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

Abstract 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.