New Self-Expanding Transcatheter Aortic Valve Device for Transfemoral Implantation – Early Results of the First-in-Asia Implantation of the ACURATE Neo/TFTM System –

BACKGROUND Feasibility and early results of transfemoral aortic valve implantation using the ACURATE neo/TF(TM)self-expanding stent are reported. METHODS AND RESULTS The study group of 15 patients (mean age 83.3±6.0) was enrolled with a mean EuroSCORE and STS score of 21.9±11.6% and 7.5±3.1%, respectively. Clinical and echocardiographic evaluations were performed at baseline, discharge, 30 days and 6 months. The primary endpoint was all-cause mortality at 30 days. Transcatheter aortic valve implantation (TAVI) using the ACURATE neo/TF device was successful in 14 patients; 1 patient underwent valve-in-valve implantation because the prosthetic valve embolized during withdrawal of the delivery system. Conversion to surgery, coronary obstruction, peri-operative stroke, and pacemaker implantation did not occur at 30 days. Mean transvalvular gradients at discharge significantly decreased from 44.2±10.5 mmHg (preprocedural) to 7.7±3.1 mmHg (P