1. CTSN Trials of Mitral Valve Repair and Replacement
Michael Mack, M.D.
Baylor Scott & White Health
Dallas, TX

2. Disclosure Statement of Financial Interest
I, MichaelMack DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

3. What is CTSN? Cardiothoracic Surgical Trials Network Goal
Evaluate surgical approaches to cardiovascular disease
Support- $50M ( )
NIH
NHLBI
NINDS
CIHR- Canadian Institute of Health Research
PI’s
Richard Weisel-Toronto
Patrick O’Gara-Boston

4. Core Sites Baylor Research Institute Cleveland Clinic Foundation
Duke University
Hopital Laval de Quebec
Montefiore Einstein Heart Center
Montreal Heart Institute
University of Pennsylvania
University of Southern California
University of Virginia
Consortium Sites -12

6. CTSN German Sites

7. Trials Completed Ischemic MR Atrial Fibrillation Ablation
Severe
Moderate
Atrial Fibrillation Ablation
Postoperative Atrial Fibrillation
Neuroprotection in SAVR
Ongoing
Moderate TR
Stem Cells in LVAD
Hybrid Coronary Revascularization
In Development
External Stenting of SVG’s
NOAC’s vs. warfarin for POAF

8. Ischemic MR Severe MR: Moderate MR:
Mitral valve repair with annuloplasty vs. mitral valve replacement with complete preservation of the sub-valvular apparatus.
Moderate MR:
Mitral valve repair combined with coronary artery bypass grafting vs. coronary artery bypass grafting alone

9. For the last 20 years surgeons have considered that for all types of ischemia related mitral regurgitation mitral repair with a ring annuloplasty was better that an valve replacement
However, because of the high mortality of this disease, it was time to find out - Was this the truth or a myth?

10. SMR Trial Design

11. Primary Endpoint Degree of left ventricular reverse remodeling
Assessed by left ventricular end systolic volume index (LVESVI) using TTE at 12 months

13. Change in LVESVI (ml/m2)
Time Repair Replace
Baseline ± ± 27.4
12 months ± ± 31.5
p=0.18

14. Mortality 12 Month Mortality: 14.2% (repair) vs. 17.6% (replacement),
30 Day Mortality:
1.6% (repair) vs. 4.0% (replacement),
p =0.26

15. MACCE at 12 Months

16. Serious Adverse Events
P=NS
P=NS
P=NS
P=NS
P=NS
P=NS

17. Recurrent MR at 1 year

18. November 18,
2013, at NEJM.org.

20. LVESVI with Recurrent MR
p < 0.001
If the repair had no MR at 1 year
There was reverse remodeling

21. J Thorac Cardiovasc Surg 2015;149:752-61)

22. Predictors of Recurrence

23. Predictors of Recurrence
Tenting Area Tenting Height
Anterior and Posterior Leaflet Angles

24. Predictors of Recurrent MR After MVA
No or Mild annular dilatation
Coaptation depth >1 cm
Posterior leaflet angle >45°
Distal anterior leaflet angle >25°
Advanced LV remodelling
LVEDD > 65 mm
Systolic sphericity index > 0.7
End systolic interpapillary muscle distance >20 mm
LVESV ≥ 145 ml (or ≥ 100 ml/m2)

25. Conclusions SIMR at 2 Years
No difference in LVESI (remodeling), MACCE, QOL, Mortality - 19% MVP and 23% MVR
Reverse remodeling occurred in both groups (1st yr)
50 % of repairs had at least moderate MR vs. replacements 2.3 % Recurrent MR = more heart failure & more readmissions
Thus, replacement more durable

26. TMVR ? VS

27. COAPT: Trial design ~610 patients enrolled at up to 75 US sites
Significant FMR (≥3+ by core lab)
Not appropriate for mitral valve surgery (local heart team)
Specific anatomical criteria
February 2017
Randomized 511 Patients at 84 Sites
Randomize 1:1
Control group
Standard of care
N=210
MitraClip
N=210
Clinical and TTE follow-up:
1, 6, 12, 18, 24, 36, 48, 60 months
PIs: Michael Mack and Gregg W. Stone
Sponsor: Abbott Vascular

28. Conclusions
The high incidence of recurrent MR at 2 years portends continued progression of ventricular remodeling.
A “no leak” repair in IMR (thus positive remodeling) should render better results than a replacement.
Expert echo imaging can predict a repair failure and guide surgeons’ selections.
Global dysfunction with apico-lateral displacement of papillary muscles portends a poor repair – due to leaflet tethering

29. Conclusions A chord sparing MVR is better than a failed mitral repair
All viable ischemic myocardium must be revascularized
RCT` suggest that MVR no riskier than a MVP in SIMR
Method selection should be based on pathologic anatomy
Probably valid implications for transcatheter techniques
Wait on COAPT trial results to see if fixing the MR really helps survival or QOL (renal denervation???).