December 2013

GENERALSURGERYNEWS.COM

December 2013 • Volume 40 • Number 12

The Independent Monthly Newspaper for the General Surgeon

Opinion

Finding the ‘Must Haves’ for Bariatric And Metabolic Surgery

State’s Approach to Medical Errors Begs Question: Are Fines Effective Deterrent?

Few Benefit From Contralateral Breast Removal, Model Shows

10 California Hospitals Hit With Penalties for Range of Errors

Misconcepptions Leading More With Earlyy Cancer To Choose Prophyylactic Procedure

Part 2 of 2 B Y G EORRGE O CHOA [[Editor’s note:: In part 1 of this series (Bariatric Procedures Decline Despite Rise of Obesity and Diabetes, October 2013, page 6), Dr. Roslin outlined his thoughts on the problem of underuse of bariatric surgery. Here, he offers solutions for improvement.]

B Y M ITCHELL R OSLIN , MD

A

s a sports fan, I often think in terms of sports analogies. A common quote from football experts goes like this: “If you have two quarterbacks, you really have none.”

I think we are in a similar situation in bariatric surgery. Our procedures produce weight loss, can cause remission of diabetes and reverse sleep apnea. Infertility has been cured after surgery. The list of improvements goes on and on. But— and this is the big but—bariatric surgery is not the undisputed standard of care for any medical entity. There is no condition, body mass index (BMI) or comorbidity for which the majority of physicians agree that the patient should be referred for bariatric surgery. Instead, our procedures are presented as reasonable options.

Surgery is presented as something to consider, not something that has to be done.

The effect of this, I believe is tremendous.

H

oping to start an infection th hat would trigger an immune response, two neurosurgeons implanted live Entterobacter aerogenes bacteria, commonly found in feces, into the brains and surrrounding bone tissue of three patients with end-stage glioblastoma multiforme.

The results: One patient deveeloped encephalitis and died; another dieed following brain swelling; and the thirrd was discharged to a skilled nursing facility and required additional operation ns due to the infection.

According to state records, th he experimental treatment was conducted at the he University of California (UC), Davis Medical Center

Hope … is a mode of knowing … within which new things are possible, options are not shut down, new creation can happen … It is the epistemology of love.

—N.T. Wright

see MEDICAL ERRORS page 6

B Y B RUCE R AMSHAW , MD

O

ne critical condition to allow for transformational change in health care is an optimistic

outlook: hope. We must believe that positive change is possible and, in fact, that positive change is absolutely inevitable. There are certainly many things we can point to in our health care system that would argue against having hope: high costs, variability in quality of care, an overwhelming feeling that it is too big to change, and so on. But, the conditions that create that kind of thinking also fuel the very mechanism

INSIDE In the News

Surgeons’ Lounge

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Endoscopic Resection Equals Esophagectomy for Early Cancer

B Y C HRISTINA F RANGOU

Hope

see MUST HAVES page 20

Doctors Rush to Employment as Corporate America Lays Off Workers

®

A Patient With Symptomatic Varicose Veins, Aching, Heaviness and Fatigue

Submit your video for our new Surgical Video Arcade.

See page 16 for details.

see HOPE page 16

WASHINGTON—Of the th housands of women with early-stage breast cancer in n one breast who opt to undergo a contralateral u prrophylactic mastectomy evvery year, less than one in 1000 will derive any survival beneffit from the procedure, a new ccomputer model suggests.

“We hope h that by providing women with accurate and easily understood information about the potential benefits for contralateral prophylactic mastectomy [CPM], this may impact current trends,” said study coauthor Pamela Portschy, MD, a surgical resident at the University of Minnesota, Minneapolis.

Dr. Portschy presented the findings at the 2013 Clinical Congress of the American College of Surgeons. see MASTECTOMY page 11

REPORT ENTEREG® (alvimopan) for Gastrointestinal Recovery Following Bowel Resection See insert at page 12

GSN Editorial

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2013

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

A

s we come to the close of 2013, many events, both good and bad, have occurred that have affected all of us in some way. One of the significant milestones in 2013 was the 50th anniversary of the assassination of John Fitzgerald Kennedy.

The outpouring of documentaries, books, magazine articles and other memorabilia heralded the significance of the presidency, the legacy of JFK and the importance of that date in 1963 when the world changed for many of us. I remember vividly where I was when I learned about the devastating and tragic events in Dallas on that November day. I want to take us back a few years to September 1960, however, and to the events just before the presidential election.

I do not have specific recollection of the election itself, but I do have vivid memories of the Nixon–Kennedy debates beginning that September. As a junior in high school, I remember sitting with my family in front of our black-and-white TV and being engrossed by what these two men were saying to us as a family and to the American people. Because this was the first time a presidential debate had been aired on live TV, it took on a new and exciting aura of spontaneity.

I think I was particularly engaged For those physicians who could easily out-debate the young because at that time in my life I was congressman from Massachuinteract with the media, setts. After all, Nixon had skillparticipating in oratorical competitions held by the Optimist Internafully handled Khrushchev in the always remember that tional organization and spent a great so-called “Kitchen Debate” in the deal of time preparing myself for your demeanor, your words Soviet Union a short time before. these events. I worked on the skills In preparing for the event, and your appearance are needed to convey ideas to people I Nixon was advised by media conextremely important in did not know and worked hard to sultants to allow his face to be preovercome my nervousness! conveying the proper and pared with some minimal makeup I do remember how relaxed and in because the glare of the lights on effective message. command JFK appeared even in the camera had a way of accentuatfirst of four debates that took place ing facial sweat and an unwanted that fall. I also remember how ill at ease Vice President shine. Kennedy accepted the cosmetic advice, whereas Nixon appeared and the overall image he conveyed of Nixon refused, which turned out to be a great advanbeing quite uncomfortable. The debate venue was a rel- tage for Kennedy. Nixon appeared on TV with a sweatatively simple format with the two men initially seat- ing brow and an uncomfortable demeanor, causing him ed on each side of Howard K. Smith, a well-known to look less than presidential. Additionally, it was not reporter who served as moderator. The starkness of the well known at the time that Nixon had sustained a knee scene was certainly much different from the extraordi- injury while campaigning, and that an infection had nary staging that occurs in our current political debates. resulted and was still causing him pain in early SepWhat I did not know at the time was that Nixon tember 1960. During that first debate, Nixon appears to had actually been counseled by President Eisenhow- be leaning on the podium and not standing solidly on er not to debate JFK because Nixon was already well his two feet as Kennedy did. Nixon’s constant shifting known and JFK was a relatively young congressman of his affected leg drew attention from the points that who some felt was not ready to be president. Eisen- he was making during the debate. hower felt that Nixon had much to lose if the debate When it came to subject matter, both men had went poorly and not very much to gain even if it went agreed to discuss domestic issues in the first debate. well. Despite this wise counsel, Nixon decided that he see MEDIA PAGE 4

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2013

Weight Loss Reduces Risk for Colorectal Cancer Diagnosis, Mortality B Y C HRISTINA F RANGOU SAN FRANCISCO—Individuals can lower their risk for colorectal cancer (CRC)— particularly cancers of the colon and especially among men—by increasing recreational physical activity, according to new research. Doing so will also significantly reduce the risk for death in patients who have been diagnosed with the disease.

Excess body weight also negatively affects diagnosis and prognosis. Obese individuals are more likely to be diagnosed with, and more likely to die of, CRC. Moreover, the effect of obesity is independent of treatment complications, meaning that obesity does not appear to negatively affect treatment, but does cause disruptions at a systemic level that treatment cannot overcome.

“Counseling patients to achieve a normal body weight or a more healthy body weight is probably indicated,” said Peter T. Campbell, PhD, a cancer epidemiologist and director of the tumor repository at the American Cancer Society, adding that patients should never lose more than two pounds per week and weight loss in cancer survivors should be achieved through exercise and proper diet.

In his presentation on the topic at the 2013 Gastrointestinal Cancers Symposium, Dr. Campbell said that the

take-home message is that people can mitigate their risk for CRC by losing weight and engaging in physical activity even while undergoing treatment.

In 2010, a large meta-analysis demonstrated that every five-unit increase in body mass index (BMI) is associated with an 18% rise in risk for CRC (Obes Rev v 2010;11:19-30). In other words, an individual with an obese BMI (≥30) has about a 40% higher risk for CRC compared with a person with a BMI in the lower range of normal (18.5-25), Dr. Campbell said, adding that the studies leave no question that “obesity is convincingly associated with colorectal cancer incidence.”

However, the relationship between weight and CRC is not entirely straightforward. Results from the same study showed that the association is stronger in men than in women, and stronger for cancers that occur in the colon than the rectum. Furthermore, a high BMI appears to correlate only with a higher risk for tumors that display the more common microsatellite-stable phenotype, Dr. Campbell said.

In a study of 1,794 case participants and 2,684 unaffected sex-matched siblings, each increase in BMI, modeled in 5 kg/m2 increments, was associated with an increased risk for microsatellite-stable tumors (odds ratio [OR], 1.38; 95% confidence interval [CI], 1.24-1.54)

The take-home message is that people can mitigate their risk for CRC by losing weight and engaging in physical activity, even while undergoing treatment.

and microsatellite instability (MSI)-low tumors (OR, 1.33; 95% CI, 1.04-1.72).

No relationship was found for MSI-high tumors (OR, 1.05; 95% CI, 0.84-1.31), according to the study published by Dr. Campbell and his colleagues in 2010 in the Journal of the National Cancer Institutee (102:391-400).

More recently, the same research team confirmed that BMI is not only linked to risk for CRC but also to prognosis. In the Cancer Prevention Study II Nutrition Cohort—an ongoing, prospective study that includes regularly updated lifestyle and outcome data from more than 2,200 CRC survivors—patients who reported

MEDIA jContinued from page 3 This proved to be another mistake by the Nixon camp because Kennedy was much more facile dealing with domestic issues.

The strength of Nixon’s prowess and knowledge of international issues gained during his tenure as vice president was relegated to a future debate. In summary, the debates heralded the downfall of Richard Nixon as a presidential hopeful in 1960. It all started as a media event.

So what’s the message? Many of us have had encounters with the media, analyzing medical issues at our own hospitals or commenting on health-related issues within the realm of our particular specialty. The public is voracious in its appetite for issues relating to our profession and the diseases that we treat. A cursory review of any local newspaper demonstrates that health-related topics have become a major part of print media in our country. Our nightly news usually contains a health-related story and, of course, features physicians who are currently practicing or who have transcended to become media stars themselves.

John F. Kennedy and Richard M. Nixon during one of four presidential debates in 1960.

Image courtesy of Wiki.com.

Regardless of what media format is employed, any physician preparing for a media encounter must be prepared and ready to project the most professional and credible image.

Our hospitals have become a particularly attractive focus for the media,

whether print or audiovisual, and the image projected has had a significant role in how communities view and relate to their hospitals and hospital systems.

There always seems to be a love–hate relationship between the local newspaper and the hospital system no matter

having an obese BMI several years before their cancer diagnosis had a higher risk for death (approximately 30%) from all causes, over the study period. They also had a 35% increased risk for death from CRC and a 68% increased risk for death from cardiovascular disease ((J Clin Oncol 2012;30:42-52).

The study also showed that an individual’s BMI after diagnosis of cancer had no bearing on their long-term mortality risk, possibly due to the effects of both the disease and its treatment on a person’s weight.

These findings were reinforced in April with the publication of a study see COLORECTAL CANCER PAGE 22

in what region of the country you live.

It is no wonder that public relations and media experts have been hired by hospitals and hospital systems to deal with the daily communication exigencies that arise. Surgeons working at these hospitals are frequently called on to represent themselves, their patients, their institution and their profession. This opportunity and responsibility should not be taken lightly.

All of us should be prepared for these media events just as JFK was in fall 1960 for that first TV debate. We must not appear unsure and ill prepared, as did Richard Nixon. The media can be ego enhancing, but they are in the business of extracting information and repackaging it for public consumption. For those physicians who interact with the media, always remember that your demeanor, your words and your appearance are extremely important in conveying the proper and effective message. These are issues that are not discussed in medical school or residency training. Perhaps they should be.

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In the News MEDICAL ERRORS jContinued from page 1

without the knowledge of the institutional review board (IRB) or the FDA. For California hospitals, making a serious medical error such as this is not only cause for self-examination, it also can draw a financial penalty. The California Department of Public Health (CDPH) issued administrative penalties to 10 hospitals whose “noncompliance with licensing requirements caused, or was likely to cause, serious injury or death to patients,” according to a CDPH press release.

The fines ranged from $50,000 for a first-time offense, such as that at UC Davis Medical Center, to $75,000 for a second and $100,000 for a third or subsequent violation.

CDPH has been issuing such penalties since 2007, and does so three to four times a year. In an email interview, Debby Rogers, RN, MS, FAEN, deputy director, Center for Health Care Quality, CDPH, Sacramento, wrote, “CDPH has issued a total of 286 administrative penalties, including those issued on August 15, 2013, to 155 California hospitals. CDPH learns of the incidents when a facility self-reports to the Department, while conducting a complaint investigation, or during a survey.”

The penalized hospitals are required quired to file a plan of correction to prevent similar incidents.

Ms. Rogers could not say wheth her other states have a similar system of penalties. Mich hael R. Cohen, RPh, MS, president, Institute for Safe Medication M Practices, said in an interview, “I haven’tt seen anything like this in other states.”

Asked for his view of California’s system of penalties, Mr. Cohen said, “I don’tt think it’s going to change anything. … We could do d better things than punishing people. For examp ple, with some of their findings, perhaps the hospital could be called upon to educate others on how they fixed the problem and how they’re ensuring that it never happens again.”

Mr. Cohen discussed the case at Alta Bates Summit Medical Center, in Oakland, Calif., one of the hospitals involved in the recent fines. Alta Bates Summit was penalized $50,000 because an enteral feeding formula was administered into an intravenoous, peripherally inserted central cath heter, resulting in the patient’s death froom a pulmonary embolus.

“Fining people for that happeniing really isn’t the answer,” Mr. Cohen said. s “The answer is changing the ends of th he catheters so that they’re not compatible, an nd that is taking place now as we speak, but itt’s going to be a couple of years.”

Robert Lagasse, MD, professor of anesthesiology, Yale University School of Medicine, New Haven, Conn., agreed that the California penaltiies likely would not be helpful.

“I think this is kind of a sttep back from the

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2013

performance improvement initiatives that you see in other industries,” Dr. Lagasse said. “They’re probably going to inhibit people from reporting and looking into the system errors that caused the problems.”

Dr. Lagasse pointed to the case at Sharp Memorial Hospital in San Diego, in which a surgeon who was charged with removing a left testicle with an abnormal lesion instead made an unnecessary incision on the right side before being alerted to his error. This happened despite the fact that the surgical team had conducted a time-out to focus on verifying the correct patient, the correct procedure and the correct side or site. The penalty to the hospital was $75,000.

“The fact of the matter,” said Dr. Lagasse, “is

‘I think this is kind of a step back from the performance improvement initiatives that you see in other industries. [Fines are] probably going to inhibit people from reporting and looking into the system errors that caused the problems.’

—Robert Lagasse, MD

wrong-sided surgery has gone up three- to fourfold since the initiation of the time-out procedure. It’s quite possible that [these] attempts to make things better are not working. … That might be what happens when you have a group as opposed to everyone believing that it’s their [individual] responsibilities.”

In another case of the recently fined hospitals, Ronald Reagan UCLA Medical Center in Los Angeles was fined $50,000 when a sponge was left inside a patient’s body after gallbladder removal and pancreatic tumor resection. “There are some systems available now that people are trialing with RFID [radio-frequency identification] built into the sponges,” said Dr. Lagasse. “The hospital that has to pay a … fine could use that money to invest in a solution.”

Another expert in patient safety suggested that the penalties might be too small to have much effect.

“One of the concerns with this approach is that an executive may mistake writing a check for fixing the system,” said Peter J. Pronovost, MD, PhD, FCCM, senior vice president for patient safety and quality and director of the Armstrong Institute for Patient Safety and Quality, Johns Hopkins Medicine, Baltimore.

“To the state department’s credit,” Dr. Pronovost said, “one of the things that is underdeveloped is an accountability system.” However, he indicated, penalties need to be more significant than California’s penalties to be effective, on the order of closing the hospital or withholding Medicaid M funding. Ms. Rogers noted that the penaltiies are expected to go up to a maximum of $125,000 in n 2014.

Marin General Hosp pital in Greenbrae, Calif., was fined $100,000 for faiilure to connect a ventilator to an endotracheal tube,, resulting in a patient’s death.

Dr. Pronovost said this might have been prevented by “an n alarm that shows the ventilator’s not connected.” (The state deficiency report stated there were alarms, but they were not working.)

Su uch technological solutions should take place alongside checkklists and better safety culture, ssaid Dr. Pronovost. “Getting a cullture that encourages teamworkk and collaboration is really key and may be the most potent intervention we have.”

Reegarding the use of bacteria to treaat brain cancer, Lawrence J. Brand dt, MD, professor of medicine and surgery, Albert Einstein College of Medicine, and emeritus chief of thee Division of Gastroenterology, Monteefiore Medical Center, both in New Yorrk City, said, “If you ask the question, can b bacteria and infection be used to alter the course oof tumor, that’s not outlandish. That’s a reasonaable question. You just need a safe way of doing iit.” However, when told that the surgeons had con nducted their research without IRB approval, hee said, “That, you see, is outlandish. That is not appropriate. a That is bad.”

Asked for commen nt, representatives from four of the five hospitals named in this article stated that their hospitals h had developed safeguards to ensure that the errorrs for which they were fined did not happen agaiin. Marin General Hospital did not respond to a request for comment.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2013

Communication Counts When Preventing Retained Surgical Items B Y B EN G UARINO

C

linicians who face unpredictable surgical settings can make a few adjustments to greatly decrease the number of items left behind in patients, according to a recent report by the Joint Commission.

The medical accreditation organization’s alert highlighted the importance of using a standardized item counting system during surgery.

“Leaving a foreign object behind is a well-known problem, but it is one that can be prevented,” said Ana McKee, MD, executive vice president and chief medical officer of the Joint Commission, during a phone conference.

Between 2005 and 2012, the Joint Commission received 772 reports of retained surgical items. Of these, 16 incidents were fatal, and about 95% of cases resulted in additional care or a prolonged hospital stay. Dr. McKee believes this figure underestimates the prevalence of retained objects.

“Our numbers are not representative of actual incidence,” Dr. McKee said, because reporting to the Joint Commission primarily is done on a voluntary basis.

The alert listed several factors that can contribute to an increased risk for retained surgical items, such as having multiple surgical teams or overweight patients. A study in January found that the risk factors associated with leaving objects behind included length of procedure and patient blood loss of more than 500 mL (J ( Am Coll Surgg 2013;216:1522). After incorrect surgical counts, unts, facfac tors that contributed to the greeatest odds of retained objects in patieents were complications during su urgery (odds ratio [OR], 10.6; 95% % confidence interval [CI], 4.09-27.3) and omitting or varyingg from safety procedures (OR, 13.5; 95% CI, 4.76-38.4).

The Joint Commission alert recommended that hospitalss create standardized counting sysystems, which can mitigate the scenarios that typically lead to retained items.

With such a system in place, Dr. McKee said, unexpected surgical changes are less disruptive to item counts.

At Ohio State University (OSU), such a system has decreased the likelihood of retained surgical items and other intraoperative adverse events. An author of

Technology, such as radiotagged sponges, can help reduce instances of retained surgical items, but it is not a substitute for counting, according to the Joint Commission report.

the 2013 study from the Journal of the American College of Surgeons, Susan D. Moffatt-Bruce MD, PhD, chief quality and patient safety officer at the OSU’s Wexner Medical Center, introduced a common safety checklist for all operations that take place at OSU hospitals.

Her colleague, Stanislaw P. Stawicki, MD, a surgeon in the Department of Trauma and Critical Care at OSU and

lead author of the 2013 study, said since the checklist’s implementation, “the incidence of retained surgical items has decreased substantially.”

An extra set of eyes, Dr. Stawicki said, also may have a protective effect.

The presence of a surgical trainee was associated with about a 70% reduction in risk for retained items, according to the 201 2013 study. A similar effect can be achievved by a change of culture in the operrating room. During every surgery at OSU, all perioperative staff arre “empowered to stop things from proceeding if a surgeon fr may have forgotten to look for a m potential retained foreign body.” p Open communication is critical, O Dr. McKee said, whenever a surD giical team member has a concern.

Technology, such as radio-tagged T sponges, can help reduce instances of retained surgical items, but it is not a substitute for counting, according to the Joint Commission report.

“That technology alone would not be a solution to the problem,” Dr. McKee said. “These are expensive systems, and many organizations may not have the wherewithal to afford them.”

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2013

Doctors Rush To Employment as Corporate America Lays off Workers B Y M ARK F. W EISS , JD

H

e was laid off. How long would it take to find a job?

What about the kids and their education? What would his wife say? That he should never have taken that job with the hospital in the first place?

In the economy in general, businesses are rushing to cut full-time employment. They are using temps. They are outsourcing. They are replacing workers with technology.

Yet physicians are turning to hospital and hospital-affiliated medical group employment at a rapid rate.

From my discussions with residents and physicians about their careers and my experience with groups considering disbandment to become hospital employees, this is an increasing trend for office-based physicians—many physicians are leaving truly private practice for jobs with large national and regional groups and other staffing companies.

So why the disconnect? Why do many physicians believe that employment in hospitals, hospital-captive medical groups or large staffing-model groups provides safety or stability when the world around them for other employees—unskilled, skilled and professional—is in turmoil?

is, those who would rather have full-time jobs—remains high.

Part-time workers enable employers to escape the coming Obamacare burden and, in general, many of the employee benefit expenses that employers incur in connection with full-time workers.

And, as to temporary workers, the key is that they can be terminated almost immediately. That flexibility is an advantage in the marketplace

touting of the upswing in employment, only 23% of the approximately 950,000 jobs the economy added from January to July 2013 are full-time. The remaining 730,000 of those jobs are part-time positions.

Physicians Many physicians see advantages in hospital or large-group employment.

Here are a few of the usual reasons: • It’s less complicated than running a group.

• My employer will find work for me.

Corporations 101 Corporations exist to make a profit. There’s nothing wrong with that. It’s a fact of life. But because all corporations, and that includes hospitals and especially staffing service model groups, exist to make a profit, they will always seek to lower their costs. Of course, costs include employment costs, which includes salaries. ...

Welcome to the Team … but Not Really It makes little difference whether it’s the added burden of providing health insurance imposed by Obamacare, the overall uncertainty in the economy or the harsh new employment reality, employers across the country, from large corporations to smaller entities, are turning to part-time and temporary workers. Fulltimers are retiring or being laid off. In the several weeks before writing this article, a small sample of announced layoffs included Merck: more than 100 employees; Heinz: 600 employees; and Cisco: 4,000 workers.

At the same time, the number of involuntary part-time employees—that

Although the health care sector of the economy is more vibrant than some others, it’s not immunized against downturns or against the need to reduce costs. akin to that gained by the lower costs of offshore personnel and the fact that employers do not have to pay nearly as much for personnel-related costs such as health insurance and other benefits. If business expands, hire temps; if business contracts, fire temps.

According to a recent Associated Press article, employers are increasingly reliant on temps and part-time labor.

Nearly 17 million people, or approximately 12% of everyone with a job, is either a temporary worker or a contracted worker or consultant. That represents a 50% increase in the number of temporary workers since the end of the recession.

And, despite the government’s

• There is no need to compete for referrals, I'll be part of the system.

• I may earn less, but at least I’ll have stability.

Sure, running your own surgical practice or group may be complicated. It is easy just working and collecting a paycheck.

But health care employers are not substitute parents. Sure, parents may kick you out of the house, but employers fire you or lay you off and never invite you back for the holidays.

The same trends affecting industry in general, leading to layoffs, part-time and temp work, also are affecting health care.

Again, in the several-week period preceding this writing, layoffs were reported

at Crestwood Medical Center in Alabama, Baptist Memorial Health Care in Tennessee, King’s Daughters Health Systems in Kentucky, Maine Medical Center, Alameda Health System in California and Samaritan Medical Center in New York, to name just a few.

Although physicians were not included in those layoffs, the fact is that hospitals are employers, too. Although the health care sector of the economy is more vibrant than some others, it’s not immunized against downturns or against the need to reduce costs. With more physicians employed by large organizations, it is only a matter of time before they, too, are affected by cutbacks.

The fact that many hospitals are nonprofit does not alter the equation. Nonprofit corporations are corporations, too.

And, remember that they are not really nonprofit. They are simply about not paying taxes. These organizations are under the same pressure as employers in general to cut expenses, and that means cutting employment costs.

Look at the rest of the corporate world: If robots can build cars, the number of factory workers goes down. If robot doctors can treat your patients, you involuntarily go part-time, or are unemployed.

The urge to seek security is entirely human and virtually universal. But what appears safe in today’s health care economy, what appears less complicated in today’s health care economy and what is clearly the trend in today’s economy— employment by hospitals—is far more risky than it appears.

There is no real security in depending on a pseudo-parent employer.

So why are so many physicians falling for this same story in regard to hospital employment?

Unfortunately, the answer is simple.

They’re not fooling you. You’re fooling yourself.

The reality is that the only safety that exists is within you. The reality is that you are self-employed no matter whether your paycheck comes from the largest hospital chain in the nation or from your solo practice. The only difference is who can tell you when to stop working.

—Mr. Weiss is an attorney who special— izes in the business and legal issues affecting physicians and physician groups on a national basis. He holds an appointment as clinical assistant professor of anesthesiology at USC’s Keck School of Medicine and practices with Advisory Law Group (dba The Mark F. Weiss Law Firm in Texas), a firm with offices in Los Angeles, Santa Barbara and Dallas representing clients across the country.

He can be reached by email at markweiss@advisorylawgroup.com.

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2013

Endoscopic Resection Equals Esophagectomy For Esophageal Cancer ‘Complete Paradigm Shift’ in the Management of Early Esophageal Adenocarcinoma B Y T ED B OSWORTH ORLANDO, FLA.—On the basis of longterm outcomes, endoscopic mucosal resection (EMR) appears to be as effective as surgical esophagectomy for early esophageal adenocarcinoma. This conclusion was drawn from an analysis of more than 1,000 patients from the Surveillance, Epidemiology, and End Results (SEER) database. No significant differences in mortality related to esophageal cancer were found at either two or five years after the procedure.

“There was a significantly higher non– cancer-related mortality in the group receiving endoscopic treatment, but this appears to reflect a selection bias,” reported Sachin Wani, MB, assistant professor of medicine-gastroenterology at the University of Colorado School of Medicine in Aurora. In a late-breaking study presented at the 2013 Digestive Disease Week meeting, Dr. Wani explained that patients treated with endoscopy tended to be older and to have more comorbidities, suggesting a preference for this treatment over surgery in this population.

Surgical resection is widely regarded as the gold standard in the treatment of early esophageal adenocarcinoma, defined in this study as carcinoma in situ (T0) or invasive tumor confined to the mucosa, lamina propria and muscularis mucosae (T1a). Interest in endoscopic eradication therapies for this early esophageal adenocarcinoma is growing due to the substantial morbidity and mortality associated with esophagectomy. Although this study was observational, it provided long-term follow-up in a relatively large patient cohort.

An analysis of the SEER database revealed that 1,098 patients meeting the definition of early esophageal adenocarcinoma were treated between 1998 and 2009. Of these, 283 (26%) underwent endoscopic therapy, usually in the form of EMR, as their first procedure. The remainder of the patients initially were treated with surgical resection. Most of these patients received total esophagectomy with partial gastrectomy.

The two groups differed markedly in baseline characteristics. Although patients treated with endoscopy were significantly older (mean age, 70 vs. 63 years; P<0.001), they also were more likely to have T0 (32.5% vs. 23.1%) rather than T1a disease (67.5% vs. 76.9%; P=0.002 for both). Patients who underP went endoscopy also had more favorable tumor characteristics. In particular, histologic grade was more likely to be well differentiated (33% vs. 24.1%; P<0.001).

Endoscopic patients also were less likely to receive radiation therapy than those undergoing surgical resection.

In the 79% of patients for whom outcomes were available at the end of two years, esophageal cancer–free survival was similar for both treatments, at 93.5% in the endoscopic therapy group and 89.6% in the surgical resection group (P=0.12).

P At five years, when follow-up data were

available for 49% of the patients, survival rates also were similar (69.3% vs.

75.8%, respectively; P P=0.23). In a Cox proportional hazard model, significant predictors of esophageal cancer–specific mortality included older age at diagnosis (P<0.001), stage T1a disease (P=0.001 P vs. stage T0), year of diagnosis (P=0.02) P and radiation therapy (P<0.001).

“Patients undergoing endoscopic

therapies were more likely to die of non– esophageal-related causes, predominantly cardiovascular disease,” Dr. Wani said. “However, the treatment arm that a patient belonged to was not a predictor of overall survival.”

The SEER database does not capture information on comorbidities, but Dr. Wani suggested that it is reasonable to infer, based on the age of the patients and greater non-cancer mortality, that those see ESOPHAGEAL CANCER PAGE 10

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2013

Sentinel Node Biopsy Falls Just Shy of False-Negative Threshold in Trial B Y M ONICA J. S MITH

S

entinel lymph node surgery appears to have too high a false-negative rate to replace axillary node dissection in women with clinically node-positive disease who undergo chemotherapy before surgery, but some surgical techniques increase the accuracy of the sentinel lymph node procedure, according to the findings of a recent study ((JAMA 2013;310:1455-1461).

Sentinel lymph node (SLN) surgery alone has become the standard of care for women with clinically nodenegative (cN0) disease. In women with clinically nodepositive (cN1) disease at initial presentation, however, available data have shown that a higher number who are treated with neoadjuvant chemotherapy and whose SLN biopsies are free of cancer still have cancer in the remaining axillary nodes.

“Most of the studies that have looked at this patient population have been very small and had pretty high false-negative rates [FNRs],” said Kelly Hunt, MD, professor of surgical oncology, the University of Texas MD Anderson Cancer Center in Houston.

“When women have cN0 disease at presentation and we do systemic chemotherapy first, we find fewer positive nodes and that means fewer women have to undergo a [completion axillary lymph node dissection] ALND,” Dr. Hunt said. “Going one step further, the Z1071 trial examined whether SLN surgery is a good tool for staging the axilla in women after chemotherapy who initially presented with disease in the axilla prior to chemotherapy.”

Setting their threshold for acceptable FNR at 10%, Dr. Hunt and colleagues enrolled 756 women from 136 centers in the United States; 663 of the patients presented with cN1 disease. Of the 649 women who underwent chemotherapy followed by SLN biopsy and ALND, 525

had two or more SLNs removed.

There was no axillary node disease found in 215 patients, for a pathologic complete response of 41%.

But in 39 patients in whom cancer was not found in the SLN, it was found in the nodes removed at ALND, for an FNR of 12.6%, exceeding the researchers’ threshold.

According to the design of the Phase II trial, however, because all patients were receiving both SLN and ALND, they did not have to convert from cN1 to cN0 disease after chemotherapy and before surgery. The authors note that a proportion of those patients were probably not appropriate candidates for SLN surgery alone.

“The false-negative rate was higher, but that’s because we included everyone who was registered and did not select patients based on response to chemotherapy,” Dr. Hunt said. “In clinical practice, you would want to do a node dissection if you knew the patient still had clinically positive nodes. Those are the patients who would be most likely to benefit from the more extensive surgery.

“The idea of SLN surgery is to reduce the extent of surgery in those who appear to be cN0 after chemotherapy.

The key is to identify and remove all of the SLNs in order to have accurate staging with a less invasive procedure.

This does not mean random sampling of axillary nodes, but removal of all SLNs, as most patients will have two or more SLNs.” Importantly, the study showed that when dualagent mapping was performed using both blue dye and radioactive isotopes to identify the SLNs, the FNR fell to 10.8%. The FNR was also lower, 9.1%, in patients who had more than two SLNs removed.

“I think that’s very encouraging for being able to move this forward into the clinical setting,” Dr. Hunt said. “Just like what we’re doing with the primary tumor and the patient’s systemic therapy, we really need to do that with surgery. In the past, everyone got an axillary dissection and everyone got radiation. Now with improved systemic

ESOPHAGEAL CANCER jContinued from page 9

receiving endoscopic treatment had a greater comorbidity index.

Retrospective analysis of SEER data has some limitations, including that only the first treatment is recorded.

As a result, the rate of recurrence and the need for subsequent therapies cannot be compared. However, there also are some advantages relative to studies with fewer patients or fewer participating centers: As patients’ data are captured across diverse treatment centers, it is reasonable to assume that SEER data are more representative of real-world results with both endoscopy and surgery.

It is notable that the proportion of esophageal cancers treated with endoscopic eradication therapies relative to surgical resection has been increasing over the past several years, according to a time-trend analysis of the SEER data. Although the relative increase in endoscopic treatment was greater in the T0 group than in the T1a group, this trend appears to reflect a growing acceptance of endoscopic procedures.

Although Dr. Wani acknowledged the limitations of an observational, population-based study and called for longer-term follow-up to confirm that these approaches provide equivalent outcomes, these data “really increase the degree of confidence” in the ability of endoscopic

Interest in endoscopic eradication therapies such as endoscopic mucosal resection for early esophageal adenocarcinoma is growing due to the substantial morbidity and mortality associated with esophagectomy. ablation to treat early esophageal cancer effectively. In the absence of a randomized trial, the large SEER database may provide the best evidence so far that endoscopic ablation is a viable treatment alternative.

Asked to comment on these data, Steven R. DeMeester, MD, assistant professor of surgery, Department of Cardiothoracic Surgery, Keck School of Medicine, University of Southern California, Los Angeles,

therapies, we need to figure out who needs what type of surgery afterward and not subject everyone to the side effects of these treatments.”

Deanna J. Attai, MD, Center for Breast Care, Inc., Burbank, Calif., said, “It is important to note that the false-negative rate is acceptable, below 10%, when three or more sentinel nodes are removed, but three sentinel nodes are not always identified during the procedure, and as Dr. Morrow correctly states [in the accompanying editorial], random sampling of additional nodes is not recommended” ((JAMA A 3013;310:1449-1450).

As noted by the study authors, neoadjuvant chemotherapy alters the axilla, even in patients with cN0 disease. “There is more scarring, and it is more difficult to identify the sentinel node, which is why dual-tracer technique is recommended,” Dr. Attai said.

In the editorial, the authors comment that further research is needed to improve the performance of sentinel node biopsy after neoadjuvant chemotherapy. “I am hopeful that new mapping techniques will be developed to improve the rate of sentinel node identification, especially in patients who receive neoadjuvant chemotherapy,” Dr. Attai said.

She found it encouraging that a subset of patients had an acceptable FNR and is optimistic that further research will lead to the identification of patients with cN1-2 disease who can indeed safely undergo sentinel node biopsy after chemotherapy.

“We are all very familiar with the consequences of axillary node dissection, and anything that allows us to decrease the number of patients who undergo this surgery without compromising oncologic safety would be welcome by physicians and patients alike,” Dr. Attai said.

“In addition, as Dr. Morrow concludes, the presence of residual nodal disease after neoadjuvant chemotherapy will likely have treatment implications in some patients, and more study is definitely needed.”

called the use of endoscopic surgery “a complete paradigm shift in the management of Barrett’s high-grade dysplasia and intramucosal adenocarcinoma in the last decade.” He believes that endoscopic therapy with resection or ablation can be curative while reducing morbidity relative to esophagectomy, but he cautioned that it cannot always be performed in a single procedure.

“Endoscopic therapy requires that all of the intestinal metaplasia, not just the dysplasia or cancer, is removed or patients are at significant risk for the development of metachronous cancers. Although repeated sessions of endotherapy usually are successful, some patients have recalcitrant or progressive disease that is best treated with an esophagectomy. Furthermore, after successful endoscopic therapy, surveillance continues indefinitely,” Dr. DeMeester said. Due to the fact that even small lesions may be malignant and must be excised, he recommended “an exhaustive” evaluation of the tissue.

“Pathologic evaluation of an endoscopic resection specimen is complicated, and should be done by an expert in gastrointestinal pathology because invasion into the submucosa must be differentiated from invasion limited to the mucosa,” Dr. DeMeester said.

Although Dr. DeMeester believes “there is no question that endotherapy is a major advance,” he said it requires a significant commitment “to achieve the oncologic success of an esophagectomy.”

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MASTECTOMY jContinued from page 1

Rates of CPM have escalated over the past 20 years. Close to 20% of women in the United States today who have cancer in one breast undergo a double mastectomy, up from about 1% in the mid1990s, said co-author Todd Tuttle, MD, chief of surgical oncology, University of Minnesota.

Experts attribute the rise in CPM to a number of factors such as increased use of magnetic resonance imaging, improved mastectomy and reconstruction techniques and greater awareness of genetic breast cancer and BRCA A testing.

Previous studies also have shown that another key factor influencing a woman’s decision to undergo CPM is her substantial overestimation of the risks for contralateral breast cancer (Ann ( Intern Med 2013;159:373-381). One study from Dr. Tuttle and his colleagues reported that women without the BRCA mutation estimate their risk for developing a contralateral breast cancer (CBC) to be about 30% to 40% within a decade, which is the risk for women with the mutation.

For women without the BRCA A mutation, the risk is around 5% ((Ann Surg Oncol 201;18:3129-3136).

Many breast cancer specialists have called for better tools to help inform women about their risks, especially in light of the publicity surrounding actress Angelina Jolie’s announcement that she underwent a preventive bilateral mastectomy. Ms. Jolie carries a mutated BRCA1 gene, putting her at very high risk for breast cancer.

Dr. Portschy and her colleagues set out to evaluate the survival benefit of CPM for women with unilateral early-stage breast cancer without a BRCA gene mutation. They developed a computer model that simulated a hypothetical cohort of women with stage I or II breast cancer to compare CPM with women who did not have a prophylactic operation to remove the second breast.

Gains in life expectancy with prophylactic mastectomy ranged from less than one month in a 60-year-old woman with estrogen receptor (ER)-positive, stage II breast cancer, to 6.3 months in a 40-year-old woman with ER-negative stage I disease.

The absolute overall difference in survival at 20 years ranged from 0.36% to 0.94% for both patient groups.

Cancer stage at diagnosis and ER status, not CPM, affected life expectancy, said Dr. Portschy.

Cancer stage on diagnosis and estrogen receptor status, not contralateral prophylactic mastectomy, affected life expectancy.

“What we are trying to tell patients is that what is going to be potentially fatal is not a cancer that you may or may not get in the opposite breast. It’s whether or not this initial cancer has metastasized to your liver, lung or brain.”

The study adds to our knowledge about survival after CPM but is limited by methodological issues, said Isabelle Bedrosian, MD, associate professor of surgical oncology, the University of Texas MD Anderson Cancer Center, Houston. The study did not adjust for comorbid conditions, which must be factored in when counseling women about risk for breast cancer and overall survival, she said.

“If you are a healthy woman for whom there are no other health conditions, it may be worth considering a prophylactic mastectomy because your chance of dying of something unrelated to cancer is remote,” she said.

Dr. Bedrosian said that many of her

patients without BRCA A mutations who opt to undergo prophylactic mastectomy do so for peace of mind. “It’s anxiety, it’s fear. There is a great desire to do something to alleviate the fear and anxiety.”

She hopes that studies such as this will help raise awareness among the public about breast cancer risks. Many patients tell her in clinic that they understand that CPM offers no substantial survival benefit but they must contend with family and friends who want them to take every measure to prevent breast cancer in future.

“In order to move women away from this trend, we need to educate the community at large, not just our patients,” said Dr. Bedrosian.

For this study, authors analyzed data from the Early Breast Cancer Trialists’ Collaborative Group and the Surveillance, Epidemiology and End Results program. They examined the risk for developing CBC, dying from CBC, dying from primary breast cancer and the reduction in CBC due to CPM. The two databases include information on the treatment and survival of early breast cancer and include more than 100,000 women who have participated in randomized trials over the past 30 years in the United States.

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POEM: An Epic Step Forward for Achalasia Treatment?

Some Experts See as Natural Progression in Innovative Care; Others Question Its Place Given Existing Procedure and Rarity of Disorder B Y M ONICA J. S MITH BALTIMORE—A dominant topic at the 2013 annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) was the emergence of per oral endoscopic myotomy (POEM), a technique that some consider emblematic of the society’s dedication to advancing endoscopic surgical approaches.

Haruhiro Inoue, MD, the enthusiastic inventor of the new procedure, opened the session on POEM by describing his technique, and met independently with General Surgery Newss to explain how it has revolutionized his institution’s treatment of patients with achalasia.

“Before starting POEM procedure for achalasia, I usually only had three new [surgical] cases of achalasia a year,” said Dr. Inoue, chief of Upper GI Endoscopy and Surgery, Digestive Disease Center, Showa University Northern Yokahama Hospital, Yokahama, Japan.

“But in the last five years, at least in my hospital, that’s totally changed. Last year, we did 140 POEM procedures,” he said. To date, surgeons at Dr. Inoue’s hospital have performed almost 400 POEMs on patients who went there from around the world to get the scarless treatment.

The cosmetic aspect seemed to be a large part of the appeal for patients, particularly young women, Dr. Inoue observed. But the patient who was largely responsible for publicizing the procedure and kicking off its surge in popularity was a schoolteacher, aged about 50 years, whose achalasia resulted in dysphagia so severe that even drinking water was difficult.

The patient kept a blog of his experiences and posted daily reports of his visits to the hospital, his exams, his treatment, and the days that followed. One day after his POEM procedure, the patient was able to drink water. On the second day, he was able to eat a soft meal, and progress continued.

“Five days after surgery, he discharged from our hospital and went straight to a Chinese restaurant, ordered a full-course meal and ate it all,” Dr. Inoue recounted. “A lot of achalasia patients have access to his blog, and after that, patients from all over Japan came to our hospital.”

How It’s Done POEM requires an exacting set of surgical and nonsurgical skills, but the procedure itself is relatively straightforward. With the patient under general anesthesia, the surgeon introduces an endoscope into the esophagus, makes a small incision in the mucosa with an endo knife, tunnels through the submucosal space (an artificial space created by the surgery) to the defective gastroesophageal valve and performs a myotomy. Once the myotomy is complete, the surgeon retracts the endoscope and closes the mucosal incision with clips. “This is really endoscopicc surgery,” Dr. Inoue said.

The goal of POEM is the same as that of a surgical myotomy: “We cut this tight band,” Dr. Inoue said.

But with the alternative surgical procedure, the bulk of the procedure’s time is spent gaining access to the esophageal surface: creating the pneumoperitoneum,

retracting the liver, and dissecting the diaphragm and the esophageal ligament to expose the abdominal esophagus.

“That is most of the surgical procedure,” Dr. Inoue said. “But when we approach from the inside, it’s not necessary to expose the esophagus. Outside, the esophageal structure is totally normal. We go directly, the shortest way, to the muscle. That is unique.”

In addition to being virtually scarless, the POEM approach allows surgeons more control over the length of the myotomy. “With a surgical myotomy, at best we can get 8 to 10 cm; but in the POEM procedure, we can easily do a 20-cm myotomy because we approach from inside,” Dr. Inoue said.

“It really is a paradigm shift from laparoscopic treatment to endoscopic treatment. So far, flexible endoscopy was mainly used by gastroenterologists, mainly for diagnostic purposes. But now, POEM is one of the typical examples of flexible endoscopic surgery.”

POEM Gaining Ground In Dr. Inoue’s hands, a POEM takes about an hour.

He has performed the procedure in patients as young as 3 years old, and has had overwhelmingly positive feedback from his patients. “Not only the high school teacher, but others have taken their experience to the Web,” he said.

Most patients do well the day after the procedure; others feel a bit of irritation that is relieved with a mild painkiller. In the approximately 400 POEMs performed at his institution, Dr. Inoue and his colleagues have experienced no major complications.

“Just minor, and those were easily controlled. We just extended the hospital stay a few days and all the patients are happy now,” he said. “Our success rate with the POEM procedure is more than 99%.”

Since the report of Dr. Inoue’s first 17 cases was published in Endoscopy (2010;42:265-271), many surgeons have traveled to Japan to observe and learn the procedure. Dr. Inoue estimates that POEM now is being performed in about 30 centers in the United States. The University of California, San Diego (UCSD) Medical Center is one of them, where POEM is being performed by Santiago Horgan, MD, and championed by professor and chairman of the Department of Surgery, Mark Talamini, MD. At a SAGES Presidential Debate on the topic of whether POEM will render laparoscopic Heller myotomy obsolete, Dr. Talamini argued that POEM is surgical endoscopy and natural orifice translumenal endoscopic surgery (NOTES) at its best, that it is the type of disruptive progression toward improving surgical care that is at the core of SAGES’ philosophy, and that the early data support the safety and efficacy of the procedure.

“When I was in medical school, this operation was done through a left thoracotomy. When I was a resident, it was being done as an abdominal operation. When I was a junior faculty member, thoracoscopy came in. Then it was done laparoscopically, then robotically in some instances,” Dr. Talamini said.

“And now, [it is done] completely through the mouth.

That’s the full progression.

“If you think of that dramatic transition for this disease, from an open thoracotomy to operating through the mouth with an endoscope, it’s hard to imagine a more significant disruption,” he said.

Dr. Talamini cited three published works—from Lee Swanstrom, MD’s group in Portland, Ore., from UCSD where the first POEM procedure was performed in the United States, and from Dr. Inoue—and noted that with the inclusion of a group in China that has performed hundreds of POEMs, there have been about 1,000 procedures worldwide (as of Spring 2013).

“So this operation is now gaining traction and experience, and I believe it is here to stay,” Dr. Talamini said.

‘This …distinguishes us from the gastroenterologists.

They can’t do this. This is something we should own.

It is the entrée to other things. So, we have to fight our anxiety and learn the technique. It’s not the end; it’s a beginning.’

—Jeffrey Ponsky, MD

Others were not so quick to embrace POEM. “I don’t do POEM, and you’ll see wh hy,” said C. Daniel Smith, chaiir of the Department of Surrgery, Mayo Clinic, Jacksonviille, Fla. Arguing the anti-POEM side of th he debate, first, he pointed d out, it’s hard to improvee on laparoscopic Heller myotomy, which takes aboutt 90 minutes to perform, requirres a one-day hospital stay, and d results in significant improvement of dysphagia in 90% to 95% % of patients.

“That’s what POEM’s got to deliver, som mething that takes less than 90 minutes in the operating room, less than one day in the hospital, an equivvalent level of dysphagia, and perhaps bettter side effects, which gets us to the topicc of reflux,” Dr. Smith said.

An adeq quate Heller myotomy relieves patients’ dyysphagia, but results in significant

The POEM teechnique. The sureon introduces an endoscope into the esophagus, makes a small incision in thhe mucosa with an endo knife, tunnelss through the submucosal space to thee defective gastroesophageal valve annd performs a myotomy.

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reflux. To avoid that consequence, surgeons can perform a fundoplication as part of the procedure. “You can’t do that with a POEM,” Dr. Smith said.

The data point to a 20% reflux rate in 10 years’ follow-up on Heller myotomy patients, while the sixto 12-month follow-up available on POEM patients shows a reflux rate of 30% to 40%.

“This new operation doesn’t seem to be an improvement in terms of outcomes, and might be worse in terms of reflux,” Dr. Smith said.

Secondly, POEM requires a specific set of surgical and endoscopic skills, possibly new equipment, training, proctoring and a sufficient caseload to maintain proficiency.

“Right now, there are 6,000 surgical achalasia patients in the country. There are 18,000 active general surgeons, and 7,000 active SAGES members,” Dr. Smith said. “There bers, There aren’t aren t enough en patients in the country to keep every surrgeon who might want to do POEMs proficcient.

We need only about 150 to 180 surgeoons in the entire country to meet the deman nd for surgical achalasia.”

Dr. Smith’s third and final pointt was that, given the expense of traiining, POEM will inflate the cost of achaa lasia treatment without necessarily improving outcomes. He sugggested those health care dollars might m be more wisely spent on disru uptive innovation that would help larger numbers of patients, such as those who have gastroesoophageal reflux disease or esoophageal cancer.

After Drs. Talamini and Smith offered their rebu uttals, Jeffrey Ponsky, MD, O Oliver H. Payne Professor, chair of the Department of Surgery, Case Western Reeserve School of Medicine; surgeon-in-chief, Univversity Hospitals, Case Meedical Center, Cleveland, offfered his perspective.

“This is difficult to doo, and it is a beginning. The thing that makes me keep d doing POEM is how well the pattients do and how good we’re geetting at it,” he said. “This is paart of

the future; it really works, although we will still need Heller myotomy for many patients.

“This also distinguishes us from the gastroenterologists. They can’t do this. This is something we should own. It is the entrée to other things,” Dr. Ponsky continued. “So, we have to fight our anxiety and learn the technique. It’s not the end; it’s a beginning.”

proficiency, defined by shorter length of procedure, standardized variability in minutes per centimeter of myotomy and decrease in inadvertent mucosotomies, reached a plateau after an average of 20 cases (Gastrointest Endosc 2013;77:719-725).

“We saw both the minor complications and stress melt away by the 20th case,” Dr. Swanstrom said. “That was in a fellow-level surgeon with the fellowship being in complex endoscopy; Who Should Do POEM, and Why they’re really the ideal learner situation.”

In fact, it appears gastroenterol- Haruhiro Inoue, MD, inventor When a surgeon or gastroenteroloogists aree performing POEMs. In of the POEM technique. gist seeks training off-site, some adjustdata presented at the annual meetments may need to be made once they ing of the American College of Gastroenterology return to their home operating room (OR).

by Stavros Stavropoulos, MD, director of endoscopy “Some ORs are not very familiar with flexible in the Department of Gastroenterology, Hepatology endoscopy, so there can be a cultural learning curve and Nutrition, Winthrop University Hospital, Mine- to get over as well,” Dr. Swanstrom said. “It’s a good ola, N.Y., on a series of 37 POEMs, all were done by idea to include both endoscopy and OR nurses in the gastroenterologists. learning phase, so that everyone knows their role.”

Whether gastroenterologists will wantt to perform Perhaps the best way physicians can shorten the POEM is a different issue. learning curve, he suggested, is to be proctored by “There is a group of physicians who are well someone with a lot of experience in POEM. “Watch equipped to start doing it quite soon, after a little bit them do it so that you can observe their operating of lab work, some didactic learning and proctoring— team. All of those details, such as where you stand, mostly surgeons who do interventional endoscopy,” how you position the operating table, where the assistsaid Lee Swanstrom, MD, chief, Division of GI and ing nurse puts her table, are hard to convey in the labMIS Surgery, The Oregon Clinic, in Portland. “Also, oratory setting, and can really slow you down on your probably some gastroenterologists who deeply under- first cases if you don’t have a map to go by.” stand the anatomy and have adequate backup in case something bad happens, maybe in the context of a POEM and Patient Demand team situation with a surgeon close by and available.”

Again, achalasia is fairly rare, and it may be difficult A pioneer in NOTES and an early adopter of for a substantial number of physicians to achieve proPOEM, Dr. Swanstrom was able to practice the pro- ficiency in a reasonable amount of time. cedure on animal models and cadavers for about three “There are probably only about a dozen, maybe 20 years before POEM became a clinical reality. centers in the United States that treat more than 20 “We were a little ahead of the learning curve because achalasia patients a year,” Dr. Swanstrom said. “So, if of that, and we had the benefit of going to Yokohama you did only three or four a year, your learning curve and watching Dr. Inoue perform some procedures as will last forever.” well, which was very helpful,” he said.

For centers that have a high enough volume to keep With this background, Dr. Swanstrom needed only the learning curve relatively brief, however, being able five or six cases before he became comfortable with to offer POEM may give them a marketable advanPOEM. But based on his experience watching other tage. “Achalasia is a chronic disease, so patients have surgeons gain proficiency in the technique, he esti- the luxury of shopping around,” Dr. Swanstrom said. mates many will need to perform about 20 cases before Despite the obstacles to widespread acceptance of they feel confident.

POEM, such as the need for advanced training, the “In the early cases, it can be frustrating trying to get relatively small number of patients indicated for such into the right plane,” he said. “There could be some treatment, and the lack for now of long-term data, minor complications involved in that. Nothing terri- physicians who do become proficient in it may find bly serious, but time-consuming; if you get a mucosal themselves in high demand. perforation, you have to add a clip, and that’s certainly “This is one of those things, like laparoscopic chonerve-wracking on the part of the physician.” lecystectomy [versus open], where patients perceive Even surgeons experienced in Heller myotomy will a massive difference between it and the laparoscopic face a learning curve because the skill set differs sig- approach,” Dr. Swanstrom said. nificantly from laparoscopic myotomy. The necessary So far, POEM has gotten a far different reaction surgical skills include strategy for identifying the lower from patients than NOTES cholecystectomy, which esophageal sphincter, safe use of energy, surgical treat- never really sparked patient interest. “They don’t see ment of capnothorax/peritoneum and advanced endo- much difference between a transgastric or transvaginal scopic hemostasis maneuvers. POEM also requires a cholecystectomy and a laparoscopic cholecystectomy,” set of nonsurgical skills, such as diagnostic endoscopy, Dr. Swanstrom said. “But for POEM, we see patients mucosotomy, creation of the submucosal tunnel, myot- flying in from all over the country to have it done.” omy and closure of the mucosotomy. The endoscopic Dr. Swanstrom encourages surgeons and censkills involve tools and techniques common to endo- ters that want to offer POEM to secure institutional scopic submucosal dissection (ESD). review board approval before doing so, not because it’s an experimental procedure, but because there is a need Time to Proficiency for people to publish their experiences.

In The Oregon Clinic’s experience of the first 82 “We want to build a critical mass of data on this rare achalasia patients treated by POEM, it was found that disease,” Dr. Swanstrom said.

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Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2013

Dear Reader, Welcome to the December issue of the The Surgeons’ Lounge.

In this last issue of the year, we are honored to have Sherry Scovell, MD, instructor, Harvard Medical School, Division of Vascular and Endovascular Surgery, Massachusetts General Hospital, Boston, as our guest expert. Dr. Scovell addresses the case of a patient with symptomatic right leg varicose veins, aching, heaviness and fatigue.

Also, be sure to check out the Expert Express: Tackers, sutures or no fixation in laparoscopic inguinal hernias?

Wishing all our readers very happy holidays! We look forward to another great year of our readers’ questions, comments and correspondence for The Surgeons’ Lounge.

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

Question for Sherry Scovell, MD From Jahan Mohebali, MD Massachusetts General Hospital, Boston

A

47-year-old woman presented with symptomatic right leg varicose veins, including aching over the varicosities and heaviness and fatigue in the leg. She also complained of mild edema at the level of the ankle after standing on her feet all day. She states that her varicose veins have been present since childhood, but worsened after her two pregnancies. Her medical history is significant for the diagnosis of scoliosis. Her orthopedic surgeon also told her that her right leg is longer than her left. She has never had a venous thromboembolic event, and there is no history of this in her family.

A focused physical examination demonstrates right leg varicose veins in the distribution of the anterior accessory saphenous vein and along the lateral aspect of the leg. There are several port wine stains (which have been present from birth) overlying these lateral varicose veins (Figure 1). Her right calf circumference is 2 cm larger than her left. Her right leg is noticeably longer than her left leg. She has 3+ femoral, popliteal, dorsalis pedis and posterior tibial pulses that are equal bilaterally.

Figure 1. Several port wine stains (which have been present from birth) overlying lateral varicose veins.

What is your initial diagnostic impression?

What would be your first choice of imaging methods to further evaluate the right lower extremity in this patient?

Is this patient at increased risk for arteriovenous malformations?

Is there a nonoperative treatment available for the patient to improve symptoms?

When is surgical intervention indicated?

Dr. Scovell’s

Reply

In this patient, a diagnosis of KlippelTrenaunay syndrome (KTS) must be considered. KTS was initially described in 1900 by Klippel and Trenaunay.1 This syndrome was originally described as a classic triad, including atypical varicose veins, capillary malformations (port wine stains) and unilateral limb hypertrophy (both soft tissue and bony hypertrophy). Patients with this syndrome have congenital venous abnormalities and may have variable deep venous drainage.

It is important to note that a syndrome similar to KTS was described in 1907 by Parkes-Weber.2 The syndrome included the three classic clinical features of KTS as well as the presence of arteriovenous malformations. Patients with KTS do not have the finding of arteriovenous malformations. This distinction is quite important as the management and prognosis of the two syndromes are distinctly different.

Most cases of KTS are sporadic, and the clinical features are present at birth or develop in early childhood.

In a study of 252 patients with KTS from Mayo Clinic, more than 50% had all three of the classic features. In all, 98% of patients had capillary malformations (port wine stains), 94% had either soft tissue or bony hypertrophy, and 72% had evidence of a dilated, atypical superficial vein, such as a lateral marginal vein or a persistent sciatic vein.3,4 Lymphedema and lymphatic malformations

Figure 2. Venous duplex ultrasound with both B-mode and color-flow imaging should be employed as an initial step to evaluate deep, superficial and perforating veins to exclude obstruction; evaluate for evidence of incompetence; and delineate any abnormalities, such as aneurysmal dilation, aplasia or hypoplasia.

may be seen frequently as well.5 Although it is typical for patients to present with the triad and with chronic symptoms, there have been documented cases of patients presenting with more acutely threatening symptoms such as hematuria, hematochezia or intracerebral hemorrhage due to venous malformations in the corresponding anatomic locations.6 Deep vein abnormalities are frequently seen in KTS and may include aneurysmal dilation, hypoplasia, aplasia or incompetent valves. As mentioned above, a persistent sciatic vein may be present and may represent the main deep venous drainage of the leg from the popliteal vein to the internal iliac vein.7 Similarly, the presence of the lateral marginal vein may represent the pathway for significant venous drainage of the lower limb terminating in either a lateral branch of the profunda femoris or into the internal iliac vein.8 Before removal of the incompetent superficial veins in patients with KTS, it is essential that the deep venous system be studied and its patency confirmed.

Venous duplex ultrasound with both B-mode and color-flow imaging should be employed as an initial step to evaluate the deep, superficial and perforating veins to exclude obstruction; evaluate for evidence of incompetence; and delineate any abnormalities, such as aneurysmal dilation, aplasia, or hypoplasia (Figure 2). Although color-flow Doppler ultrasound seems to correlate with

Surgeonsâ&#x20AC;&#x2122; Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2013

venographic studies,9 most clinicians prefer additional complementary testing for further delineation of the complex anatomic abnormalities that may be present.

Magnetic resonance venography with gadolinium is useful to provide high-quality reconstructed images of the venous anatomy without ionizing radiation, and additionally offers information regarding the presence and extent of venous malformations (Figure 3). Contrast venography with the use of a tourniquet may be needed to further delineate if there is adequate residual deep venous drainage before removal of the incompetent superficial veins.

Patients with confirmed KTS and significant deep venous abnormalities often are best treated with conservative management, such as compression stocking therapy as well as decongestion massage therapy for extensive lymphatic involvement. Symptomatic patients with KTS may be considered for surgical intervention. Again, it is critical to recognize this syndrome before removal of the superficial varicose veins as these superficial veins may represent a significant component of venous drainage of the lower limb.

Baraldini et al and Noel et al have published on the surgical management of patients with KTS and patent deep venous systems.10,11 In such select cases, they have shown that patients with KTS have been successfully treated with stripping of the lateral marginal vein, phlebectomy and sclerotherapy. As management of these patients is frequently quite complex, a multidisciplinary approach is advised, as is treatment at high-volume centers.

Figure 3. Magnetic resonance venography with gadolinium is useful to provide high-quality reconstructed images of the venous anatomy without ionizing radiation and additionally offers information regarding the presence and extent of venous malformations.

References 1. Klippel M, Trenaunay P. Du noevus variqueux osteohypertrophiques. Arch Gen Med (Paris). 1900;185:641-672.

2. Parkes-Weber F. Angioma-formation in connection with hypertrophy of limbs and hemi-hypertrophy. Br J Dermatol. l 1907;19:231-235.

3. Jacob AG, Driscoll DJ, Shaughnessy WJ, et al. KlippelTrenaunay syndrome: spectrum and management. Mayo Clin Proc. 1998;73:28-36.

4. Oduber CE, Young-Afat DA, van der Wal AC, et al.

The persistent embryonic vein in Klippel-Trenaunay syndrome. Vasc Med. d 2013;18:185-191.

5. Gloviczki P, Driscoll DJ. Klippel-Trenaunay syndrome: current management. Phlebology. 2007;22:291-298.

6. Sreekar H, Dawre S, Petkar KS, et al. Diverse manifestations and management options in Klippel-Trenaunay syndrome: a single centre 10-year experience. J Plast Surg Hand Surg. 2013;47:303-307.

7. Cherry KJ, Gloviczki P, Stanson AW. Persistent sciatic vein: diagnosis and treatment of a rare condition. J Vasc Surg. 1996;23:490-497.

8. Servelle M. Klippel-Trenaunay syndrome: 768 operated cases. Ann Surg. 1985;201:365-373.

9. Qi HT, Wang XM, Zhang XD, et al. The role of colour Doppler sonography in the diagnosis of lower limb KTS. Clin Radiol. l 2013;68:716-720.

10. Baraldini V, Coletti M, Cipolat L, et al. Early surgical management of Klippel-Trenaunay syndrome in childhood can prevent long-term haemodynamic effects of distal venous hypertension. J Pediatr Surg. 2002;37:232-235.

11. Noel AA, Gloviczki P, Cherry KJ Jr, et al. Surgical treatment of venous malformations in Klippel-Trenaunay syndrome. J Vasc Surg. 2000;32:840-847.

Expert s Expres

Q.

Tackers, sutures or no fixation in laparoscopic inguinal hernia repair?

Edward Lin, MD: Tackers

Michael Schweitzer, MD: As few tacks as

Michael Sarr, MD: Tackers

possible

Bruce Ramshaw, MD: Minimal (three Jeffrey Ponsky, MD: Tackers

to four) tacks, well away from any of the preperitoneal nerves

Natan Zundel, MD: Depends on the

situation

Ronald Hinder, MD: Tackers R Ashutosh Kaul, MD: One tacker or none A

Alfons Pomp, MD: Tackers; rarely sutures A

Alex Gandsas, MD: Tackers Daniel Herron, MD: Tacks, but only

Emanuelle LoMenzo, MD: Tackers

three or four Anthony Petrick, MD: Tackers David Edelman, MD: Edward Felix, MD: No fixation in most

cases Lee Swanstrom, MD: No fixation

Edward Phillips, MD: Tackers in

Cooperâ&#x20AC;&#x2122;s only Estuardo Behrens, MD: Tackers

Usually absorbable tacks; occasionally fibrin sealant

15

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Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2013

HOPE

jContinued from page 1 that makes change possible. As things seemingly get worse and we get closer to the edge of chaos in health care, efforts emerge that highlight the problems and begin to shed light on solutions.

Transparency Transparency about the value of health care for patients is helping to transform health care. One example of this was the article “Bitter Pill” by Steven Brill in Timee magazine earlier this year (March

4, 2013). In this investigative journalist report, several patient bills were investigated, and Mr. Brill challenged hospital leaders to explain their charges and billing practices. The article points out the lack of understanding about how the hospital charge master charges are determined. One hospital representative in the article said, “The issues related to health care finance are complex for patients, health care providers, payers and government entities alike. ...” Basically what he is saying is that it is complex, so we wouldn’t understand how they come up with the charges.

But the reality of why hospitals, and physicians for that matter, charge the way they do goes back to an event in 1929 in Texas. Dr. Justin Ford Kimball, an administrator at Baylor University Hospital noticed that many teachers were unable to pay their hospital bills. He struck a deal with the teachers’ union to collect $0.50 per month from every teacher in the school system. The hospital would then allow free hospital stays up to 21 days per year for each teacher. This gave the hospital a pool of money and a predictable payment source. And it gave teachers an affordable way to pay for hospital bills. A

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Send us your contribution to surgical education or discussion, such as •a lecture • an interesting case • a video opinion • other Launch is scheduled for March 2014, and the submission process is now open.

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Hope allows us to be open to a more complete understanding. With understanding comes the ability to act.

win–win proposal, at least at that time.

All the hospitals had to do was match the pool of money to the charges they came up with, termed fair, customary and usual charges. This was quite easy because the governing board of the pool of money happened to be the board of the hospital. As time went on, more and more hospitals saw the benefit of having stable pools of money to have easy access to reimbursement, especially for patient groups that could not afford the hospital bills. Eventually, these pools of money were combined under the American Hospital Association and became known as Blue Cross. A few years later, physician groups did the same thing and their combined pools of money became Blue Shield. In the normal life cycle of events that is common for complex systems, the initial intent of the effort, as well intended as it was, has led to unintended and unpredictable consequences.

The origin of these hospital charges was not to set rates for individuals who had no insurance, it was to obtain the funds set aside from those pooling their money. It is ironic how without anyone seemingly realizing it, the charges have ended with the perverse effect of harming the original focus—a group that could not afford to pay. These charges are typically no longer used for reimbursement from the insurance companies, who negotiate a rate that is usually based on a percentage of Medicare rates and is a fraction of the charges submitted to the individual patient. Instead, these charges are causing severe financial hardship on the very group of people they were originally intended to help.

In a blog post that followed his Time article, Mr. Brill summed up the financial reality he discovered through his investigation of our health care system: “In other words, everyone along the supply chain—from hospital administrators (who enjoy multimillion-dollar salaries) to the salesmen, executives and shareholders of drug and equipment makers—was reaping a bonanza.

The only exceptions, I found, were those actually treating the patient—the nurses and doctors.”

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2013

him what happened. The boss told Mr. Jackson to wait 15 minutes and knock again. When he knocked the door opened and he was able to complete his delivery and continued in that position for several years. Over time, he learned the content of the discussion between his boss and the manager at the Capitol Grill. His boss told the manager that if he did not allow Mr. Jackson to do his job, he would end the contract to provide linen services to the restaurant.

Imagine that, a corporate manager who was willing to lose business (a very prominent client in Atlanta, by the way)

to do the right thing. This courage gave Mr. Jackson the feeling of support from his superior. It created trust in their relationship. Over the course of his career, Mr. Jackson worked his way up through the organization and retired as an executive. He developed many personal relationships throughout his career, including a friendship with the man who slammed the door in his face. This had to have taken a good bit of forgiveness from Mr. Jackson and a change in mindset for the manager. When the former restaurant manager passed away, Mr. Jackson was one of the pallbearers at his funeral.

In our lifetime, we have seen people change their thinking and belief system regarding entire classes of people. Racism is not dead, but those who would exhibit racist behaviors are no longer in the majority and racist behavior would not be tolerated in the vast majority of organizations and in public places today.

Some of my hope lies in the knowledge that people can change their thinking and evolve their beliefs. Certainly, the change in thinking necessary to transform our health care system will not be easy.

We have all benefitted greatly from the see HOPE PAGE 18

This degree of transparency allows for a better understanding of how we are in the situation we are in as an industry and should help us to design better solutions for our future.

The Incredible Human Ability To Change Our Thinking Mr. Jackson was a 25-year-old college graduate when he accepted his first job in 1968 in Atlanta. He was educated and looking forward to doing a good job as a sales manager with an industrial linen corporation. When his boss told him to put on a delivery jacket and gave him the keys to the truck to begin his route, Mr. Jackson was a little disappointed. He did not go to school and get a college degree to be a deliveryman. But, he was also committed to doing a good job and if this job did not allow him to apply his knowledge, he figured he could look for another. But for now, he would do his best.

The first delivery was to a very upscale exclusive restaurant in one of the most affluent areas of Atlanta. He was to knock on the back door (the delivery entrance) and bring the linens through that entry. He knocked and waited. The manager opened the door and gruffly closed it in Mr. Jackson’s face. You see, the color of Mr. Jackson’s skin was black.

The manager knew the delivery was from the company he used—he knew nothing about Mr. Jackson—but he slammed the door in his face and refused to allow Mr. Jackson to do his job, just because of the color of his skin.

In the world today there are still many countries where the color of a person’s skin will determine how they are treated and the opportunities they will be given.

I have done mission work in the Dominican Republic and it is apparent that the darker the skin, the more likely you are to be in poverty. Many of those with the best jobs and in higher socioeconomic classes are lighter-skinned people. But, in the United States and most developed countries, the color of one’s skin has become much less of a barrier to success and most people are much more accepting of the various cultures and skin colors.

Mr. Jackson called his boss. He told

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Statement of Need Adhesions are the most common complication of abdominopelvic surgery, developing postoperatively in 50% to 100% of all such interventions. They can lead to serious medical complications, substantial morbidity, high monetary costs, large surgical workloads, dangerous and difficult reoperations, and an increasing number of medicolegal claims. An official definition of the Sponsored by

Expiration date: September 1, 2014 condition has not been established, and an unequivocally effective prevention method has not been identified. A standardized classification for adhesion assessment and scoring also is lacking, as are guidelines for diagnosis and management. To close these gaps, clinician education is necessary.

Goal The goal of this educational activity is to provide surgeons with up-to-date, clinically useful information concerning the prevention and management of postoperative adhesions.

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2 Summarize current strategies used to prevent postoperative adhesion formation.

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17

18

In the News HOPE

jContinued from page 17 current structures for how we deliver care for patients, and many continue to benefit from maintaining the status quo. But as research in the area of disruptive innovation has shown, when an industry or a company does not keep up with the needs of the people using their industry, products and/or services, new models and organizations will emerge to improve the value (better convenience, quality, costs and experience) for those people who are being served. The increasing complexity I described in part 2 of this series is unavoidable [November 2013, page 1]. With the knowledge of complexity science and the examples from other industries, the principles for transformation are clear: Hope in and of itself, does not lead to change. That is a cheap slogan. But hope does allow us to be open to a more complete understanding. With understanding comes the ability to act.

As physicians, we need to have the guts to support the needs of our patients. Hospital administrators are slamming the door in their faces, sending their bills to collection agencies, requiring payment that is multiple times what hospitals accept from other payors for elective care, and in some cases, putting them in bankruptcy. We need to have the courage of Mr. Jackson’s boss who risked losing business by doing the right thing.

But this should be done respectfully with dialogue to help evolve understanding, not out of anger or in a divisive way. My hope lies in our ability to come together and demonstrate a unifying goal of improving the value of care for, and more appropriately, with, our patients.

Collaboration At the end of my previous article, I wrote about a medical research problem whose solution had eluded

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2013

researchers around the globe for more Ariz., went well. According to a than a decade. Using social media story about this amazing coland a collaborative gaming laboration, which aired on community, the problem was the “Today” show a couple solved in three weeks, for of years ago, Amy had free. The same collaborabecome a part of the As physicians, we tive concepts can be used family, getting togethneed to have the guts to to provide improved care er for dinner with in the clinical environKirti and her mother support the needs of our ment as well. as often as possible. patients.

Kirti Dwivedi was Transparency, our a faithful daughter and incredible ability to social media was her paschange and evolve our sion. When her mother thinking and the growwas diagnosed with kidney ing examples of selfless disease, Kirti put up a strong collaboration to provide front. But on the inside, she sufvalue for others gives me great fered watching as her mother’s health hope for our future. But hope does declined, as a vibrant mother and friend not directly lead to change, despite transformed into a weak and sometimes bedridcheeky political sayings. It is much more chalden invalid. lenging than that. Hope, however, can open our minds Without her mother’s knowledge, Kirti created a to the possibility of learning and gaining a better, more Facebook page, “Kidney Disease & My Tiny Mother” complete understanding of our situation and potenand also began sending tweets about her situation: Her tial solutions. This understanding about how things mother needed a kidney but the wait for a donated kid- can make sense in our complex health care system ney could take years and may not have come in time for will be the path that can result in transformative and her mother. One of Kirti’s Twitter followers, Amy Dono- sustainable change. Next month, I will describe how hue, experienced the death of her father due to cancer. complexity science can help us better understand the Amy knew she could not bring back her father, but she challenges we currently face in health care and why figured she might be able to help Kirti’s mother, some- our current application of science is not adequate to one who could be saved from a devastating health prob- achieve improved value for the patient. lem. After initially communicating through tweets, Amy emailed Kirti that she would like to help her mother and —Dr. Ramshaw is Chairman and CMO, Transformative offered to donate her own kidney, if she was a match. As — they say, truth is stranger than fiction and the rest is his- Care Institute (non-profit) and Surgical Momentum LLC tory. Incredibly, Amy was a match for Kirti’s mother, and (for profit), and Co-director, Advanced Hernia Solutions, the procedure, performed at Mayo Clinic, Scottsdale, Daytona Beach, Fla.

Molecular Sequencing of C. difficile Reveals Unexpected Routes of Infection Data Dispel Old Theories of Infection Control B Y B EN G UARINO

A

study of the genetic diversity of Clostridium difficile has surprised researchers and shed new light on the way this pathogen may be transmitted between patients.

“Unexpectedly few cases appear to be acquired from direct ward-based contact with other symptomatic cases,” said study author David Eyre, MB, ChB, a clinical researcher at the University of Oxford, England. “These have previously been thought to be the main source of infections, and the focus of prevention efforts.”

The traditional view of C. difficile transmission is that, in hospital settings, the disease spreads through spores released from an infected patient’s diarrhea. Infection prevention efforts frequently focus on sterilization, using sporicides like sodium hypochlorite to disinfect hospital wards. But the new study shows that clinicians may want to adopt a wider lens when looking for sources of C. difficile (N Engl J Med 2013;369:1195-1205).

“The findings are striking in that we usually talk about transmission from symptomatic patients in hospitals,” said Curtis J. Donskey, MD, professor at Case Western Reserve University and an infectious disease physician at the Louis Stokes Cleveland VA Medical Center in Ohio. “This study clearly suggests that there are additional sources of C. difficile acquisition.”

To determine the potential sources of C. difficile infections, Dr. Eyre and his colleagues tested samples from all inpatients with diarrhea at the four Oxford University Hospitals in the Oxfordshire region of England. Between September 2007 and March 2011, the researchers performed whole-genome sequencing on more than 1,200 isolates, looking for single-nucleotide variants (SNVs) that indicate if the bacteria are genetically similar or distinct. By comparing sequences taken before April 2008 with later sequences, the researchers could determine which C. difficile cases were evolutionarily similar, defined as a difference of less than two SNVs. The researchers successfully sequenced 1,223 isolates of C. difficile. Comparing 957 isolates obtained between April 2008 and March 2011 with samples obtained from September 2007 onward, they found that only 13% of patients had isolates that were genetically related and also had close hospital contact with another patient, which had been thought to be the primary route of C. difficile transmission. Overall, 333 isolates (35%) were genetically similar to earlier cases, and 428 isolates (45%) had 10 or more SNVs compared with all previous cases.

“Distinct subtypes of infection continued to be identified throughout the study,” the authors wrote. This diversity, Dr. Eyre said, indicates a “reservoir of disease not previously appreciated.”

During the three years of the study, the rate of C. difficile infections in Oxfordshire fell, not only in hospitals but also in community-acquired cases.

“In England, [there is] a lot of media attention related to C. difficile outbreaks,” Dr. Donskey said. Infection control efforts described in this article go beyond what is normally seen in the United States, he noted.

At the Oxford University Hospitals, these efforts included daily sterilization with bleach in the rooms of patients with confirmed or suspected C. difficile, preemptive isolation of suspected cases and continued monitoring and feedback for noncompliance.

But Dr. Eyre doesn’t believe that improvements in infection control contributed to the observed decline in C. difficile infections during the study.

“It is likely that the fall in incidence in C. difficile was due to restricting the use of antibiotics rather than an improvement in infection control,” Dr. Eyre said. The administration of quinolones and cephalosporin fell significantly in the United Kingdom over the three years of the study, he noted.

Antimicrobial stewardship remains a vital part of keeping C. difficile transmission low.

“It’s not uncommon for transmission to occur in patients who received antibiotics when not necessary,” Dr. Donskey said, for example, in patients who contracted C. difficile after being prescribed antibiotics for dental procedures or viral respiratory infections.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2013

Degree of Gunshot Violence Takes Turn for the Worse, Study Suggests B Y C HRISTINA F RANGOU

W

hat was once the extraordinary has become the ordinary at Newark’s New Jersey Trauma Center.

Unfortunately, we are talking about firearm injuries.

When surgeon David H. Livingston, MD, joined the staff 25 years ago, he rarely saw a gunshot victim with more than one wound. But now, almost every day, he sees patients with multiple wounds.

The injured often arrive in clusters, two and three patients coming in the door within 15 minutes of each other. “You never used to see that,” he said. Victims now have more injuries and worse injuries than victims of firearm violence did two decades ago.

“It’s very obvious to me, to anyone who has worked at our trauma center for a long time, that the picture of gunshot violence is changing,” said Dr. Livingston, Wesley J. Howe Professor and chief of trauma surgery, Rutgers-New Jersey Medical School and director of the New Jersey Trauma Center.

The costs of day-to-day gunshot violence, tremendous whether it is measured in dollars or human life, are largely overlooked, he said.

“Incidents like Newtown get a lot of attention. But there is something very ugly that happens every day and no one is talking about it because it’s a political football.

No one is even researching it.”

Dr. Livingston, who has published d many studies on trauma over the past two decades, set out to examine the inciden nce of gunshot violence and patterns of injury at his hospital. He reviewed all th he interpersonal gunshot cases at the hosspital between 2000 and 2011, usin ng the data from the trauma registry, em mergency department billing and hospitall finance records. All patients with self-inflicted wounds or those who were shot by law enforcement were excluded.

The analysis confirmed his hypothesis: patients were coming in with far worse wounds and with more body regions injured. No steady increase in the number of gunshot victims was seen annually. The numbers jumped up and down from year to year, around 480 in 2000 and up to 575 in 2011. The number of gunshot patients peaked at around 640 in 2006 and hit a low of 395 in 2009.

Of the 6,322 patients who presented with firearm injuries, 92% were male. They were young, with a mean age of 27 years (±9 years). In fact, they were very young: 29% of all gunshot victims were between the ages of 20 and 24, and nearly 20% were teenagers aged 15 to 19.

In keeping with other studies, the research confirmed that gunshot violence disproportionately affects blacks and Hispanics. Eighty-six percent of gunshot patients who presented at the Level 1 trauma center were black, and 9% were Hispanic. Whites and Asians represented 4% and 1% of all gunshot patients, respectively.

The study showed quite clearly that the degree of violence escalated since 2000. That year, about 5% of gunshot victims presented with three or more wounds. Over the next 11 years, the proportion of patients with multiple gunshot wounds rose steadily, hitting 22% in 2011.

Patients who scored 3 or higher on the Abbreviated Injury Scale also increased over the same period, climbing to 11% from 5%.

The alarming increase in patients with multiple wounds and multiple body regions injured is, most

likely, due to the use of newer automatic handguns with amplified firing capacity, said trauma surgeons who heard the study presented at the 2013 annual meeting of the American Association for the Surgery of Trauma (AAST). The change could also reflect more perpetrators acting together. Police officials have not confirmed these suspicions. Ninety-eight percent of all gunshot injuries reviewed in the study were attributed to handguns.

Even the patterns of arrival changed over the past decade. By 2011, individuals who sustaained gunshot wounds more often arrived at the hospitaal in clusters. In 2000, only 1% of patients arrived d in a cluster of three or more gunshot patients within 15 minutes. Eleven years later, 16% of gunshot victims presented in groups of thrree or more. Clusters of two patients within 15 minutes increased from 9% to 28%.

President Obama lifted a 1996 Congressional ban on federal funding for issues related to firearm violence. The bill prohibited the CDC from using ‘funds made available for injury prevention … to advocate or promote gun control.’

Mortality rates similarly rose, from 9% to 14%, M “eveen though trauma care has improved over the sam me time,” Dr. Livingston said.

Dr. Livingston and his colleagues conducted a geograaphical mapping analysis that demonstrated the vast m majority of firearm violence that came through the hospital was not random. It was tightly restricted geographically, a fact that remained unchanged between 2000 and 2011. Seventy percent of victims were shot in the city where they lived, 15% inside their homes, 25% within a city block of their homes and 55% within a mile of their homes. Five cities in New Jersey accounted for 85% of the gunshot wounds.

Trauma surgeons stress that the study only reflects the experience of a single trauma center. The results cannot be extrapolated to make statements about gunshot violence nationally or even regionally. Dr. Livingston said his findings should not be used to support arguments by extremists on either end of the gun control debate.

But what it does show, quite poignantly, is the desperate need for a reliable national database on firearm injuries, said Demetrios Demetriades, MD, PhD, professor of surgery and director of trauma at the University of Southern California (USC), Los Angeles.

The existing registries do not track victims treated and discharged from the emergency department, which accounted for 19% of patients in this study. Moreover, registries do not include victims treated at non-trauma centers or victims who die at the scene.

“These major limitations do not allow for any meaningful conclusions and often lead us to the wrong messages,” said Dr. Demetriades.

He cited three recent reports on gunshot injuries that came to differing conclusions on firearm violence. One study, recently reported in The Wall Street Journall and performed by the Howard-Hopkins Surgical Outcomes

Research Center, concluded that the number of gunshot wounds increased over the past six years while mortality rates fell because of better medical care (The Wall Street Journal,l “In Medical Triumph, Homicides Fall Despite Soaring Gun Violence,” Dec. 8, 2013). Another study, conducted at USC and awaiting publication, used the National Trauma Data Bank to demonstrate that, over the same period, gunshot wounds decreased, incidence of severe injuries in all body regions decreased and the mortality rate rem mained unchanged. A third study from the cou unty of Los Angeles, also awaiting publicaation, backed the conclusions of the US SC report.

Meeanwhile, another study also presented d at this year’s annual meeting of th he AAST reported that firearmrelateed mortality decreased slightly beetween 2002 and 2010, although firrearm injuries increased 10% (AB Paper 2, Sise et al).

In otther words, there’s very little understanding of what is actually going understa on in the United States with regard to firearm violence and mortality.

“That’s why we need to be looking more critically at this,” Dr. Livingston said.

He hopes a presidential executive order, issued in January, will improve research into firearm violence. In the order, President Obama lifted a 1996 Congressional ban on federal funding for issues related to firearm violence.

The bill prohibited the U.S. Centers for Disease Control and Prevention from using “funds made available for injury prevention … to advocate or promote gun control.”

Firearm research accounts for a very small percentage of scientific publications focused on trauma mortality.

A report in the Journal of the American Medical Association (2013;310:532-534) showed that compared with other leading causes of death in youth, firearm violence is underrepresented: Firearms accounted for 12.6% of deaths but only 0.3% of publications. The authors could not conclude whether the Congressional ban or other events were responsible for the lack of research.

Dr. Livingston called on trauma surgeons to make firearm research a priority. Gun violence comes at too great a cost to be ignored, he said. In his study, people injured by firearms required a mean of 11 days (±21 days) in the ICU, a mean of 10 days in the hospital and a mean of five days (±9 days) on a ventilator. Each patient needed a mean of 17 units of blood and 71% of patients underwent at least one operation.

That kind of care is expensive. Three-fourths of the health care provided to these patients was not reimbursed.

The price tag was estimated at $115 million. Moreover, the costs are growing. For all patients, costs rose 282% over the study period. For admitted patients, the change was even more marked, at an increase of 323%.

“From day to day, night to night, we are ill-equipped to deal with these numbers of patients and this degree of uncompensated care. That’s important because these are our safety net hospitals and they need to be able to continue,” Dr. Livingston said.

He asked other trauma surgeons to study firearm violence in their institutions. “We needed a clearer picture of what is happening nationally. The message is ‘enough is enough.’ We as trauma surgeons need to get this back on the public health agenda.”

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20

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2013

MUST HAVES jContinued from page 1

nge the a h c o t d We nee onstrate m e d d n a n discussio edures we offer proc s than that the t l u s e r r e tt r provide be alities fo d o m e iv s other inva ns that io it d n o c and diseases g treated. in e b e r a already

I estimate that less than 10% of the patients who are referred to our practice by endocrinologists actually come to a seminar or make an appointment. In comparison, when referred for something like gallstones, almost every patient pursues a consultation. It is this perception that we have to change. Only then will we be able to counter riders and avoid being squeezed out of the increasingly competitive health care landscape.

Many believe that this has already begun to happen. Last year, The New England Journal of Medicinee published two articles demonstrating a significant improvement from m surgery for type 2 diabetes compared with th h medical therapy.1,2 This should indicate thatt the treatment of choice for type 2 diabetes is surgery. Although these articles have certainly helped with referrals from endocrinologists, they have not allowed us to cross the goal line. The question is why?

With 25 million Americans suffering diabetes and another 75 million with prediabetes, the average person or physician cannot believe that bariatric surgery is the answer for all of them. Similarly, with obesity levels exceeding 30%, it is not practical for stomach stapling to be the solution for a sizable proportion. Instead, it is my contention that we focus on smaller subgroups— find areas in which popular opinion holds that surgery is strongly recommended, and not just that it should be considered.

If we continue to target all people with severe and morbid obesity, diabetes and sleep apnea, I believe that we will continue to encounter opposition. A common complaint and major issue are the barriers placed for precertification for a bariatric procedure. Often there are requests for documented diets lasting six months, psychological evaluation and serial weights. Although not stated, the real intent is to create barriers and ration bariatric surgery. By making the process arduous, numerous individuals who start the process drop out.

Another sad by-product of this system is that it makes it difficult for those with life-threatening, yet treatable, issues to navigate the broken system. The real reason this system continues to exist is the large potential market for bariatric surgery. Each year, only so many people will develop symptomatic gallstones or be diagnosed with colon cancer. Barriers are placed for bariatric surgery, otherwise it would bankrupt the system if every potential candidate underwent surgery.

As a result, a system has developed that limits access; perpetuates patient fears; makes no allowances for the sickest individuals; and where the most determined, not the most deserving, make it through the process. It is time that we changed the debate. Instead of striving for coverage for patients with lower BMIs, our efforts should be focused on finding areas in which surgical care offers undisputable benefit for conditions that already have coverage.

Suggested areas of concentration should be the following: • Individuals with type 2 diabetes, BMI greater than 30 kg/m2 and on injectable therapy or two or more oral hypoglycemic medications with hemoglobin A1c greater than 8;

•

Patients with moderate to severe sleep apnea, as documented by an apnea-hypopnea index greater than 15, and BMI greater than 35 kg/m2; • Patients with documented coronary artery disease and BMI greater than 35 kg/m2; • Patients requiring joint replacement who have BMI greater than 35 kg/m2; • Women with infertility from polycystic ovary syndrome who have BMI greater than 35 kg/m.2 There are probably several more categories that could be suggested. The point is the same: We need to make our procedures a must-have for certain indications, not just an option.

It is my hope that if we can find these areas, then the certification for patients who meet these criteria can be simplified. Our program currently certifies more than 600 patients annually. We have three full-time employees whose primary responsibility is to obtain insurance certification. The cost is excessive. It would be far more efficient and productive if we could have immediate approval for patients who fit into narrower classes than the present system allows.

Fear of Surgery Another factor that has been suggested for the failure of bariatric surgery to grow is fear. When surgery is suggested, patients often respond that they know someone who had surgery who almost died, or did die, or regained all their weight. At that point, the discussion is usually dropped.

What this really represents is the ambiguous attitude toward obesity from both the general public and health care professionals. The hidden meaning of their objection for bariatric surgery is that obesity does not justify a potentially dangerous surgical procedure. Despite the dangers of severe and morbid obesity, despite its effects on life expectancy and on emotional health, the perception for many remains that surgical treatment is not mandatory.

The two most commonly performed general surgical procedures are cholecystectomy and hernia repair. Few patients resist surgical intervention when it is suggested, as it is presented as the proper treatment. My take is that to succeed, we need to move the discussion to areas

where treatment is already mandatory. It is my impression that many patients would consent to have diabetes surgery if the consensus opinion was that surgical intervention was the best treatment. Similarly, those with sleep apnea, heart disease and severe degenerative joint disease are more likely to proceed with surgical intervention for these conditions than obesity alone.

Again, the difference may be semantics, but today we mainly perform bariatric surgery that improves comorbidities. We need to change the discussion and demonstrate that the procedures we offer provide better results than other invasive modalities for diseases and conditions that already are being treated.

From a marketing perspective, there also will be advantages to this approach. Often, we try to approach the largest population possible for a particular service or product. Marketers often are “clumpers,” trying to gather the largest potential group that can benefit. Patients, however, are “splitters.” They see specialists in each area. They separate their issues based on the different doctors they see. They see an endocrinologist for their diabetes and a cardiologist or their primary care physician for their hypertension. A different physician is seen for each area of their body, even if obesity is the underlining cause of all their medical issues. Thus, our message has a much better chance of reaching their core if the information is tailored for their sentinel condition. Many do not see obesity as being the root of the majority of their issues. Whether this is denial or ignorance is hard to ascertain. But, how often have we heard from a patient, “I am the healthiest fat person you have ever seen”?

The Role of the ASMBS This past year has been quite dynamic for our professional society, the American Society for Metabolic and Bariatric Surgery (ASMBS). The formation of BSQIP, or the bariatric surgery quality improvement program, signals a closer collaboration with the American College of Surgeons. Hopefully, this relationship will allow us to have greater influence with national decision makers.

An additional benefit will be mandatory data contribution from all centers participating. Hopefully, data will be available to allow us the information to carve out these core areas where bariatric and metabolic surgery become the standard treatment.

Frequently, I have heard that the key to growth will be improved quality. Although it would be nice if this were true, recent data do not support this position.

According to most reports, the mortality of bariatric surgery has been reduced fivefold in the past several years. A similar increase in cases has not coincided with these encouraging results.

It is essential that procedure growth be a major objective for the ASMBS. Coordination between all committees is vital. For us to truly be a metabolic surgical society, we need our insurance arms to work to get codes for surgery for diabetes and other core areas.

Public education materials need to be developed that deliver the proper message. Funding for pivotal studies must be obtained and dedicated to areas that can push us across the goal line in key areas.

Conclusions The absence of growth in the past several years is multifactorial, but should be extremely concerning. Increasing competition for health care dollars will exacerbate the present condition and will make certification even more difficult in the future. The economy is a significant

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2013

factor, but we cannot accept that it is the only cause. designed for cardiac surgery. The robot was floundering, Stated differently, unless we do our part, there will be no and many stated that it was a technology in search of an growth even if the economy improves. application. Few urologists were capable of performing Whereas the number of individuals afflicted with the urethral anastomosis of a prostatectomy with stansevere obesity and diabetes has dramatically increased, dard laparoscopic equipment. Therefore, for the minithe volume of bariatric surgical procedures has pla- mally invasive application for prostate removal, the robot teaued and now declined. This has happened as proce- became a must-have. If this must-have were not found, dures have become safer and outcomes have improved.

Intuitive would probably not have survived as an indeThis indicates that obesity and its treatment remain pendent company. in somewhat of a state of limbo in the minds of the Now that there is much greater acceptance, the growth public, insurers and employers. Success with a nation- in robotic procedures is in the nice-to-have areas, not al coverage decision by Medicare as the must-haves. The growth areas well as with the majority of insur- Frequently, I have heard that are general, thoracic, bariatric and ers has not made the process easier the key to growth will be gynecologic surgeries. The fastfor patients or our practices. Obstaest growing procedure is hystercles for coverage such as six-month improved quality. Although ectomy. Is a robot required for treatment programs and exclusions it would be nice if this were extirpative surgery such as a hysfor coverage are common. terectomy? Certainly, our laparotrue, recent data do not Until there is a mandatory treatscopic results in bariatric surgery ment threshold for obesity, it is best demonstrate that it is not a mustsupport this position. to concentrate on core areas where have in our field. However, after bariatric surgery becomes the stanentering the market as a mustdard. We need to accept that it is not practical for every have for urologists, growth has occurred as other fields obese or diabetic individual to have surgery. Thus, we have realized its advantages. The message is clear: you need to identify subgroups that can most benefit from need your core and then you can expand to the periphsurgery; subgroups for which we can convince the ery. If you have no core, you have no sustainable business majority of physicians and the public that surgery is the model. In our field, many believe that refractive morbid treatment of choice. obesity has been and should be that core.

Returning to my Intuitive Surgical analogy from Part Bariatric surgery has been the focus of my surgical 1 of this article, Intuitiveâ&#x20AC;&#x2122;s robot da Vinci was originally practice for nearly 20 years. Although I have witnessed

21

far greater acceptance, certification remains a hassle.

Each year brings new restrictions. Furthermore, despite our efforts, there is no clear consensus regarding obesity treatment.

In bariatric and metabolic surgery, we need to find our must-haves. Our goal over the next few years is to find several core areas. If we are successful, I am certain that our numbers will improve and we can make the certification system more efficient for our patients and our practices. Most importantly, patients who can benefit the most will have a greater chance of gaining access to our procedures.

References 1. Schauer PR, Kashap SR, Wolski K, et al. Bariatric surgery versus intensive medical therapy in obese patients. N Engl J Med. 2012;366:1567-1576.

2. Mingrone G, Panunzi S, De Gaetano A, et al. Bariatric surgery versus conventional medical therapy for type 2 diabetes. N Engl J Med. 2012;366:1577-1585.

â&#x20AC;&#x201D;Dr. Roslin is chief, bariatric and metabolic â&#x20AC;&#x201D; surgery, Lenox Hill Hospital/NSLIJ, New York City, and Northern Westchester Hospital Center, Mount Kisco, N.Y.

khorty@mcmahonmed.com.

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22

Letters to the Editor

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2013

Stretta Supported by Plethora of Evidence To the Editor: I respectfully submit this letter in response to the article in the September 2013 issue of General Surgery News entitled, “Endoscopic Procedures Control Reflux Well in Trials” [page 1]. Although the main body of the article was correct, in particular the section detailing the recent 10-year, open-label Stretta prospective study, along with mention of the 32 studies “conducted to evaluate Stretta,” these facts were contradicted by inaccurate comments later in the same article. The comments in question are: • “There are lots of abstracts, but few peer-reviewed articles”; • “Stretta remains poorly supported by evidence”; and • “Few Stretta procedures are performed in academic centers of excellence.”

These incorrect statements merit attention and correction, and herein is a presentation of the facts.

Regarding the statement “There are lots of abstracts, but few peer-reviewed articles,” quite the opposite is true.

Although there are dozens of compelling abstracts, there are more than 80 peer-reviewed articles. Included in this significant body of peer-reviewed publications are: 1. Four adequately powered randomized controlled trials; 2. Thirty-two prospective observational studies employing validated and standardized measurement tools; 3. One meta-analysis that examines data from 18 Stretta trials involving approximately 1,500 patients, demonstrating significant improvements in, among other measures, lower esophageal sphincter (LES) pressure and a significant reduction and/ or normalization of esophageal pH; 4. Multiple studies demonstrating reduction in transient LES relaxations as a treatment effect; 5. Proof-of-concept studies demonstrating:

COLORECTAL CANCER jContinued from page 4

that examined the effects of BMI in more than 25,000 patients with stage II and III colon carcinoma in the Adjuvant Colon Cancer Endpoints (ACCENT) database. Obesity—as well as underweight status—was independently associated with inferior outcomes in patients with colon cancer who received treatment in adjuvant chemotherapy trials (Cancer 2013;119:1528-1536).

Dr. Campbell said several factors could explain the relationship between obesity and poorer survival rates, including fatty acid synthase expressed in colon tumor tissue and the systemic effects of obesity.

He noted that treatment did not appear to play a role. “We think, based on the evidence from our clinical colleagues, that it is not related to suboptimal treatment or surgery-related complications.”

Physical activity levels also play a major role in CRC development. Many studies in the United States have consistently found that adults with higher levels of

With respect to the statement, “Stretta remains poorly supported by evidence,” in the August 2013 issue of Surgical Endoscopy, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) published a posia. reduction in LES compliance as the direct treat- tion paper on nonsurgical treatments for GERD, which ment effect; included Stretta. The SAGES review committee judged b. decreased acid exposure to the esophagus, result- the quality of the literature on Stretta merited the highing in significant symptomatic improvement; est score of “++++,” with a grade analysis recommendac. a significant increase in LES wall thickness foltion of “Strong.” lowing Stretta, thus restoring the natural barrier The statement, “Few Stretta procedures are pereffect of the LES; formed in academic centers of excellence,” also is d. improvement in gastric yield pressure; and incorrect. What is correct is that the overwhelming e. resolution of gastroesophageal reflux disease majority of hospitals that treat patients with Stretta, (GERD)-associated gastroparesis and improved in the United States and abroad, are academic centers, gastric motility; at a ratio of 3:1 to community centers. Included in the 6. Multiple long-term studies—including three studlist of academic centers using Stretta are some of the ies of at least four years—demonstrating durability world’s most prestigious teaching programs. in response with improved GERD–Health-RelatBesides the sheer volume of positive outcomes data ed Quality of Life and satisfaction scores, with the in the peer-reviewed publications, I’d like to draw attenoverwhelming majority of patients in these studies tion to the consistency of the study results across both off all medications; academic and community-based researchers. The abili7. One 500-plus-person registry demonstrating susty to replicate clinical outcomes outside of an academtained and significant benefits of Stretta; ic, university-based setting is a fundamental requirement 8. Studies that include special populations, such as of many of the technology assessment groups patients who failed antirefluux surworldw wide. gery, those with post–barIn ssuch a challenging patient population iatric surgery GERD and and d disease state as GERD, it certainly is a those with laryngopharynbenef fit to have as many treatment options as l ro ures Cont ic Proced geal reflux disease, just to possib ble, particularly those with an excellent Endoscop l in Triaallss el Reflux W name a few. safetty, efficacy and durability record, such as I These 80-plus peer-reviewed d Streetta. We are confident that an accurate, publications make Stretta on ne com mplete and thorough analysis of the sigof the most studied device tech hnifi ficant body of peer-reviewed studies of nologies in any field of treatment, Strretta, such as the one recently conductand provide 10-fold the volu ume ed d by SAGES, will provide a clear picof studies of any currently avvailtu ure of the benefits of this unique, safe able GERD device, whether itt be aand effective treatment. transoral or surgical. The verracity William Rutan 28 13 of these facts is easily checked (e.g., Chief Executive Officer 10 PubMed search word: Stretta).

Mederi Therapeutics, Inc.

physical activity—in intensity, duration or frequency—can reduce their risk for developing colon cancer by 30% to 40% relative to those who are sedentary, regardless of BMI. A meta-analysis published in 2009 examined 14 prospective studies, and found that the most physically active men experienced a 20% reduction in the incidence of colon cancer compared with those who were least active. In women, the effect was similar at about 14% (Colorectal Diss 2009;11:689-701).

In a study published in the March edition of the Journal of Clinical Oncology, Dr. Campbell and his colleagues found that people who met the public health recommendation of at least 150 minutes of physical activity per week had a lower risk for all-cause and cardiovascular mortality (2013;31:876-885). All 2,293 patients in the study were diagnosed with invasive, nonmetastatic CRC between 1993 and 2007. Analysis showed that those who completed at least 150 minutes of moderate-intensity activity per week had a 28% reduced risk for mortality compared with those who performed less than 60 minutes

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per week of moderate physical activity.

Clinicians who treat cancer patients said they are emphasizing the importance of maintaining a healthy body weight and increasing physical activity to help patients manage their risk for recurrence.

Frank Sinicrope, MD, professor of medicine and oncology at Mayo Clinic, Rochester, Minn., and the lead author of many studies looking at cancer and obesity, said he counsels patients with a BMI of 30 kg/m2 or higher to consume nutrient-rich foods such as fruits, vegetables and whole grains; to reduce their red meat consumption; and to increase physical activity.

“Obesity appears to be a source of chronic inflammation that can adversely affect multiple organ systems and, as such, contributes to cardiovascular disease and cancer, among others,” he said.

James C. Cusack Jr., MD, associate professor of surgery at Harvard Medical School, Boston, said he and his colleagues are working increasingly with their patients to help them achieve and maintain a healthy weight before and after surgery. He said that patients rarely

have time to make significant changes in the period between diagnosis and surgery, but he does encourage them to participate in a programmatic weight loss and exercise program during neoadjuvant therapy to improve their surgical outcomes and their overall likelihood of surviving the disease.

Surgeons also should work more closely with patients to help them modify diet and lifestyle in the long term, he said.

Recent data suggest that increased activity levels and weight loss after surgery may improve the likelihood of surviving CRC, providing “a strong rationale for the surgeon to initiate the discussion of modifying diet and lifestyle for the long-term benefit of the patient.”

Dr. Cusack and his colleagues are expanding their hospital’s weight loss program for preoperative bariatric surgery patients to include patients recently diagnosed with colon or rectal cancer.

Cancer patients should not lose more than two pounds per week and any weight loss should be achieved through exercise and proper diet.

Rationale, Reversal, and Recovery of Neuromuscular Blockade Part 1: Framing the Issues Case Study Harold is a 74-year-old man undergoing a video-assisted right upper lobectomy for stage I non-small cell lung cancer.

Current Symptoms • Dyspnea • Coughing with hemoptysis • Chest pain Vital Signs • Height: 177.8 cm (70”) • Weight: 65 kg (143 lb) Signi¿cant Medical History • Hypertension • Chronic obstructive pulmonary disease (moderate) Current Medications • Metoprolol succinate ER 50 mg/d • Tiotropium bromide inhalation powder Laboratory Results • 2-cm lesion in right upper lobe revealed on chest computed tomography (CT) scan; malignancy con¿rmed with needle biopsy • No abnormal bronchopulmonary or mediastinal lymph nodes; brain CT, isotopic bone scan, abdominal ultrasonography negative for distant metastases • Forced expiratory volume in the ¿rst second: 43.6% of predicted value (1.44 L) • Carbon monoxide diffusing capacity: 71.7% of predicted values (20.19 mL/min/mmHg) • Cardiac ultrasonography: normal pulmonary artery pressure (22 mm Hg) At induction, Harold receives propofol 1.5 mg/kg and rocuronium 0.6 mg/kg. During the procedure, movement of the diaphragm interferes with surgery.

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

Supported by an educational grant from Merck.

Applied Clinical Education is pleased to introduce a new interactive 3-part CME series featuring challenging cases in neuromuscular blockade.

Each activity will present a clinical scenario that you face in your daily practice. After reading the introduction to the case, consider the challenge questions, and then visit www.CMEZone.com/nmb1 to ¿nd out how your answers stack up against those of our multidisciplinary faculty panel.

Access the activities on your desktop, laptop, or tablet to explore the issues surrounding safe, effective, neuromuscular blockade and reversal via a unique multimedia learning experience and earn 1.0 AMA PRA Category 1 Credit.™ Participate in the coming months as well to complete the whole series and earn a total of 3.0 AMA PRA Category 1 Credits.™ This activity’s distinguished faculty Jon Gould, MD Glenn S. Murphy, MD Chief, Division of General Surgery Alonzo P. Walker Chair in Surgery Associate Professor of Surgery Medical College of Wisconsin Senior Medical Director of Clinical Affairs Froedtert Hospital Milwaukee, Wisconsin

Clinical Professor, Anesthesiology University of Chicago Pritzker School of Medicine Director Cardiac Anesthesia and Clinical Research NorthShore University HealthSystem Evanston, Illinois

Challenge Questions 1. What would you do next?

2. What potential postoperative risks does this patient face?

Access this activity at www.cmezone.com/nmb1

Focus on Safety After activation, on average, the external jaw temperature of the LigaSure™ small jaw instrument is at most 155° C cooler than the Harmonic FOCUS.™*1

Infrared thermographic video image comparing the LigaSure™ small jaw instrument with the Harmonic FOCUS.™*

LigaSure™ Small Jaw Instrument for ENT Procedures When working in confined spaces, minimize risk to adjacent critical structures by choosing the device that seals effectively at cooler temperatures.1

Visit Covidien.com/smalljaw to watch a side-by-side thermal comparison video of the LigaSure™ small jaw instrument and Harmonic FOCUS.™* 1. When compared to the Harmonic FOCUS™* as part of an August 3, 2010 study comparing device temperatures during seal tests on porcine tissue either in-vivo or freshly excised. Covidien test report R0021935B from September 14, 2012.

COVIDIEN, COVIDIEN with logo, Covidien logo and positive results for life are U.S. and internationally registered trademarks of Covidien AG. TM* Trademark of its respective owner. Other brands are trademarks of a Covidien company. ©2013 Covidien. 09/13 M130593(1)

DECEMBER 2013 Brought to You by

REPORT ENTEREG® (alvimopan) for Gastrointestinal Recovery Following Bowel Resection States.2 However, research has he impairment of gastrointestinal (GI) function revealed that opioids signifFaculty Consultant following surgery is an ongoing icantly contribute to delayed challenge for clinicians. Unique GI motility and the pathogenLaurence R. Sands, MD, MBA, care approaches like enhanced esis of POI.6 Additional factors FACS, FASCRS recovery after surgery protocols, that are thought to contribute to Professor and Chief fast-track programs, or accelthe development of POI include Division of Colon and Rectal Surgery erated care pathways (ACPs) the release of endogenous University of Miami School of Medicine aim to expedite GI recovery, opioid peptides and other neuMiami, Florida decrease complications, diminrogenic, inflammatory, and ish surgical stress response, and hormonal factors.2 reduce hospital length of stay The peripheral-acting μ-opioid (LOS) and health care costs while maintaining the highest receptor antagonist alvimopan (ENTEREG ®, Cubist standards in patient safety.1 However, despite the use of Pharmaceuticals) has been shown to improve patients’ ability to tolerate solid foods and produce bowel movethese approaches, some degree of GI function impairment ments, thus improving time to GI recovery and decreasing is expected in all bowel resection patients2 and related time to hospital discharge order written (DOW).4 Recent complications after abdominal surgery may continue for a 3 prolonged duration. data show that using ENTEREG in a multimodal approach, such as an ACP, is an effective treatment option for POI.2 Although it is a common condition after GI surgery, no standard definition or commonly accepted time course Therefore, this review will discuss the clinical benefits of for postoperative ileus (POI) exists,2 and the condition is accelerating GI recovery following bowel resection and the efficacy and safety of ENTEREG in the postoperative commonly described as an impairment of GI motility that setting. lasts several days.4,5 Prolonged impairment of GI function following surgery is associated with symptoms including The Effect of Accelerating abdominal bloating and distension, pain, vomiting, an GI Recovery accumulation of gas and fluids in the bowel, nausea, and a lack of flatus and defecation.4,6 Since the resolution of POI is commonly used as a criterion for hospital discharge following abdominal Although opioid-sparing techniques are increasingly surgery, 2 reducing the length of POI may also reduce being adopted into ACPs, opioids continue to be the mainstay of postoperative pain management in the United hospital LOS and may be associated with a lower

T

Supported by

REPORT incidence of readmissions.3 Risk factors that may delay GI recovery and cause POI include abdominal surgery, surgical technique, longer operation period, prolonged opioid use, occurrence of systemic inflammation, and prolonged period of nasogastric tube (NGT) use.7 In an analysis using data from the Premier Perspective database, the largest national in-hospital patient claims database in the United States, Goldstein and colleagues examined inpatient costs of POI following abdominal-related surgery.8 This analysis found an increase in average hospital LOS among patient records that contained diagnostic coding for POI (11.5 days) compared with those without a POI diagnosis code (5.5 days).8 This increase in LOS was associated with a substantially increased cost of hospitalization for POI ($18,877 vs $9,460).8 In all, the authors estimated that the total annual cost associated with managing POI was $1.46 billion (cost adjusted to 2006).8 In their analysis of the Premier Perspective database, Iyer and colleagues reported similar negative economic outcomes associated with POI after colectomy surgery.9 These researchers also compared records with and without diagnostic coding for POI and found that POI was a significant predictor of hospital LOS (29% increase; P<0.001) and hospitalization costs (15.5% increase; P<0.001).9 The average LOS among colectomy patients with POI was 13.8 days compared with 8.9 days for colectomy patients without POI.9 The mean perstay hospitalization costs increased among patients with POI compared with those patients without POI ($25,089 vs $16,907, respectively).9

Influence of Recovery Pathways On Outcomes Various protocols and pathways for the colorectal surgery setting have been developed in order to improve time to GI recovery and potentially reduce the clinical and economic burdens associated with a prolonged postoperative healing phase for patients and health care systems. These approaches are referred to as enhanced recovery after surgery protocols, fast-track programs, or ACPs. Such approaches often are multimodal strategies that may include patient education, intraoperative fluid restriction, use of a laparoscopic surgical approach, early enteral nutrition/initiation of clear fluids, early ambulation, early removal of the Foley catheter, and effective pain control.10 Gouvas and colleagues conducted a meta-analysis of 11 trials (N=1,021 patients) that compared fast-track programs with standard care in colorectal surgery.1 Assessed end points included short-term morbidity, primary postoperative hospital LOS, total postoperative LOS, readmission rate, and mortality.1 The use of a fast-track program was associated with a significant improvement in primary hospital mean LOS (–2.35 days; 95% confidence interval [CI], –3.24 to –1.46 days; P<0.00001) and total hospital mean LOS (–2.46 days; 95% CI,

–3.43 to –1.48 days; P<0.00001) compared with standard care.1 No significant differences between the 2 groups were observed with regard to readmission rates.1 The authors concluded that fast-track programs should be integrated as a mainstay of elective colorectal surgery.1 Other published data have reported similar benefits of ACPs in colorectal surgery, including a reduction in LOS with no increases in the occurrence of complications11 and an improvement in clinical outcome parameters related to POI (ie, necessity for reinsertion of an NGT, time until initial defecation, and number of days required to attain solid food tolerance).12 Despite these positive outcomes, uptake of these approaches has not been widespread. In 2010, Delaney and colleagues published the results of a web-based survey of general or colorectal surgeons that evaluated the current state of perioperative care for elective bowel resections in the United States.13 Of the 207 general and 200 colorectal surgeons who participated in the survey, only 30% practiced in hospitals with an existing care pathway intended to accelerate GI recovery.13

ENTEREG Is an Effective Adjunct to an Accelerated Care Pathway The efficacy and safety of ENTEREG when used in a standardized ACP following abdominal laparotomy has been demonstrated in 5 pivotal multicenter, randomized, doubleblind, parallel-group Phase III studies.14-18 Despite the fact that these studies favored ENTEREG, the results were somewhat inconsistent, possibly due to the mixed surgical population containing both bowel resection and total abdominal hysterectomy patients as well as patient noncompliance with the dosing regimen.18 Furthermore, it should be noted that one of the clinical trials occurred outside of the United States, which allowed the patients in both arms to use a higher dose of nonopioid analgesics.17 However, when the results of these 5 studies were stratified according to surgery, the use of ENTEREG positively affected time to GI-2 recovery, as measured by time to tolerance of solid food and first bowel movement.14-18 Results for the bowel resection patients only indicated that using ENTEREG was capable of shortening the time to GI-2 recovery by between 11 and 26 hours (Table).4 Of the 5 studies, 4 also examined time to DOW.14-16,18 In these studies, an accelerated time to GI-2 recovery was reflected in a reduction in the time to DOW by 13 to 21 hours (Figure 1).4 Findings reported by Ludwig and colleagues, as detailed below, are of particular interest since this study focused exclusively on bowel resection patients. The researchers conducted a randomized, multicenter, double-blind Phase III clinical trial that examined the effect of ENTEREG versus placebo when used in conjunction with a standardized ACP for patients undergoing laparotomy for small or large bowel resection.18 In this study, patients were treated in-hospital with

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

2

Please see additional Important Safety Information throughout and brief summary of Prescribing Information on page 8.

REPORT Table. In 5 Pivotal Studies, ENTEREG Reduced Mean Time to GI-2 Recoverya in Bowel Resection and Radical Cystectomy Patients by Up to 1 day Study

ENTEREG 12 mg Mean/Median, h (n)

Placebo Mean/Median, h (n)

Treatment Difference Mean/Median, h

Hazard Ratio (95% CI)

Büchler et al, 2008b

98.2/92.8 (239)

108.8/95.6 (229)

10.6/3.1

1.299 (1.070-1.575)

Delaney et al, 2005

106.7/101.4 (98)

119.9/113.3 (99)

13.2/11.9

1.400 (1.035-1.894)

Viscusi et al, 2006

116.4/101.8 (139)

130.3/116.8 (142)

14.0/15.0

1.365 (1.057-1.764)

Ludwig et al, 2008

92.0/80.0 (317)

111.8/96.6 (312)

19.8/16.6

1.533 (1.293-1.816)

Wolff et al, 2004

105.9/98.0 (160)

132.0/115.2 (142)

26.1/17.2

1.625 (1.256-2.102)

Trial:14CL403

132.7/117.0 (143)

164.2/145.6 (134)

31.5/28.5

1.773 (1.359-2.311)

CI, confidence interval; GI, gastrointestinal a

GI-2 recovery was defined as time to toleration of solid food and first bowel movement.

b

The Büchler et al study was a non-US study that allowed a substantially higher use of nonopioid analgesics for both treatment groups compared with the US-based studies.

Based on reference 4.

12 mg of ENTEREG or placebo 30 to 90 minutes preoperatively to ensure compliance.18 A cohort of 654 adults undergoing laparotomy for partial small or large bowel resection with primary anastomosis were treated with either ENTEREG (n=329) or placebo (n=325) 30 to 90 minutes before surgery and then twice daily until discharge or for up to 7 postoperative days.18 A standardized ACP was used by the investigators; this plan included early NGT removal by no later than noon of postoperative day (POD) 1, early ambulation on POD 1, and a liquid diet on POD 1 followed by solid food on POD 2.18 The primary end point measured by the investigators was time to GI-2 recovery, which represented the resolution of POI.18 This is a composite end point that requires both upper GI tract recovery (as measured by the toleration of solid food) and lower GI tract recovery (as measured by the first bowel movement) with time to GI-2 recovery being based on the last event to occur.18 The secondary end points measured in this study were time to GI-3 recovery (defined as the first toleration of solid food and either first flatus or bowel movement), time to DOW, and time to actual hospital discharge.18 Ludwig and colleagues found that both primary and secondary end point measurements favored ENTEREG. The mean time to GI-2 recovery was significantly improved with

ENTEREG, decreasing the time to recovery from 112 hours in the placebo group to 92 hours in the ENTEREG group; therefore, ENTEREG significantly shortened POI by an average of 0.8 days or 20 hours (P<0.001).18 The time to GI-3 recovery also was significantly shortened by 16 hours (98 vs 82 hours; P<0.001).18 Since GI-2 and GI-3 recovery are composite end points, the time to each individual component also was measured and found to be accelerated

by ENTEREG, with patients tolerating solid food 9 hours earlier and experiencing their first bowel movement and flatus 16 and 10 hours earlier, respectively.18 ENTEREG also was associated with significant improvements in the other secondary end points measured: time to DOW and time to actual discharge. The mean time to DOW was decreased by 18 hours (138 vs 120 hours; P<0.001) and mean time to actual discharge was decreased by 17 hours (141 vs 124 hours; P<0.001).18 Overall, the mean hospital LOS of patients receiving ENTEREG was decreased by a full day (5.2 vs 6.2 days; P<0.001).18 Overall, POI-related morbidity was less likely to occur in patients treated with ENTEREG, with only 6.6% experiencing overall POI-related morbidity compared with 14.4% of patients on placebo (P=0.002).18 Patients receiving ENTEREG also were less likely to experience POI-related complications

WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY • •

Increased incidence of myocardial infarction was seen in a clinical trial of patients taking alvimopan for long-term use.

No increased risk was observed in short-term trials.

Because of the potential risk of Myocardial Infarction, ENTEREG is available only through a restricted program for shortterm use (15 doses) called the ENTEREG Access Support and Education (E.A.S.E.® ) Program.

Please see additional Important Safety Information throughout and brief summary of Prescribing Information on page 8.

3

REPORT without increasing the occurrence of TEAEs.18 Based on the combined results of the 5 pivotal clinical trials (Figure 2),4 the FDA approved ENTEREG for use in decreas0 ing the time to upper and lower GI recovery following partial large or small bowel resection sur6 HOURS gery with primary anastomosis.4 FASTER The approved dosing regimen is 12 mg orally given 30 minutes to 12 HOURS HOURS 5 hours before the surgical proFASTER FASTER HOURS cedure, followed by 12 mg twice FASTER 18 daily for up to 7 days, for a maximum of 15 doses.4 Furthermore, in October 2013, 24 the FDA approved a modified clinical indication for ENTEREG based Figure 1. ENTEREG improved the mean time to DOW by 13 to 21 hours on the results from a randomized, in 4 pivotal studies of bowel resection patients. double-blind, placebo-controlled The median time to DOW was 6 to 22 hours, in favor of ENTEREG patients.

Phase IV clinical trial, the results CI, confidence interval; DOW, discharge order written; HR, hazard ratio of which can be found in the Based on reference 4.

Table and Figure 3.4,19 The clinical indication for ENTEREG was expanded for use in accelerating GI recovery following surgeries that include bowel resection with (odds ratio, 0.25; 95% CI, 0.09-0.60; P<0.001) with a smaller primary anastomosis. percentage of patients on ENTEREG experiencing complications of POI that resulted in a prolonged hospital LOS (1.3% vs 6.4%; P<0.001).18 Of further note, patients on ENTEREG Further Clinical Studies of ENTEREG were less likely to require a postoperative NGT insertion (ENTEREG, 6%; placebo, 10.3%; P= 0.06).18 Beyond the 5 pivotal trials assessing the safety and efficacy of ENTEREG for bowel resection surgery, additional retroThe safety of ENTEREG was shown in the similar overall spective chart review studies have been performed in order incidence of treatment-emergent adverse events (TEAEs) in to examine the efficacy of ENTEREG in clinical practice.20-22 both placebo and ENTEREG groups. Almost all of the patients in each group reported 1 or more TEAE, and the 3 most These studies have found that abdominal surgery patients who common TEAEs were nausea (ENTEREG, 57.8%; placebo, used ENTEREG experienced a decreased time to GI recovery 66.2%; P=0.003), abdominal distension (ENTEREG, 17.6%; and/or shortened LOS.20-22 Of these additional studies, one placebo, 20.3%; P= 0.42), and vomiting (ENTEREG, 14%; retrospective study performed by Harbaugh and colleagues placebo, 24.6%; P<0.001).18 Only 12.2% of the patients in is of particular note. The authors performed a statewide analysis under the auspices of the Michigan Surgical Quality the ENTEREG group and 19.1% of the patients in the placebo Collaborative, an initiative designed to improve surgical outgroup reported serious TEAEs.18 Despite one patient in each comes.22 When the authors compared colectomy patients in treatment group dying, both deaths were considered unrelated to the study drug.18 hospitals that administered ENTEREG and hospitals that did not, they found that patients receiving ENTEREG had a shortThe overall conclusion by the authors was that 12-mg ened LOS.22 These results led Harbaugh and colleagues to ENTEREG dosed preoperatively 30 to 90 minutes and postoperatively twice a day for up to 7 days was an appropriate conclude that in real-world clinical practice, treating patients treatment option to use in conjunction with ACPs to accelwith ENTEREG can potentially decrease the length of time it erate GI tract recovery and reduce POI-related morbidity, takes a patient to recover from POI.22 Mean Improvement in Time to DOW, h

Delaney et al, 2005 Viscusi et al, 2006 Ludwig et al, 2008 ENTEREG (n=98) ENTEREG (n=139) ENTEREG (n=317) Placebo (n=99) Placebo (n=142) Placebo (n=312) HR, 1.4 HR, 1.6 HR, 1.4 (95% CI, 1.0-1.7) (95% CI, 1.2-2.0) (95% CI, 1.2-1.5)

Wolff et al, 2004 ENTEREG (n=160) Placebo (n=142) HR, 1.4 (95% CI, 1.1-1.8)

13

18

19

21

IMPORTANT SAFETY INFORMATION Contraindications â&#x20AC;˘

ENTEREG Capsules are contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG

Warnings and Precautions â&#x20AC;˘

4

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 pain. 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 alvimopan, including studies of patients undergoing bowel resection surgery who received alvimopan 12 mg twice daily for up to 7 days. A causal relationship with alvimopan has not been established

Please see additional Important Safety Information throughout and brief summary of Prescribing Information on page 8.

REPORT Conclusions

Estimated Probability of Achieving End Point

1.0 0.9 0.8 0.7 0.6 0.5 0.4 0.3

ENTEREG Placebo

0.2 0.1 0.0 0

24

48

72

96

120

144

168

192

216

240

264

Hours After End of Surgery

Figure 2. Time to GI-2 recoverya in bowel resection patients based on the combined data from 5 pivotal studies.

GI, gastrointestinal a

GI-2 recovery was defined as time to toleration of solid food and first bowel movement.

Based on reference 4.

1.0

Estimated Probability of Achieving End Point

Accelerating GI recovery following abdominal surgery can have a significant influence on reducing postoperative complications and hospital LOS. Solutions to accelerate GI recovery include the use of ACPs within clinical practice, with research showing that ACPs could shorten LOS after colorectal surgery via reductions in the duration of POI.1,11,12 As was shown in 5 pivotal clinical trials of patients undergoing major abdominal and pelvic operations, using ENTEREG in conjunction with a standardized ACP improved time to upper and lower GI recovery, as measured by time to GI-2 recovery.14-18 In addition to reducing the time to GI-2 recovery, 4 of the 5 clinical trials of patients undergoing major abdominal and pelvic operations also showed that ENTEREG can shorten the time to DOW.14-16,18 Together, these studies found that adding ENTEREG to an ACP can accelerate GI-2 recovery by up to 1 day (26.1 hours) and reduce the time to DOW by 13 to 21 hours.4 ENTEREG, a μ-opioid receptor antagonist, has been FDAapproved for an expanded clinical indication based on the compelling results of a randomized, double-blind, placebo-controlled Phase IV clinical trial.19 This update to the clinical indication for ENTEREG now includes its use to accelerate GI recovery following any surgery that includes a bowel resection with primary anastomosis. Therefore, incorporating ENTEREG into multimodal ACPs may provide meaningful benefits for bowel resection and radical cystectomy patients by reducing the duration of POI.2

0.9 0.8 0.7 0.6 0.5 0.4 0.3

ENTEREG Placebo

0.2 0.1 0.0 0

24

48

72

96

120

144

168

192

216

240

264

Hours After End of Surgery

Figure 3. Time to GI-2 recoverya for radical cystectomy patients using ENTEREG. GI, gastrointestinal a

GI-2 recovery was defined as time to toleration of solid food and first bowel movement.

Based on references 4 and 19.

IMPORTANT SAFETY INFORMATION (continued) •

ENTEREG should be administered with caution to patients receiving more than 3 doses of an opioid within the week prior to surgery. These patients may be more sensitive to ENTEREG and may experience GI side effects (eg, abdominal pain, nausea and vomiting, diarrhea)

•

ENTEREG is not recommended for use in patients with severe hepatic impairment, end-stage renal disease, complete gastrointestinal obstruction, or pancreatic or gastric anastomosis, or in patients who have had surgery for correction of complete bowel obstruction

Please see additional Important Safety Information throughout and brief summary of Prescribing Information on page 8.

5

REPORT

Commentary on the Use of ENTEREG (alvimopan) For GI Recovery Following Radical Cystectomy adical cystectomy is a complex matories in a patient population Ashish M. Kamat, MD, FACS surgery involving laparotomy, that may have renal impairment at Associate Professor of Urology extirpation of the lower urinary tract, baseline. ENTEREG, by antagonizDirector, Urologic Oncology Fellowship Program and the subsequent harvesting and ing the peripheral activity of opioid University of Texas MD Anderson Cancer Center use of intestinal segments for urianalgesics, offers the potential for Houston, Texas nary reconstruction. The patients mitigating some of the unwanted are returned to GI tract continuity side effects of opiates without interNeema Navai, MD with a primary anastomosis at the fering with the analgesic effects.

Fellow, Urologic Oncology A recently concluded multitime of surgery; however, frequently University of Texas MD Anderson Cancer Center center, randomized, double-blind, there is a delay in the recovery of Houston, Texas placebo-controlled Phase IV trial normal bowel function. A recent sysevaluated ENTEREG for acceleratematic review of the literature found tion of GI-2 recovery after radical the incidence of POI to be as high cystectomy.19 In this study, 280 patients were randomized as 24% in this population.23 Although there have been some improvements with efforts to introduce plans or programs to receive either ENTEREG (n=143) or placebo (n=137).19 This study found significant differences in regard to mean to accelerate POI resolution (eg, early postoperative feeding hospital LOS and morbidity. Study participants given and withdrawal of NGT), standardized uptake of these meaENTEREG recovered their upper and lower GI function sures has been limited.13 As a result, delays in postoperative GI recovery are frequently a hurdle in ACPs and the most nearly 32 hours earlier (133 vs 164 hours; P<0.0001), common cause of prolonged hospitalization. Patients who experienced a 21% reduction in ileus-related morbidity undergo radical cystectomy are regularly hospitalized for up (8.4% vs 29.1%; P<0.001), and a 19% reduction in mean to 8 days due to POI; in some instances, hospitalization can hospital LOS, which equaled 2.63 days (LOS, 7.4 vs 10.1 exceed 12 days.24 Thus, treatments aimed at accelerating days; P= 0.0051).19 Additionally, the study examined the the return of bowel function are needed. safety profile of ENTEREG and found no difference in carMany factors likely play a role in the delay of bowel diovascular morbidity.19 These clinically meaningful benfunction including the use of opiates for analgesia periopefits are sure to lead to changes in practice patterns for eratively. Although attempts have been made to minimize patients who undergo radical cystectomy, which, like many their use, the reality remains that these medications offer surgeries for advanced malignancies, often is performed in effective pain control, and are unlikely to be completely elderly individuals who have multiple medical comorbidireplaced by alternatives such as nonsteroidal anti-inflamties and diminished physiologic reserve.

R

References 1. Gouvas N, Tan E, Windsor A, et al. Fast-track vs standard care in colorectal surgery: a meta-analysis update. Int J Colorectal Dis. 2009;24(10):1119-1131.

2. Delaney CP, Kehlet H, Senagore AJ, et al. Postoperative ileus: profiles, risk factors, and definitions-a framework for optimizing surgical outcomes in patients undergoing major abdominal and colorectal surgery.

Clinical Consensus Update in General Surgery. www.clinicalwebcasts. com/pdfs/GenSurg_WEB.pdf. Accessed October 2, 2013.

3. Delaney CP, Senagore AJ, Viscusi ER, et al. Postoperative upper and lower gastrointestinal recovery and gastrointestinal morbidity in patients undergoing bowel resection: pooled analysis of placebo data from 3 randomized controlled trials. Am J Surg. 2006;191(3):315-319.

4. ENTEREG (alvimopan) [package insert]. Lexington, MA: Cubist Pharmaceuticals; 2013.

5. Vather R, Trivedi S, Bissett I. Defining postoperative ileus: results of a systematic review and global survey. J Gastrointest Surg.

2013;17(5):962-972.

6. Kurz A, Sessler DI. Opioid-induced bowel dysfunction: pathophysiology and potential new therapies. Drugs. 2003;63(7):649-671.

7. Ay AA, Kutan S, Ulucanlar H, et al. Risk factors for postoperative ileus.

J Korean Surg Soc. 2011;81:242-249.

8. Goldstein JL, Matuszewski KA, Delaney CP, et al. Inpatient economic burden of postoperative ileus associated with abdominal surgery in the United States. P & T. 2007;32(2):82-84, 87-90.

9. Iyer S, Saunders WB, Stemkowski S. Economic burden of postoperative ileus associated with colectomy in the United States. J Manag Care Pharm.

2009;15(6):485-494.

10. Aarts MA, Okrainec A, Glicksman A, et al. Adoption of enhanced recovery after surgery (ERAS) strategies for colorectal surgery at academic teaching hospitals and impact on total length of hospital stay.

Surg Endosc. 2012;26(2):442-450.

IMPORTANT SAFETY INFORMATION (continued) Adverse Reactions •

The most common adverse reaction (incidence ≥1.5%) occurring with a higher frequency than placebo among Entereg treated patients undergoing surgeries that included a bowel resection was dyspepsia (ENTEREG, 1.5%; placebo, 0.8%)

E.A.S.E. Program for ENTEREG •

6

ENTEREG is available only to hospitals that enroll in the E.A.S.E. Program. To enroll in the E.A.S.E. Program, the hospital 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

–

ENTEREG will not be dispensed to patients after they have been discharged from the hospital

Please see additional Important Safety Information throughout and brief summary of Prescribing Information on page 8.

REPORT 11. Delaney CP, Zutshi M, Senagore AJ, et al. Prospective, randomized, controlled trial between a pathway of controlled rehabilitation with early ambulation and diet and traditional postoperative care after laparotomy and intestinal resection. Dis Colon Rectum. 2003;46(7):851-859.

12. Wind J, Polle SW, Fung Kon Jin PHP, et al. Systematic review of enhanced recovery programmes in colonic surgery. Br J Surg. 2006;93(7):800-809.

13. Delaney CP, Senagore AJ, Gerkin TM, et al. Association of surgical care practices with length of stay and use of clinical protocols after elective bowel resection: results of a national survey. Am J Surg.

2010;199(3):299-304.

14. Wolff BG, Michelassi F, Gerkin TM, et al. Alvimopan, a novel, peripherally acting μ opioid antagonist. Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial of major abdominal surgery and postoperative ileus. Ann Surg. 2004;240(4):728-735.

of an international randomized, double-blind, multicenter, placebo-controlled clinical study. Aliment Pharmacol Ther. 2008;28(3):312-325.

18. Ludwig K, Enker WE, Delaney CP, et al. Gastrointestinal tract recovery in patients undergoing bowel resection. Arch Surg. 2008;143(11):1098-1105.

19. Kamat A, Chang S, Lee C, et al. Alvimopan, a peripherally acting muopioid receptor antagonist, accelerates gastrointestinal recovery and decreases length of hospital stay after radical cystectomy. Presented at: American Urological Association Annual Meeting; May 4-8, 2013; San Diego, CA. Abstract 1870.

20. Itawi EA, Savoie LM, Hanna AJ, Apostolides GY. Alvimopan addition to a standard perioperative recovery pathway. JSLS. 2011;15(4):492-498.

21. Delaney CP, Craver C, Gibbons MM, et al. Evaluation of clinical outcomes with alvimopan in clinical practice. A national matched-cohort study in patients undergoing bowel resection. Ann Surg. 2012;255(4):731-738.

15. Delaney CP, Weese JL, Hyman NH, et al. Phase III trial of alvimopan, a novel, peripherally acting, mu opioid antagonist, for postoperative ileus after major abdominal surgery. Dis Colon Rectum. 2005;48(6):1114-1129.

22. Harbaugh CM, Al-Holou SN, Bander TS, et al. A state-wide, community-based assessment of alvimopan’s effect on surgical outcomes.

Ann Surg. 2013;257(3):427-432.

16. Viscusi ER, Goldstein S, Witkowski T, et al. Alvimopan, a peripherally acting mu-opioid receptor antagonist, compared with placebo in postoperative ileus after major abdominal surgery. Results of a randomized, double-blind, controlled study. Surg Endosc. 2006;20(1):64-70.

23. Ramirez JA, McIntosh AG, Strehlow R, et al. Definition, incidence, risk factors and prevention of paralytic ileus following radical cystectomy: a systematic review. Eur Urol. 2013;64(4):588-597.

17. Buchler MW, Seiler CM, Monson JRT, et al. Clinical trial: alvimopan for the management of post-operative ileus after abdominal surgery: results

24. Chang SS, Baumgartner RG, Wells N, et al. Causes of increased hospital stay after radical cystectomy in a clinical pathway setting. J Urol.

2002;167(1):208-211.

IMPORTANT SAFETY INFORMATION WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY • •

Increased incidence of myocardial infarction was seen in a clinical trial of patients taking alvimopan for long-term use.

No increased risk was observed in short-term trials.

Because of the potential risk of Myocardial Infarction, ENTEREG is available only through a restricted program for shortterm use (15 doses) called the ENTEREG Access Support and Education (E.A.S.E.® ) Program.

Contraindications •

•

ENTEREG Capsules are contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG

ENTEREG is not recommended for use in patients with severe hepatic impairment, end-stage renal disease, complete gastrointestinal obstruction, or pancreatic or gastric anastomosis, or in patients who have had surgery for correction of complete bowel obstruction

Warnings and Precautions

Adverse Reactions

•

•

•

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 pain. 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 alvimopan, including studies of patients undergoing bowel resection surgery who received alvimopan 12 mg twice daily for up to 7 days. A causal relationship with alvimopan has not been established ENTEREG should be administered with caution to patients receiving more than 3 doses of an opioid within the week prior to surgery. These patients may be more sensitive to ENTEREG and may experience GI side effects (eg, abdominal pain, nausea and vomiting, diarrhea)

The most common adverse reaction (incidence ≥1.5%) occurring with a higher frequency than placebo among Entereg treated patients undergoing surgeries that included a bowel resection was dyspepsia (ENTEREG, 1.5%; placebo, 0.8%)

E.A.S.E. Program for ENTEREG •

ENTEREG is available only to hospitals that enroll in the E.A.S.E. Program. To enroll in the E.A.S.E. Program, the hospital 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 – ENTEREG will not be dispensed to patients after they have been discharged from the hospital

Acknowledgment Steven D. Wexner, MD, PhD (Hon), FACS, FRCS, FRCS (Ed) reviewed and served as a paid consultant for this article. He is the Professor and Chair of the Department of Colorectal Surgery at the Cleveland Clinic Florida in Weston, Florida.

Disclaimer: This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, Cubist Pharmaceuticals, 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.

Copyright © 2013, 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.

Please see additional Important Safety Information throughout and brief summary of Prescribing Information on page 8.

SR1320

Disclosures: Dr. Sands reported that he is a paid consultant for Cubist Pharmaceuticals, the manufacturer of ENTEREG. Dr. Wexner reported that he is also a paid consultant for Cubist Pharmaceuticals, the manufacturer of ENTEREG.

7

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 vitro 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 vitro 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: 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) in full prescribing information].

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) in full prescribing information].

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) in full prescribing information].

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) in full prescribing information].

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) in full prescribing information].

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