The May 2012 Digital Edition of General Surgery News

The American Society of Colon & Rectal Surgeons

Convention Issue:

®

May 2012 • Volume 39 • Number 5

GeneralSurgeryNews.com

The Independent Monthly Newspaper for the General Surgeon

Opinion

New App Predicts Chronic Pain After Inguinal Hernia Surgery

HAL B y D avid C ossman , MD

G

ood news for Dr. J.C., presumably a fellow surgeon from Florida who wrote after my last column “Spam in a Can” [ January 2012, page 1], that I was an embarrassment and needed to retire before I spit out another cranky rant. Don’t worry Dr. J.C., I think I’m done. I’ll just go spend some time with TSVBMC [the still very beautiful Mrs. Cossman] before cruel gravity takes its toll.

And so it ends for me, not with a bang, but a whimper.

Like Robert Frost, beloved poet who in his dotage couldn’t read his lines at John F. Kennedy’s inauguration, I wondered how the end would come for me.

Was it going to be fire or ice as Frost explored in his poem? A perforated tic or a demyelinating disease? My bone marrow gone wild? The shakes? My

B y C hristina F rangou New York—Surgeons and patients considering hernia surgery can now use a free app that predicts a person’s chance of experiencing chronic pain after inguinal hernia repair, based on the outcomes of nearly 1,700 patients treated over the last five years.

The app, the Carolinas Equation of Quality of Life (CeQOL), was officially launched at the 5th International Hernia Congress and is available for free download on smartphones, tablets and desktop computers.

The app will help educate patients

Patients With Codon 13 Mutations; Study Is ‘Intriguing’ Albeit Initial B y C hristina F rangou

about the risks for chronic pain, an issue sometimes glossed over in preoperative discussions between physicians and patients, said B. Todd see Chronic Pain App page 38

Cancelled Operations Costing Hospitals Millions

see HAL page 31

B y A lison M c C ook

Procedural breakthrough Anal Fistula Repair Without Sphincterotomy: The Anal Fistula Plug

see page 10

Clinical Commentary Avoiding Staple-Line Failure Enhancing Device Knowledge and Improving Patient Outcomes

see page 15

B

etween patient no-shows and cancellations on the day of surgery, hospitals are losing millions in revenue each year, researchers have found. One piece of good news, according to the study, is that patients who have a preoperative visit with an anesthesiologist are substantially more likely to keep their appointment in

K-ras Mutation Type May Render Chemo for Rectal Cancer Useless

the operating room.

Researchers at Tulane University Medical Center found that in 2009, 327 of 4,876 (6.7%) scheduled elective outpatient operations were cancelled, costing the hospital nearly $1 million that year alone. Because surgeries bring in approximately 60% of the hospital’s entire revenue, that loss has a major effect on the bottom line, see Cancelled page 9

Orlando, Fla.—For the first time, researchers have shown that a specific type of K-ras gene mutation, located on codon 13, appears to be associated with far worse outcomes following neoadjuvant chemoradiation therapy (CRT) for rectal cancer than other K-ras mutations.

The results suggest that patients with K-ras codon 13 mutations are resistant to neoadjuvant CRT for rectal cancer and cannot achieve a pathologic complete response (pCR).

Other K-ras mutations also have a reduced chance of achieving pCR compared with wild-type K-ras, but only codon 13 mutations appear to show no chance of pCR. Previous studies have shown that K-ras mutations in codons 12 and 13 appear to play a major role in the progression of colorectal cancer. They also are considered potential biomarkers in lung cancer, but the clinical relevance of these mutations remains unclear. see K-ras Mutation page 18

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GeneralSurgeryNews.com / General Surgery News / May 2012

Phronesis Frederick L. Greene, MD Chairman, Department of General Surgery

Carolinas Medical Center Charlotte, N.C.

T

hose who have been loyal readers of this column over the years will realize that I have a love for words and the meaning of words. I frequently include a word or two in these editorials, which will hopefully tantalize and encourage further exploration for definitions. It is rare that I would ever base my entire editorial on one word, but for this particular musing, I hope you forgive me. The word that I would like to highlight is phronesis. This word is derived from the Greek meaning wisdom or intelligence. The concept of phronesis often has been attributed to Aristotle in his writings on virtues and vices.

In one passage, Aristotle further defines the term phronesis as “wisdom to take counsel, to judge the good and evil and all things in life that are desirable and to be avoided … to behave rightly in society … to employ both speech and action with sagacity.”

From this definition it is obvious that

GSN Editorial

we probably need to have the term phronesis and its concepts discussed frequently in many of the activities that involve surgeons. The term has further meaning in that it assumes that one who acts phronetically is working for the welfare of others without the thought for self-aggrandizement or other rewards. The concept further indicates that we should derive some pleasure in actively seeking the development and success of others.

This concept sounds like mentoring, but it really goes a lot further. At this point in my career, I have enjoyed the opportunity to mentor students, residents and young faculty members as they think about their future and weigh the interesting opportunities that medicine has to offer. It rarely may occur to us that the advice we give as mentors is really not the issue. The issue is that we need to assure the welfare of those whom we mentor and to actively seek a role for them to ensure their success.

These concepts could be used in any facet of our daily lives and especially with our patients. We counsel our surgical patients every day about the need for an operation, the type of procedure

that should be performed, the long-term results and the effects of the chosen treatment on the lives of patients and their families. Indeed, we think about working for the welfare of our patients without necessarily dwelling on the ramifications of our advice on our surgical group, academic faculty, health care institution or ourselves. These are concepts that must never be marginalized or forgotten in this era of relative value units, public reporting, patient satisfaction surveys and other methodologies that benefit ourselves and our institutions.

At the February 2012 meeting of the board of directors of the Accreditation Council for Graduate Medical Education (ACGME), a resolution was approved regarding the concept of professionalism, one of the six core competencies introduced by the ACGME approximately 10 years ago. The resolution directed the ACGME to “review its standards and recommends any modifications … to assure that these standards and their enforcement … are met.” Perhaps the thrust of that organization

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

Los Angeles, CA General Surgery, Laparoscopy, Surgical Education

James O’Neill

Gary Hoffman, MD

Barry A. Salky, MD

Frederick L. Greene, MD

Editorial Advisory Board

Los Angeles, CA Colorectal Surgery

New York, NY Laparoscopy

Maurice E. Arregui, MD

Namir Katkhouda, MD

Paul Alan Wetter, MD

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

Kay Ball, RN, CNOR, FAAN

Los Angeles, CA Laparoscopy

Miami, FL Ob/Gyn, Laparoscopy

Editorial Staff

Philip S. Barie, MD, MBA

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

Kevin Horty

New York, NY Critical Care/Trauma, Surgical Infection

L.D. Britt, MD, MPH

Raymond J. Lanzafame, MD

David Earle, MD

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

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

Edward Felix, MD

Fresno, CA General Surgery, Laparoscopy

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

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

Michael Goldfarb, MD Long Branch, NJ Laparoscopy, Telemedicine

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Victoria Stern Associate Editor (vstern@mcmahonmed.com)

James Prudden

Manager, Editorial Services

San Francisco, CA Surgical Hospitalist

Elizabeth Zhong

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

J. Barry McKernan, MD Marietta, GA Laparoscopy

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should be to introduce the concept of phronesis as a more universal goal than conveyed by the traditional meaning of professionalism. Perhaps the behaviors encompassed by phronesis should be the seventh core competency and promulgated by the ACGME. We are asked to judge our trainees by these benchmarks of professionalism and, most likely, all practicing physicians will be judged by these parameters in the future. Obviously, the core competencies of professionalism and communication involve the virtues of phronesis, but, in my opinion, do not come close to encompassing what Aristotle had in mind. The concepts of phronesis should be introduced into all conversations dealing with bioethics in our training programs and continuing medical education events to assure that all who practice medicine understand that what we do on a daily basis is act for the welfare of others. This concept should serve as a centerpiece for how we treat our colleagues and our patients, even during difficult times. As surgeons, we should remember our roots as teachers and assure that all might practice concepts that enable the development and success of those with whom we interact.

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

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

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INFECTIOUS DISEASE SPECIAL EDITION

3

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In the News

GeneralSurgeryNews.com / General Surgery News / May 2012

Curbing the Costs of Minimally Invasive Surgery A Return to Basics Can Save Big Money While Maintaining Safety B y C hristina F rangou San Francisco—Allan Okrainec, MD, deputy head of the Division of General Surgery at the University Health Network in Toronto, Canada, starts his talk at meetings by disclosing his support from surgical device manufacturers.

And then he points out that everything he says in his presentation “may prevent you from buying anything related to my disclosures.”

It’s true. At the Clinical Congress of the American College of Surgeons (ACS), Dr. Okrainec discussed ways to make advanced minimally invasive surgery (MIS) as economical and accessible as possible.

That often means bypassing expensive, high-tech devices and using cheaper, older technologies in innovative ways.

“There are things we can do on a dayto-day basis in our own operating rooms to save on resources,” he said.

Dr. Okrainec focuses on ways to make laparoscopic surgery more affordable,

“Hook electrocautery both in his own modern hospiPart 2 provides safety comparatal in downtown Toronto and for of 3-Part Series ble with that of roboticalresource-strapped hospitals in the ly assisted Heller myotomy, avoiding developing world.

He and colleagues at the Toronto West- the added expense and operative time ern Hospital are studying intraoperative of a robotic system,” they concluded.

For appendectomy, Dr. Okrainec steps and processes of care that contribute to the high cost of MIS. They also have argues that surgeons and hospitals developed a telesimulation lab through can spare dollars with a few easy steps which they can teach minimally invasive along the way. He demonstrated ways of controlling the base of the appentechniques to surgeons in Africa.

“In many countries, health care provid- dix without using a stapler, such as ers are being asked to cut costs as much as with a clip or a ligating loop. Sevwe can. If we can avoid one extra stapler eral studies have shown that a single firing, something that small, we’re saving clip is a safe and cost-effective way to dollars. The key is to do it in a very safe close the appendicular stump (Langenbecks Arch Surg 2010;39:1077way.”

Dr. Okrainec said in some circumstanc- 1082; 397:327-331; J Laparoendosc es, surgeons can use hook electrocautery Adv Surg Tech A 2012;22:85-87).

To remove the appendix, he describes instead of more advanced energy devices.

“It requires meticulous surgical tech- using the finger of a glove rather than a nique, but it can save you more than specimen bag. For larger specimens, he $1,000 from using the advanced energy suggests using sterilized ZipLoc bags. devices which we’ve become adjusted to in “You can have almost any size specimen many of our MIS procedures.” in there. You can also use it as a wound American surgeons in Arizona, who use protector.” hook electrocautery during laparoscopic Suturing is one area of surgery in which Heller myotomy, have corroborated that costs have skyrocketed, he said. Many automated suturing devices cost $30 to finding (Surg Endosc 2009;23:602-605).

Allan Okrainec, MD, using telesimulation from his hospital in Toronto to help train a surgeon in Botswana.

Photo courtesy of Dr. Okrainec.

$40 per stitch. Instead, Dr. Okrainec suggests that surgeons go back to basics.

“Practice your suturing on the [Fundamentals of Laparoscopic Surgery (FLS)] trainer. You can certainly suture just as fast

GeneralSurgeryNews.com / General Surgery News / May 2012

if you become facile at that technique.�

Other evidence suggests that hospitals can reduce costs by improving their processes of care, he said.

In China, surgeons recently randomized 597 patients who underwent elective colorectal resection to either an enhanced recovery after surgery program (ERAS) or a control group. The patients in the ERAS had a significantly accelerated time to gastrointestinal function and a shorter postoperative stay with less expense (World J Surg 2012;36:407-414). “The ERAS protocol attenuates the surgical stress response and accelerates postoperative recovery without compromising patient safety,� the authors stated.

Developing an effective ERAS is not difficult, said Dr. Okrainec. “Very simple things like keeping patients hydrated preoperatively, mobilizing patients early and not limiting their diet postoperatively can help them get home sooner.�

The real focus of Dr. Okrainec’s work isn’t his own hospital. He and his colleagues are working to improve MIS in countries where resources are extremely limited. He believes that North American and European surgeons can effectively train their counterparts in Africa by using tools as simple as Skype and a laptop computer.

The idea developed in 2007 following an FLS course taught in Botswana

by Dr. Okrainec and pediatric surgeon Georges Azzie. They trained a group of surgeons with the FLS system and, at the end of the course, the pass rate was only 10% (Surg Endosc 2009;23:2493-2498). “These surgeons improved significantly during our course, but they still did not reach the scores needed to obtain FLS certification,� said Dr. Okrainec. “I thought there must be an easier, more effective way to do this.�

So, the team at the University of Toronto developed a telesimulation system. Using basic videoconferencing software, they created a virtual environment in which a surgeon in Toronto could train a surgeon in Botswana. They connected weekly over Skype, turned on their webcams and connected their FLS boxes.

The surgeon in Botswana could demonstrate to Dr. Okrainec and other trainers how he or she was doing the task. The trainer back in Toronto could then show the proper way to perform the technique (Surg Endosc 2010;24:417-422). “You can do this with very expensive equipment, but we’ve shown you can also do this on the cheap.�

 

The program was started three years ago. Since then, the University of Toronto team has taught 130 surgeons in 10 different countries. The program recently expanded to train other health care providers and operating room staff and other skills, too, like emergency resuscitation, a curriculum for anesthetists, basic laparoscopic nursing and a program currently being developed for maternal-newborn health. “We’re bringing these skills to countries that already have the technology.

What they need is the education and training. This is an affordable way that

 In the News we can make sure that these health care providers are trained properly,� he said.

MIS can change the health of people in the Third World, said Philip L. Glick, MD, MBA, vice chair of surgery, State University of New York at Buffalo.

Once the technology is there, patients can get back on their feet faster and more patients can be treated in a shorter period of time. “I truly think our best management of resources is how to teach Third World health care workers how to take care of their own people in an economic resource–constrained kind of way.�

He added that surgeons around the world face “really crucial issues� about the ability to offer top-notch health care, even in the United States. “All of us on a daily basis have to figure out ways to save money and we have to do it in an ethical way, in a safetyconscious way. Most importantly, we have to do it in a real way. We have to bring down the price of caring for every ICD-9 [International Classification of Diseases] code that we take care of because, otherwise, we’re going to run out of money before the end of the year.�

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In the News

GeneralSurgeryNews.com / General Surgery News / May 2012

ACGME To Introduce New System for Resident Accreditation In Place for General Surgery Programs by 2014; Milestones Based on Six Competencies B y C hristina F rangou

T

he Accreditation Council for Graduate Medical Education (ACGME) is rolling out a new accreditation system for residency programs that will be implemented in general surgery programs

by the summer of 2014, according to a new plan recently announced in The New England Journal of Medicine.

The new system, referred to as the Next Accreditation System (NAS), will require all residency programs to evaluate each of their trainees at six-months intervals using 30 to 36 educational milestones. The milestones will be based on the six competencies: patient care, medical knowledge, professionalism, interpersonal and communications skills,

practice-based learning and improvement, and systems-based practice.

Each specialty has been asked to put together specialty-specific educational milestones that will be used to measure residents’ outcomes. The milestones for surgery have yet to be finalized but the American Board of Surgery, the Association of Program Directors in Surgery and the Residency Review Committee for Surgery are working together to establish them.

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“We’re working to identify what will be meaningful milestones and assessment tools that will help provide some objective measures for knowledge and skills, but, at the same time, will not be overly burdensome for programs to implement,” said Stephen R. T. Evans, MD, vice president for medical affairs, senior associate dean for clinical education and professor of surgery at Georgetown University Medical Center, Washington D.C. Dr. Evans is also a director of the American Board of Surgery.

The surgery milestones are currently being tested in a handful of programs and will go out to about 30 programs for further testing later this year. A final version is expected by late summer or early fall.

In July 2013, the NAS will be initiated in seven of the 26 ACGME-accredited core specialties: emergency medicine, internal medicine, neurologic surgery, orthopedic surgery, pediatrics, diagnostic radiology and urology. Following that, the residency review committees in these specialties will collect milestone data to create a baseline data set for the ACGME. By July 2014, all specialties must implement the new program.

‘We’re working to identify what will be meaningful milestones and assessment tools that will help provide some objective measures for knowledge and skills, but at the same time, will not be overly burdensome for programs to implement.’

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General surgery programs can benefit from the experience of orthopedic surgery, neurologic surgery and urology, which are among the first programs to implement the new system, said John Potts, MD, a general surgeon and senior vice president of surgical accreditation for the ACGME. “We will take some lessons from their experience,” said Dr. Potts, who, until recently, was general surgery program director at the University of Texas Medical School at Houston and the university’s designated institutional official representing all specialties. “This is going to be a more collaborative system than in the past, which has been my hope for a long time. The ACGME is very intent on reducing the burden on program directors and programs in terms of documentation.”

GeneralSurgeryNews.com / General Surgery News / May 2012

The program was created to help foster innovation, ease restriction and keep educational standards apace with delivery-system changes, said ACGME CEO Thomas Nasca, MD, a board-certified internist and nephrologist, in a statement.

The new system will move the ACGME away from its old “episodic biopsy model,” in which compliance was assessed every four to five years, to 10-year site visits, complemented with annual and semi-annual data collection.

The data collected will include key educational milestones, resident and faculty surveys, and operative and case-log data.

Between formal site visits, the ACGME will carry out periodic site visits to “assess the learning environment” and help lowperforming programs identify what may be going wrong.

“The visits to sponsoring institutions will ensure that residents are exposed to an appropriate learning environment, and the milestones will ensure that they demonstrate readiness for independent practice and possess the attributes that the public deems to be important in physicians,” wrote Dr. Nasca and colleagues in the March edition of The New England Journal of Medicine (2012;366:1051-1056).

The NAS will give some freedom to high-performing programs. Programs that demonstrate high-quality outcomes will have more relaxed process standards that specify elements of residents’ formal learning experiences. For example, these programs may be able to modify the hours of lecture or bedside teaching if residents continue to show high educational achievement.

So far, one of the key criticisms levied against the program is the significant data collection required; program directors will report 30 and 36 milestones for each resident at six-month intervals, according to the broad blueprint of the program goals.

“This six-month reporting requirement will be a significant challenge to program directors,” said Gary Dunnington, MD, chair of surgery at Southern Illinois University School of Medicine, in Springfield.

Another concern is that program directors have received few specifics about what the new program will entail for surgical programs. That’s due in part to deliberate ambiguity from the ACGME, which wanted to give specialties some flexibility in how they set up these milestones.

Dr. Dunnington and his research team have spent years researching measurement and performance in surgical education.

He would like to see emphasis on workplace assessments.

“Since surgeons spend so much of their time in the operating room, we need a workplace assessment in the operating room. That’s really for us, as surgeons,

In the News

the seventh core competency,” said Dr. Dunnington.

The American Board of Surgery is revamping its requirements to include more workplace assessments. Starting this July, all chief residents must have at least two evaluations of an operative procedure based on direct observation before they can sit for their boards. Similarly, residents will have to be evaluated in clinic, using a validated instrument. But questions have been raised about how resident outcome reports will affect programs’ accreditation status.

“If you are a less competitive program

in the country and don’t bring in as competitive candidates, and they are not doing as well despite having a very good rigorous education program, will your accreditation falter just because your residents don’t perform as well? That is one concern that’s come up,” said Dr. Evans.

“More than several years down the road, we will hopefully look back on this and recognize that it had positive impact on surgical education nationally,” Dr. Evans continued. “That individuals may ultimately train at different paces and work at a different pace to achieve the milestones at different times. We may be

a long way from that now but that would allow maturation of independent selfdirected learners in a much more efficient way.”

The ACGME acknowledges that the program is still in its infancy, adding that “much more work remains to be done.” The program was not piloted in its entirety, but “pivotal elements” were tested in internal medicine and a multiyear pilot in emergency medicine. The ACGME’s new system will cover more than 9,000 medical residency programs across the country.

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In the News

GeneralSurgeryNews.com / General Surgery News / May 2012

Surgeons Work Around the Clock on Egypt’s ‘Day of Rage’ One Surgeon's Recounting; Staff Learns Many Lessons From Mass Casualty Event B y C hristina F rangou

O

n Jan. 28, 2011, general surgeon Mohamed Sarhan, MD, arrived to work at Cairo University Hospital.

He was jittery, as was almost everyone in Egypt’s capital that day.

Cairo University Hospital, the biggest and the oldest in the Middle East, is situated 1.5 miles from Tahrir Square where, for three days, tens of thousands of Egyptians had gathered to protest the regime of President Hosni Mubarak.

Outside, tensions were building by the hour. Security forces used water cannons and tear gas to disperse the protesters. But, the crowd kept growing. There was a sense that this day was going to be momentous.

The day eventually became known among Egyptians as the “Day of Rage.” The authorities shut down Internet services and mobile phone carriers. As more protesters arrived after Friday prayers, security forces fired rubber bullets into the crowd, Dr. Sarhan said. Forces drove vehicles into groups of protesters.

Injured protesters began to show up in groups at the closest hospitals. Cairo University Hospital, being the largest, received most of the injured.

Within an hour, the hospital declared a mass casualty event.

Dr. Sarhan documented the mass casualty management at the hospital over the next six days. He presented the findings at the 2011 Clinical Congress of the

American College of Surgeons. A full report will be published in a future edition of the Annals of Surgery.

The hospital triaged 3,013 patients, discharged 2,560 (85%) and admitted 453 (15%), the majority of whom came in on Jan. 28. Two-thirds of all admissions happened during a 10-hour period on that day.

Seventeen surgeons were on duty at the 5,200-bed hospital that day. Another 24 surgeons who had been demonstrating in the square joined them. These 24 surgeons rushed to the hospital when it became clear that mass numbers of people were injured.

The patients quickly overwhelmed the corridors and the resuscitation room. Eventually, staff transformed two more rooms into resuscitation areas. They opened all operating rooms. At the peak, surgical staff had 18 operating rooms going simultaneously.

Overwhelmingly, almost all the patients were male (98%) and young (the mean age of the wounded was 27 years). The youngest was 13. Many had multiple wounds.

One young man arrived with 14 gunshot wounds. The injuries were often severe, mostly to the head and abdomen.

“We were told by the media that there were only rubber bullets. Yet 93% of the injuries were firearm injuries,” said Dr. Sarhan. “Our statistics show that there was an intention to kill. Fifty-two percent of the injuries were directed to the head and neck.”

In six days, ophthalmologists treated 173 cases of ruptured globes, making it one of the largest reported cases in surgical literature. Nearly three-fourths of ruptured globe cases occurred in the busy 10-hour stretch of the first day.

General surgeons operated on 90 patients; 54 of them

Anti-government protesters gather at Tahrir Square on Feb. 10, 2011 in Cairo, Egypt. Protests in January and February brought an end to 30 years of autocratic rule by President Hosni Mubarak.

Photo by Kuni Takahashi/Getty Images.

within the first 14 hours. In all, 35% of all admissions during the mass casualty event were to general surgery.

On Jan. 28, the hospital ran out of blood. With the Internet down and communications disrupted throughout the capital, the hospital struggled to get word out about the shortage of blood. Eventually, the public learned of the shortage and, within 12 hours, the blood bank was at full capacity with 3,000 units of blood.

However, during that shortage on the first day, eight patients died postoperatively. Of these, five died from irreversible hypovolemic shock due to major vessel injury.

Surgeons, nurses and other hospital staff worked around the clock for all six days. “In the first 48 hours, I slept once for about three hours, which was the same as all of our team,” said Dr. Sarhan. “The rest, I was either operating, managing patients or organizing.” He periodically checked in with his family using a landline phone.

During the course of the six days, 40 admitted patients died in the hospital for a mortality rate of 8.8%. Of these, 26 died immediately: Thirteen patients were shot in the head, five sustained shots to the chest and five died from gunshot wounds to the abdomen or neck. One patient died after being crushed by a vehicle.

The protests continued until Feb. 11, when Mubarak resigned. Casualties continued to pour into the hospital throughout the protests, although at a reduced rate. Like most of his colleagues, Dr. Sarhan stayed at the hospital for almost 10 days, fearing new waves of mass casualties.

For years, Cairo University Hospital has been a busy trauma center, one of the busiest in the region. But, even here, staff had never experienced anything on the scale of what occurred on Jan. 28.

Lessons Learned From Mass Casuality The staff learned a great deal during that week, things that are applicable to any hospital that may face a mass casualty event, said Dr. Sarhan. Events change quickly and you need to be able to adapt, he said.

Cairo University Hospital had to reevaluate the situation frequently over the first few days and reset priorities.

Staff had to reassess patients quickly to help move them through the system. Three times in one day, they cleared patients from the intensive care unit.

The hospital put together multidisciplinary teams of surgeons, anesthesiologists and nurses to treat patients quickly and effectively. That played a key role in getting through the number of surgical patients, said Dr. Sarhan.

There are no rigid rules in a mass casualty, he added.

“Every mass casualty center has its own medical, economic, geographic and political circumstance, which affects how you manage.”

Since February, the hospital has experienced “three or four” mass casualty events, but all with less than 50 patients. The hospital now has a much more organized response to these events and is better able to manage, said Dr. Sarhan.

He hopes that the coming days bring a better outcome for the Egyptian revolution. The process to democracy appears stuck somewhere in the transition, with an anemic economy and the political future uncertain.

The Egyptian experience offers a unique glimpse into a mass casualty situation, said Barbara L. Bass, MD, chair of surgery, Methodist Hospital, Houston, after Dr. Sarhan presented his paper. “I think it’s great that surgeons took this experience and let us know how we can learn from this. I think we’ve all been stunned and amazed at what’s happened.”

GeneralSurgeryNews.com / General Surgery News / May 2012

Cancelled

continued from page 1 said study author Sabrina Bent, MD, MS, clinical associate professor of anesthesiology and director of research at the Tulane University Department of Anesthesia, in New Orleans.

“People need to recognize that there is a cost to cancelled surgeries that is not insignificant,” said Dr. Bent, who presented the findings at this year’s American Society of Anesthesiologists Conference on Practice Management

G

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IN UC

IN

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In the News

(abstract PM23).

The bulk of the cost from cancelled surgery stems from “opportunity costs,” said Dr. Bent. When surgeries are cancelled on short notice, hospitals are unable to swap in other procedures that would bring in lost revenue.

Hospitals cancel surgeries at the last minute for various reasons, Dr. Bent noted. More than 30% of patients in her study failed to show up at the time of surgery because of transportation problems, confusion over the date of the procedure, forgetting about the appointment or for other reasons, she said.

Among the minority of cancellations besides no-shows for which the reason was recorded, nearly one-third of the procedures were cancelled because of issues at the hospital itself, such as a lack of beds or equipment. Although it is not in the hospital’s interest to cancel planned operations, these issues arise, said Dr. Bent. Scheduling errors can occur when one piece of expensive equipment is needed in two operating rooms at once, other equipment fails or the intensive care units happen to be full, leaving no place for patients to recover following procedures.

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Dr. Bent and her team found that cancellations were higher among patients who did not have a preoperative clinic visit with the anesthesiologist—nearly 11% of these operations were ultimately cancelled compared with less than 4% of surgeries preceded by a clinic visit.

As a result, Dr. Bent recommended that hospitals ensure all patients receive a preoperative visit to verify patients are medically ready for surgery and that they receive the proper preoperative instructions for the day of surgery.

“That is a major factor that should be achievable,” she told General Surgery News. Other ways to reduce cancellations include improving the allocation of equipment and resources, and increasing efficiency to help patients move through the hospital faster, she added. “All of these things are multifactorial and take time, thus are hard to address easily.”

Consequently, Dr. Bent recommended that hospitals focus in areas where they could have the most impact. For instance, she and her team found that the cost of cancellation varies with specialty, with the highest loss in neurosurgery and urology. Start with these high-revenue subspecialties, she said, and analyze and develop ways to curb those losses.

“Maybe you cannot fix everything right away, but maybe there is something you can do to improve the efficiency and lack of cancellations in specialized groups.”

The rate of cancellations in the study “makes sense,” said David Glick, MD, MBA, associate professor of anesthesia and critical care at the University of Chicago, who conducts similar research. The total cost for Tulane probably exceeded $1 million, however, Dr. Glick said, because the hospital has a relatively small volume and cancelled operations also result in a loss of money when disposable equipment is opened and then must be thrown out.

“There can be significant losses to the medical centers when they lose cases because of cancellations,” Dr. Glick said.

“I think their findings are useful, insofar as they provide justification for greater financial investment by hospitals to decrease cancellations.”

For instance, Dr. Glick’s own research also showed that patients who have preoperative visits in the anesthesia clinic are less likely to delay or cancel their operations (Anesthesiology 2005;103:855859). Although these visits are largely not reimbursed, it may be in the hospital’s interest to support them financially. “I think this study suggests that it is reasonable for medical centers to bear a significant cost to maintain the anesthesia preoperative clinic,” Dr. Glick said.

“It enables them to save more money down the line, when surgeries are not cancelled.”

9

the Science Behind PoSitive Patient outcomeS

Anal Fistula Repair Without Sphincterotomy: The Anal Fistula Plug Herand Abcarian, MD Professor of Surgery Division of Colon and Rectal Surgery University of Illinois at Chicago Chicago, Illinois

Alexander Herold, MD Professor of Surgery Colorectal Department End- und Dickdarmzentrum Mannheim, Germany

Introduction Sphincter-sparing options have been sought to treat complex anal fistula, which include transsphincteric, multitract and horseshoe, and anterior fistula in women.1 nonsurgical approaches in complex fistula are attractive options to patients because of the considerable risk for incontinence if the sphincter muscle is divided.2 in complex fistula, anal fistula plugs are a viable alternative to fistulotomy, advancement flap, and other surgical procedures. currently, there are 2 commercially produced plugs available: the COOK® BiodeSiGn™ SuRGiSiS® Fistula Plug (COOK®, cook medical, inc.) and the GoRe® Bio-a® Fistula Plug (GoRe®, W.L. Gore & associates, inc.). the advantages of the GoRe® Bio-a® Fistula Plug, namely its synthetic bioabsorbable material and customizable design, allow for sphincter-preserving repair and reduces the likelihood of the plug becoming dislodged.

Risk for Incontinence Proves Challenging For surgical treatments of complex fistulas such as fistulotomy, the risk for incontinence is so great that many surgeons consider the procedure inappropriate.2 the range of reported continence disturbance after fistulotomy is from 0 to 64%.2-4 Success with the endorectal advancement flap procedure has been variable, and incontinence rates range from 0 to 35%.5 Because sphincter-sparing treatments minimize the risk for incontinence, some experts advocate these modalities as the preferred initial method in complex fistula surgery.2 after initial promise in small series, many sphincter-sparing treatments have produced disappointing results in rigorous and controlled trials. For example, incremental tightening of cutting setons, although in use for centuries,6 has produced incontinence rates as high as 67%.7 the use of fibrin sealant or glue to close the fistula, often after placement of a draining seton, has resulted in rates of recurrence approaching 70%.8 other strategies used in small series at single centers, such as a recent report of injection of collagen matrix,9 have not proven long-term benefits. ®

®

GORE BIO-A Fistula Plug: Material Matters The first-generation COOK® BiodeSiGn™ SuRGiSiS® Fistula Plug appeared to be a significant advancement when

10 GENERAL SURGERY NEWS • MAY 2012

it originally became available, according to herand abcarian, md, professor of surgery, university of illinois at chicago. although very high rates of healing were initially reported, overall long-term results appeared to be only slightly greater than that achieved with fibrin sealants, which also had been disappointing after an initial report of high rates of success. Still, efforts were made to use the plug in certain cases. alexander herold, md, professor of surgery, end- und dickdarmzentrum Mannheim, Germany, noted that COOK® BiodeSiGn™ SuRGiSiS® Fistula Plug was effective in a limited proportion of patients, but the rates of failure were sufficient that Prof. herold abandoned this device after his initial experience.

GoRe® Bio-a® Fistula Plug has several unique features.

Introduced in 2009, this plug employs a synthetic, bioabsorbable scaffold of polyglycolic acid and trimethylene carbonate copolymer to facilitate tissue generation and healing.10 Rather than a conical shape, this plug has bundled tubes connected to a circular disk, which provides a greater barrier to dislodgement, while providing exceptional versatility for fistula size, shape, and configuration. For a multi-tract fistula, a single GoRe® Bio-a® Fistula Plug can be employed in situations where previously 2 or more plugs of the former design would be needed. “the design of the GoRe® Bio-a® Fistula Plug makes sense,” said dr. abcarian. “it employs a bioabsorbable material that has already been successfully employed in hernia repair for decades, and its octopus-like design with multiple tubes is an important feature when addressing a fistula with more than one opening (Figure 1). The tubes also provide more options when attempting to shape the plug to conform to different diameters.” “the GoRe® Bio-a® Fistula Plug employs a completely different material and has a completely different design relative to the COOK® BiodeSiGn™ SuRGiSiS® Fistula Plug,” noted Prof. herold. “there are a number of features that predict substantial advantages for fistula closure. the special head of the GoRe® Bio-a® Fistula Plug is more likely to occlude the inner fistula opening and reduce the number of plugs that become dislodged. the multiple arms of the plug increase the proportion of fistulas which can be adequately filled with the scaffolding material.”

Patients who feel that incontinence is too great a risk often choose the plug, especially with the decreased risk for recurrence. “at our center, we are seeing long-term closure without recurrence of approximately 60%, but the current initiative to collect data prospectively will provide more definitive information about relative efficacy,” said Prof. herold. one of the advantages of using a fistula plug, like other sphincter-sparing treatments, is that it is possible to consider a second placement if the first is unsuccessful, explained Prof. herold. although this might provide an unacceptable delay to resolution of the fistula for some patients, others may choose to repeat the plug procedure to avoid risk for incontinence. By 6 months, the GoRe® Bio-a® Fistula Plug is completely absorbed. if the fistula

still persists, placement of a second plug can be considered, especially if improvement of the fistula tract has been achieved (Figure 2). “We have to await the results of further trials, whether we may see overall success rates rise if we include patients who achieve closure with a second (salvage) attempt,” said Prof. herold. he noted that many patients with a complex fistula opt to retry a sphinctersparing technique when concerned about complications from a more aggressive approach.

Clinical Evidence In a treatment study presented at the 2011 annual meeting of the european Society of coloproctology, results were presented for 25 patients who were treated for an anal fistula using a GoRe® Bio-a® Fistula Plug and followed for a median of 281 days.11 At that time, 11 (44%) patients had complete healing of the fistula tract, 10 (40%) had partial healing with the remaining fistula being more superficial and amenable to treatment with fistulotomy without a risk for incontinence, and 2 (8%) had a persistent transsphincteric fistula.11 In the remaining 2 patients, 1 had early loss of the fistula plug and 1 had persistent postoperative pain that led to removal of the plug even though there was no evidence of infection.11 the authors concluded that the GoRe® Bio-a® Fistula Plug is a viable treatment option. it has a low complication rate, and may be especially useful for patients with former anal fistula surgery.11 in another study presented at the same scientific meeting, 37 patients with transsphincteric fistulas were evaluated both preoperatively and postoperatively with a physical examination and transanal sonography for outcome of anal plug insertions.12 except for a single patient with crohn’s

Figure 1.. GoRe® Bio-a® Fistula Plug. image courtesy of W.L. Gore & associates.

Supported by

Case Study: Horseshoe or Multi-Tract Anal Fistula Herand Abcarian, MD

exam under anesthesia

Professor of Surgery Division of Colon and Rectal Surgery University of Illinois at Chicago

complex Fistula

Simple Fistula

draining Seton

Fistulotomy

non-closure

consider Repeat Plug or another Sphincter-Sparing approach

non-closure

Repeat SphincterSparing approach or consider Surgery

a

50-year-old college professor who was successfully treated with surgery for a noncomplex anal fistula returned with a new lesion on the opposite side that involved more than 50% of the anal sphincter muscle and was determined to have a horseshow configuration with 2 interconnected channels. The fistula was drained and a seton was placed while awaiting resolution of the inflammation. due to the substantial involvement of the sphincter, the patient wished to avoid surgery and attempt healing with sphincter-sparing therapy. When the lesion was fully drained and aseptic, 2 COOK® BiodeSiGn™ SuRGiSiS® Fistula Plugs were placed in each of the channels. however, neither channel had closed once the plug had dissolved. after a second seton had been placed for draining and resolution of inflammation, the patient agreed to a second, similar insertion of fistula plugs but the outcome was jeopardized by dislodgement.

More than 1 year after presenting, the failure of the fistula to resolve was a substantial source of discomfort and diminished quality of life. Yet, the patient was unwilling to tolerate any risk for incontinence and continued to insist on a sphincter-sparing approach. the GoRe® Bio-a® Fistula Plug, which had become available in the interval between the initial presentation and the failure of

verification of healing

Fistula closure

Follow up to verify Sustained healing

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Fistula closure

Follow up to verify Sustained healing

Figure 2. treatment algorithm. adapted from reference 6.

12

disease, the fistulas also were all of cryptoglandular origin. after fistula tracts were cleared of sepsis and curetted, the GoRe® Bio-a® Fistula Plug was inserted through the internal opening and fixed by suturing the disk to the mucosa.

The mean time for placement was 20 minutes. Of the 29 patients followed for more than 6 months, the healing rate was 71.4%.12 there were no postoperative complications and no change in the status of continence.12 Healing Rates Dr. Abcarian suggested that success rates of 50% or greater will compare favorably with current options. “We need effective sphincter-sparing treatments for complex fistulas because of the risk for incontinence associated with surgery. due to the unpredictable nature of anal fistula, there may be no perfect treatment, but it may be possible to repeat a sphincter-sparing approach after an initial failure before resorting to radical surgery,” dr. abcarian reported. although encouraged by his initial success with the GoRe® Bio-a® Fistula Plug, dr. abcarian reported that long-term efficacy data provided by multiple participating centers, which is now being collected, is needed.

Given the highly unpredictable course of anal fistulas, which can recur years after a successful procedure according

to Prof. herold, the precise efficacy of the GoRe® Bio-a® Fistula Plug requires longer follow-up, but Prof. herold is encouraged by the initial rates of success and suggested that there is an urgent need for better sphincter-sparing approaches not only for their role in reducing risk for incontinence, but for their ability to reduce recovery time. acceptable healing rates combined with a minimized risk for incontinence make sphincter-sparing treatments attractive. When faced with a measurable risk for lifetime incontinence, many patients are likely to opt for several attempts to resolve the fistula without sphincterotomy before moving to a more aggressive surgical procedure. continued improvements in the success of sphincter-sparing therapy likely are to be viewed as a substantial advance by both patients and physicians. treating complex anal fistulas is a challenging problem due to variability in the healing rates and high risk for incontinence with traditional surgical techniques. Sphincter-sparing treatments are desirable for their minimized risk for incontinence, but several have been unable to produce healing rates that are acceptable to the surgical community. the design features of the GoRe® Bio-a® Fistula Plug are engineered to overcome limitations of previous techniques, resulting in a sphincter-sparing treatment that continues to yield reports of successful applications and encouraging rates of healing.

References 1. Safar B, Jobanputra S, Sands d, Weiss eG, nogueras JJ, Wexner Sd. Anal fistula plug: initial experience and outcomes. Dis Colon Rectum.

2009;52(2):248-252.

the second plug placement, was offered. the preparation for the GoRe® Bio-a® Fistula Plug placement, including drainage and verification of clean channels, was similar to that of the COOK® BiodeSiGn™ SuRGiSiS® Fistula Plug.

With the GoRe® Bio-a® Fistula Plug, only 1 device was needed where 3 of the 6 tubes were placed in the larger of the 2 channels, 2 placed in the smaller channel, and the final tube was cut off. the head of the plug was fixed with bioabsorbable sutures.

Results in the acute healing period, the patient reported mild discomfort controlled with analgesics, but there was very little drainage, and all symptoms resolved within the first week. When re-examined 3 months after the procedure, the fistula appeared closed. there was no visible evidence of plug material. in follow-up, now out to 18 months, there has been no recurrence of symptoms, and the fistula appears to be resolved. the patient has had no change in bowel function and remains continent.

Comment due to the unpredictable nature of anal fistulas, it is impossible to determine whether the same result might have been achieved with the COOK® BiodeSiGn™ SuRGiSiS® Fistula Plug, but the resolution of this lesion with the GoRe® Bio-a® Fistula Plug is consistent with its design, which is better suited for a horseshoe configuration.

2. Lindsey i, Jones om, Smilgin-humphreys mm, cunningham c, mortensen nJ. Patterns of fecal incontinence after anal surgery.

Dis Colon Rectum. 2004;47(10):1643-1649.

3. Omner A, Wenger FA, Rolfs T, Walz MK. Continence disorders after anal surgery – a relevant problem? Intl J Colorectal Dis. 2008;23(11):1023-1031.

4. van Tets W, Kuijpers HC. Continence disorders after anal fistulotomy.

Dis Colon Rectum. 1994;37(12):1194-1197.

5. Soltani A, Kaiser AM. Endorectal advancement flap for cryptoglandular or crohn’s fistula-in-ano. Dis Colon Rectum. 2010;53(4):486-495.

6. dudukgian h, abcarian h. Why do we have so much trouble treating anal fistula? World J Gastroenterol. 2011;17(28):3292-3296.

7. Garcia-aguilar J, Belmonte c, Wong dW, Goldberg Sm, madoff Rd. cutting seton versus two-stage seton fistulotomy in the surgical management of high anal fistula. Br J Surg. 1998;85(2):243-245.

8. Loungnarath R, Dietz DW, Mutch MG, Birnbaum EH, Kodner IJ, Fleshman JW. Fibrin glue treatment of complex anal fistulas has low success rate.

Dis Colon Rectum. 2004;47(4):432-436.

9. Sileri P, Franceschilli L, del vecchio Blanco G, Stolfi vm, angelucci GP, Gaspari aL. Porcine dermal collagen matrix injection may enhance flap repair surgery for complex anal fistula. Int J Colorectal Dis. 2011; 26(3):345-349.

10. GoRe® Bio-a® Fistula Plug instructions for use. http://www.goremedical. com/resources/dam/assets/AM0175-ML2%20(EN).pdf. Accessed March 13, 2012.

11. meshkat B, Pakravan F, helmes c. evaluating the short term results of the bioabsorbable fistula plug for management of anal fistulas. In: Sixth Scientific & annual meeting of the european Society of coloProctology (ESCP); Copenhagen, Denmark; 2011.

12. heydari a, attina Gm, merolla e, Piccoli m, melotti G. treatment of anal fistulas with GoRe® Bio-a® Fistula Plug. In: Sixth Scientific and Annual Meeting of the European Society of ColoProctology (ESCP); Copenhagen, Denmark; 2011.

GENERAL SURGERY NEWS • MAY 2012 11

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anal Fistula

anal Fistula Plug

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12

In the News

GeneralSurgeryNews.com / General Surgery News / May 2012

Experts Debate Pros and Cons of Molecular Profiling for Colon Cancer B y K ate O’R ourke

San Francisco—Is molecular profiling for stage II colon cancer ready for prime time?

If you ask many oncologists and surgical oncologists, you will not find a consensus.

At the recent Gastrointestinal Cancers Symposium, two experts faced off on this issue in a pro and con debate.

Most patients with stage II colon cancer will be cured by surgery alone and the majority will not benefit from adjuvant chemotherapy. In the often-cited QUASAR (Quick and Simple And Reliable) study, the addition of 5-fluorouracil (5-FU) and folinic acid resulted in a 3% to 5% absolute reduction in risk for recurrence at five years in patients with stage II disease (Lancet 2007;370:2020-2029). Other studies have established that 5-FU–based adjuvant therapy does not help the 15% to 20% of patients with deficient mismatch repair (DMMR).

Doctors currently use clinical pathologic factors, such as T4 disease, to identify highrisk patients, but these factors do not adequately identify patients who may benefit

from chemotherapy (Table). In a study of Medicare patients identified with stage II colon cancer, adjuvant chemotherapy did not substantially improve overall survival, regardless of whether or not the patient had poor prognostic features (J Clin Oncol 2011;29:3381-3388).

“Clearly, the current paradigm for identifying high-risk patients is imperfect,” said George J. Chang, MD, MS, associate professor in the Department of Surgical Oncology and co-associate medical director of the Colorectal Center, University of Texas MD Anderson Cancer Center, Houston.

Three molecular tools have been validated for stage II colon cancer thus far. The 12-gene Oncotype DX colon cancer assay (Genomic Health) requires formalin-fixed, paraffin-embedded tumor tissue and yields a continuous recurrence score corresponding to estimated risk for recurrence at three years. It divides patients into low-, intermediate- and high-risk categories and has been validated on tumor specimens from the QUASAR and Cancer and Leukemia

Group B 9581 trials. Roughly 25% of patients are classified as high-risk.

The 18-gene ColoPrint test (Agendia) uses fresh frozen tissue and classifies roughly 40% of patients in the high-risk category and 60% as low-risk, based on time to relapse. This test has been validated on two separate single institution data sets and a multi-institution study is currently under way.

The 634-gene ColDx (Almac) uses formalin-fixed, paraffin-embedded tissue, classifies patients into low- and high-risk groups, based on time to events, and was validated in a study of 144 patients. Prognosis in all three tools is independent of standard clinical criteria.

A fourth test, Previstage (Diagnocure), measures guanylyl cyclase-C gene expression (GC-C). “When GC-C is present in the lymph nodes, it may be a marker for micrometastatic disease,” said Dr. Chang.

A small study demonstrated that this test has promise, but a larger validation study is ongoing.

GeneralSurgeryNews.com / General Surgery News / May 2012

In the News

Pro Argument Dr. Chang was given the assignment to argue the pros of using molecular tools in stage II colorectal cancer. In an ideal world, he said, physicians would be able to identify patients who would benefit from chemotherapy. With the currently available tools, however, physicians can only identify patients at high risk for recurrence, and thus in the greatest need for adjuvant chemotherapy benefit, and patients at low risk for recurrence who could be safely observed.

“The [tools] yield a proportional hazard for benefit that is across the spectrum of high- and low-risk patients,” said Dr. Chang. Presenting data from the QUASAR study,

Con Argument

for one patient to benefit, whereas in patients with high risk, 5%, you would only have to treat 20 patients to benefit one patient. If physicians observe patients who have DMMR and treat patients who have T4 tumors, he argued, then they are still making an uninformed decision about chemotherapy in 70% of patients. Physicians can use molecular profiling to stratify patients based on risk and thus make informed treatment decisions in 100% of their patients, Dr. Chang said.

A study presented at the 2011 Gastrointestinal Cancers Symposium shows that the molecular tools can be cost-effective. Investigators used a statistical model to assess out-

‘The addition of molecular profiling stratifications to current treatment algorithms maximizes potential benefit while minimizing treatment-related toxicity.’

he showed that patients classified by the Oncotype test as low-risk had an absolute risk reduction (ARR) from chemotherapy of 3.1%. Intermediate-risk patients had a 4.7% ARR and high-risk patients had a 5.7% ARR (J Clin Oncol 2011;29:4611-4619).

“We can use these signatures to stratify patients to make our treatment decisions and make our treatments more efficient,” said Dr. Chang, pointing out the MOSAIC (Multicenter International Study of Oxaliplatin/5-Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer) trial (N Engl J Med 2004;350:2343-2351) that established a 5% threshold for using oxaliplatin in patients with stage III colon cancer, so a 5.7% threshold for 5-FU is reasonable in stage II. In patients with low risk, he said, you would need to treat 50 patients

—George J. Chang, MD, MS comes associated with the use of the recurrence score from the Oncotype test in adjuvant therapy decisions in stage II disease, excluding T4 tumors and those with deficient DNA mismatch repair. The model showed a net 17% reduction in chemotherapy use, an improvement in quality-adjusted life-years of 0.035, and a reduction in net costs of $2,971 (J Clin Oncol 2011;29[suppl 4]: abstr 491).

“The addition of molecular profiling stratifications to current treatment algorithms maximizes potential benefit while minimizing treatmentrelated toxicity. It can identify highrisk patients who are most likely to benefit from adjuvant therapy, similar to oxaliplatin for stage III, and identify low-risk patients who may be safely observed,” Dr. Chang said.

Neal Meropol, MD, chief of the DiviDr. Meropol pointed out that ColDx sion of Hematology and Oncology at has a more useful high-risk group, preUniversity Hospitals Case Medical Cen- dicting a 55% risk for relapse, but the valter and Case Western Reserve Univer- idation study was small and the mismatch sity, Cleveland, was assigned to present repair status in the study population was the con side of the argument for using unknown. “Only six lymph nodes were the currently available molecular profil- required for eligibility and there was really ing tools. no treatment information with regard to He said that regardless of the strati- the patients in this study,” he said. Addification of risk, the decision for thera- tionally, low- and high-risk groups were py is ultimately one that has to be made defined retrospectively by recurrence staby the individual patient. Patients will tus, rather than by a population-based ask themselves whether the therapy will prospective assessment of the assay. be helpful and if so, how helpful will it The ColoPrint high-risk group also be. What are the side effects? What are was lacking in that it had only a 26% risk the costs and inconvenience of thera- for relapse, and because the study popupy? What is the uncertainty surrounding lation was able to receive adjuvant therthese outcomes and what is important to apy, it was not a clean validation set, Dr. me? Doctors, he said, often try to sim- Meropol said. “The overall prognosis was plify things by quantifying risk. “What very good, raising the question as to the really matters is how much an individual representativeness of the validation set patient, at an individual level of risk, will and there was a high discordance with benefit with the application of adjuvant clinical risk stratification,” he said. Pretherapy,” said Dr. Meropol. vistage has not been validated, but again Dr. Meropol said the gold standard has a subpar high-risk group that has only of a predictive marker is one that has a modest 27% risk for relapse, according a greater relative risk reduction as risk to Dr. Meropol. increases. “At this point, none of the “The validation sets we have seen today platforms that have been described so far are either small or were not entirely repremeets this bar,” he said. sentative of the modern completely staged He argued that none of the tools sin- population,” said Dr. Meropol. They do gle out a truly useful high-risk group. not identify patients at the very highest “To really be useful, you have to enrich the high-risk group ‘What really matters is how for really being at high risk,” he said. A useful test must place a much an individual patient, at an high proportion, 50% to 75%, of individual level of risk, patients in the low-risk group. will benefit with the The Oncotype DX recurrence score doesn’t meet this criapplication of adjuvant terion and has a short follow-up therapy.’ period. “The high-risk group is not a very high-risk group, hav —Neal Meropol, MD ing only a 22% risk for relapse at three years,” said Dr. Meropol. He also pointed out that many of the risk and there is no demonstrated prepatients in the validation study had less dictive value of the molecular classificathan 12 lymph nodes obtained at the time tion schemes. There is also an uncertain of surgery, suggesting an incomplete sur- impact of oxaliplatin in these high-risk gical approach or incomplete assessment. populations, and it is unclear how to inteNotably, he said, the benefit of 5-FU in grate mismatch repair testing and how to the study set was twice as great as the ben- address the discordance of clinical and efit of 5-FU in the underlying population molecular results, he argued. from the QUASAR study.

Table. Clinical Pathologic Factors Used To Determine Risk · Presence of T4 disease

· Lymphovascular invasion

· High-grade tumors

· Perineural invasion

· Signet ring histology

· Perforation

· Number of lymph nodes

· Obstruction

Dr. Chang has consulted for Genomic Health and received research funding from Agendia. Dr. Meropol has consulted for Genomic Health and Precision Therapeutics and received research funding from Genomic Health.

13

Clinical Commentary

Supported and approved by

Avoiding Staple-Line Failure

Enhancing Device Knowledge and Improving Patient Outcomes

Surgeons pay a great deal of attention to a delivered staple line, but how much attention is given to how a stapler functions? Edward Chekan, MD, FACS, medical director at Ethicon Endo-Surgery in Cincinnati, asks that question and explains clinical advantages that can result from a surgeon bringing to the table a deeper knowledge of staplers, specifically, how they interact with tissue.

Why should a surgeon care about how surgical staplers work? Isn’t it enough to just know that they do work?

At the risk for oversimplification, knowing how staplers work—and more importantly, how they interact with tissue—can help the surgeon use the device more effectively, which can help to avoid staple-line failure and improve patient outcomes.

Compression Basics

Figure 1. Benchtop compression testing.

One of the keys to good outcomes when using staplers is understanding compression. Because compression is necessary, all staplers perform this function to one degree or another. Compression not only apposes tissue, but also leads to hemostasis, and more recently has been identified as a main factor in reaching maximum anastomotic burst pressure.1 Given this, a natural question follows: What is the appropriate amount of compression?

Defining appropriate compression starts with basic science, which reminds us that most human tissue exhibits both solid and liquid properties. When compressed, tissue undergoes a viscoelastic response over time leading to a decrease in tissue thickness, as was studied in early stapling literature.2 Astafiev also demonstrated that appropriate compression takes time. Indeed, more recent benchtop testing of conventional staplers has shown that the highest rate of thickness change occurs in the first 15 seconds of compression3 (Figures 1 and 2).

5

10

15

20

0 -0.1 -0.2 -0.3 -0.4 -0.5 -0.6

Figure 2. Sample of tissue compression over time: Echelon 60 mm (after jaw closure).

Benchtop testing in porcine gastric tissue.3

This phenomenon is especially important when stapling thicker tissue, as taking the time to decrease tissue thickness can make it less likely that staples will incorrectly form, in turn, reducing the risk for stapleline failure.

Delivering Appropriate Compression So, the next time you’re stapling, think about compression. Are you delivering compression in an optimal manner?

If not, ask an industry representative. Collaboration between clinicians and device manufacturers is the best way for surgeons to understand devices and their tissue interactions. In this case, knowing how staplers work can help ensure proper use, and in the end, improve patient outcomes.

References 1.

Myers Sr, rothermel wS Jr, Shaffer l. The effect of tissue compression on circular stapler line failure. Surg Endosc. 2011;25(9):3043-3049.

2.

astafiev GV. Investigation of processes relating to tissue compression in suturing and stapling apparatus. Surgical Staplers (Chirurgicheskiey Shivayushiye Apparaty). 1967;7.

3.

Benchtop test conducted in excised porcine gastric tissue with initial thickness of approximately 2.5 mm (measured at 8 g/mm2). Data on file. 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 of reproduction, in whole or in part, in any form.

DSl#12-0262

Introduction

Time, secs 0

BB1225

Medical Director Ethicon Endo-Surgery Cincinnati, Ohio

This is especially necessary in more challenging situations, such as stapling thick or inflamed tissue. In these cases, the path to the operative solution must begin from the “knowns” of the patient, their tissue, and the device.

Surgeons undergo significant training to develop an understanding of both the patient and tissue—but comparatively little training on the device beyond blanket aphorisms such as “blue for bowel.” Although this type of advice is helpful as a guidepost, it often falls short in the realm of evidence-based instruction. At the 2011 Society of American Gastrointestinal and Endoscopic Surgeons annual meeting, a panel was convened to highlight the need for expanding the body of knowledge around the science of stapling. The panel found there was, indeed, not only a lack of quality didactic instruction, but also a dearth of information about this topic. The team called on both clinicians and device manufacturers to collaborate to better understand device–tissue interactions, and to disseminate information on this topic to improve stapler usage.

Certainly, this subject is too big for a single article. So let’s concentrate on just one element that, when applied, can change your practice and improve outcomes.

Tissue Thickness Change, mm

Edward Chekan, MD, FACS

General SurGery newS

May 2012

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16

In the News

GeneralSurgeryNews.com / General Surgery News / May 2012

Study Shows Apparent Safety of Biologic Mesh for Hiatal Hernias Conflicts with Earlier Studies; Long-Term Effects Still Uncertain B y C hristina F rangou

A

large single-center series reported no major complications associated with use of biologic mesh to repair large hiatal hernias. This finding contrasts with other recent studies that have shown an increased risk for morbidity related to prosthetic and biologic meshes in these patients.

“Given the potential benefits of biologic mesh, we believe that surgeons who pay careful attention to its placement should feel reassured in the safety of using these meshes during hiatal hernia repair,” wrote Eelco B. Wassenaar, MD, and colleagues from the University of Washington, in Seattle (Surg Endosc 2011. [Nov 16; Epub ahead of print]). They caution, however, that the low complication rate

may reflect their own technique and not that of the general community.

Use of biologic mesh for repair of paraesophageal hernia has been increasing ever since studies showed that, when used to reinforce hiatal closure, these meshes decrease short-term recurrence (Ann Surg 2006;244:481-490). But over the past few years, surgeons reported serious complications following biologic mesh repair, including erosion, dense fibrosis and esophageal stenosis (Surg Endosc 2009;23:1219-1226).

After the 2009 study was published, the research team at the University of Washington decided to review its institution’s experience. The group had used biologic mesh extensively for complicated hernia repair and led the original randomized trial. The study included all patients who had a biologic mesh placed at the hiatus and who were followed for at least one year. The investigators administered a questionnaire to identify any cases

‘This study has long-term followup, which gives us a little bit of breathing room to say that biologic meshes seem to be safe.’

—Emanuele Lo Menzo, MD, PhD

of symptoms of gastroesophageal reflux disease, dysphagia and all other operative or endoscopic interventions that occurred after mesh implantation.

Of 126 eligible patients, 73 (58%) returned a questionnaire. Of those who did not respond, four patients (3%) had died from causes unrelated to the operation, four patients (3%) did not want to participate and 47 patients (36%) were unreachable. The surveyed group had a median follow-up of 45 months.

Surveys showed that no patient reported mesh-related complications and no patient had an erosion, stricture or indication from radiographic or endoscopic evaluation. No patient required a reoperation except one man for recurrent reflux symptoms with a recurrent sliding hiatal hernia.

The surveyed patients reported an overall improvement in all symptoms after their hernia repairs. No restriction or mild restriction in what they could eat was reported by 89% of patients. Twothirds of patients graded their operative result as “excellent,” 23% as “good,” 6% as “fair” and 5% as “poor.” Among patients with poor results, one experienced severe dysphagia, one was dissatisfied with postoperative follow-up but did not have any symptoms, and another had “pain in the diaphragm” that was also recorded on the preoperative questionnaire.

The risk for dysphagia was a major focus for the investigators. When the prosthesis is placed at the hiatus, it can induce inflammation and scarring leading to fibrosis, stenosis and eventually dysphagia. In this series, six patients (9%) had worsened dysphagia after surgery. Of these, two patients said the dysphagia was severe. Follow-up studies performed elsewhere revealed that one of these patients had a “tight wrap” but without stricture or erosion, and dilation did not improve the patient’s symptoms. “It is possible that mesh could be a contributing factor,” the authors said.

Overall, the rate of dysphagia in the study was 2%. This rate compared favorably to other studies of patients who underwent Nissen fundoplication without the use of mesh.

The study provides some reassurance about the safety of biologic meshes but concerns remain, said Emanuele Lo Menzo, MD, PhD, associate professor of surgery, University of Maryland Medical Center, in Baltimore. “This study has long-term follow-up, which gives us a little bit of breathing room to say that biologic meshes seem to be safe. Certainly, at the University of Washington, it seems to be.”

He added, however, that there are flaws in the study. More than one-third

of patients treated could not be contacted and among those who were contacted, no patients underwent firsthand endoscopic or radiologic evaluation at their treating institution. Furthermore, the institution has very experienced surgeons; thus, the results are likely to be difficult to reproduce.

Dr. Wassenaar said the surgical team uses three key strategies that may reduce the risk for complications. They advocate the use of a U-shaped, rather than a keyhole configuration, which leaves an open area in the anterior aspect of the esophagus, and recommend covering the hiatus posterior to the esophagus, taking care to avoid pulling the mesh anteriorly and lifting the esophagus posteriorly to avoid narrowing the esophagus. They also suggest leaving a small space between the edge of the mesh and the esophageal wall to avoid excessive contact of the mesh with the esophagus. The team developed this technique after studies conducted in dogs revealed some fibrosis and scarring, leading to an esophageal stricture.

Despite the study’s findings, uncertainty remains about the long- and shortterm success of biologic mesh repair in large hernias, other surgeons noted.

“It’s very confusing [because of ] mixed results from the studies. We still don’t know how biologic meshes are going to hold up long-term for large hiatal hernia repairs,” said Constantine T. Frantzides, MD, PhD, director of the advanced laparoscopic and bariatric fellowship program, Saint Francis Hospital, and director of the Chicago Institute of Minimally Invasive Surgery, in Skokie, Ill. In 2011, surgeons reported results from a multicenter randomized trial of laparoscopic paraesophageal hernia repair that compared primary diaphragm repair with primary repair buttressed with a biologic prosthesis (JACS 2011;213:461-468).

The study showed that repair using biologic mesh was not associated with higher rates of complications or side effects but that there was no benefit in reducing hiatal hernia recurrence with follow-up of more than five years.

Dr. Frantzides said more time and more studies are needed to settle the issue of synthetic versus biologic mesh repair.

A randomized controlled study, led by Dr. Frantzides, confirmed the benefit of mesh in large hiatal hernia repair (Arch Surg 2002;137:649-652); however, there is little agreement about the ideal material of the mesh in these repairs, he said.

“Personally, with large defects, I don’t think the biologic mesh will hold. But this is something that we cannot settle without having time to follow these patients long-term,” he said.

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In the News K-ras Mutation Continued from page 1

Although the findings are still preliminary, it’s hoped that codon 13 and other molecular markers will one day be used to guide therapy, said lead author Marjun Duldulao, MD, a surgery research fellow and general surgery resident at City of Hope Cancer Center, Duarte, Calif.

“If we can validate these findings with future studies, and indeed codon 13 mutations do not have complete pathologic response to chemoradiation, that

would change the paradigm. We could select patients for chemoradiation by their tumors,” said Dr. Duldulao.

“No one has broken through yet to take molecular markers to the next step but that would certainly be the hope.

With more patients, more studies, perhaps we can use these genetic markers to determine treatment for patients.”

He presented the findings at the 2012 annual meeting of the Society for Surgical Oncology.

Investigators studied 148 patients with stage II or III rectal cancers who were enrolled in a multicenter prospective

GeneralSurgeryNews.com / General Surgery News / May 2012

clinical trial. All patients underwent preoperative therapy of 5-fluorouracil (5-FU) plus radiation therapy, with FOLFOX (oxaliplatin, 5-FU and leucovorin) when appropriate, followed by surgery six weeks later. DNA was extracted from the pretreatment tumor biopsies and genotyping of K-ras was completed by polymerase chain reaction and direct sequencing.

Overall, 60 patients (40.5%) were found to have a K-ras mutation. Of these, 66.7% of mutations occurred in codon 12 (n=40), 20% in codon 13 (n=12), 8.3% in codon 61 (n=5) and 5%

‘With more patients, more studies, perhaps we can use these genetic markers to determine treatment for patients.’

—Marjun Duldulao, MD

GeneralSurgeryNews.com / General Surgery News / May 2012

in other locations (n=3).

Patients with K-ras codon 13 mutations did not respond to CRT compared with patients without K-ras mutations (P=0.037). None of the 20 patients with codon 13 mutations had a pCR. For all other K-ras mutations, a minority of patients had a pCR, with rates ranging from 17.5% for patients with codon 12 to 20% for patients with codon 61.

The study did not have enough patients for the findings to be conclusive, the researchers caution. “We need bigger studies with more patients,” said Dr. Duldulao.

In the News Still, surgeons called the findings “intriguing,” saying the results suggest that patients may one day undergo investigations to determine codon location prior to treatment.

“It’s an impressive original investigation,” said Thomas K. Weber, MD, professor of surgery, State University of New York Downstate Medical Center, and chief of surgery at Department of Veterans Affairs, New York Harbor Healthcare System, New York City.

“This study will focus attention on the biology of tumors with the codon 13 mutations and should attract support for

larger studies in the future,” he said.

Patients with wild-type mutations had much better outcomes following neoadjuvant CRT than patients with K-ras mutations, with a 33% pCR rate compared with 13.5%, according to the study.

Codon 13 mutations were strongly associated with TP53 gene mutation; 75% of patients with codon 13 mutations had TP53 comutation. Other K-ras mutations had a lower rate of comutation of 38%. The comutation may result in further aggressive tumor behavior, said investigators.

Previous studies have shown that patients with colorectal cancer and K-ras mutations in codon 13 have more aggressive disease, frequently associated with local and distant metastases at first diagnosis, than patients with codon 12 mutations (Anticancer Drugs 2011;22:913-918).

The patients included in Dr. Duldulao’s study were originally enrolled in the TIMING trial, a trial published last year that looked at the optimal timing of surgery after CRT for patients with advanced rectal cancer (Ann Surg 2011:254:97-102). The results suggest that intensive neoadjuvant CRT, followed by additional chemotherapy and holding off on surgery for up to 11 weeks may result in a modest increase in pCR without increasing complications in patients undergoing total mesorectal excision for locally advanced rectal cancer.

Dr. Duldulao disclosed no financial relationships.

in your inbox The best-read publication in surgery now offers an E-newsletter that alerts you to highlights from the most recently published issue.

Register for free www.GeneralSurgeryNews.com

Futura BT 66pt & Futura Extra Bold Condensed Oblique 66pt

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Surgeons’ Lounge

GeneralSurgeryNews.com / General Surgery News / May 2012

Coverage of the 23rd Annual International Colorectal Disease Symposium All articles by Jonathan Slone, at Cleveland Clinic Florida, Weston

A Message From the Symposium Director Steven D. Wexner, MD, FACS, FRCS, FRCS(Ed) Professor and Chairman, Department of Colorectal Surgery, Cleveland Clinic Florida (CCF), Weston

It is with great pleasure that we share with you several of the many interesting presentations, which were delivered during our recent 23rd Annual David G. Jagelman MD International Colorectal Disease Symposium held from Feb. 14-19, 2012, in Fort Lauderdale, Fla. For the first time, the meeting was combined with the Rupert P. Turnbull, MD, annual symposium, which is in its 33rd year.

The combined meeting attracted approximately 800 participants from more than 50 countries. The faculty of more than 50 world-renowned experts delivered no less than 70 lectures. This issue of The Surgeons’ Lounge highlights a few of the many interesting podium presentations.

Mariana Berho, MD, chair of the Division of Pathology and Laboratory Medicine at Cleveland Clinic Florida, describes the pathologist’s view of total mesorectal evaluation. It has become clear that external audit by pathologists can enhance quality and optimize patient outcomes. Pascal Gervaz, MD, an alumnus of the Cleveland Clinic Florida training program who now works in Switzerland, discussed the definition of recurrent sigmoid diverticulitis and how these definitions have changed. Klaus Matzel, MD, of Erlangen, Germany, the first proponent of sacral nerve stimulation for fecal incontinence, described the current status of this exciting recently FDA-approved technology for chronic constipation. Giovanni Milito, MD, chief of colorectal surgery at the University Hospital Tor Vergata in Rome, Italy, presented the methods and results of ventral rectopexy for the treatment of rectal prolapse. Fabio Potenti, MD, faculty at Cleveland Clinic Florida, reviews the most recent guidelines for running fast-track protocols and critical paths.

Total Mesorectal Evaluation:

How To Optimize Outcomes?

I

n a session entitled “Debates and Dilemmas in the Management of Colorectal Carcinoma” at the 23rd Annual International Colorectal Disease Symposium, Mariana Berho, MD, chair of the Division of Pathology and Laboratory Medicine at Cleveland Clinic Florida, discussed how physicians can optimize outcomes during total mesorectal evaluation.

Recent studies have shown that pathologist reports of mesorectal integrity have been highly inconsistent, with significant variations between institutions ranging from 40% to 99% (J Clin Oncol 2007;25:1647-1650; Br J Surg 2003;90:445-451; Cancer 2009;115:3400-3411).

Several tactics can be used to create more consistency when evaluating mesorectal integrity. First, three pathological markers—integrity of the mesorectum, margins of resection and lymph node yield—should be used to indicate the quality of surgery in total mesorectal evaluation specimens. The pathological assessment of the integrity of the mesorectum is divided into three main categories: complete (mesorectal), nearly complete (intramesorectal) and incomplete (muscularis propria). Complete clearance signifies only minor irregularities, no defects deeper than 5 mm, smooth circumferential margins and no coning; nearly complete means moderate bulk to mesorectum but irregularities on mesorectal surface and some coning; and incomplete signifies little bulk to mesorectum with defects down to muscularis propria and/or very irregular circumferential margin.

Numerous studies have shown that the integrity of the mesorectum correlates with the rate of local recurrence

(Lancet 2009;373:821-828; J Clin Oncol 2001;29:21422143; Dis Colon Rectum 2007;50:168-175). In the Lancet study, for instance, the investigators found that a shortcourse preoperative radiotherapy almost did away with local recurrence in patients who had a resection in the mesorectal plane.

Additionally, investigators have found that patients with colorectal cancer have improved outcomes when they are treated with a multidisciplinary team, especially when that team agrees on the patient’s status.

In one prospective study, surgeons and pathologists assessed whether tumor clearance in 1,550 patients was complete, nearly complete or incomplete (Br J Surg 2004;91:1040-1045). One-third of patients assessed as having a complete surgical clearance had tumor recurrence, whereas patients with an uncertain or incomplete clearance had recurrence rates of 59.5% and 61%, respectively. The investigators found that the relative risk for recurrence was twice as high when the surgeon and pathologist disagreed compared with when they agreed on complete clearance.

Circumferential margin of resection is a very strong predictor of local and overall recurrence (Table; Lancet 1986;2:996-999; J Clin Oncol 2008;26:303-312). Many positive circumferential margins occurred when the tumor was at or less than 1 mm from the margin (Dis Colon Rectum 2009;52:1723-1729). The mechanism of circumferential resection margin involvement includes direct tumor extension, positive lymph node at the margin and discontinuous involvement related to vascular or perineural invasion.

Table. Distal margin of resection: Oncological outcomes according to the length of the distal margin.

Author

Year

Cases

Pollett Vernava

1983 1992

334 243

Paty

1994

Shiouzi Kwok Leo Nash Kiran

Study type

Local recurrence

5-year survival

DRM

Retro Prosp

NS 0.01

NS 0.01

2 cm 1cm

128

Retro

NS

NS

2cm

1995 1996 2009 2010

610 55 203 627

Retro Prosp Retro Retro

0.006 0.001

2011

784

Retro

NS

DRM, distal resection margin; HR, hazard ratio; NS, not significant; Prosp, prospective; Retro, retrospective.

0.03 0.19 0.03 HR increased NS

1 cm 2 cm Clear 1 cm 1cm

BROUGHT

TO

YOU

BY

Supported and approved by

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ProGrip™ Mesh: Self-Gripping Mesh for Hernia Repair Faculty: William Carney, MD, FACS Chairman, Division of General Surgery Conemaugh Memorial Medical Center Johnstown, Pennsylvania Philippe Chastan, MD General Surgeon Clinique des 4 Pavillons Lormont, France Jorge Granja, MD Assistant Professor of Surgery General Surgeon University of Minnesota Medical Center, Fairview Minneapolis, Minnesota Steven Hopson, MD, FACS Director, The Bon Secours Hernia Center Bon Secours Mary Immaculate Hospital Newport News, Virginia Andrew Kingsnorth, MS, FRCS, FACS Professor of Surgery Peninsula College of Medicine & Dentistry Derriford Hospital Plymouth, United Kingdom David Siegel, DO, FACOS General Surgeon St. John Macomb-Oakland Hospital Madison Heights, Michigan

Distributed by McMahon Publishing

Introduction The Lichtenstein technique, performed and refined over several decades, revolutionized hernia surgery as a result of its reduced risk for morbidity and its potential use in patients previously unsuitable for this type of procedure.1 Surgeons quickly popularized this technique of tension-free mesh hernia repair, and it became the gold standard for the treatment of inguinal hernias,2 of which approximately 600,000 are surgically treated each year in the United States.3 Since the introduction of Lichtenstein mesh repair, overall hernia recurrence rates have fallen to 2% or lower.4 However, with the reduced risk for recurrence, irreversible long-term complications such as chronic pain have become increasingly clinically relevant.4 Specifically, chronic pain that affects quality of life and is at least partially disabling occurs more frequently than recurrences, and may completely attenuate

the benefits of the hernia repair.4 A survey of 2,456 men and women randomly sampled from the Swedish Hernia Registry revealed that 758 patients (31%) experienced some degree of pain 2 or 3 years after surgery; 144 patients (6%) reported that the pain interfered with their daily activities.5 Many variables, including age and degree of pain before surgery, were independently associated with an increased risk for postprocedural pain. Variables potentially under the surgeon’s control included postoperative complications and operative technique.5

Self-Gripping Mesh In 2008, Covidien launched ProGrip™ mesh (Figure 1), a self-gripping mesh indicated for use in inguinal and incisional hernia repairs. ProGrip™ was designed to offer patients greater comfort following surgery, and allow physicians the ability to position and secure the mesh in less than 60 seconds, which may contribute to a reduction in operating

To learn more about ProGrip™ Mesh and to request a trial, visit: www.covidien.com/progrip

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Closing the self-gripping flap around the cord prior to lowering and positioning the mesh.

Working the mesh under the aponeurosis of the external oblique muscle.

The mesh anchors to the tissue with the micro-grips immediately and may not require any additional fixation.a

Figure 1. ProGrip™ mesh in open inguinal repair. a Additional fixation is left to the surgeon’s discretion Image courtesy of Covidien Inc.

time.2,6,7 The macroporous polyester mesh has resorbable polylactic acid (PLA) micro-grips on one side of the mesh, which secure quickly without sutures, tacks, fibrin glue, or any other form of fixation (Figure 2).7 “[ProGrip™ mesh is] a revolution because for the first time we can lay mesh without a suture, avoiding any risk for nerve entrapment and with the respect of the anatomical structures,” said Philippe Chastan, MD, general surgeon at the Clinique des 4 Pavillons in Lormont, France, who participated in the development of the mesh.

ProGrip™ Mesh: First Impressions Andrew Kingsnorth, MS, FRCS, FACS, professor of surgery at the Peninsula College of Medicine & Dentistry, Derriford Hospital in Plymouth, United Kingdom, performs open inguinal hernia repair. Pr. Kingsnorth noted that he first encountered ProGrip™ mesh at the 2007 meeting of the European Hernia Society. “I had been thinking to myself that we should have a mesh that self-sticks to the wall, so I was incredibly enthusiastic,” Pr. Kingsnorth said.

William Carney, MD, FACS, chairman of the Division of General Surgery at Conemaugh Memorial Medical Center in Johnstown, Pennsylvania, added that he was quite interested in using the self-fixing properties of ProGrip™ mesh. “It’s a unique concept,” Dr. Carney said. “It’s

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sutureless, flat on one side with little absorbable, almost feet on the other side. It looked like it would just stick to the tissue wherever you laid it, which is a neat idea.”

As director of The Bon Secours Hernia Center at Bon Secours Mary Immaculate Hospital in Newport News, Virginia, Steven Hopson, MD, FACS, said that he is always interested in evaluating new advances in mesh for hernia repair. “When I was approached by a [Covidien representative], I thought the concept [of ProGrip™ mesh] was really different,” he said. “One of the things to keep in mind, and not just in mesh, but in all medicine today—because we have to look at cost and utilization—is that a new product really has to be a game changer, a paradigm shift in what we do.

“The concept of hernia surgery in general is that you take a piece of mesh, [place] it, and attach the mesh to the patient. We’ve learned that the way you fixate the mesh is very important with regards to postoperative pain and recurrence,” Dr. Hopson said. “With ProGrip™ mesh, instead of relying solely on mechanical fixation of the mesh to the tissue and the patient, the grips on the mesh do the work for you. The fixation is integrated into the mesh. I thought that was a really great idea and that was what piqued my interest in using it.”

Despite reported benefits of ProGrip™ mesh in open procedures, some surgeons performing laparoscopic

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Figure 2. ProGrip™ mesh: resorbable PLA micro-grips.

PLA, polylactic acid Image courtesy of Covidien Inc.

hernia repairs did not begin using the mesh as readily.

“When I first saw [ProGrip™ mesh], I ran screaming,” said Jorge Granja, MD, assistant professor of surgery, and general surgeon at the University of Minnesota Medical Center, Fairview in Minneapolis, Minnesota, who performs inguinal hernia repairs laparoscopically via the total extraperitoneal approach. “I was pretty intimidated by the strong grip it had on itself and on the tissue around it. I thought that it would grab everything around it, including itself, and be difficult to manipulate in the small space I had.” Once Dr. Granja increased the number of laparoscopic procedures in which he used the material, he said that his fears were unfounded. However, he still had reservations while he worked through the 10 to 20 cases necessary to grow completely comfortable with ProGrip™ mesh.

“My observation of inguinal hernia repair is that the mesh we use has a large impact on the results we get and on the patient’s quality of life,” Dr. Granja said. Previously, Dr. Granja used 3DMax™ Mesh (Bard) because it did not require too much fixation. “Then, I saw work being done with polyester mesh and fibrin glue at a meeting,” he said. “They were using a soft mesh and

fixating it by gluing it. So I tried that for a number of cases, but it was very costly. The fibrin glue in our hospital [costs] up to $2,000 [for each application]. I thought that was a disservice to the patient, and it did not get a better result.”

Once he became comfortable with ProGrip™ mesh, Dr. Granja found that the mesh had the advantage of being soft, but had a temporary firm memory state due to the PLA grips on one side. “Now, I’m placing this mesh in a small space covering a surface that it completely sticks to, so I don’t have to worry about tacking or sewing it, and I don’t have to worry about it moving,” Dr. Granja said.

David Siegel, DO, FACOS, general surgeon at St. John Macomb-Oakland Hospital in Madison Heights, Michigan, added, “This mesh affixes to the entire surface rather than in just a few corner spots, so there is much less pulling or tugging. Before, the mesh was pulled wherever the stay sutures were, but now you have the entire mesh affixed to the floor of the hernia. That’s definitely a huge bonus.” Mesh fixation is essential to avoid dislocation or migration, as these effects could result in a recurrence, which, along with chronic pain, is one of the 2 outcomes surgeons most want to avoid following hernia surgery.8

Using ProGrip™ Mesh: Indications and Procedural Applications ProGrip™ mesh is indicated for inguinal and incisional hernia repairs. It is primarily used in open inguinal repairs but many surgeons, including several of the interviewed faculty members, also are using ProGrip™ mesh for laparoscopic inguinal and open incisional hernia repairs. “At first, I would use it for all my inguinal hernia repairs except for large direct inguinal hernias, but as my experience grew, and I would do sort of a pseudo-Bassini hernia repair with an absorbable suture, I would use it on almost any inguinal hernia,” Dr. Carney said. Dr. Siegel previously performed laparoscopic inguinal hernia repair, but now uses only an open approach with ProGrip™ mesh.

Dr. Granja noted that he uses ProGrip™ mesh for laparoscopic inguinal repair, as well as for open incisional repair. He added that there might be some limited use for the mesh in small incisional repair. “When it comes to very large [incisional repairs], I think the literature supports

To learn more about ProGrip™ Mesh and to request a trial, visit: www.covidien.com/progrip

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Figure 3. Dr. Hopson places ProGrip™ mesh in an open incisional hernia repair with component separation.

Image courtesy of Covidien Inc.

[the use of the component separation technique] for the primary closure, which I think is the technique [that] will evolve for large and complex incisional hernias,” Dr. Granja said. Dr. Hopson currently uses ProGrip™ mesh for open inguinal and open incisional repairs, and considers the mesh size its only limitation for use in incisional repair (Figure 3). The Parietex™ composite mesh material itself—a large-pored, lightweight mesh—has been found safe and effective for incisional hernias.9 “The 30-cm sheets are much anticipated, and I think the biggest advantage to having the larger sheets is that we will be able to evaluate and repair larger open incisional hernias,” said Dr. Hopson, who will soon begin a clinical trial to evaluate the use of larger sheets of ProGrip™ mesh in these procedures. “My main interest with ProGrip™ mesh has been open incisional hernia repair,” he said. Recently, larger sheets of ProGrip™ mesh (30×15 cm and 20×15 cm) have become available.

Patient and Surgeon Benefits of Self-Gripping Mesh Pain Reduction Anecdotally, all of the interviewed faculty members have found their patients report less pain after receiving ProGrip™ mesh in hernia procedures. Dr. Siegel evaluates all his patients 1 week after surgery, and

4

then again at week 3 if they are not reporting complete improvement. “Now, I’m seeing far fewer people at week 3 because they’re doing so well at week 1,” he said. Although he was more conservative with postdischarge activity instructions before using ProGrip™ mesh—evaluating patients on a case-by-case basis—Dr. Siegel now suggests that patients pay attention to their symptom severity when returning to usual activities. “A lot of [patients] are back to work, biking, jogging, within a week,” Dr. Siegel said.

“I think patient satisfaction has been good,” Dr. Hopson said. “For inguinal and open incisional repair with ProGrip™ mesh the patients seem to have less postoperative pain and discomfort.” Dr. Carney agreed that patients appear to have reduced postoperative pain. “The reason I went to this mesh is because I don’t have any sutures entrapping nerves in the groin,” Dr. Carney said.

Before using ProGrip™ mesh, he reported a chronic pain rate of approximately 10%. “I’ve probably cut that in half,” he added. Most of his patients are able to resume sedentary activities quickly, but he instructs them not to do any heavy lifting until at least 3 weeks postsurgery. “A wound is a wound, and it still takes the body 21 days to get about 98% of the wound strength,” Dr. Carney noted.

Recurrence In addition to avoiding pain, the other main complication surgeons want to avoid in hernia repair is recurrence. “The whole purpose of a hernia repair is not to get a recurrence,” Dr. Carney said. “Typically a hernia surgeon’s goal is to reproduce their results. In my 17-year career, I think the recurrence rate is very low because it’s the same procedure repeated again and again.” Dr. Granja added that, in his opinion, the selfgripping properties of ProGrip™ mesh may reduce the recurrence rate. “In my mind, in so far as ProGrip™ mesh is fixated in a complete fashion, recurrences would be a technical problem on the part of the surgeon and not of the mesh. Using ProGrip™ mesh should bring recurrences down to a negligible rate.”

Dr. Siegel considers ProGrip™ mesh to be a safe option because he has seen no change in his already low recurrence rate since he started using ProGrip™ mesh. “I think no matter what type of repair you do, if you do it right you will have a less than 1% recurrence rate, so I don’t think that has changed,” he said.

REPORT

Figure 4. Mesh before and after resorption of PLA micro hooks.

PLA, polylactic acid Reprinted with permission from Chastan P. Tension-free open hernia repair using an innovative self-gripping semi-resorbable mesh. Hernia. 2009;13(2):137-142.

Operating Time Dr. Siegel has noted a significant drop in operating time since using ProGrip™, in addition to a reduction in reported patient pain. “My surgical times have dropped by probably 10 to 12 minutes, and I only do about 5% to 10% of my surgeries,” said Dr. Siegel, who now spends more time instructing residents. “Even in the hands of residents, the time is being cut as well,” he added. “I’ve tried probably 40 meshes in the last 10 years; I’d try all of them once or twice to see if I liked them and to give myself a chance to see if a mesh presented a better way of doing things. This is the first time I made a change and I’m happier that I did.” Pr. Kingsnorth noted.

ProGrip™ mesh is evolving into a superior option for inguinal hernia repair, “in particular because of the speed with which you can perform the surgery,” he said.

ProGrip™ Mesh: Clinical and Preclinical Evaluations In 2006, Dr. Chastan and colleagues followed 52 patients (70 hernias) after hernia repair using the

lightweight (40 g/m2), large-pored mesh polypropylene incorporating resorbable PLA micro-grips (Figure 4).2 The aim of this study was to report the clinical outcomes with 1-year follow-up after open inguinal hernia repair using ProGrip™ mesh.2 During the procedures, Dr. Chastan found that mesh fixation to tissue frequently eliminated the need for sutures and no perioperative complications were reported.2 Following the operation, most patients were discharged at day 1, and the average duration before patients returned to normal activities was approximately 5 days. One month after surgery, the study found no reports of neurological pain or other major complications.2 Following this early report, subsequent studies of the new ProGrip™ mesh also showed positive results for both patients and surgeons. Hollinsky and colleagues compared outcomes in rats in which polypropylene meshes were fixed either by hernia stapler, fibrin glue, ProGrip™ mesh, or unfixed mesh.10 Results showed that, after 5 days, the strength of incorporation was significantly higher in the ProGrip™ mesh and hernia stapler-fixated group than in the fibrin glue or unfixed mesh group. After 2 months,

To learn more about ProGrip™ Mesh and to request a trial, visit: www.covidien.com/progrip

5

REPORT

VAS Percent Change From Baseline

Decreased Pain Increased Pain

60

40

39%

21% 20

Baseline

0 -10% -20

-13%

Lichtenstein

-40

ProGripTM

-53%

-60

-60% -70% -71%

-80 Discharge P=0.007

7 days P=0.039

1 month ns

3 months ns

Figure 5. ProGrip™ mesh versus traditional Lichtenstein repair.

Courtesy of Andrew Kingsnorth, MS, FRCS, FACS.

ProGrip™ mesh showed significantly better incorporation than all other groups.10 Also, inflammatory reactions, relatively high at 5 days, were reduced at 2 months. There also were no signs of mesh degradation after 2 months.10 Hollinsky and colleagues concluded that ProGrip™ mesh resulted in greater tissue strength of incorporation than other fixation systems, and that it represented an economic alternative to hernia-stapler fixation or fibrin glue fixation.10 In another animal model, Kolbe and colleagues examined the impact of ProGrip™ mesh on fertility due to concerns that self-gripping mesh could damage susceptible tissue layers around the ductus deferens.11 The researchers compared outcomes in 10 rats in which either standard lightweight polypropylene mesh or ProGrip™ mesh was wrapped surgically around the prepared ductus deferens; in 5 control rats, the ducts were bluntly separated from adherent tissue. At 2 months, the mesh implants were recovered with the ductus deferens for histology

6

and analysis by electron microscopy.11 The lumen of the ductus deferens was unrestricted in all animals, and there was only some minor inflammation with infiltrating cells. The researchers concluded that self-gripping mesh posed no harm to the ductus deferens in rat models, and that given the larger dimensions of the human ductus deferens, the risk for detrimental fertility effect on exposed tissue could be excluded.11 Recently, Kapischke and colleagues compared reports of postoperative pain following the use of ProGrip™ mesh with traditional open Lichtenstein repair in 50 patients receiving groin hernia repair.12 On postoperative day 1, pain scores on the visual analog scale (VAS) for patients who received repairs using ProGrip™ mesh were significantly lower than patients who received traditional open repairs. Later administration of analgesics also was markedly reduced for patients receiving repairs using ProGrip™ mesh over those receiving

REPORT Lichtenstein repairs.12 Also, Kapischke and colleagues found that operative time was significantly shorter for surgeons using ProGrip™ mesh (mean time, 51 min) versus traditional Lichtenstein repair (mean time, 63.2 min).12 The study authors noted that although this is the first randomized study of ProGrip™ mesh versus traditional hernia repair and further studies with larger cohorts are necessary, this pre-study did show that ProGrip™ mesh reduced operative time while also reducing overall reported pain scores for patients.12 In open inguinal hernia repair, postoperative pain may be associated with the identification and possible resection of nerves that may influence long-term neuralgia following surgery. Smeds and colleagues identified 3 nerve structures—ilioinguinal and iliohypogastric nerve, and genital branch of the genitofemoral nerve—and the difference in pain scores among patients for whom these nerves were or were not resected during hernia repair.13 The study authors found that the resection of nerves that may be damaged in surgery or due to mesh interference (particularly the iliohypogastric nerve) led to significantly less self-reported pain scores (VAS).13 A related study by Smeds and colleagues compared nerve resection and patient-reported pain scores 3 months after repairs using ProGrip™ mesh or traditional Lichtenstein repair, and found that use of ProGrip™ mesh significantly reduced pain compared with traditional Lichtenstein repair when the iliohypogastric nerve was not resected.14 Although the final results of his study will not be available until 2012, the preliminary results of a study led

by Pr. Kingsnorth of a larger cohort appear promising. Data, presented at the 14th annual meeting of the American Hernia Society in San Francisco, California, suggest that, in a study of 390 patients, those who received ProGrip™ mesh experienced significantly less pain, measured at discharge and at day 7, than those who received a traditional Lichtenstein repair (Figure 5).15 “We follow these patients for up to 1 year.

At a year, I think things equalize between the ProGrip™ mesh and other groups, but it’s the early postoperative recovery that’s important,” Pr. Kingsnorth said.

“I would say that certainly in the clinical trial we’ve done, in my experience, and talking to other surgeons, this is a step up in open mesh repair and should, in a short period of time, become the standard of care,” Pr. Kingsnorth added.

Using ProGrip™ Mesh: Tips, Techniques, And Surgeon Benefits When Dr. Granja first began using ProGrip™ mesh, he folded the mesh so that when he set it into place it would unroll to where he wanted. “Early on I think it’s important to set yourself up for success by placing it consistently and understanding where it’s situated before you start unrolling,” Dr. Granja said. Dr. Siegel folds the mesh so that the back end is completely unexposed to the tissue until he is ready to unfold it. Although he rarely uses this approach, Dr. Siegel will occasionally place a suture through the mesh and tack it down. “That way everything lays into place because you have a stay suture medial with the pubic bone,” Dr. Siegel said. “You cut that afterward, but it allows you to get the mesh into place.”

Dr. Hopson recommends ensuring that the dissection is complete before placing the mesh. “It’s easy to place, but it’s much easier if you have the dissection complete and your planes defined before you place the mesh,” he said. “That makes it a lot easier to manipulate the mesh into place.” Dr. Carney notes that the mesh has a flap that sticks to itself and creates a pseudo internal ring. He said that he uses a small clamp to hold this flap back; the front part of the mesh covers most of the Hesselbach triangle. “I’ll fold the mesh in half on the nonsticky anterior side, and then I’ll take a forceps beneath the spermatic cord, lift that up, and create my pseudo internal ring. I’ll take the apex that goes to the pubic tubercle and set that down with the forceps.”

Using his finger, Dr. Carney then implants the mesh along the shelving edge lateral to the internal ring. “I’ll put the cord down in position, and just flatten the mesh over Hesselbach’s triangle and lateral portion of the internal ring,” Dr. Carney explained. “If it doesn’t seem like it’s laying right to me, I can take it out completely, set it on the drapes, flatten it out, and reposition my clamp and forceps and start over. I’ve not had a problem.”

Future Development “The mesh was primarily designed for open inguinal hernia repair, and now it’s being applied to open incisional repair and laparoscopic inguinal repair,” Dr. Hopson said. “We’re looking forward to using it for umbilical hernia repair as well, so I think the evolution continues with this type of mesh and technology.”

To learn more about ProGrip™ Mesh and to request a trial, visit: www.covidien.com/progrip

7

REPORT References 1. Pelta D, Lafferty P. Laparoscopic versus open repair of inguinal hernia. Lichtenstein technique should be used.

BMJ. 1996;312(7026):310.

2. Chastan P. Tension-free open hernia repair using an innovative self-gripping semi-resorbable mesh. Hernia. 2009;13(2):137-142.

3. Malangoni MA, Gagliardi RJ. Hernias. In: Townsend C, Beachamp R, Evers B, Matoox K, eds. Sabiston Textbook of Surgery. 17th ed.

Philadelphia, PA: Saunders; 2004:1199-1218.

4. Douek M, Smith G, Oshowo A, Stoker DL, Wellwood JM. Prospective randomised controlled trial of laparoscopic versus open inguinal hernia mesh repair: five year follow up. BMJ. 2003;326(7397):1012-1013.

5. Fränneby U, Sandblom G, Nordin P, Nyrén O, Gunnarsson U. Risk factors for long-term pain after hernia surgery. Ann Surg.

2006;244(2):212-219.

6. Covidien. Parietex ProGrip™ mesh Instructions for Use. www.covidien.com/imageServer.aspx/doc171408.pdf?contentID=15074&co ntenttype=application/pdf. Accessed January 20, 2012.

7. Covidien. Covidien Announces Interim Data Showing Parietex ProGrip™ mesh Self-Fixating Mesh Significantly Reduces Early Pain Following Inguinal Hernia Repair. http://investor.covidien.com/ phoenix.zhtml?c=207592&p=irol-newsArticle&ID=1541254&highlig ht=ProGrip. Accessed January 20, 2012.

8. Hollinsky C, Kolbe T, Walter I, et al. Tensile strength and adhesion formation of mesh fixation systems used in laparoscopic incisional hernia repair. Surg Endosc. 2010;24(6):1318-1324.

9. Rosen MJ. Polyester-based mesh for ventral hernia repair: is it safe? Am J Surg. 2009;197(3):353-359.

10. Hollinsky C, Kolbe T, Walter I, et al. Comparison of a new selfgripping mesh with other fixation methods for laparoscopic hernia repair in a rat model. J Am Coll Surg. 2009;208(6):1107-1114.

11. Kolbe T, Hollinsky C, Walter I, Joachim A, Rülicke T. Influence of a new self-gripping hernia mesh on male fertility in a rat model.

Surg Endosc. 2010;24(2):455-461.

12. Kapischke M, Schulze H, Caliebe A. Self-fixating mesh for the Lichtenstein procedure—a prestudy. Langenbecks Arch Surg.

2010;395(4):317-322.

13. Smeds S, Löfström L, Eriksson O. Influence of nerve identification and the resection of nerves ‘at risk’ on postoperative pain in open inguinal hernia repair. Hernia. 2010;14(3):265-270.

14. Smeds S, Nienhuijs S, Schüle S, et al. Influence of nerve resection on postoperative pain following the use of non-sutured Parietex Progrip mesh repair vs sutured Lichtenstein mesh repair in open inguinal herniorraphy. Hernia. 2011;15(suppl 1):S65-S91.

15. Kingsnorth A, Nienhuijs S, Schule S, et al. Preliminary results of a comparative randomized study: benefit of self-gripping Parietex ProGrip™ mesh in open inguinal hernia repair. Paper presented at: 2011 International Congress of the European Hernia Society; May 10-13, 2011; Ghent, Belgium.

To learn more about ProGrip™ Mesh and to request a trial, visit: www.covidien.com/progrip

Developed and authored by General Surgery News through funding from Covidien. COVIDIEN, COVIDIEN with logo, Covidien logo and positive results for life are U.S. and/or internationally registered trademarks of Covidien AG. Other ™ marked brands are trademarks of a Covidien company. ™* Trademark of its respective owner. © 2012 Covidien. All rights reserved.

P120015

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SR1130

Disclaimer: This monograph is designed to be an educational summary and not an exhaustive clinical review. McMahon Publishing, Covidien, and the faculty have taken reasonable steps to ensure the completeness and accuracy of this monograph; however, we cannot warrant or guarantee that this monograph is complete or error-free and we disclaim all warranties of merchantability or fitness for a particular purpose. No liability will be assumed for the use of this monograph and readers are strongly urged to consult any relevant primary literature.

GeneralSurgeryNews.com / General Surgery News / May 2012

Surgeons’ Lounge

Time for a Redefinition of Recurrent Sigmoid Diverticulitis I

n the session “Rethinking What We Know About Benign Colorectal Diseases,” Pascal Gervaz, MD, Department of Surgery, Geneva University Hospital, Switzerland, proposed that in order for surgeons to provide optimal care for recurrent sigmoid diverticulitis, they must reach a consensus on the terminology and diagnostic criteria used when treating this disease, which extends internationally. Surgeons also must achieve a better understanding of the natural history of simple diverticulitis, to classify complicated diverticulitis, which includes computed tomography (CT) imaging.

Diverticula, for instance, should be defined as all colonic diverticula resulting from a protrusion of mucosa through a defect in the muscular layer of the bowel wall. False diverticula consists of mucosa and submucosa, and true diverticula consists of all layers of the bowel.

Diverticulosis is the asymptomatic form of the disease in which patients have diverticula, whereas diverticular disease is the symptomatic form of the disease, which includes bleeding or infection. Diverticulitis is symptomatic diverticular disease resulting in infection and perforation (micro or

larger). Recurrent diverticulitis should be defined as two episodes of diverticulitis documented with CT scan, and a free interval longer than three months. Complicated diverticulitis shows more extreme findings, which include stenosis, fistula, abscess (Hinchey I/II) and peritonitis (Hinchey III/ IV; Figure 1).

The diagnostic criteria of diverticulitis should include: • Clinical: acute abdominal pain • Biological: an inflammatory syndrome with white blood cell count greater than 11 or C-reactive protein test greater than 50; • Radiologic: a CT scan showing inflammatory changes of the sigmoid colon; and • Endoscopic evaluation to rule out cancer or inflammatory bowel disease.

Complicated diverticulitis likely requires additional treatment beyond antibiotics to include drainage or surgery. Medical management is likely to fail without further treatment. Stenosis is a complication of diverticulitis commonly associated with a Hinchey I (Figure 2). Fistula is commonly associated with a Hinchey II (Figure 3).

Figure 2. Computed tomography scan of complication of diverticulitis associated with a Hinchey I.

Figure 3. Fistula associated with a Hinchey II.

Figure 1. Hinchey classification.

continued on page

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22

Surgeons’ Lounge

Figure. Ventral rectopexy for the treatment of rectal prolapse.

®

Now Available...

Optimizing the Selection and Use of Topical Hemostats To participate in this FREE CE/CME activity, visit Release Date: April 1, 2012

www.topical-hemostats.com

Chair

Cataldo Doria, MD, PhD, FACS Nicoletti Family Professor of Transplant Surgery Director, Division of Transplantation Co-Director, Jefferson Kimmel Cancer Center - Liver Tumor Center Thomas Jefferson University Hospital Philadelphia, Pennsylvania

Faculty

Danial E. Baker, PharmD Professor of Pharmacotherapy Associate Dean for Clinical Programs Director, Drug Information Center College of Pharmacy Washington State University Spokane, Washington Bradley A. Boucher, PharmD, FCCP, FCCM Professor, Vice-Chair for Institutional Programs Department of Clinical Pharmacy Associate Professor Department of Neurosurgery University of Tennessee Health Science Center Memphis, Tennessee

Medical Writer

Mary Culpepper

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Expiration Date: April 1, 2013

Program Goal

To educate clinicians on the selection and use of topical hemostats in the hospital setting.

Learning Objectives

After completing this activity, participants should be better able to:

1 Appraise the clinical and economic effects of excessive intraoperative or postoperative bleeding and common preoperative strategies for minimizing bleeding events.

2 Describe key clinical factors that influence the selection and use of topical hemostats as adjuncts for achieving surgical hemostasis.

3 Delineate clinical characteristics and pharmacoeconomic (direct and non-medication costs) considerations by which topical hemostats should be evaluated, acquired, and used in hospitals.

4 Develop a plan for reconciling cautionary guidance and clinical best practices with regard to the selection and use of the full range of topical hemostats.

Accreditation Statements Physician: This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of AKH Inc., Advancing Knowledge in Healthcare, and Applied Clinical Education.

AKH Inc. is accredited by the ACCME to provide continuing medical education for physicians. AKH Inc. designates this enduring activity for a maximum of 2 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Pharmacist: AKH Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. AKH Inc. approves this application-based activity for 2.0 contact hours (0.2 CEUs). UAN 0077-9999-12-013-H04-P. Initial release date: April 1, 2012.

Nurse: AKH Inc. is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s COA. AKH Inc. designates this educational activity for 2 contact hours (0.2 CEUs). Accreditation applies solely to educational activities and does not imply approval or endorsement of any commercial product by the ANCC-COA.

Supported by an educational grant from

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To participate in this FREE CE/CME activity, visit www.topical-hemostats.com

Ventral Rectopexy for the Treatment of Rectal Prolapse

I

n the session “What’s New in the Management of Prolapse and Constipation?” presenter Giovanni Milito, MD, chief of colorectal surgery at the University Hospital Tor Vergata in Rome, Italy, explored whether ventral rectopexy is the appropriate treatment for rectal prolapse. Indications for a ventral rectopexy include rectal prolapse, rectal intussusception, complex rectocele, enterocele and vaginal prolapse.

In a 2006 study, investigators assessed laparoscopic ventral rectopexy for the treatment of rectal prolapse in 109 patients and found there were no patient deaths and no worsening of constipation symptoms. They reported a conversion rate of 3.6%, minor morbidity of 7% and recurrence of 3.6% (Surg Endosc 2006;20:1919-1923).

Another study with a similar design also showed positive results (Colorectal Dis 2010;12:97-104). Seventy-five patients underwent laparoscopic ventral rectopexy and were followed for a median of 12 months. The investigators reported no mortality, no major morbidity and only 4% of patients with minor morbidity. Median length of hospital stay was two days, and preoperative constipation and fecal incontinence improved significantly at three (P<0.0001) and 12 months (P<0.0001).

Additionally, indications for the use of biomesh include permanent implantation in humans, human connective tissue reconstruction, abdominal wall hernias and rectocele and rectal prolapse.

The biomesh implant used is a flexible, fibrous flat sheet of acellular porcine dermis consisting of collagen and elastin fibers. The dermal collagen implants are strong, biocompatible, easily incorporated into recipient tissue and come with no irritation or hypersensitivity. Grafts at six months are tactilely soft, pliable and free of any pleating or bulging.

GeneralSurgeryNews.com / General Surgery News / May 2012

100%

100%

78%

80 %

I

Sacral Nerve Stimulation for Constipation

n the session “What’s New in the Management of Prolapse and Constipation?” presenter Klaus E. Matzel, MD, Department of General Surgery, University Hospital Erlangen, Erlangen, Germany, provided an overview of efficacy of sacral nerve stimulation to treat constipation. Before receiving routine treatment, patients are screened to determine if sacral nerve stimulation is effective by receiving a phase of temporary stimulation (Figure 1). The definition of success is symptom improvement of 50%.

Results of the sacral nerve stimulation from a study by Medtronic of 250 patients treated for urinary voiding disorders showed that 78% reported an increase in bowel emptying and 44% reported improved bowel habits (BJU Int; 2003;91:355–359; Figure 2).

An Italian study using sacral nerve stimulation to relieve constipation obstruction showed that, on average, the bowel emptying per week improved, the percent of difficult evacuations improved from 80% to 44%, bathroom visits decreased from 29 to 6.7 times per week, and the time spent on the toilet improved from 12.5 minutes to 9.3 minutes per episode (Dis Colon Rectum 2001;44:965-970).

In a recent prospective, multicenter trial conducted at five centers, 62 patients who failed conservative treatment underwent a 21-day test of sacral nerve stimulation. The investigators found that 45 patients (73%) proceeded to chronic stimulation, and of these, 39 (87%) achieved treatment success. Successful evacuations without straining improved from 21% at baseline to 57% and 63% at 12 and 24 months, respectively, and successful evacuations per week from

baseline to 12 months improved from two to seven times, respectively. The number of unsuccessful attempts per week decreased from 5.5 times to less than two times, and times spent on the toilet decreased from baseline to 12 months from 17 minutes to nine minutes, respectively (Gut 2010;59:333-340).

23

80%

60%

60%

40%

40%

44%

19%

20%

20%

33%

14% 8%

3% 0%

Reduced Same Increased Bowel Emptying

0%

Worse Same Improved N/A Bowel Habits

Figure 2. Results from the Medtronic sacral nerve stimulation study.

Courtesy of Klaus Matzel.

In hernia repair

INNOVATING

BY BEING IN TOUCH WITH YOUR NEEDS

COVIDIEN HERNIA CARE • MESH • FIXATION • PERMACOLTM • DISSECTION At Covidien, hernia care innovation means something more. It’s about meeting the real needs of surgeons through creative, evidence-based solutions—from the development of the first mesh with a resorbable collagen barrier, to designing what will be the most advanced mesh positioning system. Discover how our comprehensive product portfolio can help you enhance any procedure.

Figure 1. Placement of electrode and stimulator.

Photo courtesy of Klaus Matzel.

To learn more about Covidien Hernia Care, visit www.covidien.com/hernia COVIDIEN, COVIDIEN with logo and Covidien logo are U.S. and/or internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company. ©2012 Covidien 3.12 M120189

Innovation that matters

24

Surgeons’ Lounge

o understand fast-track protocols, critical paths and crashing, health care professionals must become acquainted with concepts and terminology.

In the session “Rethinking What We Know About Benign Colorectal Diseases,” presenter Fabio M. Potenti, MD, MBA, administrator of research and education at Cleveland Clinic Florida, discussed these ideas in depth.

The critical path method is an algorithm for scheduling a set of project activities. A critical path is the longest sequence of activities that must be executed in order to complete a project. The term pruning refers to removing unnecessary activities on the critical path.

Fast tracking means performing activities in parallel.

Crashing refers to shortening the durations of critical path activities by adding resources to complete them in a shorter period.

In the postoperative period, there are numerous barriers to recovery, including pain, the stress response, organ dysfunction, nausea and emesis, ileus, hypoxemia, sleep disturbances, fatigue, immobilization, semi-starvation, drains and nasogastric tubes. These factors can be key constituents that delay patient recovery.

One study, in particular, paved the way for a new approach to postoperative care (Br J Surg 2002;89:446453). These investigators compared outcomes of two identical groups of 14 patients whose postoperative care was administered by conventional unmanaged methods or by a fast-track recovery program.

The table below, simplified for this article, shows how minimal changes in perioperative management can significantly affect outcomes.

Of 28 patients having colonic resection, 14 received conventional care and 14 had multimodal rehabilitation. The patients in the fast-track group showed marked improvements in those variables compared with the patients in the conventional care group. In the fast-track group, patients experienced defecation earlier (median, day 1 vs. day 4 in the conventional group) and hospital length of stay (LOS) was shorter (median, 2 vs. 12 days in the conventional group).

Lean body and fat mass decreased in the fast-track group, but not in the conventional group. Pulmonary function decreased in the conventional group,

Pre-op • • • • • • • •

Bowel Prep Patient Education Nutrition Pre-op Rehab CV Exercise Pulmonary Physical Therapy

Surgery • • • • •

Laparoscopy Fluids Epidural Temperature Entereg

GeneralSurgeryNews.com / General Surgery News / May 2012

Length of Stay 2-3 days Clear liquid diet, 2-3 days Flatus Regular diet, 1-2 days Bowel movement Discharge home, 1 day

Transition of Care

Fast-Track Protocols, Critical Paths and Crashing T

Postoperative

• • • •

Continuous epidural 3-dimension Breakthrough pain I am or IV MS Diet and fluid no standards Nasogastric tube per surgeon’s preference

Transition of Care

but not in the fast-track group, and the fast-track group experienced less nocturnal postoperative hypoxemia. Even Ambulation though this study was not randomized, it clearly validated a key concept: By managing perioperative care, surgeons can Length of Stay improve physiologic parameters. Today, it 2.5-3.5 days has become intuitive that early mobilization, avoiding starvation and minimizing Clear liquid diet, opioids offer advantages during recovery 2-3 days from surgery; however, surgeons still need tools to operationalize this notion.

Project managers have spent more than Regular diet, 1-2 days half a century attempting to organize, standardize and manage tasks associated Flatus Bowel with business projects. Similarly, surgeons movement can use a modification of the project management method to analyze and modify Discharge home, 1 day activities in the perioperative period and observe the impact of changes on key patient outcomes such as hospital LOS. Ambulation As an example of pruning, Dr. Potenti referred to the now historical practices of nasogastric tube decompression and Figure. Transition from Pre- to Postoperative Care multiple steps in diet advancement after surgery, which are now considered unnecessary practices, according to evidencebased literature (Cochrane Database Sys Rev pulmonary strength. Surgeons can set adequate expec2007;CD004929). tations on LOS, use of postoperative pain medicaSurgeons can then begin crashing our refined model tions and early mobilization by educating the patient by putting resources to work, such as laparoscopy, gen- (Figure). tle bowel manipulation, cautious use of intraoperative To further improve the model, we can begin fast fluids, body temperature control and judicious use tracking by carrying out certain steps simultaneously, of opioids and epidurals (Table). Peripherally acting such as starting a regular diet prior to the passing of µ-opioid receptor antagonists also may play a role in flatus and subsequently discharging the patient home decreasing LOS. prior to bowel movement. Surgeons can then continue Surgeons also can use resources during the preoper- the surgical rehabilitation in a transition of care model, ative phase, as an athlete would do prior to an event, with caregivers at home or in a rehabilitation facility in to improve nutrition and physical, cardiovascular and close contact with the physicians.

By using this model, surgeons can manage patient care safely and effectively while delivering Table. Minimal Changes in Perioperative Management Impact Outcomes value. This type of care relies on Conventional Care Group Multimodal Rehabilitation Group a coordinated team approach; to make it a reality, surgeons must Anesthesia • Premedication • No premedication define who will be the project • Standard T10 epidural catheter • Selective level for epidural catheter manager or, better yet, the periSurgery • Longer-acting medications • Shorter-acting medication operative care manager.

• Standard general anesthesia • Short-acting general anesthesia • Midline incision • Transverse incision • Continuous epidural 2-dimension • Breakthrough pain oral ibuprofen or epidural • Standard diet and fluid • Day of surgery Tylenol, magnesia, cisapride • POD#1 remove urinary catheter; POD#2 remove epidural • Discharge after lunch

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Their patented design permits delivery of nourishment directly to the distal duodenum while providing 12 to 14 times more effective decompression than conventional gastric suction devices.

In short, Moss Tubes help patients maximise nutritional absorption, experience greater comfort, and enjoy a quicker return to health.

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26

Opinion

GeneralSurgeryNews.com / General Surgery News / May 2012

The Private Practice Model of Medicine Must Survive B y B arry R oseman , MD, T homas F lake , MD, and D an K open , MD

A

s a nation, our spending on health care is clearly out of control. The United States faces an unfunded Medicare mandate that, by some estimates, totals more than $90 trillion. This debt burden represents a financial black hole into which our federal and state governments will collapse, unless some major

steps are taken to avoid the pending budgetary catastrophe.

However, as the federal government moves to implement the measures contained in the Patient Protection and Affordable Care Act (PPACA), it is important to carefully assess the direction this important legislation will take the delivery of health care services and the profound effect this will have on the American public. We are concerned that

governmental actions are taking place so rapidly that there may not be adequate time to evaluate the outcomes of such changes, including significant unintended consequences of emerging legislative and regulatory mandates.

A major thrust of the PPACA is to implement new, alternative payment plans that are designed to reduce current inefficiencies. This aim is thought to be achievable through a combination

of financial incentives and disincentives to health care providers. It is a worthy objective: The overall cost of health care will be reduced while quality of care will improve.

The knowledge that patients can take their business elsewhere if unhappy with their care also is a source of great comfort to patients and contributes to their sense of well-being.

However, at the heart of this plan is eliminating the Fee-for-Service/Private Practice Model (FFS/PPM). This cohort of independent FFS physicians has been incorrectly targeted as the culprit for escalating health costs, and is even described as the main source of our full spectrum of health care–related financial problems.

Although not perfect, FFS/PPM has been an integral part of the health care landscape in this country throughout our history. Americans feel most comfortable choosing their own doctor—someone often viewed as a family member, and one in whom they can trust their lives. FFS/PPM has historically allowed patients to obtain health care services from the health care professionals and hospitals of their own choosing. Patients can see doctors wherever needed, and can choose specialists without an unreasonable waiting period or requirement to see a doctor within network, a person who often is unknown to the patient.

Historically, the FFS/PPM has been a major component in helping to ensure independence and flexibility with respect to health care options.

As physicians, FFS/PPM provides the greatest autonomy in making recommendations based on medical appropriateness without overriding monetary concerns. Attention to patient care issues and competition among providers help facilitate and promote quality of care.

FFS/PPM medicine encourages adherence to strict ethical principles. Doctors act as I would like to be treated if I were the patient.

Furthermore, the FFS system insures that the patient remains the driving force in the health care landscape, by keeping physicians accountable to their patients.

The knowledge that patients can take their business elsewhere if unhappy with their care also is a source of great comfort to patients and contributes to their sense of well-being.

GeneralSurgeryNews.com / General Surgery News / May 2012

Other payment models have been tried over the past few decades with mixed success and variable patient satisfaction, including HMOs, managed care organizations, preferred provider networks and other capitated payment systems. Private insurers quite successfully have carved out a portion of Medicare reimbursements intended for physicians, under the name of controlling costs.

Employed Physicians The most recent trend in medical practice has been the explosive growth of the hospital-employed physician. This development has moved so quickly that, in 2011, the number of employed physicians exceeded the number of physicians in private practice for the first time in our nationâ&#x20AC;&#x2122;s history. Some estimates suggest that 70% of surgeons entering practice are taking positions with hospitals or large medical groups.

Why should hospitals be so motivated to employ physicians? There are several possibilities. One likely explanation is that hospitals are acting in anticipation of the Accountable Care Organization (ACO) model of hospital reimbursement, wherein hospitals and participating providers assume financial risk for the care of their patients. Hospital administrators realize that when they receive a fixed payment for managing the health of a specified population, it is better to own the physicians involved in the care of patients. Although the outcomes include the potential for more money being available for distribution to participating parties, it also is highly likely that less physician autonomy will be present in the health care recommendations made to patients.

The potential for hospitals to convert greater market power into higher prices and less competition creates a strong incentive for hospitals to employ physicians. By having physicians as employees, hospitals have more leverage to negotiate higher reimbursement from insurance companies and less fear of competing with independent venues offering inpatient care. This move toward regionalized health care delivery structures is well under way and appears to have strong support from the advocates of the PPACA. It is also the case that once a provider monopoly has been created, the controlling hospital corporation may purchase and own a major insuring entity to further the goal of attaining hegemony in the regional health care economy.

The intensive efforts hospitals put forth to hire primary care physicians (PCPs) also may be based on the understanding that physicians could ultimately become effective competitors by aggregating into larger integrated groups that direct referrals and utilization according to their own judgment and to their own

â&#x20AC;&#x201A;

â&#x20AC;&#x201A;Opinion

advantage. Unfortunately, hospitals are currently positioned such that they can use public dollars in their attempts to put private physicians out of business, and are able to use powerful and well-funded political lobbies to achieve their goals.

But what effects does this trend have on patients? Patients may not be aware that physicians who work directly for the hospital often transition to the mindset of shift workers, and once they complete their stint they then relinquish patient care to the next shift. This practice can have potentially detrimental effects on a patient, both emotionally and

The potential for hospitals to convert greater market power into higher prices and less competition creates a strong incentive for hospitals to employ physicians. physiologically. Such shift work inevitably leads to a lack of continuity of care and also may increase the potential for medical errors.

An important ethical issue that patients are generally unaware of is who owns or employs their physician.

It is easy to understand how, in practice, a physician subjected to significant employer pressures may feel the need to act in compliance with the goals of the employer (the hospital) rather than in the best interest of the patient. The inherent conflict of interest in referrals (internal self-referrals within an owned entity) made by employed physicians serves to eliminate competition from independent and in many instances better-qualified see Private Practiceâ&#x20AC;&#x201A; page 28

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28

Opinion Private Practice continued from page 27

providers and venues. Patient choice of primary physicians and specialists often is limited. The traditional patient–physician trust that is an essential dimension of quality care is undermined.

Hospitals claim that their move to employ doctors results in lower health care costs. One element of such cost reductions is reducing unnecessary medical procedures. However, this often comes as a result of reducing the volume of appropriate consults or by underpaying specialty physicians. Although streamlining services can theoretically improve quality and translate into lower costs, it often does neither.

Furthermore, there is a large (and expensive) gray zone of medical necessity when dealing with clinical decision making in real time. The value sets of those who place top priority on costs and profits stand in sharp contrast to those who hold patient care as their top priority. Patient care and outcomes may vary significantly, and this dissimilar perception of how to achieve optimal patient outcomes often leads to different styles of medical care.

In preparation for implementing the PPACA, hospitals are positioning themselves by hiring scores of personnel who work to ensure compliance with quality measures, core measures and other such standards that will be tied to reimbursement. Hospitals likely will force new practice patterns on physicians who work in the hospital, forcing providers to comply with the latest government mandates.

Unfortunately for patients, such measures are based on aggregate population studies and usually fail to take into consideration the many dimensions of patient variation, which affect individual health care outcomes. In many cases, compliance with broad statistical mandates has and will continue to result in suboptimal care, and in some instances, significant harm to the individual patient.

Ultimately, patients will potentially suffer the most under this increasingly common reimbursement system.

In a salaried format, specialists tend to have long waiting lists because there is no financial incentive for doctors to put in the extra work that would be necessary to keep patients waiting times short. Staff personnel often direct patients with acute issues to urgent care centers or emergency rooms. Physicians working in shifts have minimal incentive to increase productivity, and patients wait longer for medical interventions. The often unrecognized and unstated reality of shift-work reimbursement plans is that the employee gets paid more per unit of service the less service provided per shift. This outcome fits well with the drive to ration care in order to reduce costs.

FFS/PPM Is Not the Problem Despite the fact that all health care costs have continued to rise unabated in the face of decreasing numbers of FFS/PPM practitioners (who now constitute a minority of practicing physicians), FFS/PPM is still continually blamed for escalating health care costs. This ongoing mantra of finger pointing at the FFS/PPM deflects attention from more highly influential elements of rising costs—hospitals, for-profit private insurance companies, the pharmaceutical and medical equipment manufacturers, patients’ own poor lifestyle choices and

health behaviors, defensive medical practices and institutional fraud.

The FFS/PPM for medical practice has been vilified by many as the root cause of spiraling health care costs.

“It drives up costs” is often repeated by editorialists and health care reformers, “because it rewards quantity and not quality.” This mantra is espoused and repeated, despite data that undermine the commonly held belief that increased physician reimbursement is the major contributing factor in rising health care costs. The truth is, physicians now receive about $0.08 of every health care dollar expended, down from nearly twice that figure in 1960.

The assertion that FFS/PPM rewards quantity and not quality is somewhat harder to disprove. It seems logical to suspect that some physicians are recommending care to patients based on monetary concerns without proper regard for what is medically indicated. Because certain categories of physicians, especially specialists, are paid for performing procedures, the assertion is that

GeneralSurgeryNews.com / General Surgery News / May 2012

efficiency is at odds with the suggested goal of slowing down the system—an attempt to reduce costs by dramatically decreasing the volume of overall work done.

It has become common knowledge that one of the easiest methods of introducing and maintaining rationing without referring to the word rationing itself is to create longer waiting lines for those seeking care. The concept is called rationing by queue in medical economics textbooks. This is a common element of all socialized medical systems and has been shown to be successful in lowering health care costs, especially among the elderly.

When specialists are salaried, as in many other systems around the world, only emergent conditions are guaranteed to receive prompt attention. Elective medical conditions, such as joint replacements (as in the Canadian system) can carry waiting times of up to two years because of the previously noted lack of financial incentive to keep waiting times short. For a majority of conditions listed as urgent, there also is a tendency to delay service provision based on the same reimbursement principles as they apply to human behaviors.

Don’t Throw the Baby Out With the Bath Water

such specialists overuse services for their own benefit.

There is no question that, as in every profession, there are sporadic practitioners whose greed may impair their medical judgment, but these individuals constitute a minority of providers, compared with the vast majority of FFS/PPM physicians engaged in the honorable practice of medicine. Among this majority group, the busiest physicians are usually, quite simply, the best.

Medicare and private insurers routinely audit outliers— the one of many external pressures that limit physicians’ abuse of the FFS system.

Lost in the discussion of unnecessary service provision is the issue of defensive medicine. In the FFS/ PPM, the harsh reality of the threat of a lawsuit for underdiagnosis adds significant conscious and subconscious pressures on providers to order additional testing and procedures. Combined with the legal recognition of patient autonomy and resulting patient demands for complete evaluation, the overuse of testing and procedures is largely the result of a reasonable approach to the real-time realities of patient care. Although the pressure to practice litigious medicine may be less on employed physicians, it is unreasonable to suggest that the FFS/PPM, rather than insufficient progress in tort reform, should be the focus of this problem.

There are many beneficial aspects of FFS/PPM that are often overlooked when discussing this model. FFS encourages efficiency in medical care, in that physicians have an incentive to provide services in a timely manner, much to the satisfaction and benefit of their patients and referring physicians. Perhaps this

It is understandable that the federal government is looking for ways to control health care costs, but the current direction of attempting to decrease the physicians’ share of the health care pie is a mistake. Pointing a finger primarily at physician payments in general, and private practice FFS reimbursements in particular, as a means to control health care cost escalation is a misguided policy that will have adverse unintended consequences.

Eliminating FFS/PPM would remove the only remaining practice model in which the professional and economic autonomy of the physician is preserved. FFS/ PP doctors are the owners of their own businesses who cannot be easily pressured into compliance with suboptimal directives, unlike employees who are beholden to the boss. In order to understand how important this is, one must be aware of the ethical precepts on which the practice of medicine is based.

Surgeons, upon entry to the American College of Surgeons, pledge “to pursue the practice of surgery with honesty … to place the welfare and the rights of my patient above all else, and ….to deal with each patient as I would wish to be dealt with if I was in the patient’s position.” Surgeons also promise they will “take no part in any arrangement, such as fee splitting or itinerant surgery which induces referral or treatment for reasons other than the patient’s best welfare.”

The FFS/PPM model, as it exists today, allows physicians to remain in control of making recommendations for the care his or her patient receives and to move promptly to implement such care. FFS/PPM frees physicians from the potentially compromising financial sanctions that can be imposed by ACOs or other payment models, and thus effectively avoids situations that arise when there is conflict between what is best for the system, the physician and the patient. FFS/PPM importantly promotes the ethical practice of medicine by keeping the physician accountable to patients as individuals and not the system, the institution, or the see Private Practice page 30 insurer.

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Opinion

Private Practice continued from page 28

AWR

Attacks on the FFS/PPMs of health care delivery will undoubtedly continue in many forms, including implementation of new reimbursement models and new government regulations. These assaults currently stem from such entities as the sustainable growth rate, Independent Payment Advisory Board, ACOs, bundling schemes and pay-forvalue, outcomes, performance, quality and other measures removed from GeneralSurgeryAd 4/26/12of 12:52 PM the basic ethical principle reasonable

payment for appropriate service provision.

Perhaps our focus should be on improving FFS/PPM, rather than attempting to replace it. In this regard, individual physicians must take a greater interest in collaborating with other doctors to solve the perceived problems with FFS/PPM and fend off the trend toward a monopolistic hospital/corporation-owned practice model. Physician societies must take a strong and open stance in favor of FFS/PPM in an effort to protect the best interests of patients Page and 1their member physicians. Physicians

GeneralSurgeryNews.com / General Surgery News / May 2012

must have systems in place to continually police themselves to avoid the perception of self-serving overuse by strictly adhering to acceptable ethical rather than financial standards of care, while keeping patients’ interests first on the list of priorities.

FFS/PPM physicians must demonstrate the ability to deliver cost-effective care, although in a purely professional sense, the cost of care is not the physician’s primary concern. At the end of the day, what is best for patients must be the primary focus of all health care decisions.

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FFS/PPM Will Survive The FFS/PPM allows the physician to evaluate each patient on his or her individual merits and make decisions and recommendations based on what is medically appropriate, and move promptly to implement care. Who, other than the physician, has devoted anywhere from 12 to 16 years of rigorous education and training, in conjunction with the patient or patient surrogate, should be making medical decisions? Although doctors should consider the most cost-effective care for patients, ultimately it is the doctor’s ethical duty to do what is best for the health of the patient, relegating other concerns to secondary status.

Attacks on the FFS/PPMs of health care delivery will undoubtedly continue in many forms, including implementation of existing and new reimbursement models, and existing and new government regulations. However, a systematic and organized comparison of FFS/PPM with other practice models demonstrates that it remains the most efficient, ethically sound and highest-quality form of medical care, with a long history of physicians successfully self-regulating medical spending while keeping the individual patient and patient concerns at the center of every treatment decision.

It is understandable that the federal government is looking for ways to control health care costs, but focusing on physicians’ share of the health care pie is a mistake. Direct physician costs are not a leading contributor to our escalating health care budget. Neither owning physicians through hospital-based employment, nor attempting to control their behaviors through legislative and regulatory rules is going to ultimately reduce our nation’s overall cost of health care by any significant degree.

Health care reform should be about fixing what is wrong with our current health care system, while retaining and building on what works well. The FFS/ PPM is one of the good things about American medicine. It works and must be preserved so that physicians can help decide what care their patients should receive based on resources, ethical guidelines, and especially patients’ wishes, while placing the individual patient’s well-being at the top of the list of provider priorities.

It is time for Americans to look themselves in the mirror and ask: Who do I want my doctor to be working for— the insurance company, the hospital, the government, or for me, the patient?

—Drs. Roseman practices in Maryville, Tennessee and Atlanta, Georgia; Dr. Flake practices in Detroit, Michigan; and Dr. Kopen practices in Forty Fort, Pennsylvania.

Opinion

GeneralSurGerynewS.com / General SurGery newS / may 2012

HAL

continued from page 1 eyes? What was going to separate me from my beloved diamond-jawed needle holder?

None of the above.

It’s worse: The electronic medical record (EMR).

All those sleepless sweaty nights tossing and turning assaulted by imaginary career-ending illnesses and I’m finally being taken down by the EMR monstrosity my beloved hospital decided to go live with on March 3, 2012, a day that will live in infamy.

And they’re serious this time. We got $1,000 and eight continuing medical education (CME) credits for taking the mandatory eight hours of training, which was only a tad worse than waterboarding. Unlike the aborted attempt nearly a decade ago, EMR implementation is mandated now by the Patient Protection and Affordable Care Act (PPACA) and Centers for Medicare & Medicaid Services (CMS) in the hallowed name of patient safety, cost containment and, presumably, national security.

Cost containment is clearly a joke.

According to my calculations (which I will be happy to share with you upon request), implementation will cost nearly $300,000 per bed, or about 50% more than the cost to build the hospital from scratch (pity me, I’m still a bricks-andmortar guy in a virtual world). There are nearly 1 million staffed hospital beds in the country; so countrywide implementation will cost $350 billion or roughly

I must have a ‘Here Comes Stupid’ sign on my back because the red jackets are on me like bees on honey to help me with really complex tasks like signing an op note or discharging a patient.

half the total expenditures of the nation’s 5,700 hospitals in 2010. I know poor penmanship is a problem, but what else am I missing to justify this expense, especially when the health care business is already reeling from reduced reimbursements from a national treasury that would technically be in default of its obligations were it not for the inexplicable faith and confidence of the Chinese in our future ability to make good on our debts.

The cost is staggering. The software and hardware expense is a drop in the bucket. The rollout is being supervised

by a mercenary army of red-jacketed “super users” who are bused in daily from expensive off-campus lodging to prevent the hospital from coming to an utter standstill on “go-live day.” I must have a “Here Comes Stupid,” sign on my back because the red jackets are on me like bees on honey to help me with really complex tasks like signing an op note or discharging a patient. They are of unflagging good cheer because it’s fun knowing how to do something that no one else can do, especially when they’re doctors. Almost like teaching residents how to do surgery, don’t you think? Helping

someone in need is always satisfying and a nice way to spend your day, just like the practice of medicine used to be. I have to admit, including a college calculus course that I had to drop before I failed, I have never felt so utterly incompetent and clueless. Performance anxiety is not good for a surgeon.

Besides the cost of implementation, evidence already is accumulating that doctors order more, not fewer, imaging studies when EMR is used. Remember that PPACA was revenue-neutral by imputing $77 billion in savings to EMR see HAL page 32

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Opinion HAL

continued from page 31 use. That money is about as real as the $140 billion in savings from Medicare physician pay cuts that never happened.

Given the cost of implementation, which is exceeding expectations by a factor of 3 so far, and the unexpected lack of frugality on the part of ordering physicians, the Beltway spinmeisters need to find a new explanation for how EMR is going to bank $77 billion. So much for cost containment.

As for patient safety, if it takes you

about half an hour to figure out if you did or did not cancel the Lasix, and if you did, was it implemented, how safe can the system be? The Joint Commission dehisced over abbreviations because some poor lady missed her pain med (MSO4) and had a prodigious bowel movement instead (MgSO4), but it doesn’t seem at all concerned that virtually every doctor will privately confess that the system is running them, not vice versa. Important information is lost in noisy, unnecessary piles of data. Doctors are clicking without understanding what they’re doing or not doing. Just

GeneralSurgeryNews.com / General Surgery News / May 2012

because technology permits Helping someone in need is always permanent capture of every heartbeat and blood pressure satisfying and a nice way to spend of every patient every second your day, just like the practice of of every hour of every day, is it necessarily desirable to do medicine used to be. so, especially when it requires the entire workforce to divert its atten- study to be a “super user.” Rumor has it tion to enter all the data? Data doesn’t a super user pulls down $200 per hour. I enter itself. That’s where you and I and wouldn’t be surprised if one of them used all our colleagues in health care come to be a neurosurgeon. in. We’ve steadily been moved down I am told there have been 400 casuthe career ladder from doctors to pro- alties of implementation at my hospital. viders to caregivers to compliance offi- No, not patients, thank God; just physicers to data entry clerks. Maybe I should cians who have said “no mas” and thrown in the towel rather than take the training. Presumably many of these casualties were, like me, aging physicians already on the cusp, waiting to be nudged into retirement. Nevertheless, if you add up their loss and the incalculable loss of productivity from the rest of us twisting in the Kafkaesque confusion of the EMR, trying to execute simple tasks that used to be automatic, the delivery of health care is being forced to endure a productivity drain of tsunami-like proportion.

And so it ends for me, not with a bang, but a whimper. Not even fire or ice. How humiliating.

As for patient casualties, we’ll see how vigilant the Joint Commission, CMS and other anti-physician regulators are in reporting EMR-related errors. My guess is they will do exactly what they have always accused surgeons of doing—bury their mistakes. The investment in money and credibility will have been too great to honestly assess the fallibility of the EMR, which will be officially off message. It’s only been a few weeks, but so far I’ve seen the machine find pedal pulses in amputated limbs and aver that the spiritual needs of a patient dead for more than four hours have been met (to say nothing of the corpse’s 0 out of 10 pain score and “no need for restraints” after being zipped up in a body bag). These malaprops are comical and inconsequential but demonstrate an inherent capacity of the EMR to make mistakes no human could ever make, even on a bad day.

Will The New England Journal of Medicine, Institute of Medicine, Dr. J.C. et al go after the serious safety deficiencies of EMR with the same zeal (and exaggeration) they demonstrated in exposing physician error, real and imagined?

Alleged physician mistakes spawned a huge industry to eliminate mistakes. The Department of Energy was created in 1975 and charged its 32,000 employees with ending U.S. dependence on foreign oil and lowering the price of gas, which was $1.25 per gallon at the time and imported oil was 30% of consumption.

At 70% and more than $4 per gallon, one has to wonder what those 32,000 folks have been doing. For all the cost and committed people power, the patient

GeneralSurgeryNews.com / General Surgery News / May 2012

safety movement has been about as successful. But hold their feet to the fire at your own risk. My guess is we won’t be seeing an officially sanctioned commission any time soon to study the shortcomings of EMR. As an aside, I’m going to miss the old chart. It was how I got to know so many of my colleagues and how they got to know me. I honestly felt I knew many doctors I never met just by communicating with them through the chart. I knew from the chart that when I needed a quick opinion from a cardiologist for pre-op clearance not to call the one who wrote five-page progress notes in multicolored ink. I learned who could cut to the chase, who embellished and who said and knew nothing. It amazed me that the cardiac surgeon who wrote notes that looked like he was on a New York subway could sew coronaries with 7-0. I wondered how the dyslexic neurosurgeon avoided wrongside surgery. I tried to leave intimations of myself in my entries, hoping my work would be useful and appreciated. Now we’re all going to communicate in the same quack-quack click-click language of 0s and 1s. With all its mind-boggling capacity for choice, collation and storage, the EMR still has no frontal lobe, and save for our names, all distinctive traces of ourselves will be lost.

And isn’t that exactly the purpose of this enterprise? The final extinction of what health planners always believed to be the primary impediment to rational health care policy and implementation: you and me.

Those who have pushed for the EMR believe that humanity is code for error and risk and that individuality and creativity are the enemies of safety and cost containment. The EMR is intended to do what the government, insurers and hospital administrators have wanted to do for a long time now, but their heavy-handed methods have met resistance from physicians who had some leverage because they admitted patients. The doctors won’t fare as well negotiating their preferences with the machine as they did against hospital administrators who still needed to fill beds. The EMR is a sanitary way of cultural cleansing, replacing older physicians

Opinion who demanded a certain level of autonomy with hospitalists who, as employees, are more responsive to the administration’s wishes. Resistance will be minimal because the hospitalists are younger, sit at the keyboard all day and are far more facile with the EMR than older counterparts who will die off from EMR fatigue. The days of herding cats are over for hospital administrators. Want a cheaper antibiotic to replace a more expensive one? Done.

Want 100% compliance with a particular deep vein thrombosis prophylaxis regimen? Done. No committees. No whining from older doctors spoiled from years of

having their own way.

No one seems to be particularly concerned that the lack of humanity in the EMR will inevitably, but by necessity, spill over into how medicine is actually practiced. We’ve all seen the spectacle of residents and medical students walking in and out of a patient’s room without ever looking up from their PDAs. We’ve all seen rows of nurses at the computers entering data like office workers while poor Mrs. Oemelmahay exsanguinates in room 6122. We’ve all been miffed by the OR staff for being glued to their see HAL page 34

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Opinion HAL

continued from page 33 computers instead of paying attention to the operation.

Servicing the voracious requirements of the EMR is a full-time job and we’ve all been conscripted as data entry drones as a condition of our staff appointment. Of all the things I remember most from my surgical training, it was my professor telling me to always make human contact with a patient in some way every time I walked into a room. Sit on the bed, push the dinner tray a little closer or prop someone up in bed so they didn’t look and feel like a victim. To this day, I try to honor that teaching by physically touching a patient in some way, but all it gets me is a stern rebuke from the nurse epidemiologist and a citation for not washing my hands. I’d hate to see the agar plate from a computer keyboard swab, but it’s my hand and my patient’s hand that are considered dirty.

About 20 or 30 years ago, all the journals had article after article about humanizing medicine and training doctors to be more compassionate and less mechanical. Remember all the noise about how we’re people and not robots? Remember how they wanted us to read Shakespeare and not just the Physician’s Desk Reference so we would be more sensitive to the human condition? Remember when we were told that comfort was 90% of the cure?

Insincere lip service is all that talk turned out to be.

If it were genuine, computers would have been incorporated into humanistic care instead of becoming the agents of its destruction. It is no accident, however, that the computer is being allowed to define how we practice instead of enhancing it. Modern central planners see the human caregiver as a mistake-prone reservoir of pathogens that needs to be programmed to be safe, clean and effective. Dehumanization of medicine has actually become a goal, and EMR the perfect excuse to attain that goal. Of course, this will be denied up and down because even those pushing the EMR know how ugly a world it is they are creating, but are willing to pay the price because they’re counters, not doctors. Their mission is unmistakable: Control through central intelligent design and elimination of the quaint but archaic doctor– patient relationship.

Time will tell the consequences of removing the human element from the practice of medicine. I can only think of HAL, the soft-spoken but sinister onboard computer in Stanley Kubrick’s “2001: The Space Odyssey” that turned on the spaceship and its crew seeking new horizons for mankind. HAL mutinied. Instead of guiding mankind to new achievement, the anthropomorphic computer threw the crew and spaceship backward in time and space to the planet of the apes to start all over again from primitive beginnings. Mr. Kubrick’s cautionary tale should remind us all about the limits of technology and the willful abrogation of our unique human qualities to a machine that can think only in 0s and 1s.

The moral hazard of turning our backs on our human exceptionalism, flawed as it might be, is especially dangerous in the delivery of health care that should be grounded in compassion, trust, commitment and personal accountability. There aren’t enough gigabytes to make those.

Clearly, there are those who think we can get by without them, and unfortunately, they’re the ones in charge.

As currently designed, it is hard to identify a single need of a patient or a doctor that the EMR addresses.

For those forced to use it, it is a time-consuming distraction that eats into the art of practicing medicine and takes us away from our patients. The commercial designers of these systems were clearly given priorities for use by their potential customers that service their needs and not those of doctors and patients.

A test drive of any of the new EMR software packages makes it obvious that those priorities are regulatory compliance, coding, risk management and boxing physicians into carefully circumscribed practice patterns. We have no choice but to comply, but we need to be aware that there is more at stake than just our time and equanimity. Our integrity is on the line. The “smart phrases” that allow us to populate screens with data with a few clicks are really sanitized prepackaged lies the machine makes on our behalf to satisfy payers and regulators. I used to get a pang of guilt when I wrote in my own hand to get that a patient’s chest was clear to percussion and auscultation when my stethoscope was collecting dust in the trunk of my car.

The hook, or “sell,” of the new system is untold efficiency like doing an entire imaginary history and physical examination with just a click or two. Over time, canned goods will separate us from the authenticity of our work. Everything we do will get authenticated ad nauseam, but our work product will lack freshness and personality, and the vitality of the practice of medicine will wither. “Hard stops” will force us to make choices we never intended just to move on and get our work done. Resistance to default choices will wane because it isn’t easy to impose one’s will when other choices have been preselected as preferable. Ordering gastrointestinal and deep venous thrombosis prophylaxis will take one-twentieth the time as not ordering it. In time, all doctors will assume the clone-like fungibility that policymakers believe is central to controlling cost, limiting liability for hospitals and evaluating treatment protocols.

It is inevitable that within 10 years, the practice and culture of modern medicine and surgery that was formed in the image of the Oslers and Halsteds will be recast in the mechanistic image of the computer. What was our tool will become our master. For those of us who spent half our lives looking for x-rays in the file room and searching archives for old op reports, digitized storage and transmission of information is a miracle for which we give thanks every day. It has allowed us to take better care of our patients, and even spend more time with them. However, current EMRs threaten to remove the human imprimatur from medical care. That they eliminate the only rational, readable, coherent, contemporaneous and sometimes even delightful human narrative of what actually happened and replace it with indecipherable gobbledygook when clarity is required is only part of the problem. That they force us to compromise our integrity and attest to all kinds of things is only part of the problem. That they are expensive, time-consuming and a productivity drain of unimaginable proportion is only part of the problem.

The big problem is that HAL is once again stalking us with the sweet siren song of untold efficiencies, cost containment and protection from human fallibility if we only move over to the passenger seat and let it drive.

Don’t believe a word of it. Medicine cannot be practiced on autopilot. We will crash and burn without the human touch at the controls.

—Dr. Cossman is a vascular surgeon in Los Angeles.

GeneralSurgeryNews.com / General Surgery News / May 2012

U.S. Survey Shows Decline in Postsurgical Deaths B y V ictoria S tern The number of inpatient deaths within 30 days of surgery in the United States has declined by just over 15% between 1996 and 2006, according to a nationwide report published in Surgery (2012;151:171-182).

Before this analysis, national rates and patterns of death after surgery were unknown.

Investigators from the Harvard School of Public Health and the Center for Surgery and Public Health at Brigham and Women’s Hospital, in Boston, compared deaths that occurred within 30 days of admission for patients undergoing surgery in 1996 and 2006. Using the Nationwide Inpatient Sample, which covers approximately 20% of hospitals in the United States, the researchers examined the inpatient 30-day death rate for all surgical procedures, procedures with the most deaths, and high-risk cardiovascular and cancer procedures, and for patients who suffered a recorded complication.

The researchers found that hospital admissions with surgical procedures increased by 14.4% (from just over 12.5 million in 1996 to more than 14.3 million in 2006), while deaths within 30 days of admission dropped by 15.4% (from 224,111 in 1996 to 189,690 in 2006). The adjusted 30-day inpatient mortality rate decreased from 1.68% to 1.32% during that period (P<0.001).

“The decline in the number of deaths may have occurred through reduced mortality of individual procedures, reductions in the volume of high-risk procedures and the rescue of patients who had a complication,” the authors wrote.

The investigators identified 21 procedures associated with the most deaths in 1996 (accounting for 3,160,643 admissions and 101,146 deaths) and found that, in 2006, the same procedures accounted for 26.5% fewer deaths (3,339,722 admissions and 74,254 deaths). Additionally, the inpatient 30-day mortality rate for patients who had a complication decreased from 12.10% to 9.84% (P<0.001).

Mortality decreased for nine of 14 high-risk cardiovascular and cancer procedures. The incidence of sepsis and pneumonia increased from 1996 to 2006, but the failure-to-rescue rate declined during the study period for both groups (sepsis, from 18.69% to 14.03%; pneumonia, from 8.54% to 7.34%).

Overall, the investigators estimated that 51,000 fewer people died in 2006 than would have if the postsurgical mortality rate from 1996 had continued.

The authors noted that “additional research to determine the underlying causes for decreased mortality is warranted.”

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GeneralSurgeryNews.com / General Surgery News / May 2012

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In the News Chronic Pain App Continued from page 1

Heniford, MD, the senior researcher of the team that designed the app and chair of gastrointestinal and minimally invasive surgery at Carolinas Medical Center, in Charlotte, N.C. “This app opens up the discussion about the chance of chronic discomfort following inguinal hernia surgery and gives patients a very specific idea of risk,” said Dr. Heniford. “It’s a tool that sets the stage for what we should strive for with every operation: an objective plan to obtain personal quality-of-life outcomes for post-operation and therapy.”

Between 8% and 40% of patients who undergo inguinal hernia repair have chronic pain after surgery, according to previous studies. And that pain often triggers legal action against physicians and hospital systems. In the United Kingdom, chronic pain following hernia repair is the No. 1 cause of malpractice suits. In the United States, 35% of all malpractice case law that relates to hernia repair is related to chronic pain or discomfort.

Bruce Ramshaw, MD, a hernia surgeon and chief medical officer for the Transformative Care Institute, in Daytona Beach, Fla., said the app marks a change in the way outcomes after medical and surgical care are measured.

“This app is great because it’s focused

on patient quality of life and outcomes from the patient perspective. That’s the direction we are going as a hernia society.”

The app is based on an algorithm developed by Igor Belyansky, a fellow in laparoscopic surgery at Carolinas Medical Center. Dr. Belyansky and colleagues studied data collected between September 2007 and September 2011 by the International Hernia Mesh Registry, a prospectively collected multicenter database that includes data on patients from 30 sites in Canada, the United States, Europe and Australia.

Patients submit data to the registry, by mail or email, and answer questions regarding quality of life, Carolinas Comfort Scale scores and postoperative complications.

Researchers studied 2,146 inguinal hernia patients, after excluding cases where more than 10 tacks were used in the repair. [An earlier study, from the same group, showed that the use of more than 10 tacks increases long-term pain (Ann Surg 2011;254:709-714).]

The average age of the patients was 56.4±14.6 years; 94% were male and 38% underwent laparoscopic repair. Overall, 20% of patients had bilateral repair and 12% were treated for a recurrent hernia.

Almost 58% of patients reported preoperative pain.

Patients were queried at regular intervals for a year after their hernia repair (77.7% follow-up rate). One month after

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‘It’s a tool that sets the stage for what we should strive for with every operation: an objective plan to obtain personal quality-of-life outcomes for post-operation and therapy.’

—B. Todd Heniford, MD

surgery, just over one-fourth of patients (26.1%) reported postoperative pain. That figure dropped by more than half over the next year, with 12.5% reporting postoperative pain one year after surgery.

The investigators found that younger age, female gender, bilateral repair, recurrent inguinal hernia repair, preoperative pain, postoperative hematoma, postoperative recurrence and postoperative urinary tract problems all were predictive of chronic pain.

Based on these results, the researchers developed an algorithm to predict chronic pain. They used a random sample of 80% of patients in the database to develop the algorithm and confirmed the results in the remaining 20% of patients. A Harvard statistician independently tested the equation, and confirmed its sensitivity and specificity.

The app was developed to make the

algorithm more practical for use by physicians and patients. It is the first app for medical and surgical outcomes, said Dr. Heniford.

According to CeQOL, a young asymptomatic patient with no preoperative pain has about a 10% risk for discomfort one year after surgery. Patients with preoperative pain, bilateral inguinal hernias and recurrent hernias have an increased risk of developing chronic pain after surgery.

Interestingly, older patients are less likely tohave symptoms of chronic pain than younger patients.

Dr. Belyansky said the app will help identify high-risk individuals who may benefit from a multidisciplinary treatment approach. “Furthermore, in a preoperative or pretreatment setting, full disclosure of postoperative quality-of-life expectations should become a standard part of the counseling and consent process for surgery and major medical treatments,” he said.

Surgeons at Carolinas currently use the app for all inguinal hernia patients who come into the clinic. Surgeons fill in the app as they speak to patients, or patients do it themselves on an iPad. New products come into the hernia field at rapid speed but data on outcomes follow much more slowly, said Shirin Towfigh, MD, associate professor of surgery, Cedars-Sinai Medical Center, in Los Angeles, and assistant professor of surgery at the University of Southern California.

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The new app keeps the focus on patients, she said. “What this app helps quantify in very real terms, and for the first time ever, is how much chronic pain a typical patient may suffer based on simple preoperative symptoms,” said Dr. Towfigh. “Surgeons can help use this app to educate their patients about the risks and benefits of hernia repair.”

‘Pain complaints complaints after hernia surgery, in general, are very subjective, and often factor in many variables that are dependent on any given surgeon's technique....’

—Brian Jacob, MD

Dr. Heniford, who is the outgoing president of the American Hernia Society, encouraged surgeons and their patients to use the app. Currently, the app applies only to men, because of a shortage of outcomes data following hernia repair in women. He said CeQOL represents a paradigm shift in which the success of a procedure is judged not only by recurrence rates, which are quite low, but also by patients’ quality of life.

“The team should be congratulated for pioneering an app that bridges evolving technology and patient care outcomes. As CeQol gets used by multiple surgeons and patients, its validity and usefulness will be tested,” said Brian Jacob, MD, attending surgeon at Mount Sinai Medical Center, in New York City.

“Pain complaints after hernia surgery, in general, are very subjective, and often factor in many variables that are dependent on any given surgeon's technique, patient population and follow-up regimen,” he said. “Such variables make it tough for an app to reliably account for things like the type of hernia repair being performed, the surgeon's experience with the technique and the location or type of pain complaint being reported. Therefore, the risks that CeQol produces might have a chance to overestimate or generalize.”

Dr. Jacob said he does plan to use the app in his own practice and see “how reliable it is with my patients.”

The research team plans to recheck the algorithm and update it as needed as more information on quality of life is collected. Additionally, they are designing trials for patients with a high risk for chronic discomfort after inguinal hernia repair to perform patient-directed care instead of hernia-directed care.

Dr. Belyansky won the World Hernia Congress Resident/Fellow Research Award for 2012 for this project.

TYGACIL® (tigecycline) Brief Summary See package insert for full Prescribing Information. For further product information and current package insert, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556.

INDICATIONS AND USAGE TYGACIL is indicated for the treatment of adults with complicated skin and skin structure infections caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates), Staphylococcus aureus (methicillinsusceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, Enterobacter cloacae, Klebsiella pneumoniae, and Bacteroides fragilis.

TYGACIL is indicated for the treatment of adults with complicated intra-abdominal infections caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros.

TYGACIL is indicated for the treatment of adults with community-acquired pneumonia infections caused

by Streptococcus pneumoniae (penicillin-susceptible isolates), including cases with concurrent bacteremia, Haemophilus influenzae (beta-lactamase negative isolates), and Legionella pneumophila.

CONTRAINDICATIONS TYGACIL is contraindicated for use in patients who have known hypersensitivity to tigecycline.

WARNINGS AND PRECAUTIONS Anaphylaxis/Anaphylactoid Reactions Anaphylaxis/anaphylactoid reactions have been reported with nearly all antibacterial agents, including TYGACIL, and may be life-threatening. TYGACIL is structurally similar to tetracycline-class antibiotics and should be administered with caution in patients with known hypersensitivity to tetracycline-class antibiotics.

Hepatic Effects Increases in total bilirubin concentration, prothrombin time and transaminases have been seen in patients treated with tigecycline. Isolated cases of significant hepatic dysfunction and hepatic failure have been reported in patients being treated with tigecycline. Some of these patients were receiving multiple concomitant medications. Patients who develop abnormal liver function tests during tigecycline therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing tigecycline therapy. Adverse events may occur after the drug has been discontinued.

Mortality Imbalance and Lower Cure Rates in Ventilator-Associated Pneumonia A study of patients with hospital acquired pneumonia failed to demonstrate the efficacy of TYGACIL. In this study, patients were randomized to receive TYGACIL (100 mg initially, then 50 mg every 12 hours) or a comparator. In addition, patients were allowed to receive specified adjunctive therapies. The sub-group of patients with ventilator-associated pneumonia who received TYGACIL had lower cure rates (47.9% versus 70.1% for the clinically evaluable population) and greater mortality (25/131 [19.1%] versus 14/122 [11.5%]) than the comparator.

Use During Pregnancy TYGACIL may cause fetal harm when administered to a pregnant woman. If the patient becomes pregnant while taking tigecycline, the patient should be apprised of the potential hazard to the fetus. Results of animal studies indicate that tigecycline crosses the placenta and is found in fetal tissues. Decreased fetal weights in rats and rabbits (with associated delays in ossification) and fetal loss in rabbits have been observed with tigecycline [see USE IN SPECIFIC POPULATIONS].

Tooth Development The use of TYGACIL during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). Results of studies in rats with TYGACIL have shown bone discoloration. TYGACIL should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated.

Clostridium difficile-Associated Diarrhea Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including TYGACIL, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Patients With Intestinal Perforation Caution should be exercised when considering TYGACIL monotherapy in patients with complicated intra-abdominal infections (cIAI) secondary to clinically apparent intestinal perforation. In cIAI studies (n=1642), 6 patients treated with TYGACIL and 2 patients treated with imipenem/cilastatin presented with intestinal perforations and developed sepsis/ septic shock. The 6 patients treated with TYGACIL had higher APACHE II scores (median = 13) versus the 2 patients treated with imipenem/cilastatin (APACHE II scores = 4 and 6). Due to differences in baseline APACHE II scores between treatment groups and small overall numbers, the relationship of this outcome to treatment cannot be established.

Tetracycline-Class Effects TYGACIL is structurally similar to tetracycline-class antibiotics and may have similar adverse effects. Such effects may include: photosensitivity, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, and hyperphosphatemia). As with tetracyclines, pancreatitis has been reported with the use of TYGACIL. Superinfection As with other antibacterial drugs, use of TYGACIL may result in overgrowth of non-susceptible organisms, including fungi.

Patients should be carefully monitored during therapy. If superinfection occurs, appropriate measures should be taken.

Development of Drug-Resistant Bacteria Prescribing TYGACIL in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

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

In clinical trials, 2514 patients were treated with TYGACIL. TYGACIL was discontinued due to adverse reactions in 7% of patients compared to 6% for all comparators. Table 1 shows the incidence of treatment-emergent adverse reactions through test of cure reported in 2% of patients in these trials.

Table 1. Incidence (%) of Adverse Reactions Through Test of Cure Reported in 2% of Patients Treated in Clinical Studies Body System TYGACIL Comparatorsa Adverse Reactions (N=2514) (N=2307) Body as a Whole Abdominal pain 6 4 Abscess 2 2 Asthenia 3 2 Headache 6 7 Infection 7 5 Cardiovascular System Phlebitis 3 4 Digestive System Diarrhea 12 11 Dyspepsia 2 2 Nausea 26 13 Vomiting 18 9 Hemic and Lymphatic System Anemia 5 6 Metabolic and Nutritional Alkaline Phosphatase Increased 3 3 Amylase Increased 3 2 Bilirubinemia 2 1 BUN Increased 3 1 Healing Abnormal 3 2 Hyponatremia 2 1 Hypoproteinemia 5 3 4 5 SGOT Increasedb b SGPT Increased 5 5 Respiratory System Pneumonia 2 2 Nervous System Dizziness 3 3 Skin and Appendages Rash 3 4

Vancomycin/Aztreonam, Imipenem/Cilastatin, Levofloxacin, Linezolid.

LFT abnormalities in TYGACIL-treated patients were reported more frequently in the post therapy period than those in comparator-treated patients, which occurred more often on therapy.

In all Phase 3 and 4 studies that included a comparator, death occurred in 4.0% (150/3788) of patients receiving TYGACIL and 3.0% (110/3646) of patients receiving comparator drugs. An increase in all-cause mortality has been observed across phase 3 and 4 clinical studies in TYGACIL treated patients versus comparator. The cause of this increase has not been established. This increase should be considered when selecting among treatment options. (See Table 2.)

Table 2. Patients with Outcome of Death by Infection Type a

b

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

n/N

TYGACIL

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

Comparator

%

n/N

1.4 3.0 2.8 14.1 12.2 19.1 8.6 1.3 4.0

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

%

Risk Difference* % (95% CI)

0.7 2.2 2.6 12.2 12.2 12.3 4.7 0.6 3.0

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

CAP = Community-acquired pneumonia; cIAI = Complicated intra-abdominal infections; cSSSI = Complicated skin and skin structure infections; HAP = Hospital-acquired pneumonia; VAP = Ventilator-associated pneumonia; RP = Resistant pathogens; DFI = Diabetic foot infections. * The difference between the percentage of patients who died in TYGACIL and comparator treatment groups. The 95% CI for each infection type was calculated using the normal approximation method without continuity correction. ** Overall adjusted (random effects model by trial weight) risk difference estimate and 95% CI. a These are subgroups of the HAP population.

Note: The studies include 300, 305, 900 (cSSSI), 301, 306, 315, 316, 400 (cIAI), 308 and 313 (CAP), 311 (HAP), 307 [Resistant gram-positive pathogen study in patients with MRSA or Vancomycin-Resistant Enterococcus (VRE)], and 319 (DFI with and without osteomyelitis).

In comparative clinical studies, infection-related serious adverse events were more frequently reported for subjects treated with TYGACIL (7%) versus comparators (6%). Serious adverse events of sepsis/septic shock were more frequently reported for subjects treated with TYGACIL (2%) versus comparators (1%). Due to baseline differences between treatment groups in this subset of patients, the relationship of this outcome to treatment cannot be established [see WARNINGS AND PRECAUTIONS].

The most common treatment-emergent adverse reactions were nausea and vomiting which generally occurred during the first 1 – 2 days of therapy. The majority of cases of nausea and vomiting associated with TYGACIL and comparators were either mild or moderate in severity. In patients treated with TYGACIL, nausea incidence was 26% (17% mild, 8% moderate, 1% severe) and vomiting incidence was 18% (11% mild, 6% moderate, 1% severe).

In patients treated for complicated skin and skin structure infections (cSSSI), nausea incidence was 35% for TYGACIL and 9% for vancomycin/aztreonam; vomiting incidence was 20% for TYGACIL and 4% for vancomycin/aztreonam. In patients treated for complicated intra-abdominal infections (cIAI), nausea incidence was 25% for TYGACIL and 21% for imipenem/cilastatin; vomiting incidence was 20% for TYGACIL and 15% for imipenem/cilastatin. In patients treated for community-acquired bacterial pneumonia (CABP), nausea incidence was 24% for TYGACIL and 8% for levofloxacin; vomiting incidence was 16% for TYGACIL and 6% for levofloxacin.

Discontinuation from tigecycline was most frequently associated with nausea (1%) and vomiting (1%).

For comparators, discontinuation was most frequently associated with nausea (<1%).

The following adverse reactions were reported infrequently (<2%) in patients receiving TYGACIL in clinical studies: Body as a Whole: injection site inflammation, injection site pain, injection site reaction, septic shock, allergic reaction, chills, injection site edema, injection site phlebitis Cardiovascular System: thrombophlebitis Digestive System: anorexia, jaundice, abnormal stools Metabolic/Nutritional System: increased creatinine, hypocalcemia, hypoglycemia Special Senses: taste perversion Hemic and Lymphatic System: partial thromboplastin time (aPTT), prolonged prothrombin time (PT), eosinophilia, increased international normalized ratio (INR), thrombocytopenia Skin and Appendages: pruritus Urogenital System: vaginal moniliasis, vaginitis, leukorrhea Post-Marketing Experience The following adverse reactions have been identified during postapproval use of TYGACIL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure. Anaphylaxis/anaphylactoid reactions, acute pancreatitis, hepatic cholestasis, jaundice, and severe skin reactions, including Stevens-Johnson Syndrome.

DRUG INTERACTIONS Warfarin Prothrombin time or other suitable anticoagulation test should be monitored if tigecycline is administered with warfarin [see CLINICAL PHARMACOLOGY (12.3) in full Prescribing Information].

Oral Contraceptives Concurrent use of antibacterial drugs with oral contraceptives may render oral contraceptives less effective.

USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects—Pregnancy Category D [see WARNINGS AND PRECAUTIONS] Tigecycline was not teratogenic in the rat or rabbit. In preclinical safety studies, 14C-labeled tigecycline crossed the placenta and was found in fetal tissues, including fetal bony structures. The administration of tigecycline was associated with slight reductions in fetal weights and an increased incidence of minor skeletal anomalies (delays in bone ossification) at exposures of 5 times and 1 times the human daily dose based on AUC in rats and rabbits, respectively (28 mcg·hr/mL and 6 mcg·hr/mL at 12 and 4 mg/kg/day). An increased incidence of fetal loss was observed at maternotoxic doses in the rabbits with exposure equivalent to human dose.

There are no adequate and well-controlled studies of tigecycline in pregnant women. TYGACIL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers Results from animal studies using 14C-labeled tigecycline indicate that tigecycline is excreted readily via the milk of lactating rats. Consistent with the limited oral bioavailability of tigecycline, there is little or no systemic exposure to tigecycline in nursing pups as a result of exposure via maternal milk.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TYGACIL is administered to a nursing woman [see WARNINGS AND PRECAUTIONS].

Pediatric Use Safety and effectiveness in pediatric patients below the age of 18 years have not been established. Because of effects on tooth development, use in patients under 8 years of age is not recommended [see WARNINGS AND PRECAUTIONS].

Geriatric Use Of the total number of subjects who received TYGACIL in Phase 3 clinical studies (n=2514), 664 were 65 and over, while 288 were 75 and over. No unexpected overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity to adverse events of some older individuals cannot be ruled out.

No significant difference in tigecycline exposure was observed between healthy elderly subjects and younger subjects following a single 100 mg dose of tigecycline [see CLINICAL PHARMACOLOGY (12.3) in full Prescribing Information].

Hepatic Impairment No dosage adjustment is warranted in patients with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B). In patients with severe hepatic impairment (Child Pugh C), the initial dose of tigecycline should be 100 mg followed by a reduced maintenance dose of 25 mg every 12 hours. Patients with severe hepatic impairment (Child Pugh C) should be treated with caution and monitored for treatment response [see CLINICAL PHARMACOLOGY (12.3) and DOSAGE AND ADMINISTRATION (2.2) in full Prescribing Information].

OVERDOSAGE No specific information is available on the treatment of overdosage with tigecycline. Intravenous administration of TYGACIL at a single dose of 300 mg over 60 minutes in healthy volunteers resulted in an increased incidence of nausea and vomiting. In single-dose intravenous toxicity studies conducted with tigecycline in mice, the estimated median lethal dose (LD50) was 124 mg/kg in males and 98 mg/kg in females. In rats, the estimated LD50 was 106 mg/kg for both sexes. Tigecycline is not removed in significant quantities by hemodialysis.

This Brief Summary is based on TYGACIL direction circular LAB-0458-2.0, revised 01/11.

TYG279434 © 2011 Pfizer Inc. All rights reserved. Printed in USA/February 2011

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

Expanded broad-spectrum coverage * is on your side

*TYGACIL does not cover Pseudomonas aeruginosa.

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

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

References: 1. 3OLOMKIN *3 -AZUSKI *% "RADLEY *3 ET AL $IAGNOSIS AND MANAGEMENT OF COMPLICATED INTRA ABDOMINAL INFECTION IN ADULTS AND CHILDREN GUIDELINES BY THE 3URGICAL )NFECTION 3OCIETY AND THE )NFECTIOUS $ISEASES 3OCIETY OF !MERICA Clin Infect Dis 2. -AY !+ 3TAFFORD 2% "ULGER %- ET AL 3URGICAL )NFECTION 3OCIETY 'UIDELINES 4REATMENT OF COMPLICATED SKIN AND SOFT TISSUE INFECTIONS Surg Infect 3. 49'!#),┬о TIGECYCLINE 0RESCRIBING )NFORMATION

Wyeth Pharmaceuticals Inc. TYG281206-01 ┬й 2011 PямБzer Inc. All rights reserved. Printed in USA/April 2011