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Balloon-Expandable versus Self-Expandable Valves in Transcatheter Aortic Valve Implantation: Complications and Outcomes from a Large International Patient Cohort
Background: Both balloon-expandable (BE) and self-expandable (SE) valves for transcatheter aortic valve implantation (TAVI) are broadly used in clinical practice. However, adequately powered randomized controlled trials comparing these two valve designs are lacking. Methods: The CENTER-study include...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8432462/ https://www.ncbi.nlm.nih.gov/pubmed/34501454 http://dx.doi.org/10.3390/jcm10174005 |
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author | van Nieuwkerk, Astrid C. Santos, Raquel B Andraka, Leire Tchetche, Didier de Brito, Fabio S. Barbanti, Marco Kornowski, Ran Latib, Azeem D’Onofrio, Augusto Ribichini, Flavio Ten, Francisco Dumonteil, Nicolas Baan, Jan Piek, Jan J. Abizaid, Alexandre Sartori, Samantha D’Errigo, Paola Tarantini, Giuseppe Lunardi, Mattia Orvin, Katia Pagnesi, Matteo Nogales-Asensio, Juan Manuel Ghattas, Angie Dangas, George Mehran, Roxana Delewi, Ronak |
author_facet | van Nieuwkerk, Astrid C. Santos, Raquel B Andraka, Leire Tchetche, Didier de Brito, Fabio S. Barbanti, Marco Kornowski, Ran Latib, Azeem D’Onofrio, Augusto Ribichini, Flavio Ten, Francisco Dumonteil, Nicolas Baan, Jan Piek, Jan J. Abizaid, Alexandre Sartori, Samantha D’Errigo, Paola Tarantini, Giuseppe Lunardi, Mattia Orvin, Katia Pagnesi, Matteo Nogales-Asensio, Juan Manuel Ghattas, Angie Dangas, George Mehran, Roxana Delewi, Ronak |
author_sort | van Nieuwkerk, Astrid C. |
collection | PubMed |
description | Background: Both balloon-expandable (BE) and self-expandable (SE) valves for transcatheter aortic valve implantation (TAVI) are broadly used in clinical practice. However, adequately powered randomized controlled trials comparing these two valve designs are lacking. Methods: The CENTER-study included 12,381 patients undergoing transfemoral TAVI. Patients undergoing TAVI with a BE-valve (n = 4096) were compared to patients undergoing TAVI with an SE-valve (n = 4096) after propensity score matching. Clinical outcomes including one-year mortality and stroke rates were assessed. Results: In the matched population of n = 5410 patients, the mean age was 81 ± 3 years, 60% was female, and the STS-PROM predicted 30-day mortality was 6.2% (IQR 4.0–12.4). One-year mortality was not different between patients treated with BE- or SE-valves (BE: 16.4% vs. SE: 17.0%, Relative Risk 1.04, 95%CI 0.02–1.21, p = 0.57). One-year stroke rates were also comparable (BE: 4.9% vs. SE: 5.3%, RR 1.09, 95%CI 0.86–1.37, p = 0.48). Conclusion: This study suggests that one-year mortality and stroke rates were comparable in patients with severe aortic valve stenosis undergoing TAVI with either BE or SE-valves. |
format | Online Article Text |
id | pubmed-8432462 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-84324622021-09-11 Balloon-Expandable versus Self-Expandable Valves in Transcatheter Aortic Valve Implantation: Complications and Outcomes from a Large International Patient Cohort van Nieuwkerk, Astrid C. Santos, Raquel B Andraka, Leire Tchetche, Didier de Brito, Fabio S. Barbanti, Marco Kornowski, Ran Latib, Azeem D’Onofrio, Augusto Ribichini, Flavio Ten, Francisco Dumonteil, Nicolas Baan, Jan Piek, Jan J. Abizaid, Alexandre Sartori, Samantha D’Errigo, Paola Tarantini, Giuseppe Lunardi, Mattia Orvin, Katia Pagnesi, Matteo Nogales-Asensio, Juan Manuel Ghattas, Angie Dangas, George Mehran, Roxana Delewi, Ronak J Clin Med Article Background: Both balloon-expandable (BE) and self-expandable (SE) valves for transcatheter aortic valve implantation (TAVI) are broadly used in clinical practice. However, adequately powered randomized controlled trials comparing these two valve designs are lacking. Methods: The CENTER-study included 12,381 patients undergoing transfemoral TAVI. Patients undergoing TAVI with a BE-valve (n = 4096) were compared to patients undergoing TAVI with an SE-valve (n = 4096) after propensity score matching. Clinical outcomes including one-year mortality and stroke rates were assessed. Results: In the matched population of n = 5410 patients, the mean age was 81 ± 3 years, 60% was female, and the STS-PROM predicted 30-day mortality was 6.2% (IQR 4.0–12.4). One-year mortality was not different between patients treated with BE- or SE-valves (BE: 16.4% vs. SE: 17.0%, Relative Risk 1.04, 95%CI 0.02–1.21, p = 0.57). One-year stroke rates were also comparable (BE: 4.9% vs. SE: 5.3%, RR 1.09, 95%CI 0.86–1.37, p = 0.48). Conclusion: This study suggests that one-year mortality and stroke rates were comparable in patients with severe aortic valve stenosis undergoing TAVI with either BE or SE-valves. MDPI 2021-09-04 /pmc/articles/PMC8432462/ /pubmed/34501454 http://dx.doi.org/10.3390/jcm10174005 Text en © 2021 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 van Nieuwkerk, Astrid C. Santos, Raquel B Andraka, Leire Tchetche, Didier de Brito, Fabio S. Barbanti, Marco Kornowski, Ran Latib, Azeem D’Onofrio, Augusto Ribichini, Flavio Ten, Francisco Dumonteil, Nicolas Baan, Jan Piek, Jan J. Abizaid, Alexandre Sartori, Samantha D’Errigo, Paola Tarantini, Giuseppe Lunardi, Mattia Orvin, Katia Pagnesi, Matteo Nogales-Asensio, Juan Manuel Ghattas, Angie Dangas, George Mehran, Roxana Delewi, Ronak Balloon-Expandable versus Self-Expandable Valves in Transcatheter Aortic Valve Implantation: Complications and Outcomes from a Large International Patient Cohort |
title | Balloon-Expandable versus Self-Expandable Valves in Transcatheter Aortic Valve Implantation: Complications and Outcomes from a Large International Patient Cohort |
title_full | Balloon-Expandable versus Self-Expandable Valves in Transcatheter Aortic Valve Implantation: Complications and Outcomes from a Large International Patient Cohort |
title_fullStr | Balloon-Expandable versus Self-Expandable Valves in Transcatheter Aortic Valve Implantation: Complications and Outcomes from a Large International Patient Cohort |
title_full_unstemmed | Balloon-Expandable versus Self-Expandable Valves in Transcatheter Aortic Valve Implantation: Complications and Outcomes from a Large International Patient Cohort |
title_short | Balloon-Expandable versus Self-Expandable Valves in Transcatheter Aortic Valve Implantation: Complications and Outcomes from a Large International Patient Cohort |
title_sort | balloon-expandable versus self-expandable valves in transcatheter aortic valve implantation: complications and outcomes from a large international patient cohort |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8432462/ https://www.ncbi.nlm.nih.gov/pubmed/34501454 http://dx.doi.org/10.3390/jcm10174005 |
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