Valvular & structural heart diseaseCohort study
Intra-annular self-expanding or balloon-expandable transcatheter aortic valve implantation (TAVI) in small annuli: the NAVULTRA registry
- registry
- Propensity-matched analysis
Authors' conclusion
In patients with small aortic annuli, TAVI with both NAV and ULTRA provided comparable 1-year clinical outcomes, but NAV showed better haemodynamic performance at the cost of higher rates of mild PVL and PPI.
Study context
- Population
- Severe aortic stenosis patients with small annuli (aortic annulus area ≤430 mm²) undergoing TAVI with Navitor (NAV) or Ultra (ULTRA)524 propensity score-matched pairs analysed
- Participants
- 1,617 patients
- Exposure
- TAVI using the intra-annular NAV and the ULTRA transcatheter heart valves (THVs)
- Outcome
- Primary endpoints: 1-year mortality, composite endpoint (all-cause mortality, disabling stroke, or heart failure hospitalisation), and 30-day device-oriented outcomes (severe prosthesis-patient mismatch, moderate or greater PVL, mean gradient ≥20 mmHg)
- Follow-up
- 1 year; 30-day
Main finding
As reported in the abstract
All-cause mortality at 1 year
adjusted p=0.585
Composite endpoint
adjusted p=0.149
Device-oriented endpoint
adjusted p<0.01
Observational data: associations, not effects.
Further findings
Residual transvalvular gradient · lower with NAV
adjusted p<0.01
| Outcome | odds ratio (95% CI) | P value | |
|---|---|---|---|
| Any prosthesis-patient mismatch · reduced incidence with NAV | 0.27 (0.18–0.43) | adjusted p<0.01 | |
| 0.20.5125Odds ratio (log scale) |
Safety
Mild paravalvular leak · higher with NAV
adjusted p<0.05
Permanent pacemaker implantation (PPI) · higher with NAV
adjusted p<0.01
Original publication
Intra-annular self-expanding or balloon-expandable TAVI in small annuli: the NAVULTRA registry. EuroIntervention. Published 2 February 2026. doi:10.4244/eij-d-25-00937
Summarised from the published abstract; every number is checked against it