March 2014

CONVENTION ISSUE:

Society of American Gastrointestinal and Endoscopic Surgeons

GENERALSURGERYNEWS.COM

March 2014 • Volume 41 • Number 3

The Independent Monthly Newspaper for the General Surgeon

Opinion

Understanding Part 1 of 2

Omentum Surgery Explored For Alzheimer’s Disease Mechanism Debatable, but Effect Appears Hard To Dispute

B Y B RUCE R AMSHAW , MD B Y V ICTORIA S TERN The enemy of science is not religion. …

The true enemy is the substitution of thought, reflection, and curiosity with dogma.

—Frans de Waal, “The Bonobo and the Atheist,” 2013

From Simplistic Dogma ...

In September 2010, a 44-year-old academic superstar was named dean of the Tilburg School of Social and Behavioral Sciences faculty at Tilburg University in Tilburg, the Netherlands. Just one year earlier, this acclaimed social psychology researcher, Diederik Stapel, received the Career Trajectory Award from the Society of Experimental Social Psychology. Stapel moved to Tilburg University in 2006 and started TiBER, the Tilburg Institute for Behavioral Economics Research. By the pinnacle of his career, Stapel had authored and co-authored dozens of papers, some published in the most prominent journals, such as Science. The problem was that Diederik Stapel was a fraud. For more than a decade, Stapel made up data for his studies, regularly hoodwinking

B

abak Gayour watched his father, a prominent mathematician and physicist in Iran, become someone he no longer knew.

“My father’s brain had become a shell,” Mr. Gayour said. “Once a month for a few seconds, he’d recognize who I was, but then it was gone in a flash.”

In 1993, Mr. Gayour’s father was diagnosed with Alzheimer’s disease (AD). Over the next several years, his father’s condition deteriorated.

He could no longer speak or recognize his family.

®

Surgical Patients Show Higher Mortality From Hospital Harms B Y B EN G UARINO

R

Omentum overlying the brain and omental blood vessels penetrating directly and deeply into the brain (image colorized).

see OMENTUM SURGERY page 28

Study Provides Snapshot of Recent Bariatric Demographics, Outcomes Stability Seen; More Current Data May Alter Patterns

esearchers have long known that postsurgery recovery is a vulnerable time for patients, but a new study goes a step toward quantifying that risk.

Michigan investigators assessed patients who experienced similar harms in the hospital—such as infection, pressure ulcers or renal failure—and found surgical patients represented a significantly higher percentage of overall mortality from harm than the rest of the inpatient population (73.2% vs. 37.0%, respectively; P<0.001).

A variety of factors could contribute to the disparity in mortality rates, said Zachary M. Bauman, DO, a critical care surgeon at Henry Ford Health System, in Detroit, who presented the findings at the 2014 meeting of the Society of Critical Care Medicine (abstract 31). One factor, he said, “is the surgery see HARMS page 4

see UNDERSTANDING page 31

B Y C HRISTINA F RANGOU

The SonicisionTM Cordless Ultrasonic Dissection Device: Improving Visualization and Precision With Greater Mobility see page 10

D

espite major shake-ups in insurance coverage of bariatric surgery since 2007, the demographics of patients who undergo these procedures have not changed, a new study shows.

Also stable throughout the study period were patient safety outcomes, measured in terms of morbidity and mortality. These remain virtually unmoved since 2007, with major complications reported in around 2% of patients and deaths in 0.1%.

INSIDE Stitches

Surgeons’ Lounge

On the Spot

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Laparoscopic Techniques for Hernia Repair: A History Of Ups and Downs

Human error in the OR and strategies for improvement

Surgical Robotics: Six Experts Debate the Current Pros and Cons and Future Potential of the Technology

see DEMOGRAPHICS page 16

REPORT H.E.R.N.I.A.: Hernia Experts Roundtable and New Innovations Assembly—Expert Consensus on the Use of Biosynthetic And Biologic Mesh in Hernia Repair See insert at page 37

GSN Editorial

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2014

Do You Need a Medical Scribe?

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

O

ver the past several decades, new and interesting medical and paramedical occupations have been created to reflect the changing complexities of our health care system. We have seen the proliferation of hospitalists, surgicalists and laborists (in-hospital obstetrical specialists) on the physician side, and patient navigators, physician extenders and patient ombudsmen in the nonphysician cadre. Now, there is an additional and intriguing job title that may gain some traction even in the high-tech era of the electronic medical record (EMR): the “medical scribe.”

The medical scribe, also known as a “clinical scribe,” “ER scribe” or “ED scribe,” is a trained medical information manager who specializes in charting physician– patient encounters in real time. Although originally spawned as an adjunct in the emergency medicine environment, this clerical resource has been introduced now into the inpatient and office settings.

Traditionally, physicians would complete their history gathering, physical examination and discussion with patients prior to writing or dictating notes that would be eventually included in the paper file. With the advent

The time that physicians, and especially physicians-in-training, are spending at the patient bedside has been drastically reduced in order to spend more time with EMR entry and review.

of the EMR, data are usually prepopulated by nursing personnel and then completed either during or after a patient encounter. One of the unintended and unfortunate consequences of electronic data recording is scenarios in which physicians literally face the computer screen rather than their patients in order to populate data in the EMR. The time that physicians spend during a patient visit capturing and entering data rather than focusing on the patient can be a major hindrance to the overall quality of care. Here is where the medical scribe may serve a very important role.

The medical scribe is an unlicensed individual hired to enter information into the EMR or chart at the direction of the physician or licensed independent practitioner. In-depth guidelines were released by the Joint Commission in 2011, and include the duties and supervisory issues of the medical scribe (www.jointcommission.org/mobile/standards_information/).

In my opinion, this concept may help correct some of the negative consequences foisted on all of us by the EMR. I sense that in the inpatient setting, the time that physicians, and especially physicians-in-training, are spending at the patient bedside has been drastically reduced in order to spend more time with EMR entry and review. In deciding whether to actually see patients or to complete the EMR entries before going to the OR each morning, the lure of the EMR frequently, and unfortunately, wins. It would be a true benefit to have

clerical support to document and transcribe, in a realtime fashion, the events of physician–patient interaction on rounds and to enter the data accordingly.

The same concepts apply to the office setting where our time should be spent interacting face-to-face with our patients, while having office notes completed by the medical scribe in real time during patient encounters.

This may improve the overall quality of documentation for both granularity and specificity. Such granularity might be translated into improved billing codes and remuneration. This also would reduce the necessity of finalizing notes and EMR data after a busy clinic day. Think of the wonderful possibilities in terms of time management!

The positive results created by working with a medical scribe are legion. These benefits may become more apparent especially as physicians continue to face the morass of data acquisition created by the launching and promulgation of the EMR and the real barriers that this disruptive technology creates for patients and physicians alike.

Mission Statement

Senior Medical Adviser

Leo A. Gordon, MD

Joseph B. Petelin, MD

Sales

Frederick L. Greene, MD

Los Angeles, CA

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Michael Enright Group Publication Director (212) 957-5300, ext. 272 menright@mcmahonmed.com

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

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

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

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

David Earle, MD Springfield, MA

James Forrest Calland, MD Philadelphia, PA

Edward Felix, MD Fresno, CA

Robert J. Fitzgibbons Jr., MD Omaha, NE

David R. Flum, MD, MPH Seattle, WA

Michael Goldfarb, MD Long Branch, NJ

Peter K. Kim, MD

Paul Alan Wetter, MD

Bronx, NY

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Lauren A. Kosinski, MD Milwaukee, WI

Raymond J. Lanzafame, MD, MBA

Editorial Staff

Rochester, NY

Kevin Horty Group Publication Editor khorty@mcmahonmed.com

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John Maa, MD San Francisco, CA

Gerald Marks, MD Wynnewood, PA

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

J. Barry McKernan, MD Marietta, GA

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Letters to the Editor

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2014

Withhold Surgical Treatment for Smoking?

To the Editor: [Re: Surgeons and the First Surgeon Generalâ&#x20AC;&#x2122;s Report, January 2014, page 1] I was stunned to read Dr. Frederick Greeneâ&#x20AC;&#x2122;s suggestion that although â&#x20AC;&#x153;it may be difficult to refuse a patientâ&#x20AC;&#x2122;s request for an operation solely based on his or her continued use of tobacco products, but perhaps we have to take a hard line, especially for elective operations.â&#x20AC;? A hard line? Are you kidding me? Let the patient suffer for his own good?

While it is true that smoking carries risk, all of us engage in risky behaviors. Some people ride motorcycles on the same roads where Mack trucks ride.

Some people drink. Others eat too much.

Some have risky, unprotected sex. Some even drink sodas that are larger than 32 ounces. Would we ever withhold medical care from these people because they engage in risky behaviors that we happen to not do ourselves? Would we not offer obese patients the best care we can give them because they are fat and will, therefore, have a higher complication rate than a patient of ideal weight? We offer medical care to prisoners. We offer medical care to our enemies in war.

I find the very suggestion that we consider withholding indicated medical/surgical care from patients because we donâ&#x20AC;&#x2122;t like smoking to be deeply repugnant.

That a leader in our profession would propose that surgeons withhold care to make a point about smoking indicates

HARMS

jcontinued from page 1 itself.â&#x20AC;? Surgical patients may experience more pain and require more narcotics than patients who do not undergo surgery, Dr. Bauman said, which could lead to more severe harm from naloxone or other medications.

To determine the effect of inpatient harm on patient mortality, Dr. Bauman and his colleagues retrospectively reviewed the records of 114,677 patients admitted to a hospital in the Henry Ford Health System from 2009 to 2011. For each of the 11 inpatient harms assessed, the authors found significantly higher mortality rates among surgical patients injured in the hospital (P<0.001 for each harm reviewed). The three incidents with the highest mortality rates for surgical patients and patients who did not undergo surgery were adverse reactions to medication (32.0% vs. 13.1%, respectively), renal failure (23.5% vs. 8.3%) and hypoglycemia (20% vs. 9.9%). Procedural harm had the

I appreciate the impassioned letter from Dr. Edward Teitel regarding my editorial on the role of surgeons in tobacco control and smoking cessation. Dr. Teitel, in taking exception to the concept of avoiding elective operations in the actively smoking patient, affords the opportunity to highlight issues that are pivotal not only in the arena of surgical risk management, but are also germane to the professional integrity of practicing surgeons. I, as well as many of my surgical colleagues, have concluded that the risks of operating on patients who do not willingly participatee in smoking cessation strategies and

continue to smoke are morbid enough to counsel patients against an elective surgical procedure. The operative word in my phraseology was â&#x20AC;&#x153;continued useâ&#x20AC;? of tobacco products.

Contrary to Dr. Teitelâ&#x20AC;&#x2122;s characterization of my approach as â&#x20AC;&#x153;letting patients suffer for their own good,â&#x20AC;? the intent of such recommendations is to seize the chance to reduce the risk for postoperative respiratory complications, impaired wound healing and infection. There is sound evidence that stopping smoking for even two weeks can improve surgical outcomes. No matter how we feell about smoking or whether we smoke ourselves, how could we in good conscience withhold these data from our patients? All surgical decisions require balancing risk and benefit. In the elective surgery setting, the risk margin should be as narrow and the benefit margin as wide as possible. It is the ethos of the surgeon who fails to do this, who enjoys a patientâ&#x20AC;&#x2122;s confidence and the income from a procedure for which the patient was not optimized, that will increasinglyâ&#x20AC;&#x201D;and appropriatelyâ&#x20AC;&#x201D;be called into question. As a society, we have been struggling to empower patients to have access to health care, a goal that continues to be a work in progress. To what end will this effort be if the quality of the care we provide is not guided by seeking the best outcomes possible?

Dr. Teitel appropriately alludes to other risky behaviors that we encounter in our preoperative deliberations with patients.

Obesity is certainly a risk factor that we

largest proportional difference in mortality rateâ&#x20AC;&#x201D;a roughly sevenfold increaseâ&#x20AC;&#x201D;in surgical patients compared with nonsurgical patients (19.4% vs. 2.8%, respectively). â&#x20AC;&#x153;Even one complication puts [a patient] at risk for a completely different trajectory,â&#x20AC;? said Ilan S. Rubinfeld, MD, MBA, a specialist in trauma and emergency surgery at Henry Ford Hospital who helped conduct the study.

Martin A. Makary, MD, MPH, associate professor of surgery at Johns Hopkins University, in Baltimore, who was not involved with the research, agreed. â&#x20AC;&#x153;A single event can set off a cascade of subsequent harms,â&#x20AC;? Dr. Makary said.

Determining the consequences of having a specific harm remains a challenge. â&#x20AC;&#x153;Are some of these harms more important, or more a bellwether of bad

how deeply we bow before the altar of PC idolatry. While Dr. Greene laments that â&#x20AC;&#x153;all of the current efforts to improve health care and to support legislation such as the Affordable Care Act will be totally meaningless unless we challenge patients to take responsibility for their own health and reduce [bad] habits,â&#x20AC;? I lament that leaders like Dr. Greene would propose that we punish and harm individual patients by withholding surgical care in support of governmental legislative goals. Such a communitarian ethos must be rejected as profoundly unethical by anyone who takes the Hippocratic Oath seriously.

Edward R. Teitel, MD, FACS, JD, MBA Chairman/CEO, Aggredyne, Inc. Houston, Texas

Dr. Greeneâ&#x20AC;&#x2122;s Reply

In-hospital Harms With the Highest Mortality Rates Surgical patients

Nonsurgical patients

Medication harm

32.0%

13.1%

Renal failure

23.5%

8.3%

Hypoglycemia

20.0%

9.9%

Procedural harm

19.4%

2.8%

No matter how we feel about smoking or whether we smoke ourselves, how could we in good conscience withhold these data from our patients? frequently confront regardless of our surgical specialty. I am sure, however, that many surgeons would engage the patient in discussion regarding the importance of weight reduction before repairing a large abdominal wall hernia and would delay such operative intervention until the patient shows some evidence of BMI [body mass index] reduction that may diminish the inevitability of recurrence.

No, Dr. Teitel, I am not suggesting that we refuse patients their needed surgical procedures. What I am suggesting is that we take a lead in ensuring that patients join with us in smoking cessation strategies before their operations rather than enabling them to continue their risky behavior. In my view, this does not represent punishment or withholding of surgical care, but does meet our Hippocratic maxim of primum non nocere.

khorty@mcmahonmed.com.

things to come?â&#x20AC;? Dr. Rubinfeld asked. â&#x20AC;&#x153;We canâ&#x20AC;&#x2122;t say that for sure, but we all have our suspicions.â&#x20AC;? He added that ongoing studies would address these questions in more detail.

Differences in patient characteristics could impact the way harmful incidents affect mortality. The authors found that surgical patients had fewer comorbidities than nonsurgical patients, with a lower average Elixhauser Comorbidity Index (3.57 vs. 5.52, respectively; P<0.001). But why a patient was admitted to the surgical floor could â&#x20AC;&#x153;very well have been more serious,â&#x20AC;?

Dr. Makary said, than the reason a nonsurgical patient was admitted to the hospital.

Clinicians also suggested that stress could play a role. Dr. Makary pointed out that even minor stressors have been linked to physical conditions, such as acne or cold sore outbreaks. Surgical patients, he said, are encountering one of the â&#x20AC;&#x153;greatest physiologic stress events in medicine: an operation.â&#x20AC;?

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2014

Laparoscopic Techniques for Hernia Repair: A History of Ups and Downs B Y V ICTORIA S TERN

T

he idiom “great minds think alike” may sound like a cliché, but it rings true in the era of laparoscopic surgery. Innovative ideas and techniques from many laparoscopic pioneers emerged independently at similar periods.

Around the time that German gynecologist Kurt Semm, MD, was trying to popularize a range of laparoscopic procedures to treat gynecologic issues (General Surgery Newss April 2013, page 8), Ralph Ger, MD, FRCS, FACS, repaired an inguinal hernia through a laparoscope for the first time. But unlike laparoscopic appendectomy or cholecystectomy repairs, techniques to perfect laparoscopic hernia repair evolved over decades.

In the late 1970s, Dr. Ger, chairman of the Department of Surgery, Nassau Hospital in Mineola, N.Y., and professor of surgery, State University of New York at Stony Brook, treated a series of 13 patients with inguinal hernias, 12 of which were repaired through an open incision. For the 13th patient, however, Dr. Ger decided to try something different: He passed a laparoscope through a small subumbilical puncture and closed the neck of the sac with a series of staples, performing the first laparoscopic-guided inguinal hernia repair ((Ann R Coll Surg Engll 1982;64:342-344). Motivated by this success, Dr. Ger experimented with laparoscopic inguinal hernia repair, successfully closing the neck of the hernia sac laparoscopically in 14 of 15 beagle dogs ((Am J Surgg 1990;159:370-373).

In 1989, gynecologist Sergei Bogojavlensky, MD, first used a laparoscopic plug-and-patch technique, stoppering the hole with a rolled-up piece of polypropylene mesh during inguinal and femoral hernia repairs. That same year, Leonard Schultz, MD, a surgeon at Abbott Northwestern Hospital, Minneapolis, refined the plug-and-patch method and reported the first series of laparoscopic herniorrhaphy, in which he passed pieces of polypropylene mesh through a laparoscope, stuffing some of them into the orifice of the hernia and placing several sheets over the defect (J ( Laparoendosc Surgg 1990;1:41-45).

The plug-and-patch approach was already a popular procedure for open hernia repair, first introduced in 1968 by Irv Lichtenstein, MD, to fix femoral and small direct recurrent inguinal hernias, and later adapted by Arthur Gilbert, MD, in 1985, to repair indirect inguinal hernias.

Although the procedure initially showed promise for laparoscopic hernia repair, longer follow-up revealed a recurrence rate of 15% to 20%. Dr. Schultz found that the mesh often would migrate and patients would develop mesh hernias. As a result, this method, along with a variation introduced by J.D. Corbitt Jr., MD (Surg Laparosc Endoscc 1991;1:23-25), was soon abandoned.

“Because most surgeons couldn’t suture and there were no tacking devices yet, surgeons were rolling polypropylene mesh up like a cigarette butt and shoving it down the hernia with the idea that it would scar in and resolve the defect,” said Robert Sewell, MD, a general surgeon at the Master Center for Minimally Invasive Surgery in Southlake, Texas. “It didn’t work and caused most surgeons to look at laparoscopic hernia repair as a gimmick. Even when better techniques started to evolve, we were always trying to overcome the negative first impression created by the plug repair.”

Intraoperative view of TEP repair. 1. Genital ramus of genitofemoral nerve. 2. Preperitoneal lipom and spermatic cord.

From: Wikimedia. Author: Anpol42.

In 1990, Robert J. Fitzgibbons, MD, and Charles J. Filipi, MD, both currently professors of surgery at Creighton University School of Medicine, Omaha, were looking for ways to mimic the success of laparoscopic cholecystectomy in hernia repair and began experimenting with pigs in the lab. The duo came up with a new repair, the transabdominal preperitoneal (TAPP) approach.

“We figured out a way to cover all critical anatomical structures with mesh and tack it in place,” recalled Dr. Fitzgibbons.

At about the same time, Maurice Arregui, MD, FACS, also began experimenting with laparoscopic options for inguinal hernia repair.

“I recalled the Rives-Stoppa open repair and thought this might be the best approach, so I tried mimicking this technique using laparoscopic tools,” said Dr. Arregui, director of fellowship in Advanced GI Surgery, Laparoscopy, Endoscopy and Ultrasound at St. Vincent Hospital and Health Care Center, in Indianapolis.

In 1992, Dr. Arregui reported the results of a TAPP series in humans, performing 61 laparoscopic preperitoneal mesh repairs, using either Prolene (Ethicon) or Marlex (Davol/Bard) mesh, on 52 patients from October 1990 to December 1991 (Surg Laparosc Endosc 1992;2:53-58).

That same year, Yves-Marie Dion, MD, and Jacques Morin, MD, Department of Surgery, L’Hôpital SaintFrançois d’Assise, Quebec, Canada, independently published the results of 10 inguinal herniorrhaphies performed via TAPP using Prolene mesh (Can J Surg 1992;35:209-212). In both studies, the authors found that all patients recovered quickly compared with the open technique, and experienced less pain and no recurrences. Results of subsequent studies evaluating

the efficacy of TAPP have shown recurrence rates of less than 1% (Surg Endoscc 1995;9:16-21).

Although the TAPP technique worked very well, Drs. Fitzgibbons and Filipi wondered why they had to open the preperitoneal space and do an extensive dissection instead of simply placing the mesh one layer deeper, directly over the peritoneum. With this question in mind, they developed the intraperitoneal onlay patch (IPOM) technique, which averted the need for significant dissection by placing a piece of mesh over the peritoneal defect and securing it with staples.

Surgeons Frederick Toy, MD, and Roy T. Smoot Jr., MD, FACS, also were investigating the efficacy of IPOM, reporting positive short-term results in 10 patients who had polytetrafluoroethylene mesh secured to the inguinal floor using staples (Surg Laparosc Endoscc 1991;1:151-155). In a later series of 75 patients, IPOM was associated with a low recurrence rate (2.4%), minimal postoperative pain and short recovery time after 20 months ((J Laparoendosc Surg 1992;2:197-205).

Soon after, surgeons discovered that although IPOM worked well for repairing indirect and small hernias, it was not ideal for direct hernias or larger hernias. Additionally, intra-abdominal mesh could become involved when an unrelated intra-abdominal infection, such as appendicitis, occurred.

“As a result, many people thought this technique wouldn’t be a good long-term solution,” said Jeffrey Ponsky, MD, Oliver H. Payne Professor and chairman, Department of Surgery, Case Western Reserve University School of Medicine, and surgeon in chief, University Hospitals, Case Medical Center, Cleveland.

Although IPOM didn’t catch on for inguinal hernia repair, the technique is used currently to repair ventral hernias, Dr. Fitzgibbons noted.

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2014

TAPP Versus TEP: Laparoscopic Standard of Care Despite the success of TAPP, many surgeons still thought that entering the abdominal cavity was too invasive for an inguinal hernia repair, and so a twist on TAPP emerged. In a totally extraperitoneal prosthetic (TEP) repair, surgeons do not enter the peritoneal cavity but instead dissect directly into the preperitoneal space with the laparoscope. The key is to create an extraperitoneal space between the peritoneum and the abdominal wall. Radical dissection of the preperitoneal space and mesh placement are then performed just as they are in TAPP. It remains unclear exactly how the TEP approach came about, although it may have arisen from the animal training labs for laparoscopic cholecystectomy.

Many surgeons who taught courses would tinker in the labs afterward, experimenting with new techniques, Dr. Fitzgibbons recalled. During one such session, general surgeon Barry McKernan, MD, managed to create a space in the preperitoneum without entering the abdomen completely, and TEP was born.

French laparoscopic surgeon Jean-Louis Dulucq, MD, also a pioneer of TEP, performed a large series of 864 inguinal hernia repairs from 1990 to 1995. This series, however, largely went unnoticed in the United States and was only described years later in the book Retroperitoneoscopy, published in 1996.

Dr. McKernan and surgeon George Ferzli, MD, FACS, helped popularize TEP. In one early report, Dr. McKernan showed success repairing 51 direct and indirect inguinal hernias using this approach, with no unusual complications and all patients returning home after one day and to work within a week of the procedure (Surg Endosc1993;7:26-28).

The Balloon Initially, surgeons did the TEP repair without a balloon. “At this time, we did manual dissection to access the preperitoneal space, which many found to be tedious and difficult, but doable,” said Guy Voeller, MD, FACS, professor of surgery at University of Tennessee Health Science Center, in Memphis, adding that once balloon technology emerged, TEP became more feasible for more surgeons.

In 1989, Jay Watkins, a businessman and designer, approached Albert Chin, MD, who had developed a balloon angioplasty catheter with Tom Fogarty, MD, in the mid-1970s, and Fred Moll, MD, who had developed and patented the first safety shield trocar for laparoscopy, about cofounding a device company focusing on laparoscopic technologies. Together, the trio formed Origin Medsystems, and Drs. Chin and Moll began creating devices to simplify laparoscopic procedures, particularly structural balloons that could replace gas insufflation. By 1991, Dr. Chin had developed a prototype of a simple elastic balloon with an internal endoscope, which could create a large preperitoneal cavity.

This Preperitoneal Dissection Balloon (PDB) allowed surgeons to view critical structures through the transparent wall of the balloon and insert a structural balloon within the space.

During that time, Maciej Kieturakis, MD, a surgeon in private practice in Redwood City, Calif., took a standard esophageal catheter, called a Sengstaken-Blakemore tube, to access the preperitoneal space. He used the tube, which has a balloon on one end, to inflate the preperitoneal space and performed the first TEP procedure with a balloon. Later, Dr. Kieturakis published a series of his TEP balloon approach (Am ( J Surg 1994;168:603-604).

‘Because most surgeons couldn’t suture and there were no tacking devices yet, surgeons were rolling polypropylene mesh up like a cigarette butt and shoving it down the hernia with the idea that it would scar in and resolve the defect.’

—Robert Sewell, MD

more easily, and today the majority of TEP repair are done with the balloons.”

Several other technologies, including in-line needle holders and disposable staplers, helped laparoscopic inguinal hernia repair begin to take hold in the surgical community.

“Ethicon Endo-Surgery and U.S. Surgical Corporation developed staplers, which revolutionized the way hernia repair could be performed,” Dr. Sewell said.

“Surgeons didn’t have to suture; they could cover the defect with mesh without any tension.”

TAPP or TEP: Which Is Better?

Dr. Moll and Origin’s director of marketing, Milt McColl, MD, heard that Dr. Kieturakis had performed laparoscopic preperitoneal hernia repair with a balloon, and arranged a meeting.

“In this meeting, Dr. Kieturakis revealed that he had been inflating the small spherical distal balloon of a Sengstaken-Blakemore tube in the preperitoneal space to prepare a surgical cavity for inguinal hernia repair,” Dr. Chin recalled.

In a subsequent encounter, Drs. Moll and McColl told Dr. Kieturakis about their PDB balloon, and offered him a royalty to join forces with Origin. Dr. Kieturakis turned them down and teamed up with Dr. Fogarty to form a separate startup company called General Surgical Innovations (GSI), developing the blind balloon dissection. Both Origin Medsystems and GSI commercialized their devices.

The balloon helped catapult TEP as a standard for laparoscopic inguinal hernia repair. Dr. Voeller taught the procedure with the balloon to surgeons at his lab in Memphis and abroad.

“The balloons allowed for surgeons to access the preperitoneal space quickly, with minimal bleeding,” Dr. Voeller said. “Although it’s possible to do TEP without a balloon, the balloon allowed surgeons to do repair

AT A GLANCE In the late 1970s, surgeon Ralph Ger, MD, repaired an inguinal hernia through a laparoscope for the first time.

In 1989, gynecologist Sergei Bogojavlensky, MD, first used a laparoscopic plug-and-patch technique, stoppering the hole with a rolled-up piece of polypropylene mesh.

In 1990, Robert J. Fitzgibbons, MD, and Charles J. Filipi, MD, developed the transabdominal preperitoneal (TAPP) approach for hernia repair.

In the early 1990s, Maciej Kieturakis, MD, took a standard esophageal catheter, called a SengstakenBlakemore tube, to access the preperitoneal space. He used the tube, which has a balloon on one end, to inflate the preperitoneal space and performed the first TEP procedure with a balloon.

Reports emerged assessing the TAPP and TEP techniques. Edward Felix, MD and his colleagues from Fresno, Calif., published a study comparing 733 TAPP and 382 TEP in 866 patients (Surg Endoscc 1995;9:984989). The authors reported 11 major complications in the TAPP group versus no complications and one recurrence in the TEP group.

That same year, several surgeons, including Drs. Arregui, Fitzgibbons and McKernan, collected results from a series of 3,229 laparoscopic hernia repairs in 2,559 patients using a range of techniques, including TAPP (60% of patients), TEP (18%), laparoscopic plug-and-patch (9%) and IPOM (11%) (Surg Endosc 1995;9:16-21). The TAPP and TEP had the lowest rates of recurrence (1% and 0%, respectively) and complications (7% and 10%, respectively).

In 1998, Drs. Felix, McKernan, Sewell and their colleagues conducted a retrospective review to confirm the effectiveness of TAPP and TEP, comparing results in 7,661 patients who underwent 10,053 hernia repairs (Surg Endoscc 1998;12:226-231). Follow-up revealed that 35 TAPP and TEP repairs failed (0.4%), demonstrating an extremely low recurrence for the techniques.

“The results were exemplary,” Dr. Felix recalled.

“Here, we showed that different surgeons using different laparoscopic techniques could get the same results.

This was a milestone paper that put laparoscopic hernia repair on the map.”

Today, the majority of laparoscopic inguinal hernia repairs are performed using TAPP or TEP approaches with polypropylene prosthesis. The choice of procedure depends mostly on surgeon preference.

“TAPP is perhaps my favorite laparoscopic inguinal hernia repair because it is a safe and sturdy repair and easy to learn and teach,” Dr. Ponsky said. Drs. Sewell and Fitzgibbons also predominantly use the TAPP approach, noting that they “find it easier.”

After watching a video of surgeon Edward Phillips, MD, perform TEP, Dr. Arregui had a change of heart.

“I thought TEP would be better than TAPP because it more closely mimicked the open approach and limited opportunities for complications,” recalled Dr. Arregui, who now exclusively does TEP. Dr. Felix also prefers the TEP approach, performing 95% of his cases using TEP and only 5% with TAPP, as does Dr. Voeller, who has done 3,500 TEPs. Still, both agree the two approaches are essentially equivalent.

Laparoscopy Versus Open: Controversy Although surgeons attempted to replicate the success of laparoscopic cholecystectomy with hernia surgery, the real benefits of laparoscopic hernia repair remained questionable. As a result, in May 1993, Dr. Arregui and his colleague Robert Nagan, MD, organized the “Hernias ’93, Advances or Controversies” conference, held in Indianapolis, inviting the premier hernia experts from around see HERNIA REPAIR page 8

7

8

Stitches HERNIA REPAIR jcontinued from page 7

the world. The goal of the meeting was to promote the laparoscopic approach and discuss the effectiveness of different open and laparoscopic techniques.

Arthur Gilbert, MD, associate clinical professor of surgery at the University of Miami Medical School, now retired, and founder of the American Hernia Society, recalled the tension in the conference room, which was divided between the sharply dressed, young laparoscopic surgeons on one side and the older, dowdy

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2014

crowd of open surgeons on the other. â&#x20AC;&#x153;You could see one side talking about the other like they were ready to go to war,â&#x20AC;? he said. â&#x20AC;&#x153;It was the most contentious meeting Iâ&#x20AC;&#x2122;ve been to in my 50-year surgical career.â&#x20AC;?

Drs. Gilbert and Voeller agreed that laparoscopic inguinal hernia repair hadnâ&#x20AC;&#x2122;t yet matured by 1993, which resulted in unnecessary complications, including bowel and blood vessel injuries, that didnâ&#x20AC;&#x2122;t occur in the open repair. â&#x20AC;&#x153;The complications seen in the laparoscopic approach were awful, so when the older guard made their presentation, they

stressed complications seen with laparoscopy,â&#x20AC;? Dr. Gilbert said. â&#x20AC;&#x153;And when laparoscopic surgeons made their presentations, they stressed the complications seen with open surgery. It became a mud-slinging contest at that point.â&#x20AC;?

Dr. Voeller believes that part of the reason open hernia repair experts were so opposed to laparoscopic repair was that they felt threatened. Dr. Gilbert agreed, recalling in 1990 being approached by industry representatives who informed him that if he did not switch to laparoscopic hernia surgery, he would lose patients and go out of business.

Every matrix has a story.

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â&#x20AC;&#x2DC;You could see one side talking about the other like they were redy to go to war. It was the most contentious meeting I've been to in my 50-year surgical career.â&#x20AC;&#x2122; â&#x20AC;&#x201D;Arthur Gilbert, MD Although there was a lot of bickering during the meeting, tempers calmed afterward. â&#x20AC;&#x153;What came out of that meeting was a sense of civility,â&#x20AC;? Dr. Gilbert said. â&#x20AC;&#x153;I felt that we recognized that laparoscopic hernia surgery was here to stay, and those who thought it was a better technique would devote themselves to it, but those who wanted to stick with open surgery would do so.â&#x20AC;?

Dr. Arregui agreed, noting that â&#x20AC;&#x153;although initially polarizing the open versus laparoscopic camps, [the meeting] ultimately created relationships that grew into friendships and combined efforts to improve the art and science of hernia repair.â&#x20AC;? *** Several years later, Dr. Sewell moderated a half-day session on inguinal hernia repair at an American Society of General Surgeons meeting in Toronto. Experts from all over the country presented their experiences with their preferred techniques, including open approaches, such as Lichtenstein and Kugel repair as well as laparoscopic techniques, such as TAPP and TEP. â&#x20AC;&#x153;I titled that session â&#x20AC;&#x2DC;Hernia Wars,â&#x20AC;&#x2122; because there was so much controversy about what the best hernia repair was,â&#x20AC;?

Dr. Sewell said.

In Dr. Sewellâ&#x20AC;&#x2122;s opening remarks, he illustrated two types of surgeries with an image of a bulldozer and another of an architect sitting at a drawing board. â&#x20AC;&#x153;There are bulldozer operations like gallbladder and appendectomy where surgeons are trying to remove something,â&#x20AC;? he said. â&#x20AC;&#x153;And there are reconstructive procedures, like hernia repair, where surgeons are trying to rebuild something.â&#x20AC;?

The next slide read simply, â&#x20AC;&#x2DC;The hernia surgeonâ&#x20AC;&#x2122; with a picture of the Peanuts cartoon character Linus, holding his security blanket and sucking his thumb.

Dr. Sewellâ&#x20AC;&#x2122;s message was that hernia surgeons tend to hold on to the procedure they are most comfortable with, like they would a security blanket.

The panel of experts presented their results and proceeded to debate which procedure had the fewest complications, recurrences and pain. In the final analysis, Dr. Sewell asked the panel, â&#x20AC;&#x2DC;If you were to have a hernia repair yourself and needed it fixed by some technique other

Stitches

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2014

than your own, what technique would you choose?’

“Every member, except the expert from the Lichtenstein Clinic, who simply refused to answer the question, said they would have their hernia repaired laparoscopically,” Dr. Sewell recalled.

“Every surgeon recognized the value of the tension-free laparoscopic approach.”

Dr. Voeller, recalling the spirit of the open-versus-laparoscopy debates, fondly recounted his arguments with surgeon George Wantz, MD, a staunch advocate of open preperitoneal repair. During one debate, after TEP had become more mainstream, Dr. Wantz approached Dr. Voeller and said, “‘Guy, don’t tell anyone, but if I had a hernia, I would want you to do it laparoscopically.’ This was the day I knew the TEP was here to stay.”

Over the years, studies have reported a range of recurrence rates for open techniques. One study of patients undergoing a tension-free open Lichtenstein repair with polypropylene mesh reported a 0.1% recurrence rate (Eur J Surg 1996;162:447-453), while another found a recurrence rate ranging from 5% after tension-free open Lichtenstein repair to 15% after either Cooper’s ligament or abdominal ring repair ((Am J Surg 1996;172:315-319). Studies comparing pain after open and TEP repairs found significantly more pain and disability in patients who had open mesh repair than with TEP (Br J Surgg 2002;89:14761479; Ann Surgg 1996;224:598-602). And a randomized controlled study comparing laparoscopic and open tension-free repairs reported that the laparoscopic approach comes with lower recurrence rates (3% vs. 6%), less postoperative pain and earlier recovery (N Engl J Med 1997;336:1541-1547).

In contrast, a prospective, randomized controlled study, which compared laparoscopic and open tension-free repairs of inguinal hernias in 2,164 patients at 14 Veterans Affairs medical centers, showed a higher recurrence and complication rate in the laparoscopic group (10.1% and 39%, respectively) versus the open group (4.9% and 33.4%, respectively) (N Engl J Medd 2004; 350:1819-1827).

The study received criticism from laparoscopists who felt that the surgeons involved in the trial were inexperienced, Dr. Voeller said. “Most of the TEP procedures were done by VA residents who were not yet experts in the TAPP or TEP repairs,” he said, adding that when the study compared recurrence rates for the open and laparoscopic procedures performed by highly experienced surgeons, there was no significant difference (5.1% for laparoscopic vs. 4.1% for open approach).

Because recurrence rates are similar for open and laparoscopic approaches when performed by experienced hands, Dr.

Ponsky prefers laparoscopy if patients are healthy enough. “I do laparoscopic hernia repair in 60% of patients and open in about 40%, but which approach I choose depends heavily on the patient’s cardiac status, previous abdominal problems and surgeries, and the patient’s desire to get back to work. I tend to select the procedure based on the patient’s needs and desires as well as my preference.”

Hernia Repair Today Now, of the 900,000 inguinal hernia repairs performed each year in the United States, about 20% to 30%

are done laparoscopically, and according to data from the National Surgical Quality Improvement Project, 30% of recurrent inguinal hernias are repaired laparoscopically.

“However, these percentages vary widely from city to city and hospital to hospital, depending on the local expertise,” Dr. Felix said.

Reflecting on the laparoscopic hernia repair evolution, Dr. Felix said, “Laparoscopic hernia repair has had its ups and downs over the last 20 years. The laparoscopic hernia techniques are much harder to learn, so it never took off in the same

way that laparoscopic cholecystectomy did, not because it’s inferior but because it’s not better in everyone’s hands.”

Despite the slower pace of acceptance, the intense debates and constant evolution of ideas and techniques made for an exciting experience.

“During the early 1990s, I was in the middle of the firestorm during the emergence of laparoscopy,” Dr. Ponsky said. “It was like being on cocaine. Every day was a high. Every week, we had discussions about new instruments, new techniques, new ideas—it was electric. It was the best time I’ve ever experienced in surgery.”

9

THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

The Sonicision™ Cordless Ultrasonic Dissection Device: Improving Visualization and Precision With Greater Mobility Faculty Samuel Szomstein, MD Associate Chairman of The Bariatric and Metabolic Institute and Section of Minimally Invasive and Endoscopic Surgery Associate Director of the Minimally Invasive and Bariatric Surgery Fellowship Program Director, Bariatric Endoscopy Cleveland Clinic Florida Fort Lauderdale, Florida

James Connaughton, MD Colorectal Surgeon San Antonio Colorectal Clinic San Antonio, Texas

Introduction Energy-based devices have evolved significantly to meet the clinical demands of the operating room. As part of the armamentarium of technology-driven solutions, ultrasonic devices, which derive their dissecting and sealing capabilities from high-frequency vibration, have been found to improve outcomes including operating time and blood loss.1 Recently, Covidien expanded its portfolio of energybased surgical instruments to include the Sonicision™ cordless ultrasonic dissection device—the industry’s first cordless ultrasonic dissection device—indicated for soft tissue dissection and vessel occlusion of up to 5 mm in diameter (Figure 1).1-3 The Sonicision™ device is a handheld dissection instrument with a cordless design that simplifies the surgical setup, while enabling greater mobility for the surgical team. With possible applications in general,

bariatric, colorectal, gynecologic, and urologic procedures, as well as its simplified reusable capabilities, the Sonicision™ device may reduce the costs associated with the capital investment of several devices and their respective upgrades through technology standardization.

Table 1. Pre-clinical Performance Results For the Sonicision™ Device and the Harmonic ACE™*

Design Improvements Enhance Mobility The Sonicision™ device offers a unique advantage, particularly in the multiple tool–dependent environment of laparoscopic surgery, by allowing freedom of movement among the surgical team members. With the cordless design of the Sonicision™ device, it is possible to infinitely rotate the instrument shaft based on directional preference without cord entanglements.3 Samuel Szomstein, MD, a bariatric surgeon with Cleveland Clinic Florida, has been using the Sonicision™ device since the instrument was first introduced. He finds the device to be most advantageous in his advanced laparoscopic cases. “The cordless quality is a significant advance,” said Dr. Szomstein. “To be in control of the instrument and to not have to worry about wires, generators, and other devices that are not in your control—that’s what I like about it. It’s is very easy to maneuver, and it provides continuing energy without interruptions.”

James Connaughton, MD, whose practice consists of general and colorectal surgery at the San Antonio Colorectal Clinic in San Antonio, Texas, agrees. “During laparoscopic cases, you’ve got cords running all over the table, and having one less is definitely a significant benefit,” he said. “If I could have no cords, that would be perfection— not having it tethered to something is very helpful.”

The Sonicision™ device is easy to assemble without requiring a lot of setup time which can improve overall efficiency. “I think it’s pretty easy for the technicians to set up.

It doesn’t require the testing that the Harmonic™* does, so it hasn’t slowed me down,” said Dr. Connaughton.

The Sonicision™ device possesses an intuitive dual mode energy activation control that facilitates the transition between minimum and maximum power modes.3 Thus, surgeons are able to optimize control and focus more on the patient and procedure without looking at the device during the procedure.

Mean Dissection Speed, sec ± SD

Mean Activation Blade Cool Down Time, sec ± SD

26.1 ± 4.0

41.2 ± 1.3

Harmonic ACE™* 33.2 ± 5.1

50.4 ± 7.5

Sonicision™

P<0.001

P=0.006

Based on reference 4.

Rather than having a cord connect to a bulky generator outside the surgical field, the Sonicision™ device draws ultrasonic energy from a hand-held generator that can be reused for up to 100 uses, is easy to assemble, and can be sterilized. The system also comes with a battery charger that can charge 4 batteries simultaneously.

“The less apparatus in the OR, the fewer wires across the OR table, the easier it is to use, and this gives more control to the surgeon handling the instrument, rather than needing 3 or 4 people to work around an instrument,” noted Dr. Szomstein.

“With other ultrasonic devices, I have to switch back and forth rapidly between it and a suction device, and if there is a cord attached, it contributes to the braided mess I have by the end of the case with all these corded instruments.”

While most ultrasonic instruments possess a shaft length range between 36 and 45 cm, the Sonicision™ device has a 39-cm long shaft that furthers its application for more surgical procedures as well as patient populations.3 Given the average size of his patients, Dr. Connaughton appreciates having a longer shaft. “In San Antonio, a lot of our patients are heavier, so the longer the better—having bariatric length instruments is helpful,” he said. “With other instruments, I’ve had issues with them being too short to be effective. On the other hand, if I’m using a longer instrument and don’t need all the length, that’s not a problem. I’d rather have the longer instrument.”

Clinical Performance

Figure 1. The Sonicision™ Cordless Ultrasonic Dissection Device.

10

GENERAL SURGERY NEWS • MARCH 2014

Dr. Connaughton has long been a fan of ultrasonic energy devices for dissection for laparoscopic cases, which comprise about 90% of his caseload, because of the ease of use and speed. “That’s always what’s motivated me as far as laparoscopic procedures,” said Dr. Connaughton. “I don’t want to be limited by the equipment I’m using. That seems to be the thing with all of these technologies—the speed of use.”

Several pre-clinical studies were conducted comparing the Sonicision™ device with the other leading ultrasonic device on a variety of performance standards, including dissection speed. Both devices were evaluated by dividing 15 cm of porcine mesentery at maximum power. Results showed that the dissection time was significantly faster with Sonicision™ than with the other leading ultrasonic device (26.1 ± 4.0 vs 33.2 ± 5.1 seconds, respectively; P<0.001). Additionally, the Sonicision™ device has a faster active blade cool down time to 60 degrees (41.2 ± 1.3 vs 50.4 ± 7.5 seconds, respectively) (Table 1).4

Supported by

The studies also demonstrated comparable results for both devices in mean vessel burst pressure, thermal spread, peak active blade temperature, and seal time.4 “For all of the reasons I like ultrasonic energy, the Sonicision™ device is just better; for one thing, it’s significantly faster,” said Dr. Connaughton. “It’s noticeably quicker than the Harmonic™*.

It cuts and seals more quickly, and I can move freely without feeling like I’m waiting for the device to perform. I notice when I put the Harmonic ACE™* across something I have to sit and wait for it to cut through, whereas with the Sonicision™ device, I close it, start using it, and it moves along.”

In addition to having faster dissection speed, Dr. Connaughton recognizes the benefits of Sonicision™ in generating minimal mist (Figure 2).2,44 “[Plume] is a huge issue, because the more you have to take the camera out and clean it, the more time you add,” said Dr. Connaughton. “The less time someone spends on the operating table, the better. So if there’s less plume, there’s less cleaning of the scopes, and the better off you are.”

Using a digital quantification technique, Kim and colleagues measured plume generated by different ultrasonic devices at maximum and minimum modes.5 At minimum mode, the Sonicision™ device plume obscured 5 times less than the other market-leading ultrasonic device (Table 2).5 Surgical plume obscures visualization which may increase operating time. Dr. Connaughton routinely ventilates access ports during surgical procedures to deal with plume issues and finds this adds considerably to case time. “It creates the potential to lose the pneumoperitoneum, having to wait to resume the pneumoperitoneum. All those pauses stall operations, whether you’re cleaning the instruments or waiting for the pneumoperitoneum to come back up,” he said.

Although Dr. Connaughton has not determined whether the use of the Sonicision™ device has reduced his need to ventilate access ports, Dr. Szomstein has seen a difference.

“I do that in general, but I haven’t needed to do it with the Sonicision™ device. It does create less mist,” he said.

The reduced plume may be attributable to the shape of the blade, but it may also have to do with the fact that the Sonicision™ device moves faster, explained Dr. Connaughton.5 “I don’t know if the straight blade is directly related, though it could be,” he said. “But because it seals and cuts faster, you’re not sitting there generating that plume.”

“Anything that saves money to the hospital without compromising patient safety is beneficial,” Dr. Szomstein said. “So if there is no capital investment, that will save money. With the wireless technology and fewer devices in the OR, [Sonicision™] is time-saving, and there will probably be fewer problems.” The speed of the instrument also may be economically beneficial. “In the grand scheme of things, anything that speeds up the operation will reduce cost, because there’s less OR time involved,” noted Dr. Connaughton.

Economic Considerations for Standardization

Average Obstruction on Minimum Power Setting

Rechargeable and cordless, the Sonicision™ device minimizes the surgical setup time while enhancing mobility during surgery. Additionally, the device has built-in upgrade capability (with natural replacement) that prevent the generators from becoming outdated quickly. Because it can be integrated into a number of surgical procedures, the Sonicision™ device offers hospitals an opportunity to save money by standardizing to a technology that does not require a non-upgradeable capital investment.

A Leveled Learning Curve Based on his experience, Dr. Szomstein believes any surgeon who performs laparoscopic procedures would benefit from using the Sonicision™ device. Dr. Connaughton recommends the use of the Sonicision™ device in intra-abdominal procedures, bariatric procedures, obstetric/gynecologic procedures, and minimally invasive procedures. In particular, he recognizes the benefits in using this device for colectomies and complex ventral hernias. “Those are the big ones where it really makes a difference as far as time, because there’s a significant amount of dissection that needs to be done,” he said. “[Sonicision™] just makes things go smoother, and those are big issues when you’re doing a lot of cases in a single day. Anything that makes your life a little easier is greatly appreciated.”

According to Dr. Szomstein, the transition to the Sonicision™ device will be fairly seamless for any surgeon experienced in using ultrasonic dissectors, and is one step toward reducing the clutter in the OR and increasing mobility during surgery. “The wireless technology does provide some relief. If surgeons feel they have too many things in their surgical field, this is one way to start getting rid of some of them,” he said.

References 1. Matthews B, Nalysnyk L, Estok R, et al. Ultrasonic and nonultrasonic instrumentation: a systematic review and meta-analysis. Arch Surg.

2008;143(6):592-600.

2. Tsirline VB, Lau KN, Swan RZ, et al. Evaluation of an innovative, cordless ultrasonic dissector. Surg Innov. 2013;20(5):524-529.

Figure 2. The Sonicision™ device offers faster dissection and up to 5x less mist than Ethicon’s Harmonic ACE™*.2,4

3. Internal testing and the Sonicision Launch Book; 2013 M130236a and R0015050.

4. When compared to the Harmonic ACETM* as part of a 2010 pre-clinical analysis evaluating the performance of the Sonicision™ device versus the Harmonic ACETM* Covidien internal test report No. 2-105-10.

5. Kim FJ, Sehrt D, Pompeo A, Molina AP. Comparison of surgical plume among laparoscopic ultrasonic dissectors using a real-time digital quantitative technology. Surg Endosc. 2012;26(12):3408-3412.

Table 2. Maximum Plume Obstruction Sonicision™ Device

Harmonic ACE™*

Maximum Obstruction, %

4.80 ± 0.86

26.63 ± 3.70; P<0.001

Range, %

0.24-19.83

8.12-73.50

Maximum Obstruction, %

8.76 ±1.49

12.65 ± 0.97; P=0.026

Range, %

4.32-17.41

0.07-18.15

Average Obstruction on Maximum Power Setting

Adapted from reference 5.

BB1149

COVIDIEN, COVIDIEN with logo, and Covidien logo are U.S. and internationally registered trademarks of Covidien AG. ™* Trademark of its respective owner. Other brands are trademarks of a Covidien Company. Copyright © 2014.

US130201a 2014/01 Disclosures: Dr. Szomstein reported that he is a consultant for Covidien and Ethicon Endo-Surgery. Dr. Connaughton reported no relevant financial disclosures.

GENERAL SURGERY NEWS • MARCH 2014

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Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2014

Dear Reader, Welcome to the March issue of The Surgeons’ Lounge. In this issue, John Paige, MD, associate professor of clinical surgery, LSU Health New Orleans School of Medicine, New Orleans, replies to a very timely and interesting operative scenario in which human error is highly possible, but where trainees and other team members are strongly discouraged from voicing concerns, or questioning decisions of the attending (senior) surgeon, even when error is very evident and may negatively affect the patient.

Check out what the experts say about closure of fascia for port sites 10 mm or greater in size in Expert Express!

The April issue will feature presentations from the 25th Anniversary Jagelman/35th Anniversary Turnbull International Colorectal Disease Symposium 2014, hosted by Steven D. Wexner, MD, and Feza Remzi, MD, which took place Feb. 11-16, 2014, in Fort Lauderdale, Fla.

Readers’ feedback is our greatest asset. Tell us how we’re doing! What do you want to see more of? Less of? What is the best part of Surgeons’ Lounge? What can we do even better? We look forward to your feedback!

Sincerely, Samuel Szomstein, MD, FACS Editor, The Surgeons’ Lounge Szomsts@ccf.org Dr. Szomstein n is associate director, Bariatric Institute, Section of Minimally Invasive Surgery, Department of General and Vascular Surgery, Cleveland Clinic Florida, Weston.

Question for Dr. John Paige

Dr. Paige’s

Reply

Jessica Zagory, MD, PGY-3 LSU Health New Orleans Department of Surgery, LSU Health New Orleans Health Sciences Center, New Orleans

A

patient with a left inguinal hernia was scheduled for open repair as the third operating room (OR) case of the day.

The first two cases also were open inguinal hernia repairs and ran longer than expected, cutting into clinic time. To make up time, the patient was moved to another room and the OR staff prepped the patient so our team could come in as soon as the prior case was completed. The patient was brought into the OR prepped and draped. Our team came in and was about to begin the procedure when an OR nurse requested a time-out (even though we were itching to get started!). Needless to say, a fight ensued between my attending and the OR nurse because of this. She persisted, and we obeyed the time-out. Thank goodness! It turns out that the case that had been scheduled in the OR room before our moving our case into it had been a right inguinal hernia, and the OR staff had prepared the right side of the patient. Because there were so many inguinal hernia patients lined up that day, we did not notice until the consent form was reviewed. As it happens, the medical student had noticed the side mix-up but was too afraid to speak up because the attending surgeon had made it clear in the past that medical students (and the rest of the team for that matter) were to be seen and not heard in his room! It brought up a lot of questions for me: • What should I take away from this episode to avoid such issues in the future?

• The time-out really helped; what are other strategies out there that can help?

• How do you help ensure that those who know important things can speak up?

• You do a lot of team training with students and residents is this why?

T

hanks for such great questions. They raise several points related to systems-based practice that often can get overlooked, but, I would argue, are as important as knowing how to manage a specific disease or surgical condition.

What you have described is known as a “near miss” in human factors parlance: that is, a catastrophic event that is narrowly averted.

Human factors is a field of study focusing on man’s interaction with his environment. Human factors engineering attempts to design systems for safe and effective human use by trying to optimize the interaction through the study of human behaviors, abilities and limitations ((Am J Med Qual 2006;21:57-67). A key axiom on which such work is based is the recognition that human error is inevitable. Thus, an error-free system cannot be created, and, as a result, defenses-in-depthh are required to help identify and mitigate problems or errors when they arise. The more numerous and stronger the defenses created to prevent adverse events, the less likely the holes within each layer will line up, leading to a catastrophic outcome. This Swiss cheese model of error, promoted by James Reason (Figure), is a useful way to understand how seemingly inexplicable events, such as wrong-site, wrong-patient, or wrong-procedure, can happen within an organization (BMJJ 2000;320:768-770).

In your example, many of the so-called holes in the layers of defense had lined up to

Figure. The Swiss cheese model of how defenses, barriers and safeguards may be penetrated by an accidental trajectory. prime the system for a catastrophic event: OR delays pushing back the scheduled start time of the case, time pressure on the surgeon due to being late to clinic, similar cases scheduled in multiple rooms, changing rooms and teams to speed things up, fear of speaking up on the part of the medical student. Fortunately, one layer did not have an aligned hole: the time-out requirement and the circulating nurse who insisted on it, resulting in a “near miss” as opposed to a sentinel event (i.e., wrong-side surgery).

Unfortunately, in health care, providers often react to such close calls with a “boy, was that lucky” response and do nothing more. From a human factors perspective, such events are actually “gifts” to the organization because they reveal weaknesses in the system before something bad has happened, providing the opportunity to evaluate the system and implement changes to prevent similar future occurrences. Such responsiveness requires what is known as a “generative” organizational culture that has specific values and characteristics that prepares the organization to recognize and learn from such events. They include an orientation toward always improving performance, good cooperation within and between departments, well-trained messengers to point out issues, shared risk taking, a willingness to implement novel ideas continued ON page 14

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14

Expertess Expr

Surgeons’ Lounge

Q. Closure of fascia for port sites 10 mm or greater in size?

Michael Sarr, MD: M

FFrederick Greene, MD:

Yes Y

Yes Y

M Michael Schweitzer, MD: Depends on type M o port and size of of patient p

Edward Phillips, MD: Yes

Ashutosh Kaul, MD: In A m midline, patients with ascitis, if fascia weak a or if cutting-tip trocars o used u

Daniel Herron, MD: Ronald Hinder, MD: Always

B Bruce Ramshaw, MD: Yes M

Definitely!

Esstuardo Behrens, MD: Ye es

Natan Zundel, MD: More than 12 mm, yes

Alfons Pomp, MD: Always

Emanuele Lo Menzo, MD: Yes, if in midline

EEdward Felix, MD: Alex Gandsas, MD: A No (non-bladed) N

Anthony Petrick, MD:

Depends on patient, location and type of trocar. In bariatric surgery with noncutting trocars, it is not necessary.

Je effrey Ponsky, MD: Yes

Ye es, if 12 mm or grreater

continued FROM page 12

and a belief that failures in the system reflect an underlying problem that should prompt inquiry into solutions (Qual Saf Health Caree 2004;13:22-27).

Generative organizational cultures are the core of socalled high reliability organizations (HROs). HROs demonstrate high levels of safety; consistent performance; and reliable outcomes in unforgiving, even hostile, work environments (Surg Clin North Am 2012;92:1-14). Industry examples include aviation, the military and nuclear power. They promote mindfulness in lieu of mindlessness among their members and are constantly seeking reliability instead of achieving it (Managing the Unexpected. Jossey-Bass; 2001; Best Pract Res Clin Anesthesiol.

2011;25:133-144).

Thus, an HRO would have a near-miss reporting system in place to identify and correct those “latent conditions,” defects in layers of defense that are present but not recognizable until they manifest themselves as holes in the Swiss cheese. Therefore, your take-home lesson should be to use this close call to try to improve processes and make defenses stronger.

What are some strategies to help improve systems to “trap and mitigate” hazards? They can include decreasing complexity within a given system, optimizing processing, automating in an intelligent (as opposed to universal)

Maher Abbas, MD: Yes Y

Michael Lin, MD: Yes

manner, and thinking about and avoiding the inevitable unintended consequences of changes (BMJJ 2000;320:771773). Designing constraints within processes (e.g., hard stops) is especially useful. The most effective of these is the physical constraint that is designed to make it impossible for a person to make the error. Diesel gas nozzles are a great example of this concept. They are purposely made too large to insert into unleaded gas tanks to prevent the catastrophic effect of diesel gas use in an engine designed for unleaded gas use.

Another type of constraint is the procedural constraint.

Although not failproof like a physical constraint, procedural constraints are required processes that are designed to prevent a problem. In our profession, the muchmaligned Joint Commission–mandated time-out is one such procedural constraint. It requires a review before commencing a procedure to ensure that the correct person is being operated on, the correct side is prepared, and the correct procedure is being performed. In practice, additional components have been added to help ensure good evidence-based practice, such as checks regarding antibiotic and thromboembolism prophylaxis. In this case, this procedural constraint succeeded in doing what it was designed to do: act as a defense against operating on the wrong side.

Another strong, although not perfect constraint is the

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2014

cultural constraint. By making the “way we do things” align with values of HROs, a generative culture can be established that exerts pressure on individuals who might act otherwise to conform. Typically, such cultures are ones in which safety is the primary priority and all necessary resources are allocated to this goal (Qual Saf Health Care 2003;12:112-118). A good example outside of medicine is the culture on an aircraft carrier. Here, speaking up regarding perceived safety issues is encouraged and rewarded if it prevents a catastrophic event such as a jet crash. Thus, improving teamwork is also an important strategy in promoting HRO function.

Ensuring health care teams such as the OR team function as highly reliable units is one of the best ways to ensure any member feels comfortable speaking up when he or she identifies a problem. In fact, establishing highly reliable teams (HRT) is a prerequisite to creating an HRO (Surg Clin North Am 2012;92:1-14). Research into the science of teamwork has identified key characteristics that HRTs possess to ensure resilience in dynamic situations, and many frameworks have been established describing them. Eduardo Salas’ Big Five Model of teamwork is particularly useful because it served as the basis for the Agency for Healthcare Research and Quality’s TeamSTEPPSTM program, which is used by many health care institutions. (Small Gr Ress 2005;36:555-599; AHRQuality, Rockville, MD. www.ahrq.gov/qual/teamstepps/.

Accessed May 8, 2013).

This model identifies five core competencies essential to highly reliable teamwork: team leadership, mutual performance monitoring, backup behavior, adaptability and team orientation.

These “big five” competencies are facilitated by three key coordinating mechanisms: shared mental model, closed loop communication and mutual trust. The coordinating mechanisms help ensure that the core team-based competencies are fostered in any given situation. The “big five” are particularly useful in high-risk, dynamic environments like the OR to ensure rapid, effective responses to hazards in the environment. Teams espousing such knowledge, skills and attitudes (KSAs) maintain flattened hierarchical structures in which each member feels comfortable speaking up and leadership of the team in any given situation is based on expertise.

Good teamwork, therefore, like expert operating, can be learned. The KSAs of HRTs should be trained and fostered just as much as technical skills and medical knowledge in the surgeon, especially because poor teamwork is rife in the clinical environment. In the OR, the “silo mentality” prevails, stifling collaboration and communication and fostering a form of tribalism among the professions (Qual Saf Health Caree 2010;19:103-106). This situation negatively affects patient care and safety (Am ( J Surg 2009;197:678-685; Surgeryy 2006;139:159-173).

Strategies that have been successful in fostering HRT include the use of checklists, briefings, team training programs such as TeamSTEPPSTM, and high-fidelity simulation-based training (HF-SBT) of interprofessional teams and discipline-specific crews. HF-SBT is the strategy adopted at LSU Health New Orleans for teaching HRT functions to students and residents. The advantages of HF-SBT include the ability to create a safe learning environment in which low-frequency, high-risk events can be experienced and teams can learn from mistakes without harm to the patient (Qual Saf Health Care 2004;13:51-56). In this manner, we are trying to promote cultural change by giving you and your colleagues the team-based KSAs to be able to adapt effectively, communicate openly and anticipate one another’s needs in order to provide the best possible care to your surgical patients.

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In the News DEMOGRAPHICS jcontinued from page 1

“We’ve reached a certain stability where both morbidity and mortality are unchanged from year to year. These statistics now represent what would be considered average for these types of cases,” said Ranjan Sudan, MD, a bariatric and robotic surgeon and vice chair of education, Duke University Health System, Durham, N.C. Dr. Sudan presented the study on behalf of the research committee and the executive council of the American Society for Metabolic and Bariatric Surgery at Obesity Week 2013.

The study paints a picture of bariatric surgery at U.S. centers of excellence by gender, ethnicity, age, procedure, rate of complications and outcomes. It shows very little change between 2007 and 2011.

Overall, there were no significant increases in the percentage of minorities, males or individuals with diabetes who underwent bariatric surgery.

Of the more than 364,000 patients in the study, 1.75% experienced a serious adverse event (AE) within the first 30 days and 2.02% experienced a serious AE within a year. The one-year serious AE rate stayed close to that average

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2014

throughout the six years of data collection, peaking at 2.18% in 2009 and dropping to 1.66% in 2011.

The data are not risk-adjusted so it is impossible to compare complication or death rates across procedures. Generally, patients with a higher body mass index, more excess body weight and more comorbidities tended to undergo more extensive reconstructive bariatric procedures, such as gastric bypass or biliopancreatic diversion with duodenal switch.

For this reason, the investigators caution against comparing complication rates across different procedures.

But, they added, the complication and mortality rates within procedures could be used for benchmarking. One-year mortality rates were 0.84% for biliopancreatic diversion with duodenal switch, 0.26% for Roux-en-Y gastric bypass, 0.11% for sleeve gastrectomy and 0.05% for gastric banding.

“The study provides real-life benchmarks for common bariatric procedures, benchmarks that surgeons and credentialing bodies can use to compare a surgeon’s outcomes,” said Dr. Sudan.

The study showed a trend toward more blacks and Hispanics undergoing bariatric surgery. The percentage of black patients rose from 10.11% in 2007 to 13.43% in 2011, whereas the percentage of Hispanic

‘The study provides real-life benchmarks for common bariatric procedures, benchmarks that surgeons and credentialing bodies can use to compare a surgeon’s outcomes.’

—Ranjan Sudan, MD patients increased from 5.84% to 8.44% of the bariatric surgery population. However, the increase in these minority patients is still less than what would be expected based on the prevalence of obesity in this population, Dr. Sudan said.

The most common comorbid condition among bariatric patients was hypertension, roughly twice the rates of diabetes, sleep apnea, gastroesophageal reflux disease and musculoskeletal disorder. Notably, about one-fourth of bariatric patients between 2007 and 2011 had been diagnosed with diabetes.

Surgeons said they expect a greater percentage of patients with diabetes to undergo bariatric surgery in 2013 specifically to treat their disease. Multiple studies have shown that overweight and obese patients with type 2 diabetes improve or

reverse their condition, as well as reduce their cardiovascular risk factors, years after the surgery ((Ann Surgg 2013;258:628-636).

In 2011, the International Diabetes Federation Taskforce on Epidemiology and Prevention of Diabetes issued a statement that bariatric surgery can be considered an appropriate treatment for people with type 2 diabetes and obesity who are not achieving recommended treatment targets with medical therapies (Diabet Med 2011; 28:628-642).

Vivek N. Prachand, MD, director of the University of Chicago Medicine Center for the Surgical Treatment of Obesity, said the study provides a “very nice snapshot” of bariatric surgery in the United States during an important period for the field, but he expects that things have shifted since 2012.

“These data don’t reflect the impact of recent high-quality data published in the nonsurgical literature demonstrating the profound impact of these operations on diabetes,” he said.

“The overall message from this study is that bariatric surgery is remarkably safe, and despite the absence of published clinical guidelines for procedure selection, it is encouraging to see that patients are generally undergoing procedures proportionate to the burden of their obesity and comorbidities.”

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2014

Trauma Patients See an Upward Trend in Radiation Exposure B Y B EN G UARINO

T

rauma patients at a Nebraska hospital who underwent computed tomography (CT) scans and other diagnostic tests faced an upswing in radiation exposure over the past decade, adding to concerns that radiologic procedures may pose a greater carcinogenic risk to patients than previously understood.

The recent study, which contributes to a growing body of research on inpatient radiation exposure, reflects the belief that “we are submitting our trauma patients to a tremendous amount of radiation,” said Michel Wagner, MD, a trauma and critical care surgeon at Creighton University Medical Center in Omaha, Neb., and a co-author of the study.

The researchers could not verify the increase in radiation had a detrimental effect within the study population.

Dr. Wagner presented the results of this research at the 2014 annual meeting of the Society of Critical Care Medicine (abstract 257). “I think that this is a little bit of a warning bell.”

Using patient records from a database at a Nebraska trauma center, the researchers retrospectively determined which radiologic exams clinicians had ordered for patients between 2001 and 2010. For 7,661 trauma patients who were admitted to the hospital during that period, the authors evaluated the amount of radiation each patient received based on dose estimates for 416 different radiologic procedures.

“The goal was to come up with a standard metric of comparison,” said Jonathan Vonk, a medical student at the Roy J. and Lucille A. Carver College of Medicine in Iowa City, Iowa, who also conducted the research. “In reality, the actual received dose is highly dependent on body composition.”

Radiation exposure among trauma patients rose significantly over the 10-year period, increasing by an estimated 6.7 to 12.8 mSv. In 2001, the average radiation exposure was 14.9 mSv per trauma patient, the authors calculated. By 2010, the mean dose of radiation had increased to about 24.6 mSv per patient. In contrast, the total radiation dosage for an average American, including exposure from background radiation and medical procedures, is 6.2 mSv per year, according to a 2011 report from the U.S. Nuclear Regulatory Commission.

“As this study and many other studies show, our reliance on medical radiation continues to grow for diagnostic and therapeutic measures,” wrote Deborah Rohner, MD, in an email. Dr. Rohner, assistant professor in the Department of Anesthesiology at the University of Kentucky College of Medicine, Lexington, was not involved with this research.

“Therefore,” she wrote, “the potential iatrogenic cancer burden is expected to increase.”

The commonly accepted model is a linear relationship between radiation dose and cancer risk, Mr. Vonk said, but the researchers could not verify if the increase in radiation had a detrimental effect within the study population.

The clinical significance of radiation doses less than 100 mSv remains controversial, Dr. Rohner said. She also noted that the allowable exposure to radiation workers in the United States is 50 mSv per year. Exposure to 100 mSv of radiation is

associated with a 1% increase in lifetime risk for developing cancer, according to a 2006 report from the Board on Radiation Effects Research VII. Physicians may be reluctant to limit the number of CT scans ordered, out of concern that injuries will go undetected.

But clinicians should be willing to reassess the risks and benefits of diagnostic plans, Dr. Wagner said. CT scans are easy to order, he said, but they are not without risk.

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• Using limited studies and cumulative data, EXPAREL® claims that a single injection can provide up to three days of “patient-focused pain control.”1 Yet, in a pivotal bunionectomy study, it is no more effective than a placebo beyond 12 hours.3

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17

In his blog, Toby Cosgrove, CEO of Cleveland Clinic Foundation, recently referenced two studies done within his institution comparing robotic surgery with traditional methods for mitral valve repair and prostatectomy. The first study found that technical complexity and longer surgical time were balanced by the benefits of shorter hosptial stays and smaller incisions; the second study showed that robotic surgery was no better or worse than traditional surgery. If you follow my table that appears in this column regularly, you know that I’ve tested the waters to see how surgeons feel about this new surgical approach. The time has come to hear from surgeons beyond sound bytes and to tackle the issues in a dedicated column.

While both sides are effectively represented here, and with more objectivity and balance in each individual perspective than one might expect, I was surprised to see agreement on a

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few major aspects of robotics—most interestingly, the opinion that robotics doesn't necessarily mean more risk of inadvertent injury than with open or laparoscopic surgery. Robotics will continue to be a subject for which spirited debate and technological advancement progress in parallel. General consensus was also reached on one more important point—the robot is not only here to stay, but will continue to advance, and surgeons would be wise to advance with it. Otherwise, as Dan Jones, MD, said, the robotic surgeon may soon be eating your lunch!

Thank you to this month’s contributors for sharing their thoughts and expertise. Please feel free to email me at colleen@cmhadvisors.com with thoughts on this month’s column, or ideas for future ones.

—Colleen Hutchinson

The mechanisms and three-dimensional (3D) vision of the robot allow for maneuvering in tight spaces and enhanced viewing of smaller areas compared with the laparoscopic approach, and it provides the surgeon the benefits of the ability to manipulate tissue and provide for improved performance of surgery, as well as reducing surgeon fatigue.

Additionally, it has been proven to provide clinical patient benefits of less pain, less recovery time (and shorter hospital stay and less postoperative pain medication), generally less blood loss and improved cosmesis.

re e

with Colleen Hutchinson

Surgical Robotics

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2014

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PARTICIPANTS Yuman Fong, MD, is the Murray F. Brennan Chair in Surgery at Memorial Sloan-Kettering Cancer Center, New York City.

Dr. Jones: Disagree. Despite 3D and maneuverability, there is no proven benefit for most operations.

The bigger SILS [single-incision laparoscopic surgery] port may actually cause more pain and more hernias and be more disfiguring than needle laparoscopy.

Daniel Jones, MD, MS, is chief, Minimally Invasive & Bariatric Surgery at Beth Israel Deaconess Medical Center, and professor of surgery, Harvard Medical School, Boston.

Dr. Williams: Agree. In transoral robotic surgery [TORS], radical prostatectomy and most gynecologic procedures, the robot is far superior to traditional open and laparoscopic approaches.

Omar Yusef Kudsi, MD, MBA, is assistant professor of surgery, Tufts University School of Medicine, Boston.

Marty Makary, MD, MPH, is associate professor, Surgery and Health Policy at Johns Hopkins University, and director, Minimally Invasive HPB Surgery, Johns Hopkins Hospital, Baltimore.

Frank Rosato, MD, is director of gastrointestinal surgery, Capital Health Hospital, Pennington, New Jersey.

Noel N. Williams, MD, is professor of surgery at the Perelman School of Medicine at the University of Pennsylvania and director of the Penn Metabolic and Bariatric Surgery Program, Philadelphia.

Dr. Makary: 3D vision and added degrees of freedom may benefit patients undergoing select operations in which tight spaces cannot otherwise be reached by standard laparoscopy (e.g., posterior pharynx surgery). Future versions of the robot will expand these select indications. The benefit to a surgeon’s spine is noteworthy in some operations (e.g., prostatectomy) where bending over to perform standard laparoscopy is known to cause occupational injury. The framing of the question of whether robotic surgery is proven to yield less pain, recovery time and blood loss is precisely the problem with the robotic surgery controversy—the question of superiority lacks a comparison group (is it open or standard laparoscopic surgery?), does not specify for which operation type, and ignores the publication bias of underreporting of the rare but catastrophic complications associated with the lack of haptic feedback. Sound byte claims of robotic superiority are largely unfounded, unfairly crediting the robot with minimally invasive surgery [MIS] benefits over open surgery.

Dr. Fong: Agree. There is no doubt that the 3D vision and the articulated instruments offer technical advantages and allow more complicated operations to be performed in an MIS environment. Proving that this translates to better patient outcomes has been

more difficult because of a lack of studies and poor outcome parameters.

Dr. Rosato: Disagree. Today’s laparoscopic articulating instruments and scopes provide the ability to navigate in tight spaces with enhanced visualization similar to the robot. Furthermore, the robot’s lack of tactile feedback is a major concern. The initial studies quantifying the benefits of robotic surgery were based on claims made in comparison with open approaches. More recent studies comparing the robot with laparoscopic surgery show no difference related to pain, recovery time, blood loss or cosmesis. Patients need to understand that it is who does your surgery, and not how they do it that is important.

Dr. Kudsi: Agree. I believe that the surgeon’s skill, training and incremental learning are determining factors to successful outcomes in the field of surgery and in particular robotic surgery. In regard to robotics, we, as surgeons, have the chance to shape the future, craft it and define it using our values as our moral compass. And, most importantly, when comparing robotics outcomes, experience is the No. 1 criterion a surgeon should consider prior to judging the results (3D vision, suturing, stability and control). There isn’t a single surgical tool that wasn’t dependent on practice and on a skilled surgeon to achieve the very best results. In the words of Dr. [Francis] Sutter, a robotic cardiac surgeon, “Surgical excellence revolves around one basic principle—improving upon the existing procedure, making surgery safer and easier for the patient and surgeon.” Robotic surgery versus laparoscopic surgery is an ongoing comparison, but those judging are missing the point that robotics is another tool that, in the right hands of dedicated surgeons and programs, could deliver phenomenal outcomes. Robotics is an instrument to achieve excellence.

On the Spot

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Dr. Makary: Any medical intervention

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Dr. Kudsi: Agree. Most famous institutions and schools in the United States have a fair amount of their resources paid by third parties (donations), and many surgical centers in Europe, Middle East and Asia were donated. I do believe that [robotics] shouldn’t be considered as the only approach, but the percentage for the next decade will definitely grow.

Institutions and surgical societies need to establish a standard resident and attending curriculum for learning robotic skills to proficiency—and to not do so is to allow for a continuation of the current environment of the self-made robot expert. Residents and fellows should be trained in the technology so that they can apply it rationally and help develop the next generation of robotic interfaces.

Dr. Fong: Agree. This is where a society such as SAGES [Society of American Gastrointestinal and Endoscopic Surgeons] could be quite helpful, providing guidelines similar to those drafted for laparoscopy. We need sensible guidelines that provide for patient safety while allowing room for innovation. Having experts in the field preemptively define these will prevent onerous guidelines that may result from a reaction to an untoward event.

‘From the point of view of a robotic surgeon, and someone who has done hundreds of robotics in the field of general surgery, I could simply say that it is a phenomenal tool that permits the surgeon to deliver state-ofthe-art results to his or her patients.‘ —Omar Yusef Kudsi, MD, MBA Dr. Jones: Agree. Next-generation robots are the future.

We will realize technological breakthroughs sooner if we get the robots into the hands of trainees and multiple vendors.

Dr. Kudsi: Agree. The pace of innovation in surgery change has increased substantially over the past decade, and it will continue to accelerate in the near future. We as surgeons and surgical trainees are faced with the dilemma of

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whether to adopt robotics. We should consider four basic questions: What is the learning curve in robotics? How much commitment is needed to achieve excellent results?

Does robotics add value to the existing options? Is it financially viable?

From the point of view of a robotic surgeon, and someone who has done hundreds of robotics in the field of general surgery, I could simply say that it is a phenomenal tool that permits the surgeon to deliver state-of-the-art results to his or her patients. The potential of robotics is yet to be discovered, especially with the new generation of motivated surgeons in the field of robotic surgery. In regard to teaching facilities, robotics might provide a more controlled environment with the teaching console in comparison to laparoscopic surgery.

Dr. Williams: Agree. In our institution, all the residents are required to do a standard simulation curriculum before sitting at the console. We also have a simulation lab with Box Trainers stomach models to do full simulated operations before patient exposure at the console.

Dr. Makary: I agree, for everything we do in surgery.

Dr. Rosato: Agree. If we continue to allow industry to define training criteria and determine proficiency standards, the true indications for robotic use and the maximum benefit of this technology will never be realized.

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—Martin Makary, MD

Regarding safety, in the event of an acute life-threatening iatrogenic bleed, the entire surgical team needs to respond quickly to remove the robot. Several case reports in the literature now detailing the patient being stuck under the robot call for quick team response to be regularly practiced, yet this practice need is not being met currently within institutions or within the larger scope of surgical education.

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Dr. Rosato: Disagree. Although the effectiveness of the robot has been shown in a myriad of surgical procedures, its superiority over more traditional and less costly approaches has never been proven.

The goal of every physician should be to deliver effective and efficient health care.

The robot adds expense to every case performed. Using it for surgeries in which there is no proven superiority is not costeffective. We are not a society of unlimited resources, and although third-party

’As a society, how do we justify doing robotic cholecystectomy when there is an established, safe laparoscopic approach that costs thousands less per operation?’

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Dr. Jones: Disagree. No reason to jack up health care costs and insurance premiums. Technology must prove to be cost-effective.

that benefits our patients should be paid for, but is it really better for gallbladder surgery? As a society, how do we justify doing robotic cholecystectomy when there is an established, safe laparoscopic approach that costs thousands less per operation? We should remember that we currently have rationing of health care in America. Arizona has let, and continues to let, patients die on transplant waitlists simply because the state insurance program cannot afford the expensive procedure. We should consider our larger mission to the public.

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Dr. Williams: On the fence. Clearly there are operations where the robot is far superior to standard laparoscopic approaches. In these instances, they should be reimbursed by the third-party payors.

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Dr. Fong: Disagree. The way to make this technology available to all is not to just pass it off into the “third-party payor pool.” To make it available to all, we need to optimize robot use by using standard laparoscopy for those MIS procedures where robotics adds no advantage but does add cost. Because surgical robotic products are currently a monopoly, we should consider having it regulated as such. All essential services that are monopolies are usually regulated by the government for charges.

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The effectiveness of the robot is proven in many operations but it is clearly more expensive. As we are a society with ample resources, the extra cost of this technology should be paid by third-party payors so that it is available to all.

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2014

Dr. Williams: Agree. If a hospital has a major robotic program, there should be a dedicated OR [operating room] staff that knows how to handle emergencies in an expeditious manner to allow for rapid conversion to an open procedure. This scenario should be practiced in a simulation setting on a regular basis or when new staff members join the team. Teamwork is very important between OR staff and the surgeons.

Dr. Makary: Agree, and it’s for this reason—the need for quick conversion— that I have a preference to not use the robot for laparoscopic Whipples, where major portal vein bleeding can require rapid conversion.

Dr. Rosato: Disagree. At the institutions where I have worked, there has always been a dedicated operating room team for robotics. Each member, from anesthesia through circulating nurse, is well aware of the unique safety concerns presented while performing robotic procedures. Furthermore, for high-risk procedures with the potential for massive hemorrhage, I meet with our robotic team 24 hours before [the procedure] to review the case and expectations of all members should an emergency arise. As the applications of the robot are being applied to more complex and high-risk procedures, the importance of the rapid response will only increase. I am sure that I am not unique in my approach to these cases. Ultimately, it is the responsibility of the surgeon to assure that the team is prepared for any type of robotic emergency.

Dr. Fong: Agree. The essentials for a rapid and potentially lifesaving emergency conversion to an open operation are 1) immediate availability of open instruments and self-retaining open retractors; 2) rehearsal of emergency conversion and emergency time-out at beginning of case to define; and 3) document each participant’s role.

Dr. Jones: Agree. We recently had continued ON page 20

On the Spot

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2014

Gut Reaction: Robots and More IBM’s Watson Worst abuse of the robot right now

American College of Surgeons (ACS)

FDA’s approval process for medical devices

The one thing The one thing residents and patients forget fellows forget most is … most is …

The one thing I forget most is …

Importance of It’s just another setup of room tool

How hard laparoscopy was

Small procedures Need to Need to help with Need to be where advocate for guidelines educated laparoscopy is reimbursement equivalent

Reasonable

Dan Jones, MD

Not Apple

Lap chole

Too conservative

Too little

Innovation with Duty hours competition

Noel Williams, MD

Loser

None

Great organization

Great organization Proper Fair preparation and proctoring

Frank Rosato, MD

The beginning of Sky-Net

Transaxillary thyroidectomy

Should develop curriculum for robotic certification

Should develop curriculum for robotic certification

Practice; do easy cases; then more practice

Replaces first assistant

Medications

ICD-10

To come to clinic

To follow up

My jawbone, up at the gym

Typical government agency

Use both hands when operating

Tiny incisions don’t mean painless surgery

Humpty Dumpty can’t always be put back together

Martin A good start Makary, MD

Cholecystectomy Inspiring quality

Futuristic

Consider it on a case-bycase basis.

Is better than their postapproval monitoring process

The value of visiting other centers

The name of their What book anesthesiologist chapter deadline just passed

Omar Kudsi, da Vinci MD surgery

Giving credential Quality and to everyone who standards asks

FLS/FUSE

You are either all in or out.

Painful reality

Last chance before it’s all You

Surgery hurts

Dr. Makary: Agree, but the added risk is minimal, even negligible in the hands of a good robotic surgeon. Robotic surgery can be safe when the surgeon is experienced and is the right surgeon for that operation. Patients should choose a good surgeon first and the approach second.

Dr. Fong: Disagree. Inadvertent enterotomies occur in open, laparoscopic and robotic surgery. It will be important to document those injuries that would not have occurred with open surgery (e.g., trocar, vascular and traction injuries because of excessive robotic force).

These should be graded according to 1) no immediate or long-term adverse outcome, 2) immediate adverse outcome but no long-term disability and 3) both immediate and long-term adverse outcome.

Dr. Kudsi: On the fence. This is the greatest point of all. As a FUSE member and a robotic surgeon, I emphasized this point from day 1 in practice. In robotic surgery you are zoomed in more in comparison with laparoscopic surgery, where you usually have a larger surgical view.

In being zoomed in and having long instruments, often you don’t get to see the whole instrument and adjacent structures.

We have to be aware and educated about SAGES [FUSE] and I invite all surgeons to take the course and the actual test.

Dr. Williams: Disagree. There is a risk for inadvertent injury during all forms of surgery and no more so in robotic surgery if an appropriate training model proctoring has taken place.

Dr. Rosato: Agree. This applies to all minimally invasive approaches used for treating surgical problems. Limiting the use of monopolar energy in favor of bipolar or alternative energy devices is paramount for patient safety.

Dr. Jones: On the fence. Although the surgeon may be able to see better, one gives up haptic feedback.

Dr. Kudsi: Disagree. Robotics might provide a more controlled environment with the teaching console in comparison with laparoscopic surgery, almost similar to open surgery. Injury to a major structure could happen in any approach; it’s related to technical and judgment skills. You can’t blame the slave robot.

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As we continue to learn more regarding safety from SAGES Fundamental Use D of Surgical Energy (FUSE) program, we need to appreciate the potential from stray currents and iatrogenic burns with use of the robot and instruments in parallel.

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Dr. Rosato: Disagree. Inadvertent injury to a major structure is an inherent risk for all surgical approaches.

You got cool ideas

common settings should be part of the package insert for each instrument. Education curriculum should teach use of each of these instruments in open, laparoscopic and robotic deployment.

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Inadvertent injury to a major structure is a risk inherent in robotics compared with both laparoscopic and open approaches.

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Dr. Kudsi: Agree. Despite the fact that many hospitals have formed robotic committees with rigid restrictions, some of these features are very useful. As surgeons, we should be the most experienced in the room with regard to the machine and troubleshooting. Commitment to understand and go beyond just technical skills will demonstrate leadership skills. Understanding how to dock, drive and position trocars is as important as performing the surgery to prevent instruments and arms collisions. That’s why troubleshooting and emergency conversion should be part of the team training.

A

Best advice to the community surgeon on robot adoption

Yuman Fong, Get to work.

MD

a robot stuck over a patient when a medical student tripped over the electrical plug. We have simulation labs to practice scenarios as teams. We should mandate that all teams must practice crisis response.

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Society of American Gastrointestinal and Endoscopic Surgeons (SAGES)

Dr. Fong: Agree. These should be tracked for all forms of surgery: open, laparoscopic and robotic. The lateral spread of heat for each energy instrument in open, CO2 environment and air insufflation environment at

Dr. Jones: Agree. Especially when doing SILS, where instruments are closer together, there is a potential danger. Take FUSE and you will change the way you do SILS forever, if ever again.

Dr. Williams: Agree. The understanding of energy sources is mandatory for all surgeons performing robotic and laparoscopic surgery.

Dr. Makary: I agree; this is true for all minimally invasive surgery. continued ON page 22

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2014

Dr. Rosato: Agree. A 2011 study published in the Journal for Healthcare Qualityy [33:48-52] and conducted by Johns Hopkins School of Medicine [Baltimore] researchers found 41% of hospital websites described robotic surgery.

Among these, 37% presented robotic surgery on their home page; 73% used manufacturer-provided stock images or text; and 33% linked to a manufacturer website. Statements of clinical superiority were made on 86% of websites, with

32% describing improved cancer control, and 2% described a reference group.

None of the hospital websites mentioned risks. These investigators concluded that materials provided by hospitals regarding the surgical robot overestimate benefits and largely ignore risks, and are strongly influenced by the manufacturer. [Editor’s note: Dr. Makary was an author on this paper].

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Although robots will one day replace many precision human tasks in the OR, currently very few operations are really done better with a robot when performed by a skilled surgeon.

Therefore, currently many surgeons and medical centers are really using the robot to gain a marketing edge against competition and to attract new patients, rather than to provide for safer, improved operations and clinical outcomes for their patients.

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Dr. Fong: Agree and disagree.

Although it is true that some medical centers will form robotic surgery programs to be “competitive,” the truly

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Dr. Williams: On the fence. This statement applies to lap cholecystectomy. But for example, for cases of patients undergoing laparoscopic sleeve gastrectomy who have a very high BMI [body mass index], I feel it is safer and more precise to use the robot. In our institution, robot setup time does not add any time to the overall procedure.

Dr. Jones: Agree. I usually can do two laparoscopic cholecystectomies and have a cup of coffee in the doctors’ lounge in the time my colleague does one robotic cholecystectomy. But he may soon be eating my lunch since the photo opportunity is with the million-dollar robot and not the laparoscope these days.

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Dr. Makary: On the fence. Some surgeons and hospitals may use the robot for marketing, evidenced by robot debuts at community half-time events and shopping malls. And although some even mislead the public with unethical marketing to patients who are in a vulnerable state and shopping for quality surgery, I believe many surgeons are simply trying to be proficient with a futuristic technology. As new robot versions come out and new companies introduce next-generation robots, surgeons are smart to keep an open mind and evaluate the application for their practice mix.

Dr. Kudsi: Disagree. I can say in all confidence that it would take me less time to perform robot-assisted laparoscopic cholecystectomy than laparoscopic cholecystectomy on a personal level—skin to skin in less than 30 minutes with room turnover time less than 15 minutes from a team perspective. It

On the Spot

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2014

Dr. Kudsi: I agree, despite the fact that many hospitals have formed robotic committees with rigid restrictions and details beyond practicality at some hospitals and others driven by media and fear of lawsuits. Developing high-performance robotic surgery teams requires leadership—not the authoritarian leadership of the past, but the kind of leadership that fosters exceptional communication, mutual respect and support, and the development of the best and most straightforward to achieve the goals of our surgical society. Recently, SAGES created Minimally Invasive

Robotic Association guidelines, and it will continue to evolve.

Dr. Makary: The key is for patients to be fully informed of all their options.

Stakeholders should have created a robust, “capture-all” registry for all robotic surgery patient outcomes 12 years ago when the robot was FDAapproved. This endeavor would have allowed researchers to evaluate the benefit or harm to patients in real time.

National registries in health care require a broad investment, but are badly needed.

Dr. Rosato: Agree. It is time for a national database for robotic procedures.

This will allow for the evaluation of proper indications, as well as short- and long-term outcomes.

—Colleen Hutchinson is a communications consultant who specializes in the areas of general surgery and bariatrics.

She can be reached at colleen@ cmhadvisors.com.

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There is catch-up work to be done: Generally speaking, at centers where the robot is currently used, protocols that both ensure proper patient selection and fully inform patients of risks and benefits of all surgical options are lacking.

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was recently published in HBR [Harvard Business Review] that once you have a dedicated surgical team, the whole day becomes efficient, your outcomes are excellent and it is more fun!

It is similar to many surgeons in their surgical centers. Robotic surgery will not cause less pain and lead to faster recovery, but it will provide control over the operation where you are doing 100% of the cases, whereas in other cases you are dependent on the assistant performance and skill level. How many of us will change his or her face when a lesserskilled assistant shows up for a morbidly obese male patient who has an acute gallbladder?

Although many centers are marketing themselves to gain a marketing edge, it’s a false hope because this road will lead nowhere.

As I previously stated, robotic versus laparoscopic surgery is an ongoing point of comparison, but misses the point that robotics is a tool that in the hands of dedicated surgeons and programs can deliver remarkable outcomes—an instrument to achieve excellence. Hundreds of robots have been sold worldwide and the approach is being adopted across the universe. Focus should be on excellence—you better choose one surgeon and make him the robotic expert.

At the end of the day, it will be a more expensive option; thus, we should find a dedicated surgeon who would ensure superb results.

Dr. Fong: Disagree. At most academic medical centers, robotic surgical time is a valuable commodity. It is usually assigned to the procedures and programs of greatest promise. Credentialing processes are rigorous and include auditing of outcomes. Patients certainly must give informed consent before undergoing such an operation.

Dr. Jones: The robot is marketed as “cool” and “cutting-edge.” The surgeons who use it say it makes their operations easier and possibly better; so, no surprise, the patient signs. If the patient, rather than the insurance company were paying part of the added costs, the patient might have more questions or find a surgeon who does as well without the need for costly robotic assistance.

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2014

Endoluminal Devices: The Struggle To Arrive and Thrive in the Market B Y M AUREEN S ULLIVAN

I

t is about 14 years since the CSM Stretta System (Mederi Therapeutics) was launched as the first endoluminal treatment for patients with gastroesophageal reflux disease (GERD).

Its introduction offered an alternative to long-term medical treatment with proton pump inhibitors (PPIs) and an alternative to a Nissen fundoplication, considered major surgery for those more severely affected with the disease.

During this time, several other endoluminal devices entered the GERD market—and most of them failed.

In a 2005 review, the Agency for Healthcare Research and Quality (AHRQ) evaluated the efficacy of four endoluminal GERD devices that were on the market at that time: Stretta (Curon Medical, FDA-approved in 2000), Endocinch Suturing System (C.R. Bard, Inc., FDA-approved in 2001), Enteryx, (Enteric Medical Technologies, FDAapproved in 2002) and the Endoscopic Plication System (NDO Surgical Inc., FDA-approved in 2003).

Of these, Stretta alone survives. By the time the AHRQ published an updated review in 2011, Enteryx had been pulled from the market due to serious adverse events (AEs) and the Plication System was no longer in use. As of October 2013, the manufacturers of Endocinch confirmed that it too is no longer in production.

Why have so many failed?

Although Stretta has lasted the course where others have not, it also has withstood many challenges. Originally owned

by Curon Medical, the company eventually went bankrupt and its assets, including Stretta, were taken over by Mederi Therapeutics.

“Curon went bankrupt simply because they were unable to get widespread insurance coverage,” said Will Rutan, CEO of Mederi. “One would think that if the FDA has approved a device … that it is proven to be safe and effective … that that would be good enough for an insurance company. But it is not. Even the federal government—the Centers for Medicare & Medicaid Services that governs Medicare—does not view FDA approval as sufficient for covering Medicare constituents, even though the FDA is a branch of the federal government [as well]. There is no participation or cooperation between these two entities. Incredible, isn’t it?” Mr. Rutan said.

Although medical devices that first enter the market will have enough clinical data to satisfy the FDA that they are “safe and effective,” it is very rare for any

of them to have supporting studies longer than two years. “If you ask 10 people [for their definition] of a ‘long-term’ study, you’ll get 10 different answers,” Mr. Rutan said, “but if a product is new, then ‘long-term’ is one year.”

The litmus test of a device is its application in the real world, but the irony is that many of the endoluminal devices that launched did not survive long enough for their efficacy to be established. “Insurance companies by and large judge four years—48 months—to be long term, which is the conundrum of new technology, particularly in the United States,” said Mr. Rutan, who explained that it can take several years to progress from a new idea to a finished device due to the necessity for bench testing, animal testing, meeting FDA requirements for approval and obtaining long-term data.

‘It’s very difficult to get something approved or cleared, and it’s next to impossible to get it paid for, regardless of clinical efficacy.’

—Will Rutan, CEO, Mederi Therapeutics difficult in the current climate, according to Mr. Rutan. “We have just completed fundraising and even with the derisking we have done—we have regulatory approval, long-term Level I data, society support and tremendous unmet [market] need—even with all that, it

prove that its device is “safe and effective,” by determining that it is “substantially equivalent” to a similar or “predicate” device previously approved by the FDA, and which is supported by the manufacturer’s clinical research. For example, in its application to the FDA for approval of its SRS Endoscopic Stapling System, the manufacturer, Medigus, cited the NDO Plicator and EsophyX (EndoGastric Solutions) as predicate devices because they used similar mechanisms of action to perform a partial fundoplication.

Chris Rowland, CEO of Medigus, agreed that the FDA approval process is quite strict but in his opinion, it is necessary. “The FDA is doing its job … there are thresholds in place and the FDA holds companies accountable; [the FDA’s] first [responsibility] is patient safety,” he said.

But the FDA’s reach does not stop with

Sour So urce ce: SAGE SAGE SA GES G Gu uiddeellliiinne neess—E —End ndoollundol umiinnaal Tr m Treea aatm ttm tmen men ents nts ts for or Gaassttrroe oeso sopph hhaaaggeeaall Ref eflu lux D Diise seas eas ase, ww ww w..ssag w.s ageess.o .orgg.

How the Stretta System works. Left: Controlled radiofrequency energy delivered to tissue.

Middle: Multi-level thermal treatment remodels muscle in lower esophageal sphincter and gastric cardia.

Right: Function improved, fewer transient lower esophageal sphincter relaxations.

Source: SAGES Guidelines—Endoluminal Treatments for Gastroesophageal Reflux Disease, www.sages.org.

“That is why so many good technologies go off the market: They are unable to meet the very, very high hurdles required by the insurance companies to gain leverage, because such long-term data [required],” Mr. Rutan said. “And they require Level I clinical data, which are randomized controlled trials, and they require society support in the form of guidelines … so gathering all that is required to get widespread insurance coverage is a 10- to 12-year proposition, and very, very few new technologies have investors who are patient enough to fund it [for that long].”

“For that reason [the funding sources] for start-up medical devices are almost gone. Most of the traditional venture capitalists that would have backed new medical technologies have shifted their focus to technology investments like Instagram and Twitter,” Mr. Rutan said.

Unlike the pharmaceutical industry, most medical device companies are small start-ups with limited financial resources.

Raising capital to fund a device is no less

was far and away the hardest time that I’ve ever had raising money for a medical device.” he said.

Adding to this challenge is the belief of some industry stakeholders that the FDA’s requirements for market approval are too excessive. “Both ADVAMED [Advanced Medical Technology Association] and the MDMA [Medical Device Manufacturers Association] have been attempting to get the FDA to loosen up some, because [it has] tightened up what are already stringent requirements,” said Mr. Rutan.

All of the endoluminal devices that have launched since 2000 for the treatment of GERD were approved for commercial use through the FDA’s 510(k) preapproval process, which classifies medical devices as Class II or of moderate risk to patients. (A Class III product, such as the Linx surgical procedure, is considered “high risk” and must go through a different and stricter premarket approval [PMA] process). Under the 510(k) pathway, a manufacturer must

granting PMA: It also has the authority to make postmarketing demands such as device registration, mandatory reporting of AEs, and stipulating certain standards in the manufacturing process. Device manufacturers must consistently be vigilant to ensure that they adhere to these regulations.

“The [FDA has the] ability to look and see how the device is [performing in the market] and say ‘you know, I think we made a mistake—maybe this device shouldn’t have been out there,” said Kenneth K. Wang, MD, FASGE, president of the American Society for Gastrointestinal Endoscopy (ASGE). “The 510(k) process has become much more difficult.

Now the FDA is requiring more efficacy data to the point where a lot of [medical device] companies are saying ‘well, why bother with a 510(k)? Why not go in with a full PMA [application] for a new device because pretty much, you have to show the same things. If [the FDA] is making the 510(k) that much more see ENDOLUMINAL page 26

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26

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2014

ENDOLUMINAL

jContinued from page 24 onerous, then what’s the advantage of having that pathway?’”

As president of the ASGE, Dr. Wang, has witnessed firsthand, the difficulties inherent in launching nw devices. “New technology like GERD antireflux devices is often very challenging. It’s almost the same kind of thing you see with drugs. There is usually an attempt to try to market these very quickly, and a lot of it has to do with the way funding is for medical devices: Usually these are

not big companies with a lot of resources,” he said.

Insurance companies, as well as physicians, also view securing an endorsement from a professional society such as the ASGE favorably, and the publication of guidelines on a particular device or procedure bodes well for its success.

The guidelines, Dr. Wang explained, “is an evidence-based document that looks over a given technology and makes recommendations based on available literature.” However, endoscopists tend to be conservative in their evaluation of new devices because, on average, members of

that profession tend to be a little older in age (late 40s to early 50s). According to Dr. Wang, “I think most [of us] evaluate the data that’s out there conservatively, concerning the efficacy of a device.

I think [we] examine … if the device makes physiologic sense, [as well as] its efficacy,” he said.

“If you look at Enteryx, the injective device that was pulled from the market voluntarily by the manufacturers … [the procedure] was relatively easy to do … it was a technique that most of us were familiar with … but once it developed some serious complications with

Rationale, Reversal, and Recovery of Neuromuscular Blockade

Harold is a 74-year-old man undergoing a video-assisted right upper lobectomy for stage I non-small cell lung cancer.

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

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

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1 Advance into stomach and retroflex

2 Clamp tissue and staple 3 cm proximal to GEJ (pull SRSTM back)

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SRSTM Procedure— Step by y Step p

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3 Repeat 3 times to create 180 flap valve

patients … you know endoscopists kind of shied away from that technology,” Dr. Wang said.

The publication of guidelines is not in itself a ticket to success. Recommendations come with varying degrees of emphasis, a case in point being the “Clinical Spotlight Review” published by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), in February 2013. Although it gave Stretta the highest (“strong”) recommendation, due to the extent—and the quality—of its long-term data, it gave a “weak” recommendation to EsophyX, an endoluminal GERD treatment that was FDA-approved in 2009.

Dr. Wang explained that in addition to writing guidelines they deem appropriate, the professional societies give advice about the kinds of studies that may help to provide evidence of effectiveness and good outcomes, whether or not the new developments have already gone before the FDA. “[Companies] don’t need to go

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2014

In July of 2013, Medigus, an Israeli-based company, received its first order for the SRS in the United States from Columbia University Medical CenterNewYork Presbyterian Hospital. The unique advantage of the SRS over the endoluminal devices that have tried and failed is its simple approach, Mr. Rowland said. â&#x20AC;&#x153;We know that a Nissen fundoplication works. We know that the partial wrap or the full wrap actually is successful, so weâ&#x20AC;&#x2122;re not trying to recreate that surgical procedure,â&#x20AC;? Mr. Rowland said. â&#x20AC;&#x153;Instead we are recreating the direction in which it is performed, so instead of going

laparoscopic, we are going endoscopic.â&#x20AC;?

Interestingly, Mr. Rutan said the reason Stretta has lasted well over a decade is that, in constrast, it did not seek to emulate a fundoplication, relying instead on radiofrequency ablation. â&#x20AC;&#x153;All the other treatments [that failed] were a variation on a fundoplication â&#x20AC;Ś whether you suture it, staple it or put an implant around it, itâ&#x20AC;&#x2122;s still surgery and there are complications associated with it.

Stretta is the least invasive, longest lasting â&#x20AC;Ś and has the lowest complication rate.â&#x20AC;?

Ultimately, a device must survive long enough in the market to have a chance

to prove its commercial success. The reasons why so many endoluminal technologies have failed to date could simply be explained as insufficient financing and challenging market forces. â&#x20AC;&#x153;None of them achieved insurance coverage; none of them was around long enough to get the quality of data â&#x20AC;Ś or society support that is necessary,â&#x20AC;? Mr. Rutan said. â&#x20AC;&#x153;Itâ&#x20AC;&#x2122;s very difficult to get something approved or cleared, and itâ&#x20AC;&#x2122;s next to impossible to get it paid for, regardless of clinical efficacy.â&#x20AC;?

Drs. Fanelli, Fass and Wang reported no relevant disclosures.

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through societies,â&#x20AC;? Dr. Wang said, â&#x20AC;&#x153;but generally, societies do a better job of vetting what the evidence is for their devices.

You know we can present a more unbiased view than they can.â&#x20AC;?

Despite the market challenges and the time-consuming process of obtaining insurance coverage, devices can still gain a foothold in the market, albeit slowly, as manufacturers target early adopters of new devices and techniques. â&#x20AC;&#x153;Some [physicians] require less [clinical] data and some require more, depending on their comfort levelâ&#x20AC;&#x201D;on their ability to adopt a new technology, just like some physicians have iPhones and some still have flip phones,â&#x20AC;? Mr. Rowland said.

Mr. Rutan also found that the medical profession is open to new technology but that a very limited window exists to get a new product in the door. â&#x20AC;&#x153;The fact that [devices] are not covered is not an obstacle initially because the market loves new technologies. Many times, it involves doctors and hospitals losing money on [new devices] but they are willing to do that for a short period of time. â&#x20AC;Ś [However,] itâ&#x20AC;&#x2122;s a short-term proposition because before long, you have to have insurance coverage or the product will fail,â&#x20AC;? Mr. Rutan said.

Even with insurance, the success of a new medical procedure also depends on whether it is fully embraced by the medical profession as an effective, safe and durable treatment option for patients.

Ronnie Fass, MD, chair, Division of Gastroenterology and Hepatology and head of the Esophageal and Swallowing Center at MetroHealth Medical Center in Cleveland, said, â&#x20AC;&#x153;At the beginning, we had a rush of endoluminal approaches.

For some of them, I donâ&#x20AC;&#x2122;t think there were significant data to support their long-term effect and some of them â&#x20AC;Ś ended up in the hands of people who were not experienced in using them, resulting in some terrible side effects. To convince people that a technique is effective and durable in the long term, you need at least five years [of data].â&#x20AC;?

Robert Fanelli, MD, FACS, FASGE, chief of minimally invasive surgery and chief of surgical endoscopy at The Guthrie Clinic, Sayre, Pa., said GERD experts are â&#x20AC;&#x153;searching for a continuum along which to treat patients at various stages of the disease,â&#x20AC;? and endoluminal therapies offer valid treatment alternatives. â&#x20AC;&#x153;We [tend to] hold them up against the standards established by surgery and Iâ&#x20AC;&#x2122;m not sure that it makes a lot of sense for us to look at endoluminal therapy as competition with a Nissen fundoplication."

In carefully selected patients, he said, â&#x20AC;&#x153;A nicely performed, low-risk, endoluminal procedure might be just exactly the thing that they would benefit from,â&#x20AC;? said Dr. Fanelli, who co-authored the SAGESâ&#x20AC;&#x2122; â&#x20AC;&#x153;Clinical Spotlight Review.â&#x20AC;?

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OMENTUM SURGERY jcontinued from page 1

In 1999, Mr. Gayour heard about a general surgeon, Harry Goldsmith, MD, who had performed surgery on five patients with AD, four of whom recovered some extent of memory, recognition and verbal abilities (Neurol Res 2001;23:555-564).

Mr. Gayour contacted Dr. Goldsmith, who explained that the operation centered on a structure called the omentum. The omentum is essentially a thin layer of fat, blood vessels and connective

tissue in the abdomen that covers surrounding organs, but it also has special properties. Studies have shown the omentum can repair vascular damage and supply blood to the heart, spinal cord and brain ((Acta Neurochirurgica 1990;106:145-152).

In the surgery, Dr. Goldsmith partially detaches the omentum from the abdomen, while keeping its main blood supply intact. He then lengthens it into a pedicle, stretching it through a subcutaneous tunnel along the chest up to the neck and behind the ear. Finally, a neurosurgeon performs a craniotomy, lays

the omentum on the brain like a tablecloth on a table, and closes the wounds.

Several weeks after the meeting, Dr. Goldsmith performed the elective procedure on Mr. Gayour’s father at the American University Hospital of Beirut, Lebanon. “His recovery was dramatic, especially considering his condition prior to surgery,” Dr. Goldsmith recalled.

Just days after the surgery, Mr. Gayour’s father could recognize and talk to his wife and son. A few weeks later, he was doing simple mathematical computations. Four months after the surgery,

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his wife and doctoors reported that he seemed almost noormal.

The patient died shortly after this period from a heart attack, but his life after the surgery had undergone an undeniable change. “Thee surgery is not a cu ure, but whatever Drr. Goldsmith iss doing is working,” Mr. Gayour said.

Omental Transpoosition Dr. Goldsmith’’s surgery to treat AD may sou und radical, but the omentum m’ss therapeutic potential has been studied for decades. Whilee investigating new surgical treatments for coronary arttery disease in the 1950s, Can nadian cardiac surgeon Artthur Vineberg, MD, PhD, discovered the omentum’s ab billity to vascularize the heartt (Can Med Assoc J 1962;86:11 116-1118).

In the 1960s, Dr. Vineberg debuted a new procedure for people wiith coronary artery insufficienccy, in which he removed a piece of the omentum, wrapped thee graft around a patient’s heart, an nd sutured it to the aorta and pullmonary artery. The majority of patieents who underwent this surgery showed weed marked improvements in heart function and blood flow (Can Med Assoc J 1965;92:325-332).

Intriguingly, Dr. Vineberg found that the omentum graft sought out new connections with surrounding arteriolar networks.

Despite its preliminary success, Dr. Vineberg’s procedure was abandoned when Michael DeBakey, MD, a surgeon from Texas, introduced coronary artery bypass surgery in 1964, an effective and simpler procedure.

Despite this, Dr. Goldsmith saw untapped potential in using the omentum to bring new life to damaged tissue. Dr. Goldsmith, head of a surgical division at Memorial Sloan-Kettering, in New York City, in the 1960s, wondered whether he could generate a new lymphatic system using the omentum in patients suffering from lymphedema.

He envisioned surgically lengthening the omentum up a patient’s arm while keeping part of the lining attached to its original blood supply. He soon showed that this operation was possible with about half of his lymphedema patients reporting favorable outcomes (Rev Surgg 1966;23:303-304; Ann Surg 1974;180:847-849).

Dr. Goldsmith began to investigate whether he could use the omentum’s

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2014

‘What may be happening is the omentum acts as a delivery system for these stem cells and growth factors. …

There’s enough data to show the omentum has tremendous regenerative potential and should be rigorously looked at for treating Alzheimer’s disease.’

series, Dr. Goldsmith performed surgery on 25 patients with advanced disease, of whom six demonstrated no improvement, 10 showed moderate changes, and nine had significant cognitive improvements in areas including verbal communication and short-term memory ((J Alz 2011;25:209-212).

Also notable were autopsy findings from Dr. Goldsmith’s first patient, who had shown cognitive improvements for several years following omental surgery. When neurologist Norman Relkin, MD, PhD,

—William Shankle, MD, FACP

examined the patient’s brain postmortem, he found none of the characteristic pathology of AD—the β-amyloid plaques—where the omentum had been in direct contact with the cortex, but extensive pathology just a few millimeters away where they were not connected (Neurol Res 1996;18:291-294).

Roadblocks and Future Exploration Despite decades of promising clinical work, OT has never undergone scrutiny in a randomized controlled study, nor has it garnered widespread support from see OMENTUM SURGERY page 30

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angiogenic properties to treat strokee patients. In animal experiments, hee found that when he tied off a mon-key’s middle cerebral artery, nine of 133 monkeys developed a cerebral infarctt, but after placing the omentum over the brains of 13 additional monkeys with occluded cerebral arteries, onlyy two experienced a stroke (Stroke (Stroke 1978;9:224-229).

In 1990, Dr. Goldsmith published the first longitudinal study on omental transposition (OT) surgery in longterm stroke patients. Following the surgery, five of six patients showed an increase in blood flow over the entire brain, and four showed normal cerebral blood flow levels for their age (Acta ( Neurochirurgica 1990;106:145-152).

In 1993, Dr. Goldsmith shifted his focus to AD when he realized that decreased cerebral blood flow might be the key to treating the disease.

“Over the years, experts have observed a decrease in cerebral blood flow in Alzheimer’s disease and have theorized that it occurred because neurons need less blood as they deteriorate and die,” Dr. Goldsmith said. “I think the opposite is true: It’s the blood flow decrease that causes the neuronal deterioration in Alzheimer’s disease.”

Dr. Goldsmith hypothesized that infusing the brain with blood from the omentum could breathe new life into damaged tissue, improve neuronal function, and slow or reverse the symptoms of AD. Throughout the 1990s and early 2000s, Dr. Goldsmith performed omental procedures for AD. In his largest

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© 2014 Vector Surgical, LLC 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

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In the News OMENTUM SURGERY jcontinued from page 29

experts who often view the procedure as too experimental or invasive.

“If you describe the surgery to someone, the person will look at you like you’re from Mars,” said William Shankle, MD, FACP, The Judy and Richard Voltmer Chair in Memory and Cognitive Disorders at Hoag Neurosciences Institute, and associate researcher in the Department of Cognitive Science, University of California (UC), Irvine.

In 1994, Dr. Shankle recalled that the

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2014

director of basic science research at UC Irvine “thought the idea was crazy and wouldn’t consider it.”

Dean M. Hartley, PhD, director of science initiatives at the Alzheimer’s Association, also is skeptical of OT. “One of the primary difficulties with this sort of procedure is that it’s very invasive,” Dr. Hartley said. “An elderly person doesn’t necessarily recover very well from such invasive surgery. If that person also has a progressive, degenerative condition such as Alzheimer’s, they may face multiple complications, often causing further cognitive decline.”

Pockets of interest in the scientific community, however, have prompted further research on OT. In 2002, Dr. Shankle oversaw an investigation in which eight patients with biopsyconfirmed AD underwent OT at the Fountain Valley Regional Hospital and Medical Center, in California, where he had obtained institutional review board approval. After the surgery, the five patients without postoperative complications showed enhanced memory and slowed cognitive decline. One patient remained stable for 10 years after OT. “The surgery wasn’t without risk, but

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I could see there was something good happening,” Dr. Shankle said.

Dr. Shankle recounted similar outcomes in subsequent studies: Patients without complications from the surgery often showed significant improvements in cognitive function (Neurol Res 2008;30:313-325) and increased cortical activity below the transposed omentum (Neurol Res 2009;31:766-769).

“These studies clearly reveal clinical and imaging improvements in Alzheimer’s disease after surgery,” Dr. Shankle said.

However, Dr. Shankle thought the omentum’s therapeutic value lay not in its ability to increase cerebral blood flow, but in its capacity to deliver several stem cells and growth factors that promote neurogenesis and neuron survival ((J Surg Res 1997;67:147-154; Neurol Res 2005;27: 807-811).

“What may be happening is the omentum acts as a delivery system for these stem cells and growth factors,” Dr. Shankle said. Regardless of the mechanism, he believed “there’s enough data to show the omentum has tremendous regenerative potential and should be rigorously looked at for treating Alzheimer’s disease.”

Considering the riskiness of OT, Dr. Shankle thought treatment should focus on using less invasive methods—including intranasal, intravenous, subcutaneous and intrathecal infusion pump—to deliver the omentum’s therapeutic stem cells and growth factors.

Although Dr. Goldsmith does not see surgery as a long-term answer, he believes OT can offer patients with AD a strong possibility of improvement, and this warrants scrutiny in a well-controlled study.

Sunil J. Patel, MD, chief in the Division of Neurosurgery at the Medical University of South Carolina, Charleston, also thought the omentum has therapeutic value and the surgery deserved further study.

“I have personally seen patients with spinal cord injuries, stroke, Alzheimer’s disease and Moyamoya disease improve after omental surgery,” Dr. Patel said.

“Although such anecdotal reporting has no value, basic science work shows the omentum has an amazing ability to revascularize tissues in the body.”

Dr. Patel hopes to investigate the safety and efficacy of OT for AD trreatment, although he realizes it will be difficult to garner support for a pilot study.

“Given that Alzheimer’s disease has no cure or effective treatment, it’s crucial to continue to dig into the science and explore all avenues so we can understand the pathophysiology of disease and how to treat it,” Dr. Patel said.

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2014

UNDERSTANDING jcontinued from page 1

his co-authors, colleagues and students alike. Why would a recognized brilliant student and young researcher do this?

He was clearly beyond capable of producing valuable scientific research. Why would he risk so much when he had the ability to do the work honestly?

Stapel did genuinely want to publish honest research and he did attempt to present the complexity of multiple variables interacting to produce varied and unpredictable results. In an interview in an article in The New York Times, Stapel gives reasons explaining his actions that help to also explain many of the other fraudulent activities that we see in published research and in our world in general.

From the Timess article: In his early years of research—when he supposedly collected real experimental data—Stapel wrote papers laying out complicated and messy relationships between multiple variables.

He soon realized that journal editors preferred simplicity. “They are actually

We have overlooked the fact that even the most costeffective and beneficial treatment strategies can have complex outcomes that lead to harm and waste in various ways.

telling you: ‘Leave out this stuff. Make it simpler.’” So, Stapel decided it would be better for his career to make the results of his studies simple to understand. He chose to make things up because that is what the editors, and presumably the journal readers, wanted to read.

Also from the Timess article: [Stapel] insisted that he loved social psychology but had been frustrated by the messiness of experimental data, which rarely led to clear conclusions.

His lifelong obsession with elegance and order, he said, led him to concoct sexy results that journals found

attractive. “It was a quest for aesthetics, for beauty, instead of truth,” he said.

Although blatant fraud, as in the case of Diederik Stapel, does exist, it is not very common. A much more common problem in medical research is that the simplistic conclusions of published studies do not completely make sense when tested in the real world of patient care.

Our traditional clinical research methods seek to prove or disprove a hypothesis to produce generalizable medical knowledge: that is, scientific medical truths that will apply to most (or to average)

patients. Complexity science shows how incomplete this kind of thinking is when applied to the real (complex) world of patient care. Patients bring variability into the process and local variables make processes different in different clinical settings, even when the same disease is being treated with the same test or treatment.

This simplistic thinking is easy to identify in our world. Anytime you hear a direct cause-and-effect story in the news, this simplistic thinking is at play.

For example, if the stock market goes up see UNDERSTANDING page 32

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32

Opinion

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UNDERSTANDING

even the most cost-effective and beneficial treatment strategies can have It is very difficult due to a favorable jobs report, you can be complex outcomes that to convince the sure that the real factors that contributlead to harm and waste ed to the effect of a stock market increase in various ways. mother of a child are much more complex than that simple I’ll use vaccines as an who suffers... report. Yet it seems that our mass media example. Most people reporters suffer from the same simplisaccept that vaccines have tic thinking as scientific journal editors been a valuable treatwhen reporting on things like movement strategy for a numments in the stock market. In the finanber of diseases, especially cial market, a simplistic understanding for the most vulnerable in our might only hurt someone financially. In society, including children. It is health care, a simplistic understanding unconscionable to fail to support a treatment strategy that can eradicate a devastating disease such as polio. And the work of innovators, such as Jonas Salk; pharmaceutical companies; and public health organizations have saved millions of people from contracting a variety of diseases that would cause pain, suffering, disability and death. The Bill and Melinda Gates Foundation, with its multiple interests, has as a primary focus the funding of vaccination programs in impoverished areas throughout the world.

Compare your outcomes But like all other things we do in to the Collaborative outcomes health care, in addition to the good that they do, vaccines can cause harm and be wasteful. Each specific vaccine results in its own variable proportion of ben• Post-op complications • Total patients efit, waste and harm. But, clearly every • Risk factors • Laparoscopic operations vaccine does result in benefit, waste and • Mesh type utilization • Total operations harm. Despite the real and potential • Wound class • Myofascial release benefits of vaccines, it is clearly wasteful to vaccinate a person, child or adult, who would not contract the disease that is targeted for prevention by the vaccine.

And there is a group (or subpopulation) The Americas Hernia Society Quality Collaborative aims to improve the value in hernia care delivered to of people who will be harmed by the act patients. AHSQC utilizes concepts of continuous quality improvement to advance outcomes and optimize of receiving a vaccination. This is where costs through patient-centered data collection, ongoing clinician performace feedback, and analysis of it gets more complex. The simplistic thinking that vaccines are clearly good collected data and collaborative learning. and so everyone should be vaccinated does not make sense for those children who are harmed and for the parents who see their children harmed by a treatment that helps millions of other people. It is very difficult to convince the mother Join today and see how your outcomes of a child who suffers or dies as a result stack up against other surgeons of receiving a vaccine that vaccinating everyone is justified solely on the basis of and improve patient safety the numbers of other children and parents who are helped.

It is important to note that I am not talking about the sensationalized “vaccines can cause autism” debate. The decisions from multiple legal cases have not supported that theory and some of the organizations developed to help vet that theory have been disbanded. However, these same vaccines that have not been shown to cause autism do cause harm and death. Some children with autism and other complications from receiving Participation is FREE for AHS members vaccinations have been awarded comHelp Advance Hernia Care pensation because of the recognition jcontinued from page 31

will potentially cause financial, physical and even emotional harm as well as waste in our health care system.

For even the most beneficial tests and treatments in health care, there still will be a group of patients who suffer harm and a much larger group who will have no benefit (waste) from a test or treatment. Until now, such unnecessary harm and waste generally has been acceptable within our health care system. We have overlooked the fact that

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34

Opinion UNDERSTANDING jcontinued from page 32

that vaccines cause harm and death. On Oct. 1, 1988, the National Childhood Vaccine Injury Act of 1986 (Public Law 99-660) created the National Vaccine Injury Compensation Program (VICP).

There are numerous rules and restrictions, but one thing is clear: Vaccines cause harm and death. By 2010, nearly $2 billion had been awarded to victims of harm from vaccines. The fund is created by an excise tax levied on the producers of vaccines, at $0.25 per vaccine. This

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2014

must seem a welcome tradeoff to minimize the product liability potential if this program did not exist, especially because the maximum compensation is $250,000 regardless of the degree of harm or suffering, including death.

... To Thoughtful, Reflective Curiosity Using a paternalistic view of health care makes this complex issue even more complex. To push a treatment on a very diverse society, highlighting the benefits of a treatment and not transparently disclosing the potential harm can lead to unintended harm and consequences that

Save the Date!

will paradoxically prevent achieving the goal of 100% compliance for vaccination.

I was interviewing a very bright and competitive applicant for our surgery residency program recently and she was talking about some of the challenges she experienced caring for patients in an urban setting (where she is currently in medical school). She is from a more rural area and she was expressing frustration with the lower socioeconomic class of people who were less educated than she was used to. The example she gave to validate her frustration was a group of parents who refused vaccinations

The American Society of C l and Colon dR Rectall SSurgeo ons

Annual Scientific Meeting

May 17-21, 2014 Westin Diplomat

Hollywood Florida

Program available online in February at www.fascrs.org

for their children. I asked her what accountability we had as health care professionals who did not define the harm vaccines can cause and did not disclose that there is a fund that has paid out almost $2 billion for those who have been harmed by vaccines to these parents. We no longer live in the dark ages (pre-Internet)—people do find this information and if we deny or are not well informed about the harm and waste our recommendations for medical care can cause, then we can become the bad guy, as if we are intentionally hiding information.

We are a major part of the problem when we do not understand the complexity of the tests and treatments we prescribe and recommend. This very bright medical student had no knowledge of the VICP and only knew about potential vaccine harm through the mass media presentation of the autism–vaccine theory. I do not blame her at all. I blame us—the seasoned medical educators who are committed to high-quality patient care, education and research.

We need to evolve beyond our simplistic understanding of the results and application of medical research and apply a much more complete understanding of our world.

In general surgery, we have numerous examples of how simplistic interpretations of medical research can cause harm and waste. To finish this dialogue about why we need to evolve our understanding in health care, I will present the complex research surrounding the use of screening mammography. I am intimately familiar with the use of mammography for the detection of early-stage breast cancer because one of the pioneers in this effort was my senior partner in my surgical practice for eight years.

A. Hamblin Letton was the president of the American Cancer Society and was present at the signing of the National Cancer Act

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2014

than 30 years of screening mammography have shown, that it is not so simple and we are perpetrating a degree of waste and harm in patient care that is not sustainable and not ethical.

To understand how to define the subpopulations that are harmed and those who do not benefit (causing waste), a more complete understanding of research and data analysis is required.

In Part 2 of “Understanding,” I will describe complex systems data analytics, or how to understand data from real patient care—nonlinear and messy, but real.

Diederik Stapel was a fraud, but he is not a villain. The villain in our world is not a person or an organization. The villain is our lack of understanding of complexity. Stapel’s desire to seek success by accommodating the desire to read simple results of complex biologic processes is the fault of no one individual but the fault of all of us who participate in the application of biological sciences. That Diederik Stapel did this to gain a meteoric rise in academic stature is as much a reflection of our lack of understanding as it is his personal character flaw. When we gain a more complete understanding

35

of health care and our world, we will not only not allow simple-minded efforts like that of Diederik Stapel to achieve undeserved rewards, but we will also begin to address the waste and harm that is caused every day in our system that results from a much too simplistic understanding of how we care for patients and how we try to improve patient outcomes.

—Dr. Ramshaw is chairman and chief medical officer, Transformative Care Institute (nonprofit) and Surgical Momentum LLC (for profit), and co-director, Advanced Hernia Solutions, Daytona Beach, Fla.

BRIEF SUMMARY ®

ENTEREG (alvimopan) Capsules The following is a brief summary only; see full prescribing information for complete product information.

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

with Richard Nixon in 1974. He truly believed that if we could get all women to have mammograms, we would find and cure breast cancer before it could harm these women. It was a very noble effort that I completely believed during my early surgical career. Unfortunately, like all other tests and treatments in health care, this is a much too simplistic understanding of reality. This simple screening test has caused immense harm and waste for women and our system, and unfortunately, those women who have been harmed and those who received mammograms unnecessarily are unknown and unknowable with our methods of medical research. If a respected organization recommends that a woman should have a screening mammogram if she is between the ages of 40 and 69 and the primary care physician follows that recommendation for every woman, then many of these women will be harmed by getting a mammogram and most of these women will be put through an unnecessary test.

For essentially every test and treatment we have in health care, there are basically three subpopulations of patients who undergo a test or receive a treatment. First, there is a group that benefits from the test or treatment, but there is also a group that does not benefit (this is waste in our system), and finally, there is a group of people who are harmed by the test or treatment (directly or indirectly). Until now, our simplistic thinking has allowed us to rationalize that the waste and harm was just a necessary evil to help those patients who benefit from a test or treatment. Who could argue that a few unnecessary mammograms are justified to save a woman’s life? But complexity science argues, and the data from the use of vaccines and more

There was a greater incidence of myocardial infarction in alvimopan-treated patients compared to placebo-treated patients in a 12-month clinical trial, although a causal relationship has not been established. In short-term trials with ENTEREG®, no increased risk of myocardial infarction was observed [see Warnings and Precautions (5.1)]. ] Because of the potential risk of myocardial infarction with long-term use, ENTEREG is available only through a restricted program for short-term use (15 doses) under a Risk Evaluation and Mitigation Strategy (REMS) called the ENTEREG Access Support and Education (E.A.S.E.®) Program [see Warnings and Precautions (5.1) and (5.2)]. ] 1

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

4 CONTRAINDICATIONS ENTEREG is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG [see Warnings and Precautions (5.3)].

5 WARNINGS AND PRECAUTIONS 5.1 Potential Risk of Myocardial Infarction with Long-term Use There were more reports of myocardial infarctions in patients treated with alvimopan 0.5 mg twice daily compared with placebo-treated patients in a 12-month study of patients treated with opioids for chronic non-cancer pain (alvimopan 0.5 mg, n = 538; placebo, n = 267). In this study, the majority of myocardial infarctions occurred between 1 and 4 months after initiation of treatment. This imbalance has not been observed in other studies of ENTEREG in patients treated with opioids for chronic pain, nor in patients treated within the surgical setting, including patients undergoing surgeries that included bowel resection who received ENTEREG 12 mg twice daily for up to 7 days (the indicated dose and patient population; ENTEREG 12 mg, n = 1,142; placebo, n = 1,120). A causal relationship with alvimopan with long-term use has not been established.

ENTEREG is available only through a program under a REMS that restricts use to enrolled hospitals [see Warnings and Precautions (5.2)].

5.2 E.A.S.E. ENTEREG REMS Program ENTEREG is available only through a program called the ENTEREG Access Support and Education (E.A.S.E.) ENTEREG REMS Program that restricts use to enrolled hospitals because of the potential risk of myocardial infarction with long-term use of ENTEREG [see Warnings and Precautions (5.1)].

Notable requirements of the E.A.S.E. Program include the following: ENTEREG is available only for short-term (15 doses) use in hospitalized patients. Only hospitals that have enrolled in and met all of the requirements for the E.A.S.E. program may use ENTEREG. To enroll in the E.A.S.E. Program, an authorized hospital representative must acknowledge that: hospital staff who prescribe, dispense, or administer ENTEREG have been provided the educational materials on the need to limit use of ENTEREG to short-term, inpatient use; patients will not receive more than 15 doses of ENTEREG; and ENTEREG will not be dispensed to patients after they have been discharged from the hospital.

Further information is available at www.ENTEREGREMS.com or 1-877-282-4786.

5.3 Gastrointestinal-Related Adverse Reactions in Opioid-Tolerant Patients Patients recently exposed to opioids are expected to be more sensitive to the effects of μ-opioid receptor antagonists, such as ENTEREG. Since ENTEREG acts peripherally, clinical signs and symptoms of increased sensitivity would be related to the gastrointestinal tract (e.g., abdominal pain, nausea and vomiting, diarrhea).

Patients receiving more than 3 doses of an opioid within the week prior to surgery were not studied in the postoperative ileus clinical trials. Therefore, if ENTEREG is administered to these patients, they should be monitored for gastrointestinal adverse reactions. ENTEREG is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG. 5.4 Risk of Serious Adverse Reactions in Patients with Severe Hepatic Impairment Patients with severe hepatic impairment may be at higher risk of serious adverse reactions (including dose-related serious adverse reactions) because up to 10-fold higher plasma levels of drug have been observed in such patients compared with patients with normal hepatic function. Therefore, the use of ENTEREG is not recommended in this population.

5.5 End-Stage Renal Disease No studies have been conducted in patients with end-stage renal disease. ENTEREG is not recommended for use in these patients.

5.6 Risk of Serious Adverse Reactions in Patients with Complete Gastrointestinal Obstruction No studies have been conducted in patients with complete gastrointestinal obstruction or in patients who have surgery for correction of complete bowel obstruction. ENTEREG is not recommended for use in these patients.

5.7 Risk of Serious Adverse Reactions in Pancreatic and Gastric Anastomoses ENTEREG has not been studied in patients having pancreatic or gastric anastomosis. Therefore, ENTEREG is not recommended for use in these patients.

6 ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be compared directly with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The adverse event information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

The data described below reflect exposure to ENTEREG 12 mg in 1,793 patients in 10 placebo-controlled studies. The population was 19 to 97 years old, 64% were female, and 84% were Caucasian; 64% were undergoing a surgery that included bowel resection. The first dose of ENTEREG was administered 30 minutes to 5 hours before the scheduled start of surgery and then twice daily until hospital discharge (or for a maximum of 7 days of postoperative treatment).

Among ENTEREG-treated patients undergoing surgeries that included a bowel resection, the most common adverse reaction (incidence ≥1.5%) occurring with a higher frequency than placebo was dyspepsia (ENTEREG, 1.5%; placebo, 0.8%). Adverse reactions are events that occurred after the first dose of study medication treatment and within 7 days of the last dose of study medication or events present at baseline that increased in severity after the start of study medication treatment.

7 DRUG INTERACTIONS 7.1 Potential for Drugs to Affect Alvimopan Pharmacokinetics An in vitroo study indicates that alvimopan is not a substrate of CYP enzymes. Therefore, concomitant administration of ENTEREG with inducers or inhibitors of CYP enzymes is unlikely to alter the metabolism of alvimopan.

7.2 Potential for Alvimopan to Affect the Pharmacokinetics of Other Drugs Based on in vitroo data, ENTEREG is unlikely to alter the pharmacokinetics of coadministered drugs through inhibition of CYP isoforms such as 1A2, 2C9, 2C19, 3A4, 2D6, and 2E1 or induction of CYP isoforms such as 1A2, 2B6, 2C9, 2C19, and 3A4.

In vitro, ENTEREG did not inhibit p-glycoprotein.

7.3

Effects of Alvimopan on Intravenous Morphine Coadministration of alvimopan does not appear to alter the pharmacokinetics of morphine and its metabolite, morphine-6-glucuronide, to a clinically significant degree when morphine is administered intravenously. Dosage adjustment for intravenously administered morphine is not necessary when it is coadministered with alvimopan.

7.4 Effects of Concomitant Acid Blockers or Antibiotics A population pharmacokinetic analysis suggests that the pharmacokinetics of alvimopan were not affected by concomitant administration of acid blockers or antibiotics. No dosage adjustments are necessary in patients taking acid blockers or antibiotics.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category B Risk Summary: y There are no adequate and/or well-controlled studies with ENTEREG in pregnant women. No fetal harm was observed in animal reproduction studies with oral administration of alvimopan to rats at doses 68 to 136 times the recommended human oral dose, or with intravenous administration to rats and rabbits at doses 3.4 to 6.8 times, and 5 to 10 times, respectively, the recommended human oral dose.

Because animal reproduction studies are not always predictive of human response, ENTEREG should be used during pregnancy only if clearly needed.

Animal Data: Reproduction studies were performed in pregnant rats at oral doses up to 200 mg/kg/day (about 68 to 136 times the recommended human oral dose based on body surface area) and at intravenous doses up to 10 mg/kg/day (about 3.4 to 6.8 times the recommended human oral dose based on body surface area) and in pregnant rabbits at intravenous doses up to 15 mg/kg/day (about 5 to 10 times the recommended human oral dose based on body surface area), and revealed no evidence of impaired fertility or harm to the fetus due to alvimopan.

8.3 Nursing Mothers It is not known whether ENTEREG is present in human milk. Alvimopan and its ‘metabolite’ are detected in the milk of lactating rats. Exercise caution when administering ENTEREG to a nursing woman [see Clinical Pharmacology (12.3)].

8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use Of the total number of patients in 6 clinical efficacy studies treated with ENTEREG 12 mg or placebo, 46% were 65 years of age and over, while 18% were 75 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No dosage adjustment based on increased age is required [see Clinical Pharmacology (12.3)].

8.6 Hepatic Impairment ENTEREG is not recommended for use in patients with severe hepatic impairment.

Dosage adjustment is not required for patients with mild-to-moderate hepatic impairment. Patients with mild-to-moderate hepatic impairment should be closely monitored for possible adverse effects (e.g., diarrhea, gastrointestinal pain, cramping) that could indicate high drug or ‘metabolite’ levels, and ENTEREG should be discontinued if adverse events occur [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.3)].]

8.7 Renal Impairment ENTEREG is not recommended for use in patients with end-stage renal disease. Dosage adjustment is not required for patients with mild-to-severe renal impairment, but they should be monitored for adverse effects. Patients with severe renal impairment should be closely monitored for possible adverse effects (e.g., diarrhea, gastrointestinal pain, cramping) that could indicate high drug or ‘metabolite’ levels, and ENTEREG should be discontinued if adverse events occur [see Clinical Pharmacology (12.3)].

8.8 Race No dosage adjustment is necessary in Black, Hispanic, and Japanese patients. However, the exposure to ENTEREG in Japanese healthy male volunteers was approximately 2-fold greater than in Caucasian subjects.

Japanese patients should be closely monitored for possible adverse effects (e.g., diarrhea, gastrointestinal pain, cramping) that could indicate high drug or ‘metabolite’ levels, and ENTEREG should be discontinued if adverse events occur [see Clinical Pharmacology (12.3)].

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: g Two-year carcinogenicity studies were conducted with alvimopan in CD-1 mice at oral doses up to 4000 mg/kg/day and in Sprague-Dawley rats at oral doses up to 500 mg/kg/day. Oral administration of alvimopan for 104 weeks produced significant increases in the incidences of fibroma, fibrosarcoma, and sarcoma in the skin/subcutis, and of osteoma/osteosarcoma in bones of female mice at 4000 mg/kg/day (about 674 times the recommended human dose based on body surface area). In rats, oral administration of alvimopan for 104 weeks did not produce any tumor up to 500 mg/kg/day (about 166 times the recommended human dose based on body surface area).

Mutagenesis: g Alvimopan was not genotoxic in the Ames test, the mouse lymphoma cell (L5178Y/TK+/−) forward mutation test, the Chinese Hamster Ovary (CHO) cell chromosome aberration test, or the mouse micronucleus test. The pharmacologically active ‘metabolite’ ADL 08-0011 was negative in the Ames test, chromosome aberration test in CHO cells, and mouse micronucleus test.

Impairment p of Fertility: y Alvimopan at intravenous doses up to 10 mg/kg/day (about 3.4 to 6.8 times the recommended human oral dose based on body surface area) was found to have no adverse effect on fertility and reproductive performance of male or female rats.

17 PATIENT COUNSELING INFORMATION 17.1 Recent Use of Opioids Patients should be informed that they must disclose long-term or intermittent opioid pain therapy, including any use of opioids in the week prior to receiving ENTEREG. They should understand that recent use of opioids may make them more susceptible to adverse reactions to ENTEREG, primarily those limited to the gastrointestinal tract (e.g., abdominal pain, nausea and vomiting, diarrhea).

17.2 Hospital Use Only ENTEREG is available only through a program called the ENTEREG Access Support and Education (E.A.S.E.) Program under a REMS that restricts use to enrolled hospitals because of the potential risk of myocardial infarction with long-term use of ENTEREG. Patients should be informed that ENTEREG is for hospital use only for no more than 7 days after their bowel resection surgery.

17.3 Most Common Side Effect Patients should be informed that the most common side effect with ENTEREG in patients undergoing surgeries that include bowel resection is dyspepsia.

ENTEREG and E.A.S.E. are registered trademarks of Adolor Corporation, a wholly owned subsidiary of Cubist Pharmaceuticals, Inc. Any other trademarks are property of their respective owners.

Manufactured for: Cubist Pharmaceuticals, Inc. Lexington, MA 02421 USA October 2013

Experience the ENTEREG EFFECT Accelerate your patients’ GI recovery after surgeries that include bowel resection,

such as radical cystectomies

› In clinical trials, ENTEREG reduced mean time to GI recovery by 11-31.5 hours vs. placebo.1

FIRST & ONLY agent of its kind ENTEREG is indicated to accelerate the time to upper and lower gastrointestinal (GI) recovery following surgeries that include partial bowel resection with primary anastomosis.

Important Safety Information for ENTEREG WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY › Increased incidence of myocardial infarction was seen in a clinical trial of patients taking alvimopan for long-term use.

No increased risk was observed in short-term trials. › Because of the potential risk of Myocardial Infarction, ENTEREG is available only through a restricted program for short-term use (15 doses) called the ENTEREG Access Support and Education (E.A.S.E.®) ENTEREG REMS Program.

Contraindications

› ENTEREG Capsules are contraindicated in patients who have

taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG.

Warnings and Precautions

› There were more reports of myocardial infarctions in patients

treated with alvimopan 0.5 mg twice daily compared with placebo-treated patients in a 12-month study of patients treated with opioids for chronic pain. In this study, the majority of myocardial infarctions occurred between 1 and 4 months after initiation of treatment. This imbalance has not been observed in other studies of alvimopan, including studies of patients undergoing bowel resection surgery who received alvimopan 12 mg twice daily for up to 7 days. A causal relationship with alvimopan has not been established.

› ENTEREG should be administered with caution to patients receiving more than 3 doses of an opioid within the week

prior to surgery. These patients may be more sensitive to ENTEREG and may experience GI side effects (e.g., abdominal pain, nausea and vomiting, diarrhea).

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

Adverse Reactions

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

E.A.S.E.® Program for ENTEREG

› ENTEREG is available only to hospitals that enroll in the E.A.S.E. ENTEREG REMS Program. To enroll in the E.A.S.E. Program, the hospital must acknowledge that:

– Hospital staff who prescribe, dispense, or administer

ENTEREG have been provided the educational materials on the need to limit use of ENTEREG to short-term, inpatient use

– Patients will not receive more than 15 doses of ENTEREG – ENTEREG will not be dispensed to patients after they have been discharged from the hospital

Please see following brief summary of Prescribing Information.

Reference: 1. ENTEREG (Prescribing Information). Cubist Pharmaceuticals, Inc.; Lexington, MA.

www.cubist.com ©2012 Cubist Pharmaceuticals 5628121613 January 2014. ENTEREG and E.A.S.E.® are registered trademarks of Cubist Pharmaceuticals, Inc.

Brought g to You by y

MARCH MARCH 2014 2014

REPORT H.E.R.N.I.A.: Hernia Experts Roundtable and New Innovations Assembly Expert Consensus on the Use of Biosynthetic And Biologic Mesh in Hernia Repair Moderator Alfredo M. Carbonell II, DO, FACS, FACOS Associate Professor of Surgery Chief, Division of Minimal Access and Bariatric Surgery Co-director, The Hernia Center Greenville Health System University of South Carolina School of Medicine Greenville, South Carolina

Faculty James J. Chao, MD, FACS

Kristi L. Harold, MD, FACS

Professor, Division of Plastic Surgery University of California, San Diego San Diego, California

Associate Professor of Surgery Mayo Clinic Phoenix, Arizona

William S. Cobb IV, MD, FACS

Hobart W. Harris, MD, MPH, FACS

Vice Chair of Clinical Affairs Co-director, The Hernia Center Greenville Health System University of South Carolina School of Medicine Greenville, South Carolina

Professor and Chief Division of General Surgery Vice-Chair, Department of Surgery J. Engelbert Dunphy Endowed Chair in Surgery University of California, San Francisco San Francisco, California

Andrew Dennis, DO, FACOS Trauma and Burn Surgeon Cook County Hospital Associate Professor RUSH Medical College Chicago, Illinois

B. Todd Heniford, MD, FACS Chief, Division of Gastrointestinal and Minimally Invasive Surgery Co-director, Carolinas Laparoscopic and Advanced Surgery Program Director, Carolinas Hernia Center Clinical Professor of Surgery, University of North Carolina at Chapel Hill Charlotte, North Carolina

Ara J. Feinstein, MD, MPH Trauma and Critical Care Surgeon Banner Good Samaritan Medical Center Assistant Professor Department of Surgery University of Arizona College of Medicine-Phoenix Phoenix, Arizona

Brent D. Matthews, MD, FACS Chief, Section of Minimally Invasive Surgery Professor of Surgery Washington University School of Medicine in St. Louis St. Louis, Missouri

Supported by

REPORT

In November 2013, W. L. Gore & Associates, Inc. hosted the Hernia Experts Roundtable and New Innovations Assembly (H.E.R.N.I.A.) in Scottsdale, Arizona, a consensus meeting where leaders in the field of hernia repair and highvolume hernia surgeons from around the United States met to discuss issues related to ventral hernia repair.

The aim was to outline the clinical and laboratory evidence with regard to mesh function and outcomes; to foster clinical trial standardization; and to improve safety and cost-effectiveness in ventral hernia repair. The participants focused largely on repairs in contaminated fields, which are among the most expensive but least understood areas in hernia repair.

“This is a time in hernia repair when many people are rethinking their standard procedure with regard to repair and why they use certain meshes. The H.E.R.N.I.A. meeting was an opportunity to address indications and materials used in hernia repair as well as cost-effectiveness,” said Alfredo M. Carbonell, II, DO, FACS, FACOS, associate professor of surgery at the University of South Carolina School of Medicine and codirector of the Hernia Center, Greenville Health System.

T

he past 2 decades gave rise to more advancements in abdominal wall reconstruction than in the previous 2 centuries.1 During this period, several developments helped alter how clinicians approached abdominal wall repair: 1) the understanding that direct suture repair of ventral hernias results in higher recurrences than mesh-reinforced repairs1; 2) the development of the component separation technique2; and 3) the introduction of biologic mesh as an alternative to synthetic mesh.1 Despite the speed of progress in hernia repair—or perhaps because of it—little consensus exists concerning best practices in abdominal wall reconstruction. The mesh market has exploded with an astonishing number of products available or in the pipeline. Meshes fit into 3 categories: biologic, biosynthetic or bioabsorbables, and permanent synthetic. 3 Surgeons are concerned about risk for infection, adhesions, and fistulas with permanent synthetic meshes, particularly in contaminated fields. Biologic mesh was introduced to reduce these risks, but can be more expensive and has a higher rate of hernia recurrence compared with permanent synthetic mesh.3 The newest generation of mesh, biosynthetic mesh, is seen as a bridge between the biologics and permanent synthetics by offering a temporary scaffold for tissue ingrowth with no permanent material left behind, and at a fraction of the cost of biologics; however, biologic and biosynthetic mesh lacks long-term clinical trial data.

Wound Healing and Mesh-Based Repair The success of any hernia repair depends on the quality of wound healing and tissue remodeling. The scaffold provided by mesh creates a favorable environment for cell growth and angiogenesis. Once implanted, fibroblasts migrate into the mesh, secrete collagen, and populate the scaffold. With a biologic or biosynthetic mesh, the scaffold is designed to be

2

completely reabsorbed, thereby potentially reducing the longterm risk for mesh-related morbidity.1 Four key phases of wound healing have been identified: hemostasis, inflammation, proliferation, and remodeling.4 Hemostasis takes place immediately after surgery.5 Once hemostasis is achieved, monocytes, neutrophils, and other leukocytes infiltrate the area, initiating an inflammatory phase. This may last several days or longer with a foreign body in the wound. During the inflammatory phase, monocytes differentiate into macrophages and release growth factors key to tissue remodeling.4,6 The proliferation phase typically starts near the third week and could last anywhere from months to years. This phase is marked by collagen deposition that, in time, allows for load bearing and compliance within the wound.6 In the remodeling phase, collagen is further synthesized, degraded, and dramatically reorganized as it stabilizes into a scar. Despite the long duration of remodeling, the resulting scar ultimately never reaches the strength of the skin.5 These complex processes can be influenced by multiple factors related to the patient, surgeon, and mesh. Patient characteristics like tobacco use, malnutrition, obesity, age, and gender can affect the process of wound healing. Additionally, some patients have tissue matrix disorders that contribute to primary hernia formation and likely also impair surgical wound healing. This is supported by investigations of skin specimens in patients with abdominal wall hernias that revealed a reduction in the collagen I/III ratio.7 Mesh material also influences the wound-healing process. Synthetic meshes were engineered for strength and do not degrade, thereby potentially increasing the risk for chronic infection following microbial colonization. Biologic mesh was developed to take the place of synthetic mesh in cases where infection is of high concern, particularly contaminated fields.1 “Theoretically, the primary advantage of using

REPORT

such scaffolds is that minimal foreign material is left behind at the repair site, resulting in less potential inflammation and foreign body response,” said Brent D. Matthews, MD, FACS, chief of minimally invasive surgery and professor of surgery at Washington University School of Medicine in St. Louis, Missouri, during his presentation.

Biologic meshes are derived from different sources (human, porcine, or bovine) and undergo a variety of proprietary processing methods for decellularization and sterilization (γ-radiation, ethylene oxide gas sterilization, or nonsterilized).1 Some are then intentionally cross-linked using different chemical techniques.

However, uncertainty exists about how these materials work once the mesh is implanted. Animal and laboratory studies demonstrate that cross-linked materials exhibit differences from non–cross-linked meshes in terms of a higher melting temperature and greater resistance to enzymatic degradation.8 On the whole, however, the properties are similar. Studies conducted by Dr. Matthews’ lab have shown that variables other than cross-linking, such as decellularization/ sterilization treatments or species/tissue type also contribute to the properties of the scaffolds.8 In a detailed analysis published in October 2013 in Surgical Clinics of North America, Novitsky et al noted: “Recent data have been disappointing on several fronts. Animal investigations have failed to demonstrate consistent evidence of biological mesh remodeling and replacement of biological grafts with collagen-like tissue. In addition, recent human experience has revealed that true remodeling of biologics occurs at the periphery of an implanted graft, if at all.” 9

Clinical Trial Data for Biologic Mesh To date, few high-quality studies have been conducted in the field of ventral hernia repair. This is reflected in the published literature on biologic mesh. Three recent reviews assessed the current evidence for biologic mesh and arrived at the same conclusion: The literature lacks quality primary data.10-12 Most published studies are either case series or case reports, and data are reported inconsistently with differing inclusion and exclusion criteria, outcome variables, and follow-up periods.12 Hobart W. Harris, MD, MPH, FACS, professor and chief of general surgery at the University of California in San Francisco, noted that many procedures reported in the literature involve the use of human acellular dermal matrix ALLODERM ® Regenerative Tissue Matrix (LifeCell Corporation), which may be disproportionate to current practice in the United States. Also out of line with current practice, most of the studies of biologic mesh were conducted in noncontaminated wounds. The shortcomings of poor-quality primary data “cannot be overcome, no matter how rigorous and robust the analytic methods,” Dr. Harris said. He added that available data suggest that use of biologic mesh is associated with significant rates of wound complications, and infections account for many of these complications. Other common complications include seromas, hematomas, fistulas, and skin necrosis. Lastly, he noted that 1-year recurrence rates of 15% and

higher are frequently reported with biologic mesh.13 Level 1b evidence indicates that using biologic mesh to bridge a fascial defect is associated with a 38% failure rate at 1 year.13

Animal and Clinical Trial Data for Biosynthetic Mesh Available data on biosynthetic and absorbable mesh also is limited. Early absorbable meshes, such as DEXON Mesh (Covidien) and VICRYL® Mesh (Ethicon Endo-Surgery, Inc.), have been cleared by the FDA for clinical use for more than 30 years. These devices are absorbed rapidly within 90 days and are not typically used as the sole prosthesis in hernia repair. Recently, newer absorbable meshes have been developed and termed biosynthetic for their use as an alternative to biologic mesh. Since 2005, GORE® BIO-A® Tissue Reinforcement (W. L. Gore & Associates), TIGR® Resorbable Matrix (Novus Scientific), PHASIX Mesh (Davol Inc.), and SERI® Surgical Scaffold (Allergan, Inc.) have been cleared for use by the FDA and introduced to clinicians for hernia repair applications. Each of these devices has a longer absorption profile compared with early absorbable meshes, allowing more time for tissue integration. Among recently developed biosynthetic meshes, only GORE® BIO-A® Tissue Reinforcement has had published peer-reviewed clinical literature.

GORE ® BIO-A® Tissue Reinforcement is created from a web of biocompatible polymers that are gradually absorbed by the body. As the mesh is synthetically produced, the product is designed to absorb more predictably than biologic grafts.14 GORE® BIO-A® Tissue Reinforcement is comprised of a uniquely designed 3-dimensional matrix of open, highly interconnected pores that facilitate cell infiltration and tissue generation, much like a collagen fiber network.

As synthetic polymers are absorbed, the matrix is replaced by revascularized soft tissue at an approximately 1:1 ratio over 6-7 months, leaving behind no permanent material. Within 1 to 2 weeks, the patient’s cells move into the scaffold and begin producing vascularized soft tissue.14 A preclinical study compared this mesh with 3 biologic meshes. Twenty-four meshes were implanted subcutaneously in rabbits and harvested at regular intervals.15 Analysis showed a more rapid increase in cellular and vascular ingrowth, along with collagen deposition, for the biosynthetic mesh versus the biologic meshes.

Biosynthetic mesh also exhibited the least inflammatory infiltrates over time.15 Meeting participants discussed how the clinical uses for the new biosynthetic meshes as an alternative to biologics include hiatal hernia repair, incisional hernia repair following infected mesh removal, incisional hernia repair in contaminated fields, stoma reinforcement, and prophylaxis of high-risk situations, such as Roux-en-Y gastric bypass and colostomy reversal.

Like biologics, biosynthetics were not recommended for bridging fascial defects. However, the absence of level 1 data for both biologic and biosynthetic meshes means that there is no

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accurate means to compare these mesh types. B. Todd Heniford, MD, FACS, chief of the Division of Gastrointestinal and Minimally Invasive Surgery, co-director of the Carolinas Laparoscopic and Advanced Surgery Program, and director of the Carolinas Hernia Center at Carolinas Medical Center in Charlotte, North Carolina, is leading a prospective, randomized study to evaluate GORE® BIO-A® Tissue Reinforcement and STRATTICE Reconstructive Matrix (LifeCell Corporation) during ventral hernia repair in at-risk patients and will soon provide insight on the comparative performance of these 2 mesh categories.16

Mesh Options in Contaminated Fields It is important to define clearly what is meant as contamination in hernia repair. Varying interpretations of the terms contaminated and clean-contaminated have led to discrepancies in reported results. The definition most broadly accepted is that from the US Centers for Disease Control and Prevention (CDC).17 In recent years, there has been a shift from synthetic mesh use in contaminated wounds to use of biologic mesh. Studies conducted in the 1980s reported that 50% to 90% of synthetics placed in contaminated fields ultimately would be removed.18 By their nature, the foreign materials in synthetics decrease the bacterial burden required for clinical infection, thereby increasing risk for excessive foreign body reaction, chronic inflammation, unorganized scar plate formation, and shrinkage from bridging fibrosis, according to Dr. Carbonell. As a result, many surgeons have expressed a reluctance to use synthetics in contaminated wounds.

A study published in December 2013 in the Journal of the American College of Surgeons reported favorable early outcomes for patients who underwent synthetic mesh repair for ventral hernias in contaminated fields.19 In a retrospective study of patients who underwent open ventral hernia repair with polypropylene mesh in clean-contaminated and contaminated fields, the incidence of hernia recurrence and surgical-site occurrences were 7% and 31%, respectively, with a mean follow-up of 10.8±9.9 months.19 “Synthetics are probably the most cost-effective thing we can use right now based on their low cost and superior efficacy. Having said that, I think it’s going to be a long time before the use of synthetic mesh in contaminated fields permeates surgical practice in the United States,” Dr. Carbonell said.

Today, options for contaminated repairs include both 2-stage and single-stage operations, with each carrying its own set of risks. Two-stage repairs can be lengthy and associated with increased risks for long-term morbidity and costs.

However, the 2-stage repair may address the contamination effectively and facilitate repair of the hernia in a clean setting 6 to 12 months later. The single-stage operation has the advantage of streamlining the process into 1 procedure by combining decontamination with a tissue-based or mesh-reinforced repair and/or component separation. Component separation also has risks: It requires skin-flap dissection, carries a high rate of recurrence, and can limit future options for repair.

Single-stage reconstruction with biologic mesh reinforcement

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has become popular over the past 5 years, according to Dr. Carbonell.

As longer-term results are reported from case series and a multicenter trial, biologics have shown a high rate of recurrence, although an acceptable rate of wound healing.

The 80-patient RICH (Repair of Infected or Contaminated Abdominal Incisional Hernias) trial reported favorable 1-year outcomes using STRATTICE Reconstructive Matrix with an 18.8% recurrence rate. However, after 2 years, recurrence rates rose to 28% and wound events occurred in 66% of patients.13 Other case reports also showed that recurrence risk increases with time and is highest among patients who underwent bridged repairs. One study that included 37 patients receiving either bridged (n=11) or reinforced (n=26) repairs reported that 80% of patients receiving bridged repairs available for follow-up recurred compared with 20% of available patients who received reinforced repairs.20 A 5-year retrospective review of biologic mesh for singlestage reconstruction of contaminated fields demonstrated high recurrence rates with longer follow-up. With a mean followup of 21.7 months, hernia recurrence was identified in 31.3% (n=40) of patients.21 At 3 years, recurrence reached 51%. In their conclusion, the study authors questioned whether use of biologics only provided a temporary reinforcement until complex hernia recurrence eventually occurs.21 To date, the most significant evidence with regard to biosynthetic meshes in hernia repair comes from the COBRA (Complex Open Biosynthetic Reconstruction of the Abdominal Wall) study, a prospective, multicenter study involving 9 institutions in the United States and the Netherlands, and 104 patients.

The industry-sponsored, observational study was designed to assess outcomes after use of biosynthetic material to reinforce the midline fascial closure in single-stage, open, clean-contaminated or contaminated ventral hernia repairs.22 The study included 77% contaminated and 23% clean-contaminated wounds. The mean defect size was 138 cm2 and 94% were repaired in a retrorectus fashion.22 To date, the mean followup period is 210 days. Follow-up at 12 months occurred for 37 patients (36%). Twenty-nine wound events were reported and the early recurrence rate was 4%.22 “That is going to increase, but at least the early data is quite encouraging compared to the biologic data that is out there,” said William S. Cobb, IV, MD, FACS, vice chair of clinical affairs and co-director of The Hernia Center at Greenville Health System, at the meeting.

In summarizing the data, Dr. Harris noted, “the cumulative data regarding biologic mesh use on ventral hernias under contaminated conditions does not support the claim that they are better than synthetic mesh used under the same conditions.”

Mesh Location Presently, there is no broadly accepted algorithm for mesh placement during abdominal wall reconstruction and the optimal location of mesh used to reinforce a repair remains unknown.

The most common locations of mesh placement include onlay, sublay (either retrorectus or preperitoneal), and intraperitoneal.

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Few studies have specifically addressed the question of mesh location and outcomes. Many reports omit details of mesh location in the discussion of surgical technique.

In a November 2013 analysis published in the journal Plastic and Reconstructive Surgery, y authors could identify only 62 papers between 1996 and 2012 that satisfactorily documented placement of mesh during studies of abdominal wall reconstruction.23 When evaluating outcomes based on mesh location, onlay and interposition placement resulted in the highest overall rates of recurrence, 17% for both compared with retrorectus (5%) or intraperitoneal (7.5%) mesh placement (P=0.01).

For biologic mesh, recurrence was 8% for mesh placed in a retrorectus position and 16% for intraperitoneal (P=0.12).23 The RICH trial was not designed to assess mesh location but authors did analyze a subset of 49 of the 80 patients enrolled in this trial of contaminated ventral hernia repairs.

The patients were selected for study because they had successful fascial closure after musculofascial centralization and mesh reinforcement. Mesh was placed in the retrorectus position in 23 patients and the intraperitoneal position in 26.24 Retrorectus defects were significantly wider and had larger area than the intraperitoneal repairs. At 1-year follow-up, analysis demonstrated no difference in wound infections, seromas, or hematomas. Recurrent hernias were identified in 10% of retrorectus repairs and 30% of intraperitoneal repairs (P=0.14).24 In the discussion, Rosen et al hypothesized that the retrorectus space may provide superior vascular ingrowth, which would prevent bacteria degradation and graft failure. The authors cited a German study that examined collagenous ingrowth after synthetic mesh placement in a rabbit model.24 That study showed that reduced recurrence using mesh reinforcement and the sublay technique may allow for quality perifilamentary connective tissue formation and that larger, low-weight mesh may provide more positive outcomes due to the reduced inflammation shown in patients who received this type of material (the sublay technique demonstrated in the Figure).25 The aforementioned 5-year retrospective review by Rosen et al demonstrated a marked difference in recurrence rates based on mesh location. Recurrences were identified in 45% of patients with mesh placed intraperitoneally and 24% of patients with retrorectus mesh placement. When adjusted for differences in follow-up time between these groups, this was not a statistically significant difference (P=0.06).21 The authors concluded that despite recurrence rates fluctuating due to location, these results may have been influenced by selection bias and that future studies should continue to investigate how mesh location affects the outcome of hernia repair and recurrence rate.21

Financial Implications of Hernia Incidence and Repair Ventral hernia repairs have significant economic ramifications for employers, insurers, providers, and patients because of the volume of procedures, complication rates, the significant rate of recurrences, and escalating costs. 26

Figure. GORE® BIOA® Tissue Reinforcement in the sublay position lying behind the muscle prior to abdominal wall closure.

Image courtesy of Alfredo M. Carbonell II, DO, FACS, FACOS.

Ventral hernia repairs in the United States are estimated to cost at least $3.2 billion annually, based on 2006 data.27 This figure is likely an underestimation, as the analysis excluded procedures performed in the federal system as well as physician fees and other societal costs. In a study examining the cost of ventral hernia repairs, Poulose et al noted that inpatient ventral hernia repair procedural costs steadily increased between 2001 and 2006.27 This period coincides with increased application of biologic meshes. Notably, the report also found that every reduction in recurrence results in substantial cost savings—each 1% reduction would save about $32 million annually.27 Increasingly, these kinds of economic considerations influence the way surgeons practice. There is growing support for the concept of high-value health care that delivers optimal outcomes at the lowest cost. Moreover, more physicians today have joined in alignment practices with hospitals due to changes in quality, financial, and regulatory demands.

This shift requires physicians to be more fiscally responsible to their hospitals, Dr. Carbonell noted. A further uptake of this trend is expected with the advent of accountable care organizations and the Patient-Centered Outcomes Research Institute. “Cost-effectiveness in surgery, especially in hernia repairs, is not a new concept but will be increasingly important going forward,” Dr. Carbonell said. “When we perform operations well—particularly operations that do not require a reoperation—we will affect the overall financial landscape. More and more, when we look at hernia repair, we have to consider the cost of a product versus its effectiveness.”

Two small studies compared the cost-effectiveness of open suture versus mesh repair for primary incisional hernias.

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Table. H.E.R.N.I.A.: Hernia Experts Roundtable and New Innovationsa Assembly Consensus Statements on Ventral Hernia Repair The wound complication rate is higher after surgery in a contaminated field than in a clean surgical field.

Biologic and biosynthetic meshes are alternatives to permanent synthetic mesh for hernia repairs in a contaminated field.

To ensure the most durable repair, biologic and biosynthetic meshes should be used as a reinforcement of an abdominal wall repair.

Biologic mesh comes from variable sources and manufacturing processes that may in fact lead to variable remodeling and integration in different patients undergoing operations for different clinical scenarios.

Location of biologic and biosynthetic mesh placement has an effect on hernia recurrence rate. The retromuscular plane may be the best location for mesh integration.

Heavily contaminated operative fields are associated with increased collagenase activity, to which biologics are susceptible, and thus their use in these scenarios may be less than ideal.

No data exist to demonstrate that out-of-the-package handling characteristics of any biologic or biosynthetic mesh has an effect on the ultimate performance and efficacy of the product.

Although there are known patient risk factors for surgical site infection, the routine use of biologic and biosynthetic mesh in clean cases should be balanced against the known durability of permanent synthetic mesh in these cases.

Insufficient data exist to make any reasonable recommendation on mesh choice for patients with a history of prior wound infection, prior MRSA infection, or current MRSA colonization.

Mesh cost is important, and surgeons should make informed decisions based on cost-effectiveness that will arise from carefully designed clinical trials.

Biosynthetic mesh is a cost-effective alternative to biologic mesh.

A wide-pore lightweight polypropylene mesh is a reasonable option for hernia repair in the retrorectus space in a clean-contaminated field; 80% agreed.

MRSA, methicillin-resistant Staphylococcus aureus a

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The H.E.R.N.I.A.: Hernia Experts Roundtable and New Innovations Assembly was sponsored by W. L. Gore & Associates, Inc., makers of GORE速 BIO-A速 Tissue Reinforcement. Meeting attendees were asked if they agreed with the statement: The H.E.R.N.I.A. symposium was a balanced event; 88% agreed.

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Both studies concluded that, overall, open mesh repair is a more cost-effective treatment because the initial higher cost of mesh repair is offset by a significant reduction in recurrences.28,29 Biologic mesh dramatically changes economic assessments and cost-effectiveness as it is 20 to 30 times more expensive than synthetic alternatives, said Dr. Harris.

Another recent study evaluated hospital net revenue and profits and losses in the context of open hernia repair and found inpatient synthetic mesh-based repairs performed as the primary procedure were budget-neutral. All other repairs resulted in net financial losses. Losses were greatest in cases involving use of biologic mesh, which resulted in a median net financial loss of $8,370. Biologic mesh more than doubled the direct costs of incisional hernia repair compared with synthetic repair ($16,970 vs $7,590).30 The authors concluded: “While mesh utilization is associated with higher direct costs, its role in decreasing hernia recurrence adds to its global cost-effectiveness, and this should be considered in reimbursement strategies.”30 The authors added that in the tertiary care environment and other settings, patients may experience better outcomes when a biologic mesh is used for abdominal wall reconstruction, although use of this mesh increases costs.30 Nevertheless, the long-term durability of biologics is questionable. Rosen et al found that with the high recurrence rate of biologics at 3 years, it appeared that the biologics actually may be used in a multistage approach. If this is the case, the authors suggest that biologics should not have such price

premium.21 Provided clinical efficacy is demonstrated, costeffective biosynthetics could prove to be a better mesh choice.

Conclusion At the end of the H.E.R.N.I.A. meeting, attendees approved a number of statements about mesh use in hernia repair (Table). Surgeons highlighted the paucity of high-quality data in hernia repair and called for better research, both into outcomes and costs associated with hernia repair.

Dr. Carbonell said he was pleased with the “overwhelming consensus,” particularly with regard to the types of mesh used in contaminated and clean-contaminated repairs.

“We have a much better idea now of where we are with regard to biologics, biosynthetics, and synthetics,” he said. The consensus meeting addressed indications for mesh use in hernia repair, noting that biologic mesh is less than ideal in contaminated fields, whereas biosynthetic mesh is a cost-effective alternative. They agreed that wide-pore lightweight polypropylene mesh is a reasonable option for hernia repair in the retrorectus space in a clean-contaminated field. No matter what mesh is used, the retromuscular plane may be the best place for mesh integration, they said.

“Finally, it’s important that we recognize that surgeons need to look at the costs associated with these decisions,” said Dr. Carbonell. “As surgeons, we have a major role in cost containment and the expense of medicine. We need to be doing our part.”

References 1.

Butler CE, Baumann DP, Janis JE, et al. Abdominal wall reconstruction. Curr Probl Surg. 2013;50(12):557-586.

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Ramirez OM, Ruas E, Dellon AL. “Components separation” method for closure of abdominal-wall defects: an anatomic and clinical study. Plast Reconstr Surg. 1990;86(3):519-526.

10. Beale EW, Hoxworth RE, Livingston EH, et al. The role of biologic mesh in abdominal wall reconstruction: a systematic review of the current literature. Am J Surg. 2012;204(4):510-517.

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Robinson TN, Clarke JH, Schoen J, Walsh MD. Major mesh-related complications following hernia repair: events reported to the Food and Drug Administration. Surg Endosc.

2005;19(12):1556-1560.

11. Bellows CF, Smith A, Malsbury J, et al. Repair of incisional hernias with biological prosthesis: a systematic review of current evidence. Am J Surg. 2013;205(1):85-101.

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Singer AJ, Clark RA. Cutaneous wound healing. N Engl J Med. 1999;341(10):738-746.

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Witte MB, Barbul A. General principles of wound healing. Surg Clin North Am. 1997;77(3):509-528.

12. Primus FE, Harris HW. A critical review of biologic mesh use in ventral hernia repairs under contaminated conditions. Hernia.

2013;17(1):21-30.

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Sadava EE, Krpata DM, Gao Y, et al. Wound healing process and mediators: Implications for modulations for hernia repair and mesh integration. J Biomed Mater Res A. 2013 Apr 30.

[Epub ahead of print]

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Rosch R, Junge K, Knops M, et al. Analysis of collagen-interacting proteins in patients with incisional hernias. Langenbecks Arch Surg. 2003;387(11-12):427-432.

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Deeken CR, Eliason BJ, Pichert MD, et al. Differentiation of biologic scaffold materials through physicomechanical, thermal, and enzymatic degradation techniques. Ann Surg.

2012;255(3):595-604.

Novitsky YW. Biology of biological meshes used in hernia repair.

Surg Clin North Am. 2013;93(5):1211-1215.

13. Itani KM, Rosen M, Vargo D, et al; RICH Study Group. Prospective study of single-stage repair of contaminated hernias using a biologic porcine tissue matrix: the RICH Study. Surgery.

2012;152(3):498-505.

14. W.L. Gore & Associates, Inc. GORE® BIO-A® Tissue Reinforcement Product Brochure. www.goremedical.com/resources/dam/ assets/AQ3037-EN2.pdf. Accessed February 6, 2014.

15. Zemlyak AY, Colavita PD, Tsirline VB, et al. Absorbable glycolic acid/trimethylene carbonate synthetic mesh demonstrates superior in-growth and collagen deposition. Presented at: 2012 Abdominal Wall Reconstruction Conference; June 13-16, 2012; Washington, D.C.

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16. ClinicalTrials.gov. The use of biologic mesh vs bioabsorbable mesh during ventral hernia repair in at-risk patients (NCT01794338). http://clinicaltrials.gov/ct2/show/ NCT01794338. Accessed February 6, 2014.

23. Albino FP, Patel KM, Nahabedian MY, et al. Does mesh location matter in abdominal wall reconstruction? A systematic review of the literature and a summary of recommendations. Plast Reconstr Surg. 2013;132(5):1295-1304.

17. Centers for Disease Control and Prevention. Guideline for Prevention of Surgical Site Infection, 1999. Table 7 Surgical Wound Classification. www.cdc.gov/hicpac/SSI/table7-8-9-10-SSI.html.

Accessed February 6, 2014.

24. Rosen MJ, Denoto G, Itani KM, et al. Evaluation of surgical outcomes of retro-rectus versus intraperitoneal reinforcement with bio-prosthetic mesh in the repair of contaminated ventral hernias.

Hernia. 2013;17(1):31-35.

18. Dayton MT, Buchele BA, Shirazi SS, et al. Use of an absorbable mesh to repair contaminated abdominal-wall defects. Arch Surg.

1986;121(8):954-960.

25. Binnebösel M, Klink CD, Otto J, et al. Impact of mesh positioning on foreign body reaction and collagenous ingrowth in a rabbit model of open incisional hernia repair. Hernia. 2010;14(1):71-77.

19. Carbonell AM, Criss CN, Cobb WS, et al. Outcomes of synthetic mesh in contaminated ventral hernia repairs. J Am Coll Surg.

2013;217(6):991-998.

26. Bower C, Roth JS. Economics of abdominal wall reconstruction.

Surg Clin North Am. 2013;93(5):1241-1253.

20. Jin J, Rosen MJ, Blatnik J, et al. Use of acellular dermal matrix for complicated ventral hernia repair: does technique affect outcomes? J Am Coll Surg. 2007;205(5):654-660.

27. Poulose BK, Shelton J, Phillips S, et al. Epidemiology and cost of ventral hernia repair: making the case for hernia research.

Hernia. 2012;16(2):179-183.

21. Rosen MJ, Krpata DM, Ermlich B, et al. A 5-year clinical experience with single-staged repairs of infected and contaminated abdominal wall defects utilizing biologic mesh. Ann Surg. 2013; 257(6):991-996.

28. Finan KR, Kilgore ML, Hawn MT. Open suture versus mesh repair of primary incisional hernias: a cost-utility analysis. Hernia.

2009;13(2):173-182.

22. Rosen M, Bauer J, Carbonell A, et al. Quality of life improves after complex ventral hernia repair using a biosynthetic material: Preliminary results of a prospective, multicenter study. Presented at: 15th American Hernia Society Annual Hernia Repair Conference; March 13-16, 2013; Orlando, FL.

29. Israelsson LA, Jönsson L, Wimo A. Cost analysis of incisional hernia repair by suture or mesh. Hernia. 2003;7(3):114-117.

30. Reynolds D, Davenport DL, Korosec RL, et al. Financial implications of ventral hernia repair: a hospital cost analysis.

J Gastrointest Surg. 2013;17(1):159-166; discussion 166-167.

Refer to the Instructions for Use for a complete description of all warnings, precautions, and contraindications.

Products listed may not be available in all markets.

SERI ® is a trademark of Allergan, Inc. DEXON is a trademark of Covidien. PHASIX is a trademark of Davol Inc. a subsidiary of C.R. Bard, Inc. VICRYL® is a trademark of Ethicon Endo-Surgery, Inc. ALLODERM ®, and STRATTICE are trademarks of LifeCell Corporation. TIGR ® is a trademark of Novus Scientific.

GORE ®, BIO-A®, and designs are trademarks of W. L. Gore & Associates. 2014 W. L. Gore & Associates, Inc. AT1824-EN1 JANUARY 2014 Gore products referenced within, if any, are used within their FDA approved/cleared indications. Gore does not have knowledge of the indications and FDA approval/clearance status of non-Gore products. Gore makes no representations as to the surgical techniques, medical conditions or other factors that may be described in the article(s). The reader is advised to contact the manufacturer for current and accurate information. AQ0061-EN1.

Copyright © 2014, 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, W. L. Gore & Associates, Inc., 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.