1. Mitral Valve Surgery: Lessons from New York State Joanna Chikwe, MD Professor of Cardiovascular Surgery Icahn School of Medicine at Mount Sinai Chairman & Program Director Department of Cardiovascular Surgery Mount Sinai St Luke’s

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3. Disclosures Icahn School of Medicine at Mount Sinai receives royalties from Edwards Lifesciences and Medtronic for Dr. David Adams’ involvement in developing two mitral valve repair rings and one tricuspid valve repair ring. Dr. David Adams is the National Co-Principal Investigator of the CoreValve United States Pivotal Trial, which is supported by Medtronic. None of the sponsoring organizations had any role in the design and conduct of the study. None of the other authors have any conflicts of interest to disclose.. 3

4. Background In non-elderly patients undergoing mitral valve replacement, the optimal prosthesis type is controversial. 1,2 Current guidelines recommend either mechanical or bioprosthetic valves in patients under 70 years of age, 3,4 and state that the balance of risks favors mechanical valves in patients <60 years. 3 4 1 Kaneko, Cohn & Aranki, Circulation 2013 2 Suri & Schaff, Circulation 2013 3 Nishimura, Otto, & Bonow et al, JACC 2014 4 Vahanian, Alfieri, & Andreotti et al, Eur Heart J 2012

5. Current evidence base 5 StudySettingAge rangePatientsSurvival Oxenham et al Heart, 2003Randomized 1975-1979 56-79AVR: 211 MVR: 261 Both: 61 Mech (overall): 25.0% Bio (overall): 22.6% (p=0.39) at 20 years Hammermeister et al JACC, 2000 Randomized 1977-1982 56-79AVR: 394 MVR: 181 Mech (MVR): 19% Bio (MVR): 21% (p=0.30) at 15 years Kaneko et al JTCVS, 2014Cohort 1991-2012 <65MVR: 250Mech: 62.6% Bio: 40.4% (p<0.004)

6. Research question In non-elderly patients undergoing mitral valve replacement: Is there a survival difference between prosthesis types? If not, does the balance of complications such as stroke, reoperation, or major bleeding favor one prosthesis type over the other? Statewide planning and research cooperative Syststem(SPARCS) Mandatory All admissions, all visits to the emergency room, all ambulatory visits Administrative 6

7. Methodology 7 Inclusion criteria Primary mitral valve replacement (n=5340) 1997-2007 Age 50-69 Exclusion criteria Out-of-state residents (7.0%, n=) Prior replacement of any valve (7.8%) Concomitant valve replacement (21.9%) Concomitant aortic/pulmonary valve repair (1.1%) Concomitant CABG (33.4%) Concomitant thoracic aortic surgery (1.2%)

8. Trend in mitral prosthesis choice 8

9. Patient characteristics 9 Co-morbidityBioprosthetic (n=664) Mechanical (n=664) P value Male42% 0.7 Age60.861.00.58 Endocarditis3%4%0.46 Bleeding disorder7%8%0.52 Hypertension56%58%0.28 Diabetes21%24%0.68 Coronary artery disease39% 0.11 Peripheral vascular disease3%5%0.43 Cerebrovascular disease8%9%0.63 Congestive heart failure57%60%0.28 Atrial fibrillation46%44%0.35 COPD21%23%0.47 Chronic kidney disease9%10%0.43 Liver disease7%9%0.18 Cancer4% 0.89

10. 30-day outcomes 10 ComplicationBioprosthetic (n=664) Mechanical (n=664) P value Mortality5%4%0.12 Stroke2% 0.85 Atrial fibrillation13%10%0.13 Acute kidney injury4% 0.67 Respiratory failure21%16%0.014 Readmission22%20%0.41

11. Results: survival 11 59.9% 57.5%

12. Results: reoperation 12 5.0% 11.1%

13. Results: major bleeding 13 9.0% 14.9%

14. Results: stroke 14 14.0% 6.8%

15. Summary of findings 15 We did not observe a survival difference between mechanical and bioprosthetic mitral valves in propensity matched patients aged 50 to 69 years. The 15-year cumulative incidence of stroke and major bleeding were both significantly higher in the mechanical group The 15-year cumulative incidence of reoperation was lower in the mechanical prosthesis group

16. Conclusions 16 The main trade-off is between reoperation and stroke: patients with mechanical valves had a lower risk of reoperation but a greater risk of stroke. These findings support the expanded use of bioprosthetic valves in younger patients undergoing mitral valve replacement.

17. 17 Strengths & limitations Large sample size All levels of care represented – from tertiary referral centers to community hospitals Important clinical endpoints Accuracy of coding Unable to determine when patients were hospitalized outside of New York State Absence of potential confounding variables e.g. etiology of valve disease, extent of coronary artery disease, and ventricular dysfunction Lack of operative detail

18. NYS work in progress 18 Validating method of reliably identifying degenerative and ischemic patients Combining SPARCS data with clinical datasets such as New York State report cards: Additional validation of dataset Better information on LV function, valve dysfunction and precise distribution of coronary artery disease More detailed operative Long-term outcomes of repair versus replacement in ischemic mitral valve disease Long-term outcomes of isolated CABG versus concomitant mitral surgery in patients with ischemic MR undergoing CABG Impact of surgeon experience on degenerative mitral valve repair rates and durability Impact of atrial fibrillation on long-term outcomes after mitral valve surgery

19. Thank you 19 David H. Adams MD Yuting Chiang MSc, MD Natalia Egorova PhD Annetine Gellijns MD Shinobu Itagaki MD Alan Moskowitz MD Nana Toyoda MD