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. 2025 Mar 8;14(6):1824.
doi: 10.3390/jcm14061824.

Does Intra-Annular Valve Design Equal Intra-Annular Valve Design? Comparison of Two Transcatheter Aortic Valve Prostheses

Clemens Eckel  1   2 , Fadi Al-Rashid  1   3 , Sophie Bargon  1 , Judith Schlüter  1   2 , Dagmar Sötemann  1 , Albrecht Elsässer  2 , Johannes Blumenstein  1   2 , Helge Möllmann  1 , Christina Grothusen  1   4
Affiliations

Does Intra-Annular Valve Design Equal Intra-Annular Valve Design? Comparison of Two Transcatheter Aortic Valve Prostheses

Clemens Eckel et al. J Clin Med. .

Abstract

Background: Prosthesis-patient mismatch (PPM) has been demonstrated to affect the outcome of both surgical (SAVR) and transcatheter aortic valve replacement (TAVR) patients. Supra-annular transcatheter valves (SAV) appear to offer a superior solution to intra-annular valves (IAV) in this regard. However, data on the comparison of the intra-annular self-expanding (SE) NAVITOR and the intra-annular balloon-expandable (BE) Sapien 3 Ultra in small annuli are limited. Methods: A total of 179 patients with severe native aortic valve stenosis were treated with either the SE NAVITOR (SEV; n = 104) or the BE Sapien 3 Ultra (BEV; n = 75) between March 2019 and June 2024. We compared the clinical and hemodynamic outcomes of the cohort according to the implanted prostheses. BMI-adjusted PPM was defined in accordance with the VARC-3 recommendations. Results: The device success at 30 days was superior in patients treated with the NAVITOR prosthesis (94.2% vs. 80.0%, p < 0.001), mainly driven by a higher rate of elevated gradients in the BEV group. The post-procedural mean gradient (8.0 mmHg vs. 13.0 mmHg, p < 0.001) as well as the rate of moderate to severe prosthesis patient mismatch (12.2% vs. 33.3%, p = 0.002) was higher in BEV recipients while the rate of more than moderate paravalvular leakage (PVL) or Valve in Valve (VinV) due to PVL (1.0% vs. 1.3%, p = 1.000) was similar between both groups. Pacemaker implantations were numerically more common after SEV (18.4% vs. 8.5%, p = 0.110). There was a trend towards higher thirty-day all-cause mortality among patients treated with SAV (3.8% vs. 1.3%, p = 0.401). Conclusion: The NAVITOR system may offer a more favorable hemodynamic profile compared to the Sapien 3 Ultra device in patients with small aortic annuli.

Keywords: Navitor; PPM; Sapien Ultra; TAVI; TAVR; THV; balloon expandable; self-expanding; small annulus.

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Conflict of interest statement

Helge Möllmann has received proctor fees and speaker honoraria from Boston Scientific, Biotronik, and Abbott. Johannes Blumenstein has received proctor fees and speaker honoraria from Boston Scientific and Abbott. The remaining authors declare no conflicts of interest.

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