Long‐term prognosis of patients treated by coronary sinus‐based percutaneous annuloplasty: single centre experience

AIMS: This study aims to report long‐term mortality, echocardiographic, and clinical outcomes of patients receiving treatment for functional mitral regurgitation (FMR) with the Carillon device. METHODS AND RESULTS: This was a single centre analysis of prospectively collected data from patients treated with the Carillon Mitral Contour System for symptomatic congestive heart failure despite guideline‐directed medical therapy, who were included from a single centre from the TITAN II study. All patients presented with New York Heart Association (NYHA) class 2 or greater symptoms, grade 2+ to 4+ FMR, left ventricular enlargement, and reduced ejection fraction. Surviving patients were evaluated for long‐term follow‐up post‐procedure, averaging 6.9 years. Fifteen (15) patients (mean age 72 years, 60% male, 100% NYHA class III or IV, 50% MR grade 3+ or 4+) were treated with the Carillon device. The Kaplan–Meier mortality rate was 40% at 6 years of follow‐up. Long‐term survival through 6 years was associated with echocardiographic improvement in mitral regurgitation (change in effective regurgitant orifice area in survivors versus non‐survivors from baseline to 1 year follow‐up, −9.0 ± 5.6 vs. −1.7 ± 1.5, P = 0.02) and clinical status at 12 months (difference in NYHA at 1 year follow‐up between survivors versus non‐survivors, P = 0. 05) which was sustained throughout follow‐up. All patients at 6 year follow‐up had ≤2+ MR, with 6 of 7 having 0–1+ MR. Left ventricular end‐diastolic volume was reduced from 154.0 ± 65.7 mL at baseline to 104.5 ± 59.2 mL at 6 year follow‐up, P = 0.03 in survivors with both measurements. CONCLUSIONS: Among patients with congestive heart failure treated with the Carillon device, long‐term survival is associated with favourable 1 year and sustained improvements in mitral regurgitation, left ventricular volume, ejection fraction, and clinical status.