Hemodynamic comparison of CoreValve and SAPIEN-XT TAVI valves in Japanese patients

Heart Vessels. 2019 Oct;34(10):1674-1683. doi: 10.1007/s00380-019-01414-0. Epub 2019 Apr 16.

Abstract

Transcatheter aortic valve implantation (TAVI) is a viable treatment option for high-risk patients with severe aortic stenosis. In Japan, TAVI can be performed using first-generation self-expandable Medtronic CoreValve or balloon-expandable Edwards SAPIEN-XT from 2012. Since the durability and hemodynamic outcomes after transcatheter heart valve (THV) implantation in Japanese patients have not been clearly elucidated, we assessed serial changes in post-TAVI THV performances over a-3-year period by transthoracic echocardiography (TTE). From January 2012 to September 2014, among 83 patients with severe aortic stenosis, 26 underwent TAVI with CoreValve and 57 underwent TAVI with SAPIEN-XT. We assessed the serial changes in first post-implant (FPI) and 3-year post procedure THV hemodynamics by TTE. Valve performance was evaluated by serial assessment of aortic valve mean pressure gradient (PG) and aortic valve area (AVA) assessments. Three-year clinical outcomes were compared between the patients with CoreValve and those with SAPIEN-XT. Seventeen patients with CoreValve and 34 patients with SAPIEN-XT had FPI and 3-year TTEs. The AVA decreased significantly from FPI to 3-year follow-up among patients with SAPIEN-XT, but not among patients with CoreValve. The mean aortic PG decreased significantly from FPI to the 3-year follow-up point among patients with CoreValve; however, it was not significantly different from those with SAPIEN-XT. The absolute change in mean PG from FPI to the 3-year follow-up point decreased significantly among those with CoreValve compared to those with SAPIEN-XT. Clinical outcomes after TAVI were similar for both devices at 3-years after TAVI. In this study, long-term clinical outcomes for CoreValve and SAPIEN XT were similar. The 3-year THV performance of both devices was maintained after TAVI. Serial change in mean aortic PGs for CoreValve decreases significantly from FPI to the 3-year follow-up point compared to that for SAPIEN-XT.

Keywords: Aortic stenosis; Durability; Transcatheter aortic valve implantation; Transcatheter heart valve performance.

Publication types

  • Comparative Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve / diagnostic imaging*
  • Aortic Valve / physiopathology
  • Aortic Valve Stenosis / diagnostic imaging
  • Aortic Valve Stenosis / mortality
  • Aortic Valve Stenosis / therapy*
  • Balloon Valvuloplasty / adverse effects
  • Bioprosthesis
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / instrumentation*
  • Echocardiography
  • Female
  • Heart Valve Prosthesis
  • Hemodynamics*
  • Humans
  • Japan
  • Male
  • Prosthesis Design
  • Survival Analysis
  • Transcatheter Aortic Valve Replacement / adverse effects
  • Transcatheter Aortic Valve Replacement / instrumentation*
  • Treatment Outcome