Transcatheter reshaping of the mitral annulus in patients with functional mitral regurgitation: one-year outcomes of the MAVERIC trial.

ABSTRACT

AIMS: The aim of this study was 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 multicentre, prospective, non-randomised pre-commercial study. Eligible patients were on guideline-recommended therapy for NYHA Class II-IV systolic heart failure and had an FMR grade ≥2+. The ARTO system was implanted in forty-five (100%) patients. The 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), respectively. 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 that 24 (66.7%) had grade 3+/4+ mitral regurgitation at baseline; however, only five (13.9%) and three (8.3%) patients remained at grade 3+/4+ 30 days and one year post procedure (p<0.0001). Echocardiographic parameters such as anteroposterior annulus diameter decreased from 41.4 mm (baseline) to 36.0 and 35.3 mm 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 nine (25.0%) at 30 days and eight (22.2%) at one year post procedure (p<0.0001). CONCLUSIONS: The ARTO transcatheter mitral valve repair system is both safe and effective in decreasing FMR up to one year post procedure.