AimsFunctional mitral regurgitation (FMR) contributes to morbidity and mortality in heart failure (HF) patients. The aim of this study was to determine whether percutaneous mitral annuloplasty could safely and effectively reduce FMR and yield durable long-term clinical benefit.Methods and resultsThe impact of mitral annuloplasty (Carillon Mitral Contour System) was evaluated in HF patients with at least moderate FMR. Patients in whom the device was placed then acutely recaptured for clinical reasons served as a comparator group. Quantitative measures of FMR, left ventricular (LV) dimensions, New York Heart Association (NYHA) class, 6 min walk distance (6MWD), and quality of life were assessed in both groups up to 12 months. Safety and key functional data were assessed in the implanted cohort up to 24 months. Thirty-six patients received a permanent implant; 17 had the device recaptured. The 30-day major adverse event rate was 1.9%. In contrast to the comparison group, the implanted cohort demonstrated significant reductions in FMR as represented by regurgitant volume [baseline 34.5 ±11.5 mL to 17.4 ±12.4 mL at 12 months (P < 0.001)]. There was a corresponding reduction in LV diastolic volume [baseline 208.5 ±62.0 mL to 178.9 ±48.0 mL at 12 months (P =0.015)] and systolic volume [baseline 151.8 ±57.1 mL to 120.7 ±43.2 mL at 12 months (P =0.015)], compared with progressive LV dilation in the comparator. The 6MWD markedly improved for the implanted patients by 102.5 ±164 m at 12 months (P =0.014) and 131.9 ±80 m at 24 months (P < 0.001).ConclusionPercutaneous reduction of FMR using a coronary sinus approach is associated with reverse LV remodelling. Significant clinical improvements persisted up to 24 months.

ObjectiveFunctional (or secondary) mitral regurgitation (FMR) is associated with greater morbidity and worse outcomes in patients with congestive heart failure (CHF) and cardiomyopathy. The Carillon® Mitral Contour System® is a coronary sinus-based percutaneous therapy to reduce FMR. We evaluated the safety and efficacy of a modified version of the Carillon device in the treatment of patients with cardiomyopathy and FMR.Methods36 patients with CHF, depressed left ventricular function (ejection fraction <40%) and at least moderate FMR underwent the Carillon device implant.ResultsThere was 1 major adverse event within 30 days—a death (not device related)—occurring 17 days after the implant. Reductions in FMR and improvements in functional class and 6 min walk tests were seen, similar to prior studies. Device fractures in the high strain region of the proximal anchor (seen in prior studies) were not seen in this study.ConclusionsThe modified Carillon device was associated with improvements in clinical and echocardiographic parameters in treating patients with FMR, while successfully addressing the issue of anchor fracture. This version of the Carillon device will be used in a blinded randomised trial of symptomatic patients with FMR.

Percutaneous mitral annuloplasty results in acute and chronic reduction of functional MR in experimental HF.

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 Ͻ40%, 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 307Ϯ87 m at baseline to 403Ϯ137 m at 6 months (PϽ0.001). Quality of life, measured by the Kansas City Cardiomyopathy Questionnaire, improved from 47Ϯ16 points at baseline to 69Ϯ15 points at 6 months (PϽ0.001). 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. (Circulation. 2009;120:326-333.)