Bariatric (Metabolic) Surgery must be “delivered” safely with minimal complications

1. John Hagen MD FRCS(C) Assistant Professor Surgery University of Toronto Bariatric (Metabolic) Surgery must be “delivered” safely with minimal complications

2. Disclosures • Honorarium- Covidien • Honorarium-Ethicon

3. Bariatric (Metabolic) Surgery must be “delivered” safely with minimal complications • Humber River Regional Hospital experience • Development of Centers of Excellence in USA • Surgical Review Corporation • Surgical training

4. Humber River Regional Hospital • Community hospital in the north of Toronto • Bariatric surgery program began in 1999 • Laparoscopic bariatric surgery began 2004 • Over 1100 laparoscopic gastric bypasses have been done with funding for 450 cases/year • 5 surgeons • Designated “Center of Excellence” by the Ministry of Health in Ontario

5. Surgical deaths • First 880 cases done with acceptable results • Over a 6 month period September 2009-February 2010 there were 5 deaths within 30 days of surgery • With the help of the coroner’s office, the program was shut down while an external review was done by a well known expert

6. Deficiencies in the program • Poor selection of patients • Medical conditions not optimized prior to surgery • Lack of integration between anaesthesia, internal medicine, surgery and bariatric clinic • Inadequate post-op monitoring • Diagnostic laparoscopy when problems occur not utilized enough

7. Deficiencies corrected • The program is up and running • Application to become “ACS Center of Excellence” has been made • Hiring of nurse practioners • Integration of the bariatric clinic with specialists and staff • What began as an “interest in laparoscopy” has been transformed into a program

8. Poor outcomes will not be tolerated Bariatric (metabolic) surgery must be “delivered” safely with minimal complications

9. Centers of Excellence • In the 1950’s and 1960’s results were less than ideal with small bowel bypass • Weight loss occurred, diarrhea, liver disease and malnourishment • High mortality rate • Bariatric surgeons were not viewed favorably by their colleagues

10. 1960’s-1990;s Bariatric surgery could be performed with few complications NIH recognized the effectiveness of bariatric surgery in its Consensus Statement of 1991

11. Early 2000’s • Celebrity patients- Carnie Wilson, Sharon Osbourne • Number of surgeries per year exploded from 4,900 in 1990 to 140,000 in 2003 • Then 200,000 cases in 2010 • Insurance companies started raising red flags • Some saw surgery as opportunity to fill OR blocks • Laparoscopic surgeons wanted to add weight loss surgery to their repertoire

12. Some surgeons took a weekend course and had no bariatric program in place • Higher mortality rate for inexperienced surgeons • With no bariatric program, and poor follow up, weight regain occurred frequently

13. www.gastric-bypass-surgery-lawsuits.com • “Surgeon not properly trained or experienced” • “Equipment not available for obese patients” • “Failure for a surgeon to respond immediately when problems arise” • “Surgery done for inappropriate reasons”

14. Establishment of Centers of Excellence • Standards for training and resources • The need to recognize the centers that perform well

15. 1. The hospital must have a high level of commitment and a regular program of in-service training 2. The hospital must perform 125 cases per year 3. There must be a Medical Director of Bariatric Surgery 4. A full team of specialists must be available 5. The hospital must have appropriate equipment

16. 6. The bariatric surgeon must be board certified 7. Bariatric surgery is to follow standardized procedures and clinical pathways 8. There must be a designated nurse or physician who is involved in continued care 9. There must be availability of a support group 10. The practice must follow up on 75% of patients after 5 years and show outcomes

17. Dr. Walter J. Pories

18. Walter J. Pories, MD, FACS Chairman of the Board Surgical Review Corporation Quality Control In Bariatric Surgery:Lessons Learned

19. The big lesson: 20th Century E=mc2 21st Century Data = Power

20. Two Major Epidemics: Obesity and Diabetes 1950 – 2000: Development of Bariatric and Metabolic Surgery. • Durable control of obesity with reduction of mortality • Full, durable remission of diabetes and other co-morbidities independent of weight loss • With remarkable safety

21. Weight Loss After Bariatric Surgery @ 16 Years (95% Followup) 106 lb

22. And Durable, Full Remission of Type 2 Diabetes Independent of Weight Loss 608 morbidly obese 146 Type 2 Diabetics 152 IGT “impaired” 150/152 (99%) euglycemic 121/146 (83%) euglycemic

23. Outcome: • Enthusiastic gratitude for the conquest of obesity and diabetes? • No

24. Crisis in 2003 • Carriers: Who will pay for this? • Colleagues: can’t be true • Variable outcomes in US • Press reports of complications • Increased litigation • Unaffordable malpractice premiums • Loss of access

25. The Carriers respond: • Could not deny the advances • Carriers develop Centers of Excellence Programs • Multiple Standards • Multiple Applications • Inadequate databases • Arbitrary Decisions • No sharing of data • Patients denied; surgeons hassled

26. The specialty responds • It’s up to us….. • How shall we proceed?

27. The specialty responds To win: • Must be able to document our results • But we do not have the information • Selected data were from major centers • Overcome variable levels of care in U.S. • Without information • We cannot improve • We cannot defend

28. A Major Challenge

29. The Process Must Be • Credible • Useful • Clinically reasonable • Economic • Ethical/Confidential

30. What is a Center of Excellence? • Centers = Surgeons + Hospitals • One level of excellence throughout US • Full resources must be available • Standardization of operations and care • Required reporting of all cases • A large, reliable database (BOLD) • Data verified by site inspections • Utilization of data for improvement of care, research, negotiations

31. Response • OK. We can do it. • The American Society of Bariatric Surgery will develop its own Centers of Excellence Program • Not so fast: • Restraint of trade issues • Legal vulnerability of the Society • Credibility(Fox guarding the hen house)

32. Response • A separate, non-profit, transparent organization • Policy: Board of Directors with stakeholders on the Board • Surgical Decisions: A Review Committee of experienced, respected surgeons • Corporate Structure to manage the complex programs • Nov. 2003: THE SURGICAL REVIEW • CORPORATION

33. SRC: Four Divisions • Clinical Quality and Compliance • Strategic Alliances • Operations • Research

36. Bariatric Surgeons and their Hospitals Demonstrate Overwhelming Support Total applicants 719 Hospitals, 1,235 Surgeons Centers of Excellence 233 Hospitals 458 Surgeons Applicant Patient Data Base 108,200+ patients Cost $8.75 per patient

37. Performance of 210 Centers Based on Applications Data

38. ASMBS Centers of Excellence Outcomes based on BOLD data DeMaria, EJ.  Baseline data from ASMBS-designated bariatric surgery centers of excellence using the Bariatric Outcomes Longitudinal Database.  Paper presented at:  26th Annual Meeting of the American Society for Metabolic and Bariatric Surgery; June 24, 2009; Grapevine, TX.

39. Mortality rates following common operations in U.S. hospitals ] [i] Dimick JB, Welch HG, Birkmeyer JD. Surgical mortality as an indicator of hospital quality. JAMA 2004,292, 847-851 SRC: Bariatric Surgery Mortality 0.3% (55,567 patients) 106 Hospitals reporting Average Case Load: 312 cases/year

40. Mortality rates across OntarioCancer Care Ontario

41. So Far, So Good • 2006: Medicare and Medicaid granted National Coverage Determination (NCD) • SRC (and ACS) named a CMS Certifying agency • Favorable coding changes • Carriers are listening and negotiating • SRC asked to manage some carriers’ COE programs • Improved access, improved care

42. But the fight is not over • SRC is vigilant and responds • Carriers constantly try other approaches to limit access • Benefit packages, co-pays, etc. • Responding with Education • Patients • Public • Colleagues

43. Summary • To care for our patients • To improve our care • To negotiate fair contracts • To preserve our profession • We need reliable information • The Surgical Review Corporation is meeting that challenge

44. Data = Power

45. The Gold Standard

46. Further Definitions • The first organized effort by a professional society to improve care through cooperation with colleagues, hospitals, the government and industry stakeholders • A Centers of Excellence effort based on outcomes verified by site inspections • BOLD: A software program that is affordable, includes widely agreed upon definitions, allows measurable population data analysis and, most important, avoids free text entries • Clear documentation that the effort now delivers bariatric surgical care to the US, in spite of the severe risks characteristic of these patients, with the safety of cholecystectomies • Data owned by surgeons, available to surgeons in their negotiations with payers, malpractice carriers ---finally providing a basis for fair negotiation • The framework for future, consortium, prospective controlled studies in real time. • The admiration of industry, the government and the payers.

47. SRC Statistics Total Applicants: 1,110 Hospitals 1,922 Surgeons Centers of Excellence: 405 Hospitals 697 Surgeons ICE Centers located in United Kingdom, Taiwan and Brazil BOLD Database: 210,050+ Patients Entered Over 12,000 new patients entered each month 969 surgeons and 724 facilities using BOLD

48. Quality IndicatorsSt. Mary’s Hospital, Richmond, VA

50. How do we train surgeons? • Guidelines of Institutions Granting Bariartic Privileges Utilizing Laparoscopic techniques • SAGES 07/2009