New Self-Expanding Transcatheter Aortic Valve Device for Transfemoral Implantation - Early Results of the First-in-Asia Implantation of the ACURATE Neo/TF™ 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<0.0001) and effective orifice area significantly increased from 0.77 +/- 0.12 to 1.69 +/- 0.25 cm(2) (P<0.0001). None or trace paravalvular leak was revealed in 50.0%, and no patient exhibited moderate or higher paravalvular leak. The overall mortality at 30 days and 6 months was 0% and 6.7%, respectively. Conclusions: A new self-expanding TF TAVI device, ACURATE neo/TF, is safe and effective in the treatment of severe aortic stenosis in elderly patients at high risk for surgery.