James Hermiller, MD, FACC, FSCAI St Vincent Hospital, Indianapolis, IN Structural Heart & Valve FDA Workshop - February 22, 2010 Debate #5 The Enemy of Good is Better?: Percutaneous Mitral Valve Procedures Don’t Have to Match Open Surgical Results James Hermiller, MD, FACC, FSCAI St Vincent Hospital, Indianapolis, IN

Disclosure Information The following relationship exists: Grant support: Evalve EVEREST Studies Consultant for Abbott

Euro Heart Survey: Surgery is often denied in the older patients Isolated MR (n=877) Severe MR (n=546) No Severe MR (n=331) 2/3 of symptomatic MR patients >70 are denied surgery Symptoms (n=396) No Symptoms (n=144) No Intervention (n=193) 49% Intervention (n=203) 51% Mirabel et al, European Heart J 2007;28:1358-1365 3

Surgery vs Percutaneous Repair Large group of patients who have severe mitral regurgitation who surgical correction is not an option (or not offered) In these non-surgical patients clearly percutaneous mitral valve procedures don’t have to match open surgical results; compare to medical therapy/CRT alone

Euro Heart Survey: Isolated MR (n=877) Severe MR No Severe MR (n=546) Symptoms (n=396) No Symptoms (n=144) No Intervention (n=193) 49% Intervention (n=203) 51% Mirabel et al, European Heart J 2007;28:1358-1365 8

EFFICACY INVASIVENESS Goal Traditional Less invasive surgery BAD Traditional surgery Less invasive Goal Percutaneous techniques EFFICACY INVASIVENESS 9

The Balance Percutaneous Repair Surgical Repair Less Invasive Lower Morbidity More Rapid Return to Function Surgical Repair Long Term Outcome Known Better Efficacy – Less MR and Durable

Surgery vs Percutaneous Repair The Efficacy Metric MR reduction by echocardiography Is zero/trivial MR better than 2+??? Symptom relief Mortality

MR Reduction and Remodeling LVEDVI and LVESVI (Indexed Volumes) MitraClip Therapy: Significant Reverse LV Remodeling P<.0001 P=.0007 89 74 36 31 Diastolic Systolic Baseline 12 Months 12 month matched data, n=47, MR≤2 at 12 months

EVEREST Preliminary FMR Cohort: NYHA Class 75% (9/12) Improved 17% (2/12) No Change 8% (1/12) Worsened w/o MR > 1+ Freedom from NYHA Class III or IV from 25% to 75%” Patients included in the Matched Pair Analysis at 12-m: 01-0003, 03-0002, 03-0003, 03-0010, 04-0002, 04-0701, 17-501, 18-502, 19-501, 21-501, 23-501, 25-501

Is a Ticket Burned? Are Surgical Options Preserved?

Flow chart :Outcomes of patients who had surgery after a clip attempt. Mitral valve (MV) repair with the use of a surgical approach to create a double-orifice valve was first performed by Alfieri in 1991 (Fig. 1) (1–3). Durable results in surgically-treated patients without annuloplasty have been described in selected patients for as long as 12 years after surgical repair (4,5). Percutaneous mitral repair based on this surgical technique has been developed by the use of a clip rather than suture to secure the mitral leaflets (6,7). The Feldman et al. JACC, 2009:686–94

If a Bridge Isn’t Burned – Any Harm in Delaying/Avoiding Surgical Intervention?

Recurrence of Mitral Valve Regurgitation After Mitral Valve Repair in Degenerative Valve Disease Willem Flameng, MD, PhD; Paul Herijgers, MD, PhD; Kris Bogaerts, MSc Freedom from severe MR (>2/4) was 18% at 5 yrs and 29% at 7 yrs Circulation. 2003;107:1609-1613.

Conclusions Large group of patients not offered surgical option – in these (at least half) percutaneous repair clearly does not have to match surgical results In those with a surgical option, less procedural morbidity/mortality, more rapid return to function, preservation of surgical options, and limitations of surgical repair, suggests that percutaneous mitral valve procedures don’t have to match open surgical results