October 2013

CONVENTION ISSUE:

American College of Surgeons Clinical Congress

GENERALSURGERYNEWS.COM

October 2013 • Volume 40 • Number 10

The Independent Monthly Newspaper for the General Surgeon

®

Opinion

Surfing the Bore Tide

Better Patient Care Requires a New Way of Thinking

B Y L AUREN K OSINSKI , MD

How ‘Complexity Science’ Can Be Used To Improve Health Care And Provide Better Value to Our Patients

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hen I lived in Alaska, everyone knew someone who had died, whether seasoned outdoorsman or novice. Extreme weather, solitude and the wilderness are part of the allure of Alaska, but even small mistakes can have big consequences there. Exposure. Capsized boats. Floatplane crashes. Lost footing on a trail. Animal encounters.

Even bad divorces.

But some stories grip the imagination and are told over and over again. One such apocryphal tale is of an obese woman fishing alone in her boat who cast anchor before turning in for the night but misgauged the bay’s depth and the speed of the incoming tide. As the tide rushed in, the anchored end of the boat tilted, icecold sea water rushed over the deck and the cabin door at the aft end submerged before she awakened to discover the crisis. By then, the cabin door could not be opened, and she was too large to escape through a cabin window. Her plight is haunting: trapped not just in her boat but in her body, waiting to die as minutes filled hours, hoping for hypothermia see BORE TIDE page 35

B Y B RUCE R AMSHAW , MD feew months ago, I was in Gdansk, Poland, foor the annual meeting of the European H Hernia Society. In a session on guidelines, Dr. JJaap Bonjer presented a paper that looked at exxpert consensus regarding guidelines published by the International Endo Hernia Soociety. Guidelines were presented based on levels of evidence, with Level 1 evidence being the highest quality and Level 5 being the lowest. Interestingly in this revview, Level 5 guidelines were evaluated as appropriate by experts about 85% of the tim me (a solid B grade), but amazingly, Level 1 gguidelines were judged as appropriate only aboout 60% of the time, a near-failing grade. see COMPLEXITY SCIENCE page 38

Surgical Entrepreneurism An Interview With the Inventor of the Bookwalter Retractor

BY PETER KIM, MD

No act of kindness, however small, is wasted.

—Aesop, 600 BC

PROCEDURAL BREAKTHROUGH ®

Case-Based Report on XCM BIOLOGIC Tissue Matrix for Ventral Hernia Repair

see page 12

W

hen surgeons need to convert from a laparoscopic case to open abdominal surgery, they often shout, “Get the Bookwalter!” The

INSIDE In the News

Surgeons’ Lounge

Stitches

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22

Expert Pro/Con Debate on the Treatment of Colorectal Liver Metastases: Yes or No on Chemotherapy?

A Patient With a Grade IV Splenic Laceration

Landmark Strides in Laparoscopic Technologies

Bookwalter retractor is the most popular retractor system for holding open abdominal incisions. The man who invented and promotes the retractor system is John Bookwalter, MD, and I had the good fortune to sit next to him by chance at a dinner meeting of the New York see BOOKWALTER page 32

Protocol Promises Better Surgical Recovery B Y M ICHAEL V LESSIDES SAN DIEGO—Programs that promote enhanced recovery after surgery are beneficial for both patients and institutions, according to a recent study that supports the use of the increasingly common treatment plans.

Popularized in Europe, so-called ERAS programs are becoming more widespread in the United States, although the data for their overall efficacy here are still lacking. The latest study should help. North Carolina researchers found that surgical patients undergoing the novel program had significantly reduced lengths of stay and 30-day readmission rates, as well as potentially lower hospital costs, than those who received conventional care.

“Enhanced recovery after surgery is a concept that integrates a number of evidence-based practices into protocolized care, in this case into colorectal surgery patients,” said Tong Joo (T.J.) Gan, MD, vice chair of anesthesiology at Duke University, in Durham, N.C., who led the work.

Dr. Gan and his colleagues studied 236 see ERAS page 42

REPORT Ventral Hernia Repair: State of the Art, Current Challenges, and Future Directions See insert at page 22

GSN Editorial

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2013

Surgical History—Lest We Forget Frederick L. Greene, MD, FACS Clinical Professor of Surgery UNC School of Medicine Chapel Hill, North Carolina

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n this issue, reporter Victoria Stern captures the history of the past several decades and highlights the individuals and advances that helped shape the era known as the “laparoscopic revolution.” This is a valuable opportunity to note recent surgical milestones and to appreciate the surgical leaders and the thought processes that were used to reach our goals.

For many of us, recounting surgical history was a daily exercise. Our mentors expected us to have at least some basic knowledge of our surgical forefathers and the contributions that created our culture. As with many other things, this fascination with surgical history has waned somewhat, but I am hopeful there will be a resurgence in the interest and that recent surgical trainees will once again embrace the rich tradition that has spawned so many of the important contributions that we appreciate in today’s surgical practice.

It is difficult to say why we have lost some of the excitement for our surgical

heritage. Perhaps it is because we are so immersed with the daily pressures of modern practice that past achievements take a backseat. This month’s opinion article, “Surfing the Bore Tide” by Lauren Kosinski, MD, spells out these additional daily pressures. I would like to think that given the opportunity, and despite the real-world issues that abound, many of us would continue to have a strong interest in past surgical contributions that affect our patients and us so greatly today.

Since this edition of GSN N is published in concert with the Clinical Congress of the American College of Surgeons (ACS), I am pleased to note that surgeons will convene at the 2013 meeting for the purpose of establishing a group devoted to American surgical history. Given the rich archives housed at the ACS, one can only assume that this will be a fruitful experience. Like most discussions of history, I am sure those of us who have been out of training for several decades, but who understand the importance of surgical lore will populate this initial gathering. We will relish exploring the pursuits of Sims, Cushing, Halsted and many lesser-known innovators who predated the modern days of minimal access surgery,

interventional endoscopy and robotics.

The interview process was the approach that Victoria Stern took in this edition of GSN N as she was able to speak with many of the leaders who played major roles leading up to the 1980s and 1990s when laparoscopic surgery exploded onto the surgical scene. One of the concepts that we must support and promulgate is to capture surgical history while it is current. We have a unique opportunity to use modern audio and video digital techniques to immortalize the words, thoughts and images of those surgeons who are currently leaders in their respective surgical fields. It is one thing to read about the exploits of surgeons who have come before us, but the opportunity to hear and see the images of surgical leaders is imminently more powerful and should be captured.

During the past few years, I have had the opportunity to lecture on the history of surgery as part of the Medical Humanities series at Davidson College. Although not all of the students are heading into medicine, it is interesting that these young people have a strong interest in the traditions of surgeons and can relate these concepts to many of their modern nonmedical pursuits. Many of us have tried to

include surgical historical facts in M&M conferences, preoperative conferences and CME events. Only when we use these opportunities to light a flame of interest will students and surgical trainees carry this forward and sustain a desire to learn more about their surgical heritage.

There seems to be a great need for us to think about the past and how it provides guidance for the future. This should not be a generational curiosity, but should be pervasive for all those who have an interest in what has gone on before, no matter their profession. I think the key is to make history a living part of what we do on a daily basis and to incorporate at least something relating to an historical surgical perspective in each of our presentations, conferences or symposia.

I salute the ACS for highlighting the history of American surgery at this year’s Clinical Congress. Certainly many of the past and present invited lectures at the Congress have used historical frameworks to make cogent points about the modern care of the surgical patient, and this obviously should continue. Each of our surgical organizations should use this paradigm to assure that we keep the contributions of our surgical ancestors alive and relevant.

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2013

Debating Treatment of Colorectal Liver Metastases: Yes or No on Chemo?

B Y K ATE O’R OURKE

S

hould adjuvant chemotherapy be given to all patients undergoing hepatic resection for colorectal liver metastases? At the recent annual meeting of the Society of Surgical Oncology, a spirited pro–con debate was devoted to this topic. (The debaters, it should be noted, were assigned their positions.)

Surgery Alone Is Best “Surgery alone for colorectal hepatic metastases is enough,” said Nicholas Petrelli, MD, medical director of the Helen F. Graham Cancer Center, Newark, Del. “We do not need chemotherapy.

Hepatic resection is the only potentially curable treatment for colorectal liver metastases.” He argued that overall survival (OS) is “the end point that matters,” and because available drugs don’t improve OS in this patient population, individuals should not be exposed to the agents’ toxicities.

Chemotherapeutics and biologics can cause side effects from skin rash to myocardial infarction, neurotoxicity, steatohepatitis, cerebral hemorrhage, tracheal stenosis and bowel perforation, all of which negatively affect quality of life.

For example, irinotecan causes steatohepatitis; 5-fluorouracil (5-FU) and irinotecan cause steatosis; oxaliplatin causes sinusoidal dilatation; and bevacizumab (Avastin, Genentech) is associated with liver degeneration and hemorrhage.

“These side effects can [cause] surgical mortality, especially with prolonged chemotherapy, in general six cycles or more,” said Dr. Petrelli, pointing to a study in Annals of Surgeryy (2006;243:1-7). A study in the Journal of Clinical Oncology also concluded that chemotherapy had a detrimental effect on 90-day mortality (2006;24:2065-2071).

Three prospective randomized trials demonstrate that chemotherapy doesn’t improve OS, said Dr. Petrelli. In a pooled analysis of two randomized trials evaluating complete resection of colorectal liver metastases, investigators did not identify any statistically significant difference in OS or progression-free survival (PFS) in patients who received adjuvant 5-FUleucovorin chemotherapy postsurgery and those who received surgery alone ((J Clin Oncoll 2008;26:4906-4911).

In the EORTC (European Organisation for Research and Treatment of Cancer) 40983 trial, 364 patients with colorectal cancer and one to four resectable hepatic metastases were randomized to surgery alone or six cycles of FOLFOX4 (oxaliplatin, 5-FU and leucovorin) followed by surgery and six cycles

of postoperative FOLFOX4 (Lancet 2008;371:1007-1016). At three years, patients who received chemotherapy had higher PFS rates (42.4% vs. 33.2%), but this did not translate into improved OS at 8.5 years, according to a study presented at the 2012 American Society of Clinical Oncology annual meeting (abstract 3503). Furthermore, said Dr. Petrelli, patients in the chemotherapy arm had higher rates of postoperative complications, including biliary fistula (8% vs. 4%), hepatic failure (7% vs. 5%), intraabdominal infection (7% vs.

2%) and the need for reoperation (3% vs.

2%) (P=0.04).

P “How good are the agents that we use today? They are not good at all,” said Dr. Petrelli.

Even when patients receiving chemotherapy for colorectal liver metastases have a complete response on computed tomography (CT), this does not mean they are cured. In a recent study, 66 lesions disappeared on CT, but macroscopic cancer was seen in 20 of these patients at surgery ((J Clin Oncol 2006;24:3939-3945). Sites of 15 initial liver metastases invisible at surgery were resected and 12 had viable tumors. The sites of 31 other initial liver metastases, invisible at surgery, were left in place during surgery, and at one year of followup, 23 of the 31 liver metastases considered in complete response had recurred in situ.

The last nail in the coffin, said Dr. Petrelli, is a study evaluating the effect of bevacizumab on future liver remnant hypertrophy after portal vein occlusion before major hepatectomy for colorectal liver metastases ((Ann Surg Oncol 2008;16:1553-1559). Patients with a portal vein occlusion had a smaller increase in volume hypertrophy if they received bevacizumab (15% vs. 40%; P<0.05).

With no improvement in OS, said Dr. Petrelli, these agents are hard to justify, especially when you consider the cost.

Eight-week courses of FOLFOX (oxaliplatin plus 5-FU; $11,889), FOLFOX plus bevacizumab ($21,033), and FOLFIRI (irinotecan, 5-FU and leucovorin) plus cetuximab ($30,790) are pricey (N Engl J Medd 2004;351:317-319).

“Value is cost and quality of care.

‘Value is cost and quality of care. Chemotherapy increases patient cost and health care costs. … There is no improvement in overall survival, leading to no value.’ —Nicholas Petrelli, MD Chemotherapy increases patient cost and health care costs. It increases hepatic toxicity, systemic toxicity and poor quality of life, said Dr. Petrelli. “There is no improvement in overall survival, leading to no value.”

Chemotherapy Improves Outcomes Mitchell Posner, MD, Thomas D. Jones Professor and chief of general surgery and surgical oncology, University of Chicago, argued the pro-chemotherapy position. With a five-year survival of 38% after resection of hepatic metastases (Clin Epidemioll 2012;4:283-301), patients with colorectal cancer have a substantial risk for recurrence, and chemotherapy can improve outcomes.

“When you take patients who are initially unresectable (R1), treat them with chemotherapy and then resect them, you see the [survival] curve closely approaches those patients who are initially resectable (R0),” said Dr. Posner, pointing to a study in Annals of Surgery (2008;248:626-637). This, he said, demonstrates the efficacy of chemotherapy in stage IV disease.

He then pointed out that in the previously mentioned pooled analysis of randomized trials of adjuvant chemotherapy after hepatic resection, a multivariate analysis revealed a statistically significant improvement in PFS (hazard ratio [HR], 1.39; P P=0.026) and OS (HR, 1.39; P P=0.046) with chemotherapy.

Additionally, overall, there was a trend for improved median PFS (27.9 vs. 18.8 months; P P=0.058) and median OS (62.2 vs. 47.3 months; P=0.095).

P OS is not the only end point that should matter, argued Dr. Posner.

Patients who received chemotherapy in the EORTC 40983 trial had improved PFS (HR, 0.73; P=0.025), an end point that many clinicians value. A clinical trial of 173 patients in France showed that adding chemotherapy after hepatic resection resulted in improved

‘When you take patients who are initially unresectable (R1), treat them with chemotherapy and then resect them, you see the [survival] curve closely approaches those patients who are initially resectable (R0).’

—Mitchell Posner, MD

disease-free survival (DFS) rates (33.5% vs. 26.7%; P=0.028) and a trend for improved OS (51.1% vs. 41.9%; P=0.13) ((J Clin Oncol 2006;24:4976-4982). In a French study of 1,471 patients with solitary, metachronous colorectal liver metastases, postoperative chemotherapy improved DFS and OS at five years (65% vs. 55%; P<0.01) (Ann ( Surg 2010;252:774-787).

According to Dr. Posner, clinicians are capable of managing treatment toxicities, and these do not increase mortality and cause only mild morbidity when chemotherapy is limited to a reasonable number of cycles. In patients with colorectal liver metastases who received preoperative chemotherapy before major hepatectomy, morbidity was roughly 10% in patients who received no chemotherapy, 20% in patients who received five cycles of chemotherapy or less, 50% in patients who received six to nine cycles, and more than 60% in those who received 10 cycles or more ((Ann Surgg 2006;244:897-907; Ann Surg 2008;247:118-124).

Rebuttals In rebuttal remarks, Dr. Petrelli said he completely agreed that using chemotherapy to make unresectable patients resectable was a good idea, but this was not the group of patients they were debating.

“We are talking about patients who present initially with resectable disease, and in those patients, the toxicity is sky high and there really is no benefit in terms of overall survival,” he said.

Dr. Posner, in his rebuttal, called Dr. Petrelli a “flip-flopper.” If OS is actually the only important end point, Dr. Posner wondered, then why is Dr. Petrelli, currently chair of the NSABP Gastrointestinal committee, involved in designing trials with primary end points other than OS? The NSABP C09 trial tested the addition of chemotherapy for hepatic resection using a PFS end point and the NSABP C11 trial, which examined perioperative versus postoperative chemotherapy for resectable hepatic metastases, also used recurrence-free survival as the primary end point, said Dr. Posner.

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Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2013

Bariatric Procedures Decline Despite Rise in Obesity and Diabetes Why This Is, and What We Should Do About It B Y M ITCHELL S. R OSLIN , MD, FACS

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magine there is an investment opportunity for a product in the medical space that treats a condition that is growing in prevalence, is increasingly associated with

Part 1 of 2

premature morbidity and mortality, has little competition, and has years of data documenting safety and efficacy. Sounds like a great investment and the chance to invest in the next Intuitive Surgical. Intuitive Surgical is the darling of Wall Street. Its share price has increased 400% in the past five years.1 This growth has been achieved despite the fact that the daVinci system has never shown better outcomes in any area over standard laparoscopy,

while being a good deal more expensive.2 That is why the story of bariatric surgery is so confounding. Despite data that have shown remission of diabetes, cardiac risk reduction, improved quality of life and weight loss results that cannot be challenged by any other treatment for obesity, the amount of procedures performed in the United States has, at best, remained stable since 2010.3 In all probability, the total number of cases

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The new Minilaparoscopic Instruments from om KARL STORZ

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performed has declined by approximately 10%. If revisions are subtracted, the number of people having bariatric surgery has declined even further.

These statistics are even harder to understand when you add the documented safety improvements that have reduced mortality from 0.5% to less than 0.1%.4 Furthermore, each year numerous fellows complete outstanding minimally invasive training programs that emphasize bariatric surgery. As a relatively young field, the number of people entering bariatric surgery practice far exceeds the number of surgeons with large bariatric practices who are retiring. The purpose of this article is to examine the factors and propose potential solutions for this issue.

Some may believe this is inconsequential. Some may think, “My practice is fine, so why be concerned?” To the contrary, I believe that this is the most sentinel issue facing our field. Absence of growth and penetration of an exceedingly low percentage of the potential population that could benefit from bariatric surgery is a strong indicator that our message is still not being heard, and as health care reform moves forward, bariatric surgery will be a low priority. With increasing economic pressure, further decline is inevitable.

Returning to my corporate analogy, if bariatric surgery was a company, shareholders would be questioning current executives and the board of trustees. As surgeons, we are not a company or corporation, but it is imperative that part of the mission of our national specialty society, journals and publications be to disseminate the outstanding data accumulated and to improve access for these lifesaving procedures. As our data have improved, we need to begin the difficult task of questioning our strategy and see how, collectively, our field can succeed, even in the current economic decline.

Penetration and the Numbers

KARL STORZ Endoscopy-America, Inc., 2151 E. Grand Ave, El Segundo, CA 90245, USA, Phone: (424) 218-8100, Fax: (800) 321-1304, E-Mail: info@ksea.com KARL STORZ GmbH & Co. KG, Mittelstraße 8, D-78532 Tuttlingen/Germany, Phone: + 49 7461 / 70 80, Fax: 07461 / 70 81 05, E-Mail: karlstorz-marketing@karlstorz.de KARL STORZ Endoscopy Canada, Ltd., 2345 Argentia Road, Suite 100, Mississauga, Ontario, Canada L5N 8K4, Phone: (800) 268-4880, Fax: (905) 858-0933 KARL STORZ Endoscopia, Latino-America, 815 NW 57 Ave, Suite #480, Miami, Florida 33126-2042, USA, Telefono: (305) 262-8980, Telefax: (305) 262-8986 A-609042

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The exact number of bariatric procedures performed in the United States has been estimated to be as high as 250,000.

Although all agree that the number has stabilized or plateaued after rapid growth from 2000 to 2008, the actual number is one of debate, and, by my calculation, frequently overestimated.5 I believe that the most accurate way to determine the number of bariatric procedures is to use the revenue reported by Allergan for its obesity unit. As a publicly traded company, it is easy to determine the maximum amount of gastric bands that Allergan has sold. From these data, we can estimate the percentage of bands representative of the total market, as well as the percentage of total bands that the Lap-Band comprises.

For the past year, Allergan’s total

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2013

Despite widespread media attention that has highlighted strong advantages for surgical therapy for obese individuals with diabetes, we treat less than 1% of afflicted individuals. I know of no other area in medicine where the data and the penetration are this discordant. revenue for its bariatric unit was $160 million. This is down from $269 million the year before.6 For simplicity, assume that the revenue per band-patient is $3,000. This would include cost of needles, accessory ports and so on. The amount of cases done with their system was around 53,000 in 2011. At maximum, it was approximately 85,000. Several years ago it was estimated that bands replaced, or nearly equaled gastric bypass as the most prevalent procedure. Add at most 10% market share for the Realize band, and the maximum number of cases performed was 200,000. Lap-Band revenue has declined more than 30% in the past two years. Some have argued that stapling procedures have stayed the same and the number of band procedures has declined.

If that is true, then the total number of cases performed in the United States is approximately 170,000, which I believe is reasonably accurate. It is not likely that all the patients who would have had bands have had a sleeve gastrectomy or gastric bypass instead. What is far more likely is a significant decline for the total market.

This has occurred as the prevalence of obesity and diabetes has continued to increase. It is now estimated that 6.6% of the U.S. population has a body mass index (BMI) greater than 40 kg/m2. This percentage more than doubles if one includes individuals with severe obesity, or BMI greater than 35 kg/m2. Furthermore, the American Diabetes Association estimates that there are 25 million individuals with diabetes in the United States and another 79 million with prediabetes. The most recent estimate of the U.S. population is 311 million. So, there are at least 20 million individuals with a BMI greater than 40 kg/m2. If we conservatively estimate the potential target market for bariatric surgery as 30 million people, we have a penetration of only 0.5%. Thus, despite widespread media attention that has highlighted strong advantages for surgical therapy for obese individuals with diabetes, we treat less than 1% of those individuals. I know of no other area in medicine where the data and the penetration are this discordant.

Our challenge is to be critical and determine how we can better present our message. We need to determine what data are most critical to assemble, and how we can accumulate them in a cost-effective manner. Finally, we have to realize the relevance of these facts. For medical device manufacturers, bariatric and

metabolic surgery represented growth.

As a result, they became our partners battling for insurance approval for novel procedures such as sleeve gastrectomy. They provided financial support for our educational meetings, research

grants and fellowship programs. It was a win–win situation. We were treating an undertreated deadly condition using equipment they manufactured, such as staplers and bands. Growth was expected to continue, and more than justify their investment in our field. The numbers are vastly different today. The anticipated market potential for obesity and diabetes has not approached even conservative estimates. As a result, we can expect a reduction in their support and investment. Recently, Johnson & Johnson eliminated its bariatric specialty sales unit. Instead, it has combined

with hernia and thoracic surgery. In my opinion, this is not a trivial change.

We all know that the better financed lobbies and fields are going to fare best with health care reform. Although the Obesity Action Coalition has done a great job, its task is complicated by the present diversity of opinion regarding obesity. As opposed to the National Multiple Sclerosis Society, the Arthritis Foundation, the American Heart Association and the American Cancer Society, there is little uniformity regarding the mission of the obesity lobby. Are they fighting for cure, see BARIATRIC PROCEDURES page 8

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The Problem Medical research shows discordance rates of ϯϭй ƚŽ ϱϮй ŝŶ ƚŚĞ ŝĚĞŶƟ Į ĐĂƟ ŽŶ ŽĨ ƐƉĞĐŝŵĞŶ ŵĂƌŐŝŶƐ ďĞƚǁĞĞŶ ƐƵƌŐĞƌLJ͕ ƉĂƚŚŽůŽŐLJ ĂŶĚ ƌĂĚŝŽůŽŐLJ͘2,3 ZĞͲĞdžĐŝƐŝŽŶ ƌĂƚĞƐ ĞdžĐĞĞĚ ϮϬй ŝŶ ďƌĞĂƐƚ ƐƵƌŐĞƌLJ͘4

dŚĞ ^ŽůƵƟ ŽŶ͗ DĂƌŐŝŶDĂƌŬĞƌ ĂŶĚ ŽƌƌĞĐƚ ůŝƉƐ sĞĐƚŽƌ ^ƵƌŐŝĐĂů͛Ɛ Ɵ ƐƐƵĞ ŽƌŝĞŶƚĂƟ ŽŶ ƐLJƐƚĞŵ ƉƌŽǀŝĚĞƐ ƐĞĐƵƌĞ ĂŶĚ ĂĐĐƵƌĂƚĞ ĚĞƐŝŐŶĂƟ ŽŶ ŽĨ ƐƉĞĐŝŵĞŶ ŵĂƌŐŝŶƐ͕ ĐŽŶƚƌŝďƵƟ ŶŐ ƚŽ͗ Fewer unnecessary re-excisions;

ƉƌĞǀĞŶƚƐ ĚĞůĂLJ ŽĨ ĐƌŝƟ ĐĂů ĂĚũƵǀĂŶƚ therapy More accurate re-excisions Lower cancer recurrence /ŵƉƌŽǀĞĚ ĐŽƐŵĞƐŝƐ /ŵƉƌŽǀĞĚ KZ ƐĂĨĞƚLJ WůĞĂƐĞ ǀŝƐŝƚ ƵƐ Ăƚ

ŵĞƌŝĐĂŶ ŽůůĞŐĞ ŽĨ ^ƵƌŐĞŽŶƐ ůŝŶŝĐĂů ŽŶŐƌĞƐƐ ϮϬϭϯ džŚŝďŝƚ ϰϰϰ ®

+1 (262) 798-7970 ZĞĨĞƌĞŶĐĞƐ͗ ;ϭͿ ŽŽůĞLJ͕ t͘ ĂŶĚ WĂƌŬĞƌ͕ :͘ ͞hŶĚĞƌƐƚĂŶĚŝŶŐ ƚŚĞ DĞĐŚĂŶŝƐŵƐ ƌĞĂƟ ŶŐ &ĂůƐĞ WŽƐŝƟ ǀĞ >ƵŵƉĞĐƚŽŵLJ DĂƌŐŝŶƐ͘͟ American Journal of Surgery ϭϵϬ ;ϮϬϬϱͿ͗ ϲϬϲͲϲϬϴ͘ ;ϮͿ ƌŝƩ ŽŶ͕ W͘ ͖͘ ^ŽŶŽĚĂ͕ >͘/͖͘ zĂŵĂŵŽƚŽ͕ ͘<͖͘ <ŽŽ͕ ͖͘ ^ŽŚ͕ ͖͘ ĂŶĚ 'ŽƵĚ͕ ͘ ͞ ƌĞĂƐƚ ^ƵƌŐŝĐĂů ^ƉĞĐŝŵĞŶ ZĂĚŝŽŐƌĂƉŚƐ͗ ,Žǁ ZĞůŝĂďůĞ ƌĞ dŚĞLJ͍͟ European Journal of Radiology ϳϵ ;ϮϬϭϭͿ͗ ϮϰϱͲϮϰϵ͘ ;ϯͿ DŽůŝŶĂ͕ D͘ ͖͘ ^ŶĞůů͕ ^͖͘ &ƌĂŶĐĞƐĐŚŝ͕ ͖͘ :ŽƌĚĂ͕ D͖͘ 'ŽŵĞnj͕ ͖͘ DŽī Ăƚ͕ &͘>͖͘ WŽǁĞůů͕ :͖͘ ĂŶĚ ǀŝƐĂƌ͕ ͘ ͞ ƌĞĂƐƚ ^ƉĞĐŝŵĞŶ KƌŝĞŶƚĂƟ ŽŶ͘͟ Annals of Surgical Oncology ϭϲ ;ϮϬϬϵͿ͗ ϮϴϱͲϮϴϴ͘ ;ϰͿ DĐ ĂŚŝůů͕ >͘ ͖͘ ^ŝŶŐůĞ͕ Z͘D͖͘ ŝĞůůŽ ŽǁůĞƐ͕ ͘:͖͘ &ĞŝŐĞůƐŽŶ͕ ,͘^͖͘ :ĂŵĞƐ͕ d͘ ͖͘ ĂƌŶĞLJ͕ d͖͘ ŶŐĞů͕ :͘D͖͘ ĂŶĚ KŶŝƟ ůŽ͕ ͘ ͘ ͞sĂƌŝĂďŝůŝƚLJ ŝŶ ZĞĞdžĐŝƐŝŽŶ &ŽůůŽǁŝŶŐ ƌĞĂƐƚ ŽŶƐĞƌǀĂƟ ŽŶ ^ƵƌŐĞƌLJ͘͟ :ŽƵƌŶĂů ŽĨ ƚŚĞ ŵĞƌŝĐĂŶ DĞĚŝĐĂů ƐƐŽĐŝĂƟ ŽŶ ϯϬϳ͘ϱ ;ϮϬϭϮͿ͗ ϰϲϳͲϰϳϱ͘ Ξ ϮϬϭϯ sĞĐƚŽƌ ^ƵƌŐŝĐĂů >>

ŶŶŽƵŶĐŝŶŐ ŽƵƌ ŶĞǁ ǁĞďƐŝƚĞ ǁǁǁ͘ǀĞĐƚŽƌƐƵƌŐŝĐĂů͘ĐŽŵ

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Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2013

BARIATRIC PROCEDURES jcontinued from page 7

treatment or tolerance? It is thus essential that we continue to gain support from our industry partners, until our lobby becomes stronger and we can join forces with other key players such as the American Diabetes Association.

Prejudice Against Obesity A common rationale for the above data is discrimination against obesity and obese individuals. George Cowan, MD, a retired bariatric surgeon from Tennessee

liked to say, “obesity was [the] last bastion of accepted prejudice in the USA.” Certainly, when states, unions or employers reduce coverage for bariatric surgery, many blog posts are supportive. But if we had a referendum on what is covered, few things other than child care and vaccinations would be popular. In all probability, the popularity of coverage would vary directly with the number afflicted. This should be promising, because if current growth rates continue, virtually the entire population will be obese by 2040.7 As a result, it would seem logical that prejudice against obese individuals will

decline as more people and their family members desire treatment. This will be offset by the difference between an individual’s actual level of obesity and their perception. Frequently, many underestimate their degree of obesity. Additionally, there is the widespread belief that obesity is a condition of choice, caused by an absence of personal responsibility. The argument continues: Why should I pay for coverage for a condition that is self-inflicted? There are limitations to this argument. Certainly, cigarette smoking causes the majority of lung cancers, and there are no limitations on treatment.

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Similarly, even liver transplant in reformed IV drug addicts and alcoholics is a covered procedure. It is doubtful that this discrepancy can be explained by the fact that alcoholics, smokers and drug addicts are more popular than obese individuals.

Then what is the difference? In my estimation, it is the fact that there is consensus that the treatment of choice for end-stage liver failure is liver transplantation. All would agree that without treatment, lung cancer is a terminal disease. Even with treatment, the prognosis often is dismal. In contrast, for obesity, there is no mandatory treatment level.

The patient determines whether his or her obesity requires treatment. There is no accepted pathway. For example, for hypertension, the first-level treatment may include behavioral changes followed by reexamination. If severe, medical therapy will be started. If appropriate metrics are not reached, then the dose will be raised or additional agents will be started. For obesity, this metric does not exist.

Thus, although bariatric surgery is considered the treatment for refractory morbid obesity, there is no accepted medical definition of what constitutes refractory morbid obesity. It is akin to being at the top of a nonexistent food chain. If there were an accepted treatment threshold, then those who do not respond would go up the chain. Many would ultimately be referred for surgery.

The existence of prejudice is an unfortunate fact of life. However, what limits treatment is the lack of consensus and a level that mandates treatment. It is essential that we understand this complex issue and work with other societies to develop an accepted clinical pathway for the treatment of obesity. The development of Obesity Week and the combined meeting of the American Society for Metabolic and Bariatric Surgery with the Obesity Society hopefully will initiate this process.

The Economy

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It is the opinion of many that an important cause of the decline or stabilization in bariatric surgery is the downturn of the economy. Certainly, one cannot discount the effect of the current economic condition. Unemployment levels have been approximately 10%. Not counted are many people who have given up even searching for jobs. Struggling companies have had to reduce or at least stabilize their contribution for health insurance.

Wages have been stagnant, yet health care costs and insurance rates have risen. Both employers and employees have been reluctant to increase their level of contribution for health insurance. To keep costs stable, covered benefits have been reduced.

Individual and family deductibles, as well as copays have been raised. The net result is that the cost to an individual for elective surgery has increased. To reduce

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2013

expenditures, less robust benefit packages are being purchased. Often these contain riders or exclusions for services that are deemed not essential. Unfortunately, riders that exclude coverage for the treatment of obesity and surgical treatment for morbid obesity are not uncommon. The importance of this point cannot be overstated. Thus, although recent data have resulted in virtually all national insurance companies covering bariatric surgery, many of their clients purchase programs that exclude this coverage.

The combination of fewer people with health insurance and exclusions for coverage for those with health insurance is certainly a major issue. Another cause has been the decline in net worth and total assets of Americans. As people are less wealthy, with declining home values, they are reluctant to pay out of pocket for bariatric surgery. This has certainly been a major issue for laparoscopic adjustable gastric bands. The cash pay market has decreased significantly.

Although economic issues certainly play a role, they do not completely explain why market penetration is so low. In fact, after a sharp reduction at the beginning of the economic crisis, most fields have recovered. Some areas such as joint replacement and spine surgery have flourished.

There are many essential messages.

Rather than caused by the recession and economic turbulence, I believe these data demonstrate how vulnerable our field is.

Why are exclusions for obesity so popular? What can we do about it? It seems clear to all that cost pressures are only going to increase, and all fields in medicine will be competing for a smaller pie.

Where will bariatric and metabolic surgery land when we have struggled even before the fiscal cliff?

To combat exclusions, it has been suggested to insurers and employers that bariatric surgery will offer a return on investment (ROI) in two to three years; thus, it is an excellent investment for health care plans and employers. The problem is whether this is true. Recently, I met with leadership of the Optimum Division of United Healthcare. Even with low in-network rates, their clients failed to have an ROI. In fact, more than 30% of the covered lives who had bariatric surgery had revisional procedures in less than three years. The majority had laparoscopic adjustable bands.

An additional misnomer is the implication that all patients who have bariatric surgery or a BMI greater than 40 kg/ m2 are actuarial disasters for their insurers. In fact, major portions of patients who have bariatric surgery are premenopausal women without life-threatening risk for heart disease. In order to see an ROI, patients selected for surgery would need to have advanced disease. Unfortunately, the same people may be more

likely to have significant complications, thus increasing costs.

These issues should not be cause for concern. I doubt there is any surgical procedure that can clearly show an economic ROI. Probably immunizations can, but few other areas. Even screening programs for cancer are only cost-effective if you add improved quality of life and reduced mortality. In terms of medical costs, they probably result in an increased number of procedures, such as biopsies that are frequently negative. Thus, as bariatric surgeons, we should stop being actuaries and investment advisors, and highlight the fact

that we can offer reversal and remission of serious chronic health issues. In contrast, without surgery, stabilization is often the goal. The key point is that we need to convince people of the value of our procedures for their immediate health care needs. The long-term health of an individual is affected by so many things, it is doubtful that any procedure or treatment can offer a return in hard health care costs.

References 1. ISRG Historical Price; Yahoo Finance.

2. J Healthc Qual. 2011;33:48-52.

3. JAMA. 2012;308:1122-1131.

4.

5.

6.

7.

Curr Atheroscler Rep. 2012;14:597-605.

Am J Surg. 2010;200:378-385.

Allergan Inc. Yearly report, 2008-2011.

J Health Econ. 2012;31:781-796.

—Dr. Roslin is chief, bariatric and met— abolic surgery, Lenox Hill Hospital/NSLIJ, New York City, and Northern Westchester Hospital Center, Mt. Kisco, N.Y. In Part 2, Dr. Roslin discusses potential approaches to recuce the discrepancy between the number of people who would benefit from bariatric surgery and those who actually receive it.

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Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2013

Dear Readers, Welcome to the October issue of the The Surgeons’ Lounge. In this issue, our guest expert John McNelis, MD, FACS, FCCM, chairman, Department of Surgery, North Bronx Healthcare Network, Jacobi Medical Center and North Central Bronx Hospital, New York City, discusses the case of a patient with a grade IV splenic laceration. Plus, check out the reply to the September challenge—how did you do?

I look forward to your questions, comments and feedback.

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

Surgeon’s Challenge From September 2013 Issue Submitted by: S. Al-Bahri, MD, M. Casasanta, MD, and E. McCarron, MD from the Department of Surgery, MedStar Union Memorial Hospital, Baltimore, Md. An 80-year-old woman with a history significant for hypertension, pneumonia and coronary artery disease, as well as a remote history of hysterectomy for symptomatic fibroids, was admitted for hydration and a workup for pneumonia.

During her hospital stay, she developed diarrhea and abdominal pain for which a computed tomography (CT) scan of the abdomen and pelvis was obtained. A pelvic mass of unclear origin was seen; tumor markers CEA and CA 125 were well within normal limits. Attempts were made to perform an image-guided biopsy, but were unsuccessful due to the mobile nature of this mass. A recent colonoscopy failed to show any significant pathologic process originating in the colon.

The patient recovered from the acute

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

Figure 1. Parasitic leiomyoma, which derives its blood supply from local structures such as the colon.

infectious process and was scheduled for exploratory laparotomy. Upon entering the peritoneal cavity, all surfaces were free of any pathology. The mass, originating off of the transverse colon, was readily identified. It had several serpentine arteries feeding into it from the mesentery of the bowel (Figure 1).

Challenge question: What is the diagnosis? a. carcinoid tumor; b. colonic adenocarcinoma; c. parasitic leiomyoma; d. Meckel’s diverticulum; or e. omental cyst.

Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2013

Answer to Challenge Parasitic leiomyoma. A rare cause of laparotomy for a presumed malignancy, a parasitic leiomyoma can mimic the presence of a malignant mass on CT imaging, and cause symptoms depending on its location and size. It is defined as an extra-uterine seeding from a uterine leiomyoma.1It is most commonly seen in patients who have undergone a hysterectomy for uterine fibroids. Of particular

Question for Dr. McNelis Edward Chao, PGY-5, Montefiore Medical Center, New York, NY

I

would appreciate your advice regarding a 26-year-old woman with no significant comorbidities who presented to our emergency room after falling in the bathtub one morning. She fell to her left side, landing awkwardly on her flank region against the tub. She did not lose consciousness or suffer any head trauma. Her vital signs were: blood pressure 110/77; heart rate 83, respiratory rate 16, and SaO2 on room air of 98%. The patient was otherwise alert and oriented complaining only of left flank pain. She appeared pale but was not diaphoretic.

interest is that these masses are “parasitic,” which means they derive their blood supply from local structures, such as the colon in this case.

Parasitic leiomyomas are so uncommon that discussion about this topic is limited to case reports. It is hypothesized that seeding from morcellation of the uterus or even an open hysterectomy can result in the pathogenesis of this tumor.

It can present as a painful symptomatic

Figure 2. A simple excision of the parasitic leiomyoma.

A focused abdominal sonogram was performed, which was positive in the left upper quadrant (LUQ). Chest and pelvic x-rays were unremarkable. A CT scan with IV contrast was obtained, which revealed hemoperitoneum secondary to a grade IV splenic laceration with active extravasation of IV contrast (Figures 1 and 2). Associated left rib fractures (eighth to 11th) were the only other pertinent findings.

Question: How would you manage this patient?

Dr. MacNelis’

Reply

Good question, Edward. In the past, the answer would have been simple: To the operating room (OR) for splenectomy or possibly a splenorrhaphy. Given the CT appearance here, I would suspect that this could be a possible grade V injury1 (Figure 3). Your CT certainly demonstrates extravasation of contrast consistent with an active bleed. Indeed, if you were in a solo setting without advanced capabilities to actively observe

this patient, and if the patient had associated injuries or manifested any form of hemodynamic instability, the OR would be the next appropriate step.

In most modern trauma centers, however, there is another approach to managing hemodynamically stable patients with splenic injuries. Angiographic embolization is rapidly gaining favor in managing these patients. In the May 2012 issue of the Journal of Trauma, Bhullar et al published an excellent review on angiographic embolization of splenic injuries.2 In their experience at a level 1 trauma center, the addition of angiographic embolization in selected cases significantly decreased the failure rates of nonoperative management in grades IV and V splenic injuries. In grade IV splenic lacerations, a nonoperative failure rate of 23% was reported, whereas in grade V, a nonoperative failure rate of 63% was reported, as would be expected. When angiographic embolization was added, the failure rates dropped to 3% and 9% for grades IV and V, respectively. Indeed, I would recommend angiographic embolization in that subset of patients who have an associated pelvic fracture requiring embolization as well.

Splenic embolization, however, does

Figure 3. Organ injury scale Grade

Injury Type

Injury Description

I

Hematoma

Subcapsular <10% surface area

Laceration

Capsular tear <1 cm parenchymal depth

Hematoma

Supcapsular 10-50% surface area: intraparenchymal <5 cm

Laceration

Capsular tear 1-3 cm parenchymal depth not involving trabecular vessel

Hematoma

Subcapsular >50% surface area or expanding; ruptured subcapsular or parenchymal hematoma; intraparenchymal haematoma >5 cm or expanding

II

III

Figures 1 and 2. CT scan with IV contrast revealed hemoperitoneum secondary to a grade IV splenic laceration with active extravasation of IV contrast.

mass or an incidental finding on imaging performed for other reasons. A thorough examination of the abdominal cavity is required to search for other such masses and it can be removed by a simple excision (Figure 2).

It is therefore reasonable to consider this diagnosis on the differential in a patient with an extraluminal mass and a history of hysterectomy.2

have its limitations. Success is dependent on many factors such as the operator’s skill, and the availability of equipment and interventional radiology. Embolization coils, microspheres, absorbable gelatin sponges, endogenous clots, or a vascular plug device have all been employed to embolize the splenic artery.1 One word of caution: Splenic artery embolization may not stop bleeding from the short gastrics due to collateral flow from the left gastric and left gastroepiploic arteries. In this case, the angiographer should be facile with celiac artery arteriography to stem the bleeding.3 Other possible complications include failure of therapy, and transfusion-related risks (reaction, infections, transfusion-related acute lung injury, etc.), as well as shock and coagulopathy. Preservation of the spleen, on the other hand, eliminates the risk for overwhelming postsplenectomy infection, a viable consideration in this woman.

Follow-up is an issue that frequently arises post-discharge. The general recommendation is to avoid any high-risk contact activity for up to three months.4 This would include contact sports or any activity that would risk injury to the LUQ. There also is controversy regarding the question of obtaining a followup CT. Repeat CT indications are variable, but a selective approach has been advocated for individuals returning to high-risk activities.5 Given this patient’s clinical presentation and your institution’s interventional radiology capabilities, I would recommend nonoperative management with selective embolization.

Our institutional success rate is very high in embolization of these injuries.

References 1. J Trauma. 1995;38:323-324.

Laceration

>3 cm parenchymal depth or involving trabecular vessels

IV

Laceration

Laceration involving segmental or hilar vessels producing major devascularization (>25% of spleen)

2. J Trauma Acute Care Surg. 2012;72:1127-1134.

V

Laceration

Completely shattered spleen

4. J Trauma. 2005;59:836.

Vascular

Hilar vascular injury with devascularized spleen

5. Clin J Sport Med. 2002;12:400.

Advance one grade for multiple injuries up to grade III. From: Moore et al. Organ Injury Scaling: spleen and liver J Trauma 1995;38:323.

3. J Trauma. 2008;65:1346.

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THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

Case-Based Report on XCM BIOLOGIC® Tissue Matrix For Ventral Hernia Repair Michael A. Baumholtz, MD, FACS Plastic Surgeon, Private Practice San Antonio Cosmetic Surgery San Antonio, Texas

Introduction Ventral hernia repair is a common surgical procedure, and there is no shortage of techniques or materials from which surgeons may select to reconstruct the abdominal wall.

Mesh repairs are generally used for most defects, a practice trend based on observed failure rates that are relatively lower in repairs performed with mesh rather than sutures.1-3 In addition, biologic grafts provide an extracellular matrix (ECM) scaffolding that is fundamental for tissue repair.3,4 A durable and functional surgical outcome is the optimal clinical end point in ventral hernia repair. With mesh repairs, constructive tissue remodeling is necessary for quality outcomes. XCM BIOLOGIC Tissue Matrix, a sterile, non-crosslinked 3-dimensional ECM derived from porcine dermis, provides strength and has properties that facilitate soft tissue healing with good host acceptance.5,6 A proprietary manufacturing process removes cells and DNA, minimizing damage to native tissue architecture and facilitating eventual tissue remodeling.5,6 XCM BIOLOGIC Tissue Matrix also is supplied in a variety of sizes, from 4 × 7 cm to 20 × 30 cm; it is prehydrated and can be used directly from the package,5 which minimizes the risk for contamination during soaking and eliminates preparation time. Larger sizes of XCM BIOLOGIC Tissue Matrix, up to 25 × 45 cm, will be available soon.

physiologic repair you can get,” he said of the underlay technique, which he usually performs in conjunction with components separation.

The approach has yielded positive results. “Hernias seem to be stable with XCM BIOLOGIC Tissue Matrix, at least within the past 4 years or so that we’ve been using it,” said Dr. Baumholtz, who balances a patient’s overall risk with the importance of minimizing potential for complications.

Not every hernia needs a mesh, Dr. Baumholtz noted, and not every mesh needs to be a biologic. “For ventral hernia repair, porcine dominates the market and XCM BIOLOGIC Tissue Matrix is as good a product as any other. It has what I’m looking for, and what a lot of surgeons are looking for. You want strength, you want pliability, you want a material that’s supple, that you can work with, that’s going to hold a stitch and tolerate the abdominal wall forces. It also comes in a variety of sizes and that’s quite helpful.”

Case Presentationa A 61-year-old man presented approximately 18 months after having been involved in a motor vehicle accident. Following the accident, he had been comatose for approximately 8 days and sustained injuries to the hip and lower extremities; a splenectomy was performed because of the injury. He subsequently was managed using an open abdominal approach (temporary closure with an absorbable mesh, then skin grafts once stable). This approach resulted in a large ventral hernia (Figure 1). The patient’s past medical history included treatment for chronic hypertension, borderline kidney function (creatinine clearance 120 mL/min), respiratory complaints, and skin cancer that had been treated.

He was otherwise healthy.

Three months after initial presentation, a ventral hernia repair was performed in a single operation as a combination of bilateral components separation (Figure 2) and XCM

“Hernias seem to be stable with XCM BIOLOGIC Tissue Matrix, at least within the past 4 years or so that we’ve been using it.”

—Michael A. Baumholtz, MD, FACS

Discussion and Clinical Considerations Abdominal wall reconstruction is necessarily complex.

Patients requiring this procedure may have experienced recurrent hernias and multiple surgeries, and they may have significant scarring, loss of domain, and substantial medical comorbidities. “By the time a hernia comes my way, either someone’s surgery plan hasn’t worked out for the patient or the patient has some other complicating factor,” said Michael A. Baumholtz, MD, FACS, a San Antonio, Texas-based, double board-certified plastic and reconstructive surgeon.

Dr. Baumholtz generally selects a biologic mesh in complex abdominal wall reconstruction, typically placing the mesh in an underlay position. “We feel that’s the most

a

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Figure 1. Patient’s large ventral hernia prior to surgery.

Figure 2. Bilateral components separation to expose fascia.

Image courtesy of Michael A. Baumholtz, MD, FACS.

Image courtesy of Michael A. Baumholtz, MD, FACS.

Results from case studies are not predictive of results in other cases. Results in other cases may vary.

GENERAL SURGERY NEWS • OCTOBER 2013

Supported by

BIOLOGIC Tissue Matrix (20 × 25 cm) placement in an underlay position. Before placement, the mesh was drawn into quadrants using methylene blue; the midpoint was clearly delineated and a 3-cm circle was drawn all the way around the mesh, providing visual guidance (Figure 3) to prevent stitching no closer than 3 cm to the edge—a buffer zone to minimize risk for suture pullouts or failure at the attachment.

A #1-polydioxanone absorbable suture material was used to secure the mesh in a horizontal mattress (U stitch). This anchoring method has the advantage of securing fixation through well-vascularized tissue.7 The mesh was inspected to ensure that each quadrant had a uniform number of stitches and was then parachuted into the abdomen, and all sutures were held up before tying in order to offload tension of the closure onto the mesh. Native tissue was reapproximated in the midline (Figure 4) and suturing was performed with #2-nylon material in interrupted figure-of-8 fashion.

Subcutaneous drains were placed and an abdominal binder was applied.

Subcutaneous drains on operated site were removed on postoperative day 14. No seroma or hematoma were noted.

After the patient’s small bowel function returned, he was

discharged from the hospital on postoperative day 5 with instruction to wear a binder for 30 to 60 days. He continued to recover at home and did very well wearing the binder for approximately 45 days and then resumed daily activities without it.

Conclusion An excellent result was obtained with a single operation with no further procedures required. The patient fully recovered and his progress was noted at follow-up visits. XCM BIOLOGIC Tissue Matrix was selected for this patient and procedure based on an appraisal of factors including complexity of the abdominal wall defect, patient age and comorbidities, and evidence and Dr. Baumholtz’s clinical experience demonstrating the effectiveness of XCM BIOLOGIC Tissue Matrix in facilitating strong and durable ventral hernia repairs characterized by good postoperative tissue healing. XCM BIOLOGIC Tissue Matrix is easy to use directly from the package and is supplied in a variety of sizes that are helpful to surgeons in acute and elective abdominal wall surgical procedures; the range of available sizes of XCM BIOLOGIC Tissue Matrix also may be beneficial in minimizing waste.

Image courtesy of Michael A. Baumholtz, MD, FACS

Disclosure Dr. Baumholtz received funding from Synthes, Inc. for his participation in this project.

References 1. Luijendijk RW, Hop WC, Van den Tol P, et al. A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med. 2000;343(6):392-398.

2. Burger JWA, Luijendijk RW, Hop WC, et al. Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg. 2004;240(4):578-585.

3. Harth KC, Rosen MJ. Repair of ventral abdominal wall hernias. In: Ashley SW, Wilmore SW, eds. ACS Surgery: Principle and Practice. Ontario, Canada: Decker Intellectual Properties; 2010:1-20.

4. Badylak SF. The extracellular matrix as a scaffold for tissue reconstruction. Cell Dev Biol. 2002;13(5):377-383.

J12589-A

Image courtesy of Michael A. Baumholtz, MD, FACS

Figure 4. Closing fascia over XCM Biologic Tissue Matrix following repair.

5. XCM BIOLOGIC tissue matrix [general brochure]. West Chester, PA: Synthes, Inc.; 2010.

6. Data on file. Kensey Nash Corporation; 2010.

7. Mathes SJ, Steinwald PM, Foster RD, et al. Complex abdominal wall reconstruction: a comparison of flap and mesh closure. Ann Surg.

2000;232(4):586-596.

BB137

Figure 3. XCM Biologic Tissue Matrix drawn into quadrants.

“For ventral hernia repair, porcine dominates the market and XCM BIOLOGIC Tissue Matrix is as good a product as any other. It has what I’m looking for, and what a lot of surgeons are looking for. You want strength, you want pliability, you want a material that’s supple, that you can work with, that’s going to hold a stitch and tolerate the abdominal wall forces. It also comes in a variety of sizes and that’s quite helpful.”

—Michael A. Baumholtz, MD, FACS

13

14

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2013

Risk Management LLC Helps Physicians Reduce Claims, Lower Premiums the like,” said Ms. Lagnese. “These are all avoidable via practical risk mitigation practices.” review of malpractice cases involvEven though roughly four-fifths of all ing general surgeons over the past cases are resolved in favor of the physitwo decades found that, in those cases cian, billions of dollars are paid out in where medical malpractice was alleged, settlements that, according to Mr. Danthe most common problems cited were: aher, “should never have seen the light • errors in diagnosis; of day” (Table 1). The estimated medi• failure to supervise or monitor a cal malpractice payments in 2011 totaled patient; $4.65 billion.

Proactive Approach to Risk • failure to recognize a complication In 2003, with the crisis in mediManagement of treatment; cal malpractice liability becoming dire, • leaving a foreign body in the patient In 2003, attorneys Neil Danaher, MRM sought to generate strategies that after a surgical procedure Joyce Lagnese and Kenneth Neal, all of would help reduce malpractice exposures • procedure performed when either whom are associated with DanaherLag- and improve patient safety. The companot indicated or contraindicated nese, a Connecticut legal practice with ny’s goal is to create a proactive attitude • a delay in performing a procedure; extensive experience in medical mal- toward risk management, and ultimately and practice defense litigation, partnered patient safety, and discard what hitherto • medication errors. with Mr. Kelly to launch Medical Risk has been a reactive, ineffective approach.

A careful review of claims records Management, LLC (MRM), based in MRM focuses on areas of high malpracshows that there is no shortage of posHartford, Conn. tice exposure and areas of emerging risk, sible ways to end up in court. Specific “As seasoned defense attorneys, we and then teaches its clients what the examples of malpractice pitfalls are not understand that most malpractice cases company has found. hard to come by, and sometimes come stem not from bad doctors practicing “The key to why we’ve been successful from surprising sources. bad medicine but rather by administra- is that 70% of claims are not due to bad Take, for example, the rise of hostive gaffs, communication errors, and doctors, which means they are preventpitalists, who theoretically able,” Mr. Danaher said. “They are keep primary care physifrom things like communication ‘As seasoned defense attorneys, we understand that most malpractice cians (PCPs) fully apprised lapses, follow-up lapses, system cases stem not from bad doctors practicing bad medicine but rather by of their patients’ status durdeficiencies, inadequate informed ing hospitalization. Pracconsent and poor patient relaadministrative gaffs, communication errors, and the like. These are all tically speaking, however, tions—all things that we can work avoidable via practical risk mitigation practices.’ —Joyce Lagnese complete communication is on, and provide education and rare. As it turns out, interimplement practical intervenprovider communication tions in order to reduce or elimbetween the hospitalist and inate them altogether.”

PCP is an increasingly fre“We identify the 20% of quent issue in malpractice types of claims that represent claims. A patient arrives in 80% of the malpractice lossthe emergency room with es, and we determine these left quadrant belly pain, and high-exposure areas by speappendicitis is diagnosed. cialty,” Mr. Kelly added. “We The patient has chest x-rays do a frequency-severity distrithat the radiologist reads, bution analysis, and then focus and the patient is cleared our educational curriculum on Table 1. Total Amount Paid in Medical Claims by State in 2011: Top 10 those areas where the highest for emergency surgery. Incidental to the appendectoyield will be.” my is the finding of a lung Number Total Amount Average Amount MRM collects cartons of nodule, the fact of which Rank State of Claims Paid, $ Per Claim, $ medical malpractice files and the PCP does not notice as mines them for data, separat1 New York 1,379 627,067,500 454,726 it is buried on page 23 of ing information out by spe2 Pennsylvania 767 299,671,500 390,706 the electronic health record cialty and sorting them by risk (EHR). The appendectoissue. The files are redacted for 3 Florida 758 188,324,250 248,449 my is successful, but the HIPAA purposes and then a 4 California 758 186,235,900 209,489 lung nodule is not biopsied case-based, specialty-specific 5 Illinois 315 183,968,050 584,026 and the patient succumbs to educational program is created. lung cancer two years later.

The firm is dedicated to mul6 New Jersey 429 164,494,500 383,437 Among the problems evitimodal risk education—much 7 Massachusetts 212 130,749,750 616,744 dent in this example is the of it comprising continuing 8 Missouri 159 100,348,250 631,121 education of hospitalists, medical and/or nursing educamany of whom are gradution (CME and CNE)—that is 9 Maryland 249 84,688,000 340,112 ates of internal medicine delivered via a variety of media, 10 Texas 445 76,144,750 171,112 residency programs but are including: relatively inexperienced in • annual specialty-speSource: Data from The Kaiser Family Foundation, State Health Facts, available at http://kff.org/statedata. managing complex surgicific risk management lectures; cal patients and assuring see MALPRACTICE RISK PAGE 16 B Y J AMES P RUDDEN

A

comprehensive follow-up.

Another generator of malpractice claims stems from the advent of EHR systems.

“The Obama administration has provided significant financial incentives through stimulus funds for physicians to quickly adopt EHRs,” said Kevin W. Kelly, president and CEO of Medical Risk Management LLC. “The problem has been that, during the adoption period of EHRs, there are many unintended consequences that may increase malpractice exposures. The vast majority of smaller physician groups are ill-prepared—they don’t have an information technology department, they don’t have the infrastructure.”

Mr. Kelly offered two examples. First is the “all-normal” button, which a physician can click to document that the assessment was normal for all physical systems. “However, if the exam was not complete but the results were posted as ‘all normal,’ there could be significant consequences if an adverse event occurred,” Mr. Kelly said. “This could be

portrayed very negatively to a jury.”

He added, “A second example is to copy and paste, or the ‘carry forward’ function. In this situation a physician can copy and reuse the exact text, but if there are multiple notations in the EHR that are all exactly the same, then the EHR record can lose credibility in the eyes of a jury. Again, that is portrayed very negatively in court.”

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15

16

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2013

MALPRACTICE RISK

Thus, the clinicians at ProHealth Physicians were enthusiastic and successful students of the programs offered by MRM, and the resultant claims data from • web-based learning modules and movies, featur- the years following its implementation bear this out. For ing a defense attorney, a physician and a content instance, a comparison of the number of claims from the expert; six years before the program was initiated (10±3.46) to • risk alerts sent via email, offering short vignettes; the eight years after (3.62±2.13) shows an impressive • tutorials; and 63.8% reduction in the average number of claims. The • an Automated Risk Knowledge System, a web- claims for failure to diagnose or treat, an area that was based learning management platform developed a focus of study for the group, were reduced by 67.9%.

by MRM that allows users to access customized Meanwhile, the severity of claims, measured in dollars educational materials at any time over the Internet. per physician, was reduced by 73%. Eventually, premiMRM sets itself apart from other medical risk man- ums fell as a result of the reduced claims. Since 2005, agement companies, such as ELM Exchange, Inc. the gross premiums for ProHealth Physicians are down (www.elmexchange.com) and Medical Risk Manage- 59.7% for the specialties of internal medicine/famiment Inc. (www.medrisk.com), by offering a greater ly practice and pediatrics (Table 2). Reduced premiums emphasis on live, specialty-specific presentations using resulted in an aggregate savings of about $14 million expert defense lawyers and practicing physicians who from their malpractice insurance underwriting. discuss real-life cases.

“Medical Risk Management LLC has been a winner for our patients and doctors,” Mr. Reed said.

“We have about 200 physicians in our group, Table 2. Decline in Premiums Following but we also have several hundred other providers, such as nurse practitioners and physician Implementation of Risk Management Program at ProHealth Physicians assistants,” added Dr. Cox-Chapman. “It is not just the physicians who are taking these courses—anyone who interacts with patients needs to Year Internal Pediatrics take them.”

Medicine/ Premiums, $ Indeed, MRM provides educational instrucFamily Practice tion for office managers and others involved in Premiums, $ administration.

It comes as an unpleasant shock to many phy2004-2005 19,424 17,851 sicians to hear that the allegations against them 2005-2006 17,453 16,122 will not be heard in court for two or more years as the case wends its way through the legal sys2006-2007 15,069 13,849 tem, during which time they must live with a 2007-2008 13,799 12,681 professional cloud hanging over their heads.

2008-2009 12,749 11,717 “Medical Risk Management LLC is constantly evaluating its educational endeavors, 2009-2010 10,904 10,021 but the unmeasured benefit of all 2010-2011 9,476 8,708 this is the increased confidence 2011-2012 7,827 7,193 that comes with preparation and use of one’s resources Source: Jacobs L et al. Conn Med. d 2012;76:291-297 to deal with the problem of risk management,” Dr. Cox-Chapman said. “Don’t underestimate the emoFewer Claims, Lower Costs tional distraction that comes MRM can point to significant successes in its with a lawsuit—there is a decade of existence. Key performance metrics are regmuch higher level of confidence ularly assessed by MRM, and include basic knowledge, that exists when you are prepared.” attitudinal measures, behavior change, and claims and The savings achieved by ProHealth Physicians are premium reductions. extraordinary, but overall savings are a frequent byThe firm’s first client was ProHealth Physicians, one product of the risk management programs. MRM’s cliof the largest primary care group practices in Connect- ent base is diverse, including large health care systems, icut. In an interview, Jack Reed, president and CEO, like Hartford HealthCare; specialty-specific hospitals, and James Cox-Chapman, MD, chief medical officer like the Hospital for Special Surgery in New York City and senior vice president, recounted the effect that the and Connecticut Children’s Medical Center; university implementation of the risk management program had teaching centers, like the University of Connecticut; and on their group, a story that they summarized in Connect- smaller hospitals and group practices (Box). MRM has icut Medicinee ( Jacobs L et al. 2012;76:291-297). Partic- been able to customize its programs based on practice ipant rates for the CME modules and risk management size and need. grand rounds were 98.7% or higher since their incepUltimately, everybody wins—the culture of safety that tion in 2004, and participation in focused educational develops from managing medical risk helps lower preefforts in high-exposure areas, such as failure to diag- miums for physicians and heightens safety for patients. nose colon cancer, was 100%. More than 90% of phyMr. Kellyy is president and CEO, Ms. Lagnesee is chief sicians agreed that the educational efforts were worth legal officer and Mr. Danaherr is chairman of MRM. MRM their time or relevant to their practice, and between was founded in 2003 by a team of health care and legal pro93.3% and 99.5% of respondents indicated they would fessionals dedicated to developing practical risk management “somewhat” or “completely” change their practice as a solutions for health care providers. For more information result of what they had learned. about MRM, visit www.1mrm.com. jContinued from page 14

Two Case Studies in Risk Management Case 1. University of Connecticut School of Medicine Kiki Nissen, MD, associate dean for graduate medical education and professor of medicine at University of Connecticut School of Medicine (UCSM), oversaw the institution of a risk management curriculum, developed

by Medical Risk Management, LLC (MRM), together with UCSM, for UCSM residents (there are approximately 630 residents at UCSM). A review of the experience was published in the Journal of Graduate Medical Education (Nissen K et al. 2010;2:589-594).

The multimodality program relied on live lectures, webbased video modules, and emailed publications designed to educate residents about medical risk management. Pretests and post-tests were administered, and participant satisfaction was measured. The entire curriculum spanned two years.

Of survey respondents, 97% found the content to be relevant to their specialty, and 95% agreed that the live sessions should be held annually. When asked if they would change their practice based on what they had learned in the program, only 2.5% said not at all—nearly 70% said mostly or completely.

“The program was extended to include fellows in 2011,” Dr. Nissen said. “The medical risk program is called the Patient Safety Curriculum.”

The improvements in reduced malpractice claims are being tracked.

Case 2. Connecticut Children’s Medical Center Martin J. Gavin, president and CEO, and Trisha Farmer, director of risk management, Connecticut Children’s Medical Center, described the medical risk educational program initiated for the medical center, which has 187 beds and employs 160 physicians in 26 subspecialties.

“We were looking at providing much more standardization in our approach to medical education,” Mr. Gavin explained, which was one impetus for starting the MRM program five years ago.

The program entailed attending a live presentation once a year, and viewing two online web modules each year.

“We have seen a dramatic reduction in claims, due in large measure to the work done by this program,” he said.

The attitude of the physicians toward the process also was very positive.

“Physicians are very data-driven people, so when they are shown data that can help them improve their exposure, and also improve patient safety, they quickly accepted the program and got on board with it.”

“The program really changed our culture,” Ms. Farmer added. “We are a culture of safety and a culture of risk awareness, and all of the educational efforts have made us more aware. And this is a program that goes well beyond the physicians—we have had 850 people go through the program, including allied health professionals and administrators.”

“This program protects the physicians,” Mr. Gavin noted.

“It protects them and helps them not end up in court, but it also is in the best interests of their patients and families.

It puts the physicians back firmly where they should be, which is working as a caregiver and not a risk manager.”

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and patients typically return to work the same day.

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atraumatic, pain-free approach allows patients to return to work the same day, and the excellent outcomes result in an extremely high level of both patient and physician satisfaction. In my own experience, I actually look forward to working with these patients, as the interactions are the most positive that I’ve experienced in my career!

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Mitchel Guttenplan, MD, FACS Medical Director CRH Medical Corporation Reference 1. Cleator IGM, Cleator MM. Banding hemorrhoids using the O’Regan disposable bander. US Gastroenterology Review. 2005:69-73.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2013

19

FDA Reverses Course on Fecal Transplantation for C. Difficile Swayed by Pleas From Doctors, Patients to Not Require INDs B Y G EORGE O CHOA

A

fter stating that the use of fecal microbiota for transplantation (FMT) to treat Clostridium difficile infection would require an Investigational New Drug Application (IND), the FDA reversed course after a public outcry, and announced that it would not require INDs for this therapy, at least for the time being.

In a guidance dated July 2013, the FDA said that it intended “to exercise enforcement discretion,” regarding the IND requirements, which, according to FDA spokesperson Morgan Liscinsky, means INDs will not be required.

“If practitioners are using FMT to treat C. difficile infection that is not responsive to standard therapies and they obtain informed consent, [the] FDA will not enforce the IND requirements,” Ms. Liscinsky told General Surgery News.

“However, if a practitioner would like to submit an IND, they may do so, and [the] FDA will work with them.”

The FDA guidance states that informed consent “should include, at a minimum, a statement that the use of FMT products to treat C. difficile is investigational, and a discussion of its potential risks.”

“I applaud the FDA’s behavior in altering their ruling to allow FMT to go forward with much less severe restriction,” said Lawrence J. Brandt, MD, professor of medicine and surgery, Albert Einstein College of Medicine, Bronx, New York City. “It’s not that frequent that a governmental agency changes its direction, and here we have a reversal of course that I think has to be applauded and recognized for the benefit I think it will allow.

This is a happy conclusion to what was a long and painful process for most of us who had been doing FMT,” said Dr. Brandt, who is also emeritus chief of the Division of Gastroenterology, Montefiore Medical Center, New York City.

“Several of us who were doing FMT for C. difficile infection had been writing to the FDA, asking them to change their policy,” Dr. Brandt said. “After several months of physicians and patients calling them, and their becoming aware of the fact that this was a procedure that was in great need [in order to] help a lot of people, they called a public conference on May 2-3. That conference had maybe five or six of us as panelists who were actively working in the field, and an audience of professional, as well as lay people. I was one of the more outspoken

panelists,” he said.

The workshop influenced the FDA to change its policy because—according to the guidance—physicians and scientists “expressed concern to the FDA that FMT is not appropriate for study under the agency’s IND regulations.”

Dr. Brandt recalled that he told the FDA: “I have the highest regard for the reasons why you went about making your judgment that the use of FMT should require an IND, namely that you

‘This is a happy conclusion to what was a long and painful process for most of us who had been doing FMT.’ —Lawrence J. Brandt, MD

are concerned about the safety and well being of the patients who might potentially receive this treatment. But thousands of FMTs have been done, and the incidence of severe acute adverse effects [AEs] is virtually zero. Your major concern is that by doing a fecal transplant, you might be predisposing the recipient of the stool to develop all or some of the diseases that the donor’s microbiota might predispose that donor to develop see FMT PAGE 20

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will maintain antimicrobial effectiveness for at least 48 hours.4,5 References: 1. Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009;91(8):1949–1953. 2. Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005;87(5):980–985. 3. Adler MT, Brigger KR, Bishop KD, Mastrobattista JM. Comparison of bactericidal properties of alcohol-based chlorhexidine versus povidone-iodine prior to amniocentesis. Am J Perinatol. 2012;29(6):455–458. Epub 2012 Mar 7. 4. Denton GW. Chlorhexidine. In: Block SS. Disinfection, Sterilization, and Preservation. 5th ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2001:321–336. 5. Hibbard JS. Analyses comparing the antimicrobial activity and safety of current antiseptic agents: a review. J Infus Nurs.

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2013

Controversial Data Show RF Ablation Beneficial for Low-Grade in Barrett’s B Y T ED B OSWORTH ORLANDO, FLA.—Radiofrequency ablation in Barrett’s esophagus patients with low-grade dysplasia provides significant protection against progression to highgrade dysplasia or esophageal adenocarcinoma, according to the findings of a multicenter, randomized trial presented at the 2013 Digestive Disease Week (DDW) meeting.

In fact, the benefit of radiofrequency ablation (RFA) relative to surveillance alone was so great, that the trial’s safety monitoring committee recommended terminating the trial after an interim analysis.

The demonstration that RFA can reduce the risk for progression in patients with LGD has immediate relevance to clinical practice, said senior author of the study, Jacques J. Bergman, MD, PhD, of the University of Amsterdam.

“The data suggest that if you can confirm LGD [low-grade dysplasia], the risk for progression does not appear to be much different than it is for patients with HGD. We are now working to change the Dutch guidelines,” Dr. Bergman said.

An important implication of the study was the need for rigorous confirmation of LGD by expert pathologists. The screening process for LGD is pivotal to the benefits associated with RFA, and LGD was “frequently overdiagnosed,” noted study coauthor K. Nadine Phoa, MD, of Academic Medical Center, in Amsterdam. A diagnosis of LGD was confirmed in less than half of the who were patients evaluated for entry into the study.

The study was conducted at nine European centers. Exclusion criteria eliminated 111 patients at the outset, and the remaining 136 patients were randomized to undergo surveillance or RFA, in two equal groups. After two years of a planned three-year study, 17

(25%) of the 68 patients randomized to the surveillance group progressed to HGD or esophageal adenocarcinoma.

Only one patient in the RFA group progressed to cancer (P<0.01). Six of the 17 patients with progression in the surveillance group developed cancer. The single progression in the RFA arm was a cancer that developed early, and the patient has remained cancer free since undergoing an endoscopic resection.

A second analysis presented at the DDW meeting also showed high rates of progression when LGD is confirmed by an expert panel. Both studies validate a national program for expert pathologic review of LGD in patients with BE that has been under way in the Netherlands for more than a decade.

A Barrett’s Advisory Committee (BAC) was formed in the Netherlands in 1998. The BAC provides an expert review of all LGD pathology specimens from any community hospital in the country.

The committee was formed because a large divergence in reported progression after diagnoses of LGD suggested a disparity in the quality of the diagnoses.

Follow-ups collected by the BAC on 466 patients diagnosed with LGD support this premise. After the expert pathology review by the BAC, 71% of the LGD diagnoses were downstaged either to nondysplastic BE or indefinite for dysplasia. LGD was confirmed in the remainder of patients with the exception of 2% of specimens that were upstaged to HGD. Of the 406 patients who were either downstaged or confirmed as having LGD, a median 51-month follow-up showed the rate of progression was 10% annually in the group with LGD versus 1% in the group that was downstaged.

“The estimated cumulative risk for progression over five years in [patients] with LGD was 40% as opposed to 5% for patients downstaged to non- or indefinite dysplasia,” said Lucas C. Duits, MD, research fellow in the Department

FMT

jContinued from page 19 over the next 10 or 20 years. Because of that major concern, you are preventing hundreds to perhaps thousands of people from getting FMT and, I believe, that more people are going to die as a result of that judgment than will ever be hurt by fecal transplant,” Dr. Brandt said.

Dr. Brandt’s concerns, and those of others on the panel, were persuasive enough to convince the FDA to reverse its previous decision.

“Understanding that C. difficile infection can be very serious, often with few or no other treatment options for patients, [the] FDA listened to the concerns expressed to us that the IND requirements may impact

‘The estimated cumulative risk for progression over five years in [patients] with LGD was 40% as opposed to 5% for patients downstaged to non- or indefinite dysplasia.’

—Lucas C. Duits, MD of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, and coauthor of the study. The median time to progression was 35 months.

In a 2010 study by Dr. Bergman’s group, 75% of cases initially identified as LGD were downstaged after an expert review (Curvers WL et al. Am J Gastroenterol 2010;105:1523-1530). The progression rate in this study was 13.4% per year in those whose LGD diagnosis was confirmed versus 0.49% in those who were downstaged after a median 51 months of follow-up.

In the Netherlands, digitized biopsies are streamlining the review process

such patients getting the treatment quickly, and therefore determined that it would exercise enforcement discretion for the use of FMT for these specific patients,” Ms. Liscinsky said.

Concerning the “potential risks” of FMT that physicians should inform their patients about, Dr. Brandt said, “The FDA does not mandate what risks you have to tell the patient about, and in fact there are only theoretic risks, none of which have been proven. There are very few acute serious AEs of FMT. Most commonly, patients develop transient gas, bloating, cramps and perhaps constipation that lasts for several days,” he said.

“Remember we’re not going to be doing fecal transplants forever,” Dr. Brandt added, “because there already are substitutions for FMT that are coming onto the

between community hospitals and the BAC, but Drs. Phoa and Bergman believe that biomarkers eventually will replace histopathologic reviews of biopsies for staging BE. However, these data immediately challenge clinical practice by suggesting that RFA is justified for LGD, if LGD can be confirmed by experts.

Due to the stark divergence of these results from past evidence, one of the moderators of the DDW session where the data were presented expressed some skepticism. Noting that the progression rate in this population of patients with LGD was about the same as the progression rates previously reported in HGD, Pradeep Bhandari, MBBS, MD, professor at Spire Portsmouth Hospital, Portsmouth, United Kingdom, said, “This is not an average LGD population.” Rather, by eliminating nearly 75% of the LGD patients considered for entry, Dr. Bhandari felt the trial center may have recruited a high-risk subset of patients with LGD. Nicholas J. Shaheen, MD, MPH, professor of medicine and epidemiology and director of the Center for Esophageal Diseases & Swallowing, University of North Carolina, Chapel Hill, said that the study “fills an important gap.”

Although the value of RFA in patients with HGD is well established, the controversial benefit for LGD has been “a reflection of the heterogeneity in outcomes” in this population; these data suggest that heterogeneity arises from failure to adequately document LGD, Dr. Shaheen said.

Dr. Bergman has received consulting fees and research support from Boston Scientific, C2 Medical, Cook Inc., Covidien, Olympus and Spectra Science.

Dr. Shaheen has received consulting fees and research support from AstraZeneca, BARRX Medical, CSA Medical Inc., NeoGenomics, Oncoscope Inc., Proctor & Gamble Pharmaceuticals, Shire Pharmaceuticals and Takeda Pharmaceuticals.

radar. Two examples are a prepared mixture of 33 species of bacteria, and freshly donated and then filtered and frozen material from a highly vetted set of donors.

Both are considered safer in terms of infection risk than [using] whole stool.”

The FDA still plans to develop a policy for the study and use of FMT, according to the agency.

“FDA intends to exercise this discretion on an interim basis while the agency develops appropriate policies for the study and use of FMT products under IND,” the guidance states.

Asked how long this interim period will last, Ms. Liscinsky wrote, “[W]e cannot predict a specific issue date.”

Every matrix has a story.

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Landmark Strides in Laparoscopic Technologies: Video to Robotics B Y V ICTORIA S TERN

F

or more than a century, the development of new optical and surgical tools, from lighting systems to video and robotic technologies, has been instrumental for thes advancement of laparoscopic surgery.

Georg Kelling, MD, and Hans Christian Jacobaeus, MD, performed the first exploratory laparoscopic procedures in the early 1900s, but it would take almost 50 years for surgeons to recognize the many benefits of minimally invasive surgery (MIS), as we know it today.

Like most advances, it began with small steps. In 1960, German gynecologist and engineer Kurt Semm, MD, invented the automatic insufflator that could inflate the abdomen with carbon dioxide (CO2) gas Surgeons perform traditional laparoscopy, without the while monitoring intraabdominal pressure (see Gener- aid of a camera. al Surgery Newss April 2013, page 1). Now, for the first time, surgeons could see inside the body without the ‘Once we had the VCR, we could patient’s abdominal wall impeding their vision. This invention would be an essential facilitator of intramake video tapes, and it was like abdominal surgery. night and day.‘ The 1960s also brought about an 80-kg camera coupling technology that allowed laparoscopists to observe —J. Barry McKernan, MD intraabdominal images on a television screen. In June 1962, George Berci, MD, senior director of Minimally Invasive Endoscopic Research at Cedars-Sinai Hospital, Los Angeles, published an article in which he discussed how the television could be used to improve endoscopy techniques, including the capability of viewing the images immediately, enlarging and recording them, correcting for brightness and contrast, and allowing multiple observers access to images (BMJ 1962;1:1610-1613).

But television technology left something to be desired; namely, the weight and bulk of the camera and the level of illumination that hampered its utility in endoscopy. These limitations led Dr. Berci and his col- Dr. Camran Nezhat in 1980 performing videolaparoscopy leagues to develop a miniature camera that was consid- with an early video camera prototype. erably lighter than its predecessors (0.35 vs. 80 kg) and that could be attached directly to the endoscope. This device produced an enlarged black-and-white image that could then be recorded using a 16-mm synchro- University of New York at Buffalo, Dr. Nezhat was diagnized movie camera. nosing and treating endometriosis laparoscopically and To test the value of the miniature camera, Dr. Berci wanted the ability to peer inside the patient without performed a bronchoscopy on a dog and concluded bending over and squinting through the laparoscope. that, although color documentation is generally prefer“I started borrowing cameras that were used for microable, “the quality of the black-and-white image appears surgery to see if I could rig it so the procedure was disto be good enough to make it of value in diagnosis” played on a monitor,” recalled Dr. Nezhat, currently chair (BMJJ 1962;1:1610-1613). of the Association of the Adjunct Clinical Faculty, StanIn 1970, after relocating from Australia to Los Ange- ford University Medical School, and adjunct clinical proles, Dr. Berci began training dozens of obstetricians and fessor of surgery and gynecology at Stanford University, gynecologists to do laparoscopy, and helped establish a in California. center for laparoscopy at Cedars-Sinai Hospital, perOperating with a monitor not only allowed surgeons forming as many as 700 laparoscopic procedures in the to stand upright and view the procedure more easily, but first year. Later, Dr. Berci developed a miniature color also permitted the entire OR team to see what was hapTV camera that became popular in the operating room pening and to coordinate their movements.

(OR) ((J Reprod Medd 1986;31:585-588).

“Videolaparoscopy changed the environment for sur“My personal role was to develop and help improve geons,” said Dr. Nezhat, who pioneered the technique. video technique,” Dr. Berci said, adding that recording “Dr. Nezhat wasn’t the first to bring a TV monitor procedures made it easier to teach students laparoscop- into the OR and use a video camera to view the inside ic techniques and to lecture. of the body, but he was the first to re-imagine those two Meanwhile, in the 1970s, gynecologic surgeon Cam- elements and combine them into something entirely ran Nezhat, MD, FACS, FACOG, became fascinated new and, most importantly, something that saves countwith the potential of video technology to revolution- less lives and improves millions of others each year,” said ize laparoscopic procedures. In the mid-1970s, during Barbara Page, a research assistant for Dr. Nezhat. his obstetrics and gynecology residency at the State After a two-year reproductive endocrinology

fellowship at Medical College of Georgia in Augusta, Dr. Nezhat started his own infertility practice in Atlanta, which gave him the time to focus on improving video laparoscopy techniques and instruments.

For instance, he developed several tools, including the Nezhat Coherent Coupler that allowed him to use a CO2 laser through the operative channel of the laparoscope.

However, he had no luck convincing companies to invest in his ideas or journal editors to publish his work. “I went after every company that would listen, but no one was interested, and publications were rejecting my technique of video laparoscopy, saying operating off the monitor was dangerous and could kill the patient,” he said.

Throughout the 1970s, laparoscopy would primarily remain the domain of obstetricians and gynecologists, but by the early 1980s, Dr. Nezhat’s work started to attract more attention. In 1982, Dr. Nezhat began teaching postgraduate courses in operative video laparoscopy at Georgia Institute of Technology in Atlanta, with his colleague, pediatrician Scott Crowgey, MD. French gynecologists Maurice Bruhat, MD, and Hubert Mahnes, MD, came to their courses in the United States to learn video laparoscopy and lectured on the technique upon returning to France. Dr. Nezhat also presented his video technique at meetings in France. This is how the work really started to take off, Dr. Nezhat recalled.

Soon the media picked up on the video technology, with Newsweek and Time publishing stories featuring Dr. Nezhat’s videolaparoscopic techniques in 1986.

After observing Dr. Nezhat’s video technique, general surgeon Phillip Mouret, MD, performed his first laparoscopic cholecystectomy using a video display in 1987, and a year later Barry McKernan, MD, and William Saye, MD, did the same in the United States (General Surgery News, July 2013, page 1). In 1987, Drs. Nezhat and Crowgey also published two articles on videolaparoscopy (Br J Hosp Medd 1987;38:219-224; Contrib Gynecol Obstet 1987;16:303-312).

Not only did video technology permit surgeons to operate with greater ease, but it also served as a common language for surgeons around the world to learn and improve on the techniques. Surgeons, such as Drs. McKernan, and Nezhat and general surgeon Eddie Joe Reddick, MD, displayed their video-based laparoscopic procedures at medical meetings throughout the United States. As the use of video gained acceptance, surgeons were able to perform more advanced procedures.

Ultimately, the published data caught up with practice, revealing the benefit of using video technology to facilitate laparoscopic surgery.

“Once we had the VCR [video cassette recorder], we could make video tapes, and it was like night and day,” Dr. McKernan said. “I recorded all my procedures of laparoscopic cholecystectomies, appendectomies and more. Observers could actually see these operations were possible.”

Ethicon and US Surgical When laparoscopic cholecystectomy started to gain popularity in the United States, two companies, United States Surgical Corporation (USSC) and Ethicon, Inc., a division of Johnson & Johnson ( JnJ), stood out as the main driving forces behind technological advances in laparoscopy. Both companies became

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actively involved in the laparoscopic revolution, working closely with surgeons in the United States and abroad to facilitate education and the development of new techniques and tools.

“The time of laparoscopic cholecystectomy was a whirlwind, unlike anything else in surgery,” said Edward Chekan, MD, director of medical education at Ethicon Endo-Surgery, Cincinnati, who worked closely with USSC for many years at the start of his surgical education. “At the time, there were two big dogs in the manufacturing arena. It felt like two wagons going out West: The territory was immense and the opportunity was overwhelming. Everything was moving quickly, careers were skyrocketing and, most importantly, patients were the main [beneficiaries].”

Nicholas Valeriani, CEO of the West Health Institute, La Jolla, Calif., who worked at JnJ for more than three decades and was president of Ethicon Endo-Surgery for many years, agreed: “It was truly a unique time where the medical community and industry worked collaboratively to advance the techniques of laparoscopic surgery to ultimately improve patient care.”

New Tools In 1960, Russian surgeons and engineers developed surgical stapler prototypes. Excited by these devices, Mark Ravitch, MD, a surgeon at Johns Hopkins University in Baltimore, attempted to introduce the staplers in the United States, but surgeons and nurses experienced difficulty with manually loading staples into the apparatus, and the stapler initially failed to gain traction in this country.

That year, entrepreneur Leon Hirsch visited a patent attorney in hopes of expanding his business of manufacturing dry cleaning equipment to manufacturing helicopter parts. Mr. Hirsch saw the Russian stapler equipment sitting on the attorney’s desk and became intrigued, prompting him to contact Dr. Ravitch. Mr. Hirsch soon modified the flawed design, inventing the first stapling cartridge with preloaded staples. This marked the beginning of USSC. In 1967, USSC introduced its reusable Auto Suture Stapling devices with disposable stapling cartridges. During the next 20 years, laparoscopic techniques began to evolve more quickly, with pioneers like gynecologist Dr. Semm and surgeon Henk de Kok, MD, performing the first laparoscopic appendectomies, and surgeon Erich Muhe, MD, doing the first laparoscopic cholecystectomy (General Surgery News, April 2013, page 1). The evolution of laparoscopic tools followed.

By 1987, USSC introduced the first disposable trocar, the SurgiPort. The device permitted surgeons to slide a laparoscopic camera or other tools through its tube-like design, and came with a safety shield that covered the trocar tip to protect the underlying abdominal organs. Frederick Greene, MD, former chairman of the Department of Surgery at Carolinas Medical Center in Charlotte, N.C., recalled that these trocars were safer because surgeons could watch the trocar as it entered the abdomen and avoid piercing any organs accidentally.

That same year, USSC also introduced the first laparoscopic clip applier. This multiple EndoClip Applier was fashioned with a reusable handle and could automatically fire 20 clips without reloading. Hospitals, however, had a difficult time maintaining their limited supply of reusable handles, prompting USSC to introduce the first fully disposable, multiple EndoClip Applier in 1989.

“We no longer had to wait around to take apart and

Carlos Babini (left) of U.S. Surgical and David Sabiston, MD, at the opening of the first Laparoscopic Center of Excellence at Duke University Medical Center, where Dr. Sabiston served as surgical chair. sterilize the complex reusable trocars or clip appliers,” said Robert Sewell, MD, a general surgeon at the Master Center for Minimally Invasive Surgery in Southlake, Texas.

USSC recognized the advantages of disposable instruments and started to modify its design. In January 1990, the company came out with the Auto Suture EndoGIA, a disposable laparoscopic surgical stapler that fit through the SurgiPort trocar, and could be used for a range of laparoscopic procedures.

At this time, USSC dominated the market on laparoscopic equipment and surgeon training. The company worked with 20 top medical schools in the United States and abroad to establish Laparoscopic Centers of Excellence, the first of which was Duke University Medical Center under the guidance of surgical chair David Sabiston, MD. These collaborative laparoscopic training centers helped enhance laparoscopic product development and reached both the surgeon-in-training and the practicing surgeon.

“We had a waiting list of surgeons who wanted to take USSC-sponsored laparoscopic courses,” said Carlos Babini, currently executive vice president of SurgiQuest, Inc., who held various management and executive positions at USSC from 1979 to 1999, including vice president and general manager of advanced technology.

“Ultimately, we went on to help train 45,000 general surgeons globally from the late 1980s to the late 1990s. Like so many other great historical contributors, the company helped change the future of surgery,” Mr. Babini said. “However, we did not take this lightly. My thought was that if one invents the future, then one has the responsibility to facilitate a pathway there.”

Soon, Ethicon saw the value of MIS and launched its own disposable instrumentation at the beginning of 1991 to compete with USSC in the laparoscopic surgery arena.

“The trocar was the first minimally invasive device we had,” Mr. Valeriani said. “When we first met Dr. McKernan in 1991, we began to understand the potential of this tool, and started to see a world in which we could help transform surgery from open to laparoscopic procedures.”

That year, Dr. McKernan spoke at Ethicon’s corporate headquarters in New Jersey, when the company had only one trocar and a suture ligature, the EndoLoop.

“During my talk, I let the crowd know that USSC was already working on multiple instruments,” Dr. McKernan said. “After that, I helped Ethicon design its new tools and laparoscopic teaching facility in Cincinnati.”

To facilitate education and development, Ethicon Endo-Surgery built training centers, the first of which was a $50 million facility in Cincinnati. The company’s approach was to work closely with surgeons in a range of specialties to develop tools that would allow them to shift from open to laparoscopic procedures.

“We looked for a procedure-enabling technology, the device that would take surgery from an open technique to a laparoscopic one,” Mr. Valeriani noted. “For gallbladder, it was a clip applier; and for hernia, it was a hernia tacker.”

Surgeons worked with Ethicon’s Procedure Development Team, which included engineers and scientists, to develop the new techniques and identify the necessary instrumentation.

“There was a great collaboration among surgeons and our company,” Mr. Valeriani said. “If a doctor described the kind of device he or she wanted on Monday, our engineers could develop a prototype within 24 to 48 hours. The surgeon was the center of our world, deeply embedded in the development process.”

With 45 new products on the market by the end of 1991, Ethicon was expanding fast, selling about $55 million in endoscopic tools that year, while USSC pulled in about $300 million in sales of endoscopic equipment in 1991 (The New York Timess Feb. 28, 1992).

Dr. Chekan said he felt “the companies were in competition with themselves as to how quickly and efficiently they could meet the manufacturing demands and how well they could foster an environment of innovation.”

Although the competition between USSC and Ethicon was fierce, Mr. Valeriani and Mr. Babini noted that the competition made each company better.

Overall, the laparoscopic revolution goes far beyond any single innovation, person or device. “Laparoscopy does not represent a point in time, but rather an integral part of an exciting ongoing evolution, which means we’re still improving technology and surgical skill to move us toward a better horizon,” Mr. Babini said.

Instrument Shortage The demand for learning and performing the procedure went hand-in-hand with the demand for instruments. But, for a time, there just weren’t enough tools to go around.

“Many of the surgeons we trained were unable to start doing procedures because they couldn’t get the instruments,” Dr. Sewell said. “In those early days, surgeons were hard-pressed to find a set of laparoscopic instruments in the United States, and hospitals had to wait a long time to be outfitted with the new technologies, like insufflators. If you had one of the clip applier handles, you were lucky, and if you didn’t, you were pretty much out of business.”

Dr. Greene recalled the instrument shortage: “[In 1991], I was coming back to Columbia, South Carolina, to do my first laparoscopic cholecystectomy, and I had to borrow the instruments from Wolf Surgical because we didn’t have them at my hospital yet.”

(Dr. McKernan noted that for about a year, salespeople made a living going from hospital to hospital with high-demand equipment.)

Soon, the companies began to develop equipment faster because they saw the huge demand driven by compelling patient benefits and the opportunity for increased profitability, said Edward Felix, MD, director of bariatric surgery, Clovis Hospital, Fresno, Calif. “It was like the ‘Gold Rush’ of laparoscopy.” see TECHNOLOGY page 24

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TECHNOLOGY

jcontinued from page 23

Robotic Surgery Technology In 1983, Meredith Thring, ScD, a mechanical engineer at the University of London, England, described a novel idea in which surgeons could perform an operation without ever touching the patient. He dubbed this concept telechiric surgery. Unfortunately, Dr. Thring’s concept for telechiric surgery was limited to an artist’s rendering. But then in the early 1990s, a team of innovators at Stanford Research Institute (SRI) International in Menlo Park, Calif., decided to bring this idea to life, developing a robotic system that would allow surgeons to operate on patients remotely.

“The fact that laparoscopy was valuable in concept and yet so difficult to learn for the average surgeon represented a problem that we could potentially solve with the help of robotic technology,” said Ajit Shah, PhD, former executive director at SRI International.

The team of engineers and scientists, which included Dr. Shah, Philip Green, Joel Jensen and John Hill, began to explore how technology could help surgeons overcome the challenges associated with laparoscopic surgery. While working with Dr. Nezhat and observing him perform complex laparoscopic procedures, the team realized that the real challenge was to build a machine that could allow less experienced surgeons to perform laparoscopic procedures with the same level of expertise that Dr. Nezhat exhibited.

The team needed to create a system that could reproduce the normal, precise motions of a surgeon.

To accomplish this, the team turned to Mr. Hill, an expert at designing robotic systems, as well as Mr. Jensen, who specialized in developing complex mechanisms for medical purposes. With Mr. Hill and Mr. Jensen’s leadership, the team created the SRI Telepresence Surgery System, a technology that gave surgeons the visual and tactile sense of being inside the patient. This robotic technology eventually became the foundation for the da Vinci system.

Surgeons initially tested the telepresence system on animals, by performing a range of procedures, including hysterectomies and cholecystectomies, and found that robotic assistance prolonged surgery, but allowed for similar accuracy and outcomes as open sur- EndoGIA stapler. gery ((J Vasc Surgg 1996;23:281-287).

The National Institutes of Health decided to support the pioneering work at SRI with Sierra Ventures in Menlo Park, Calif., to commerciala three-year grant. After the team had demonstrated ize the technology developed by SRI. Dr. Vanio saw the potential of the telepresence system, the Defense the potential of the telepresence technology and led Advanced Research Projects Agency became interest- the financing of a new company that would promote ed in the technology as a way to treat casualties of war its advancement. from a safe, remote location, and helped fund develIn 1995, Intuitive Surgical was born. Researchers at opment of the Telepresence Surgery System for battle- Intuitive Surgical, initially in collaboration with the field applications. original team at SRI, continued to develop progresDespite success in demonstrating that robotic sur- sively more advanced prototypes of the telepresence gery was feasible, the SRI team found commercializ- system, including “Leonardo” and “Mona.” These proing the technology to be difficult. After almost three totypes eventually morphed into the da Vinci robot. years and a series of failed attempts to garner interIn 1999, Intuitive Surgical introduced the da Vinci est from investors, Dr. Shah teamed up with Petri Surgical System, and in July 2000, the FDA approved Vanio, PhD, general partner at the venture capital firm its use in general laparoscopic surgery. The da Vinci

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outcomes.” Dr. Breeden concluded that robotic technology may be most useful as a teaching tool and for unusual and complex clinical conditions, not as standard surgical practice.

Dr. Shah, in contrast, expressed a different perspective on the benefits of da Vinci robots. Today, pressure to contain costs in medicine has resulted in a reluctance to invest in or adopt novel technologies. Although using costeffectiveness as a filter for adoption is useful in some contexts, this reluctance often works to stifle innovation.

“Much like the effort to land on the

moon or introduce the automobile to a horse-and-carriage society, the benefit of robotic surgery cannot be measured purely in short-term dollars and cents,” Dr. Shah said. “Rather, the introduction of technology that fundamentally transforms the practice of medicine and creates a platform for the next disruption is the basis on which all great advances in society have been built.”

SurgiPort and EndoClip applier.

robot was the first robotic system of its kind to receive FDA clearance.

The robotic surgery system works by deploying four robot arms, each of which carries a microtool, outfitted with a camera, for manipulating, cutting, cauterizing and suturing. The surgeon sits at a control console that manipulates a movable cart that holds the robotic arms and is next to the operating table. The surgeon’s hand movements are translated into precise cuts and sutures by the robotic arms, through a microprocessor chip embedded in each microtool.

Currently, more than 2,000 da Vinci systems are used in almost 1,500 hospitals in the United States. Dr. Nezhat says he performs half of his procedures with the da Vinci robot and teaches the technique to his students, but also acknowledges several limitations of the robot. For instance, studies show that the robotic arm does not improve outcomes when the surgeon is experienced in laparoscopic techniques.

“The robot is not doing the surgery; it’s simply a computer-enhanced technology, which makes it much easier for surgeons to learn laparoscopic techniques. In other words, the robotic arm is an enabling device that helped laparoscopy spread faster,” Dr. Nezhat said.

Dr. Nezhat also pointed out that the data show the robotic arm makes procedures more expensive, and lengthier, and requires bigger incisions. One robot costs $1 million to $2.3 million, in addition to $140,000, on average, in annual maintenance costs and approximately $2,000 disposables costs per surgery.

James T. Breeden, MD, president of the American College of Obstetricians and Gynecologists, issued a statement on March 14, 2013, in which he put the existing robotic technology into perspective: “At a time when there is a demand for more fiscal responsibility and transparency in health care, the use of expensive medical technology should be questioned when less costly alternatives provide equal or better patient

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It’s Come To Pass Once Again: Notable Breast Cancer Papers of 2012 B Y M ONICA S MITH CHICAGO—Long-time attendees of the annual meeting of the American Society of Breast Surgeons (ASBS) have been enjoying Dr. Helen Pass’s talk on top breast papers, with yearly updates, for a decade. Fans appreciate Dr. Pass’s annual contribution as a labor of love; this year, her PubMed search yielded more than 18,000 English-language, clinical breast papers.

Because it’s impossible for her to include every innovative and outstanding article she finds, Dr. Pass limits her selections to those that stand out for one reason or another: “[whether] patients ask about them, or they’re subjects we argue over in tumor board, or they have the potential to be practice-changing,” said Dr. Pass, director, Division of Breast Surgery, and co-director, Women’s Breast Center, Stamford Hospital, Stamford, Conn.

1.

van Schoor G, Otten J, den Heeten G, et al. Breast cancer among women over 75 years: An important public health problem.

Eur J Public Health 2012;22:424-429.

The U.S. Preventive Services Task Force has not yet defined an upper age limit for mammography screening.

Seeking to determine if breast cancer in elderly women is a public health concern, researchers analyzed data from the Netherlands where women over 75 are not prohibited from being screened, but are not sent a reminder letter.

They included 15,508 women who had been involved in a regimented screening program until age 75, but not after. Allcause median survival was 10 years, and more than 25% lived up to 15 more years.

Only 341 were diagnosed with breast cancer, an incidence equivalent to that seen in screening mammography trials.

Of those who had breast cancer, 223 died, 73 from breast cancer, for a mortality risk of 30%. The researchers concluded that breast cancer in women over 75 is still a significant clinical concern.

Dr. Pass: “This is where we have to use some clinical judgment. A healthy elderly woman should be able to choosee to get mammograms. You have to understand the patient’s goals. Most of the time, this is maintaining their independence and quality of life. My bias is that when you find cancer early, patients can be treated with less invasive measures, so I use this to justify continued screening to my internal medicine colleagues in patients without significant comorbidities.”

2.

Sajid M, Hutson K, Akhter N, et al. An updated meta-analysis on the effectiveness of preoperative

prophylactic antibiotics in patients undergoing breast surgical procedures. Breast J 2012;18:312-317.

Do patients need preoperative antibiotics for what is supposed to be a clean case? It’s a common argument. This paper was an analysis of nine randomized trials of the risk for subsequent infection in patients who did or did not have preoperative antibiotics. It included 3,720 patients evenly randomized to receive or not receive antibiotics.

The researchers found a significantly decreased risk for surgical site infection (SSI) in breast surgery patients who got preoperative antibiotics (P=0.0005), P and the use of antibiotics was not associated with an increase in adverse reactions.

They concluded antibiotics mayy be administered, but are not mandatory.

The ASBS’s position statement on the use of preoperative antibiotics states IV antibiotics are indicatedd for mastectomies or partial mastectomies with or without an axillary procedure, and with or without reconstruction; suggestedd for excisional open biopsies; and oral antibiotics should be consideredd if an accelerated partial breast irradiation (known as APBI) device is placed, and the antibiotic of choice is first-generation cephalosporin.

Dr. Pass: “It’s nice to have this data to guide management decisions.”

3.

Lee M, Plews R, Rawal B, et al. Factors affecting lymph node yield in patients undergoing axillary node dissection for primary breast cancer: A single-institution review. Ann Surg Oncol 2012;19:1818-1824.

A total of 10 nodes has always been the hallmark of a complete axillary lymph node dissection (cALND). But surgeons sometimes find that despite performing a formal level I-II procedure, they get far fewer nodes in patients who had neoadjuvant chemotherapy.

This review, done at an institution of the National Comprehensive Cancer Network (NCCN), sought to determine if neoadjuvant chemotherapy reduces total lymph node yield. The researchers compared lymph node yield between 240 patients who received adjuvant chemotherapy and 903 patients who received primary surgical therapy alone.

The median lymph node yield was about the same in the adjuvant chemotherapy and primary surgery groups (15 and 17, respectively), but the range (1-46 and 2-64) was quite variable (P=0.0003).

P The neoadjuvant chemotherapy group had significantly more patients with fewer than 10 nodes.

The researchers suggested considering a revision of the NCCN guidelines

regarding the number of lymph nodes for patients who have received neoadjuvant treatment.

Dr. Pass: “When it comes to the tumor board and the medical and radiation oncologist’s assessment of the completeness of your surgical technique, it’s nice to have this paper to support your contention that ‘I did do a formal operation; it’s just the biology of the disease.’”

4.

Fitzal F, Mittlboeck M, Steger G, et al.

Neoadjuvant chemotherapy increases the rate of breast conservation in lobular-type breast cancer patients. Ann Surg Oncol 2012;19:519-526.

Patients with invasive lobular carcinoma (ILC) tend not to respond as well to neoadjuvant chemotherapy as do patients with invasive ductal carcinoma (IDC) in terms of pathologic complete response. But that does not necessarily mean they do not benefit.

This study sought to establish the rate of conversion to breast-conserving therapy in patients previously considered not eligible. The researchers reviewed data on 325 patients, 21% of whom had ILC, participating in three neoadjuvant therapy trials.

They found a conversion rate to breast-conserving therapy of 45% in ILC patients and 52% in IDC patients.

The local recurrence rate in ILC patients was the same whether they had breastconserving therapy or mastectomy. They concluded that ILC patients should not be excluded from neoadjuvant chemotherapy.

Dr. Pass: “If we can convert 45% of women to [breast-conserving therapy] and that’s what they want, we should be willing to do it, especially since we’re not sacrificing oncologic outcomes.

The other thing we have to remember is that patients with ILC who are ER/ PR [estrogen receptor/progesterone receptor]-positive respond very well to neoadjuvant endocrine therapy. This is where multidisciplinary decision-making becomes very critical.”

5.

Davies C, Pan H, Godwin J, et al.

Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor–positive breast cancer: ATLAS, a randomized trial. Lancet 2013;381:805-816.

The ATLAS trial, which investigated the effect of prolonging tamoxifen therapy, found recurrence, breast cancer mortality and overall mortality were all lower in patients randomized to an additional five years of tamoxifen after

completing the initial five years. Non– breast cancer–related mortality, however, was about the same in both groups.

Although the risk for pulmonary embolism did go up in the 10-year group, mortality was the same. The risk for stroke was not significant; ischemic heart disease was lower in the longertreated group. The risk for endometrial cancer was higher in the 10-year group, but the risk for dying from the disease still was far lower than the risk for dying from breast cancer.

Dr. Pass: “I think we all accept that 10 years of treatment is superior, but we worry about the side effects. However, for premenopausal women, 10 years of tamoxifen should be employed. They can’t get aromatase inhibitors, and they have a very low risk of uterine cancer.”

6.

Weigert J, Steenbergen S. The Connecticut experiment: The role of ultrasound in the screening of women with dense breasts. Breast J 2012;18:517-522, 2012.

To assess the utility of ultrasound in women with dense breasts and a normal screening mammogram, researchers conducted a retrospective chart review of six radiology practices in Connecticut, which has a robust screening ultrasound program.

Of the 8,647 women who underwent screening ultrasound, about 5% met the indication for biopsy, and of those patients, 28% had cancer. There was one false-negative screening ultrasound.

In this patient population, screening ultrasound had a positive predictive value of 6.7%, a negative predictive value of 99.9%, a sensitivity of 97% and a specificity of 95%.

There are some obstacles to adoption of the modality: in particular, the unwillingness of radiologists to embrace whole breast ultrasound, and the lack of a billing code for the screening ultrasound.

Dr. Pass: “But it will find cancers, and in women with dense breasts who have a [positive] family history, it’s definitely one more tool in the armamentarium that should be considered.”

7.

Peled A, Foster R, Stover A, et al.

Outcomes after total skin-sparing mastectomy and immediate reconstruction in 657 breasts. Ann Surg Oncol 2012;19:3402-3409.

Researchers looked at postoperative complications, tumor involvement in the nipple areolar complex (NAC) and recurrence in 428 patients who underwent 657 total skin-sparing mastectomies over see BREAST CANCER page 28

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In the News BREAST CANCER jcontinued from page 26

a nine-year period.

They found a partial nipple loss of 2%, a complete nipple loss of 1.5%, and skin flap necrosis in 11.9%. Only 3% of the patients had tumor involvement in the NAC, which was managed by repeat excision or radiation. Median local recurrence was 2% at 28 months, and 2.4% at three years. There was no recurrence in the nipple skin itself.

They concluded that total skin-sparing

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2013

mastectomy is oncologically safe with a low level of complications.

Dr. Pass: “They also made some technical suggestions. For example, ‘the extent of the periareolar incision must be limited to less than one-third of the diameter of the NAC or avoid the NAC entirely.’ Also, avoid tension on the skin for patients undergoing implant expansion.”

8.

Setton J, Cody H, Tan L, et al. Radiation field design and regional control in sentinel lymph node-positive breast cancer patients with omission of axillary

dissection. Cancer 2012;118:1994-2003.

Complete ALND is no longer recommended for women with a low axillary burden, but the value of additional axillary radiation is unknown. This paper assessed the impact of radiation field design on 326 patients with positive sentinel nodes who underwent breastconserving therapy without cALND, 93% of whom received radiation.

At four years, regional control was 99%, local control was 98%, disease-free survival was 95%, and overall survival (OS) was 91%. They concluded that whole breast irradiation was sufficient

treatment after breast-conserving therapy for patients with low axillary burden.

Dr. Pass: “So, we do not need to extend the radiation field to include the axilla, no matter how much our radiation oncologist is tempted. The point is we’re trying to minimize side effects.

Radiation carries a risk just like surgery, so let’s not substitute one complication for another.”

9.

Allred D, Anderson S, Paik S, et al.

Adjuvant tamoxifen reduces subsequent breast cancer in women with estrogen receptor-positive ductal carcinoma in situ: A study based on NSABP Protocol B-24. J Clin Oncol 2012;30:1268-1273.

The B-24 trial demonstrated a 37% relative risk reduction in local recurrence and contralateral breast cancer in patients with ductal carcinoma in situ (DCIS) who received tamoxifen.

Receptor status, however, was not a component of patient enrollment.

In this study, researchers evaluated the influence of receptor status on response. Of the 732 patients in the original study population with DCIS, 76% were ER-positive. In those patients, tamoxifen significantly decreased the risk for breast cancer; no benefit was found in ER-negative DCIS patients.

They concluded tamoxifen should be considered in patients with ER-positive DCIS. Dr. Pass: “Some people figure the risk– benefit ratio does not favor the addition of tamoxifen in patients with DCIS. But there’s a reported greater than 40% reduction in subsequent breast cancer … [in ER-positive patients who receive tamoxifen], so I really think a balanced conversation is necessary.”

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Chlebowski R, Col N. Postmenopausal women with DCIS postmastectomy: A potential role for aromatase inhibitors. Breast J 2012;18:299-302.

Women with DCIS are at increased risk for subsequent breast cancer, but are not commonly given tamoxifen due to the perception of an unfavorable risk– benefit ratio. In this subset analysis of the MAP.3 primary breast cancer prevention trial, researchers evaluated outcomes in the patients who underwent mastectomy for DCIS and received exemestane.

At 35 months’ median follow-up, there was a 65% reduction in invasive breast cancer and a 53% reduction in in situu breast cancer in women who received exemestane compared with those who received placebo. There was no difference in skeletal events, cardiovascular events or quality of life.

Dr. Pass: “In postmenopausal women who have had a mastectomy where you

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2013

have concerns about tamoxifen, it’s good to know you can justify using an [aromatase inhibitor]. However, currently tamoxifen is the only FDA-approved drug for use in patients with DCIS.”

11.

Truin W, Voogd A, Vreugdenhil G, et al. Effect of adjuvant chemotherapy in postmenopausal patients with invasive ductal versus lobular breast cancer. Ann Oncol 2012;23:2859-2865.

Recent studies have shown that women with receptor-positive ILC who receive neoadjuvant chemotherapy have lower pathologic complete response than those with IDC. These researchers evaluated the effect of adding neoadjuvant chemotherapy to hormonal therapy in ILC and IDC patients.

In 19,609 IDC patients, 10-year survival was 69% for those who received hormonal therapy alone and 74% for those who also received chemotherapy.

In the 3,685 ILC patients, however, 10-year survival was about 67% with or without the addition of chemotherapy.

The researchers concluded adjuvant chemotherapy does not confer additional benefit to postmenopausal women with ILC receiving endocrine therapy.

3. Niikura N, Liu J, Hayashi N, et al. Loss of human epidermal growth factor receptor 2 (HER2) expression in metastatic sites of HER2-overexpressing primary breast tumors. J Clin Oncol 2012;30:593-599.

These three papers all found a change in receptor status.

Dr. Pass: “Taken together, they tell us that metastatic lesions need to be biopsied not to document that they’re metastatic disease, but to get a new receptor profile to guide subsequent therapy.”

4. Baselga J, Cortes J, Kim S, et al.

Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer.

N Engl J Medd 2012;366:109-119.

5. Baselga J, Campone M, Piccart M, et al. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med 2012;366:520-529.

6. Mehta R, Barlow W, Albain K, et al. Combination anastrozole and fulvestrant in metastatic breast cancer.

N Engl J Med 2012;367:435-444.

7. Hadji P, Kieback D, Tams J, et al. Correlation of treatment-emergent adverse events and clinical response to endocrine therapy in early breast cancer: a retrospective analysis of the German Cohort of TEAM. Ann Oncol 2012;23:2566-2572.

8. Fontein D, Houtsma D, Hille E, et al. Relationship between specific adverse events and efficacy of exemestane therapy in early postmenopausal breast cancer patients. Ann Oncoll 2012;23:3091-3097.

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Dr. Pass: “This reinforces what we know, but we need to be careful applying population-based information to one person. That’s where molecular profiling is much more specific and appealing.”

12.

Verna S, Miles D, Gianni L, et al.

Trastuzumab emtansine for HER2positive advanced breast cancer. N Engl J Med 2012;367:1783-1791.

The EMILIA trial found trastuzumab emtansine (TDM-1) significantly prolonged progression-free survival and OS compared with lapatinib plus capecitabine in women with HER2positive advanced breast cancer who had already been treated with trastuzumab and a taxane.

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Also Mentioned 1. Lindstrom L, Karlsson E, Wilking U, et al. Clinically used breast cancer markers such as estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 are unstable throughout tumor progression.

J Clin Oncoll 2012;30:2601-2608.

2. Amir E, Miller N, Geddie W, et al.

Prospective study evaluating the impact of tissue confirmation of metastatic disease in patients with breast cancer. J Clin Oncoll 2012;30:587-592.

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2013

More Women Eligible for Nipple-Sparing Mastectomy, Study Shows B Y M ONICA J. S MITH CHICAGO—Recent research suggests that more women can safely undergo nipple-sparing mastectomy (NSM), especially as surgeons become increasingly proficient in the procedure. The absolute contraindications for NSM are generally agreed upon, but additional selection criteria are less clear and vary from one institution to another.

Suzanne Coopey, MD, assistant in surgery, Massachusetts General Hospital, Boston, and her colleagues analyzed data on all patients at their institution who underwent NSM between January 2007 and 2012. “We began performing NSM at Massachusetts General in 2007. As experience was gained, we found that eligibility for the procedure was extended to patients who were initially excluded,” Dr. Coopey said.

“In 2007, only 1% of all mastectomies, with reconstruction, were nipple-sparing. By 2011, it had grown to 28%, and the trend seemed to be continuing into 2012.”

In September 2011, with the approval of the Institutional Review Board, Dr. Coopey and her colleagues created an NSM database, retrospectively entering patients’ data for the years 2007 to 2011, and prospectively entering them from that point forward. The study assessed trends in patient selection and outcomes between the two time periods. Dr. Coopey presented the study at the American Society of Breast Surgeons’ annual meeting ((Ann Surg Oncoll 2013, Aug. 13. [Epub ahead of print]).

Altogether, the study included 645 consecutive NSMs in 370 patients with a mean age of 47 years and a mean BMI of 24 kg/m². Few of the patients were active smokers or diabetic. The indication for NSM was risk reduction in 330 breasts, invasive cancer in 226, and ductal carcinoma in situ in 89.

The mean invasive tumor size was 1.8 cm, and the mean estimated tumor-to-nipple distance was 4 cm, with 25% of the patients having a tumor-to-nipple distance of less than 2 cm. Fifty-one patients had positive

‘We also found the rate of positive subareolar/nipple margins decreased over time, even when more operations were being performed for cancer, suggesting improved patient selection.’

—Suzanne Coopey, MD lymph nodes; 27 had undergone neoadjuvant chemotherapy; and 48 breasts had received previous radiation.

Most of the patients underwent a single-stage implant reconstruction, with 96% having tissue expander or implant-based reconstruction.

The surgeons used a variety of incisions, favoring the inferolateral incision, which begins at the 6 o’clock position of the intramammary fold, travels along the fold and up along the lateral portion of the breast for 10 to 12 cm.

“We feel this gives the best cosmetic result and allows for greatest access to the axilla,” Dr. Coopey said.

Total nipple necrosis occurred in 1.7% of breasts, and an additional 3.7% of nipples needed to be removed due to positive subareolar/nipple margins. At a mean follow-up of 22.1 months, local recurrence occurred in four of the 156 breasts that had been operated on for cancer between the years 2007 and 2011, and four of those recurrences happened in patients with genetic mutations.

“To date, no recurrences have occurred in patients operated on in 2012, and no recurrence has involved a nipple–areolar complex [NAC],” Dr. Coopey said.

“Also, no prophylactic NSM patient has developed breast cancer.”

Patients in the 2011-2012 group had a higher rate of positive lymph nodes, which is not surprising given that they were more likely to have a cancer diagnosis than

GSN Bulletin Board

those in the earlier group. The later group also had a significantly higher BMI (24.4 vs. 22.9 kg/m2) and significantly higher breast volume (519 vs. 366 cm3). “Despite this, there was no difference in total nipple necrosis rates between the two groups,” Dr. Coopey said.

The 2011-2012 group also included more current smokers, more patients with diabetes, and more patients who had undergone neoadjuvant chemotherapy, although the differences between those proportions were not significant.

In summary, Dr. Coopey’s team found that the eligibility for NSM at their institution had expanded to include women with higher BMI and larger breasts, with no increase in nipple loss due to ischemia.

“We also found the rate of positive subareolar/nipple margins decreased over time, even when more operations were being performed for cancer, suggesting improved patient selection,” Dr. Coopey said.

The researchers concluded that in the absence of absolute contraindications (i.e., clinical or imaging evidence of NAC involvement; locally advanced breast cancer with skin involvement; inflammatory breast cancer; and bloody nipple discharge), NSM should be considered for patients who at one time might not have been given that option, including patients with cancer, higher BMI and larger breasts.

Shawna Willey, MD, vice chair, Clinical Affairs, Department of Surgery and director, Betty Lou Ourisman Breast Health Center at MedStar Georgetown University Hospital, Washington, D.C., has witnessed a similar trend at her institution.

“I think there was appropriate caution early in the course of doing NSM, and as with many operations, the contraindications were broad so that we could be sure that it was a safe approach and that we weren’t compromising the oncologic care of patients,” Dr. Willey said.

“We are now seeing that the guidelines we published out of Georgetown in 2009 have become passé, and we know now that we can expand the indications safely as long as we pay attention to margins and characteristics of the skin,” she said.

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B Y C HRISTINA F RANGOU SAN FRANCISCO—The majority of patients newly diagnosed with metastatic colorectal cancer (mCRC) in the United States have not undergone KRAS testing, despite recommendations to the contrary.

Only 47.5% of patients with mCRC who were diagnosed between Jan. 1 2008 and Dec. 31, 2011 underwent KRAS testing.

“This is extremely surprising,” said Sanjay Goel, MD, associate professor of medicine (oncology), Albert Einstein College of Medicine and Jack D. Weller Hospital, New York City, who was not affiliated with the study. “A small fraction

of patients are being tested. This is not standard of care practice.”

An analysis of the study, which was presented at the 2013 Gastrointestinal Cancers Symposium, showed there was a boost in KRAS testing following the 2008 recommendations from the National Comprehensive Cancer Network (NCCN) calling for universal testing for the gene in patients with mCRC. Testing rates rose from 5.8% before 2008 to 15.9% % in 2008. They peaked at 29.1% of eligible patien nts in 2009, and havee remained relativelyy unchanged ever sin nce. Of

OCTOBER

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31 eligible patients, 27% and 28% were tested for the KRAS gene in 2010 and 2011, respectively.

“While KRAS testing increased during the 2008-2009 period—corresponding to changes in treatment guidelines and anti-EGFR [epidermal growth factor receptor] product labels—the majority of patients were not tested,” concluded study author Gebra Cuyun Carter, PhD, and her colleagues from Eli Lilly and Company, Indianapolis.

In an email interview, Dr. Carter said that it is important to increase the proportion of patients who are KRAS tested so that clinicians and patients can better understand all available treatment options.

The NCCN guidelines stipulate that cetuximab and panitumumab are only indicated for patients with tumors that express the wild-type KRAS gene.

The current study is based on an analysis of data from the Accelerated Community Oncology Research Network’s (ACORN) Oncology Data Warehouse.

The warehouse integrates patientreported outcomes, electronic medical records, claims data and laboratory information systems garnered from community oncology practices across the United States, representing 85% of cancer care.

The study revealed that the majority of testing is done at diagnosis. Of patients tested, 27.4% were tested at diagnosis in 2008; 65.4% in 2009; 73.2% in 2010; and 78.4% in 2011.

Patients with greater comorbidities and poorer performance status (PS) were more likely to undergo KRAS testing than healthier patients. KRAS-tested patients were younger (58.5% vs. 51.5% age <65 years; P P=0.004); had more baseline comorbid conditions (3.7±4.0 vs.

2.7±3.4; P<0.001); had poorer PS and were more likely to have metastases.

Investigators did not know why healthier patients were less likely to undergo testing for the KRAS gene. Dr. Goel said there might be multiple reasons why patients fail to undergo testing, including lack of insurance, reluctance to undergo core needle biopsy or lack of tumor blocks or unstained slides. But physicians need to find ways to overcome these problems, he said.

All physicians who treat colorectal cancer patients should be aware of the need for universal [KRAS] testing, he said. “There may be practitioners who are not aware of this, but that’s a very sad scene if it’s true.”

Dr. Carter is employed by Lilly. Other authors of the study are employed by Truven Health Analyttics and the Seattle Cancer C Care Alliance/Fred Hutchinson n Cancer Research C Center.

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BOOKWALTER jcontinued from page 1

Surgical Society last winter. It was quite an honor talking to the man who developed a surgical instrument that has been used in almost every American hospital for the past 25 years.

At the meeting, I spoke with Dr. Bookwalter about my acceptance to the Master of Medical Management program at USC Marshall School of Business, and he was very encouraging of my desire to learn about entrepreneurship.

We spoke about his efforts 30 years ago

to create the surgical device that bears his name. Because of my interest in developing surgical devices and working with instrument-manufacturing companies, I decided to take the opportunity to interview Dr. Bookwalter at his home in Vermont. We sat at a large wooden table in his kitchen and spoke for five hours about his life, his family and his mentors.

Personal Mentors Dr. Bookwalter’s main mentor was his father, a general practitioner at Case Western Reserve University in

Youngstown, Ohio. When he was 12 years old, Dr. Bookwalter’s father took him on house calls, and one day he said to him, “It is a privilege to take care of sick people.” That was the moment Dr. Bookwalter distinctly remembers he wanted to become a doctor. His grandfather also was a doctor who delivered about 5,000 babies during his career, and taught his grandson to “take care of any patient as if they were a member of your family.”

There were many illnesses in Dr. Bookwalter’s family that shaped his memories. Just after he received his John Bookwalter, MD, inventor of the Bookwalter retractor.

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driver’s license at age 16 years, Dr. Bookwalter’s father asked him to drive his grandfather to the hospital one day.

His grandfather died there of pancreatic cancer. On another occasion, after he had graduated from medical school, his father asked him to operate on his uncle for lung cancer. Dr. Bookwalter’s uncle survived the operation but later died of a ruptured abdominal aortic aneurysm. His mother, who was a nurse, died of breast cancer. “The key to success in innovation is the unconditional love from our mothers,” Dr. Bookwalter said. Throughout his life, he recognized that “the opportunity for improvement occurs when something is difficult.”

Luck played a part in this major development of the invention, but it also was his willingness to try something different to help his surgical patients that led to the creation of the device.

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After graduating from Amherst College in Massachusetts, Dr. Bookwalter went to Harvard Medical School and trained at Boston City Hospital (now Boston Medical Center) as a general surgeon. There, he learned from his heroes like Cornelius E. Sedgwick, MD, who, as his mentor, told him “good judgment comes from experience; good experience comes from bad judgment.”

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The idea for the retractor first occurred to Dr. Bookwalter in the middle of a night in 1964, when he fell asleep in the operating room (OR) while holding a retractor during an emergency operation. When he awoke he found that it hadn’t mattered he had fallen asleep, and he began to

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2013

at Codman, and nine days later he had the prototype. Dr, Bookwalter attributes this success to the relationship he had with the machinists and people in the central sterile units at the company.

In 1991, the tilt ratchet mechanism was modified so the release was on the side instead of the back. These ratchets were easier to deploy with one hand by the operating surgeon. The entire retractor was successful because it freed the hands of the senior surgeon, so he could delegate more of The Bookwalter retractor being used in an open surgical case. think about the possibility of replacing hand-held retractors with a mechanical device. He went into active duty in the U.S. Army at Fort Bragg, N.C., during 1970 to1972, where the idea germinated further. To make the retractor, he took what was called a Smith ring—a smooth, flat metal ring—and he created notches at the edges with a metal cutter. The Smith retractor fastened to the table at two points and retractor blades could be moved and tightened around the perimeter. However, one day in the OR, there was only one bar available for the Smith retractor instead of two, so he decided to try it with only one bar and it worked. Dr. Bookwalter said luck played a part in this major development of the invention, but it also was his willingness to try something different to help his surgical patients that led to the creation of the device.

Luck and Strategy: Dealing With Start-Up Risks At that time, Dr. Bookwalter was working with Codman & Shurtleff, Inc., a medical device manufacturer, on another device called a pistol grip needle holder, so he was able to show company representatives his new invention: the notched, uniform, single-post retractor.

Tom Jones, CEO of Johnson & Johnson, who had just purchased the company, wanted to expand product lines, so he invested a lot of money in research and development that helped Dr. Bookwalter financially to develop and ultimately manufacture his retractor.

Over the next three years, from 1975 to 1978, Dr. Bookwalter worked on developing the retractor and attributes some of his greatest ideas to the time he spent driving on the I-91 highway and country roads in Vermont. One night at Exit 3, he had the idea to develop a tilt-ratcheted system that originally had come from the Bailey-Gibbon Rib Approximator. He called Allen West, who worked at the metal shop

the surgery to the junior surgeon learning how to operate. “Good exposure is the key to good surgery,” his mentor, Dr. Sedgwick, told him.

Traits of an Entrepreneur: Don’t Ask Why, Ask Why Not Dr. Bookwalter succeeded because he worked in the field of surgery—an established industry—that allowed him to follow his passion for helping people and that also compensated him while he proceeded to innovate. By partnering with a well-known instrument see BOOKWALTER page 34

33

34

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2013

BOOKWALTER

By partnering with a well-known instrument company such as Codman & Shurtleff that was interested in supporting innovation, he decreased the start-up risks and took advantage of their sales and distribution expertise.

jcontinued from page 33 company, such as Codman & Shurtleff that was interested in supporting innovation, he decreased the start-up risks and took advantage of its sales and distribution expertise. This allowed him to continue to practice surgery, and at the same time improve the eponymous retractor. â&#x20AC;&#x153;It is easier to make an improvement than to make it from scratch,â&#x20AC;? Dr. Bookwalter said of successful innovation, and

this was his approach to creating the Bookwalter retractor.

To administrators and doctors, the concept of error is unpleasant, demoralizing and misleading. Dr. Bookwalter

said we should eliminate the term â&#x20AC;&#x153;trial and errorâ&#x20AC;? and instead use â&#x20AC;&#x153;trial and evaluation,â&#x20AC;? when we strive to innovate.

Since this interview, Dr. Bookwalter and I have kept in touch, exchanging

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An early ad for the Bookwalter retractor, circa 1981, when the first tilt ratchet was introduced. Note the single screw post coupling and the 1" diameter of both the table post (formerly 7/8") and the horizontal bar. The quote is from Dr. Cornelius Sedgwick, Dr. Bookwalter's mentor.

ideas, phone calls and introductions to more and more people. â&#x20AC;&#x153;No act of kindness, however small, is wasted,â&#x20AC;? Dr. Bookwalter said to me, quoting Aesop: words to remember for this young surgeon in the age of burnout and regulopathy, where shower caps replace surgical hats. Regardless of the type of head covering, letâ&#x20AC;&#x2122;s remember the head, the heart and the hands underneath. â&#x20AC;&#x201D;Dr. Kim is associate professor of surâ&#x20AC;&#x201D; gery, Albert Einstein College of Medicine, New York City.

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Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2013

BORE TIDE

jcontinued from page 1 to numb the senses before the inevitable drowning.

Perhaps this story is a kind of cautionary tale. Like the bore tide in Cook Inlet* which can flood at up to 15 mph, the incoming tide of legislation and corporatization of surgical practice seems insurmountable, and we are like the obese fisherwoman, sleeping in her cabin.

There is no doubt in my mind that we have contributed to our own potential professional demise by failing to reckon with the changing circumstances—cultural and financial—in which we work.

On one hand, a kind of fierce autonomy is necessary to function as a surgeon. “Trust no one.” This is a dictum of training and practice. A poem purportedly composed by a surgeon was recited to me in medical school by an incredulous internist:

for a less-experienced robotic surgeon?

Could laparoscopic surgeons evaluate stapling devices and assess the needs of a group, sifting through preferences, data and critical requirements to make unified purchasing recommendations? It’s hard to imagine. We are seen as thoughtless spendthrifts who are swayed by sales reps like children in a candy store. We commonly step on one another to assert our own needs and establish our place. In the wake of our disputes, we leave the distinct impression that we are self-serving prima donnas who are best governed by more altruistic nurses and administrators.

In the allegorical wilderness of the operating room, seemingly small divergences can have big consequences.

Such stubbornness and lack of insight pit us against one another and seal our fate to drown in the cabin of our small boats.

A colleague was recently censured for exclaiming, “F@#%!” in a challenging case. An instrument he routinely used

for this procedure was missing. Several efforts to locate it were unsuccessful, and he tried four alternatives before he could complete the procedure. His stress level mounted as successive alternatives proved to be inadequate substitutions.

Perhaps he would have had difficulty even with the standard instrument, but his frustration was amplified by the absence of the familiar and dependable tool. It can be very lonely in the operating room—no one else could solve the problem for him; all they could do was bring what he needed, and even that see BORE TIDE page 36

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Row upon serried row, they sit.

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Medicine doctors, it counsels, can sit in the tiered bleachers of the historical operating theater, arguing about the differential diagnosis, its work-up and subsequent treatment; but in surgery, one person has to perform the operation. One person stands in the arena and “fights the bull.” To be sure, this is not at all the same as working alone. This task is never performed in complete isolation, but one person has made an operative plan with the patient and must not only see that patient through the implementation of the plan but also technically execute the plan. One person makes the incision and gains entrance to the inner sanctum of another human body. The psychological preparation for this (which, by the way, is so critical and yet so unexamined among surgeons) is not necessarily what prepares us to see beyond one patient or to be trusting of, well, anyone. We are trained to be accountable for every aspect of the perioperative patient’s care. Their outcome, our reputation, and our sense of well-being and worthiness beyond what others think, depends on our shouldering responsibility for the operation.

On the other hand, we have been the cats who swish our tails and lick our paws, looking on with disdain at any attempts to herd us. Could a group of surgeons in a community hospital or an academic department agree to meet and negotiate contracts for operating room equipment? Could it ever happen that the robustly experienced robotic urologic surgeon would cede his suite or compromise in any measure to ease the way

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36

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2013

BORE TIDE

jcontinued from page 35 wasnâ&#x20AC;&#x2122;t working, which can leave the surgeon feeling even more strained. Underlying this is always the anxiety of failing the patient, of being inadequate to a task that has high stakes.

Every surgeon knows the frustration of the incorrect preference card. Each time we ask for something particular (a stouter 7-inch needle driver to close the fascia, a right angle with a finer tip to facilitate delicate dissection, or undyed 4-0 vicryl

on a PS-2 not a PS-3), or when we are disgruntled about a substitution (Demerol must be used instead of fentanyl for colonoscopies today), we are seen as temperamental. Yet it is a hallmark of expertise to appreciate the differences between instruments, to know the nuances of each and to select it precisely. Every circulator loves the surgeon who makes do with whatâ&#x20AC;&#x2122;s already on the back table, but every scrub tech wants the surgeon to be quite specific about what instrument to place in an outstretched hand. Chaos ensues when a surgeon is incapable of specifying what she or he needs.

I may still be a bit naive, but I continue to believe that most people who work in health care were drawn to this work because they actually want to help.

*To appreciate the bore tide (pictured above), visit: www.youtube.com/ watch?v=HCPln8miVs4

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In the allegorical wilderness of the operating room, seemingly small divergences can have big consequences. A 1 or 2 cm displacement of a suprapubic port can make the difference between successful and unsuccessful stapled transection of the rectum in an ultra-low laparoscopic proctectomy. Similarly sized endostaplers from different vendors may have identical performance parameters, but they will still not handle or behave identically. The discriminating surgeon will recognize these differences and learn to make adjustments, but the period of adjustment can have deleterious consequences for patients. The surgeonâ&#x20AC;&#x2122;s stress level is higher during the transition, as it should be. In addition to the patientâ&#x20AC;&#x2122;s well-being, the surgeonâ&#x20AC;&#x2122;s stature and self-worthâ&#x20AC;&#x201D;and potentially referrals and reimbursementâ&#x20AC;&#x201D;depend on achieving good operative outcomes. No one else in the operating room or the hospital bears that burden more vividly. Clinical decisions, material and instrument substitutions are sometimes relatively inconsequential or are made to realize the benefits of new technology, but the assessment of the magnitude of that impact and strategies for overcoming it cannot be made by administrators who do not use and depend on the performance of those supplies and equipment.

My colleagueâ&#x20AC;&#x2122;s behavior was not tolerated. Whether reported as merely temperamental or more seriously as disruptive, he depended on the resourcefulness of staff who had less visible and personal investment in the outcome than he did. After the report of his behavior, the instrument he needed was found 10 feet from the operating room in which he struggled.

Where do we begin? How can we set anchor more thoughtfully and be more fit and flexible? How do we surf the bore tide rather than be swamped by it?

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2013

So, how do we reverse the tide? Perhaps we canâ&#x20AC;&#x2122;t reverse the tide, but we can adapt to changing needs and help shape expectations. We can ask for help. I may still be a bit naive, but I continue to believe that most people who work in health care were drawn to this work because they actually want to help. I also still believe that regardless of the skill level, every person derives satisfaction from a job they do well and basks in appreciation and the feeling that he or she counts. We all want to be on a winning team. By asking for help and admitting exactly what we need and why, we let our team members

Perhaps we can begin by taking small steps, by finding more effective ways to communicate our endeavor that more successfully draw team members into the solution. Paradoxically, at a time when it seems there is pressure to diminish the relative contribution of the surgeon to the performance of a successful operation, it actually may be critical to clarify it. This may require that we surgeons overcome maladaptive behaviors for reckoning with the psychological task of cutting another person open and hurting them to help them. We can minimize our awareness of this monumental event in a number of ways, one of which is to obscure just how remarkable it is. We make it mundane. We also tend to exteriorize or project outside of ourselves uncertainty and risk. We cultivate our own mythology that we have almost superhuman powers: We donâ&#x20AC;&#x2122;t need to sleep; we donâ&#x20AC;&#x2122;t need to eat; we donâ&#x20AC;&#x2122;t need to wear coats in cold weather or seatbelts in cars (Cult Med Psychiatryy 1987;11:229-249). Like epiphytes that appear to live on air alone, we subsist on a steady diet of surgery, research and consultations.

We may need to recognize our vulnerability, not in an angry and victimized way but rather as a matter of fact.

We simply need the very best help we can get in the operating room and clinic. The environment must support our relaxed concentration. Every other person in the room can more easily take a break or be replaced. The surgeon cannot leave the job unfinished. We may need to admit that a little juju helps achieve this state of mind. We make choices because we have to, and then we wed ourselves to those choices because when we make as much of an operation as routine as possible, when we work out the little kinks and establish a mental template for what things ought to look like at every step of the procedure, things go more smoothly.

We cannot settle for letting these positive adaptations be characterized negatively. â&#x20AC;&#x153;Master,â&#x20AC;? â&#x20AC;&#x153;expert,â&#x20AC;? â&#x20AC;&#x153;heroâ&#x20AC;? and â&#x20AC;&#x153;heroineâ&#x20AC;? are synonyms for prima donna.

know how much they matter. Itâ&#x20AC;&#x2122;s possible, then, that instead of resenting what seems to be our demanding, dismissive attitude and healthier income, they might want to help protect our time and support our performance. We do not, despite our professional mythology, have endless private resources to draw on. Finally, by doing a better job of expressing our needs and limitations, our humanity, we might better account for what we can and cannot do and more faithfully take a seat at the table to help shape the decisions that affect us so profoundly. We can ride the tide more gracefully, in full cognition of

our original intention and help chart the course, one step at a time, one conversation at a time, one honest moment of reflection at a time. â&#x20AC;&#x201D;Dr. Kosinskii is an assistant â&#x20AC;&#x201D; professor of surgery in the Division of Colorectal Surgery at the Medical College of Wisconsin, Milwaukee.

khorty@mcmahonmed.com.

New Wave Surgical

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Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2013

COMPLEXITY SCIENCE jcontinued from page 1

How could that be? Based on our current understanding and interpretation of medical guidelines, this makes no sense.

But, if we allow ourselves to understand how this could possibly happen, it might help us to understand why our health care system is struggling, and what we might be able to do to improve it.

Because we tend to accept simple explanations for events and concepts that sometimes are quite complicated, we often end up misinterpreting and

misunderstanding phenomena that are not simple. Our health care system is one troubling example of this. And because the science we have applied to health care, with its hierarchy of evidence, is based on the investigation of isolated or mechanical systems rather than complex biologic systems, we often are left with incomplete and inaccurate results and interpretations. I believe our misinterpretations and misunderstandings of medical evidence and health care laws have contributed to the current problems in health care.

Let me try to explain.

Misinterpretation Misinterpretation of a law can lead to unintended harm and consequences. The misinterpretation of the Health Insurance Portability and Accountability Act (HIPAA) is a prime example. A gut-wrenching demonstration of this error occurred in December 2012, after the Sandy Hook Elementary School shootings in Newtown, Conn.

Many parents were denied information about their children by the hospital, with HIPAA cited as the reason. This is a clear misinterpretation of the law and led to significant emotional harm

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for family members of the involved children.

This event resulted in a Congressional hearing on the misinterpretation of HIPAA. On April 26 this year, Leon Rodriguez, JD, director of the Office of Civil Rights under the Department of Health and Human Services (HHS), testified, “We have never taken enforcement action because [a] provider decided that the best interest of the patient [was] to disclose information to a third party. In fact, of the 80,000 complaints of HIPAA violations that HHS has received, only twelve have resulted in monetary penalties.”

In an article by David Pittman in MedPage Today, which covered the hearing, Mark Rothstein, JD, director of the Institute for Bioethics, Health Policy and Law at the University of Louisville, in Kentucky, was quoted: “Physicians frequently misinterpret what they’re allowed to share under HIPAA. ¼ The outcome is that some use of disclosures permitted by the privacy rule are not allowed by some covered entities, perhaps out of ignorance or an overabundance of caution.”

Although one would think that a daylong Congressional hearing would lead to changes in hospital and physician policies, and that there would be more transparency with patients and family members regarding the use of their information, that has not happened. In fact, I have not found anyone who even knows there was a Congressional hearing on the misinterpretation of HIPAA. What’s more, this was not even the first hearing on the misinterpretation of the law.

On Sept. 23, 2003, Richard Campanelli, the director of the Office for Civil Rights at that time, testified, “A number of concerns that have come to our attention actually are not a problem with the rule itself, but rather, misconceptions about the rule.” He continued to explain that the rule “specifically allowed doctors and other providers to share this information for treatment purposes, to obtain payment, or to carry out their day-to-day operations without first having to obtain a patient’s written approval.”

It is my belief that the problem has been one in which the rule was interpreted by organizations out of fear of how it could harm them, rather than how it could help patient and their families have access to medical information. Improving the value of patients’ care should be our focus when interpreting laws and rules. Laws and rules must be made and used to continuously improve the value of care for patients and their families.

Misunderstanding Another challenge is to really understand the massive amount of information see BOOKWALTER page 40 Rev 2 ©2013 Aspen Surgical Products, Inc. All Rights Reserved.

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Robert H. Anderson, et al September 9, 2013 This classic textbook on cardiac anatomy, written from the stance of the cardiac surgeon, features many new images, including computed to og ap y angiography. tomography a g og ap y Itt iss essential esse t a reading ead g for o cardiac ca d ac surgeons. su geo s GSN1013

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Opinion COMPLEXITY SCIENCE jcontinued from page 38

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2013

an anticipated punitive response. I have heard many of these recordings and it is chilling to hear one human being reject another’s plea to be heard just minutes or seconds before a fatal crash.

Each airline subsequently developed its own checklists and crew resource training. There is no standardized, one-size-fits-all solution. In fact, in a recent article in the Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine, the authors interviewed experts from a variety of highly reliable organizations, including the aviation industry, about the use of checklists. Their message was consistent and clear: Checklists are tools, not solutions unto themselves. Checklists should be implemented and used locally by those who do the work. None of the authors recommended that a checklist be developed in a standardized way. In fact, they noted that the local group had to have the authority and resources to adapt the checklist over time. This is not the current simplistic understanding of our governing bodies and organizational leaders in health care. This lack of understanding in health care continues to lead to patient harm and death,

that is being produced in health care, including information from traditional medical research. If we apply only simplistic levels of understanding to medical problems, we can end up with good intentions that result in unexpected harm and waste. One example of this arises out of the wonderful research done by Drs. Atul Gawande and Peter Pronovost and others. Patient safety and quality improvement have been significant areas of research focus for these physician scientists. In fact, some of the studies they have led have resulted in central-line and operating room (OR) checklists. In work done with the World Health Organization, a surgical safety checklist has been created and used with varying degrees of success around the world.

The problem is not that a multidisciplinary team developed a tool (a checklist) to address a problem (patient safety/need to improve quality). The problem is the simplistic thinking that a tool such as a checklist can be generalized and be the solution for all hospital ORs, intensive care units, etc., in all locations and for every condiThe problem is the tion. From the perspective of complexity science, the actual solution was the prosimplistic thinking that a cess of getting a diverse team together to tool such as a checklist come up with a solution and to implement it locally. The solution was not the can be generalized checklist, but a diverse local team given and be the solution for the authority and resources to implement ideas for process improvement. It all hospital operating is my belief that to make optimum use rooms, intensive of this valuable concept, if a checklist is determined to be an appropriate tool, care units, etc., in all teams need to modify the checklist to locations and for every take into consideration the local differences and conditions that exist in every condition. hospital setting.

The aviation industry often is cited as an example of how to use checklists to improve safety. I have had the privilege of working with Dr. Jerry Berlin, one of the early pio- the extent of which is unknown and perhaps unknowable. neers in the development of new methods for improvThere is another harm done when simplistic undering aviation safety. Dr. Berlin has recounted the pain standing is applied by forcing the implementation of he experienced as he investigated commercial and mili- a checklist, as in the example of mandating the use of tary accidents of the 1960s, 1970s and 1980s. Checklists antibiotics before all operations. The problem is there had been used for years with some significant success, is a gradual change in focus, especially when the goal is but there were also many accidents involving risk vari- tied to reimbursement, from improving the value to the ables, especially complicated ones, that were entirely patient to achieving the target goal or benchmark. inappropriate for inclusion in checklists. A good examA friend of mine was the CEO of a chemical compaple of this was the horrific airport disaster in Tenerife, ny in California. He recently recounted a story from his Canary Islands, in 1977, when two 747s collided on a industry that he related to the situation in health care. runway. It was the deadliest accident in aviation history. He used to sell large amounts of cyanide to gold-mining The cause, like many previous accidents, was the human companies. The mining companies used the cyanide to factors related to communication within the cockpit and erode rock quarry to facilitate extraction of the gold. They between the cockpit and air traffic control. The solution encountered a problem with ducks dying from exposure to the communication problem was a long painful pro- to the cyanide after landing on the tubs. A wildlife founcess to transform the relationships and the hierarchy of dation discovered this and levied fines for each duck that the traditional aviation culture. was killed. Spotters would count the number of ducks The term cockpit (or crew) resource management was that were killed. This amounted to a large sum of money a process of change in how the pilot and crew interacted each year. The mining company addressed the problem with one another. (By the way, Jerry, an organization- by putting up nets and noisemakers, and this method al design psychologist, always says pilots and surgeons worked. Fewer ducks were killed. But instead of being are very similar psychologically.) Aircraft commanders happy about the success of their efforts, spotters for the and captains had to go through a significant behavior- wildlife foundation began to use duck calls to entice the al change and understand that protectiveness of their ducks to the cyanide tubs. They were missing their revauthority led to either their not listening to a co-pilot enue from the fines. I cannot vouch for the accuracy of or engineer who discovered a problem or the co-pilot this story, but I believe the analogy to the current state of or engineer becoming afraid of speaking up because of our health care system is an apt one.

Complexity Science I would like to start a dialogue over the next several months within the pages of General Surgery News about the science of complexity, or complex systems, as applied to patient care. Just as Einstein discovered the incompleteness of Newtonian physics, we are only just beginning to understand the incompleteness of our traditional research and management methods in medicine. I will use the terms “simple” or “simplistic” to describe our traditional thinking, management and research principles, which are based on the understanding of isolated or mechanical systems. In these systems, a cause is always followed by a predictable effect. I will use the terms “complexity” or “complex systems” to describe our complex biological world, in which the same cause (or causes) can have multiple results, some of which are not predictable.

I first began to understand this concept of complex systems when our mesh lab group studied the effects of the body on hernia mesh. We have explanted and studied hundreds of mesh, and we learned that the same mesh (the cause) can have very different effects in different bodies (unpredictable results). This finding helped me to better understand the science of complexity. To learn more about complexity science applied to health care, I refer you to Appendix B of Crossing the Quality Chasm: A New Health System for the 21st Century, written by Paul Plsek (2001, Institute of Medicine; National Academy Press). In this article, “Redesigning Health Care with Insights from the Science of Complex Adaptive Systems,” Mr. Plsek outlined what he saw to be the key components of establishing a health care system based on the theory of complex systems.

We are approaching the law of diminishing returns using current traditional research and organizational management methods in health care. The billions of dollars spent on traditional research methods and technologies, such as electronic medical records, and our current medical training have not led to much improvement of patient value in our system. A better understanding of complexity science will allow us to apply new concepts of research and management as a natural part of caring for patients. Interestingly, some of these concepts are contained in the HIPAA law from 1996, but we have yet to interpret and apply them.

Continuous improvement research and care coordination patient care management have the potential to focus on the goal of improving the value of care for our patients. That also will improve the value for all the parts of our system that contribute to that value.

This will take effort at the level of all local environments. There is no single right answer to our health care problem and no simple fix. One of the first objections I heard about implementing a new approach to patient care and research is that we cannot afford to do it. My response is that clearly, we cannot afford nott to.

To view a TEDx talk by Dr. Ramshaw on health care, visit www.youtube.com/ watch?v=QPeLlbh0BAw —Part 2 of this series will focus on the denial, despair and depression that can occur when good people struggle within our current system when encountering increasing complexity and increased pace of change.

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42

In the News ERAS

jContinued from page 1 patients undergoing elective colorectal surgery. Patients within the ERAS program (n=137) were compared with a historical cohort of 99 consecutive patients who did not go through the program.

“Patient education is important with the ERAS program, so we educate our patients about their care and what they’ll be going through,” said Dr. Gan, whose group presented its findings at the 2013 annual meeting of the International Anesthesia Research Society and the 2013 annual meeting of the American Society of Anesthesiologists.

“Preoperatively, instead of starving them for six to eight hours, we actually give them a carbohydrate drink up to two hours before surgery. We use an epidural for every case, whether the procedure is open or laparoscopic, plus multimodal analgesia with IV acetaminophen and [nonsteroidal anti-inflammatory drugs].”

As part of the program, patients undergo esophageal Doppler monitoring (Cardio Q, Deltex) to track their fluid management.

Patients are encouraged to start consuming fluids the night of surgery, and solid food the next day. Early ambulation is also a key component of the ERAS program.

The investigators found that mean length of stay was 8.4 days in non-ERAS patients compared with six days for those who went through the ERAS program (P<0.001). Rates of readmission 30 days after surgery were 20.2% and 8.8%, respectively (P=0.012).

P Median

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2013

postoperative crystalloid consumption was 10.5 L in nonERAS patients and 4.6 L in ERAS patients (P<0.001).

Use of opioids after surgery was significantly greater among non-ERAS patients (196±191 mg) than their counterparts (85±175 mg).

Perhaps not surprisingly, mean total hospitalization costs were $3,640 (15.8%) lower for ERAS patients ($19,344) than non-ERAS patients ($22,984). These differences reached statistical significance with respect to costs for lab tests ($856 vs. $1,172; P P=0.011) and chest x-rays ($135 vs. $262; P P=0.046), but not overall.

The investigators also examined the level of practitioner compliance with ERAS protocols, and the effect between full and partial compliance on patient outcomes.

They found that 74 of the 137 ERAS patients had full compliance. Patients who received fully compliant care were in the hospital for a mean of 5.7 days compared with 6.3 days for those who received partially compliant care. Thirty-day readmission rates were 5.4% and 12.7%, respectively. Median consumption of postoperative crystalloids was greater in patients who received fully compliant care (4.7 L vs. 3.8 L), whereas mean postoperative morphine equivalent consumption was comparable.

“Given that the ERAS protocol was associated with shorter length of stay and less cost, we are beginning to extend the program to other procedures,” Dr. Gan said.

Elizabeth A.M. Frost, MD, professor of anesthesiology at the Carl Icahn School of Medicine at Mount Sinai, in New York City, said that although the benefits of fluid restriction have been understood for at least a decade, few clinicians have heard the message.

“Physicians are very slow to change and still cling to fluid resuscitation,” said Dr. Frost.

“The Duke researchers are reemphasizing the point of the need for fluid restriction rather than continuing with Shire’s old concept of replacing the third space—which as we know, does not exist,” Dr. Frost said.

Although the patient population is small, the findings are statistically significant and agree with multiple recent, and not so recent, studies, she added.

“The next step is to get TEE [transesophageal echocardiography] capability into all operating rooms and train [physicians] in interpretation of the findings. We are a long way from that point. Another useful technique is the several computerized machines that are now available that display stroke volume variation or pulse pressure variation along with cardiac output on a single screen.”

However, these technologies are expensive and require both arterial cannulation and controlled ventilation, which may not be feasible in an awake patient in the ICU. Another way to assess fluid requirements is by measuring lung water, a simple and noninvasive technique.

“It would be interesting to find out how well ERAS protocol compliance has increased and/or infiltrated surgical management at this major academic center, perhaps as a benchmark for other institutions,” Dr. Frost said.

“I think this is the way most hospitals are going to go, especially with the new health care system,” Dr. Gan said. “In fact, following this study, our hospital administration asked our other surgeons to incorporate ERAS into their practice. And I think that’s probably going to spread.”

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / OCTOBER 2013

Optimizing the Prevention and Management of Postsurgical Adhesions To participate in this FREE CME activity, log on to

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Release date: December 1, 2012

Expiration date: December 1, 2013

Chair

Goal Provide surgeons with up-to-date, clinically useful information concerning the prevention and management of postoperative adhesions.

Jon Gould, MD Chief, Division of General Surgery Alonzo P. Walker Chair in Surgery Associate Professor of Surgery Medical College of Wisconsin Senior Medical Director of Clinical Affairs Froedtert Hospital Milwaukee, Wisconsin

Intended Audience General surgeons, vascular surgeons, colon and rectal surgeons, critical care surgeons, surgical oncologists, trauma surgeons, and thoracic surgeons.

Faculty

Course Format: Monograph

Michael J. Rosen, MD

Estimated Time for Completion: 60 minutes

Associate Professor of Surgery Division Chief, General Surgery University Hospitals Case Medical Center Cleveland, Ohio

Learning Objectives 1 Review the pathophysiology and complications of postoperative adhesion formation.

2 Summarize current strategies used to prevent postoperative adhesion formation.

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3 Describe the various types of barrier materials used to prevent postoperative adhesion formation.

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

Designation of Credit Statement The Medical College of Wisconsin designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Creditâ&#x201E;˘. t Physicians should only claim credit commensurate with the extent of their participation in the activity.

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Current Symptoms Â&#x2021; Dyspnea Â&#x2021; Coughing with hemoptysis Â&#x2021; Chest pain Vital Signs Â&#x2021; Height: 177.8 cm (70â&#x20AC;?) Â&#x2021; Weight: 65 kg (143 lb) 6LJQLĂ&#x20AC; FDQW 0HGLFDO +LVWRU\ Â&#x2021; Hypertension Â&#x2021; Chronic obstructive pulmonary disease (moderate) &XUUHQW 0HGLFDWLRQV Â&#x2021; Metoprolol succinate ER 50 mg/d Â&#x2021; Tiotropium bromide inhalation powder Laboratory Results Â&#x2021; 2-cm lesion in right upper lobe revealed on chest computed tomography (CT) VFDQ PDOLJQDQF\ FRQÂż UPHG ZLWK QHHGOH ELRSV\ Â&#x2021; No abnormal bronchopulmonary or mediastinal lymph nodes; brain CT, isotopic bone scan, abdominal ultrasonography negative for distant metastases Â&#x2021; )RUFHG H[SLUDWRU\ YROXPH LQ WKH Âż UVW VHFRQG RI SUHGLFWHG YDOXH /

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Â&#x2021; Cardiac ultrasonography: normal pulmonary artery pressure (22 mm Hg) At induction, Harold receives propofol 1.5 mg/kg and rocuronium 0.6 mg/kg.

During the procedure, movement of the diaphragm interferes with surgery.

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OCTOBER 2013

REPORT Ventral Hernia Repair: State of the Art, Current Challenges, and Future Directions Faculty Igor Belyansky, MD

Stephen J. Ferzoco, MD

Maurice Nahabedian, MD, FACS

Anne Arundel Medical Center Annapolis, Maryland

General Surgery Dedham Medical Associates Dedham, Massachusetts

Professor and Vice Chairman Department of Plastic Surgery Georgetown University Washington, DC

Parag Bhanot, MD, FACS Director, MedStar Georgetown University Hospital Comprehensive Hernia Center Assistant Professor Division of General Surgery MedStar Georgetown University Hospital Washington, DC

Jeffrey E. Janis, MD, FACS Professor and Executive Vice Chairman Chief of Plastic Surgery Ohio State University Hospitals Department of Plastic Surgery Ohio State University Wexner Medical Center Columbus, Ohio

David C. Chen, MD Assistant Clinical Professor Department of Surgery Associate Director of Surgical Education Clinical Director Lichtenstein Amid Hernia Clinic at UCLA David Geffen School of Medicine University of California, Los Angeles Los Angeles, California

George DeNoto III, MD, FACS Chief, General Surgery St. Francis Hospital Roslyn, New York Clinical Associate Professor of Surgery Hofstra North Shore-LIJ School of Medicine Hempstead, New York

Mike K. Liang, MD

Yuri W. Novitsky, MD Associate Professor of Surgery Case Western Reserve University School of Medicine Co-Director Case Comprehensive Hernia Center Director, Surgical Research University Hospitals Case Medical Center Cleveland, Ohio

Assistant Professor of Surgery Michael E. DeBakey Department of Surgery Bryan K. Richmond, MD, MBA, FACS Baylor College of Medicine Professor of Surgery Michael E. DeBakey VAMC Section Chief, General Surgery Houston, Texas West Virginia University Charleston, West Virginia

Robert G. Martindale, MD, PhD Professor of Surgery Chief Division of General and GI Surgery Medical Director for Hospital Nutrition Services Oregon Health & Science University Portland, Oregon

Supported by

Paul Szotek, MD Assistant Professor of Clinical Surgery General & Trauma Surgery Indiana University Health Physicians Indianapolis, Indiana

REPORT

T

he repair of ventral hernia is a common clinical challenge, with more than 350,000 cases performed in the United States each year.1 Demographic trends and advances in the management of severely injured and critically ill patients have increased the volume of cases requiring repair of challenging ventral hernias. Despite advances in surgical technique and materials, these complex patients frequently experience recurrence and wound complications (eg, surgical site occurrences [SSO]). These common adverse outcomes represent significant issues for surgeons, impose additional financial burdens on hospitals and payors, and often leave patients with reduced abdominal wall function and decreased quality of life.

The management of patients with challenging ventral hernia remains hampered by a lack of consensus regarding the optimal approach to these complex cases. Only limited highlevel evidence currently is available, leaving clinicians to base therapeutic decisions on lower-level data and expert opinion.

The lack of a widely accepted classification system and the broad heterogeneity among patients with ventral hernias has made the institution of standardized approaches to repair difficult. Furthermore, the vast majority of available evidence is low quality (eg, level 4 case series with no controls), making comparisons of outcomes between studies impossible. Additionally, standardized terminology and definitions are lacking for many of the procedures and outcomes of ventral hernia repair, both for clinical research and clinical practice. Indeed, there is an outstanding need for evidence-based guidelines for the stratification of risk and individualization of care to minimize complications and optimize outcomes. Questions that still require a higher level of evidence to address include which patients to operate on, how to prepare patients for surgery, what are the best surgical techniques, and which repair material to use.

In 2008, a panel of experts convened a Ventral Hernia Working Group (VHWG), sponsored by LifeCell Corporation (Branchburg, NJ) to produce a set of recommendations regarding techniques for the repair of ventral hernia and grading of risk for SSO.2 The VHWG was an attempt to initiate a

discussion to identify best practices, define categories of risk for SSO, and facilitate further research. The recommendations and grading scale proposed by this group (Table 1) 2,3 were based on the best evidence available at the time; however, as noted by the authors, many of the recommendations relied on low-quality evidence and expert opinion.

In May 2013, a second summit sponsored by LifeCell brought together 13 leading surgeons with extensive experience in the repair of challenging ventral hernia. The goal of this summit was to discuss the evolution of ventral herniorrhaphy since the original VHWG publication; identify current challenges, both clinical and economic; and discuss potential next steps to advance the state of the art. This article presents the key points identified by this expert panel and reviews the challenges and salient questions in ventral hernia repair faced by surgeons today.

The Challenging Ventral Hernia Patient The patient with a challenging ventral hernia may possess any number of a variety of characteristics (Table 2). For example, many patients with ventral hernia have comorbid conditions, such as obesity or diabetes, which increase the risk for SSO. Other characteristics that complicate ventral hernia repair and increase risk for adverse outcomes include a history of prior repairs, possibly including the removal of prosthetic mesh (often due to infection); larger defects; and/or higher VHWG classification.4-9 Although advances in surgical techniques and materials have evolved ventral herniorrhaphy toward predicting and reducing recurrence and SSO, both outcomes remain unacceptably high, especially among patients with complex hernia. Even in the landmark trial by Luijendijk and colleagues, the 3-year cumulative rate of recurrence remained at 24%, despite reinforcement of the relatively small hernias (median size 30 cm2, range 1-36 cm2) among participants in this study.10 Rates of recurrence may be even higher following the repair of challenging ventral hernia, such as in patients with more severe comorbidities (median body mass index [BMI] was 26 kg/m2 in

Table 1. Recommendations of the Ventral Hernia Working Group Recommendation

Strength of Recommendation a

Level of Evidence a

Reinforcement recommended for repair of all incisional ventral hernias

1

A/B

Centralize and reapproximate rectus muscles when feasible under physiologic tension

1

C

Reduce bioburden before repair

1

B

Placement of repair material: Underlay is the recommended technique for the placement of appropriate repair material for open and laparoscopic repairs; overlay placement of repair material should only be considered when complete fascia-to-fascia repair has been achieved

2

B

In the setting of gross, uncontrolled contamination, it is appropriate to consider delayed repair

1

C

a Grading of recommendations based on published guidelines.

Based on references 2 and 3.

2

REPORT the Luijendijk study), history of multiple repairs, and larger hernia size. In a retrospective cohort study of a hospital discharge database, the 5-year rate of reoperation following ventral hernia repair was 23.8% after the first operation, 35% after the second, and 39% after the third.11 Data such as these highlight the challenges inherent in ventral hernia repair, the importance of optimizing outcomes with the first repair, and the costs associated with treatment.

Factors that contribute to risk for SSO (defined by the VHWG as infection, seroma, wound dehiscence, and the formation of enterocutaneous fistulae) 2 include prior history of wound infection, violation of the gastrointestinal (GI) tract, use of corticosteroids, low preoperative serum albumin levels, wound classification, and certain comorbid conditions.5-9 Comorbidities are a major risk factor for SSO and include obesity, diabetes, smoking, immunosuppression, and COPD.5-9 The risk for SSO increases with the number of comorbidities, from 9% of patients with 1 comorbidity to 67% of patients with 4 comorbidities in one recent study.9 Wound classification has a clear influence on risk for SSO. An analysis of 33,932 patients with ventral hernia repairs from the National Surgical Quality Improvement (NSQIP) database found significantly increased risk for SSO in clean-contaminated and contaminated cases compared with clean cases.12 Furthermore, complications were significantly more common among patients reinforced with prosthetic repair material compared with those without repair material in clean-contaminated cases, leading the authors to conclude that repair material should be avoided in wounds with any level of contamination.

Because the NSQIP does not identify type of repair material (ie, biologic vs synthetic), no comparison between categories of materials could be made.

Prosthetic Repair Material and Complications of Hernia Repair Other characteristics that define the challenging hernia patient include complications associated with the use of prosthetic repair materials. Although the use of repair material has been shown to reduce hernia recurrence, these materials also are associated with important risks, such as adhesion formation, fistula formation (to the skin or bowel), implant infection, and implant failure.

The formation of adhesions between abdominal viscera and repair material may be more common when synthetic materials are placed near or in contact with the bowel, and less common with biologic materials.13-16 Adhesions may lead to erosions into the bowel and the formation of enterocutaneous fistulae, often requiring reoperation.

A second consideration with prosthetic reinforcement is its use and management in the setting of infection. As noted, infection is a common complication of hernia repair, particularly for patients with multiple comorbidities. Unfortunately, many repair materials, particularly certain synthetic prostheses, often require removal in the setting of infection, contributing to an even larger defect still in need of repair and reinforcement.17,18 Removal of repair material also may be required for subsequent abdominal operations following ventral hernia repair. One chart review study reported that approximately 25% of patients underwent a subsequent abdominal operation after ventral hernia repair, and two-thirds of these patients then required repeat hernia repair.19

An analysis of the NSQIP database identified predictors of explantation of repair material following incisional hernia repair.18 Infection was the most common reason for explantation, accounting for 69% of cases. On multivariate analysis, same-site concomitant surgery and the use of expanded polytetrafluoroethylene (ePTFE) placed during an open repair were associated with increased risk for explantation, as were postoperative surgical site infection (SSI) and enterocutaneous fistulae. The authors concluded that the use of permanent synthetic repair material in the setting of concomitant intraabdominal operations is associated with a greater than 6-fold increase in risk for explantation, suggesting that these products should be used with caution in clean-contaminated procedures.

Conversely, biologic repair materials generally do not require removal in the setting of contamination or reoperation.20-24

Placement of Repair Material and Primary Fascial Closure The plane of placement of repair material (eg, underlay [intraperitoneal], sublay [preperitoneal or retrorectus], overlay [anterior to rectus sheath], or interpositional) remains a matter of debate and is typically driven by individual surgeon preference. Uniform definitions of different planes of

Table 2. Characteristics That Contribute to Challenging Ventral Hernia Larger defect Prior ventral hernia repair(s) Multiple prior abdominal surgery Presence of comorbidities: COPD Diabetes Immunosuppression Overweight/obesity Smoking VHWG classification ASA class 3 or 4 Wound classification Enterocutaneous fistula Presence of stoma/ostomy Skin ulcerations or tenuous skin coverage Loss of domain COPD, chronic obstructive pulmonary disease; VHWG, Ventral Hernia Working Group; ASA, American Society of Anesthesiologist Based on references 4-9.

3

REPORT placement have not been established, further complicating comparisons of outcomes between studies of different planes of placement.

The VHWG noted a preference for retrorectus repair, based solely on expert opinion. Recent studies have demonstrated good outcomes with placement of synthetic or biologic materials in the retrorectus space.9,20 However, there are challenges in finding robust data in the literature comparing outcomes with different planes of placement across similar patient populations. Additional considerations in the management of challenging ventral hernia include whether the retrorectus space remains available for the placement of repair material in patients with a history of multiple prior repairs. Clinicians may benefit from standardization of terms describing the plane of placement of repair material (eg, underlay, sublay, overlay, interpositional), and a discussion of options for patients with challenging hernia, for whom preferred options may not be feasible.

Defining Challenging Ventral Hernia The data reviewed thus far begin to outline the challenging ventral hernia patient. These patients often have a history of multiple previous repairs, placing them at very high risk for recurrence; multiple comorbidities, substantially increasing their risk for SSO; the presence of infected mesh, requiring removal and repeat repair; the need for concomitant abdominal operations; bowel adhesions to repair material and/ or enterocutaneous fistulae, requiring management; and/or clean-contaminated or contaminated wounds, increasing risk for infection and recurrence. This diversity of conditions and the lack of strong evidence regarding the management of this patient population are major obstacles to the delineation of an optimal approach to challenging ventral hernia repair.

Estimating Risk for SSO Estimating risk for SSO has implications for the selection of surgical technique and repair material, as well as for establishing surgeon and patient expectations. As noted, certain repair materials may require excision in the setting of infection, and surgeons may consider avoiding such materials in patients deemed to be high risk for infection. Given the high rate of SSO associated with ventral hernia in general, it is important for surgeons to be cognizant of the likelihood of complications following a hernia considered to be higher risk for SSO. These risks should be thoroughly reviewed with patients to set their expectations for possible postoperative complications, overall function, and potential management options.

In its initial publication, the VHWG proposed a hernia grading system to estimate risk for SSO. 2 The scale defined 4 categories of increasing risk, from grade 1 (low risk for complications), to grade 2 (presence of comorbidities), grade 3 ( potentially contaminated), and grade 4 (contaminated). The authors based this classification on published evidence of risk factors for SSO and their expert opinion.

Since its publication, several groups have evaluated the VHWG grading scale. For example, one retrospective study of nearly 1,000 patients found increased rates of return for additional surgical interventions and treatment of complications in association with higher VHWG grades.25 A second retrospective study of 299 patients undergoing open ventral hernia repair found that the incidence of SSO was significantly

4

greater with each higher VHWG grade (14% grade 1, 29% grade 2, 38% grade 3, 49% grade 4).26 However, patients with a history of previous wound infection (considered grade 3 by the VHWG scale) were found to have an incidence of SSO similar to grade 2 patients, whereas patients with stoma or violation of the GI tract had rates similar to grade 4 patients.

Based on these findings, the authors proposed a 3-level grading system, with grade 2 including patients with comorbidities and history of wound infection, and grade 3 including all clean-contaminated, contaminated, and dirty wounds.

In support of this proposition, a separate retrospective study of 146 patients undergoing clean, open repairs also found no difference in the rate of SSI between those with and without a history of previous wound infection.27 However, both of these studies have small sample sizes and insufficient power to validate a grading system.

Although the VHWG grading scale was designed to estimate risk for SSO, studies have found an association between VHWG grade and recurrence.25,28 In one retrospective review of prospectively collected data at a single institution, VHWG hernia grade was found on multivariate analysis to predict recurrence and return for hernia-related procedures.25 It is worth noting that patients in this study treated with biologic repair materials were more likely to be older and have higher VHWG grades and larger defects. Overall, biologic materials were used more often in patients with contaminated wounds and complex repairs; conversely, synthetic materials most often were used in VHWG grade 2 hernias, regardless of size.

This selective use of materials is a common finding in studies of reinforced hernia repairs, and suggests that surgeons tend to avoid synthetic repair materials in more challenging hernias.

It also represents a selection bias common to many studiesâ&#x20AC;&#x201D; in particular, nonrandomized, nonblinded database and registry studiesâ&#x20AC;&#x201D;and complicates outcomes comparisons between synthetic and biologic materials.

Current State of the Art Among recent evolutions in the management of complex hernia, investigators have shown that the use of advanced surgical techniques and repair materials may allow for successful single-stage reconstructions. One recent study by Itani and colleagues evaluated 80 patients with challenging ventral hernia.29 The majority of patients had a history of prior hernia repairs; one-fourth was obese; and many had comorbidities, such as diabetes, chronic obstructive pulmonary disease, or enterocutaneous fistulae. Component separation was used when necessary to reduce the defect, and repairs were reinforced with a non-crosslinked porcine acellular dermal matrix. Fascial closure was achieved in 64 patients; 16 required bridging of the defect. After 24 months of follow-up, 53 patients (66%) experienced SSO, including infection in 24 patients (30%). Most events were managed nonoperatively. Of the 64 patients in whom fascial closure was achieved, the rate of recurrence was 23%. Only 7 of these patients required repeat repair during the study period, and none required removal of the repair material. This study demonstrated that single-stage definitive reconstruction of contaminated ventral hernia can be achieved in many patients.

Another large, retrospective study evaluated the singlestage repair of challenging ventral hernia in contaminated fields using a wide array of biologic repair materials.20 Patients in

REPORT this study were obese (mean BMI 34 kg/m2), had large hernia defects (mean size 431 cm2), and contaminated wounds due to infected repair material, stoma, concomitant GI surgery, enterocutaneous fistulae, or other conditions. The mean number of previous abdominal surgeries was 5, and number of prior hernia repairs, 2.5. Most patients also had comorbidities, most commonly diabetes. After a median follow-up of 21.7 months, 40 recurrences were identified (31.3%). The incidence of wound morbidity was 47.7%. Among cases of wound infection, 45.9% required reoperation, readmission, or an interventional procedure. Of note, patients with repair material placed in the retrorectus space had significantly lower wound morbidity. These findings again describe successful outcomes in approximately 70% of patients with challenging hernia, including contaminated wounds, comorbidities, and a history of multiple prior repairs and abdominal operations. Of the patients with recurrence, only 7 (5.5%) required reoperation, whereas the majority remained asymptomatic and were managed nonsurgically. Importantly, no cases required removal of the biologic repair material or developed chronic draining sinuses or infections of the repair material, despite placement in contaminated wounds.

Other studies also reported single-stage approaches to particularly complex patients, such as those with large abdominal wall defects, enterocutaneous fistulae, and parastomal hernias. Using component separation and biologic prostheses, surgeons have reported the successful single-stage management of abdominal wall repair and take down of enterocutaneous fistulae, although high rates of SSI (65%) and recurrence (32%) were reported.30

Current Challenges and Questions in Challenging Hernia Repair Studies such as those described here raise several key issues and challenges. The foremost challenge is the lack of high-quality evidence regarding the repair of ventral hernia. The vast majority of evidence consists of uncontrolled case series (ie, level 4 evidence). The future challenge will be to conduct high-quality studies of approaches to ventral hernia repair to provide surgeons with level 1 evidence on which to base practice decisions.

Another important issue is identifying appropriate treatment goals for patients with challenging ventral hernia. Criteria commonly cited for measuring success in challenging hernia repair are listed in Table 3.21,23,24,31 Clearly, patients and surgeons wish to avoid serious complications, such as infection requiring removal of a prosthesis or recurrence requiring reoperation. Such outcomes are associated with significant morbidity, technical challenges for the surgeon, reduced patient satisfaction and quality of life, and increased costs to patients, hospitals, and payors.

However, many questions and challenges remain regarding the optimal management of complex ventral hernia (Table 4).

These unmet needs include standardized definitions for commonly reported risk factors, outcomes, and techniques of repair. For example, recurrences diagnosed clinically are far less common than those identified radiographically.32

Table 4. Outstanding Questions and Needs in Repair of Challenging Ventral Hernia Table 3. Criteria Cited for Measuring Success in Challenging Hernia Repair Single-stage procedure Reduced recurrence Avoiding abdominal reoperation

Standardization of definitions Hernia classification system Outcomes Plane of placement of repair material Risk factors Watchful waiting versus surgical therapy in high-risk or oligosymptomatic patients

Avoidance of long-term complications, including: Draining sinus Explantation of repair material Fistula Infection Seroma Small bowel obstruction Other wound complications

Identification of goals of repair for individual patients

Patient satisfaction

Implementation of accurate, validated quality-of-life measures

Patient function

Validation of evidence-based scoring system for risk for SSO/SSI and recurrence Identification of approaches to limit costs and readmissions Guidance on selection of appropriate repair material for individual patients

Prospective randomized controlled trials to answer major questions

Based on references 21, 23, 24, and 31.

5

REPORT Recurrence may need to be differentiated based on its effect on patient function and quality of life and the need for operative management (ie, clinical asymptomatic, clinical symptomatic, or radiographic recurrence). It also must be determined if clinical bulging without true hernia recurrence represents a type of â&#x20AC;&#x153;recurrence,â&#x20AC;? particularly when symptomatic. The use of more objective end points such as mortality, hospital readmission/length of hospital stay, and reoperation/mesh explantation may make it easier to compare between different studies. Similarly, risk factors for SSO and recurrence require thresholds for consideration, such as how recent a history of wound infection or smoking to consider.

The goals of ventral hernia repair are worth discussing in light of data that describe high rates of complications and reoperation. For example, patients who have large hernias that effect function and quality of life and multiple risk factors for SSO and recurrence may benefit from a repair that simply reduces the defect. A small bulge might be an acceptable outcome for a patient who had a large defect, several comorbidities, and a history of multiple prior repairs, particularly in light of the effect of untreated hernia and the risk for reoperation following hernia repair. However, depending on study methodology, this outcome might be considered a recurrence in clinical research and, therefore, a failure. This scenario points to the need to set appropriate goals and expectations for patients with challenging ventral hernia.

Key features of ventral hernia repair that often are not reported in clinical research include patient satisfaction, restoration of abdominal wall functionality, and potential improvements in quality of life, such as the ability to return to work and perform normal daily activities. Studies have reported reduced quality of life and function in association with ventral hernia,33 and many patients report dissatisfaction, chronic pain, and functional limitations following hernia repair. For example, a retrospective study of 201 patients who underwent laparoscopic ventral hernia repair found that 25% were dissatisfied with their repair, 17% had chronic abdominal pain, and 26% had poor functional status.34 Chronic pain has been reported as a common complication of incisional hernia repair, occurring in 28% of patients treated with underlay synthetic repair material.35 Together, these studies suggest that patients often have low satisfaction and quality of life even after ventral hernia repair and indicate the need for increased focus on patient-centered outcomes. Several such instruments have been developed and tested to varying degrees. The Activities Assessment Scale has been externally validated and can be used to assess function following ventral hernia repair.36 A hernia-specific quality-of-life scale, called HerQLes, was recently developed, but has not yet been widely used in clinical studies.37 The Carolinas Comfort Score has demonstrated utility for assessment of patients following reinforced hernia repairs; external validation of this scale is currently under study.38

Emerging Strategies: A Ventral Hernia Risk Scoring System Surgeons currently lack a simple, reliable, and validated system for quantifying risk for adverse outcomes, such as SSO and recurrence, based on individual patient characteristics.39 Emerging data reviewed during the 1-day summit in

6

May 2013 may represent a step toward the construction of such a system. The lead author of this work, Mike K. Liang, MD, discussed his findings in detail with the expert panel, and the group together emphasized the potential of such data to advance the science of predicting outcomes in challenging ventral hernia repair.

Dr. Liang and his colleagues used a large Veterans Administration database to identify 888 patients who underwent open ventral hernia repair between 2000 and 2010. The investigators conducted multivariate analyses using internal resampling to identify characteristics associated with SSO and SSI.40 Approximately one-third of the patients studied developed 415 unique SSO, most commonly SSI (21.5%), seroma (12.1%), wound dehiscence (7.1%), hematoma (3%), and fistula (1.4%).

Identified risk factors for reoperation and mesh explantation included number of prior abdominal surgeries and VHWG grade, respectively. Independent risk factors identified for SSO/SSI included use of repair material, concomitant abdominal procedures, the raising of skin flaps, BMI of 40 kg/ m2 or greater, American Society of Anesthesiologists Physical Status classification score 3 or 4, and wound class. Characteristics of the complex ventral hernia patient suggested by this study are listed in Table 5.28,40-42 Patients with none of these risk factors had similar risk for SSI/SSO as a class I wound, whereas patients with multiple risk factors were at exorbitantly high risk for SSI/SSO. Based on these factors, the authors have constructed a risk scoring system for SSO and SSI. These results were validated using a receiver operator characteristic curve. Evaluation and external validation of these scales is ongoing.

In another study, Liang and colleagues43 performed a casematched analysis of patients treated with a non-crosslinked porcine acellular dermal matrix and identified reduced rates of recurrence compared with primary repair with no increased risk for SSI, fewer recurrences compared with reinforcement with synthetic repair material, and increased rates of seroma compared with primary repairs or repairs with synthetic prostheses.

Economic Considerations Among the many unresolved issues regarding ventral hernia repair are economic considerations. Ventral hernias and their management, especially in a comorbid patient population, create significant costs and affect multiple stakeholders, including direct costs to hospitals and payors and indirect costs to patients and society in terms of lost wages and productivity. The costs of hernia repair may be influenced by choice of repair material, type of operation (eg, open vs laparoscopic), surgical outcomes, and the management of complications, particularly those requiring reoperation. The current reimbursement system does not adequately reimburse for the complexity of treatment required for this patient population. Indeed, a recent study found that a remarkably small proportion of patients consume a disproportionate amount of hospital resources when treated for in-patient ventral hernia repair.44 Some authors have reported increased direct costs associated with open ventral hernias repaired with biologic prostheses compared with synthetic materials.45 However, the cost of managing serious complications, such as infected

REPORT repair material, also should be considered. Cost analysis of a case series of 119 patients who required removal of infected repair material estimated average hospital costs of mesh removal to be $35,610.46 Of cases in which type of repair material was noted, 89% had synthetic repair material, with ePTFE most common, and 11% had biologic repair material. Indeed, the costs of managing major complications, such as mesh explantation, may outweigh the costs of the initial surgery and repair material. Similar results were seen from an analysis of insurance claims from US private insurers and Medicare plans from Truven Health Analytics MarketScan ÂŽ research databases.47 The authors performed a retrospective review of insurance claims data for 18 months from the index repair in patients with VHWG grade 3 or 4 hernias. Complication rates were higher in patients with grade 3 hernias who were treated with synthetic materials (P= 0.001 vs biologic material or primary repair). In grade 3 patients, xenograft patients had the lowest overall complication rate (17.9%) over 18 months compared with synthetic mesh (36.9%) and primary repair (24.3%). Although initial costs were higher when biologic materials were used, the 18-month costs were similar between the 3 groups when the total costs to manage complications were considered.

An emerging consideration in light of changes in reimbursement policies is 30-day readmission rate. In a retrospective chart review study of 420 patients who underwent open or laparoscopic ventral hernia repair, 12% required readmission within 30 days of discharge, 57% of these for wound infection.48 Multivariate analysis identified 4 independent predictors of readmission: the presence of fistula, defect size greater than 300 cm2, active abdominal infection, and open repair. An analysis of the Danish Ventral Hernia Database identified recurrent hernia and larger defects as significantly associated with worse outcomes, including readmission within 30 days.49 Readmissions in this study were mainly for treatment of wound infections and pain. Preventing readmissions will be a major goal for hospitals in the near future, and further research is needed to delineate patient characteristics that predispose to readmission.

Conclusions Tremendous progress has been made in the repair of challenging ventral hernia. However, the management of these patients remains a common and formidable clinical scenario in general surgery, and suboptimal outcomes are frustratingly frequent. The wide heterogeneity among patients with ventral hernia and low quality of published evidence preclude the implementation of standardized approaches to repair. Furthermore, high-level evidence is lacking regarding the efficacy and appropriate use of different types of repair materials and surgical techniques.

Although risk factors for SSO and recurrence have been identified, their relative contribution to these risks remain undefined, leaving surgeons without clear guidance on the selection of appropriate surgical techniques and repair materials for individual patients. Recent findings suggest that evidence-based risk scoring systems based on individual risk factors may soon be developed. Such systems, if validated, would help to guide the selection of techniques and materials, set patient expectations and facilitate communication, and possibly provide

payors guidance on appropriate reimbursement for these complex and challenging procedures.

For patients, the management of ventral hernia, particularly challenging hernia, may continue over many years, with multiple recurrences and reoperations, and associated risks for complications after each procedure. This cycle of repeat surgeries and poor outcomes may lead to reduced function and quality of life, increased medical expenses, and lost productivity. Optimizing the outcomes of each procedure is essential and may require a re-evaluation of the goals of hernia repair and a thorough discussion of expectations with patients.

A new effort is needed to update the findings of the VHWG and promote a dialogue around identification of standardized terminology, evidence-based risk scoring systems, and optimal technical approaches to the repair of ventral hernia. Such an effort also could provide a platform for promoting payment reform, as current levels of facility and physician payment are inadequate for the treatment of these complex patients.

Table 5. Characteristicsa of the Complex Ventral Hernia Patient Recurrence Failure to use prosthetic repair material Higher BMI Lower serum albumin levels Type of hernia (incisional) Reoperation Prior abdominal surgeries (â&#x2030;Ľ4) SSO/SSI Concomitant abdominal procedure Higher ASA class Higher BMI Higher wound class Presence of skin flaps Use of prosthetic repair material Mesh explantation VHWG grade 3 or 4 Readmission Duration of surgery >2 h History of prior SSI ASA, American Society of Anesthesiologists; BMI, body mass index; SSI, surgical site infection; SSO, surgical site occurrence; VHWG, Ventral Hernia Working Group a

These characteristics are based on identified factors influencing risk for SSO/SSI, recurrence, reoperation, mesh explantation, and readmission.

Based on references 28 and 40-42.

7

REPORT References 1.

Poulose BK, et al. Hernia. 2012;16(2):179-183.

29. Itani KM, et al. Surgery. 2012;152(3):498-505.

2.

Breuing K, et al. Surgery. 2010;148(3):544-558.

3.

Guyatt G, et al. Chest. 2006;129(1):174-181.

30. Krpata DM, et al. Am J Surg. 2013;205(3):354-358; discussion 358-359.

4.

Sailes FC, et al. J Am Coll Surg. 2011;212(1):119-123.

31. Clemens MW, et al. Plast Reconstr Surg. 2013;131(1):71-79.

5.

Houck JP, et al. Surg Gynecol Obstet. 1989;169(5):397-399.

32. Gutierrez de la Pena C, et al. Eur Radiol. 2001;11(7):1161-1164.

6.

Dunne JR, et al. J Surg Res. 2003;111(1):78-84.

33. van Ramshorst GH, et al. Am J Surg. 2012;204(2):144-150.

7.

Finan KR, et al. Am J Surg. 2005;190(5):676-681.

34. Liang MK, et al. World J Surg. 2013;37(3):530-537.

8.

Merkow RP, et al. J Am Coll Surg. 2009;208(1):53-61.

35. Gronnier C, et al. World J Surg. 2012;36(7):1548-1554.

9.

Krpata DM, et al. Surgery. 2013;153(1):120-125.

36. McCarthy M, et al. J Am Coll Surg. 2005;201(2):171-178.

10. Luijendijk RW, et al. N Engl J Med. 2000;343(6):392-398.

37. Krpata DM, et al. J Am Coll Surg. 2012;215(5):635-642.

11. Flum DR, et al. Ann Surg. 2003;237(1):129-135.

38. Heniford BT, et al. J Am Coll Surg. 2008;206(4):638-644.

12. Choi JJ, et al. Ann Surg. 2012;255(1):176-180.

39. Montgomery A. Hernia. 2013;17(1):3-11.

13. Turza KC, et al. Plast Reconstr Surg. 2012;130(5 suppl 2): 206S-213S.

40. Berger RL, et al. Development and validation of a risk stratification score for surgical site occurence and surgical site infection following open ventral hernia repair. J Am Coll Surg. In Press.

15. Butler CE, et al. Plast Reconstr Surg. 2004;114(2):464-473.

16. Leber GE, et al. Arch Surg. 1998;133(4):378-382.

17. vanâ&#x20AC;&#x2122;t Riet M, et al. Hernia. 2007;11(5):409-413.

18. Hawn MT, et al. Am J Surg. 2011;202(1):28-33.

19. Snyder CW, et al. J Am Coll Surg. 2011;212(4):496-502.

20. Rosen MJ, et al. Ann Surg. 2013;257(6):991-996.

41. Liang MK, et al. Mesh explantation and reoperation following open ventral hernia repair. Presented at: American Hernia Society Annual Meeting, March 13-16, 2013: Orlando, FL. 42. Nguyen MT, et al. Readmissions following open ventral hernia repair: incidence, indications, and predictors. Am J Surg. In Press.

22. Rosen MJ, et al. Am J Surg. 2010;199(3):416-420.

43. Liang MK, et al. Outcomes with porcine acellular dermal matrix versus synthetic mesh and suture repair in complicated open ventral hernia repair. Surg Infect (Larchmt). In Press.

23. Butler CE, et al. Plast Reconstr Surg. 2011;128(3):698-709.

44. Poulose BK, et al. Am Surg. 2013;79(8):815-818.

24. Cicilioni O, et al. Ann Plast Surg. 2012;68(3):265-270.

45. Reynolds D, et al. J Gastrointest Surg. 2013;17(1):159-166.

25. Le D, et al. Am J Surg. 2013;205(5):602-607.

46. Martindale RG, et al. Removal of infected surgical mesh following ventral incisional hernia in a case series of 119 patients at a tertiary referral center: examination of economic implications.

Presented at: Pacific Coast Surgical Association Annual Meeting, 2013: Kauai, Hawaii.

21. Patel KM, et al. Ann Plast Surg. 2012;69(4):394-398.

26. Kanters AE, et al. J Am Coll Surg. 2012;215(6):787-793.

27. Blatnik JA, et al. Am J Surg. 2012;203(3):370-374.

28. Li LT, et al. Comparing predictive value of two model selection approaches in multivariate logistic regression: A case study on recurrence following open ventral hernia repairs. Presented at: Association of VA Surgeons Annual Meeting, April 21-23, 2013: Milwaukee, WI.

47. DeNoto G, et al. Open Access Surgery. 2013;6:23-32.

48. Blatnik JA, et al. Surg Endosc. 2011;25(5):1446-1451.

49. Helgstrand F, et al. Ann Surg. 2012;256(6):955-958.

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

Copyright Š 2013, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.

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SR1329

14. Bauer JJ, et al. Mt Sinai J Med. 1999;66(1):20-25.

Brought to You by

NOVEMBER 2013

REPORT Techniques for Using Biologic Mesh in Hernia Repair:

Clinical Experience With VERITAS Collagen Matrix D

esigned for use when synthetic mesh is contraindicated or otherwise undesirable, biologic mesh provides surgeons with the ability to achieve a sturdy repair without undue risk for infection or the long-term complications often associated with synthetic products.1 Despite some benefits over synthetic meshes, some biologic meshes possess features—such as a high elastin content or conversely, crosslinked rigidity1—that make them a less optimal choice for specific procedures. Introduced in 2001, VERITAS Collagen Matrix (Synovis) is a non-crosslinked biologic mesh comprised of bovine pericardium.2,3 VERITAS is designed to provide surgeons an additional option that aims to further reduce operative and postoperative complications related to biologic mesh use.

VERITAS is intended for use in reconstruction of the

pelvic floor excluding transvaginal pelvic organ prolapse, the repair of rectal prolapse excluding rectocele, and for use as an implant for the surgical repair of soft tissue deficiencies: abdominal and thoracic wall repair, muscle flap reinforcement and repair of hernias (eg, diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical).2 Preclinical data showed VERITAS resulted in more favorable remodeling than other meshes, including another similarly non-crosslinked mesh.4,5 VERITAS displays high remodeling characteristics, low foreign body response, and good deposition of the extracellular matrix (ECM).4 Its pliability may make VERITAS easier to pass through a trocar, handle, and suture, according to Craig G. Chang, MD, FACS, program director of Bariatric Surgery in the DeTar Healthcare System in Victoria, Texas.

Faculty*

Craig G. Chang, MD, FACS

Charles K. Lee, MD, FACS

Program Director Bariatric Surgery DeTar Healthcare System Victoria, Texas

Chief of Plastic Surgery St. Mary’s Medical Center, San Francisco Assistant Clinical Professor of Plastic & Reconstructive Surgery University of California, San Francisco San Francisco, California

Eric G. Weiss, MD, FACS, FASCRS, FACG

Director, Education Center DIO and Chairman of Graduate Medical Education Associate Residency Program Director Department of Colorectal Surgery Cleveland Clinic Florida Weston, Florida * All 3 surgeons are paid consultants of Baxter Healthcare Corporation.

Supported by

REPORT VERITAS for Hiatal Hernia Repair

Techniques for Effective Repair

Dr. Chang performs approximately 4 sleeve gastrectomies per week. When performing these procedures, he noted that he also examines for the presence of hiatal hernias in need of repair. Considering that obese patients who have undergone sleeve gastrectomy may be affected by the presence of hiatal hernias and postoperative gastroesophageal reflux disease,6 Dr. Chang repairs hiatal hernias at the time of the bariatric procedure.

“I’m not sure many of my colleagues recognize the importance of fixing hiatal hernias as part of sleeve gastrectomy,” Dr. Chang said. “What we tell patients is that the sleeve is a reflux-producing operation because food backs up into that upper pouch. We’ve long known that the sleeve tends to cause reflux, but we’re finding that if we aggressively treat their hiatal hernias, the incidence of reflux tends to be pretty low.”

As the level of stress to the area of paraesophageal hiatal hernias can be high, sutures-only primary repair of these types of hernias may not be sufficient to prevent disruption.7 In one study, there was a statistically significant reduction in recurrence when the repair was reinforced with mesh (9% of the mesh repair group) compared with sutures-only repair (24% of the primary repair group) (P=0.04).7 Nevertheless, the presence of a foreign material carries its own risks, according to Dr. Chang. “If you use prosthetic mesh like a polytetrafluoroethylene or polypropylene mesh, it tends to erode into the stomach or the esophagus, or both. This is why most surgeons tend to use a biologic mesh at the hiatus,” he said.

Currently, there is little long-term data to recommend the use of one biologic mesha over another for hiatal hernia repair.

A recent multicenter, randomized trial of a biologic mesh (SURGISIS, Cook) to reinforce the primary repair of paraesophageal hernia found a recurrence rate of 54% compared with 59% for the control group.8 In the absence of evidence-based recommendations, there are other qualities Dr. Chang weighed and considered before forming a preference for VERITAS Collagen Matrix. “SURGISIS tended to be a little harder to handle because you have to soak it. If you don’t soak it thoroughly enough, it is more difficult to sew through,” he said. “FLEXHD (Ethicon) is pretty thick. That’s not necessarily bad, but it can be more difficult to make it conform to all the irregular contours of the diaphragm and the hiatus, where there are many areas where the mesh needs to conform.

So, I’ve gravitated toward a slightly thinner biologic mesh.”

In patients undergoing sleeve gastrectomy who have hiatal hernias, Dr. Chang first turns his attention to the hernia repair to avoid subjecting a newly created sleeve and staple lines to the pulling and tugging of the esophagus inherent to hiatal hernia repair.

“First, I try to mobilize as much of the esophagus as I can,” he said. “I go through the hiatus and about half-way up to the clavicles, if I can get that far, and I try to bring as much of the stomach and esophagus down into the abdominal cavity as I can.” Then, he closes the crura of the diaphragm posterior to the esophagus with a figure-eight suture using a braided polyester suture, and reinforces the repair with a mesh onlay of VERITAS 6×8 cm in which he has formed a keyhole defect to allow space for the esophagus to pass through (Figure 1).

“I place that piece of VERITAS up against the diaphragm so that it is overlaying the repair posteriorly, then suture the mesh to the diaphragm with 0 VICRYL [Ethicon] interrupted sutures, using an absorbable suture that will hold the mesh in place until it adheres.” Animal data has demonstrated positive remodeling—meaning both mesh degradation and generation of new tissue—with VERITAS at 1 month postoperatively.4 This can present pros and cons for hiatal hernia repair. “When it incorporates and basically dissolves, it’s not there to erode into the esophagus obviously. But as it disappears, it’s not there to support the repair any more either,” he said. “Having said that, in the cases where I’ve taken patients back for another surgery such as a cholecystectomy, I’ve seen some evidence of the mesh.”

Dr. Chang commented, “We’re seeing pretty good symptomatic relief of reflux with sleeve gastrectomy patients, in part because we’re mitigating one of the risk factors for reflux, which is obesity. When you address obesity with sleeve gastrectomy and repair the hiatal hernia, the reflux tends to get better.”

VERITAS for Incisional and Parastomal Hernia Repairs For Eric G. Weiss, MD, FACS, FASCRS, FACG, director of the Education Center, DIO and chairman of Graduate Medical Education, and associate residency program director in the Department of Colorectal Surgery at Cleveland Clinic Florida in Weston, Florida, finding the right biologic mesh for abdominal wall reconstruction started with surgeons and industry coming to a better understanding of the overall abilities of mesh.

Figure 1. Hiatal hernia repair using VERITAS Collagen Matrix.

Images courtesy of Craig G. Chang, MD, FACS.

a

2

Biologic mesh products are classified by the FDA as a Medical Device.

REPORT For example, although biologic mesh offers obvious advantages in a contaminated or clean-contaminated field, they cannot bridge a fascial defect and achieve remodeling of the fascia at the edges of the mesh, according to Dr. Weiss.

With the capacities of biologic meshes clarified, however, it became apparent that some materials underperformed in the area of abdominal wall reconstruction. “We found that ALLODERM (LifeCell) became more stretchy as it remodeled,” Dr. Weiss said. “Although the mesh incorporated well and was replaced by host tissue, that tissue would bulge. That was not a true hernia, but patients were unhappy with the cosmetic result, and so were we.”

Other meshes Dr. Weiss tried needed soaking or rehydrating.

Some required the surgeon to determine which side should face up or down. “These seem like relatively minor issues, but when you’re in the operating room, the less you have to think about the products you use on a daily basis, the easier procedures are.”

Due to its bovine pericardium composition, Dr. Weiss found that VERITAS Collagen Matrix had minimal stretch and more closely resembled native fascia than did the dermal products he used. He said that “now, we find VERITAS is easy to use and handles well from a surgical perspective, and all the nursing staff has to do is retrieve the size you need, open the package, and you’re good to go.

“We’ve been very happy with the outcomes in the sense that we don’t get any bulging; the mesh seems to incorporate well, and we haven’t gotten many seromas,” he added. “Also, VERITAS tends to be less expensive than some of the dermal products and even some of the other competitive products.”

Techniques for Effective Repair One of Dr. Weiss’s two most common uses for VERITAS is in a nonbridging abdominal construction when a patient has a large incisional hernia and possibly, an enterocutaneous fistula (Figure 2). “In these cases, we achieve primary abdominal wall closure with a component separation, and then place the mesh either in a sublay position or, more commonly, as an onlay on top of the component separation,” he explained. “We had found in the past that, over time, people started developing bulges—almost hernias—in locations away from the repair. So, we started buttressing the entire repair with a biologic mesh. In this approach, we buttress the lateral aspect of the component separation where we slid the rectus medially, so there is no fascia overlying the external oblique.”

The second common use Dr. Weiss has for VERITAS is in the repair of parastomal hernias. “In this situation, we most commonly perform the repair laparoscopically, and use the Sugarbaker technique with VERITAS, but we also have performed these repairs in an open manner,” he said.

Features of VERITAS and the Process Meshes made from bovine pericardium are composed of dense, regular connective tissue, and in the case of VERITAS, harvested from cattle less than 30 months of age.2 Additionally, VERITAS is non-crosslinked. Although proponents of crosslinked meshes argue that the process of crosslinking results in a superior repair due to the longer lasting presence of the mesh,5 this may not in fact be the case. A comparison of 4 crosslinked and non-crosslinked meshes composed of different materials found that although there were differences between the

Figure 2. Abdominal wall reconstruction using component separation and VERITAS Collagen Matrix.

Images courtesy of Eric G. Weiss, MD, FACS, FASCRS, FACG.

products in terms of ECM deposition, cellular infiltration, scaffold degradation, and neovascularization, crosslinking had no significant effect on the strength of the repair.5 “All biologic meshes become degraded over time, and manufacturers of crosslinked products often say crosslinkage slows down the degradation process. But animal data shows that whether products are crosslinked or not, at 12 months, the strength of the abdominal wall is equivalent,” Dr. Weiss observed. “Furthermore, in some non-crosslinked products, specifically VERITAS, the fact that they are not crosslinked allows for some remodeling, such as vascular ingrowth, and the laying down of collagen and the ECM, to occur earlier.”

Dr. Weiss uses VERITAS for abdominal wall reconstruction because “bovine pericardium is most similar to native fascia, and VERITAS is easy to use,” he said. “It handles well, it sutures well, and there is no subjectivity in terms of how you place it.

Also, it does not need to be stretched, comes in multiple sizes, and can be used right out of the package.”

VERITAS for Abdominal Wall And Breast Reconstruction Charles K. Lee, MD, FACS, chief of Plastic Surgery at St. Mary’s Medical Center, San Francisco and assistant clinical professor of Plastic & Reconstructive Surgery at the University of California, San Francisco, turned to VERITAS as soon as the product became available to him about 5 years ago.

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REPORT Dr. Lee used VERITAS Collagen Matrix in extensive abdominal wall reconstruction and breast reconstruction in the hopes that it would meet demands not satisfied by other biologic meshes.

“I’ve used ALLODERM, FLEXHD, ALLOMAX™ [Davol], and PERMACOL™ [Covidien]. The problems I had with these were poor incorporation, infections, and difficulty with handling,” Dr. Lee recalled. “Sometimes they are not very easy to use and they require a long hydration time.” Dr. Lee wanted a mesh that he could use right out of the package, that did not require rehydration, and that would act like the fascia itself, the very tissue he sought to replace. “I also wanted to make sure that it would actually revascularize,” he said. “And VERITAS was the only biologic mesh available that was made of pericardial tissue.”

Techniques for Effective Repair Abdominal wall reconstruction typically involves the removal of skin and fat from the lower abdomen as well as removal of a portion of or the entire abdominal muscle in some cases. In complex abdominal wall repair, to close a larger hernia, Dr. Lee uses VERITAS as an augmentation in component separation, usually as an underlay, but also occasionally as an overlay. “For the underlay, I use polydioxanone ‘U’ stitches size 1-0 through the fascia,” he explained. “Then, I create a primary fascial closure over the VERITAS.” Depending on the tension of the suture line, Dr. Lee might place an overlay atop the repair, using interrupted polydioxanone stitches or running sutures.

In breast reconstruction, Dr. Lee uses VERITAS as a fascial sling for the tissue expander or implant. “I use it in the lower pole, as a fascial sling below the pectoralis muscle,” he explained.

“For this, I use a 2-0 polydioxanone suture from the lower border of the pectoralis down to the intra-mammary crease.”

Since switching to VERITAS, Dr. Lee has been pleased with the product and the clinical outcomes it has provided for his patients. “I’ve had great success with it in both abdominal wall and breast surgeries. I’ve discovered that it revascularizes very quickly. It’s very strong and acts like fascia,” he said.

Dr. Lee noted that the processing of VERITAS makes it particularly useful for the type of complex reconstructive procedures he performs. “It is non-crosslinked. One of the things we’ve discovered in the use of biologic meshes is that crosslinking may inhibit their ability to revascularize.5 Crosslinking causes the biologic mesh to act more like a foreign substance, not crosslinking allows it to act more like true biologic material.

I think VERITAS, not being crosslinked, but still able to maintain its strong structure, offers some advantages.”

Conclusion Due to its risk for infection—which was reported as high as 30.9% in one study 9 —surgeons have avoided synthetic mesh for certain procedures. One alternative has been the use of biologic mesh, specifically bovine pericardium. Surgeons have

used this material extensively for years, and a history of welltolerated biocompatibility has been shown.4,5 “We have many choices now with biologic meshes, and I think that certain biologic meshes have advantages over others,” Dr. Lee said. “Surgeons looking for a biologic product that acts more like fascia, reincorporates very quickly, and is easy to handle, should consider VERITAS.” For hiatal hernia repair, Dr. Chang is quite pleased with VERITAS to date, but with the paucity of data on the use of biologic meshes in hiatal hernia repair, he feels strongly that this is an area in which more clinical trials, studies, etc. should be conducted. “This is a bit of a philosophical statement, but community surgeons like myself can contribute a lot of case volume and work with our academic colleagues to study some of these issues,” Dr. Chang said. “With a high long-term failure rate, we need to do better than that and establish best practices. I think the responsibility is on us as general surgeons to do that.”

References 1. Cavallaro A, Lo Menzo E, Di Vita M, et al. Use of biological meshes for abdominal wall reconstruction in highly contaminated fields.

World J Gastroenterol. 2010;16(15):1928-1933.

2. VERITAS [instructions for use]. St. Paul, MI: Synovis Surgical Innovations; 2013.

3. Synovis Surgical Innovations. VERITAS collagen matrix. www. synovissurgical.com/veritas_collagen_matrix.php. Accessed September 18, 2013.

4. Melman L, Jenkins ED, Hamilton NA, et al. Early biocompatibility of crosslinked and non-crosslinked biologic meshes in a porcine model of ventral hernia repair. Hernia. 2011;15(2):157-164.

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

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

6. Daes J, Jimenez ME, Said N, et al. Laparoscopic sleeve gastrectomy: symptoms of gastroesophageal reflux can be reduced by changes in surgical technique. Obes Surg. 2012;22(12):1874-1879.

7. Oelschlager BK, Pellegrini CA, Hunter J, et al. Biologic prosthesis reduces recurrence after laparoscopic paraesophageal hernia repair: a multicenter, prospective, randomized trial. Ann Surg.

2006;244(4):481-490.

8. Oelschlager BK, Pellegrini CA, Hunter JG, et al. Biologic prosthesis to prevent recurrence after laparoscopic paraesophageal hernia repair: long-term follow-up from a multicenter, prospective, randomized trial. J Am Coll Surg. 2011;213(4):461-468.

9. Diaz JJ Jr, Gray BW, Dobson JM, et al. Repair of giant abdominal hernias: does the type of prosthesis matter? Am Surg. 2004; 70(5):396-401; discussion 401-402.

Baxter and Veritas are registered trademarks of Baxter International Inc. All other products or trademarks appearing herein are the property of their respective owners.

Disclosures: Dr. Chang reported that he is a consultant for Baxter. Dr. Lee reported that he is a consultant for Baxter, Pacira, and Smith & Nephew, and has received grant/research funding from Smith & Nephew. Dr. Weiss reported that he is a consultant for Baxter.

Copyright © 2013, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.

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