1. AATS/STS Congenital Heart Disease Symposium: Unsettled and Unanswered Questions in Congenital Heart Surgery Lessons Learned from the SVR Trial: Update at Three Years Richard G. Ohye, M.D. Head, Section of Pediatric Cardiovascular Surgery University of Michigan C.S. Mott Children’s Hospital Congenital Heart Center

2. Disclosure Sorin, Inc. –Medical Advisory Board (paid) Cryolife, Inc. –FDA panel testimony (unpaid) No off-label usage

3. LESSONS LEARNED FROM THE SVR TRIAL: UPDATE AT THREE YEARS AATS/STS Congenital Heart Disease Symposium: Unsettled and Unanswered Questions in Congenital Heart Surgery

4. SVR Trial

5. WHAT HAVE I LEARNED FROM THE SVR TRIAL? Lessons learned from the SVR Trial: Update at Three Years

6. I CAN DECREASE NORWOOD MORTALITY BY HALF… From what I learned from the SVR trial…

7. I CAN DECREASE NORWOOD MORTALITY BY HALF… …TOMORROW From what I learned from the SVR trial…

8. What We Learned Norwood Procedure transplant-free survival –Median 83% –Range 93%-61% –High Performing Centers 90% –Standard Performing Centers <80%

9. VOLUMES-OUTCOMES RELATIONSHIPS What else do we know?

10. Volumes-Outcomes Relationships

11. 2003 Kids’ Inpatient Database (KID) –Arterial Switch Operation n=547 74 hospitals (range of case #, 1-24) –Norwood Procedure n=624 60 hospitals (range of case #, 1-31)

12. Volumes-Outcomes Relationships Inverse relationship between volume and mortality –Arterial Switch Operation (p=0.006) 2 ASOs/yr – 9.4% mortality 10 ASOs/yr – 3.2% mortality 20 ASOs/yr – 0.8% mortality

13. Volumes-Outcomes Relationships Inverse relationship between volume and mortality –Norwood Procedure (p=0.001) 2 Norwoods/yr – 35% mortality 10 Norwoods/yr – 26% mortality 20 Norwoods/yr – 17% mortality

14. Volumes-Outcomes Relationships

15. Society of Thoracic Surgeons Congenital Heart Surgery Database (2000 to 2009) –2,555 patients –55 centers –111 surgeons

16. Volumes-Outcomes Relationships Lower center Norwood volume was associated with higher mortality –Odds ratio for centers with ≤10 vs. >20 cases/yr 1.56

17. Volumes-Outcomes Relationships Lower surgeon Norwood volume was associated with higher mortality –Odds ratio for surgeons with ≤5 vs. >10 cases/year 1.60

18. Volumes-Outcomes Relationships Adjusted mortality rates by center volume –0-10 Norwoods/yr - 26% –11-20 Norwoods/yr - 22% –>20 Norwoods/yr - 18%

19. Volumes-Cost Relationship

20. WHAT HAVE I LEARNED FROM THE SVR TRIAL? Lessons learned from the SVR Trial: Update at Three Years

21. PRACTICE PATTERN VARIATION What else did we learn?

22. What We Know

23. SVR Trial – Practice Pattern Variation Pre-Operative Variation –Intubation – Range 29-91% Operative Variation –CPB time – Range 78-188 minutes –Lowest HCT on CPB – Range 23-40% Post-Operative Variation –G Tube placement – Range 2-72% –Home monitoring – Range 1-100% Mortality during Norwood Hospitalization –Range 7-39%

24. Reducing Practice Pattern Variation Northern New England Cardiovascular Disease Study Group –The Northern New England Cardiovascular Disease Study Group exists to develop and exchange information concerning the treatment of cardiovascular disease. It is a regional, voluntary, multi-disciplinary group of clinicians, hospital administrators, and health care research personnel who seek to improve continuously the quality, safety, effectiveness, and cost of medical interventions in cardiovascular disease.

25. Reducing Practice Pattern Variation The Michigan Society of Thoracic and Cardiovascular Surgeons Quality Collaborative –MSTCVS Quality Collaborative Mission: The MSTCVS Quality Collaborative is a multidisciplinary group of medical professionals dedicated to improving the care of cardiac and general thoracic surgery patients in Michigan. The MSTCVS Quality Collaborative promotes and shares optimal processes of care and cardiac and general thoracic surgery outcomes and implements quality improvement initiatives based on regional and national data as well as clinical research and evidence based cardiac and thoracic surgery practice and guidelines.

26. Reducing Practice Pattern Variation Pediatric Heart Network Collaborative Learning Project –Early extubation following cardiac surgery –Developed a common Clinical Practice Guideline –Deploying CPG (5 centers)

27. Reducing Practice Pattern Variation Pediatric Cardiac Critical Care Consortium (PC4) –>25 Pediatric CICU –Common nomenclature –Collecting data –Real-time performance data –Developing best practices

28. WHAT HAVE I LEARNED FROM THE SVR TRIAL? Lessons learned from the SVR Trial: Update at Three Years

29. IT AIN’T ABOUT THE SHUNT Lessons learned from the SVR Trial: Update at Three Years

30. AATS/STS Congenital Heart Disease Symposium: Unsettled and Unanswered Questions in Congenital Heart Surgery Lessons Learned from the SVR Trial: Update at Three Years Richard G. Ohye, M.D. Head, Section of Pediatric Cardiovascular Surgery University of Michigan C.S. Mott Children’s Hospital Congenital Heart Center