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

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.