[Transapical transcatheter aortic valve replacement for high risk pure non-calcified aortic regurgitation: two years outcome of a multi-center study].

Objective: To report on the two years outcome of Chinese multi-center study of the treatment of high risk non-calcified pure aortic regurgitation with transcatheter heart valve replacement (TAVR) using domestic made J-Valve™ system. Methods: The national multi-center clinical study of the treatment of high risk non-calcified pure aortic regurgitation with transcatheter heart valve replacement using domestic made J-Valve™ system was conducted during the period from April 2014 to July 2015. The follow-up time was up to 2 years. Forty-three cases with predominant aortic valve regurgitation were enrolled for transapical implantation of the J-Valve™ system from 3 Chinese centers, including 16 patients from Zhongshan Hospital, Fudan University, 23 patients from West China Hospital, Sichuan University, and 4 patients from Fuwai Cardiovascular Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. There were 30 males and 13 females in this cohort. The age of the patients was (74±6) years (range: 61 to 84 years). The patiens were all sympotmatic preoperatively. All patients were considered at prohibitive or high risk for surgical valve replacement (Logistic European System for Cardiac Operative Risk Evaluation of (25.5±5.3)%, range: 20.0% to 44.4%) after evaluation by an interdisciplinary heart team. Comprehensive clinical and echocardiographic assessments were scheduled before discharge and at 30 days, 12 months, and 24 months after the procedure. Results: One patients was converted to surgical aortic valve replacement (SAVR) due to valve embolism into the arch. The other 42 cases had J-Valve™ systems implanted successfully. One patient died from multi-organ disorder due to paravalvular leak (PVL) during perioperative period. There was no acute myocardial infarction, stroke or coronary obstruction during the perioperative period. The median follow-up time was 725 days (range: 6 to 1 082 days). There were 5 patients died during the 2 years, follow-up, 2 patients had stroke, 2 patients had permanent pacemaker implanted. Three patients had valve related reinterventions: One for intraoperative valve embolism into the aortic arch followed by a conversion to SAVR which was mentioned above. One patient underwent SAVR on the postoperative day 6 due to moderate PVL and ventricular dysfunction. One patient underwent SAVR 6 months after primary procedure due to prosthesis thrombosis and severe aortic valve stenosis.Thirty-six patients with J-valve™ implanted survived to the latest echocardiogram follow-up, 25 patients had trivial or less PVL, 9 patients had mild PVL, and the transvalvular gradient after valve implantation was favorable at (9.8±5.8) mmHg (1 mmHg=0.133 kPa). Conclusions: Transapical implantation of domestic made J-Valve™ transcatheter heart valve system for patients with predominant aortic regurgitation has a excellent early outcome. This novel technology is safe and effective.