Center of Excellence in Hernia Surgery Neil E. Hutcher, MD, FACS Chief Medical Officer Surgical Review Corporation Minimally Invasive Surgery Symposium Salt Lake City, Utah ▪ February 22,

Disclosures …Surgical Review Corporation: Chief Medical Officer; Chairman, Board of Directors …Stevens & Lee: medical consultant …Cook Biotech: research grant recipient (hernia prevention) 2

Hernias, A Growing Problem …Hernias are a major international medical problem …In the United States, 200,000+ hernia procedures are performed each year  Cost: $2.5 billion  Recurrence rate: 20-45% …Abdominal wall reconstruction is (and will be) increasing as a result of many factors  Aging population  Obesity epidemic  Abuse of tobacco and other substances  Widespread use of steroids and other immunosuppressants  Failure rate  Cost  Lack of consensus regarding best practices  Frequency  Morbidity  Complexity 3

Why a Center of Excellence Program? Improved patient care leads to better outcomes and decreased complications Better outcomes lead to decreased costs Reduction in surgeon stress and professional liability Reliable, prospective data leads to best practices and clinical studies Hernia society gains recognition for a quality initiative Increased surgical volumes Justify changes in reimbursement (centers of excellence will not only survive healthcare reform but will thrive) Marketing opportunities 4

What Justifies Forming a Center of Excellence Program? …Common procedure  2 million laparotomies per annum  11-20% incidence of incisional hernia …Complex operations (especially when recurrent) …High-risk patients …Evidence that high-volume centers have improved outcomes and are cost-effective …High-volume centers are more likely to have the needed multidisciplinary team 5

And most important of all… If you don’t do it yourself… someone will do it for you. 6

Comprehensive Requirements 1.Institutional commitment to excellence 2.Surgical experience and volumes 3.Designated medical director 4.Responsive critical care support 5.Appropriate equipment and instruments 6.Surgeon dedication and qualified call coverage 7.Clinical pathways and standardized operating procedures 8.Program coordinator, physician extenders and skilled nursing care 9.Pre- and postoperative patient education 10.Long-term patient follow-up, including a prospective, comprehensive outcomes database 7

 Wound/stoma care  Psychology/smoking cessation  Physical/rehab medicine  Critical care  Infectious disease  Nutritional support Major Issues to Resolve 8 …Requirement 2: Volumes  Surgeon training  Defining operations  Surgeon volume (open for discussion)  Lifetime: 200 complex hernia procedures  Annual: 75 complex hernia procedures  Facility volume (open for discussion)  Annual: 125 complex hernia procedures …Requirement 4: Multidisciplinary team …Requirement 10: Outcomes database

 Primary umbilical hernia  Initial incisional hernia  Recurrent incisional hernia  Re-recurrent incisional hernia  Infected/contaminated hernia  Loss of domain  Fistula/stoma takedown associated with hernia  Inguinal hernia if recurrent or strangulated Which Procedures Should be Covered and Counted? 9 ?

Outcomes Database …Characteristics  Comprehensive  Prospective  Longitudinal …Data use – follows data dissemination policies and procedures  Compliance  Research  Publications and presentations …Main tenets  Surgeons own their own data  Surgeon-specific data is never released to a third party without written permission 10

Why Is This Type of Database Needed? …None exist …Missing information in current operative notes …Conflicting studies and opinions …Poor long-term follow-up …High rates of recurrence and re-recurrence 11

“The Art of Herniology” General Surgery News, January 2012 Q: Do all biologic grafts heal the same?  Dmitry Oleynikov, MD: “Because there are so little data, the best advice I can offer is buyer beware.”  Michael J. Rosen MD: “I am not sure we currently know exactly how any biologic heals in all of the fields and locations we are placing them.” Q: Should asymptomatic inguinal hernias be repaired?  Karl A. LeBlanc, MD: “On the fence.”  B. Todd Heniford, MD: “As I tell patients almost every day, hernias do not fix themselves.”  Dr. Rosen: “In elderly patients, I ascribe to the watchful-waiting trial published by Fitzgibbons et al (JAMA 2006;295: ).” 12

“The Art of Herniology” General Surgery News, January 2012 Q: Is bridging wide gaps with mesh the Achilles heel of current laparoscopic techniques?  Dr. LeBlanc: “I agree.”  Dr. Rosen: “I agree 100%.”  Dr. Heniford: “I cannot say that this is true.”  Dr. Oleynikov: “On the fence.”  Michael G. Sarr, MD: “I agree.”  Parviz Amid, MD, and David Chen, MD: “On the fence.” 13

Hernia Op-Note Template …Name …Sex …Age …Race …BMI …Steroid use …Associated DX, DM, CHD, cancer …Smoking status (packs per day – years)  Last smoked …ETOH 14

Hernia Op-Note Template …Location of hernia  Zone/Zones …Primary …Dimensions metric  Length  Width …Recurrent  Number of recurrences …Access  Open  Laparoscopic  Combined …Component separation  Mesh  Synthetic  Biologic  Bovine  Porcine  Allograft  Type  Combined …Location  Extraperitoneal  Preperitoneal  Intraperitoneal …Operative time 15

Summary …Problem  Frequency  Complexity  Costs  Morbidity  Mortality  Economic  Unanswered questions  Need for data  Reality of healthcare changes Justifies creation and support of center of excellence program for hernia surgery 16 “You have to know what you don’t know.”

Thank You 17