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

J Interv Cardiol. 2017 Feb;30(1):72-78. doi: 10.1111/joic.12356. Epub 2016 Nov 24.

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.

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve Insufficiency / etiology
  • Aortic Valve Stenosis / diagnostic imaging
  • Aortic Valve Stenosis / surgery*
  • Aortic Valve*
  • Bioprosthesis*
  • Echocardiography
  • Female
  • Heart Valve Prosthesis*
  • Humans
  • Male
  • Prosthesis Design
  • Retrospective Studies
  • Transcatheter Aortic Valve Replacement*
  • Treatment Outcome