Does Intra-Annular Valve Design Equal Intra-Annular Valve Design? Comparison of Two Transcatheter Aortic Valve Prostheses
<b>Background:</b> 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. <b>Methods:</b> A total of 179 patients with severe native aortic valve stenosis were treated with either the SE NAVITOR (SEV; <i>n</i> = 104) or the BE Sapien 3 Ultra (BEV; <i>n</i> = 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. <b>Results:</b> The device success at 30 days was superior in patients treated with the NAVITOR prosthesis (94.2% vs. 80.0%, <i>p</i> < 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, <i>p</i> < 0.001) as well as the rate of moderate to severe prosthesis patient mismatch (12.2% vs. 33.3%, <i>p</i> = 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%, <i>p</i> = 1.000) was similar between both groups. Pacemaker implantations were numerically more common after SEV (18.4% vs. 8.5%, <i>p</i> = 0.110). There was a trend towards higher thirty-day all-cause mortality among patients treated with SAV (3.8% vs. 1.3%, <i>p</i> = 0.401). <b>Conclusion:</b> The NAVITOR system may offer a more favorable hemodynamic profile compared to the Sapien 3 Ultra device in patients with small aortic annuli.
Authors
- Johannes Blumenstein (ORCID: https://orcid.org/0000-0003-1032-7472)
- Fadi Al‐Rashid (ORCID: https://orcid.org/0000-0001-5229-9612)
- Helge Möllmann (ORCID: https://orcid.org/0000-0002-6047-0990)
- Judith Schlüter
- Clemens Eckel (ORCID: https://orcid.org/0000-0002-8853-8096)
- Dagmar Sötemann
- Christina Grothusen
- Sophie Bargon
- Albrecht Elsässer
Institutions
- Carl von Ossietzky Universität Oldenburg (DE)
- University Hospital Schleswig-Holstein (DE)
- St.-Johannes-Hospital Dortmund (DE)
- University of Duisburg-Essen (DE)
- University of Lübeck (DE)
Publication Details
- Journal
- Journal of Clinical Medicine
- Published
- 2025-03-08
- DOI
- https://doi.org/10.3390/jcm14061824
- Citations
- 4
- Primary Topic
- Cardiac Valve Diseases and Treatments
- Type
- article
- Field-Weighted Citation Impact
- 5.55