Ten-year survival after indirect mitral annuloplasty with the Carillon Mitral Contour System in functional mitral regurgitation. A single-center followup from the REDUCE-FMR trial

Indirect mitral annuloplasty with the Carillon Mitral Contour System reduces regurgitant volume, induces favorable left ventricular remodeling, and is associated with favorable survival rates through 6 years; however, longer term data are limited. This observational study included all 17 patients from a single center implanted with the Carillon device in the REDUCEF-MR trial. Patients had New York Heart Association class IIIV symptoms, left ventricular ejection fraction <50%, and mitral regurgitation grade ≥2+ despite stable guideline-directed medical therapy. Patients underwent clinical and echocardiographic followup in the REDUCE-FMR trial for 1 year. Thereafter, vital status was ascertained after a median of 9.2 years (range: 8.010.3 years). KaplanMeier methods were used to estimate overall and cardiovascular survival. Univariable Cox regression was used to identify predictors of longterm mortality, with results reported as hazard ratios (HR) and 95% confidence intervals (95% CI). The 10year survival rate was 35% (median survival 5.6 years), and the corresponding cardiovascular survival rate was 66%. Baseline left ventricular ejection fraction <35% (HR=7.1; 95% CI: 1.4, 36.5; p=0.02), first-year heart failure hospitalization (HR=8.0; 95% CI: 2.0, 32.1; p=0.004), and tent height decrease during the first year (HR=5.1; 95% CI: 1.3, 20.8; p=0.02) were associated with increased all-cause mortality. First year heart failure hospitalization (HR=9.6; 95% CI: 1.1, 88.8; p=0.046) was the only variable associated with higher cardiovascular mortality. This study provides the first evidence of survival beyond 6 years after indirect mitral annuloplasty with the Carillon device, with 10-year outcomes suggesting durability of this treatment.