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April 2014 • Volume 41 • Number 4

The Independent Monthly Newspaper for the General Surgeon


Understanding Part 2 of 2 Although it is inappropriate, and potentially inaccurate, researchers frequently use linear regression on nonlinear phenomena, calculus on discontinuous functions, or χ2 when data points are interdependent. —Eric Dent PhD, 1994

Controlling All of the Variables? In December 2003, Gordon Smith and Jill Pell published an article in the British Journal of Medicinee entitled, “Parachute Use to Prevent Death and Major Trauma Related to Gravitational Challenge: Systemic Review of Randomized Controlled Trials” (BMJJ 2003;327:14591461). It was a tongue-in-cheek demonstration of the lack of common sense sometimes exhibited when groups attempt to apply mechanical tools, like prospective, randomized, controlled trials (PRCTs) to health care. It is quite ironic that the study they described, testing the benefits of using a parachute when jumping out of an airplane is actually a much better application for the use of a PRCT than most of the treatments and tests we have subjected to PRCTs in our complex health care system. Let me try to explain. PRCTs are designed to test a hypothesis

Reports Show Recent Uptick In Hospital Violence Shootings Still Very Rare; Increase Possibly Due to Better Reporting; Targets of Violent Acts Usually not Random

Let me start with the accountable care organization (ACO), which is the brainchild of Elliot Fisher, MD, MPH, of Dartmouth Institute for Health Care Policy. Dr. Fisher’s group at Dartmouth had made the initial observation that we have a poor see THUMB WRESTLING page 18



Thumb Wrestling and d ‘Oklahoma!’


GSN is now on

follow us @gensurgnews


Accountable Care Organizations

INSIDE In the News






New Guideline Addresses Appropriate Breast Cancer Margins: No Ink on Tumor

T he History of Laparoscopic Obesity/Metabolic Surgery

B Y C HRISTINA F RANGOU ritical care organizations have announced a list of five practices in the ICU that should be questioned because they are costly, may not always be necessary and could, in fact, be harmful. The project is part of the “Choosing Wisely” initiative of the American Board of Internal Medicine (ABIM) Foundation, which has challenged physicians to look at various medical interventions that are overused and may add needlessly to the country’s health care expenditures. Some critics have panned nned the program as an infringeement on a physician’s right to make decisions about care, but its supporters—and there are many—say this is a case of physicians proactively setting the standard for what is considered high-quality but costeffective health care. “It should be clear to everyone in the audience that rationing is unavoidable,” said Scott Halpern, MD, assistant professor of internal medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, as he presented the

WASHINGTON—In December, an angry former fo patient p walked into a medical al office in Reno, Nev., and fatally shot urologist Charles Garo Gholdoian and injured two oothers before turning the gun on n himself. In a note left at his home, the gunman g made it clear he was targeting t physicians, an act of revvenge for what he deemed were errors made during a vasectomyy years before, according to mediia reports.

his article comes with a disclaimer. You must read to the end to discover how I am going to connect a child’s game and a Broadway musical to accountable health care.

Project Targets Unnecessary Practices in ICU





Out of Touch: Feeling Further and Further Removed From My Patients


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GSN Editorial


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


here is an interesting verb phrase that I recently discovered that has emanated from the lexicon of social psychology. To birg, meaning, “to bask in reflected glory,” is a wonderful concept. A more complete definition embodies the idea of identifying with a larger organism or organization than yourself; when something good happens to another member of that organism or social group, your selfesteem goes up. The organism can be a variety of entities including family, surgical group, hospital, local community, editorial board, surgical organization, and so on. All of us belong to one or more of these social bodies, but I wonder how many of us have truly had the occasion or pleasure to birg. What a good feeling one should have when an individual member of the organization or organism excels and achieves recognition. It would be such a good sensation to bask in the warmth of that achievement just because we are a part of the whole. The ideal is to be proud of an entity to which we belong and to have a good feeling of accomplishment when any element or portion of that entity is successful. I think one way of increasing the likelihood of

fulfilling the birgg concept is to become Over the years, SAGES has not only embraced involved in the workings of the organiflexible endoscopy, but also has championed and zation or organism and not be content to remain as an outsider or bystander. promulgated the concepts of laparoscopy and By contributing to the group, the likeliminimal access surgery, operative ultrasound, hood of emotionally benefiting from its collective success is enhanced. To birgg is surgical simulation, natural orifice procedures, the ultimate expression of being part of energy sources and robotics—just to name a few. the social strata of any entity. Falling into the abyss of feeling or expressing petty jealousy when our colleague or group is recognized for success is the antithesis of the birgg model, along with international colleagues who have embraced but, alas, this occurs all to frequently. this outreach and mandate that began 35 years ago. I take This month, one of our surgical organizations, the pride as a member knowing that 10 years ago SAGES Society of American Gastrointestinal and Endoscopic developed and, more recently, partnered with the AmerSurgeons (SAGES), convenes its 2014 annual meeting ican College of Surgeons and the American Board of dedicated to “Putting the patient first; Promoting inno- Surgery in promoting improved cognition and manual vation and safety in the OR and beyond.” This marks skills which, under the rubric of Fundamentals of Lapanother year in the continued incredible vibrancy of an aroscopic Surgery, is now the benchmark that helps to organization that was spawned in the early 1980s by a verify competency in graduating general surgery resigroup of dedicated surgeons who passionately wanted to dents. The program, Fundamentals of Endoscopic Surpreserve flexible endoscopy as an important tool in the gery (FES) has been launched and will be a significant surgical armamentarium to be used by surgeons in the addition to the surgical curriculum. treatment of their patients. Over the years, SAGES has Many of us can and should view our surgical organizanot only embraced flexible endoscopy, but also has cham- tions as our personal foci of pride and increased esteem. pioned and promulgated the concepts of laparoscopy and When I think of SAGES, I truly understand the concept minimal access surgery, operative ultrasound, surgical espoused by the social psychologists. To birgg for me is simulation, natural orifice procedures, energy sources and to realize the successes and eminence of SAGES as one robotics—just to name a few. of our great surgical organizations. As a member, it has The scope of SAGES has expanded into global health allowed me to bask in its reflected glory.

Mission Statement

Senior Medical Adviser

Leo A. Gordon, MD

Joseph B. Petelin, MD


Frederick L. Greene, MD

Los Angeles, CA

Shawnee Mission, KS

Charlotte, NC

Gary Hoffman, MD

Richard Peterson, MD

Michael Enright Group Publication Director (212) 957-5300, ext. 272

Los Angeles, CA

San Antonio, TX

Namir Katkhouda, MD

Joseph J. Pietrafitta, MD

Los Angeles, CA

Minneapolis, MN

Jarrod Kaufman, MD

David M. Reed, MD

Freehold, NJ

New Canaan, CT

Michael Kavic, MD

Barry A. Salky, MD

Youngstown, OH

New York, NY

Editorial Advisory Board Maurice E. Arregui, MD Indianapolis, IN

Kay Ball, RN, CNOR, FAAN Lewis Center, OH

Philip S. Barie, MD, MBA New York, NY

L.D. Britt, MD, MPH Norfolk, VA

David Earle, MD Springfield, MA

James Forrest Calland, MD Philadelphia, PA

Edward Felix, MD Fresno, CA

Robert J. Fitzgibbons Jr., MD Omaha, NE

David R. Flum, MD, MPH Seattle, WA

Michael Goldfarb, MD Long Branch, NJ

Peter K. Kim, MD

Paul Alan Wetter, MD

Bronx, NY

Miami, FL

Lauren A. Kosinski, MD Milwaukee, WI

Raymond J. Lanzafame, MD, MBA

Editorial Staff

Rochester, NY

Kevin Horty Group Publication Editor

Timothy Lepore, MD Nantucket, MA

John Maa, MD San Francisco, CA

Gerald Marks, MD Wynnewood, PA

James Prudden Group Editorial Director Robin B. Weisberg Manager, Editorial Services Elizabeth Zhong Associate Copy Chief

J. Barry McKernan, MD Marietta, GA © 2014 by McMahon Publishing, New York, NY 10036. All rights reserved. General Surgery News (ISSN 1099-4122) is published monthly by McMahon Publishing, Sales, Production and Editorial Offices: 545 W. 45th St., 8th Floor, New York, NY 10036, Tel. (212) 957-5300. Corporate Office: 83 Peaceable St. West Redding, CT 06896. Periodicals postage paid at New York, NY, and at additional mailing offices. POSTMASTER: Please send address changes to General Surgery News, 545 W. 45th St., 8th Floor, New York, NY 10036.

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It is the mission of General Surgery Newss to be an independent and reliable source of news and analysis about the current state of surgery. It strives to provide a venue for discussion and opinions, from all viewpoints, on the issues most important to surgeons.

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

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In the News


N.C. Surgeons Call for License Requirement for Moped Drivers Pattern of Risky Behavior; Intoxication Common Ingredient in Moped Accidents B Y C HRISTINA F RANGOU SAVANNAH, GA.—Surgeons from North Carolina are calling for all states to pass legislation requiring moped drivers to obtain a license. Orthopedic surgeon Anna N. Miller,

MD, made the appeal based on results from a study that showed one out of every two moped drivers involved in collisions in North Carolina had previous convictions for driving while intoxicated, and many had convictions for other driving-related crimes. “We believe that mopeds serve as a mode of transport for those who are driving without a license and who may have a history of prior high-risk behavior,” said Dr. Miller, lead study author and a surgeon

at Wake Forest School of Medicine, Winston-Salem, N.C. “The use of these vehicles without a license likely presents a risk to public safety,” she said. Dr. Miller presented the study at the 2014 Annual Scientific Meeting of the Southeastern Surgical Congress. Most states require that drivers possess a valid license to operate a moped, defined as a motor vehicle with less than 55 cc engine displacement. However, six

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states do not. They are North Carolina, Indiana, Kentucky, Montana, Utah and Virginia. A handful of other states allow an individual to obtain a moped license regardless of eligibility for or status of their driver’s license. Dr. Miller and her colleagues reviewed their hospital’s experience after noticing that moped drivers who arrived at the hospital following a collision were often intoxicated. The investigators felt that patients were using mopeds as a legal means of transportation after having their licenses revoked for driving offenses. The investigators studied all adult patients from North Carolina who were treated at their level 1 trauma center between January 2005 and October 2010 following motorcycle or moped collisions. They compared the results with corrections databases from the state to identify any prior convictions for driving while intoxicated (DWI) and other nonDWI offenses. Over the study period, 249 moped drivers and 730 motorcycle drivers were treated for injury following a collision. Of these, 49% of moped drivers had a history of DWI compared with only 8% of motorcycle drivers. Almost two-thirds of moped drivers (64%) were previously convicted of a crime, a rate 44% higher than that for motorcycle drivers. Moped drivers also had statistically higher rates of revoked licenses—28% versus 6%— and more than twice as many serious driving convictions (65% vs. 31%). In response to questions at the meeting, Dr. Miller said moped drivers had


For those treated for injuries after a collision:


% of moped drivers had a prior history of DWI compared with only 8% of motorcycle drivers.

Lower cancer recurrence


More accurate re-excisions



% of moped drivers were previously convicted of a crime, 44% more than motorcycle drivers.


% of moped drivers had revoked drivers’ licenses compared with 6% of motorcycle drivers. © 2014 Vector Surgical, LLC ZĞĨĞƌĞŶĐĞƐ͗;ϭͿŽŽůĞLJ͕t͘ĂŶĚWĂƌŬĞƌ͕:͘͞hŶĚĞƌƐƚĂŶĚŝŶŐƚŚĞDĞĐŚĂŶŝƐŵƐƌĞĂƟŶŐ&ĂůƐĞWŽƐŝƟǀĞ>ƵŵƉĞĐƚŽŵLJDĂƌŐŝŶƐ͘͟ American Journal of SurgeryϭϵϬ;ϮϬϬϱͿ͗ϲϬϲͲϲϬϴ͘;ϮͿƌŝƩŽŶ͕W͖͘͘^ŽŶŽĚĂ͕>͘/͖͘zĂŵĂŵŽƚŽ͕͘<͖͘<ŽŽ͕͖͘^ŽŚ͕͖͘ĂŶĚ'ŽƵĚ͕͘͞ƌĞĂƐƚ^ƵƌŐŝĐĂů^ƉĞĐŝŵĞŶZĂĚŝŽŐƌĂƉŚƐ͗,ŽǁZĞůŝĂďůĞƌĞdŚĞLJ͍͟ European Journal of Radiologyϳϵ;ϮϬϭϭͿ͗ϮϰϱͲϮϰϵ͘;ϯͿDŽůŝŶĂ͕D͖͘͘^ŶĞůů͕^͖͘&ƌĂŶĐĞƐĐŚŝ͕͖͘:ŽƌĚĂ͕D͖͘'ŽŵĞnj͕͖͘DŽīĂƚ͕&͘>͖͘WŽǁĞůů͕:͖͘ĂŶĚǀŝƐĂƌ͕͘͞ƌĞĂƐƚ^ƉĞĐŝŵĞŶKƌŝĞŶƚĂƟŽŶ͘͟ Annals of Surgical Oncologyϭϲ;ϮϬϬϵͿ͗ϮϴϱͲϮϴϴ͘;ϰͿDĐĂŚŝůů͕>͖͘͘^ŝŶŐůĞ͕Z͘D͖͘ŝĞůůŽŽǁůĞƐ͕͘:͖͘&ĞŝŐĞůƐŽŶ͕,͘^͖͘:ĂŵĞƐ͕d͖͘͘ĂƌŶĞLJ͕d͖͘ŶŐĞů͕:͘D͖͘ĂŶĚKŶŝƟůŽ͕͘͘ ͞sĂƌŝĂďŝůŝƚLJŝŶZĞĞdžĐŝƐŝŽŶ&ŽůůŽǁŝŶŐƌĞĂƐƚŽŶƐĞƌǀĂƟŽŶ^ƵƌŐĞƌLJ͘͟:ŽƵƌŶĂůŽĨƚŚĞŵĞƌŝĐĂŶDĞĚŝĐĂůƐƐŽĐŝĂƟŽŶϯϬϳ͘ϱ;ϮϬϭϮͿ͗ϰϲϳͲϰϳϱ͘

In the News


New Guideline Addresses Acceptable Breast Cancer Margins ‘No Ink on Tumor’ for Stage I and II Patients; Goal of Reducing Unnecessary Re-Excisions B Y C HRISTINA F RANGOU


new guideline on margins in breast cancer therapy establishes “no ink on tumor” as the standard for invasive cancer, saying it is associated with low rates of ipsilateral breast tumor recurrence (IBTR). Wider margin widths do not significantly lower this risk, regardless of a woman’s age or biologic subtype, according to the guideline. This new approach is expected to reduce re-excision rates, improve cosmetic outcomes and cut health care costs, according to the document issued by the Society of Surgical Oncology and the American Society for Radiation Oncology. the American Society for Clinical Oncology and the American Society of Breast Diseases also have endorsed the recommendations.

‘This is a recognition that all physicians who treat breast cancer need to shift their thinking and move into the modern era of breast cancer care in which wider is not better in terms of margins.’

room] for a second trip to have their margins excised. That’s not the only reason mastectomy rates are rising but it is a reason.” No clinical trial has ever directly addressed the question of adequate margins. Instead, surgeons and radiation oncologists rely on indirect evidence, resulting in differing opinions over the definition of an adequate margin. Even at the same institution, surgeons and radiation oncologists often

disagree on margin width. To settle this question, an expert methodologist reviewed all available scientific evidence on margins. Leaders in surgical, radiation and medical oncology; pathology; and patient advocacy then met to review the findings and develop consensus. In an interview, Dr. Moran said that the meta-analysis made it difficult to tease out the distinction between “no ink on tumor” and a margin of 1 mm.

As a result, the panel took into account the current trends in IBTR and outcomes from randomized trials that demonstrated very low breast relapse rates. Together, these data strengthened the argument that “routine use of margins wider than no ink on tumor” will not necessarily further decrease these breast relapse rates, she said. The full rationale behind the guideline is explained in an article in the February see MARGINS page 6


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—Deanna Attai, MD Currently, about one in four breast cancer patients in the United States undergoes re-excision after lumpectomy, and nearly half of these procedures are performed with the rationale of obtaining wider margins in women whose tumor cells do not touch the inked margin. “Our hope is that this guideline will ultimately lead to significant reductions in the high re-excision rate for women with early-stage breast cancer undergoing breast-conserving surgery,” said Meena S. Moran, MD, associate professor of therapeutic radiology at Yale School of Medicine and Yale Cancer Center, New Haven, Conn., and cochair of the consensus panel. The professional organizations came together to examine the evidence on margins, in part, because of rising mastectomy rates in the United States, said panel co-chair Monica Morrow, MD, chief of breast surgery at Memorial Sloan-Kettering Cancer Center, New York City. “We hear from patients that they don’t want to go back to the OR [operating


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In the News



jcontinued from page 5 editions of the Annals of Surgical Oncology, the International Journal of Radiation Therapy Biology Physics and the Journal of Clinical Oncology (Epub ahead of print). The authors stress that “no ink on tumor” should be the standard for all patients with stage I or II invasive breast cancer who were treated with wholebreast irradiation, including those who do not receive adjuvant systemic therapy, for all biologic subtypes and for patients with invasive lobular cancer.

None of these situations is justification for wider margin widths, they said. However, each patient’s care must be individualized, stressed Dr. Moran, and each case needs to be individualized to account for the patient’s risk for breast cancer relapse and how much a re-excision will decrease that risk. “As a panel, we talked about [what we would do] if we had a very young woman with a triple-negative, high-grade tumor and no ink on tumor but had a portion of her tumor that closely approached the inked margin. Given that she’s a higherrisk, young patient without any targeted

therapies or hormonal therapies available to her, it would be reasonable to consider a re-excision.” A guideline issued last year by the American Society of Breast Surgeons “left a bit more wiggle room” about what to do with patients who had margins in the 1- to 2-mm range or focally involved margins, said Deanna Attai, MD, a surgeon in private practice at the Center for Breast Care, Inc., Burbank, Calif. “If the margin is less than 2 mm, oftentimes I’m comfortable with it but that’s a case I take to the tumor board because I need to get the opinion of the

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other doctors who are going to be treating this patient as well, like the medical oncologists and radiation oncologists. “We look at everything, and most of the time, my colleagues agree [not to reexcise a 1- to 2-mm margin] but sometimes we do have some discussion.” (See “Additional Expert Commentary.”) One of the strengths of the new guideline is that professional organizations representing surgeons, radiation oncologists, pathologists and medical oncologists support the recommendations, she said. “This is a recognition that all physicians who treat breast cancer need to shift their thinking and move into the modern era of breast cancer care in which wider is not better in terms of margins,” said Dr. Attai. The panel found no evidence that increasing the margin width in younger patients would nullify their increased risks for relapse after breastconserving therapy. Patients with an extensive intraductal component (EIC) may have a large residual ductal carcinoma in situ (DCIS) burden after lumpectomy, the panel found. But, they added, no evidence exists in support of an association between increased risk for IBTR and EIC when margins are negative. The panel also approved the “no ink on tumor” approach for women with invasive lobular carcinoma in situ (LCIS) but noted the significance of “pleomorphic LCIS at the margin is uncertain.” Some early studies suggested that “larger margin width may have resulted in small reductions in local recurrence” but this is no longer relevant in the current setting of multimodality treatment, said the authors. Improvements in drug therapy, such as the development of endocrine therapy, chemotherapy, pertuzumab and Herceptin, made the “no ink on tumor” recommendation possible, said Dr. Morrow. “Drugs we give to prolong survival in breast cancer have the added benefit of reducing the risk for recurrence in the breast. So it makes sense to take advantage of this benefit, which wasn’t there when the first studies of lumpectomy were done,” said Dr. Morrow. “Can we take advantage of this to decrease the extent of surgery? The answer to that is yes.” The guidelines stress that positive margins, defined as ink on invasive cancer or DCIS, are associated with at least a twofold increase in IBTR. This risk is not nullified by delivery of a boost, delivery of systemic therapy or favorable biology. The panel recommended that the choice of whole-breast radiation delivery technique, fractionation and boost dose not be dependent on the margin width.

In the News


Dr. Moran said she expects the guideline will be widely accepted by surgeons, radiation oncologists and medical oncologists. “The key is that any guideline just provides a framework. The decision for re-excision must still be individualized for each patient. I believe that treating physicians understand this, and I hope they will welcome the guideline so that the routine use of a re-excision for all narrow—1 or 2 mm—margin widths is no longer justified,” she said. The guideline is based on a metaanalysis and review of 33 research studies published between 1965 and 2013. The studies include 28,162 patients with stage I or II invasive breast cancer who were treated with whole-breast irradiation and a minimum median follow-up of four years. Patients treated with neoadjuvant chemotherapy or those with pure DCIS breast cancer were not included.

Additional Expert Commentary


jcontinued from page 4 blood alcohol levels that more than doubled those of motorcycle drivers on admission, and a significantly higher number of moped drivers were over the legal limit. The findings have important implications for health care costs and injury prevention, said Ronald F. Sing, DO, a trauma surgeon from Carolinas Medical Center in Charlotte, N.C. He noted that this is the third study from North Carolina in three years to

demonstrate that a significant proportion of moped drivers who are treated at trauma centers are recidivists with multiple alcohol-related traffic charges (Am ( Surg 2011;77:304-306; 2011;202:697700). Both prior studies, which Dr. Sing co-authored, called for changes to licensure laws. But Dr. Sing questioned whether such changes would deter moped drivers from drinking and driving. “These people have already shown a disregard for the law. It’s not clear if prohibiting individuals with prior DWI charges or revoked licenses will have an

impact on this population.” Mopeds have experienced a resurgence of popularity over the past decade, with a 60% increase in sales, according to a study published in the Journal of Trauma (2011;71:217-222). That study looked at more than 5,600 moped crashes in Florida between 2002 and 2008. Alcohol and drug use was a significant risk factor in severe and lethal crashes, investigators found. Alcohol has consistently been involved in 40% to 50% of motor vehicle collision deaths annually and is implicated in nearly 50% of trauma admissions annually.


Michael Goldfarb, MD Program Director, Department of Surgery, Monmouth Medical Center, Long Branch, New Jersey Advisory Board Member


here are surgeons who have proceeded with a lot more wiggle room than 1- to 2-mm margins. We published our experience in The Breast Journall in 2006 (12:208-211). To date, there have been no local recurrences in those 100 patients. Of those patients, 13 required re-excision for close margins, and four were found to have additional tumor. Statistics from the Jacqueline M. Wilentz Comprehensive Breast Center in Long Branch, N.J., from 1994 to 2012 revealed 739 women had breast-conservation surgery, and 108 had reexcisions with 22.2% additional tumor in the re-excised specimens. One of the 739 women had a local recurrence. In 65 of the women, a subsequent mastectomy rather than re-excision was performed because of extensive multiple margin issues with the first excision, and 46.7% were found to have additional tumor. Because of the risk for additional tumor with close margins, we feel that re-excision is reasonable.

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In the News HOSPITAL VIOLENCE jcontinued from page 1


collection about hospital violence has improved, a change that may account, at least in part, for the growth in known violent incidents. According to the figures reported, hospitals experienced significant escalations in assault, rape and homicide between 2007 and 2010, according to a 2011 report by the Joint Commission. A survey of health care security professionals suggests that this trend has continued since 2011. According to the U.S.-based International Association of Healthcare Security and Safety, the number of simple assaults, rapes and sexual assaults in hospitals rose annually since 2010, representing a 37% increase in three years. Eight homicides were reported at health care facilities in 2012. It’s important to note that the survey’s information is incomplete: It does not break down violence by country, although multiple

The tragedy was a real-life event of a scenario that many health care workers fear, unfathomable as it may be in a workplace dedicated to saving lives. “Hospitals used to be considered a sanctuary, where you saw violence but not a lot of violence. You [went] there to get help. But as times change, society changes. We are seeing more violence in the world for reasons like access to guns and economic changes. Hospitals are no different,” said Marilyn Hollier, director of hospital and health center security services at the University of Michigan Hospitals and Health Centers, Ann Arbor. Ms. Hollier also serves as the president of the International Association for Healthcare Security and Safety. Shootings happen very rarely in hospitals or on hospital prop- ‘People will always panic. They freeze. erty. In an often-cited comparison, But they will sink to the level of their a health care worker has a greater risk for being struck by lightning training. So if you can give them a than being shot on the job ((Ann fundamental level of training and Emerg Medd 2012;60:790-798). Despite this, shootings do happen, keep it alive by practicing, that’s and they occur more often in hos- the best you can do.’ pitals today than they did a decade ago. This shift has made health —Andrew Dennis, DO care workers, hospital administrators and security experts look at AT A GLANCE ways to prevent, and practice for, these dire situations. “Active shooters in hospitals are the 800-pound gorilThe number of simple assaults, la in the room that no one wants to talk about because everyone is scared of it,” said Andrew Dennis, DO, a rapes and sexual assualts in hospitals trauma surgeon and chair of resuscitative and prehosrose annually from 2010, representing pital traumatology at Cook County Hospital, Chicaa 37% increase in three years. go. Dr. Dennis is a Chicago SWAT cop and director of medical operations of the Cook County sheriff ’s office. Nurses are often the No. 1 target of “But hospitals can’t bury their heads to the reality. You hospital violence. have to accept the risk for the environment you’re in. The fact is that you have a higher risk of being stuck with a Most perpetrators of hospital violence needle than being involved in an active shooter situahad a personal association with their tion in your hospital. But do I still think that we need victims. training to give people realistic expectations about what could occur and what the response will be? Absolutely.” Most of the time a clear motive was Dr. Dennis works with the Chicago police department in its emergency planning, and lectures to schools identified: a grudge or revenge (27%), and teachers around the country about active shooter suicide (21%) or ending the life of an ill preparedness. Like teachers, he said, hospital staff needs hospitalized relative (14%). to be trained to deal with active shooter situations. “People will always panic. They freeze. But they will sink to the level of their training. So if you can give countries were represented. Furthermore, many facilithem a fundamental level of training and keep it alive ties do not participate in the survey because of concerns by practicing, that’s the best you can do.” about potential liability and negative publicity. Violence always has been part of the emotionally Even if the exact number of violent incidents is charged environment of a hospital. Stress levels are high unknown, there is no question that the hospital setting in health care facilities as families grapple with life-and- poses a “unique security challenge,” Ms. Hollier said. death issues. A significant proportion of inpatients and “The situation is different at every hospital. But, in outpatients suffer from mental illness. There’s a long general, the majority of violence in a hospital is targethistory of violence from the streets spilling over into ed acts, not random. Nurses are often the No. 1 target. hospital emergency departments. It’s things like people lashing out at them because they The difference is that the degree of violence in hospi- don’t think they are getting the right kind of service.” tals has intensified over the past eight years. Experts say firearm violence accounts for a very small “The country has experienced a definite uptick in percentage of overall crimes in hospitals, but these violent episodes in hospitals,” said Esmeralda Valague, events are happening with increasing regularity. the regional emergency preparedness manager at Chris“When you consider the number of people who go tus Santa Rosa Health System in San Antonio. through hospitals and clinics in the United States in a It’s difficult to measure that uptick, she explained, single day, the number of events involving guns is minbecause many violent incidents in hospitals are unre- iscule; that’s important. But, exponentially, these have ported. The Joint Commission started tracking crimes increased,” said Daniel J. Holden, director of hospiin hospitals in 1995. In the two decades since, data tal security for a U.S. security firm and immediate past

chair of the security and safety committee of the Hospital Association of Southern California. Statistics from the Hospital Employee Health Association indicate that about 3% of hospitals experienced a shooting incident between 2000 and 2011. Another study identified 154 shootings at U.S. hospitals over the same 12-year period, ranging from a low of six shootings in 2000 to 28 in 2010 ((Ann Emerg Medd 2012;60:790798). Gun violence in hospitals occurred far more frequently in the second half of the study: A mean of nine shootings was reported annually in the first six years of the study; that rose to 16.7 per year in the latter half. A caveat: The increase was limited to firearm violence that occurred outside of hospital walls but still on hospital grounds. Shootings on hospital property increased from 2.0 per year in 2000 to 8.5 per year just over a decade later. At the same time, shootings within hospital walls remained relatively stable, at 7.0 versus 8.2 per year. Over tthe 12 years of study, 59% of shootings took place inside the hospital and 41% outside oon hospital grounds. No matter how one looks at th he numbers, firearm violence in hospitals is rare compared with other forms of workplace violence, the study investigators stressed in their conclusions. “The Department of Labor, Bureau of Labor Statistics indicated that less than 2% of workplace shootings involve the health care sector, a percentage that is similar to that of college and university campuses that reported 1.5% ‘active shooter on campus’ incidents within a five-year period and is otherwise lower than the percentage of lightning-related deaths.” The study was conducted by physicians at Johns Hopkins Hospital in Baltimore, itself the site of one of the more high-profile episodes of hospital gun violence in recent memory. In September 2010, a gunman, upset over news about his mother’s medical condition, opened fire inside the hospital, wounding an orthopedic surgeon before turning the gun on his mother and then himself. In the aftermath of the shooting, physicians set out to characterize gunfire in hospitals. They wanted to find patterns that could help prevent future deaths. The physicians discerned a handful of patterns. Hospital size and location were not predictors of violence. The majority of perpetrators, 91%, were men, representing all ages. Most had a personal association with their victims: 32% were in current or estranged intimate relationships; 25% were current or former patients; and 5% were current or former employees. In only 13% of events was the association not obvious. Most of the time, a clear motive was identified: a grudge or revenge (27%), suicide (21%) or ending the life of an ill hospitalized relative (14%). Escape attempts by patients in police custody accounted for 11%. In nearly one-fifth of cases, the perpetrator did not bring his or her own firearm. In 8% of cases, the perpetrator took the gun of a security or police officer. “Health care providers and employees are unlikely to be victims of indiscriminate violence,” the researchers stressed. “In fact, unlike those in education campuses, most hospital shootings have an intended specific target.” The study reported that only the emergency department appeared to be associated with a higher risk for see HOSPITAL VIOLENCE page 10

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In the News HOSPITAL VIOLENCE jcontinued from page 8

shootings. Nearly one in four shootings in the emergency department related to a person in custody who was being guarded or watched by armed security personnel. The authors concluded that impenetrable hospital security in an open society “represents a particular challenge” and “zero risk is not achievable.” That concept of an “unachievable” zero risk is changing the way health care administrators and workers think about security. Today, hospitals and medical centers are stepping up their emergency preparedness efforts, with many institutions now planning specifically for active shooter scenarios. In March, the Hospital Association of Southern California conducted a major “active shooter” drill that involved more than 230 participants. The day started with an actor playing the role of an active shooter stalking both the hospital’s emergency department and the administrative offices. That was followed by intensive discussion with participants on responding to an active shooter. In Massachusetts, major hospitals have adopted and practice “Code Silver” protocols. In November 2013, Brigham


and Women’s Hospital, in Boston, created a 10-minute “Active Shooter Preparedness Training” video that gives step-by-step instructions on the proper procedures for dealing with a shooter. The video was shown to 16,000 employees, and is now part of the hospital’s yearly training requirement. The video voiceover states that the odds of an active shooter scenario are “quite remote. … But the consequences are so potentially catastrophic that it is important to be prepared so we can protect our patients, their families, our visitors and each other,” according to the video. “As health care providers, we embrace a duty of care commitment that compels us to be more than just survivors but protectors as well. That’s why thinking about your actions in advance is so important.” The Brigham video hits on an issue of major concern for physicians, nurses and other health care workers: What is their responsibility to protect their patients if an active shooter targets their hospital? There is no standard for how health care workers should respond if an active shooter barges into their place of work. Adding to the confusion, discrepancies exist among agencies and professional bodies regarding care providers’ obligations in such an event.

‘Nurses are often the No. 1 target. It’s things like people lashing out at them because they don’t think they are getting the right kind of service.’ “The Texas Board of Nursing says that if you abandon your patients, even for an active shooter threat, it may be investigated for disciplinary action, and life safety (fire) codes stress open access for egress, not ease of lockdown,” Ms. Valague said. “On the other hand, you have [the U.S.] Occupational Safety and Health Administration and law enforcement agencies saying that workers need to protect their own life and safety first so they can help others later.” Every situation is different, but the goal should be to limit the number of casualties, Mr. Holden said. “Under an active shooter situation, the patient abandonment issue would probably not be, in my opinion, as stringently enforced, provided you follow your organization’s protocols and training.” He also said, “[In] the end, what purpose do you fulfill if you try to run back

to help your patient and you become a victim? Who is going to help the patients now?” Dr. Dennis recommended that health care workers watch a video produced by Houston’s Office of Public Safety and Homeland Security, called “Run. Hide. Fight.” The video, which has received more than 2 million views on YouTube, recommends that people flee, hide, or as a last option, fight in the event of an attack. “It is by far the easiest thing to remember,” Dr. Dennis said. “It says that if you are involved in an active shooter [situation], the first thing you should do is run. If you can’t run and flee the scene, then you should hide. Turn the lights out, barricade the door, become silent. As a last resort, fight. You have to remember that the goal is to minimize casualties as much as possible. You want to preserve your skilled workforce and as many people as you can.” He added that hospitals need a plan that is unique to their institution. Planning and organizing active shooter drills is expensive and time-consuming, and can be frightening to the public and the staff, he acknowledged, but “you’re not going to know what to do until you drill this for real. It should be as automatic as fire drills or disaster response.”

In the News



Hypoxia After Surgery Much More Common Than Previously Believed B Y A DAM M ARCUS


surprisingly large fraction of patients experiences prolonged periods of hypoxemia while recovering from surgery, new research shows. Although the implications of the findings for patients are not yet clear, experts said results suggest that efforts to monitor oxygen saturation on the ward are not nearly as effective as clinicians might assume. “The way we’re doing it now is not providing physicians with what they really want, which is an early warning sign of respiratory distress,” said Daniel I. Sessler, MD, chair of the Department of Outcomes Research at Cleveland Clinic, in Ohio, who helped conduct the study. “I’m guessing that in 10 years, maybe even in five years, continuous pulse oximetry will be the standard of care on hospital wards because hypoxia is so common,” Dr. Sessler said. The prospective observational study, which Dr. Sessler, Andrea Kurz, MD, and their colleagues presented at the 2013 annual meeting of the American Society of Anesthesiologists was a subanalysis of the VISION study, which looked at 40,000 patients over 45 years old undergoing noncardiac inpatient surgery. Patients were included if they were over age 45 and were admitted for inpatient procedures at Cleveland Clinic and a second hospital. The roughly 1,500 patients in the substudy had continuous pulse oximetry from the time they left the postanesthesia care unit or the intensive care unit for up to 48 hours. Unlike previous studies of continuous pulse oximetry, the Cleveland Clinic researchers masked the monitors and muted their alarms to blind clinicians to their output. “They thus had no way of knowing the saturations we recorded,” Dr. Sessler said, although they were permitted to perform their own clinical routines. That blinding was important, Dr. Sessler added, because “if alarms go off, people come in and do things. You can’t then ask how long patients would otherwise have remained hypoxic.” The results, he said, were “pretty sobering”: Approximately 21% of patients averaged at least 10 minutes per hour with SpO2 values below 90%, and approximately 8% of patients averaged at least 20 minutes per hour. Approximately 8% of patients averaged at least 5 minutes per hour with SpO2 less than 85%. Although the researchers did not evaluate clinical sequelae of hypoxic episodes—and the study wasn’t powered to do so—Dr. Sessler said the implications are concerning. “Most people don’t think that it’s a good thing to have prolonged

periods of desaturation.” One likely consequence, he noted, is poor wound healing because adequate tissue oxygenation is key to both healing and fighting infection. Opioids surely contribute to postoperative hypoxia, Dr. Sessler said. Another obvious cause is sleep apnea. Indeed, the Cleveland group is now evaluating the relationship between sleep apnea and hypoxia in hospitalized patients. Dr. Sessler and his colleagues also are comparing nursing reports with their

continuous pulse oximetry results. “We think there’s a huge discrepancy there. Nurses wake patients up and start taking vital signs, and by then people are breathing fine. Then they go back to sleep and start desaturating.” Eugene Viscusi, MD, professor and director of acute pain management at Thomas Jefferson University Hospitals, in Philadelphia, said the study raised cause for concern. “Generally, we would think of 85% saturation as needing treatment. We

consider these patients to be on the cusp of disaster, which I don’t deny. However, it is interesting that there were no catastrophic results. “I see two lines of questions here,” Dr. Viscusi added. “One is the above: Just how risky is this hypoxia? Can we quantify the risk of these progressing to a bad outcome? The second question is how to predict which patients will become this hypoxic,” which boils down to demographics that aren’t yet clear.

14th World Congress of Endoscopic Surgery Paris, France 25-28 June 2014

Hosted by the EAES and incorporating the 22nd EAES congress EAES European Association for Endoscopic Surgery IFSES International Federation of Societies of Endoscopic Surgery

HIGHLIGHTS Congress President:

Prof. Abe Fingerhut Program Committee Chair:

Prof. Nicola Di Lorenzo

r Postgraduate courses r Hands-on training r New technologies r “How I do it” video session r Pro and contra discussions r Free paper sessions: oral, video and poster r Special awards and grants r Technical exhibition

r Consensus conference on Clinical Robotics r Consensus conference on Early Rectal Cancer r Virtual live surgery r 3D video session r Management of complications r New technologies r Abdominal hernias r Keynote Lectures

The online abstract submission page will open end of September. Abstract submission deadline 15th of January 2014.

To register your interest in the congress simply return the form below to the EAES Office Fax or send it to: EAES ES O Office P.O.. Box 335 5500 AH AH,Veldhov Veldhoven The Nether Netherlandss Phone: +31(0)40 252 5288 Fax: +31(0) 40 252 3102 E-mail: Internet: er www.e eu

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EAES Membership If you are interested to become an EAES Member, please complete and return this reply card. E-mail:

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Resident in Training




The Early Days of Laparoscopy for Metabolic and Obesity Surgery From ‘Voodoo’ to Today’s Best Weapon Against Obesity and Metabolic Syndrome, Laparoscopic Surgery Hits Stride in Past Decade B Y V ICTORIA S TERN


lan Wittgrove, MD, FACS, became intrigued by laparoscopy during his surgical residency at San Diego Naval Hospital in the late 1970s. Jerry Ragland, MD, a staff surgeon at the hospital, felt that operating with scopes would be the future of general surgery. His prediction turned out to be correct. In the early 1990s, after laparoscopic cholecystectomy had gained a foothold in the United States, surgeons began investigating minimally invasive approaches for a range of procedures. At the time, Dr. Wittgrove was exploring ways to reduce the high rate of incisional hernia complications (16%) associated with open gastric bypass, a procedure initially described in the late 1960s by surgeons Edward Mason, MD, and Chikashi Ito, MD (Surg Clin North Am 1967;47:1345-1351). During Dr. Wittgrove’s travels to Belgium to learn laparoscopic Nissen fundoplication, he realized that he could turn an open gastric bypass into a laparoscopic technique. Upon his return to California in 1992, Dr. Wittgrove and G. Wesley Clark, MD, co-directors of a private practice bariatric surgery program in San Diego, began investigating ways to mimic the open procedure laparoscopically in the animal lab. The duo teamed up with Ethicon EndoSurgery to help develop new stapling technology. Once the circular stapler was approved, the surgeons had everything in place. In 1993, they performed the first laparoscopic Roux-en-Y gastric bypass in a patient. Next, Drs. Wittgrove and Clark reported a case series of five laparoscopic Roux-en-Y gastric bypasses (Obes Surg 1994;4:353-357). They hand-selected patients with body mass indexes (BMIs) between 35 and 40 kg/m2 to ensure the best possible outcomes, given the early stage of the technique. The procedure was free for the patients: The anesthesiologist didn’t bill, Ethicon EndoSurgery donated equipment and follow-up was free. “Bariatric surgery was still a bit of voodoo in early 1990s,” said Dr. Wittgrove. “We were very attuned to the fact that this procedure might be controversial, so it was important for us to keep track of our patients’ data to refute any malicious attacks.” Initially, Drs. Wittgrove and Clark were training surgeons at their primary

facility but hospital administration became concerned that the facility might run into legal troubles if a patient had complications. The surgeons then began holding courses with a company named Vista, and later partnered with the American Society for Metabolic and Bariatric Surgery (ASMBS), then the ASBS, to run a laparoscopic gastric bypass program, in which they trained a select group of bariatric surgeons with laparoscopic experience to perform their technique on human cadavers. During this time, the procedure began to spread, mostly among surgeons in private practice, and some surgeons, including Michel Gagner, MD, Philip Schauer, MD and James Ken Champion, MD, FACS, started bariatric programs and courses to help train surgeons throughout the United States. Over the next few years, Drs. Wittgrove and Clark reported outcomes on a growing series of patients. By 1996, they had completed a series of 100 laparoscopic Roux-en-Y gastric bypasses (Obes Surg 1996;6:500-504), and by 2000, the series

had grown to 500 patients (Obes Surg 2000;10:233-239). In this later series, the authors found that the average percent excess body weight loss at five years was 75%, and the procedure appeared to be safe, with few complications and no mortalities. Additionally, 96% of preoperative comorbidities, including gastroesophageal reflux disease, sleep apnea and diabetes had resolved after surgery. But even before Drs. Wittgrove and Clark had performed a laparoscopic gastric bypass, Belgian general surgeon Guy-Bernard Cadière, MD, PhD, had done the first adjustable gastric banding procedure laparoscopically in 1992 (Br J Surg 1994;81:1524). However, Dr. Cadière had used a Kuzmak adjustable silicon gastric band, designed for open procedures, so credit for the first laparoscopic adjustable gastric banding procedure initially went to Belgian surgeon Mitiku Belachew, MD, who did the procedure with a lap band on Sept. 1, 1993 (World J Surg 1998;22:955-963). This lap band had been modified from the Kuzmak adjustable silicon gastric band for laparoscopic applications. Subsequently, Dr. Cadière performed the procedure with the lap band one week later ((J Celio Chirr 1994;10:27-31).

‘Bariatric surgery was still a bit of voodoo in early 1990s. We were very attuned to the fact that this procedure might be controversial, so it was important for us to keep track of our patients’ data to refute any malicious attacks.’ —Alan Wittgrove, MD


2005, the number of bariatric procedures performed

laparoscopically surpassed that of the open approach nationwide. Between Oct. 1, 2008 and Sept. 20, 2012, laparoscopic sleeve gastrectomy rose from the third most popular procedure to the second, accounting for in 2012.

36.3% of all bariatric procedures done


23.8% of bariatric procedures performed in 2008 to 4.1% in 2012. Laparoscopic gastric bypass dropped from 66.8% in 2008 to 56.4% in 2012, and remains the most commonly performed Laparoscopic gastric banding dropped from

laparoscopic bariatric/metabolic procedure. a

J Am Coll Surg 2013;216:252-257.

Duodenal Switch and Sleeve Gastrectomy Intrigued by the possibility of more minimally invasive approaches to bariatric surgery, Dr. Gagner established a laparoscopic program at the University of Montreal, Hotel-Dieu, where he was assistant professor of surgery. Despite experiencing staunch resistance from the chief of surgery there, Dr. Gagner set up a pig lab at Hotel-Dieu in July 1990, and for the next five years worked on various laparoscopic techniques, including adrenalectomy, pancreatectomy and Roux-en-Y gastric bypass (Surg Laparosc Endoscc 1997;7:294-297). Eventually, however, the administrative roadblocks proved too intrusive, and Dr. Gagner relocated to the Cleveland Clinic in summer 1995 where he established the Minimally Invasive Surgery Center, and in early 1996, initiated a course on laparoscopic gastric bypass. Two years later, Dr. Gagner moved to the Icahn Medical School at Mount Sinai in New York City, and took on the role of chief of laparoscopy, starting a minimally invasive surgery program that later became one of the biggest in the United States. After hearing about the success of an emerging open bariatric procedure—a biliopancreatic diversion with a duodenal switch—Dr. Gagner wondered whether he could perform the procedure laparoscopically. In spring 1999, Dr. Gagner, along with clinical fellow Gregg Jossart, MD, FACS, and surgical resident John de Csepel, MD, FACS, performed laparoscopic biliopancreatic diversion with a duodenal switch on six 50-kg pigs, restricting food intake with a sleeve gastrectomy and achieving malabsorption with Roux-en-Y ((J Laparoendosc Adv Surg Tech A 2001;11:79-83). On July 2, 1999, Dr. Gagner performed the first laparoscopic duodenal switch in a severely obese patient with a BMI greater than 60 kg/m2. “This was a very difficult patient, and soon we conducted a series using this technique on 40 morbidly obese patients,” Dr. Gagner said. “After presenting our results at the 2000 ASBS meeting, people took notice. We showed that gastric bypass was not the only bariatric surgery we could do laparoscopically.” In the 40-patient series, patients showed significant excess weight loss of 46% after six months and 58% after nine months (Obes Surgg 2000;10:514523). However, Dr. Gagner also found high rates of complications, including one anastomotic leak, four staple-line hemorrhages and one mortality.



“In my introspection, I realized that the problems were a result of performing this surgery on such severely obese patients,” Dr. Gagner said. “If such patients have a leak or infection, they are at high risk for severe complications.” A solution soon emerged. One day, Dr. Gagner was performing a duodenal switch on a morbidly obese patient. The surgical team had begun the sleeve gastrectomy, but because the patient was severely obese, the anesthesiologist was finding it difficult to maintain hemodynamics. The team finished the sleeve gastrectomy and stopped the operation. “At that moment, we had done the first isolated sleeve gastrectomy,” Dr. Gagner said. The patient lost more than 100 pounds after undergoing the sleeve gastrectomy. Dr. Gagner realized that they could reduce the rate of complications associated with laparoscopic duodenal switch by dividing the procedure into two parts, initially performing a sleeve gastrectomy and then performing the duodenal switch months later, after the patient had lost weight. Dr. Gagner began conducting a series of sleeve gastrectomies in these highrisk patients, which he followed up with duodenal switches months later. He soon realized that some patients did so well after the sleeve gastrectomy that they did not require the second part of the operation. However, after presenting results of a small series of laparoscopic sleeve gastrectomies at several meetings, the paper was rejected by Surgical Endoscopy because, according to the editors, the follow-up time was too limited. “It can be difficult to get publication on first concept, which infuriates me,” Dr. Gagner said. “Insurance companies in the United States were refusing duodenal switch so we started doing laparoscopic gastric bypass instead as the second part of the procedure,” added Dr. Gagner, noting that the results of a two-phase sleeve gastrectomy and gastric bypass procedure were published earlier with co-authors Alfons Pomp, MD, FACS, and William B. Inabnet, MD (Obes Surgg 2003;13:861-864). Dr. Gagner also began courses on sleeve gastrectomy in New York every six to 12 months, and interest grew exponentially. “During the first course, about 25 to 30 people came, but then the audience started doubling in subsequent courses,” Dr. Gagner recalled. Michael McMahon, MD, a general surgeon from the University of Leeds, United Kingdom, for example, was also an early pioneer of sleeve gastrectomy, developed from the concept off Magenstrasse and Milll in 2000. The procedure

The laparoscopic sleeve gastrectomy, originally done as the first part of a duodenal switch, was shown to produce good results as a stand-alone operation.

laparoscopic sleeve gastrectomy rose from the third most popular procedure to the second, accounting for 36.3% of all bariatric procedures done in 2012. This increase in laparoscopic sleeve gastrectomy accompanied a significant decline in laparoscopic gastric banding (23.8% in 2008 to 4.1% in 2012) as well as a reduction in laparoscopic gastric bypass (66.8% in 2008 to 56.4% in 2012), which continues to be the most commonly performed bariatric procedure. Part of the reason laparoscopic sleeve gastrectomy outstripped laparoscopic gastric banding in popularity is because it affords better weight loss (55% vs. 47% excess weight) with fewer reoperations down the road, said Dr. Pomp. More importantly, Dr. Wittgrove noted, laparoscopic gastric banding doesn’t alter patients’ hormone levels like laparoscopic gastric bypass or sleeve gastrectomy does. “Now we’re really understanding that to get a durable, predictable response, the procedure has to manipulate our hormones in a beneficial and lasting way,” he said. In other words, patients need a metabolic operation, not just a weight loss one.

Image courtesy of Michel Gagner, MD.

Down the Road also started to take off abroad in France, Belgium, Austria and Germany. “This was the beginning of sleeve gastrectomy, which is fast becoming one of the most popular bariatric operations worldwide,” Dr. Gagner said.

Rise of Laparoscopy When laparoscopic techniques for bariatric surgery were introduced, critics complained the operations were unsafe and associated with high morbidity compared with the open approach. Although a proponent of the laparoscopic approach, Ninh Nguyen, MD, chief of gastrointestinal surgery at UC Irvine Medical Center, in California, recognized safety issues in the early days of the procedure. “I reviewed my initial experience of laparoscopic gastric bypass and found that it took 75 cases to overcome the steep learning curve,” he said. The criticism prompted Dr. Nguyen to conduct a randomized trial comparing open versus laparoscopic gastric bypass. He and his colleagues found a significant benefit for the laparoscopic approach, including less postoperative pain, lower rate of wound-related complications and a quicker recovery ((J Am Coll Surgg 2001;192:469-476). Over the years, an emphasis on surgical education and fellowship training in bariatrics allowed the procedures to mature and resulted in significantly fewer risks and complications as well as a decline in the mortality rate.

Dr. Gagner believes this improvement in outcomes is due in great part to changes in technology. “Initially, the available technology limited us and perhaps that’s why we had higher complication rates early on,” he said. “However, industry responded by making better flexible, long staplers for super obese patients as well new suture material to do running sutures, more intelligently designed, smaller bougies and balloons with holes for leak tests.” By 2005, the number of bariatric procedures performed laparoscopically surpassed that of the open approach nationwide. “It took time to become more mainstream, but by the mid-2000s, about 60% of all weight loss surgeries were done laparoscopically and today the percentage is closer to 90%,” said Dr. Pomp, Leon C. Hirsch Professor and vice chairman, Department of Surgery, chief, Section of Laparoscopic and Bariatric Surgery, Weill Medical College of Cornell University, NewYork-Presbyterian Hospital. “Although some practices still perform open bariatric surgery with good results, most of the time, there’s significant patient-driven demand to do minimally invasive surgery.” Dr. Nguyen recently mapped the changing landscape of bariatric operations performed in the United States ((J Am Coll Surgg 2013;216:252-257). He and his colleagues found that of 60,738 bariatric procedures performed between Oct. 1 2008 and Sept. 20 2012,

A major concern for the future is that obesity has become the “new norm,” according to Dr. Pomp “This is the first generation that won’t live as long due to accumulating cardiovascular problems and diabetes,” he said. Despite a growing obese population, patients have limited access to preventative and surgical care, largely due to social stigma and inadequate insurance coverage. “People tend to perceive this as radical surgery and every time a complication occurs, it gets a headline,” Dr. Pomp said. “However, 99.7% of patients live through this operation, with a 3% to 4% likelihood of a major complication.” Dr. Wittgrove agreed, noting that surgery is clearly the best treatment for metabolic syndrome and for the serious comorbidities that accompany it, including diabetes, hypertension, dyslipidemia and obstructive sleep apnea. Arthritis, depression and many other comorbidities of morbid obesity also can be treated effectively. Looking to the future, Kelvin Higa, MD, FACS, director of Minimally Invasive and Bariatric Surgery, Fresno Heart and Surgical Hospital, in California, defined where the focus of attention should be (Medscape J Medd 2008;10:101): “It’s about time that we recognize the disease of obesity for the multifaceted killer that it is, understand better why it has become so prevalent in today’s society, work on preventative measures, and treat those already afflicted.”





Out of Touch L EO A. G ORDON , MD


ouching is the culmination and the fortification of the hallowed physician–patient relationship. The act of touching creates a bond unlike any other in clinical medicine. It was this magnificent act of directly touching disease that led me to choose surgery as a career. I was thrilled to be able to cradle human pathology in my hands. I felt innate satisfaction identifying the nature of and removing offending pathology. I reveled in recreating the patient and relieving that patient’s problems. There was something magical about using my prehensile limbs—limbs that had evolved over the millennia—to rearrange or to remove diseased parts of a fellow human. As I touched those organs, their rich evolutionary history was always in my mind. As I dissected the gallbladder with my hands guiding an instrument I was at one with Dr. John Bobbs and his patient on a kitchen table in Indiana in 1867. As I grasped the top of the gallbladder, I always looked for a Phrygian cap. Why? Because the history of Phrygia and its cap of freedom has meaning for me and for every American. As I searched for the base of the appendix, I was at one with Houdini and Edward VII. I was Charles McBurney and Reginald Heber Fitz. I had earned the privilege to establish direct personal contact with these organs. And because of that direct personal contact I became part of human history and the evolution of surgery. I was one of the chosen vehicles for passing the accrued knowledge of centuries on to the next generation of surgeons. Over the years, that sense of touch became refined. These hands could assess degrees of inflammation and the extent of disease. My hands became finely tuned tensiometers. They had achieved, as the old professor described it, “tissue sense.” Tissue sense is the ability to assess human tissue with your hands and to gauge the extent of the underlying process. Tissue sense tells you what you can and cannot do to that particular tissue. As the years of practice went by, I was

no longer “just a surgeon.” I was part of a grand arc of historical and embryologic one-on-ones. That sigmoid lesion in my hands conjured up the embryology of the hindgut. I pondered. (And much to the chagrin of the resident, I queried): How did the haustra get their name? How did the tenia get their name? Why is it called the sigmoid? The value of asking these critical questions was enhanced with my hands. Then, with my hands, we would join together. The anastomosis became a metaphor not only for making the patient whole, but for making the surgical team whole. Who was Connell? Who was Lembert? Has anyone ever read Erle Peacock’s treatise on wound healing? Does it matter? Of course it matters because I had earned the privilege of touchingg this diseased organ. I wanted to communicate what was required to achieve that privilege. Through the touching we achieved the Zen of the intestinal anastomosis. The surgical process was a communal touching of the evolution of the mud-slug who slithered out of the primordial ooze as its gastrointestinal system evolved. Is not the sense of touch one of the basic senses? Why did the sense of touch evolve embryologically? All of these questions were magnified—dignified—by d holding the pathology directly in my hand. Then, in a critical blow to the value and the joy of surgical touching, the laparoscope and grasper replaced my hands. Is the surgical event the same when the pathology is a yard away at the end of a light stick projected onto a video screen? The relativity of the surgical process changed. Einstein explained relatively this way: “Put your hand on a hot stove for a minute, and it seems like an hour. Sit with a pretty girl for an hour, and it seems like a minute.” Einstein was, in a sense, describing surgical relativity. Yes, the time is the same. But the relative influence and

Surgical Gloves. Copyright © 2014 Leah Tran. All rights reserved.

impact of that time is vastly different. Progress is never easy. Old habits and prejudices die a slow and sometimes agonizing death. The history of medical progress has always been the history of the past clashing with a vision of the future. Laparoscopic surgery, for many of my generation, resembled a love affair gone awry. The enchanting and enticing object of our affection began to move away. That object no longer sits next to us. What was close and intimate is now distant and disinterested. The touching, whether a handshake or an embrace, has disappeared. Laparoscopy, the single greatest advance in general surgery during

the course of my career, distanced me from the entity to which I was slavishly devoted. My lover left me for a more attractive mate. Even as a scorned surgeon, I accepted the rejection. I learned the ways of the laparoscope. My romance with human pathology, once an evolution, became a speed date. Laparoscopic surgery was better for the patient. As time went by it made remarkable progress. I now no longer even look directly at the organs I had come to love and appreciate. They have undergone some sort of visual plastic surgery. They are larger and brighter. They appear stunningly, absolutely beautiful on the screen. Are there Hollywood makeup artists



â&#x20AC;&#x153;Operatingâ&#x20AC;? on these organs is now like visiting someone in a maximumsecurity prison. â&#x20AC;&#x153;Touchingâ&#x20AC;? is now separated by a thick glass partition. Our loving hands are separated from the object of our desire. We speak remotely rather than whisper lovingly into a receptive ear. The clock has been turned back on my prehensile limbs to the Mesozoic era. I can no longer touch my cave-mate. Further and further away I moved. But I have adapted. I took solace in the fact that I would never, everr be further away from the object of my surgical affection. I could live and even flourish with this new visual and tactile approach that had transformed my chosen profession. Then, my distanced lover moved even further away. She left me for a robot. Instead of the direct approach to the organ by laparotomy, or the onceremoved approach via the laparoscope, the robot now placed the operating surgeon even further away from the patient. In some instances, the surgeon was even moved out of the operating room. Everyoneâ&#x20AC;&#x2122;s hospital wants a robot. Every patient inquires about the robot. Who would ever think that â&#x20AC;&#x153;He is a robotic surgeonâ&#x20AC;? would be a compliment! From Hippocrates to Osler to Halsted to Tobor IV, we are now further away from the patient than we have ever been. I have marveled at the robotâ&#x20AC;&#x2122;s â&#x20AC;&#x153;handsâ&#x20AC;? performing a 360-degree turn. I have admired the robotâ&#x20AC;&#x2122;s â&#x20AC;&#x153;handsâ&#x20AC;? as they extend rigid and free of a tremor. I have seen the robot maintain a fixed position for hours. I have seen the joy and sense of accomplishment by robotic surgeons as they robotosize and romanticize their efforts. But for me it is not the same. I think this is why Internet grocery shopping failed. Everyone wants to squeeze the cantaloupes before they buy them! As I approach the third and final period of my professional life (as a hockey fan I divide my career into three periods), I feel a sense of accomplishment for the patients I have helped. But I also feel a profound sense of loss as the human pathology I was educated to eliminate is retreating further and further away from me.

Instead of the direct approach to the organ by laparotomy, or the once-removed approach via the laparoscope, the robot now placed the operating surgeon even further away from the patient.


lurking in the Foramen of Winslow? Are these organs real or are they apparitions?

I envision a future conversation in the common room of an assisted living facility. A lovely couple is sitting next to meâ&#x20AC;&#x201D; Servor I and his wife Servina. They are retired robots. We chat for a while. I notice a certain sadness and regret in the conversation. They were at a major medical center several years ago. They fell in love and prospered. But then, facing the inexorable wave of medical progress, they too were distanced from the objects of their professional

affections. Their â&#x20AC;&#x153;handsâ&#x20AC;? were no longer useful. Most of the diseases they treated were now cured with genetically engineered pills or with stem cells. Servina focuses her dark blue triple chip lens on me and says wistfully: â&#x20AC;&#x153;Can you imagine these beautiful titanium arms, joints and graspers being replaced by some pill? I was always thrilled to be able to cradle human pathology in my hands.â&#x20AC;? â&#x20AC;&#x201D;Dr. Gordon is a general surgeon in â&#x20AC;&#x201D; Los Angeles, California.

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CHOOSING WISELY jcontinued from page 1

list in January at the Society of Critical Care Medicine’s (SCCM) 2014 Critical Care Congress. “Health care needs are boundless. You cannot reconcile boundless needs to bounded funds,” he said. The recommendations were developed and endorsed by the American Association of Critical Care Nurses, the American College of Chest Physicians, the American Thoracic Society and the SCCM. A task force representing these

organizations identified the five evidence-based recommendations that they believe will help physicians, patients and families make decisions together about the most appropriate care for a patient. The measures consist of the following: 1. Don’t order diagnostic tests at regular intervals, such as every day, but rather in response to specific clinical questions. “The routine ordering of tests increases health care costs, does not benefit patients and may in fact harm them,” according to the statement. 2. Don’t transfuse red blood cells in

hemodynamically stable, nonbleeding ICU patients with a hemoglobin concentration greater than 7 g/dL. 3. Don’t use parenteral nutrition in adequately nourished critically ill patients during the first seven days of an ICU stay. 4. Don’t deeply sedate mechanically ventilated patients without a specific indication and without daily attempts to lighten sedation. 5. Don’t continue life support for patients at high risk for death or severely impaired functional recovery without offering patients and their families the

‘Some patients receive lifesustaining therapies due to clinicians’ failures to elicit preferences and provide recommendations [about end-of-life care].’ —Hannah Wunsch, MD, MSc alternative of care focused entirely on comfort. The last recommendation may be the most controversial, said Hannah Wunsch, MD, MSc, assistant professor of anesthesiology, Columbia University College of Physicians and Surgeons, New York City, but it’s “the one, perhaps, that the task force felt the most strongly about. “Some patients receive life-sustaining therapies due to clinicians’ failures to elicit preferences and provide recommendations [about end-of-life care],” she said. “We felt that, whether or not there are large resulting savings with this item, it was very important as a general topic to be included and [it] opens up everybody to a dialogue on the issue.” Attendees at the meeting offered wide support for the guidelines. One commentator noted, however, that more evidence is needed on withdrawal of end-of-life care, citing a Canadian study that demonstrated a higher rate of mortality at trauma centers following withdrawal of life-sustaining therapy, particularly in the early phase of care. The authors of the study called for caution regarding prognostication and early withdrawal of life-sustaining therapy


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Share your knowledge, show off your skills, speak to your colleagues. General Surgery News is calling for video submissions to feature in our new Surgical Video Arcade, on one of the most viewed websites in surgery. Send us your contribution to surgical education or discussion, such as ÜYÚd][lmj]Ú ÚÜÚÚYfÚafl]j]klaf_Ú[Yk]Ú ÚÚÚÚÜÚYÚÚna\]gÚghafagfÚÚÚÚÚÜÚgl`]j CYmf[`ÚakÚk[`]\md]\Ú^gjÚDYj[`Ú‡~”ÚYf\Úl`]ÚkmZeakkagfÚhjg[]kkÚakÚfgoÚgh]f VisitÚ^gjÚkaehd] afkljm[lagfkÚgfÚ`goÚlgÚmhdgY\ÚYf\ÚkmZealÚqgmjÚna\]g

BY THE NUMBERS Critical care in the United States accounts for about 0.66% of gross domestic product, or roughly $103 billion in 2012.

In the News


(CMAJ 2011;183:1581-1588). Dr. Wunsch emphasized that the guideline stresses early discussion with patients and families about end-of-life care issues and does not call for premature withdrawal of care. One of the key elements of the “Choosing Wisely” list is the emphasis that it places on discussions between physicians and patients and their families. Jeremy Kahn, MD, associate professor of critical care, medicine and health policy, University of Pittsburgh School of Medicine, said many clinicians often feel the ICU environment is too complex to heavily involve patients in decision making. “But we can use this to better educate critical care patients and their families. Perhaps we’re not giving families enough credit.” Consumer Reports, a partner of the ABIM Foundation, will publish all the “Choosing Wisely” summaries for patients. The aim is that patients will learn to question physicians about when tests and treatments are needed and when they are not. The critical care measures, along with detailed explanations and supporting references, can be found online at The list was developed from 59 items nominated by committee members representing internal medicine, surgery and anesthesiology, and critical care nurses. Each item was evaluated on evidence, prevalence, cost, relevance and innovation. Committee members researched and debated the items before creating the final list. Critical care in the United States currently accounts for about 0.66% of gross domestic product; Dr. Halpern cited a figure of roughly $103 billion spent in 2012. These costs are driven primarily by

‘Unfortunately, the myth that physicians are innocent bystanders merely watching health care costs zoom out of control cannot be sustained.’ —Howard Brody, MD, PhD

the number of ICU beds nationally. Another major contributing factor to cost is the discretionary practices of physicians and other clinicians. Dr. Halpern quoted an often-cited sentence from Howard Brody, MD, PhD, who, in 2010, called on all

specialty societies to create a ‘Top Five’ list of their commonly ordered tests that have only limited benefit (N Engl J Medd 2010;362:283-285). “Unfortunately, the myth that physicians are innocent bystanders merely watching health care costs zoom out of control cannot be

sustained,” he said. To date, more than 50 specialty societies have published “Choosing Wisely” guidelines, including the American College of Surgeons and the Society of Thoracic Surgeons. Dr. Halpern reported receiving grant support from the Greenwall Foundation, the Otto Haas Charitable Trust, Robert Wood Johnson Foundation and Betty Moore Foundation. He is a paid consultant for the World Bank. Dr. Kahn reported grant funding from the Gordon and Betty Moore Foundation. Dr. Wunsch reported no relevant disclosures.

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Opinion THUMB WRESTLING jcontinued from page 1

distribution of physicians and health care resources in the United States, and this has led to more expensive care in some regions. It was not particularly surprising that health care spending varied in different regions of the country, but the shocking revelation was that those parts of the country that spent the most did not get the best results. In fact, excessive spending in many situations correlated with, or led to, worse results. Furthermore, the regions that had invested heavily in primary care and that provided the least expensive care had the best overall health care results. In economic science parlance, they were “getting the most bang for the buck.” The second important observation by the Dartmouth group and others is that 80% of all health care spending in this country is for chronic illnesses such as diabetes, cardiovascular disease, chronic obstructive pulmonary disease (COPD) and osteoarthritis. These diseases are on the upswing in our aging and increasingly obese population, and are better managed by primary care physicians. Dr. Fisher’s idea was that most health care should be based on primary care, and providers should have accountability for maintaining the health of patients rather than treating episodes of acute illness. This idea was recognized by Mark McClellan, MD, head of the Centers for Medicare & Medicaid Services under former president George W. Bush, as the best way to meet the health care needs of Medicare patients while saving some money for that agency. Although I have spent my entire professional life as a tertiary care, hospitalbased surgeon, I have become a convert to this way of thinking. I now speak about it to groups of surgeons and, even though in an auditorium I can’t see their eyes rolling up in their heads, the silence in the room gives the same message. But I think they are not hearing my complete message. Although health care should be primary care–centric and primary care– driven, there is still a very distinct and important role for secondary and tertiary care physicians, most notably the surgeons. The best way to practice acute care is to distinguish between acute and chronic care and keep them separated but seamlessly integrated. Does this sound like bureaucratic-speak? What I am getting at is that primary care is something that is better done in the community, and even in the home, whereas secondary and tertiary care are better done in a hospital. Acute care and primary care providers offer different services that require different environments. Acute care tends to focus on individual problems, whereas primary care deals more with


populations. Surgeons operate on and take care of their patients one at a time, whereas primary care physicians manage panels of patients. Both of these groups have a role in the health care system but when you combine the two, the result is inefficiency. Surgeons require wellequipped hospitals and trained support staff to be successful. As their care becomes more specialized, it should be centralized into centers of excellence. Primary care physicians, on the other hand, should try to decentralize their efforts and keep their patients closest to home and out of the hospital. The concept of a general hospital that is “onestop shopping,” where you can get all of your health care needs serviced, is outdated. Chronic care is most effectively done in clinics, or even better, in the

spend time and resources promoting care at that point. Furthermore, when you move primary care out of the hospital and into the community, health maintenance such as blood pressure and glucose control is more successful. At the same time, when primary care is taken out of the hospital, acute care thrives. The Veterans Affairs medical system provides a useful example. In 1995, the VA recognized that care for chronic illnesses was its main problem and was not something to be managed in a hospital. The VA closed 29,000 beds from its 170-hospital network, and increased the number of outpatient facilities to 1,700. Although the VA had intentionally become one of the primary care leaders in the country, it had not foreseen the effect on

We have regional shortages of surgeons now, but in the next decade, there will be global shortages. If primary care physicians can keep more people away from the hospitals and out of the operating rooms, this will be helpful for our depleted ranks. It is one of the few win– win situations in a zero-sum game. So, how do ACOs fit in? Anyone who has read the description of a Medicare ACO knows the rules are complicated. There are contracts between multiple providers, and both savings and losses are distributed between CMS and the providers with complex formulas. Although the details are complicated, the concept of an ACO is simple: It is just primary care and acute care providers working together to care for patients efficiently and effectively. If they save

Territory folk should stick together, territory folk should all be pals; Cowmen dance with farmers’ daughters, farmers dance with the cowmen’s gals.

home, and the lesson for the acute care physician is this: When chronic care is not managed appropriately, chronically ill patients end up in the emergency rooms and ultimately in the hospitals, occupying beds that are intended for acute care needs. For example, a diabetic patient must have his hemoglobin A1c followed and get proper counseling about diet and exercise. If that does not happen, his diabetic vasculopathy progresses and leads to ulcers, gangrene and ultimately amputation. We see the same scenario play out for coronary artery disease, COPD and other chronic illnesses. Poor primary care leads to overburdened secondary and tertiary care facilities that don’t have the manpower or resources to accomplish what they are best at, which is acute care. The most effective way to treat any chronically ill patient is at the primary care stage, and this is why we should

acute care: Acute care thrived. Operative volumes increased by 10% immediately and have continued to increase every year since. The acuity of the inpatient population increased as ward beds were replaced by critical care beds. The lesson learned was that taking primary care out of the hospitals was good for primary care, but even better for secondary and tertiary care. Another point I make to doubtful surgeons comes from our own surgical literature. It is well known that we have a workforce problem. The American College of Surgeons has devoted a lot of time to studying the present as well as projecting the future for our profession, and their reliable predictions are for extreme surgical workforce shortages in the near future. There will be no lack of work for the inadequate numbers of general surgeons and surgical subspecialists we are currently training.

money doing it, they share in the profits. ACOs just realign incentives so that providers are rewarded less for treating illness and more for promoting health. Primary, secondary and tertiary care physicians all have roles, and when they are all working toward a common goal, their efforts are more likely to be profitable for themselves as well as less expensive for the industry. That last sentence seems to be a little accounting sophistry. How can something cost less, yet bring greater profits for the provider? The reason is buried in the reality that we have a redundant and inefficient system that has embarrassing excesses at the same time that it has glaring gaps in coverage. Resources are squandered on care that is often not indicated or even harmful. Nonintegrated care spends more money on unneeded care, unnecessary accounting, reduced efficiency, voluminous



When we donâ&#x20AC;&#x2122;t invest in primary care, we will be forced to manage more advanced acute care, which is the most expensive (and least effective) way to care for patients. paperwork, and occasionally fraud. There is also a financial reality to pursuing the more expensive alternatives of secondary and tertiary care instead of promoting primary care. When we start to run out of resources, the primary care side of the equation loses out. For example, if our resources run low, our diabetic patients may not get proper counseling on management of their diets and blood sugars, but compassion dictates they will always get their gangrenous extremities amputated or revascularized. This kind of care is certainly not in the patientâ&#x20AC;&#x2122;s best interest. So, although the incentive for an ACO for a primary care physician is obvious, there is an equally strong argument to be made for secondary and tertiary care physicians. When we donâ&#x20AC;&#x2122;t invest in primary care, we will be forced to manage more advanced acute care, which is the most expensive (and least effective) way to care for patients. Surgeons and primary care physicians should share a common goal to manage patients jointly, keep them out of the hospital, and have lean and efficient hospitals that are equipped for the complicated secondary and tertiary care that patients will need episodically. We should appreciate the role that we each play, integrate our efforts and learn to work together.

Thumb Wrestling Now, whatâ&#x20AC;&#x2122;s the connection to thumb wrestling? Some years ago, I participated in a program about team building. At the end of a day-long session with multiple lectures, the organizers had the participants pair up to play a game. Each group was asked to thumb wrestle and the rules were simple. Everyone would thumb wrestle for one minute, and each time a wrestler pinned down his or her opponent, he or she would win $1,000. As soon as the game clock started, people began thumb wrestling and attempted to pin each other down. About half of the groups had one winner earning $1,000, and the other groups earned $2,000 or had no winner at all. One particular pair, who had obviously been paying attention to the team-building lectures, planned their strategy. They took turns allowing their opponent to pin them down, and then they pinned down their opponent. They did it as quickly as their thumbs could move and

pinned each other more than 100 times during the minute, and both walked away with $50,000. Although the prize money was only virtual, the lesson was real: If you struggle against each other, you will have limited success; but when you work together toward a common goal, your results can be extraordinary.

â&#x20AC;&#x2DC;Oklahoma!â&#x20AC;&#x2122; And what would Richard Rodgers and Oscar Hammerstein II have to say about ACOs? Part of their musical â&#x20AC;&#x153;Oklahoma!â&#x20AC;? dealt with the struggle between cowmen and farmers. In

the early days of Oklahoma, the cowmen and the farmers were competitors for the same land. The farmers had their land fenced off to keep animals out of their crops, and the cowmen liked the open spaces to graze their herds. One of the key scenes is a dance number, during which the point is made that there is enough land for everyone and that they were all Oklahomans and would do better if they would only help each other out. The finale to the scene is this appeal: Territory folk should stick together, territory folk should all be pals;

Cowmen dance with farmersâ&#x20AC;&#x2122; daughters, farmers dance with the cowmenâ&#x20AC;&#x2122;s gals. At our hospital, we have a very talented and competent chief of primary care. At this yearâ&#x20AC;&#x2122;s Christmas party, I think Iâ&#x20AC;&#x2122;ll ask her to dance. â&#x20AC;&#x201D;Dr. Whitee is Professor of Surgery, â&#x20AC;&#x201D; George Washington University, and Chief of Surgical Services, VAMC, Washington, D.C.

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Opinion UNDERSTANDING jcontinued from page 1


the principles of complexity science to health care is in its infancy, there are only early, small examples to show the benefits, but in other industries and applications, these principles have led to impressive results. Two examples come from the study of spaghetti sauce and the game of Jeopardy.

in a mechanical (simple) or isolated system. It requires that all-important variables be controlled so that the intervention can be tested against a control group under like circumstances. For the parachute study described in the BMJJ article, this could actually be done fairly well: Defining Clusters and Patterns The height of the plane and the landing surface could In one of his TED talks, Malcolm Gladwell tells a both be reasonably well controlled. Other factors, often story about the brilliance of Howard Moscowitz and important in other medical studies, such as DNA vari- how we have all benefitted from his enlightened underation, body mass index, medications, age, etc., proba- standing of the consumer food industry. Moscowitz is bly don’t matter to the primary outcome in this trial. a psychophysicist, and over the past several decades, he A 65-year-old diabetic woman on chemotherapy will has been frequently hired by food companies probably have a result similar to that of a healthy to consult and help them determine 30-year-old man. the best tasting ... whatever So, the test would actually result in an outproduct they were come that can prove to be clinically significant and likely provide a research conclusion that is generalizable to other populations. This is not the case for the great majority of clinical research in health care, where the variables are much more important and much more Interpreting data from a complex difficult—actually impossible—to control. Also, any attempts to control the popuand changing system is different lation being tested (inclusion and excluthan collecting data from a simple, sion criteria) lead to outcomes that are less likely to apply to the real world. Even static and isolated system. These traditional techniques of controlling varicomplex systems data analytics ables, such as using identical twins to limit DNA variation are now known to will be necessary to improve the be insufficient and ineffective. By the time value-based outcomes in our they are adults, “identical” twins can have more DNA differences than similarities, health care system. and these changes may start in utero. Unfortunately, most of our health care treatments are not so simple, and the more complex the problem is, the less useful a mechanical tool like a PRCT is. The outcomes of the parachute study would likely be clear and generalizable: Wearing a parachute when jumping out of a plane (at a certain height and speed) would not be wasteful, would not be harmful and would save lives. Almost all of our health care treatments and tests are different; they are complex. Even for the most clearly supported treatments, such as the vaccine and screening mammography examples I used in part 1 of this article (March 2014, page 1), there is a significant amount of waste (the person receiving the treatment or screening focusing on test did not really need it) and some real harm (death at the time. It and harm done to children and adults from the vaccines could be how much artiand over diagnosis and overtreatment in women after ficial sweetener to put into a diet mammography). soft drink, the best blends of coffee or whatever. He This reality challenges our beliefs and our thinking. would set up tasting focus groups and collect data from If there were no alternative, then I imagine this reali- sometimes thousands of people to determine the best ty would be a moot point. However, complexity science next product. But he struggled with the data because has evolved over 100 years and can contribute tools, as much as he tried, it did not fit well on a bell curve to such as clinical quality improvement principles and give him that one best answer. complex systems (nonlinear) data analytics and predicMoscowitz knew a direct study comparing two varitive analytics, that will allow us to better define patient ables would not work, so he did observational testing groups that are helped, those that are harmed and those with a variety of options and collected a vast amount for which a treatment or test is wasteful. Over time, this of data. It still did not lead to a single best product. will allow us to improve the value of patient care for all While working for Prego, he had his “aha” moment. care processes in which we apply these principles. Moscowitz had collected his data and it hit him: PeoThe research is conclusive and the science of com- ple’s tastes did not exist on a bell curve, but they tendplex adaptive systems is clear: We are using research ed to cluster around a variety of choices. It was not a tools designed for static, isolated, linear and mechani- simple bell curve, but it was also not completely chaotic cal systems, but humans beings are nonlinear, adaptive, or random; there were patterns and clusters that could biologic and heavily influenced by interactions with the be observed. And this led to a revolution in the conrest of our constantly changing world. Because applying sumer food industry: many more varieties of spaghetti

sauce and many choices of variations in taste for almost everything else we eat and drink. Interpreting data from a complex and changing system is different than collecting data from a simple, static and isolated system. These complex systems data analytics will be necessary to improve the value-based outcomes in our health care system. But, how do we get the data? There are plenty of data in health care. Why can’t we analyze the massive amount of data that already exists? In a simple answer, it is the lack of context that produced the data. There are also problems with the accuracy and relevance of the data as well as how the data is analyzed and used in our current system for patient care. Understanding these concepts and an example of predictive analytics will hopefully help to explain how to apply these principles to health care.

Predictive Analytics: Context and Collaboration One of the most successful, and famous, applications of predictive analytics was demonstrated for three days of competition on the long-running game show Jeopardy. Ken Jennings and Brad Rutter, the two most successful champions in the history of the game, were pitted against a computer, IBM’s Watson. Knowing how Watson was programmed to attempt to beat the best of the best Jeopardy contestants can help us understand how to apply predictive analytics to health care. The key to Watson’s somewhat surprising victory was not just filling the computer with searchable facts (a la Google or Wikipedia), the key was to provide context for the knowledge and generate the knowledge of learning language from multiple collaborations. Instead of asking the Jeopardy champions to recommend what knowledge should be put into the computer (which would be like asking physician experts to enter knowledge about diseases and treatments), the programmers realized that the real context would come from Jeopardy’s question writers, so they loaded all prior questions and answers ever written for Jeopardy going all the way back to the first episode on March 30, 1964. They also needed to have the best computer understanding of the English language, termed natural language processing. Rather than just entering the “best practice” from one natural language programming laboratory, they entered the research and findings from many of the laboratories, with their various findings and strategies and pooled them together in Watson. In a multiyear, iterative process—many testing phases were done almost continuously—Watson’s ability to predict the correct answer improved over time. There were failures along the way and the outcome of the competition was not guaranteed, but the result was impressive, with Watson scoring $77,147 compared with Ken Jennings’ $24,000 and Brad Rutter’s $21,600.

The New Paradigm And now, this application of complexity science, or the ability to apply complex systems data analytics, is just beginning to be applied to health care. In fact, Watson has been contracted to perform data analytics services with several health care organizations. But, the ability to use health care data to generate accurate predictive analytics is in question. So far, the application of data analytics to health care has omitted consideration of the essential contribution of context and collaboration. Instead of defining the true context of the patient’s cycle



of care, either poor data (payer claims data) or misunderstanding of context (asking doctors what information to put into the computer), or both, are used. Asking the doctor, the expert, is like asking the Jeopardy champions what information to put into Watson, instead of the question writers. Since we don’t have question writers for our patients’ health care problems, we will need to define their processes of care (the questions) and their value-based outcomes (the answers). This context will allow us to iteratively improve over time and lead to ongoing improved patient value. The other necessary component is collaboration. We will need many teams defining patient processes and improving valuebased outcomes. Otherwise we will have limited ability to continue improving, termed the law of diminishing returns. For Watson and for Howard Moscowitz, using one “best practice,” one natural language processing lab or one person’s taste, was inadequate. It is the same in our complex system of health care. It is true that when we try to implement ideas for improvement, we can make mistakes and have bad outcomes and unintended consequences. In fact when the programmers loaded the Urban Dictionary in Watson in an attempt to have an improved range of language understanding there was an unexpected consequence. In tests, Watson answered “Bulls--t” to a researcher’s query. The team decided to remove the Urban Dictionary from Watson’s memory. We already have a massive amount of waste and harm in health care, and almost none of it is intentional. But, to implement a new way of thinking and evolve our system structure for patient care we will need to be prepared to acknowledge and deal with unintended consequences. We will all need to be accountable to the patient problems that we choose to diagnose and treat. In his book “Predictive Analytics: The Power to Predict Who Will Click, Buy, Lie or Die,” Eric Siegel describes the story of IBM Watson’s Jeopardy victory in more detail. He said it is one of the best examples of machine learning and the potential for wonderful benefits if applied appropriately to health care. But, he is clear in the need for an accurate context that produces the data and the need for multiple collaborations to share what is learned from the data. In health care, we have a very poor understanding of the context that produces the data available that we see in fragmented care, often primarily from coding and billing data. This data are incredibly inaccurate. Some estimate that 30% to 40% of billing data is wrong, with the great majority from human and systems error, not fraud. But when predictive analytics are done well, and Siegel gives many examples in his book, then the use of a well-defined

context and meaningful collaboration can prevent the law of diminishing returns, or as Siegel calls it in his book, “overlearning,” which can allow for continuous improvement of value. We are going through a paradigm shift in the scientific understanding of our world, from the machine as a metaphor for human beings to an understanding that we are complex, adaptive and dynamic systems—yes, imperfect and nonlinear, but able to adapt in many various and wonderful ways. We can deny this shift, we can try to ignore it, we can even be defensive and aggressively argue against

it, but what no one can do is prevent it from occurring. On the other hand, if we decide to accept it (and it is a conscious decision) and go through the discomfort of opening our minds and learning about the science behind it, we will begin the adventure of our lives. This journey is never over and it can be uncomfortable at times, but as we truly learn about the complexity of our world, the hope and potential for improvement becomes real and palpable. The simple rule that emerges to achieve this potential is clear and consistent. To transform our health care system to one

that is sustainable and always improving the value for the patient, we will need to treat each other and our patients with empathy, compassion and love. In the final article in this series I will present the human potential that is in all of us to drop our fears and defenses and allow our authentic selves to be present as we do our work in caring for each other. —Dr. Ramshaw is chairman and chief — medical officer, Transformative Care Institute (nonprofit) and Surgical Momentum LLC (for profit), and co-director, Advanced Hernia Solutions, Daytona Beach, Fla.

Optimizing the Prevention and Management of Postsurgical Adhesions To participate in this FREE CME activity, log on to and enter keyword “MN125” Release date: December 1, 2012


Jon Gould, 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


Michael J. Rosen, MD Associate Professor of Surgery Division Chief, General Surgery University Hospitals Case Medical Center Cleveland, Ohio

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.

Learning Objectives 1 Review the pathophysiology and complications of postoperative adhesion formation. 2 Summarize current strategies used to prevent postoperative adhesion formation. 3 Describe the various types of barrier materials used to prevent postoperative adhesion formation.

Intended Audience The intended audience for this educational activity includes general surgeons, vascular surgeons, colon and rectal surgeons, critical care surgeons, surgical oncologists, trauma surgeons, and thoracic surgeons. Supported by an Educational Grant from

Estimated Time for Completion: 60 minutes Course Format Monograph (print and online)

Accreditation Statement This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the Medical College of Wisconsin and Applied Clinical Education. The Medical College of Wisconsin is accredited by the ACCME to provide continuing medical education for physicians.

Designation of Credit Statement The Medical College of Wisconsin designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit™. t Physicians should only claim credit commensurate with the extent of their participation in the activity.

Method of Participation There are no fees for participating in or receiving credit for this activity. To receive CME credit, participants should read the preamble and the monograph and complete the post-test and evaluation. A score of at least 70% is required to complete this activity successfully. Distributed via



In the News


Cleveland Clinic Researchers Develop Online CRC Risk Predictor B Y B EN G UARINO


new online calculator created by researchers at Cleveland Clinic is designed to help physicians determine a patientâ&#x20AC;&#x2122;s risk for colorectal cancer (CRC). Using age, weight, family history of colon cancer and other risk factor data, the calculator estimates the chance that a patient will develop CRC in the next 10 years. Using a predictive tool such as this one is â&#x20AC;&#x153;much more effectiveâ&#x20AC;? than relying on an age cutoff to assess whether or not a patient should receive a colonoscopy, said investigator Brian Wells, MD, PhD, a research associate at Cleveland Clinicâ&#x20AC;&#x2122;s Lerner Research Institute, in Ohio. â&#x20AC;&#x153;Not that the age 50 cutoff is arbitrary, but I think thatâ&#x20AC;&#x2122;s a crude estimate of risk,â&#x20AC;? he said. Dr. Wells and his colleagues developed the new risk predictor, called the ColoRectal Cancer Predicted Risk Online (CRC-PRO) calculator, using data from the Multiethnic Cohort Study, which followed more than 180,000 participants in California and Hawaii for 11.5 years. They published the results in the

January-February issue of the Journal of the American Board of Family Medicine (Wells BJ et al. 2014;27:42-55). Factors that were significantly associated with CRC risk included age, race, smoking status, alcohol intake, family history of colon cancer, diabetes and use of multivitamins or nonsteroidal anti-inflammatory drugs. The Multiethnic Cohort Study did not assess whether patients

had inflammatory bowel disease (IBD), a recognized risk factor for CRC; however, Dr. Wells believes the lack of this data should not greatly affect the calculatorâ&#x20AC;&#x2122;s accuracy because of the expected rarity of IBD in such a large study population. Compared with other available CRC risk calculators, which use caseâ&#x20AC;&#x201C;control data, Dr. Wells said the CRC-PRO tool is â&#x20AC;&#x153;less prone to bias than previous models, since the data was derived from a prospective cohort of patients.â&#x20AC;? However, patients who have a history of colon cancer or who have polyps should not rely on this calculator, he cautioned. Physicians may be reluctant to use risk calculators such as these, particularly if entering information becomes time-consuming. â&#x20AC;&#x153;If we can integrate calculators with electronic health records (EHRs), it will get past hurdles of trying to get physicians to use these tools,â&#x20AC;? Dr. Wells predicted. Mark H. Ebell, MD, MS, associate professor of epidemiology at the University of Georgia, in Athens, who was not involved with developing the calculator, agreed.

GSN Bulletin Board

â&#x20AC;&#x153;Calculators like this, that help us determine the risk for cancer in an individual patient, especially when they can be integrated with EHRs, have the potential to help us individualize screening and prevention recommendations someday,â&#x20AC;? he said. About one in three Americans between the ages of 50 and 75 years have not been screened for CRC, according to a 2013 report from the Centers for Disease Control and Prevention. But if every American who is eligible to undergo a colonoscopy chose to do so, Dr. Wells said, there may not be enough physicians for the task. Cost, as well as the small but serious risk for bowel perforations or other complications, also may affect who undergoes a colonoscopy. â&#x20AC;&#x153;If we did a better job of identifying who needs [a colonoscopy],â&#x20AC;? Dr. Wells said, â&#x20AC;&#x153;maybe we could get better at allocating that resource.â&#x20AC;? The CRC-PRO calculator and other cancer prediction tools created by Cleveland Clinic are available for free online at â&#x20AC;&#x201D;Drs. Wells and Ebell reported no relevant conflicts of interest.



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In the News


New Sequencing Tool Gauges Breast Cancer Risk B Y K ATE O'R OURKE SAN ANTONIO—In a cohort of 2,000 patients, next-generation sequencing using a panel of 25 cancer susceptibility genes identified 4.8% more patients with mutations than the 9.3% identified by testing the BRCA1/2 genes alone. The results were presented at the San Antonio Breast Cancer Symposium. “Identifying individuals with a hereditary cancer risk provides opportunities for early detection, through more intensive screening, and cancer prevention, through the use of prevention medications or prophylactic surgery,” said Nadine Tung, MD, director of the Cancer Risk and Prevention Program at Beth Israel Deaconess Medical Center in Boston. The 25-gene panel is a precursor to the MyRisk Hereditary Cancer Test, which was launched in September 2013. The 25 genes are associated with eight major hereditary cancers including breast, colon, ovarian, endometrial, pancreatic, prostate, gastric and melanoma. The average price of the test is $3,700. The new study included two patient cohorts. Cohort 1 included 1,951 prospective cases referred for BRCA1 and BRCA2 testing to Myriad Genetics. There were no Ashkenazi Jews in this cohort. Cohort 2 included 390 patients with hereditary breast and ovarian cancer history at Beth Israel Deaconess Medical Center who previously tested negative for BRCA1 or BRCA2. Some patients in this latter cohort had Ashkenazi ancestry. Ninety-one percent of patients in cohort 1 and 97% of patients in cohort 2 had breast cancer. Of the patients in cohort 1, 9.3% had a mutation in BRCA1 or BRCA A 2 and 4.8% of patients had a mutation in a gene other than BRCA1/2. In cohort 2, 4.4% had a mutation in at least one of 23 genes other than BRCA1/2. The most common mutations in genes other than BRCA1/2 were CHEK2 (31.8%), NBN N (14.5%), ATM (12.7%) and PALB2 (12.7%). At least one variant of unknown significance was found in 44% of cohort 1 and 45.4% in cohort 2. The typical predictors of BRCA1/2 mutations, such as age at breast cancer diagnosis and family history of breast and ovarian cancer, did not appear to predict for mutations in genes other than BRCA1/2. There was a trend toward increased prevalence of mutations in genes other than BRCA1/2 in patients with multiple breast cancers (P=0.061). P “Factors that predict for BRCA1/2 mutations do not seem to predict for mutations in other genes,” said Dr. Tung. “It

may well be that the cancer spectrum and phenotype are different for mutations in each gene.” Matthew Ellis, MB, PhD, the director of the Breast Cancer Program at the Washington University School of Medicine in St. Louis, said the study shows that BRCA1 and 2 remain the dominant causes of hereditary breast cancer and that testing the other 23 genes unearthed only a few percent of patients who wouldn’t have been identified

with BRCA1/2 testing. “What that says is that all of these other causes are relatively rare, and because they are rare, we actually don’t have very good information on key issues that are used in clinical decision making like penetrance. Penetrance is the likelihood that you will develop cancer if you have inherited the allele,” said Dr. Ellis. “We know the penetrance is high for BRCA1/2, but it is not really clear how penetrant PALB2 or RAD51C C mutations

or any of these other genes really are.” Dr. Ellis had several concerns as the test begins to be used in clinical practice. “We don’t really have good data to base practice guidelines yet, so a call for a lot more research is needed,” he said. Great care needs to be taken so patients are not misinformed as to the strength of the evidence, especially when the information is used to guide decisions about prophylactic therapy, particularly surgery, he added.

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 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


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