An individual patient data meta‐analysis was conducted from 3 prospective studies that enrolled heart failure patients with reduced ejection fraction and functional mitral regurgitation (FMR) implanted with the Carillon Mitral Contour System. The main outcomes assessed were changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Summary Scores (KCCQ-OSS), six-minute walk test (6MWT) distance and New York Heart Association (NYHA) classification at month 1 and 12 post device implantation.
- Among 139 patients included in the analysis, Carillon device significantly improved the 6MWT distance (63.0m; 95%CI 18.8-107.2, p=0.0056) and KCCQ-OSS score (15.1; 95%CI 5.6-24.7, p=0.0022) at 1 month from baseline. These benefits were sustained at 12 months (64.1m; 95%CI 13.2-115.0, p=0.0141for 6MWT distance, and 12.3; 95%CI 4.7-19.8, p=0.0019 for KCCQ-OSS score).
- More than 50% of the patients had improvements in KCCQ-OSS by ≥ 5 (60.4%; 95%CI 47.4-72.1) and 10 points (50.5%; 95%CI 34.9-66.0) at 12 months.
- Almost half of the patients experienced a ≥1 class improvement in NYHA class after implantation of the device at 1 month (67.9%; 95%CI 37.3-88.3) and at 12 months (48.8%; 95%CI 31.8-66.2).
- Results remained similar for KCCQ-OSS, 6MWT distance and NYHA classification when only patients with grade 3 or 4 mitral regurgitation were analyzed.
The Carillon Mitral Contour System significantly improved patient reported quality of life outcomes in heart failure patients with functional mitral regurgitation. Quality of life improvement in patients who were treated with the Carillon device was similar or better than other recently reported heart failure trials.