Percutaneous mitral annuloplasty using the CARILLON device was feasible, with a 13% major adverse event rate at 30 days and significant improvements in 6-minute walk distance (P<0.001).
Does percutaneous mitral annuloplasty with the CARILLON device improve functional mitral regurgitation, exercise tolerance, and quality of life in patients with heart failure?
Percutaneous mitral annuloplasty with the CARILLON device is feasible and associated with improvements in exercise tolerance and quality of life in patients with heart failure and functional mitral regurgitation.
BACKGROUND: Functional mitral regurgitation (FMR), a well-recognized component of left ventricular remodeling, is associated with increased morbidity and mortality in heart failure patients. Percutaneous mitral annuloplasty has the potential to serve as a therapeutic adjunct to standard medical care. METHODS AND RESULTS: Patients with dilated cardiomyopathy, moderate to severe FMR, an ejection fraction <40%, and a 6-minute walk distance between 150 and 450 m were enrolled in the CARILLON Mitral Annuloplasty Device European Union Study (AMADEUS). Percutaneous mitral annuloplasty was achieved through the coronary sinus with the CARILLON Mitral Contour System. Echocardiographic FMR grade, exercise tolerance, New York Heart Association class, and quality of life were assessed at baseline and 1 and 6 months. Of the 48 patients enrolled in the trial, 30 received the CARILLON device. Eighteen patients did not receive a device because of access issues, insufficient acute FMR reduction, or coronary artery compromise. The major adverse event rate was 13% at 30 days. At 6 months, the degree of FMR reduction among 5 different quantitative echocardiographic measures ranged from 22% to 32%. Six-minute walk distance improved from 307+/-87 m at baseline to 403+/-137 m at 6 months (P<0.001). Quality of life, measured by the Kansas City Cardiomyopathy Questionnaire, improved from 47+/-16 points at baseline to 69+/-15 points at 6 months (P<0.001). CONCLUSIONS: Percutaneous reduction in FMR with a novel coronary sinus-based mitral annuloplasty device is feasible in patients with heart failure, is associated with a low rate of major adverse events, and is associated with improvement in quality of life and exercise tolerance.
Schöfer et al. (Mon,) conducted a other in Functional mitral regurgitation in heart failure (n=48). Percutaneous mitral annuloplasty (CARILLON Mitral Contour System) was evaluated on Major adverse events at 30 days. Percutaneous mitral annuloplasty using the CARILLON device was feasible, with a 13% major adverse event rate at 30 days and significant improvements in 6-minute walk distance (P<0.001).