TY - JOUR
T1 - Intra-annular self-expanding or balloon-expandable TAVI in small annuli
T2 - the NAVULTRA registry
AU - Cannata, Stefano
AU - Sultan, Ibrahim
AU - Van Mieghem, Nicolas M.
AU - Giordano, Arturo
AU - Backer, Ole De
AU - Byrne, Jonathan
AU - Tchétché, Didier
AU - Buccheri, Sergio
AU - Nombela-Franco, Luis
AU - Campante Teles, Rui
AU - Barbanti, Marco
AU - Barbato, Emanuele
AU - Amat Santos, Ignacio
AU - Blackman, Daniel J.
AU - Maisano, Francesco
AU - Lorusso, Roberto
AU - La Spina, Ketty
AU - Millin, Antonella
AU - Kliner, Dustin E.
AU - van den Dorpel, Mark
AU - Acerbi, Elena
AU - Lulic, Davorka
AU - Fayed, Hossam
AU - De Biase, Chiara
AU - Chavez Solsol, Jorge Francisco
AU - Brito, Joao
AU - Costa, Giuliano
AU - Casenghi, Matteo
AU - Cordon, Clara Fernandez
AU - Sherwen, Amanda
AU - Buzzatti, Nicola
AU - Pasta, Salvatore
AU - Turrisi, Marco
AU - Manca, Paolo
AU - Nuzzi, Vincenzo
AU - Tamburino, Corrado
AU - Bedogni, Francesco
AU - Gandolfo, Caterina
AU - Latib, Azeem
N1 - Publisher Copyright:
© Europa Group 2026. All rights reserved.
PY - 2026/2/2
Y1 - 2026/2/2
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/105029328888
U2 - 10.4244/EIJ-D-25-00937
DO - 10.4244/EIJ-D-25-00937
M3 - Article
C2 - 41627781
AN - SCOPUS:105029328888
SN - 1774-024X
VL - 22
SP - e161-e171
JO - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
JF - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
IS - 3
ER -