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Does Intra-Annular Valve Design Equal Intra-Annular Valve Design? Comparison of Two Transcatheter Aortic Valve
Clemens Eckel1,2, Fadi Al-Rashid1,3, Sophie Bargon1
1Department of Cardiology, St. Johannes Hospital, 44137 Dortmund, Germany.
Journal of Clinical Medicine
|March 27, 2025
Summary
The NAVITOR prosthesis demonstrated superior 30-day device success compared to the Sapien 3 Ultra in patients with small aortic annuli. NAVITOR offers a better hemodynamic profile, reducing prosthesis-patient mismatch and elevated gradients.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials and Medical Devices
Background:
- Prosthesis-patient mismatch (PPM) negatively impacts outcomes in surgical (SAVR) and transcatheter aortic valve replacement (TAVR).
- Supra-annular transcatheter valves (SAV) may mitigate PPM more effectively than intra-annular valves (IAV).
- Limited comparative data exists for intra-annular self-expanding (SE) NAVITOR versus intra-annular balloon-expandable (BE) Sapien 3 Ultra in small aortic annuli.
Purpose of the Study:
- To compare the clinical and hemodynamic outcomes of the SE NAVITOR and BE Sapien 3 Ultra valves in patients with severe native aortic valve stenosis.
- To evaluate the incidence of prosthesis-patient mismatch and device success between the two valve types in small annuli.
Main Methods:
- A retrospective study of 179 patients with severe aortic stenosis treated with either SE NAVITOR (SEV, n=104) or BE Sapien 3 Ultra (BEV, n=75) between March 2019 and June 2024.
- Comparison of 30-day device success, hemodynamic parameters (mean gradient), prosthesis-patient mismatch (PPM), paravalvular leakage (PVL), and pacemaker implantation rates.
- BMI-adjusted PPM defined per VARC-3 recommendations.
Main Results:
- Superior 30-day device success for NAVITOR (94.2%) versus Sapien 3 Ultra (80.0%), primarily due to lower elevated gradients in the SEV group.
- Lower post-procedural mean gradient (8.0 mmHg vs. 13.0 mmHg) and moderate-to-severe PPM rates (12.2% vs. 33.3%) in the NAVITOR group.
- Similar rates of moderate-to-severe PVL (1.0% vs. 1.3%); pacemaker implantations were numerically higher after SEV (18.4% vs. 8.5%).
Conclusions:
- The NAVITOR system demonstrated superior device success and a more favorable hemodynamic profile compared to the Sapien 3 Ultra in patients with small aortic annuli.
- NAVITOR may be a preferred option for reducing prosthesis-patient mismatch and achieving better hemodynamic outcomes in this specific patient population.
- Further research is warranted to confirm long-term outcomes and explore the trend in pacemaker implantation rates.
