Impact of Aortic Annulus Size on Clinical and Hemodynamic Outcomes of Transcatheter Aortic Valve Implantation With the Navitor Valve.

Authors

Matteo Casenghi, Sara Corradetti, Pasquale Paolisso, Marta Belmonte, Emanuele Gallinoro, Emiliano Fiori, Linda Piras, Daniele Barzetti, Rita Tufo, Carlo Barsali, Stefano Rigattieri, Liesbeth Rosseel, Eric Wyffels, Andrea Berni, Marc Vanderheyden, Emanuele Barbato

Published in

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. Sep 17, 2026. Epub Sep 17, 2026.

Abstract

Patients with small aortic annuli undergoing transcatheter aortic valve implantation (TAVI) are at risk of higher residual transvalvular gradients. Evidence on the performance of new-generation intra-annular self-expanding valves in this anatomical setting remains limited.
To evaluate the impact of annular size on procedural, hemodynamic, and mid-term clinical outcomes after TAVI with the Navitor valve.
Patients were stratified by annular area measured by multi-slice computed tomography, defining a small annulus as ≤ 430 mm². Primary endpoints at 12 months were: (i) a clinical composite of all-cause death, disabling stroke, or heart failure rehospitalization, and (ii) a composite endpoint of bioprosthetic valve dysfunction. Secondary endpoints included VARC-3-defined procedural and early outcomes and valve hemodynamic performance.
The study population comprised 218 patients, of whom 91 (41.7%) had a small annulus. VARC-3 technical success was high and comparable between small and non-small annuli (96.7% vs. 96.1%). Patients with small annuli had higher early post-procedural mean transvalvular gradients (7.7 ± 3.8 vs. 6.6 ± 3.0 mmHg; p = 0.029) and smaller effective orifice areas index (1.1 ± 0.3 vs. 1.3 ± 0.2 cm²/m²; p = 0.037), while the incidence of mean gradients ≥ 20 mmHg remained low (1.1% vs. 0.0%; p = 0.432). At 12 months, the clinical composite endpoint occurred in 8.8% of patients with small annuli and 10.2% with non-small annuli (p = 0.759). Bioprosthetic valve dysfunction was infrequent and similar between groups (6.6% vs. 6.3%; p = 0.875).
TAVI with the Navitor intra-annular self-expanding valve was associated with high procedural success, favorable valve hemodynamics, and comparable mid-term clinical outcomes irrespective of annular size.

PMID:
42753172
Bibliographic data and abstract were imported from PubMed on 18 Sep 2026.

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