Intra-annular self-expanding or balloon-expandable TAVI in small annuli: the NAVULTRA registry.
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Cannata Stefano, Sultan Ibrahim, Van Mieghem Nicolas M, Giordano Arturo, Backer Ole De, Byrne Jonathan, Tchétché Didier, Buccheri Sergio, Nombela-Franco Luis, Campante Teles Rui, Barbanti Marco, Barbato Emanuele, Amat Santos Ignacio, Blackman Daniel J, Maisano Francesco, Lorusso Roberto, La Spina Ketty, Millin Antonella, Kliner Dustin E, van den Dorpel Mark, Acerbi Elena, Lulic Davorka, Fayed Hossam, De Biase Chiara, Chavez Solsol Jorge Francisco, Brito Joao, Costa Giuliano, Casenghi Matteo, Cordon Clara Fernandez, Sherwen Amanda, Buzzatti Nicola, Pasta Salvatore, Turrisi Marco, Manca Paolo, Nuzzi Vincenzo, Tamburino Corrado, Bedogni Francesco, Gandolfo Caterina, Latib Azeem
Аннотация
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.