Issuu

Convention issue:

International Hernia Congress ®

GeneralsurGerynews.Com

The Independent Monthly Newspaper for the General Surgeon J anuary 2012 • V olume 39 • n umber 1

opinion

Spam in a Can b y D aViD C ossman, mD

ACOs: The Latest Experiment In Health Care Delivery First Accountable Care Organizations To Be Unveiled Soon; The Theory: Cost Savings by Pooled Patient Risk, Coordinated Care

while back, I joined in on a conference call between the American College of Surgeons (ACS) and heads of the surgical specialty societies, including orthopedics, neurosurgery, ENT, vascular and thoracic. On this call (which was open to surgeons of the societies), I could listen but could not speak—a communication format family and friends have recommended I use more often. But nobody said I couldn’t write, so here goes. To my surprise, the atmosphere on the call that night seemed tense. Accountable care organizations (ACOs) and private contracting and balance billing were on the table. The ACS supported the former and opposed the latter, whereas the subspecialty societies lined up unanimously on the opposite side. When it was asked if there was any representative from the specialty societies who supported the ACS’s positions on these issues, the silence, in my opinion, felt long, awkward and deeply meaningful. If nothing else, it begged the question: Why would any surgeon be a member of both a specialty surgery association and the ACS? For those of you who have been

b y G abriel m iller

pam in a

see aCCountable Care page 7

AMA Delegates Balk at ICD-10 Implementation Docs Voice Frustration: “Burdensome,” “Expensive,” “Worthless”

EXTENDED HERNIA COVERAGE Pullout Section Page 15

San FranciSco—One in every six American surgeons meets the criteria for alcohol abuse or dependence, according to a new study presented at the 2011 Clinical Congress of the American College of Surgeons (ACS). Of 7,164 surgeons surveyed, 1,112 (15.5%) had scores consistent with alcohol abuse or alcohol dependence. Among women, excess alcohol consumption was even higher: 25.6% of female surgeons screened positive for alcohol abuse or dependence compared with 13.9% of male surgeons. “The results are very compelling; these are high numbers and I would suggest that they are very accurate,” said lead author Michael Oreskovich, MD, clinical professor of psychiatry at the University of Washington, Seattle, and see alCohol abuSe page 11

New Product

b y C aroline h elwiCk

new orleanS—At its 2011 Interim Meeting held in November, the House of Delegates of the American Medical Association (AMA) approved a number of resolutions its members felt would affect patient access to care and the organization’s

Higher Than General Population; Researchers Find Predictors b y C hristina F ranGou

or physicians, one of the most talked about phrases to come out of the Affordable Care Act two years ago has been “accountable care organization” (ACO). As a concept, ACOs represent a change far broader than many other aspects of the health care reform bill, promising to change health care delivery on a systemwide scale. And yet,

EXTENDED see HERNIA COVERAGE S C page 42

Alcohol Abuse High Among Surgeons

own financial bottom line. Delegates voted to “work vigorously” to stop the implementation of ICD-10 diagnostic coding system. The International Classification of Diseases and Related see iCD-10 page 41

ExparEl™ from pacira pharmaceuticals, Inc.

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exPert APProAches Novel Breakthroughs in Hernia repair see page 18

INSIDE In the News

Surgeons’ Lounge

Torso Gunshot Victims Require at Least 24 Hours of Observation. ................... 6

Case Study of a Difficult Hernia. ....................... 35 Hernia........................

see ”Gut reaction” page 24

SIGNIFICANTLY DECREASES SURGICAL SITE INFECTION

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“The results of this study demonstrate that wound infection decreased significantly in the With Alexis retractor group.” 5

“...wound protection in open colorectal resectional surgery has demonstrated a statistically significant decrease in the rate of SSI.” 2

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To receive a clinical study booklet, please visit www.AlexisO.com or call 800.282.2212 1. Horiuchi T., MD. PhD., et al. A Wound Protector Shields Incision Sites from Bacterial Invasion. Surg Infect (Larchmt). 2010 Dec; 11(6): 501-503. Epub 2010 Sep. 2. Reid K., B.Med., et al. Barrier Wound Protection Decreases Surgical Site Infection in Open Elective Colorectal Surgery: A Randomized Clinical Trial. Dis Colon Rectum. 2010 Oct; 53(10):1374-1380. 3. Lee P., MD., et al. Use of Wound-Protection System and Postoperative Wound-Infection Rates in Open Appendectomy. Arch Surg. 2009 Sep; 144(9): 872-875. 4. Horiuchi T., MD. PhD., et al. A wound retractor/protector can prevent infection by keeping tissue moist and preventing tissue damage at incision sites. Helix Review Series: Infectious Diseases. 2007; 3: 17-23. 5. Horiuchi T., MD. PhD., et al. Randomized Controlled Investigation of the Anti-Infective Properties of the Alexis Retractor/Protector of Incision Sites. J Trauma. 2007 Jan; 62(1): 212-215.

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Gsn editorial

GENERALSURGERyNEWS.COM / GENERAL SURGERy NEWS / JANUARy 2012

Prognostication on the Internet Frederick L. Greene, MD Chairman, Department of General Surgery Carolinas Medical Center Charlotte, N.C.

e live in a world where any information we can possibly desire is at our fingertips via the Internet. Depending on our needs, obtaining everything from driving directions to the name of a restaurant in a foreign destination is easy and fairly risk proof. The Internet even provides medical advice. Although it is hard to get absolute numbers regarding various disease-related sites on the Internet, it is fair to say that these numbers must fall in the millions. Every possible disease process is represented and patients have the ability to search for information, which may not always be factual. My concern about all of this information is that, on certain Web sites, people can type in data specific to different illnesses that can be individualized with demographic, physiologic or histologic information. Individual patient outcomes using these prognostic factors then can be derived. Unfortunately, there has never been a way to legislate material on the

Internet and only the very savvy browser can be assured that the information either received or derived is reliable. In the area of cancer, for instance, there are numerous nomograms that can be used to plug in information relating to the likelihood of recurrent disease and overall survival. In fact, many organizations and patient advocacy groups are now providing survivorship information to patients. Providing this information to patients is problematic because now patients can navigate the Internet and use the provided data to learn their survival likelihood and whether the treatment they are receiving is appropriate, without seeking the counsel or direction of a physician. All physicians try to counsel their patients appropriately and employ as much up-to-date information as they can glean from traditional sources. No individual physician has everything at his or her fingertips. When patients challenge their care or have fear and trepidation because of information they have gleaned from a potentially unreputable source, physicians are forced to counsel from a position of weakness. I continue to feel that this is a very dangerous opportunity for misadventure and misinformation and

that unless patients have the ability to be accompanied by a trained navigator on this cyber quest, undo patient stress and misunderstanding between physician and patient will likely result. Many professional organizations have supported the concept of Internet-based computer models that have the ability to enter thousands of data points in order to come up with appropriate outcomesbased information. However, the material that is obtained from these sites is only as good as the time and effort put into developing the models and comparing them with known data sets. These are all openaccess opportunities where physicians and patients alike can derive information and outcomes. Unfortunately, the patient may not have the background material to fully comprehend the information generated from these prognostic sites. My recommendation is that health care sites that really believe that physicians and patients should navigate these together should provide password protection so that patients do not have the opportunity to steer through them, plug in their own data and come up with answers that may complicate their ongoing therapeutic circumstances. Physicians should be able to enter these sites with their patients, creating an important opportunity for communication and assurance.

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

Los Angeles, CA General Surgery, Laparoscopy, Surgical Education

Gary Hoffman, MD

Barry A. Salky, MD

Editorial Advisory Board

Los Angeles, CA Colorectal Surgery

New York, NY Laparoscopy

Maurice E. Arregui, MD

Namir Katkhouda, MD

Paul Alan Wetter, MD

Kay Ball, RN, CNOR, FAAN

Los Angeles, CA Laparoscopy

Miami, FL Ob/Gyn, Laparoscopy

Editorial Staff

Philip S. Barie, MD, MBA

Peter K. Kim, MD Bronx, NY General Surgery, Trauma/Critical Care

Kevin Horty

New York, NY Critical Care/Trauma, Surgical Infection

L.D. Britt, MD, MPH

Raymond J. Lanzafame, MD

David Earle, MD

Springfield, MA General Surgery, Laparoscopy

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

Edward Felix, MD

Fresno, CA General Surgery, Laparoscopy

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

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

Michael Goldfarb, MD Long Branch, NJ Laparoscopy, Telemedicine

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In the future, I believe we will only continue to see an exponential increase in the promulgation of disease-site computer models and nomograms that include traditional staging parameters as well as new molecular prognostic factors. As the number of factors in disease prognostication increases, the creation of nomograms and computer modeling will increase because our ability to incorporate all of these factors using the human brain will be exceeded. Now is the time that we need to think about reducing the opportunity for patient misunderstandings because of these sites. One or more physicians, not a computerized modeling system, should care for a patient. The concept of password protection for prognosis-directed disease sites should be included. The patient’s physician should be the gatekeeper in this quest. It seems reasonable that the opportunity to enter the world of nomograms and computerized models for health care purposes be structured so that patients are less likely to increase their fear and anxiety. Until the day when there are safeguards in place, all of us should offer some warning to our patients and indicate that whatever information is gleaned, we, as their physicians, stand ready to help with interpretation.

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

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

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

INFECTIOUS DISEASE SPECIAL EDITION

in the news

GENERALSURGERyNEWS.COM / GENERAL SURGERy NEWS / JANUARy 2012

Researchers Predict ‘Scary’ Rate of Diabetic Conditions by 2020 Obesity-related Health Care Costs Would Top $1 Trillion

The implications of our expanding waistlines are severe for both our heart health and pocketbooks, the study authors reported. If current trends continue, rates of sickness and death from cardiovascular disease will increase and related health care costs will reach an estimated $1.1 trillion per year by 2030. The projected numbers from the study are based on patterns found in the National Health and Nutrition Examination Surveys (NHANES) from

b y V iCtoria s tern

y 2020, more than 66% of people in the United States will be overweight or obese and more than 50% will suffer from diabetes or prediabetic conditions, according to a study presented at the 2011 American Heart Association) meeting.

1988 to 2008. Mark D. Huffman, MD, MPH, and his colleagues at Northwestern Memorial Hospital used the NHANES data to determine sex-specific trends for cardiovascular health behaviors as well as age-adjusted projections for obesity prevalence in 2020. The research showed that, currently, 72% of men and 63% of women are overweight or obese and 62% of men and 43% of women have dysglycemia. But by 2020, the number of overweight

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or obese people will increase to 83% in men and 72% in women (when excluding overweight individuals, obesity prevalence becomes 43% in men and 42% in women). Additionally, 77% of men and 53% of women will have dysglycemia. For a more detailed breakdown, see the Table. “We’ve been dealing with the obesity trend for the past three decades, but the impact we project on blood sugar is a true shock,” said Donald Lloyd-Jones, MD, chair and associate professor of preventive medicine at the Northwestern University Feinberg School of Medicine, a physician at Northwestern Memorial Hospital, both in Chicago, and senior author of the study. “Those are some really scary numbers.” In a separate study, published in The Lancet in August (2011;378:815825), investigators projected similar obesity outcomes for 2030 despite using different methods. Using NHANES data from 1988 to 2008, the researchers created health and economic projections based on historic and recent trends, and estimated obesity prevalence of 50% in men and 45% to 52% in women by 2030.

’reducing calorie intake on a mass scale requires social, political and economic solutions that are derived from local, regional and national communities.‘ —Mark D. Huffman, MD

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“Despite these differences in methods, our results are similar in their trajectories and independently demonstrate very high rates of obesity projected for 2020,” said Dr. Huffman, assistant professor in preventive medicine and medicinecardiology at Northwestern University Feinberg School of Medicine and a cardiologist at Northwestern Memorial Hospital. To gage the impact of these striking trends, the Northwestern researchers also determined the degree to which cardiovascular health influences cancer incidence. Investigators included 13,360 participants who reported no history of cancer at baseline exam, conducted between 1987 and 1989. They determined which participants met the definition of ideal cardiovascular health, a measure based on seven metrics defined by the AHA (smoking, body mass index, physical activity, diet, cholesterol, blood pressure and serum fasting glucose).

in the news

GENERALSURGERyNEWS.COM / GENERAL SURGERy NEWS / JANUARy 2012

table. Prevalence estimates and 2020 Projections of Poor, intermediate and ideal levels of Cardiovascular Health Components for u.s. men 1988-1994

2007-2008

P Value

2020 Projection

Body weight Poor

19.9

31.6

<0.01

43.4

Intermediate

41.2

40.2

0.48

39.8

Ideal Glucose/diabetes

38.9

28.2

<0.01

16.8

Poor

5.5

11.1

0.03

13.6

Intermediate

26.6

50.5

<0.01

63.1

Ideal

67.9

38.4

<0.01

23.3

Source: National Health and Nutrition Examination Surveys. Visit www.generalsurgerynews.com for the complete table.

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Daniel L. Miller, MD

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Samuel Szomstein, MD, FACS Associate Director, The Bariatric and Metabolic Institute and Section of Minimally Invasive and Endoscopic Surgery Director, Bariatric Endoscopy Cleveland Clinic Florida Weston, Florida Associate Professor of Surgery Florida International University Miami, Florida Clinical Assistant Professor of Surgery Nova Southeastern University Fort Lauderdale, Florida

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Using cancer registries, they obtained the incidence of breast, colorectal, lung and prostate cancers in this population between 1987 and 2006. The investigators found 1,833 cases of cancer by 2006: 322 colon cancer cases, 418 lung cancer cases, 526 female breast cancer cases and 613 prostate cancer cases. Overall, the more ideal health metrics participants displayed early on, the less likely they were to develop cancer (P=0.0013). Notably, when smoking was removed from the sum of ideal health metrics, the association was no longer significant, but participants with more ideal health metrics still had a lower incidence of cancer. In response to the NHANES data, the AHA has set a target to help Americans improve their overall heart health by 20% in 2020. But, “to increase overall heart health by 20%, American adults would need to rapidly reverse these unhealthy trends, starting today,” said Dr. Huffman. Achieving a healthy weight through diet and physical activity and not smoking are the best ways most Americans can improve their cardiovascular health. “Reducing calorie intake on a mass scale requires social, political and economic solutions that are derived from local, regional and national communities,” Dr. Huffman said. “Yes, policies such as penny-per-ounce sugar-sweetened beverage taxes and restricting advertising of junk food to children should have a substantial impact on reducing intake of nutrient-poor foods (and may improve weight and subsequent comorbidities), but communities must engage the sociopolitical process to drive such changes,” he said. “As a physician, I strongly encourage my patients to reduce their caloric intake, eat healthy foods (fruit/vegetables, baked/ broiled fish, whole grains, for example) and increase their physical activity to maintain a healthy body weight. Nonetheless, it is a difficult climb for many, so a combined individual-level and population-level approach is required.”

in the news

GENERALSURGERyNEWS.COM / GENERAL SURGERy NEWS / JANUARy 2012

Torso Gunshot Victims Require at Least 24 Hours of Observation Investigators Pinpoint Indicators Of Laparotomy b y C hristina F ranGou

atients with gunshot wounds to the torso who do not require operative management should be kept under close observation in the hospital for a minimum of 24 hours, researchers reported at the American Association for the Surgery of Trauma annual meeting.

“Until now, we did not have good data to support how long we should be observing these patients undergoing nonoperative management before they could be safely discharged home,” said lead investigator Kenji Inaba, MD, assistant professor of surgery and medical director of the Surgical Intensive Care Unit at the University of Southern California (USC), Los Angeles. “Now, we watch them carefully for 24 hours and if there is no evidence of a missed injury, we discharge them home.”

An earlier retrospective study from USC suggested that all patients undergoing selective nonoperative management required a minimum of 24 hours of close observation before discharge (J Trauma 2010;68:1301-1304). Dr. Inaba and colleagues then performed a prospective study of all patients who presented to the USC hospital with torso gunshot wounds between January 2009 and January 2011 to confirm the intial findings. In the study, 270 patients presented to

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the hospital with torso gunshot wounds; 130 met the criteria for observation. They were stable, had no peritonitis, were examinable without evisceration and had computed tomography (CT) scans. Based on those results, 39 (30%) underwent a therapeutic laparotomy after positive findings, whereas 44 were placed under close observation after negative CT results (33.8%) and 47 after equivocal results (36.2%). Of the patients observed after CT scan, eight (8.8%) who initially had equivocal CT results ultimately required laparotomies. Investigators identified several clear patterns in the patients who eventually needed laparotomy. Importantly, the symptoms that prompted the laparotomy "were apparent within hours of admission, starting with tachycardia,” said Dr. Inaba. Tachycardia, the most common early indicator of trouble, occurred in 75% of patients in the group that required operative treatment. Peritonitis was the “most common final trigger” for surgical intervention (63%). Other symptoms included a white blood cell count increase of more than 11,000 (63%), fever higher than 38 C (38%) and a drop in hemoglobin of at least 2 g/dL. The mean time for a patient to “fail” was 2.43 hours. Half of the failures occurred within the first six hours, 75% within the first 12 hours and all within the first 24 hours. Overall, the failed patients were a mean age of 26.3 years (range 16-55); 86% were male; and all had a mean Injury Severity Score of 7.9. Patients had sustained between one and three gunshot wounds. The breakdown of injuries varied: 29% had multiple injuries, 23% pelvic, 17% flank, 14% back, 11% anterior and 6% were thoracoabdominal injuries. The study results corroborated results from the 2010 retrospective review, revealing that nonoperative management could be a way to “more appropriately use physician and hospital resources” for patients with penetrating trauma as long as patients are selected very carefully, said Timothy Fabian, MD, professor and chair of surgery, University of Tennessee Health Sciences Center, Memphis. If patients are well selected, nonoperative management can spare them the morbidity of an exploratory laparotomy. But patients who end up having a delayed operation after a period of observation are at greater risk for infectious complications. “It’s going to increase morbidity in that group of patients you were wrong about,” said Dr. Fabian. He added, however, that the study follow-up is too short and the numbers of patients studied too few to be conclusive. “We need a little more work in terms of multicenter, prospective studies to make sure we are selecting the right group of patients.”

in the news

GENERALSURGERyNEWS.COM / GENERAL SURGERy NEWS / JANUARy 2012

AccountAble cAre continued from page 1

because ACOs are still in the development stage, almost nothing concrete can be said about them. “The question is, what is an accountable care organization? In the interest of full disclosure, nobody knows,” said Andrew Warshaw, MD, chair of the American College of Surgeons (ACS) Health Policy and Advocacy Group, at the 2011 annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in San Antonio, last April. There have been a number of demonstration projects with goals similar to those that ACOs promise, but “right now ACOs do not exist,” said Matthew Hutter, MD, assistant professor in surgery at Harvard Medical School in Boston, at SAGES. That ACOs are largely undefined is in keeping with the overall nature of the health care reform act, which left a significant amount of legislation to be interpreted by the executive branch. “This was an unprecedented law in the sense that the legislative body gave enormous power to the executive branch. That’s not the way it usually works,” said John Armstrong, MD, associate professor of surgery at the University of South Florida in Tampa, who chairs the ACS political action committee (PAC). “There is a lot that is unknown even now about how things will unfold.” This unfolding process will take place across the dozens of health care agencies within the federal government charged with fleshing out and then implementing the different legislative mandates. As an example, the act expressly states no fewer than 1,000 times that the secretary of the Department of

Health and Human Services must act to enforce some aspect of the legislation, Dr. Armstrong said. “The legislation has to move through regulation, and they are not the same,” he added. “It translates into thousands of decisions by Health and Human Services and other [agencies],” said Dr. Warshaw. “Ultimately it’s 30,000 pages of regulations that will really determine what is going to happen.” This is perhaps best expressed by the projected time line for the act’s implementation, which stretches out as far as 2018 for some provisions. In other words, a great deal is still

the basic aCo framework is built heavily on a primary care physician base. Primary care physicians may participate in only one aCo, but specialists may participate in multiple aCos.

unknown about what shape the Affordable Care Act, and ACOs in particular, will take.

Becoming a reality ACOs took one critical step closer to becoming reality in late October when the Centers for Medicare & Medicaid Services (CMS) released its final rule on ACO structure and governance. These final rules also established a start date of April 2012 for those organizations with ACO agreements in place. There are two chief types of ACOs see aCCountable Care page 8

YOUR PATIENT. OUR CANCER-FIGHTING STRENGTH.

By the Numbers

250

Number of surgeons who attended the Joint Surgical Advocacy Conference in Washington, D.C., in 2011.

Percentage of American College of Surgeons (ACS) fellows who responded to “calls for action” by the college asking them to email or phone their congressmen.

Percentage of ACS fellows who participate in the ACS Professional Association– Surgeons Political Action Committee.

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in the news AccountAble cAre continued from page 7

in development: those that are CMSlinked and those that are private-payer ACOs. CMS’s final rule refers only to CMS-linked ACOs; private-payer ACOs will have much more freedom in how they choose to set up their structure and governance. ACOs are based on the idea of reducing costs by pooling patient risk and coordinating care. If they are effective, ACOs will then receive a fraction of these cost savings in return.

‘many surgeons are looking at their business model and asking the question, “should i be employed or can i still participate in this as an independent?”’ —Frank Olpeka, MD The fundamental idea is that ACOs— as a group of physicians, hospitals and other providers—have a financial incentive to work together and provide better-coordinated care for patients. Better coordination, for example through preventative, primary care as opposed to a visit to the emergency room, would reduce overall costs to payers who would in turn give some of that savings back to the ACO. It’s then up to the ACO to divide this money among the physicians and providers within their organization. “Basically, it is intended to coordinate care that hopefully will produce savings,” said Dr. Warshaw. “It’s all about quality,” added Dr. Hutter. “If you have appropriate quality, and your costs are low enough, you’ll get some of that [savings] back.” In March 2011, CMS released its proposed rules on ACOs and they were roundly rejected by most of the major health care systems in the country. Nine of the 10 health systems involved in a major Medicare demonstration project similar to an ACO model said they would not develop a fully fledged CMS-linked ACO unless the agency made major changes to its proposed rules. CMS responded, releasing its updated final rule in October. “[ACOs] are a national experiment and CMS took a shot at this highlevel vision by writing the first-ever rule for accountable care. There was no way that they were going to get all the dimensions right in round 1, but they put a framework on the table,” said Frank Opelka, MD, assistant medical director of the ACS Advocacy and Health Policy

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Division, in an interview with General Surgery News. “We don’t know if this experiment is going to work but CMS partnering through the comment process was a great start.” From this process, CMS made creating an ACO less financially risky as well as less burdensome for health care organizations. For example, the agency essentially reduced the number of measures organizations would have to report from 65 to 33. In the proposed rule, an electronic health records (EHR) system was mandatory to develop or join an ACO; in the final rule, EHR is no

longer mandatory for participation. CMS also allowed ACOs to begin sharing savings earlier than was proposed in the original guidelines. In terms of design, an ACO can be comprised of hospitals, physicians, networks of physician practices or joint ventures between hospitals and physicians. Essentially, any group of health care providers that wishes to assume the risk for a pool of patients can start an ACO. Physicians will still be paid a fee for service, but the performance of the ACO will be measured against a benchmark

established by CMS. Importantly for surgeons and other specialties, the basic ACO framework is built heavily on a primary care physician (PCP) base. PCPs may participate in only one ACO, but specialists may participate in multiple ACOs. More detailed information on the financial structure and governance of proposed ACO models can be found in “Accountable Care Organizations: A Primer for Surgeons” in the September 2011 issue of the Bulletin of the American College of Surgeons.

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the effect on surgeons Because surgeons provide primarily episodic care, and ACOs are meant to manage patients’ care over the long term, one of the most pressing issues for specialists is how they will fit into these new models. The biggest issue, health policy experts emphasize, is referrals. “For surgeons, think back a little bit to the gatekeeper-type models; [ACOs] are not the same, but they are not that different either. While patient choice will remain, the referral to a surgeon may be constrained,” said Dr. Warshaw. One of the chief goals of the

‘organizational advocacy strength is really measured on PaC contributions from the membership and market share. and nature abhors a vacuum, so if someone chooses not to participate, there are other groups ready to do it.’ —John Armstrong, MD ACO model is to reduce overused specialist services and unnecessary referrals. If there is a high rate of referrals to one specific specialty in a

community, then those referrals will be a natural target for reduction by an ACO. This is really the essence of any relationship a surgeon or physician’s

group may have with an ACO: The ACO is not responsible for delivering the patient’s care per se, but is responsible for managing the cost and quality. In other words, the attraction of any surgeon or individual physician practice lies in their value relative to other surgeons or groups of surgeons in their community. There are currently no fixed models for ACOs, but one emerging difference is whether an ACO chooses to be integrated or not, that is, whether specialists are formally part of the ACO or whether the ACO, as a group of PCPs, will subcontract specialty services. In either case, a surgeon or specialty practice will have to demonstrate their value to the ACO. In the case that a surgeon formally joins an integrated ACO, those who can clearly demonstrate their value—better quality or reduced costs—will be able to argue more persuasively for a portion of any shared savings the ACO will dole out, provided it is successful. And in the case of an ACO that subcontracts its specialty services, the point is even clearer: The practice that can prove its value will be the most attractive to the ACO and will be the one that will get referrals. “There are still a lot of unknowns in the different models that are going to emerge; however, I think surgery will end up focusing on the accountability component and the resources used in their delivery system,” said Dr. Opelka. “It’s going to be market-dependent and model-dependent.” Another key point is data collection. Terms like quality and accountability are really watchwords for knowing practice costs and patient outcomes. And collecting data will be critical not only for working with ACOs, but for a number of important emerging trends in medicine, from maintenance of certification to any form of pay-for-performance program. “You’re going to need data not only to look at yourself from the standpoint of patients and your outcomes at the hospital level, but you’re going to need it for maintenance of certification; you are probably going to need it to participate in payer programs like the [Physician Quality Reporting Initiative]; and you’re going to need it for ongoing privileging at your hospital,” said David Hoyt, MD, executive director of the ACS, speaking at SAGES. The need for data collection is one of the driving forces behind surgeons’ increasing employment by large health care organizations, Dr. Opelka said. “It makes it very difficult for the smallgroup surgeon or individual surgeon,” he said. “Many surgeons are looking at their business model and asking the question, ‘Should I be employed or can I still participate in this as an independent?’” see aCCountable Care pAge 10

in the news AccountAble cAre continued from page 9

Although it is possible for independents to remain that way, at the very least it involves development of data-sharing relationships with the major health care organizations in their practice community. More broadly, one overarching aspect of data collection for surgeons as a whole will be setting quality metrics by which to judge the field. Unless surgeons have data that are robust enough for risk adjustment, the specialty will be at a disadvantage when it comes to demonstrating quality relative to other specialties and subspecialties. “The key thing is value—quality over cost—and if we cannot create discriminatory metrics for quality that distinguishes good and bad care, then value will be determined by cost alone,” said Dr. Hutter. “And that’s what we’re facing right now. We need to have clinically rich data so that we know how to properly risk-adjust it. This is the future.”

Politics as usual One of the points that health policy experts make time and again is that the drawn-out and interpretive nature of the Affordable Care Act means that

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physicians still have an opportunity to shape how the law is ultimately enacted. “It’s an opportunity for us to be part of the process and develop relationships so that we can have a voice in what happens. The legislation is simply the opening act. How it plays out is a daily lobbying effort,” said Dr. Warshaw. At the same time, these policy experts point out that physicians, and in particular surgeons, have been largely absent from the discussion. “Why isn’t Washington working better for us? Basically, we are disunited,” said Dr. Warshaw. For example, only 250 surgeons of more than 250,000 nationwide, attended the March 2011 Joint Surgical Advocacy Conference ( JSAC) in Washington, D.C. Typically, only 3% of ACS fellows respond to “calls for action” by the college asking surgeons to email or phone their congressmen on important legislative issues. And perhaps most damningly, only 4% of ACS fellows are part of the ACSPA–SurgeonsPAC. “That 4% is just embarrassing,” said Mark Talamini, MD, chairman of surgery at the University of California, San Diego and a former SAGES president. In 2009-2010, the ACS PAC raised $1.3 million, less than half of what orthopedic

surgeons donated to their PAC and well below a number of other specialists, including radiologists, emergency physicians and ophthalmologists. Even pathologists, who seem to have far less skin in the health care reform game than surgeons, raised more money and have five times the member participation in their PAC. When congressmen see that only 4% of surgeons give to their PAC, it reads loud and clear that surgeons aren’t politically engaged and that the consequences of ignoring them are negligible, said Dr. Armstrong. “Organizational advocacy strength is really measured on PAC contributions from the membership and market share,” said Dr. Armstrong. “And nature abhors a vacuum, so if someone chooses not to participate, there are other groups ready to do it.” “When you deal with legislators, you have to understand a couple of things. They are bandwidth-constrained and they are resource-constrained,” said Timothy Murphy, who served as then- Gov. Mitt Romney’s secretary of health and human services in Massachusetts when universal coverage was enacted in that state. “If you’re not then setting a platform for them to understand what your issues are,

if you’re not engaging them, they will then allow people to figure that out for you.” As a model for delivering health care services, there is still a lot that has to be determined with ACOs, particularly in the private sector. Many of these may incorporate other aspects of the health care reform bill, like bundled payments and value-based purchasing, which also have yet to be shaped. Alternately, the national experiment that is ACOs may not even gain traction and take hold. “This is a very complex animal and we don’t know if it’s going to work, but we cannot sit around and do nothing,” said Dr. Opelka. Disclosures Dr. Talamini reported receiving royalties or other financial relationships with Max Endoscopy and Medscape. Dr. Opelka reported serving as a consultant or advisor to Amedisys Health, Blue Cross Blue Shield of America, Humana, iHealth Alliance/PDR and United Health Group, as well as serving on committees of several surgical and quality improvement organizations. Drs. Hoyt, Hutter, Warshaw and Armstrong did not report any financial or significant commercial relationships.

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Alcohol Abuse continued from page 1

the former medical director and chief executive officer of the Washington Physicians Health Program. Most reports on the general public estimate that about 9% of Americans suffer from alcohol abuse or dependence, although that figure is based on older data. “It’s difficult to make a direct comparison to the general population, but our study suggests that surgeons suffer from alcohol abuse or dependence at a rate higher than the general population,” said Dr. Oreskovich. The study is the latest in a series of reports commissioned by the ACS to investigate the well-being of American surgeons. Previous studies from the ACS have shown that as many as 40% of surgeons meet diagnostic criteria for burnout and up to 20% may have depression (Ann Surg 2009;250:463-471). Until now, however, no study has looked at substance abuse among surgeons. Dr. Oreskovich, a member of the ACS Board of Governors’ Committee on Physician Competency and Health, is a general surgeon as well as a psychiatrist. Ten years ago, after 20 years of surgical practice, he completed his psychiatry residency, followed by a clinical fellowship and research fellowship with a focus on substance abuse. Over the past several years, he—along with colleague Krista L. Kaups, MD, health sciences clinical professor of surgery at UCSF Fresno and chair of the ACS Board of Governors Committee on Physician Competency and Health—joined forces with the ACS to address substance abuse issues among surgeons. Drs. Oreskovich and Kaups set out to measure alcohol use among surgeons and identify predictors for problem drinking. They sent a survey to the 24,372 fellows who had permitted their email to be used to correspond with the ACS. Of these, 29.3% completed the multipart survey, which included an alcohol screen, an abbreviated Maslach Burnout Inventory, the two-question PRIME-MD for depression, and a personal and professional quality of life with Likert scales. Participants also filled out the Alcohol Use Disorders Identification Test (AUDIT-C), a three-item alcohol screen endorsed by both the Department of Veterans Affairs (VA) and the World Health Organization. “It is generally held to be the most validated instrument and the instrument of choice. We feel this is very accurate data,” said Dr. Oreskovich. The AUDIT-C test has a minimum score of 0, for nondrinkers, and a maximum score of 12. It’s considered positive for unhealthy alcohol use with a score

of 4 or above for men and 3 or above for women. Men scoring above 5 and women above 4 are considered to have alcohol abuse or dependence. The investigators found more than 15% of the survey respondents scored in the category of alcohol abuse or dependence. Younger surgeons, married surgeons and surgeons without children (odds ratio [OR], 0.769; P<0.001) were more likely to screen positive for alcohol abuse and dependence. Drinking was more problematic among surgeons in private practice than in other kinds of practice or in the VA system.

Interestingly, long hours of ‘we know that surgeons are work appear to protect surgeons from substance abuse: Surgeons perfectionists and when faced who worked more hours per with more stress, they just work week or took call more nights per week had lower AUDIT- harder to overpower the stress.’ C scores. “It appears the busi- —Michael Oreskovich, MD er one was, the more time in the hospital, the less opportunity to drink,” said Dr. Oreskovich. doubled among surgeons abusing alcoOverall, surgeons who are isolated, hol, from 3.9% to almost 8% among depressed and burned out are more likely those with high AUDIT-C scores. to drink heavily. The incidence of burnIt may be that surgeons turn to alcoout and depression was almost 50% high- hol to help deal with the pressure of their er in the abuse group. Suicidal ideation see alCohol abuSe pAge 12

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Alcohol Abuse continued from page 11

careers and the stress of work–life balance, said Dr. Oreskovich. “I think it is the stress, the burnout, the depression and the way we practice the profession.” Dr. Oreskovich added, “We know that surgeons are perfectionists and when faced with more stress, they just work harder to overpower the stress. That’s not a very healthy way to do it. So I think that the substance abuse ends up being the next step along the line. If you

can’t overpower stress with discipline and focus and the stress is really wearing one down, then a tendency to have a couple of drinks makes sense.” Men had much lower risk for alcohol abuse or dependence than women (OR, 0.55; P<0.001). That’s a reversal from alcohol abuse patterns in the general population where men generally have twice the reported alcoholism rates as women. This difference may be explained by personal factors that further predispose female surgeons to problems with alcohol. For female surgeons, previous studies have shown that they experience higher

levels of stress and burnout than their male colleagues. Women also generally have higher levels of stress at home than men as they take on more duties outside of work, such as bearing children. “Women surgeons have an extra stressor. That is, they are more inclined to want to try to balance their personal and professional life and have more personal life responsibilities. That puts them at an increased risk,” said Dr. Oreskovich. The study also revealed a strong relationship between medical errors and alcohol abuse or dependence, although it’s not clear what that relationship is and

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• Axillary management in breast cancer—the next step toward individualized cancer care • Ablative therapy for benign lesions and small breast cancers • Management of common benign problems— case-based panel discussion • Surgical technique in intra-operative radiotherapy • Nipple-sparing mastectomy • Mammoplastic techniques in oncologic surgery • Partial breast reconstruction with pedicled perforated ﬂap • Contralateral prophylactic mastectomy: pros and cons • Prophylactic mastectomy and autologous breast reconstruction • Managing breast cancer in patients with breast implants • Implant reconstruction in the irradiated breast • Management of central breast tumors • Acellular tissue matrices in breast reconstruction • Radiotherapy and autologous breast reconstruction • Surgical treatment of lymphedema

Co-Chairs Patrick I. Borgen, MD Robert DerHagopian, MD J. Michael Dixon, MD Debu Tripathy, MD

Surgical Faculty Charles E. Cox, MD Moustapha Hamdi, MD Kevin S. Hughes, MD Kelly K. Hunt, MD Eleftherios Mamounas, MD, MPH, FACS Elizabeth Morris, MD Rache M. Simmons, MD Scott L. Spear, MD Welela Tereffe, MD, MPH Jayant Vaidya, MD Pat W. Whitworth, MD

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how one influences the other. However, surgeons who had made a major error in the most recent months had significantly higher rates of problem drinking, with a 44% increased risk for a positive screen for alcohol abuse or dependence (OR, 1.447; P=0.0005). Asked about possible selection bias in the study, Dr. Oreskovich said that the survey likely underestimates the prevalence of alcohol abuse and dependence among surgeons. Surgeons with an alcohol problem are less likely to have answered the questionnaire, he said. The study, however, could not differentiate between alcohol abuse and alcohol dependence among surgeons. It’s not clear how many surgeons have a dependence that requires treatment. The definitions of alcohol abuse and dependence differ, according to substance abuse experts. Alcohol abuse requires one major consequence of drinking over a 12-month period. It could be a charge of driving while impaired or a spouse filing for divorce because of a partner’s drinking. Alcohol dependence, on the other hand, is irreversible. It requires three consequences in three different areas of life, for instance, work, marriage and health.

PHYSICIANS’ EDUCATION RE SOURCE, LLC

AUDIT Consumption Questions (AUDIT-C) 1. How often did you have a drink containing alcohol in the last year? Never Monthly or less Two to four times per month Two to three times per week Four or more times per week

(0) (1) (2) (3) (4)

2. On a day in the past year when you drank alcohol, how many drinks do you typically drink? One or two Three or four Five to six Seven to nine Ten or more

(0) (1) (2) (3) (4)

A score of 4 or more (for men) and 3 or more (for women) indicates unhealthy alcohol use. A score a 5 or more (for men) and 4 (for women) indicates alcohol abuse or dependence.

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People with alcohol abuse can be educated and motivated on their own not to use alcohol in a dangerous situation. Those with dependence need treatment, said Dr. Oreskovich. Dr. Oreskovich estimated that about one-third of the 15% who screened positive on the AUDIT-C test has alcohol dependence. “If they did, they probably should not be practicing. But I don’t know that and we have not analyzed the results in that way.” He said the goal of the study was not to deter any surgeons from coming forward with a problem. In fact, the investigators are trying to achieve the opposite. They want to remove any shame and stigma surrounding substance abuse for surgeons and make it easier for these physicians to seek help. “Instead of our members hiding it, let’s get out there and say we’ve got a problem and let’s deal with it,” said Dr. Oreskovich. He praised the ACS and its Committee on Physician Competency and Health for supporting the study and for allowing the paper to be presented. “This is a really good example of an organization saying, ‘we are going to de-stigmatize this disease, we’re going to try to rehabilitate you and get you back to work.” Surgeons who heard the paper presented said they were astonished at the results. “Speaking as a woman in surgery who has been here a long time and for all those coming behind, it’s sobering—no pun intended—and leads me to wonder if an intervention is necessary. What do we do with this information?” asked Barbara Bass, MD, chair of surgery at The Methodist Hospital, Houston, and a regent of the ACS. “This is fascinating work. I wish this room was full,” said another surgeon who did not identify himself. Related research led by Dr. Oreskovich’s group shows that surgeons have extremely high success rates with rehabilitation programs for substance abuse. In a study that is expected to be published soon, 81% of surgeons with an admitted substance abuse problem who committed to an intervention went on to complete the program, finish treatment, undergo monitoring and return to practice without a single relapse recorded over five years of monitoring. “That is better than anything that’s ever been published previously,” said Dr. Oreskovich.

Dr. Oreskovich and colleagues are currently conducting a similar alcohol survey of members of the American Medical Association. The study should demonstrate how surgeons compare with other physicians in terms of substance abuse. As a result of the recent research, plans are currently under way to establish an online anonymous program to help surgeons assess their drinking habits and find treatment when necessary. The Committee on Physician Competency and Health is now moving forward to put an online self-assessment toolkit for surgeons on the ACS Web site. Members will be able

‘speaking as a woman in surgery who has been here a long time and for all those coming behind, it’s sobering—no pun intended—and leads me to wonder if an intervention is necessary. what do we do with this information?’ —Barbara Bass, MD

to log in and anonymously complete the AUDIT-C, a depression and anxiety inventory or a quality-of-life inventory. The surgeons would receive immediate feedback on their results. For those at risk, the program would link to available resources in their community. Anonymous assessment and treatment programs available to physicians should encourage more surgeons to seek help. Of the physician help programs that exist in 48 states, most allow physicians to approach them for help and receive assistance without informing the medical board.

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EXTENDED HERNIA COVERAGE Surgeons Face More Complex Hernias In More Complex Reimbursement World

EXTENDED HERNIA COVERAGE

Older, Sicker Patients; Obesity and Smoking; Experts Discuss Strategies for Optimzing Outcomes

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A Global Vision For Hernia Repair Improvement

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waShington—The right repair, the proper mesh and careTS ful patient selection are all part of the formula that leads N E to successful hernia repair; but in an increasingly unfit TI A population, outcome-thwarting comorbidities are hard to avoid. Surgeons discussed the scope of the problem and possible ways to address it at the 2011 Abdominal Wall Reconstruction program. “Why do we have so many people in this room for what many consider simple hernia surgery?” asked Stephen Ferzoco, MD, a private practice surgeon from Boston. “I think we all realize that hernia surgery in 2011 is a lot more challenging and complex than it was five, 10, 15 years ago.” The good news is that surgeons who repair ventral hernias won’t suffer for lack of employment. “This is a great line of work if you’re willing to roll up your sleeves and jump in,” Dr. Ferzoco said. He estimates U.S. surgeons perform 190,000 to 200,000 ventral hernia repairs each year, a number that is increasing by 1% to 2% annually. This growth is driven partly by shifts in patient characteristics. Patients are older. Within the next several years the majority of baby boomers will enter their seventh generation, driving the population of

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IN ThIS ISSue

On the Spot The ”Art of Herniology”: Experts in the Field Discuss Reimbursement, Biologic Materials, Abdominal Wall Reconstruction and More.

Gut Reaction Experts React to Controversial Topics in Hernia Repair and Surgery in General

In the News Fixing Mesh to the Diaphragm Carries Major Risks, According to Study

Bilateral Hernias Should Be Repaired Simultaneously, Data Indicate b y C hristina F ranGou

large Swiss study has shown that bilateral total extraperitoneal (TEP) inguinal hernia repair has a risk profile comparable with that of unilateral hernia repair, a finding that suggests there is no value in delaying the second repair (Surg Endosc 2011 Nov 24 [Epub ahead of print]). “For patients with bilateral inguinal hernia, a simultaneous endoscopic approach represents an excellent therapeutic option,” concluded Markus Gass, MD, and colleagues from the department of visceral surgery and medicine, University Hospital, Bern, Switzerland. Their study, which was published online in November, is the first population-based analysis in the literature to compare these different approaches and

outcomes in a prospective cohort, which included more than 6,500 patients undergoing TEP repairs. For years, surgeons debated whether bilateral hernias should be repaired simultaneously or sequentially when using a TEP repair. A minority recommended a two-stage procedure because of concerns that bilateral repairs may cause more postoperative complications and a higher recurrence rate. Although several reviews have supported bilateral repair as the “gold standard,” no large study has specifically compared complication rates for the two procedures. Investigators studied data collected by the Swiss Association of Laparoscopic and Thoracoscopic Surgery, which see bilateral herniaS, page 33

he 5th International Hernia Congress, a joint meeting between the American Hernia Society and the European Hernia Society, will be held in New York City March 28-31, and will be known as “The World Hernia Celebration.” This meeting will feature discussions of science and innovation for continued improvement of abdominal wall repair, and will look to outline guidelines for the future. Rather than looking

it is an exciting time to be a hernia surgeon. broadly at technical aspects of hernia repair, the congress will focus on ways in which science and innovation can be directly applied to improve patient care. It will highlight the people and programs involved with the study of hernia—from basic science research to applied research—with the end goal of presenting new, effective ways to treat the abdominal wall defects in patients around the world. The official mission of the 5th International Hernia Congress is to improve the understanding and increase communication around the world on topics related to the treatment of hernias. The flow of scientific information from one country to another must be appreciated. As such, I am happy to announce that, for the first time, the American Hernia Society will have a conference with simultaneous translation into Spanish. From both national and international standpoints, these efforts represent that the world has become a “global village.” And so, we have invited the world’s leading surgeons to New York City to work on a global vision see Future

hernia repair page 33

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Y IT

Unlike the patient with colon cancer who needs surgery, a hernia patient with significant comorbidities and several failed short-lived repairs may have his or her surgery delayed. Requesting, even insisting, that patients address their modifiable risk factors before agreeing to operate may be a step toward reducing the complications and recurrences that make hernia repair so challenging and expensive. “I hate to say this,” Dr. Ferzoco told General Surgery News, “but someOB times our patients think, ‘I’ll just ES go see the surgeon again and get it fixed.’ I think we, as surgeons, need to pause and think, if we’re doing the same technique time and again and our patients are getting the same outcomes, we need to change what we’re doing.” Delaying surgery until patients are healthier is not such a far-fetched idea. “It seems that 4 some physicians think it is obligaP tory to fix a hernia, but in many cases, it isn’t. It can wait,” Dr. Dunn said. Surgeons may need to have a frank discussion with the patient about what he or she needs to do to increase the likelihood that the repair will hold. “People don’t talk enough about a patient’s own responsibilities,” Dr. Ferzoco said. “But the onus really is on surgeons to stress to their patients: ‘Stop smoking, get your diabetes under control and try to lose weight.’” These words are rarely easy for anyone to hear, but Dr. Dunn has found patients willing to listen when the challenge to lose weight and quit smoking is framed in terms of optimizing care. “I’ve been getting a little more strict with some patients who have these risk factors. What’s interesting is that they take it very well when I tell them that it’s not that I don’t want to do their surgery, but that I don’t want to put them at risk,” he said. A self-described “surgeon of last hope,” Dr. Ferzoco has had remarkable success persuading patients to take responsibility for the risk factors that they can control to some degree. “They come to me either because no other surgeon is willing to operate on them, or because they have had a lot of complications. I tell them, ‘You don’t have an infected piece of mesh, you’re not strangulated or incarcerated, so we have the luxury of planning an opportunity to really get you better. But it’s going to be a six-month or one-year process.’” The reward of a better surgery may, in fact, be a powerful motivator for patients who were reluctant or unable to address modifiable risk factors in the past. “If you tell a patient you won’t operate until they stop smoking, more often than not, they will stop smoking,” Dr. Ferzoco said. “Most of these folks don’t want to live with a hernia for the rest of their life.” Addressing these health problems, however, may require coordination beyond the surgeons’ typical realm. “If we simply turn patients away, in many cases, they just won’t be successful,” Dr. Dunn said. “We have to find ways to identify and work with experts in other areas. That requires access to a complex health system set-up.”

NIAS ER

Perhaps it’s not surprising that a health care system looking for ways to trim its costs might focus on the repair of incisional hernias, which occur in 11% to 15% of laparotomy patients, amounting to an annual cost of about $2.5 billion, and recur in 20% to 45% of patients. Part of what makes these repairs so challenging is the way the abdominal wall responds to injury. “Incisional hernias are not simple structural defects, simple holes in the abdominal wall, they are tendon injuries, complex neuromuscular deformities,” explained William M. Kuzon Jr., MD, PhD, Reed O. Dingman Professor of Surgery, and section head of plastic surgery at University of Michigan Health Systems, Ann Arbor. “A laparotomy is a tenotomy for the abdominal muscles. Even a simple tenotomy results in significant changes in muscle structure and function, the most important of which are an increase in connective tissue and a decrease in compliance and elasticity. Because the abdominal wall is normally stretchy and compliant to let us breathe and cough, these myopathic changes, and especially the change in mechanical properties, work against attempts to restore abdominal wall

the role of Patient accountability

integrity,” Dr. Kuzon said. S “Frankly, it’s surprising NT E I to me that laparotomies AT ever heal because everything is going in the wrong direction. I’m PLEX H not surprised that this has been a prevalent and persistent clinical problem.” That said, with the availability of increasingly sophisticated materials, surgeons have gotten better at fixing ventral hernias. “I think we’re getting much closer. A well-supported primary repair that takes the tension off the repair and protects it to some extent is showing the best statistics,” Dr. Kuzon said. “But there’s still a 10% to 15% recurrence rate in even the best series, which of course is still a huge problem.” Add to that the potential for complications, and the problem grows larger and more expensive. Dr. Ferzoco referenced a study presented at the European Hernia Society in 2010 in which 20% of nearly 680 ventral hernia repair patients had some sort of wound complication. Patients with wound complications had a longer hospital length of stay of eight days compared with five, hospital charges of $56,000 compared with $36,000 and seven postoperative visits compared with two for patients who did not have wound complications. The biggest gap was in the cost of treating wound infections: $10,000 in those with complications compared with $300 in those who did not have complications. “Anything that can be done to mitigate complications is going to have a favorable impact on outcomes. It’s that simple. So we should be looking closely at what factors predispose a patient to complications and whether they can be avoided or mitigated preoperatively,” said Raymond M. Dunn, MD, professor and chief in the Division of Plastic and Reconstructive Surgery, at UMass Memorial Medical Center, Worcester. As it happens, surgeons have been pondering this issue for years, and it’s outlined in the American College of Surgeon’s National Surgical Quality Improvement Plan (NSQIP). “They’ve demonstrated that if your patient has COPD [chronic obstructive pulmonary disease], uses steroids, smokes, has low preoperative serum albumin, then they have up to a fourfold increase in wound complication rates,” Dr. Ferzoco said. Patients with such comorbidities are not necessarily avoidable. Dr. Ferzoco referenced a study of NSQIP data published in 2009 showing that colon surgery patients with a body mass index more than 35 kg/m2 have an increased risk for wound dehiscence and infection (J Am Coll Surg 2009;208:53-61). “My patients start with a BMI of 35 and go up from there. These

G IN

the Challenge: what makes it Difficult

are the patients who will be at an increased risk for complications.”

—Stephen Ferzoco, MD

OK SM

patients aged 65 and older to between 20% and 25%. Patients are fatter. Obesity, a major risk factor for incisional hernia, is more prevalent than ever, especially among those aged 20 to 74. And patients are still smoking, another known risk for incisional hernia. After 50 years of decline, smoking rates have risen slightly in the past couple of years, particularly among men aged 18 to 21. “If they’re smoking at that age, the likelihood is that they’ll be smoking when they’re 40 to 60, 60 to 80,” Dr. Ferzoco said. Growth in hernia repair also is driven by improvements in critical care medicine. Patients who would have died from massive injury 10 years ago are surviving. “They’ve survived their trauma, blood transfusion, laparotomy, three months in the ICU [intensive care unit]. Now they’re showing up in your office with a large incisional hernia that needs to get fixed,” Dr. Ferzoco said. Patients also are living longer after cancer. Twenty years ago, patients who received a Whipple procedure for pancreatic cancer rarely lived more than six months longer. “Now I’m seeing patients five years out from their Whipple,” Dr. Ferzoco said. “They are disease-free, but they have a huge hernia from the chevron incision and they want it fixed.” This would paint a fairly rosy picture in terms of job security were it not for the bad news. “It’s coming down on a runaway railroad track, and it’s pay-for-performance [P4P],” Dr. Ferzoco said. “This is causing us as surgeons and health care providers to really evaluate the type of medicine and the cure we’re providing.” Last year, Blue Cross/Blue Shield of Massachusetts, following P4P guidelines, withheld 5% to 10% of surgeons’ fees, Dr. Ferzoco said. “It’s not too hard to foresee that as we continue doing cases in challenging patients with high comorbidities and high risk factors, a hospital may not get reimbursed for that procedure if the patient develops a postoperative complication. Even more shocking, you as a surgeon may not get reimbursed. So P4P is out there, insurers are looking at it, the government is looking at it and we need to do something about it to stay ahead of the curve.”

’i think we, as surgeons, need to pause and think, if we’re doing the same technique time and again and our patients are getting the same outcomes, we need to change what we’re doing.’

COM

Continued from page 15

OLD ER P

complex herniAs

see Complex herniaS pAge 20

ExpErt ApproAchEs

the Science Behind PoSitive Patient outcomeS

Novel Breakthroughs in Hernia Repair Brent D. Matthews, MD, FACS Chief, Section of Minimally Invasive Surgery Professor of Surgery Washington University School of Medicine Barnes-Jewish Hospital St. Louis, Missouri

Introduction despite advances in hernia repair techniques and technology, recurrence complications continue to be a common challenge to this procedure.1-3 although the availability of various meshes to reinforce repairs has reduced hernia recurrences, characteristics of the mesh can compromise the functionality and integrity of the abdominal wall, leading to a repair that may hold but is less than ideal.4 “Functional means that patients are able to perform their daily activities,” said Brent matthews, md, FacS, professor of surgery, division of General Surgery, Washington university School of medicine in St. Louis. Whether patients decide to engage in manual labor, recreational activities, or lead a more sedentary lifestyle, they should be able to continue life as usual after a hernia repair, he said. “essentially, functionality means the hernia repair does not restrict the patient’s ability to do any of their activities,” explained dr. matthews. impediments or restrictions on the patient’s normal activities are typically the

absorbatacktma

result of pain or discomfort. “they’re not able to do a certain function because it hurts from the hernia repair,” said dr. matthews. “So one of the challenges is to decrease the amount of pain [the patient] has.” according to dr. matthews, the pain can be related to the fixation used to hold the mesh in place in laparoscopic repairs. “Pain is still a big problem and it often is related to the fixation, whether that be sutures or mechanical fixation, such as tacks,” he explained. in his practice, approximately 10% of patients experience some degree of chronic pain that limits their activities after a hernia repair. in the past, fixation devices were constructed from permanent materials, such as stainless steel or titanium; however, the most recent fixation devices are created from absorbable materials consisting of various polymers.2,5 “this evolution was toward minimizing any foreign body that, left behind, may cause an infrequent problem such as erosion into the bowel wall or more frequent issue of chronic pain from the fixation device itself,” said dr. matthews. “a metallic device left in place could be a cause of chronic pain.” until recently, absorbable tacking devices used the same spiral or screw-like shape as the permanent materials and failed to address the challenge of tacking into soft tissue. “it’s not like you’re putting something into bone,” said dr. matthews. “the biggest challenge from an engineering standpoint is being able to make an absorbable tacking

SoRBaFiXtmb

ethicon SecuReStRaPtm Fixation device

Figure 1. Penetration of fixation devices at various deployment angles. a

absorbatacktm instructions for use require that the distal tip of the device is at a right angle to the targeted tissue to aid suitable insertion of the tack. b SoRBaFiXtm instructions for use state that the fasteners should be placed completely into the tissue and the head of the fastener should be firm against the tissue or mesh in order to obtain the best fixation performance. Based on references 7-10.

18 general surgery news • january 2012

device that is appropriate for soft tissue, not a hard surface or dense material.” Patient comfort also can be related to the type of mesh used. in order for mesh to be an effective option, the total amount of material must be kept to a minimum while sustaining the strength necessary to handle the stresses of the fixation points and the forces of the abdominal wall from normal, daily activities or more vigorous demands.6 “if you have a mesh that is too stiff or produces too much of an inflammatory reaction that results in scarring, the abdominal wall will become less compliant and that can cause pain and a decrease in function,” dr. matthews added. according to dr. matthews, an ideal mesh would be lightweight and fairly flexible, would stretch to increase abdominal wall compliance, and would fully integrate into the abdominal wall. “as you increase the abdominal pressure with activity, the mesh will stretch; that will help dissipate some of the intraabdominal pressure and resolve some of the discomfort with tension between the mesh and the abdominal wall,” dr. matthews said. Surgical techniques also have evolved toward more restorative repairs. “more than a decade ago there was a real push toward minimally invasive, laparoscopic hernia repair, and now we’re starting to see a shift back toward open repairs, but open repairs where you restore the anatomy of the abdominal wall,” dr. matthews said. mesh is an important factor in restorative repair because this technique relies on the mesh to support the repair. “Whether that’s a Rives-Stoppa rectorectus repair on the posterior rectus muscle or a classic Ramirez component-separation release on the external oblique, techniques are really concentrating on restoring the midline anatomy, getting the rectus abdominus muscles back together, and using the mesh simply to reinforce that repair,” said dr. matthews. novel approaches are combining classic repairs with minimally invasive techniques, “such as an endoscopic component separation release,” dr. matthews said. “But a lot of these things are still in development, and we don’t know if these techniques will deliver on the outcomes that we would like to see.” Given the concerns about recurrence and complications in hernia repair, it is essential that surgeons possess a comprehensive knowledge of the cutting-edge devices currently on the market.

ETHICON SECURESTRAPTM 5-mm Absorbable Strap Fixation Device in spring 2011, ethicon launched ethicon SecuReStRaPtm Fixation device, a 5-mm fixation device for various minimally invasive and open procedures, such as hernia repair. ethicon SecuReStRaPtm Fixation device features a strap design with 2 points of fixation, rather than a helical or screw-shaped

design. this allows for appropriate tissue capture and penetration, leading to superior holding strength at various deployment angles (Figure 1).7-10 “i am extremely optimistic that this product is going to do well because the geometry is appropriate for soft tissue application. You’re getting a more reliable interaction between the construct and soft tissue with this design than you will with something shaped like a screw that really just drills into the soft tissue,” said dr. matthews, who has been using the device since it first became available. the ability to achieve superior holding strength at different deployment angles is key for laparoscopic surgeons working in tight spaces (Figure 2).7 “You don’t have to be at a complete 90-degree angle to get it to penetrate through the mesh and into the abdominal wall, so this helps eliminate some of the difficulty you might face if you’re putting the device in at an odd angle,” said dr. matthews. it stands to reason that if mesh reinforcement is critical to preventing recurrence, secure fixation is a crucial step.2,11 another feature that gives ethicon SecuReStRaPtm Fixation device an edge over other absorbable fixation options is the length of its strap. “this makes a difference if you’re using it for laparoscopic ventral hernia repair,” said dr. matthews. “When you push the strap through the mesh into the abdominal wall, you are more likely to actually get purchase of the abdominal wall fascia. With smaller tacks, you’re less likely to get a true purchase into the abdominal wall fascia, and this could have some short- and long-term consequences. i think the length of the strap in this new device is better.” Furthermore, the strap—with its 2 points of fixation—allows the surgeon to target deployment around a specific fiber or group of fibers in the mesh, which is not possible with other absorbable fixation devices currently on the market.11 “Fixation devices shaped like a screw or rivet can just spiral right through the interstitial hole of wide-pore meshes without grasping the mesh fibers,” explained dr. matthews. once deployed, the strap has a low profile, leaving minimal foreign material exposed to the viscera.11 the strap’s polymer blend is essentially absorbed within 12 to 18 months of placement.12 the design of the instrument’s tip, which contains an orientation and positioning system, also helps the surgeon pinpoint its placement before firing (Figure 3).7,8 “When you press it against a surface, it won’t slide off as easily,” he said. “When you are using the more wide-pore meshes, you could easily put screw-like or helical tacks right through those pores and the tacks will do nothing but sit in the abdominal wall.” additionally, the device is spring-loaded so surgeons do not need to rely on only

Dr. Matthews is a paid consultant of Ethicon, Inc.

Supported by

themselves for assuring the tack meets its mark.8 “You are not relying on how hard you yourself are pushing on the device or externally on the opposite side of the abdominal wall to get the tack to deploy,” dr. matthews said. “What you want is consistency from fire to fire. this device is less operator-dependent, so the consistency is good.”

ETHICON PHYSIOMESHTM Flexible Composite Mesh

flexibility and lightweight nature, i think will help patients achieve a more normal abdominal wall function postoperatively than a mesh that is stiffer or causes a greater inflammatory reaction.”

Synergy Both of these products provide surgeons with innovative new tools in their efforts to provide better patient outcomes in terms of reducing recurrence and activity-limiting pain. For instance, ethicon PhYSiomeShtm has a large-pore construction that is designed to be physiologically compatible with the abdominal wall,13 and ethicon SecuReStRaPtm Fixation device is designed to fixate a variety of meshes, including large-pore constructions.13 this is a significant difference from previously available options. “When you use a screw-like tack with a wide-pore mesh, it can wiggle itself around that tack,” said dr. matthews. “i think there’s no doubt that SecureStrap gives you more reliable fixation in these situations.” additionally, the hope is that patients will benefit from retaining less foreign material, as ethicon PhYSiomeShtm is partially absorbable and the strap from ethicon SecuReStRaPtm Fixation device is fully absorbable over time.12,14 “the combination of the strap and mesh has only been in clinical use for 4 or 5 months now, so we don’t completely know, but for the first time we’re in a situation where

patients might benefit from this combination of technologies,” dr. matthews said. dr. matthews is participating in a multicenter trial of laparoscopic ventral hernia repair using both ethicon SecuReStRaPtm Fixation device and ethicon PhYSiomeShtm to examine recurrence, perioperative complications, and pain in patients followed for up to 1 year. “We will have some early outcomes data to help surgeons have a better understanding of outcomes in patients,” he said. the results should be available in summer 2012.

References 1. Halm j, jeekel j. Incisional hernia–long term complications of abdominal surgery. US Gastroenterology Review. 2006;2(2):1-4. 2. Park ae, roth js, Kavic sM. abdominal wall hernia. Curr Probl Surg. 2006;43(5):326-375.

2.50

3. albright e, Diaz D, Davenport D, roth js. The component separation technique for hernia repair: a comparison of open and endoscopic techniques. Am Surg. 2011;77(7):839-846.

ETHICON SECURESTRAPTM Fixation Device, n=200a AbsorbaTackTM, n=100 SORBAFIXTM, n=100

2.00

4. junge K, Klinge u, Presher a, giboni P, nieweira M, Schumpelick v. elasticity of the anterior abdominal wall and impact for reparation of incisional hernias using mesh implants. Hernia. 2001;5(3):113-118.

1.50

5. Glassow F. inguinal hernia repair using local anaesthesia. Ann R Coll Surg Engl. 1984;66(6):382-387. 6. Cobb w, Kercher Kw, Heniford BT. The argument for lightweight polypropylene mesh in hernia repair. Surg Innov. 2005;12(1):63-69.

1.00

7. aSt (angled Firing). data on file, ethicon, inc.

0.50

9. absorbatack™ 20 Short Fixation device for open ventral hernia Repair: Procedure Guide.

90 degrees

60 degrees

45 degrees

10. SoRBaFiX™ absorbable Fixation System: instructions for use.

30 degrees

11. 28-day fixation study. data on file, ethicon, inc.; 2010. 12. Report ivivc Prediction orion absorption time. data on file. ethicon, inc.

Figure 2. average strength of tacks delivered at various angles.

13. data on file. ethicon, inc.

two points of fixation and mid-plane symmetry required that data be collected horizontally and vertically. data were generated using a benchtop test method with porcine flank, using consistent pre-load force. at 45 and 30 degrees, ethicon SecuReStRaPtm Fixation device has a statistically significant difference in median holding strength compared to absorbatacktm (P<0.05). at 90, 45, and 30 degrees, ethicon SecuReStRaPtm Fixation device has a statistically significant difference in median holding strength compared to SoRBaFiXtm (P<0.05). the third-party trademarks used herein are trademarks of their respective owners.

eP-463-11-11/13

0.00

8. ethicon, inc. Ethicon SecureStrap Fixation Device. Ethicon 360. http://www.ethicon360.com/products/ ethicon-securestrap. accessed october 7, 2011.

Firing Angle a

Figure 3. orientation and positioning system.

14. ethicon Physiomesh Flexible composite mesh prescribing information. http://www.ethicon360. com/sites/default/files/products/ethicon_PhYSiomeSh_iFu.pdf. accessed october 7, 2011. 15. ethicon, inc. Ethicon Physiomesh Flexible Composite Mesh. Ethicon 360. http://www.ethicon360.com/ products/ethicon-physiomesh. accessed october 7, 2011.

general surgery news • january 2012 19

iP101

Acute Shear Holding Force, lb

ethicon SecuReStRaPtm Fixation device can be used with a variety of meshes, including large-pore constructions; recently, dr. matthews has been using it with ethicon PhYSiomeShtm, a large-pore mesh that is designed to stretch with the abdominal wall,6,13 as part of a prospective clinical trial. its design provides strong and comfortable healing for the patient,4,6,13 and several features, such as mesh transparency and exceptional intraoperative handling, and the ability to trim the mesh make it appealing to surgeons from an ease-of-use standpoint.11,14 For one, ethicon PhYSiomeShtm is not directionally dependent—either side can be placed against the abdominal wall.14 “You don’t have to worry about putting it in incorrectly,” said dr. matthews. also, although it is not self-adhesive and does require additional fixation, it clings to the abdominal wall to ease placement.13 “this allows the mesh to sit up against the abdominal wall and makes

manipulation of the mesh much easier,” said dr. matthews. Furthermore, the large pores and translucence of the polymer mean that the abdominal wall can be viewed through ethicon PhYSiomeShtm.15 “once you put it against the peritoneum and start placing sutures or any kind of mechanical fixation, you can see through the mesh to the other side,” said dr. matthews. this helps the surgeon to avoid placing tacks through the mesh and into any critical anatomy. as a professor of surgery, dr. matthews conducts every procedure with a resident or fellow and has experienced the impact that the ease of an instrument or material’s design has on surgeons in training. “i think there are some features of the mesh in terms of its ease of use, the ability to position it, how it stays on the abdominal wall, [and] the ability of the surgeon to see through it to the abdominal wall, that may help the residents and fellows with the learning curve.” he added, “most of these observations have been made while participating in a prospective multicenter trial evaluating outcomes for laparoscopic and open ventral hernia repair utilizing ethicon PhYSiomeShtm.” dr. matthews suggests that ethicon PhYSiomeShtm can help abdominal wall functionality that might otherwise be compromised by mesh-related complications. “the compliance of the mesh, its

extended Hernia Coverage complex herniAs Continued from page 17

For patients who need to lose weight, this may require coordinating with bariatric surgeons or aligning with a weight loss center. “We have a weight center and a strong nutritional program, so I can send patients to a weight center for consultation and nutritional counseling,” Dr. Dunn said. He does not have a clear path for his patients who smoke, and generally sends them back to their primary care physicians for tobacco-cessation counseling. “I am a bit remiss right now; if that’s what a patient needs, they should be able to walk out my door with guidance on where to go,” Dr. Dunn said. “But it should be coming from their primary care [doctors], who likely have a greater expertise in that area.” The upside of all this, for the patient, the physician and the health care system, is that patients who are able to do what it takes to get their hernia surgery scheduled have likely made themselves healthier in the process. “The patients who are able to do this do very well,” Dr. Ferzoco said. He gave as an example the patient who stopped smoking, lost 200 pounds in a year through diet and exercise and was able to have his hernia repaired. “Every time he sees me he gives me a big hug and says, ‘You really changed my life from telling me to take accountability for it,’” Dr. Ferzoco said. “No one had done that.”

GENERALSURGERyNEWS.COM / GENERAL SURGERy NEWS / JANUARy 2012

mesh Confusion: so many available, But which ones to use and when? “In order to get good results, you need to accurately assess the risk for infection in highrisk patients, use good surgical technique and understand your options when it comes to the right repair material,” Dr. Ferzoco said. The latter part, however, can raise a lot of questions. With hundreds of meshes on the market, each seeming to serve a different and specific purpose, it’s no wonder there’s a bit of head scratching around the issue. Although it’s well substantiated in the literature that the use of mesh is associated with about a 50% reduction in ventral hernia recurrence, matching each patient with the repair and the mesh ideally suited to his or her needs is a continual challenge. “There is confusion and a little bit of contention on this issue,” Dr. Dunn said. The most basic distinction between meshes is whether they derive from synthetic or biologic materials. Synthetics are relatively finite in cost—around $2 per cm2 for polypropylene; whereas the sky is the limit for

biologics, which can range up to $30 per cm2 or more depending on their source. Part of the rationale for using costly biologic meshes is that they are more resistant to infection than synthetics. An infection or other complication that results in reoperation and removal of a synthetic mesh is not only expensive, but requires expanded recovery. Theoretically, placement of biologic mesh is not only financially, but also humanely justifiable in patients at risk for such morbidity. Otherwise, the price tag is a bit hard to swallow. “I would support the contention that you should only use the biologic graft where it’s truly appropriate and will absolutely benefit the patient,” Dr. Dunn said. In patients with known or suspected contamination or who are at high risk for contamination from subsequent wound or bowel-healing complications, biologic meshes generally are considered appropriate. “The disagreement comes down to exactly who fits into those categories, which are not black and white,” Dr. Dunn said.

In addition to considering the nature of the defect, choosing the type of repair and prosthetic also depends on issues of the specific patient. “Not everyone needs a bilateral open component separation and biologic repair,” Dr. Dunn said. Some patients with negligible symptoms may not need to be aggressively managed; in others, the restoration of normal abdominal wall function will have a substantial impact on their quality-adjusted life years. “We need to make sure patients are thoroughly evaluated preoperatively,” Dr. Dunn said. Any patient with a significant ventral hernia needs preoperative imaging of the defect; computed tomography imaging has become a standard of care. Surgeons also need to have a thorough understanding of the limitations of the meshes available. “I do feel strongly that in the past five to six years we have learned a lot more about our choices and are able to do better at selecting what to use,” Dr. Dunn said.

Happy New Year From GSN! The staff of General Surgery News would like to wish our readers a very happy new year and best wishes for 2012. From left: Dan Radebaugh (production director), Deanna Cosme (art director), Michael Enright (publication director), Victoria Stern (associate editor), Kate Carmody (manager of sales) and Kevin Horty (managing editor). The photo was taken on West 48th Street in New York City, not Vail, Colorado or the Alps. (The horse carriage is real, however.) We would like to send a special thanks to our editorial advisory board and our reporters for their service this past year, and also to all of you in the surgical community who contributed to our newspaper in 2011. The past year would never have been as successful, or fun, without all of you. As always, we’d like to thank those of you who take the time to read General Surgery News each month. We look forward to serving you in 2012 and hope that our paths will cross in the new year. Sincerely, Dan, Deanna, Michael, Vicky, Kate and Kevin

INTRODUCING

In hernia repair, a perfect match of

STRENGTH AND

FLEXIBILITY

ETHICON PHYSIOMESH™ and ETHICON SECURESTRAP™ Fixation Device

U Large pore mesh allows for excellent parietal

tissue integration1-3* U The film using MONOCRYLTM (poliglecaprone 25) Suture polymer is an effective tissue separating barrier1,3* U Exceptional intra-operative handling. Clings to the abdominal wall to ease in placement and can be positioned easily1

UÊÊUnique, absorbable “strap” design uses 2 points of

fixation to straddle mesh pores and fibers including large-pore constructions1 UÊÊProvides superior holding strength at various deployment angles1 UÊÊStrap is low profile, minimizing foreign material exposure to the viscera1

Call 1-800-4ETHICON or visit www.ethiconsecurestrap.com and www.ethiconphysiomesh.com. *Evidence shown in an animal model. References: 1. Data on ﬁle. Ethicon, Inc. 2. Pascual G, Rodriguez M, Gomez-Gil V,Garcia-Honduvilla N, Bujan J, Bellon JM. Early tissue incorporation and collagen deposition in lightweight polypropylene meshes: bioassay in an experimental model of ventral hernia. Surgery. 2008; 144(3): 427-436. 3. diZerega, G. Peritoneal Surgery. New York, NY: Springer-Verlag; 1999:4-31.

For complete product details, see Instructions for Use. ©Ethicon, Inc. 2011

EP-278-11-7/13

extended Hernia Coverage

GENERALSURGERyNEWS.COM / GENERAL SURGERy NEWS / JANUARy 2012

with Colleen Hutchinson Parviz Amid, MD, FACS, is clinical professor at UCLA LichtensteinAmid Hernia Clinic, David Geffen School of Medicine at UCLA, Los Angeles, California. David Chen, MD, MD, FACS, is assistant clinical professor at UCLA Lichtenstein-Amid Hernia Clinic, David Geffen School of Medicine at UCLA, Los Angeles. B. Todd Heniford, MD, is chief in the Division of Gastrointestinal and Minimally Invasive Surgery at Carolinas Medical Center, Charlotte, North Carolina. Karl A. LeBlanc, MD, MBA, FACS, is associate medical director at Our Lady of the Lake Physician Group, director and program chair of Fellowship Program, Minimally Invasive Surgery Institute, both in Baton Rouge, Louisiana, as well as clinical professor of surgery at Louisiana State University, New Orleans. Dmitry Oleynikov, MD, is professor of surgery and director of Minimally Invasive Surgery at the University of Nebraska Medical Center, Omaha. Alfons Pomp, MD, FACS, FRCSC, is chief of laparoscopy and bariatric surgery and the Leon C. Hirsch Professor of Surgery as well as an attending surgeon at the New York-Presbyterian Hospital/Weill Cornell Medical Center, New York City. Aurora D. Pryor, MD, FACS, is professor and chief, Division of of General Surgery, Stony Brook University Medical Center, Stony Brook, New York.

William Richards, MD FACS, is professor and chair in the Department of Surgery, University of South Alabama, Mobile, Alabama.

”the art of Herniology” introduction It’s impressive to me that thought leaders in the various fields of surgery care enough about surgical innovation and education to take the time to be a part of this column. This month’s participants, some old and some new, took the time to contribute during the holiday rush, and I want to thank them for so freely giving of their time and thoughts. I’d also like to especially thank Bill Richards, MD, who was instrumental in seeing this installment of “On the Spot” to fruition. This month we focus on, as Parviz Amid, MD, puts it, “the art of herniology.” We have another round of hernia meetings coming up, and their high annual attendance reflects the need for guidance, education and maybe even consensus in this area

statement

of general surgery. But there are still many options within the realm of hernia care that surgeons do not agree on, and we explore those areas of debate here and in the Gut Reaction Table on page 24. So, before you attend the 11th Annual Surgery of the Foregut Symposium, the 12th Annual Minimally Invasive Surgery Symposium, the 15th Annual American Hernia Society Hernia Repair conference or the Society of American Gastrointestinal and Endoscopic Surgeons meetings, take some time to read what the experts think in the comfort of your home or office, and feel free to comment online. As long as hernia repair remains the most common procedure performed by surgeons in the United States, this should be required reading. —Colleen Hutchinson

it is the standard of care, when performing laparoscopic adjustable gastric banding (laGB) revisions, to repair hiatal hernias whether or not they are symptomatic. Dr. leBlanc: I agree. I believe that a significant number of patients will experience symptoms related to these hernias. We have seen this in many of our patients and have studied it to some extent. Smaller hernias generally will be harder to detect in the previously operated field, but larger ones are obvious and should be dealt with at that time. Reoperations will be extremely difficult and risky after these revisions. Dr. Pomp: Yes, data from George Fielding, MD, and Christine Ren-Fielding, MD, both associate professors of surgery at New York University School of Medicine, New York City, are fairly convincing that LAGB decreases slip rate. Dr. oleynikov: Agree. Hiatal hernias at the time of LAGB should be addressed as we are increasingly seeing complications related to these hernias after LAGB. Our results, as well as those of others, show no risk associated with doing the repair. Therefore, it is my opinion that it should be the standard of care at the time of the surgery.

Dr. sarr: Yes, most surgeons would do so provided it is a real hiatal hernia and not just a small slider. Dr. richards: Agree! It is incredibly important, and is the standard of care to repair all hiatal hernias in order to prevent gastroesophageal reflux disease and provide optimal weight loss. Dr. Heniford: I do not perform gastric banding, but the consideration of returning the anatomy to a more normal state appears appealing. However, the band slippage rate might be somewhat higher. Drs. amid/Chen: Agree. The development of hiatal hernias has been reported in patients who undergo LAGB. It also is a recognized cause of many of the symptoms associated with band intolerance and failure. Repair of a hiatal hernia may improve symptoms and allow for salvage of the band. Hiatal hernias in the setting of revision LAGB clearly should be repaired if they are symptomatic. In the presence of an asymptomatic hiatal hernia, repair is likely the most continued on page 24

Michael J. Rosen MD, FACS, is associate professor of surgery and chief of the Division of GI and General Surgery at University Hospitals of Cleveland, Case Medical Center, and the director of the Case Comprehensive Hernia Center in Ohio.

Michael G. Sarr, MD, FACS, is the J.C. Masson Professor of Surgery and vice chair of research in the Department of Surgery at Mayo Clinic in Rochester, Minnesota. He has been in practice for 30 years, and approximately 40% of his practice involves abdominal wall reconstruction.

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GENERALSURGERyNEWS.COM / GENERAL SURGERy NEWS / JANUARy 2012

Continued from page 22

Gut Reaction: Hernia Contributor

Component separation: standard of care?

Hernia repair in the morbidly obese patient: before, during or after bariatric surgery?

Synthetic vs. biologic in hernia repair during RYGB

Watchful waiting in direct inguinal hernias

Fibrin glue for inguinal hernia

Fibrin glue vs. tack fixation

Dr. leBlanc

yes, in the appropriate setting

Preferred during if not wide mouthed or with incarcerated omentum

Biologic due contamination

Proven successful

Proven to work

yes for laparoscopic; no tacks for open

Dr. rosen

No way

After

Biologic

Sure

Great idea

Fibrin glue

Dr. richards

Agree, a very valuable technique but not the standard of care

Best done after bariatric surgery and the nadir of weight loss has occurred

I always try to wait until the patient has lost weight before repairing hernias and then to use synthetics.

If asymptomatic I will just watch

I prefer sutures or tacks

Tack fixation is more satisfying

Dr. oleynikov

yes, but only in highly selected patients

When BMI is less than 35 kg/m2

Biologic if you like to sleep at night

Only works until patient finds out about having a hernia

Maybe… not enough data

Tacks are standard of care in laparoscopic approach

Dr. Pomp

Not without mesh

Usually after; rarely before or during

Synthetic (and there are data for this)

Acceptable

Not necessary (and expensive!)

Tacks

Dr. Heniford

Needs more study

First time, maybe not weight loss surgery but weight loss encouraged. Recurrent hernia, medical versus surgical weight loss may be a must.

I often do not disturb the hernia if possible and come back after weight loss

Educate patients and let them decide

Long-term QoL is less than tacks

May I have the tacker, please?

Drs. amid/Chen

In the right setting

During if small; after if large

Probably extraperitoneal synthetic if clean; otherwise biologic

Asymptomatic and elderly

Good potential for small hernias; added expense. Jury is out.

Probably equivalent for small hernias (large hernias need more secure fixation)

Dr. sarr

NO for hernias; yes for cosmetic reasons

After = safer, better health for the patient

Biologic; infected mesh is a disaster

Agree, evidence-based

No good data

Dr. Pryor

No. Great for some patients, not for everyone.

Lose the weight then fix the hernia

I try primary repair first!

Only if asymptomatic

May work, but I haven’t bought in yet.

Good adjunct, not stand-alone

Colleen Hutchinson

Not enough consensus here to deem it standard of care.

"After" won by a landslide.

Go with biologic and a good night's sleep, or with sound data per Pomp?

To each his/her own.

As Amid says, the jury is out.

Somebody please hand Heniford the tacker.

reasonable course of action, especially in the setting of LAGB revision. Initial repair of hiatal hernias at the time of LAGB placement has been demonstrated to decrease reoperation rates. The symptoms that necessitate a revision often will overlap with those of a hiatal hernia, and addressing both processes simultaneously is recommended. Dr. Pryor: I believe that patients with herniated bands do not fare well. Along that line of thought, I repair any significant hiatal hernia encountered at the time of revision for LAGB. However, if the patient has a hiatal hernia and a band, it also may be time to consider revision to a Roux-en-Y.

there are enough data to support the use of biologic prosthetic materials preferentially over synthetics in contaminated fields.

statement

Dr. leBlanc: I disagree. Much of the literature that has been published in the past regarding synthetics in the contaminated settings were mainly dealing with the older, heavyweight, small-pore polypropylene meshes. Current lightweight, large-pore polypropylene meshes generally are less prone to infection than their older predecessors. Biologics, however, do appear to have an advantage over the older polypropylene products, but there are no good studies comparing the newer products with biologics. That being said, if I have an opportunity to choose between these two products, I will nearly always favor the biologic prosthesis.

clean

Dr. sarr: Difficult question. In terms of evidence-based medicine the answer is “no,” but if the defect is large, the only other real option is a vicryl mesh. Many of us use a biologic as a longer biologic dressing, hoping that it will provide about four to six months of support. If it is possible to use the biologic as reinforcement, then yes—most or many of us would use it in this situation, but there are no good data to support this. Dr. rosen: Interestingly, there are probably more data in peer-reviewed literature to suggest that lightweight, largepore, synthetic mesh performs better than biologic mesh in contaminated situations. However, we don’t know if these only represent a publication bias or real results. We are currently starting a randomized controlled trial comparing biologic mesh with lightweight polypropylene during contaminated abdominal wall reconstruction to answer this question.

Dr. oleynikov: Agree. In general, there are a lot of data to support the use of biologic prosthetics in contaminated fields. However, the degree of contamination often is not included in those data. Therefore, it is unclear when exactly you need to switch to synthetic from biologics because we do not know the degree of contamination that synthetic material can withstand. We also are seeing that in bridging situations, biologics fail at an alarming rate. It is my practice to decontaminate the field and then use a synthetic if I think bridging over 5 cm is necessary. Dr. Pomp: Disagree, except for perhaps providing a temporary (and very expensive!) bridge that may tide the patient over until a definitive repair can be done. Dr. Pryor: There are data to support that placement of permanent mesh in an infected setting can lead to mesh

GENERALSURGERyNEWS.COM / GENERAL SURGERy NEWS / JANUARy 2012

Gut Reaction: Hernia My nightmare case

Adhesions

Fellowships

Robotics

Multiple fistulas after an open abdomen

Most challenging part of hernia repair

Not just for hernia repair

Lateral abdominal wall hernia after component separation

Who cares?

Good idea

Waste of money and time; can’t believe hospitals still allow this

Redo Nissen after use of synthetic mesh to repair the esophageal hiatus.

Necessary so that we can perform complex and even simple gastrointestinal surgery

Absolutely needed to train surgeons for the complexities of laparoscopic GI surgery

Much like the Wizard of Oz, the person behind the curtain is more important than the machine.

Obese, infected, multiple recurrent

Fact of life

Here to stay

Need better technology

Made me a better surgeon

Usually amenable to laparoscopic dissection

Better now that Fellowship Council has criteria

Waiting for a general surgery application

Operating on Dr. Rosen—no muscle to sew to

Bane of my existence

Finishing school

Not needed for me yet

Strangulated, contaminated and morbidly obese

Stay extraperitoneal unless forced

Good adjunct if not well exposed in residency

Hiatal hernias (maybe)

Huge hernia in morbidly obese patient with skin breakdown

Avoid them, be careful

Great idea; bariatric fellowships are the most successful fellowships ever

Marketing tools or for less experienced surgeons except in special situations (cardiac surgery, maybe prostate)

Where to start .... Incarcerated hernia with necrosis and fistula through previous mesh

Fun to lyse—for about 15 minutes

The final year of residency

Enabler for some; added time for others; definitely added cost

Anything beyond a simulator.

Based on this feedback, I hope I never have an adhesion.

I'm with Sarr.

Dr. Rosen doesn't pull punches, and Dr. Richards, is that a hidden endorsement of Mehmet Oz?

infection. In general, I try to do a native tissue repair in contaminated fields and use a biologic buttress as needed. Drs. amid/Chen: Agree. Although controversy remains over the necessity and cost of using biologics in primary repairs or with the at-risk patient in the noncontaminated setting, biologics play an important role in the management of hernias in the contaminated field. There clearly are enough data to contraindicate the use of permanent synthetics in the grossly contaminated field. Absorbable synthetics are an option, but will guarantee recurrence. The option of primary closure often is not possible and when it is achieved, recurrence rates are unacceptably high. The data that we do have are animal-based or from retrospective series, but there clearly is consistent experience that biologics can be used safely in these challenging settings. Further studies will help to establish the

specifics, including method of repair, choice of biologic, long-term outcomes, recurrence rates, complications and overall cost, but there are enough data to safely choose a biologic over a permanent synthetic.

statement

Declining reimbursement for hernia repair will discourage the best and brightest from getting into the field.

Dr. Heniford: I tend to answer this question by elimination. In the truly contaminated field, the use of standard synthetic meshes remains a no-no. There are data from our lab and some clinical work from Eduardo Parra-Davila, MD, that demonstrate that lightweight polypropylene is less infectable than the heavier

Inappropriate for hernia repair in general

meshes and can heal, even by secondary intention, in bacteria-laden fields. It is more likely that certain bacteria cause the majority of our mesh-related issues. Staphylococcus aureus is the culprit in 90% of synthetic mesh infections. If we could safeguard against Staph with a potent antimicrobial on mesh, the application of synthetics in the “at-risk” field certainly would be acceptable. Dr. richards: There are enough data to support the use of biologics in terms of preventing short- and long-term infections, but not enough data about longterm results with hernia recurrence. Dr. Heniford: If one wants to know what the “best and brightest” should do, perhaps this is the wrong group to ask! There are a number of economic considerations: the volume of the market (most common general surgery procedures in the United States and the world), the

pre- and postoperative resources required for the care of patients, the surgical call implications, and so on. I think I can speak not only for myself but also for my colleagues when I say that we did not begin to take on hernia surgery and then move to the much more difficult cases because they were easy or lucrative. I often tell my fellows that while they have to make a living to support themselves and their families, there are many ways to get paid. Overcoming the challenge of the operation, restoring a patient’s health and quality of life and having a practice essentially anywhere are just a couple of the rewards for surgeons in this area. Dr. leBlanc: Yes, I agree, and I will make a broader statement than that. Declining reimbursement will make the field of general surgery unattractive to all students considering the career. I published a study several years ago that predicted that a practice devoted solely to the repair of hernias will not be profitable and will not be sustainable. The reimbursement for an inguinal hernia repair is only $3 more today than in 1993 for Medicare patients! High-risk patients will have to find specialized centers for treatment because of this. Drs. amid/Chen: Disagree. Although declining reimbursement affects all of medicine and especially those of us in fields that deal with medically necessary problems, there hopefully will always be an interest in addressing this ubiquitous problem. Our best and brightest are drawn to the challenges of taking excellent care of patients and solving complex problems. Although declining reimbursement clearly is a difficult constraint, hopefully this trend will remain. Dr. rosen: Every field (not just medicine) is suffering from declining reimbursement. I’m not sure what options are left. Fixing hernias, particularly complex hernias, is one of the most rewarding things that can be done for these patients. I think reimbursement is something we all have to look at and honestly assess. Dr. sarr: An inguinal herniorrhaphy is the bread and butter of many general surgeons. If the reimbursement goes down, it may threaten the practice of many surgeons who might opt not to perform these operations at all. That would be a disaster. On the other hand, I don’t think it will discourage young medical students from going into general surgery. see on the Spot pAge 26

extended Hernia Coverage on the spot

Continued from page 25 There are other operations and parts of the practice that are still exciting. Dr. Pomp: Agree. Declining reimbursement has been the “gorilla in the closet” for all general surgery procedures. Reimbursement for operations and surgeon availability has not kept pace with the onerous increase of bureaucratic requirements of private and Centers for Medicare & Medicaid Services insurance and

GENERALSURGERyNEWS.COM / GENERAL SURGERy NEWS / JANUARy 2012

the cost of maintaining a practice. Also, the best and brightest are choosing the lifestyle and financial benefits of other specialties. Dr. oleynikov: Agree. Declining reimbursement is a global problem for surgery. Taken to its extreme, such as a one-payer social system, the best and the brightest will certainly not pursue medicine. This is a complicated problem that the entire country will continue to grapple with.

Dr. richards: Generally I agree, but I recognize that reimbursements for surgeons are going down in all areas. In order to continue to have bright people enter surgery, we must improve efficiency and show improved outcomes and provide adequate remuneration. Dr. Pryor: I think hernia going through an exciting now, with newer techniques rials. It is a field ripe for the eager.

surgery is transition and mateyoung and

statement

all biologic

grafts heal the same.

Dr. oleynikov: Disagree. In a paper we recently wrote titled “Not All Biologics Are Equal” (Hernia 2011;2:165-171), we specifically address the issue of various biologic graft properties. What we found is what you’d expect—every biologic, depending on its source, preparation, thickness and application varies from one surgery to the next. Because there are so little data, the best advice I can offer is buyer beware. Dr. Pryor: Strongly disagree. There are multiple factors that affect healing with a biologic graft. Type of material and cross-linking are just two of the variables that affect ingrowth and remodeling.

There’s revolution in the air

Dr. leBlanc: I disagree. The method of processing these materials differs greatly. Consequently, the method of resorption and integration will differ among all of them even if they are based on the same animal tissue. Without question, cross-linking will make those grafts last significantly longer than the non–crosslinked grafts. The choice of these materials should take this into consideration. Dr. sarr: I do not agree that all “heal” or have the same incorporation or architectural histology to the tissue’s response to their presence. Dr. rosen: I am not sure we currently know exactly how any biologic heals in all of the fields and locations we are placing them. There are so little data with these materials that most of our understanding on how these materials heal is from marketing departments of these companies and extraordinary computer animations, not actual histology or comparative data.

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Dr. Heniford: This is certainly not true. Grafts that contain cross-linked collagen do not heal as well as non–cross-linked biologics. We have seen this definitively in the lab. Clinically, we have operated on many referred patients in whom cross-linked grafts were placed and never healed or remained infected, much like a synthetic. These grafts had been placed both in contaminated and even clean fields and never incorporated or healed. At this point, I would strongly recommend that heavily cross-linked grafts not be used at all. In contradistinction, our lab work demonstrates that the non– cross-linked grafts incorporate in clean fields but do so even faster in the contaminated spaces. Drs. amid/Chen: Disagree. With the plethora of different biologics on the

GENERALSURGERyNEWS.COM / GENERAL SURGERy NEWS / JANUARy 2012

market, this is an increasingly important issue. All biologics share similar properties. However, not all biologics are equal. There are differences in tissue incorporation, granulation and complications. Cross-linked biologics have demonstrated increased graft strength but behave in vivo similar to synthetic meshes. As a result, these cross-linked materials remain inert, and explanted cross-linked biologic specimens often have very poor incorporation. These properties will need to be closely followed over the next several years as a shared experience in multiple centers to look at long-term outcomes and establish which biologics and which properties are beneficial or detrimental. Dr. richards: Definitely disagree because there are substantial data to show significant differences in healing between cross-linked and non–cross-linked.

without statement prohibitive risk factors, asymptomatic inguinal hernias should be repaired.

Dr. leBlanc: On the fence. In general, these should not be repaired if they are primary and small. There is a real risk for postoperative complications in all hernia repair patients such that some of these individuals will be worse off after the repair. The data are fairly clear that most of these can be observed, but careful instruction regarding adverse symptomology of these hernias to these patients is critical. As always, this statement should not be meant to be an absolute, as the patient’s clinical status will necessarily dictate the final decision. Dr. Heniford: We now know that asymptomatic inguinal hernias have a small chance of requiring an emergency operation, and education and observation are reasonable for patients who have scheduling, insurance or fear issues. But, as I tell patients almost every day, hernias do not fix themselves; they get bigger with time, tend to become symptomatic and carry a risk for an emergency operation, although that risk is small. I believe that patients who are healthy and present with a hernia should consider picking a good time in their life to have surgery and consider doing so. When we follow patients long-term, we have found that those who have statistically the best quality of life after surgery are those who are asymptomatic or relatively asymptomatic preoperatively. Those who have a greater chance of having negative quality-of-life issues following surgery are very symptomatic patients, young men, those who have bilateral hernias and recurrent hernias.

Dr. rosen: I would agree that it is acceptable to tell young patients that they probably should pick a time in their life that works to get their hernia repaired. In elderly patients, I ascribe to the watchful-waiting trial published by Fitzgibbons et al. (JAMA 2006;295:285-292). Synthetic meshes tend to cause problems with adhesion to the abdominal wall or to the underlying viscera. Dr. Pomp: This is not true, particularly in elderly males. There are significant data that hernias rarely become symptomatic with incarceration/strangulation,

and they usually can be electively repaired when or if they become symptomatic. Drs. amid/Chen: On the fence. There clearly are good data regarding the safety of expectant management or “watchful waiting” with asymptomatic hernias. That being said, most hernias will progress over time to become symptomatic and will enlarge. In young, healthy, active patients, elective repair is recommended with the option of observation. In elderly patients who are entirely asymptomatic, expectant management is reasonable.

Dr. richards: I agree that small, indirect hernias in younger individuals should be repaired, and I disagree that direct hernias in older patients should be repaired. Dr. oleynikov: Disagree. In my experience, the only asymptomatic hernia is the one that the patient doesn’t know about—that is, until you examine and point out to them that they have a hernia, then invariably it becomes symptomatic. Whether this is the patients’ imagination or their closer scrutiny of see on the Spot pAge 28

extended Hernia Coverage on the spot

Continued from page 27 what’s going on within their bodies, I cannot tell you. I repair all hernias that are presented to me. Dr. Pryor: Although it is acceptable to observe an asymptomatic inguinal hernia, it is a rare patient who opts for this approach in my practice.

statement

synthetic meshes tend to cause problems with adhesion to the abdominal wall or to the underlying viscera. Dr. Heniford: They can. Adhesions to the abdominal wall are usually what we want. Scarring to the intestine most often is not what we would prefer. The barriers that have been created by industry to prevent bowel-tomesh adhesions typically work pretty well, but they are not created equal. I would not say that biologic meshes should be substituted for synthetics when they are placed next to the bowel, but they can be positioned safely inside the abdomen. In open operations, I tend to place the mesh in the preperitoneal position, even in very large and recurrent hernias. Often minimal adhesiolysis is required when we have reoperated on these patients. Dr. sarr: Absolutely agree unless there is some type of a barrier between the prosthetic and the underlying viscera—the key is finding an effective one! Drs. amid/Chen: On the fence. Synthetic meshes are meant to incorporate into the surrounding tissue. This can be a favorable or unfavorable property depending on the setting, location and indication. In the abdominal wall, this adhesion contributes to the strength of the repair and incorporation. Intraabdominally, this process can lead to adhesions, erosion, fistula formation and other complications if the viscera is not protected. An uncoated mesh should not contact the visceral compartment. Once a mesh has incorporated and peritonealized, this risk should diminish. Dr. Pryor: Adhesions are a consideration with any mesh. They are, in general, designed to promote tissue ingrowth. In my practice, however, I have found that the meshes with an anti-adhesion barrier tend to work quite well. Dr. richards: The problem particularly with the polypropylene meshes is that some patients develop severe adhesions and circatrix formation, whereas some do extremely well with nary a problem. Dr. leBlanc: Agree and disagree as this is worded. They do not cause adhesion problems to the abdominal wall if they are placed properly and not directly underneath skin alone. However, if these meshes are unprotected, they can directly result in adhesive problems to the underlying viscera. There are animal data that show varying degrees of problems with even those meshes that have a protective barrier. We simply do not know if this translates to the human condition in all cases. There is a real question regarding these barriers as to the length of time that is adequate to protect against

GENERALSURGERyNEWS.COM / GENERAL SURGERy NEWS / JANUARy 2012

adhesions and if these materials actually perform as well as they are advertised. More independent research is needed in this area.

quality of life is equal to those patients who had a large ventral hernia repair where a components release was not required.

Dr. rosen: No great data to support this either way. I think a lot of adhesions have to do with the patients themselves and not the material. At the end of the day, I don’t think adhesions are that big of a deal; the bigger problems are erosions, fistulas and bowel obstructions. I think unprotected polypropylene and polyester should never be placed intraperitoneally, but there are many good anti-adhesive meshes available that do fine.

Dr. Pomp: Likely mostly true—although the functional result may be adequate, the cosmetic result is less than satisfactory, particularly in thinner patients.

Dr. Pomp: In my experience, this is true for polypropylene type meshes. Adhesions to polytetrafluoroethylene usually are flimsy and do not cause problems to the underlying viscera. Dr. oleynikov: On the fence. Synthetic meshes used in an intraperitoneal position have to be placed in a careful manner, as mesh erosion due to dense adhesions can occur. Bowel obstructions also have been reported from the use of Prolene mesh unshielded in the intraperitoneal position. I either perform a retrorectus placement of an unshielded synthetic or work with synthetic meshes that have a proven record for decreased adhesions and some degree of shielding for intraperitoneal placement.

Dr. oleynikov: On the fence. … We have seen that bridging large abdominal wall hernias can cause poor abdominal wall function and lead to increased rates of recurrence. How large a defect one can bridge still remains to be determined; I offer component separations for all the effects where the rectus muscles are greater than 10 cm apart. Smaller defects, in my opinion, can be safely bridged. Dr. sarr: I agree, but in many cases a bridging is all that is needed in older patients that do not need the added advantage of an abdominal wall reconstruction.

Drs. amid/Chen: On the fence. Wide bridging leads to higher rates of recurrence and eventration. It does not allow for a restoration of a dynamic abdominal wall and often will result in a contour defect with larger hernias. This is a limitation in both open and laparoscopic repairs and the ideal remains abdominal wall reconstruction. That being said, there are instances in patients with comorbidities, poor ambulation, poor nutritional status, significant obesity or infectious risk in whom the safest operation the era of wide bridging with meshes statement would be to repair the hernia defect as expewithout abdominal wall reconstruction needs to end and is the ditiously as possible without a larger operaachilles heel of current laparoscopic techniques. tion or incision. As with everything in the art of herniology, it is best to have many techDr. leBlanc: I agree. The definition of “wide” is niques at your disposal to tailor the right treatment for unclear at this point. Certainly, if the defect is larger each patient. In the otherwise healthy, active patient than 15 cm in transverse dimension, bridging is inap- with a large hernia, mesh-reinforced abdominal wall propriate whether it is with open or laparoscopic tech- reconstruction should be the ideal. Endoscopic componiques. The overall result will be less than satisfactory in nent separation is a useful adjunct that confers many of these cases. Bridging is not the Achilles heel of current the benefits of laparoscopy with those of open repair. laparoscopic methods if these techniques are applied to the right patient with the appropriate indication. This Dr. richards: Agree completely! And it is my practechnique has stood the test of time in nearly all cases of tice to always try to close the fascial defect after compohernias less than 10 cm. The “gray area” of repair choic- nent separation or other techniques to bring the fascial es are those hernias between the sizes of 10 and 15 cm. edges together. Critical decisions can be challenging in these patients and the overall status of the patient must be considered. Dr. Pryor: Large abdominal wall defects are difficult to address with any approach. Although I agree that Dr. rosen: I agree 100% for most hernias; however, abdominal wall reconstruction is a very good choice obese patients with small defects still probably benefit for these types of defects, it isn’t for every patient. I from laparoscopy. do think some patients, particularly those with higher operative risk, may benefit from the less-invasive lapaDr. Heniford: I cannot say that this is true. We know roscopic approach. that laparoscopic ventral hernia techniques can lead to good, long-term repair with a good quality of life. It Dr. Heniford has done research for Ethicon Inc., also offers a lower risk for infection when compared LifeCell, Synovis and W.L. Gore. Dr. Oleynikov has with open herniorrhaphy. But this is probably where the received educational grants from Covidien and W.L. Gore, advantage stops. Open and laparoscopic hernia repairs educational and research grants from LifeCell, and is a offer pretty equal recurrence rates, pain levels, time stockholder at Virtual Incision. Dr. Pomp has received required to return to work and even time in the hospi- honoraria and has been a consultant for Covidien, Ethicon tal. When an open hernia repair is performed, it does Endo-Surgery and W.L. Gore. Dr. Pryor has been a tend to make sense that the abdominal wall should be speaker for and received grant support from Covidien; he closed if possible. The functional considerations make also has ownership interests in Barosense and Transenterix. sense: An intact abdomen works more like normal, but — Colleen Hutchinson is a this consideration is not absolutely proven. Also, if a communications consultant who specializes surgeon can close the fascia over the mesh, the resulin the areas of general surgery and tant mesh infection rate is substantially reduced. Last, bariatrics. She can be reached at even if a components separation is required, David colleen@cmhadvisors.com. Klima, MD, from our lab, has shown that the long-term

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1989

1999

Discovery of SIS

Surgisis® is released

Small intestinal submucosa (SIS) is used as an aortic replacement in a canine model. Remarkably, the SIS is fully remodeled into vascular tissue.

After rigorous research and development, Cook receives FDA clearance for release of Surgisis, the ﬁrst medical-grade hernia device made from SIS-based technology.

ÂŽ

2008

Processing improvements

Biodesign is released

In response to surgeon feedback, substantial improvements in the processing are made, opening the structure to allow the body to more easily inďŹ ltrate and remodel the graft.

Additional improvements are made to the base technology, speeding rehydration and mitigating perioperative issues. New generation of grafts are renamed Biodesign.

Learn more. Visit www.cookbiodesign.com

ÂŠ COOK 2011

2006

SUR-BADV-MBCI-EN-201109

extended Hernia Coverage

GENERALSURGERyNEWS.COM / GENERAL SURGERy NEWS / JANUARy 2012

Fixing Mesh to Diaphragm Carries Major Risks by Christina FranGou

new report warns surgeons to use caution when anchoring mesh to the diaphragm after discovering 15 cases of cardiac tamponade caused by mesh fixation to the diaphragm. Eight patients died as a result of the complication, according to the report (Surgery 2011 Sep 24 [Epub ahead of print]). “Anchoring mesh to the diaphragm

is not to be taken lightly, regardless of the type of mesh being used. The careless placement of sutures, staples and especially the helical tacker may result in a catastrophic injury to the heart,” wrote Constantine Frantzides, MD, PhD, and Scott Welle, DO, of the Chicago Institute of Minimally Invasive Surgery, Skokie, Ill. The investigation began when Dr. Frantzides became a medical expert in two cases where patients had cardiac injury after mesh repair. One patient had

a ventral herniorrhaphy, the other a hiatal hernia repair. Both were injured when helical tacks were used to fixate the mesh to the central tendon of the diaphragm; diagnoses of cardiac tamponade were established at autopsy. To find additional cases, Drs. Frantzides and Welle searched the PubMed Medline database and the FDA’s Web site, and identified 15 distinct cases of cardiac injury—10 in hiatal hernia repair, resulting in six deaths, and five in ventral hernia

Now Available... Novel Applications for Biologic Mesh Innovations in Complex Hernia Repair

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Chair

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Goal

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3 Identify appropriate surgical techniques to optimize the use of biologic mesh in abdominal wall reconstruction and complex hernia repair.

4 Review new treatment algorithms designed to provide best-practice measures and aid in handling surgical complications.

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most surgeons are aware of this issue but many don’t realize that it’s very often lethal and that it occurs in ventral hernias, too. ‘this issue needs to be publicized.’ —Emanuele Lo Menzo, MD, PhD repair, four of which were fatal. The most common cause of injury was helical tacks, in 10 of the 15 injuries; two injuries were caused by sutures, one by a straight stapler and the rest from unknown causes. The ProTack helical tacks, made from titanium wire about 4 mm long, are often delivered in the tissue blindly and, after thinning the tissue, are deployed completely before ejecting the tack. Thus, the tack is advanced into the tissue with the leading edge penetrating beyond visualization. The package insert for the ProTack discourages use of tacks on tissue that cannot be inspected for hemostasis or that's at least 4 mm thick. “If the tack is fired into tissue less than a minimum of 4 mm thick, injury to an underlying organ (e.g., pericardium, heart or intestines) is possible,” the authors said. The authors also noted that clinical manifestation of tamponade can present at any time postoperatively; in the study, symptoms of tamponade presented as late as 14 days. The initial symptoms of tamponade— tachycardia and hypotension—can be mistaken for more common complications, such as pulmonary embolism, heart failure and myocardial infarction. Based on these results, Drs. Frantzides and Welle have adopted the Endopath EMS stapler for mesh fixation. This stapler has the ability to partially deploy so the user can grab the mesh with one arm of the stapler while the other arm bites into the tissue. It has less penetration and requires less force than the helical tacker. But even with a straight stapler, surgeons must avoid the tendonous portion of the diaphragm. The authors recommend using minimal force and deploying the staples judiciously and primarily posteriorly, avoiding the central tendon. “In general, the placement of any fixation device ... should be avoided,” they said. “Cardiac tamponade secondary to injury to the heart from an anchoring device is a complication that can be avoided with the awareness of critical anatomy and proper operative technique.” Most surgeons are aware of this issue but many don’t realize that it’s often lethal and can occur in ventral hernias, said Emanuele Lo Menzo, MD, PhD, associate professor of surgery, University of Maryland Medical Center, Baltimore. “This issue needs to be publicized; it should be a well-established problem and we should know to use extreme care.”

GENERALSURGERyNEWS.COM / GENERAL SURGERy NEWS / JANUARy 2012

Future oF herniA repAir Continued from page 15

for the future development of hernia surgery. This vision should ensure that science is carried out on national and international levels, and it also should ensure that projects requiring more substantial resources are established as global from the outset. The consideration of herniorrhaphy among most general surgeons has changed. The past thinking of “it’s just a hernia” is passé and has been replaced with the science-based consideration of patient-related factors, patient selection, anatomic application, fixation, strength requirements and healing considerations of biomaterials, as well as thoughtful and true physical world-based postoperative activity restrictions. This realm of greater understanding of abdominal wall problems and their repair has improved patient outcomes and delivered this form of surgery to a true specialty. It is

this realm of greater understanding of abdominal wall problems and their repair has improved patient outcomes and delivered this form of surgery to a true specialty. an exciting time to be a hernia surgeon. In recent years, the surgical approach to abdominal wall hernias has been focused on mesh-based treatment options. More than 80 international experts will discuss in detail all aspects of the mesh world, and we are anxiously awaiting the results of their research. After posing the question of whether meshes have prevented recurrences in the groin, epidemiologic clinical data on recurrences well be presented and show that this problem still exists. In particular, novel molecular, biology-based research results stress the pathophysiologic importance of a defective scarring process in these patients with inherent implications for future therapies. Regarding the variety of existing meshes, there are already more than 100 different mesh devices. A comprehensive review of their chemical and textile properties will be presented, with emphasis on their impact on biologic responses. The differentiated use of meshes in various procedures will be addressed and discussed, including groin, incisional, parastomal, diaphragm and hiatal hernias as well as their use in extended abdominal wall defects or in pediatric or plastic

surgery. Inguinal hernia repair has made enormous progress throughout the ages. The main reasons for intervention, however, remained the same— continuous increase of inguinal and/or scrotal swelling, the risk for incarceration of the hernia content, and the ineffective results of conservative methods such as truss placement. Surgical techniques have rapidly evolved since Eduardo Bassini proposed his first successful reconstruction of the inguinal floor. The various adaptations of his technique, however, did not result in a substantial reduction in the number of recurrences. The tension-free repair, introduced by Irving Lichtenstein, caused a dramatic drop in the recurrence rate and became the procedure of choice. Since the introduction of laparoscopic techniques, these methods have become equally accepted for inguinal hernia. It is exciting to think of how hernia repair will evolve in the next few decades. The preliminary program for the congress lists many new topics. We received a record high number of abstract submissions, and we have included some new sessions for participants to discuss case reports. This is a truly worthwhile meeting that provides outstanding, up-to-date information in the fields of abdominal wall surgery. The congress’s highlights include: • Plastic Surgery: Considerations with Abdominal Wall Reconstruction; Inguinal Hernia Guidelines; Improving Outcomes in Abdominal Wall Surgery; Prevention, Management of the parastomal hernia; Hernias Among Women; Innovative Solutions in Abdominal Wall Closure; a Great Debate: Management of the Sportsman’s Hernia. • For the first time we will provide to all attendees a Learning Center with new simulators and simulation for hands-on learning. • Scenarios and three postgraduate courses: Chronic Pain after Hernia Repair; Advanced Component Separation from A-Z; and, Optimizing Laparoscopic Inguinal Hernia Repair. We look forward to seeing you in March. Sincerely, Sergio Roll, MD Program Chair and President Elect American Hernia Society

bilAterAl herniAs Continued from page 15

maintains a prospective database of consecutive patients undergoing laparoscopic procedures in Switzerland. The study included all patients aged 18 years or older who underwent elective primary unilateral or bilateral TEP for inguinal hernia from 1995 to 2006, except those with recurrent hernias.

‘For a long time, we’ve known that the bilateral approach is better in terms of cost-effectiveness, time off from work and recuperation. as a practitioner, i can now say to my patients that i am not adding any significant risk with bilateral repair.’ —George S. Ferzli, MD Of 6,505 patients studied, 53% (n=3,457) underwent elective unilateral repair, whereas the remainder (n=3,048) had bilateral repair. More than 95% of patients in each group were men, with a mean age of approximately 54 years and an American Society of Anesthesiologists score of 1.4. The study showed that patients who underwent bilateral repairs had slightly increased rates of intraoperative complications compared with patients who had unilateral repairs (3.1% vs. 1.9%; P=0.002) as well as slightly higher rates of surgical postoperative complications (3.2% vs. 2.3%; P=0.026). The differences were statistically significant, but the authors said the absolute differences were “very small and of minor clinical relevance.” The investigators calculated that if 83 patients underwent bilateral endoscopic hernia repair, there would be one additional intraoperative complication compared with unilateral hernia repair. Similarly, if 111 patients underwent bilateral endoscopic hernia repair,

only one additional surgical postoperative complication would occur. Operative times were 19 minutes longer for the patients undergoing bilateral TEP (86 vs. 67 minutes; P<0.001). No significant differences between the bilateral and unilateral TEP groups were observed in terms of postoperative length of stay (2.5 vs. 2.3 days; P=0.196), general postoperative complications (1.0% vs. 0.7%; P=0.151) or conversion rates (1.1% vs. 1.0%; P=0.699). “The slight increase in complications was counterbalanced by the avoidance of all the potential problems, inconveniences and costs of two hospital stays and two operations, each time with the patient under general anesthesia,” they said. The study provides very strong support for the bilateral approach, said George S. Ferzli, MD, professor of surgery at SUNY Downstate and chairman of surgery, Lutheran Medical Center, Brooklyn. “For a long time, we’ve known that the bilateral approach is better in terms of costeffectiveness, time off from work and recuperation,” he said. “As a practitioner, I can now say to my patients that I am not adding any significant risk with bilateral repair.” He said the study authors had extremely low rates of complications and conversions, especially as the study focused on the years from 1995 to 2006, when many surgeons were very early in the learning curve. “That makes their conclusion very well supported.” He added, however, that the study lacks details on the types of surgical complications and the number of incipient contralateral hernias that were discovered during surgery, and investigators were unable to assess the incidence of hernia recurrence, long-term pain or degree of patient satisfaction with the two repairs. Overall, the evidence shows that “for patients with bilateral inguinal hernia, a simultaneous endoscopic approach represents an excellent therapeutic option,” the authors wrote.

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surgeons’ lounge

GENERALSURGERyNEWS.COM / GENERAL SURGERy NEWS / JANUARy 2012

Dear Readers,

Welcome to the January 2012 issue of The Surgeons’ Lounge. On behalf of all of us here, we wish our readers and contributors a very happy, healthy and prosperous new year. We begin another year of The Surgeons’ Lounge with experts from our International Series: Mr. Steve Hornby, BMBS, MRCS, upper GI clinical research fellow, General Surgical Registrar in the South Peninsula, and director of education for the Association of Surgeons in Training, London, as well as Andrew Kingsnorth, MD, consultant surgeon and honorary professor of surgery at the Peninsula College of Medicine and Dentistry, president of the surgical section of the Royal Society of Medicine, and past president of the European Hernia Society and the British Hernia Society, London. I also want to give special mention to commander Rory Rickard, MD, a consultant plastic and reconstructive surgeon, London. These surgeons have prepared a detailed case report of a patient with an abdominal wall hernia and have

Letter Regarding November 2011 Issue inadequacies of our surgical training Programs

The responses and opinions given by the invited guest were largely predictable. Only Dr. [Lee] Swanstrom addressed the real problem: the apparent inadequacies of our surgical training programs. Thirty years ago, the average resident completed the fifth year with 1,500 or more cases in which he or she actively participated. The average fifth-year resident now is lucky to have participated in 900 cases. This represents a terrible downturn in surgical experience (both inside and outside the operating room), the result of which is poorly or inadequately trained surgeons who are unable to care or uncomfortable caring for patients with a variety of surgically correctable illnesses. The solution, as expressed here, is to provide more training. However, this training is “super-focused” to the point that the trainee is only “adept” at treating a very narrow spectrum of surgical disease. Even then, the most advanced and sophisticated surgical procedures will need to be referred to tertiary specialists (such as laparoscopic pancreaticoduodenectomy, laparoscopic hepatectomy, etc.). Although much of what is said is true, especially regarding the “need” for certification

described how they managed this very complex case. We also kick off the year with the popular Expert Express, in which we poll a host of Surgeons’ Lounge veterans about laparoscopic repair in initial unilateral inguinal hernias: Do they or don’t they? Keep reading to find out! As always, we look forward to your comments and questions. Sincerely, Samuel Szomstein, MD, FACS Editor, The Surgeons’ Lounge Szomsts@ccf.org Dr. Szomstein is associate director, Bariatric Institute, Section of Minimally Invasive Surgery, Department of General and Vascular Surgery, Cleveland Clinic Florida, Weston.

from non-medical (and some medical) institutions and the constraints a surgeon who lacks that certification faces, the real problem is that the “teachers” of the skills required to become reasonably expert in any field (in this case, minimally invasive surgery) have ignored their mission to teach and pass on those skills to their general resident staff. These “teachers” have become self-serving, protecting their own “turf,” to the detriment of those who wish to serve in this noble profession. Additionally, while there are several reasons that more than 75% of residents choose to do a fellowship (which is a whole different discussion), the result is that we are rapidly becoming underserved within our own surgical community, since the “super/subspecialists” no longer can or no longer desire to care for the myriad of problems that present on a daily basis to our hospitals, clinics, and so forth. The end result will be less accessible and timely care, which will nonetheless be more expensive and not necessarily better quality. It would seem apparent that we are rapidly adopting the European model regarding resident training, registrar indenture (fellowship) and eventual consultative practice. Craig J. Schaefer, MD, FACS Cambridge, Maryland

Case Study of a Difficult Hernia A 62-year-old man presents as a national referral to your specialist complex hernia clinic. He has massive lower abdominal wall herniation. The patient was initially treated several years ago for bilateral inguinal hernias and since then has had at least five attempts to repair recurrences. A variety of mesh materials and tissue planes have been used, including laparoscopic approaches. On physical examination, the entire abdominal wall below the umbilicus is affected, and with the patient in standing position, the hernia reaches his knees (Figures 1 and 2). With the patient in lying position, the hernia appears to be completely reducible, and several of the previously implanted meshes are palpable. It appears from the examination and the evidence provided from a magnetic resonance imaging (MRI) scan that the right inguinal ligament is destroyed. This patient’s quality of life is so adversely affected by his hernia that he is desperate for a further attempt at repair. How is this complex problem managed?

Description of Case management A key first step in patients such is this one is to manage their expectations. This patient should be informed that the risk for further failure of the repair is approximately 50% and that there would be a significant risk for mortality associated with a reconstruction of this scale. The patient is not overweight, but if mr. steve Hornby he were, he would be strongly advised to lose weight and, if necessary, referred to a specialized dietetic team. Given the high likelihood he will require tissue replacement of the inguinal ligaments, it is recommended he receive the help of a specialist andrew Kingsnorth, mD

Figure 4. rectus femoris fascia reconstruction. Figure 1. Front view.

Figure 2. side view.

Figure 3. Previous mesh material.

continued on page 36

Figure 5. Biological mesh.

surgeons’ lounge

GENERALSURGERyNEWS.COM / GENERAL SURGERy NEWS / JANUARy 2012

continued from page 35

laparoscopic repair in initial unilateral Q.inguinal hernias: yes or no? natan Zundel, mD: mesh, yes. Laparoscopic repair not a must

Figure 6. synthetic mesh.

e edward Felix, mD: why not?

of course,

David edelman, mD: almost always, unless contraindication for laparoscopy or general anesthesia

Frederick Greene, mD: no

Figure 7. Postoperative follow-up, front view. Figure 8. Postoperative follow-up, side view. plastic surgeon. A theater (operating room) slot of at least eight hours should be set aside. The patient was taken to theater with two consultant surgeons specializing in abdominal wall reconstruction, a herniologist and a plastic surgeon. The operation required six hours and 40 minutes to complete. On opening the redundant skin, several large pieces of mesh were found and excised (Figure 3). The abdominal wall consisted of only atrophied rectus abdominis muscles about 2 cm wide, and the right inguinal ligament was absent. The redundant skin was excised and adhesiolysis was performed. The right inguinal ligament was reconstructed by mobilizing a strip of rectus femoris fascia and securing it using nonabsorbable sutures between the anterior superior iliac spine and the pubic tubercle (Figure 4). When completed, this reconstruction was used as a platform to place an underlapping biological mesh to close the hernia defect (Figure 5). This region was further reinforced with an onlay polypropylene mesh (Figure 6). Both meshes were affixed with a nonabsorbable suture. Drains were placed on top of the mesh with instructions not to remove for five days and to only drain less than 50 mL every 24 hours. The patient initially had an unstable recovery. He developed pulmonary edema and right lower lobe collapse, and required a two-day intensive care unit admission for noninvasive ventilation. After these issues were dealt with, recovery was steady and he was discharged on day 13 postsurgery. The patient has been followed up for nine months. At this stage, he has complained of several aches and pains as well as gastroesophageal reflux, but his hernia repair remains intact and this has been confirmed on MRI scan (Figures 7 and 8). In summary, here are several points to consider when treating this patient: • Multidisciplinary teamwork: This patient benefited from specialist care by a hernia surgeon, a plastic surgeon, an anesthetist, an intensivist, physiotherapists and nursing staff, all of whom had roles to play in his repair and recovery

Daniel Herron, mD: yes, unless general anesthesia contraindicated

lee swanstrom, mD: yes

ronald Hinder, mD: no

Expertess Expr

Jeffrey Ponsky, mD: yes

Bruce ramshaw, mD: yes, but with the patient making the final decision

alejandro Gandsas, mD: a emanuelle lo menzo, mD:

yes

estuardo Behrens, mD: yes anthony Petrick, mD: yes a

michael schweitzer, mD: yes

alfons Pomp, mD: a yes, absolutely. y

michael sarr, mD: no, unless special circumstances

ed lin, mD: yes

ed Phillips, mD: no ashutosh Kaul, mD: yes

• • • •

Considered use of mesh Biological mesh for tissue reconstruction Synthetic mesh for reinforcement and strength Drain management: The drains in our cases are left until the postsurgical collection is drained to dryness. Seromas remain an unsolved problem,

but the use of tissue glues and talc products may offer solutions Autologous tissue repair techniques, such as the components separation and rectus femoris fascia flaps, should be in the armamentarium of any surgeon tackling these complex reconstructions.

A Non-narcotic Option for Patients Who Require Analgesia at the Opioid Level

SPRIX® (ketorolac tromethamine) Nasal Spray is indicated for the short-term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level. WARNING: LIMITATIONS OF USE, GASTROINTESTINAL, BLEEDING, CARDIOVASCULAR, and RENAL RISK Limitations of Use–SPRIX® (ketorolac tromethamine) Nasal Spray, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for short-term (up to 5 days in adults) management of moderate to moderately severe pain that requires analgesia at the opioid level. Do not exceed a total combined duration of use of SPRIX® and other ketorolac formulations (IM/IV or oral) of 5 days. SPRIX® is not indicated for use in pediatric patients and it is not indicated for minor or chronic painful conditions. Gastrointestinal Risk–Ketorolac tromethamine, including SPRIX®, can cause peptic ulcers, gastrointestinal bleeding and/or perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Therefore, SPRIX® is contraindicated in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation, and in patients with a history of peptic

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IMPORTANT SAFETY INFORMATION WARNING: LIMITATIONS OF USE, GASTROINTESTINAL, BLEEDING, CARDIOVASCULAR, and RENAL RISK Limitations of Use–SPRIX® (ketorolac tromethamine) Nasal Spray, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for short-term (up to 5 days in adults) management of moderate to moderately severe pain that requires analgesia at the opioid level. Do not exceed a total combined duration of use of SPRIX® and other ketorolac formulations (IM/IV or oral) of 5 days. SPRIX® is not indicated for use in pediatric patients and it is not indicated for minor or chronic painful conditions. Gastrointestinal Risk–Ketorolac tromethamine, including SPRIX®, can cause peptic ulcers, gastrointestinal bleeding and/ or perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Therefore, SPRIX ® is contraindicated in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation, and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. Elderly patients are at greater risk for serious gastrointestinal events. Bleeding Risk–Ketorolac tromethamine inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding. Cardiovascular Risk–NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. SPRIX® is contraindicated for treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. Renal Risk–SPRIX® is contraindicated in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion.

SPRIX® is contraindicated in patients with known hypersensitivity or history of asthma, urticaria, or other allergic-type reactions to aspirin, ketorolac, other NSAIDs or EDTA. However, anaphylactoid reactions may occur in patients with or without a history of allergic reactions to aspirin or NSAIDs. SPRIX® is contraindicated in patients as a prophylactic analgesic prior to major surgery; or in labor, delivery, or nursing mothers because of the potential adverse effects of prostaglandin-inhibiting drugs on neonates. SPRIX® should not be used concomitantly with IM/IV or oral ketorolac, aspirin, or other NSAIDs, or with probenecid or pentoxifylline. When ketorolac is administered with aspirin, its protein binding is reduced, although the clearance of free ketorolac is not altered. The clinical signiﬁcance of this interaction is not known; however, as with other NSAIDs, concomitant administration of SPRIX® and aspirin is not generally recommended because of the potential of increased adverse effects. Do not use SPRIX® in patients for whom hemostasis is critical. Clinical studies, as well as postmarketing observations, have shown that ketorolac can reduce the natriuretic effect of furosemide and thiazides in some patients. Concomitant use of ACE inhibitors and/or angiotensin II receptor antagonists may increase the risk of renal impairment, particularly in volume-depleted patients. NSAIDs may diminish the antihypertensive effect of ACE inhibitors and/or angiotensin II receptor antagonists. Consider this interaction in patients taking SPRIX® concomitantly with ACE inhibitors and/or angiotensin II receptor antagonists. Ketorolac can cause serious GI adverse events including bleeding, ulceration, and perforation. Elderly patients are at increased risk for serious GI events. Use SPRIX® with caution in patients with impaired hepatic function or a history of liver disease. The pharmacologic activity of SPRIX® in reducing inﬂammation and fever may diminish the utility of these diagnostic signs in detecting infections.

SPRIX® is a non-narcotic option for patients who require analgesia at the opioid level In a study of post-abdominal or -orthopedic surgery, SPRIX® provided signiĮcantly greater pain reducƟon vs placebo2 P=0.012 SPRIX®

1392

31.5 mg + Morphine

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500

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less morphine3

1167

+ Morphine

Patients taking SPRIX® required

(51.4 mg vs 77.4 mg) over 48 hours P<0.001 1500

Summed Pain Intensity Difference over 48 hours (SPID48)

4.77 in SP SPRI RIIX® grooupp. Mo R Morp rphi rp h ne ne usee redduc uctit oonn wass a seecconnda dary aryy end ndpo poin po int. ntt.. 3 A ph phas aasse 3 raanddom mizzed ed,, dooubblee--bblilind n , ppllac nd a eb eboo cont ocoonttro rollleedd stu roll tudy d to ev dy eval a ua uate te thee anaalg lges esic es siicc effificaccy an and tole ttooleeraabi b lility tyy of si sing ngglee- an and mu multltip llttipplee-d -dos dos ose SP SPRI RIX® in maj a or abd bdom omin om inal in a and orttho al hope peedi pedi dicc su s rrgger e y paatit en e tss rem em mai aini ai n ngg in ho ni hosp spittal sp al foorr 2–5 days. ays. ay s Pat a ieenntts ts w weeree raanndo doml m y asssi sign g ed gn ed in a 2: 2 1 ra ratitio io too reccei eive ve ve S RI SP RIXX® 31. 1.55 mg m or m maatc t hiing plaace cebo boo foollloow wiiing ng suurrggeeryy (da d y 0)). Al A l pa p titiennts t hadd accceesss ss to to morph orrpphhinne su sulf ulfat lffat a e (M MS) S) by pa patitien tien entt co cont ontro nttroolllledd ana nalg lgges esia es siaa (PCA (P CA)) be CA begi giinn nnin ingg on dayy 0. Th in T e sttud u y wa wass ddeessiignneedd wiitth a muulttiddosse regi reegiime m n of SPRIX PPR RIX IX® 311..5 mg mg or matc matc ma tchi tchi h ng ng pla lace ceeboo addm min inis isste tereed th thre ree titime time mess p r da pe dayy foor up to 5 daays ys.. B Baack ckup kupp ana nalg llgges esia iaa was per ermitt mitt mi tted teedd. TToottaal hy hyst stteerrecto ecto ec tomi miies m e weerre th the ma majoorir tyy of ab abdo bddoom miina nal suurgger ery pr proc oced oc eddurre (887% 7%). %). Hipp reepl plac acceem acem men entss wer eree th t e mo most st com mmo mon or orthhoped orth oppeddic pro roceedu duree (72 72%)). O Ottheer pprroc o eedduurres es werre ov ovaarria ian cy cyst steccto tomy omy my,, laam miinneeccttom my, y rot otaattoorr cufff rreepa pair airr, frac fr actu ac tuure redduc uctitit on andd fixat a ioon, saallpi ping n oo--ooph ooopphhoorreecctoomy my,, bbrrea east sstt rec econ onnst onst struct ruuccttioon, n, appppennde dect dect ctom oom my, y, anndd kne neee an and aannkklle reepl p acceem men e t.3 A ter Af teer suurg rger ery, er y int y, ntrraave v noouuss opi pioi oiid wa was aaddmi mini n st ster ereedd at thhe ddiiscre er ssccreettiion on of thhe innvveessttiggator aattorr. Pa Patitit eennts reeccor orde dedd pain de paainn int nten ensi en s ty (PI si PI)) raatit nggs us u ing inng a Vi Visu sual a al Anal An a ogg Scaale al l (VA V S) S) of 0 (n ( o pa pain iinn) to to 100 00 mm (w wor orst st pai a n) n). Wh Wheenn PI rraatiting ngs eq equa u leed at ua at lea east asstt 40 on the he VAS AS, paatitien ents en ts rec ecei eive ei vedd SP ve S RI R X® or pl p ac aceb ebo. o4 o.

SPRIX® (ketorolac tromethamine) Nasal Spray is indicated in adult patients for the short-term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.

Avoid contact of SPRIX® with the eyes. If eye contact occurs, wash out the eye with water or saline, and consult a physician if irritation persists for more than an hour. Ketorolac can cause renal injury. SPRIX® Nasal Spray should be used with caution in patients with advanced renal disease or patients at risk for renal failure due to volume depletion and should be used with caution in patients taking diuretics or ACE inhibitors. Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury such as interstitial nephritis and nephrotic syndrome. NSAIDs can cause serious dermatologic adverse reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal. These serious events may occur without warning. SPRIX® should be discontinued immediately in patients with skin reactions. During pregnancy, use of SPRIX® beyond 30 weeks’ gestation can cause premature closure of the ductus arteriosus, resulting in fetal harm (Pregnancy Category D). Prior to 30 weeks’ gestation, SPRIX® should be used during pregnancy only if potential beneﬁt justiﬁes the potential risk to the fetus (Pregnancy Category C). NSAIDs can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the

1-888-354-4855

increased incidence of cardiovascular events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. Fluid retention, edema, retention of NaCl, oliguria, and elevations of serum urea nitrogen and creatinine have been reported in clinical trials with ketorolac. Only use SPRIX® very cautiously in patients with cardiac decompensation or similar conditions. The most common adverse reactions (incidence ≥ 2%) in patients treated with SPRIX® and occurring at a rate at least twice that of placebo are nasal discomfort, rhinalgia, increased lacrimation, throat irritation, oliguria, rash, bradycardia, decreased urine output, increased ALT and/or AST, hypertension, and rhinitis. Treat patients for the shortest duration possible, and do not exceed 5 days of therapy with SPRIX®. Please see following pages for Brief Summary of Prescribing Information, including Boxed Warning. References: 1. Boyer KC, McDonald P, Zoetis T. A novel formulation of ketorolac tromethamine for intranasal administration: preclinical safety evaluation. Int J Toxicol. 2010;29(5):467-478. 2. Levin RA. Clinical Review of NDA 22.382. FDA Center for Drug Evaluation and Research. October 5, 2009. 3. Brown C, Moodie J, Bisley E, Bynum L. Intranasal ketorolac for postoperative pain: a phase 3, double-blind, randomized study. Pain Med. 2009;10(6):1106-1114. 4. Singla N, Singla S, Minkowitz HS, Moodie J, Brown C. Intranasal ketorolac for acute postoperative pain. Curr Med Res Opin. 2010;26(8):1915-1923.

www.SPRIX.com

5/2011

SPRIX® (ketorolac tromethamine) Nasal Spray

R Only Rx

HIGHLIGHTS OF PRESCRIBING INFORMATION * * * *

WARNING: LIMITATIONS OF USE, GASTROINTESTINAL, BLEEDING, CARDIOVASCULAR, and RENAL RISK See first page for complete boxed warning • Limitations of Use – The total duration of use of SPRIX and other ketorolac formulations should not exceed 5 days. • Gastrointestinal (GI) Risk – Ketorolac can cause peptic ulcers, GI bleeding, and/or perforation of the stomach or intestines, which can be fatal. SPRIX is CONTRAINDICATED in patients with peptic ulcer disease or history of GI bleeding. • Bleeding Risk – SPRIX inhibits platelet function and is CONTRAINDICATED in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or high risk of bleeding. • Cardiovascular (CV) Risk – NSAIDs may cause an increased risk of serious CV thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with CV disease or risk factors for CV disease may be at greater risk. SPRIX is CONTRAINDICATED for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. • Renal risk – SPRIX is CONTRAINDICATED in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion. SPRIX is available as an intranasal spray product containing the active ingredient (ketorolac tromethamine) and the excipients edetate disodium (EDTA), monobasic potassium phosphate, sodium hydroxide, and water for injection. Each single-day nasal spray bottle contains a sufficient quantity of solution to deliver 8 sprays for a total of 126 mg of ketorolac tromethamine. Each spray delivers 15.75 mg of ketorolac tromethamine. ®

INDICATIONS AND USAGE SPRIXX® is indicated in adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level. (1)*

• Serious and potentially fatal cardiovascular thrombotic events, myocardial infarction, and stroke can occur with NSAID treatment. (5.6)

resulted in renal papillary necrosis and other renal injury such as interstitial nephritis and nephrotic syndrome.

• Fluid retention and edema have been observed in patients taking NSAIDs. SPRIX® should be used with caution in patients with cardiac decompensation or similar conditions. (5.4, 5.6)

Anaphylactoid Reactions. As with other NSAIDs, anaphylactoid reactions may occur in patients with or without a history of allergic reactions to aspirin or NSAIDs and in patients without known prior exposure to ketorolac. SPRIXX® should not be given to patients with the aspirin triad.

• NSAIDs can cause serious dermatologic adverse reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal. SPRIXX® should be discontinued immediately in patients with skin reactions. (4, 5.7) • During pregnancy, use of SPRIX® beyond 30 weeks gestation can cause premature closure of the ductus arteriosus, resulting in fetal harm. (5.8) ADVERSE REACTIONS The most common adverse reactions (incidence > 2%) in patients treated with SPRIXX® and occurring at a rate at least twice that of placebo are nasal discomfort, rhinalgia, increased lacrimation, throat irritation, oliguria, rash, bradycardia, decreased urine output, increased ALT and/or AST, hypertension, and rhinitis. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact American Regent, Inc. at 1-800-734-9236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch DRUG INTERACTIONS • Concomitant use with anticoagulants may increase the risk of serious GI bleeding. (7.1) * * * * SEE ADDITIONAL INFORMATION BELOW AND FULL PRESCRIBING INFORMATION. Limitations of Use. The total duration of use of SPRIX® alone or sequentially with other formulations of ketorolac (IM/IV or oral) must not exceed 5 days because of the potential for increasing the frequency and severity of adverse reactions associated with the recommended doses. Treat patients for the shortest duration possible, and do not exceed 5 days of therapy with SPRIX®. SPRIX® must not be used concomitantly with other forms of ketorolac or other NSAIDs. CONTRAINDICATIONS • Use in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation, and in patients with a history of peptic ulcer disease or gastrointestinal bleeding

DOSAGE AND ADMINISTRATION

• Use in patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs

• For adult patients < 65 years of age: 31.5 mg (one 15.75 mg spray in each nostril) every 6 to 8 hours. The maximum daily dose is 126 mg. (2.2)

• Use as a prophylactic analgesic before any major surgery

• For patients > 65 years of age, renally impaired patients, and patients less than 50 kg (110 lbs): 15.75 mg (one 15.75 mg spray in only one nostril) every 6 to 8 hours. The maximum daily dose is 63 mg. (2.3) • SPRIXX® has not been shown to be safe and effective in pediatric patients. (2.1) • SPRIX® nasal spray should be discarded within 24 hours of taking the first dose, even if the bottle still contains some medication. (2.4)

• Use during the perioperative period in the setting of coronary artery bypass graft (CABG) surgery. Use in patients with advanced renal disease or patients at risk for renal failure due to volume depletion • Use in labor and delivery. Through its prostaglandin synthesis inhibitory effect, ketorolac may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage

DOSAGE FORM AND STRENGTHS

• Use in nursing mothers because of the potential adverse effects of prostaglandin-inhibiting drugs on neonates

Nasal spray: 15.75 mg of ketorolac tromethamine in each 100 μL spray. Each 1.7 g bottle contains 8 sprays. (3)

• Use in patients a with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or those for whom hemostasis is critical

CONTRAINDICATIONS • Known hypersensitivity to ketorolac, aspirin, other NSAIDs, or EDTA (4, 5.5, 5.7, 5.11)

• Known hypersensitivity to ketorolac tromethamine, aspirin, to other NSAIDs or ethylenediamine tetraacetic acid (EDTA) T

• Use in patients with active peptic ulcer disease, recent GI bleeding or perforation, or a history of peptic ulcers or GI bleeding (4, 5.2)

• Concomitant use with probenecid or pentoxifylline W WARNINGS AND PRECAUTIONS

• Use in patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (4, 5.5, 5.7, 5.11)

Gastrointestinal (GI) Effects - Risk of Ulceration, Bleeding, and Perforation

• Use as a prophylactic analgesic before any major surgery (4, 5.3) • Use during the perioperative period in the setting of coronary artery bypass graft (CABG) surgery (4, 5.6) • Use in patients with advanced renal disease or patients at risk for renal failure due to volume depletion (4, 5.4, 5.6) • Use in labor and delivery (4, 5.8) • Use in patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis, and those at high risk of bleeding (4, 5.3) W WARNINGS AND PRECAUTIONS • SPRIXX® should not be used concomitantly with IM/IV or oral ketorolac, aspirin, or other NSAIDs. (5.1) • Ketorolac can cause serious GI adverse events including bleeding, ulceration, and perforation. SPRIX® should be prescribed with caution in patients with a prior history of ulcer disease or GI bleeding. Elderly patients are at greater risk for serious GI events. (4, 5.2) • NSAIDs affect platelet aggregation and may cause bleeding complications. SPRIX® should be used with caution in patients who have coagulation disorders or are on therapy that affects hemostasis. Do not use SPRIX® in patients for whom hemostasis is critical. (4, 5.3) • Ketorolac can cause renal injury. SPRIX® should not be used in patients with advanced renal disease or patients at risk for renal failure due to volume depletion, and should be used with caution in patients taking diuretics or ACE inhibitors. (4, 5.4, 12.4) • Anaphylactoid reactions may occur in patients with or without a history of allergic reactions to aspirin or NSAIDs. SPRIX® should be discontinued immediately in patients with allergic reactions. (4, 5.5, 5.7, 5.11) * Numbers refer to section of full prescribing information.

SPRIXX® is contraindicated in patients with previously documented peptic ulcers and/or GI bleeding. Ketorolac tromethamine can cause serious GI adverse events including bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. The incidence and severity of GI complications increases with increasing dose of, and duration of treatment with, ketorolac. In addition to past history of ulcer disease, other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients, and therefore, special care should be taken in treating this population. To T minimize the potential risk for an adverse GI event, the lowest effective dose should be used for the shortest possible duration. For high risk patients, consider alternate therapies that do not involve NSAIDs. Use great care when giving SPRIXX® to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn’s disease) as their condition may be exacerbated. a Hematological Effects. Use caution with use of ketorolac tromethamine in patients who have coagulation disorders, and monitor these patients carefully. Postoperative hematomas and other signs of wound bleeding have been reported in association with peri-operative use. Therefore, use SPRIX® with caution in the postoperative setting when hemostasis is critical. Do not use SPRIX® in patients for whom hemostasis is critical. Renal Effects. Ketorolac and its metabolites are eliminated primarily by the kidneys. Patients with reduced creatinine clearance will have diminished clearance of the drug. SPRIX® is contraindicated in patients with advanced renal impairment. Patients treated with SPRIX® should be adequately hydrated. Use SPRIX® with caution in patients with impaired renal function, heart failure, liver dysfunction, those taking diuretics or ACE inhibitors, and the elderly. Long-term administration of NSAIDs has

Cardiovascular Effects • Cardiovascular (CV) Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious CV thrombotic events, myocardial infarction and stroke, which can be fatal. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. • Hypertension NSAIDs can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. • Congestive Heart Failure and Edema Fluid retention, edema, retention of NaCl, oliguria, and elevations of serum urea nitrogen and creatinine have been reported in clinical trials with ketorolac. Therefore, only use SPRIX® very cautiously in patients with cardiac decompensation a or similar conditions. Skin Reactions. NSAIDs, including ketorolac, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin manifestations, and discontinue use of the drug at the first appearance of skin rash or any other sign of hypersensitivity. Pregnancy. Starting at 30 weeks gestation, SPRIX® can cause fetal harm when administered to a pregnant woman due to an increased risk of premature closure of the ductus arteriosus. If SPRIX® is used at or after 30 weeks gestation, the patient should be apprised of the potential hazard to a fetus. Hepatic Effects. Use SPRIX® with caution in patients with impaired hepatic function or a history of liver disease. Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs, including ketorolac. In addition, rare cases of severe hepatic reactions, including jaundice, fulminant hepatitis, liver necrosis, and hepatic failure, some of them with fatal outcomes, have been reported. Inflammation and Fever. The pharmacological activity of SPRIX® in reducing inflammation and fever may diminish the utility of these diagnostic signs in detecting infections. Preexisting Asthma. Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm which can be fatal. Since cross reactivity, including bronchospasm, between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, a do not administer SPRIXX® to patients with this form of aspirin sensitivity, and use with caution in patients with preexisting asthma. Eye Exposure. Avoid contact of SPRIX® with the eyes. If eye irritation occurs, wash out eye with water or saline, and consult a physician if irritation persists for more than one hour. ADVERSE REACTIONS The most frequently reported adverse reactions were related to local symptoms, i.e., nasal discomfort or irritation. These reactions were generally mild and transient in nature. The most common drug-related adverse events leading to premature discontinuation were nasal discomfort or nasal pain (rhinalgia).The data described below reflect exposure to SPRIXX® in patients enrolled in placebo-controlled efficacy studies of acute pain following major surgery. Most patients were receiving concomitant opioids, primarily PCA morphine. Table 1. Post-operative Patients with Adverse Reactions Observed at a rate of 2% or more and at least twice the incidence of the placebo group.

SPRIX® (N=455) Placebo (N= 245) Nasal discomfort

15%

Rhinalgia

13%

<1%

Lacrimation increased

Throat irritation

<1%

Oliguria

Rash

<1%

Bradycardia

<1%

Urine output decreased

<1%

ALT and/or AST increased

Hypertension

Rhinitis

<1%

GENERALSURGERyNEWS.COM / GENERAL SURGERy NEWS / JANUARy 2012

In controlled clinical trials in major surgery, primarily knee and hip replacements and abdominal hysterectomies, seven patients (N=455, 1.5%) treated with SPRIX® experienced serious adverse events of bleeding (4 patients) or hematoma (3 patients) at the operative site versus one patient (N=245, 0.4%) treated with placebo (hematoma). Six of the seven patients treated with SPRIX® underwent a surgical procedure and/or blood transfusion and the placebo patient subsequently required a blood transfusion. DRUG INTERACTIONS Ketorolac is highly bound to human plasma protein (mean 99.2%). There is no evidence in animal or human studies that ketorolac induces or inhibits hepatic enzymes capable of metabolizing itself or other drugs. Warfarin, Digoxin, Salicylate, and Heparin. Therapeutic concentrations of digoxin, warfarin, ibuprofen, naproxen, piroxicam, acetaminophen, phenytoin, and tolbutamide did not alter ketorolac protein binding. Aspirin. When ketorolac is administered with aspirin, its protein binding is reduced, although the clearance of free ketorolac is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of SPRIX® and aspirin is not generally recommended because of the potential of increased side effects. Diuretics. Clinical studies, as well as postmarketing observations, have shown that ketorolac can reduce the natriuretic effect of furosemide and thiazides in some patients. Probenecid. Concomitant administration of oral ketorolac and probenecid resulted in decreased clearance and volume of distribution of ketorolac and significant increases in ketorolac plasma levels (total AUC increased approximately threefold from 5.4 to 17.8 mcg/h/mL), and terminal half-life increased approximately twofold from 6.6 to 15.1 hours. Therefore, concomitant use of SPRIX® and probenecid is contraindicated. Lithium. NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance was decreased by approximately 20%. Thus, when SPRIX® and lithium are administered concurrently, observe patients carefully for signs of lithium toxicity. Methotrexate. NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Use caution when SPRIXX® is adminitered concomitantly with methotrexate. ACE Inhibitors/Angiotensin II Receptor Antagonists. Concomitant use of ACE inhibitors and/or angiotensin II receptor antagonists may increase the risk of renal impairment, particularly in volume-depleted patients. Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors and/or angiotensin II receptor antagonists. Consider this interaction in patients taking SPRIX® concomitantly with ACE inhibitors and/or angiotensin II receptor antagonists. Antiepileptic Drugs. Sporadic cases of seizures have been reported during concomitant use of ketorolac and antiepileptic drugs (phenytoin, carbamazepine). Psychoactive Drugs. Hallucinations have been reported when ketorolac was used in patients taking psychoactive drugs (fluoxetine, thiothixene, alprazolam). Pentoxifylline. When ketorolac is administered concurrently with pentoxifylline, there is an increased tendency to bleeding. Therefore, concomitant use of SPRIX® and Pentoxifylline is contraindicated. Nondepolarizing Muscle Relaxants. In postmarketing experience there have been reports of a possible interaction between ketorolac and nondepolarizing muscle relaxants that resulted in apnea. Selective Serotonin Reuptake Inhibitors (SSRIs). There is an increased risk of gastrointestinal bleeding when selective serotonin reuptake inhibitors (SSRIs) are combined with NSAIDs. Fluticasone/Oxymetazoline. The rate and extent of absorption of ketorolac from SPRIX® administration were assessed in subjects with allergic rhinitis before and after the administration of a single daily dose of fluticasone and oxymetazoline. There was no effect on the pharmacokinetic characteristics of SPRIX® that can be considered clinically significant. DRUG ABUSE AND DEPENDENCE Ketorolac does not bind to opiate receptors. Symptoms and Signs. Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur.r Hypertension, acute renal failure, respiratory depression, and coma may occur, but are rare. Treatment. Manage patients using symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. PATIENT COUNSELING INFORMATION Instruct patients to read the NSAID Medication Guide that accompanies each prescription dispensed.

BS8880A Revised 7/2011

Distributed by: American Regent, Inc. Shirley, NY 11967

icD-10

Continued from page 1 Health Problems, 10th Revision, contains approximately 68,000 codes and its implementation is slated for October 2013. ICD-10 will replace ICD-9, which has 14,000 codes. The resolution presented at AMA’s 2011 Interim Meeting asked that the AMA “vigorously work to stop the implementation of ICD-10 and to reduce its unnecessary and significant burdens on the practice of medicine,” and that the AMA “do everything possible to let the physicians of America know that the AMA is fighting to repeal the onerous ICD-10 requirements on their behalf.” The resolution further asks that the AMA work with other national and state medical and informatics associations to assess an appropriate replacement for ICD-9. Delegates were vocal about their disdain for ICD-10 during the Legislative Advocacy Committee meeting, which they view as overly complex, burdensome to their practices, expensive to implement and worthless in terms of patient care. For example, Jeff Terry, MD, a urologist from Mobile, Ala., questioned, “Who cares if your concussion is secondary to a lamppost or to the iron that your wife threw at you?” Mike Green, MD, of Macon, Ga., agreed. “It doesn’t take an expert in coding to review this and ask, ‘Do we really need to know what kind of dog bit you to be able to code a dog bite?’” Dr. Terry summed up the feelings of the committee members: “ICD-10 does nothing to improve the care of our patients. It simply adds unnecessary paperwork, time and expense to our practices.” Members also criticized the expense of implementing ICD-10, which is projected at $83,000 for a three-physician office and $285,000 for a 10-person group. “Our eight-physician group barely has its head above water. With ICD-10, we will be under water, and how will that help our patients?” Dr. Terry said. “The fact is, this will be an absolute disaster for the physicians in this country,” added David Teuscher, MD, an orthopedic surgeon with Beaumont Bone and Joint Institute in Beaumont,

in the news

Texas. “And it will be a boondoggle for researchers and RAC (Recovery Audit Contractor) auditors. Already, our physicians can’t understand ICD-9. What will happen when we implement the new version?” Dr. Teuscher agreed that the cost of implementation will be a burden. “This comes off the bottom line ... with no appreciable improvement in clinical outcomes or safety. It’s time for the AMA to stand up and loudly say ‘no.’” In addition to the expense of implementation, there is another form of financial fallout, the delegates predicted. “This will be used by every insurer in the country to deny payment, because with so many codes it’s simple to say, ‘You coded this wrong.’ At best, it will significantly delay payment,” said Dr. Green. “There are many practices in my area that run month to month. You interrupt the cash flow and the physician is either taking out a loan or closing his doors. It’s time the AMA told the government where they can shove this,” he said. Dr. Terry said that opposition to ICD-10 is not only a “crisis” but also an “opportunity” for the AMA to provide something of value to its membership. “I am concerned that our AMA is floundering in a sea of political correctness and compromise. I see this resolution as one of the ways to start setting a new tone,” he said. “Our lobbyists need to take this to Capitol Hill with a forceful message and not a defeatist attitude.” Robert Wah, MD, chair of the AMA Board of Trustees, said one of the reasons for the widespread frustration is that ICD-10 implementation coincides with other immense pressures on physicians. “Our environment is one in which we are asking physician practices to employ electronic medical records and to find innovative delivery systems such as accountable care organizations and medical homes. Now, within this milieu, we have to change to an entirely new coding system. That is layer on layer of significant stress,” said Dr. Wah. Although one of the reasons for the backlash against ICD-10 is the perception that ICD-11 is just around the corner, Dr. Wah pointed out that the diagnostic code revisions are a “multiyear process” and that mandated use of ICD-11 would not be expected for years.

opinion spAm

GENERALSURGERyNEWS.COM / GENERAL SURGERy NEWS / JANUARy 2012

cAn

Ownership and labor never agree on any- strip away the thin veneer of status, and the thing. Ever. Only the possibility of mutual continued from page 1 self-destruction through financial ruin brings chief of surgery at Johns Hopkins and the management and labor together, and that only junior surgeon at Kaiser both serve at the spending your days operating and taking care of patients happens in the private sector that cannot tax or instead of keeping up with the latest machinations from print money. For 75 years, most surgeons were pleasure of a boss, punch a clock and central planning to separate you from the fruits of your small business owners. During the past decade, take fire training and corporate labor and control of your practice, ACOs are bundles of there has been a mass migration of surgeons providers who will receive a global payment for a specif- from ownership to employee status for well- compliance classes. ic patient encounter, like a cholecystectomy. Who will known reasons (too much educational debt, bill, receive and divide the money is uncertain, except reduced reimbursements, inability of young surgeons As an employee, the economic that it won’t be you, the surgeon. The only thing cer- to earn a living assisting, increased expenses, exorbitant imposition of discovery and trial tain is that like diagnosis-related groups, the sustainable malpractice premiums, the burden of compliance, etc). is also eliminated. To a smallgrowth rate, and relative value units, this latest iteration Now, more than 70% of surgeons work for someone business owner, sitting in court for in health care spending discipline will be gamed and else. Even though those with academic appointments three weeks as a defendant with no ultimately relegated to the alphabet graveyard of design- seem to have chosen a dramatically different career path income while bills pile up on your er cost-containment programs invented by health poli- from those who work for Kaiser, a hospital or health desk is almost worse than the indigcy wonks who have an aversion to traditional medicine plan, they are all employees and share the values and nity of being sued. When you’re drawbased on the private doctor–patient relationship. I’ll say concerns of traditional labor. Strip away the thin veneer ing a salary and someone else is paying this much for them: They are undeterred by their unbro- of status, and the chief of surgery at Johns Hopkins and the practice expenses, three weeks in ken string of failures. Maybe they’re Cubs fans. the junior surgeon at Kaiser both serve at the pleasure trial that starts at 10 a.m. and ends at 4 These regulatory engineers keep trying, and with the of a boss, punch a clock and take fire training and cor- p.m. with 90 minutes for lunch Monday through borrowing power of the U.S. government behind them porate compliance classes. Thursday, unless the judge has a dental appointment, (even with the recent downgrade), there will be plenty If, in the past, you felt a kinship to the people whom can be a relief from the daily grind. Working in a sysof money and prerequisites to pass around to enthusi- you met in the surgeons’ lounge, it was not only because tem also depersonalizes malpractice actions because the asts and early adopters. I don’t think private contract- you shared the common experience of training and entity is the defendant. In the Kaiser system, the plaining and balance billing require any further explanation practice, but also because you had the common val- tiff ’s case is brought against Kaiser and its employees. It to you working stiffs out there who know what they are, ues, aspirations and headaches typical of small-business is not necessary to single out the emergency room docwant them, but won’t get them if the professional orga- owners. You worried about whether or not Mrs. Jones tor, nurse, hospitalist, internist, anesthesiologist or surnization that represents you prevails. was going to rebleed, but you also worried about pay- geon. Nasty finger pointing among co-defendants who So how can it be that the ACS and the specialty roll, hiring a new office manager, finding reliable ven- are colleagues has no strategic value and is eliminated. societies are so far apart across this acrimonious divide dors and whether or not to renew your lease or buy into With all the defendants lined up like fish in a barrel, when their interests should be aligned? Aren’t we all sur- an equity position in an office building with other doc- the job of the plaintiff ’s lawyer is easier and cheapgeons with shared interests? Isn’t it more than odd that tors. This second layer of shared experience amplified er. Are you surprised the plaintiff ’s lawyer winds up the leadership of the ACS seems to be on the opposite character traits acquired through the practice of surgery being the main beneficiary from the shifting attitudes side from its membership on two issues of fundamental itself: independence, self-reliance, accountability, and an among surgeons concerning the litigation crisis? Intracimportance? The explanation for this is that the lead- aversion for idleness and the unimportant. Being a sur- table problems rarely get solved. Problems cease when ership of the ACS and the specialty societies represent geon and running your own business also informed atti- those affected have a change in circumstances or pertwo distinct groups of surgeons from different eras with tudes about what was going on outside the hospital in ception. Replace surgeons in private practice with surdifferent core values and attitudes concerning the signa- politics, family and community. geons who don’t pay their own insurance premiums and ture health care issues of our time: health care reform, During this rapid transformation of the surgeon the malpractice crisis for doctors becomes a line item tort reform, life–work balance, compensation and out- from the ownership class to labor, accelerated by the expense for ownership. You can argue about the wisside secular influence in medical decision making. If you changing demographics of surgeons themselves, it is dom of replacing the court system with medical tribustand at the divide between the ACS and its compos- not surprising that attitudes have shifted dramatically nals, limiting damages for noneconomic awards and the ite specialty societies, all the traffic of young surgeons on almost all hot-button health care issues, as well as ultimate cost of defensive medicine, but it all becomes is moving away from the specialty societies that oppose political and social ones. Put bluntly, ownership favors academic to the surgeon when the boss starts paying ACOs and advocate for balance billing and private con- the Republican agenda and labor favors the Democratic the bills. tracting to stay alive. agenda. The most striking example is the shift in attiWhat’s happening to the surgical communiWhat’s responsible for this mass migration of young tude about tort reform. Only 18 months ago, the ACS ty reminds me of how the Chinese solved the Tibet surgeons? Simply put, in a remarkably short period of did not support the Patient Protection and Afford- problem. What promised to be a hundred years’ war time, the surgical workforce has been transformed by able Care Act (PPACA) because of the absence of tort of Tibetan resistance melted as a result of incentivizmacroeconomic factors from the ownership class to reform, but now that it is the law of the land, the ACS ing intermarriage between Chinese men and Tibetan the labor class. Collective values and attitudes among seems to have accommodated to it remarkably quickly. women. Within two generations, only Brad Pitt and surgeons who no longer work for themselves as small The absence of tort reform seems mysteriously to have Angelina Jolie remember the Chinese occupation, and business owners embrace the classical labor tradition of lost its sting. even the Dalai Lama can’t get into the White House being more concerned with working conditions than A politician recently complained to me she couldn’t through the front door. My guess is the ACS underwork, benefits more than revenues and profit, retirement get doctors riled up about tort reform anymore. It used stands the shift in status of its members from smallmore than career, process more than product, security to be the one issue she could count on to get the MDs business owners to employees, so it is confident the more than growth and conformity more than originality. agitated across almost all gender, age, ethnic and spe- standoff with the specialty societies will blow over in cialty lines. I explained to her the answer time. As more and more surgeons work for someone is simple: The doctors are not paying their else, they will align themselves with the ACS’ apparent you can argue about the wisdom of replacing premiums anymore, their bosses are. The apathy about tort reform, its support of ACOs and its the court system with medical tribunals, limiting days of opening the envelope from the opposition to private contracting. insurance company and gagging while The new breed of surgeons will also be more accomdamages for noneconomic awards and the you converted the premium to surgical modating to government interference in the practice of units are over (how many carotids am I medicine, specifically to the 15-member independent ultimate cost of defensive medicine, but it all to have to do to pay this monster advisory board that is a central element to PPACA. becomes academic to the surgeon when the boss going with premiums going up and fees going Like the Tibetans, the opposition from the specialty down!). I doubt the majority of surgeons societies will disappear as older members die out and starts paying the bills. even see their premium notices anymore. get replaced with younger members with the collective

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consciousness of labor instead of ownership. Perceptions about work-hour restrictions and cookbook medicine are similarly rapidly changing in the new surgical culture. If the entrepreneur is flexible and energetic, ready for anything, labor wants duties and responsibilities clearly defined, even if by an outside authority. Clearly defined duties and responsibilities conform nicely into

swagger cannot be made even though all our internal medicine colleagues have tried. The current leadership of the ACS clearly supports the sentiments expressed by Dr. Russell in “That Was Then, This Is Now,” even though for the time being it puts itself in direct conflict with the specialty societies. Because Dr. Russell and the ACS seem so concerned with “transparency,” the ACS should clearly articulate its position on how it views the future for its members. It needs to explain the reasons for which it went public against PPACA but now appears to be on board with most of its provisions. It needs to explain why it wants contributions to its political action committee (PAC) if the ACS and its political arm are not fighting for what donors seem to want. It seems that most of us believe the PAC is fighting for what was right for “then” but the leadership has shifted over to what it wants for “now.” Do most members of the ACS know that the organization is in favor of ACOs and against balance billing? Is this the advocacy our contributions are supporting? While we’re on the issue of “transparency,” the ACS needs to disclose whether or not it sees its future as a regulatory body called on by this government to monitor surgeons or as a professional organization committed to promoting surgery and surgeons. Does the ACS intend to model itself after the American Medical Association (AMA), which has enormous political clout despite no membership to speak of? The AMA receives $60 million per year from Medicare by licensing its Current Procedural Terminology codes and has been assured i understand the appeal continued licensure for early the “shift mentality” circumscribed by a civ- of having your hands on and vigorous support of ilized workweek of no more than 80 hours. PPACA. The money frees If you mentioned the 80-hour week to the the controls, and in fact the AMA up from having surgeon–small-business owner just a few have relished it for the to support positions popushort years ago, you could count on apopleclar with doctors in order to tic seizure activity. We all knew that a seven- past 30 years, but i admit attract and retain members. year, 24/7 residency was unnecessary to learn you can’t get to the moon There will be other what you needed to know. It was the impoopportunities for professition of outside rule on the profession that in an F-15. sional organizations to cash caused the initial outrage. Now, as employin on support of PPACA, ees, 68 hours seems acceptable, with mandatory napping mostly in areas of compliance, maintenance of certifithrown in. cation (MOC) and record keeping. These opportunities Read the truly remarkable piece, “That Was Then, will alter the relationship between leadership and memThis Is Now,” by Tom Russell, MD, former executive bership from one of collaboration to supervision. Interdirector of the ACS (J Am Coll Surg 2011;213:205- necine warfare has already broken out in family medicine 211), in which he enumerates the multiple advantages and internal medicine because their boards have conof moving surgeons out of the shadows of old-fashioned tracted to supervise MOC by enforcing requirements “silos” (private practice) into the sunshine of large, inte- the membership has deemed to be disruptive to their grated care organizations. I don’t think anyone has ever practices and educationally bankrupt. The online blogs made a better case against what I would call the lega- of the family and internal medicine communities reflect cy of “surgical exceptionalism,” that derived from surviv- the same feeling of betrayal that hung so heavily in the ing our training and mastering our craft in the service air during the conference call I listened in on. The leadof seriously ill patients. We saw ourselves differently ership of the ACS also needs to understand, despite Dr. from internists, pediatricians and radiologists. We val- Russell’s assertions, that what it deems to be inevitable ued our services differently, as did the open market. We organic change toward the better is nothing more than had what we thought was richly deserved swagger. Dr. a specific political philosophy that can be overturned by Russell defines the old era of surgical exceptionalism as regime changes or judicial fiat. There is a great moral being driven by the need for “authority,” “autonomy” and hazard in trying to convince membership to see the light “control,” whereas the new era to which he invites us is and change instead of advocating for the needs of the defined by “compliance,” “evidence,” “collaboration” and current membership. “transparency.” He clearly assigns a higher value to the I’m not here to debate the virtues of the “then” and the new era because, in his view, the values of the old sys- “now” in Dr. Russell’s piece, even though he seems to be tem encouraged greed, selfishness and an insensitivity to quite certain that the “now” will be superior to the “then” the needs of patients, whereas the new era of collabora- in every regard. Will surgery progress more rapidly with tion, evidence and transparency encourage quality, com- surgeons as employees rather than small-business ownpassion and accountability. A better case against surgical ers? The conversation borders on whether government

or the private sector should be counted on to create jobs and reduce debt. The contributions of technology aside, I wouldn’t expect much from the employee-surgeon. Labor doesn’t have a strong history of innovation or quality or “transparency.” Working in groups might earn better grades for citizenship, but the work product of labor in a noncompetitive system where the worker has no skin in the game has always been suspect. History will judge if the next era surpasses the last. The old order was not only colorful, but also clearly massively productive. It is being dismantled for economic reasons largely unrelated to its performance, integrity or service to mankind. I’m reminded of Chuck Yeager, the fighter pilot, who refused to become an astronaut because he felt like “spam in a can” sitting in a module controlled by technicians in Houston at the mercy of a million pounds of thrust with no joy stick to control. I understand the appeal of having your hands on the controls, and in fact have relished it for the past 30 years, but I admit you can’t get to the moon in an F-15. It is also true that if we feel diminished as surgeons by being forced to work for someone else, we would have had to deal with the same feelings anyway, as open surgery is being replaced by robots and less-invasive therapies where the skill and mettle of the operator is less important than the tools. There is no doubt that technology, conceived by man for the benefit of mankind, ultimately requires less and less from us to get the job done. We are not alone. In the military, drones are replacing boots on the ground. It’s unlikely we’ll see another Mr. Yeager or General George Patton for that matter because extraordinary skill and temperament are no longer required. Science will prevail. There will be a cure for cancer, organs will be replaced and we’ll live longer. Surgeons won’t be heroes, however, like they were in the first big leap forward, and in that sense, accommodation and collaboration will be more important skills. Hard to get my mind around surgeons punching clocks. It is ironic that for 50 years, the community of doctors was always referred to as “organized medicine” when we were anything but organized. What has happened to us during the past 20 years could only have occurred in the absence of any meaningful organization. There are a million reasons why we weren’t organized when we should have been because even small-business owners in the secular world recognized the need for a Chamber of Commerce to advance and protect their interests. There must be something in our professional DNA that blinded us to our own self-interest. Perhaps it was just arrogance or misguided sense of invulnerability. Maybe it was the oath we took. It is equally ironic that as surgeons morph into the employee class, surgeons will inevitably organize as labor, if not alone, then with other providers. Labor always understands vulnerability, and organizing is its only tool. As I read the pronouncements from the ACS, I don’t think the leadership sees itself as the leader of labor, however. I sense loftier goals, deeper ambition. I think it senses new opportunities with central planning. Where does that leave us? Most of us thought the missions of the ACS were to set standards, defend quality and promote the American surgeon who proudly joined the organization. But, “that was then, and this is now.” —Dr. Cossman is a vascular surgeon in Los Angeles.

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Letters

January 2012

Treating Patients, Not Charts [Editor’s note: The following letter was originally posted at www. anesthesiologynews.com.] [Re: Lessons Learned in the Peace Corps, October 2011, page 1] I feel that the issues discussed by Dr. [ Jon] White demand serious consideration and rigorous debate. The regulatory state has become burdensome to the point where I sincerely think we put our patients at risk. Our time can only be divided so many ways. I think that perhaps the “boiling a frog” analogy pertains—the amount of nonessential stuff that we must do lest we are threatened with loss of CMS funding (or of losing our licenses) has ballooned exponentially, but in small, often imperceptible, yet ever increasing increments over a long period of time, in my opinion, to the detriment of patient care. I suspect that good studies will bear this out. Let’s see some studies on the degree of morbidity and mortality caused by Joint Commission regulations, which are created, ironically, in the name of “patient safety.” There is an awful lot of anecdotal evidence of damage done. As with any overreaching, thirdparty payer/insurance, lawyer-driven, largely self-serving, self-perpetuating bureaucratic state, the unintended consequences of perhaps well-meaning, but misdirected, administrators and regulators, ends up causing untold damage. I encourage a more vigorous debate on the current state of regulatory and administrative burden. Let’s stop and think about all the unessential things that we must do all day to satisfy some agency or to protect ourselves from lawyers. Why are we rewarded for “documenting” and not for our bedside manner or the amount of time we devote to just being with our patients? It was proposed at my private hospital at a meeting last week that the physicians need paid assistants who follow them through the day just to do the endless documentation required now by law. The fact that this was taken seriously suggested to me that, indeed, the king has no clothes. Why are we treating charts instead of people? Let’s consider how much more time we could be giving to devoting ourselves to our raison d’etre, what most of us spent the best years of our lives training to do—our essential task of diagnosing and treating patients at the bedside. William Brown, MD Forest, Virginia

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