Multicenter Comparison of Novel Self-Expanding Versus Balloon-Expandable Transcatheter Heart Valves*1

Study Design

ACURATE neo vs. SAPIEN 3

  • Observational, propensity-matched multicenter comparison of ACURATE neo and SAPIEN 3 from 3 high volume centers in Germany (DHZ Munich, UK Regensburg, Kerckhoff Klinikum Bad Nauheim)
  • 1,121 consecutive patients between Jan. 2014 and Jan. 2016 with symptomatic, severe stenosis of the native aortic valve treated with transfemoral TAVI using ACURATE neo (n = 311) or SAPIEN 3 (n = 810)
  • To increase statistical power, a 1-to-2 nearest neighbor matching was used to identify 2 control cases treated with SAPIEN 3 (n = 622) for each case treated with ACURATE neo (n = 311)
  • Endpoints: device failure and early safety composite endpoint at 30 days according to VARC-2 criteria