Abstract 16322: Safety and Efficacy of Transapical Transcatheter Aortic Valve Replacement in the Treatment of Pure Non-calcified Native Aortic Regurgitation

Abstract

Background: Transcatheter aortic valve replacement (TAVR) in patients with pure aortic regurgitation (AR) is still “off-label” use due to the lack of suitable transcatheter heart valve. This study aimed to evaluate the safety and efficacy of TAVR with J-Valve TM (JieCheng Medical Technology Co., Ltd., Suzhou, China) transcatheter heart valve for the treatment of patients with pure non-calcified native AR. Methods: The clinical and follow-up data of patients with pure non-calcified native AR treated by TAVR with J-Valve TM between April 2014 and November 2019 in the West China Hospital were summarized. Procedural results and clinical outcomes were analyzed using Valve Academic Research Consortium-2 criteria. Results: A total of 123 patients were enrolled with a mean age of 72.1±6.4 years. There were 28 cases with bicuspid aortic valve and 95 cases with trilobal aortic valve. The median follow-up period was 18 months. Transapical implantation with J-Valve TM was successful in all patients (100%). By the end of the follow up, the rate of all-cause mortality was 5.7%, among which 5 cases died during the perioperative period. Other results include stroke (1.6%), new permanent pacemaker implantation (8.9%), major bleeding (6.5%), acute kidney injury (2.4%) and aortic valve-related re-intervention (3.3%, they were given surgical aortic valve replacement for thrombosis of artificial valve (2 cases) or severe post-procedural paravalvular leakage (2 cases)). Among the 112 survival cases without re-intervention, Echocardiography revealed that none of them had moderate or severe paravalvular leakage; mild and mild-moderate paravalvular leakage occurred in 9.8% and 8.0% cases, respectively. Mean transvalvular gradient after valve implantation was 9.2±3.5 mmHg. At 6 months of follow up, left ventricular end diastolic diameter was remarkably smaller compared to that before procedure (53.5±8.2 mm vs 64.3±8.9 mm, P<0.001) and left ventricular ejection fraction was significantly increased (56.3±11.8 % vs 54.2±12.4 %, P=0.031). Conclusions: TAVR with J-Valve TM transcatheter heart valve system for treatment of patients with pure non-calcified native AR is safe and effective which may be a reasonable option in the future treatment.