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

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 s...

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Autores principales: Eckel, Clemens Enno, Kim, Won-Keun, Grothusen, Christina, Tiyerili, Vedat, Elsässer, Albrecht, Sötemann, Dagmar, Schlüter, Judith, Choi, Yeong-Hoon, Charitos, Efstratios I., Renker, Matthias, Hamm, Christian W., Dohmen, Guido, Möllmann, Helge, Blumenstein, Johannes
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10299266/
https://www.ncbi.nlm.nih.gov/pubmed/37373693
http://dx.doi.org/10.3390/jcm12123999
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author Eckel, Clemens Enno
Kim, Won-Keun
Grothusen, Christina
Tiyerili, Vedat
Elsässer, Albrecht
Sötemann, Dagmar
Schlüter, Judith
Choi, Yeong-Hoon
Charitos, Efstratios I.
Renker, Matthias
Hamm, Christian W.
Dohmen, Guido
Möllmann, Helge
Blumenstein, Johannes
author_facet Eckel, Clemens Enno
Kim, Won-Keun
Grothusen, Christina
Tiyerili, Vedat
Elsässer, Albrecht
Sötemann, Dagmar
Schlüter, Judith
Choi, Yeong-Hoon
Charitos, Efstratios I.
Renker, Matthias
Hamm, Christian W.
Dohmen, Guido
Möllmann, Helge
Blumenstein, Johannes
author_sort Eckel, Clemens Enno
collection PubMed
description 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 cm(2) vs. 1.99 cm(2), 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.
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spelling pubmed-102992662023-06-28 Comparison of the New-Generation Self-Expanding NAVITOR Transcatheter Heart Valve with Its Predecessor, the PORTICO, in Severe Native Aortic Valve Stenosis Eckel, Clemens Enno Kim, Won-Keun Grothusen, Christina Tiyerili, Vedat Elsässer, Albrecht Sötemann, Dagmar Schlüter, Judith Choi, Yeong-Hoon Charitos, Efstratios I. Renker, Matthias Hamm, Christian W. Dohmen, Guido Möllmann, Helge Blumenstein, Johannes J Clin Med Article 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 cm(2) vs. 1.99 cm(2), 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. MDPI 2023-06-12 /pmc/articles/PMC10299266/ /pubmed/37373693 http://dx.doi.org/10.3390/jcm12123999 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Eckel, Clemens Enno
Kim, Won-Keun
Grothusen, Christina
Tiyerili, Vedat
Elsässer, Albrecht
Sötemann, Dagmar
Schlüter, Judith
Choi, Yeong-Hoon
Charitos, Efstratios I.
Renker, Matthias
Hamm, Christian W.
Dohmen, Guido
Möllmann, Helge
Blumenstein, Johannes
Comparison of the New-Generation Self-Expanding NAVITOR Transcatheter Heart Valve with Its Predecessor, the PORTICO, in Severe Native Aortic Valve Stenosis
title Comparison of the New-Generation Self-Expanding NAVITOR Transcatheter Heart Valve with Its Predecessor, the PORTICO, in Severe Native Aortic Valve Stenosis
title_full Comparison of the New-Generation Self-Expanding NAVITOR Transcatheter Heart Valve with Its Predecessor, the PORTICO, in Severe Native Aortic Valve Stenosis
title_fullStr Comparison of the New-Generation Self-Expanding NAVITOR Transcatheter Heart Valve with Its Predecessor, the PORTICO, in Severe Native Aortic Valve Stenosis
title_full_unstemmed Comparison of the New-Generation Self-Expanding NAVITOR Transcatheter Heart Valve with Its Predecessor, the PORTICO, in Severe Native Aortic Valve Stenosis
title_short Comparison of the New-Generation Self-Expanding NAVITOR Transcatheter Heart Valve with Its Predecessor, the PORTICO, in Severe Native Aortic Valve Stenosis
title_sort comparison of the new-generation self-expanding navitor transcatheter heart valve with its predecessor, the portico, in severe native aortic valve stenosis
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10299266/
https://www.ncbi.nlm.nih.gov/pubmed/37373693
http://dx.doi.org/10.3390/jcm12123999
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