Valvular & structural heart diseaseCohort study
First-in-Human Multicenter Experience of the Newest Generation Supra-Annular Self-Expanding Evolut FX Transcatheter Aortic Valve Replacement (TAVR) System
- Retrospective multicentre cohort study
- first-in-human
- limited market release
- 9 US centres
- consecutive patients
- comparison with single-centre PRO+ experience
- Characteristics retrospectively reviewed
Authors' conclusion
The Evolut FX system demonstrated favorable 30-day outcomes with a significant improvement over PRO+ in achieving commissural alignment, fewer device recaptures, and more symmetrical implantation.
Study context
- Population
- Patients undergoing transfemoral TAVR for native AS (89.4%) or prosthetic valve degeneration (10.6%)
- Participants
- 226 patients · 9 US centres
- Exposure
- Evolut FX vs Evolut PRO+
- FXn = 226
- Outcome
- Clinical and echocardiographic outcomes (VARC-3 definitions)
- Follow-up
- 30 days
Main finding
As reported in the abstract
Paravalvular leak
Mild paravalvular leak
14.3%
Moderate paravalvular leak
0.9%
Severe paravalvular leak
0
Observational data: associations, not effects.
Further findings
FX vs single-centre Evolut PRO+ experience
P < 0.001
Device recaptures
P = 0.004
Commissural alignment
P < 0.001
- FX vs single-centre Evolut PRO+ experience: more symmetrical implantation, shallower depth at left coronary cusp
Procedural results
- Optimal hat marker orientation during deployment
- 98.4%
- Commissural alignment
- 96.5%
Original publication
First-in-Human Multicenter Experience of the Newest Generation Supra-Annular Self-Expanding Evolut FX TAVR System. JACC Cardiovasc Interv. Published 10 July 2023. doi:10.1016/j.jcin.2023.05.004
Summarised from the published abstract; every number is checked against it