The One-Stop Trans-Apical Device for Aortic Valvular Disease: 1-Year Results of the Multi-Centre Study on J-Valve System

Objectives: This study presents the first report of multi-centre outcomes of the J-ValveTM system with a novel designed positioning element and a two-step positioning mechanism for easy and accurate implantation in patients with AS or AR. Methods: This multi-centre, prospective study, conducted at three largest cardiac centers in China, enrolled 107 patients (mean age 74.4 ± 5.18). Preoperative Euro-SCORE was (27.5 ± 8.3%). Clinical and echocardiographic evaluations were performed at baseline, post-procedure, discharge and 30 days, and also at 6 and 12 months. Results: TA-TAVI with the J-Valve device was successfully implanted in 98 patients (procedural success rate 93.33%). The overall mortality at 30 days and 12months was 4.7% and 5.0% respectively. Conversion to surgery was necessary in 6 patients (5.6%). Among 58 patients with AS, 12-month follow-up echocardiography demonstrated a favorable reduction of mean transvalvular gradients from 51±17 mmHg to 15±8 mmHg. All patients with completed follow up (n...