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

Background: The 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. Methods: This 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. Results: The 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). Conclusions: Our study provides further evidence on the safety and efficacy of the J-Valve in high-risk patients with AS or AR for surgery. (C) 2018 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.