A versatile transapical device for aortic valvular disease: One-year outcomes of a multicenter study on the J-Valve system

Abstract

BackgroundThe novel J-Valve (JC Medical Inc, Burlingame, CA, USA) was developed to cope with aortic valvular disease by facilitating accurate positioning. We present the first one-year results regarding the safety and efficacy of the J-Valve system implantation in patients with severe aortic stenosis (AS) or aortic regurgitation (AR) undergoing transapical-transcatheter aortic valve implantation. MethodsThis prospective multicenter study enrolled 107 high-risk patients (mean age 74.4 ± 5.2 years; mean EuroSCORE-I 11.2 ± 1.2%) with severe AS (n = 64) or AR (n = 43), at the three largest cardiac centers in China. The study was fully monitored, and adverse events were adjudicated by an independent clinical events committee using Valve Academic Research Consortium criteria. ResultsThe success rate of the procedure was 91.6% (98/107). At 1 year, the all-cause mortality was 5.0%, stroke 2%, and rate of new pacemakers 5.0%. Only mild paravalvular leak was reported. Among the patients with AS, the 1-year follow-up demonstrated a sustainable reduction of mean transaortic gradient from 57.7 ± 15.4 mmHg to 15.5 ± 8.3 mmHg. All patients who completed the follow-up reported improvements in New York Heart Association functional class (n = 93) and health-related quality of life as assessed by the EuroQol five dimensions questionnaire index (n = 94). In intergroup comparisons, the 1-year major adverse cardiovascular events-free survival was similar between the groups based on valve disease (AS vs. AR, log-rank p = 0.17) or morphology (tricuspid vs. bicuspid aortic valve, log-rank p = 0.25). ConclusionsOur study provides further evidence on the safety and efficacy of the J-Valve in high-risk patients with AS or AR for surgery.