Transapical Transcatheter Aortic Valve Implantation Using a New TAVI System for High-Risk Patients With Severe Aortic Stenosis

Abstract

To evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) for high-risk patients with aortic stenosis using the J-Valve system. 30 high-risk patients with severe AS underwent TAVI procedure were enrolled with mean age 74.5±4.5 years and mean logistic Euro-SCORE-I of 28.4±9.6%. All patients were followed up for 6 months. Outcomes were analysed in accordance with the updated standardised endpoints defined by the Valve Academic Research Consortium -2 (VRAC-2) criteria. VARC-2 defined device success was obtained in 93% (28 of 30 patients). No operative mortality was noted. No major complications such as third-degree AV-block, myocardium infraction or cerebrovascular events were noted during procedure and follow-up. Transvalvular PG was decreased at 6 months compared with preoperative state (PG mean: 55.4±14.9 vs 14.6±6.9mmHg p<0.01). No moderate or above degree paravalvular leakage (PVL) was noted. All patients with successful valve implantation were alive with improved exercise tolerance. Our initial result has demonstrated that the J-Valve system has the potential to become a feasible treatment option for high-risk patients with severe AS.