The September 2012 Digital Edition of General Surgery News

American College of Surgeons Clinical Congress

CONVENTION ISSUE:

40th Anniversary 1972-2012

GENERALSURGERYNEWS.COM

September 2012 • Volume 39 • Number 9

The Independent Monthly Newspaper for the General Surgeon

Opinion

Res Ipsa Loquitur B Y J ON C. W HITE , MD

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es ipsa loquiturr or “the thing speaks for itself ” is the core principle applied in many medical malpractice cases where culpability for a tort has to be established.

It is the job of the plaintiff ’s legal team to make a clear-cut case, which is not always easy. As all physicians know, medicine is part art and part science, and clinicians rely on their experience and judgment as well as a body of established facts to determine what course of action is appropriate for an individual patient. When there is a bad outcome resulting from such a clinical decision, the nuances of the case may be difficult for the lay public to grasp. The facts must be presented so that there is a convincing inference of negligence, which can be understood by a jury. Thus, the argument must “speak for itself.”

Texas Physician Population Surges Since Tort Reform Legislation in 2003 A 44% Increase; Report Does Not Prove Causality; Number of General Surgeons Decrease B Y C HRISTINA F RANGOU SAN DIEGO—Texas’ 2003 tort reform legislation was associated with an upsurge in actively practicing physicians in the state, with physician population growth outstripping regular population growth and increasing the per capita number of physicians in

20 of 22 trauma service areas, a new study shows.

“Tort reform is associated with a very significant increase in the number of Texas physicians relative to the Texas population,” said lead author see TEXAS PHYSICIANS page 20

Tort Happens As physicians, we also know that mistakes do occur. We have all made mistakes, know others who have made mistakes and have seen the resulting bad outcomes. None of us is or should be expected to be perfect. When a minor lapse in judgment is linked to an unfortunate set of comorbidities or circumstances, the outcome can be bad. These types of errors are not and should not be considered malpractice. At other times,

Device-Tissue Interaction: Evaluating New Devices for Your Surgical Practice

Program Cuts SSI Rates in Colorectal Surgery Patients B Y K ATE O’R OURKE

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comprehensive unit-based safety program (CUSP) has cut the surgical site infection rate of colorectal surgery patients at Johns Hopkins Hospital by 33%.

Hopkins researchers say that if similar programs are adapted nationwide and applied to all surgical procedures, 170,000 surgical site infections (SSIs) could be avoided at a savings of $102 million to $170 million annually. The key to success, say researchers, is that the program engaged frontline providers.

“The message is not that our bundle is the solution, but that engaging the frontline is the solution,” said Elizabeth Wick, MD, a colorectal surgeon at Hopkins who led the study. “Instead of having a top down quality improvement, where a bundle is imposed on [clinicians] by the administration, you should instead educate the frontline and have them come up with a list of defects, address them and work together with the leadership to address the problem.” The study appeared in the August issue of the Journal of the American College of Surgeons.

The use of CUSP by hospitals has been growing in recent years, with the see SURGICAL SITE INFECTION page 20

see TORT REFORM 53

CLINICAL COMMENTARY

®

In this piece, Ephemera #8, 48"x48" oil on canvas, Chad Hoover heightens the contrast between light and dark, displaying a luminous operative field and creating a great sense of theatricality. See page 17 for further description.

see page 25

REPORT Technological Advancements in Tissue-Sealing Devices See insert at page 28

INSIDE Opinion Emergency Room Call Is Ruining My Credit Rating . ................... 6

Obesity Care CMS Green Lights Sleeve; Sexual Misconduct by Pro- Weight Discrimination Law; fessionals: A New Model Experts Debate Sleeve of Understanding .......... 12 Gastrectomy for Teens .... 22

CLINICALLY PROVEN TO

REDUCE SSI Rate of Incisional SSI Alexis速 Wound Protector/Retractor

22.7% (15/66)

Standard Retractors

14.6%

P = 0.004

(7/48)

79%

P = 0.02

P = 0.0021

89%

RRR*

RRR*

8.1%

100% RRR*

(9/110)

1.6%

4.69%

(1/61)

(3/64)

0%

(0/111)

Lee, et al. 2

Reid, et al. 1

For more information, please visit

Horiuchi, et al. 3

Scan to request a clinical study booklet or contact from a representative.

Applied Medical Booth 2304 at ACS or visit www.appliedmedical.com

速

WOUND PROTECTOR/RETRACTOR e Applied Medical logo and Alexis are U.S. registered trademarks of Applied Medical Resources Corporation. 1917AL0812

GSN Editorial

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

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

D

id you ever have the feeling that each day was just like the one preceding it and that tomorrow will be little different? Although our days are characterized by singular events involving patients, procedures, meetings, conferences, rounds and so on, they can blend together without our ability to appreciate the variety that can lead to excitement and creativity. Perhaps this repetition (the “Ground Hog Day� phenomenon) is the ultimate reason why we need vacations to break the “sameness� that may be the basis for the stress in our lives.

In thinking about the repetitiveness of this cycle, it occurs to me that we should be challenged to ask ourselves three vital questions at the end of each day. For years I frequently challenged the medical students and surgical residents to make sure they asked themselves the question, “What new piece of information did I learn today?� Although factual knowledge about disease processes is important,

perhaps this question is of secondary importance and ultimately nonsustaining.

So what are the real questions?

Question 1—for reflection at the end of the day should be “What surprised me today?�

When I awakened this morning, what event or experience was I not anticipating? Obviously for surgeons, the surprise may take the form of unanticipated pathology in the operating room or the unexpected challenge of a patient’s diagnosis.

The real essence of Question 1, however, is to gauge the effect of any unexpected interaction with another person, either positive or negative. Did the comment of a patient or colleague elate or disappoint us and, if so, did we incite the surprise comment or action? If we were surprised during the day, did we react appropriately and in a manner that would make us proud should we encounter the same event tomorrow, next week or next year?

There are many events that are not anticipated throughout the day. Perhaps we are too distracted to remember these isolated events, but reflection at day’s end will be rewarding. rewardin Question 2—“What moved or touched me today?� As physicians, we have great opportunities to interact in activities

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Senior Medical Adviser Frederick L. Greene, MD Charlotte, NC General Surgery, Laparoscopy, Surgical Oncology

Editorial Advisory Board Maurice E. Arregui, MD Indianapolis, IN General Surgery, Laparoscopy, Surgical Oncology, Ultrasound, Endoscopy

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

Philip S. Barie, MD, MBA New York, NY Critical Care/Trauma, Surgical Infection

L.D. Britt, MD, MPH Norfolk, VA General Surgery, Trauma/Critical Care

David Earle, MD Springfield, MA General Surgery, Laparoscopy

James Forrest Calland, MD Philadelphia, PA General Surgery, Trauma Surgery

Edward Felix, MD Fresno, CA General Surgery, Laparoscopy

Robert J. Fitzgibbons Jr., MD Omaha, NE General Surgery, Laparoscopy, Surgical Oncology

David R. Flum, MD, MPH Seattle, WA General Surgery, Outcomes Research

Michael Goldfarb, MD

Leo A. Gordon, MD Los Angeles, CA General Surgery, Laparoscopy, Surgical Education

Gary Hoffman, MD Los Angeles, CA Colorectal Surgery

Namir Katkhouda, MD Los Angeles, CA Laparoscopy

that are both heartwarming and heartrending. How did we feel when we talked to our patient about the maximally invasive operation that he was going to experience? Did we understand the emotion and life-changing experience of the mother with two small children when we introduced her to her breast cancer diagnosis? Did we appreciate the struggle and pain experienced by the postoperative patients who passed us in the inpatient unit as we made rounds?

Novellas could be written about the experiences and interactions that we fail to appreciate each day. The challenge is to keep our eyes, ears and hearts open and tuned in to the incredible interactions that we encounter daily. Here, some note taking at day’s end would be advantageous since even the most poignant encounters or life-changing experiences may become lost if not chronicled. At the end of a full day, we may have difficulty discerning those fleeting moments that really enhanced our day. The very act of keeping a journal and giving answers to these first two questions will give future pleasure, insight and solace as we peruse our notes and reflect on these experiences at a later date. It might be a revelation to relive those events that moved us and perhaps changed us as a human being.

Art/MAX Graphics & Production Staff Michele McMahon Velle

David M. Reed, MD

Deanna Cosme

New Canaan, CT General Surgery, Laparoscopy, Medical Technology Development/Assessment

Art Director

Barry A. Salky, MD New York, NY Laparoscopy

Please send letters to: khorty@mcmahonmed.com.

James O’Neill Senior Systems Manager

Dan Radebaugh Director of Production and Technical Operations

Brandy Wilson

Miami, FL Ob/Gyn, Laparoscopy

Circulation Coordinator

Change of Address Procedure

McMahon Group Raymond E. McMahon,

Peter K. Kim, MD

Kevin Horty

Bronx, NY Emergency General Surgery

Group Publication Editor (khorty@mcmahonmed.com)

Raymond J. Lanzafame, MD

Associate Editor (vstern@mcmahonmed.com)

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

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John Maa, MD

Robin B. Weisberg

San Francisco, CA Surgical Hospitalist

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Wynnewood, PA Colon and Rectal Surgery, Colonoscopy

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Sales Michael Enright

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Š 2012 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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Minneapolis, MN General Surgery, Laparoscopy, Colon and Rectal Surgery, Laser Surgery

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mcmahonmed.com

That brings us to Question 3—“What inspired me today?�

What did I witness that made me really appreciate my choice of a career or push me to develop a new thought, activity or even different life direction? This is really the ultimate question. This is really why I want to get up in the morning and have the desire to repeat the exercise tomorrow, next week and in years to come. Was I inspired by my work in the OR? Was I inspired by my rounds with students and residents? Was I inspired by the Grand Rounds presentation or discussion at Morbidity and Mortality Conference, and did these discussions challenge me or create a new awareness?

Yes, each day can feel repetitive and unrewarding unless we make the effort to appreciate and chronicle those special moments, thoughts and encounters. We live in a rich and complex work environment and we should make the most of it.

At the end of the day, ask yourself these three questions. You will be surprised to hear the rich and rewarding answers that are forthcoming.

Joseph J. Pietrafitta, MD

Michael Kavic, MD

Long Branch, NJ Laparoscopy, Telemedicine

Novellas could be written about the experiences and interactions that we fail to appreciate each day.

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

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

All U.S. general surgeons, colorectal surgeons, vascular surgeons, surgical oncologists and trauma/critical care surgeons should receive General Surgery News free of charge.

If you are changing your address or name, you must notify the AMA at (800) 262-3211 or the AOA (if appropriate) at (800) 621-1773 to continue receiving GSN. You need not be a member; however, they maintain the ultimate source of our mailing addresses.

If you are not a general surgeon or other specialist listed above and would like to subscribe, please send a check payable to General Surgery News. Please allow 8-12 weeks for the first issue. Subscription: $70 per year (outside U.S.A., $90). Single copies, $7 (outside U.S.A., $10).

Send checks and queries to: Circulation Coordinator, General Surgery News, 545 West 45th Street, 8th Floor, New York, NY 10036.

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INFECTIOUS DISEASE SPECIAL EDITION

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

Exam Verifies Laparoscopic Competency for Practicing Surgeons Research Suggests FLS Should Be Mandatory for Residents and Practicing Surgeons Alike B Y M ONICA S MITH SAN DIEGO—Since 2009, general surgery residents have been required by the American Board of Surgery (ABS) to pass an exam in the Fundamentals of Laparoscopic Surgery (FLS) before

moving on to take the ABS Qualifying Exam in Surgery. Current research suggests mandatory FLS certification should be extended to practicing surgeons as well (S076, SAGES 2012).

“Only one study to date has looked at FLS certification in practicing surgeons, and it found they had a 19% overall failure rate for certification (Surg Endosc 2010;24:616-623). Our aim was to evaluate the feasibility and potential need for certifying practicing surgeons within

the University of Texas health care system,” said Melanie Hafford, MD, chief surgical resident, University of Texas (UT) Southwestern Medical Center, Dallas, who presented the study at the 2012 meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES; abstract S076).

A team led by Daniel J. Scott, MD, vice chairman of education, UT Southwestern, enrolled all attending general surgeons credentialed in laparoscopy

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from four UT medical centers. The project was supported by a grant from the UT Healthcare Safety and Effectiveness Grants Program. Surgeon participation was mandated by institution chairmen; eight gynecologists and three urologists also enrolled on a voluntary basis.

Dr. Scott said, “This project was important since very little work had been done previously for practicing surgeons using the FLS program. There is an increasing need for validated, objective measures to verify competency, even for faculty.”

Although experience levels varied, all of the surgeons were credentialed in laparoscopy at their hospitals, which were academic institutions. More than half said they had learned laparoscopy during training rather than by experience, based largely on when they completed their residency. Participants had been in practice an average of 13 (±10) years.

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Participants underwent an orientation of online cognitive FLS materials and did a pretest involving a single repetition of all five FLS tasks. “They then had a two-month interval during which they could practice their skills and study the cognitive materials, after which they took the FLS certification examination and, if necessary, remediated,” Dr. Hafford said.

About one-third of the 83 surgeons who completed the baseline skills assessment failed the manual skills pretest.

Participants were notified of their performance on the exam and were allowed to practice as much as they felt they needed to before taking the FLS certification exam. They spent an average of 3.7 hours training on both the manual skills and cognitive materials.

Of the 76 surgeons who took the certification exam, one failed the manual skills test and nine failed the cognitive exam; six of these participants remediated successfully.

Of note, a subset analysis showed that those who scored very well on the pretest practiced less for the certification exam, whereas those who scored poorly studied more. “This shows that the people who needed to practice did so, and they improved,” Dr. Hafford said.

“This is a win–win,” Dr. Scott said. see LAPAROSCOPIC COMPETENCY page 37

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Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

Emergency Room Call Is Ruining My Credit Rating B Y C LAIRE C RONIN , MD

To Whom It May Concern:

prayers to not go off until you have fallen asleep for at least three hours. Of course, now you can’t relax and end up tossing and turning until your husband yells at you to quit it. You lie still doing mental calculations that if the beeper goes off now, you would have time to do a colectomy and colostomy and get back home to pack the kids’ lunches for school. Somehow you fall asleep for a couple of hours only to be woken up from the snoring of the aforementioned husband, at which point you instinctively glance at the clock to see what time it is and you spot your beeper and it starts all over again. Except now there is no time for a colectomy and you start to wonder who will bring the kids to school if you get called in because your husband has to leave early the next morning and DSS will be called if they show up to school in pajamas … again.

It is during these long hours that I have dissected what it is that I truly dislike about call and it’s not the part that I consider to be my job, which is to admit and treat surgical patients. It is the stupid stuff, which makes up the top 40.

I regret that I can no longer participate in the roster of general surgeons who cover the emergency room (ER) and it’s not for the usual top 40 reasons. It’s not because of the lack of adequate financial reimbursement for call that I may or may not have complained about in angry letters to the editor in certain surgical publications. It’s not because of the late-night disruption to be asked if I will see a patient in my office later in the week for his gallstones when an email would have sufficed. It’s not even because of the midnight hot-potato arguments about whose service a patient should go to between the ER doctor, the hospitalists and the surgeons, which I hate more than anything.

Usually at this point, as I get closer to the top 10, someone accuses me of complaining about a career that I knew beforehand would come with nocturnal Credit Rating interruptions. To be fair, when we chose But now I have a new reason that I can professions as medical students, it wasn’t no longer participate in the call schedule with what one would call full disclosure. and that is because it is ruining my credWe weren’t answering pages to come lay it rating. I have just received my second hands on a patient with belly pain and bill from the ER asking for $180 for a a normal computed tomography (CT) physician visit that never happened and scan in case there was “hidden free air.” because I have no plans to pay it, I expect We just got up to save lives in the middle that I will soon be sent to collections. of the night, which at that point meant Not that I should complain too much, holding a retractor in the operating room, as this bill is way better than the $560 after the resident had done all the dirty work. Having You lie still doing mental calculations saved many a life with my that if the beeper goes off now, you retractor-holding abilities, I chose a career in surgery would have time to do a colectomy and understanding that people never come to the hos- colostomy and get back home to pack pital during daytime hours the kids’ lunches for school. with an abdominal catastrophe. (Dibbs on naming this phenomenon if it hasn’t been taken that the hospital charged me for a blood yet: The Cronin Coincidence.) draw on the same day. As a side note, I I have thought about this extensively at think we can all do the math and see that night when I am on call and can’t sleep the health care system assigns more value because of my “beeper anxiety.” (That one to a vial of blood than to the physician is up for grabs if anyone wants to name it encounter. I find this as equally disturband add it to the next version of the Diag- ing as the concept of being charged $740 nostic and Statistical Manual of Mental for a night of call. Doctors are notoriDisorders [DSM]. I would be laughed ously bad business people, but even I can out of the surgical societies with a DSM see that the cash flow is going the wrong disorder named after me.) Beeper anx- way here. iety is that feeling you get in the pit of It all started like it usually does, with your stomach when you crawl into bed in a call from the ER around 4 p.m. on a your flannel pajamas, making little coo- Friday night by one of my favorite ER ing sounds at how comfy it is and as you attendings, Antonio Beemer (names reach over to turn off the light, you spot have been changed because of HIPAA, your beeper and need to throw up. You a concept that I still don’t fully underlie awake looking at it, while offering up stand). Antonio was concerned about a

The cost of doing business.

victim of a motor vehicle accident who was found at the scene without a pulse.

She was being brought by ambulance to our hospital to be pronounced dead.

Antonio had a feeling that she wasn’t going to be all dead and asked me to come up to the “trauma” bay. One of the main reasons I work at a community hospital is that we don’t have trauma, but every now and then the emergency medical technicians (EMTs) confuse us for Massachusetts General Hospital (probably because of all that co-branding) and a few patients slip through.

After I arrived, the EMTs came barreling around the corner with a young exchange student who was hit by a truck while crossing the road. They were able to intubate her at the scene but she had no pulse and her pupils were fixed and dilated. We moved her over to the gurney and asked them to stop cardiopulmonary resuscitation (CPR) so we could check for pulses. Antonio miraculously found a femoral pulse and we stared at her unexpected cardiac activity on the

electrocardiography monitor. IVs were placed and x-rays performed while we examined her. She had an isolated head injury. Her pupils overshadowed her irises and they didn’t shrink with light. A blood pressure was difficult to come by but the pulse was unmistakably there.

Antonio came back from looking at the films and asked me to put a chest tube in her right pleural cavity. I called for the kit and washed her skin. As I made my incision, someone yelled out that her pulse was gone. CPR was resumed just as my blade entered her skin, and ended up in my finger. The chest tube was inserted in seconds and her pulse returned. Antonio was in the process of making arrangements to have the patient transferred to a trauma center. I interrupted to tell him that I had cut myself and that we needed to draw blood from her before she left for HIV and hepatitis testing.

A helpful nurse announced, “It’s hospital policy to obtain a patient’s consent before drawing blood for HIV.” We all see CREDIT RATING page 8

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Opinion CREDIT RATING jcontinued from page 6

turned to look at the patient who was intubated and probably brain dead, and then looked back at each other blankly.

Consent was out of the question. Curiously, no one seemed to mind that I didn’t have consent for the chest tube.

“It’s implied,” Antonio concluded and directed another nurse to draw the blood.

Phone calls were undertaken by the helpful nurse before we could proceed. The patient was then transferred to the closest

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

trauma center.

Employee health was closed by this time and my blood was drawn in the ER. I had to register first, which is where the real trouble began. I walked over to the registration desk where a gum-cracking junior high student took my information.

“What’s the problem?” she asked.

“I was in the trauma over there and I cut my finger with a scalpel.”

She looked to where I was pointing with disbelief.

“There was a trauma a few minutes ago over there,” I insisted. “I’m Dr. Cronin.”

Blank stare.

“I’m a surgeon. I just put a chest tube in the girl who was transferred downtown.”

I was a little proud of the chest tube thing as it had been a long time since my last one and it was just like riding a bike, except for the stabbing myself bit.

She was not impressed and asked me, “How would you like to take care of your co-pay?”

I thought this is what you get for hiring people who came to work on a learner’s permit and smugly told her, “There won’t be one.”

My blood was drawn and I was told to show up in Employee Health the following

week to report this event. I was promised that the patient’s rapid HIV results would be forwarded to me when they came back later that night. I never did hear about the HIV results but figured that no news is good news. I was thus delighted on the following Monday to have an email from ClaireCronin1@parentcompany.org, a nurse at Massachusetts General Hospital, who forwarded me the email that she received with the negative HIV results of the trauma patient. I have never met this Claire Cronin but I suspect she knows a fair bit about me based on the number of emails I, ClaireCronin2@parentcompany. org, get of hers. I am sure that she was just as happy for me as I was to see those negative results and I appreciate that she sent them on.

I called Employee Health the following week and was told to fill out an incident report in order to get my own HIV results. As far as I was concerned, incident reports were a dreaded nursing tool used to complain about doctors and not made available to those outside of the union.

After much discussion about the fact that I wasn’t a hospital employee, it was decided that no incident report was required and I was told that I was HIV-negative.

I contemplated letting Claire Cronin No. 1 know to close the loop but figured she would find out one way or another.

A few days later, another ER doctor called me to close the matter on this case.

It may have been a satisfaction survey but we started talking about the Bruins, so I think I missed the point of the call. I did mention that they might want to know that the HIV results were emailed to Massachusetts General Hospital but because they were negative, I didn’t mind.

The following day Claire Cronin No. 1 forwarded me the email from the ER saying that the case was officially closed.

All was good until a month later when I received my first bill from the hospital for $560. Actually that’s not true, my insurance had paid 75% of it already so I only owed $140. We got a big laugh about it among the surgeons and I took it to Employee Health to be fixed. On arriving in Employee Health, I introduced myself as a surgeon who had just been there a month earlier with an exposure issue and now I had a bill.

“Did you fill out an incident report?” the secretary asked me.

“No I didn’t because I am not an employee.”

“The problem is that you haven’t filled out an incident report.”

“No it’s not because I am not a member of the secret nursing society that actually knows how to use them. Can I speak with the director?”

The nurse who runs Employee Health is called for and agrees with me about the ridiculousness of being billed for something that happened while I was

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 20122

On my way back to the offfice with the bill still in hand,, I passed by the office of our chief mediical officer. He took the bill and offered d to pay it himself.

Two weekks later, my first bill for $180 arrived from m the ER physician visit. I gave it to Antonio. I wanted to tell him that he should valuee his services more but talking about m money is always awkward. We shared a lau ugh about the bill and relived the dramaa of the trauma resuscitation (i.e., th he chest tube).

Ih have enclosed my second bill alongg with this letter in the hopes

that something can be done before I get brought to small claims court. I am sure you can understand that I cannot continue to take ER call because frankly I can’t afford it. I will have to pay for two college tuitions in a few years (although getting past middle school is looking like it will be a stretch) and can’t risk additional assaults to my credit rating every time I get paged to the ER. Thank you for your understanding, Claire Cronin, MD P.S. You should consider hiring the gum-cracking teenager in the ER as a

9

future chief financial officer. She has a better grasp of how hospital finances work than I do, having predicted my co-pay that fateful night. —Dr. Cronin is a general surgeon in — Newton, Mass.

khorty@mcmahonmed.com.

As a side note, I think we can all do the math and see that the health care system assigns more value to a vial of blood than to the physician encounter. I find this as equally disturbing as the concept of being charged $740 for a night of call. covering the ER. Unfortunately, because a bill was generated she had no power to do anything about it except laugh at how silly it was. She advised me to speak with the chief of the emergency department (ED).

I presented him with the bill and told him the story, spending a lot of time on the details of the chest tube placement. “Unfortunately, I can’t do anything about this because it didn’t come from the ED,� he explained. “It came from the hospital. I can tell because our bills are far less than this. You would be shocked to see the difference in the amount one of my docs gets compared to a hospital charge.� It’s not a spoiler to admit that I eventually was. “I can send it in to the hospital for them to review if you write a letter that you were dissatisfied with your care during your ER visit,� he offered. “If you complain about your service, they will usually void it.� “But, I was never seen in the ER. I had to register to have my blood drawn because Employee Health was closed.

That’s the hospital policy,� I explained. “In fact, I don’t even think my insurance should have had to pay the $420 let alone me having to pay the differential.�

He put down his pen and looked at me, “Well now, that’s a whole different issue. I can’t help you with that. Just email me a letter about how you weren’t happy with your visit and this will go away.�

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10

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

Partial Breast Irradiation Gains Traction as Effective Therapy Possibly as Effective as Whole Breast Irradiation B Y M ONICA J. S MITH PHOENIX X—Accelerated partial breast irradiation (APBI) may be as effective as whole breast irradiation (WBI) for the prevention of local recurrence, according to research presented at the 2012 meeting of the American Society of Breast Surgeons (ASBrS; Ann Surg Oncol 2012 Jul 27. [Epub ahead of print]).

“I guess this is particularly timely, since there have been a few articles that are showing some controversy in APBI,” said Peter Beitsch, MD, director of the Dallas Breast Center.

For the past seven years, Dr. Beitsch has been the co-principal investigator of the ASBrS MammoSite registry, which was set up to collect data on women undergoing APBI with the MammoSite single-balloon catheter. The registry was established by the device manufacturer shortly after the FDA approved the device in May 2002. One year later, the ASBrS assumed primary management of the registry.

“It’s been my feeling over the last several years that there’s something quite unique about APBI and its ability to control the tumor bed,” Dr. Beitsch said. “We give radiation to lumpectomy patients really for one reason, and that’s to control disease that remains in the breast tissue surrounding the lumpectomy cavity.”

When surgeons first began performing breast-conserving therapy using lumpectomy and radiation, most women still were receiving mastectomies. “The concept of conserving the breast had to be coupled with something that treated the whole breast. There was no science behind how much to radiate, either the whole breast or just around the tumor; it was just to make it breast conservation equivalent in people’s minds to mastectomy,” Dr. Beitsch said.

The National Surgical Adjuvant Breast and Bowel Project (NSABP) trial that compared mastectomy with breast-conserving therapy with and without radiation found a much higher recurrence rate in women who did not receive whole breast irradiation (WBI); about 30% to 40% had recurrences at 10 years. Recurrence rates fell to 3% to 4% in women who did receive radiation (N Engl J Med 1989;320:822-828).

“The interesting thing is that if the patient did not receive radiation, most of the recurrences were around the lumpectomy cavity,” Dr. Beitsch said.

“When the patient was radiated, the

lumpectomy bed recurrences went down markedly but the ‘recurrences’ elsewhere in the breast did not and were actually equal to elsewhere recurrences in patients who were not radiated. I think these elsewhere recurrences are not recurrences of the first cancer, but new primaries. It makes sense to me that we need to deliver radiation to the lumpectomy bed, and that elsewhere in the breast it matters little if at all in patients with early-stage cancers.”

The ASBrS MammoSite Registry Trial followed 1,440 patients with breast cancer (1,449 cases) treated with APBI

statistically significant association was seen between IBTR and age under 50 years, positive or close margins, tumor size or positive nodes in patients with invasive cancer; however, there was an association between IBTR and younger age and close or positive margins in the DCIS group.

The researchers concluded that IBTR recurrence rates in patients treated with APBI using the MammoSite device are very good and similar to those seen in patients who receive WBI. APBI, however, was associated with proportionally fewer tumor bed recurrences than WBI.

‘Of course we wait for prospective randomized trials, but women in America can’t or won’t necessarily wait for all those results because they have cancers that must be treated today.’

— Peter Beitsch, MD

at 97 institutions between May 2002 and July 2004. Of those patients, 87% had invasive breast cancer, and 13% had ductal carcinoma in situ (DCIS). The median follow-up period was more than five years.

Ipsilateral breast tumor recurrence (IBTR) was seen in 50 patients (3.5%), with 14 recurrences (1.1%) seen at the initial tumor site and 36 (2.6%) elsewhere in the same breast. The only variable associated with IBTR was estrogen receptor-negative status. No

“Looking at the MammoSite data over the years, it struck me that we have a very low tumor bed recurrence,” Dr. Beitsch said. “If you look at every whole breast series, they all have a higher local tumor bed recurrence rate than elsewhere in the breast. So we flipped that ratio.”

There may be two explanations for this flip, he said. “Either the tumor bed is better controlled with brachytherapy, or brachytherapy causes more elsewhere occurrences. But I don’t think

‘The results...are quite good in properly selected patients, but we need a comparison to contemporaneous whole breast radiation therapy patients, not historical controls.’

—Hiram S. Cody III, MD brachytherapy causes more elsewhere recurrences because if you look at our elsewhere recurrence number, it’s basically the same as contralateral new breast primaries.”

The findings of the MammoSite registry contrast with the University of Texas MD Anderson Cancer Center study comparing APBI with WBI, that found about the same survive, but a higher rate of subsequent mastectomy and complications in women who underwent APBI ( (JAMA A 2012;307:1827-1837).

“The problem with the MD Anderson study is that it’s based on Medicare claims, not on reviews chart by chart.

Claims data never give you a clear picture of what you’re getting,” said Hiram S. Cody III, MD, attending surgeon on the Breast Service, Memorial SloanKettering Cancer Center, and professor of clinical surgery, Weil Cornell Medical College, both in New York City. “I think it’s suggestive information, but it’s not really clear proof that APBI has more complications than whole breast irradiation. We still really don’t know.”

Ideally, randomized trials, such as the NSABP B-39 comparing partial and whole breast radiation, will clarify the advantages and disadvantages of one treatment strategy over another.

Until then, said Dr. Cody, who does not use APBI in his practice, “my take on [the MammoSite registry study] is that the results of APBI are quite good in properly selected patients, but that we need a comparison to contemporaneous whole breast radiation therapy patients, not historical controls. We don’t have a definitive answer as to complication rates, but we should [get it] from randomized trials.”

Dr. Beitsch addressed the question of randomized trials, or lack thereof, during his presentation. “I hope this [study] will lead to some good discussion and further science. Of course we wait for prospective randomized trials, but women in America can’t or won’t necessarily wait for all those results because they have cancers that must be treated today,” he said.

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12

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

Study Seeks Predictors o Researchers Also Identitfy Rate and Risk of Conversion from Laparoscopic to Open B Y M ONICA S MITH

The researchers foound that a preoperative radiographic tum mor size greater than 8 cm significantly in ncreased the odds for conversion, as did th he need for any concomitant procedure.. “Interestingly, the indications for operaation in the converted patients really did not affect their odds for conversion,” Drr. Bittner said. The presence of metastases did increase the odds for conversion 5 to 1, but the number of such tumors was too small for this to reach statistical siggnificance.

Other factors rellated to conversion, although less important, included operative time longer thaan 240 minutes, estimated blood loss grreater than 100 mL and need for blood transfusion.

Surgeon experien nce also played a role in the rates of conversion: 2.6% in surgeons with a heavily advanced minimaally invasive surgery practice, compared with 17.2% in general surgeons, Dr. Bittner said.

assessing the operative approach and the risks for adrenalectomy.”

Gerald Fried, MD, professor and chairman, Department of Surgery, McGill University Faculty of Medicine, and surgeon-in-chief, McGill University Health Center Hospitals, in Montreal, who moderated the session, commented that one

SAN DIEGO—A growing body of literature supports laparoscopic adrenalectomy as the procedure of choice for most adrenal lesions, but few studies have evaluated factors leading to open adrenalectomy, risk factors for converting to open and morbidity associated with these decisions.

Researchers at the Washington University School of Medicine, in St. Louis, investigated this topic by retrospectively reviewing data on 402 patients, aged 16 years and older, who underwent adrenalectomy at their general surgery department between 1993 and 2010. James Bittner, MD, presented their study’s findings at the 2012 meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

‘We feel that the nature of the underlying Over the seven-year study period, 356 patients underwent adrenal pathology, tumor size and the need laparoscopic procedures and 42 for concomitant procedures significantly had open adrenalectomy. “The two groups were quite dispaimpact the selection of patients for an open rate,” said Dr. Bittner, instructor approach, the likelihood of conversion and in surgery, Section of Minimally Invasive Surgery, Mary Culver 30-day perioperative morbidity.’

Department of Surgery.

—James Bittner, MD The study’s first objective was to define factors predictive of patients selected for open adrenalectomy. The researchers found that Regarding outcom mes and 30-day mor- problem with reviews of large sets of retpatients in the open group were six years bidity, the open grou up had a longer time rospective data is figuring out how to older on average than those in the lap- to solid food intake, longer hospital stay use that information prior to surgery to aroscopic group, had significantly larger and higher rate of readmission, and inform decision making. “The greatest radiographic tumor size before surgery about half experiencced some complica- value of such a study would be to limit and had far more nonfunctioning lesions. tion, mostly minor, within 30 days. The the predictors to information available Indications for surgery, too, varied appre- greatest predictor of morbidity was indi- beforee surgery, so the surgeon could use ciably. The most common indications for cation for surgery. “In this group, a large, this information in discussion with the open adrenalectomy were a large and indeterminate or concerning mass; adre- patient and plan the required resources indeterminate mass and adrenocortical nocortical carcinoma; and primary adre- better,” Dr. Fried said. “Information like carcinoma, whereas the most common nal hyperplasia all increased or predicted intraoperative bleeding really isn’t useful indications for a laparoscopic adrenalec- 30-day morbidity,” Dr. Bittner said. and shouldn’t be used in the model.” tomy were pheochromocytoma and aldoTumor size larger than 6 cm, initial sterone-producing adenoma. selection for open adrenalectomy, conAlthough some larger Almost two-thirds of the patients in version to open and the need for conthe open group (63%) also required con- comitant procedures also increased the tumors can be removed comitant procedures, most often multi- odds for morbidity at 30 days. Additionlaparoscopically by organ resections. They also had a higher al predictors of 30-day morbidity includestimated blood loss, a greater need for ed longer operating times and blood loss surgeons experienced blood transfusion and a higher overall greater than 200 mL. with this technique, there complication rate.

“In conclusion, we feel that the nature “The second objective of our study was of the underlying adrenal pathology, is going to be a greater to define the rate and risk of conversion tumor size and the need for concomrisk for conversion to open from laparoscopic adrenalectomy to open itant procedures significantly impact adrenalectomy,” Dr. Bittner said. Of the the selection of patients for an open adrenalectomy,” 356 patients in the laparoscopic group, 22 approach, the likelihood of conversion —L. Michael Brunt, MD (6.2%) required conversion, a proportion and 30-day perioperative morbidity,” that remained consistent over the course Dr. Bittner said. “We feel these metof the study. rics should be at least considered when

L. Michael Brunt, MD, professor of surgery, Washington University School of Medicine, and senior author for the study, said the best way to use the findings is to understand the two most important variables that complicate adrenalectomy. “The take-home message is that larger tumor size is an indicator of increasing difficulty with adrenalectomy. Although some larger tumors can be removed laparoscopically by surgeons experienced with this technique, there is going to be a greater risk for conversion to open adrenalectomy,” Dr. Brunt said.

“The other point about tumor size is that for adrenocortical tumors, as size increases, the chances that it is a malignant adrenal cortical cancer goes up,” he said. “The plus side is that aldosteronomas, cortisol-producing adenomas and most pheochromocytomas can almost always be done laparoscopically in experienced hands.”

Dr. Bittner had no disclosures to report.

Dr. Brunt receives speaking and teaching honoraria from Ethicon Endo-Surgery and LifeCell Corporation.

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14

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

Sexual Misconduct by Professionals: A New Model of Understanding B Y G REGORY E. S KIPPER , MD, AND S TEPHEN S CHENTHAL , MD [Editor’s Note: The following articles (see also page 18) were originally published in two parts in Missouri Medicine, May/June 2012].

Illustrations The following are but a few fictional examples drawn from compilations of real cases: •

An overworked married pediatrician was attracted to a single mom in his practice. They became friendly and one day he offered to help if she ever needed anything fixed around the house. Eventually she called and asked him to come over to fix a leaky faucet. This started an affair that lasted several months. When his wife discovered the affair, he broke it off. The mother became angry, felt exploited and retained an attorney.

Comment It’s important to realize that the family of patients can be considered patients too, especially in pediatrics, where the parents are considered patients along with their children.

---------• A general surgeon kissed an employee, who also was his patient, when she came to him crying about a problem she was having. Word got out in the office and a formal complaint was made to the medical board.

Comment Treating an employee, neighbor or anyone else, means that the person then becomes a patient.

---------• A family practitioner finally gave in to a seductive patient who brazenly seduced him.

Comment Claiming that an affair was the patient’s fault doesn’t work. It’s the doctor’s sole responsibility to set limits and act professionally. If you are uncomfortable with a seductive patient, refer him or her to another doctor.

Professional Sexual Misconduct Betrayal and exploitation are among the most egregious of human offenses, and when they involve a health professional preying on a vulnerable patient, the most basic of ethical principles are violated. When the patient– physician relationship is exploited and professional sexual misconduct (PSM) occurs, it is particularly problematic because it strikes at the core spirit of the profession.

The breach of trust associated with PSM is damaging to the patient, the health professional and the medical profession at large. It’s damaging to the patient, who is exploited and may never trust another health professional. It’s damaging to health professionals, who often lose their reputations, find their finances plundered and their licenses revoked and in more than two dozen states, find themselves subject to criminal charges and imprisonment. Finally, it’s damaging to the medical profession at large because of degradation in the perceived legitimacy of the profession each time this happens.

Unfortunately, claims of PSM are not rare. A confidential survey1 found that 8% of physicians admitted committing some degree of PSM with one or more

Physician sexual misconduct is behavior that exploits the physician– patient relationship in a sexual way, whether verbal or physical, or expressions of thoughts and feelings or gestures that are sexual or that reasonably may be construed by a patient as sexual. patients, and most physicians acknowledge they’ve been tempted. Despite this, there is a generalized denial in the health professions regarding the risks and/or existence of PSM and a taboo regarding discussing it. Even with the “sexual” nature of the offense, it turns out that health professionals who’ve committed PSM rarely have any type of sexual disorder. Very few are true sociopaths. Most of the time, in fact, these physicians simply lose good judgment and believe they’ve “fallen in love” with the patient.

Most physicians who commit PSM do so in times of personal trauma or professional crisis, when judgment is diminished. Unresolved vulnerabilities may arise associated with overwork or professional dissatisfaction. The turbulent times of midlife often trigger PSM. To flee the pain of parental death, a failing marriage or empty nest issues with the departure of children to college are times when physicians may “act out” inappropriately.

All this becomes more relevant by the fact that PSM is preventable. Educating physicians about good boundaries and helping them become more aware of their vulnerabilities and risks and ways of setting up their practice to protect patients and themselves is critical. Not only is PSM preventable, but doctors who commit PSM usually are treatable, and relapses are rare when good treatment and education occurs and precautions are taken.

Considering the very damaging real-life consequences

of PSM, it is surprising how casually it is depicted on TV and in movies. The discordance between how professional boards and criminal agencies view PSM versus its media portrayal is troubling, and may contribute to the risk for PSM because it creates a false sense of acceptability for inappropriate relationships with patients. Additionally, there are many stories about relationships between doctors and their patients leading to successful marriage, without any apparent harm. These, however, are the exceptions. More typically, the patient eventually becomes aware of a sense of exploitation and becomes very angry. Not uncommon are cases in which a physician–patient marriage ends in divorce, at which time the ex-spouse files a complaint and lawsuit—and wins. It’s tragic that as terrible and devastating as PSM is, it is essentially a taboo subject; little or nothing is taught regarding PSM in medical schools, and it’s rarely a subject for postgraduate training.

To help prevent PSM, it’s important to have a basic understanding of boundary theory and the dynamics that underlie boundary violations, to develop vigilance for early warning signs of potential boundary problems with patients, and to gain insight into professional and personal vulnerabilities and risk factors. Excellent continuing medical education–based courses are available for further in-depth training.

PSM (synonymous with “sexual boundary violation”) can be defined as any action of a sexual nature that oversteps or disregards ethical or legal limits of professional behavior. For our purposes, sexual refers to any erotic physical contact, and also may include sexual behavior involving language or gesture. Even the use of sexual humor or informal speech can be deemed misconduct.

The somewhat vague concept of “boundary” is made more explicit by reference to professional ethical and legal norms.

Ethical prohibition against sexual relations with patients dates back at least as far as the Hippocratic oath of ancient Greece. An abbreviated version of the passage states: “[I] will abstain from every voluntary act of mischief and corruption; and, further from the seduction of females or males, of free men or slaves.” Most professional societies have a code of ethics that contains clear statements regarding what constitutes appropriate sexual boundaries. The major area in which these codes differ is regarding how long, if ever, it is necessary following termination of the patient–physician relationship before a relationship can be pursued. On the subject of where the lines are drawn inside the professional relationship, they are essentially identical.

The Federation of State Medical Boards, in a policy statement in 2007, clearly defines what it considers sexual boundaries, and states that disciplinary action should be taken against any physician who violates them. Here are some salient excerpts from that document: “Physician sexual misconduct is behavior that exploits the physician–patient relationship in a sexual way. This behavior ... may be verbal or physical, and may include expressions of thoughts and feelings or gestures that are sexual or that reasonably may be construed by a patient as sexual. … There are primarily two levels of sexual misconduct: sexual violation and sexual impropriety. Behavior listed in both levels may be the basis for disciplinary action by a state medical board. ... Sexual violation may include physician–patient sex, whether or not initiated see SEXUAL MISCONDUCT page 16

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16

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

SEXUAL MISCONDUCT jcontinued from page 14

by the patient, and engaging in any conduct with a patient that is sexual or may be reasonably interpreted as sexual. Sexual impropriety may comprise behavior, gestures or expressions that are seductive, sexually suggestive or sexually demeaning to a patient.”

The document goes on to state, “Findings of sexual misconduct are often sufficiently egregious as to warrant revocation of a physician’s medical license, although

a lesser action may be considered for cases of sexual impropriety.”

It is important to know that most acts of PSM occur following progressive problems with boundaries that precede the PSM. Often these steps are referred to as “boundary crossings,” which may be initiated with the best of intentions, but progressively tumble down a “slippery slope” of professional destruction. Although these precedent behaviors are not necessarily unethical in and of themselves, they are major warning signs. In order to prevent sexual boundary violations, it is important to understand this progression

and the precedent boundary disturbances.

Sometimes these boundary disturbances are limited to one patient or one particular type of patient, and in other cases they may characterize the clinician’s general practice style. In the context of rehabilitation from sexual boundary violation(s), it is incumbent on the professional to address all of these boundary issues.

Precedent boundary problems can include time issues, such as extending the time of office visits (often by scheduling at the end of the day), conducting the visit during non-office hours or by extending the visit from the last appointment of the

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An important adage to remember is that when it comes to boundaries, “perception is everything.”

The misinterpretation of a therapeutic hug as romantic may be impossible to defend. day into non-office hours (after the staff leave the office).

Another category of precedent behaviors includes “concepts of place and space,” for example, making home visits (except when clearly part of regular practice), meeting a patient at a social occasion or agreeing to share a meal with a patient at a restaurant. Another area, giving or receiving gifts, can be a problem if it tends to “deprofessionalize” the relationship, encourage romanticizing of the relationship or interferes with therapeutic aims. In general, it is a good idea to have an office policy that gifts from patients are not accepted (except to the office as a whole).

Physical contact is another area of concern. There are times in the course of clinical practice where touching the patient outside of a physical examination is accepted, such as a handshake at the beginning or end of an appointment, or the placing of a hand on the shoulder as a comforting gesture. Some practitioners also feel it is permissible to hug patients at times, although, depending on the characteristics of the patient, this can be very dangerous. Context clearly is important in determining the extent that a hug may be thought of in this way. Hugging can cause serious confusion in the professional relationship, can be interpreted or experienced in a romantic way by the patient and can lead to greater intimacy. An important adage to remember is that when it comes to boundaries, “perception is everything.” The misinterpretation of a therapeutic hug as romantic may be impossible to defend.

Boundary issues involving money can precede PSM. Examples include lending or borrowing of money from patients, business activities with patients or even bartering in place of the standard fee.

It’s also important to be careful of the language used with patients. Using the title of doctor, for example, helps establish the professional relationship. The use of a too-familiar tone of voice, the use of inappropriate colloquial language or the use of first names can be risky, especially in some settings. Wearing a white coat reinforces the professional image. Informal dress may convey the opposite. Finally, the issue of self- disclosure should be mentioned. Although it is not uncommon

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

for clinicians to occasionally share a story with a patient or to reveal selective aspects of their personal experience, the injudicious sharing of private information clearly is a boundary crossing, and interferes with the aim of the professional relationship. The disclosure of personal problems is virtually always inappropriate. Sharing by the doctor with the patient that he or she has an unethical attraction to the patient is highly inappropriate. This type of boundary crossing commonly precedes PSM. Preexisting vulnerabilities afflicting the physician, such as psychiatric illness; alcohol and/or substance abuse disorder; paraphilia; personality or mood disorders; sexual compulsivity or addiction; and/or insufficient support, supervision, oversight or accountability make PSM more likely to occur. Other factors that can predispose the physician to PSM include marital/family problems, midlife or late midlife stage-of-life crisis and burnout. Similar preexisting vulnerabilities affecting a patient also can increase risk.

Patients with histories of sexual abuse appear to be particularly vulnerable.

It is important for every physician to know that PSM is unethical and can carry harsh consequences. Physicians should recognize inappropriate behaviors and not act inappropriately due to their emotional attractions to patients. Ultimately, it’s best to refer the patient causing concerns to another physician.

Before pursuing a relationship with a patient, the physician should contact his or her specialty society for more guidelines to ensure it is ethical and safe. Consulting a good therapist prior to taking any action also is a good idea. Physicians also are ethically responsible to protect their colleagues. If a physician sees red flags of an evolving boundary problem in another physician, an intervention should be considered. Stepping in can save a professional and protect a patient. Failing to follow these recommendations is very likely to be costly to everyone involved.

Reference 1. Bayer T, Coverdale J, Chiang E. A national survey of physicians’ behaviors regarding sexual contact with patients.

SMJ. October 1996. http://www.fsmb. org/pdf/GRPOL_Sexual %20Boundaries.pdf

Gregory E. Skipper, MD, is director of professional health services, Promises, and former medical director, Alabama Physician Health Program.

Stephen Schenthal, MD, is founder of www.professionalboundaries.com, Destin, Fla. See page 18 for ways on safeguarding yourself against allegations of sexual harassment.

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OFIRMEV should be administered only as a 15-minute intravenous infusion.

Discontinue OFIRMEV immediately if symptoms associated with allergy or hypersensitivity occur. Do not use in patients with acetaminophen allergy.

The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients.

OFIRMEV is approved for use in patients ≥2 years of age.

The antipyretic effects of OFIRMEV may mask fever in patients treated for postsurgical pain.

To report SUSPECTED ADVERSE REACTIONS, contact Cadence Pharmaceuticals, Inc. at 1-877-647-2239 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.com.

Please see Brief Summary of Prescribing Information on adjacent page or full Prescribing Information at OFIRMEV.com.

*Randomized, double-blind, placebo-controlled, single- and repeated-dose 24-h study (n=101). Patients received OFIRMEV 1 g + PCA morphine or placebo + PCA morphine the morning following total hip or knee replacement surgery. Primary endpoint: pain relief measured on a 5-point verbal scale over 6 h.

Morphine rescue was administered as needed. †SPID24=sum of pain intensity differences, based on VAS score, from baseline, at 0 to 24 h.

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

2. Data on file. Cadence Pharmaceuticals, Inc.

©2012 Cadence Pharmaceuticals, Inc. All rights reserved.

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

OFV11310112

OFIRMEV.com

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Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

Safeguarding Yourself Against Allegations of Sexual Abuse or Patient Impropriety B Y H ARVEY T ETTLEBAUM , JD, AND K EVIN M EYERS , JD

B

y drawing boundaries between their personal and professional lives, physicians can protect their practices and themselves while also still achieving their true goal: providing quality care to their patients.

As an attorney, I know that lawyers and doctors are frequently strange bedfellows. However, the two professions

have one thing squarely in common, and likely always will. No matter where we are or who we’re surrounded by, be it at a church, synagogue or mosque, at a dinner party, having a drink at a pub, or even when simply spending time with extended family over the holidays, the same question always comes up, “Hey, can I ask you something?”

The lines between patient and professional are frequently blurred, especially in rural areas, where “the family doctor”

can, after knowing a particular family of the common good is still bound by ethical requirements, and it can be tough to tell where the line between the two begins or ends. With allegations of physician sexual abuse of patients continuing to be in the headlines, doctors need to be alert to prevent even the appearance of impropriety. Physicians can safeguard themselves with a few simple suggestions that will ensure that quality care is being provided with a minimum of issues.

1. Use Your Office The simplest line to draw is to always insist that patients be seen in-office whenever possible. This rule frequently can be used to politely brush aside random inquiries that doctors (and I, as a lawyer) frequently get at social occasions. The person saying, “Hey, can I ask you something? I’ve got this issue with my back...” should be politely redirected by merely saying, “Of course you can.

Here’s my card. Why don’t you call my office and we can set up an appointment for next week.” By directing patients to your office whenever possible, you help to maintain the line between friendship and professional practice.

2. Redirect When Necessary If a patient or potential patient behaves in a way that gives you pause or you otherwise feel as though you cannot remain professionally objective with respect to that person’s care, refer the individual to another physician immediately. If someone asks you for your advice on an informal basis, providing that person with the contact information of a doctor who is a specialist in the area of inquiry will help to redirect the conversation away from your own medical expertise. Physicians who field phone calls from their patients at all hours of the day and night are advised in nonemergent situations to politely ask the patient to call again in the morning or refer the individual to the on-call physician (e.g., “You need me at my best and asking me to give an opinion late at night does not fully benefit either of us”).

3. Charge for Your Services Although it may seem difficult to charge friends or family for your services, remember your expertise and knowledge are all you have to sell. Giving away your time devalues your skills. You deserve to be compensated for your services. If you charge for your services, it helps to remove any doubt that your advice and treatment were made in your full capacity as a physician, not “just as a friend.”

Finally, in some instances, this practice will likely dissuade some people from coming to you during off-hours with trivial complaints.

4. Always Ask Yourself if Your Objectivity Is Being Compromised Every professional must be vigilant to ask this very question as relationships and issues change. Although you may be comfortable treating your child’s ear infection, objectively as a professional could you perform surgery on your

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

Romantic relationships with married patients, married or single staff or minors, is a professional, financial and legal disaster of the gravest order. own child? What about the child of a close friend or a co-worker? In those instances, it is not an issue of competence but one of clearly separating personal and professional relationships. As situations change, you may be called on to re-evaluate whether you can objectively treat a patient you have treated for several years or decades. As time passes and relationships change, the nature of the physician–patient relationship should be re-evaluated as well.

same office, for care. Romantic relationships with married patients, married or single staff or minors, is a professional, financial and legal disaster of the gravest order.

Conclusion The key to retaining professional objectivity and to finding the right balance between being a professional and being a person is vigilance. The five suggestions given here easily can

be combined into one general principle: Draw boundaries. By drawing boundaries between their personal and professional lives, physicians can protect their practices and themselves while also still achieving their true goal: providing quality care to their patients.

—Harvey Tettlebaum, JD, is a part— ner in the Jefferson City, Mo., office Husch Blackwell LLP. Kevin Meyers, JD, is an associate at Husch Blackwell’s Springfield office.

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5. Avoid Charges of Sexual Harassment In today’s world of heightened sensitivity to what may appear to be inappropriate conduct, it is recommended, especially within the physician’s office, to maintain an atmosphere of political correctness. This requires maintaining the appearance of appropriate, professional distance between yourself and your patients at all times. It may require a staff person of the same sex as the patient be in the room during an examination of patients of opposite sex from the physician. It requires sensitivity to appearances.

For example, when patients are close friends of the opposite-sex physician, greeting them with a kiss on the cheek or a hug may be regarded by staff and colleagues as inappropriate because they may not know of the prior existing relationship. A physician should always be ready for the patient who is sexually forward or otherwise a bit too friendly.

This behavior must be immediately and politely deflected with statements that do not embarrass the patient but make clear your position on such conduct (e.g., “I am sorry but professional standards do not allow what may be regarded by others as not appropriate conduct with a patient”).

If the behavior does not stop, you should consider seriously terminating the physician–patient relationship. Of paramount importance, for unmarried physicians, the development of romantic relationships with office staff or patients must be approached with the greatest of caution. It is recommended that the physician refer his or her romantic interest to another physician, ideally not in the

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In the News SURGICAL SITE INFECTION

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

$168,000 and $280,000 during one year.

The success is even more striking when pitted against four studies over the first program being the landmark inilast two years that did not find an assotiative by Pronovost et al. This study ciation between compliance with Surgidemonstrated that a multidisciplinary cal Care Improvement Project measures team approach involving a safe practicand SSI rates. According to Dr. Wick, es checklist dramatically reduced central top-down bundles may fail because they line–associated bloodstream infections may address the wrong issues or caregivin an intensive care unit (N Engl J Med ers may be reluctant to embrace them.

2006;3552725-2732).

“If people are going to use these proThe Hopkins team that adapted cesses, make sure they are CUSP to the surgical setting includ- “It is important to go around and check involved in developing ed surgeons, nurses, anesthesiologists to make sure that what you have begun them, and then they think and a hospital administrator. Through they are valuable,” she said. an anonymous survey, this team pro- and initiated is actually being done.”

Dr. Wick pointed out vided input into how they thought an —Christopher Mantyh, MD that the Centers for MediSSI would develop and what could be care & Medicaid Services done to prevent it. After analyzing the will begin using SSI rates responses, they created a list of six inter- was actually done. as a quality indicator in ventions, taking into account the burIn the year prior to the 2013. den of implementing each measure and CUSP program, the overChristopher Manthe published evidence supporting it. A all SSI rate in patients tyh, MD, chief of senior executive attended CUSP meet- undergoing colorectal surgastrointestinal and ings to ensure that resources were avail- gery was 27.3% (76 of 278 colorectal surgery at able to address safety concerns and assist patients). During the year that Duke University Mediwith system-wide barriers.

CUSP was implemented, the cal Center, Durham, N.C., The interventions included standard- rate fell to 18.2% (59 of 324 patients). pointed out that the Hopkins ization of skin preparation, adminis- With an average SSI estimated to cost SSI rate is still high, compared with the tration of preoperative chlorhexidine between $6,000 and $10,000 (Ann ( national average that hovers around 13% washcloths, selective elimination of Surgg 2004;239:599-605), the CUSP for colorectal operations, but he said the mechanical bowel preparation, warming intervention saved Hopkins between CUSP program did a good job of quickly reducing SSI rates. He is curious as to whether the rates can be maintained.

Table. Interventions Used for the Comprehensive “What I have found in our bundled Unit-Based Safety Program for Colorectal Surgery programs and quality improvement projects is that it is important to go around Standardized skin preparation and check to make sure that what you have begun and initiated is actually being Skin preparation is standardized and performed by done,” Dr. Mantyh said. gastrointestinal surgery nurses only. Prior to this Dr. Mantyh said Duke also uses a simstandardization, the preparation application technique was ilar checklist approach in their Enhanced variable and performed by residents or nurses.

Recovery After Surgery program. This Chlorhexadine wash cloths initiative involves closure trays, chlorhexidine sponges and patient-warming proChlorhexidine gluconate is used for all patients undergoing cedures, in addition to a slew of other colorectal surgery, including patients with ostomies. Patients measures. also are instructed to use chlorhexidine wash cloths on the “A lot of people are paying particular evening before surgery. attention to surgical site infections for lots of reasons, everything from finanSelective elimination of mechanical bowel preparation cial reasons to the fact that this will be Mechanical bowel preparation with oral antibiotics is reportable in the next year or so,” said recommended.

Dr. Mantyh. “Surgical site infection rates will be something that patients can look Warming patients in the preanesthesia area up and see what a hospital’s SSI rate is. At Lower-body forced-air warming blankets are placed on some point, it may be surgeon-specific.” colorectal surgery patients as soon as they change clothes The Agency for Healthcare Research from their out-of-hospital attire to patient attire. and Quality has launched a national project to implement CUSP in operating Enhanced sterile techniques rooms called SUSP (surgical unit-based safety program). The project is currentA set of instruments is used exclusively for bowel ly enrolling participating hospitals. For manipulation. more information, contact Lisa LubomImproving administration of prophylactic antibiotics ski, PhD, a Johns Hopkins health services researcher, at lluboms1@jhmi.edu.

To address incorrect administration of prophylactic antibiotics, the CUSP team implemented an education program involving Drs. Wick and Mantyh had no relevant grand rounds lectures and Web presentations. A Web-based disclosures. calculator also was installed in the documentation system to facilitate appropriate dosing. jContinued from page 1

of patients in the preanesthesia area, adoption of enhanced sterile techniques for bowel and skin portions of the case, and addressing lapses in prophylactic antibiotics (Table). The CUSP team reviewed unit-level safety data monthly and developed local quality improvement initiatives to improve teamwork, communication and address identified hazards. A checklist traveled with the patient to ensure that each intervention

TORT REFORM

jContinued from page 1 Ronald M. Stewart, MD, professor and chair of surgery, University of Texas Health Science Center, San Antonio.

Dr. Stewart presented the study at the 2012 annual meeting of the Society for Surgery of the Alimentary Tract, part of Digestive Disease Week 2012.

Dr. Stewart measured the changes in physician population in Texas after tort reform was implemented, and compared the results with overall population data and hospital survey data for the next 10 years. To count the number of physicians in the state, they used data from the Texas Medical Board and included all in-state licensed physicians who were actively practicing.

Results showed that the population of Texas grew by 21% between 2002 and 2012. Over the same period, physicians practicing in the state increased by 44%, or 15,611, resulting in an additional 30 physicians per 100,000 residents of the state.

The change was most pronounced in metropolitan areas, which received the bulk of population growth for both physicians and the overall population. The population of the state’s metropolitan residents rose 23%, but was outpaced by a 46% increase in physician migration to these areas. Non-metropolitan areas had no per-capita growth in physicians.

The study findings challenge a controversial 2011 report from the consumer advocacy group, Public Citizen. In it, the group claimed that the rate of new doctors in Texas actually fell after the state’s $250,000 noneconomic damages cap was enacted in 2003. The report also argued that health care in Texas became more expensive and less accessible after the malpractice caps took effect.

Doctors and other tort reform advocates immediately took issue with Public Citizen’s report, arguing that it underestimates the physician manpower in the state by omitting all physicians who list research time and all physicians at academic medical centers.

Andrew Warshaw, MD, the W. Gerald Austen Distinguished Professor of Surgery at Harvard Medical School and surgeon-in-chief emeritus at Massachusetts General Hospital, both in Boston, said the new study demonstrates that tort reform can improve health care by reducing the economic and human costs associated with malpractice litigation.

“The number of malpractice suits fell substantially; liability premiums declined for doctors and hospitals; and the number of licensed physicians adjusted for rising population increased significantly after the passage of tort reform.”

But, he said many important questions remain unanswered, questions such

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

as: Is the resulting quality of care better?

Are any of the health care savings passed along to patients?

Most importantly for critics of tort reform, the report does not prove causality, a fact acknowledged by the study authors. Other factors, particularly the state’s strong economic growth in the post-tort reform era, could have spurred some of the physician migration to the state after 2003.

For nearly every year after 2000, the rate of Texas job growth was a full percentage point or more above the national average. The state’s population, too,

‘A fivefold reduction in lawsuits with significant reduction in litigation, as we showed in a previous paper, is not trivial.’

—Ronald M. Stewart, MD grew at a pace far above the national average.

Although the state economy certainly attracts some physicians, it is not likely the sole driver of the increased numbers

of actively practicing physicians, said Dr. Stewart. The economic situation for Texas physicians isn’t all rosy, he pointed out: Reimbursements have fallen, and the payer mix is unfavorable compared with other states.

Dr. Stewart said he believes physicians are attracted at least in part by reduced insurance premiums and lessened litigation risk. “A fivefold reduction in lawsuits with significant reduction in litigation, as we showed in a previous paper, is not trivial.”

The study also showed that the increases varied by specialty. Overall,

By the Numbers Physician Population Change In Texas by Specialty S urgeons (Total)

+4%

General surgeons

PCPs

+15% +3%

OB/GYNs

OB/GYN, obstetricians/gynecologists; PCPs, primary care physicians

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the number of surgeons practicing in the state increased by 1,557, or 4% per capita. That figure largely represents subspecialist surgeons; surgeons who identified as general surgeons fell over the 10-year time period. Primary care physicians increased by 15% in per-capita representation, whereas OB/GYN physicians increased by 3% per capita.

It’s a surprise that more OB/GYNs did not move to the state following tort reform, as they were the specialists most targeted by malpractice suits, said Dr. Warshaw.

The investigators also compared their data with hospital survey results in an attempt to see how tort reform and the subsequent increase in physicians played out in hospitals.

Results indicate that tort reform legislation has resulted in liability savings for hospitals, money that was redirected at least in part to programs for patients.

In the 2008 survey, 58% of hospitals reported that they expanded patient safety programs, and 69% said they were able to grow or maintain services.

Eighty-five percent of hospitals reported that they found it easier to recruit physicians after tort reform legislation was implemented.

This is the third study from Dr. Stewart and colleagues to examine changes in the Texas practice environment after tort reform. A study published in the Journal of the American College of Surgeons in April found that the total number of complaints, investigations, disciplinary decisions, license revocations or surrenders, and financial penalties from the Texas Medical Board significantly increased (2012;214:567-571). A study published in 2011 showed that implementation of tort reform in Texas was associated with a significant decrease in the prevalence and cost of surgical malpractice lawsuits at one academic medical center ((JACS 2011;212:463-467).

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012 ISSUES FOR THE BARIATRIC & METABOLIC PROFESSIONAL

Extended Quarterly Coverage

Sleeve Gastrectomy Gets Partial Green-light Coverage From CMS A Case-by-Case Approach; Some Early Success; National Coverage Still the Hope B Y C HRISTINA F RANGOU

T

he Centers for Medicare & Medicaid Services (CMS) will give local Medicare contractors the right to cover laparoscopic sleeve gastrectomy (LSG) on a case-by-case basis.

In a June 27 letter announcing the decision, the CMS said there is not enough evidence to warrant a broad approval of coverage of LSG. But, the agency said, individual patients may benefit from this procedure.

Local contractors are “in a better position” to consider the characteristics of individual beneficiaries and the performance of eligible bariatric centers within their jurisdiction, according to the CMS statement.

“Taking into consideration the seriousness of obesity, the possibility of benefit in highly selected patients in qualified centers, we believe that local Medicare contractor determination on a case-bycase basis balances these considerations in the interests of our beneficiaries.”

The decision only relates to the laparoscopic approach and to a sleeve gastrectomy done as a “stand-alone” procedure.

The American Society for Metabolic and Bariatric Surgery (ASMBS) said the decision will make LSG an option for more Americans.

“On behalf of our patients, ASMBS is very pleased and gratified that CMS has recognized the true value and compelling

need for coverage of this procedure,” said the ASMBS in a statement.

Right now, LSG is the fastest growing in popularity of all bariatric procedures and is covered by all major insurers other than CMS. The ASMBS said that the organization would have preferred a broad national approval of LSG. The partial go-ahead will require additional work at the regional level to secure coverage.

The national Medicare program is divided into 10 Medicare Administrative Contractor (MAC) jurisdictions, and each jurisdiction will have the power to decide on LSG coverage.

John M. Morton, MD, associate professor and director of bariatric surgery and surgical quality at Stanford School of Medicine, in Stanford, Calif., said the ASMBS has identified a “local champion” in each region who will work with Medicare administrators.

So far, a number of ASMBS members have reported that local authorities have already cleared patients for an LSG. “We’ve heard very positive feedback and believe everything will work out. It looks like it will take some time and effort but, at the end of the day, Medicare beneficiaries are going to enjoy the same level of coverage as the rest of America,” said Dr. Morton.

The ASMBS still hopes to achieve national CMS coverage for the LSG. The recent announcement from CMS comes after a proposed decision from the agency in March in which CMS said it would not cover sleeve gastrectomy outside of randomized clinical trials, calling

‘It’s remarkable how consistent this is in showing the validity of the data. It shows that the sleeve gastrectomy, a brand new, very complex procedure, can be introduced safely and effectively when performed at a standard bariatric accreditation program.’

—Matthew Hutter, MD

for more long-term studies and more randomized studies.

The ASMBS appealed the decision immediately, citing several recently published clinical studies on sleeve gastrectomy, including two randomized trials and one prospective cohort study.

“These studies provide clear and compelling evidence that the laparoscopic vertical sleeve gastrectomy is safe and effective on a randomized trial basis with both medical therapy and CMS-covered bariatric surgeries as controls,” the ASMBS wrote in a letter appealing the decision.

In the month following the CMS’ proposed decision, hundreds of surgeons and patients wrote in to comment on the decision. The overwhelming majority argued for full coverage, although two bariatric surgeons and one manufacturer of a gastric band device agreed with the CMS proposal; all three said that although shortterm outcomes were available, there are insufficient medium and long-term data.

At the ASMBS annual meeting in June, just prior to the CMS announcement, researchers presented more evidence to support the agency’s full coverage of laparoscopic sleeve gastrectomy. The data was submitted to CMS in advance of the meeting.

In the largest reported series to date, Dr. Morton and his colleagues showed that the sleeve gastrectomy has a safety and efficacy profile that fits in between the two CMS-sanctioned bariatric procedures, gastric bypass and laparoscopic gastric banding.

The researchers studied nearly 270,000 metabolic and bariatric operations see CMS COVERAGE PAGE 36

The Murky Landscape of Weight Discrimination Law Different Courts Interpret Law Differently in Defining Morbid Obesity as a Disability B Y V ICTORIA S TERN

A

fter almost eight years at her job, Lisa Harrison was fired from the Family House of Louisiana, a long-term residential treatment facility for chemically dependent women and their children in Terrytown, La. One month after her termination, Ms. Harrison filed a discrimination charge with the Equal Employment Opportunity Commission (EEOC) against the Family House, claiming she was let go because her employer considered her disabled by her obesity, in violation of the Americans With Disabilities Act (ADA) of 1990.

At 5’2” and weighing more than 500 pounds, Ms. Harrison’s body mass index (BMI) was over 91 kg/m2 (more than twice the BMI threshold for morbid obesity). The

same person who had hired her in had failed to accommodate her.

1999 terminated her, and no one Courts have disagreed The arguments that followed and the at the company was aware of sigjudge’s ultimate ruling highlight how on several issues nificant fluctuations in her weight murky and inconsistent the law can be regarding weight during that time. when dealing with weight discrimination While the charge was still pend- discrimination, such as issues. ing, Ms. Harrison died at age 48 on Nov. 1, 2009. Her death certificate whether an individual Weight Discrimination Law listed the cause of death as “morMichigan state law specifically bans needs to prove an bid obesity” and included hyperweight discrimination, and six cities tension, diabetes and congestive underlying physiologic (Washington; San Francisco; Madison, heart failure as other conditions disorder for obesity. Wis., Santa Cruz, Calif.; Birmingham, contributing to death. A year later, N.Y.; and Urbana, Ill.) also offer some on Sept. 30, 2010, the EEOC went type of protection, but currently no fedforward with the suit on Ms. Harrison’s behalf. Like eral law prohibits obesity discrimination. As a result, Ms. Harrison, the EEOC claimed that her employer plaintiffs have brought claims under the ADA, which regarded her as disabled because of her obesity; howev- have met with varying degrees of success. er, unlike Ms. Harrison, the EEOC alleged that she was “Weight, in and of itself, is not a protected actually disabled by her obesity and that Family House see DISCRIMINATION PAGE 24

24

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012 ISSUES FOR THE BARIATRIC & METABOLIC PROFESSIONAL

Extended Quarterly Coverage

DISCRIMINATION jContinued from page 22

characteristic under federal law,” Tanya Goldman, senior trial attorney for the plaintiff, EEOC, New Orleans Field Office, told General Surgery News, in an email. “It is only where a person’s weight rises to the level of being an impairment, might that person be disabled. At that point, the individual would still have to show that her weight substantially limits her in a major life activity, that she is qualified and that the adverse employment action was taken because of the disability.”

The ADA of 1990 defines “disability” as a physical or mental impairment that substantially limits one or more major life activities, a history of such an impairment or being regarded as having one.

According to the ADA, no person can discriminate against a qualified individual on the basis of a disability “in regard to job application procedures, the hiring advancement or discharge of employee.”

A qualified individual with a disability “can perform the essential functions” of his or her job, including those who “can only do so with reasonable accommodation.” To prove an employer violated the ADA due to weight discrimination, “the plaintiff must allege that the employer

believed, however erroneously, that the plaintiff suffered from an ‘impairment’ that, if it truly existed, would be covered under the statutes and that the employer discriminated against the plaintiff on that basis.”

However, courts have disagreed on several issues regarding weight discrimination, such as whether an individual needs to prove an underlying physiologic disorder for obesity. Some courts, for instance, have found morbid obesity to be a covered impairment only when evidence establishes that the obesity was caused by a physiologic disorder, such as hypothyroidism (N Engl J Med 2008;359:192199). In such instances, simply overeating would not be protected.

In the 1993 case Cook v. Rhode Island, Department of Mental Health, Retardation, & Hospitals, the First Circuit Court of Appeals determined that an employee (who was 5’2” in height and weighed more than 320 pounds) was disabled and entitled to the protections of the ADA because her morbid obesity was caused by a “dysfunction of both the metabolic system and the neurological appetite-suppressing signal system.”

In Francis v. City of Meriden (2nd Cir., 1997), the court ruled that a firefighter, who was terminated for failing to meet the weight guidelines of his job, was not

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“I think it stands to reason that if environmental factors favor obesity development and these factors are reversed, we would see a decrease in obesity prevalence. But in reality, in the vast majority of obese people, this doesn’t happen. Obesity is very hard to reverse.”

— Michael Schwartz, MD

protected under the ADA because “obesity, except in special cases where obesity relates to a physiological disorder, is not an impairment.”

Other cases, however, have not required proof of a physiologic disorder. In E.E.O.C. v. Texas Bus Lines (S.D. ( Tex., 1996), an employer’s perception that a former employee was disabled by her morbid obesity was enough for the employee to win the discrimination suit, without arguing a physiologic cause.

Although some courts, as in E.E.O.C. v. Texas Bus Lines, have ruled that perceiving an employee to be disabled by obesity is against the law, others have found that this perception is only unlawful if the employer believes that there is a physiologic basis for the obesity. In Walton v.

Mental Health Ass’n (3rd Circ., 1999), for instance, the court ruled that no cause of action lies “against an employer who discriminates against an employee because it perceives the employee as disabled by obesity.”

Because of the confusion and uncertainty caused by the ADA and the courts’ varied interpretations of its scope, the ADA Amendments Act (ADAAA) was passed in 2008. The ADAAA expanded the definition of disability to include impairments of manual tasks, walking, seeing, hearing, speaking, breathing, learning and bending as well as impairments of the immune system, digestive, bowel, brain, respiratory, circulatory, endocrine and reproductive functions.

Disability or No Disability?

In preparation for Ms. Harrison’s trial, the plaintiff consulted with an obesity expert, George A. Bray, MD, who if called to trial, would have testified that

she suffered from a physiologic/pathologic disease and should be considered disabled.

“In my opinion, to a reasonable medical certainty, Ms. Harrison had a physiologic disorder, which I have termed progressive obesity, a reflection of underlying susceptibility to obesity, which is probably genetic,” Dr. Bray, professor of medicine at the Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, wrote in his report.

According to Dr. Bray, progressive obesity is a physical condition, which, in the majority of cases, leaves a person unable to prevent extreme obesity, despite efforts to diet or exercise. This progressive condition stems from the fact that overweight and obese individuals not only have a surplus of fat cells, they also have larger ones, Dr. Bray explained.

“In my opinion, the people with progressive obesity have an underlying disturbance in their physiologic function that leads to this progressive weight gain.”

To this end, a recent study showed that the number of fat cells in both thin and obese people is essentially determined during childhood (Nature 2008;453:783787). By adulthood, the number of fat cells remains fairly constant; thus, fluctuations in weight do not come so much from shedding or gaining fat cells, but from the expanding and shrinking volume of these cells.

Dr. Bray argued that as Ms. Harrison gained weight during her childhood, the number of fat cells she possessed increased as well, releasing more and more harmful chemicals into her body.

The chemicals released in the body “raise blood pressure, alter the immune system, see DISCRIMINATION page 26

Clinical Commentary

Supported and approved by

Device-Tissue Interaction:

Evaluating New Devices for Your Surgical Practice Director of Medical Education Ethicon Endo-Surgery Cincinnati, Ohio

As a resident, it was pretty straightforward. Start as early in the morning as possible, stay on top of things all day long, do no harm to the patient in your care, and be open to the multiple learning opportunities available to you each day.

After 5 to 7 years of coupling these experiences with a professionally managed didactic curriculum (ie, residency program), a competent surgeon emerged. Following residency, some then chose to pursue further training while others moved directly into practice. Either way, our formal training stopped, and we became practicing surgeons.

As surgeons today, we personally manage all aspects of our surgical career—caregiver, business manager, and program director. We understand that we must design our own curriculum, work through learning curves, and update our practical skills, oftentimes while running a small business. And yet, we also have to consider new devices that can range from trocars to robots.

When considering new devices, it is easy to focus simply on personal experience and a single trial: Does the product work? However, relying on these lightweight criteria can tilt our decision making away from the scientific, evidence-based decisions that mark progress in the art of surgery toward simply relying on traditionbased aphorisms that we may have learned early on in our careers such as “blue for bowel.”

This is all the more necessary because new instruments are being introduced today at a rapid pace. As discussed in a previous commentary1, it is increasingly important to understand not only how to use the instruments properly but also how they work, leading to decisions grounded in thoughtful, science-based consideration.

Here are 4 key questions we should consider when evaluating the adoption of a new device for use within our surgical procedures: 1. Does the new technology meet any unmet needs?

2. Is it fundamentally sound?

3. What are the risks?

4. Is there enough data to support its use?

These questions can be considered in the context of a new class of mechanical stapler that was recently released: powered endocutters, such as the ECHELON FLEXTM Powered ENDOPATH® Staplera (Figure 1).

Endocutters have enabled us to perform surgery through smaller incisions, work consistently, and hold true to important surgical principles such as providing hemostasis. They have existed in some form since minimally invasive staplers were first invented in the late 1970s.2 Despite these positive traits, however, we might ask: “If a powered endocutter is just an endocutter with a button and battery, is it really an advancement for surgery and the patient?”

Consider the 4 questions.

DOES THIS TECHNOLOGY MEET AN UNMET NEED? At first glance, one might think that the powered endocutter does not provide any added benefit for an unmet need. Yet, when we dive deeper into procedural specifics a potential surgical advantage becomes evident when thinking of using powered endocutters in narrow spaces.

Specifically, when endocutters are used in procedures with narrow spaces, such as in thoracic cases (Figure 2), 2 key factors should be considered. First, it is imperative to precisely and comfortably control the movement of the end effector when precise placement within the chest is required within a narrow space. Second, due to the close proximity of easily damaged collateral structures, it is important to have stability.

The value proposition for an improved, powered endocutter, if it can be achieved, is the ability to operate with more precise control and stability in tight spaces.

IS THE DEVICE FUNDAMENTALLY SOUND? In the case of the ECHELON FLEX™ Powered ENDOPATH® Stapler, the powered platform is designed with the same operating principles as the (non-powered) ECHELON endocutters. The mechanism of action is the same as the predicate device except a motor, rather than our hands, drives the blade. The anvil and cartridge, key parts of the stapler that drive outcomes, remain the same. As such, the fundamentals remain valid.

WHAT ARE THE RISKS? There are risks to using any device within a surgical procedure. Even the scalpel can impart significant problems if used improperly or by someone without appropriate training. Risk cannot be eliminated, but it should be managed.

An important step toward managing the risk for using a surgical device is to understand the potential effect of the risk to the patient and procedure. In the case of the powered endocutter, questions to consider include the following: • How does the power pack work?

• What steps are necessary to ensure optimal performance in every case?

Figure 2. ECHELON FLEX™ Powered ENDOPATH® Stapler used in thoracic surgery.

• How is it best operated for optimal usability?

• Does the endocutter have a manual override?

A device representative of the manufacturer can provide this information.

IS THERE ENOUGH DATA TO SUPPORT USE OF THE PRODUCT? Data comes with experience. In order to release a new device, all regulatory pathways must be followed.

Once released, we then integrate these new devices and the experience produces more data. With more data it ultimately is possible to define the device’s position within our armamentariums.

Last Thoughts When considering the adoption of a new device, the easiest route to follow may be to accept old adages.

But “the road less traveled” is never easy especially where new technologies abound. Remember, many surgical instruments are highly intricate, technologically advanced devices. It is imperative that we have a thorough understanding of the value of a new device, the fundamentals of how it works with tissue, potential risks, and the existing device-centric data.

Much of this information can be obtained by talking with an industry partner. In the case of powered endocutters, stapling representatives can provide information about the device’s design, indications, and limitations. Collaboration often leads to the best patient outcomes.

References 1.

Chekan E. Avoiding staple-line failure: enhancing device knowledge and improving patient outcomes. General Surgery News. 2012;39(5):15.

2.

Hardy KJ. Non-suture anastomosis: the historical development. Aust N Z J Surg. 1990;60(8):625-633.

BB1226

Figure 1.

ENDOPATH® Stapler.

Application: Powered Endocutters

DSL 12-0748

Edward Chekan, MD, FACS

a

M ECHELON FLEXTM Powered ENDOPATH® Stapler is a registered trademark of Ethicon Endo-Surgery, Inc.

This commentary is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, Ethicon Endo-Surgery, and the author neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of the article, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature. Copyright © 2012, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the U.S.A. All rights reserved, including the right i of reproduction, in whole or in part, in any form.

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DISCRIMINATION jcontinued from page 24

increase blood pressure and lead to diabetes,â&#x20AC;? Dr. Bray wrote, adding that some cases of progressive obesity result from known genetic diseases, but for the most part, obesity cannot be attributed to any one gene or environmental factor.

Asked to comment on the validity of Dr. Brayâ&#x20AC;&#x2122;s obesity theory, Michael Schwartz, MD, said, â&#x20AC;&#x153;I wouldnâ&#x20AC;&#x2122;t agree that number of fat cells determines whether youâ&#x20AC;&#x2122;ll become obese. Simply put, to become obese, you have to consume more calories

than you expend. Anyone who does that will be able to store the excess as fat, irrespective of the number of fat cells.â&#x20AC;?

Dr. Schwartz, RH Williams Professor in the Department of Medicine, Division of Metabolism, and director of the Diabetes and Obesity Center of Excellence at University of Washington Medical School, Seattle, said there is no one explanation for what causes obesity. Rather, obesity may be influenced by a slew of issues, including genetic and developmental factors, both of which determine your weight before birth; environmental factors, such as diet, physical activity,

environmental chemicals (Mt Sinai J Med 2011;78:22-48); medications (such as certain antidepressants) and medical conditions (such as Cushingâ&#x20AC;&#x2122;s syndrome); as well as a host of emotional and social variables that affect this energy inputâ&#x20AC;&#x201C;output balance. â&#x20AC;&#x153;I think it stands to reason that if environmental factors favor obesity development and these factors are reversed, we would see a decrease in obesity prevalence,â&#x20AC;? Dr. Schwartz said. â&#x20AC;&#x153;But in reality, in the vast majority of obese people, this doesnâ&#x20AC;&#x2122;t happen. Obesity is very hard to reverse.â&#x20AC;?

Dr. Schwartz explained: â&#x20AC;&#x153;In both obese and lean individuals, the level of body weight is being actively biologically defended by the brain.â&#x20AC;? In other words, our body fights to keep our weight within a specific range it deems â&#x20AC;&#x153;normal,â&#x20AC;? even if that range actually extends far outside of normal.

The Ruling and the Future Ivan Lemelle, the presiding judge, ruled in favor of the plaintiff, Ms. Harrison. Falling in line with a small number of courts, Judge Lemelle determined that morbid obesity even with no physiologic basis qualifies as a disability. Part of the court's ruling read:

A study conducted at Yale University found that weight discrimination ranked as the third most common cause of perceived discrimination among women and was the fourth most common form of discrimination among men.

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Research, Education, Action.

â&#x20AC;&#x153;A careful reading of the EEOC guidelines and the ADA reveals that the requirement for a physiological cause is only required when a charging partyâ&#x20AC;&#x2122;s weight is within the normal range. However, if a charging partyâ&#x20AC;&#x2122;s weight is outside the normal rangeâ&#x20AC;&#x201D;that is, if the charging party is severely obeseâ&#x20AC;&#x201D;there is no explicit requirement that obesity be based on a physiological impairment. â&#x20AC;Ś Therefore, according the EEOC Guidelines to the ADA the appropriate deference, the Court should recognize that severe obesity qualifies as a disability under the ADA and that there is no requirement to prove an underlying physiological basis.â&#x20AC;?

Because Judge Lemelle determined that severe obesity is, in fact, an impairment under the ADA, and that plaintiffs do not need to present proof of a physiologic cause, he did not need to evaluate Dr. Brayâ&#x20AC;&#x2122;s expert opinion, which was relevant primarily as evidence that Ms. Harrisonâ&#x20AC;&#x2122;s obesity was the result of a physiologic condition or disorder, Ms. Goldman said.

On April 9, the Louisiana federal court signed a consent decree resolving all claims. Family House agreed to pay Ms. Harrisonâ&#x20AC;&#x2122;s estate $125,000 and to conduct more training of its employees on the ADA and on making reasonable accommodations.

After the decision, the EEOC also changed its definition of disability, stating that severe obesity may be considered

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Weight Discrimination With No Disability Outside of the disability context, weight discrimination is not protected.

About a year ago Citizens Medical Center, in Victoria, Texas, instituted a controversial requirement to its hiring policy: To be eligible for a job, applicants had to have a BMI below 35 kg/m2.

Citizens Medical may have been the first medical facility in the United States to adopt such a hiring policy, but there was talk of it at the

a disability regardless of physiologic impairment. The EEOC insists, however, that its revised definition is not a change in the law.

“The EEOC cannot create or change the definition of disability, which is a matter of statute,” Ms. Goldman said. “The ADA, and the ADA as amended, provide the definition of disability.”

Ms. Goldman added, “This case does not represent a changed definition of disability with respect to obesity. Rather, we believe it reflects the court’s correct application and interpretation of the statute. Judge Lemelle’s ruling in this case is an excellent starting point, but I suspect that there will still continue to be a fair bit of litigation over whether severe obesity is an impairment, regardless of the cause of the obesity.”

A study conducted at Yale University found that weight discrimination ranked as the third most common cause of perceived discrimination among women (with gender and age ranked higher), and was the fourth most common form of discrimination among men (with gender, race and age ranked higher; Int J Obess 2008;32:992-1000). And in a recent issue of International Journal of Obesity, investigators found that obese women had lower chance of being hired than their non-obese counterparts (2012 Apr. 24. [Epub ahead of print]). Specifically, study participants viewed resumes with an attached photo of a woman either before or after undergoing bariatric surgery; obese candidates had a lower likelihood of being hired, and if they were considered for the job, they confronted a lower starting salary.

When asked whether Judge Lemelle’s ruling will affect future weight discrimination rulings, Ms. Goldman said, “This case does clarify standards concerning when weight discrimination violates the ADA and is likely to serve as guidance to other courts and attorneys in applying the ADA and/or ADAAA to similar cases.” However, Ms. Goldman added, “Ultimately, the court in each case has to assess the alleged disability under the specific facts presented.”

Cleveland Clinic several years ago, Michelle Mello, JD, PhD, told General Surgery News. In Texas, such a policy is likely legal, said Dr. Mello, who is professor of law and public health, Department of Health Policy and Management, Harvard School of Public Health, Boston.

Tanya Goldman, who spoke with General Surgery News, agreed: “This policy would not likely be illegal on its face. However, if as a result of the

policy, the Center refused to hire an individual, and she could show, for example, that she is severely obese, her obesity affects a major life activity, she was qualified for the job, and was not hired because of this policy, she might have a discrimination claim.”

Not everyone agrees with this assessment. “This is a clear form of weight discrimination,” said Jennifer Pomeranz, JD, MPH, director of legal initiatives at the Yale Rudd Center for Food Policy & Obesity in New Haven, Conn. “Policies that

discriminate against people based on their weight in the medical setting are especially problematic when a majority of the patients are likely to be overweight. This sends a negative message to potential patients that they are not the type of person the hospital considers a positive representation of a human being.”

We may never know. Citizens Medical Center suspended its BMI hiring policy on April 12, after being criticized for its practices.

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Alcohol Use Disorder Increases in Second Year After Bariatric Surgery of AUD after surgery. Other variables independently related to higher likelihood of postoperative AUD were he prevalence of alcohol use dispreoperative AUD, regular alcohol conorder (AUD) increases in the secsumption, recreational drug use, male ond year after bariatric surgery compared sex and younger age. with the year prior to surgery and postThere are a number of reasons why operative year 1 (POY 1), according to a AUD prevalence might increase after study in JAMA (2012;307:2516-2525). gastric bypass. “When patients lose The association is weight, they become more social,” said John Morton, MD, MPH, FACS, FASMBS, associate professor, section chief, Minimally Invasive Surgery, and director, Bariatric Surgery & Surgical Quality, Stanford School of Medicine, Stanford, Calif., ‘I think the study is valuable, if who was not associated with only for the education it offers. … We the study. “They may fall into bad habits, and start drinkshould call on gastric surgeons to educate ing because they’re thinner. … patients about the potential for alcohol misuse.’ There are [also] physiologic issues.”

—John Morton, MD, MPH, FACS, FASMBS Dr. Morton also noted that patients might have more diffiparticularly strong for patients past-year AU AUD symptoms as determined cultly processing alcohol after RYGB. In who underwent a Roux-en-Y gas- with the A Alcohol Use Disorders Identi- a study Dr. Morton conducted, patients tric bypass (RYGB). The large, pro- fication T Test, a 10-item instrument for exhibited a higher peak breath alcospective study confirmed previous assessing ng alcohol use and alcohol-related hol content after drinking and required retrospective reports suggesting that consequ quences in the prior 12 months. more time to become sober post-RYGB gastric bypass might increase AUD. Alt lthough there was no significant dif- ((J Am Coll Surgg 2011;212:209-214). A “Although there have been anecdot- feren ence in prevalence of AUD symptoms possible explanation is that after gasal reports of alcohol-related problems bet etween one year prior to surgery and tric RYGB surgery, alcohol bypasses after bariatric surgery and pharma- on one year after (7.6% vs. 7.3%; P=0.98), P the stomach and enters the bloodstream cokinetic studies that have shown p prevalence of AUD symptoms in POY 2 from the small intestine, which is “very that patients experience alcohol was significantly higher (9.6%; P=0.01).

P absorptive,” said Dr. Morton. differently after Roux-en-Y gastric Undergoing RYGB was independentThe reason AUD prevalence did bypass, there has not been good empirical al ly associated with an increased likelihood not increase until POY 2 may be that B Y G EORGE O CHOA

evidence that the risk for AUD increases after bariatric surgery,” lead author Wendy C. King, PhD, assistant professor, Department of Epidemiology, Graduate Schoo School of Public Health, University of Pittsburgh, h, said sai in an interview.

Dr. King and her er colleagues col conducted a prospective cohort study of adults undergoing bariatric surgery at 10 1 hospitals in the United States. O Of 2,458 patients, 1,9945 completed pre-- and postoperative assesssments. The main outcomee measure was

patients who underwent RYGB reduced alcohol consumption in POY 1 and, in POY 2, resumed drinking at preoperative levels. “Thus the increase in AUD seen in the second year may have resulted from an increase in alcohol sensitivity following the surgery coupled with the resumption of preoperative drinking levels,” she commented. “However, our study did not assess why patients drank more the second year.”

Dr. Morton said the study’s major limitation is generalizability. “It’s not an enormous number of centers. The results might have been mitigated at other centers where there was better counseling.”

He added, “I think the study is valuable, if only for the education it offers. … We should call on gastric surgeons to educate patients about the potential for alcohol misuse. I would caution about rejecting bariatric surgery. The benefits of gastric bypass outweigh the drawbacks.”

Dr. King also stressed the need for education. “Given our findings, as well as the findings from pharmacokinetic studies, patients should be educated about the potential of at least some bariatric surgical procedures, such as the Roux-en-Y gastric bypass, to increase the risk of problem-related drinking.”

Drs. King and Morton reported no relevant financial conflicts of interest.

Laparoscopy Superior Approach for Appendectomy in Obese Patients B Y G EORGE O CHOA

O

bese patients who underwent laparoscopic appendectomy had superior clinical outcomes, including lower overall morbidity, than those who underwent an open approach, according to a recent study (J ( Am Coll Surgg 2012;215:88-100).

Using data from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database (2005-2009), the researchers included 13,330 obese patients (body mass index [BMI] >30 kg/ m2) who underwent open (22%) or laparoscopic (78%) appendectomy as the primary surgical procedure and who had a postoperative diagnosis of acute appendicitis. To minimize the effects of treatment-selection bias in the aggregate cohort, the investigators created a 1:1 matched cohort (N=2,228) using 41 baseline risk-adjustment factors.

In the aggregate cohort, laparoscopic appendectomy was associated with a 57% reduction in 30-day overall morbidity after multivariable risk-adjusted analysis (odds ratio [OR], 0.43; 95% confidence interval [CI], 0.360.52; P<0.0001). In the matched cohort, the reduction in

overall morbidity associated with laparoscopic appendectomy was 53% (OR, 0.47; 95% CI, 0.32-0.65; P<0.0001).

Laparoscopic appendectomy was associated with reduced serious morbidity/mortality in both the adjusted aggregate cohort (OR, 0.54; 95% CI, 0.43-0.68; P<0.0001) and matched cohort (OR, 0.57; 95% CI, 0.35-0.93; P=0.021). Mortality by itself was not associated with P either surgical approach.

Morbidity increased substantially with greater BMI in patients receiving open appendectomy, but not in patients receiving laparoscopic appendectomy. In the matched cohort, mean hospital length of stay (1.2 days less) and operative time (11 minutes less) were shorter in the laparoscopic than the open group.

The study had several limitations, namely that it only included patients from NSQIP-affiliated hospitals, and it was a retrospective data analysis.

“For obese patients with appendicitis, laparoscopic appendectomy is the preferred surgical approach as it is the safest, least morbid and quickest, which also has the shortest length of hospital stay,” said lead author of the current study, Rodney Mason, MD, PhD, associate professor of clinical surgery, Keck School of Medicine, University of Southern California, Los Angeles.

Dr. Mason noted that there are approximately 70 published randomized trials comparing open with laparoscopic appendectomy, but none specifically look at obese patients; such a trial examining obese patients would take time and likely involve one or just a few hospitals. The alternative, “using this matching technique [on] the large NSQIP database, provides … evidence which is as good as or, in some aspects, even superior to a randomized controlled trial.”

Commenting by email, Esteban Varela, MD, MPH, FACS, associate professor of surgery, Minimally Invasive and Bariatric Surgery, Washington University School of Medicine, St. Louis, who was not associated with the study, said, “Although the study is not novel, it confirms the findings of other similar studies using large numbers of patients from administrative and clinical databases. See our study from 2008 referenced in the paper (Am ( J Surg 2008;196:218-222), which used an administrative database to compare outcomes of morbidly obese patients undergoing laparoscopic versus open appendectomy.”

Dr. Varela added, “I don’t anticipate any clinical changes at this time, as most surgeons now understand the benefits of laparoscopy in this population.”

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Obesity Care Progresses With Drug Approvals, Policy Changes B Y C HRISTINA F RANGOU

A

fter a series of national policy changes and drug approvals this summer, physicians now have new tools to help their patients who struggle with obesity.

In late June, the U.S. Preventive Services Task Force (USPSTF) recommended that all adults be screened for obesity during their checkups—a directive geared to

RM1718 7/2012

primary care physicians but all physicians are asked to heed the recommendations.

The USPSTF also called on clinicians to refer patients with a body mass index (BMI) of 30 kg/m2 or greater to intensive multicomponent behavioral interventions, or offer these patients interventions.

Several days later, the FDA approved Belviq (lorcaserin hydrochloride; Eisai Pharmaceuticals) as an addition to a reduced-calorie diet and exercise for chronic weight management. Belviq was

the first anti-obesity drug to be approved in the past 13 years, and marked a significant shift in FDA policy. For the past decade, the agency has been reluctant to approve new diet drugs, largely because of a history with product withdrawals and serious side effects.

Weeks after endorsing Belviq, the FDA also approved Qsymia (Vivus Pharmaceuticals), which combines the antiseizure/migraine drug topiramate and the appetite-suppressant phentermine.

‘This is a chance not just to take care of a symptom that’s related to obesity but to encourage a full lifestyle change.’

—Amy Foxx-Orenstein, MD “Obesity threatens the overall wellbeing of patients and is a major public health concern,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a statement. “Qsymia, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides another treatment option for chronic weight management in Americans who are obese or are overweight and have at least one weightrelated comorbid condition.”

Neither of the new anti-obesity drugs is on the market yet, but both are expected by late 2012 or early 2013. Prior to Belviq and Qsymia, the only prescription drug currently approved for long-term treatment of obesity was orlistat, marketed as Xenical (Roche). Orlistat also is sold over the counter in a lower dose as Alli.

The FDA recommended that the U.S. Drug Enforcement Administration (DEA) classify Belviq as a scheduled drug. Once the DEA has provided the final scheduling designation, the company will announce when Belviq will be available to patients and physicians in the United States. Belviq is not recommended for pregnant women, and should be used with caution in patients with congestive heart failure. The approved labeling for Belviq recommends that the drug be discontinued in patients who fail to lose 5% of their body weight after 12 weeks of treatment, as these patients are unlikely to achieve clinically meaningful weight loss with continued treatment.

With Qsymia, too, the approval comes with restrictions. The drug must not be used during pregnancy, for patients with glaucoma or hyperthyroidism, and, because Qsymia can increase heart rate, usage in patients with unstable heart disease or stroke within the past six months is not recommended. recommended Regular heart rate monitoring is recommended for all patients, especially when starting the drug or when increasing the dose.

The FDA approved

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Qsymia with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a medication guide advising patients about important safety information and elements to assure safe use that include prescriber training and pharmacy certification.

In its recommendation, which came prior to the two new drug approvals, the USPSTF found that there is significant evidence that intensive, multicomponent behavioral interventions for obese adults leads to an average weight loss of 4 to 7 kg, and improves glucose tolerance and other physiologic risk factors for cardiovascular disease.

The approval of the new drugs along with the policy changes provide an opportunity for physicians to take a more proactive approach to managing obesity in their patients, said Amy Foxx-Orenstein, MD, associate professor of medicine at Mayo Clinic, Phoenix. “This is a chance not just to take care of a symptom that’s related to obesity but to encourage a full lifestyle change.”

Dr. Foxx-Orenstein said she expects to prescribe the new drugs when they come to market. She’s anticipating that her patients will be interested in these treatment options. Community gastroenterologists should also consider prescribing the new medications when their patients are committed to changing their weight, said Dr. Foxx-Orenstein.

Lisa Ganjhu, DO, gastroenterologist at St. Luke’s-Roosevelt Hospital Center, in New York City, said she expects primary care physicians or obesity specialists to take the lead in prescribing new obesity drugs. “I have not [prescribed Belviq], yet.

I am not sure I will. I would like to see it being used by others and see what their outcomes are prior to considering it.”

She said she is watching to see if Belviq will play a role in the management of nonalcoholic steatohepatitis. “This may be the ideal population to use the drug in. I would just be concerned about the potential long-term adverse outcome.”

The new drugs do come with important restrictions. Both should be used in conjunction with a balanced diet and exercise, and both should be taken for life in patients who respond to and can tolerate the drugs.

“For many people, obesity is a lifelong condition, but we don’t always think of it or treat it—as it—or it as such, such ” said Amy Egan, Egan MD, MPH, deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products, in a statement.

Overall, physicians and device manufacturers have been frustrated with the slow process of trying to get approval for devices and endoscopic procedures that could potentially facilitate weight loss and treat obesity, said Steven A. Edmundowicz, MD, professor of medicine and chief of endoscopy, Washington University School of Medicine, St. Louis. The hope is that the FDA follows the recent drug approvals with greater willingness to approve devices for obesity management.

To this end, the FDA has recently made steps toward speeding up that approval process. Earlier this year, the FDA held a

panel meeting with physicians and device manufacturers and will generate a consensus statement based on those results. The statement is expected to outline the criteria the FDA will use for obesity devices in terms of the risk to the patient and the effectiveness, or how much weight loss, the devices are going to be able to generate in trials.

“What we’re hoping for in endoscopy and gastroenterology are new effective tools that we can use in addition to the medications that are currently available or going to be available,” said Dr. Edmundowicz.

The recent changes indicate that the government recognizes the obesity crisis and is starting to implement change, said Dr. Ganjhu. But patients have to be willing to change, as well, she said.

In New York City, where trans fats are banned in restaurant food, government officials are now debating a ban on super-sized sodas. Others, however, have fought back, saying the government is overreaching into people’s personal lives.

“I find the argument frustrating.

Simple changes can make great results if only they are made,” said Dr. Ganjhu.

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Experts Debate Sleeve Gastrectomy as Gold Standard for Teens Procedure Is Growing in Popularity, But Long-term Efficacy Remains Unknown B Y M ONICA S MITH SAN DIEGO—Sleeve gastrectomy, a procedure rarely performed a few years ago, seems to be emerging as the favored bariatric surgery in adolescents, and although it will be some time before researchers accrue enough long-term data to endorse the sleeve as the gold standard in young patients, mounting evidence in favor of the procedure suggests the trend will continue.

Surgeons debated the evidence in favor of and against performing pediatric bariatric operations in teens, as well as the rise in popularity of the sleeve, at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES).

“It used to be that every once in a while we would do a sleeve; now every once in a while we do a Roux-en-Y gastric bypass [RYGB],” said Marc P. Michalsky, MD, associate professor of clinical surgery, Ohio State University College of Medicine, and surgical director, Center for Healthy Weight and Nutrition, Nationwide Children’s Hospital, Columbus.

Since 2008, bariatric surgeons at the Cincinnati Children’s Hospital Medical Center, also have witnessed a spike in interest in sleeve gastrectomy in the adolescent population. “There is a clear three-to-one preference if you allow families to hear pros and cons of both surgeries and make a partnership in deciding what operation to use,” said Thomas H. Inge, MD, PhD, professor of pediatrics and surgery, University of Cincinnati, during the debate at SAGES. Pradeep Pallati, MD, University of Nebraska Medical Center, Omaha, and colleagues evaluated all pediatric bariatric cases in the University Health System Consortium database between October 2008 and September 2011 and witnessed a similar trend, which he described during a plenary session at SAGES that was recently published (session S054; Surg Endosc 2012 May 12 [Epub ahead of print]).

Aayed R. Alqahtani, MD, director, King Saud University Obesity Chair, and associate professor, College of Medicine, King Saud University, Riyadh, Saudi Arabia.

“We noticed that initially, just three years ago, only eight [adolescent] patients had sleeve gastrectomy. Last year, 24 had sleeve gastrectomy,” Dr. Pallati told General Surgery News.

“At the same time, we saw that laparoscopic gastric banding has gone down. Our theory is that since the band has been around for many years and more researchers and surgeons are looking at complications related to the band, they are using the band less and picking up sleeve gastrectomy as a primary procedure.”

Dr. Pallati and colleagues found complications related to sleeve gastrectomy in the pediatric population were low, with no major morbidity. Although others have reported serious perioperative complications with the procedure, this series found no readmissions in the first month. “But as far as long-term weight loss and other outcomes, we don’t know yet,” Dr. Pallati said.

This unknown was a common refrain in presentations and discussions at the SAGES meeting regarding adopting sleeve gastrectomy in teenagers and children. Is sleeve gastrectomy the best surgery for young people? How young is too young? Awaiting long-term outcomes, we simply don’t know yet.

Bariatric Surgery in Adolescents There are many persuasive arguments in favor of early intervention for obesity.

Notably, there is the predictive value of knowing what lies ahead for obese children. “A large percentage of obese children go on to become obese as adults, particularly if they have a body mass index [BMI] over 40 kg/m2,” said Mary Brandt, MD, professor of surgery, Baylor College of Medicine, and surgical director, Adolescent Bariatric Surgery Program, Texas Children’s Hospital, Houston.

Second, children tend to experience worse and/or different comorbidities than adults. Obese children suffer worse asthma and sleep apnea than adults, and can develop Blount’s syndrome and

Mary Brandt, MD, professor of surgery, Baylor College of Medicine, and surgical director, Adolescent Bariatric Surgery Program, Texas Children’s Hospital, Houston.

‘If you look at three and six years, you see a weight loss curve [with the sleeve] almost identical to what happens with the bypass, where you see initial dramatic weight loss, and then the system resets itself a few years out at about 50% excess weight loss.’

—Thomas H. Inge, MD

slipped capital femoral epiphysis, which adults do not experience. Furthermore, hypertension and cardiac disease early in life tend to shorten life.

Then there is quality of life. “Healthrelated quality of life in obese children is similar to that of children with cancer,” Dr. Brandt said. “Because we think the consequences of obesity are greater over time, the morbidity and mortality of adult obesity is worse when it begins in childhood.”

With behavioral changes and drug therapies unlikely to result in satisfactory long-term weight loss, many consider surgery the preferred treatment for management of obesity in adults. Questions remain, however, about the role of bariatric surgery in younger people due to concerns about nutritional deficiencies, perioperative complications, compliance and long-term outcomes.

In 1991, when the National Institutes of Health (NIH) published its stance on surgical treatment for obesity, it could not conclude for or against bariatric surgery in adolescents (NIH Consensus Statement 1991;9:1-20). Today, however, the Academy of Pediatrics recommends bariatric surgery for patients with a BMI

Thomas H. Inge, MD, PhD, professor of pediatrics and surgery, University of Cincinnati.

Marc P. Michalsky, MD, associate professor of clinical surgery, Ohio State University College of Medicine, and surgical director, Center for Healthy Weight and Nutrition, Nationwide Children’s Hospital, Columbus.

of 50 kg/m2 or greater, or a BMI of at least 40 kg/m2 plus severe comorbidities (Pediatricss 2007;120:S254-S288).

But attitudes toward bariatric surgery in adolescents vary by specialty.

Although surgeons have shown increasing acceptance of surgical intervention in young patients and interest in developing surgical programs for adolescents, primary care physicians remain less than eager to refer adolescents to surgery for obesity (Obes Surgg 2005;15:1192-1195; Obes Surg 2011;20:937-942).

The Sleeve At this point, even among those who agree that surgery should be an option, no one really knows which is the best procedure for young people. Gastric banding, RYGB and sleeve gastrectomy all have their strengths and weaknesses, pitting weight loss and resolution of comorbidities against complications and long-term nutritional deficiencies. But the surging popularity of the gastric sleeve suggests surgeons and informed patients and their families think it offers the best tradeoff.

“The gastric sleeve offers excellent treatment of obesity with very few complications,” said Dr. Inge, arguing in favor of sleeve gastrectomy during SAGES’s debate session on pediatric bariatric surgery.

“There is no foreign body left to erode or require removal, no adjustments are needed, and malabsorption should be less. There is a great reduction in ghrelin, so hunger satiety signals are quite dramatically affected after sleeve gastrectomy. Bowel obstruction later in life is unlikely, the pylorus is preserved and the biliary tract is not excluded.”

He pointed to a randomized controlled trial that found weight loss at three years to be about the same in adult see SLEEVE PEDIATRIC page 34

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34

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012 ISSUES FOR THE BARIATRIC & METABOLIC PROFESSIONAL

Extended Quarterly Coverage

SLEEVE PEDIATRIC jcontinued from page 32

patients who underwent either RYGB or sleeve gastrectomy, with the latter being associated with reduced nutritional deficiencies (Obes Surg 2011;21:1650-1656).

“But people are always concerned with long-term outcomes,” Dr. Inge said. “If you look at three and six years, you see a weight loss curve almost identical to what happens with the bypass [RYGB], where you see initial dramatic weight loss, and then the system resets itself a few years out at about 50% excess weight loss” (Ann ( Surg 2010;252:319-324).

Hard data on the gastric sleeve in adolescents was unavailable until recently, but results from the largest study to date look promising. Aayed R. Alqahtani, MD, director, King Saud University Obesity Chair, and associate professor, College of Medicine, King Saud University, Riyadh, Saudi Arabia, and his colleagues reported an average excess weight loss of 62% at two years in 108 obese adolescents who underwent the procedure ((Ann Surg 2012;00:1-8).

“That parallels what we might see with gastric bypass, and it’s certainly greater than the average results we might see with the band procedure,” Dr. Inge said.

“There is also a 90% reduction in sleep apnea symptoms, a 94% resolution of diabetes, prehypertension, hypertension and dyslipidemia,” 83%, 75% and 70%, respectively. “So the data are very striking and similar to what we’ve come to expect from gastric bypass,” Dr. Inge said.

Dr. Inge hopes to contribute to accumulating evidence about the efficacy and safety of several procedures through the NIH-sponsored Teen Longitudinal Assessment of Bariatric Surgery, which has completed enrollment and includes a sizeable number of adolescents undergoing sleeve gastrectomy.

“We are collecting hundreds of variables prospectively, so we should be able to add numbers as well as rigorous research methodology to questions of ultimate outcome of sleeves in teenagers,” Dr. Inge said. “From adult data, we are worried about reflux, so we are monitoring reflux very carefully in teens who have undergone this procedure.”

Dr. Brandt, taking the role in the debate against sleeve gastrectomy, argued that there is not long-term data to make this the procedure of choice in children.

“My only concern is that we really don’t have good 10-year data yet,” Dr. Brandt said. “For instance, the lap band was hugely popular, but now that long-term data is being reported, it is being proven to be not such a good choice.”

Although she does not expect the sleeve to be a failure 15 or 20 years from now, the possibility of poor long-term outcomes is an unsettling proposition.

“Physiologically, there is certainly the potential that the sleeve will dilate, and the procedure could cause damage to the esophagus. Also, there is a possibility that the ghrelin cells could repopulate,” which might nullify effect on satiety. “So it’s like any new procedure. The data we have now suggest the sleeve is the best procedure [for adolescents]. But this is why we do research and why we follow patients long term.”

For the record, Dr. Brandt performs RYGB in her adolescent patients, although her group has done sleeve gastrectomies when they thought the risks associated with RYGB were high enough to warrant the simpler procedure. “I really think Roux-en-Y gastric bypass is the gold standard, and that until we have all the data we need, in this vulnerable population we are obligated to do what is proven,” she said.

patients undergoing sleeve gastrectomy included many patients who do not meet current recommendations for bariatric surgery in adolescents; 21 had a BMI less than 40 kg/m2, and five had a BMI less than 35 kg/m2. Furthermore, the patients’ ages ranged from 5 to 21 years, with 47 patients under the age of 14 years.

Comorbidities did not discriminate by age, and were seen in about 83% of all patients. Younger children, in fact, had a higher prevalence of sleep apnea, which was seen in 49%, compared with 21% of the older children. Type 2 diabetes was seen in about 20% of both groups, and nearly 50% of all children had dyslipidemia.

In addition to the sleep apnea, diabetes and hypertension, 40% of the younger children had nonalcoholic fatty liver disease activity scores greater than 5, and 12% had bridging fibrosis.

‘I really think Roux-en-Y gastric bypass is the gold standard, and that until we have all the data we need, in this vulnerable population we are obligated to do what is proven.’—Mary Brandt, MD How Young Is Too Young?

Many pediatric surgeons, concerned about developmental issues in children who are still physiologically and psychologically immature, are hesitant to extend bariatric surgery to children below the age of 13 or 14 years. Others, troubled by the potential effect of a lifetime of obesity when intervention is delayed, feel that reserving bariatric surgery for teens is too restrictive.

“Bariatric surgery is a solution, and yes, there are some concerns … about safety,” said Dr. Alqahtani, arguing for bariatric surgery at any age during the debate session. “But sleeve gastrectomy in children is not a new idea.” A survey conducted since 1965 of sleeve gastrectomy for various indications in children under the age of 12 years has found consistent normal growth, he said.

Dr. Alqahtani’s review of 108 young

“Do we want to leave these patients suffering and living with their problems? Should we leave these patients to die of cirrhosis in the future? It is not an option,” Dr. Alqahtani said.

Over the 24 months of follow-up, 90% of the patients experienced successful weight loss, and resolution of comorbidities ranged from 70% to 100%.

“Excess weight loss is no different in [children] less than 14 or more than 14 years of age,” Dr. Alqahtani said. “Regardless of age, and based on comorbidities, we should not deny [surgical] treatment.”

He did caution that bariatric surgery for very young people should be performed only by qualified bariatric surgeons in institutions with a committed program; that the program adhere to a clear, clinical pathway; that the program assure long-term follow-up with a goal of 75% at five years; and that surgery

is justified by valid, clearly documented indications on a case-by-case basis.

Many surgeons, however, feel that bariatric surgery in children who have not completed puberty is unproven, and probably not indicated. Dr. Michalsky argued against the idea of bariatric surgery at any age.

“If you look at severely obese 4-yearolds, the probability of developing adult obesity is about 20%; by the teens, that concordance is up to 80%. We don’t know the probability of an 8- or 9-yearold developing severe obesity.”

It comes down to a risk-ratio analysis in determining the appropriate time to operate. What is the risk associated with allowing patients to continue in their trajectory until they reach a more traditional time frame for adolescent bariatric surgery, compared with the risk of performing such dramatic procedures in the very young?

“Although I think these operations can be done at any age, and you can document effective weight loss as Dr. Alqahtani has shown, my concern is that we really have no long-term data looking at the nutritional consequence of doing so,” Dr. Michalsky said.

Physiology and metabolism differ between children and adolescents, particularly in bariatric patients, where adolescents tend to be physiologically similar to adults. “Most of these patients have completed their growth potential, so the concept of stunted growth in these patients is more theoretical,” Dr. Michalsky said. “But nutritional deficiencies are still a concern. There is evidence across all the different operations that nutritional and vitamin deficiencies need to be attended to.”

One of the first studies to examine nutritional status in adolescents undergoing bariatric surgery (RYGB in this case) found that although the proportion of protein, fat and carbohydrates went unchanged from baseline intake, protein, calcium and fiber intakes fell below the recommended daily intake (Surg Obes Relat Dis 2012;8:331-336).

“That’s a big problem for a bunch of 8or 9-year-olds,” Dr. Michalsky said.

The main objection to performing bariatric surgery in preteens is that there simply is not enough data available to support the safety of this approach.

“Until there is evidence that we can perform operations of this nature on children that young with our current armamentarium of operations, they are not going to be widely accepted in that population,” Dr. Michalsky said. “But the current age range may need to be revisited in the future in the event that technologies and/or procedures that would provide significant weight reduction without micro- and macro-nutrient deficiencies become available.”

Focus on What Matters.

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American College of Surgeons Clinical Congress Booth 1829 Before use, physicians should review essential prescribing information, including all risk information, which can be found in the Instructions for Use attached to the packaging of each LifeCell™ Tissue Matrix. ©2012 LifeCell Corporation. All rights reserved. LifeCell™ and Strattice™ are trademarks of LifeCell Corporation. MLC3074/2482/8-2012

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012 ISSUES FOR THE BARIATRIC & METABOLIC PROFESSIONAL

Extended Quarterly Coverage

CMS DECISION jContinued from page 22

performed between 2007 and 2010, and recorded in the Bariatric Outcomes Longitudinal Database (BOLD). Nearly 16,000 of the procedures were sleeve gastrectomies, which had a 30-day serious complication rate of 0.96% compared with a rate of 1.25% for gastric bypass and 0.25% for gastric banding. Deaths were extremely rare following all three procedures, at 0.03, 0.14 and 0.08 for adjustable gastric banding, gastric bypass and sleeve gastrectomy, respectively (Table).

Similarly, in terms of weight loss, sleeve gastrectomy was associated with outcomes that fell in between those for gastric bypass and gastric banding. Sleeve gastrectomy patients experienced a 30% drop in body mass index (BMI), from 47.5 to 31.2 kg/m2. It was less than the 40% reduction associated with gastric bypass (47.7 to 31.2 kg/m2), but more than the 20% for adjustable gastric banding (45.1 to 31.2 kg/m2).

All major series of LSG report similar outcomes, said Matthew Hutter, MD, assistant professor in surgery at Harvard Medical School in Boston.

Table. Key End Points of Study From the Bariatric Outcomes Longitudinal Databasea Gastric Bypass, %

Gastric Sleeve Banding, % Gastrectomy,%

30-day serious complication rate

1.25

0.25

0.96

Death rate

0.14

0.03

0.08

Weight loss (% BMI lost)

40

30

20

BMI, body mass index a Presented at the 2012 annual meeting of the American Society of Metabolic and Bariatric Surgery

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“It’s remarkable how consistent this is in showing the validity of the data.

It shows that the sleeve gastrectomy, a brand new, very complex procedure, can be introduced safely and effectively when performed at a standard bariatric accreditation program.”

The CMS decision was one of several developments in obesity treatment over a one-week period this summer.

On June 25, the United States Preventive Services Task Force (USPSTF) recommended that clinicians not only screen adults for obesity but offer or refer patients with a BMI of 30 kg/m2 or higher to intensive, multicomponent behavioral interventions for 12 to 26 sessions a year. The guideline did not mention bariatric surgery as an intervention. Dr. Morton said surgery is not typically included in USPSTF recommendations because the task force generally considers it preventive care.

“As a surgeon who treats obese patients, I welcome that [the USPSTF] endorsed counseling and treatment for the obese patient. I anticipate that, in the future, the task force will endorse bariatric surgery given its special role as the only effective and enduring treatment for the seriously obese.”

Two days later, the FDA approved the first new drug to treat obesity in 13 years, giving a go-ahead to Belviq (lorcaserin hydrochloride), which was developed by Arena Pharmaceuticals (story, page 30).

On July 1, the Cleveland Clinic Health Plan in Ohio, announced it would expand coverage for employees with type 2 diabetes and BMI between 30 and 35 kg/ m2 who are not optimally managed with medical therapy. The decision marks the first time in the United States or internationally that an insurance health plan has agreed to cover bariatric surgery for patents with BMI less than 35 kg/m2.

“This means that many patients with poorly controlled diabetes will now have access to surgical treatment that will provide them with an opportunity to achieve glycemic control and reduce complications of type 2 diabetes such as renal failure, blindness, heart attack and stroke,” said the ASMBS in a statement.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

LAPAROSCOPIC COMPETENCY jContinued from page 4 â&#x20AC;&#x153;FLS allows faculty to refine their skills and knowledge in a short amount of time and ensures that competency is verified.â&#x20AC;?

Rajesh Aggarwal, MBBS, MA, PhD, FRCS, NIHR Clinician Scientist in Surgery, Department of Surgery & Cancer, Imperial College London, considers this research important from both a methodology and innovation point of view. â&#x20AC;&#x153;I credit the authors and team for using this extensively validated tool in an institutional review boardâ&#x20AC;&#x201C;approved protocol to assess the performance of practicing surgeons,â&#x20AC;? he said.

Dr. Aggarwal also commended the study participants. â&#x20AC;&#x153;Itâ&#x20AC;&#x2122;s a really big challenge to assess senior people who have been practicing surgery regularly. This is something we need to do.â&#x20AC;?

He pointed out that it would be helpful to know what level the surgeons had been performing at before taking the pretest. â&#x20AC;&#x153;A glance at the page would suggest that one out of four of our surgeons does not have essential laparoscopic skills,â&#x20AC;? Dr. Aggarwal said. â&#x20AC;&#x153;Are these general surgeons regularly performing laparoscopic surgery at their institutions?

I assume they are, but thatâ&#x20AC;&#x2122;s an important point.â&#x20AC;?

He also found it interesting that the surgeons were able to increase their skills sufficiently with an average of only 2.5 hours of training. â&#x20AC;&#x153;I wonder whether this might not mean theyâ&#x20AC;&#x2122;ve improved their laparoscopic skills, but that theyâ&#x20AC;&#x2122;ve managed to pass a test on a simulator. If FLS certification is mandatory within an institution or a state or across the country, will this enhance the quality of laparoscopic surgery we deliver to our patients?â&#x20AC;? asked Dr. Aggarwal. â&#x20AC;&#x153;The authors here are beginning to ask that question.â&#x20AC;?

A joint recommendation issued by SAGES and the American College of Surgeons suggests that the two societies hope and suspect that it will, in one way or another, and part of figuring that out means having large enough numbers to make an assessment. â&#x20AC;&#x153;Unless you have enough people doing the same program, you canâ&#x20AC;&#x2122;t measure it,â&#x20AC;? said Steven D. Schwaitzberg, MD, associate professor of surgery, Harvard Medical School, chief of surgery, Cambridge Health Alliance, and president of SAGES (2011-2012).

At this point, more than 5,600 surgeons have passed FLS certification, and about 1,000 new surgeons join that roster every year. â&#x20AC;&#x153;One of the values of getting people on a common platform is that you can start to engage in a new fieldâ&#x20AC;&#x201D; the comparative effectiveness of training,â&#x20AC;? Dr. Schwaitzberg said. â&#x20AC;&#x153;No one program will solve all of the world of

surgeryâ&#x20AC;&#x2122;s problems, but this allows you to see whether the outcome needle is moving or not.â&#x20AC;?

Dr. Schwaitzberg and colleagues have been studying clinical outcomes in cholecystectomy as related to FLS. â&#x20AC;&#x153;The issue around specific procedures is that FLS is general education; it doesnâ&#x20AC;&#x2122;t necessarily follow that the common bile duct injury rate will fall,â&#x20AC;? he said. â&#x20AC;&#x153;If it does, that would be amazing. If it doesnâ&#x20AC;&#x2122;t, that does not detract from the FLS program because thereâ&#x20AC;&#x2122;s nothing in it about biliary safety; this would become the needs analysis for future validated procedure

training programs.â&#x20AC;?

It takes commitment to get all surgeons in a practice certified in FLS. Cambridge Health Alliance requires FLS certification before general surgeons can gain hospital privileges in laparoscopy. â&#x20AC;&#x153;If someone in my department hasnâ&#x20AC;&#x2122;t done it, we send them off to do it,â&#x20AC;? Dr. Schwaitzberg said. â&#x20AC;&#x153;We feel that this is a playing field leveling, minimum expectation in laparoscopy.â&#x20AC;?

His department, however, is relatively small. â&#x20AC;&#x153;If I were in a hospital with 50 private practice surgeons, it would be more difficult, but there are a lot of ways to

incentivize people,â&#x20AC;? he said. For example, a few years ago, Dr. Schwaitzberg and some of his colleagues undertook a Harvard-wide training program in surgery, gynecology and urology and successfully negotiated a rebate with their malpractice carrier, CRICO. â&#x20AC;&#x153;You donâ&#x20AC;&#x2122;t have to take everyone kicking and screaming,â&#x20AC;? Dr. Schwaitzberg said. â&#x20AC;&#x153;CRICO announced, â&#x20AC;&#x2DC;This is a patient safety initiative, and if you demonstrate that you have these skills, we will support this.â&#x20AC;&#x2122; And they did, financiallyâ&#x20AC;? (Surg Endosc 2010;24:616-623).

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9LVLW www.RECOTHROM.com RU VFDQ WKH 45 FRGH ZLWK \RXU VPDU WSKRQH

RECOTHROM is a registered trademark of ZymoGenetics, Inc. Â&#x2039; =\PR*HQHWLFV ,QF $OO ULJKWV UHVHUYHG 57

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

INDICATION RECOTHROM Thrombin, topical (Recombinant) is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical.

IMPORTANT SAFETY INFORMATION Contraindications Â&#x2021; Topical use only â&#x20AC;&#x201C; DO NOT INJECT directly into the circulatory system Â&#x2021; Do not use for the treatment of massive or brisk arterial bleeding Â&#x2021; Do not administer to patients with known hypersensitivity to RECOTHROM, any components of RECOTHROM or hamster proteins Warnings and Precautions Â&#x2021; Potential risk of thrombosis if absorbed systemically Â&#x2021; In patients with known hypersensitivity to snake proteins, there may be a potential for allergic reaction Adverse Reactions Â&#x2021; 7 KH VHULRXV DGYHUVH HYHQW WKDW RFFXUUHG LQ Â&#x2022; Q RI SDWLHQWV H[SRVHG WR 5(&27+520 LQ FRPSOHWHG FOLQLFDO WULDOV ZDV DWULDO žEULOODWLRQ 7KH PRVW FRPPRQ DGYHUVH HYHQWV UHSRUWHG LQ WKHVH WULDOV 1 ZHUH LQFLVLRQ VLWH SDLQ

SURFHGXUDO SDLQ DQG QDXVHD $GYHUVH HYHQWV UHSRUWHG LQ WKHVH WULDOV were consistent with those commonly observed in surgical patients Please see Brief Summary of Full Prescribing Information on following page.

40

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

Controversy Swirls Over Up-and-Coming Procedure for Achalasia POEM Shows Promise in Early Studies as Experts Urge Caution and Patience B Y C HRISTINA F RANGOU

P

hysicians are gaining more experience with peroral endoscopic myotomy (POEM), an up-and-coming treatment for achalasia, but experts remain divided regarding the safety, efficacy and

long-term viability of this procedure.

At the annual meeting of the American Surgical Association, surgeons from The Oregon Clinic reported the largest series of patients to date in the United States to undergo POEM, concluding that POEM is “safe and effective.”

But other achalasia experts say they are concerned about the potential for major complications if the practice of POEM continues to spread before well-designed studies with long-term

follow-up are completed.

“There are some potentially catastrophic consequences,” said Carlos Pellegrini, MD, Henry N. Harkins Professor and chair in the Department of Surgery, University of Washington, Seattle, after the results were presented. “[POEM] is too new. It may be great, but we have to introduce it carefully, review the results carefully and give it time—at least five years—before widely adopting it.”

POEM is carried out under general

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

BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION RECOTHROM® Thrombin, topical (Recombinant) Rx Only The following is a brief summary of the full prescribing information for RECOTHROM Thrombin, topical (Recombinant).

CONTRAINDICATIONS Do not inject directly into the circulatory system.

Do not use for the treatment of massive or brisk arterial bleeding.

Do not administer to patients with known hypersensitivity to RECOTHROM, any components of RECOTHROM, or hamster proteins.

WARNINGS AND PRECAUTIONS Potential risk of thrombosis if absorbed systemically.

In patients with known hypersensitivity to snake proteins, there may be a potential for allergic reaction.

ADVERSE REACTIONS The serious adverse event that occurred in ≥ 1% (n=6/583) of patients exposed to RECOTHROM in completed clinical trials was atrial fibrillation. The most common adverse events in patients exposed to RECOTHROM in clinical trials (N=583) were incision site pain (51%), procedural pain (30%), and nausea (28%).

Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug product cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical trials have been performed with RECOTHROM applied with absorbable gelatin sponge (Phase 2, Phase 3, and Phase 3b studies) and applied with a spray applicator (Phase 2 study). Adverse events reported in clinical trials were consistent with those commonly observed in surgical patients.

Clinical Trials of RECOTHROM Used in Conjunction with Gelatin Sponge Among the 411 patients treated with study drug in the randomized, double-blind, Phase 3 study that compared RECOTHROM to bovine thrombin, both applied with gelatin sponge, in patients undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access, all but 2 patients (1 patient/treatment group) reported adverse events. Most events were moderate in severity and had a similar incidence in the RECOTHROM and bovine thrombin treatment groups. The most common adverse events were incision site pain (63% for both treatment groups), procedural pain (RECOTHROM 29%; bovine thrombin 34%), and nausea (RECOTHROM 28%; bovine thrombin 35%). Serious adverse events were reported by 18% of patients treated with RECOTHROM and 22% with bovine thrombin.

In the randomized, double-blind, Phase 3 study that compared RECOTHROM to bovine thrombin, both applied with gelatin sponge, in patients undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access, the development of specific anti-product antibodies was evaluated in both treatment groups. Blood samples were collected at baseline and at day 29 for 97% of the patients in both treatment groups.

For patients randomized to RECOTHROM, the samples were analyzed by ELISA for antibodies to RECOTHROM, Chinese hamster ovary (CHO) host cell protein, and pro-thrombin activator (used in the conversion of single chain precursor to active RECOTHROM). For patients randomized to bovine thrombin, the samples were analyzed by ELISA for antibodies to bovine thrombin product.

At baseline 1.5% of patients (n=3/198) in the RECOTHROM group had positive anti-product antibody titers compared with 5% of patients in the bovine thrombin group (n=10/200). Of the patients who had detectable anti-product antibodies at baseline, 0 of 3 in the RECOTHROM group and 8 of 10 in the bovine thrombin group exhibited ≥ 1.0 titer unit (≥ 10-fold) increases in antibody levels after study treatment.

Treatment with RECOTHROM applied with absorbable gelatin sponge resulted in a statistically significantly lower incidence of specific anti-product antibody development. Three of 198 (1.5%; 95% CI, 0 to 4%) of the patients in the RECOTHROM arm developed specific anti-thrombin product antibodies (1 patient also developed anti-CHO host cell protein antibodies). No patients developed antibodies to pro-thrombin activator. Forty-three of 200 patients (22%; 95% CI, 16 to 28%) in the bovine thrombin arm developed specific antibodies to bovine thrombin product. None of the antibodies in the RECOTHROM group neutralized native human thrombin. Antibodies against bovine thrombin product were not tested for neutralization of native human thrombin. Because the study was not powered to detect a difference in clinical outcomes attributable to antibody formation, no conclusions can be drawn regarding the clinical significance of the difference in antibody formation based on the results of this study.

In the open-label, single group, Phase 3b study in patients with a high likelihood of prior bovine thrombin exposure undergoing spinal, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access, 15.6% of patients (n=32/205) had anti-bovine thrombin product antibodies at baseline prior to treatment with RECOTHROM. Following treatment, none of the 200 evaluable patients (patients for whom specimens were available for antibody testing at baseline and post-RECOTHROM treatment) developed antibodies to RECOTHROM. In the randomized, double-blind, controlled Phase 2 studies of RECOTHROM compared to placebo (RECOTHROM excipients reconstituted with 0.9% sodium chloride, USP) applied in conjunction with absorbable gelatin sponge, which were performed across a range of surgical settings (spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access), the incidence of antibody development to RECOTHROM was 1.2% in the RECOTHROM group (n=1/83) compared to 2.4% (n=1/41) in the placebo group. In the open-label, single group Phase 2 study of RECOTHROM applied with the spray applicator to excised burn wounds, 1 patient developed antibodies following treatment (1.6%, n=1/62).

Adverse events of interest were pre-specified, based on the thrombin mechanism of action, use of absorbable gelatin sponge, USP, historical reporting in association with cross-reacting antibodies to bovine thrombin product, and results from Phase 2 clinical trials of RECOTHROM applied with absorbable gelatin sponge. The incidences of these pre-specified adverse events were similar between treatment groups (see Table 1).

The detection of antibody formation is highly dependent upon the sensitivity and specificity of the assay. The absolute immunogenicity rates reported here are difficult to compare with results from studies of other products due to differences in assay methodology, patient populations, and other underlying factors.

Table 1. Events of Interest in the RECOTHROM Phase 3 Study

To report p SUSPECTED ADVERSE REACTIONS,, contact ZymoGenetics, y , Inc. at 1-888-784-7662,, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. g

AE Category* Patients with any event category Bleeding Cardiac Hypersensitivity Nausea + vomiting Other infection Post-operative wound infection Thromboembolic

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

†

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

*

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

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

DRUG INTERACTIONS Drug interactions have not been formally studied.

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with RECOTHROM. It is also not known whether RECOTHROM can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RECOTHROM should be given to a pregnant woman only if clearly needed.

Pediatric Use Of the 72 patients undergoing burn wound excision and grafting treated with RECOTHROM applied with the spray applicator in the open-label, single group, Phase 2 study, 4 were pediatric patients.

All were age 12 to 16 years. The safety and effectiveness of RECOTHROM in all pediatric age groups have not been fully established.

Geriatric Use Of the total number of patients in Phase 2 and Phase 3 clinical studies of RECOTHROM with absorbable gelatin sponge, 38% were 65 years old and over, while 16% were 75 years old and over.

No substantive differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

For Full Prescribing Information, access www.RECOTHROM.com Manufactured for ZymoGenetics, Inc. RT022-06, January 2011

anesthesia, and involves making a tiny incision in the lining of the mid-esophageal lining to allow passage of a flexible endoscope into the wall of the esophagus, creating a submucosal tunnel into the gastric cardia. The endoscopist divides only the circular muscle layer and closes the mucosal entry with conventional hemostatic clips.

In 2007, Pankaj Jay Pasricha, MD, currently professor of medicine at Stanford Medical Center, in Stanford, Calif., and formerly at the University of Texas Medical Branch, in Galveston, and colleagues reported they had performed an endoscopic method of esophageal myotomy in animal studies (Endoscopy 2007;39:761-764). Soon after, Japanese surgeon Haruhiro Inoue performed a peroral endoscopic myotomy in humans with achalasia and other spastic esophageal motility disorders (Endoscopy 2010;42:265-271).

So far, reports suggest that about 300 patients in China, 200 in Japan, 70 in Europe and 100 in the United States have had the procedure, which is still considered investigational.

“The approach is quite unconventional, and with the early data we have so far, the results look very good,” said William Richardson, MD, head of general surgery and director of laparoscopic surgery, Ochsner Health System, New Orleans.

“I consider laparoscopic Heller myotomy to be the standard, and in that procedure we do everything we can to avoid making a hole in the mucosa. And yet, for POEM, that is exactly what you do.”

No confirmed deaths or disabling complications have been reported. However, there are unconfirmed reports that one woman in the United States may have died following a POEM procedure. Three different surgeons cited this case in interviews with General Surgery News and gave the details as follows: A 19-year-old female patient died in a hospital in Baltimore, from mediastinal sepsis secondary to a perforation.

Before her death, she told hospital staff that three days earlier she underwent an endoscopic Heller myotomy. The hospital has released no further details. It is unknown whether the woman indeed underwent POEM or if she had a laparoscopic Heller myotomy.

“The procedure was done in a community hospital where they failed to recognize a perforation,” said Marco Patti, MD, professor of surgery and director of the Center for Esophageal Diseases at the University of Chicago Pritzker School of Medicine. “We don’t want this to be first of a long series of patients that will die.”

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

â&#x20AC;&#x2DC;All too often we have seen rapid adoption of new procedures simply because they are new, procedures that eventually fade away from practice after [a] considerable price has been paid by society.â&#x20AC;&#x2122; â&#x20AC;&#x201D;Carlos Pellegrini, MD The New Study All previous studies of POEM focused on the technical aspects of the procedure.

So, in their recent study presented at the 132nd annual meeting of the American Surgical Association, lead investigator Lee Swanstrom, MD, a surgeon in the minimally invasive surgery division at The Oregon Clinic, in Portland, and colleagues set out to measure POEMâ&#x20AC;&#x2122;s effect on symptoms and esophageal function, which will be important in defining the ultimate role for POEM in the spectrum of treatments for achalasia.

The investigators studied 18 patients who underwent POEM since October 2010, at The Oregon Clinic. The group included nine women and nine men with manometrically defined achalasia who were eligible for laparoscopic myotomy. The cohort had a median American Society of Anesthesiologists (ASA) physical status score of 2, had experienced symptoms for a median of 25 months and lost a median of 12 pounds prior to POEM. Ten patients had advanced achalasia (Eckhardt score >6) and 11 had prior endoscopic interventions. The procedures lasted a median of 146 (Âą44) minutes, and the median length of the myotomy was 9 cm with a median of six clips used for mucosotomy closure.

Post-procedural exams showed that patients experienced a significant improvement in dysphagia and lower esophageal sphincter pressure, which was measurable one month after surgery and was still present up to six months after POEM. Additionally, patients had very low pain levels after treatment; only two of 18 (11%) required any pain medication following POEM, and returned to full activities within a mean of three days, investigators reported.

One patient experienced a major complication, a full-thickness entry incision.

Surgeons recognized the problem immediately and placed a single endoscopic suture to close it at the end of the procedure. The patient experienced no ill effects as a result, said Dr. Swanstrom.

Minor complications included five cases of capnoperitoneum, one capnothorax and four mucosotomies.

Additionally, test results for acid reflux at six months were not so good.

Notably, 46% of patients had 24-hour pH evidence of mild to moderate gastroesophageal reflux after six months.

This finding appears to contradict one of the arguments for POEM, namely that it may avoid the risk for reflux commonly associated with conventional achalasia treatments because it leaves intact the anatomy of the lower esophageal sphincter. The study suggests that the reflux rate after POEM is comparable to that of balloon dilation and perhaps even laparoscopic Heller myotomy

with fundoplication, with estimates ranging from 10% to 42% (Surg Endosc 2012;26:18-26; Arch Surgg 2005;140:827833). Patients who had reflux were started on peptic medications even if they were asymptomatic (50%). The implications of the acid reflux on long-term results are not yet determined, said Dr. Swanstrom.

POEM patients did have a faster response to treatment with better early dysphagia relief, less pain and a quicker return to work than surgery patients, based on results from previously published trials. Median Eckhardt scores

41

fell from 6 preoperatively to 1 at one month after surgery, and to 0 by six months (P=0.0002).

P Dysphagia scores decreased from 3 to 0 at one and six months (P=0.0002), P and chest pain scores fell from 1 to 0 (P=0.01).

P Lower esophageal sphincter (LES) pressure decreased by 60%, and 88% of patients in the study had normal LES relaxation six months after POEM. The investigators also performed timed barium swallows pre- and postoperatively to measure esophageal emptying five minutes after eating. Before POEM, 48% see POEM page 42

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42

In the News POEM

jcontinued from page 41 achieved emptying within five minutes, which increased to 100% post-procedure.

The study provides “the first objective evidence that the POEM procedure is a safe and effective surgical treatment for achalasia palliation,” said Dr. Swanstrom.

He stressed that the procedure is a surgical treatment, despite being performed endoscopically, and should be done by surgeons experienced with endoscopy and achalasia.

No studies to date directly compare POEM with laparoscopic Heller myotomy, leaving some experts saying the excitement over the procedure is premature.

“What I am concerned about is the widespread use of POEM as it is currently being observed without appropriate evaluation of its place in the therapeutic armamentarium for achalasia,” said Dr. Pellegrini.

“All too often we have seen rapid adoption of new procedures simply because they are new, procedures that eventually fade away from practice after [a] considerable price has been paid by society.”

He pointed to past experiences with botulinum toxin and other treatments, which had excellent results at six months

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

‘My gut feeling is that it is absolutely unethical to do this procedure outside of IRB protocols in tertiary care centers.’

—Marco Patti, MD but failed within two to five years. “It is not until we have a follow-up of at least several years that we can say that a treatment modality is effective in this disease.”

Dr. Patti said that this technique is spreading. In recent months, he has received phone calls from other physicians looking for referrals so they can do POEM on patients. Dr. Patti said he has refused to refer patients to surgeons and gastroenterologists who do not have a proven record with both achalasia and POEM. “Unfortunately, outside of the centers like Dr. Swanstrom’s, where it is done with IRB [institutional review board] approval, centers are not explaining that this is experimental and that we really don’t know the results. Dr. Swanstrom is a very skilled endoscopist and surgeon, and yet even he has a high rate of complications,” Dr. Patti said. “In the hands of

a less experienced person, some of those complications could be lethal.”

Dr. Patti concluded: “My gut feeling is that it is absolutely unethical to do this procedure outside of IRB protocols in tertiary care centers where they will have long-term follow-up. Second, it should be done by a multidisciplinary group that involves a surgeon, a gastroenterologist and [a] radiologist.”

Still, POEM certainly has appeal. It is done endoscopically and specifically targets the muscle layers of the lower esophageal sphincter affected by achalasia, leaving the anatomic integrity of the LES anatomy alone.

“I have looked into the POEM procedure and am excited about it,” said Dr. Richardson. “The POEM procedure, an endoscopic myotomy, offers the hope of an improved recovery. Outcomes such as the improvement in dysphagia, risk of reflux and rate of complications still need to be elucidated, but initial results are encouraging.”

Dr. Richardson was one of the authors, in 2011, of the Guidelines for the Surgical Treatment of Esophageal Achalasia, from the Society of American Gastrointestinal and Endoscopic Surgeons. POEM is barely mentioned in the guidelines because the authors found that there is

insufficient evidence to make a definitive statement (Surg Endoscc 2012;26:296-311); however, the authors did state that an endoscopic technique has been described for myotomy and that short-term outcomes have been reported in a small number of patients by Japanese investigators.

“This technique is in its infancy, and further experience is needed before recommendations can be provided,” they wrote in the guidelines.

Dimitrios Stefanidis, MD, PhD, medical director at Carolinas Simulation Center at Carolinas Medical Center, Charlotte, N.C., and a co-author of the SAGES guidelines, said he wants to start learning POEM but is watching for more data. The debate about POEM is one that happens with all new surgical procedures, he said. “Where is the balance between innovation and practice of evidence-based medicine?

“I don’t think the debate is yet resolved, although I think we lean to being more evidence-based. When you learn something new, it is often at the expense of somebody and that somebody is often the patient. That’s what we must be very careful of,” he said.

Dr. Swanstrom reported relationships with Boston Scientific and Olympus Medical.

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

In Medicine, More ‘Big Brother’ Than Ever Before B Y L UCIAN N EWMAN , III, MD

M

ake no mistake. Big Brother is watching you.

Written by George Orwell in 1949, the novel 1984 4 describes Big Brother (government/authoritarian figure) peering over your shoulder via telescreens to examine almost everything in your life. How prescient this seems today in medicine.

Whether life imitates art or vice versa, inspection of our practice of medicine is occurring at record levels today by way of telescreens, 63 years after Orwell’s prediction. As we move into the new era in medicine, there is nothing left to chance in the examination of physician and hospital behavior. The products of our treatment are scrutinized based on costs, presumed quality, hospital length of stay and increasingly, and controversially, patient satisfaction.

Harder numbers are created by your claims history analyzed by third-party payers. This includes Medicare, Medicaid and the myriad of private insurers. Claims data do not accurately reflect the reality of patient care, but recently, large private companies have invested in this concept to analyze what claims data can show. Hospitals and individuals are displayed now at www.hospitalcompare. hhs.gov.

Many state Departments of Health

have robust sites with data for public review that will besmirch the lack of your proficiency based on collected comorbidity on Medicare claims. A striking example is found on the California Department of Health Web site regarding cardiovascular surgery, where it lists the surgeons and hospitals with a “worse” designation in red reserved for those with unacceptable results based on expected versus observed mortality rates. These programs may indeed be inferior, or,

“

see BIG BROTHER page 50

novusmd.com

A niche

malpractice

It would seem prudent to recognize what is required to protect our profession, while maintaining some semblance of the medicine we learned to practice.

The Internet phenomenon has facilitated the prolific spread of information and results-based choices in medical care are becoming expected rather than a threat. Although the conversion to electronic medical records has faced strong headwind, the pace forward is quickening. And although all physicians can agree that providing the safest care is our goal, we simply disdain being told how to do so. The same electronic systems created to improve information transfer will be used to sharpen retrospective analysis.

Examination of the mechanisms used to measure you and your practice can take many forms, many of which occur without your knowledge. The obvious starting point is simple perception. Although nonscientific, your staff, the hospital staff, your colleagues, your friends and the local population develop opinions about your care based on personality and “image.”

This has always been present in our profession and frankly all professions. The many specialty societies are charged with policing activities of the members based on peripheral input. The National Practitioner Data Bank assembles the product of legal and disciplinary action against physicians. Your local and state medical boards collect various bits of information pertinent to maintaining licensure.

perhaps, their documentation of comorbidities may be deficient. Hospitals and physicians have argued ad infinitum that they themselves have the sicker populations to treat while the neighboring facility gets the “better” patients. Many of you realize this is happening but feel ill equipped to fight back.

Other retrospective review occurs at the facility level, and if your facility is part of a larger collection of hospitals you may

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43

44

Letters to the Editor

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

ERSAR 40th ANNIV

A Keynesian Take on Health Care To the Editor: [Re: â&#x20AC;&#x153;A Keynesian View of Health Care,â&#x20AC;? June 2012, page 1] Dr. [ Jon C.] White wrote a very nice article on the role of government in providing health care and what can be done to rein in spiraling costs. I read with interest and agree with his suggestion that tort reform is a good place to start.

However, I read with shock and dismay his suggestion that â&#x20AC;&#x153;means testingâ&#x20AC;? be used to decide which seniors should be offered Medicare and which seniors

should have to pay for own health care.

FICA (Federal Insurance Contributions Act) taxes are used to fund Social Security and Medicare. They are composed of 12.4% (6.2% employee and 6.2% employer) for Social Security taxed up to the first $110,000 of gross income in 2012, and 2.9% for Medicare (1.45% employee and 1.45% employer) taxed on the entire gross income. For the average surgeon making $350,000 a year, that calculates to $6,820 plus $6,820 for Social Security and $5,075 plus $5,075 for Medicare.

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Next thing you know, they are going to be charging my kids tuition to go to public schools funded by my property taxes.

O Over the course of a 30-year career in ttodayâ&#x20AC;&#x2122;s dollars, a surgeon can expect to ccontribute more than $200,000 to Social Security and more than $150,000 to S Medicare. With the employer matching M tthe same amount, the total contribution comes to more than $400,000 for Social Security and $300,000 for Medicare.

Thatâ&#x20AC;&#x2122;s more than $700,000, and roughly twice what the average elderly couple pays in health care expenses from 65 years of age to the bitter end.

While I understand that Medicare was designed to ensure that all people over age 65 are covered with health insurance, and Social Security to prevent extreme poverty in the elderly, what I donâ&#x20AC;&#x2122;t understand is why people keep telling us that we have no right to receive these benefits when we have paid for them for our entire working lives. I have less of a problem with this concept as long as it is considered a tax by the working class to care for the poor elderly instead of a purported benefit that I am laying up in store for myself. But that is nott what it is, nor what it was designed to be.

Is Dr. White suggesting that all doctors in this country could expect to have zero Medicare and zero Social Security when they turn 65 simply because they didnâ&#x20AC;&#x2122;t qualify on the â&#x20AC;&#x153;means testâ&#x20AC;?? Does savingâ&#x20AC;&#x201D;i.e., taxing $350,000 of our own moneyâ&#x20AC;&#x201D;not account for something?

And donâ&#x20AC;&#x2122;t forget the kicker: Those of us who are self-employed pay the entire 15.3% in FICA taxes!

Where do you draw the line? Next thing you know, they are going to be charging my kids tuition to go to public schools funded by my property taxes; Iâ&#x20AC;&#x2122;m going to have to pay tolls on the roads in my subdivision; [give] extra money to call EMS/fire/police; and I will personally be required to sponsor at least three soldiers who are fighting to protect my freedom.

Steven R. Casos, MD, FACS Boise, Idaho To the Editor: or those with an interest in economics, Dr. [ Jon] Whiteâ&#x20AC;&#x2122;s commentary, â&#x20AC;&#x153;A Keynesian View of Health Care,â&#x20AC;? particularly draws attention. Lord Keynesâ&#x20AC;&#x2122; influence on Western governments since the 1930s has been profound. Keynes was a proponent of heavy government interventionism, central banking, fiat currency, the use of money

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Letters to the Editor

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

depreciation and inflation in order to promote the concept of “full employment,” copious borrowing and debt, bailouts, price fixing and high taxation, to name a few. If any single economist could be linked to the current fiscal status of Western nations, it would be John Maynard Keynes.

Any person who follows current events will recognize the economic disasters that loom throughout the European Union, with Greece and Spain leading the way. The United States follows closely behind with a $15 trillion national debt, a trillion-dollar per year budget shortfall, and future expenditures promised to the citizenry that are unfunded to an amount that may run into many tens of trillions of dollars.

The author quotes Keynes’ assessment that “private-sector decisions about the economy sometimes lead to bad macroeconomic outcomes for the economy.”

That may be true. What is not mentioned, however, is that an economy heavily influenced by a relatively small number of bureaucrats and academics, often educated beyond their intelligence, also will make bad decisions. In the latter case, those decisions become fixed by way of government diktat, regulation and law in such a way that productive change is much more difficult. Incentives are distorted on a grand scale, mal-investments (of other people’s money) are made that are hard to correct, and processes and entities that should be allowed to fail are bailed out and supported.

While the article describes the necessary fluid nature of medicine, the application of Keynesian principles to our profession is antithetical to that versatility; it discourages, if not punishes, any deviation from the mandated standards set forth by the governing bodies. I disagree with the author’s assertion that medicine “seems to be on a path of selfdestruction.” I believe instead that the problems with medicine, its delivery and its financing are primarily the fruition of interventions into the doctor–patient relationship that have been shaped by 50 years of legislation, government–corporate collaboration, distorted tax law and perhaps well-meaning but misguided entitlement expansion.

The full application of Keynesian economic principles to medicine will culminate in the deceptive promise of full access for all, but to a diluted value of medical services paid at fixed government rates through national debt with an ever-depreciating currency. I would say that many in our profession, in concert with politicians, have very nearly achieved just that.

—M. Todd Rice, MD Dr. Rice is an anesthesiologist in private practice in Arlington, Texas.

To the Editor: was amused by the article “Keynesian View of Health Care” ( Jon C. White, MD). The author proposed a number of reasons we need more heavy-handed federal intervention in health care, with some grand principles on “the many ways the government can and should intervene in our health care system.” We were teased with the suggestion that physicians will be given great authority to apply these principles.

Dr. White did not address drug shortages, a recent hot topic. Like many readers, I remember a time when drug

I

shortages were practically unheard of.

However, probably thanks to perfect application of Keynesian principles in the manner the author describes, we now have medication shortages that complicate our lives to the point of patient risk.

In 2003, Congress passed the Medicare Modernization Act. Included were a series of complicated de facto price controls through average sales price requirements. Our president has promoted strict enforcement of this policy.

Sadly, we see the results when critical injectable medications are unavailable

because of disincentives to manufacture them. We never heard of raw material shortages, insufficient manufacturing capacity or distributor hoarding until federal intervention distorted and politicized the basic economics of production. Further worship of the religion of John Maynard Keynes will bring shortages of more than just medications in health care.

—Sean S. Adams, MD The author is an anesthesiologist in Naperville, Ill.

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Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

Dear Readers, Welcome to the September issue of The Surgeons’ Lounge. This issue features Rami E. Lutfi, MD, FACS, clinical assistant professor of surgery, University of Illinois at Chicago, and director, the Chicago Institute of Advanced Bariatrics, Saint Joseph Hospital, who discusses gastric plication, sometimes known as “the sleeve killer.” Read on!

In this issue, we also bring you the first of a new series, The Latin Quarter. The series features surgical updates and events from our South American editor, Natan Zundel, MD, FACS, FASMBS, clinical professor of surgery, Florida International University, Herbert Wertheim College of Medicine, Miami.

We greatly value our readers’ opinions and encourage all feedback.

Sincerely, Samuel Szomstein, MD, FACS Editor, the Surgeon’s Lounge Szomsts@ccf.org

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

Question for Dr. Lufti From Dr. Chris Joyce, bariatric surgeon in New Lenox, Illinois

G

astric plication is a novel operation that we are starting to hear more about. Despite general skepticism by many, the enthusiasm about this operation is rapidly growing and the procedure already has been called by some “the sleeve killer.” What makes the plication attractive to our patients, and do you think it will become a standard procedure?

How do you perform the plication, and do you truly believe that it is easier to perform with fewer complications?

Dr. Lufti

stomach onto itself ” to decrease its storage capacity with the intent of inducing earlier satiety. Research is under way to investigate other mechanisms of action such as hormonal changes and change in gastric emptying, but, for now, I would say this is a restrictive operation.

The simple concept of this operation (folding the stomach) is what we see is most appealing to our patients. They look at the plastic model, and many seem most interested in it. They like the idea of “suturing” the stomach, rather than cutting it (sleeve gastrectomy), along with the minor anatomic changes, and its reversibility. All this translates in the patients’ minds to an easier and safer operation, despite the fact that we discuss with patients that it is investigational and review its associated risks and complications.

This operation, however, is by no means an easy one. It is most similar to a

sleeve gastrectomy, although I believe it requires more skill than a sleeve gastrectomy to be performed well. The reason for this is twofold: First, the stomach is not removed in this operation; this means that extra care should be paid to avoid burning the gastric wall during freeing the greater curvature. This could be challenging in certain patients, as opposed to a sleeve gastrectomy, where the stomach is excised and thus liberal use of energy devices is possible.

The second reason is that the plicated portion of the stomach could cause severe narrowing of the lumen despite using a bougie (we use the endoscope as a bougie) as the plicated part could always push medially to reach the lesser curvature once the bougie is removed. For that reason, extra care should be paid to leave a safe distance from the lesser curvature while placing the plicating sutures. We strongly recommend scoping all patients

afterward to ensure preserving adequate lumen, especially at the incisura.

Two rows of nonabsorbable sutures are needed. The first row is interrupted with no more than 2- to 3-cm gaps, and the second is a running suture (Figures 1 and 2).

Although, early on, anterior plication was attempted (mainly to avoid the need to release the greater curvature and further simplify this procedure), greater curvature plication proved superior with weight loss (23% vs. 53% estimated weight loss [EWL] at one year) and quickly became the standard.1 We perform this operation using four, 5-mm trocars and a liver retractor (two right-sided working trocars, a camera port and a left-sided assistant trocar).

Robotic technology proved useful when we used it due to the amount of suturing required, but it is not a necessity. continued ON page 48

Reply

Thank you, Dr. Joyce, for your relevant and timely questions. It is true that gastric plication is becoming increasingly popular with both surgeons and patients. Let me start by stating that there is no good answer to most questions about this operation, as we do not have enough data at this time to give an educated opinion. My opinion is based on my personal experience performing this procedure and talking to others who have done it, along with reviewing the small amount of published data.

In this operation, we simply “fold the

Figure 1. Intraoperative view of completed stomach plication.

Figure 2. Postoperative upper gastrointestinal series view of the completed stomach plication.

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Surgeons‘ Lounge jcontinued from page 46

We release the greater curvature the same way we do for the sleeve gastrectomy, starting at about 5 cm from the pylorus all the way to the left crus. The left crus should be well dissected and any hiatal hernias should be repaired, if found.

Early data show wide variation in weight loss, mostly due to the lack of standardization (especially in regard to the “tightness” of the plication). Overall, however, the numbers have been

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

encouraging, with about 50% EWL at one year1-3 and 60% at 2 and 3 years.3 No long-term data have been published to date, and, until those exist, we cannot judge the effectiveness of this procedure.

Complications, of course, have been reported. Most are similar to the sleeve gastrectomy, including dysphagia, severe heartburn and obstruction. Leaks have been reported in many series, despite the stomach not having to be divided. Additionally, we are seeing new types of complications that seem to be specific to this operation, such as esophageal obstruction from retrograde intussusception of

the plicated gastric fold,4 and gastric compartment syndrome.5 Finally, I should mention that we also are looking at the plication performed along with the placement of a gastric band with the intention of improving weight loss after banding using fewer adjustments. All these are theoretical advantages at this point, but we are collecting the data, along with other centers, to better judge the value of adding the plication part. Just as with the plication alone, no long-term data are available at this point, but early data are promising with EWL of 60% at one year.6

It is of utmost importance for these operations at this time to be performed only under an Institutional Review Board/ethics committee protocol, and patients should be informed that these are still investigational procedures.

For now, we offer gastric plication mainly to those patients who do not have bariatric insurance coverage or who get denied for coverage, as a cheaper option for paying out of pocket. We see increased access to weight loss surgery as the main advantage for this procedure at this point because the gastric plication could be completed with minimal use of disposables, thereby making it a cheaper option and more affordable to patients.

As to your questions about its place as a potential standard bariatric operation, this will not be answered before data are collected and analyzed. Only then can accurate decisions could be made about the value and the fate of this operation.

References 1. Brethauer SA, Harris JL, Kroh M, Schauer PR. Laparoscopic gastric plication for treatment of severe obesity. Surg Obes Relat Dis. 2011;7:15-22.

2. Ramos A, Galvao Neto M, Galvao M, et al. Laparoscopic greater curvature plication: initial results of an alternative restrictive bariatric procedure. Obes Surg.

2010;20:913-938.

3. Talebpour M, Amoli BS. Laparoscopic total gastric vertical plication in morbid obesity. J Laparoendosc Adv Surg Tech A. 2007;17:793-798.

4. Andraos Y, Ziade D, Achcouty R, Awad M. Early Complications of 120 laparoscopic greater curvature plication procedures. Bariatric Times. 2011;8:10-15.

5. Watkins BM. Gastric compartment syndrome: an unusual complication of gastric plication surgery. Surg Obes Relat Dis. 2011 Sep 10. [Epub ahead of print].

6. Huang CK, Lo CH, Shabbir A, Tai CM. Novel bariatric technology. Laparoscopic adjustable gastric banded plication: technique and preliminary results. Surg Obes Relat Dis. 2012;8:41-45.

The Latin Quartter Hola Amigos y Colega! This is the first report from the Latin Quarter, which will offer readers monthly current events in Latin America, including coverage of con ngresses, research, new publications and d other h relevant news.

This first issue will include coverage of the main congress event in Latin America this year, the 13th World Congress of Endoscopic Surgery (WCES). The WCES is a biannual event, under the auspices of the International FederaNatan Zundel, tion of Societies of MD, Editor

Surgeons‘ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

discussed endoscopic stenting, primary and secondary bariatic procedures and the “per oral” endoscopic myotomy for the treatment of achalasia.

The four-day hands-on robotic training course, under the direction of Dr. Eric Wilson, offered more than 80 surgeons the opportunity to experience the simulators and practice a variety of surgical tasks. The “Learning Center” organized by Dr. Humberto Vazquez Sanders, allowed participants access to various simulators and the opportunity to be guided by a panel of experts in the acquisition of basic and advanced skills in

laparoscopy and endoscopy. Participants were also able to view videos related to technical tips and pearls on how to perform laparoscopic and endoscopic tasks such as suturing and other techniques.

The Learning Center was a tremendous success and filled to capacity during the duration of the congress.

Overall, the 13th WCES provided a great opportunity for endoscopic surgeons from all corners of the globe to come together in an outstanding venue and discuss the latest advances of minimally invasive and endoscopic surgery. Exciting and vigorous academic

discussions took place during the wellattended meeting, during which experts as well as the attendees were provided the opportunity to exchange views and share experiences.

We look forward to the next WCES, which will be hosted by the European Society of Endoscopic Surgery in Paris, in 2014. We also wish to congratulate Professor Seigo Kitano, from Japan, who was elected as the new president of IFSES for the next four years.

The new standard f viscera retention for f safe for f r, r easier abdominal closures.

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Endoscopic Surgery (IFSES), presided by Dr. Alberto Chousleb. The Latin American Societies, Federación Latinoamericana de Cirugia (FELAC) and Asociación Latinoamericana de Cirujanos Endoscopistas (ALACE), had the honor of hosting this event this year, under the presidency of Dr. Natan Zundel.

The WCES took place April 23-27, 2012 in the new, state-of-the-art convention center in Puerto Vallarta, Mexico. The main congress was preceded by 12 precongress courses organized by the Mexican Society of Endoscopic Surgery (AMCE), the Laparoscopic Institute of South Florida and the Mexican College of Obesity Surgery and Metabolic Diseases. More than 200 international experts from various countries in Latin America, Europe, Asia and the United States, among others in the fields of minimally invasive, endoscopic, bariatric and robotic surgeries were gathered in the beautiful coastal town to participate as faculty. More than 2,600 registered surgeons from all around the world and a massive Allied Health Group participated in this congress, making it a great success.

The precongress courses included a variety of current topics including hernia, hands-on robotics, obesity and singleport surgery. There were transmissions of live operations from hospitals in Mexico City, as well as the opportunity for surgeons to practice their skills in an animal lab. A Resident’s Course on Wheels was offered for those trainees who were granted full scholarships to attend the congress, and where faculty members gave lectures on diverse topics while on route (by bus) to Puerto Vallarta!

The congress had very active participation from all the IFSES member societies who provided an expert panel from each society to discuss the most recent advances in the fields of therapeutic and advanced endoscopy, minimally invasive techniques for cancer, robotic surgery, single-site surgery, among other currently hot topics.

The American Society for Metabolic and Bariatric Surgery (ASMBS) hosted a variety of events detailing the current management of obesity and metabolic disease. Dr. Jacques Marescaux, president of the International Research Institute Against Digestive Cancer (IRCAD) in Strasbourg, France, wowed participants with the latest novel technological advances related to intraoperative imaging techniques as well as integration of various imaging modalities to allow for better diagnosis.

The main lectures were related to topics ranging from needlescopic surgery to laparoscopic management of pancreatic cancer. Specific focus was placed on novel endoscopic techniques, in which experts

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Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

BIG BROTHER

jcontinued from page 43 be compared with physicians within your specialty at both local and corporate levels. A notable weakness is created within any given specialty because very often there are variations in practice patterns within the broader specialty. Consider a general surgeon in a large metropolitan area who does not do any pediatrics, vascular, thoracic, trauma, endocrine, versus smaller facilities where they do. Or consider orthopedic surgeons who specialize in spine or joints or trauma versus

general orthopedic care. Comparing discordant groups based on small samples is very difficult.

Within your facility you are scored on compliance with protocols including the Surgical Care Improvement Project, deep vein thrombosis, acute myocardial infarction, stroke, heart failure and renal failure, among others. The health information and quality management teams, retrospectively, review documentation within all facilities to report success and failure with these efforts. To many readers, PEPPER (Program for Evaluating Payment Patterns Electronic Reports ) is

simply what sits on the table beside the saltshaker, to others it is a file to analyze and report discrepancies in billing, diagnosis-related group assignment and medical necessity of treatment and admission to the Centers for Medicare & Medicaid Services. This document effects the probability of successful defense of recovery audit contractor audits.

A more egregious example of review occurs regularly in the “blogosphere,” where a physician can be disemboweled without a chance to effectively respond.

There are nationally sponsored sites that tout their ability to help consumers

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find a good doctor. Certainly, as we deal with life-altering problems, all of our patients undergoing sometimes painful procedures, will be kind in their opinions about us online, won’t they? In fact, patient satisfaction ratings are part of our future payment formulas, like it or not!

The old adage “I’d rather fight than switch” was popularized promoting Tareyton cigarettes in the 1960s. Notably, the smoker wound up with the black eye.

This reminds me of the confrontation between physicians and the changing landscape of medicine. Unfortunately, physicians are likely the ones with a black eye. There continues to be resistance to electronic changes as well as the concepts of measurements thought to promote a “cookbook” approach to treatments. Societal response to the purported “98,000 medical errors” has certainly caused focus on process and a demand for more detailed statistical information. Proper description and documentation of all encounters should mitigate the risks for appearing substandard.

As we move forward, it would seem prudent to recognize what is required to protect our profession, while maintaining some semblance of the medicine we learned to practice. Specific documentation is a must. Complete documentation likewise is required to differentiate the expectations for morbidity. A physician friend of mine who is an expert in coding consultation illustrated that congestive heart failure can mean the patient got his or her Lasix refilled regularly but plays golf orr is in the emergency room needing IV diuresis orr is on a ventilator with a balloon pump in place and not expected to survive. All are congestive failure but have radically different meanings and expected morbidity.

Common misconceptions surround the belief that you are only judged on the diseases you treat directly. Unfortunately, you will be judged on the expectations and management attendant with the aggregate morbidity, not just your part. The winners in the future may have a somewhat different set of skills than was cultivated in the past. Learning how to maximize access to available information would seem to enhance patient safety as well as protect individual reputations. Over dramatizing our plight and comparing to the Kubler-Ross model of dealing with grief reminds that the final stage is acceptance. (“I can’t fight it/I may as well deal with it.”)

It would seem that Big Brother is alive and well, and hiding from the telescreens described as the eyes of the beast does not seem possible today.

—Dr. Newman is a general surgeon in — Gadsden, Alabama, and the founder and CMO of Comply MD.

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LD Britt; Andrew Peitzman; Phillip Barie; Gregory Jurkovich June 4, 2012 Acute Care Surgery y is a comprehensive textbook covering the related fields of trauma, critical care and emergency general surgery. The full spectrum of acute care surgery is expertly addressed, with each chapter highlighting cutting-edge advances in the field and underscoring stateof-the-art management paradigms.

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Eugene Toy; Terrence Liu; Andre Campbell June 19, 2012 You need exposure to high-yield cases to excel in the surgery clerkship and on the shelf exam. Case Files: Surgery presents 56 real-life cases that illustrate essential concepts in surgery. Each case includes a complete discussion, clinical pearls, references, definitions of key terms, and USMLE-style review questions. With this system, you’ll learn in the context of real patients, rather than merely memorize facts.

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General Surgery Board Review, Fourth Edition

Larry A. Scher; Gerard Weinberg October 17, 2011 This book is indispensable for surgical residents and general surgeons preparing for the American Board of Surgery’s certification and recertification examinations. This study guide maintains the core features that have made it one of the most popular board review books in the field, including questions and answers after each chapter and succinct but detailed reviews of all topic areas found on the ABSITE and certification exam.

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Enrico Ascher September 19, 2012 In recent years the vascular surgeon’s purview has expanded and the number of tools at her/his disposal has increased significantly. Particular advancements have been made in the areas of imaging, endovascular techniques, and the increasingly popular minimally invasive and non-surg ca management gical a age e t options opt o s for o vascular ascu a disease. d sease

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Anthony N. Kalloo; Jacques Marescaux; Ricardo Zorron July 17, 2012 Just as laparoscopic surgery revolutionized surgical practice in the 1980s and 90s, offering genuine competition to traditional open surgery, natural orifice translumenal endoscopic surgery presents a genuinely different alternative for surgeons and patients alike in the 21st century.

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Opinion

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TORT REFORM jcontinued from page 1

however, physicians do make mistakes that they should not have made. This happens most often when they work knowingly outside their scope of practice or outside the standard of practice for their community. When this action is deliberate and avoidable, it is malpractice and may merit some kind of compensation. The problem with the current tort system is that it does not differentiate between these two types of bad outcomes.

The system, which often is blind to the true merits of a case, makes decisions that often are determined by the party with best legal representation.

As imperfect as the U.S. tort system is, some people still argue that it is better than nothing and that people need some legal recourse to malpractice when it occurs. Even if you accept this reasoning, the truth is that the malpractice industry has become so expensive that it is driving up the costs of health care, which is passed on to the consumer. Ironically, this system is hurting the very people it purports to protect. For its steep price, very few people are justly compensated for true malpractice and very few providers are sanctioned appropriately for volitional and avoidable mistakes. On the other hand, some patients (and lawyers) get ludicrous awards for situations beyond anybodyâ&#x20AC;&#x2122;s control and some victimized providers are charged with malpractice when

The system, which often is blind to the true merits of a case, makes decisions that often are determined by the party with best legal representation.

53

cases have no merit. Malpractice attorneys exacerbate the situation by working on contingency, meaning that the plaintiff pays nothing unless the case is won. The effect of this wrongheaded practice is that there is no monetary disincentive to prevent plaintiffs from filing completely frivolous lawsuits. The only consistent winners in this lottery-style rewards system are lawyers, whose take of any judgment can be as much as 30%. In the case of multimillion-dollar awards this can add up to serious money. Can there be any question as to why the trial lawyersâ&#x20AC;&#x2122; major lobbying arm, the American Association of Justice, went into hyperdrive during the recent health care debate and effectively expunged any real tort reform from the quixotically named Patient Protection and Affordable Care Act.

A Lawyer and a General Surgeon Walk Into a Bar After a few drinks the surgeon said to the bartender, â&#x20AC;&#x153;Malpractice premiums are destroying my practice.â&#x20AC;?

The lawyer was sitting close by and joined the conversation. â&#x20AC;&#x153;Malpractice insurance premiums represent only 3.2% of a physicianâ&#x20AC;&#x2122;s total billing.

And I read recently that median salary for a general surgeon in the country is about $350,000. I have no sympathy for you surgeons.â&#x20AC;?

The surgeon had done her homework and see TORT REFORM page 54

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54

Opinion TORT REFORM jcontinued from page 53

pointed out, “The cost of malpractice insurance varies widely depending on the state where the practice is located. In Minnesota, general surgery malpractice premiums in 2009 were about $10,000 per surgeon, whereas in Florida the rate was as high as $175,000. I practice in Pennsylvania, an average-cost state, where premiums vary between $28,000 and $55,000. Even though a surgeon from Minnesota might think that malpractice insurance rates are

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

reasonable, one from Florida would certainly say that they are oppressive.

There are surgeons in areas of the country where rates are so high that surgeons have been forced to relocate their practices, retire early or limit the services they provide. It is making things more difficult for patients in these areas that are now underserved.”

The lawyer was not going to be outargued by a surgeon. “But malpractice is so rampant in this country that 100,000 hospitalized patients die a year from medical errors. Something has to be done about that.”

Take a skeptical look at surgery.

The Skeptical Scalpel posts a weekly blog on issues most relevant to surgical practice. Join the conversation at GeneralSurgeryNews.com by clicking on the “Bl “Blogs” s” tab at the upper righ right.

“The data that you are quoting has come from physicians analyzing our own performance,” she explained. “The Institute of Medicine [IOM] had researched and published ‘To Err is Human: Building a Safer Health System’ in November 1999. And, as disturbing as this number is, it must be coupled with the fact that there are 37 million admissions to American hospitals every year, meaning that 99.7% of all hospitalized patients manage to avoid lethal errors during their hospitalization.”

“One hundred thousand deaths is still a problem,” he sniffed.

“It is a point well taken and duly noted by our ranks. Physicians have not been complacent with these numbers or our own performance. The IOM generated this data and presented it to the medical community as a challenge to improve patient safety. We physicians have responded by conscientiously devoting our time, effort and resources to addressing the problem. Concern for patient safety is changing the way we practice. It makes our daily lives more challenging, but it is a good cause and most of us are proud of our efforts.”

She drained her glass and asked, “And what efforts are you making on the other side of the courtroom?”

“My law firm is paying for television ads that encourage victims of malpractice resulting in cerebral palsy to contact our firm. We have other ads to advise innocent victims who might have taken medications that had unexpected toxicities or side effects to call a number on the screen.”

“And that number is for a free clinic set up to assist people with the medical consequences of these complications?”

When the lawyer was quiet she said, “I thought so. Although you present yourselves as champions of innocent victims, the truth is that you lawyers, and often your clients, are fully aware of the cynical business that you engage in every day. When you present yourselves as social crusaders, you are fooling nobody, except maybe your mothers.

You know you are siphoning money and resources away from medical care to line your own pockets while distributing very little to the true victims.”

The red-faced lawyer finished his drink, left the bar and stiffed the surgeon on the bill.

The surgeon turned to the bartender and explained, “The real cost of this system is much more than the malpractice premiums paid by the physicians or the blood money pocketed by the lawyers.

Most physicians live in fear of frivolous lawsuits and practice defensive medicine. It is difficult to know exactly how much this costs, but it is very expensive. We are all told that one-third of all malpractice suits result from a failure to diagnose a problem and know that there is an endless variety of very expensive diagnostic tests. Although we would like to be selective in ordering these tests, the current malpractice atmosphere encourages us to order every one that might be even remotely related to the problem at hand. Diagnostics is one of the fastest-growing sectors of health care and you are paying for it with your health insurance premiums.”

A Solution I am fortunate to be covered by the Veterans Affairs (VA) system, which

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2012

works within the confines of the problematic American legal system but offers a solution to part of the tort problem.

All malpractice claims brought against VA physicians are defended by government lawyers but allso are reviewed by other physicians in the VA system. These reviewers are selected from appropriate specialists working at any of the 132 VA hospitals across the country. They usu ually donâ&#x20AC;&#x2122;t know the defendaant but have real expertisee in the fields that theyy are reviewing and havee access to all of the medical records through thee VA electronic medical records system system. These reviews help the VA legal office defend the accused physician, but if the provider is found to be at fault, then he or she may be reported to the National Practitioner Data Bank (NPDB).

This system has many benefits. The patient still has legal recourse and legitimate cases can still go in the patientâ&#x20AC;&#x2122;s favor. If a physician has truly committed malpractice, then he or she will be appropriately censored and reported to the NPDB. On the other hand, physicians do not feel obligated to practice defensive medicine because they know that well-qualified experts who have full access to their records and can fully grasp the subtleties of their case will judge them. They know that as long as they practice within the accepted standard of care, they will not be held accountable for bad outcomes. There has been some discussion of taking medical malpractice out of the civil courts and having a VA-type review process with a panel of experts to adjudicate all claims.

An ideal panel would include subspecialty specific medical experts, laypeople and lawyers. This type of review has a better chance of discovering the true merits of any case and would go a long way toward lessening defensive medicine, decreasing frivolous claims and, ultimately, saving money for the system.

Many states have medical boards with a peer-review function, which is designed to investigate the details of medical mishaps and thus protect the public. Unfortunately, these boards usually employ a small stable of retired practitioners as their expert witnesses who are no better qualified than the hired guns used by the plaintiff â&#x20AC;&#x2122;s lawyers. The lay public cannot spot an unqualified physician rendering an opinion about a matter in which he or she has no expertise and, when the medical opinion is bogus, the system has no merit. The legal system in the United States is one of our countryâ&#x20AC;&#x2122;s crowning achievements and the concept that everybody is equal in the eyes of the law and can present their grievances to a jury of peers

The system works only when the peers understand the issues being presented well enough that they can render fair judgments.

is a quintessential right of citizenship. However, the system works only when the peers understand the issues being presented well enough that they can render fair judgments.

All evidence points to the conA clussion that tort system as it is curreently practiced must be reformed.

There are complicated issues T involved that may be difficult for the lay public to understand. Our job as representatiives of the medical profession an nd advocates for our patients is too make the case for tort reform.

55

If we can state our case clearly, it should be obvious to even the layperson. Our argument is overwhelming and truly speaks for itself â&#x20AC;Ś res ipsa loquitur. â&#x20AC;&#x201D;Dr. White is a Professor of Surgery â&#x20AC;&#x201D; at George Washington University, and Chief of the Department of Surgery, VA Hospital, Washington, DC.

khorty@mcmahonmed.com.

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REPORT Technological Advancements in Tissue-Sealing Devices Introduction Laparoscopic surgery began to gain ground in the operating rooms (ORs) of the 1990s. Since then, this minimally invasive approach has amassed substantial evidence to support its equivalence and/or superiority to open techniques in terms of blood loss, pain, hospital length of stay, return to normal activities, cosmesis, and a host of other factors.1-3 Laparoscopy is now considered the standard of care for the majority of procedures for

which it is indicated. Although researchers continue to explore its utility, few would dispute its overall advantages for patients.

Laparoscopic surgery still presents challenges to the surgeon in terms of access, visualization, and tactile feedback, as well as ergonomic compromises that result in an occupational injury rate similar to that of symphony musicians.4,5 Hemostasis, one of the basic components of surgery, is particularly demanding during

Faculty David Arrese, MD

Benyamine Mizrahi, MD

Sonia Ramamoorthy, MD

Surgical Oncologist Riverside Methodist Hospital Columbus, Ohio

Colorectal Surgeon Colorectal Surgical Associates, PC Kansas City, Missouri

Matthew Kalady, MD

Sharon L. Stein, MD

Assistant Professor of Surgery Cleveland Clinic Cleveland, Ohio

Director, Acute Intestinal Failure Clinic Case Western Reserve University Medical Center Cleveland, Ohio

Associate Professor of Surgery Chief, Section of Colon and Rectal Surgery Rebecca and John Moores Cancer Center University of California, San Diego Health System La Jolla, California

James Dana Kondrup, MD Minimally Invasive Surgeon Lourdes Hospital Binghamton, New York Surgeonsâ&#x20AC;&#x2122; views are based on individual experiences and are not to be construed as claims made by EES.

Supported by

REPORT

laparoscopic procedures due to the limitations of vesselsealing methods that solely rely on compression, such as sutures, clips, and staples. Thus, as technology has evolved to propel the adoption of laparoscopy, surgeons have come to depend on energy-based vessel-sealing devices that offer reliable seals within the confines of a laparoscopic port.

But not all energy-based devices are created equal. In bipolar energy devices, the current only passes through tissue that is located between the instrument’s electrodes.

This offers potential advantages over monopolar devices regarding safety and precision related to the unintended dispersal of current.6 Even bipolar energy devices do not perform the same, as they can vary in measures such as burst pressure and thermal damage to vessels.7 The ENSEAL® System, marketed by Ethicon Endo-Surgery, Inc., was developed to meet and exceed the demands of vessel sealing while also offering the ability to perform other functions. Specifically, ENSEAL® Devices provide reliable hemostasis, are designed to minimize thermal spread, and can be used to grasp and dissect tissue,8 which can offer flexibility and efficiency to surgeons. In 2003, the FDA cleared the bipolar ENSEAL® Device to seal vessels up to 7 mm in diameter.9 Since then, ENSEAL® Technology has been modified and refined, largely based on surgeon feedback. Today, ENSEAL® Devices are indicated for an array of procedures, including general, colorectal, gynecologic, bariatric, thoracic, and urologic surgeries.9 The latest additions to the ENSEAL® Portfolio include the G2 Curved and Straight Tissue Sealers for laparoscopic surgery and the G2 Super Jaw Tissue Sealer for open procedures, which expand the ENSEAL® Line with superior sealing and a superior sealing experience.

liked the fact that he could tell where the cutting blade was at all times. “The ENSEAL® I-BLADE™ has a gold square that tells you exactly where it is during the surgical procedure,” he added (Figure 1).

“Finally, another feature I like is the learning curve. As I travel all over the world, I have to teach residents and new surgeons how to use ENSEAL® on demand. I find the learning curve to be very manageable,” said Dr. Kondrup.

Sonia Ramamoorthy, MD, associate professor of surgery, chief, Section of Colon and Rectal Surgery, Rebecca and John Moores Cancer Center, University of California, San Diego Health System in La Jolla, performs approximately 80% of her cases laparoscopically. The majority of these cases are cancer- and inflammatory bowel disease–related procedures. Dr. Ramamoorthy described herself as a former diehard user of LigaSure™ devices. However, she noticed that many of her colleagues—including those recognized as pioneers and innovators of minimally invasive surgery and laparoscopy—were using ENSEAL® Devices in videos of laparoscopic procedures presented at surgical meetings.

“I wondered what the difference was,” she said. “So I thought I’d give it a try and see how I liked it.”

It took Dr. Ramamoorthy a few cases to get used to the ENSEAL® System, especially when training residents. “But once I started, I really found it to be very reliable in terms of getting at mesenteric vessels,” she said. “I think LigaSure™ and ENSEAL® are both good devices, but the reliability of one over the other is what really matters to me. When I am

Considerations for the ENSEAL® System James Dana Kondrup, MD, a minimally invasive surgeon at Lourdes Hospital in Binghamton, New York, has been practicing minimally invasive surgery for 24 years. He began using the ENSEAL® System 3 years ago to bolster his armamentarium (rather than to replace his existing devices).

“In the early years, I was using the tri-polar electric cautery, then I started using the HARMONIC ®,” he said. “I travel around the world and teach internationally, and I always come across surgeons using different energy sources. I knew it was important for all surgeons to be familiar with at least 2 energy sources, so when ENSEAL® came out, it was an excellent opportunity to add it to my regimen of surgical tools.”

There were several features that Dr. Kondrup liked in particular about the ENSEAL® System. “The first was that the energy inside the device had minimal thermal spread, only a few millimeters from the instrument,” he said. Dr. Kondrup also

2

Figure 1. Additional compression is achieved by advancing the I-BLADE™ during coagulation.

Image courtesy of James Dana Kondrup, MD.

REPORT

going through difficult or inflamed mesenteries, or [performing surgery on] obese patients, I find ENSEAL® does a good job of sealing the tissue.”

This reliability also may have been the factor that influenced her peers. “I asked quite a few of them why they use ENSEAL®, and they said they just thought it was reliable in sealing the vessels. They felt confident about the hemostasis, and I would agree with that,” said Dr. Ramamoorthy.

ENSEAL® Vessel-Sealing Technology Advancing Superior Sealing ENSEAL® Devices use a patented temperature-controlled, bipolar energy delivery system in the jaw and a unique cutting mechanism, the I-BLADE™, to produce minimal thermal spread and strong, uniform compression across the entire length of the seal.8 Teeth located along the jaw of each instrument serve to facilitate the handling and grasping of tissue. Surgeons also can combine different shaft lengths and jaw configurations (ie, straight or curved) to accommodate a variety of procedures.10 Together, these features allow for the safe and thorough transection of large tissue bundles, multifunctionality, and superior sealing.

Excessive thermal spread from bipolar instruments is a major concern for laparoscopic surgeons.11 The nature of laparoscopy limits surgeons’ ability to assess the degree to which potentially traumatizing heat is being transferred beyond its intended target. Surgeons usually cannot feel it themselves, so they need to be able to understand the thermal spread and capabilities of their energy device.

“During an open procedure, if it’s getting too hot I can adjust appropriately to make sure any tissue is far enough away,” said David Arrese, MD, a surgical oncologist at Riverside Methodist Hospital in Columbus, Ohio. “But when I’m operating laparoscopically, I don’t have my hand in there. I’m concerned about thermal spread because I’m dissecting close to ureters, the small bowel, or the colon, and I’m really concerned about injuring these structures.”

ENSEAL® uses sophisticated technology to measure the temperature of the instrument and to modify the energy flow so that the temperature is high enough to seal vessels, but low enough to minimize lateral thermal spread. “The thermal spread is very minimal with ENSEAL®,” Dr. Arrese said. “It has carbon fibers within the jaw that deactivate when the tissue reaches 100 οC, so that limits the thermal spread.”

ENSEAL® Devices use positive temperature coefficient (PTC) technology to achieve closely regulated energy with a minimal degree of thermal spread. The PTC polymer located in the instrument’s top jaw contains chains of conductive particles that continuously modulate energy throughout

the activation cycle. As the temperature in the jaw reaches 100 οC, the polymer expands and the chains break apart.

The disconnection of the chains results in a discontinuation of conductivity, which prevents the flow of electric current, ultimately reducing the temperature. When temperatures fall below 100 οC, the conductive particle chains come back together, thus restoring the flow of electricity and bringing the temperature back up.12 This back-and-forth, hot–cold cycle continuously relays while the instrument is in use, and it is sensitive along the entire length of the jaw. This is important because tissues can be highly heterogeneous and can vary in density.

“The PTC in the ENSEAL® Jaw has sensing particles, so it does a good job in making sure the temperature is uniform throughout rather than having a portion where, for example, if it’s just spreading from a middle line toward the sides, the temperature might not be as uniform and you might not get the same kind of seal in all places,” said Sharon L. Stein, MD, director, Acute Intestinal Failure Clinic, Case Western Reserve University Medical Center in Cleveland, Ohio.

Dr. Ramamoorthy appreciates being able to rely on the designed minimal thermal spread of the ENSEAL®. “The lateral spread is minimal in either direction, and I think that is very important, especially as you’re doing work around neurovascular bundles,” she said. “You want to make sure you are treating only the vessel you want to treat and not, perhaps, the nerves that are sitting around it. Otherwise, you could injure or damage someone’s nerve supply for bladder or sexual function, as we see in colorectal surgery.”

Dr. Kondrup feels confident in how ENSEAL® functions.

“ENSEAL® only goes up to 100 οC. It will not go above that, and other instruments will go well above that,” he said. “Tissue damage can result from direct cautery from the electricity and from heat damage, when the temperature goes so high it actually damages the tissue laterally. So I feel it’s important to keep heat down so that you don’t cause any additional damage to the tissue.”

Advantages of the I-BLADE™ For Dr. Stein, the most important feature of any vesselsealing device is its ability to provide sound, reliable hemostasis. “The most important thing is the security of the vessel transection. I don’t typically use staplers to transect vessels; for the inferior mesenteric artery or ileocolic artery, I typically use an advanced-energy device,” she said. “Having the security that the device is going to seal and seal well every time is imperative—a no brainer. If you start to have leaks or bleeding afterward, that is completely unacceptable.”

ENSEAL® uses tissue compression along with heat to seal vessels, and its cutting mechanism, the I-BLADE™,

3

REPORT

■ ENSEAL® G2 Curved

250

Average Compression, psi

■ LigaSure™ 5 mm Blunt Tip

200

150

100

50

0

Proximal third

Medial third

Distal third

Jaw Position

Figure 2. Compression analysis of 2 laparoscopic energy-delivery devices.a a

In side-by-side benchtop testing, average compression at distal 0.11 in of jaw: 187 psi (SD=81 psi) for ENSEAL® TRIO vs 40 psi (SD=9 psi) for LigaSure™.

From reference 13.

thoroughly and cleanly transects tissue. It offers strong, uniform compression along the entire length of the jaw,7 and it delivers appropriate doses of energy to each tissue thickness within it. The cutting blade is located within the instrument’s teeth, which enables the blade to stay in place. “Being [located] within the teeth, it’s sort of like the I-BLADE™ is between railroad tracks. The knife cannot jump out of the teeth of the instrument,” said Dr. Arrese.

“With a lot of other devices now, the cutting already happens or you just push a button and it’s an automated process. But the ENSEAL® gives you a little more visual and physical control over how quickly your tissue is cut,” explained Dr. Ramamoorthy. “The way the ENSEAL® works is that you first grasp the tissue and then apply the compression. As you apply compression, you activate energy; you advance the I-BLADE™ forward and energy delivery moves with the blade because you’re compressing. The I-BLADE™ is nice because you can see how fast or slow you are cutting the tissue; that’s under your control.”

Although competing energy devices may lose compression as the surgeon moves distally,a ENSEAL® is designed to provide durable, consistent, and reliable compression throughout the entire length of the instrument (Figure 2).13 Matthew Kalady, MD, assistant professor of surgery at the

a

4

Cleveland Clinic in Ohio, noted that during both his surgical residency and fellowship, he and most of his peers used LigaSure™ devices. “But I tried ENSEAL® because its technology is a little bit different,” he said. “[ENSEAL® ] has the I-BLADE™ Technology, and I think there is a bit more uniform distribution of the energy and compression on the vessels. I think it gives a good seal, and [the compression] goes all the way out to the end of the vessel as well.”

ENSEAL® Devices can seal tissue of all sizes, up to and including vessels that are 7 mm in diameter.8 “It’s a very consistent instrument when it comes to hemostasis,” said Dr. Kondrup. “That’s one of the advantages of ENSEAL®, the reliable hemostasis when I’m doing more difficult cases.

It’s very user friendly as far as controlling blood vessels.” In a benchtop comparison of seal strengths across 52 device activations, porcine arteries sealed with ENSEAL® displayed superior burst strengths versus those sealed with LigaSure™ (P<0.05; Figure 3).13 Dr. Ramamoorthy also is confident that the ENSEAL® will reliably perform the tasks for which it is indicated. “I think any device I use has to be able to seal a large amount of tissue. Being able to reliably seal 5- and 7-mm vessels is important,” she said. The ability of the ENSEAL® to seal large vessels may reduce reliance on other instruments,

In side-by-side benchtop testing, average jaw compression was 201 psi (SD=42 psi) for ENSEAL® TRIO versus 96 psi (SD=9 psi) for LigaSure™.

Data on file. Ethicon Endo-Surgery, Inc.

Vessel Burst Pressure, mm Hg

REPORT

1,600 1,500 1,400 1,300 1,200 1,100 1,000 900 800 700 600

ENSEAL® G2 Curved

2

9

16

ENSEAL® G2 Straight

23

30

37

LigaSure™ 5 mm

44

51

Figure 3. Strength of tissue seals across multiple device activations.a a

Benchtop study using 5-mm porcine carotid arteries. Burst pressure was measured over 52 activation cycles (P<0.05).

From reference 13.

and may improve efficiency in the OR by reducing the number of instruments needed.

Versatility and Customization The ENSEAL® System is designed not only to provide consistent, reliable hemostasis in vessel sealing, but also can serve as a tissue grasper and dissector. “These days we’re trying to find instruments that are multifunctional, that don’t just deliver energy, but that also can help us to do a little dissection or pick things up, and I think ENSEAL® allows us to do things like that,” Dr. Ramamoorthy said. “It’s a nice device for us to use in terms of not having to switch multiple devices in and out of the patient’s abdomen. I can dissect with it, I can seal vessels with it, and then I can keep going with my dissection. I don’t have to switch out to a grasping device. It works pretty well for several different applications in the abdomen.”

Dr. Ramamoorthy suspects that being able to use an energy device that fits through a 5-mm port, unlike a large stapler that would require a 12-mm port, allows surgeons to reduce the size of the incision needed to achieve reliable vessel sealing. “This really facilitates laparoscopic cases,” she added.

Dr. Kondrup finds that the multifunctionality of ENSEAL® Devices improves his operating efficiency (Figure 4). “There are some instruments on the market that just cauterize, but don’t cut,” he said. “With ENSEAL® you have the ability

to activate the cautery and then quickly cut; when you’re moving along and cutting adhesions, it’s very rapid. You don’t have to take the instrument out and get a hemostatic device, because it is a hemostatic device.”

A study by Person and colleagues investigated several parameters of vessel sealing in porcine vessels and compared

Figure 4. An ENSEAL® Device coagulating and cutting the mesoappendix during an appendectomy.

Image courtesy of James Dana Kondrup, MD.

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Figure 5. The ENSEAL® G2 Advanced Bipolar Tissue Sealer.

ENSEAL® with the LigaSure™ V and LigaSure Atlas™.7 They found that ENSEAL® offered faster seal times, comparable seal quality, and higher burst pressure versus LigaSure™.

ENSEAL® also created less radial thermal damage to the adventitial collagen than LigaSure™.7 Several risk factors are associated with time on the operating table and shorter times on the operating table offer better patient outcomes.14 “So it’s nice to be able to save some time, save the patient money, save the hospital money, and reduce risk by getting patients off the table,” said Dr. Kondrup.

ENSEAL® also offers surgeons a greater degree of ergonomic flexibility. It can be used by right- or left-handed surgeons and is available in shaft lengths of 14, 25, 35, and 45 cm.10 Surgeons can choose a straight or curved tip, the latter of which Dr. Ramamoorthy prefers. “I think having a curved tip allows me to get around certain vessels at the proper angle, so I like having that option,” she noted.

“We’re able to do a lot of different things with ENSEAL®.

It used to be very difficult to take a fatty mesentery with an energy device, and I don’t think that’s the case any more—we don’t have to convert to do the mesentery extracorporeally,” said Dr. Ramamoorthy. “In some ways, I think ENSEAL® has really facilitated what we can do laparoscopically or robotically, allowing us to complete more of the operation with a minimally invasive approach.”

The ENSEAL® G2 Platform In September 2011, Ethicon Endo-Surgery invited an experienced group of surgeons to try out the latest generation

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of ENSEAL® Technology: The ENSEAL® G2 Platform (Figure 5) and the ENSEAL® G2 Super Jaw Tissue Sealer. Both of these devices, along with HARMONIC® Devices, are compatible with the Ethicon Endo-Surgery Generator G11. The surgeons who attended this workshop included both dedicated ENSEAL® users and those who use competing devices.

Dr. Stein felt that the ENSEAL® G2 Platform is a major improvement over other devices because of its intuitive nature. “Before, I felt like I was about to cut when I wanted to be burning, and vice versa,” she said. “For most of us, we cut when we’re pulling something. But [before], that was the burning device and to me, that was very counterintuitive and backward.”

As a user of a competing device, Dr. Stein found the new ENSEAL® G2 Device did not challenge her muscle memory or make her ponder her every move. “Every time you do a case, you can’t be thinking, for example, ‘I have to burn, then I have to cut—clamp, burn, cut, open.’ [Instead,] you want it to be fluid and easy,” she said.

Dr. Arrese was particularly pleased with the ENSEAL® G2 Super Jaw, which is indicated for use in open procedures.

“This is where I really see the big difference between ENSEAL® and LigaSure™. Also, the blade will never come out of the curve of the teeth,” he said.

Most modifications to the new ENSEAL® G2 Platform were meant to provide a superior sealing experience 8 through enhanced ergonomics, tactile feedback, and safety, while retaining the positive characteristics of the older ENSEAL® Portfolio. Dr. Kondrup was among the first to test the ENSEAL® G2 Platform when it was first approved for human

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cases. “The first thing I noticed about it was the handle,” he said. “It was extremely comfortable compared with the original ENSEAL® Device, similar to the HARMONIC® ; very user friendly and very easy to advance the blade. The reduction in finger fatigue is just amazing.”

The second thing that Dr. Kondrup noticed were the changes to the instrument’s jaw. “The positive electrode is now welded to the lower jaw, so there is 1 piece, as opposed to 2 separate pieces. I believe it’s sturdier,” he said.

Some features, however, are hard to improve on. “The hemostasis is just as reliable as the original. [But] it’s hard to imagine an improvement in hemostasis when you’ve had good hemostasis to start with,” noted Dr. Kondrup.

“They made a few changes from the prior instruments.

In one prior edition, you could cut through the tissue without sealing it first—the previous edition did not have a mechanical stop to prevent you from cutting the tissue without sealing it first,” said Dr. Kalady. “I work with fellows every day, and if they’re not familiar with how to handle the instrument they could actually cut through a vessel or through tissue before it’s sealed. There were safety controls on the handle of that instrument, but I found it cumbersome to go between the safety mode and the [working mode].”

Dr. Kalady also found the noise produced by the previous ENSEAL® Generator to be bothersome. “When the machine was activated, it made a very annoying tone,” he said. “They changed that to make a much more pleasing background noise [with the Ethicon Endo-Surgery Generator G11]. Now there is one tone when it is activated to work, another tone when you’re at the point where you start to cut, and a final, single tone that goes off to indicate that you’re safely through everything.”

Benyamine Mizrahi, MD, a colorectal surgeon at Colorectal Surgery Associates, PC, in Kansas City, Missouri, has used LigaSure™ devices since his surgical residency. This continued through his 2 fellowships and his past 2 years as a practicing surgeon. But he is open to the possibility of using another instrument. “I think there is room to make things better in an energy device. I’m not committed to one product over another, I just want the best tool to make surgery go smoother and faster,” he said. “If ENSEAL® has what it takes, then I’d love to use it.”

All vessel-sealing devices have their pros and cons, explained Dr. Mizrahi. “One thing ENSEAL® does better is the compression it provides, because of the I-BLADE™ Technology.a You have a better, tighter seal and closure from the beginning of the blade to the end,” he said.

ENSEAL® G2 Devices (G2 Straight, G2 Curved, and G2 Super Jaw) offer more than twice the compression at

the distal tip of the jaws than the LigaSure™,8,b and this characteristic can pay off in many ways. “The better the seal, the less bleeding you get and the less often you need to coagulate, so that makes the procedure go faster,” said Dr. Mizrahi. “That means less time in the OR, less time the patient is under anesthesia, and the more cases you can do—everyone is happy.”

In addition to its superior compression, Dr. Mizrahi believes that the ability to see exactly where he is burning and cutting gives ENSEAL® an edge over LigaSure™. “With the Ligasure™, you close, you burn, it lets you know when it’s done, and then you cut. You don’t see the blade. With ENSEAL®, you’re sealing and you can see right where you’re sealing, and you can bring the blade up to that point.

Essentially, you control what you’re cutting,” he said.

Although LigaSure™ is the device with which he is the most familiar and comfortable, Dr. Mizrahi sees room for ENSEAL® in his OR. “ENSEAL® definitely has promise. If I’m able to do the case more efficiently and with less fatigue and can get the same job done, then I’m definitely going to be using it,” he said.

Dr. Kondrup estimated that surgeons who are unfamiliar with ENSEAL® would be able to quickly adjust to it. “I find the learning curve to be very manageable and I think that most surgeons will be able to adapt from other energy devices,” he said. “There are no adjustments to be made, no numbers to turn on and off. You simply plug it into the generator, the generator tests the instrument, and you’re ready to go.”

He does recommend that surgeons exercise caution with any new instrument before trying it out on a case. “I think it’s important to use the instrument in a benchtop demonstration first—don’t take it right into the OR,” said Dr. Kondrup. “The only real concern I have is that surgeons get to know how the instrument operates.”

Dr. Stein always takes a cautious approach when she uses a new instrument on a case for the first time. “I’ll start off on something that is not imperative, like a little piece of omentum, to make sure I’m comfortable with what I’m doing,” she said. “With the G2 [Device], once I’d used it a handful of times, I saw that what I needed to do was very intuitive and I could just go on with my case.”

Conclusion ENSEAL® Devices deliver strong seals while providing a superior sealing experience. Their multifunctionality and customization provide surgeons with a high level of flexibility with minimal thermal spread. The availability of the ENSEAL® G2 Portfolio gives surgeons another option for performing a variety of surgical procedures.

a

Average jaw compression: 110 psi ENSEAL® G2 Super Jaw versus 91 psi LigaSure Impact™ and 80 psi LigaSure Atlas™, P<0.0000.

Test conducted on an inanimate model. Data on file. Ethicon Endo-Surgery, Inc.

b

In side-by-side benchtop testing, average jaw compression was 201 psi (SD=42 psi) for TRIO versus 91 psi (SD=13 psi) for Impact™.

Data on file. Ethicon Endo-Surgery, Inc.

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1. Reza MM, Blasco JA, Andradas E, Cantero R, Mayol J. Systematic review of laparoscopic versus open surgery for colorectal cancer. Br J Surg. 2006;93(8):921-928.

2. De U. Laparoscopic versus open appendicectomy: An Indian perspective. J Minim Access Surg. 2005;1(1):15-20.

3. Jin C, Hu Y, Chen XC. Laparoscopic versus open myomectomy—a meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2009;145(1):14-21.

4. Raymond DM, Romeo JH, Kumke KV. A pilot study of occupational injury and illness experienced by classical musicians. Workplace Health Saf. 2012;60(1):19-24.

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

8. Ethicon Endo-Surgery. ENSEAL® G2 Tissue Sealer (Curved/ Straight) Product Fact Sheet. http://www.ees.com/node/43144.

Accessed July 30, 2012.

9. ENSEAL® 510(k) submission. www.accessdata.fda.gov/cdrh_ docs/pdf4/KO43008.pdf. Accessed July 30, 2012.

10. Ethicon Endo-Surgery. ENSEAL® G2 Curved and Straight Tissue Sealers–Description and Specs. http://www.ees.com/Clinician/ Product/energy/enseal-g2-tissue-sealers#!Description%20&%20 Specs. Accessed July 29, 2012.

11. Newcomb WL, Hope WW, Schmelzer TM, et al. Comparison of blood vessel sealing among new electrosurgical and ultrasonic devices. Surg Endosc. 2009;23(1):90-96.

12. Ethicon Endo-Surgery. Energy Devices Portfolio. http://www. ees.com/sites/default/files/generalsurgery_EES_Energy_ Devices_Portfolio.pdf. Accessed July 30, 2012.

13. Data on file. Ethicon Endo-Surgery, Inc. 14. Jackson TD, Wannares JJ, Lancaster RT, Rattner DW, Hutter MM. Does speed matter? The impact of operative time on outcome in laparoscopic surgery. Surg Endosc.

2011;25(7):2288-2295.

Financial Disclosures: Drs. Arrese and Kalady reported that they have received honoraria from Ethicon Endo-Surgery. Dr. Kondrup reported that he has served as a consultant and member of the speakers’ bureaus for Ethicon Endo-Surgery, Ethicon Women’s Health & Urology, and PALL Medical.

Dr. Mizrahi reported that he has received honoraria from Ethicon Endo-Surgery. Dr. Ramamoorthy reported that she has served as a consultant for and has received honoraria from Ethicon Endo-Surgery. She also has served as a consultant for Covidien. Dr. Stein reported that she has received honoraria from Covidien and Ethicon Endo-Surgery.

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

Copyright © 2012, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.

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OSS# ECP615

References

7. Person B, Vivas DA, Ruiz D, Talcott M, Coad JE, Wexner SD. Comparison of four energy-based vascular sealing and cutting instruments: a porcine model. Surg Endosc. 2008; 22(2):534-538.

DSL# 12-0653

For complete product information, please refer to the instructions for use in the package insert.

6. Massarweh NN, Cosgriff N, Slakey DP. Electrosurgery: history, principles, and current and future uses. J Am Coll Surg. 2006; 202(3):520-530.

SR1123/SR1228

“The new ENSEAL® G2 Platform is an amazing improvement in the design of the handle, and the addition of the Ethicon Endo-Surgery Generator G11, which provides feedback as you use the instrument, is extremely helpful, especially for new surgeons,” said Dr. Kondrup. “I don’t think anything else on the market comes close to allowing you to see where the blade is, cut and cauterize, and dissect. I’m extremely happy with that instrument, and I’m also happy to be able to choose either the ENSEAL® or HARMONIC® Technology, as indicated for a particular case.”