Transcatheter Reshaping of the Mitral Annulus in Patients with Functional Mitral Regurgitation: One-year Outcomes of the MAVERIC Trial.

AIMS To assess the one-year safety and efficacy of the transcatheter ARTO™ system in the treatment of functional mitral regurgitation (FMR). METHODS AND RESULTS MAVERIC is a multicenter, prospective, non-randomized pre-commercial study. Eligible patients were on guideline-recommended therapy for NYHA class II-IV systolic heart failure and had an FMR grade≥2+. ARTO™ system was implanted in forty-five (100%) patients. Primary safety composite endpoint (death, stroke, myocardial infarction, device related surgery, cardiac tamponade, renal failure) at 30-days and one-year was 4.4% [95%CI 1.5-16.6] and 17.8% [95%CI 9.3-32.4]. Periprocedural complications occurred in seven patients (15.5% [95%CI 6.5-29.5]) and five patients (11.1% [95%CI 4.9-24.0]) died during one-year follow-up. Paired results for 36 patients demonstrated 24 (66.7%) had Grade 3+/4+ mitral regurgitation at baseline however, only 5 (13.9%) and 3 (8.3%) patients remained at Grade 3+/4+ 30-days and one-year post-procedure (p<0.0001). Echocardiographic parameters such as antero-posterior annulus diameter decreased from 41.4mm (baseline) to 36.0 and 35.3mm at 30-days and one-year respectively (p<0.0001). Twenty-five patients (69.4%) had baseline NYHA Class III/IV symptoms decreasing significantly to 9 (25.0%) at 30-days and 8 (22.2%) at one-year post-procedure (p<0.0001). CONCLUSION The ARTO™ transcatheter mitral valve repair system is both safe and effective in decreasing FMR up to one-year post-procedure.