Valvular & structural heart diseaseCohort study
Transcatheter Aortic Valve Replacement With Intra-Annular Self-Expanding or Balloon-Expandable Valves
- Registry-based cohort study
- propensity-score matched
- multicentre (16 centres)
Authors' conclusion
Both intra-annular THVs were associated with similar 1-year clinical outcomes; however, differences were observed in secondary clinical endpoints and valve hemodynamic performance.
Study context
- Population
- Consecutive patients undergoing transfemoral TAVR, November 2018–April 20241,363 PS-matched pairs
- Participants
- 1,746 vs 2,176
- Exposure
- Navitor vs SAPIEN 3 Ultra intra-annular Transcatheter Heart Valves (THVs)
- Navitor (NAV)n = 1,746
- Ultra (ULTRA)n = 2,176reference
- Outcome
- All-cause death; composite of all-cause death, disabling stroke and HF hospitalization
- Follow-up
- 1 year
Main finding
As reported in the abstract
All-cause death
adjusted P = 0.585
Primary composite
adjusted P = 0.218
Observational data: associations, not effects.
Further findings
HF rehospitalization · 1 year
adjusted P < 0.05
| Outcome | mean change (95% CI) | P value | |
|---|---|---|---|
| Mean transprosthetic gradient · 1 year · lower with NAV | −3.90 (−4.47 to −3.34) | adjusted P < 0.01 | |
| −6−4−202Difference (linear scale) |
Safety
New permanent pacemaker implantation
adjusted P < 0.01
| Outcome | OR (95% CI) | P value | |
|---|---|---|---|
| Mild paravalvular leak · 1 year | 1.53 (1.01–2.33) | adjusted P < 0.05 | |
| 0.512Odds ratio (log scale) |
Original publication
Transcatheter Aortic Valve Replacement With Intra-Annular Self-Expanding or Balloon-Expandable Valves. JACC Cardiovasc Interv. Published 10 May 2025. doi:10.1016/j.jcin.2025.03.015
Summarised from the published abstract; every number is checked against it