The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)
Outcomes of Transcatheter Mitral Valve Repair for Secondary Mitral Regurgitation by Severity of Left Ventricular Dysfunction
Stamatios Lerakis1; Annapoorna S Kini1; Federico M Asch2; Saibal Kar3; D Scott Lim4; Jacob M Mishell5; Brian K Whisenant6; Paul A Grayburn7; Neil J Weissman2; Michael J Rinaldi8; Samin K Sharma1; Samir R Kapadia9; Vivek Rajagopal10; Ian J Sarembock11; Andreas Brieke12; Gilbert HL Tang1; Ditian Li13; Aaron Crowley13; JoAnn Lindenfeld14; William T Abraham15; Michael J Mack16; Gregg Stone17;
1. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY 2. MedStar Health Research Institute, Washington, DC; Georgetown University, Washington, DC 3. Los Robles Regional Medical Center, Thousand Oaks, CA; Bakersfield Heart Hospital, Bakersfield, CA 4. Division of Cardiology, University of Virginia, Charlottesville, VA 5. Kaiser Permanente - San Francisco Hospital, San Francisco, CA 6. Intermountain Heart Center, Salt Lake City, UT 7. Baylor University Medical Center, Baylor Heart and Vascular Institute, Dallas, TX 8. Sanger Heart & Vascular Institute/Atrium Health, Charlotte, NC 9. Cleveland Clinic, Cleveland, OH 10. Piedmont Hospital, Atlanta, GA 11. The Christ Hospital, Cincinnati, OH 12. University Of Colorado Hospital, Aurora, CO 13. Clinical Trials Center, Cardiovascular Research Foundation, New York, NY 14. Advanced Heart Failure and Cardiac Transplantation Section, Vanderbilt Heart and Vascular Institute, Nashville, TN 15. Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH 16. Baylor Scott & White Health, Plano, TX 17. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY; Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, United States
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BACKGROUND—In the COAPT trial, transcatheter mitral valve repair with MitraClip plus maximally-tolerated guideline-directed medical therapy (GDMT) improved clinical outcomes compared with GDMT alone in symptomatic patients with heart failure (HF) and 3+ or 4+ secondary mitral regurgitation (SMR) due to left ventricular (LV) dysfunction.
AIMS—In this COAPT substudy we sought to evaluate 2-year outcomes in HF patients with reduced LV ejection fraction (HFrEF; LVEF £40%) versus preserved LVEF (HFpEF; LVEF >40%) and in those with severe (LVEF £30%) versus moderate (LVEF >30%) LV dysfunction.
METHODS—The principal effectiveness outcome was the 2-year rate of death from any cause or HF hospitalizations (HFH). Subgroup analysis with interaction testing performed according to baseline LVEF; 472 patients (82.1%) had HFrEF (mean LVEF 28.0%±6.2%; range 12% to 40%) and 103 (17.9%) had HFpEF (mean LVEF 46.6%±4.9%; range 41% to 65%), while 292 (50.7%) had severely depressed LVEF (LVEF ≤30%; mean LVEF 23.9% ± 3.8%) and 283 (49.3%) had moderately depressed LVEF (LVEF >30%; mean LVEF 39.0% ± 6.8%).
RESULTS—The 2-year rate of death or HFH was 56.7% in patients with HFrEF and 53.4% with HFpEF (HR 1.16, 95%CI 0.86-1.57, p=0.32). MitraClip reduced the 2-year rate of death or HFH in patients with HFrEF (HR 0.50, 95%CI 0.39-0.65) and HFpEF (HR 0.60, 95%CI 0.35-1.05), pint=0.55. MitraClip was consistently effective in reducing the individual endpoints of mortality and HFH, improving MR severity, quality-of-life, and 6-minute walk distance in patients with HFrEF, HFpEF, LVEF £30%, and LVEF >30%.
CONCLUSIONS—In the COAPT trial, among patients with HF and 3+ or 4+ SMR who remained symptomatic despite maximally-tolerated GDMT, MitraClip was consistently effective in improving survival and health status in patients with severe and moderate LV dysfunction and preserved LVEF.