Transcatheter Repair In Patients With Functional Mitral Regurgitation From The CLASP Study: Outcomes To 2 Years

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<h3>Background</h3> Transcatheter mitral valve repair is a favorable option in patient care for treating functional mitral regurgitation (FMR). We report 2-year outcomes from the FMR group of the multicenter, prospective, single arm CLASP study with the PASCAL transcatheter valve repair system. <h3>Methods</h3> Patients with symptomatic FMR ≥3+ deemed candidates for transcatheter repair by the local heart team were eligible. Follow-up was conducted to two years with echocardiographic outcomes evaluated by the core laboratory at all timepoints; other outcomes included major adverse events (MAEs) evaluated by an independent clinical events committee to one year (site-reported thereafter); six-minute walk distance (6MWD) and quality of life evaluated to one year. <h3>Results</h3> Eighty-five FMR patients were treated; mean age 72 years, 55% male, 65% in NYHA Class III-IVa, mean LVEF 37%, and 100% ≥3+ MR. Successful implantation was achieved in 96% of patients. MAEs included one cardiovascular mortality (1.2%) and one conversion to mitral valve replacement surgery (1.2%) at 30 days, and two reinterventions between 30 days and two years. Kaplan-Meier (KM) estimates for survival were 88% at one year and 72% at two years. Freedom from heart failure (HF) rehospitalization was 81% at one year and 78% at two years. Reduction in annualized HF hospitalization rate was 81% (p<0.001). MR ≤1+ was achieved in 73% of patients at 30 days, 75% at one year, and 84% at two years; MR ≤2+ was achieved in 96% of patients at 30 days, 100% at one year, and 95% at two years (all p<0.001). Mean LVEDV of 199 mL at baseline decreased by 9 mL at 30 days (p=0.039), 29 mL at one year (p<0.001), and 31 mL at two years (p<0.001). NYHA class I-II was achieved in 87% of patients at 30 days, 86% at one year, and 88% at two years (all p<0.001). Average 6MWD improved by 22 m at 30 days (p=0.004) and 40 m at one year (p=0.003). Kansas City Cardiomyopathy Questionnaire (KCCQ) score improved by 16 points at 30 days and one year (all p<0.001). <h3>Conclusions</h3> : The PASCAL transcatheter valve repair system demonstrated sustained favorable outcomes at two years in patients with FMR. Results showed a high survival rate of 72% and freedom from HF rehospitalization of 78% with an 81% reduction in annualized HF hospitalization rate. Sustained MR reduction of MR ≤2+ was achieved in 95% and MR ≤1+ in 84% of patients, with evidence of left ventricular reverse remodeling. Improvements in functional status were clinically significant and durable. The CLASP IIF randomized pivotal trial (NCT03706833) is ongoing.