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Transcatheter Aortic Valve Replacement With a Fully Retrievable Self-Expanding Dry-Tissue Valve: First-in-Man Study.

Zhengang Zhao1, Yong Peng1, Fei Chen1

  • 1Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China; Laboratory of Cardiac Structure and Function, Institute of Cardiovascular Diseases, West China Hospital, Sichuan University, Chengdu, China; Cardiac Structure and Function Research Key Laboratory of Sichuan Province, West China Hospital, Sichuan University, Chengdu, China.

The American Journal of Cardiology
|April 2, 2025
PubMed
Summary

The novel Venus-PowerX Valve offers full retrievability at complete deployment for transcatheter aortic valve replacement (TAVR). This first-in-man study shows promising feasibility, safety, and excellent 1-year outcomes for severe aortic stenosis patients.

Keywords:
TAVRaortic stenosisdry tissuefully retrievable

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Area of Science:

  • Cardiovascular Medicine
  • Interventional Cardiology
  • Medical Device Technology

Background:

  • Contemporary transcatheter aortic valve replacement (TAVR) devices offer partial retrievability, but migration risk persists during final deployment.
  • A novel self-expanding, dry-tissue TAVR device, the Venus-PowerX Valve, allows complete retrievability even at 100% deployment.

Purpose of the Study:

  • To evaluate the feasibility and safety of the Venus-PowerX Valve in a first-in-man study.
  • To assess clinical outcomes and adverse events using Valve Academic Research Consortium-3 (VARC-3) criteria.

Main Methods:

  • A prospective first-in-man study enrolled 25 patients with severe aortic stenosis.
  • Patients underwent TAVR with the Venus-PowerX Valve.
  • Outcomes including technical success, device success, adverse events, and 1-year follow-up were assessed.

Main Results:

  • 100% acute technical success was achieved, with successful valve recapture in 2 patients due to suboptimal positioning.
  • At 30 days, device success was 88.0%, with minor complications including residual gradient, paravalvular leak, and bleeding.
  • At 1 year, survival was 96.0%, with significant improvements in aortic valve gradient and effective orifice area, and low rates of paravalvular leak.

Conclusions:

  • The Venus-PowerX Valve demonstrates feasibility and safety for TAVR.
  • The device's full retrievability enhances predictable positioning.
  • Satisfactory hemodynamic and clinical outcomes were observed in patients with bicuspid and tricuspid aortic valve stenosis.