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Observational Study
. 2025 Jun 23;18(12):1557-1568.
doi: 10.1016/j.jcin.2025.03.015. Epub 2025 May 10.

Transcatheter Aortic Valve Replacement With Intra-Annular Self-Expanding or Balloon-Expandable Valves: The Multicenter International NAVULTRA Registry

Stefano Cannata  1 , Ibrahim Sultan  2 , Nicolas Van Mieghem  3 , Arturo Giordano  4 , Ole De Backer  5 , Johnathan Byrne  6 , Didier Tchetche  7 , Sergio Buccheri  8 , Luis Nombela-Franco  9 , Rui Campante Teles  10 , Marco Barbanti  11 , Emanuele Barbato  12 , Ignacio Amat Santos  13 , Daniel J Blackman  14 , Francesco Maisano  15 , Roberto Lorusso  16 , Ketty La Spina  17 , Antonella Millin  18 , Dustin E Kliner  2 , Mark van den Dorpel  3 , Elena Acerbi  19 , Davorka Lulic  5 , Kaivalya Divekar  6 , Vincenzo Cesario  7 , Jorge Francisco Chavez Solsol  9 , Joao Brito  10 , Giuliano Costa  20 , Matteo Casenghi  12 , Clara Fernandez Cordon  21 , Amanda Sherwen  14 , Nicola Buzzatti  15 , Salvatore Pasta  22 , Marco Turrisi  17 , Michele Minacori  17 , Paolo Manca  17 , Vincenzo Nuzzi  17 , Corrado Tamburino  23 , Francesco Bedogni  19 , Caterina Gandolfo  17 , Azeem Latib  18
Affiliations
Observational Study

Transcatheter Aortic Valve Replacement With Intra-Annular Self-Expanding or Balloon-Expandable Valves: The Multicenter International NAVULTRA Registry

Stefano Cannata et al. JACC Cardiovasc Interv. .

Abstract

Background: No comparative data exist with the self-expanding Navitor (NAV) and the balloon-expandable SAPIEN 3 Ultra (ULTRA) transcatheter heart valves (THVs).

Objectives: This study sought to investigate the 1-year outcomes of transcatheter aortic valve replacement using the intra-annular NAV and the ULTRA THVs.

Methods: The NAVULTRA (Navitor and SAPIEN 3 Ultra) registry included consecutive patients who underwent transfemoral transcatheter aortic valve replacement at 16 centers with NAV or ULTRA between November 2018 and April 2024. Propensity score matching was used for adjustment. The primary outcomes of interest were all-cause death and the composite of all-cause death, disabling stroke, and hospitalization for heart failure at 1 year.

Results: The overall study cohort included 3,878 patients treated with NAV (n = 1,746) or ULTRA (n = 2,176). The propensity score-matched population resulted in 1,363 pairs. At 1 year, the rate of death from any cause was 9.7% with NAV and 9.9% with ULTRA (adjusted P = 0.585). Similarly, there were no significant differences in primary composite outcome (13.6% in the NAV group and 12.6% in the ULTRA group; adjusted P = 0.218). The rate of new permanent pacemaker implantation (20.6% vs 10.6%; adjusted P < 0.01) and heart failure rehospitalization (4.6% vs 2.8%; adjusted P < 0.05) was higher in NAV group. At 1 year, the use of NAV was associated with higher rates of mild paravalvular leak (OR: 1.53; 95% CI: 1.01 to 2.33; adjusted P < 0.05) but lower mean transprosthetic gradients compared with ULTRA (mean change:-3.90, 95% CI: -4.47 to -3.34; adjusted P < 0.01).

Conclusions: Both intra-annular THVs were associated with similar 1-year clinical outcomes; however, differences were observed in secondary clinical endpoints and valve hemodynamic performance.

Keywords: Navitor; SAPIEN 3 Ultra; TAVR; intra-annular.

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Conflict of interest statement

Funding Support and Author Disclosures Dr Van Mieghem has received research grants from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Medtronic, Meril, Pie Medical, PulseCath BV, and Teleflex; and served as a consultant for Abbott, Abiomed, Alleviant Medical Inc., AncorValve, Anteris, Approxima Srl, Bolt Medical, Boston Scientific, Daiichi-Sankyo, LUMA Vision, Materialise, Medtronic, Pie Medical, Polares, PulseCath BV, and Siemens. Dr De Backer has received institutional research grants and consulting fees from Abbott, Boston Scientific, and Medtronic. Dr Byrne has served on the advisory board or as a physician proctor for Abbott and Edwards Lifesciences; and received educational grants from Edwards Lifesciences. Dr Barbanti has served as a consultant for Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Nombela-Franco has served as a proctor for Abbott Vascular and Edwards Lifesciences. Dr Maisano has received grant and/or research institutional support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, NVT, Terumo, and Venus; has received consulting fees and honoraria (personal and institutional) from Abbott, Boston Scientific, Medtronic, Edwards Lifesciences, Xeltis, CardioValve, Occlufit, Simulands, Mtex, Venus, Squadra, Valgen, and CroiValve; has also royalty income from and IP rights with Edwards Lifesciences; and is a shareholder (including share options) of Magenta, Transseptalsolutions, and 4Tech. Dr Lorusso has received research grant support from Medtronic and LivaNova; received speaker fees from Abiomed; served on the medical advisory board of Xenios and Eurosets; and served as a consultant for Medtronic and LivaNova. Dr Tamburino has served as a consultant for Medtronic. Dr Gandolfo has served as a proctor for Edwards Lifesciences. Dr Latib has served on the advisory board or as a consultant for Medtronic, Boston Scientific, Philips, Edwards Lifesciences, Abbott, Philips, Tresquare, and Anteris. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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