November 2014

CONVENTION ISSUE:

Obesity Week

GENERALSURGERYNEWS.COM

November 2014 • Volume 41 • Number 11

The Independent Monthly Newspaper for the General Surgeon

Opinion

A Presidential Apology to the Medical Profession

African Surgeons Do Best in Time of Fear and Lacking Resources B Y C HRISTINA F RANGOU

B Y P AUL M ALASPINA , MD

see PRESIDENTIAL APOLOGY page 26

D

espite heroic efforts from the handful of surgeons who are operating in Ebola-stricken countries of West Africa, patients in

need of surgery are languishing in isolation units or outside of hospitals as Ebola gobbles up resources and fuels fears in health systems that possess only elementary capabilities at the best of times.

B Y L OUISE G AGNON

see EBOLA page 28

Photo courtesy of Lawrence Sherman, MD

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s your newly inaugurated president, I have an important statement to make to the medical profession, you, the doctors of our country.

Allow me to start with a brief background on the topic of presidential apologies, or political apologies in general. They typically arise as a retrospective realization that some great wrong has occurred. The wrong is often a side effect of historical events, or tides that swept through a country’s culture, or simply the prevailing views of the day. The wrong seems to become apparent only later.

It is time that a presidential apology is delivered to you, the American medical profession, the undervalued segment of our society that saves our lives and relieves our pain and suffering, as your life’s work.

There are those of us in every family, in every community, living on every

Surgeons Debate Use of Robot or Laparoscopy for Bariatric Surgery

Fear of Ebola Delays Efforts To Treat Surgical Patients in Need

OR team prepping patient for surgery at Firestone Hospital in Liberia on October 15, 2014. The patient was not a confirmed Ebola case but all necessary precautions were taken as if he were.

‘Bloodless’ Methods Cause Lower Surgical Morbidity, Mortality

MONTREAL—Bariatric surgery via a robotic approach may require more time and be more expensive up front than laparoscopy, but recent data are pointing to advantages of the former, particularly Roux-en-Y gastric bypass (RYGB), the most common weight loss surgery in the United States and regarded as the gold standard in this type of surgery.

Debating the use of robotic surgery in the bariatric arena at the recent World Congress of the International Federation of Surgery for Obesity and Metabolic Disorders (IFSO), Erik Wilson, MD, medical director of bariatric surgery at Memorial Hermann–Texas Medical Center and chief of elective general surgery at the University of Texas Health Science Center, both in Houston, stressed that although the robot is more costly than standard laparoscopic surgery, some research suggests it delivers superior outcomes.

Investigators in one study compared 389 laparoscopic RYGB cases with 388 robotic RYGB cases over a 10-year see DEBATE page 22

B Y S COTT V AN V OORHIS

ISSUES FOR THE BARIATRIC & METABOLIC PROFESSIONAL

Extended Quarterly Coverage Section begins on page 14

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atients who declined transfusions but were treated with blood-conservation methods suffered fewer deaths, infections and other morbid outcomes than those

INSIDE In the News

Surgeons’ Lounge

Opinion

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Fidaxomicin May Be the Best Choice for C. difficile Infections

Marginal gastrojejunal Bundled Billing or ulcers after Bungled Billing? gastric bypass surgery Expert Gives Surgeons Advice on Staying Competitive and Out of Trouble

who accepted donor blood and received standard care, a new Johns Hopkins study concluded.

Mortality rates were almost see BLOODLESS SURGERY page 4

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2014

It’s Electric!

Frederick L. Greene, MD, FACS Clinical Professor of Surgery UNC School of Medicine Chapel Hill, North Carolina

S

ince the dawn of surgical practice, the use of heat or energy sources to manage bleeding or cauterize wounds has been a mainstay of the surgical practitioner. Obviously, great progress has been made from the 6th century BC, when heated stones were used to achieve hemostasis, through the introduction of the electrosurgical unit by William T. Bovie and Harvey Cushing in the 1920s, up to the modern use of bipolar and other advanced ablative energy sources.

Unfortunately, many of us, although introduced to cauterization and the use of thermal energy in our surgical training, never really experienced or benefited from a true curriculum on the principles of using thermal energy. This was one of those surgical tenets that we tended to learn by seeing our seniors apply early in training and then replicating in our own practices. Now, for the first time, a curriculum has been designed to introduce surgeons and other physicians to the principles of electrophysiology in the use of the classic electrocautery and other thermal devices.

Once again, as was seen in the development of the Fundamentals of Laparoscopic Surgery (FLS) and Fundamentals of Endoscopic Surgery (FES), the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) has assumed a leadership role and has created

a template for formal instruction in the use of electrical energy under the clever acronym of FUSE: Fundamental Use of Surgical Energy (www. fuseprogram.org). This much-needed curriculum will hopefully serve to increase overall safety in our operating rooms (ORs), endoscopy suites, emergencyy departments and other areas in which thermal energy is used.

The inappropriate use of energy sources and the creation of significant problems relating to their use are not trivial. Approximately 600 fires occur annually in ORs throughout the United States. In the twoyear period, 1996 to 1998, 628 cases of burns caused d by electrosurgical devices were documented. It is obvious that after the introduction of laparoscopic surgery, the burn injuries and subsequent bowel perforations created by occult thermal injury were a problem that still occurs in our ORs. This continues to be a major safety issue in view of the more than 2 million laparoscopic procedures performed in United States each year.

I think it is safe to say that few surgical trainees are adequately introduced to and evaluated on their abilities to understand and use thermal devices. The lack of understanding by teachers of surgical trainees regarding thermal devices has been a long-term problem that needs correction. Although manufacturers of surgical devices have attempted to create appropriate training modules, there has never been a concerted effort by the surgical community to ensure that proper training and use of thermal energy occur in a universal manner.

FUSE is the first comprehensive program consisting of a defined curriculum in the basic science of surgical energy developed by surgeons, anesthesiologists, nurses

and engineers resulting in a Web-based multim media curriculum and a validated certification examination. At this time, there is no hands-on trraining or assessment component. Presumably this will still be left to local training programs to develop. It is my hope that certifying and verifying bodies such as the Residency Review Committees (RRCs) for surgical specialties and the appropriate boards of surgery will embrace FUSE, just as the American Board w off Surgery has recognized the role of FLS and FE ES. I heartily endorse this effort by surgeons working undeer the banner of SAGES, and recommend that all traaining programs avail themselves of the wealth of criticcal information contained in this curriculum. We can no longer assume that proper training is achieved by traditional methods of passing on information from one generation to the next. In this era when safety both in and out of the OR is an absolute necessity, the introduction and utilization of the FUSE curriculum is mandatory. As new thermal devices are introduced in the future, basic understanding of both physics and physiology is needed to ensure that mistakes are not repeated and inappropriate information is not handed down from one generation of surgeons to the next one.

Correction The article “101 Tips for a Chief Surgical Resident” [October 2014, page 1] by Devin Flaherty, DO, contained two #67 tips, bringing the actual total to 102. We hope you appreciate the bonus tip.

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In the News BLOODLESS SURGERY jcontinued from page 1

fourfold lower in patients who declined allogeneic blood transfusions (ABT) but were treated with blood-conservation methods, or 0.7%, compared with 2.7% in patients who accepted transfusions, reported the Center for Bloodless Medicine and Surgery in an upcoming paper in the journal Transfusion.

Blood-conservation measures ranged from iron supplements to autologous blood salvage, in which a patient’s blood is cleaned and cycled back into the body during surgery.

Other blood-conservation methods included the diagnosis and treatment of pre-hospital anemia, the reduction of intraoperative blood loss, and in-hospital use of IV iron and erythropoietin.

When patients who declined transfusions (so-called bloodless patients) were discharged, their hemoglobin concentrations (10.8±2.7 g/dL) were similar to patients in the control group who received transfusions (10.9±2.3 g/dL; P=0.42), according to the center’s study.

P Overall, the study found that bloodless care is not an independent predictor of either death or a morbid event, said Steven M. Frank, MD, medical director of the Bloodless Medicine and Surgery Program at Johns Hopkins, in Baltimore.

“Giving them a $5 bottle of iron beats $500 worth of blood, plus … you produce your own red cells and don’t require someone else’s red cells that have been stored in a blood bank for up to six weeks,” he said.

Morbid outcomes were lower, with a trend toward lower infections and thrombotic complications, with incidences of renal and respiratory conditions and myocardial infarction also examined, but with no differences between the two groups, Dr. Frank said.

The study examined 294 patients

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2014

treated at the center, mainly Jehovah’s Witnesses, who are prohibited from accepting blood from donors. The group was then compared with 1,157 patients with closely matched backgrounds who underwent surgery or received treatment at Johns Hopkins Hospital and who received blood transfusions.

The study examined billing records at Johns Hopkins and noted potential reduced costs for hospital systems now grappling with the rising cost of blood.

The combination of no ABT and blood conservation resulted in substantial savings, with a reduction in total and direct hospital costs of 12% and 18%, respectively, the study found.

costs in the bloodless group were $18,880 and $10,347, respectively, compared with $23,752 and $12,359 in the control group, the report found. Hospital lengths of stay were roughly the same for the bloodless patients and in the control group.

The study is unique because it compared the outcomes of bloodless patients with those of a control group; it used risk adjustment; and it examined a wide array of surgeries and medical procedures, said Dr. Frank, who added that most studies of patients who decline transfusions have lacked a control group, did not use risk adjustment or focused exclusively on cardiac surgery.

The average total charge for bloodless patients who underwent surgery was $25,568, compared with $30,162 for their counterparts in the control group.

The savings were particularly pronounced in patients who underwent surgery. The average total charge for bloodless patients who underwent surgery was $25,568, compared with $30,162 for their counterparts in the control group. Total costs and direct

The study selected a “propensity, scorematched cohort” from a wider group of 60,652 patients admitted to Johns Hopkins during the study period, which ran from June 2012 to August 2013. Four control patients were matched to each bloodless patient, which both increased

the sample size and made it easier to detect different outcomes between the two groups.

“We matched on a four-to-one ratio,” Dr. Frank said. “That way, you get more power in the analysis.”

Reviewers of the paper questioned the size of the bloodless group, suggesting it could have been larger, Dr. Frank said.

The center, which is just two years old and takes in 400 patients a year, is working to increase its number of patients.

The decision to look at medical as well as surgical patients also was questioned because medical patients may not have the same requirements for transfusion. However, Dr. Frank noted the medical group included patients battling cancer and suffering from gastrointestinal bleeding. “I think it’s a strength that we included both medical and surgical patients,” Dr. Frank said.

Paul M. Ness, MD, director of the Division of Transfusion Medicine at Johns Hopkins Hospital, said advocates for bloodless medicine too often rely on anecdotal evidence to make their point.

In contrast, the study offers a comprehensive, data-intensive look at the issue.

“I think this is very interesting work and I support the findings,” said Dr. Ness of the study, in which he was involved. “We had a good group of control patients and a larger sample size than some of the studies bloodless medicine advocates often quote.”

The study’s use of a control group was a significant advance of past studies on outcomes of patients who decline transfusions, agreed Sherri Ozawa, RN, clinical director of the Institute for Patient Blood Management and Bloodless Medicine and Surgery, Englewood Hospital and Medical Center, in Englewood, N.J. “The data get better when you have a comparative cohort so that you are comparing apples with apples,” she said.

Enhanced Recovery Program for Colon Cancer Cuts Costs B Y P AUL B UFANO

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program to help patients recover after colorectal cancer surgery reduced their hospital length of stay (LOS) by three days and saved $4,800 without increasing 30-day readmission rates, researchers have found.

The researchers examined practice patterns and patient outcomes for 244 patients undergoing elective colon and rectal resection at an Oregon community hospital before and after institution of the recovery program ((JAMA Surgg 2014 Jul 23. [Epub ahead of print]). The program focused on patient education, optimal management of fluids, minimal incision length, decreased use of tubes and drains, opioid-sparing analgesia, and early

mobilization and eating after surgery.

From 2009, before implementation of the program, to 2012, the use of laparoscopy increased by about 30%, from 57.4% to 88.8% of cases, and LOS decreased by three days, from 6.7 to 3.7 days, according to the researchers at Oregon Health & Science University (OHSU), in Portland.

Some researchers found that although they were able to reduce the initial hospital LOS with so-called Early Recovery After Surgery (ERAS) programs, this came at the cost of more patients requiring readmission, according to study author Cristina Geltzeiler, MD, a surgeon at OHSU. “In our study, we did not find this to be the case,” she said. “In our study, patients were able to recover more

quickly, and be safely discharged without an increased risk for requiring hospital readmission. In fact, with the ERAS program, our patient population had a decreased risk for requiring readmission, although this decrease did not reach statistical significance.”

Reductions in LOS resulted in estimated cost savings of $3,202 per patient in 2011 and $4,803 per patient in 2012.

The use of patient-controlled opioid analgesia also decreased, from 63.2% to 15% of patients, as did the duration of use (67.8 vs. 47.1 hours before and after the intervention, respectively). The incidence of postoperative ileus also declined, from 13.2% to 2.5% of cases, as did the proportion of patients who experienced intraabdominal infection, from 7.4% to 2.5%, according to the researchers.

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2014

Study Favors Regional Over General Anesthesia for General Surgery B Y K AREN B LUM NEW ORLEANS—Patients undergoing elective surgery may fare better if they receive regional anesthesia (RA) instead of general anesthesia (GA), according to researchers at Vanderbilt University Medical Center, in Nashville, Tenn.

The study, presented at the 2014 annual meeting of the American Society of Anesthesiologists, found that 0.81% of adults receiving RA died within 30 days of surgery, compared with 1.13% of those receiving GA (abstract JS01). It’s a small percentage difference, said lead author Nahel Saied, MB BCh, associate professor of clinical anesthesiology, Division of Anesthesiology Critical Care Medicine at Vanderbilt, “but over large numbers of

patients, it adds up.”

Regional anesthesia was associated with lower odds for 30-day mortality as well as postoperative respiratory and renal complications, especially in general surgical patients. This choice also was particularly beneficial in patients with prior renal failure, reducing the odds of 30-day mortality and respiratory complications.

“The take-home message is if RA is an option, we should consider it,” Dr. Saied said, although physicians still need to determine which patients are most likely to benefit.

Dr. Saied and his colleagues analyzed pooled data from the American College of Surgeons’ National Surgical Quality Improvement Program database from 2005 to 2011, pulling records for 682,362

elective surgical procedures. They compared 30-day mortality and postoperative complications between patients who received RA and GA during surgery, using multiple logistic regression analysis to examine these associations and account for confounders.

After adjustment for demographic characteristics, type and length of surgery, smoking, alcohol use, body mass index and preoperative comorbidities, the odds of 30-day mortality were 46% lower in patients given RA than in those with GA (95% confidence interval [CI], 7%-69%; P<0.001) among general surgical patients and 68% lower in patients with preexisting renal failure (95% CI, 36%-84%). The odds of major postoperative complications were 40% lower in patients receiving RA

(odds ratio, 0.60; P<0.001), the authors noted. However, there was no significant effect of anesthesia technique on pulmonary embolism, perioperative myocardial infarction or peripheral nerve injury.

Comparing anesthesia outcomes retrospectively in a study such as this is difficult, said Mark Neuman, MD, assistant professor of anesthesiology and critical care at the University of Pennsylvania School of Medicine, in Philadelphia.

“From a clinical standpoint, it’s possible that the type of anesthesia” is what accounted for the difference in outcomes, he told General Surgery News, but other factors could have affected the findings.

“The findings are provocative and interesting, but demand follow-up in a randomized controlled clinical trial."

Anesthesiologist Sees Further Lowering of Post-op Mortality as Possible B Y J AMES P RUDDEN STOCKHOLM—Professor Francois Clergue, director of anesthesia of the University Hospitals of Geneva, challenged attendees of the European Society of Anaesthesiology (ESA) annual meeting to extend their demonstrated success in improving anesthesia safety to the entire perioperative period. The goal: Reduce postoperative mortality by 20%.

Dr. Clergue, delivering the Sir Robert Macintosh Lecture, discussed the recent improvements in anesthesia care, which started in the 1980s when a series of surveys on safety were published. These surveys found intraoperative mortality rates of 2 per 10,000 cases in Finland and 1 to 4 instances of death or coma per 10,000 cases in France. Research found similar results across Europe. Analyses showed that equipment failures and disconnection accidents were not rare. “It suggested that with better equipment, we would prevent some of these catastrophes,” said Dr. Clergue, who is also head of Intensive Care Medicine. “Remember, at that time instrumental monitoring was applied to less than 50% of anesthetized patients.”

Epidemiological studies have since found that mortality has plummeted more than 10-fold from 1980 to the end of the 1990s, with current anesthesia-related mortality rates in both Europe and the United States between 4 and 8 deaths per million cases.

How did that happen? “We first had to change the mental model in which we had been educated,” Dr. Clergue said. “We had to admit that these errors are not so rare.” From that admission came a series of improvements that focused on three overall areas: the standardization of training, better medical equipment and drugs, and improved facilities (e.g., the postanesthesia care unit). Training was improved to reflect the new understanding of how errors occurred, and errors in selection, dilution and labeling of drugs were addressed by color-coding the drugs and making labeling easier to read.

With the resultant diminution of accidents came reduced

insurance premiums for anesthetists and a reduction in their malpractice claims, even in the United States. “I think we can be very proud,” Dr. Clergue said.

However, since anesthesia has become safer, the demand for anesthesia has increased dramatically. “About 7% of the European population was anesthetized in 1980, which increased to 13.5% in 1996.” The largest percentage increases in anesthetization have occurred in elderly patients, and the number of surgeries per population in many cases has doubled.

The challenge is to manage the explosion in demand for anesthesia. “The population growth over the last 30 years in Europe was about 16%, but during the same time the growth of anesthesia cases was 322%,” Dr. Clergue noted. This represents a staffing challenge. The density of anesthesiologists in Western Europe was 5.1 per 100,000 population in 1980; today, it is 16.2 per 100,000. That sounds good, but baby-boomer anesthesiologists are retiring: “Between 2012 and 2016, 2,000 French anesthesiologists will retire. The growth of the number of anesthesiologists was greater than the growth of the activity between 1980 and 1996, but during the next period, between 1996 and 2010, this was reversed.”

Countries will deal with this problem in different ways. Some European countries now allow nurse anesthetists to work unsupervised by anesthesiologists in the operating room, and this practice will increase as the decade progresses. Dr. Clergue emphasized the connection between staffing and safety. “An important challenge that we have for the next few years will consist of maintaining the present level of safety, but this can be done only if staffing is still growing and adapting to the increasing demand for anesthetics. If this is not the case, in 10 years, our staffing should increase by 50%, and in 20 years our staffing should double. Is that realistic?”

For Dr. Clergue, the challenge for anesthesiologists

over the next decade will be to tackle the problems of safety within the perioperative period with the same deliberation and success as the problems that were confronted back in the 1980s in intraoperative anesthesia safety.

“With the improvement in anesthesia safety, we have come to the present situation in which the indications for surgery have been extended to more severe patients.

The result is that if anesthesia [remains] safer, postoperative mortality will remain unchanged, around 1.5%,” Dr. Clergue said.

“For the next decade, the major safety challenge of the surgical patient is to reduce postoperative complications. It is known that the first complications to appear postoperatively greatly increase the risk for death. Yet not many complications that begin in the postoperative period are directly related to anesthesia, so anesthesiologists might be wading into an area outside their direct control—perhaps, but not necessarily outside anesthesiologists’ direct influence.”

Anesthesiologists, together with surgeons, can embrace procedures that heighten safety. One such procedure is the implementation of the SURPASS (SURgical Patient Safety System) checklist (Qual Saf Health Caree 2009;18:121-126) which averts preventable adverse events through the implementation of multidisciplinary checklists. In one study (N Engl J Medd 2010;363:19281937), infection rates were reduced from 4.8% to 3.3% (P=0.006) P and death rates from 1.5% to 0.8% (P=0.003) P in hospitals that implemented the SURPASS program.

Dr. Clergue challenged his audience to reduce postoperative mortality by one-fifth by maintaining and improving levels of patient safety, ensuring adequate staffing, controlling demand for anesthetic agents, and embracing the additional oversight of the perioperative period. Anesthesiologists have proved that they are capable of analyzing safety procedures and implementing corrections, he said. The next decade should see those capabilities used to improve the full spectrum of perioperative care.

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2014

SIOG Updates Guidelines on Colorectal Cancer for Older Patients B Y P AUL B UFANO

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ue to the increasing complexity and diversity of treatment options for patients with colorectal cancer (CRC), the International Society of Geriatric Oncology (SIOG) assembled a taskforce to update its recommendations for the treatment of older patients with the disease.

CRC is one of the most commonly diagnosed cancers in the world (Int J Cancer. 2010;127(12):2893-2917), with 60% of patients over 70 years old.

While the majority of patients with stage I or II CRC are treated with surgery (N Engl J Med. d 2004;350(23):23432351), (Bull Cancer. 2006;93 Suppl 1:S5-9), treatment differs for those with stage III or metastatic CRC. Further, because of varying issues including frailty and comorbidity, many elderly patients require a personalized assessment and approach (Int J Cancer.

2013;132(9):2157-2163).

The guidelines highlight this notion that elderly patients need individualized

treatment, and stress that multidisciplinary teams are essential in doing so. They also suggest using a comprehensive geriatric assessment to inform clinical decision-making and providing patients with detailed information in advance to support their involvement in the decision-making process.

The guidelines highlight the notion that elderly patients need individualized treatment.

These recommendations are necessary as they improve and elaborate on solutions for a crucial health problem that affects a sizeable population, said Al Benson, MD, professor of medicine at Northwestern University School of Medicine, Chicago.

“The authors outlined all the essential points of concerns, as well as summarizing the literature and treatment models for both colon and rectal cancer,” he said. “They also point out that there are

a number of important factors in terms of elderly patients, such as comorbidity and function performance status that could potently influence treatment.”

These factors in particular were highlighted as they are associated with early postoperative mortality in patients with gastrointestinal malignancies ((Ann Surg Oncol. l 2013;20(2):371-380).

This could have major consequences for treatment of these patients. For example, the number of new cases of bowel cancer diagnosed in patients older than 75 in the United Kingdom has risen by 30% from 1993 to 2010 (13,400 to 17,300), (NCIN. UK Cancer Information Service. http://www.ncin. org.uk/cancer_information_tools/ukcis.

Accessed October, 9, 2014).

It was in part because of these rising numbers that SIOG decided to update its guidelines on the disease for older patients. The taskforce it assembled consisted of 10 medical oncologists, two surgeons, two radiation oncologists, one epidemiologist, one statistician and one geriatrician.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2014

Microbiome Analysis May Improve Colon Cancer Detection B Y D AVID W ILD

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ecal microbiome analysis may enhance the accuracy of noninvasive colorectal cancer screening, a recent study suggests.

Investigators found that a combination of fecal microbiome analysis and fecal occult blood testing (FOBT) was significantly more accurate than FOBT alone in distinguishing between colorectal adenoma and carcinoma (CRC). Adding microbial analysis to demographic risk factors for colorectal cancer improved the identification of high-risk patients who should undergo colonoscopy, according to the study (Cancer Prev Res 2014 Aug 7.

[Epub ahead of print]).

“The findings of this paper are both interesting and important,” said Randall Burt, MD, emeritus professor of medicine at the University of Utah Huntsman Cancer Institute, in Salt Lake City, who was not involved in the research.

“The results of this study alone do not yet justify using microbiome evaluation to guide screening strategies, but they are nonetheless exciting and indicate that further work in this area is certainly justified.”

In the first phase of the study, coinvestigator Patrick Schloss, PhD, associate professor in the Department of Microbiology and Immunology at the University of Michigan, in Ann Arbor, and his colleagues conducted gene sequencing to profile the microbial composition of stool from 30 healthy people, 30 subjects with adenoma and 30 with CRC. The groups were similar in age and medication use, but those with CRC were more likely to be white and male and to have higher body mass index (BMI).

Dr. Schloss’ team isolated several microbial gene sequences that, when absent, were highly predictive of the presence of adenomas and CRC. After testing several models, they found that age and race risk factors along with the absence of five microbial gene segments accurately identified 90% of those with adenoma and ruled out 80% of those without adenoma—a 4.5-fold increase in the predictive accuracy over using only age and race as predictors (P=0.002).

Similarly, a model including age, race, BMI and the absence of six microbial gene segments was 90% sensitive and 83.3% specific in identifying CRC patients—a fivefold increase in accuracy compared with use of age, race and BMI alone (P=0.012).

“Incorporating microbial analyses in this way could help clinicians select

individuals who should undergo colonoscopy,” Dr. Schloss said.

The investigators also examined whether microbiome analysis could be used to distinguish between individuals with adenoma and those with CRC. The absence of four specific microbial gene sequences discriminated between the presence of CRC and adenoma better than did FOBT, according to the study.

Finally, a combination of microbiome analysis and FOBT further improved

the accuracy of distinguishing between adenoma and CRC, above and beyond either method alone.

The researchers noted that previous research has shown that the abundance of several bacterial species, such as Fusobacterium and Bacteroides fragilis, is associated with colorectal cancer (Genome Res 2012;22:299-306).

“In contrast, our study emphasizes that the depletion of potentially protective bacteria—most importantly,

species of Clostridium, Bacteroides and the Lachnospiraceae family of bacteria—also likely plays a role in colorectal cancer pathology,” Dr. Schloss’ team reported.

Although the findings suggest that microbiome analysis may prove useful as part of a noninvasive CRC screening protocol, “we think it should complement, rather than replace, other colorectal cancer screening approaches,” Dr. Schloss said.

Introducing the only antibacterial-coated biologic graft *

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Protection when and where it’s needed. *It’s the first biologic graft for ventral hernia repair demonstrated to prevent colonization of MRSA and E. coli.

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Bard, Davol, and XenMatrix are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners. © Copyright 2014, C. R. Bard, Inc. All rights reserved.

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Indications: Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including: abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. The Rifampin and Minocycline coating has been shown in preclinical in vitro and in vivo testing to reduce or inhibit microbial colonization in the device. The claim of reduction of bacterial colonization of the device has not been established with human clinical data, nor has a clinical impact associated with this claim been demonstrated.

Contraindications: 1. XENMATRIX™ AB Surgical Graft should not be used on patients with known sensitivity to porcine products.

2. Do not use in patients with allergy, history of allergy or hypersensitivity to tetracyclines or rifamycins or other components in the device.

3. Do not use in pregnant or nursing women.

4. The contraindications, warnings and precautions regarding the use of the antimicrobial agents Rifampin (a derivative of rifamycinB) and Minocycline (a derivative of tetracycline) apply and should be considered when using this device. See FDA’s drug labeling database for Rifampin and Minocycline labeling.

The use of this product in patients with compromised hepatic function should be carefully considered since rifampin can cause additional stress to hepatic metabolism. Implantation of this device would not result in detectable systemic concentrations of Rifampin or Minocycline.

Warnings: 1. This device is not indicated for the treatment of infection. If an infection develops, treat the infection aggressively.

2. To minimize recurrences when repairing hernias, the graft should be large enough to provide sufficient overlap beyond the margins of the defect on all sides.

3. An allergic reaction that is unrelated to other therapy is an indication to consider removal of XENMATRIX™ AB Surgical Graft.

Precautions: 1. Do not alter practice of pre-, peri-, or postoperative administration of local or systemic antibiotics.

Adverse Reactions: Potential complications with the use of any prosthesis may include, but are not limited to, allergic reaction or hypersensitivity to device materials or antimicrobial coating, seroma, infection, inflammation, adhesion, fistula formation, erosion, hematoma, and recurrence of tissue defect.

9

10

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS S / NOVEMBER 2014

Fidaxomicin May Be Best Choice for C. difficile Infections B Y M ARIE R OSENTHAL WASHINGTON—Overall treatment costs for cancer patients with Clostridium difficilee infection (CDI) appear lower with fidaxomicin than with vancomycin, resulting in a potential cost savings of $9,051 per patient, according to new data presented at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2014).

“Patients with cancer represent a vulnerable population who are at high risk for CDI, often resulting from their compromised immune system. CDI can be a devastating addition for patients who are already battling preexisting conditions,” said lead investigator Sebastian Heimann, a health economist at the University Hospital of Cologne, Germany.

The pharmacoeconomic model combined data from a study exploring CDI in cancer patients treated with fidaxomicin

or vancomycin, and a recent cost-of-illness analysis on CDI conducted at the University Hospital of Cologne in Germany (abstract K-364). Fidaxomicin is marketed as Dificlir (Astellas) in Europe and as Dificid (Cubist) in the United States.

The Cost of an Infection Although the study looked at European hospitals, CDI is a serious and costly problem in U.S. hospitals. An estimated

107,700 cases of hospitalacquired CDI occur in the United States each year, according to the Centers for Disease Control and Prevention (CDC). The estimated cost of treating these cases ranged from $6,408 to $9,124, according to a 2003 CDC report (http://1.usa.gov/RUbCoo).

Based on current health care costs, that financial burden may well be higher, the federal investigators noted.

The ICAAC analysis explored direct cost parameters including drug costs, treatment on the general ward and intensive care unit as well as microbiological diagnostics for C. difficile. Mean overall treatment costs per patient treated with fidaxomicin and vancomycin were $35,867 and $44,910, respectively. The lower costs associated with fidaxomicin were primarily due to the significantly lower rate of recurrence in patients treated with fidaxomicin compared with vancomycin.

In other data presented at ICAAC, physician perceptions of the burden of CDI and the negative health effects of recurrent infection were assessed. Nearly all of the 1,567 European health care professionals surveyed accepted that a recurrence of CDI would have a medium or strong effect on patient health, in particular immunocompromised patients and those with a severe underlying disease.

Despite this, most respondents (60%) did not often consider this impact in their treatment decisions (abstract K-350).

Laboratories Given Short Shrift Additionally, only 26% of respondents in this survey said they always request a laboratory test for patients presenting with diarrhea that is not clearly attributable to an underlying condition or therapy, despite recent epidemiologic data suggesting the incidence of CDI is increasing in Europe. Interestingly, physicians believed 25% of clinically significant CDI cases remain undiagnosed in a hospital setting, increasing to as much as 45% in the community. This is supported by a recent epidemiologic study that revealed that as many as 39,000 cases of CDI may be missed each year in Europe.

“CDI is a huge economic and societal burden and causes additional and unnecessary suffering to already sick patients, so there is clearly more that needs to be done to improve patient care and CDI management,” said Professor Oliver A. Cornely, University Hospital of Cologne, Germany.

Dr. Heimann is a research contractor for Astellas, Gilead, Merck and Pfizer. Dr. Cornely is a research contractor for 3M, Actelion, Astellas, Basilea, Bayer, Biocryst, Celgene, Cubist, F2G and Genzyme.

In the News

GENERALLSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2014

11

ProoCESS Trial May Lead to Sepsis Protocol Tweaks B Y P AUL B UFANO

T

h hirteen years ago, a seminal study on early, protocol-driven therapy for severe sepsis showed that the aggressive intervention boosted survival in these critically ill patients. Now, a new look at the treatment strategy suggests that such a rigid approach may be no more effective than current bedside treatments.

The original single-center study (N Engl J Medd 2001;345:1368-1377) found that in-hospital mortality was significantly reduced in patients with severe sepsis or septic shock who were treated based on a six-hour protocol of early goal-directed therapy (EGDT) than in those who were provided usual care (30.5% vs. 46.5%, respectively). The protocol consisted primarily of central venous catheterization to monitor central venous pressure and oxygen saturation, along with a targeted resuscitation strategy.

To determine if the findings from that study are still generalizable, and to assess whether all of the protocol components are still needed, investigators conducted the ProCESS (Protocolized Care for Early Septic Shock) trial (N Engl J Med 2014;370:1683-1693). They enrolled 1,341 patients from 31 emergency departments across the United States, of whom 439 were randomly assigned to EGDT, 446 to protocol-based standard therapy and 456 to usual care. Resuscitation approaches varied regarding the observation of central venous pressure and oxygen, and the use of vasopressors, inotropes, intravenous fluids and blood transfusions.

At 60 days, there were 92 deaths in the EGDT group (21%), 81 in the protocolbased standard therapy (18.2%) and 86 in the usual-care group (18.9%). These differences in mortality were not statistically significant, the investigators reported.

There also were no major disparities in 90-day mortality, one-year mortality and the necessity for organ support. As a result, the researchers concluded that there was no substantial advantage, with respect to death or illness, of protocol-based resuscitation over the current standard.

The design of the ProCESS trial has several merits compared with the earlier research, according to Ishaq Lat, PharmD, FCCM, clinical coordinator of critical care at University of Chicago Medical Center, who was not involved with either study. He noted, for example, that the randomized controlled trial design of ProCESS was impressive, given the challenge of screening and enrolling patients with severe sepsis in hectic critical care settings. Moreover, â&#x20AC;&#x153;including patients from all over the country makes [the newer study] a better representation

of patients with severe sepsis and septic shock than before, and gives it a broader level of relevance.â&#x20AC;?

But he stressed that the ProCESS study results should be interpreted in the context of acknowledging the last decade of improved sepsis management. â&#x20AC;&#x153;The initial NEJM M trial called for early recognition to institute treatment with antimicrobial agents, timely administration of fluids and vasopressor agents, and conservative transfusion thresholdsâ&#x20AC;&#x201D;all of which are

now reflective of the care in most institutions today,â&#x20AC;? Dr. Lat said.

That would explain, he added, why survival in the usual-care arm of the ProCESS trial was significantly increased compared with survival in the original goal-directed resuscitation study. â&#x20AC;&#x153;This may well be representative of the dramatic improvement in sepsis treatment that weâ&#x20AC;&#x2122;ve seen in recent years,â&#x20AC;? he said.

To make future studies more relevant to real-world clinical practice, â&#x20AC;&#x153;perhaps

we select an end point other than [survival], such as health care resources or patient quality of life,â&#x20AC;? Dr. Lat suggested. â&#x20AC;&#x153;Or maybe we should design smaller studies that wonâ&#x20AC;&#x2122;t impact a heterogeneous pool of patients with the syndrome, leading to more patient-specific treatment strategies, such as those that have been developed for heart failure or hypertension.â&#x20AC;?

The study was supported by a grant from the National Institute of General Medical Sciences.

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: / *RUH $VVRFLDWHV ,QF Ăź )ODJVWDĹ? $= Ăź JRUHPHGLFDO FRP 3URGXFWV OLVWHG PD\ QRW EH DYDLODEOH LQ DOO PDUNHWV *25(ÂŽ 3(5)250$1&( 7+528*+ ,1129$7,21 6($0*8$5'ÂŽ DQG GHVLJQV DUH WUDGHPDUNV RI : / *RUH $VVRFLDWHV k : / *RUH $VVRFLDWHV ,QF $3 (1 6(37(0%(5

)UDQNOLQ 6DIHW\ DQG HIILFDF\ RI WKH XVH RI ELRDEVRUEDEOH á6HDPJXDUGø LQ FRORUHFWDO VXUJHU\ DW WKH 7H[DV (QGRVXUJHU\ ,QVWLWXWH Surgical Laparoscopy, Endoscopy & Percutaneous Techniques

&RQVWHQ (&- *DJQHU 0 3RPS $ ,QDEQHW :% 'HFUHDVHG EOHHGLQJ DIWHU ODSDURVFRSLF VOHHYH JDVWUHFWRP\ ZLWK RU ZLWKRXW GXRGHQDO VZLWFK IRU PRUELG REHVLW\ XVLQJ D VWDSOHG EXWWUHVVHG DEVRUEDEOH SRO\PHU PHPEUDQH Obesity Surgery : / *RUH $VVRFLDWHV ,QF Clinical Performance with Staple Line Reinforcement. 6FLHQWLILF /LWHUDWXUH $QDO\VLV Q SDWLHQWV

)ODJVWDII $= : / *RUH $VVRFLDWHV ,QF $3 (1 ZZZ JRUHPHGLFDO FRP VHDPJXDUG 0$8'( 0DQXIDFWXUHU DQG 8VHU )DFLOLW\ 'HYLFH ([SHULHQFH 8 6 )RRG DQG 'UXJ $GPLQLVWUDWLRQ :HE VLWH KWWS ZZZ DFFHVVGDWD IGD JRY VFULSWV FGUK FIGRFV FIPDXGH VHDUFK FIP

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2014

Surgeon Discusses Ways To Streamline Early Breast Cancer Care Expert Lists Procedures To Avoid Because They Do Not Add Value

Table. Use of MRI and Contralateral Breast Cancer Detection

B Y K ATE O'R OURKE

I

n an era when health care resources are limited, clinicians are under increasing pressure to avoid therapies that provide marginal or no benefit. At the 2014 annual meeting of the American Society of Clinical Oncology (ASCO), Monica Morrow, MD, chief of the breast surgery service at Memorial Sloan-Kettering Cancer Center, in New York City, identified five procedures that should be avoided in the treatment of early breast cancer because they do not add value.

“Value” is defined as a fair return in goods, services or money for something exchanged. “In the context of health care, return should be in overall survival [OS], disease-free survival [DFS], local control or quality of life, to balance the cost of treatment, not only economic cost but toxicity,” Dr. Morrow said.

Incidence of Contralateral Breast Cancer, %

Study

N

Patients Undergoing MRI, %

Eur Radioll 2004;14:1725-1731

346

35

3.4

1.7

4

<0.001

J Clin Oncoll 2008;26:386-391

756

28

8

6

6

0.39

Radiology 2013;267:57-66

3,094

57

3.8

0.5

1.4

0.02

J Surg Oncoll 2013;107:815-821

615

37

5.7

2.2

1.3

0.51

Followup, y

MRI

No MRI

P Value

MRI, magnetic resonance imaging

The List of Practices To Avoid

1.

Magnetic resonance imaging (MRI) for staging The arguments for using MRI for local staging include improved selection of patients for breast-conserving surgery (BCS), improved definition of tumor extent, synchronous identification of contralateral cancer and decreased local recurrence. According to Dr. Morrow, however, these arguments aren’t supported by data.

A recent meta-analysis involving 3,112 patients revealed that patients who undergo MRI before surgery and those who do not have the same rate of re-excision and unexpected conversion to mastectomy ((Ann Surgg 2013;257:249-255).

MRI significantly increased mastectomy rates (1.5 to threefold) without improving outcomes. Additionally, studies showing that MRI improves the detection of contralateral cancer are inconclusive, and even when there is a benefit, it is slight (Table).

2.

Contralateral prophylactic mastectomy There is no evidence that contralateral prophylactic mastectomy improves survival for the average woman with breast cancer, but there are costs. “We know if you have twice as much surgery, it doubles your risk of surgical complications,” Dr. Morrow said.

3.

Routine re-excision of margins A year ago, the Society of Surgical Oncology (SSO) and the American Society for Radiation Oncology (ASTRO)

held a consensus conference to review the evidence for routine re-excision of close margins in patients who undergo BCS. These groups commissioned a meta-analysis of 33 studies involving 28,162 patients with stage I/II breast cancer and a minimum mean/median follow-up of four years. There was no statistically significant difference between local recurrence and threshold margin distances of 1, 2 or 5 mm (Ann ( Surg Oncoll 2014;21:717-730).

According to the consensus statement, endorsed by SSO, ASTRO, ASCO and the American Society of Breast Surgeons, negative margins (no ink on tumor) optimize local control; wider margins do not significantly improve local control, and the routine practice of obtaining margins more widely clear than no tumor on ink is not indicated. Pointing to the 26,550 re-excisions performed annually for close margins, Dr. Morrow said the potential impact of this guideline adoption is a minimum savings of $30 million annually using Medicare data ((Ann Surg Oncol 2014;21:1512-1514).

4.

Routine axillary lymph node dissection (ALND) for one to two positive sentinel nodes

The 10-year follow-up of the National Surgical Adjuvant Breast and Bowel Project B32 trial showed that the presence of micrometastases had no effect on DFS and OS in node-negative invasive breast cancer (abstract 1000; ASCO

2013 annual meeting). The International Breast Cancer Study Group trial 23-01 demonstrated that there was no difference in local, regional or distant recurrences based on performing ALND for micrometastases (Lancet Oncol 2013;14:297-305). Similar results were seen in patients with macrometastases undergoing BCS and receiving whole-breast irradiation and systemic therapy (JAMA ( A 2011;305:569-575). The American College of Surgeons Oncology Group Z0011 trial showed a nodal recurrence rate of less than 1% and no difference in DFS or OS for patients randomized to the group not undergoing ALND; additionally, these women had significantly fewer side effects than those having ALND.

5.

Radiation after BCS in women older than age 70 years with estrogen receptor (ER)-positive, early-stage breast cancer The Cancer and Leukemia Group B-9343 study demonstrated that adjuvant radiation therapy after BCS and tamoxifen in women age 70 years and older with early-stage breast cancer had no effect on OS, DFS or breast preservation ((J Clin Oncoll 2013;31:2382-2387).

Fred Hutchinson Cancer Research Center, and a co-director of the Hutchinson Institute for Cancer Outcomes Research, in Seattle, applauded the list.

“I agree with all five of these in general, with the understanding that every generalization has exceptions, and it still behooves the oncologist to use their best judgment when applying any of these recommendations,” Dr. Lyman said. For example, every oncologist has been in the situation where an MRI identified other unsuspected lesions, but MRI has a high false-positive rate, is very expensive, and has not been shown to be useful on a routine basis. Despite these drawbacks, there may be specific cases for which, based on an examination or a complicated history, MRI may be useful and warranted.

The one recommendation that Dr. Lyman said he would challenge “a bit” was radiation in elderly patients. He does not like using age per se as a criterion. “It is not so much about chronological age as physiological age and life expectancy,” he said. A frail, elderly woman with multiple comorbidities may be a good candidate to skip radiation, but radiation may be reasonable for an active 75-year-old who may live into her 90s.

Expert Reaction From Oncology Gary Lyman, MD, MPH, a medical oncologist specializing in breast cancer at the University of Washington and the

Drs. Morrow and Lyman reported no relevant financial relationships.

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14

Obesity Care

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2014

Data Presented on New Intragastric Balloons for Weight Loss B Y L OUISE G AGNON MONTREAL—One of the emerging approaches for weight loss in obese patients is the use of the intragastric balloon, and research on several forms of intragastric balloons was highlighted at the 2014 annual meeting of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO).

Shantanu Gaur, MD, chief scientific

officer, Allurion Technologies in Wellesley, Mass. discussed the Elipse intragastric balloon, a technology that includes a capsule and an attached delivery catheter. Patients swallow the capsule, and the balloon fills with 450 mL of bacteriostatic water. The catheter is then removed.

“It opens up [in the stomach] and empties on its own,” Dr. Gaur said in his oral presentation.

In an interview with General Surgery News, Dr. Gaur pointed out that

the Elipse has distinct advantages over other intragastric balloons. “The difference with our device, compared to other intragastric balloons, is that it does not require endoscopy or anesthesia,” Dr. Gaur said.

Intragastric balloons pose a risk for spontaneous deflation and bowel obstruction, but this risk is lessened with this novel design, Dr. Gaur noted. “There is no secondary procedure required to remove the balloon,” he said. “The

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The ReShape Duo is a dual intragastric balloon treatment where two balloons are connected. balloon passes through the GI [gastrointestinal] tract and is excreted [without endoscopy].”

A study in eight patients was designed to assess the safety of the device, and investigators observed the safe passage of the balloon through the GI tract.

Dr. Gaur noted that investigators also observed a signal for weight loss with the device in the patients, who had a mean body mass index (BMI) of 31.0 kg/m2.

The lack of need for endoscopy or anesthesia could mean that clinicians, such as endocrinologists, would be able to offer the device to their patients, Dr. Gaur said. Manufacturers of the device plan to initially seek commercial approval outside the United States.

Data on the use of the ReShape Duo, a dual intragastric balloon treatment where two balloons are connected, were also presented at the IFSO meeting.

Single intragastric balloons have been shown to lose efficacy after about three months, which has prompted the design of novel technologies such as dual intragastric balloons. The device is filled with 900 cc of saline, with 450 cc in each balloon, said Gontrand Lopez-Nava, MD, a gastroenterologist based at Madrid Sanchinarro University Hospital, in Madrid.

Sixty patients with a mean baseline BMI of 38.9 kg/m2 and a mean weight of 107.4 kg who participated in the study experienced a mean total body weight loss of 13.5%, or 14.4 kg. In terms of complications, investigators noted one balloon deflation.

The manufacturer of the ReShape Duo, ReShape Medical, submitted a premarket approval application for the device to the FDA in July.

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2014 ISSUES FOR THE BARIATRIC & METABOLIC PROFESSIONAL

15

Extended Quarterly Coverage

Calcium Absorption Plunges After Gastric Bypass, Study Shows B Y R OSEMARY F REI , MS C

C

alcium absorption appears to decline precipitously after gastric bypass surgery, according to a new study, suggesting that people who undergo the procedure may need to boost their intake of the nutrient.

The study showed a decline in average fractional calcium absorption (FCA) from normal levels, of 33% at baseline to 7% six months after surgery. This drop occurred despite the fact that patients had optimized levels of 25-hydroxyvitamin D, which facilitates calcium absorption in the small intestine. Bone mineral density also decreased significantly, although the reduction was not significantly correlated with the fall in FCA. “The skeleton of the gastric bypass patient experiences mechanical unloading with weight loss, as well as hormonal and nutritional changes,” said Anne Schafer, MD, assistant professor of medicine at the University of California, San Francisco, who led the study. “The dramatic decrease in calcium absorption—with corresponding increase in parathyroid hormone and bone turnover marker levels that we also observed in our study—is part of this big picture,” Dr. Schafer said.

Dr. Schafer’s group presented their findings at the 2014 annual meeting of the American Society for Bone and Mineral Research. The study involved 33 men and women who were scheduled for Roux-en-Y gastric bypass. The patients had an average age of 45 years and a mean body mass index of 45 kg/m2. All participants received 1,200 mg per day of calcium in the form of chewable supplements.

Six months after surgery, the patients had lost an average of 26% of their preoperative weight. Furthermore, their FCA dropped by an average of 26%. The mean 25-hydroxyvitamin D level remained relatively stable through supplementation, decreasing from 42 to 36 ng/mL. The patients with the highest percentage weight loss at six months’ follow-up had the largest reductions in FCA. This finding was independent of age, sex and race. Bone mineral density as measured by x-ray imaging fell by 4.9% at the femoral neck (P<0.01) and by 4.4% at the total hip (P<0.01). Mean levels of parathyroid hormone increased from 46 to 52 pg/ mL (P=0.01).

P In addition, mean levels of serum C-terminal telopeptide—a marker of bone resorption—rose from 0.292 to 0.975 ng/mL (P<0.01), and patients with the greatest increases had lower FCA (P<0.01) after surgery.

Bone mineral density did not fall with FCA—a finding stressed by Arvinpal Singh, MD, medical director of Emory

Bariatric Center, in Atlanta, who was not involved in the study. What’s more, FCA is known to decrease with increasing calcium intake—meaning it might be premature for physicians to start counseling patients to consume more calcium.

“Either six months isn’t long enough to see an association between decreased FCA and decreased bone mineral density post-op, or there may be other variables involved,” Dr. Singh said. “Many

would argue that bone health or bone mineral density is more a product of calcium homeostasis/balance than calcium intake, and several factors may be playing a role in this population. Of course, exercise improves bone density and reduces the resorption of calcium from the bone,” he added. “Sodium, sodas, caffeine, smoking and excess protein increase calcium resorption from bone and promote loss of calcium from kidneys.”

Dr. Schafer acknowledged those factors, but said she remained concerned about the implications of the reduction in calcium. “I worry about its longterm effects on bone health,” she said.

“Our results suggest that gastric bypass patients may need higher calcium intakes to prevent perturbations in calcium homeostasis, although the specific approach to calcium supplementation needs to be established.”

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What is MISP? The mission statement of the Merck Investigator Studies Program (MISP) is to advance science and improve patient care by supporting, through the provision of drug/vaccine and total/partial funding, high-quality research that is initiated, designed, implemented and sponsored by external investigators.

Who Can Participate?

The Merck Investigator Studies Program is open to all academic and community-based physicians, anesthesiologists, surgeons, and researchers worldwide who are interested in conducting their own research.

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This program consists of committees of medical and scientific staff from different therapeutic areas who meet regularly to review Merck investigator study proposals. Support and funding are provided based on the scientific merit of the proposal as well as whether it is in alignment with the published areas of interest.

Copyright © 2014 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. Printed in USA ANES-1124773-0000 07/14

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16

Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2014

Welcome to the November issue of The Surgeons’ Lounge. In this issue, we welcome our guest expert Armando Castro, MD, FACS, assistant professor of clinical surgery, general surgery program director, Minimally Invasive/Bariatric Surgery Program, New York Hospital Medical Center and Weill Cornell Medical College, both in New York City. Dr. Castro responds to a question regarding marginal gastrojejunal ulcers occurring after gastric bypass surgery.

Also in this issue, Sandiya Bindroo, MD, MS, research intern, Providence Hospital and Medical Center, Southfield, Mich., and Yaniv Cozacov, MD, PGY2 surgical resident, Cleveland Clinic Florida, Weston, Fla., provide an interesting perspective on the origin and evolution of the Morbidity and Mortality Conference, now a staple at health care facilities in the United States.

Readers’ feedback is our greatest asset. Tell us how we’re doing! What do you want to see more of? Less of?

What is the best part of Surgeons’ Lounge?? What can we do even better? We look forward to your feedback!

Dr. Szomstein n is associate director, Bariatric Institute, Section of Minimally Invasive Surgery, Department of General and Vascular Surgery, Cleveland Clinic Florida, Weston.

Sincerely, Samuel Szomstein, MD, FACS Editor, The Surgeons’ Lounge Szomsts@ccf.org

Question for Dr. Armando Castro Omar Bellorin, MD, General Surgeon University Hospital, Universidad Central de Venezuela, Caracas, Venezuela

A

54-year-old woman with a past surgical history of antecolic antegastric Roux-en-Y gastric bypass in 2004 and recently diagnosed with unresectable pancreatic cancer status post-chemotherapy, presented with severe left upper quadrant abdominal pain and leftsided chest pain that began 12 hours before. Her pain was sudden in onset, sharp and radiating to her left shoulder. She had no previous episodes and no recent esophagogastroduodenoscopy (EGD). Physical exam revealed tachycardia, tachypnea, hypotension and left upper quadrant tenderness, and guarding consistent with peritonitis. Computed tomography (Figure 1) showed moderate to large amounts of intraperitoneal free air, likely representing bowel perforation. The gastric remnant was markedly distended and the free air is seen only in the upper abdomen (Figure 2). A pancreatic mass was obstructing the second portion of the duodenum (Figure 3).

Figure 1. Computed tomography showes moderate to large amounts of intraperitoneal free air.

The patient was resuscitated with IV fluid and given antibiotics, and then taken to the operating room for exploratory laparotomy. Intraoperative findings were consistent with a perforated ulcer located at the gastrojejunal anastomosis (GJA) and a distended gastric remnant caused by a pancreatic mass invading and obstructing the second portion of the duodenum. The abdominal cavity was thoroughly washed and the gastrojejunal perforation was repaired using an omental patch (Graham’s). A gastrostomy for decompression of the remnant was also performed. The patient had a satisfactory postoperative period and was discharged on postoperative day 7.

Questions: What is the incidence of marginal gastrojejunal ulcers after gastric bypass; what are the risk factors; and how often is perforation the initial presentation?

What are the surgical options for this type of complication?

The patient also had an unresectable pancreatic cancer. Is the surveillance for gastrointestinal (GI) malignancies in gastric bypass patients different from that for the rest of the population? Are obese patients prone to developing cancer?

Figure 2. Gastric remnant markedly distended and the free air is seen only in the upper abdomen.

Dr. Castro's

Reply

Question 1 Patients with gastric bypass may experience a wide variety of complications that can be classified as acute or chronic. Marginal ulcers of the GJA usually represent a chronic complication that the bariatric surgeon frequently encounters. The reported incidence of marginal ulceration of the GJA after gastric bypass surgery varies widely, ranging from 0.6% to 16%.1-8 The risk factors for ulceration are smoking, use of nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids, stress, recent surgery and the presence of gastro-gastro fistulas.

A higher incidence has been reported in patients who have undergone gastric bypass using circular staplers for the construction of the GJA, as opposed to a linear stapler.1,3,6,7 The use of nonresorbable sutures in the GJA is also associated with marginal ulceration.9 The

Figure 3. Pancreatic mass obstructing the second portion of the duodenum.

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presence of Helicobacter pylorii may play an additional underwent an open approach by general surgeons, and role in the development of marginal ulcers. Schirmer five underwent laparoscopic repair by bariatric suret al described a 2.4% incidence of marginal ulcers in geons. The laparoscopic group experienced less morpatients who underwent treatment for H. pylorii preop- bidity, no deaths and shorter hospital stay than the eratively compared with 6.8% in those who did not.10 patients who underwent open surgery.

The majority of these ulcers can be treated medicalPostoperatively, these patients should have a reducly. However, a subset of patients will have intractable tion of risk factors, prolonged H2 blockers/PPI regidisease requiring surgery for definitive management as men and eradication of H. pylorii in those who initially the last resort. Patients with marginal ulcers are pri- tested positive. I also recommend an upper endoscopy marily medically treated with H2 blockers or proton three months after the procedure to assess the GJA. pump inhibitors (PPIs). Sucralfate is also added to the treatment, as well as smoking cessation and sub- Question 3 stitution of ulcerogenic medications. An upper GI Obesity and cancer are strongly related. In the study is advised if a gastro-gastric fistula is suspected United States, approximately 85,000 new patients and/or for patients with no improvement after medi- with cancer annually are related to obesity.18 Studies cal management. There is no consensus on the treat- have found that an increase in the body mass index by ment duration, but the majority of bariatric surgeons 5 kg/m2 is associated with a 10% higher cancer-relatchoose a minimum of a two- to three-month regimen, ed mortality. Conversely, obese patients who undergo followed by an upper endoscobariatric surgery have a lower incidence py to confirm resolution. Some The decision to use a of cancer and a decrease in cancer-relatsurgeons advocate endoscoped mortality. This is presumably relatlaparoscopic approach ed ic removal of nonresorbable to weight loss, as demonstrated by sutures, if present. depends solely on the Adams et al in a 12.5-year mean folClinically, the symptoms suglow-up study of patients who underwent surgeon’s expertise and gastric gestive of marginal ulceration bypass surgery compared with include, but are not limited to, severely obese controls.19 confidence in upper abdominal pain or prodetection and treatment of canadvanced laparoscopy. cerEarly gressive upper abdominal disin patients undergoing bariatric surcomfort and intolerance of food, gery may also play a role. These patients and upper GI bleeding. Intractability is generally undergo a preoperative comprehensive GI, pulmonary defined as persistence of symptoms after three months and cardiovascular workup that is not routinely underof medical treatment. Patel et al reported on 39 taken in the general population. Moreover, the stompatients with intractable marginal ulcers, whose pri- ach remnant after gastric bypass surgery will no longer mary signs and symptoms included chronic abdominal be conveniently accessible, thus making the preoppain (66.6%), GI bleeding (20.5%), stomal obstruc- erative assessment of the upper GI tract even more tion (10.2%) and perforation (2.5%).11 A minority important. Zeni et al reported the presence of Barrett’s of these patients will present with an acute abdomen esophagus in preoperative EGD in 1.3% of patients, similar to the patient in this case, and free perfora- gastrointestinal stromal tumor in 0.7%, gastric poltion of the ulcer must be ruled out. Perforation of GJA yps in 5%, H. pylori–associated i gastritis in 27% and ulcers is relatively uncommon, with incidence ranging duodenitis in 6%, respectively.20 This extensive workfrom 0.25% to 1%.11-14 The risk factors for perforation up may result in early cancer diagnosis and may partly are similar to those for ulceration, but smoking, histo- explain why patients undergoing obesity surgery have ry of recent surgery, and use of NSAIDs and steroids a lower cancer-related mortality. are the common denominators in this particular sitOnce gastric bypass for obesity is performed, access uation.15 They represent a life-threatening condition to the gastric remnant and the biliary tree becomes with a mortality rate of 10%.15 complicated. There is no standard recommendation for a routine assessment of the gastric remnant after Question 2 gastric bypass. Although technically difficult, douPatients with perforation of a GJA ulcer need ble-balloon enteroscopy is a feasible way to assess the aggressive fluid resuscitation and prompt initiation duodenum and the residual stomach when the patient of antibiotic therapy before any urgent surgical man- experiences symptoms that warrant further workup. agement. The definitive approach can be performed Ultrasound or computed tomography–guided percuby open surgery or laparoscopy, and includes prima- taneous gastrostomy and subsequent gastroscopy is ry repair of the ulcer and omental patch along with a another option. Combined laparoscopy–endoscopy thorough washout of the abdominal cavity. A gastros- can be used as a last resort for diagnosis and treatment. tomy for feeding purposes should also be performed.

This anatomic exclusion certainly may result in Large perforations not amenable to primary and patch delayed diagnosis and treatment of a gastric/duoderepair may require revision of the GJA. nal/pancreatic/periampular cancer. A locally advanced The decision to use a laparoscopic approach pancreatic mass in a patient who has undergone a gasdepends solely on the surgeon’s expertise and confi- tric bypass may result in gastric outlet obstruction, dence in advanced laparoscopy. Several studies have which may lead to gastric distention and eventual percompared open and laparoscopic repair of perforated foration. A decompressive gastrostomy of the remnant peptic ulcers that have demonstrated better outcomes is the treatment of choice to avoid this complication. in the laparoscopic group.16-17 Shorter hospital length Overall, the approach performed in the present of stay, reduced wound pain and earlier return to nor- patient corresponds to the current standard of care mal activities are the main reported advantages. Kal- and the published literature. However, it is my opinaiselvan et al reported on a series of 10 patients who ion that the laparoscopic approach by an experienced presented with perforated GJA ulcers.15 All patients surgeon may afford the patient the advantages associwere treated with abdominal washout, primary closure ated with minimally invasive surgery. of the perforation and omental patch. Five patients

References 1. Suggs WJ, Kouli W, Brolin RE, et al. Complications at gastroenterostomy after laparoscopic Roux-en-Y gastric bypass: comparison between 21 and 25 mm circular staplers. Surg Obes Relat Dis. 2007;5:508-514.

2. Higa KD, Boone KB, Ho T. Complications of the laparoscopic Roux-en-Y gastric bypass: 1,040 patients: what have we learned? Obes Surg. 2000;6:509-513.

3. Gonzalez R, Lin E, Venkatesh KR, et al. Gastrojejunostomy during laparoscopic gastric bypass. Arch Surg.

2003;138:181-184.

4. Lujan JA, Frutos MD, Hernandez Q, et al. Experience with the circular stapler for the gastrojejunostomy in laparoscopic gastric bypass (350 cases). Obes Surg.

2005;15:1096-1102.

5. DeMaria EJ, Sugerman HJ, Kellum JM, et al. Results of 281 consecutive total laparoscopic Roux-en-Y gastric bypasses to treat morbid obesity. Ann Surg.

2002;235:640-647.

6. Kligman MD, Thomas C, Saxe J. Effects of the learning curve on the early outcomes of laparoscopic Roux-en-Y gastric bypass. Am Surg. 2003;69:304-309.

7. Schwartz MD, Drew RD, Rolger RW, et al. Stenosis of the gastrojejunostomy after laparoscopic gastric bypass.

Obes Surg. 2004;14:484-491.

8. Shikora SA, Claros L, Kim JJ, Tarnoff ME. Late complications: ulcers, stenosis and fistula. In: Pitombo C, ed.

Obesity Surgery Principles and Practice. New York, NY: McGraw-Hill; 2008:.313-318.

9. Sacks BC, Mattar SG, Qureshi FG, et al. Incidence of marginal ulcers and the use of absorbable anastomotic sutures in laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2006;2:11-16.

10. Schirmer B, Erenoglu C, Miller A. Flexible endoscopy in the management of patients undergoing Roux-en-Y gastric bypass. Obes Surg. 2002;12:634-638.

11. Patel RA, Brolin RE, Gandhi A. Revisional operations for marginal ulcer after Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2009;5:317-322.

12. Lublin M, McCoy M, Waldrep DJ. Perforating marginal ulcers after laparoscopic gastric bypass. Surg Endosc.

2006;20:51-54.

13. MacGregor AM, Pickens NE, Thorburn EK. Perforated peptic ulcer following gastric bypass for obesity. Am Surg.

1999;65:222-225.

14. Felix EL, Kettelle J, Mobley E, Swartz D. Perforated marginal ulcers after laparoscopic gastric bypass. Surg Endosc. 2008;22:2128-2132.

15. Kalaiselvan R, Exarchos G, Hamza N, Ammori B. Incidence of perforated gastrojejunal anastomotic ulcers after laparoscopic gastric bypass for morbid obesity and role of laparoscopy in their management. Surg Obes Relat Dis. 2012;8:423-428.

16. Siu WT, Leong HT, Law BK. Laparoscopic repair for perforated peptic ulcer: a randomized controlled trial.

Ann Surg. 2002;235:313-319.

17. Minutolo V, Gagliano G, Rinzivillo C. Laparoscopic surgical treatment of perforated duodenal ulcer. Chir Ital.

2009;61:309-313.

18. Bassen-Engquist K, Chang M. Obesity and cancer risk: recent review and evidence. Curr Oncol Rep. 2001;13:71-76.

19. Adams T, Stroup A, Gress R, Adams K, et al. Cancer incidence and mortality after gastric bypass surgery. Obesity. 2009;17:796-802.

20. Zeni TM, Frantzides CT, Mahr C, et al. Value of preoperative upper endoscopy in patients undergoing laparoscopic gastric bypass. Obes Surg. 2006;16:142-146.

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History and Other Facts

The Morbidity and Mortality Conference: Origin and Evolution B Y S ANDIYA B INDROO MD, MS, Y ANIV C OZACOV , MD

AND

These standards of objective truth and criticism may teach him (the individual man) to try again and to think again; to challenge his own conclusions, and to use his imagination in trying to find whether and where his own conclusions are at fault.

They may teach him to apply the method of

trial and error in every field, and especially in science; and thus they may teach him how to learn from his mistakes, and how to search for them. These standards may help him to discover how little he knows and how much there is he does not know.

They may help him to grow in knowledge, and also to realize that he is growing. They may help him to become aware of the fact that he owes his growth to other people’s

criticism and that reasonableness is readiness to listen to criticism.

—Karl Popper, 1978 The morbidity and mortality conference (M&MC) appears to have sprung from the efforts of physicians to improve practice through the examination of medical errors and bad outcomes. It developed as a means of quality control

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for medical practice, by which the profession would regulate its activities with the intention of improving overall patient care.1 The first antecedents of the M&MC are difficult to trace. The rise of a modern hospital as a center of clinical practice and education stimulated the development of systems to review, standardize and improve medical procedures. Hospital committees were established to examine adverse outcomes. These committees represent the most immediate precursors of the M&MC.

Florence Nightingale's methodical approach is recognized as one of the earliest programs of outcomes management.

The first clinical audit was undertaken by Florence Nightingale during the Crimean War of 1853-1855, in Scutari, in modern-day Turkey, at Medical Barracks Hospital. Nightingale was appalled by the unsanitary conditions and high mortality rates among injured or ill soldiers. She and her team of 38 nurses applied strict sanitary routines and standards of hygiene to the hospital and equipment, and kept meticulous records of the mortality rates among the patients. After this change, the mortality rate fell from 40% to 2%.

Nightingale’s methodical approach is recognized as one of the earliest programs of outcomes management.2 Historically, clinical audit was introduced by Ernest W. Hey Groves, MD, in 1908 in Great Britain and Ernest Amory Codman, MD, in 1910 in the United States.

Formal collection of hospital records and statistics was advocated by Percival in his “Medical Ethics,”3 by Florence Nightingale in her “Notes on Hospitals,”4 and by Groves in an article in the British Medical Journall in 1908.5 Although they all argued that this organized approach would help the systematic improvement of hospital treatment, their pleas fell on deaf ears.

In 1900, Dr. Codman conceived his “end result idea,” a vision that each hospital should analyze the results of treatment in every patient and study the long-term outcomes with a view toward improving treatment. Dr. Codman applied the methods of the natural scientist and the industrial manager to surgical practice at Massachusetts General Hospital, in Boston. He reflected a desire

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to improve medical practice by the examination of experience. He developed the concept of the end result card, which documented each patient’s symptoms, clinical diagnosis, treatment plan, complications, final diagnosis and annually updated outcome. Whenever perfection was not achieved, an analysis of the cause was detailed on the card, based on the taxonomy of errors he developed.6 Dr. Codman called for open acknowledgment of these “end results” to physicians and to the public, and challenged hospitals to hire clerks to record these data, to publish results and to establish efficiency committees empowered to correct errors identified by this process.

Dr. Codman’s ideas elicited intense opposition from physicians, who resisted the loss of autonomy inherent in his model. In 1910, Abraham Flexner published a scathing attack on the standard of American medical schools and hospitals,7 which led to drastic changes in these schools and stimulated the Clinical Congress of North America to announce plans for the reform of hospital care and surgical practice. Congress was influenced by Dr. Codman, who had resigned from Massachusetts General Hospital because of his dissatisfaction with the standards of surgical care.8 Dr. Codman set up his own hospital, published abstracts of all cases admitted between 1912 and 1916, and analyzed unfavorable results. He advocated critical appraisal of the care of individual cases, arguing that it would help to discover correctable deficiencies and to improve the overall quality of medical care. Dr. Codman’s views were ahead of their time.9 His zeal alarmed some doctors, and no hospital fully accepted his challenge to analyze and compare cases according to his proposals.

The American College of Surgeons (ACS) took over the work of Dr. Codman and his colleagues, and introduced a “hospital standardization program.” But this was limited to five aspects: medical staff organization; qualifications for medical staff membership; rules and policies governing professional work in the hospital; medical records; and diagnostic and therapeutic facilities. The program’s results were beneficial. Yet this program omitted the analysis of outcomes and the identification of avoidable errors, the two points about which Dr. Codman was most concerned. Dr. Codman’s ideas ultimately contributed to the standardization of hospital practices by the ACS in 1916. This has relevance even today for both the M&MC and quality assurance practices.

There were sporadic but unsuccessful attempts to promote the audit of patient care during the 1920s and 1930s.

In 1935, the Philadelphia County Medical Society continued in this tradition

The American College of Surgeons took over the work of Dr. Codman and his colleagues, and introduced a ‘hospital standardization program.’ by forming a group initially called the Anesthesia Mortality Committee, which was an early precursor of the M&MC. Its objective was to facilitate discussion and to share knowledge about fatalities

secondary to anesthesia, and “other interesting anesthetic situations.”10 This multi-institutional review group attempted to disseminate new information and to improve community standards of care.

In 1940, the name of the organization was changed to the Anesthesia Study Commission and its mandate was expanded to review a variety of topics, not limited to fatalities. It met monthly and was composed of anesthesiologists, surgeons and internists representing a variety of institutions. Its meetings were open to “all physicians, residents and

interns … as well as numerous nonresident visitors.” The commission generated periodic public reports of its activities. In his 1945 review of the commission’s history and data, anesthesiologist Henry Ruth, MD, reported that at least two-thirds of fatalities reviewed were classified as preventable, and that the commission’s conclusions often differed from the causes of death included on death reports.10 The goals and format of the Anesthesia Mortality Committee have been highly influential and widely replicated. It is see MORBIDITY & MORTALITY page 22

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Surgeon Suggests Combo Approach When Training For Robotic Bariatric Surgery B Y L OUISE G AGNON MONTREAL—Performing a hybrid approach to bariatric surgery, which combines robotic and laparoscopic surgeries, is an effective way to introduce robotic procedures to surgeons new to the modality, according to a surgeon who spoke recently at the 2014 annual meeting of the International Federation for the Surgery of Obesity and Metabolic Disorders.

“It’s a great way to get people started in robotic surgery [to do hybrid procedures],” said Erik B. Wilson, MD, who spoke about whether robotic surgery will result in better results than laparoscopic surgery for bariatric and metabolic procedures. Dr. Wilson is a professor in the Department of Surgery, vice-chair of clinical affairs, division chief of elective general surgery, minimally invasive surgery/bariatric surgery at the University of Texas Health Science Center at Houston.

“We greatly encourage surgeons when they are on a learning curve to use hybrid procedures,” said Dr. Wilson. “If you are starting out, and you do a case with complete robotic surgery, those cases will last very long, sometimes four or five hours.

There’s so much learning around how to operate the console. When I train surgeons, I suggest they do part of the operation as a laparoscopy, and other parts, robotically.

“They can reserve the robot for the part of the case where it can make a big difference, like the anastomosis,” he said.

“They can evolve the procedure from hybrid to completely robotic in time.”

The anastomosis is a component of gastric bypass surgery that Dr. Wilson describes as “more risky” and where he has found robotic surgery to be superior to laparoscopic surgery.

Hybrid procedures were very common when robotic surgery was first introduced, but as the robotics and instrumentation improved, more hybrid procedures progressed to completely robotic, Dr. Wilson said. Still, hybrid procedures remain valid and represent a great teaching tool for young surgeons who want to learn about robotic surgery.

Another application of robotic surgery, according to Dr. Wilson, is that it can serve as an objective way to grade the skills of practicing surgeons, and it will save time compared with blinded, video assessments of surgeons.

“You can perform independent video evaluations of surgeons, but that is very

time-consuming,” said Dr. Wilson.

“Using the robot, you can measure the surgeon’s movements. It’s a very objective way of analyzing a surgeon as the surgeon is actually operating.”

The data on outcomes with robotic surgery are accumulating, and there are currently more data on outcomes with robotic gastric bypass than sleeve gastrectomy, noted Dr. Wilson.

“When we start getting a sense of what movements (in robotic surgery) generate good outcomes, we can start grading surgeons through simulation, putting them on a simulator before they even operate,” said Dr. Wilson. “We can continue to grade them while they operate.”

An objective measure that hospitals use to measure the performance of a surgeon is the 30-day complication rate after surgery, but largely hospitals rely on word of mouth about a surgeon’s ability, said Dr. Wilson.

“It is a value proposition to hospitals that are looking to hire the best surgeons,” Dr. Wilson said in an interview with General Surgery News. “You can’t accuse the robot of cheating or playing favorites. When you are hiring a surgeon to your institution at this point in time, it generally boils down to reputation.”

Patients With Psychiatric Illness Require Close Watch After Bariatric Surgery B Y L OUISE G AGNON MONTREAL—Patients with psychiatric illness who are choosing bariatric surgery require very close psychiatric follow-up after surgery, according to the medical director of a community-based internal medicine weight management clinic.

A study conducted in Brazil and presented at a poster session at the 2014 annual meeting of the International Federation for the Surgery of Obesity and Metabolic Disorders looked at six cases in which patients committed suicide or attempted suicide after bariatric surgery. The study did not specify the form of weight loss surgery that each patient underwent.

Three of the six patients who underwent the surgery had an anxiety disorder and had previous psychiatric treatment, a fact that needs to be given consideration, said Sean Wharton, MD, PharmD, FRCP(C), medical director of the

Wharton Medical Clinic, internist at Toronto East General Hospital in Toronto, Ontario, Canada, and Hamilton Health Sciences in Hamilton, Canada, and an adjunct professor at York University in Toronto, who was not involved with the study.

The study investigators noted that the patients had psychological follow-up until the third month after their operations.

They also noted that all but one patient committed or attempted suicide one year after surgery, which led them to conclude the surgery does not immediately spur patients to an act of suicide.

“They absolutely need follow-up care for their psychiatric illness,” Dr. Wharton told General Surgery News. “They will need long-term follow-up for their psychiatric illness. Their psychiatric illness does not go away after [bariatric] surgery.”

The research suggested that patients who seek bariatric surgery have a greater burden of psychiatric illness than obese patients who do not choose the surgery.

Dr. Wharton stressed that patients should not discontinue their psychiatric medications before or after surgery.

Many mood-stabilizing therapies that psychiatric patients are exposed to produce the undesirable side effect of weight gain, but newer pharmacologic therapies have been designed to have a weight-neutral effect on patients, he said.

Clinicians should favor initiation of weight-neutral medication in their newly diagnosed psychiatric patients and may consider switching to a weight-neutral medication in patients whose psychiatric illness is well controlled, said Dr. Wharton. A preferred strategy, however, would be to maintain psychiatric patients on their medication if they are stabilized, and treat the associated weight gain with lifestyle interventions like dietary modification and exercise.

Surgical centers should ensure that psychiatric patients who opt for bariatric surgery are seen by a mental health care professional, added Dr. Wharton.

Pathology Common in Tissue From Gastric Sleeve Resection B Y R OSEMARY F REI , MS C

T

hree-fourths of the gastric tissue samples retrieved during gastric sleeve resection had potentially significant cellular abnormalities, new research indicated.

The review of patient charts and histology at a large Midwest hospital found that among tissue samples from 343 gastric sleeve surgery cases, 237 (69%) had gastritis, six (1.7%) had ulcers, two (0.58%) had gastrointestinal stromal tumors and one (0.3%) each had adenocarcinoma, polyp, gastric diverticulum and pyloric stenosis.

Rachel Gordezky, MD, a pathology resident at the University of Illinois Hospital and Health Sciences System, in Chicago, who led the study, noted that at most institutions, these tissues currently are routinely examined by pathologists.

“But there’s been talk in different medical communities that tissues from procedures like sleeve gastrectomy, because of budget cuts, don’t need to be routinely examined,” she said.

Dr. Gordezky presented the findings at the College of American Pathologists’ 2014 annual meeting (poster 84). She and her colleagues found that 75.2% of patients who underwent bariatric surgery at the University of Illinois between January 2009 and August 2013 had incidental findings in their gastric sleeve surgical specimens that were not documented in their charts preoperatively.

Dana Telem, MD, associate director of the Bariatric and Metabolic Weight Loss Center at Stony Brook University, in Stony Brook, N.Y., said, “The way you could look at this is, with the high rate of findings, many of which are significant, should all patients undergo preoperative endoscopy?

“My practice right now is to perform selective endoscopy—for example, if there’s clinical indication or family history that would put out a red flag” for possible underlying gastric abnormalities, said Dr. Telem, who was not involved in the latest study. “But I’ve been considering switching to routine endoscopy performance preoperatively.”

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DEBATE

jcontinued from page 1 period. The robotic cases were longer in duration than the laparoscopic ones, but there was a lower conversion rate with the robotic approach, fewer complications and fewer gastrointestinal leaks. In addition, they found less early reoperations and shorter hospital lengths of stay among robotic cases. The investigators noted that the reduction in body mass index was significantly greater with the laparoscopic approach at the end of the first year after surgery (Obes Surgg 2014 Jun 26. [E-pub ahead of print]).

“The use of the robot has been shown to reduce complications,” Dr. Wilson said. “The robotic [approach] was more expensive to use at the time of surgery, but surgeons have felt it is worth it to use because it reduces complications—in particular, leaks.”

Jacques Himpens, MD, a bariatric surgeon in Leuvens, Belgium, who has published widely on bariatric surgery and is regarded as a pioneer in robotic surgery, said robotic surgery remains cumbersome and inefficient for surgeons.

“There has been much less progress [with robotic surgery] than we would have hoped for,” Dr. Himpens told the IFSO attendees. “The robot is bulky; it takes a long time to set up; and the surgical time is longer with the robot.”

Dr. Himpens highlighted a systematic review that included 10 studies, representing results from 2,557 bariatric surgery patients. The review found no significant difference between major and minor complications in patients undergoing robotic and laparoscopic surgical procedures. Specifically, the rates of anastomotic leak, bleeding, stricture and reoperation were not significantly different between approaches. The investigators performed an economic analysis and found that costs were significantly greater for robotic RYGB than for laparoscopic RYGB, about $3,500 more per procedure (Surg Endoscc 2014;28:414-426).

“There is less time lost now with the robot than previously, but it’s still about 15 minutes longer to

MORBIDITY & MORTALITY jContinued from page 19

instructive to review the elements of this antecedent of the M&MC that remain relevant to our current conferences.

Meetings were held monthly, and error was confronted directly, albeit anonymously. The style was participatory; discussion proceeded with comments from the floor. Physicians caring for the patient were not identified by name, but Dr. Ruth reports that they not infrequently chose to identify themselves during the discussion of the case. Dr. Ruth’s work stressed the instructional value of open discourse of problematic cases while protecting participants through optional participation. Nevertheless, Dr. Ruth describes tension within the Mortality Committee between its educational goals and a fear of incrimination on the part of participants.

The historical tensions inherent in

perform the surgery with the robot,” Dr. Himpens said.

One of the purported advantages of the robotic surgery is the recovery of a number of lost degrees of freedom with the ability to have intra-abdominal articulations, Dr. Himpens noted.

Another purported benefit of installing a computer interface between the surgeon and the patient, or implementing a robotic approach to bariatric surgery, was to provide surgeons with greater ergonomic comfort, Dr. Himpens said.

’The robotic [approach] was more expensive to use at the time of surgery, but surgeons have felt it is worth it to use because it reduces complications—in particular, leaks.’

—Erik Wilson, MD One study used surface electromyography to detect ergonomic differences between laparoscopic and robotic platforms. The investigators found that the mean activation of right bicep and right deltoid muscles was significantly elevated during the laparoscopic compared with robotic approach in one task. In another task, the mean activation of the right trapezius muscle was significantly higher with the robotic approach than with the laparoscopic approach (Surg Endosc 2014;28:2459-2465).

“It’s not clear-cut [whether there is an ergonomic benefit], but the surgery is longer in duration [with the robotic approach], and is still pretty tiring in our hands,” Dr. Himpens said.

A key observation of Dr. Himpens is that surgeons continue to use a lot of staples—which are used routinely in laparoscopic RYGB to separate the stomach into two sections—in the robotic approach to RYGB surgery.

Staple-line leaks are a common complication in the laparoscopic RYGB procedure.

“Using the staples contributes to the cost [of robotic

the roots of the M&MC remain relevant today. Over the years, the M&MC has evolved as a forum for resident education. The conference is now a required component of surgical resident training, mandated by the Accreditation Council for Graduate Medical Education.11 Although application was irregular, surgical audit was promoted internationally by 1950. In 1953, the ACS, in collaboration with the Committee on Professional Hospital Activities, initiated a research program, to “develop an adequate surgical audit.” The audit system was adopted for a range of surgical specialties; continuing modifications were made; and the ability to analyze very large databases became available. A regional audit committee was first established in Yorkshire, England, in 1989.11 Despite this progress, several shortcomings of the M&MC and surgical audits were frequently noted, and this led to a proactive approach in the form of

RYGB surgery],” he said. “We should think about strategies to use the robot more efficiently than we use it now.”

Some disadvantages that Dr. Himpens cited with the robot include a smaller operating field, the lack of tactile feedback, and poor communication between the surgeon and the assistant at the operating table.

“There’s an assistant at the bedside to perform minor tasks and to ensure safety,” said Dr. Himpens in an interview after the debate. “The quality of the [sound] communication between the surgeon at the console and the assistant at the bedside is poor. There can be possible misunderstandings, which can lead to errors.”

Dr. Wilson agreed that sound communication is not optimal between the surgeon and the assistant at the operating table, but this shortcoming underscores that surgeons should be more involved in advocating for enhancements in the robotic approach to bariatric surgery.

“This [poor sound communication] reinforces the argument that we need to be engaged with the process [of implementing robotic surgery],” Dr. Wilson said.

Robotic surgery continues to evolve, and Dr. Wilson suggested that general surgeons and bariatric surgeons should take the opportunity to advocate for robotic surgery at their respective institutions or hospitals.

“If we become more involved in the process, we can be more involved in improvements to the technology,” Dr. Wilson pointed out.

Dr. Himpens agreed that the future may see the emergence of newer models of robots that will come with instrumentation that will permit more delicate tasks to be performed inside the patient.

There is currently a lack of standardization and best practices in robotic bariatric surgery, and it would be wise to develop a consensus regarding practice guidelines in bariatric surgery to eliminate inefficiencies, such as the use of staples, in robotic RYGB, Dr. Wilson noted.

“In my hands, I injure fewer vascular structures and cause less bleeding using the robot [for RYGB],” he said.

“We need to define best practices in the operating room [for these procedures].”

a surgical quality improvement program.

The ACS’s National Surgical Quality Improvement Program is the first validated, outcome-based, risk-adjusted and peer-controlled program for the measurement and enhancement of the quality of surgical care.12

References 1.

2.

3.

4.

Bulstrode CJK, Russel RCG, Williams NS. Surgical audit. In: Bailey & Love’s Short Practice of Surgery. 23rd ed. London, UK: Arnold; 2000:1307-1313.

Morrell C, Richard B, Shaw E, et al.

Principles of Best Practices in Surgery.

NICE 2002. Scrivener R, Morrell C, Baker R, et al. Principles for Best Practice in Clinical Audit. National Institute for Clinical Excellence. Abingdon, UK: Radcliffe Medical Press; 2002.

Percival T. Medical Ethics. 3rd ed.

Oxford, UK: John Henry Parker; 1849.

Nightingale F. Notes on Hospitals. 3rd ed.

London, UK: Longman, Green, Longman, Roberts, and Green; 1863.

5.

Groves EW. Surgical statistics: a plea for uniform registration of operation results.

Br Med J. 1908;7:ii:1008-1009.

6. Reverby S. Stealing the golden eggs: Ernest Amory Codman and the science and management of medicine. Bull Hist Med. 1981;55:156-171.

7. Flexner A. Medical education in the United States and Canada. New York, NY: Carnegie Foundation; 1910.

8. Codman EA. A study in hospital efficiency: the first five years. Boston, MA: Thomas Todd Co; 1916. Available from University Microfilms, Ann Arbor, Michigan.

9. Lembcke PA. Evolution of the medical audit. JAMA. 1967;199:534-550.

10. Ruth HS. Anesthesia study commissions. JAMA. 1945;127:514-517.

11. Amanda JL, Gabbay J, McNicol MC, et al. What did audits achieve? Lessons from preliminary evaluation of a year’s medical audit. Br Med J. 1990;301:526-529.

12. Wright JE. The history of surgical audit.

J Qual Clin Pract. 1995;15:81-88.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2014

Blood Clotting for Liver Donors Worse Than Suspected coagulation factor concentration at any given point—something that was missing from this study—would be important to know. His group plans to conduct further research in order to know more about which coagulation factor was affected most by hepatectomy.

The researchers presented their study at the 2014 annual meeting of the American Society of Anesthesiologists (abstract 1205).

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ealthy liver donors may be at increased risk for blood clots after hepatectomy, Japanese researchers have found.

The retrospective study looked at 55 adult donors, all from the University of Tokyo Hospital, and found that hepatectomy influenced coagulation status, especially in the extrinsic pathway of coagulation.

According to the study, one-third of the healthy liver donors showed a level of prothrombin time-international normalized ratio (PT-INR) of at least 1.5 after hepatectomy. According to guidelines from the American Society of Regional Anesthesia and Pain Medicine, manipulation of an epidural catheter in patients whose PT-INR is more than 1.5 raises their risk for epidural hematoma.

“Coagulation capacity after hepatectomy may be impaired by both reduction in hepatic production of coagulation factors and consumption of extrahepatically stored coagulation factors,” said Yuho Tamai, MD, assistant professor of anesthesiology at the University of Tokyo Hospital, who led the study.

Researchers found that PT-INR did show significant prolongation in hepatectomy patients, which usually does not occur in patients after major abdominal surgeries with equivalent blood loss or operation times. Results of the study also showed that PT-INR increased significantly on postoperative day 1 (1.43±0.13) and continued through day 7, then fell to the preoperative level at discharge. Of the 55 donor patients, 18 showed a PT-INR of at least 1.5 at any postoperative point.

The decreased production capacity of coagulation factors is mostly influenced by the volume of the liver graft. Consumption of coagulation factors stored outside the liver is likely determined by both halflife and distribution of each coagulation factor, Dr. Tamai said.

“I think the best we can do at the present time is to identify donors who may be at a greater risk of having hypercoagulable states,” said David Mulligan, MD, director of the Yale-New Haven Transplantation Center, in New Haven, Conn.

“Donors are healthy people. We owe it to them.”

Although safety always is a top concern for donor surgery of living donor liver transplantation (LDLT) with measures like epidural catheter for postoperative analgesia performed on a routine basis, Dr. Tamai said it is important to know as many details as possible about coagulation status to ensure optimal postoperative management.

of bleeding, blood transfusion volume and liver ischemia time. Baseline characteristics, including age, sex, body weight, amount of bleeding, operating time and graft site also were examined in the donors.

Dr. Mulligan said looking at PT-INR for blood clotting is complicated because minor factors can influence clotting not reflected in the PT-INR. Graft site—left or right lobe—was the only factor found to influence coagulation status in this study.

Dr. Tamai said data on blood

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“It may be better to pay more attention to coagulation status to prevent postoperative hemorrhagic complications including epidural hematoma after hepatectomy,” Dr. Tamai said.

The study investigators reviewed the medical and anesthesia records of 24 male and 31 female patients who underwent donor hepatectomy for adult LDLT from January 2010 through December 2012.

The researchers analyzed several measures of coagulation, including amount

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2014

Is â&#x20AC;&#x2DC;Resect and Discardâ&#x20AC;&#x2122; Gaining Acceptance?

B Y C AROLINE H ELWICK

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or diminutive polyps, is â&#x20AC;&#x153;resect and discardâ&#x20AC;? ready for widespread use, or are there too many unknowns for clinicians to adopt the approach in their practices?

According to colonoscopy expert Douglas K. Rex, MD, the concept is safe, rational and cost-saving, and the approach should move forward, although

GI pathologist Robert H. Riddell, MD, argued for a more cautious approach.

The two spoke on the subject at Digestive Disease Week 2014.

Dr. Rex is Distinguished Professor of Medicine at Indiana University School of Medicine, and director of endoscopy at Indiana University Hospital, both in Indianapolis. Dr. Riddell is head of the Sections of Gastrointestinal Pathology and Immunopathology, and professor of laboratory medicine and pathobiology

at the University of Toronto, in Ontario, Canada.

Elements of New Approach â&#x20AC;&#x153;Resect and discardâ&#x20AC;? refers to a practice in which polyps less than a certain size thresholdâ&#x20AC;&#x201D;in the United States, 5 mm or smallerâ&#x20AC;&#x201D;are evaluated during colonoscopy by narrow-band imaging or another modality. The clinician determines the probable diagnosis, and assuming a high level of confidence, he

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or she may choose to resect and discard the lesion instead of sending the tissue to the pathologist.

The resect and discard concept seeks to reduce expenditures by eliminating unnecessary testing when the diagnosis is certain, reserving the lab for uncertain diagnoses, Dr. Rex said. â&#x20AC;&#x153;A cost analysis suggests this approach leads to substantial savings, as much as $1 billion per year in the United States in one study [Kessler WR, et al. Endoscopyy 2011;43:683-691],â&#x20AC;? he said.

Dr. Rex argued that resect and discard is now supported by evidence.

Polyp differentiation, which is central to the strategy, can be learned by motivated endoscopists. Pathology reports are not always reliable. And adoption of the approach will result in huge cost savings.

The endoscopist can be confident about determining the presence or absence of cancer and differentiating between conventional or serrated adenomas. The pathologist typically determines whether cancer is present and evaluates histology, but not all this information is reliable, he maintained, especially the degree of dysplasia and the presence of villous elements in conventional adenomas, and the differentiation between hyperplastic and sessile serrated polyps among serrated lesions.

Dr. Rex said he also is concerned about the lack of standard definitions to describe the degree of dysplasia in conventional adenomas and what distinguishes a sessile serrated polyp from one that is hyperplastic.

Thatâ&#x20AC;&#x2122;s a â&#x20AC;&#x153;moving target,â&#x20AC;? he said. â&#x20AC;&#x153;We recently discovered for sub-centimeter polyps, even expert pathologists were not necessarily using the same definition for high-grade dysplasia in conventional adenomas [Lasisi F, et al. Dig Liver Dis 2013;45:1049-1055].â&#x20AC;?

More importantly, interobserver variability is high, an observation that has led some post-polypectomy guidelines to not include villous elements and dysplasia as stratifiers of risk.

Furthermore, cancer is rare in polyps 5 mm or smaller, Dr. Rex added, and on this point, the literature and â&#x20AC;&#x153;our dayto-day, and year-to-year experienceâ&#x20AC;? are consistent. For computed tomography colonography, the presence of polyps that size is not even reported, he said.

Clearing the Colon Is Most Important What determines outcomes, Dr. Rex emphasized, is not so much the histology of a tiny polyp, but how well the colon is cleared. â&#x20AC;&#x153;What is almost certainly less important is whether the diminutive polyp has high-grade dysplasia or villous elements, and whether it is hyperplastic

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2014

or sessile serrated,” he said.

In view of these considerations, the American Society for Gastrointestinal Endoscopy established its PIVI (Preservation and Incorporation of Valuable endoscopic Innovations) goals: Discarding polyps below 5 mm with high confidence, along with sending lowconfidence diminutive polyps and those under 5 mm to pathology, is associated with more than a 90% agreement with surveillance intervals established by pathology. The second concept in PIVI is that diminutive hyperplastic polyps can be left in place if the negative predictive value for adenomas exceeds 90%. This approach is cost-effective, he reiterated.

The confidence of the endoscopist cannot be overemphasized, if cost-effectiveness is to be demonstrated, Dr. Rex added. “When your pretest probability is extremely high for the diagnosis,” he said, “ordering a confirmatory test is money that is wasted.”

Can Targets Be Met? The use of appropriate imaging techniques can help endoscopists meet the PIVI goals, according to numerous studies and two recent meta-analyses (Wanders LK, et al. Lancet Oncol 2013;14:1337-1347; McGill SK, et al.

Gutt 2013;62:1704-1713) that have established narrow-band imaging, I-Scan, flexible spectral imaging color enhancement (FICE), confocal laser microscopy and autofluorescence as adequate for the everyday application of resect and discard.

“But recently, we have seen studies suggesting that PIVI criteria are not met by endoscopists in community practices,” Dr. Rex acknowledged (Ladabaum U, et al. Gastroenterologyy 2013;144:81-91; Schachschal G, et al. Gutt 2014;63:458465). He suggested that the endorsement of PIVI by societies and a means of credentialing performance may be needed for resect and discard to move forward.

“Perhaps, in reality, what we most need is motivation,” Dr. Rex added.

“What happens in clinical practice often depends on the reimbursement environment, and we may need reimbursement for endoscopic interpretation. A bundled payment approach that includes the cost of pathology may make resect and discard more attractive. I believe resect and discard can, and should, go forward, and that widespread acceptance will occur when financial incentives are aligned.”

Too Many Unknowns Dr. Riddell responded that resect and discard transfers the diagnosis of colorectal cancer from the pathology lab to the endoscopy suite, making it in effect a point-of-care test. “Point-of-care tests are tightly regulated,” he said.

“How will we guarantee the universal quality of this test?” Dr. Riddell asked.

“Will each endoscopy unit need to be accredited? Will each endoscopist need to demonstrate his or her own diagnostic competence? How will this be done?

What will be the cost of this? How will we prove maintenance of competence?

If you argue that this approach will not need accrediting, you may find opposition from the College of American Pathologists, clinical laboratories and other bodies.”

Guidelines are in place because of the need to precisely know the pathology of

colorectal lesions and to be able to identify those containing invasive carcinoma, which often is not obvious, because size is not a perfect indicator, Dr. Riddell pointed out. There are also rare instances when the unexpected occurs.

“There are less common things that can easily be missed by this technique,” Dr. Riddell said, for example, neuroendocrine polyps in the rectum, metastatic carcinomas presenting as small polyps, and lymphomas and melanomas in the gastrointestinal tract.

“Can we assume that all these variants really do get picked up and sent to

pathology?” he asked. “Throwing these away is not without its consequences.”

Dr. Riddell also offered a few “intangibles,” asking the gastroenterologists in attendance, “Are you comfortable with never knowing what you are dealing with? And are you happy having your own polyps thrown out?”

Dr. Rex has financial relationships with American BioOptics, Boston Scientific, Braintree Laboratories Inc, CheckCap, EndoAid, Epigenomics, Exact Sciences, Given Imaging and Olympus America.

Dr. Riddell has a commercial interest in Santarus.

Read the #1 general surgery publication in the country anywhere, anytime.

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Opinion PRESIDENTIAL APOLOGY jcontinued from page 1

street in America who historically would have died, or would have never been conceived, or would have never been born alive, or whose mother would have died giving birth to us, or who would have died in infancy or childhood or in the prime of our lives, if not for you.

Disease and trauma can be overwhelming. Not everyone can be saved, but every one of us has family members who have been saved, often multiple times throughout their lives.

And, in even far greater numbers than those saved from a mortality, are those who have their years of life and quality of life immeasurably increased by medical treatment of their chronic conditions, their diabetes, their blood pressure, heart disease, joint disease, depression, infections, injuries and cancers. You make the diagnoses, you counsel us, you prescribe the medical treatments and you perform the surgery. You treat us, you heal us, you cure us … and we go on with our lives.

And yet, our nation does not treat our doctors as the invaluable resource they are.

To understand this, we must first openly recognize that there are many cultural sectors with decidedly antiphysician sentiments. The word “physician” is a common noun, often intentionally used to avoid using the word “doctor,” which is an earned title.

Becoming a doctor takes extreme effort, commitment and sacrifice, which some resent. In college, while others spent their afternoons playing Frisbee on the quad (perhaps some journalism majors), you had 400level courses in inorganic chemistry, organic chemistry, biology and physics (for which the labs alone took all afternoon) and that’s just to prepare for the MCAT [Medical College Admission Test], to try to get into medical school in the first place.

In journalism by now, the style guides of most publications and media outlets intentionally delete the doctor’s credentials. Rex Morgan is often the only MD designated in an entire edition of your hometown newspaper, and that is only because the copyrighted name of the syndicated comic strip is “Rex Morgan, MD.” Doctors are now marginalized as a special-interest group, and caricaturized as avaricious. Doctors often are cited for the purpose of inciting class envy. These are the ploys of the political demagogue and the journalistic iconoclast, but are ploys used to their shame. This is not professional of them, and not true. You are now cast as but one of many “stakeholders” in the “health care system.”

In fact, the widespread shift to the use of the term “health care” constitutes the triumph of the nonphysician stakeholders, including the anti-physician stakeholders, to dilute the doctor’s role. “Health care” is so effectively inserted into our national lexicon that we use the term conversationally, but doctors don’t “do” health care—doctors practice medicine. Doctors diagnose, doctors counsel, doctors prescribe and doctors perform surgery. The unique and special nature of the knowledge and skill required define your learned profession.

As president, I ask, how does the United States of America contribute to the inappropriate ways we treat our doctors today? Specifically, to what extent have our federal and state governments, their bureaucracies and policies harmed our doctors and our nation’s medical system? And what can we do about it?

The two basic assumptions our federal and state governments make that cause harm to the medical profession, and thus ultimately harm patients, are that they

GENERALSURGERYNEWS.COM GENERALSUR GENERALSURG NERALS / GENERAL SURGERY NEWS / NOVEMBER 2014

‘Health care’ is so effectively inserted into our national lexicon that we use the term conversationally, but doctors don’t ‘do’ health care—doctors practice medicine.

know better than you do, doctor, and that they should tell you what to do. Governments are literally gravely wrong in using these assumptions as the basis for overregulation.

For lawyers, documents establish legal proof of something. From this arises the notion that creating more proof is a good thing, so we aver that no job is complete until the paperwork is finished and further, that if you didn’t document it, you didn’t do it. We’ve insinuated inappropriate degrees of legalism into your medical schools and nursing schools so graduates are indoctrinated to think that their job is to do documentation.

Then our regulators assume they should tell you what to say and how to say it. Next, our government insurance entities assume the power of deciding whether they will pay for a covered service, based not on the fact you actually did provide the service, but on whether they find your documentation acceptable … and that is often without revealing their criteria.

Although there is no evidence that regulation-mandated documentation improves any outcome, doctors and nurses today spend half of their working time not on patients, but on producing required documentation.

What a shameful systematic waste of crucial resources!

Even with that, insurers widely abuse documentation excuses to not pay doctors and hospitals. Keeping reasonable records in some understandable form is necessary, but documentation has become a “false god,” and we the government must stop forcing you to serve it.

You should be serving the patient.

The governmental practice of not paying hospitals and doctors for goods and services is not new. The most monumental governmental step to not pay for medical services rendered was Medicare’s Prospective Payment System. In the late 1970s, inflation was the excuse used as an imperative to institute a bundled payment system based on diagnosis-related groups. Instead of reimbursing hospitals their costs to treat Medicare patients, the new model paid hospitals a government-determined rate based on the patient’s diagnosis. As do all

“command economies,” this imposed business model functions in failure. Its greatest success lies in establishing government control over our hospital system.

The Omnibus Budget Reconciliation Act of 1989 limited the amount Medicare providers could balancebill Medicare beneficiaries. On Jan. 1, 1992, Medicare produced the Medicare Fee Schedule (MFS), a list of about 7,000 services that can be billed for. Physicians initially accommodated these undervalued fees as a charity they extended to the elderly. Each fee is now set by the government within the contrived ResourceBased Relative Value Scale. Medicare’s reimbursements to physicians have been cut repeatedly under the unsustainable sustainable growth rate methodology, and essentially all other insurers have cut their reimbursements down to Medicare rates. Medicare also “bundles” surgical fees, which by any other definition is theft of services.

The voluminous free medical care poured out daily by doctors and hospitals in this country has been unacknowledged for decades. The current rallying cry of insuring the uninsured is a false flag. If an underinsured, uninsured or indigent patient comes into any U.S. hospital, they get the same excellent level of medical treatment or surgery I would receive, whether or not they can pay for it. For the patients who never pay, the government sure doesn’t either; the doctors and hospitals are simply stuck with the bills, and absorb these operating losses all the time.

The health care reform initiatives of the 1990s were not fully implemented, but behind the scenes, commercial insurers successfully assumed controls similar to governmental controls, thus “unleashing the dogs” of managed care. Long before the Affordable Care Act was passed, every aspect of our medical system was subject to progressive regulatory control.

In 2000, the government-funded Institute of Medicine (IOM) released “To Err Is Human,” which clearly asserts that the problem in medical errors is not bad people; it’s that good people are working in bad systems

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2014

Poor outcomes and complications are no longer understood as consequences of dreadful disease and injury, but are seen as obvious evidence of rampant medical incompetence.

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that need to be made safer. Nonetheless, the IOM’s now famous statistic of 96,000 preventable medical deaths per year has been continuously used to tar physicians, not the systems in which they work, and certainly not the counterproductive governmental interference. The enduring legacy of this misattribution has been to destroy the patient’s and the public’s confidence in their doctors, and we the government have seized on that to regulate you even more.

That 96,000 number has been compared to the crash of a jet airliner occurring every day of the year, yet airliners are certified as healthy before takeoff, whereas patients have to be seriously diseasestricken to get into a hospital today. As complex as jet airliners may be (and they are modern engineering marvels), no jet airliner is anywhere near as complex as a single cell in the human body, let alone the complex organism we call a human being. Poor outcomes and complications are no longer understood as consequences of dreadful disease and injury, but are seen as obvious evidence of rampant medical incompetence.

The combined effect of the cultural, journalistic, legal, political and governmental injury of the medical profession in creating today’s anti-physician culture can be reasonably called the “war on doctors.”

What can we now do about this? We can start with an apology. Then we can follow with an active reset of our national medical realizations. We owe you that.

So, here is the first recognition and apology: Throughout our country, in every family, there is someone alive today who would be dead, or someone who can see, hear, think, breathe, eat, speak, sit, stand, walk or work again, who would not be able to, if not for you, the American doctor.

American medicine is the quintessential example of American exceptionalism, not (as criticized by some) by an assumption of superiority, but by leadership, innovation and a willingness to benevolently share its advances with the world.

This address is to recognize that all of you are just like the rest of us, arising from humble beginnings, but through incredible hard work, constant personal sacrifice, and at a cost to your families that few of us can understand, you are our doctors. To be a doctor today is to represent a great pursuit of the American Dream, and our nation should place far fewer barriers in your path.

As president, I hereby apologize for the governmental intrusion into your profession, for reducing you to being “providers” and for the costly make-work of documentation and compliance burdens.

I apologize for our “system” putting you out of business, closing a thousand hospitals in recent decades and hundreds of thousands of private practices in recent

years. I vow to work with you in reversing that course.

The only one who should tell a doctor what to do is the patient, not the government. I apologize for our government failing to recognize the value of your life’s work, and I promise to work with you to preserve, protect and defend your profession.

Medical Society. However, to any elected U.S. official, the governor of any state, any state senator, congressman or congresswoman, any mayor or other holder of a public office, permission is hereby granted to adopt these words in whole or in part, as long as parsing is not used to change the message. Thank you for your time and kind consideration.

Epilogue Of course, these remarks are not those of the president of the United States, but merely those of the incoming president of the Erie County (Pennsylvania)

— —Paul Malaspina, MD, is a general surgeon and the current president of the Erie County Medical Society, Erie, Pennsylvania.

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In the News EBOLA

jContinued from page 1 “One of the most tragic things is that people who have surgical diseases—not Ebola—are now getting shunted and left untreated because of the fear of Ebola,” said Sherry M. Wren, MD, professor of surgery and director of global surgery at the Center for Innovation in Global Health, Stanford University School of Medicine, Stanford, Calif.

In West Africa, patients with fever or vomiting, common with surgical emergencies, are being directed to Ebola evaluation and isolation units. Forced to wait days for a negative test for Ebola, some will die before they can undergo surgery.

“This is the problem we face now,” Thaim B Kamara, MD, chief of surgery, Connaught Hospital, Freetown, Sierra Leone, wrote in an email.

“I know a patient with a perforated duodenal ulcer who survived this harrowing experience and got operated days after he was discharged from the isolation unit.”

The grim situation is further complicated by fears among operating room (OR) staff about personal risk for infection, Dr. Kamara explained. Hospitals in the region lack most of the protective gear recommended for workers caring for patients with confirmed or suspected Ebola.

In Liberia, surgeons report that a colleague died after operating on a woman later found to have Ebola.

Lawrence Sherman, MD, a surgeon at Firestone Hospital in Liberia, wrote in an email that doctors at a mission hospital operated on an obstetrics patient who was eventually confirmed as a case of Ebola when hemostasis could not be established. The doctor was subsequently diagnosed with Ebola.

“The OR team used the standard precaution of cap, mask, apron, rain boots and obstetrics gloves for the surgery,” he said.

Surgical personnel are concerned not just about patients with Ebola-like symptoms but about patients with no symptoms at the time of surgery who later manifest symptoms, risking the lives of staff and other patients in the wards, he said.

As a result, even emergency cases have been cancelled.

“Yesterday (Oct. 4, 2014), the anesthetists refused to anesthetize a patient who badly needed a laparotomy for peritonitis because he had a documented history of vomiting and fever!” Dr. Kamara wrote.

He added, “surgeons find it morally difficult to

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2014

pressure others to accept patients who have been reviewed and booked for surgery by them.”

Martin Smith, head of general surgery, Chris Hani Baragwanath Academic Hospital in South Africa and president of the Pan African Association of Surgeons, said he has many surgical friends and colleagues at the center of the outbreak “who have either succumbed or are at high risk.

“To our colleagues in West Africa, some of whom we know personally and others we have trained, we need to say that our hopes and prayers are with them every day. We salute their efforts and support them in every decision they make.

“I am sure that they must feel incredibly isolated and alone in their practice but they should know that we will do whatever we can to assist them during this time.”

In South Africa, there has not been a single case of Ebola but surgeons feel “that this is only a matter of time,” said Dr. Smith.

“Our concern is that we have not managed universal precautions very effectively in the past and this outbreak will require significant upscaling of such precautions.”

Dr. Wren and Adam L. Kushner, MD, MPH, a surgeon at Johns Hopkins Bloomberg School of Public Health, Baltimore, worked extensively in Africa over the past decade. As the Ebola outbreak spread, they reached out to colleagues in Africa to inquire about surgical services. Surgeons on the ground said that some emergency surgical procedures continue but OR staff lack protective gear, as well as guidelines on surgical treatment of patients with Ebola.

“We shudder at the personal sacrifice and bravery of these surgeons who are unsung heroes,” said Dr. Wren.

Drs. Wren and Kushner quickly put together a protocol for OR personnel who might need to perform surgery on a patient with confirmed or suspected Ebola infection.

Within a matter of days, it was endorsed by the American College of Surgeons and other U.S. surgical societies; the Pan African Association of Surgeons; the College of Surgeons of East, Central, & Southern Africa; and the West African College of Surgeons.

They hope the protocol will bring attention to the need for more personal protective equipment in West

Email From Thaim B. Kamara, Chief of Surgery, Connaught Hospital, Freetown, Sierra Leone We are doing emergency operations such as amputations, laparotomies, etc. and C-Sections are done in most District Hospitals. The Medical Superintendent of Kailahun Government Hospital told me he had done a section on a pregnant woman infected with Ebola.

Yesterday (Oct. 4, 2014), the anesthetists refused to anesthetize a patient who badly needed a laparotomy for peritonitis because he had a documented history of vomiting and fever!! This is the problem we face now, if a patient has any of the symptoms regarded as part of the case definition for Ebola, he/she may be sent to the isolation unit and kept there until the result of their test comes

back. This may take days to happen, so if the patient is indeed having a surgical problem, [he or she] may die while waiting for the Ebola test result. I know a patient with a perforated duodenal ulcer who survived this harrowing experience and got operated days after he was discharged from the isolation unit.

This problem is not recognized by the EOC [Emergency Operations Centre], the Centre handing the Ebola emergency. Due to inadequate protective equipment like waterproof operating gowns, visors etc., surgeons find it morally difficult to pressure others to accept patients who have been reviewed and booked for surgery by them.

Highlights of Surgical Protocol for Possible or Confirmed Ebola Cases

•

•

• •

• •

•

• Elective surgical procedures should not be performed in cases of suspected or confirmed Ebola.

When an emergency procedure must be performed, operative approach should minimize potential hazards to all members of the OR team.

All patient providers should wear gloves, Association of the Advancement of Medical Instrumentation (AAMI) level 3 fluid-resistant gown, eye protection and facemask.

Patient’s Ebola status should be discussed in pre- and postoperative briefing.

OR personnel should wear AAMI level 4 impervious surgical gowns, leg coverings with full plastic film coating, full-face shield, mask, double gloves and surgical hood.

AAMI level 4 surgical drapes should be used.

Sharps should be kept to a minimum; use instrument, not fingers, when able; announce verbally when passing sharps and avoid hand-to-hand passage; use alternative cutting methods; use endoscopic surgery when possible; use round-tipped scalpel blades; use electrocautery preferentially to scalpel; no needles or sharps to be placed on Mayo stand; continue “sharps safety” throughout table cleanup.

Any staff with percutaneous or mucocutaneous exposures to blood, body fluids, secretions, or excretions from a patient with suspected or confirmed Ebola should: o Stop working and immediately wash the affected skin surfaces with soap and water. o Mucous membranes should be irrigated with water or eyewash solution. o Immediately contact infectious disease consultant at hospital for post-exposure evaluation.

These guidelines were created October 6, 2014 and will be updated if and when new data are available.

Africa. Even before the outbreak, hospitals in the area lacked adequate resources. One 2008 study found that U.S. hospitals during the U.S. Civil War had more equipment and supplies than modern-day hospitals in Sierra Leone.

“We need a better world response to help our colleagues and their patients in West Africa. Could you imagine having appendicitis and being thrown into an isolation unit with people who have Ebola because you have abdominal pain and a fever and nobody is going to help you until you are proven not to have Ebola?”

Dr. Wren called for an international agency to take the lead on delivery of surgical supplies and protective gear. She cited reports that medical supplies are being siphoned to the black market.

“How do we get the equipment to the people who don’t have it? That’s the part that’s frustrating.”

GSN Bulletin Board

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2014

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Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2014

Bundled Billing or Bungled Billing?

B Y M ARK F. W EISS , JD

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ore competition. Rising practice expenses. How do you become more competitive? How do you become more profitable?

Some surgeons, chiefly those with their own facilities, have turned to the concept of bundled billing to gain a competitive edge.

For those not familiar with the concept, bundled billing is the combination of multiple individualsâ&#x20AC;&#x2122; or entitiesâ&#x20AC;&#x2122; fees into a single price. So, for example, in connection with a certain procedure, your fee, the facility fee, the anesthesia fee and the pathology fee could be rolled, at a discount, into a bundled price.

What could be wrong with that?

Nothing. That is, unless you bungle it, in which case you might be committing a crime.

Hospital-Centered History The concept of bundled billing came out of the hospital world: In order to market for a discrete serviceâ&#x20AC;&#x201D;for example, a certain surgical procedureâ&#x20AC;&#x201D;the hospital sought to have all, or at least some, of the physician providers involved in that procedure agree with the hospital on a fixed

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Education are pleased to introduce part 2 of a 3-part interactive CME series featuring challenging cases in NMB. Each activity presents a clinical scenario that you face in your daily practice. After reading the introduction to the case, consider the challenge questions, and then visit ZZZ &0(=RQH FRP QPE WR ÂżQG out how your answers stack up against those of our multidisciplinary faculty panel.

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

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

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

Medical Director, Manager New Medical Center Nancy, France

Access this activity at ZZZ FPH]RQH FRP QPE

This activity is jointly provided by Global Education Group and Applied Clinical Education.

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price for their services. Those prices were then added, along with the hospitalâ&#x20AC;&#x2122;s fixed fee, into the bundle.

The idea was to present a coordinated, discounted, competitive price for the bundled procedure or service.

Fast Forward: The ASC Setting Today, surgeons and other proceduralists, particularly those with ownership in free-standing surgical facilities, are turning to the concept of bundled billing to gain a competitive edge.

Even in the hospital setting, bundled billing raises several concerns about compliance. But those concerns reach a crescendo when it appears that individuals in a position to refer are using bundled billing either to capture a portion of a referral sourceâ&#x20AC;&#x2122;s fees or to make their own, lesser discounted fees more attractive to payors or patients.

In a real sense, these concerns center on the same issues present in an alternative, potentially abusive structure, that of the so-called â&#x20AC;&#x153;company model.â&#x20AC;?

As a quick refresher, in the company model arrangement, either the ambulatory surgery center (ASC) controlled by referring physicians or the referring physicians themselves set up a company to deliver the services of â&#x20AC;&#x153;downstreamâ&#x20AC;? physicians. The concept is most prevalent in connection with anesthesia services: A separate anesthesia company is established to employ the anesthesiologists and nurse anesthetists working at the facility.

The owners, the referring physicians or their ASC, retain the anesthesia companyâ&#x20AC;&#x2122;s profits.

Of course, the central compliance issue in the company model arrangement is whether the deal violates federal and state anti-kickback laws.

In the bundled billing scenario, instead of cajoling the downstream physicians into an employment or subcontract relationship via a company model entity, those who control referrals coax the physicians into bundling their billing, generally at a discount, together with their own.

The danger occurs when bundling is misused to shift a portion of the downstream providerâ&#x20AC;&#x2122;s feeâ&#x20AC;&#x201D;for example, the pathologistâ&#x20AC;&#x2122;s feeâ&#x20AC;&#x201D;into the pocket of the bundler: â&#x20AC;˘ The bundler collects a larger pathology fee from the payor or patient and retains the difference after paying the pathologist his or her agreed-to discounted amount; or â&#x20AC;˘ Instead of discounting his or his facilityâ&#x20AC;&#x2122;s fee, the bundler uses the pathologistâ&#x20AC;&#x2122;s discount, but no discount on the bundlerâ&#x20AC;&#x2122;s part, to create a lower-priced package. As a

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2014

Depending on the nature of the services provided, it is possible that the arrangement violates the Stark law, the federal “self-referral” prohibition that applies to any physician who makes referrals to those with whom the physician has a direct or indirect ownership or investment interest. result, the pathologist’s willingness to take less accrues to the advantage of the bundler who is now able to collect his or her full fee.

spoken of as “whistleblower actions”) in which violators stand liable to regurgitate reimbursement, plus treble damages, and up to $11,000 per claim.

Conclusion In terms of intent, all may be above board in connection with a bundling relationship. Or, it could be a poorly designed substitute for a direct kickback, or an alternative to a kickback-infested company model arrangement. No matter which, innocent or deceitful, bundling arrangements implicate a number of federal and state compliance laws.

Tread carefully before entering into a bundled billing arrangement.

On the other hand, if you’ve already become involved in one without considering the risks, it’s essential that you engage

in a thorough evaluation immediately.

Bundled billing is often bungled billing.

—Mark F. Weiss, JD, is an attorney — who specializes in the business and legal issues affecting physicians and physician groups on a national basis. He served as a clinical assistant professor of anesthesiology at USC Keck School of Medicine and practices with The Mark F. Weiss Law Firm, a firm with offices in Dallas, Los Angeles and Santa Barbara, Calif., representing clients across the country. He can be reached by email at markweiss@ advisorylawgroup.com.

Compliance Quagmire The federal Anti-Kickback Statute (AKS) is designed to prohibit payments to physicians and other providers that are made in order to induce the referral of patients whose care is paid for by federally funded health care programs.

The AKS is a criminal statute and intent is required, but that intent can be inferred from the circumstances and many seemingly appropriate arrangements are, on examination, viewed by the Office of Inspector General of the Department of Health and Human Services, which enforces the law, as highly suspect.

The states have AKS-counterpart statutes, some of which approach the issue from the same angle as the federal provision but which may not make any distinction between the source of the patient’s funding, and others of which approach the issue from the angle of “fee-splitting”—the sharing of a physician’s fee with certain third parties under certain circumstances.

A bundling arrangement that results in the transfer of the referral receiving physician’s fee to the referral source may implicate the AKS and similar state statutes.

Even arrangements that do not involve transfer of wealth from the receiving physician to the person or entity coordinating the bundling may trigger a state’s feesplitting prohibitions and its corporate practice of medicine prohibitions.

Depending on the nature of the services provided, it is possible that the arrangement violates the Stark law, the federal self-referral prohibition that applies to any physician who makes referrals to those with whom the physician has a direct or indirect ownership or investment interest, or a compensation arrangement. Stark is a “strict liability” statute that imposes civil, not criminal penalties, although the severity of the penalties makes it a distinction without much difference.

States, too, have counterpart self-referral statutes that, depending again on the nature of the services involved, might be triggered.

And last, but by no means least, violations of Stark and of the AKS lead to federal False Claims Act liability (commonly

BRIEF SUMMARY

ENTEREG® (alvimopan) Capsules The following is a brief summary only; see full prescribing information for complete product information.

WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY There was a greater incidence of myocardial infarction in alvimopan-treated patients compared to placebo-treated patients in a 12-month clinical trial, although a causal relationship has not been established. In short-term trials with ENTEREG®, no increased risk of myocardial infarction was observed [see Warnings and Precautions (5.1)]. ] Because of the potential risk of myocardial infarction with long-term use, ENTEREG is available only through a restricted program for short-term use (15 doses) under a Risk Evaluation and Mitigation Strategy (REMS) called the ENTEREG Access Support and Education (E.A.S.E.®) Program [see Warnings and Precautions (5.1) and (5.2)]. ] 1

INDICATIONS AND USAGE ENTEREG is indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis.

4 CONTRAINDICATIONS ENTEREG is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG [see Warnings and Precautions (5.3)].

5 WARNINGS AND PRECAUTIONS 5.1 Potential Risk of Myocardial Infarction with Long-term Use There were more reports of myocardial infarctions in patients treated with alvimopan 0.5 mg twice daily compared with placebo-treated patients in a 12-month study of patients treated with opioids for chronic non-cancer pain (alvimopan 0.5 mg, n = 538; placebo, n = 267). In this study, the majority of myocardial infarctions occurred between 1 and 4 months after initiation of treatment. This imbalance has not been observed in other studies of ENTEREG in patients treated with opioids for chronic pain, nor in patients treated within the surgical setting, including patients undergoing surgeries that included bowel resection who received ENTEREG 12 mg twice daily for up to 7 days (the indicated dose and patient population; ENTEREG 12 mg, n = 1,142; placebo, n = 1,120). A causal relationship with alvimopan with long-term use has not been established.

ENTEREG is available only through a program under a REMS that restricts use to enrolled hospitals [see Warnings and Precautions (5.2)].

5.2 E.A.S.E. ENTEREG REMS Program ENTEREG is available only through a program called the ENTEREG Access Support and Education (E.A.S.E.) ENTEREG REMS Program that restricts use to enrolled hospitals because of the potential risk of myocardial infarction with long-term use of ENTEREG [see Warnings and Precautions (5.1)].

Notable requirements of the E.A.S.E. Program include the following: ENTEREG is available only for short-term (15 doses) use in hospitalized patients. Only hospitals that have enrolled in and met all of the requirements for the E.A.S.E. program may use ENTEREG. To enroll in the E.A.S.E. Program, an authorized hospital representative must acknowledge that: hospital staff who prescribe, dispense, or administer ENTEREG have been provided the educational materials on the need to limit use of ENTEREG to short-term, inpatient use; patients will not receive more than 15 doses of ENTEREG; and ENTEREG will not be dispensed to patients after they have been discharged from the hospital.

Further information is available at www.ENTEREGREMS.com or 1-877-282-4786.

5.3 Gastrointestinal-Related Adverse Reactions in Opioid-Tolerant Patients Patients recently exposed to opioids are expected to be more sensitive to the effects of μ-opioid receptor antagonists, such as ENTEREG. Since ENTEREG acts peripherally, clinical signs and symptoms of increased sensitivity would be related to the gastrointestinal tract (e.g., abdominal pain, nausea and vomiting, diarrhea).

Patients receiving more than 3 doses of an opioid within the week prior to surgery were not studied in the postoperative ileus clinical trials. Therefore, if ENTEREG is administered to these patients, they should be monitored for gastrointestinal adverse reactions. ENTEREG is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG. 5.4 Risk of Serious Adverse Reactions in Patients with Severe Hepatic Impairment Patients with severe hepatic impairment may be at higher risk of serious adverse reactions (including dose-related serious adverse reactions) because up to 10-fold higher plasma levels of drug have been observed in such patients compared with patients with normal hepatic function. Therefore, the use of ENTEREG is not recommended in this population.

5.5 End-Stage Renal Disease No studies have been conducted in patients with end-stage renal disease. ENTEREG is not recommended for use in these patients.

5.6 Risk of Serious Adverse Reactions in Patients with Complete Gastrointestinal Obstruction No studies have been conducted in patients with complete gastrointestinal obstruction or in patients who have surgery for correction of complete bowel obstruction. ENTEREG is not recommended for use in these patients.

5.7 Risk of Serious Adverse Reactions in Pancreatic and Gastric Anastomoses ENTEREG has not been studied in patients having pancreatic or gastric anastomosis. Therefore, ENTEREG is not recommended for use in these patients.

6 ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be compared directly with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The adverse event information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

The data described below reflect exposure to ENTEREG 12 mg in 1,793 patients in 10 placebo-controlled studies. The population was 19 to 97 years old, 64% were female, and 84% were Caucasian; 64% were undergoing a surgery that included bowel resection. The first dose of ENTEREG was administered 30 minutes to 5 hours before the scheduled start of surgery and then twice daily until hospital discharge (or for a maximum of 7 days of postoperative treatment).

Among ENTEREG-treated patients undergoing surgeries that included a bowel resection, the most common adverse reaction (incidence ≥1.5%) occurring with a higher frequency than placebo was dyspepsia (ENTEREG, 1.5%; placebo, 0.8%). Adverse reactions are events that occurred after the first dose of study medication treatment and within 7 days of the last dose of study medication or events present at baseline that increased in severity after the start of study medication treatment.

7 DRUG INTERACTIONS 7.1 Potential for Drugs to Affect Alvimopan Pharmacokinetics An in vitroo study indicates that alvimopan is not a substrate of CYP enzymes. Therefore, concomitant administration of ENTEREG with inducers or inhibitors of CYP enzymes is unlikely to alter the metabolism of alvimopan.

7.2 Potential for Alvimopan to Affect the Pharmacokinetics of Other Drugs Based on in vitroo data, ENTEREG is unlikely to alter the pharmacokinetics of coadministered drugs through inhibition of CYP isoforms such as 1A2, 2C9, 2C19, 3A4, 2D6, and 2E1 or induction of CYP isoforms such as 1A2, 2B6, 2C9, 2C19, and 3A4.

In vitro, ENTEREG did not inhibit p-glycoprotein.

7.3

Effects of Alvimopan on Intravenous Morphine Coadministration of alvimopan does not appear to alter the pharmacokinetics of morphine and its metabolite, morphine-6-glucuronide, to a clinically significant degree when morphine is administered intravenously. Dosage adjustment for intravenously administered morphine is not necessary when it is coadministered with alvimopan.

7.4 Effects of Concomitant Acid Blockers or Antibiotics A population pharmacokinetic analysis suggests that the pharmacokinetics of alvimopan were not affected by concomitant administration of acid blockers or antibiotics. No dosage adjustments are necessary in patients taking acid blockers or antibiotics.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category B Risk Summary: y There are no adequate and/or well-controlled studies with ENTEREG in pregnant women. No fetal harm was observed in animal reproduction studies with oral administration of alvimopan to rats at doses 68 to 136 times the recommended human oral dose, or with intravenous administration to rats and rabbits at doses 3.4 to 6.8 times, and 5 to 10 times, respectively, the recommended human oral dose.

Because animal reproduction studies are not always predictive of human response, ENTEREG should be used during pregnancy only if clearly needed.

Animal Data: Reproduction studies were performed in pregnant rats at oral doses up to 200 mg/kg/day (about 68 to 136 times the recommended human oral dose based on body surface area) and at intravenous doses up to 10 mg/kg/day (about 3.4 to 6.8 times the recommended human oral dose based on body surface area) and in pregnant rabbits at intravenous doses up to 15 mg/kg/day (about 5 to 10 times the recommended human oral dose based on body surface area), and revealed no evidence of impaired fertility or harm to the fetus due to alvimopan.

8.3 Nursing Mothers It is not known whether ENTEREG is present in human milk. Alvimopan and its ‘metabolite’ are detected in the milk of lactating rats. Exercise caution when administering ENTEREG to a nursing woman [see Clinical Pharmacology (12.3)].

8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use Of the total number of patients in 6 clinical efficacy studies treated with ENTEREG 12 mg or placebo, 46% were 65 years of age and over, while 18% were 75 years of age and over. No overall 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. No dosage adjustment based on increased age is required [see Clinical Pharmacology (12.3)].

8.6 Hepatic Impairment ENTEREG is not recommended for use in patients with severe hepatic impairment.

Dosage adjustment is not required for patients with mild-to-moderate hepatic impairment. Patients with mild-to-moderate hepatic impairment should be closely monitored for possible adverse effects (e.g., diarrhea, gastrointestinal pain, cramping) that could indicate high drug or ‘metabolite’ levels, and ENTEREG should be discontinued if adverse events occur [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.3)].]

8.7 Renal Impairment ENTEREG is not recommended for use in patients with end-stage renal disease. Dosage adjustment is not required for patients with mild-to-severe renal impairment, but they should be monitored for adverse effects. Patients with severe renal impairment should be closely monitored for possible adverse effects (e.g., diarrhea, gastrointestinal pain, cramping) that could indicate high drug or ‘metabolite’ levels, and ENTEREG should be discontinued if adverse events occur [see Clinical Pharmacology (12.3)].

8.8 Race No dosage adjustment is necessary in Black, Hispanic, and Japanese patients. However, the exposure to ENTEREG in Japanese healthy male volunteers was approximately 2-fold greater than in Caucasian subjects.

Japanese patients should be closely monitored for possible adverse effects (e.g., diarrhea, gastrointestinal pain, cramping) that could indicate high drug or ‘metabolite’ levels, and ENTEREG should be discontinued if adverse events occur [see Clinical Pharmacology (12.3)].

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: g Two-year carcinogenicity studies were conducted with alvimopan in CD-1 mice at oral doses up to 4000 mg/kg/day and in Sprague-Dawley rats at oral doses up to 500 mg/kg/day. Oral administration of alvimopan for 104 weeks produced significant increases in the incidences of fibroma, fibrosarcoma, and sarcoma in the skin/subcutis, and of osteoma/osteosarcoma in bones of female mice at 4000 mg/kg/day (about 674 times the recommended human dose based on body surface area). In rats, oral administration of alvimopan for 104 weeks did not produce any tumor up to 500 mg/kg/day (about 166 times the recommended human dose based on body surface area).

Mutagenesis: g Alvimopan was not genotoxic in the Ames test, the mouse lymphoma cell (L5178Y/TK+/−) forward mutation test, the Chinese Hamster Ovary (CHO) cell chromosome aberration test, or the mouse micronucleus test. The pharmacologically active ‘metabolite’ ADL 08-0011 was negative in the Ames test, chromosome aberration test in CHO cells, and mouse micronucleus test.

Impairment p of Fertility: y Alvimopan at intravenous doses up to 10 mg/kg/day (about 3.4 to 6.8 times the recommended human oral dose based on body surface area) was found to have no adverse effect on fertility and reproductive performance of male or female rats.

17 PATIENT COUNSELING INFORMATION 17.1 Recent Use of Opioids Patients should be informed that they must disclose long-term or intermittent opioid pain therapy, including any use of opioids in the week prior to receiving ENTEREG. They should understand that recent use of opioids may make them more susceptible to adverse reactions to ENTEREG, primarily those limited to the gastrointestinal tract (e.g., abdominal pain, nausea and vomiting, diarrhea).

17.2 Hospital Use Only ENTEREG is available only through a program called the ENTEREG Access Support and Education (E.A.S.E.) Program under a REMS that restricts use to enrolled hospitals because of the potential risk of myocardial infarction with long-term use of ENTEREG. Patients should be informed that ENTEREG is for hospital use only for no more than 7 days after their bowel resection surgery.

17.3 Most Common Side Effect Patients should be informed that the most common side effect with ENTEREG in patients undergoing surgeries that include bowel resection is dyspepsia.

ENTEREG and E.A.S.E. are registered trademarks of Adolor Corporation, a wholly owned subsidiary of Cubist Pharmaceuticals, Inc. Any other trademarks are property of their respective owners.

Manufactured for: Cubist Pharmaceuticals, Inc. Lexington, MA 02421 USA October 2013

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REPORT Bovine Pericardium Mesh Use in Parastomal Hernia Repair F

ollowing the creation of an ileostomy or colostomy, the risk for parastomal herniation is high. Data have shown hernias to occur in up to 28% of ileostomy cases and up to 48% of colostomy cases.1 Although many of these hernias present without symptoms, their incidence can become life threatening if strangulation, perforation, or obstruction occur.2 More generally, hernia symptoms can range from discomfort and pain to leakage and skin excoriation due to a poorly fitting pouch system.3 Thus, although patients experiencing asymptomatic hernias may benefit from conservative management including abdominal support or girdles,4 those experiencing more severe symptoms, such as constant pain, incarceration, strangulation, or those who have cosmetic concerns stemming from the herniation, will require surgery.5 Surgical treatment options include stoma relocation, direct suture repair, bridging, or reinforcement with prostheses by laparotomy 3 ; however, these options each present with several challenges. Both stoma relocation

and direct suture repair have demonstrated a high rate of hernia recurrence.5,6 In a literature review on recurrence and morbidity following suture or prosthetic repair of parastomal hernias, Hansson and colleagues concluded that because of the high rate of recurrence following suture repair (69.4%; n=106; 95% confidence interval), its use should be abandoned.5 Additionally, although recurrence rates after stoma relocation are lower,1 relocation may increase the risk for incisional hernia at the site of the old stoma.6 The development of synthetic mesh has provided an option for reinforcement or bridging at the defect site 5 and is associated with lower recurrence rates whether placed during an open or laparoscopic procedure7; however, synthetic mesh has been associated with a risk for erosion and development of dense adhesions.5 Biologic graftsâ&#x20AC;&#x201D;processed from human or porcine dermis, porcine small intestinal submucosa, or bovine pericardiumâ&#x20AC;&#x201D;may offer a better alternative for parastomal

Moderator

Faculty

Stephen M. Cohen, MD, MBA, FACS, FASCRS

David Beck, MD

Michael Page, MD

Professor and Chairman Emeritus Department of Colon & Rectal Surgery Ochsner Clinic Foundation New Orleans, Louisiana

Department of Colorectal Surgery The Iowa Clinic West Des Moines, Iowa

Director, Acute Care Surgery at Community Health Systems Greenbrier Valley Medical Center Ronceverte, West Virginia

Supported by

REPORT hernia repair.3 Preimplantation processing is designed to sterilize these grafts and remove cells that might otherwise provoke a foreign body response. Preimplantation processing also preserves the extracellular collagenous structure that allows for the host tissue ingrowth. Potentially, the enhanced biocompatibility of these grafts compared with synthetic grafts also allows for rapid vascularization and migration of host cells and may be associated with a reduced rate of infection.3 Finally, beyond selecting the appropriate prosthesis, the type of procedure (open or laparoscopic) and mesh placement position (eg, onlay, retromuscular, intraperitoneal) also may have an effect on the quality of the repair. Additionally, repairs can be stratified by the type of technique (eg, keyhole, Sugarbaker) that modify how the mesh supports the bowel or abdominal tissue to prevent hernia recurrence.5,6 In reviewing studies on prosthetic repair, Hansson and colleagues found that certain mesh positions (intraperitoneal, sublay) used in open procedures showed some benefit over their use in laparoscopic procedures, although the result was not significant.

Also, the Sugarbaker technique resulted in lower recurrence rates than the keyhole technique when used in laparoscopic procedures.5 Overall, variability exists in how mesh can best be utilized to provide optimal outcomes for patients.

This report features the perspectives of leading clinicians and reviews best practices for patients presenting with parastomal hernias, including the benefit of different techniques and procedure types as well as the rationale behind the selection of a prosthesis—bovine pericardium—for hernia repair.

David Beck, MD, professor and chairman emeritus of the Department of Colon & Rectal Surgery at the Ochsner Clinic Foundation in New Orleans, Louisiana, and Michael Page, MD, of the Department of Colorectal Surgery at The Iowa Clinic in West Des Moines, Iowa, participated in a discussion moderated by Stephen M. Cohen, MD, MBA, FACS, FASCRS, director of acute care surgery at Community Health Systems Greenbrier Valley Medical Center in Ronceverte, West Virginia.

when the synthetic mesh retracts, that hole gets bigger. With a biologic mesh, I’m more willing to make a cruciate incision and place some biologic material against the bowel, which I think gives a better repair. I’m also less concerned about erosion.”

For Dr. Page, mesh selection is related to the surgical treatment employed: “If I’m going to move the stoma, then I’m more inclined to use a biologic,” he said. “If I’m not going to move the stoma, and I’m not going to involve the mucocutaneous junction—and I have a well-prepared patient with a sealed off ostomy—then I typically do a Sugarbaker underneath with a permanent mesh. If I am moving the stoma, or I’m correcting the prolapse, then I will use a biologic exclusively. I don’t worry about putting a more permanent piece of mesh on the bowel itself when I’m doing the Sugarbaker technique,” Dr. Page said. “Rather, I’ll use a wider keyhole and position the colon against the abdominal wall and place a piece of more permanent mesh there.”

Processing Another issue related to the use of these grafts is that different processing techniques for biologic grafts might result in different graft properties and performance.

“The importance of processing cannot be underestimated in choosing the right product,” Dr. Cohen said. “All biologic material needs to be processed in order to render the material inert so when placed inside an individual, the patient’s own body does not reject the implant. This can lead to limited tissue ingrowth, neovascularization, and a failed repair.”

In investigating the issue of processing, researchers with RTI Surgical (Alachua, FL) compared two differently treated grafts, Tutopatch™ bovine pericardium (RTI Surgical) and Veritas Collagen Matrix (Baxter, previously Synovis). The Tutopatch implant is a non–cross-linked, sterile bovine pericardium graft processed through the Tutoplast ® Tissue Sterilization Process. This process consists of 3 elements: 1) osmotic, oxidative, and alkaline treatments that break down cell walls, inactivate pathogens, and remove bacteria; 2) solvent dehydration that allows room temperature storage of tissue without damaging the collagen structure; and 3) low-dose γ-irradiation to ensure the sterility of the final packaged graft.8 Veritas Collagen Matrix is a non–cross-linked, sterile bovine pericardium processed using a proprietary chemical treatment that decellularizes and stabilizes the tissue immunologically by capping free amine groups rather than cross-linking them.

Comparing these two grafts with in vitro studies using scanning electron microscopy and histological analysis, researchers

Considerations for Mesh Use With Parastomal Hernias When deciding which prosthesis to use for parastomal hernia repair, Dr. Beck noted that he almost exclusively uses a biologic mesh due to concerns surrounding synthetic types. “With the synthetics, I worry about erosion against the bowel wall,” he said. “When we have used synthetics in the past, we made a circular incision to keep the mesh away from the bowel, and

Table. Mechanical Testing of Tutopatch™ Bovine Pericardium and Veritas Collagen Matrix8 Tutopatch™ Bovine Pericardium Average SD Thickness, mm

0.60

0.15

0.92

0.13

Max load, N

17.0

9.63

11.9

3.8

UTS, MPa

5.13

1.48

2.67

0.94

Modulus, MPa

24.9

7.1

10.7

4.1

MPa, megapascals; SD, standard deviation (±); UTS, ultimate tensile strength

2

Veritas Collagen Matrix Average SD

REPORT found that the Veritas graft preimplant was significantly thicker than nonprocessed bovine pericardium signifying a change in the matrix after processing (Figure). Furthermore, a collagenase assay revealed that Veritas appeared more susceptible to enzyme digestion. Finally, mechanical testing showed that the Veritas preimplant had lower maximum force and tensile strength than the Tutopatch implant (Table).8 In follow-up in vivo experiments using graft implantation in rats, Veritas appeared to have more graft shrinkage and a higher suture pull-out rate after implantation. The Tutopatch implant showed significantly greater cell repopulation and revascularization than Veritas after 12 weeks of implantation. These researchers concluded that the Tutopatch implant’s collagen structure was more consistent and had properties that were better suited for use in repair of parastomal hernias.8 Dr. Cohen said that, similar to the findings of this study, the thickness of the mesh might not determine its quality. “I hear many physicians will handle the bovine pericardium and say ‘this is too thin; it’s not strong,’” he said. “Again, thin doesn’t necessarily mean it’s not strong because we’re looking for something different in a mesh product. We want tissue ingrowth; we want something that’s not going to create a foreign body reaction. The Tutopatch implant is processed in a way that allows for maximal tissue ingrowth and success when choosing this product.”

good tissue apposition because products of this type work with tissue ingrowth. By placing the mesh as an underlay, the abdominal pressure really supports the mesh.

“Also, I like to use tackers because it’s easier if you’re performing a laparoscopic procedure. In an open procedure, I will leave the bovine pericardium mesh exposed and I have been impressed with the tissue ingrowth I’ve seen with this mesh,” Dr. Cohen said. “I’ve experienced fewer complications like

Cost One of the major limitations for all biologic mesh products is cost. Neither the hospital nor the physician is remunerated for placement of these implants, and in most cases, the cost of a single piece of mesh required to fix a hernia defect is more than the procedure itself, according to Dr. Cohen. He also noted that hospitals are limiting the number of different implants available for surgeons’ use because of the cost. However, compared with other biologic mesh grafts, the Tutopatch implant can provide a significant cost savings, often by up to one-third of other biologic mesh costs. “Since a major driver of medical implants has placed cost in the forefront, it is important for surgeons to not only choose products that add value to patients in terms of clinical outcomes, but also to pay attention to how that same value can be brought to the entire organization,” Dr. Cohen said.

Mesh Placement The differences among mesh implants as well as the multiple methods for their use and potential consequences also are important for clinicians to understand when selecting a product.

When discussing placement of a biologic mesh, Dr. Page said he seeks to cover the material. “I like placing the biologic mesh as a sublay, but placing peritoneum over the top of it. I always worry about abscesses and infection using an onlay position because it seems to me that you’re coming down on the bowel.

If I come up from a sublay position, that seems cleaner.”

“I almost never do overlay just because I think you get more seromas,” Dr. Beck said. “I tend to do either underlay or sublay depending on the condition of the peritoneum. If it’s a new stoma, then you can create a peritoneal flap and I’ll place the mesh in a sublay position. Many times with parastomal hernias, scar tissue develops and by the time you reapproximate the muscle, the peritoneum is not usable. However, the difficulty with the Sugarbaker technique is that it requires a larger piece of mesh and you must have bowel laxity. Sometimes you don’t have that.”

Dr. Cohen agreed: “To me, it makes intuitive sense because when you use the biologic material you need to get

Figure. SEM micrographs of serosa surfaces of Tutopatch™ Bovine Pericardium (A) and Veritas Collagen Matrix (B and C) preimplants (t=0).

Intact collagen bundles were seen in the Tutopatch graft (indicated by arrows in A). A and B: 250x magnification; C: 10,000x magnification of an area (*) in B. A smooth surface area (*) where collagen fibers could not be discerned is shown in C. SEM, scanning electron microscope Images courtesy of RTI Surgical, Inc.

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REPORT abscess and encapsulation formation. When I would use other dermal-based biologic grafts, you would see that they had the natural tendency to stretch. When you’re repairing a parastomal hernia, just due to the pure nature of it, there is a high likelihood of recurrence or a pseudo-hernia where you will find that stretching. And I haven’t seen that with bovine pericardium.”

Surgical and Postsurgical Considerations Beyond mesh selection and procedure type, each clinician noted that there are other factors that must be considered during a repair and following surgery to ensure patients can return to normal activity with a low risk for recurrence. Dr. Cohen said the size of the mesh used is an important factor. “I am a believer that larger sizes of mesh are better,” he said. “With the sizes of mesh that most companies offer, you will have 3 to 5 cm fit quite easily around the bowel. As long as you adhere the biologic mesh—either as a sublay or as an underlay, somewhere where you would want the tissue ingrowth—it’s going to be helpful. I always seek to reapproximate the fascia because a patient with a parastomal hernia will have a defect there.

I almost always primarily close and tighten up the fascia around the colostomy and then perform an underlay.”

Drs. Beck and Page agreed that when performing hernia repair, they aim to cover the defect with a larger sheet of mesh.

Particularly, Dr. Beck noted, “I don’t know of any stomal hernia data, but most all of the ventral hernia data suggest about 5 cm of coverage. That’s what I try and do when repairing parastomal hernias.”

Risk for infection is another concern for clinicians repairing hernias. Dr. Page noted that percutaneous drainage is effective based on the type of procedure he favors: “Most of the infections I have seen have been above the fascia from flaps after performing a component separation. These areas become a little hematoma; they may become infected. For those infections, I can use percutaneous drainage. I have seen CT [computed tomography] scans in patients in whom I’ve used the biologic mesh as an underlay and I have seen some fluid collection, but

the patient presents with no fever or elevated white blood cell count. However, on follow-up CT scan, that fluid resorbs. It’s a foreign body; you’re going to have some reaction to it, but I have never removed a biologic mesh due to infection.” Dr. Page also noted that he has used wound vacuum-assisted closure on a biologic mesh with positive outcomes.

Following repair, Dr. Beck recommended the use of binders and hernia belts on selected patients. “I place binders on the operating room table,” he said. “So the patient wakes up wearing a binder. I’ve used hernia belts in selected patients who are not ready for their repair but were symptomatic.”

Dr. Page added that if a hernia is large, he recommends patients wear a binder as long as they can. “The stomal therapist will also use a hernia belt on some patients,” he said.

As previously mentioned, hernia recurrence is a critical concern for clinicians upon follow-up.

Conclusion Parastomal herniation is an important and common problem that can occur after creation of an ileostomy or colostomy.1 The development of biologic grafts has resulted in improvements in incorporation and decreases in infection rates.3 According to the interviewed faculty members, bovine pericardium grafts, in particular, possess unique properties that make them well suited for use in repair of parastomal hernias.

However, clinicians should be aware that different graft processing techniques could result in variability in graft properties and performance. Processed using a variety of methods to ensure safety and performance, a bovine pericardium graft, such as the Tutopatch implant, has been shown, in studies and anecdotally in over 20 years of use in Europe, to provide rapid revascularization at a lighter weight than other grafts.9,10 Although cost remains a factor potentially limiting the use of other biologic mesh implants, the faculty members described how the Tutopatch graft is a more affordable option— one that does not sacrifice strength, durability, and a highquality repair for its value.

References 1. Carne PW, Robertson GM, Frizelle FA. Parastomal hernia. Br J Surg. 2003;90(7):784-793.

2. Suwa K, Hanyu K, Suzuki T, et al. Parastomal hernias successfully repaired using a modified components separation method: two case reports. J Med Case Rep. 2013;7(1):180.

3. Slater NJ, Hansson BM, Buyne OR, et al. Repair of parastomal hernias with biologic grafts: a systematic review. J Gastrointest Surg. 2011;15(7):1252-1258.

6. Muysoms F. Laparoscopic repair of parastomal hernias with a modified Sugarbaker technique. Acta Chir Belg. 2007;107(4): 476-480.

7. Târcoveanu E, Vasilescu A, Cotea E, et al. Parastomal hernias clinical study of therapeutic strategies. Chirurgia (Bucur). 2014; 109(2):179-184.

8. Data on file. RTI Surgical.

4. Husain SG, Cataldo TE. Late stomal complications. Clin Colon Rectal Surg. 2008;21(1):31-40.

9. Deeken CR, Melman L, Jenkins ED, et al. Histologic and biomechanical evaluation of crosslinked and non-crosslinked biologic meshes in a porcine model of ventral incisional hernia repair.

J Am Coll Surg. 2011;212(5):880-888.

5. Hansson BM, Slater NJ, van der Velden AS, et al. Surgical techniques for parastomal hernia repair: a systematic review of the literature. Ann Surg. 2012;255(4):685-695.

10. Novitsky YW, Rosen MJ. The biology of biologics: basic science and clinical concepts. Plast Reconstr Surg. 2012; 130(5 suppl 2):9S-17S.

Disclosures: Dr. Beck reported that he is a consultant for LifeCell, Pacira, and RTI Surgical; received grant/research funding from LifeCell and Pacira; and received speaker fees from LifeCell. Dr. Cohen reported that he is a consultant for Baxter, Medtronic, Olympus, Pacira, RTI Surgical, and THD America. Dr. Page reported that he is a consultant for and received speaker fees from Cadence, Myriad, and Pacira, and received grant/research funding from Pacira and Salix.

Tutopatch™ is a trademark of RTI Surgical, Inc. Tutoplast ® is a registered trademark of Tutogen Medical GmbH.

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Copyright © 2014, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.

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Disclaimer: This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, RTI Surgical, and the authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature.