OBJECTIVES: To evaluate balloon-expandable and self-expanding third-generation transcatheter aortic valve replacement (TAVR) devices according to patient selection criteria and outcomes. BACKGROUND: Two competing third-generation TAVR technologies are currently commercially available in the US. There are no published head-to-head comparisons of the relative performance of these two devices. METHODS: 257 consecutive patients undergoing TAVR with a third-generation balloon-expandable (Edwards Sapien 3) or self-expanding device (Medtronic CoreValve Evolut R) at a single US medical center were included. Choice of TAVR device was at the discretion of the multidisciplinary Heart Team. Baseline clinical characteristics, echocardiographic and CT imaging, procedural and 30-day outcomes were prospectively collected. RESULTS: 74 patients received a self-expanding valve (SEV) and 183 received a balloon-expandable valve (BEV). Patients selected for SEV were more frequently women, with lower body surface area and smaller calcified iliofemoral arteries. Three SEV patients required implantation of a second valve to successfully treat paravalvular leak. Only one BEV patient had moderate paravalvular regurgitation. There was no difference in the rate of stroke, major vascular complication or bleeding. Permanent pacemaker implantation rate was significantly higher with SEV (12.7% vs 4.7%, P = 0.49) and hospital length of stay was longer (8.3% vs 6.5%, P = 0.043), but 30-day mortality was comparable (1.4% vs 1.6%, P = 1.00). CONCLUSIONS: Short-term outcomes were equivalent between the two technologies. Clinically significant paravalvular regurgitation was rare. SEV were more frequently selected in women and patients with challenging transfemoral access, but were associated with higher permanent pacemaker implantation rate and longer hospital length of stay.
OBJECTIVES: To evaluate balloon-expandable and self-expanding third-generation transcatheter aortic valve replacement (TAVR) devices according to patient selection criteria and outcomes. BACKGROUND: Two competing third-generation TAVR technologies are currently commercially available in the US. There are no published head-to-head comparisons of the relative performance of these two devices. METHODS: 257 consecutive patients undergoing TAVR with a third-generation balloon-expandable (Edwards Sapien 3) or self-expanding device (Medtronic CoreValve Evolut R) at a single US medical center were included. Choice of TAVR device was at the discretion of the multidisciplinary Heart Team. Baseline clinical characteristics, echocardiographic and CT imaging, procedural and 30-day outcomes were prospectively collected. RESULTS: 74 patients received a self-expanding valve (SEV) and 183 received a balloon-expandable valve (BEV). Patients selected for SEV were more frequently women, with lower body surface area and smaller calcified iliofemoral arteries. Three SEV patients required implantation of a second valve to successfully treat paravalvular leak. Only one BEV patient had moderate paravalvular regurgitation. There was no difference in the rate of stroke, major vascular complication or bleeding. Permanent pacemaker implantation rate was significantly higher with SEV (12.7% vs 4.7%, P = 0.49) and hospital length of stay was longer (8.3% vs 6.5%, P = 0.043), but 30-day mortality was comparable (1.4% vs 1.6%, P = 1.00). CONCLUSIONS: Short-term outcomes were equivalent between the two technologies. Clinically significant paravalvular regurgitation was rare. SEV were more frequently selected in women and patients with challenging transfemoral access, but were associated with higher permanent pacemaker implantation rate and longer hospital length of stay.
Authors: Peter E Umukoro; Paul Yeung-Lai-Wah; Sunil Pathak; Sabri Elkhidir; Deepa Soodi; Brooke Delgoffe; Richard Berg; Kelley P Anderson; Romel J Garcia-Montilla Journal: Clin Med Res Date: 2020-10-14
Authors: Constantin von Zur Mühlen; Klaus Kaier; Peter Stachon; Philip Hehn; Dennis Wolf; Timo Heidt; Vera Oettinger; Manfred Zehender; Christoph Bode Journal: Clin Res Cardiol Date: 2021-09-21 Impact factor: 5.460
Authors: Harish Appa; Kenneth Park; Deon Bezuidenhout; Braden van Breda; Bruce de Jongh; Jandré de Villiers; Reno Chacko; Jacques Scherman; Chima Ofoegbu; Justiaan Swanevelder; Michael Cousins; Paul Human; Robin Smith; Ferdinand Vogt; Bruno K Podesser; Christoph Schmitz; Lenard Conradi; Hendrik Treede; Holger Schröfel; Theodor Fischlein; Martin Grabenwöger; Xinjin Luo; Heather Coombes; Simon Matskeplishvili; David F Williams; Peter Zilla Journal: Front Cardiovasc Med Date: 2022-03-03
Authors: Max-Paul Winter; Philipp Bartko; Felix Hofer; Martin Zbiral; Achim Burger; Bahil Ghanim; Johannes Kastner; Irene M Lang; Julia Mascherbauer; Christian Hengstenberg; Georg Goliasch Journal: Sci Rep Date: 2020-09-23 Impact factor: 4.379