1. ©2015 MFMER | 3428638-1 Robotic Repair of Simple vs. Complex Degenerative Mitral Valve Disease Clinical and Echocardiographic Outcomes During Mid-Term Follow-up RM Suri, A Taggarse, H Burkhart, R Daly, W Mauermann, H Michelena, Z Li, R Nishimura, M Enriquez-Sarano Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota

2. ©2015 MFMER | 3428638-2 Disclosure Mayo Clinic Division of Cardiovascular Surgery Research funding Edwards Lifesciences St. Jude Medical Sorin Group Current technology licensing agreements Sorin Group and St. Jude Principle Investigator FDA Perceval Trial – Sorin Group Co-Investigator PARTNER II, COAPT, SURTAVI, PORTICO No personal relationships with Industry

3. ©2015 MFMER | 3428638-3 A.At risk B.Progressive C.Asymptomatic severe C1: Asymptomatic – ventricle compensated C2: Asymptomatic – decompensated ventricle D.Symptomatic severe 2014 ACC/AHA Guideline Summary Stages of Progression of VHD Unknown mid-term outcomes Complex disease Minimally invasive approaches Unknown mid-term outcomes Complex disease Minimally invasive approaches When leaflet dysfunction is sufficiently limited so that only annuloplasty and repair of the posterior leaflet are necessary… superior outcomes … 80% freedom from recurrent moderate/severe (≥3+) MR 20 years after operation.

4. ©2015 MFMER | 3428638-4 Hypothesis In patients undergoing robotic correction of severe primary degenerative MR, overall survival, rate of recurrence of mitral regurgitation and mitral reoperation are influenced by repair complexity.

5. ©2015 MFMER | 3428638-5 Inclusion and Methods Jan. 2008 – Jan. 2015: 520 pt. robotic mitral valve repair for primary degenerative disease Study consent 487 pt. – analysis Stratified simple vs. complex disease Two surgeon approach: HMB / RMS 85% RCD / RMS 15% Procolized follow up Data collection

6. ©2015 MFMER | 3428638-6

7. ©2015 MFMER | 3428638-7 Posterior 57.9% Bileaflet 39.0% Anterior 2.9% Traditional Stratification Prolapse Categories

8. ©2015 MFMER | 3428638-8 New Classification – Complexity Intervention Categories Simple 59% Complex 41% Repair rate – 100% 1 Death – 0.2% 4 Neurologic events – 0.8%

9. ©2015 MFMER | 3428638-9 Patient Characteristics Total (n=487) Simple (n=289) Complex (n=198)P NYHA III/IV25 (5.1)13 (4.5)12 (6.1)0.443 Congestive heart failure12 (2.5)7 (2.4)5 (2.5)0.943 Atrial fibrillation43 (8.8)23 (8.0)20 (10.1)0.413 Ejection fraction, mean (SD)64.8 (6.3)64.9 (6.4)64.6 (6.1) 0.568 LVEDD, mm, mean (SD)58.0 (5.3)57.8 (5.3)58.4 (5.4) 0.278 LVESD, mm, mean (SD)35.6 (4.3)35.5 (4.3)35.6 (4.4) 0.772 LAVI, mL/m 2, mean (SD)56.3 (18.0)55.4 (18.4)57.6 (17.4) 0.191 Age, years, mean (SD)55.6 (11.0)56.7 (10.1)53.9 (12.1)0.005 Male sex360 (73.9)235 (81.3)12 (63.1)<0.001 Regurgitant volume, mL, median (IQR) 76 (63-96)79 (64-102)73 (61-90) 0.009

10. ©2015 MFMER | 3428638-10 Total (n=487) Simple (n=289) Complex (n=198)P Plication39 (8.0)11 (3.8)28 (14.1)<0.001 Gore-Tex Neochord111 (22.6)3 (1.0)107 (54.0)<0.0001 Annuloplasty487 (100.0)287 (100.0)200 (100.0)>0.99 Cryoablation maze 29 (5.9)16 (5.5)13 (6.6) 0.524 Left atrial appendage ligation29 (5.9)17 (5.7)12 (6.1) 0.524 Post-op ICU stay, hrs, median (IQR)8 (6.5-19.5)8 (6.5-19.0)8 (6.0-20.0) 0.734 Blood bank RBC requirement, median (IQR) 0 (0-0) 0.936 MR grade at dismissal None to trivial436 (89.7)259 (89.6)177 (89.8) 0.935 Mild50 (10.3)30 (10.4)20 (10.2) Procedure and Early Outcomes Leaflet resection430 (88.3)276 (95.5)154 (77.8)<0.001 Commissuroplasty any148 (30.4)43 (15.0)105 (52.5)<0.001 X-clamp time, min, median (IQR)53 (45-66)50 (42-62)58 (49-72)<0.001 Post-op ventilation, hrs, median (IQR)0 (0-0) 0.291 Perfusion time, min, median (IQR)76 (66-94)74 (64-91)81 (70-98) 0.002 98.8% Complete follow-up

11. ©2015 MFMER | 3428638-11 Overall Survival Repair Complexity % P = 0.51 28915677462712 19811160382310 Complexity Simple repair Complex repair Follow-up time (year) 99.5%

12. ©2015 MFMER | 3428638-12 Probability Mitral Regurgitation Recurrence Repair Complexity Recurrence ≥Moderate MR % Follow-up time (year) 289153754424 9 19811057372110 Complexity Simple repair Complex repair P = 0.67 0.6% 5.4%

13. ©2015 MFMER | 3428638-13 X-Clamp Time (per 15 min) Regurgitation Volume  90 Prolapse: Anterior & Posterior Prolapse: Anterior Plication Myxo Disease: Yes LVESD preop  40 LVEDD preop  60 Leaflet Resection Gore-Tex Neochord Gender: Male EF Preop:  60 Complex Comissuroplasty: Any Age  70 Predictors Mitral Regurgitation Recurrence Univariate Hazard ratio *

14. ©2015 MFMER | 3428638-14 Probability Mitral Re-operation Repair Complexity Follow-up time (year) 28915476452510 19810958382210 Complexity Simple repair Complex repair P = 0.13 1.2% 2.3% Mitral Reoperation %

15. ©2015 MFMER | 3428638-15 X-Clamp Time (per 15 min) Regurgitation Volume  90 Prolapse: Anterior & Posterior Prolapse: Anterior Plication Myxo Disease: Yes LVESD preop  40 LVEDD preop  60 Leaflet Resection Gore-Tex Neochord Gender: Male EF Preop:  60 Complex Comissuroplasty: Any Age  70 Mitral Reoperation Univariate Hazard ratio * *

16. ©2015 MFMER | 3428638-16 Conclusions First mid-term clinical and echocardiographic stratify - repair complexity 100% repair, 0.2% mortality, 0.8% neurologic Simple vs. complex - similar mid-term survival, freedom from MR and reoperation Univariate anterior prolapse may be associated with: MR recurrence Reoperation Robotic mitral repair High quality alternative to traditional approaches Relevant comparator percutaneous technology

17. ©2015 MFMER | 3428638-17 Division of Cardiovascular Surgery