학술논문
Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation.
Document Type
Article
Author
Stone, Gregg W.; Abraham, William T.; Lindenfeld, JoAnn; Kar, Saibal; Grayburn, Paul A.; Lim, D. Scott; Mishell, Jacob M.; Whisenant, Brian; Rinaldi, Michael; Kapadia, Samir R.; Rajagopal, Vivek; Sarembock, Ian J.; Brieke, Andreas; Marx, Steven O.; Cohen, David J.; Asch, Federico M.; Mack, Michael J.
Source
Subject
Language
ISSN
0028-4793
Abstract
BACKGROUND Data from a 5-year follow-up of outcomes after transcatheter edge-to-edge repair of severe mitral regurgitation, as compared with outcomes after maximal doses of guideline-directed medical therapy alone, in patients with heart failure are now available. METHODS We randomly assigned 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 to undergo transcatheter edge-to-edge repair plus receive medical therapy (device group) or to receive medical therapy alone (control group) at 78 sites in the United States and Canada. The primary effectiveness end point was all hospitalizations for heart failure through 2 years of follow-up. The annualized rate ofall hospitalizations for heart failure, all-cause mortality, the risk of death or hospitalization for heart failure, and safety, among other outcomes, were assessed through 5 years. RESULTS Of the 614 patients enrolled in the trial, 302 were assigned to the device group and 312 to the control group. The annualized rate of hospitalization for heart failure through 5 years was 33.1% per year in the device group and 5Z2°/o per year in the control group (hazard ratio, 0.53; 95% confidence interval ICI],0.41 to 0.68). Allcause mortality through 5 years was 5Z3°6 in the device group and 67.2% in the control group (hazard ratio, 0.72; 95% CI, 0.58 to 0.89). Death or hospitalization for heart failure within 5 years occurred in 73.690 of the patients in the device group and in 91.5°6 ofthose in the control group (hazard ratio, 0.53; 95°6 CI, 0.44 to 0.64). Device-specific safety events within 5 years occurred in 4 of 293 treated patients (1.4°/o), with all the events occurring within 30 days after the procedure. CONCLUSIONS Among patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite guideline-directed medical therapy, transcatheter edge-to-edge repair of the mitral valve was safe and led to a lower rate of hospitalization for heart failure and lower all-cause mortality through 5 years of follow-up than medical therapy alone. [ABSTRACT FROM AUTHOR]