Two-year outcomes from the MitrAl Valve rEpaiR Clinical (MAVERIC) Trial: a novel percutaneous treatment of functional mitral regurgitation.

Abstract

We report two year outcomes of the MitrAl Valve rEpaiR Clinical (MAVERIC) Trial. Functional mitral regurgitation (FMR) is associated with poor outcomes for which there remains an unmet clinical need. ARTO is a transcatheter mitral repair system for treatment of FMR and an emerging alternative for patients at high surgical risk. The MAVERIC trial was designed to evaluate safety and performance of the ARTO system annular reduction device in FMR and heart failure (HF). MAVERIC is an international multi-centre prospective single arm study enrolling patients with FMR grade≥2, NYHA class≥2 symptoms despite maximal medical therapy. Patients were excluded with significant structural mitral valve abnormality or life expectancy<1 year. Primary outcome measures were composite safety outcome and efficacy defined as MR reduction 30-days post-procedure. Secondary outcome measures included safety, change in MR grade, NYHA class and hospitalisation for HF at 2-years. Forty-five patients were enrolled. The composite safety outcome was met (2/45 adverse events at 30-days) and no device related deaths at 2-year follow up. A sustained reduction in MR (grade<2: 21/31(68%) versus 31/31(0%); P<0.0001), LV end-diastolic volume index (90.0±30 versus 106±26ml/m2 ; P=0.004) and AP diameter (35.5±4.7 versus 41.4±4.6mm; P<0.0001) was seen at 2-years compared to baseline. Progressive symptomatic improvement was seen at 2-years compared to baseline (NYHA≤2: 27/34(80%) versus 12/34(36%); P<0.0001) and reduction in HF hospitalisations (19.8% 2-years post versus 52.3% 2-years prior; P<0.001). We demonstrate that ARTO is a safe, effective treatment for FMR with reductions in LV end-diastolic volumes sustained to 2-years. This article is protected by copyright. All rights reserved.