Thirty-day VARC-2 and performance data of a new self-expanding transcatheter aortic heart valve.
Hendrik Treede, Edith Lubos, Lenard Conradi, Florian Deuschl, Federico M Asch, Neil J Weissman, Niklas Schofer, Johannes Schirmer, Dietmar Koschyk, Stefan Blankenberg, Hermann Reichenspurner, Ulrich Schaefer
EuroIntervention | Published : 2015
AIMS: Transcatheter aortic valve therapy has become an established procedure for patients at high risk for surgical valve replacement. The BIOVALVE-I study aims to assess the safety and performance of a novel self-expanding transcatheter heart valve. METHODS AND RESULTS: In this prospective, single-centre, first-in-human study, 13 patients with severe aortic stenosis suitable for transfemoral transcatheter aortic valve implantation were enrolled. Mean logistic EuroSCORE was 14.4±3.7% and mean STS PROM score was 4.3±1.6%. The primary endpoint, 30-day early safety composite per VARC-2, was observed in two patients (15.4%, one life-threatening bleeding and one valve-in-valve procedure). The imp..View full abstract