Comparison of the New-Generation Self-Expanding NAVITOR Transcatheter Heart Valve with Its Predecessor, the PORTICO, in Severe Native Aortic Valve Stenosis

Author:

Eckel Clemens Enno12,Kim Won-Keun34,Grothusen Christina15,Tiyerili Vedat1,Elsässer Albrecht2,Sötemann Dagmar1,Schlüter Judith12,Choi Yeong-Hoon3ORCID,Charitos Efstratios I.3ORCID,Renker Matthias46ORCID,Hamm Christian W.67,Dohmen Guido8ORCID,Möllmann Helge1,Blumenstein Johannes12

Affiliation:

1. Department of Cardiology, St. Johannes Hospital, 44137 Dortmund, Germany

2. Department of Cardiology, University of Oldenburg, 26129 Oldenburg, Germany

3. Department of Cardiac Surgery, Kerckhoff Heart Center, 61231 Bad Nauheim, Germany

4. Department of Cardiology, Kerckhoff Heart Center, 61231 Bad Nauheim, Germany

5. Department of Cardiac and Vascular Surgery, University of Kiel, 24098 Kiel, Germany

6. German Center for Cardiovascular Research (DZHK), Partner Site Rhine-Main, 55131 Bad Nauheim, Germany

7. Department of Cardiology, University of Giessen, 35390 Giessen, Germany

8. Department of Cardiac Surgery, St. Johannes Hospital, 44137 Dortmund, Germany

Abstract

Background: Third-generation transcatheter heart valves (THVs) are designed to improve outcomes. Data on the new intra-annular self-expanding NAVITOR are scarce. Aims: The aim of this analysis was to compare outcomes between the PORTICO and the NAVITOR systems. Methods: Data from 782 patients with severe native aortic stenosis treated with PORTICO (n = 645) or NAVITOR (n = 137) from 05/2012 to 09/2022 were evaluated. The clinical and hemodynamic outcomes of 276 patients (PORTICO, n = 139; NAVITOR, n = 137) were evaluated according to VARC-3 recommendations. Results: Rates of postprocedural more-than-mild paravalvular leakage (PVL) were significantly lower for NAVITOR than for PORTICO (7.2% vs. 1.5%, p = 0.041). In addition, severe bleeding rates (27.3% vs. 13.1%, p = 0.005) and major vascular complications (5.8% vs. 0.7%, p = 0.036) were lower in the NAVITOR group. The mean gradients (7 vs. 8 mmHg, p = 0.121) and calculated aortic valve areas (1.90 cm2 vs. 1.99 cm2, p = 0.235) were comparable. Rates of PPI were similarly high in both groups (15.3 vs. 21.6, p = 0.299). Conclusions: The NAVITOR demonstrated favorable in-hospital procedural outcome data, with lower rates of relevant PVL, major vascular complications, and severe bleeding than its predecessor the PORTICO and preserved favorable hemodynamic outcomes.

Publisher

MDPI AG

Subject

General Medicine

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