Saibal Kar1,2, Michael J Mack3, JoAnn Lindenfeld4, William T Abraham5, Federico M Asch6,7, Neil J Weissman6,7, Maurice Enriquez-Sarano8, D Scott Lim9, Jacob M Mishell10, Brian K Whisenant11, Jason H Rogers12, Suzanne V Arnold13, David J Cohen14,15, Paul A Grayburn16, Gregg W Stone17,18. 1. Los Robles Regional Medical Center, Thousand Oaks, CA (S.K.). 2. Bakersfield Heart Hospital, CA (S.K.). 3. Baylor Scott & White Heart Hospital Plano, TX (M.J.M.). 4. Advanced Heart Failure and Cardiac Transplantation Section, Vanderbilt Heart and Vascular Institute, Nashville, TN (J.L.). 5. Division of Cardiovascular Medicine, The Ohio State University, Columbus (W.T.A.). 6. MedStar Health Research Institute, Washington, DC (F.M.A., N.J.W.). 7. Georgetown University, Washington, DC (F.M.A., N.J.W.). 8. Mayo Clinic, Rochester, MN (M.E.-S.). 9. Division of Cardiology, University of Virginia, Charlottesville (D.S.L.). 10. Kaiser Permanente-San Francisco Hospital, CA (J.M.M.). 11. Intermountain Heart Center, Salt Lake City, UT (B.K.W.). 12. University of California Davis Medical Center, Sacramento (J.H.R.). 13. Saint Luke's Mid America Heart Institute, Kansas City, MO (S.V.A.). 14. University of Missouri-Kansas City School of Medicine (S.V.A.). 15. St Francis Hospital, Roslyn, NY (D.J.C.). 16. Baylor University Medical Center, Baylor Heart and Vascular Institute, Dallas, TX (P.A.G.). 17. Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (D.J.C., G.W.S.). 18. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (G.W.S.).
Abstract
BACKGROUND: In the randomized COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation), among 614 patients with heart failure with 3+ or 4+ secondary mitral regurgitation (MR), transcatheter mitral valve repair (TMVr) with the MitraClip reduced MR, heart failure hospitalizations, and mortality and improved quality of life compared with guideline-directed medical therapy (GDMT) alone. We aimed to examine the prognostic relationship between MR reduction and outcomes after TMVr and GDMT alone. METHODS: Outcomes in COAPT between 30 days and 2 years were examined on the basis of the severity of residual MR at 30 days. RESULTS: TMVr-treated patients had less severe residual MR at 30 days than GDMT-treated patients (0/1+, 2+, and 3+/4+: 72.9%, 19.9%, and 7.2% versus 8.2%, 26.1%, and 65.8%, respectively [P<0.0001]). The rate of composite death or heart failure hospitalizations between 30 days and 2 years was lower in patients with 30-day residual MR of 0/1+ and 2+ compared with patients with 30-day residual MR of 3+/4+ (37.7% versus 49.5% versus 72.2%, respectively [P<0.0001]). This relationship was consistent in the TMVr and GDMT arms (Pinteraction=0.92). The improvement in Kansas City Cardiomyopathy Questionnaire score from baseline to 30 days was maintained between 30 days and 2 years in patients with 30-day MR ≤2+ but deteriorated in those with 30-day MR 3+/4+ (-0.3±1.7 versus -9.4±4.6 [P=0.0008]) consistently in both groups (Pinteraction=0.95). CONCLUSIONS: In the COAPT trial, reduced MR at 30 days was associated with greater freedom from death or heart failure hospitalizations and improved quality of life through 2-year follow-up whether the MR reduction was achieved by TMVr or GDMT. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01626079.
BACKGROUND: In the randomized COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation), among 614 patients with heart failure with 3+ or 4+ secondary mitral regurgitation (MR), transcatheter mitral valve repair (TMVr) with the MitraClip reduced MR, heart failure hospitalizations, and mortality and improved quality of life compared with guideline-directed medical therapy (GDMT) alone. We aimed to examine the prognostic relationship between MR reduction and outcomes after TMVr and GDMT alone. METHODS: Outcomes in COAPT between 30 days and 2 years were examined on the basis of the severity of residual MR at 30 days. RESULTS: TMVr-treated patients had less severe residual MR at 30 days than GDMT-treated patients (0/1+, 2+, and 3+/4+: 72.9%, 19.9%, and 7.2% versus 8.2%, 26.1%, and 65.8%, respectively [P<0.0001]). The rate of composite death or heart failure hospitalizations between 30 days and 2 years was lower in patients with 30-day residual MR of 0/1+ and 2+ compared with patients with 30-day residual MR of 3+/4+ (37.7% versus 49.5% versus 72.2%, respectively [P<0.0001]). This relationship was consistent in the TMVr and GDMT arms (Pinteraction=0.92). The improvement in Kansas City Cardiomyopathy Questionnaire score from baseline to 30 days was maintained between 30 days and 2 years in patients with 30-day MR ≤2+ but deteriorated in those with 30-day MR 3+/4+ (-0.3±1.7 versus -9.4±4.6 [P=0.0008]) consistently in both groups (Pinteraction=0.95). CONCLUSIONS: In the COAPT trial, reduced MR at 30 days was associated with greater freedom from death or heart failure hospitalizations and improved quality of life through 2-year follow-up whether the MR reduction was achieved by TMVr or GDMT. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01626079.
Entities:
Keywords:
heart failure; mitral valve insufficiency; prognosis; quality of life
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