Intra-annular self-expanding or balloon-expandable TAVI in small annuli: the NAVULTRA registry.

Cannata, S.; Sultan, I.; Van Mieghem, NM.; Giordano, A.; Backer, O.; Byrne, J.; Tchetche, D.; Buccheri, S.; Nombela-Franco, L.; Campante Teles, R.; Barbanti, M.; Barbato, E.; Amat Santos, I.; Blackman, DJ.; Maisano, F.; Lorusso, R.; La Spina, K.; Millin, A.; Kliner, DE.; van den Dorpel, M.; Acerbi, E.; Lulic, D.; Fayed, H.; De Biase, C.; Chavez Solsol, JF.; Brito, J.; Costa, G.; Casenghi, M.; Cordon, CF.; Sherwen, A.; Buzzatti, N.; Pasta, S.; Turrisi, M.; Manca, P.; Nuzzi, V.; Tamburino, C.; Bedogni, F.; Gandolfo, C.; Latib, A.

Intra-annular self-expanding or balloon-expandable TAVI in small annuli: the NAVULTRA registry.

All Authors

Cannata, S.

Sultan, I.

Van Mieghem, NM.

Giordano, A.

Backer, O.

Byrne, J.

Tchetche, D.

Buccheri, S.

Nombela-Franco, L.

Campante Teles, R.

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LTHT Author

Blackman, Daniel
Sherwen, Amanda

LTHT Department

Cardio-Respiratory
Cardiology

Publication Date

2026

Item Type

Journal Article

Subject

HUMANS , HOSPITALISATION , AORTIC VALVE , MEN , WOMEN , AORTIC VALVE STENOSIS , AGED, 80 AND OVER , REGISTRIES , HEART VALVE PROSTHESIS , AGED , TREATMENT OUTCOME , PROSTHESES AND IMPLANTS , MODELS, STATISTICAL

Abstract

BACKGROUND: Comparative data between self-expanding Navitor (NAV) and balloon-expandable SAPIEN 3 Ultra (ULTRA) transcatheter heart valves (THVs) in patients with small aortic annuli are lacking. AIMS: This study sought to evaluate outcomes of transcatheter aortic valve implantation (TAVI) using the intra-annular NAV and the ULTRA THVs in severe aortic stenosis patients with small annuli. METHODS: Patients with an aortic annulus area <=430 mm2 undergoing TAVI with either NAV or ULTRA from the NAVULTRA registry were included. Propensity-matched analysis was performed for adjustment. Primary endpoints included 1-year mortality, a composite endpoint (all-cause mortality, disabling stroke, or heart failure hospitalisation), and 30-day device-oriented outcomes (severe prosthesis-patient mismatch, moderate or greater paravalvular leak [PVL], mean gradient >=20 mmHg). RESULTS: Among 1,617 patients, 524 propensity score-matched pairs were analysed. At 1 year, all-cause mortality was 8.8% with NAV versus 9.0% with ULTRA (adjusted p=0.585), and the composite endpoint occurred in 11.3% versus 11.8%, respectively (adjusted p=0.149). The device-oriented endpoint favoured NAV compared to ULTRA (6.0% vs 29.3%; adjusted p<0.01), with a lower residual transvalvular gradient (7.3 mmHg vs 12.7 mmHg; adjusted p<0.01), and reduced incidence of any prosthesis-patient mismatch (odds ratio 0.27, 95% confidence interval: 0.18-0.43; adjusted p<0.01). However, NAV was associated with higher rates of mild paravalvular leak (NAV 33.5% vs ULTRA 23.2%; adjusted p<0.05) and permanent pacemaker implantation (PPI; NAV 20.1% vs 11.9% ULTRA; adjusted p<0.01). CONCLUSIONS: 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.