Objective: The management of severe functional mitral regurgitation (FMR) in patients with heart failure (HF) and low ejection fraction is controversial, but percutaneous transcatheter procedures are promising. In this retrospective analysis, we aimed to assess the efficacy of the Carillon Mitral Contour System in patients with "inoperable" severe FMR.
Methods: Seventy three patients (mean age 66.89, range 31-90 years) with congestive heart failure (CHF), severe FMR, and reduced ejection fraction (<35%) who underwent Carillon device implantation were examined. The study group consisted of patients with successfully implanted devices whereas the control group comprised patients in whom the device could not be deployed. The primary endpoint was combined all-cause mortality and first hospitalization for HF (whichever came first).
Results: The median (Q1, Q3) follow-up was 31 (11-49) months. The device was deployed successfully in 50 patients (implant group) and not in 23 patients (non-implant group). Both the primary endpoint and all-cause mortality were lower in the "implant" group, but the differences were not significant. The median to primary endpoint was 21 [95% confidence interval (CI) 8.8-33.2] and six (95% CI 0.1-11.9) months for the implant group and the non-implant group, respectively (p=0.078).
Conclusion: Carillon Mitral Contour System implantation is a safe procedure and results in the reduction of all-cause mortality and combined endpoint of mortality and hospitalizations for HF in inoperable patients with severe FMR and low ejection fraction, although the difference did not meet the significance level.