsurgical treatments include chemotherapy and radiation. Surgical treatments for lung cancer, which are most effective for early stage non-small cell lung cancers, include open thoracotomy or a minimally invasive approach, videoassisted thoracic surgery (VATS).4 Typically, open thoracotomy involves a large incision, significant disruption to the chest muscles and ribs, and an extensive hospital stay.4 VATS is designed to reduce or eliminate these factors of open surgery due to the development of specific surgical technologies and techniques.

General SurGery newS

June 2012

Shanda H. Blackmon, MD, MPH, FACS, head of the Section of Thoracic Surgery at The Methodist Hospital in Houston, Texas, and assistant professor of surgery at Weill Cornell Medical College, has been performing VATS procedures—mostly lobectomies—since 2006. At present, approximately 80% of lobectomies and segmentectomies performed at her institution are VATS procedures. “It’s well established in the literature that VATS procedures have less blood loss, shorter hospital length of stay, significantly less pain, and earlier return to preoperative status and to work,” Dr. Blackmon said. “We definitely see this at our institution, where patients who have VATS procedures stay, on average, 2 days fewer than those who have open procedures.” Thomas Fabian, MD, FCCP, chief of the Section of Thoracic Surgery, associate professor of surgery, and director of the Cardiothoracic Surgery Residency Program at Albany Medical College in New York, has experienced similar benefits in using VATS procedures, which he has performed since 2002. His institution performs approximately 300 VATS procedures each year, of which nearly one-third are lobectomies. Based on this experience, Dr. Fabian noted, “In addition to patients experiencing less blood loss and a quicker return to function, they also demonstrate an increased ability to tolerate adjuvant chemotherapy if required.” He added that the evidence for clinical patient benefits from a VATS approach continues to grow. A randomized American College of Surgeons Oncology Group trial published in The Journal of Thoracic and Cardiovascular Surgery in 2010 demonstrated that patients who undergo VATS procedures tend to have fewer respiratory complications in conjunction with their shorter hospital length of stay.5 Similarly, a recent analysis of the Society of Thoracic Surgeons database by Paul and colleagues found that VATS is associated with lower risk for complications and fewer arrhythmias, blood transfusions, and intubations when compared with open thoracotomy.6 Despite these widely reported benefits, VATS procedures have a relatively low adoption rate in the surgical community at large. “[Community

adoption is] probably less than 20% for VATS lobectomy,” Dr. Fabian said. “There are a number of reasons why it’s so low. One significant reason is that it is a technically challenging procedure and it’s hard to ask surgeons who have been doing a good job with open pulmonary resections throughout their career to suddenly change their dissection technique.” Dr. Blackmon agreed and elaborated, “When earlier generations of surgeons learned to perform lung resections, we were trained to look from the back—to operate from the posterior aspect of the patient toward the anterior aspect of the patient,” she explained. “A VATS lobectomy is more effectively done when approaching the lung from the front, which requires surgeons to reorient themselves with the anatomy.” To address this need, both Drs. Fabian and Blackmon actively participate in and direct courses teaching the VATS technique. Recently, Dr. Blackmon and her colleagues have established 4 new VATS training courses to enable more access to the opportunity for regional and remote surgeons who might not have training opportunities in their locale. Another obstacle hindering widespread adoption of the technique may be lack of confidence in the ability to address challenging surgical situations or the concern that visibility will be limited during VATS. “Some surgeons fear not being able to control bleeding,” said Dr. Blackmon, who discusses the handling of specific difficult intraoperative scenarios in her institution’s training course. In conjunction with training, surgical device technology can play a significant role in these situations.

Use of Surgical Staplers in VATS Dr. Fabian commented that older endoscopic stapler models sometimes were problematic in handling the extra-thick tissue that thoracic surgeons commonly encounter, particularly when completing lung parenchyma in diseased lung fields and during sublobar resections of large tumors or completion of fissures. Dr. Fabian noted, “Today, with the new Endo GIA™ Black reloads with Tri-Staple™ technology from Covidien, I find

11 Supported and approved by

of this improved maneuverability from the curved tip, along with the increased stapling performance from the Tri-Staple™ technology cartridge in one device.” “Generally, there are certain portions of the procedure that in the past have been difficult. Now, in some cases, [these procedures are] much easier to perform when using the curved tip reload,” Dr. Fabian added. “Anything that makes surgery easier to perform usually results in more efficient procedures, which can translate ultimately into a quicker, better operation.”

surgeon—and protecting them with the appropriate proctors and preceptors, and then creating the appropriate credentialing.” The changing health care landscape also will play a role, Dr. Fabian noted. “There are cost issues associated with advancing technologies and the surgical techniques that use them, so it’s very important that physicians try to establish cost benefits from these newer approaches,” Dr. Fabian said. “It [may] cost more for me to do the operation, but these costs are saved in having a shorter length of stay and less recovery time.”

Future Outlook

References

Dr. Fabian believes that in the next 10 years the majority of straightforward pulmonary resections will be performed using VATS. “What we’ll find in the next decade or 2 is not only the routine application of VATS lobectomies, but the application of VATS lobectomies and other pulmonary resections that have not been considered possible in the past—and new techniques to deal with more complex problems,” he said. Such technological innovations as Endo GIA™ reloads with Tri-Staple™ technology and powered devices will undoubtedly play a role making these procedures accessible to more surgeons. “These are the first staplers that were designed with the intention of improving stapling outcomes in thoracic surgery specifically,” Dr. Fabian said. When Dr. Blackmon first trained to perform VATS lobectomy, the latest technology was not yet available. “I was able to adopt this technique with traditional open thoracotomy instruments and traditional laparoscopic staplers,” she said. “But as the equipment improves, it becomes easier to teach other people. I also think the development of instrumentation with double-action hinges and long, curved instruments has facilitated a more rapid adoption of the technology. “The key to this evolution will be our society and national organizations continuing to focus on advanced surgical education,” Dr. Blackmon added. “One of the big issues in thoracic surgery today is teaching surgeons to acquire new technology in a safe and effective manner. This means training the whole team—not just the

american Cancer Society. what are the key statistics about lung cancer? www.cancer.org/Cancer/lungCancer-non-SmallCell/ DetailedGuide/non-small-cell-lung-cancer-key-statistics. accessed april 23, 2012.

national Cancer Institute. Seer Stat Fact Sheets: lung and Bronchus. http://seer.cancer.gov/statfacts/html/lungb.html. accessed april 23, 2012.

edwards BK, ward e, Kohler Ba, et al. annual report to the nation on the status of cancer, 1975-2006, featuring colorectal cancer trends and impact of interventions (risk factors, screening, and treatment) to reduce future rates. Cancer. 2010;116(3):544-573.

Cleveland Clinic. lobectomy, VaTS lobectomy. http:// my.clevelandclinic.org/services/lobectomy/ts_overview.aspx. accessed april 23, 2012.

Scott wJ, allen MS, Darling G, et al. Video-assisted thoracic surgery versus open lobectomy for lung cancer: a secondary analysis of data from the american College of Surgeons Oncology Group Z0030 randomized clinical trial. J Thorac Cardiovasc Surg. 2010;139(4):976-981.

Paul S, altorki nK, Sheng S, et al. Thoracoscopic lobectomy is associated with lower morbidity than open lobectomy: a propensitymatched analysis from the STS database. J Thorac Cardiovasc Surg. 2010;139(2):366-378.

Covidien. endo GIa™ Black reloads with Tri-Staple™ Technology. www.covidien.com/imageServer.aspx/doc206410.pdf?contentID=19 044&contenttype=application/pdf. accessed april 23, 2012.

Dr. Blackmon reports that she is a consultant or advisory board member for Covidien and MAQUET, and has received speaker fees from CareFusion, Covidien, Karl Storz, and MAQUET. Dr. Fabian reports receiving grant/research funding from Covidien. Developed and authored by General Surgery News with the assistance of Shanda H. Blackmon, MD, MPH, FACS, and Thomas Fabian, MD, FCCP, through funding from Covidien.

General SurGery newS

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Sr111

that stapling through thick fissures has become a much easier part of my operation. Additionally, the fixed anvil, stepped cartridge face, new knife blade, and 3 staple heights contribute to the improved performance in thick tissue applications. Due to Tri-Staple™ technology and the larger staple heights, I’m comfortable using the Black reloads on tissues that are easily between 2.25- and 3-mm thick, when compressed.7 “The Black reloads with Tri-Staple™ technology have allowed us to obtain more generous tissues with the sublobar resections,” Dr. Fabian added. “The benefits delivered from the Tri-Staple™ technology configuration allow us to operate with fewer problems.” In addition to thick tissue situations, Dr. Fabian noted that difficult vascular anatomy is particularly challenging in VATS procedures. “In the past, staple technology was quite reliable to maintain hemostasis once fired, but adequately visualizing your dissection plane and encircling vascular structures was a big challenge,” Dr. Fabian said. “Several of the new design changes found on the Endo GIA™ reloads with Tri-Staple™ technology from Covidien, have simplified a challenging step—encircling those vessels—by making the anvil fixed and allowing you to see around corners. One interesting version of the new design is the Curved Tip reload, which allows for improved visualization and maneuverability for the surgeon due to the gold curved tip at the distal end of the reload. This curved tip guides the fixed anvil around target tissues and vessels.” Dr. Blackmon echoed Dr. Fabian’s thoughts on how the Curved Tip reload has improved visibility and maneuverability in the tight spaces of the intrathoracic domain. “When maneuvering around vessels becomes a problem, I find the gold tip of the tan curved tip reload enhances my ability to pass around vessels,” Dr. Blackmon said. “It also comes with a flexible introducer, which I often use to guide the stapler around a posterior ascending pulmonary artery or a posterior left upper lobe pulmonary artery branch that traditionally is difficult to navigate. By passing a leader that guides the stapler, I can now perform that procedure in half the time with more confidence and less risk of avulsing a vessel. It’s a significant leap forward to have the combination

Surgeons’ Lounge

GeneralSurgeryNews.com / General Surgery News / June 2012

Pathophysiology continued from page 9 include nausea, retching, vomiting, stomach fullness, not able to finish a normalsized meal, feeling excessively full after meals, loss of appetite, and bloating stomach or belly that is visibly larger. The grading system is as follows:

•

Grade 1. Mild gastroparesis: symptoms relatively easily controlled; able to maintain weight and nutrition on a regular diet. Grade 2. Compensated gastroparesis: moderate symptoms with only

•

partial control with use of daily medications; able to maintain nutrition with dietary and lifestyle adjustments and medications. Grade 3. Gastroparesis with gastric failure: refractory symptoms that

are not controlled despite medical therapy, frequent physician visits, emergency room visits or hospitalizations, and inability to maintain nutrition via the oral route.

Evolution of Bile Duct Exploration At the symposium, Edward H. Phillips, MD, FACS, director of the Saul and Joyce Brandman Breast Center, A Project of Women’s Guild, chief of the Division of General Surgery, director of the Wasserman Breast Cancer Risk Reduction Program at the Colorectal Cancer Center, at Cedars-Sinai Medical Center, in Los Angeles, presented The Robert Hermann Keynote Lecture entitled “Evolution in the Management of Common Bile Duct Stones.” As the title suggests, Dr. Phillips took meeting attendees through the progress in bile duct exploration over decades and up to the present. The first medical doctor known by name was an Egyptian named Imhotep who lived around 2650 B.C. He was an adviser to King Zoser at a time when Egyptians were making progress in medicine. Among his contributions to medicine was the first textbook on the treatment of wounds, broken bones and even tumors. Imhotep was also an astrologer and architect of the earliest Egyptian pyramid. In later centuries, the Egyptians worshipped Imhotep as a god. In A.D. 150, Aelius Galenus described the humoral hypothesis, which includes diseases of yellow bile. His concepts were based on animal dissections. In 1420, Antonio Benivieni, a Florentine pathologist, described gallstones in women who died with abdominal apoplexy. Andreas Vesalius described the extrahepatic biliary tree in 1543. In 1658, Francis Glisson described his own biliary colic, “from which there is no relief except by death,” and in 1687, Stalpert von der Wiel drained a purulent right-upper-quadrant abscess containing gallstones. In 1733, Jean Louis Petit, MD, wrote that if a patient has biliary colic and redness of the skin, then lance the abscess, remove stones and leave the fistulae. In 1761, Giovanni Morgagni, MD, published the first book on pathophysiology entitled, “The Seats and Causes of Disease Investigated by Anatomy,” which was the only description at

that time of how stones caused disease in humans.

Biliary Surgery Firsts

Ephraim McDowell, MD, performed the first successful abdominal operation to remove a very large ovarian cyst in 1809. The first successful public demonstration of surgical anesthesia took place at Massachusetts General Hospital in 1846; this was a major advancement because anesthe- Figure 2. Choledochoscopy introduced by Dr. McIlver in 1941 in the U.S. sia led to longer operations. Shortly after, biliary surgery began. In 1859, a two-stage cholecystostomy took place by Johann Ludwig Wilhelm Thudichum, MD, followed by a primary suture cholecystostomy in 1867 by John C. Bobbs, MD. In 1878, Marion Sims, MD, performed a primary cholecystostomy but the patient died; however, two months later, Emil Theodore Kocher, MD, performed the same procedure successfully. In 1882, Carl Langenbuch, MD, performed the first cholecystectomy, which was preceded by years of cadaver dissection. The mortality rates then began to dictate what procedure was performed; 16% of patients died from cholecystectomy versus 26% from cholecystostomy. The first choledochotomy was performed by Robert Abbe, MD, in New York in 1889, as a way of treating common bile duct stones. In 1913, Hans Kehr, MD, pub- Figure 3. Laparoscopic common bile duct exploration. lished the first surgical atlas, which described 300 cholecystectomies, 30 choledochotomies and placement of Rigid choledochoscopes were introduced by Monroe a T-tube. In 1898, Charles McBurney, MD, performed McIver, MD, in 1941, followed by the flexible counterthe first transduodenal sphincterotomy for common bile part from Georg Berci, MD, in 1963 (Figure 2). duct stones, and one year later, William Stuart Halsted, In 1974, Meinhard Classen, MD, and Keiichi Kawai, MD, did a choledocho-duodenostomy. In 1901, Dimi- MD, performed the first endoscopic retrograde choltri von Ott, MD, and Georg Kelling, MD, performed angiopancreatography and endoscopic sphincterotomy. the first peritoneoscopy, and in 1913, Dr. Kocher This was a monumental discovery due to the minimally invasive nature of this procedure and proved superior for conducted the first sphincteroplasty. William Halsted, MD, who did the first cholangitis. In 1986, Erich Muhe, MD, performed the choledocho-duodenostomy in 1899, was also first laparoscopic cholecystectomy, followed by Dr. Philinstrumental in transitioning surgery to hospi- lips in 1990 with the first laparoscopic choledochoscopy tals because of better lighting. In 1923, J. Bakes, with common bile duct exploration. MD, performed the first choledochoscopy using Common Bile Duct Stones a “funnel” headlight-illuminated mirror. In a series of 2,000 laparoscopic cholecystectomies, Imaging Firsts 11% had common bile duct stones found with intraopIn 1925, Evarts A. Graham, MD, and War- erative cholangiography; 25% had abnormal liver funcren H. Cole, MD, performed the first cholecys- tion tests (30% of whom had common bile duct stones); tography, which reduced negative explorations. 10% had acute cholecystitis (18% of whom had common By 1931, the first cholangiogram was performed bile duct stones); and 4% had unsuspected common bile by Pablo Mirizzi, MD, further reducing nega- duct stones. In a study by Leon Morgenstern, MD, 220 tive common bile duct explorations to 50% and patients underwent open common bile duct exploration retained stones to 30%. Fluoroscopy with image (Figure 3). Mortality in patients younger than 60 years was successfully performed in 1958 by Pierre was 0% compared with 4.3% in those 60 years and older. Figure 1. Fluoroscopy with Image Amplification performed by Mallet-Guy, MD (Figure 1). Mallet-Guy in 1958. see Surgeons’ Lounge page 14

12 to 14 times more effective

maximised absorption

early enteral feeding

Speed Patient Recovery with Moss Tubes Feeding patients immediately after surgery has been proven to accelerate healing and shorten hospital stays. The best way to adminster post-operative feeding is with Moss Gastrostomy Tubes. Their patented design permits delivery of nourishment directly to the distal duodenum while providing 12 to 14 times more effective decompression than conventional gastric suction devices. In short, Moss Tubes help patients maximise nutritional absorption, experience greater comfort, and enjoy a quicker return to health. For more information, call (800) 827-0470 or fax (518) 674-8067 Moss Tubes, Inc. P.O. Box 378, West Sand Lake, NY 12196-0378

www.mosstubesinc.com

Made in the U.S.A.

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Management of Gastroparesis

GeneralSurgeryNews.com / General Surgery News / June 2012

Table. Effect of Botox Injections on Symptoms and Gastric Emptying in Gastroparesis Author

Etiology

In another presentation, Andrew Ukleja, MD, CNSP, AGAF, assistant professor of medicine in the Department of Gastroenterology at Cleveland Clinic Florida, discussed the goals of treating gastroparesis, including controlling symptoms (nausea and vomiting), improving delayed gastric emptying (prokinetics), and enhancing dietary and nutritional support (correcting electrolytes and nutritional deficiencies). The stepwise progression of treatment options for chronic gastroparesis from base to apex is presented (Figure).

Dose

Follow-up (wk)

Symptom Reduction

Gastric Emptying Improvement

Various dietary modifications can Ezzeddine Diabetic 6 100 IU 6 55% 52% improve patient symptoms, includMiller Idiopathic 10 100 IU 4 38% 48% ing restricting meal volumes, increasLacy Diabetic 8 200 IU 12 55% 33% ing meal frequency to five to six times Bromer Mixed 63 200 IU 20 43% N/A per day, avoiding late evening meals, eating small-particle meals, avoiding excessive fat or dietary fiber, takArts Mixed 20 100 IU 4 29% 35% ing supplementary nutrition, adding high-protein liquid formulas and get- Aliment Pharmacol Ther. 2007;26(suppl 2):37-46. ting support from a specialized dietitian. Metabolic control is another key have significant delays in gastric empty- control is tightly regulating glucose levfactor in improving the symptoms of gas- ing, decreased antral contractility and gas- els, which will result in increased gastric troparesis. Patients with hyperglycemia tric dysrhythmias. The key to metabolic emptying. When gastroparesis is refractory to dietary modifications and glycemic control, medications with gastric prokinetic qualities can be implemented. Between Discover Tri-Staple™ 26% and 75% of patients are intolerant of Technology or unresponsive to promotility medications. When these agents fail, more invasive procedures, such as surgery, become options. Botox injection, for instance, inhibits the release of excitatory transmitters to pyloric muscle and improves gastric emptying (Table). Other options for refractory gastroparesis include switching prokinetic and antiemetic agents, combining prokinetic agents, using a jejunostomy feeding tube, placing a gastric electric stimulator and undergoing gastric bypass. There are several indications for considering placement of a jejunostomy feeding tube for providing enteral nutrition, including severe weight loss (5% to 10%) of usual body weight over three to six months, repeated emergency room visits or hospitalizations for refractory gastroparesis requiring IV hydration/electrolyte replacement or IV promotility medication, or overall poor quality of life. Dr. Ukleja concluded that dietary changes and prokinetic medications are often ineffective; prokinetic drugs are only effective for short-term therapy; and the role of Botox is unclear with limited longterm effects. Nutritional support, howev† er, does seem to play an important role in treating severe gastroparesis. Still, novel medications, including motility drugs, are greatly needed. With its stepped cartridge face, Tri-Staple™ technology delivers graduated compression,

INTELLIGENT DESIGN FOR INTELLIGENT TISSUE COMPRESSION optimizing interaction between the tissue and stapler because it:

• Generates less stress on tissue during compression and clamping1 • May allow greater perfusion into the staple line2 • Provides outstanding performance in variable thicknesses UNIFORM COMPRESSION

Figure. Management of severe chronic gastroparesis. Nat Clin Pract Gastroenterol Hepatol 2008;5:162-171.

GRADUATED COMPRESSION

Stapling Made Smarter Compared with uniform compression, graduated compression produces less tissue stress1

See Tri-Staple™ technology in action at www.tristapletechnology.com Always refer to Instructions for Use supplied with the product for complete Indications, contraindications, warnings, precautions and instructions. 1. When compared to Echelon Flex™ green reloads in computer-generated Aachen model to demonstrate stress imparted on porcine GI tissue during compression. 2. When compared to Echelon Flex™ green reloads in bench top model using a porous medium and saline solution. Beneﬁts are due to graduated tissue compression technology. Device is not software controlled.

†

GeneralSurgeryNews.com / General Surgery News / June 2012

In the News

Nasal MRSA a Risk Factor for Post-op Surgical Site Infections First Study To Document Link in Gastrointestinal Surgery B y D avid W ild San Diego—Preoperative methicillinresistant Staphylococcus aureus (MRSA) colonization increases the risk for surgical site infections (SSIs) and increases hospital length of stay (LOS) following major gastrointestinal (GI) surgery, according to a study presented at the 2012 Digestive Diseases Week. Investigators said the results may justify a policy of universal preoperative nasal swabbing and MRSA decolonization. “Preoperative nasal swab testing with decolonization of MRSA-positive patients could decrease lengths of stay and reduce the incidence of MRSAassociated SSI after major gastrointestinal surgery,” said lead researcher Harry Papaconstantinou, MD, who is chief of colorectal surgery at Scott and White Memorial Hospital, in Temple, Texas. Dr. Papaconstantinou and colleagues conducted nasal swab tests for MRSA and methicillin-sensitive S. aureus (MSSA) in 1,137 patients who underwent major GI surgery between December 2007 and August 2009 (abstract 374). Patients were swabbed within 48 hours of hospital admission. Swabs showed 6.4% (73 patients) were MRSA-positive, 14.7% (167) were MSSA-positive and 78.9% (897) were S. aureus-negative on admission. Demographic traits of the three groups were similar. The researchers found 13.7% (10) of MRSA-positive patients developed an SSI, compared with 4.2% (seven) of MSSA-positive patients and 9.4% (84) of uninfected patients (P<0.05 for MRSA vs. MSSA and uninfected). Patients with SSIs (aggregated across MRSA, MSSA and uninfected groups) had an LOS of 15.7 days, compared with 6.2 days among those with no SSIs (P<0.001). Including individuals with and without SSIs, MRSA-positive patients had significantly longer hospital stays (mean, 12.5 days for MRSA-positive vs. 8.8 and 7.6 days for MSSA-positive and uninfected, respectively; P<0.001). However, when the investigators examined only those with SSIs, they found no significant differences in LOS between patients with wound MRSA colonization and those with MRSA-free SSIs. Mortality rates also did not differ among the three groups, with each approximately 4%. Dr. Papaconstantinou was surprised that 70% of MRSA-positive patients also had MRSA-positive wound

cultures. He said that he expected most post-GI surgery wound pathogens to originate from the gut. In contrast, only 8.5% of patients who had negative nasal swabs had MRSApositive wound cultures (P<0.0001). Philip S. Barie, MD, MBA, professor of surgery and professor of public health at Weill Cornell

Medical College, in New York City, who was not involved in the study, said that MRSA colonization has been linked to an increased risk for SSIs in cardiac and orthopedic surgery patients (J Am Acad Orthop Surg 2012;20:94-101). He said that this is the first study to document a link in the GI surgery patient

population. “These findings get the message out that MRSA-related SSIs can occur after a broader spectrum of operations than was previously believed,” Dr. Barie told General Surgery News. “The question remains as to what is the best course of preventive action. This retrospective study makes an important observation, but does not constitute proof that screening and decolonization will be effective before GI surgery.”

Less pain. Less opioids. OFIRMEV® provides significant pain relief*1 • OFIRMEV 1 g (Q6h) + patient-controlled analgesia (PCA) morphine demonstrated significant pain relief vs placebo + PCA morphine (P<0.05 over 6 h)1 • OFIRMEV 1 g (Q6h) + PCA morphine showed greater reduction in pain intensity over 24 h (SPID24)† compared to placebo + PCA morphine (P<0.001)2

OFIRMEV reduces opioid consumption*1 • OFIRMEV 1 g (Q6h) + PCA morphine significantly reduced morphine consumption vs placebo + PCA morphine (–46% over 6 h, P<0.01; –33% over 24 h, P<0.01)1 • The clinical benefit of reduced opioid consumption was not demonstrated

Schedule OFIRMEV Q6h for the first 24 h • Continue OFIRMEV or transition to PO analgesia based on patient assessment

Indication OFIRMEV is indicated for the management of mild to moderate pain; the management of moderate to severe pain with adjunctive opioid analgesics; and the reduction of fever. Important Safety Information OFIRMEV is contraindicated in patients with severe hepatic impairment, severe active liver disease or with known hypersensitivity to acetaminophen or to any of the excipients in the formulation. Acetaminophen should be used with caution in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment. Do not exceed the maximum recommended daily dose of acetaminophen. Administration of acetaminophen by any route in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death.

OFIRMEV should be administered only as a 15-minute intravenous infusion. Discontinue OFIRMEV immediately if symptoms associated with allergy or hypersensitivity occur. Do not use in patients with acetaminophen allergy. The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients. OFIRMEV is approved for use in patients ≥2 years of age. The antipyretic effects of OFIRMEV may mask fever in patients treated for postsurgical pain. To report SUSPECTED ADVERSE REACTIONS, contact Cadence Pharmaceuticals, Inc. at 1-877-647-2239 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.com. Please see Brief Summary of Prescribing Information on adjacent page or full Prescribing Information at OFIRMEV.com.

*Randomized, double-blind, placebo-controlled, single- and repeated-dose 24-h study (n=101). Patients received OFIRMEV 1 g + PCA morphine or placebo + PCA morphine the morning following total hip or knee replacement surgery. Primary endpoint: pain relief measured on a 5-point verbal scale over 6 h. Morphine rescue was administered as needed. †SPID24=sum of pain intensity differences, based on VAS score, from baseline, at 0 to 24 h.

References: 1. Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. 2005;102:822-831. 2. Data on file. Cadence Pharmaceuticals, Inc.

OFIRMEV and the OFIRMEV dot design are trademarks of Cadence Pharmaceuticals, Inc.

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OFIRMEV.com

In the News

GeneralSurgeryNews.com / General Surgery News / June 2012

Hospitals Feeling Pain of Sedative Shortage B y A dam M arcus

and

G eorge O choa

n late January, the call went out at Rochester Medical Center in upstate New York. Clinicians were advised to dramatically cut back on their use of two mainstay IV sedatives, diazepam and lorazepam, supplies of which were becoming increasingly tight. Curtis Haas, PharmD, director of pharmacy at the hospital, sent an email to

staff clinicians, stating that “we currently have very low supplies of both IV diazepam and IV lorazepam and have directed providers ... to use IV midazolam. However, we’re not counting on receiving any more shipments of any IV products until at least next week and maybe not until mid-February and do expect this shortage to be long-term.” Dr. Haas said he knew the switch to midazolam, although helpful, would only be a temporary solution; he anticipated

there would be a domino effect causing midazolam to become scarce. He thus urged his colleagues to use oral benzodiazepines whenever possible “even in our intubated patients if the gut works,” and to choose propofol for hemodynamically stable intubated patients with gastrointestinal function. For hemodynamically unstable patients, he recommended “trying to use a fentanyl infusion along with intermittent or even ATC [around-theclock] oral [benzodiazepines],” and to use

IV midazolam “as our preferred intermittent-dose benzodiazepine for anxiety and agitation if an oral route is not an option.” Dr. Haas ended the email with an optimistic plea: “We ask that you pass this along to the appropriate providers and encourage judicious use of the IV products. Hopefully, if we all conserve as much as we can we’ll be able to squeeze by until our next shipment.” Unfortunately, as soon as one shortage of sedatives or anesthesic agents is dealt with, another one crops up, Dr. Haas said in an interview. “Just last week [late February], a shortage of preservative-free morphine for neuroaxial anesthesia hit us. Whether it’s Astramorph or Duramorph and other equivalents, they’re simply unavailable. We hear there may be some new shipments coming in early March, but there’s no guarantees; we have maybe enough drug to last another seven to 10 days.” In the meantime, Dr. Haas noted, his colleagues in anesthesiology are looking at possible alternatives, such as fentanyl. “It’s not preferred, but at least it’s an option,” he said. Preservative-free hydromorphone or bipuvacaine are other options for neuroaxial anesthesia, “but bipuvacaine has been in short supply as well. So this is very much still a moving target.”

Nationwide Problem Rochester is far from alone in feeling the pinch on key sedatives and anesthetics. Hospitals across the country are facing similar shortfalls in the supply of these and other important drugs, including certain treatments for cancer. One major facility in the Midwest listed no fewer than eight “new or high-priority” shortages during the second week of January. On the list: etomidate, heparin, ketorolac, morphine, ropivacaine and alfentanil. Those drugs joined a roster of nearly two dozen other agents, from diazepam and midazolam to lorazepam and rocuronium, in the “ongoing” category. Reasons for the low supply are unclear, but involve production issues, indefinite plant shutdowns and drugmakers exiting the market. When they are able, hospitals and clinics adapt by using substitute drugs or stretching their stocks to the limit. When no alternative is possible, many facilities are turning to the so-called “gray market” for pharmaceuticals, a poorly regulated network of suppliers who charge several times the usual rate for the medications. Keith Candiotti, MD, director of clinical research and chief of perioperative medicine at the University of Miami Leonard M. Miller School of Medicine, said his facility recently had been forced to pay as much as 20 times the regular

GeneralSurgeryNews.com / General Surgery News / June 2012

rate for some anesthetic agents. Miami is having trouble finding fentanyl, sufentanil and even midazolam, Dr. Candiotti said, as well as diazepam and lorazepam. “If you are willing to pay a premium you can find drug right now, but the supply is clearly reduced,” he said.

Beyond Anesthesia Although anesthesiologists may have workarounds, other clinicians who depend heavily on benzodiazepines have been even harder hit by the shortages. Gastroenterologists, who rely on the drugs in combination with opioids for endoscopic procedures, are among them, according to Lawrence Cohen, MD, of Mount Sinai School of Medicine in New York City. “We, like many other groups throughout the country, have been affected by the shortage of certain sedatives and opioid drugs,” Dr. Cohen said. “Currently, there are shortages of fentanyl, midazolam and meperidine—the last one created by the unavailability of fentanyl, which has led to increased use and hoarding of meperidine.” The fallout from the sedative shortage could range from limiting the number of endoscopic procedures to a shift in sedation methods, Dr. Cohen continued. In early February, the American College of Gastroenterology wrote to FDA Commissioner Margaret Hamburg, MD, to express its “deep concern” regarding the shortage of sedatives. “Members across the United States are experiencing tremendous difficulty in accessing certain sedative and narcotic agents that are used routinely during endoscopic procedures such as colonoscopy,” the letter stated. “We urge FDA to use its full authority under current law to help resolve these shortages as supplies continue to dwindle.” The letter, which cited shortages of fentanyl, meperidine and midazolam, noted that the cost of endoscopy might rise if gastroenterologists turned to propofol and required the presence of an anesthesiologist to perform monitored anesthesia care. An FDA representative said Dr. Hamburg would “carefully review the letter and respond directly to the American College of Gastroenterology in a timely manner.” On Jan. 18, an FDA interim final rule took effect, broadening the circumstances under which the sole manufacturer of certain critical drugs must report to the FDA about stopping production. No longer will a company that interrupts, but does not permanently cease, the manufacture of a critical drug be exempt from the requirement to give the FDA a sixmonth advance notice. According to the U.S. Department of Health and Human Services, the intent of the presidential

In the News

executive order that led to the rule was “to take action to help reduce and prevent drug shortages, protect consumers, and prevent stockpiling and exorbitant pricing of drugs in shortage.” The rule does not set monetary penalties for failure to provide the required advance notice. Senate bill 296 and House bill 2245 do specify such fines; both bills await committee action. Joseph M. Hill, director of federal legislative affairs for the American Society of Health-System Pharmacists, said there is a “downstream hope” that with more information, the FDA may be

able to work behind the scenes to help stop shortages. Mr. Hill said 2011 was a record-setting year for drug shortages, with 267 reported. At the time this article went to press, the FDA had at least 115 drugs on its list of current shortages, with the latest addition being IV zinc sulfate caused by “manufacturing delays.” Drug shortages create more than logistic headaches for hospitals and clinics—they also pose ethical dilemmas. In a recent editorial in the American Journal of Health-System Pharmacy, Michael Manolakis, PharmD, PhD, assistant

dean at the Wingate University School of Pharmacy, in Wingate, N.C., wrote of three such ethical problems: rationing, hoarding and gray market buying. To the last problem, he wrote: “Despite assurances of pedigree, a purchase from a secondary market represents a disruption in the integrity of the drug supply chain, and it places a patient at risk. Until every hospital refuses to pay the marked-up prices for short-supply products, the problem will persist.”

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In the News

GeneralSurgeryNews.com / General Surgery News / June 2012

ASCO/CAP Guidelines To Determine ER Status May Need Rehaul B y C hristina F rangou Orlando, Fla.—A new study calls into question the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) 2010 recommendations for immunohistochemistry (IHC) estrogen (ER) and progesterone receptor (PR) testing in breast cancer. “We believe that the ASCO/CAP guidelines of using 1% to define ER-positive tumors does not accurately reflect the biology of the tumor,” said Rachel Ellsworth, MD, director of translational breast research, Clinical Breast Care Project, Windber, Pa. “Based on our results, we suggest having greater than 10% concentration of cells would be a more accurate threshold for defining hormone receptor status,” said Dr. Ellsworth, who presented the study at the 2012 annual meeting of the Society of Surgical Oncology (parallel session 21). Prior to 2010, there was no agreement on thresholds for differentiating positive from negative disease. The ASCO/CAP guidelines were created to standardize recommendations regarding the use of targeted therapies by improving accuracy of testing for these receptors and their utility as predictive markers. The current guideline recommends that all ER and PR assays be considered positive if 1% or more of tumor nuclei come up positive and that endocrine therapy should be considered in all ER-positive patients due to its sizeable effect on mortality and relatively low toxicity. The panel cautioned that most prospective data showing correlation between the amount of ER and response to therapy are based on ligand-binding assays (LBA), rather than IHC.

‘Based on our results, we suggest having greater than 10% concentration of cells would be a more accurate threshold for defining hormone receptor status.’ —Rachel Ellsworth, MD Now new research suggests that up to 5% of tumors will stain low, defined as 1% to 10% positive tumor nuclei, and that the underlying molecular biology of these tumors may resemble that of ER-negative tumors. As a result, these tumors are not likely to respond to endocrine therapy. Earlier this year, a retrospective review published in Cancer concluded that endocrine therapy had no effect on survival outcomes in patients with ER/PR less than 10% (2012;118:1498-1506). The study was based on a review of 1,257 patients who were categorized by ER/PR percentages less than 1%, 1% to 5% and 6% to 10%. The study showed low levels of ER/PR expression (1%-5%) by IHC did not appear to have a significant effect on survival outcomes, whereas patients with ER/PR 6% to 10% trended toward a survival effect. The authors concluded that the overall prognosis of patients with low-staining ER “is probably similar” to patients with undetectable ER/PR expression. They concluded: “Although the clinical significance of substantial benefit of endocrine therapy in ER-positive cases is indisputable, we believe its application to patients with low level of ER/PR expression, specifically

those with ER/PR 1% to 10%, needs further study.” The newest findings presented by Dr. Ellsworth, from an ongoing study of more than 5,300 patients treated since February 2001, also support the idea that endocrine therapy does not significantly benefit patients with ER/PR less than 10%. Of these, 1,238 patients underwent IHC staining to determine ER status. The majority were ER-positive, defined as greater than 10% positive tumor nuclei (76%); 19% had ER-negative tumors; and 5% were classified as low-staining with positive tumor nuclei between 1% and 10%. Analysis showed significant differences between patients with low-staining and positive tumors. Patients in the low-staining group were more likely to be younger than age 40 years (14% vs. 4%; P=0.004), to be black (29% vs. 13%; P=0.002), to have TNM stage IV (11% vs. 2%; P=0.001), to have high-grade tumors (60% vs.

According to the ASCO guidelines, the low-staining tumors would be recommended for endocrine therapy. But basal-like tumors, which accounted for nearly two-thirds of low-staining tumors in the study, do not respond to endocrine therapy. 19%; P<0.001) and positive HER2 status (24% vs. 12%; P=0.003). Nearly half (47%) of patients with low-staining tumors in the study were treated with tamoxifen, anastrozole, letrozole or exemestane. Outcomes did not differ significantly between those who received endocrine treatment and those who did not. Low-staining tumors were evaluated by principal component analysis to do a molecular subtype analysis. Results showed that the majority of low-staining tumors were ER-negative subtypes, HER2-enriched (27%) or basal-like (61%). According to the ASCO guidelines, the low-staining tumors would be recommended for endocrine therapy. But basal-like tumors, which accounted for nearly two-thirds of low-staining tumors in the study, do not respond to endocrine therapy. By classifying them as ER-negative, patients with basal-like tumors could be excluded from receiving other therapies, such as poly(ADP-ribose) polymerase (PARP) inhibitors. Funda Meric-Bernstam, MD, the surgical oncologist who worked on the study published in Cancer, said more information is still needed to guide the best management of patients with low-staining tumors. She and colleagues do consider low-staining tumors to be ERpositive, based on the ASCO/CAP guideline, and discuss endocrine therapy with these patients. “Depending on the tumor characteristics, patients with 1% to 10% ER-positive tumors are offered endocrine therapy and also may be offered chemotherapy,” said Dr. Meric-Bernstam, who is also medical director of the Institute of Personalized Cancer Therapy at the University of Texas MD Anderson Canter Center, Houston. Christopher Gallagher, MD, chief of hematology and

medical oncology, and Craig Shriver, MD, chief of general surgery, Walter Reed National Military Medical Center, Bethesda, Md., worked with Dr. Ellsworth on her study. In a joint email, they said that they offer adjuvant hormonal therapy to all women with IHC staining greater than 1%. For women who are otherwise appropriate candidates to receive chemotherapy, they also offer adjuvant chemotherapy to those with small tumors that are lymph node–negative with low-staining ER by IHC (<10%). “Some of this decision process is obviated by genomic testing with assays such as Oncotype Dx that may identify ER low-staining tumors that have high recurrence scores and predict benefit from chemotherapy,” they said, adding that their comments represent their personal views.

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In the News Endocrine

continued from page 1 requiring mastectomy underscores the value of neoadjuvant endocrine therapy,” said lead author John A. Olson, MD, Campbell and Jeanette Plugge Professor of Surgery, University of Maryland Medical Center, Baltimore. Dr. Olson said the findings suggest that it is “reasonable to consider neoadjuvant endocrine therapy for select women who desire breast-conserving therapy.” Dr. Olson presented the results with principal investigator Matthew J. C. Ellis, MD, PhD, professor of medicine and head of breast oncology at Washington University in St. Louis. In two prior international randomized trials of neoadjuvant endocrine therapy, women had objective response rates between 37% and 55%. And at least one study has suggested that an AI can be more effective than tamoxifen (N Engl J Med 2005;353:2747-2757; J Natl Cancer Inst 2008;10:1380-1388). To date, however, U.S. surgeons have lagged behind their European counterparts in adopting neoadjuvant endocrine therapy as general practice due, at least partly, to a lack of large randomized trials examining this possibility. No Phase III randomized comparisons with chemotherapy have been completed, and no large neoadjuvant endocrine studies have been conducted in the United States, further slowing the U.S. adoption rate. The new study is the first large,

multicenter trial to examine this issue in the United States. The results are based on the ACOSOG Z1031 trial, which compared the AIs letrozole (2.5 mg/day), anastrozole (1 mg/day) or exemestane (25 mg/day) in postmenopausal women with ER-rich clinical stage II or III breast cancers and palpable tumors larger than 2 cm. The investigators enrolled 374 women, who were randomized to letrozole, anastrozole or exemestane for 16 to 18 weeks prior to surgery. Surgery was completed between weeks 16 and 18. At the outset of the trial, 163 women were deemed inoperable or in need of a mastectomy. After the four-month course of AIs, 51% of patients originally slated for mastectomy or as inoperable were downgraded to breast-conserving surgery (n=91). Of these, 88% ultimately had successful breast-conserving surgery. Many patients (39%) required a second excision to attain negative margins. All three AIs were associated with a marked improvement. Of the women slated for mastectomy, breast-conserving surgery became possible for 48.1% of those on exemestane, 43.1% of those taking letrozole and 64.7% of those on anastrozole. Although more women on anastrozole were converted to breast-conserving surgery, there was no statistically significant difference between the three therapies, said investigators. In the study, investigators also examined the treatment and clinical factors associated with breast-conserving surgery

‘Conversion from mastectomy to breastconserving surgery in 51% of women who were initially classified as requiring mastectomy underscores the value of neoadjuvant endocrine therapy.’ —John A. Olson, MD

and mastectomy in women who received neoadjuvant endocrine therapy. Overall, baseline clinical T stage was associated with an increased likelihood of conversion from mastectomy to breast-conserving surgery after AI therapy (P<0.001). They noted that the final decision on surgery was the surgeon recommendation in 75% of cases, and patient preference in 25%. Of the 172 patients initially thought to be eligible for breast-conserving surgery, 156 (91%) had that procedure. The first attempt was successful in 66% of patients, whereas 33% required further excision. Seven patients needed mastectomy after a failed attempt at breast-conserving surgery. The overall incidence of pathologic stage I disease following endocrine therapy was between 24% and 45%, and did not differ between treatment arms.

New Breast Cancer Susceptibility Gene Identified B y G eorge O choa

n international team of researchers has identified a new breast cancer susceptibility gene, XRCC2 (Am J Hum Genet 2012;90:734-739). In an interview, senior author Melissa C. Southey, PhD, Grad Dip Law, FHGSA, FFSc (RCPA), professorial fellow and head of Genetic Epidemiology Laboratory, and group leader at the Victorian Breast Cancer Research Consortium, National Health and Medical Research Council, Australia, stated, “We found a gene that when mutated predisposes to breast cancer, and this adds to the small collection of breast cancer susceptibility genes previously identified.” By exome sequencing families with multiple individuals affected by breast cancer, the researchers identified two families with XRCC2 mutations. Subsequently, two further studies were conducted: one a populationbased case-control mutation screening study of XRCC2 and the other additional mutation screening of XRCC2 in index cases from multiple-case families and in male breast cancer cases. The researchers identified six distinct rare variants in the gene that were predicted to severely affect protein function: Two of these variants were protein-truncating mutations and four resulted in missense changes.

GeneralSurgeryNews.com / General Surgery News / June 2012

Dr. Southey, also senior research fellow and deputy head in the Department of Pathology, University of Melbourne, Australia, said the study would be relevant to “clinical oncologists who work with families with multiple cases of breast cancer. This is another gene they can test for.” No commercially available tests have yet been developed based on these findings; however, Dr. Southey said, “I imagine there will be [tests] soon, to help women determine their personal risk for breast cancer. Some treatment choices might be influenced by knowing if a woman has a mutation in XRCC2.” In the paper, the researchers noted that specific targeted treatments such as poly(ADP-ribose) polymerase (PARP) inhibitors might benefit patients whose breast cancer is associated with homologous-recombination DNA repair dysfunction, as is the case with deleterious XRCC2 mutations. The study is the first report of massively parallel sequencing being used in the discovery of a breast cancer susceptibility gene, said Dr. Southey, who called this “one of the really exciting things about this paper.” She added, “We anticipate finding more genes related to susceptibility to breast cancer by applying this methodology.” Massively parallel sequencing has been used previously to identify the genetic explanation for relatively

One-fourth of patients who had mastectomy wound up having T1 disease, indicating that they were surgically overtreated, said Dr. Olson. “The high rate of T1 tumors in patients who had mastectomy suggests that improvements are needed in presurgical staging for women who have neoadjuvant therapy,” he said. Surgeons who heard the study presented said it could have significant implications for patient care. “This is an extremely important study,” said Sheldon Marc Feldman, chief of breast surgery and Vivian L. Milstein Associate Professor of Clinical Surgery at Columbia University College of Physicians and Surgeons, New York City. “The advantage of endocrine therapy is that it is much less toxic than chemotherapy and, if additional studies demonstrate comparable efficacy, they will open the door for many more women to achieve breast conservation.” The study will now move into a second phase. Investigators will follow women enrolled after the original cohort, and will examine whether patients who have a high Ki-67 value (>10%) after two weeks of neoadjuvant aromatase inhibitor treatment experience a higher pathologic response rate than that typically observed for postmenopausal patients with unselected ER-positive rich tumors. If so, investigators believe that an early assessment of Ki-67 proliferation may be a useful approach to the identification of a chemotherapy sensitive subgroup of ERpositive rich tumors.

‘This is the first report applying it to a complex disease. Now the world’s our oyster.’ —Melissa C. Southey, PhD, Grad Dip Law, FHGSA, FFSc

simple autosomal-dominant diseases, Dr. Southey stated. “This is the first report applying it to a complex disease. Now the world’s our oyster.” Dr. Southey is currently using the technique to study genetic predisposition to prostate and colorectal cancers. “A large number of genetic research groups are applying this technology.”

GeneralSurgeryNews.com / General Surgery News / June 2012

In the News

Lynch Mutation Cancer Risks Clarified Fourfold increase in breast cancer risk contradicts previous studies B y C hristina F rangou A new prospective study of patients with Lynch syndrome provides the strongest evidence yet that relatives without the characteristic mutation face no greater risk for cancer than the general population. “Family members who do not have the mutation will not need any more

surveillance than anybody out on the street, based on these findings. That, of course, is a very, very big advantage not only for the patients’ peace of mind but also money-wise for the health system,” said Albert de la Chapelle, MD, PhD, professor of molecular virology, immunology and medical genetics at the Ohio State University in Columbus.

Table. Standardized Incidence Ratios of Cancers in Patients With Lynch Syndromea

The findings, which were published Feb. 13 in the Journal of Clinical Oncology, may have implications for screening and early detection of cancers in patients who do have this mutation (2012;30:958-964). The study provides clearer estimates of the risks for cancers already known to be associated with Lynch syndrome, including colon, uterus, ovary, kidney, stomach and bladder malignancies. It also suggests that people with this inherited disorder a

Next stop: GeneralSurgeryNews.com

Your Grand Central Station for all the latest news, opinions and analysis in surgery.

Endometrial cancer

30.62

Colorectal cancer

20.48

Ovarian cancer

18.81

Renal cancer

11.22

Pancreatic cancer

10.68

Stomach cancer

9.78

Bladder cancer

9.51

Breast cancer

3.95

in AK, Young JP, Lindor NM, et al. Colorectal W and other cancer risks for carriers and noncarriers from families with a DNA mismatch repair gene mutation: a prospective cohort study. J Clin Oncol. 2012;30:958-964,

may have increased risks for breast and pancreatic cancers. This is the first study to show a possible link between breast cancer and Lynch syndrome, contrary to previous studies that found no association between the two (Genes Chromosomes Cancer 2012;51:8391; Clin Cancer Res 2010;16:2214-2224). The finding will need confirmation in larger studies, according to investigators. “Further clarification of the risk for breast cancer for women at various ages is needed to determine the recommended age for mammography for each patient, and to determine whether additional tests such as MRI [magnetic resonance imaging] are warranted for women with Lynch syndrome,” said Mark A. Jenkins, PhD, senior author of the study and associate professor at the University of Melbourne, in Australia. Lynch syndrome is an inherited condition characterized by a mutation in one of the four key mismatch repair (MMR) genes—MLH1, MSH2, MSH6 and PMS2. Carriers are already known to be at high risk for developing some cancers, particularly colon cancer, and are diagnosed at younger ages than the general population. Previous research has suggested that three to five out of every 100 colon cancers are caused by Lynch syndrome. In this study, researchers followed a group of 446 carriers with one of four mismatch repair gene mutations related to Lynch syndrome and 1,029 of their relatives who did not have these mutations. The participants were evaluated at fiveyear intervals at research centers in the United States, Canada and Australia. At a median follow-up of five years, the researchers found that compared with the general population, mutation carriers had a 20-fold greater risk for colorectal cancer (standardized incidence ratio [SIR], 20.48; 95% confidence interval [CI], 11.71-33.27; P<0.001); a 30-fold higher see Mutation page 41

22 Issues for the Bariatric & Metabolic Professional

GeneralSurgeryNews.com / General Surgery News / June 201

Extended Quarterly Coverage

Surgeons Discuss Bariatric Options for GERD and Hiatal Hernias Optimal Approach in Some Patients; Insurance Remains Frustrating Challenge B y M onica J. S mith San Diego—Should bariatric surgery be a part of treatment options for gastroesophageal reflux disease (GERD) and/or large hiatal hernias in obese patients? “Yes!” said Jon C. Gould, MD, emphatically, at the 2012 meeting of the American Society of Gastrointestinal and Endoscopic Surgeons (SAGES). Dr. Gould, associate professor of surgery, Medical College of Wisconsin and chief, Division of General Surgery, Froedtert Hospital, Milwaukee, specializes in bariatric surgery, but a large part of his practice is foregut surgery, and he sees many patients with severe GERD, an increasing number of whom are obese. Although procedures specifically for the treatment of GERD and/or hiatal hernia may address those problems, they do nothing to address the underlying obesity that contributes to or exacerbates those problems and may increase risk for recurrence. The patient with a body mass

index (BMI) of 40 kg/m2 who receives a fundoplication at age 35 is likely to be just as heavy if not heavier 10 years later, and to accumulate the comorbidities associated with obesity. “If they are interested then in pursuing bariatric surgery, it’s going to be much more difficult,” Dr. Gould said. “You’ve burned a few bridges by that point.” Dr. Gould frames the context of bariatric surgery for these patients in three different scenarios. First is the obese patient with GERD who wants help for reflux. “They have been sent to you to talk about fundoplication, but you need to bring up the fact that bariatric surgery is probably the better choice once they get into that BMI category,” Dr. Gould said. “Fundoplication has a higher failure rate [in obese patients], and in my experience, it’s much more difficult to do a Nissen than a gastric bypass on patients with a BMI in the 40s and 50s.” As a surgeon who does a lot of reoperative anti-reflux surgery, Dr. Gould gets a bit frustrated when he sees obese patients with failed fundoplications who were not informed about the option of bariatric surgery. “Even more frustrating is the patient who has a Nissen for GERD and later

‘I’ve done gastric bypasses on people with GERD and they are better immediately. Also, as they lose weight, the elevated intra-abdominal pressure associated with obesity starts to decrease.’ —Jon C. Gould, MD enrolls in a bariatric program and wants surgery,” he said. “They could have had one operation up front. Now it’s a risky procedure because you have to take down the Nissen before doing a gastric bypass.” The second scenario Dr. Gould sees is the patient interested in and indicated for bariatric surgery who turns out to have GERD with or without a hiatal hernia. In this case, the question is whether the choice of bariatric surgery should be guided by the presence of the hernia or the diagnosis of GERD. The third scenario is an obese patient with a large, symptomatic paraesophageal hernia who may or may not have GERD but is experiencing symptoms related to

the hernia such as chest pains or dysphagia. “Should you do a traditional laparoscopoic paraesophageal hernia repair, or manage that hernia with a gastric bypass or sleeve gastrectomy?” For patients from the first scenario, Dr. Gould suggests gastric bypass as an ideal procedure for a variety of reasons (Ann Surg 2010;251:244). After the gastric pouch is created and the stomach is divided, most of the parietal cells remain in the bypassed stomach, so the acid, as well as pepsin and bile, are for the most part mechanically diverted away from the esophagus. “I’ve done gastric bypasses on people with GERD and they are better immediately. Also, as they lose weight, the elevated intra-abdominal pressure associated with obesity starts to decrease,” lowering one of the risk factors for GERD, Dr. Gould said. The evidence is less clear for gastric banding and GERD. In a review of 20 studies of 3,200 patients, “resolution versus improvement, versus worsening of GERD symptoms, versus newly developed GERD symptoms after band placement, it’s all over the map,” Dr. Gould see GERD in Obese page 24

Panel Issues Statement on Sleeve Gastrectomy To Guide Surgeons Experts Stress That Recommendations Are Not a Standard of Care; Based on Opinion, Not Randomized Data B y C hristina F rangou

n international panel of surgeons with expertise in laparoscopic sleeve gastrectomy has issued a consensus statement on best practices, intended to foster standardization and improve safety for this increasingly popular technique. “Standardization of the technique of laparoscopic sleeve gastrectomy (LSG) is paramount to improving the safety and maintaining the minimal morbidity and high weight loss efficacy rates,” wrote the authors in their report, published in Surgery for Obesity and Related Diseases (2012;8:8-19). This marks the first attempt to standardize a bariatric/metabolic surgical procedure with respect to patient selection, technique and complication management based on concurrent best practices, said Kelvin Higa, MD, one of the panelists and clinical professor of surgery, University of California, San Francisco, and director of minimally invasive and bariatric surgery at the Fresno Heart and Surgical Hospital, in California. “It is intended to serve as a guide for both experienced surgeons and surgeons new to the procedure,” he said.

Early studies of the procedure as a standalone He cautioned, however, that the document operation have been “encouraging” was intended to serve as a guide, and not to but the operation is poorly standictate standard of care. dardized; long-term results The field is changing so rapidand randomized studies are ly that already some of the recomlacking. mendations in the statement are In March 2011, 27 of outdated. And among recomthe world’s most experimendations that haven’t been enced surgeons in the affected by newer data, there procedure (all have perwas wide variation, in opinformed at least 500 ions on many items. LSGs) met to develop a “This represents a snapconsensus statement that shot in time and even now, could improve safety and I suspect, some of the constandardization. clusions reached remain Led by Raul J. Rosencontroversial,” said Dr. Higa. thal, MD, professor of sur“For example, Barrett’s gery and chair of minimally esophagus was felt to be an invasive surgery and the bariatabsolute contraindication (81%); ric and metabolic institute, Cleveone might argue as to the severity of Clinic Florida, the panel Barrett’s in relation to other patient ‘This represents a snapshot land agreed on 69 key recommendafactors such as age and cardiopulmotions for best practices, based on nary risk.” in time and even now, their collective experience of more In recent years, LSG has morphed I suspect, some of the from its original role as the first step than 12,000 cases. in a two-stage operation for patients Consensus was determined by conclusions reached with super-morbid obesity to a standgreater than 70% agreement. On remain controversial.’ alone restrictive bariatric procedure in —Kelvin Higa, MD people with less severe obesity. see Consensus page 36

24 Issues for the Bariatric & Metabolic Professional

GeneralSurgeryNews.com / General Surgery News / June 201

Extended Quarterly Coverage

GERD

Obese

continued from page 22

said (Aliment Pharmacol Ther 2009;30:1112). “Data suggests short-term resolution or improvement of symptoms, but in the long term, there are concerns about worsening or newly developing symptoms with the band.” Sleeve gastrectomy is probably not the best option. “There’s data out there suggesting that patients who have GERD at the time of sleeve gastrectomy are very likely to continue to have GERD, and

there is a fair number of people who do not have symptoms prior to sleeve who develop those symptoms later,” Dr. Gould said. In the obese patient with a hiatal hernia, gastric banding could be feasible. “Hiatal hernia has been considered a contraindication for a band, but that’s less nowadays,” Dr. Gould said. In past studies examining the repair of small hiatal hernias (1-2 cm), at the time of band placement, the incidence of band slippage is low. Sleeve gastrectomy may be a good

option for the patient with a large, symptomatic paraesophageal hernia and associated short esophagus in whom it is difficult to mobilize the gastroesophageal junction below the diaphragm during surgery. “A sleeve gastrectomy is like a really long neo-esophagus, a tube that goes all the way down to the pre-pyloric area of the stomach,” Dr. Gould said. “It’s a pretty radical esophageal-lengthening procedure, and it minimizes the opportunity for the stomach to herniate back through the diaphragm into the chest for a recurrent

surgeon preferred anatomical coverage and conformance…

‘When I think a patient needs to have a gastric diversion done, I submit to insurance and typically they reject it.’ —Dimitrios Stefanidis, MD, PhD paraesophageal hernia.” Although there are no long-term data to support sleeve gastrectomy in patients with paraesophageal hernias, Dr. Gould thinks it makes sense. “It’s analogous to the lengthening procedure we would do.” The flip side of success in treating these three patient scenarios with bariatric surgery is the agony of getting insurance to pay for it. “That’s the difficult part,” Dr. Gould said. “You and the patient decide bariatric surgery is the right thing to do, but the insurance company says no and the only thing they’ll pay for is the fundoplication. That’s not an uncommon scenario in my practice and it’s really frustrating.”

Failed Fundoplication

a new dimension in laparoscopic hernia repair.

Find out more about Atrium’s C-QUR CentriFX™ hernia repair solutions at

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Dimitrios Stefanidis, MD, PhD, who has been using bariatric surgery to treat patients after prior failed fundoplications, also usually gets stonewalled at first by insurance companies that reject his request to perform a gastric diversion, which is much like a gastric bypass. “When I think a patient needs to have a gastric diversion done, I submit to insurance and typically they reject it,” said Dr. Stefanidis, who is medical director, Carolinas Simulation Center, Carolinas Medical Center, Charlotte, N.C. “Then I have to talk to one of the medical directors, and most of the time they approve it. They understand the rationale of why it’s important,” said Dr. Stefanidis, noting that this approach does not always work with Medicare, which does not follow a precertification process. Dr. Stefanidis started performing gastric diversions instead of redo fundoplications after noting the high rate of fundoplication failure in obese patients and high recurrence rates of reflux after redo fundoplications. In research presented at the 2012 SAGES meeting, Dr. Stefanidis and colleagues assessed outcomes and quality of life in 25 patients who underwent gastric diversions, which is like a gastric bypass but includes removal of the gastric fundus, after one or more failed fundoplications (S051). The mean BMI was 34.4 kg/m2 (2250 kg/m2). The patients had undergone a total of 40 prior anti-reflux operations, and 23 had associated hiatal hernias. There were no deaths, but 11 patients had complications, and five required reoperation.

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Extended Quarterly Coverage

At 14 months, mean excess weight loss was 60%, and 96% of patients reported being free of reflux and feeling better about their appearance. Many felt the operation had improved their social and sexual lives, and 96% indicated they would do it again. There was no difference in quality of life between the obese and nonobese patients. The researchers concluded that gastric diversion results in excellent control of reflux and improved quality of life, but noted that the procedure can be quite challenging, especially in patients whose anatomy has been severely compromised by scarring from past operations. “We did the vast majority of these cases laparoscopically; many of those patients had two or three prior surgeries, and about 50% had had open surgeries,” Dr. Stefanidis said. “It can take five to seven hours to do these procedures laparoscopically.” A frequent challenge he has faced has had more to do with bowel obstructions due to previous scar tissue and less to do with taking down the Nissen. “Especially after prior open surgeries, a lot of these patients have incisional hernias in the abdominal wall,” Dr. Stefanidis said. In addition to the technical challenges is the difficulty in working with patients who may have trouble adjusting to the impositions of bariatric surgery. “When we do a gastric bypass on obese patients, they know what they’re having and why,” he said. “But the bypass requires a big adjustment phase. You can only eat about one ounce after the surgery, and some of the patients who have the procedure for reflux have difficulty adjusting initially despite the counseling we have given them beforehand.” He often will place a feeding tube in the gastric remnant of normal-weight and/or more complicated patients to help them stay hydrated and avoid hospitalization. Incidentally, although the normal-weight patients also lose some weight early on, they tend to gain most of it back and stabilize at normal. Bipan Chan, MD, of the Cleveland Clinic in Ohio, and colleagues considered an entirely different population in their research on longitudinal gastrectomy—following the principles of a Collis procedure with some elements of sleeve gastrectomy—in obese patients with GERD and/or hiatal hernia. “Most people would agree that the best operation for these patients is a gastric bypass, but there is a patient population that either doesn’t like the idea of gastric bypass or who don’t qualify based on their insurance,” said John H. Rodriguez, MD, a postgraduate year 4 resident with Dr. Chang’s group who presented the research at SAGES (S106). “That leaves these patients untreated because

we don’t want to do an anti-reflux procedure that is likely to fail, and we can’t do a gastric bypass.” Under institutional review board protocol, the researchers performed longitudinal gastrectomy in 19 patients with a mean BMI of 37.8 kg/m2 and type III or IV paraesophageal hernias. Of the 17 who completed follow-up questionnaires on weight loss, patient satisfaction, use of proton pump inhibitors and/or H2 blockers at a 13-month follow-up, there was a significant decrease in symptoms and use of medication. Mean excess weight loss

was 29%, with three patients losing no weight, and some losing quite a bit. In the question-and-answer session following Dr. Rodriguez’s presentation, the procedure was criticized for both destroying the hiatus and for resulting in little weight loss. “Anytime you try something new, you get a lot of criticism,” Dr. Rodriguez said. “Our operation tries to reproduce the anatomic and physiologic components that prevent reflux. It also adds the benefits of weight loss, which reduces the risk for a symptomatic recurrence.”

Dr. Rodriguez explained that they reconstruct the hiatus as they would with any other patient, doing a primary closure and reinforcing with mesh depending on how the defect looks. As for the sleeve portion, which is less restrictive than a traditional sleeve gastrectomy and doesn’t reach as far, the creation of a tubular stomach eliminates the risk for a volvulus in the event of a recurrence. “I don’t think we’re combining the worst of both worlds—I think we’re doing the exact opposite, combining the best of both worlds,” Dr. Rodriguez said.

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the Science Behind PoSitive Patient outcomeS

Advances in Vessel Sealing for Laparoscopic Bariatric Surgery Hierarchy of Needs in Vessel Sealing

An Interview With: George M. Eid, MD

Associate Professor of Surgery Minimally Invasive Bariatric and General Surgery Program University of Pittsburgh Pittsburgh, Pennsylvania

Dean J. Mikami, MD

Assistant Professor of Surgery The Center for Minimally Invasive Surgery Ohio State University Columbus, Ohio

Introduction In 1998, Covidien introduced the LigaSure™ technology for vessel sealing, which has provided surgeons with an alternative to clamps, ties, and cautery. Over the years, the company has created an array of energybased vessel-sealing devices that provide consistent, reliable hemostasis and dissection when used in both open and laparoscopic procedures across a variety of surgical specialties. Bariatric surgery requires a vessel-sealing device that reduces the risk for thermal spread and postoperative complications. Vessel-sealing devices now are being designed to perform tasks such as grasping, cutting, dividing, and sealing to reduce the need for instrument exchanges during procedures. This technology has seen significant improvements over the years, including reductions in thermal spread and smoke production, and the ability to safely dissect and seal larger vessels. The decision of which instrument to use comes down to understanding what each has to offer for laparoscopic bariatric surgery.

George M. Eid, MD, associate professor of surgery, Minimally Invasive Bariatric and General Surgery Program, University of Pittsburgh in Pennsylvania, performs minimally invasive procedures with a focus on bariatric surgery and hernia repair. Dr. Eid described some of the qualities that he desires in a vessel-sealing device. “First and foremost would be good and reliable hemostasis. I want good hemostasis throughout the procedure so I won’t have to worry about any bleeding later on,” he said. Second on Dr. Eid’s list is a device that allows him to effectively seal and dissect larger vessels. “If I get good hemostasis from the first cut, that speeds up the process; I do not have to add sutures or clips to get good hemostasis.” Third, Dr. Eid wants a device that creates minimal tissue damage. Dean Mikami, MD, assistant professor of surgery, Center for Minimally Invasive Surgery, the Ohio State University in Columbus, echoed this sentiment. “The most important thing about any energybased device is its safety profile. I used to use ultrasonic instruments, but I worried about their thermal spread and the extreme heat that was generated at the tip of the instrument as it could damage areas in proximity to what you’re working on,” he said. Finally, Dr. Eid said he wants a device that does not produce a lot of smoke, which can hinder visibility during a case. “And I would like all of these characteristics delivered in a 5-mm device that would allow me to be more versatile in what I can use it for laparoscopically,” he added.

The LigaSure™ 5 mm Blunt Tip Sealer/Divider The LigaSure™ 5 mm blunt tip laparoscopic sealer/ divider is indicated for use across a number of procedures, including colectomy, gastric bypass, Nissen fundoplication, splenectomy, and nephrectomy. It features a 37-cm shaft and is capable of sealing and dividing vessels up to 7 mm in diameter. Dr. Mikami, who has used LigaSure™ technology for more than 7 years and performs in excess of 150 bariatric procedures per year, feels that its ability to seal these large vessels is an important factor.

Table. Properties of Laparoscopic Vessel-Sealing Devicesa

LigaSure™ V

Mean burst pressure, mm Hg

Mean seal time, sec

386

Gyrus PK™

290

11.1

HARMONIC® Scalpel

204

14.3

ENSEAL® PTC

255

19.2

a evaluation conducted on 5-mm bovine arteries adapted from reference 3.

General SurGery newS

June 2012

Figure 1. The LigaSure™ 5 mm blunt tip device mobilizing and sealing short gastrics and larger vessels within the greater curvature of the stomach during a sleeve gastrectomy. Image courtesy of Covidien.

“I’m not afraid to take large vessels down with the LigaSure™ device. With ultrasonic technology, I’d look at a vessel and consider clipping it first, but now I can handle almost every short gastric with the LigaSure™ [5 mm blunt tip sealer/divider] device.” The LigaSure™ 5 mm blunt tip device offers several qualities from Dr. Eid’s list, particularly the one he considers to be of the utmost importance: “The main draw for me is its superior hemostatic capabilities, which any surgeon would be interested in,” said Dr. Eid, who has completed approximately 500 procedures with LigaSure™ devices. LigaSure™ technology has been used successfully in studies of novel laparoscopic techniques, such as singleincision laparoscopic surgery and 3-trocar laparoscopic Roux-en-Y gastric bypass.1,2 Saber and colleagues successfully used a LigaSure™ 5 mm blunt tip device to completely mobilize the stomach, to eliminate any redundant posterior wall in the sleeve, and to exclude fundus from the gastric sleeve.1,2 The LigaSure™ vessel-sealing technology allows surgeons to be confident in the strength of their seals (Table).3 “This technology helps us avoid going back to address bleeding. We don’t have to worry as much as we did in the past,” said Dr. Mikami. Dr. Eid also is confident in the ability of the device to seal larger vessels often found during laparoscopic sleeve gastrectomies, which is the procedure for which he most often uses the device (Figure 1). “In that operation, we have to mobilize the greater curvature where we come across short gastrics and other vessels that can bleed if good hemostasis is not maintained,” Dr. Eid explained. Dr. Eid also uses the LigaSure™ 5 mm blunt tip device for laparoscopic colon resections. The jaw design aids procedures in the large bowel/pelvic cavity by facilitating blunt dissection and allowing bigger tissue bites. Although he does not have any hard data to compare operating times between different vessel-sealing devices, anecdotally, Dr. Eid feels that the LigaSure™

27 Supported and approved by

20-cm shaft

37-cm shaft

44-cm shaft

Figure 2. The complete portfolio of LigaSure™ 5 mm blunt tip devices.

“I can be sure that the trainee has per- in general. “The current instrument has formed those processes because I can good characteristics, but a longer instrusee that they’ve got a good clamp. Sound ment will improve dissection by allowing feedback from the device tells the trainee the surgeon to reach the different parts of and me that it is ready to be used,” added the abdomen without the need to struggle Dr. Eid. “It is very intuitive, which allows or apply additional pressure on the ports,” me to have confidence that the process said Dr. Eid. To better accommodate the needs of has been done properly. That gives it another advantage over the other devices.” surgeons who rely on LigaSure™ techThe blunt tip design of the LigaSure™ nology, Covidien will be introducing a new Ease of Adoption 5 mm blunt tip device is another important version of the LigaSure™ 5 mm blunt tip Dr. Eid, who teaches general surgery feature for both experienced surgeons device with a 44-cm shaft (Figure 2). Drs. residents at the University of Pittsburgh, and residents alike. “Since the tip is blunt, Eid and Mikami believe the longer shaft is particularly impressed by the minimal there’s much less chance of something will allow them to comfortably access learning curve associated with the Liga- bleeding that you don’t want to bleed. difficult-to-reach areas, such as those Sure™ 5 mm blunt tip device. This allows You can grasp things you eventually want near the spleen, hilum, or gastroesophahim to be confident that his trainees can to seal without cutting that tissue,” said geal junction. thoroughly execute a procedure. “This Dr. Mikami. “The 44-cm instrument will make the device is simple to use,” he said. “The The intuitive experience provided by sleeve gastrectomy a much easier opersteps are so simple: clamp, and you will the LigaSure™ 5 mm blunt tip device not ation,” said Dr. Mikami. “Sometimes with hear when it is closed; activate, and when only makes it easier for residents and fel- the 37-cm instrument, you can’t reach you hear a beep, you advance the knife to lows to learn, but it also may reduce post- upper parts of the stomach to take down cut the tissue. Then you open it.” operative complications. “If we can lower the short gastric, regardless of where Dr. Mikami believes that the audio the risk for a postoperative complication— we place the ports. Having that extra cues provided by the ForceTriad™ energy even 1 out of 100—you save a lot of mis- 7-cm shaft is really going to help,” said platform and the LigaSure™ 5 mm blunt ery, time, and money,” said Dr. Mikami. Dr. Mikami. Operating on obese patients tip device offer his surgical residents and gets more difficult the further the surfellows an improved level of confidence. geon works from the port, which happens The Future of Vessel Sealing “This [audio] technology is very importo be where a lot of critical structures are Dr. Eid has been relatively pleased located. “A 44-cm shaft would offer me tant; the active signals tell you when the tissue has been sealed. In the past, we with the ability of the LigaSure™ 5 mm the versatility to reach distant spots, such didn’t have these signals and you had blunt tip device to deliver on the 4 char- as around the angle of His or up in the to rely on visual cues or, during an open acteristics that he looks for in a vessel- gastroesophageal junction,” explained Dr. case, look and feel the tissue,” said Dr. sealing device. But he does see room for Eid. “These are places where you really Mikami. “When I teach residents and fel- improvement with an instrument used don’t want to get any bleeding.” lows, it’s very easy to walk them through for bariatric surgery or any laparoscopic Exposure can be especially challenging procedure performed on larger patients in obese patients with excessive adiposity the steps required to use the device.”

Developed and authored by General Surgery News with the assistance of George M. Eid, MD, and Dean Mikami, MD, through funding from Covidien.

COVIDIEN, COVIDIEN with Logo are U.S. and internationally registered trademarks of Covidien AG. ® Trademark of its respective owner. Other brands are trademarks of a Covidien company. © 2012 Covidien. R0029546

and enlarged livers, so the reduced smoke production offered by the LigaSure™ 5 mm blunt tip device would improve visualization in areas that are hindered by a patient’s anatomy. “This feature would be a major plus for any surgery, but especially the sleeve gastrectomy, which is where I would be using this product,” said Dr. Eid. “The longer shaft length will be advantageous for other laparoscopic bariatric procedures, such as laparoscopic banding, particularly for dissection of the crura and the hernia sac if a hiatal hernia is present,” said Dr. Eid, who uses the current LigaSure™ 5 mm blunt tip device to deal with adhesions in ventral hernias. “In larger patients, I have to work in spots further away from the port. In big hernias, sometimes we have to put the port further out to allow for triangulation further from the abdomen laterally, so having extra length in those cases would be beneficial.”

Conclusion The LigaSure™ 5 mm blunt tip laparoscopic sealer/divider was designed to provide optimal patient outcomes while offering surgeons a comfortable and versatile vessel-sealing option. The LigaSure™ 5 mm blunt tip device offers superior hemostasis and the ability to seal and dissect larger vessels, which is particularly advantageous during bariatric surgery. The instrument confines its effect to the target tissue and allows minimal thermal spread to surrounding tissues. Dr. Eid believes that these features also may decrease operating times for laparoscopic bariatric procedures. With the upcoming release of a new LigaSure™ 5 mm blunt tip device with a 44-cm shaft, bariatric surgeons will have yet another resource at their disposal for operating on larger patients.

References 1.

Saber aa, elgamal M, Itawi e, rao aJ. Single incision laparoscopic sleeve gastrectomy (SIlS): a novel technique. Obes Surg. 2008; 18(10):1338-1342.

Saber aa, elgamal MH, el-Ghazaly TH, elian ar, Dewoolkar aV, akl aH. Three trocar laparoscopic roux-en-y gastric bypass: a novel technique en route to the single-incision laparoscopic approach. Int J Surg. 2010;8(2):131-134.

lamberton Gr, His rS, Jin DH, lindler Tu, Jellison FC, Baldwin DD. Prospective comparison of four laparoscopic vessel ligation devices. J Endourol. 2008;22(10):2307-2312.

Park a, lee G, Seagull FJ, Meenaghan n, Dexter D. Patients benefit while surgeons suffer: an impending epidemic. J Am Coll Surg. 2010;210(3):306-313.

To learn more about the LigaSure™ 5 mm blunt tip portfolio, please scan the QR code (using Scan or Microsoft Tag Reader).

General SurGery newS

June 2012

BB1148

5 mm blunt tip device has reduced his operating time. “I have definitely cut down my operating time because now I do not have to chase any bleeders,” he said. “It also speeds up an operation because I don’t have to clip and suture vessels, which improves safety and reduces complications,” he said. The LigaSure™ 5 mm blunt tip device produces minimal smoke, which is particularly important during minimally invasive procedures. “The LigaSure™ device does produce some smoke, but not as much as some other instruments. I do not have to constantly evacuate and clean up my scope to get better visualization,” said Dr. Eid. “This allows me to maintain good visualization and also makes me more efficient, so the operation goes faster without losing exposure.” The ergonomic design of the LigaSure™ 5 mm blunt tip device is another feature that pleases Dr. Eid. The importance of ergonomics in the operating room is now being recognized. First-generation laparoscopic surgeons have begun to experience the wear and tear associated with the profession.4 “The ergonomics allow for a firm grip of the tissues, and at the same time the tips can still perform blunt dissection,” he said. “That allows me to be more comfortable in the surgery that I’m performing, and it also cuts down on hand fatigue.”

28 Issues for the Bariatric & Metabolic Professional

GeneralSurgeryNews.com / General Surgery News / June 201

Gut Reaction: Metabolic and Bariatric Surgery

Extended Quarterly Coverage Contributor

Jaime Ponce, MD Dalton, Ga.

Robin Blackstone, MD Scottsdale, Ariz.

Walter Pories, MD Greenville, NC

Manuel GalvaoNeto, MD Sao Paulo, Brazil

Emma Patterson, MD Portland, Ore.

Dan Jones, MD Boston, Mass.

Raul Rosenthal, MD Weston, Fla.

Aurora Pryor, MD Stony Brook, NY

Natan Zundel, MD Miami, Fla.

Surgical instrument I can’t live without or substitute with a competitor

I don’t have one, but I sure love my laparoscopic needle driver.

The powered Echelon Flex 60 stapler

Stapler

Harmonic scalpel

Battery-operated linear stapler

Jones anvil grasper

My needleholder

Endostitch

My hands, my brain

The next new standardized procedure in bariatrics will be ––––

Sleeve

A less-invasive procedure with similar efficacy to the gastric bypass

A standardized gastric bypass; we need to know which variations work best.

Gastric plication

Banded plication

Sleeve

Banding for low BMI

Metabolic procedures

Sleeve gastrectomy (yes, we are not there yet)

Percent of sleeves that will require revision at 5 to 10 years

10%-25%

30%

10%

Up to 20%

20%

Few

Between 5% and 10%. Main reasons: intractable GERD and failure of weight loss

All weight loss procedures have some failure rate. I expect sleeve to fall between band and Roux— maybe 10% failure in 5 to 10 years.

Around 25%

Most overrated instrument or medical device in bariatrics is ––––

Robotic instrumentation

Gastric band Mechanical stitching devices—why not use suture off the shelf?

Can’t decide!

The robot

Fork

Stenting

The robot

Pacemakers

My criteria for using gastric band is ––––

Younger, lower BMI, no severe diabetes, able to understand and willing/able to comply

Low BMI, patient exercising and eating well, a driven, successful person with a great ego, strength and little metabolic disease

Perhaps in teenagers and the highrisk superobese

No bands anymore ...

Patient who meets FDA criteria and wants a band

BMI >35 kg/ m²

BMI <50 kg/ m² and no hiatal hernia

When the paitent prefers a band after I describe the risks and benefits, and, most importantly, failure rates of various procedures

Patient preference, if case does not go against my contraindications for the band: diabetes, BMI >45 kg/ m², hiatal hernia >4 cm, GERD, Barrett’s, and sweet eaters

Greater curvature plication is ––––

Experimental, maybe

Don’t do it unless you are using an IRB. We don't know how it works.

Not ready for broad Limited perspective It is investigause in mature bariatric tional and hopes to be as good as markets a sleeve

I plicate the distal staple line

Experimental; needs to be studied in control trials

Interesting, may save money; not likely reversible

Ok for some secondary obesity revisions (eg, dilated gatric pouches, dilated sleeves); revisions after primary plication: Ouch

Adding greater curvature plication to the gastric band— yes or no?

Experimental, maybe

It is investigational, and I think has the potential to “turbo charge” the band’s early satiety and weight loss

Usually

More experimental than plication alone

Maybe; could be beneficial; could just increase risk

No, that’s like adding bile reflux to acid reflux. The patient does not get the benefits of either, but will get the complications

Centers of excellence

We are all excellent, let's move to quality improvement

One standard in metabolic and bariatric surgery with the ACS through a successful transition to the unified MBS-AQIP

Proof that major surgery can be performed effectively and safely on highrisk patients when surgeons and the setting are optimal

Way to go in order to have bariatric surgery establish a good reputation

Have helped us raise the quality of bariatric surgery, our outcomes and our respect

Surgery at its best and worst

The one that has good results independent of volume

Raising the bar in patient care, but need more evidence-based decision making

Need to adapt now to lower standards? We also need a mechanism to evaluate our COE parameters.

Accepted procedures for the diabetes patient—early, with one medication

Band, sleeve, bypass, [duodenal switch]

Sleeve, LGBP

Gastric bypass

Yes, if one defines early as at least two to three years of disease with poor control; less than that, and IRBapproved trial is preferred.

Band, sleeve or bypass

Band, sleeve, Depending on BMI and age, all are bypass, acceptable [duodenal] switch

Accepted procedures for the diabetes patient—late, with insulin requirement

Bypass, [duodenal] switch, sleeve

LGBP, LDS

Gastric bypass

Yes, but know that insulin users may have a poorer response

Band, sleeve or bypass

Bypass, [duodenal] switch, sleeve

Depending on BMI and age, all procedures are valid

Use of stent for sleeve leak

The best choice

Every single time ... early

Seems to be useful Use it as early as possible (up to 30-40 days)

Yes, early

Not yet

An option for acute, Works well most of the time early and late leaks; Would not use after 12 wk

All procedures are ok, RYGB, sleeve, BPD, but I prefer bypass band.

I encourage bypass (or switch) for these patients

RYGB, BPD

As early as needed, (esp if simultaneous with stricture), but not that good ≥12 wk

BMI, body mass index; BPD, biliopancreatic diversion; COE, centers of excellence; DS, duodenal switch; GERD, gastroesophageal reflux disease; IRB, institutional review board; LDS, laparoscopic biliopancreatic diversion with duodenal switch; LGBP, laparoscopic gastric banding procedure; MBS-AQIP, Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program; RYGB, Roux-en-Y gastric bypass

GeneralSurgeryNews.com / General Surgery News / June 2012

29 Issues for the Bariatric & Metabolic Professional

Extended Quarterly Coverage

See introduction on page 30. Christine RenFielding, MD New York, NY

Alfons Pomp, MD New York, NY

Kelvin Higa, MD Fresno, Calif.

John Morton, MD Stanford, Calif.

Jeff Allen, MD Louisville, Ky.

Marina Kurian, MD New York, NY

Dan Herron, MD New York, NY

Ricardo Cohen, MD Sao Paulo, Brazil

Michel Gagner, MD Montreal, Canada

Colleen Hutchinson

Nathanson liver retractor

Harmonic

Harmonic Ace

Jarit NeedleDriver—simply the best

Nathanson liver retractor

I love my brand of Nathanson retractor with staplers and would its table-mounted holder never change without hard data

Endostitch

None

Dr. Natan’s answer

Sleeve

Has there ever been a standardized procedure in bariatrics?

What operations are standardized now? None

Extra-gastric compression

An endoscopic procedure that is yet to be mainstream

Sleeve gastrectomy with duodenal jejunal bypass or ileal interposition

I didn’t realize there were Short DS any “standardized” procedures in bariatrics ... all are done slightly differently by each surgeon

Second stages after sleeve gastrectomy

The high level of parity in opinion on basic procedures here is astounding.

30%

35%

20%, just like all other procedures

Small; <5%

Cup is half empty: 50%

Probably 10%15%, if patients are following a low glycemic diet

55% Very few (<5%) will require revision, but up to 10% may seek additional surgery for a secondstage procedure for more weight loss.s

Depends on initial BMI; BMI <50 kg/ m2=15%

I made sure Ricardo’s 55% was not a typo. He and Walter are on opposite ends of the spectrum here, which is unusual.

Any single-port access device

Lap-Band

Robot

Long instruments

Different stapler loads

Hmmm … maybe Endo barrier

The robot

Adjustable gastric banding

Robotics

Wow, not a good day for the robot.

Previous successful nonsustained weight loss; comprehensive understanding of band as a tool

Becoming more difficult to justify this operation

Becoming narrower with time

BMI <50 kg/m², no Patient choice, serious reflux, and excepting contraindications motivated, local patient

Patients who are interested and are willing to commit to the after care

The patient will not accept sleeve gastrectomy or bypass, or their insurance will not accept sleeve gastrectomy

Never

No more

Kelvin seems to hit the nail on the head of the trend here.

Bad; more complications than sleeve

How will we revise this?

Not optimistic it will be a viable option

Interesting idea and time will tell

Cup is emptier as primary standalone procedure

It’s investigational and without longer-term results, it’s hard to offer it to patients

That its benefits are unclear and unproven, and do not warrant its risks for surgical morbidity and weight regain

Waste of time

Cheap in the developing world

Raul wins for clean answer of the month

Yes

Bells and whistles to a bad operation

Holy crap! Are you kidding? No!

Need a randomized trial

May help a little, but also may increase risk

It may work for initial banding patients

Two suboptimal procedures do not add up to one good procedure

Never

No bands; therefore, No!

Kelvin wins for honest answer of the month

Is now very confusing

Here to stay

Isn’t “Centers of Competence” a more accurate description?

Improved outcomes; bariatric surgery in last decade is a surgical success story. Nationwide, a 0.2% 30-day mortality rate

A necessary evil? Hopefully will evolve into a useful concept

A great proactive idea and I love the changes to come! Who better than the surgeons to identify excellence?

Will be significantly improved by the unification of certifying organizations

A way to deliver quality

Not excellent yet

I’m with Jaime

Band, sleeve

Bypass or sleeve

All, but application depends on other variables

Absolutely. Why wait for disease progression? Band, bypass, sleeve: all for one and one for all

Depending on the patient, any of the big 4 may be appropriate

Absolutely! Nip it in the bud.

I lean toward gastric bypass, but any metabolic/bariatric procedure is better than nonsurgical therapy. The operation needs to be individualized to the patient’s needs and desires.

Must be customized, no general rule

Sleeve

There is basic common acceptance here; Marina nails it.

RYGB

Bypass or sleeve

All, but application depends on other variables

Bypass is best, but any surgical intervention is better than no surgical intervention

Depending on the patient, any of the big 4 may be appropriate

Sleeve, bypass band and DS

Same as my above answer, but I might consider duodenal switch more strongly

Must be customized, no general rule

Sleeve ±DS, Second stage

John Morton = truth!

Yes

Indicated for early leaks, but don’t eternalize

I wish it would work better than it does.

Can be helpful if used early and appropriately

An option for a potentially recalcitrant problem

Definitely; make sure the angularis is dilated before sleeve placement

Very important, probably approaching the standard of care

Sometimes it works; but it’s a long process

Yes, in acute leaks (nitinol, silicone-covered)

Although most say yes, especially to early leaks, this is no consensus

O nthe

Spot with Colleen Hutchinson

CMS Versus the Sleeve

Plus, Monster ‘Gut Reactions’ and Other Candid Pearls

This month’s On the Spot was a collaboration with thought leaders in the field and specifically with Jaime Ponce, MD, incoming president of the American Society of Metabolic and Bariatric Surgery (ASMBS). Here’s an excerpt of our wrap-up on this one (the rest is off the record): Dr. Ponce: Colleen, when you interview an expert surgeon, how do you prepare for it? Colleen Hutchinson: Ok, well first, sign this nondisclosure. … No, really, I look at who has published recently on what topics, and then I listen to them while at the podium and when they step down from the podium—as they’re speaking un-miked with colleagues, in the meeting rooms, at dinner, in emails. … You name it. And, I always follow up on suggestions of collaborators and topics that I receive. There is food for thought and debate everywhere in surgery, and especially in bariatrics right now, and I like to give those who give so much time to research and education

Statement

(beyond their OR time) a platform to share in a way they can’t when they’re speaking into a microphone. Then I put them on the spot and let ‘em go and this is what I get. Think they were candid here, Dr. Ponce? Dr. Ponce: Of course, I wouldn’t expect any different from these experts! Do you prefer to ask questions via email interview, by phone or live with a glass of wine? CH: Well, a glass of wine is always nice. Let’s go work on five more columns! Seriously, what’s the boldest answer you read here, Jaime? Dr. Ponce: Let’s see, it has to be one of the following: Allen’s expectation to revise 50% of the sleeves and Ricardo’s

Laparoscopic sleeve gastrectomy should be a covered procedure by Centers for Medicare & Medicaid.

Michel Gagner, MD: Should CMS [Centers for Medicare & Medicaid] not cover the sleeve?—Wow! I think that CMS should continue to cover laparoscopic adjustable gastric banding (LAGB), which was approved by the FDA without any randomized studies in 2011 (initially unapproved by the expert panel, and disregarded). CMS should continue to cover LAGB, which has been approved by CMS experts without their own randomized studies. CMS should cover their eyes on costs of LAGB reoperations. CMS is continuing to cover vertical-banded gastroplasties (VBG), which has been proven to be inferior for weight loss than Roux-en-Y gastric bypass in all eight published randomized studies. VBG was shown to be superior to LAGB in randomized studies before CMS approval. Duodenal switch was approved by CMS without any randomized studies (they were done after). So, if sleeve is inferior to gastric bypass in randomized studies, will they approve it, since the outcome will likely be the

GeneralSurgeryNews.com / General Surgery News / June 201

same as VBG versus gastric bypass? If they are consistent, then the answer is yes. If the results of randomized studies show the sleeve to have superior results compared with LAGB in randomized studies (level 1 evidence already exists), should they approve it? Yes. Therefore, no randomized studies are necessary (it does not seem to matter to CMS whether the results are inferior or superior in randomized studies!), and CMS should cover the sleeve right away, or they do not have any logic. Natan Zundel, MD: Of course! CMS arrived to conclusions without including or considering the most relevant current sleeve publications. With the data available, the sleeve is a great surgical option for patients in need of an operation, one that fits perfectly in between the gastric bypass and the gastric band in terms of weight loss, complications, and total results—and this also is a procedure that does not include the presence of a

55% of sleeves, Higa’s “Holy crap!” for plicated bands and “antichrist” for the insurance companies, Rosenthal’s “funny” for single-port and “cute” for robotics, Pories’ reminder about “pen and paper,” Zundel’s most needed “hands and brain,” Ren’s confusion about centers of excellence, and Higa’s ASMBS is “family.” [Editor’s note: some of these answers appear in Part 2 of the Gut Reaction, in the July 2012 issue.] CH: Did you have to lower your own level of candor being that you are the incoming president of ASMBS? Honestly? Dr. Ponce: Not really, I try to behave myself as always. CH: What’s a question no one will answer? Dr. Ponce: I think this group of surgeons will answer anything! CH: I’ll bear that in mind. ASMBS appears to be really coming into its own based on responses shared in this On the Spot, in terms of levels of growth, respect,

impact and international weight and collaboration. We’ve seen tremendous growth and momentum. What’s next for ASMBS in 2013? Dr. Ponce: We have several challenges and work to do for next year: First, we need to finalize and implement our new quality improvement program so that we can improve quality, access and insurance acceptance. At the same time, we need to be able to offer our quality process to our international colleagues. Second, we need to consolidate our new annual meeting structure that will be called “Obesity Week” to become the best and largest obesity meeting in the world as a joint venture with The Obesity Society. Finally, another important challenge will be to establish guidelines for new procedures to be recognized or approved by the ASMBS—specifically what kind of data or studies are needed, number of studies, follow-up and quality. CH: Thanks, Jaime. That’s a wrap.

foreign body and is very cost-effective. Other procedures with worse results and more complications have been accepted.

Manoel Galvao Neto, MD: I’m not fully aware about this matter as I am not American, but it may be useful to know the status of sleeve gastrectomy coverage in Brazil. The surgical societies headed by the Brazilian Society of Bariatric and Metabolic Surgery recommended and got approval for the sleeve gastrectomy as a primary bariatric procedure by the Brazilian Federal Consul of Medicine and, consequently, this procedure is now fully covered by private and public insurance in morbidly obese patients.

Dan Jones, MD: Yes. The data clearly show that sleeve patients lose more weight compared with those receiving a lapband and it’s a less risky operation than Roux-en-Y gastric bypass (Ann Surg 2011;254:410-420). Jeff Allen, MD: The sleeve is evolving into a viable option for morbidly obese patients based on early U.S. and intermediate international data. It is unclear to me if this restrictive procedure will add long-term benefit when compared with the adjustable gastric band. However, there are patients who request and prefer this operation based on the research they have done and the education they received from their surgeons. In fact, some patients will say they want this operation or none at all. With this in mind, it should be covered by CMS. If this requires a trial to determine effectiveness, then I applaud their effort to ensure its efficacy.

Jaime Ponce, MD: Yes, because 1) CMS analysis did not include recent studies that can add to the data validation of this procedure; 2) CMS patients are in many instances not acceptable candidates to the options already accepted by CMS: sometimes they are too sick for gastric bypass and sometimes they are less complaint for the needed gastric band follow-up and adjustments. The sleeve gastrectomy has taken a role in some patients who need a stronger effect from the procedure that doesn’t limit their ability to obtain outcomes see On the Spot page 32

TYGACIL is in the IDSA/SIS guidelines for cIAI and the SIS guidelines for cSSSI.1,2

Expanded broad-spectrum coverage * is on your side

*TYGACIL does not cover Pseudomonas aeruginosa.

TYGACIL is indicated for the treatment of adults with: s Complicated skin and skin structure infections caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, Enterobacter cloacae, Klebsiella pneumoniae, and Bacteroides fragilis s Complicated intra-abdominal infections caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros s Community-acquired bacterial pneumonia caused by Streptococcus pneumoniae (penicillin-susceptible isolates), including cases with concurrent bacteremia, Haemophilus inямВuenzae (beta-lactamase negative isolates), and Legionella pneumophila

Important Safety Information s 4 9'!#), IS CONTRAINDICATED IN PATIENTS WITH KNOWN HYPERSENSITIVITY TO TIGECYCLINE s !NAPHYLAXIS ANAPHYLACTOID REACTIONS HAVE BEEN REPORTED WITH NEARLY ALL ANTIBACTERIAL AGENTS INCLUDING TIGECYCLINE AND MAY BE LIFE THREATENING 49'!#), SHOULD BE ADMINISTERED WITH CAUTION IN PATIENTS WITH KNOWN HYPERSENSITIVITY TO TETRACYCLINE CLASS ANTIBIOTICS s )SOLATED CASES OF SIGNIl CANT HEPATIC DYSFUNCTION AND HEPATIC FAILURE HAVE BEEN REPORTED IN PATIENTS BEING TREATED WITH TIGECYCLINE 3OME OF THESE PATIENTS WERE RECEIVING MULTIPLE CONCOMITANT MEDICATIONS 0ATIENTS WHO DEVELOP ABNORMAL LIVER FUNCTION TESTS DURING TIGECYCLINE THERAPY SHOULD BE MONITORED FOR EVIDENCE OF WORSENING HEPATIC FUNCTION !DVERSE EVENTS MAY OCCUR AFTER THE DRUG HAS BEEN DISCONTINUED s 4HE SAFETY AND EFl CACY OF 49'!#), IN PATIENTS WITH HOSPITAL ACQUIRED PNEUMONIA HAVE NOT BEEN ESTABLISHED s An increase in all-cause mortality has been observed across phase 3 and 4 clinical studies in TYGACIL-treated patients versus comparator-treated patients. The cause of this increase has not been established. This increase in all-cause mortality should be considered when selecting among treatment options s TYGACIL may cause fetal harm when administered to a pregnant woman s The use of TYGACIL during tooth development may cause permanent discoloration of the teeth. 49'!#), SHOULD NOT BE USED DURING TOOTH DEVELOPMENT UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED s !CUTE PANCREATITIS INCLUDING FATAL CASES HAS OCCURRED IN ASSOCIATION WITH TIGECYCLINE TREATMENT #ONSIDERATION SHOULD BE GIVEN TO THE CESSATION OF THE TREATMENT WITH TIGECYCLINE IN CASES SUSPECTED OF HAVING DEVELOPED PANCREATITIS s Clostridium difямБcile ASSOCIATED DIARRHEA #$!$ HAS BEEN REPORTED WITH USE OF NEARLY ALL ANTIBACTERIAL AGENTS INCLUDING 49'!#), AND MAY RANGE IN SEVERITY FROM MILD DIARRHEA TO FATAL COLITIS s -ONOTHERAPY SHOULD BE USED WITH CAUTION IN PATIENTS WITH CLINICALLY APPARENT INTESTINAL PERFORATION s 4 9'!#), IS STRUCTURALLY SIMILAR TO TETRACYCLINE CLASS ANTIBIOTICS AND MAY HAVE SIMILAR ADVERSE EFFECTS 3UCH EFFECTS MAY INCLUDE PHOTOSENSITIVITY PSEUDOTUMOR cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, and hyperphosphatemia). As with tetracyclines, pancreatitis has been REPORTED WITH THE USE OF 49'!#), s 4O REDUCE THE DEVELOPMENT OF DRUG RESISTANT BACTERIA AND MAINTAIN THE EFFECTIVENESS OF 49'!#), AND OTHER ANTIBACTERIAL DRUGS 49'!#), SHOULD BE USED ONLY TO TREAT INFECTIONS PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY SUSCEPTIBLE BACTERIA !S WITH OTHER ANTIBACTERIAL DRUGS USE OF 49'!#), MAY RESULT IN OVERGROWTH OF NON SUSCEPTIBLE ORGANISMS INCLUDING FUNGI s 4HE MOST COMMON ADVERSE REACTIONS INCIDENCE ARE NAUSEA VOMITING DIARRHEA INFECTION HEADACHE AND ABDOMINAL PAIN s 0ROTHROMBIN TIME OR OTHER SUITABLE ANTICOAGULANT TEST SHOULD BE MONITORED IF 49'!#), IS ADMINISTERED WITH WARFARIN s #ONCURRENT USE OF ANTIBACTERIAL DRUGS WITH ORAL CONTRACEPTIVES MAY RENDER ORAL CONTRACEPTIVES LESS EFFECTIVE s 4HE SAFETY AND EFFECTIVENESS OF 49'!#), IN PATIENTS BELOW AGE AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED Please see brief summary of Prescribing Information on adjacent page. References: 1. 3OLOMKIN *3 -AZUSKI *% "RADLEY *3 ET AL $IAGNOSIS AND MANAGEMENT OF COMPLICATED INTRA ABDOMINAL INFECTION IN ADULTS AND CHILDREN GUIDELINES BY THE 3URGICAL )NFECTION 3OCIETY AND THE )NFECTIOUS $ISEASES 3OCIETY OF !MERICA Clin Infect Dis 2. -AY !+ 3TAFFORD 2% "ULGER %- ET AL 3URGICAL )NFECTION 3OCIETY 'UIDELINES 4REATMENT OF COMPLICATED SKIN AND SOFT TISSUE INFECTIONS Surg Infect 3. 49'!#),┬о TIGECYCLINE 0RESCRIBING )NFORMATION Wyeth Pharmaceuticals Inc. TYG281206-01 ┬й 2011 PямБzer Inc. All rights reserved. Printed in USA/April 2011

the

On the Spot 2012

Spot

continued from page 30

TYGACIL® (tigecycline) Brief Summary See package insert for full Prescribing Information. For further product information and current package insert, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556. INDICATIONS AND USAGE TYGACIL is indicated for the treatment of adults with complicated skin and skin structure infections caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates), Staphylococcus aureus (methicillinsusceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, Enterobacter cloacae, Klebsiella pneumoniae, and Bacteroides fragilis. TYGACIL is indicated for the treatment of adults with complicated intra-abdominal infections caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros. TYGACIL is indicated for the treatment of adults with community-acquired pneumonia infections caused by Streptococcus pneumoniae (penicillin-susceptible isolates), including cases with concurrent bacteremia, Haemophilus influenzae (beta-lactamase negative isolates), and Legionella pneumophila. CONTRAINDICATIONS TYGACIL is contraindicated for use in patients who have known hypersensitivity to tigecycline. WARNINGS AND PRECAUTIONS Anaphylaxis/Anaphylactoid Reactions Anaphylaxis/anaphylactoid reactions have been reported with nearly all antibacterial agents, including TYGACIL, and may be life-threatening. TYGACIL is structurally similar to tetracycline-class antibiotics and should be administered with caution in patients with known hypersensitivity to tetracycline-class antibiotics. Hepatic Effects Increases in total bilirubin concentration, prothrombin time and transaminases have been seen in patients treated with tigecycline. Isolated cases of significant hepatic dysfunction and hepatic failure have been reported in patients being treated with tigecycline. Some of these patients were receiving multiple concomitant medications. Patients who develop abnormal liver function tests during tigecycline therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing tigecycline therapy. Adverse events may occur after the drug has been discontinued. Mortality Imbalance and Lower Cure Rates in Ventilator-Associated Pneumonia A study of patients with hospital acquired pneumonia failed to demonstrate the efficacy of TYGACIL. In this study, patients were randomized to receive TYGACIL (100 mg initially, then 50 mg every 12 hours) or a comparator. In addition, patients were allowed to receive specified adjunctive therapies. The sub-group of patients with ventilator-associated pneumonia who received TYGACIL had lower cure rates (47.9% versus 70.1% for the clinically evaluable population) and greater mortality (25/131 [19.1%] versus 14/122 [11.5%]) than the comparator. Use During Pregnancy TYGACIL may cause fetal harm when administered to a pregnant woman. If the patient becomes pregnant while taking tigecycline, the patient should be apprised of the potential hazard to the fetus. Results of animal studies indicate that tigecycline crosses the placenta and is found in fetal tissues. Decreased fetal weights in rats and rabbits (with associated delays in ossification) and fetal loss in rabbits have been observed with tigecycline [see USE IN SPECIFIC POPULATIONS]. Tooth Development The use of TYGACIL during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). Results of studies in rats with TYGACIL have shown bone discoloration. TYGACIL should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated. Clostridium difficile-Associated Diarrhea Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including TYGACIL, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. Patients With Intestinal Perforation Caution should be exercised when considering TYGACIL monotherapy in patients with complicated intra-abdominal infections (cIAI) secondary to clinically apparent intestinal perforation. In cIAI studies (n=1642), 6 patients treated with TYGACIL and 2 patients treated with imipenem/cilastatin presented with intestinal perforations and developed sepsis/ septic shock. The 6 patients treated with TYGACIL had higher APACHE II scores (median = 13) versus the 2 patients treated with imipenem/cilastatin (APACHE II scores = 4 and 6). Due to differences in baseline APACHE II scores between treatment groups and small overall numbers, the relationship of this outcome to treatment cannot be established. Tetracycline-Class Effects TYGACIL is structurally similar to tetracycline-class antibiotics and may have similar adverse effects. Such effects may include: photosensitivity, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, and hyperphosphatemia). As with tetracyclines, pancreatitis has been reported with the use of TYGACIL. Superinfection As with other antibacterial drugs, use of TYGACIL may result in overgrowth of non-susceptible organisms, including fungi. Patients should be carefully monitored during therapy. If superinfection occurs, appropriate measures should be taken. Development of Drug-Resistant Bacteria Prescribing TYGACIL in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, 2514 patients were treated with TYGACIL. TYGACIL was discontinued due to adverse reactions in 7% of patients compared to 6% for all comparators. Table 1 shows the incidence of treatment-emergent adverse reactions through test of cure reported in 2% of patients in these trials. Table 1. Incidence (%) of Adverse Reactions Through Test of Cure Reported in 2% of Patients Treated in Clinical Studies Body System TYGACIL Comparatorsa Adverse Reactions (N=2514) (N=2307) Body as a Whole Abdominal pain 6 4 Abscess 2 2 Asthenia 3 2 Headache 6 7 Infection 7 5 Cardiovascular System Phlebitis 3 4 Digestive System Diarrhea 12 11 Dyspepsia 2 2 Nausea 26 13 Vomiting 18 9 Hemic and Lymphatic System Anemia 5 6 Metabolic and Nutritional Alkaline Phosphatase Increased 3 3 Amylase Increased 3 2 Bilirubinemia 2 1 BUN Increased 3 1 Healing Abnormal 3 2 Hyponatremia 2 1 Hypoproteinemia 5 3 4 5 SGOT Increasedb b SGPT Increased 5 5 Respiratory System Pneumonia 2 2 Nervous System Dizziness 3 3 Skin and Appendages Rash 3 4

Vancomycin/Aztreonam, Imipenem/Cilastatin, Levoﬂoxacin, Linezolid. LFT abnormalities in TYGACIL-treated patients were reported more frequently in the post therapy period than those in comparator-treated patients, which occurred more often on therapy. In all Phase 3 and 4 studies that included a comparator, death occurred in 4.0% (150/3788) of patients receiving TYGACIL and 3.0% (110/3646) of patients receiving comparator drugs. An increase in all-cause mortality has been observed across phase 3 and 4 clinical studies in TYGACIL treated patients versus comparator. The cause of this increase has not been established. This increase should be considered when selecting among treatment options. (See Table 2.) Table 2. Patients with Outcome of Death by Infection Type a

Infection Type cSSSI cIAI CAP HAP Non-VAP a VAPa RP DFI Overall Adjusted

n/N

TYGACIL

12/834 42/1382 12/424 66/467 41/336 25/131 11/128 7/553 150/3788

Comparator

n/N

1.4 3.0 2.8 14.1 12.2 19.1 8.6 1.3 4.0

6/813 31/1393 11/422 57/467 42/345 15/122 2/43 3/508 110/3646

Risk Difference* % (95% CI)

0.7 2.2 2.6 12.2 12.2 12.3 4.7 0.6 3.0

0.7 (-0.3, 1.7) 0.8 (-0.4, 2.0) 0.2 (-2.0, 2.4) 1.9 (-2.4, 6.3) 0.0 (-4.9, 4.9) 6.8 (-2.1, 15.7) 3.9 (-4.0, 11.9) 0.7 (-0.5, 1.8) 0.6 (0.1, 1.2)**

CAP = Community-acquired pneumonia; cIAI = Complicated intra-abdominal infections; cSSSI = Complicated skin and skin structure infections; HAP = Hospital-acquired pneumonia; VAP = Ventilator-associated pneumonia; RP = Resistant pathogens; DFI = Diabetic foot infections. * The difference between the percentage of patients who died in TYGACIL and comparator treatment groups. The 95% CI for each infection type was calculated using the normal approximation method without continuity correction. ** Overall adjusted (random effects model by trial weight) risk difference estimate and 95% CI. a These are subgroups of the HAP population. Note: The studies include 300, 305, 900 (cSSSI), 301, 306, 315, 316, 400 (cIAI), 308 and 313 (CAP), 311 (HAP), 307 [Resistant gram-positive pathogen study in patients with MRSA or Vancomycin-Resistant Enterococcus (VRE)], and 319 (DFI with and without osteomyelitis). In comparative clinical studies, infection-related serious adverse events were more frequently reported for subjects treated with TYGACIL (7%) versus comparators (6%). Serious adverse events of sepsis/septic shock were more frequently reported for subjects treated with TYGACIL (2%) versus comparators (1%). Due to baseline differences between treatment groups in this subset of patients, the relationship of this outcome to treatment cannot be established [see WARNINGS AND PRECAUTIONS]. The most common treatment-emergent adverse reactions were nausea and vomiting which generally occurred during the first 1 – 2 days of therapy. The majority of cases of nausea and vomiting associated with TYGACIL and comparators were either mild or moderate in severity. In patients treated with TYGACIL, nausea incidence was 26% (17% mild, 8% moderate, 1% severe) and vomiting incidence was 18% (11% mild, 6% moderate, 1% severe). In patients treated for complicated skin and skin structure infections (cSSSI), nausea incidence was 35% for TYGACIL and 9% for vancomycin/aztreonam; vomiting incidence was 20% for TYGACIL and 4% for vancomycin/aztreonam. In patients treated for complicated intra-abdominal infections (cIAI), nausea incidence was 25% for TYGACIL and 21% for imipenem/cilastatin; vomiting incidence was 20% for TYGACIL and 15% for imipenem/cilastatin. In patients treated for community-acquired bacterial pneumonia (CABP), nausea incidence was 24% for TYGACIL and 8% for levofloxacin; vomiting incidence was 16% for TYGACIL and 6% for levofloxacin. Discontinuation from tigecycline was most frequently associated with nausea (1%) and vomiting (1%). For comparators, discontinuation was most frequently associated with nausea (<1%). The following adverse reactions were reported infrequently (<2%) in patients receiving TYGACIL in clinical studies: Body as a Whole: injection site inflammation, injection site pain, injection site reaction, septic shock, allergic reaction, chills, injection site edema, injection site phlebitis Cardiovascular System: thrombophlebitis Digestive System: anorexia, jaundice, abnormal stools Metabolic/Nutritional System: increased creatinine, hypocalcemia, hypoglycemia Special Senses: taste perversion Hemic and Lymphatic System: partial thromboplastin time (aPTT), prolonged prothrombin time (PT), eosinophilia, increased international normalized ratio (INR), thrombocytopenia Skin and Appendages: pruritus Urogenital System: vaginal moniliasis, vaginitis, leukorrhea Post-Marketing Experience The following adverse reactions have been identified during postapproval use of TYGACIL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure. Anaphylaxis/anaphylactoid reactions, acute pancreatitis, hepatic cholestasis, jaundice, and severe skin reactions, including Stevens-Johnson Syndrome. DRUG INTERACTIONS Warfarin Prothrombin time or other suitable anticoagulation test should be monitored if tigecycline is administered with warfarin [see CLINICAL PHARMACOLOGY (12.3) in full Prescribing Information]. Oral Contraceptives Concurrent use of antibacterial drugs with oral contraceptives may render oral contraceptives less effective. USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects—Pregnancy Category D [see WARNINGS AND PRECAUTIONS] Tigecycline was not teratogenic in the rat or rabbit. In preclinical safety studies, 14C-labeled tigecycline crossed the placenta and was found in fetal tissues, including fetal bony structures. The administration of tigecycline was associated with slight reductions in fetal weights and an increased incidence of minor skeletal anomalies (delays in bone ossification) at exposures of 5 times and 1 times the human daily dose based on AUC in rats and rabbits, respectively (28 mcg·hr/mL and 6 mcg·hr/mL at 12 and 4 mg/kg/day). An increased incidence of fetal loss was observed at maternotoxic doses in the rabbits with exposure equivalent to human dose. There are no adequate and well-controlled studies of tigecycline in pregnant women. TYGACIL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers Results from animal studies using 14C-labeled tigecycline indicate that tigecycline is excreted readily via the milk of lactating rats. Consistent with the limited oral bioavailability of tigecycline, there is little or no systemic exposure to tigecycline in nursing pups as a result of exposure via maternal milk. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TYGACIL is administered to a nursing woman [see WARNINGS AND PRECAUTIONS]. Pediatric Use Safety and effectiveness in pediatric patients below the age of 18 years have not been established. Because of effects on tooth development, use in patients under 8 years of age is not recommended [see WARNINGS AND PRECAUTIONS]. Geriatric Use Of the total number of subjects who received TYGACIL in Phase 3 clinical studies (n=2514), 664 were 65 and over, while 288 were 75 and over. No unexpected overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity to adverse events of some older individuals cannot be ruled out. No significant difference in tigecycline exposure was observed between healthy elderly subjects and younger subjects following a single 100 mg dose of tigecycline [see CLINICAL PHARMACOLOGY (12.3) in full Prescribing Information]. Hepatic Impairment No dosage adjustment is warranted in patients with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B). In patients with severe hepatic impairment (Child Pugh C), the initial dose of tigecycline should be 100 mg followed by a reduced maintenance dose of 25 mg every 12 hours. Patients with severe hepatic impairment (Child Pugh C) should be treated with caution and monitored for treatment response [see CLINICAL PHARMACOLOGY (12.3) and DOSAGE AND ADMINISTRATION (2.2) in full Prescribing Information]. OVERDOSAGE No specific information is available on the treatment of overdosage with tigecycline. Intravenous administration of TYGACIL at a single dose of 300 mg over 60 minutes in healthy volunteers resulted in an increased incidence of nausea and vomiting. In single-dose intravenous toxicity studies conducted with tigecycline in mice, the estimated median lethal dose (LD50) was 124 mg/kg in males and 98 mg/kg in females. In rats, the estimated LD50 was 106 mg/kg for both sexes. Tigecycline is not removed in significant quantities by hemodialysis. This Brief Summary is based on TYGACIL direction circular LAB-0458-2.0, revised 01/11.

regardless of other psychosocial and medical limitations; 3) Clinical trials are difficult to perform in the private setting and the patient access will be extremely compromised. It is unrealistic to wait several years until some data are obtained, as more data have become available and will continue to be available in the near future. CMS needs to look at the new proposed ACS/ASMBS Accreditation and Quality Improvement Program (MBSAQIP) that would enable us to collect data and improve quality, and a potential collaboration with CMS can address the need for specific answers to specific questions. Being too restrictive in coverage is not the solution for a disease that causes a lot of health problems and cost. Kelvin Higa, MD: The sleeve should absolutely be covered by CMS. Given our current data, lack of viable nonsurgical options and the limitations of the current operations covered by CMS, this decision places many of us in an ethical dilemma. Given the type of patients and the medical conditions in this patient population, the sleeve is often the single best option. Finally, sleeve is a potentially cost-effective answer to many chronic conditions; with this type of leadership, no wonder CMS is bankrupt. Dan Herron, MD: Yes! There is no question in my mind that sleeve gastrectomy should be covered by CMS! A significant body of literature—large case series from multiple countries, systematic reviews and prospective randomized trials—support sleeve gastrectomy as providing both metabolic and bariatric efficacy between that of band and bypass. This is achieved without the need for an implanted medical device and with no requirement for frequent adjustments. More important, the sleeve gastrectomy presents minimal long-term complications, either nutritional or surgical. Two large populations of patients who would benefit most from the safety profile of this operation are the elderly and medically disabled, precisely the population covered by Medicare. As an example, in my hospital we see many pre- and postkidney transplant patients with morbid obesity and type 2 diabetes who are covered by Medicare. These patients would be best served by sleeve gastrectomy, but with the recent CMS decision, this is not an option. Although no one would deny that more research on sleeve is warranted

GeneralSurgeryNews.com / General Surgery News / June 2012

and eagerly anticipated, there are enough data in 2012 to support the use of sleeve gastrectomy in Medicare patients. Sleeve gastrectomy is safe and effective; delaying its approval does a disservice to the patients who need it most. Marina Kurian, MD: Sleeve gastrectomy is proving to be an interesting option for surgical weight loss with sustainable results. There are clear hormonal changes both with GLP-1 and ghrelin that have a substantial effect on maintenance of weight loss. The effect on type II diabetes mellitus also is greater than seen with gastric banding. More of the hormonal effects of sleeve gastrectomy are being elucidated through different studies now, and the weight loss results from sleeve are between banding and gastric bypass. It is a durable weight loss option that should be approved by CMS just as it already has been approved by many of the major third-party insurers.

â&#x20AC;&#x201A;

â&#x20AC;&#x201A; On the Spot

surgical intervention appropriate for atrisk patient populations like transplant patients and the vertical sleeve gastrectomy is routinely covered by other payers. Alfons Pomp, MD: The recent decision by CMS to deny coverage of the sleeve gastrectomy is very disappointing as this is a low maintenance operation with an excellent safety profile that seems tailor made for the type of population insured by this coverage. The operation has

enough literature to support its efficacy (Surg Obes Rel Dis 2009;5:469-475) and safety in the large ACS Center of Excellence review (Ann Surg 2011;254:410420) that it is an accepted procedure for all the major insurance carriers. Worldwide, it also is an accepted procedure (see International Sleeve Consensus Meetings and the recent publication by Rosenthal et al in SOARD [Surg Obes Rel Dis 2012;8:8-19] [and story on page 22 of this issue]). The laparoscopic adjustable gastricÂ band, which required almost three FDA trials to approve (as concerns efficacy), and on which more recent literature

(Obes Surg 2006;16:829-835; Arch Surg 2011;146:802-807) casts at least some doubt on long-term outcomes, remains covered. It seems curious that the sleeveÂ operation that others and I have shown to beÂ an excellentÂ staged, and now standalone,Â procedureÂ almost a decade agoÂ still does not fit appropriate criteriaÂ for coverage. (Would that many approved chemotherapies be that effective in putting patients in â&#x20AC;&#x153;remissionâ&#x20AC;?). It seems to me that not only does society at largeÂ continue to discriminate against the obese,

Experience Performance.

Emma Patterson, MD: Yes, because it is similar in safety and efficacy to the other two procedures that are covered by CMS, the band and the gastric bypass. All three improve health and comorbidities, and to a much greater degree than any nonsurgical therapies for obesity or diabetes, as shown in the recent trials published in The New England Journal of Medicine. I think that there is enough accumulated experience and outcomes published to justify adding coverage for the sleeve. If there were one perfect procedure, I would perform only one. But, currently I believe we have three safe and effective bariatric procedures and each has their unique sets of pros and cons. In many categories, such as invasiveness, risk and weight loss, the sleeve seems to fit between the band and the bypass. John Morton, MD: I am fully confident that CMS will find there is adequate evidence for evaluating health outcomes of the vertical sleeve gastrectomy for the indications listed in the current Bariatric Surgery for the Treatment of Morbid Obesity National Coverage Determination (NCD). I believe it is fitting and proper that CMS support this NCD for the vertical sleeve gastrectomy for the following reasons: The Medicare population is at risk for obesity and its consequences, the vertical sleeve gastrectomy is safe and effective and comparable to CMS-covered gastric bypass and gastric banding, the vertical sleeve gastrectomy is a unique

see On the Spot page 37

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Issues for the Bariatric & Metabolic Professional

GeneralSurgeryNews.com / General Surgery News / June 2012

Extended Quarterly Coverage

Consensus

Continued from page 22 most areas of consensus, 90% or more of surgeons supported the statement. The panel could not come to consensus on 26 questions, many on technical areas of stapling and on the role of LSG as a conversion procedure. Among the recommendations, the panel found that LSG is a valid standalone procedure and a valid option for high-risk patients, transplant candidates, morbidly obese patients with metabolic syndrome, patients with a body mass index of 30 to 35 kg/m2 with associated comorbidities, patients with inflammatory bowel disease and adolescent morbidly obese patients. The panel just missed agreement on the statement “LSG will become the most FILE SLUG frequently CMEzone qtrpg.indd performed [bariatric/metabol1ST PROOF LAYOUT APPROVED AND DATE ic] procedure,” although INITIALS 67% supported MAX sign-off the position. Senior Editor Panelists were highly divided on many Copy Editor issues regarding revisions. They did not R 2 that LSG is a validSalesoption to conagree vertJunea11, failed gastric 2012 4:33 PM laparoscopic adjustable Production band (67%). Consensus Creative was reached on theHalfpoint that Roux-en-YCOMMENTS: gastric bypass, Vertical not4C LSG, is the best option to convert a failed gastric band but with only 71% of

“I would suggest surgeons surgeons in agreeshould use a bigger bougie ment. Most memsize than in the consensus bers of the panel, statement,” said Dr. Gagner. 95%, said that The panel agreed that staLSG is an “acceptple-line reinforcement reduces able option to conbleeding along the staple line vert a successful but (100%). And 95% of the panel complicated gastric said it is acceptable to oversew and band” but only 72% said 77% said it is acceptable to buttress the that it can be done in a sinstaple line. gle step. According to the panel, staple heights The panel came to agreement on optimal bougie size, saying that a bou- are still up for debate. They agreed that gie between 32 and 36 Fr (87%) is ideal. staples should not be used with a closed They cautioned that a bougie less than height less than that of a blue load (1.5 32 Fr might increase complications and mm) on any part of a sleeve gastrectoa bougie larger than 36 Fr could lead to a my (81%). They suggested that nothing lack of long-term restriction and possible less than a green load up to the incisura angularis, nothing less than blue from the dilation of the sleeve. Studies presented since the panel’s incisura angularis to the angle of His and less than green when performing consensus suggest that bougie size can nothing STATUS AND HISTORY revisions should be used. be largerFINALthan 36 Fr, said Michel GagOK PROOF 1 12/10 PICKED UP FROM: INITIALS AND DATE REV 1 12/17 ner, MD, clinical professor of surgery inAPPLIED TO: The authors stressed that it is imporREV 2 tant to completely mobilize the funMontreal. REV 3 REV 4 Two meta-analyses presented at the dus before transection (96%) and to take 5 International FederationREV for the Sur- down short gastric vessels before resection REV 6 gery of Obesity and Metabolic Disorders (82%). REV 7 REV 8 showed that meeting in September 2011 On the issue of leaks, the panel widely REV 9 bougie size below 40 Fr resulted in higher agreed that Roux-en-Y reconstruction is a rates of leaks and bioabsorbable buttress valid treatment option in proximal chronmaterial had decreased the rate of leaks ic leaks (90%), while stenting has limited utility for chronic leaks (86%). Stents can by threefold.

be used for an acute proximal leak (93%). Dr. Gagner warned that the statement represents expert opinion, and not randomized data. Expert opinion is rated as the lowest level of evidence-based medicine at level 5, he said. “An expert opinion is just an expert opinion and an expert opinion of 20 experts is just an expert opinion of 20 people.” “This statement is out there just to help practitioners know what the experts are thinking about sleeve gastrectomy at a particular moment.” He added, “I would suggest that surgeons don’t need to concentrate on making the most perfect sleeve and aiming for radical weight loss for their patients; I think they should concentrate on making the sleeve in the safest way possible, not getting any strictures and avoiding leaks should be their No. 1 concern.” Dr. Rosenthal said he and his colleagues are working on a second publication on LSG that will be based on data from the 12,799 cases submitted to the consensus panel. The Centers for Medicare & Medicaid Services (CMS) currently restricts coverage for LSG. In fall 2011, CMS announced it is reviewing available evidence on the use of LSG for the treatment of morbid obesity.

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On the Spot

Continued from page 33 but CMS is in some way is on the same bandwagon. The ASMBS must continue to lobby for acceptance of this procedure. Walter Pories, MD: The gastric sleeve has been shown to be effective, efficient and safe in rigorous clinical studies from a number of reliable institutions. Accordingly, it should be available for those patients in which the sleeve appears to be the best choice. Christine Ren-Fielding, MD: Yes. Morbid obesity is a multifactorial disease that cannot be treated with simply one treatment option. We already know that nonsurgical treatments are best suited for the overweight population. However, the morbidly obese have far fewer options for treatment, all surgical. Not all patients will be suited to or do well with a single operation type. This complex population deserves a variety of options to be tailored to it. For example, some patients may not be suited for a gastric band due to inability to follow up (e.g., the patient lives alone, is immobile), but may have contraindications to gastric bypass (e.g., osteoporosis). Therefore, access to surgical treatment would be limited unless an option such as sleeve gastrectomy is available. Robin Blackstone, MD: The sleeve gastrectomy has been shown to be a powerful metabolic operation that offers many of the same essential changes in the signaling between the brain and gut that are present in the gastric bypass. Additionally, it is a bridge for many high-risk patients who can be maximized for more complex operations if needed to address continuing risk for type 2 diabetes. Most importantly, the decision of what metabolic and bariatric surgery (MBS) to offer should not be mandated by a federal agency remote from the patient. The expert MBS surgeon should have full responsibility and prerogative to apply the peer-reviewed data to the individual patient and patient’s social and support situation to determine the best possible option for treatment of that patient’s obesity-specific disease. Aurora Pryor, MD: The CMS decision to cover laparoscopic gastric sleeve (LSG) only in clinical trials is a disservice to

On the Spot

Medicare and Medicaid patients. Sleeve is an excellent weight loss procedure with proven outcomes in many published studies. The major benefit of LSG as I see it is the lack of longer-term complications. Band patients require adjustments and the device can slip or erode. Bypass patients can develop internal hernias or ulcers. Sleeve patients have fewer issues than patients with other procedures once they get over the perioperative recovery period. The CMS population in general has more difficulty with access to care than privately insured patients. I have seen

these patients follow up less frequently and have trouble affording medications, including proton pump inhibitors. For these reasons, a procedure such as LSG with fewer long-term needs is ideal. If a patient should struggle with follow-up, they would be unlikely to suffer a major medical complication as a result. For those completing follow-up as scheduled, results should be excellent for most patients as evidenced from previous studies. Many surgeons also use LSG for higher risk patients as an alternative to band or bypass. In fact, this is how LSG was initially developed. The results in this

population were excellent, leading to the widespread use of LSG today. The highrisk Medicare and Medicaid patients should be offered this alternative as well. I hope CMS reconsiders the decision on LSG. If not, I suspect many Medicare and Medicaid patients will be looking for clinical trials and a chance to have LSG.

—Colleen Hutchinson is a

health care communications consultant who specializes in the areas of general surgery and bariatrics. She can be reached at colleen@cmhadvisors.com.

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In the News

GeneralSurgeryNews.com / General Surgery News / June 2012

Surgeons Learn Basics on Energy-based Devices From Course SAGES Program Seeks To Fill Knowledge Gap

The society appointed a multidisciplinary task force in October 2010 to identify the 11 domains that would comprise the curricula. Among these domains were safety issues, monopolar devices, bipolar devices, radiofrequency ablation, ultrasonic energy and microwave, as well as considerations for pediatric surgery and integration with other devices, such as pacemakers.

knowledge gaps, and hope this can contribute to a safer operating environment. An important aspect of the curriculum, as with the other SAGES Fundamentals programs, is the creation of a validated, high-stakes examination to verify knowledge.” Dr. Feldman said. They are currently beta testing the examination. Gerald Fried, MD, professor and chairman, Department of Surgery, McGill University Faculty of Medicine and surgeon-in-chief, McGill University Health Center Hospitals, brought up a concern. “There are a lot of individual devices on the market that each have specific features, with issues particular to their safe use in our work environment,” Dr. Fried said. “It’s one thing to learn the theoretical basis, but once you get into the operating room with a specific device in your hand, you want to make sure you’re pressing the right buttons.” Dr. Feldman clarified that the FUSE program under way now will help participants build on the fundamentals, learning the vocabulary that will allow them to communicate effectively with vendors. “We consider this FUSE 1.0,” she said. “Then we will move to FUSE 2.0, in which we will work with industry to develop curricula of training modules around individual devices.” These modules will be a collaborative project between SAGES and industry, rather than having surgeons learn solely from industry representatives. “I think that will be the best of both worlds,” Dr. Feldman said.

depending on where they practiced. Surgeons in Illinois, Indiana, Michigan, Minnesota, Ohio and Wisconsin earned the most, with a mean income of $297,000. The second-highest earners were surgeons in the West, at $295,000, followed by those in the Southwest, at $285,000. Surgeons earned the least in the Northwest, at $233,000. In 2010, hospital-employed surgeons earned the most; however, that changed in this year’s survey. Surgeons employed by health care organizations took the top spot, with a mean income of $339,000, whereas hospital-employed surgeons earned closer to $226,000. Surgeons who were members of single-specialty or multispecialty group practices had the nexthighest earnings, with mean incomes of

responding surgeons believed that ACOs will cause either a large or slight decline in income. Overall, surgeons expressed increasing frustration with their pay and their careers. About 57% of surgeons said that they weren’t happy with their level of compensation, citing debt and high expenses as reasons, and 41% said that their income was no better than that of many non-physicians. While 69% of responding surgeons said that they would still choose a career in medicine in 2010, only 49% felt that way in 2011. Additionally, in 2010, 60% of respondents said that they would choose the same specialty but only 47% said that they would do so in 2011, and only 21% of surgeons said that they would choose the same practice setting again.

On the pre-test, the median number of the 11 questions the SAGES leaders got right was 6.5 (59%), with less than onefourth of participants scoring below 50%. B y M onica S mith The other volunteers fared only slightly worse, with a median score of 55%, and San Diego—Just as many drivers don’t slightly more than one-fourth scoring really know the principles of internal below 50%. combustion, many surgeons lack knowl“There were definite knowledge gaps edge of the basic science behind the enerin items that addressed such objectives gy-based devices ubiquitous in as defining proper electrosurgical ‘Once you get into the operating room their practice. Surgeons who terms, and identifying the differparticipated in a pilot course, with a specific device in your hand, you ent input and output functions of however, were able to close this an electrosurgical generator,” Dr. want to make sure you’re pressing the Feldman said. knowledge gap in half a day, said Liane S. Feldman, MD, at “It’s no surprise that people don’t right buttons.’ the 2012 annual meeting of the know much about microwave, but —Gerald Fried, MD Society of American Gastroin30% did not correctly identify the testinal and Endoscopic Sursurgical device that does not cause geons (SAGES). The task force then assembled a post- electromagnetic interference with a pace“In order to maximize the safety and graduate pilot course at SAGES’s 2011 maker,” Dr. Feldman said. utility of these devices, we should have meeting, where they gleaned questions for Post-course, the numbers looked much some understanding of how they work each domain from the participating fac- better, particularly in areas where scores and what sort of safety issues are involved. ulty to create both a pre-test and a post- were low to begin with, such as electroSome surgeons have this, but many don’t,” test to assess knowledge of participants in surgical terminology, safety and microsaid Dr. Feldman, professor of surgery, the pilot course. These were not validat- wave. “Their scores went to a median of McGill University and surgeon, McGill ed exams and will not be part of the final 90%, with only 4% scoring below 50%,” University Health Center, in Montreal. FUSE project, but were simply a way to Dr. Feldman said. This gap in knowledge stems partly gauge surgeon knowledge before and after In summary, many surgeons had subfrom the fact that standard general sur- participation in the course. optimal understanding of energy devices gery curricula do not address the use of The pre-test was administered to a they use every day, particularly in the areas energy-based devices. Most of what sur- sample of volunteers that included 48 of electrosurgical nomenclature and funcgeons know comes from industry repre- SAGES leaders from the board of direction, response to operating room fires and sentatives focused on a particular device tors, the Quality Outcomes and Safe- interaction with other devices, but test or on electrosurgery in general. Hence, ty Committee, and the FUSE task force, performance improved after the half-day SAGES, well known for its fundamentals as well as 27 postgraduate course partic- course (S072). programs, created the Fundamental Use ipants. Most participants took the post“We think there’s a role for a formal of Surgical Energy (FUSE) program. test as well. curriculum to address these identified

Survey

continued from page 1 board-certified. Generally, physicians’ incomes declined from 2010 to 2011, with general surgeons experiencing a 12% drop in yearly earnings. In 2011, 29% of general surgeons reported a decrease in income. Approximately 19% of general surgeons earned $100,000 or less in 2011, almost double the percentage of surgeons who earned that amount in 2010 (10%). About 9% of surgeons earned $500,000 or more, down from about 13% according to last year’s survey. On the flipside, 32% of this year’s respondents reported an increase in their earnings, compared with 21% last year. A gender gap continues to exist. Male surgeons bank significantly more than female surgeons, earning $276,000 compared with $223,000 for women—a difference of 24%. Income for general surgeons varied

$332,000 and $324,000 respectively. Surgeons in solo practice were in the middle of the pack, earning $250,000, whereas those employed in an academic setting or outpatient clinic earned the least, at $177,000 and $135,000, respectively. Only about 3% of surgeons currently participate in accountable care organizations (ACOs), but 6% said that they plan to do so in 2012. Almost 60% of

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GeneralSurgeryNews.com / General Surgery News / June 2012

Bills Would Permit Companies To Update Warnings on Generics B y G eorge O choa

n April, the U.S. House of Representatives and the Senate introduced bills that would permit generic drug manufacturers to update the warning information for their products in the same way that brand manufacturers currently can. The bills (H.R. 4384 and S. 2295) are intended to address a 2011 Supreme Court ruling, Pliva v. Mensing, which held that generic drug companies cannot be held liable for failure to warn because they are legally required to use the same label as their brand-name counterparts. U.S. Sen. Patrick Leahy (D-Vt.), who, with six co-sponsors, introduced the bill in the Senate, said: “The Mensing decision creates a troubling inconsistency in the law governing prescription drugs. If a consumer takes the brand-name version of [the] drug, she can sue the manufacturer for inadequate warnings. If the pharmacy happens to give her the generic version, she will not be able to seek compensation for her injuries. The Patient Safety and Generic Labeling Improvement Act will promote consumer safety

by ensuring that generic drug companies can improve the warning information for their products in the same way that brand manufacturers can under existing law.” “Consumers have the right to know the truth about the safety of drugs they are taking—both brand and generic,” Rep. Chris Van Hollen (D-Md.) said in a statement. Mr. Van Hollen, with Rep. Bruce Braley (D-Iowa), introduced the bill in the House, as the Patient Safety and Drug Labeling Improvement Act. Public Citizen, a nonprofit consumer advocacy group, wrote a letter to Mr. Leahy in support of the bill, stating. In August 2011, the group filed a citizen petition with the FDA arguing that the agency could address the issue through a change in regulation, without waiting for a change in the law. Allison Zieve, JD, director, Public Citizen Litigation Group, Washington, D.C., said that Pliva v. Mensing “turns on regulation not statute. The FDA has a process for revising regulations.” Frederick Stearns, JD, partner, Keller and Heckman LLP, Washington, D.C., said, “There is at least arguably a basis for FDA to do it through regulation, but

having the statute amended takes care of that issue.” He noted, “The statutory language [of the legislation] doesn’t directly address Pliva, but it potentially opens the door to lawsuits against generics.” The only response to the citizen petition from the FDA so far, said Ms. Zieve, has been a form letter that the petition had been received and there was no decision yet. Ms. Zieve said: “The FDA has the power to do it. Congress could do it. The question, is which one has the will?” FDA spokewoman Sandy Walsh commented: “Specific to the Supreme Court case regarding generic drug liability lawsuits, we are concerned about this issue and are actively looking at what actions … may be appropriate for FDA to take [in] light of the Supreme Court’s ruling. But we are not able to discuss the issue further at this time.” Explaining why the proposed legislation should be supported, Ms. Zieve said: “Because generic companies represent the bulk of the market for many prescription drugs, the companies are in a great position to assess risks.” By contrast, when a drug goes generic, the “brand-name company stops focusing on or even making

the drug—they’re not paying the same degree of attention to it.” Ralph G. Neas, president and CEO of the Generic Pharmaceutical Association, the industry trade group, said in a statement: “Federal law requiring that generic medicines have the identical label as the corresponding brand products has provided American consumers the confidence to trust in generics for 80% of their prescription needs. The legislation introduced by Sen. Leahy would disrupt this confidence and unduly burden physicians who would have to be aware of multiple labels for the same product.” Ms. Zieve responded: “The FDA can order other companies to make the same change and can reject the change. There’s no reason to think that there will be a lot of dueling labels.” Regarding the burden on physicians, she said, “Give the doctors some credit. This is their field of expertise.” She noted that the American Medical Association had filed an amicus brief in Pliva v. Mensing arguing against the generic companies’ position. The prospects for the bills may be doubtful, Mr. Stearns said. “I seriously doubt we will see action in the foreseeable future.”

GeneralSurgeryNews.com / General Surgery News / June 2012

Mutation

continued from page 21 risk for endometrial cancer (SIR, 30.62; 95% CI, 11.24-66.64; P<0.001); a 19-fold greater risk for ovarian cancer (SIR, 18.81; 95% CI, 3.88-54.95; P<0.001); an 11-fold greater risk for renal cancer (SIR, 11.22; 95% CI, 2.31-32.79; P<0.001); and a 10-fold greater risk for pancreatic, stomach and bladder cancers (SIR, 10.68; 95% CI, 2.68-47.70; P=0.001; SIR, 9.78; 95% CI, 1.18-35.30; P=0.009; SIR, 9.51; 95% CI, 1.15-3.37; P=0.009, respectively). The analysis also showed a fourfold greater risk for breast cancer (SIR, 3.95; 95% CI, 1.59-8.13; P=0.001). But experts have questioned the significance of that finding. Only seven cases of breast cancer were reported in the study and only two cases of pancreatic cancer. Although the analysis showed a statistically significant increased risk for breast cancer, the numbers are too few to be definitive. C. Richard Boland, MD, chief of gastroenterology at Baylor University Medical Center in Dallas, said larger studies have not shown a link between Lynch syndrome and these two cancers. The nine cases reported in this study are not enough to counter the previous studies. “There is nothing wrong with this study, but I will not change any aspect of my clinical practice based on this work,” he said. Dr. de la Chapelle said the numbers “absolutely call” for this question to be reexamined in future studies. “Even if there is an increased risk, I don’t consider the risk very high,” he said. “If somebody asked about the risk, I would say ‘yes, there may be one but it is not possible today to give a definitive answer,’” he continued. “This may call for greater alertness to the possibility. In other words, maybe these people should see their doctor a tad more often than they would otherwise regarding breast cancer.” The study confirmed that mutation carriers who developed cancer were generally diagnosed at a younger age than the general population. The median age for diagnosis of colorectal cancer was 49 years. Most previous studies of Lynch syndrome families have been retrospective. This new study is one of the first to prospectively quantify the risks for cancer for MMR gene mutation carriers and their family members. Close biological relatives such as parents, children, sisters and brothers of people with Lynch syndrome are at a 50% risk for also having Lynch syndrome. Other relatives such as grandparents, aunts, uncles, nieces and nephews are at increased risk as well. The question now is what these results mean for people who have the gene mutations.

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For colorectal cancer, these individuals are already undergoing increased surveillance and should continue to do so, the researchers said. But for pancreatic and breast cancers, as well as other cancers, the appropriate course of action is less clear. Very limited evidence supports screening for pancreatic cancers, so it is unlikely that MMR gene mutation carriers would undergo pancreatic screening. “There is no data demonstrating that screening for these other cancers is beneficial, in part due to the absence of effective screening tests,” said Dr. Jenkins. The researchers are continuing to follow

this cohort. Since much larger numbers of carriers are needed to determine the cancer risks specific to each of the four genes for Lynch syndrome, the researchers are establishing the International Mismatch Repair Consortium to pool data from 51 clinical research centers around the world. Collectively, these centers treat more than 7,500 families with Lynch syndrome and over 13,000 mismatch mutation carriers. In 2009, the Evaluation of Genomic Applications in Practice and Prevention Working Group, which was supported by the U.S. Centers for Disease Control and Prevention (CDC), recommended

that all individuals with a new diagnosis of colorectal cancer, regardless of age or family history, be offered genetic testing for Lynch syndrome in order to help prevent cancer in their close relatives. The primary benefit will be the identification of relatives who also are carriers of a gene mutation for Lynch syndrome. Affected relatives can be offered appropriate screening beginning at ages 20 to 25 years, according to their report. The working group is independent, and recommendations are not official positions of the CDC or the U.S. Department of Health and Human Services.

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In the News ERCP

continued from page 1

At this point, the researchers are working on a prospective randomized study with 100 patients in each arm in hopes of achieving significance in areas that were underpowered in their initial small study (SAGES P009). “This could be a practice changer,” said Brian P. Jacob, MD, associate clinical professor of surgery, Mount Sinai Medical Center, New York City, who moderated the session at which this research was presented.

ERCP in hopes of reducing patient days in the hospital, hospital costs, the amount of anesthesia that patients receive and the need for ERCPs in general; if we do a cholangiogram and it’s negative, there’s no need to do an ERCP,” said Matthew Johnson, MD, acute care surgery fellow with the University of Nevada School of Medicine, University Medical Center, Las Vegas. Nathan Ozobia, MD, FACS, one of the authors of the paper, has been performing one-step procedures for selected cases of obstructing biliary disease since 1997, a laparoscopic cholecystectomy with intraoperative cholangiogram (IOC) to confirm the presence or absence of stones followed by an intraoperative ERCP if necessary. To examine the feasibility and potential cost savings of this approach, the researchers conducted a retrospective chart review of Dr. Ozobia’s experience from 2008 to 2010 with 10 patients who received the onestep procedure and 10 who underwent the traditional twostep procedure. Surgical residents, under close supervision of the attending surgical endoscopist, performed the procedures, including ERCP. In the one-step procedures, an IOC was obtained at the same time of the cholecystectomy. If the IOC showed positive for common bile duct stones, or if a cholangiogram was not possible due to technical challenges, the physicians performed an intraoperative ERCP. Notably, patients were maintained exclusively in a supine position during the ERCP. Depending on findings of the latter, they went on to conduct a sphincterotomy, balloon exploration of the “This is one of those things that we should be able to common bile duct with stone extraction, and/or bile- bring home and just start doing; but it raises the quesduct stenting. tion, why aren’t we doing it today?” Dr. Jacob said. In the two-step procedure, a gastroenterologist con- “Very often, the reason is simply that most ERCPs are ducted an ERCP prior to the cholecystectomy, with done by highly skilled gastroenterologists; most choprocedures carried out by the gastroenterology team if lecystectomies are done by surgeons; and to get the warranted. The laparoscopic cholecystetwo schedules to blend is often very ‘This could be a challenging. If more surgeons learned comy would be performed 24 to 48 hours later, usually without IOC. practice changer.’ how to do ERCP, there would be no The researchers noticed a downward reason not to do it at the same time.” trend in hospital stay and preoperative —Brian P. Jacob, MD Across the country, many surgeons time (defined as time to laparoscopic do in fact employ endoscopy, but this cholecystectomy) in the one-step group varies by state, is hospital-specific compared with the two-step group, 3.8 versus 5.3 days, within each state and skill at endoscopy does not necand 2.3 versus 3.1 days, respectively. Where the num- essarily include skill at ERCP. “For instance, in New bers really got interesting, and statistically significant, York City, at our hospital, surgeons don’t do much of was in cost savings. Total hospital charges for the one- their own advanced endoscopy,” Dr. Jacob said. “But step procedure were $58,145, compared with $78,895 that represents a small percentage of most practices. for the standard two-step procedure. Neither group It would make sense in cases with a positive cholanexperienced complications, and operative times were giogram to then perform an intraoperative ERCP at comparable. that same time, as long as professionals and hospitals

GeneralSurgeryNews.com / General Surgery News / June 2012

‘I truly feel that this is more beneficial to patients, and not just looking at the numbers, but in terms of having one team to care for the patients rather than having it spread out to three separate teams: medicine, gastroenterology and surgery.’ —Matthew Johnson, MD

could still get reimbursed for both procedures.” The truth is ERCP is difficult, with an increased risk for pancreatitis and injury to the duodenum, and it typically hasn’t been a part of surgeon training. “Experience is a huge part of ERCP being successful,” Dr. Jacob said, noting it would take him possibly hundreds of ERCPs before his experience with the latter caught up to his experience with laparoscopic cholecystectomy. “If more surgeons could obtain ERCP experience starting out in fellowship, it could save patients with positive intraoperative cholangiograms from needing a second procedure, and I do think it’s probably more straightforward than the laparoscopic common bile duct exploration,” Dr. Jacob said. “But we need more data to suggest that that’s true.” Dr. Johnson, who considers himself lucky to have a mentor who was trained in ERCP, is optimistic that their ongoing research will corroborate and strengthen their current findings. “If our numbers continue to be very statistically significant, we could hopefully change the standard of care in relation to these diseases, and perhaps have a [gastroenterology] collaboration in the training of surgeons if there is a need in fact,” he said. “I truly feel that this is more beneficial to patients, and not just looking at the numbers, but in terms of having one team to care for the patients rather than having it spread out to three separate teams: medicine, gastroenterology and surgery.” Due to increased resident interest, Drs. Johnson and Ozobia are developing a training module for the University of Nevada School of Medicine that will incorporate ERCP in hopes of instituting this training early on for surgical residents. “Learning ERCP has been one of the most difficult tasks in my surgical training, but it is an invaluable tool in the surgeon’s armamentarium,” Dr. Johnson said. “This is especially true in the management of complicated biliary disease, which we encounter so frequently.”

GeneralSurgeryNews.com / General Surgery News / June 2012

In the News

Patients Prefer Colonoscopy to CTC, Study Shows B y D avid W ild San Diego—Patients undergoing screening for colorectal cancer (CRC) experience less pain and have less anxiety with colonoscopy than patients undergoing computed tomographic colonography (CTC) screening, according to findings from a prospective questionnaire-based study presented at the 2012 Digestive Disease Week meeting (abstract 445).

patient satisfaction questionnaire following each procedure. The findings showed that 36% of patients felt less anxious during colonoscopy, whereas 14% reported experiencing less anxiety with CTC (P<0.0001). Additionally, 69% of patients said they felt less pain or discomfort during colonoscopy, whereas only 4% said they felt more comfortable during CTC (P<0.0001). In terms of overall satisfaction, 30% of participants preferred colonoscopy rather

than CTC in contrast to 4% who were more satisfied with CTC (P<0.0001). The remainder of respondents to the three questions did not demonstrate a strong preference either way. Notably, 77% of patients said they would rather undergo colonoscopy for repeat screening. Although the palatability of CTC may be improved if patients were to receive sedation and analgesia, Dr. Rosenfeld insisted the conclusions point to the

continued place of colonoscopy as the gold standard in screening for CRC. “I think that, overall, colonoscopy is a better test than CTC for screening, and CTC should be reserved for cases where patients are unwilling to undergo colonoscopy or it cannot be safely completed,” Dr. Rosenfeld concluded. —Drs. Faigel and Rosenfeld have no conflicts of interest.

‘I think that, overall, colonoscopy is a better test than CTC for screening and CTC should be reserved for cases where patients are unwilling to undergo colonoscopy or it cannot be safely completed.’ —Greg Rosenfeld, MD Researchers asked 90 patients being screened for CRC to undergo both CTC and colonoscopy on the same day and found that 77% said they would prefer colonoscopy for repeat screening. The findings are important “in that they allow me say with confidence that colonoscopy is not less comfortable than CTC, but that most patients would find it more comfortable,” said Douglas Faigel, MD, professor of medicine at Mayo Clinic in Scottsdale, Ariz., who was not involved in the study. “Along with these findings, and given that colonoscopy has been shown to prevent CRC incidence and mortality while similar data are lacking on CTC, I would recommend colonoscopy as the best test for detecting and preventing CRC,” Dr. Faigel added. “I would reserve CTC for the subset of patients who are truly unwilling to undergo colonoscopy but [are] willing to have a CTC.” Patient preference may affect adherence to a CRC screening schedule, said lead investigator Greg Rosenfeld, MD, clinical assistant professor in the Department of Family Practice and a gastroenterology fellow at the University of British Columbia’s Department of Medicine in Vancouver. To better understand the question, Dr. Rosenfeld and his colleagues enrolled 90 patients (mean age, 55 years) to undergo CTC and subsequent colonoscopy on the same day. Participants received midazolam and fentanyl or meperidine during colonoscopy, but no sedation or analgesia during CTC. The subjects completed a 13-item

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For more information about Duet TRS™ reloads and the Endo GIA™ Universal, visit www.duettrs.com 1 Richdeep S. Gill, Noah Switzer, Mike Driedger, Xinzhe Shi, Andrey Vizhul, Arya M. Sharma, Daniel W. Birch and Shahzeer Karmali Laparoscopic Sleeve Gastrectomy with Staple Line Buttress Reinforcement in 116 Consecutive Morbidly Obese Patients”, Obesity Surgery, 2012, 22: 560-564

9LVLW www.RECOTHROM.com

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7KURPELQ PDGH ZLWK D WZLVW RECOTHROM is human thrombin produced using recombinant DNA technology Â˛ ,Q D JHQHWLFDOO\ PRGLĂ&#x20AC;HG &+2 &KLQHVH KDPVWHU RYDU\ FHOO OLQH Q 1RW GHULYHG IURP FDWWOH RU KXPDQ SODVPD Q &RQYHQLHQW DQG HDV\ WR XVH Â˛ 5(&27+520 &RQYHQLHQFH .LWV DOORZ IRU TXLFN DQG HDV\ UHFRQVWLWXWLRQ Q )OH[LEOH SURGXFW OLQH ZLWK PXOWLSOH DSSOLFDWLRQ PHWKRGV Â˛ 0D\ EH DSSOLHG GLUHFWO\ RU LQ FRQMXQFWLRQ ZLWK DEVRUEDEOH JHODWLQ VSRQJH 863

INDICATION RECOTHROM Thrombin, topical (Recombinant) is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical. IMPORTANT SAFETY INFORMATION Contraindications Â&#x2021; Topical use only â&#x20AC;&#x201C; DO NOT INJECT directly into the circulatory system Â&#x2021; Do not use for the treatment of massive or brisk arterial bleeding Â&#x2021; Do not administer to patients with known hypersensitivity to RECOTHROM, any components of RECOTHROM or hamster proteins Warnings and Precautions Â&#x2021; Potential risk of thrombosis if absorbed systemically Â&#x2021; In patients with known hypersensitivity to snake proteins, there may be a potential for allergic reaction Adverse Reactions Â&#x2021; 7KH VHULRXV DGYHUVH HYHQW WKDW RFFXUUHG LQ Â&#x2022; Q RI SDWLHQWV H[SRVHG WR 5(&27+520 LQ FRPSOHWHG FOLQLFDO WULDOV ZDV DWULDO ÂžEULOODWLRQ 7KH PRVW FRPPRQ DGYHUVH HYHQWV UHSRUWHG LQ WKHVH WULDOV 1 ZHUH LQFLVLRQ VLWH SDLQ SURFHGXUDO SDLQ DQG QDXVHD $GYHUVH HYHQWV UHSRUWHG LQ WKHVH WULDOV were consistent with those commonly observed in surgical patients Please see Brief Summary of Full Prescribing Information on following page.

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GeneralSurgeryNews.com / General Surgery News / June 2012

A Call to Arms: Changing the Health Care System B y K ate O’R ourke Houston—In the next five to 10 years, health care will change dramatically, and if physicians don’t lead the process of health care reform, the politicians will. The prospect of politicians leading the way will not bode well for doctors and patients, according to Robert Pearl, MD, executive director and CEO of The Permanente Medical Group, Oakland,

Calif. At the recent annual meeting of the Society of Critical Care Medicine, he encouraged physicians to take action. “If together we don’t lead change, we will pay a price, but more importantly, our patients will pay a bigger price,” said Dr. Pearl. Since the inception of Medicare and Medicaid in the 1960s, the cost of health care has risen between 7% and 8% per year and the ability to pay for it, the gross domestic product (GDP), has only risen

Immunogenicity The potential development of antibodies to RECOTHROM has been evaluated in multiple clinical trials. These pre-speciﬁed evaluations were performed in order to characterize the immunogenicity of RECOTHROM and the neutralizing potential of any detected antibodies. In completed clinical studies 5 of 552 (0.9%) patients exposed to RECOTHROM with both baseline and post-treatment antibody specimens available developed speciﬁc anti-RECOTHROM product antibodies. None of these antibodies were found to neutralize native human thrombin.

BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION RECOTHROM® Thrombin, topical (Recombinant) Rx Only The following is a brief summary of the full prescribing information for RECOTHROM Thrombin, topical (Recombinant). CONTRAINDICATIONS Do not inject directly into the circulatory system. Do not use for the treatment of massive or brisk arterial bleeding. Do not administer to patients with known hypersensitivity to RECOTHROM, any components of RECOTHROM, or hamster proteins. WARNINGS AND PRECAUTIONS Potential risk of thrombosis if absorbed systemically. In patients with known hypersensitivity to snake proteins, there may be a potential for allergic reaction. ADVERSE REACTIONS The serious adverse event that occurred in ≥ 1% (n=6/583) of patients exposed to RECOTHROM in completed clinical trials was atrial fibrillation. The most common adverse events in patients exposed to RECOTHROM in clinical trials (N=583) were incision site pain (51%), procedural pain (30%), and nausea (28%). Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug product cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinical trials have been performed with RECOTHROM applied with absorbable gelatin sponge (Phase 2, Phase 3, and Phase 3b studies) and applied with a spray applicator (Phase 2 study). Adverse events reported in clinical trials were consistent with those commonly observed in surgical patients. Clinical Trials of RECOTHROM Used in Conjunction with Gelatin Sponge Among the 411 patients treated with study drug in the randomized, double-blind, Phase 3 study that compared RECOTHROM to bovine thrombin, both applied with gelatin sponge, in patients undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access, all but 2 patients (1 patient/treatment group) reported adverse events. Most events were moderate in severity and had a similar incidence in the RECOTHROM and bovine thrombin treatment groups. The most common adverse events were incision site pain (63% for both treatment groups), procedural pain (RECOTHROM 29%; bovine thrombin 34%), and nausea (RECOTHROM 28%; bovine thrombin 35%). Serious adverse events were reported by 18% of patients treated with RECOTHROM and 22% with bovine thrombin. Adverse events of interest were pre-specified, based on the thrombin mechanism of action, use of absorbable gelatin sponge, USP, historical reporting in association with cross-reacting antibodies to bovine thrombin product, and results from Phase 2 clinical trials of RECOTHROM applied with absorbable gelatin sponge. The incidences of these pre-specified adverse events were similar between treatment groups (see Table 1). Table 1. Events of Interest in the RECOTHROM Phase 3 Study AE Category* Patients with any event category Bleeding Cardiac Hypersensitivity Nausea + vomiting Other infection Post-operative wound infection Thromboembolic

RECOTHROM (N=205) n (%) 124 (60%) 27 (13%) 41 (20%) 30 (15%) 68 (33%) 26 (13%) 19 (9%) 12 (6%)

3% to 4% per year. Health care as a percent of GDP has doubled every 20 years. “Today, health care is 18% of everything that is produced, sold and provided in this country,” said Dr. Pearl. “If nothing changes between now and 2030, health care will become 36%. If health care consumes more than one out of $3 in the United States, there will be no money for schools, infrastructure, police or fire.” Dr. Pearl continued, “Everyone in

Thrombin-JMI (N=206) n (%) 136 (66%) 24 (12%) 38 (18%) 37 (18%) 83 (40%) 31 (15%) 22 (11%) 10 (5%)

†

Adverse events were included in event categories based on a blinded review of the investigator verbatim and coded terms. † THROMBIN-JMI® Thrombin, Topical (Bovine). *

In an open-label, single-group Phase 3b study, 209 patients with documented or highly likely prior exposure to bovine thrombin within the previous 3 years were treated with RECOTHROM when undergoing surgeries (spinal or peripheral arterial bypass or arteriovenous graft formation for hemodialysis access). The most common adverse events were incision site pain (45%), procedural pain (39%), and nausea (27%). Similar to the Phase 3 study, serious adverse events were reported by 22% of patients treated with RECOTHROM. Clinical Trials of RECOTHROM Applied with Spray Applicator In an open-label, single-group, Phase 2 study in burn patients, 72 patients were treated with RECOTHROM applied with a spray applicator at the burn wound excision site prior to autologous skin grafting. This study included both adults (≥ 17 years of age, n=68) and pediatric patients ≤ 16 years of age (n=4). The most common adverse events in the adult and pediatric age groups included procedural pain (35%), pruritis (25%), and constipation (19%).

In the randomized, double-blind, Phase 3 study that compared RECOTHROM to bovine thrombin, both applied with gelatin sponge, in patients undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access, the development of specific anti-product antibodies was evaluated in both treatment groups. Blood samples were collected at baseline and at day 29 for 97% of the patients in both treatment groups. For patients randomized to RECOTHROM, the samples were analyzed by ELISA for antibodies to RECOTHROM, Chinese hamster ovary (CHO) host cell protein, and pro-thrombin activator (used in the conversion of single chain precursor to active RECOTHROM). For patients randomized to bovine thrombin, the samples were analyzed by ELISA for antibodies to bovine thrombin product. At baseline 1.5% of patients (n=3/198) in the RECOTHROM group had positive anti-product antibody titers compared with 5% of patients in the bovine thrombin group (n=10/200). Of the patients who had detectable anti-product antibodies at baseline, 0 of 3 in the RECOTHROM group and 8 of 10 in the bovine thrombin group exhibited ≥ 1.0 titer unit (≥ 10-fold) increases in antibody levels after study treatment. Treatment with RECOTHROM applied with absorbable gelatin sponge resulted in a statistically significantly lower incidence of specific anti-product antibody development. Three of 198 (1.5%; 95% CI, 0 to 4%) of the patients in the RECOTHROM arm developed specific anti-thrombin product antibodies (1 patient also developed anti-CHO host cell protein antibodies). No patients developed antibodies to pro-thrombin activator. Forty-three of 200 patients (22%; 95% CI, 16 to 28%) in the bovine thrombin arm developed specific antibodies to bovine thrombin product. None of the antibodies in the RECOTHROM group neutralized native human thrombin. Antibodies against bovine thrombin product were not tested for neutralization of native human thrombin. Because the study was not powered to detect a difference in clinical outcomes attributable to antibody formation, no conclusions can be drawn regarding the clinical significance of the difference in antibody formation based on the results of this study. In the open-label, single group, Phase 3b study in patients with a high likelihood of prior bovine thrombin exposure undergoing spinal, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access, 15.6% of patients (n=32/205) had anti-bovine thrombin product antibodies at baseline prior to treatment with RECOTHROM. Following treatment, none of the 200 evaluable patients (patients for whom specimens were available for antibody testing at baseline and post-RECOTHROM treatment) developed antibodies to RECOTHROM. In the randomized, double-blind, controlled Phase 2 studies of RECOTHROM compared to placebo (RECOTHROM excipients reconstituted with 0.9% sodium chloride, USP) applied in conjunction with absorbable gelatin sponge, which were performed across a range of surgical settings (spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access), the incidence of antibody development to RECOTHROM was 1.2% in the RECOTHROM group (n=1/83) compared to 2.4% (n=1/41) in the placebo group. In the open-label, single group Phase 2 study of RECOTHROM applied with the spray applicator to excised burn wounds, 1 patient developed antibodies following treatment (1.6%, n=1/62). The detection of antibody formation is highly dependent upon the sensitivity and specificity of the assay. The absolute immunogenicity rates reported here are difficult to compare with results from studies of other products due to differences in assay methodology, patient populations, and other underlying factors. To report SUSPECTED ADVERSE REACTIONS, contact ZymoGenetics, Inc. at 1-888-784-7662, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Drug interactions have not been formally studied. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with RECOTHROM. It is also not known whether RECOTHROM can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RECOTHROM should be given to a pregnant woman only if clearly needed. Pediatric Use Of the 72 patients undergoing burn wound excision and grafting treated with RECOTHROM applied with the spray applicator in the open-label, single group, Phase 2 study, 4 were pediatric patients. All were age 12 to 16 years. The safety and effectiveness of RECOTHROM in all pediatric age groups have not been fully established. Geriatric Use Of the total number of patients in Phase 2 and Phase 3 clinical studies of RECOTHROM with absorbable gelatin sponge, 38% were 65 years old and over, while 16% were 75 years old and over. No substantive differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. For Full Prescribing Information, access www.RECOTHROM.com Manufactured for ZymoGenetics, Inc. RT022-06, January 2011

medicine understands that health care is not affordable, but none of us believe that we are the source of the problem or, maybe if we recognize our contribution, we don’t want to do anything about it.” He pointed out that Stanford University has a newly constructed pediatric building on its campus, and 25 miles away, the University of California, San Francisco has built a new pediatric hospital. Most likely, Dr. Pearl said, individuals involved in these business decisions on both campuses planned for an increased volume, revenue and profit margin, not a decrease in the health care cost trajectory. Anyone driving from San Francisco to San Jose, a distance of 50 miles, will pass 10 hospitals that provide cardiovascular surgery, three of which perform fewer than 300 cases a year. “I question whether you can provide quality medical care when you are doing one case a day on average, but one can assume that when you are doing one case a day … it is impossible to run that service in a costeffective way,” said Dr. Pearl. Consolidating cardiovascular services would raise quality and lower costs, but “I don’t think that any of the hospital CEOs are talking about closing their cardiovascular services, so that the health care trajectory can go [down],” said Dr. Pearl. Although Dr. Pearl believes the health care reform law has many good aspects, he also predicts that as more people with severe health problems have coverage, costs are likely to rise in the short term. He described multiple ways that in the longer run, the law might lower costs. These include the creation of accountable care organizations (ACOs), which bring physicians together to care for patients; the reimbursement incentive for meaningful use of electronic health records; and the creation of a comparative effectiveness research group. The effect of these items, however, remains to be seen. For example, although Lipitor has no advantage over a generic statin for the majority of patients, it became the most commonly prescribed

GeneralSurgeryNews.com / General Surgery News / June 2012

‘Sometimes the best option is to do less or nothing. Unfortunately we get paid to do something and we’re afraid of getting sued for not doing things. This defensive medicine drives up the cost of what we do.’ —Peter Kim, MD

In the News

in these countries will stay reasonable in the future is uncertain. The fourth scenario is that physicians are going to lead the process of change. “Together we will form the organizations that are like the ACOs, not the hospitals and not the insurance companies, but the medical professionals will come together and we will make those difficult decisions. We will say that it doesn’t make sense to do one heart surgery a day. We will lead the process of consolidation, coordination and integration,” said Dr. Pearl. Dr. Pearl pointed out that much of U.S. health care resembles a 19th-century

cottage industry. It is fragmented, with doctors working in small offices unconnected from their colleagues in the community. It is paid at the delivery system on a piecemeal, fee-for-service basis, rewarding volume over outcomes. It is paper-based and devoid of structure and effective leadership. And this is what Dr. Pearl hopes will change. “If physicians and national societies can come together, create integrated structures that pay more for higher quality and better service and use 21st-century technology effectively, we can overcome the health care challenges of today,” he

said. “Left to its own, the process will be led by for-profit insurance companies and elected officials, and the solutions are unlikely to provide the excellence in health care we all want.” In contrast, Dr. Pearl believes that physicians working together “can transform medical care and in the process provide mission-driven medicine for this country.”

Surgeons Respond Several board members at General Surgery News responded to Dr. Pearl’s stance on the state of health care in this country see Health Care page 48

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Future Initiative for Health Care To date, said Dr. Pearl, a plan has not been put into place to address the fundamental underlying problem with U.S. health care: affordability. He outlined four possible scenarios for the future of health care. The first is that the fundamental health care system does not change, and the cost issues are addressed by freezing Medicare payments and raising patient-paid deductibles. This option will lead to a two-tiered system, one in which the rich have health insurance and the middle and lower classes do not. Few physicians will treat Medicare patients because of declining reimbursement, and in many cases, individuals will only have catastrophic insurance because of everincreasing deductibles. The second scenario is rate regulation, the establishment of the maximum increase in health care premiums. This plan is on the ballot in a variety of states this year. In this scenario, there would be a limit on insurance rates, leading to growing access problems and undermining of medicine, as has been seen in a number of European countries, said Dr. Pearl. This scenario also would produce a two-tier system as physicians and hospitals refuse the governmentally determined payments, similar to Medicaid today. The third scenario is health care being transferred overseas. “Much of medicine can be outsourced. If you look at places like India and Thailand, you have U.S.trained surgeons doing procedures, such as heart surgery and coronary bypass for $10,000, total joint replacement for $5,000 and cataracts for $1,000—high volume with excellent outcomes,” said Dr. Pearl. But whether health care costs

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In the News Health Care continued from page 47

and what the future may hold. “Dr. Pearl is right on,” said Edward Felix, MD, assistant clinical professor of surgery, University of California, San Francisco, and medical director of the Bariatric Program at Clovis Community Medical Center. “If doctors give up control, it’s like the inmates running the sanitarium.” John Maa, MD, assistant professor of surgery, Division of General Surgery,

director, Surgical Hospitalist Program at the University of California, San Francisco, also agreed with Dr. Pearl’s message: “I applaud Dr. Pearl’s call to action for physicians to lead the way forward in health reform, and agree with his concerns about cost containment and the need for a visionary future strategy. “Powerful market forces have shaped the current health care crisis, and leaving our national challenges to the business sector will not be the final answer. Single institutions will be unable to reform health care on a larger scale, and ultimately hospitals will need to work

GeneralSurgeryNews.com / General Surgery News / June 2012

‘If physicians and national societies can come together, create integrated structures that pay more for higher quality and better service and use 21stcentury technology effectively, we can overcome the health care challenges of today.’ —Robert Pearl, MD together, rather than compete against one another, to meet the pressing needs of society,” Dr. Maa added. To help contain rising health care costs, Peter Kim, MD, assistant professor of

surgery, Albert Einstein College of Medicine, New York City, proposed reconfiguring how physicians think about the care they provide. Specifically, he noted how physicians’ fee-for-service mentality can detract from practicing the best medicine. “Sometimes the best option is to do less or nothing,” Dr. Kim said. “Unfortunately we get paid to do something and we’re afraid of getting sued for not doing things. This defensive medicine drives up the cost of what we do.” Instead, physicians should focus on “how well we’re taking care of patients and whether we’re getting value out of what we spend,” Dr. Kim said. “In other words, instead of worrying about cost, we should worry about how the cost relates to the improvement we provide: a new concept of value!” Dr. Kim recently visited the Surgical Infection Society meeting in Dallas and, like Dr. Pearl, found that “as physicians, we really don’t play a part in the political process” and physicians need to get involved in the process to change health care. “We don’t want to have physicians against politicians or administrators. We need physicians who work with administrators and who are administrators at the same time.” Dr. Maa also proposed that physicians should integrate themselves into the political process. “Instead of regarding the field of medicine as distinct from the political and health policy process, perhaps the answer is for physicians to now develop a deeper understanding of the law, and assimilate into state capitals and Washington, D.C., to enlighten the health reform debate,” Dr. Maa said. “Over the past 50 years, three separate laws passed by Congress and signed by the president have had the greatest impact on the current practice of medicine: Medicare, Emergency Medical Treatment and Active Labor Act, and the Affordable Care Act. The time has now arrived for physicians to harness the power of the political and legal process to enlighten the discussion and strengthen these three struggling federal mandates, and thereby define a better future for the practice of medicine in America.” —Additional reporting by Victoria Stern

GeneralSurgeryNews.com / General Surgery News / June 2012

In the News

Overweight Patients Are Often Overdosed With Vecuronium B y M ichael V lessides A large proportion of overweight patients receiving vecuronium are being overdosed, a practice that may increase rates of reintubation, Florida researchers have found. The investigators concluded that because the use of total body weight results in excessive dosing, ideal body weight may be a more desirable denominator. “In Florida, we have one of the highest reintubation rates in the country,” said Lalitha V. Sundararaman, MD, anesthesiology resident at the University of Miami’s Jackson Memorial Hospital. “To help get to the root of this issue at our institution, Drs. Michael Vigoda, Luis Rodriguez and I started looking at iatrogenic factors that may contribute to reintubation.” Previous research showed that using total body weight to determine dose in obese patients may increase the duration of action of neuromuscular blockers. Dr. Sundararaman and her colleagues analyzed the electronic medical records of 3,004 elective cases performed by senior anesthesiology providers in all subspecialties. Patients were aged between 3 and 80 years, and their body surface area ranged from 25 to 32 kg/m2. Calculations of ideal body weight were adjusted for age and sex. Intubation doses of vecuronium and rocuronium were compared with the traditional maximum accepted doses of 0.1 and 1.2 mg/kg, respectively. “We found that we are sadly overdosing our patients,” said Dr. Sundararaman, who reported the results at the 2011 annual meeting of the American Society of Anesthesiologists (abstract 440). In the 1,921 patients who received rocuronium, the maximum acceptable dose was exceeded in 3.59% of cases when total body weight was used to calculate appropriate doses. Vecuronium was used in 1,071 cases. In those patients, the maximum acceptable dose was exceeded in 23% of patients when total body weight was used. The difference was found to be statistically significant (P<0.01) in both the rocuronium and vecuronium groups. The investigators also tracked dosing based on sex, and found that 70% of the patients who received higher-than-maximum doses were women. “I think the reason we overdose vecuronium so much is that it is so shortacting, and we tend to be more liberal with it,” Dr. Sundararaman said. “We think our patients will come out quickly and it won’t be a problem. But that’s not a good strategy, because there are always some patients in whom the surgery finishes early and we’re caught red-handed. So it’s always better to give the right dose.” Making estimates of ideal body weight

is a tricky undertaking at the best of times, so Dr. Sundararaman recommended several free smartphone applications that help. “Then you can note the patient’s ideal body weight in the preoperative chart, so it’s readily available when you need it.” Although the researchers have yet to report if their efforts have affected reintubation rates, Dr. Sundararaman said these and other changes can serve only to improve patient care at the institution.

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“We also made it mandatory that anesthesiologists have to check the 100-Hz fade to tetanus before they extubate,” she said. “There is a significant iatrogenic component to all of this, and one we think can actually be corrected easily.” Michael Higgins, MD, MPH, professor of anesthesiology, surgery and biomedical informatics at Vanderbilt University School of Medicine, in Nashville, Tenn., said anesthesiologists could take a

few lessons from the pediatric subspecialty. “Not to insult anyone, but in pediatrics—because of the variable weights of our patients—we keep dosing sheets for the typical medications in every operating room,” Dr. Higgins said. “We’re sort of entering into that realm with adult patients now, with high variability and extremes of weight. And maybe it’s not too inconceivable to think of doing the same thing with adults.”