Structural Heart Valve FDA Workshop February 22 2010

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) MR patients 2/3 of symptomatic >70 are denied surgery No Symptoms (n=144) Symptoms (n=396) No Intervention (n=193) 49% Mirabel et al, European Heart J 2007; 28: 1358 -1365 Intervention (n=203) 51%

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 (n=546) No Severe MR (n=331) No Symptoms (n=144) Symptoms (n=396) No Intervention (n=193) 49% Mirabel et al, European Heart J 2007; 28: 1358 -1365 Intervention (n=203) 51%

l a o EFFICACY G Less invasive surgery Traditional surgery Percutaneous techniques BAD INVASIVENESS

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

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) P<. 0001 Mitra. Clip Therapy: Significant Reverse LV Remodeling 89 P=. 0007 74 36 Diastolic Baseline 31 Systolic 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+

Is a Ticket Burned? Are Surgical Options Preserved?

Flow chart : Outcomes of patients who had surgery after a clip attempt. 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, Ph. D; Paul Herijgers, MD, Ph. D; 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