1. University of Pennsylvania Philadelphia
Disclosures
Research Funding: Edwards LifeSciences Evalve, Inc.
Consultant/Equity: Endovalve, Inc.
Discussion will include unapproved devices and indications
Percutaneous Mitral Valve Repair and Replacement Will Change the Indications for Mitral Valve Procedures
Howard C. Herrmann, MD
University of Pennsylvania
Philadelphia

2. Mitral Regurgitation Cleft Accessory orifice Anamolous arcade
Short chordae
Myxomatous
Rheumatic
Endocarditic
Drug-induced
CT diseases
Annular calcific
Dilated CM
HOCM
Ischemic

3. Valvular heart disease
Distribution of Class of Recommendation and Level of Evidence in Current Guidelines
Valvular heart disease
1/320 (0.3%)
Tricoci, P. et al. JAMA 2009;301:

4. Indications for Surgery in Severe MR
Symptomatic patients (Class I)
Normal LV function
Abnormal LV function
Asymptomatic patients
Abnormal LV function – LVEF < 0.60 (Class I)
LV ESD > 45 mm, AF, pul HTN (Class IIa)
“Consider if high likelihood (>90%) successful repair”
Conflicting data:
Sarano et al (favors early repair)
Rosenhek et al (watchful waiting)
Kang et al (1%/year) ACC/AHA Guidelines, 2006

5. Natural History of Asymptomatic Severe Degenerative MR and Preserved LV Function
456 pts followed prospectively
Long term mortality decreased when ERO > 40 mm2
Unclear what criteria used by individual physicians to recommend surgery
Sarano, NEJM 2005;352:875
132 pts followed by serial echo
38 (30%) required surgery within 5 yrs for:
Symptoms (24)
Fall in EF <60 or LVE (9)
Pulmonary htn or AF (5)
No operative mortality
Overall survival 96% 4 yr, 91% at 8 yrs
? Diff due to younger, less LV dilatation, less severe MR
Rosenhek, Circulation 2006;113:2238
447 pts followed prospectively
Surgery in 161, conserv care 286
Cardiac mortality at 7 years:
0% with surgery
5% conservative
Kang, Circulation 2009;119:797

6. Surgery for MR is the “Gold Standard”
Alleviate symptoms
Prevent complications
Improve survival

7. Rationale for Percutaneous MR Therapies
Results with surgery good, but …
Risks (particularly morbidity) higher than most realize
MR outcomes rarely reported (none with core lab)
May include moderate MR to start
Benefits of repair overstated (particularly in functional disease and elderly patients)
Generally report freedom from re-op, not survival, and actual repairs, not intent-to-treat.
No randomized comparisons to replacement
Most prior to valve-sparing surgery, current gen. bioprostheses
For ischemic MR, numerous controversies
Increased late mortality compared with degenerative patients
Does MR contribute to late mortality or is it a consequence of LV dysfunction?
No randomized trials have demonstrated improved survival with MR treatment (most patients treated for symptoms)
Type of surgery is debated

8. Questions to Consider Will reduction in MR improve the patients
Survival?
Quality of Life?
2) What is the risk of the cure?
3) Does the treatment have to be perfect?
Percutaneous repair is not surgery: balance of risk and benefit (and now also efficacy)
Benefits of MR correction are less clear and easy to assess than AS
Are different results more acceptable in functional compared with organic disease etiology?
Approval pathways are likely to differ from clinical practice pathways – is this appropriate?

9. EVEREST II Complete! – Await with great interest
Patient Scenario 1
EVEREST II Complete! – Await with great interest
Freedom from surgery for valve dysfunction, death, and moderate to severe (3+) or severe (4+) mitral regurgitation at 12 months
Comment: Unless surgery is worse than expected (possible) or MitraClip repair is better than in phase 1 (possible), surgery is likely to remain the preferred option for this patient despite a positive trial (potential disconnect between approval and clinical practice)

10. Patient Scenario 2 Many Questions:
Are the patient’s symptoms due to MR?
Is survival improved with MR reduction?
How decide between perc approaches if mechanism involves both annular dilation and leaflet tethering?
If surgery, should a complex repair be performed or replacement?
Comment: This may be the sweet spot for less invasive approaches, but much harder to determine when to intervene and how to assess results

11. Where May Indications Change With Percutaneous Therapies?
Young patients with degenerative disease and indicated for low risk repair in a high volume center (symptoms or LV dysfunction)
Asymptomatic patients with preserved LV function (“early intervention”)
Ischemic and functional disease without symptoms (for survival)
Ischemic and functional disease with symptoms (particularly those at high risk for surgery)
Probably not
Possibly - need to confirm true benefit of strategy (surgically) and ability to repair very late after percutaneous therapy
Possibly – first need to prove this hypothesis (ripe for trial)
Yes