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N Engl J Med. 2018 Dec 13;379(24):2307-2318. doi: 10.1056/NEJMoa1806640. Epub 2018 Sep 23.

Transcatheter Mitral-Valve Repair in Patients with Heart Failure.

Author information

1
From New York-Presbyterian Hospital and the Cardiovascular Research Foundation (G.W.S.) and Columbia University Medical Center (G.W.S., S.O.M.), New York; Advanced Heart Failure, Vanderbilt Heart and Vascular Institute, Nashville (J.L.); the Departments of Medicine, Physiology, and Cell Biology, Division of Cardiovascular Medicine, and the Davis Heart and Lung Research Institute, Ohio State University, Columbus (W.T.A.), the Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland (S.R.K.), and Christ Hospital, Cincinnati (I.J.S.) - all in Ohio; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (S.K.), and Kaiser Permanente-San Francisco Hospital, San Francisco (J.M.M.) - both in California; the Division of Cardiology, University of Virginia, Charlottesville (D.S.L.); Intermountain Medical Center, Murray, UT (B.W.); Baylor University Medical Center, Baylor Heart and Vascular Institute, Dallas (P.A.G.), and Baylor Scott and White Heart Hospital Plano, Plano (M.J.M.) - both in Texas; Carolinas Medical Center, Charlotte, NC (M.R.); Piedmont Hospital, Atlanta (V.R.); University of Colorado Hospital, Aurora (A.B.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine, Kansas City (D.J.C.); and MedStar Health Research Institute, Hyattsville, MD (N.J.W.).

Abstract

BACKGROUND:

Among patients with heart failure who have mitral regurgitation due to left ventricular dysfunction, the prognosis is poor. Transcatheter mitral-valve repair may improve their clinical outcomes.

METHODS:

At 78 sites in the United States and Canada, we enrolled patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline-directed medical therapy. Patients were randomly assigned to transcatheter mitral-valve repair plus medical therapy (device group) or medical therapy alone (control group). The primary effectiveness end point was all hospitalizations for heart failure within 24 months of follow-up. The primary safety end point was freedom from device-related complications at 12 months; the rate for this end point was compared with a prespecified objective performance goal of 88.0%.

RESULTS:

Of the 614 patients who were enrolled in the trial, 302 were assigned to the device group and 312 to the control group. The annualized rate of all hospitalizations for heart failure within 24 months was 35.8% per patient-year in the device group as compared with 67.9% per patient-year in the control group (hazard ratio, 0.53; 95% confidence interval [CI], 0.40 to 0.70; P<0.001). The rate of freedom from device-related complications at 12 months was 96.6% (lower 95% confidence limit, 94.8%; P<0.001 for comparison with the performance goal). Death from any cause within 24 months occurred in 29.1% of the patients in the device group as compared with 46.1% in the control group (hazard ratio, 0.62; 95% CI, 0.46 to 0.82; P<0.001).

CONCLUSIONS:

Among patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline-directed medical therapy, transcatheter mitral-valve repair resulted in a lower rate of hospitalization for heart failure and lower all-cause mortality within 24 months of follow-up than medical therapy alone. The rate of freedom from device-related complications exceeded a prespecified safety threshold. (Funded by Abbott; COAPT ClinicalTrials.gov number, NCT01626079 .).

PMID:
30280640
DOI:
10.1056/NEJMoa1806640
[Indexed for MEDLINE]

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