Improvements of Procedural Results With a New-Generation Self-Expanding Transfemoral Aortic Valve Prosthesis in Comparison to the Old-Generation Device

Abstract

Objectives: In this study, we compare procedural results of our first Evolut R (Medtronic, Minneapolis, MN, USA) implantations with the last CoreValve implantations. Main endpoints include paravalvular regurgitation, major vascular complications, stroke, and pacemaker implantation. Background: The evolution of transcatheter aortic valve replacement (TAVR) was possible due to various technical improvements, leading to better periprocedural and long-term outcome. The newly designed Evolut R valve has the potential to further improve TAVR's performance. Methods: We retrospectively analyzed our first 100 consecutive patients who received the Evolut R valve with the last 100 consecutive patients who received the CoreValve prosthesis between July 2013 and February 2016. Only patients treated with a 26 mm or 29 mm bioprosthesis were included. Results: No significant differences in patient characteristics were noticed. Both angiography and echocardiography after TAVR showed significantly higher rates of “none or trace” regurgitation in the Evolut R group (angiography: 67% Evolut R vs. 29.3% CoreValve; P < 0.001; echocardiography: 68% Evolut R vs. 46.5% CoreValve; P < 0.05). No significant differences were seen in 30-day mortality (7% CoreValve vs. 1% Evolut R), stroke rates (3% CoreValve vs. 2% Evolut R), pacemaker implantation rates (24% CoreValve vs. 23% Evolut R), and major vascular complications (6% CoreValve vs. 1% Evolut R). Implantations were significantly higher with the Evolut R prosthesis. Conclusions: TAVR with the new Evolut R resulted in significantly lower paravalvular regurgitation. This may be due to redesigned cell geometry and higher precision during implantations, as well as the ability to resheath a malpositioned valve.