Key result
Small annulus yields similar 12-month outcomes and valve performance to larger annuli after Navitor TAVI.
Why the study?
Patients with small aortic annuli undergoing TAVI face higher risks of residual transvalvular gradients, and evidence on the performance of new-generation intra-annular self-expanding valves like the Navitor valve in this setting remains limited.
Does a small aortic annulus (≤430 mm²) impact 12-month clinical composite outcomes and bioprosthetic valve dysfunction compared to a non-small annulus in patients undergoing TAVI with the Navitor valve?
Observational (n=218)
Does a small aortic annulus (≤430 mm²) impact 12-month clinical composite outcomes and bioprosthetic valve dysfunction compared to a non-small annulus in patients undergoing TAVI with the Navitor valve?
TAVI with the intra-annular self-expanding Navitor valve achieves high procedural success, favorable hemodynamics, and comparable 12-month clinical outcomes and bioprosthetic valve dysfunction rates in patients with small versus non-small aortic annuli.
Comparable outcomes in small annuli after Navitor TAVI; extends observational evidence but leaves open need for randomized confirmation.
Background 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. We evaluated the impact of annular size on procedural, hemodynamic, and clinical outcomes after TAVI with the Navitor valve. Methods Patients were stratified by annular area measured by multi-slice computed tomography, defining 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. Results The study population consisted in 218 patients, including 91 (41.7%) with 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). Conclusions TAVI with the Navitor valve was associated with high procedural success, favourable valve hemodynamics, and comparable mid-term clinical outcomes irrespective of annular size.12-months clinical and Haemodynamic Outcomes
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Capparelli et al. (2026) conducted an observational in Aortic stenosis requiring transcatheter aortic valve implantation (TAVI) (n=218). Small aortic annulus (≤430 mm²) undergoing TAVI with Navitor valve vs. Non-small aortic annulus (>430 mm²) undergoing TAVI with Navitor valve was evaluated on Co-primary endpoints at 12 months: (i) clinical composite of all-cause death, disabling stroke, or heart failure rehospitalization; and (ii) composite of bioprosthetic valve dysfunction (p=0.759). Small aortic annulus (≤430 mm²) in Navitor TAVI had similar 12-month death, stroke, or HF rehospitalization (8.8% vs 10.2%; p=0.759) and valve dysfunction (6.6% vs 6.3%; p=0.875) as larger annuli.
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