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Comparative one-month safety and effectiveness of five leading new-generation devices for transcatheter aortic valve implantation
Transcatheter aortic valve implantation (TAVI) for aortic stenosis is becoming an appealing alternative to surgical aortic valve replacement in high-risk patients and to medical therapy for inoperable ones. Several new-generation TAVI devices have been recently introduced, but comparative analyses a...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group UK
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6864033/ https://www.ncbi.nlm.nih.gov/pubmed/31745198 http://dx.doi.org/10.1038/s41598-019-53081-w |
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author | Giordano, Arturo Corcione, Nicola Ferraro, Paolo Morello, Alberto Conte, Sirio Testa, Luca Bedogni, Francesco Iadanza, Alessandro Berti, Sergio Regazzoli, Damiano Romagnoli, Enrico Trani, Carlo Burzotta, Francesco Pepe, Martino Frati, Giacomo Biondi-Zoccai, Giuseppe |
author_facet | Giordano, Arturo Corcione, Nicola Ferraro, Paolo Morello, Alberto Conte, Sirio Testa, Luca Bedogni, Francesco Iadanza, Alessandro Berti, Sergio Regazzoli, Damiano Romagnoli, Enrico Trani, Carlo Burzotta, Francesco Pepe, Martino Frati, Giacomo Biondi-Zoccai, Giuseppe |
author_sort | Giordano, Arturo |
collection | PubMed |
description | Transcatheter aortic valve implantation (TAVI) for aortic stenosis is becoming an appealing alternative to surgical aortic valve replacement in high-risk patients and to medical therapy for inoperable ones. Several new-generation TAVI devices have been recently introduced, but comparative analyses are lacking. We aimed to compare 1-month outcomes associated with such five leading new-generation TAVI devices exploiting data collected in the prospective observational RISPEVA (Registro Italiano GISE sull’impianto di Valvola Aortica Percutanea) Study. We queried the dataset of the ongoing RISPEVA study to retrieve baseline, procedural and 1-month outcome details of patients undergoing TAVI with Acurate, Evolut, Portico, Lotus, and Sapien3. Analysis was based on unadjusted and propensity score-adjusted methods. We included 1976 patients, 234 (11.8%) treated with Acurate, 703 (35.6%) with Evolut, 151 (7.6%) with Lotus, 347 (17.6%) with Portico, and 541 (27.4%) with Sapien3. Unadjusted analysis for baseline features highlighted several significant differences, and other discrepancies were found for procedural features. Despite these differences, device and procedural success were similarly high (ranging from 98.0% to 99.4%, p > 0.05). However, procedural valve migration appeared more common with Acurate (p = 0.007), and major bleeding with Sapien3 (p = 0.002). Unadjusted analysis for 1-month outcomes also highlighted significant differences in the composite of death, stroke, myocardial infarction, major vascular complication, major bleeding, or renal failure (favoring Portico, p < 0.001), major vascular complications (favoring Lotus, p < 0.001), renal failure (favoring Portico, p = 0.035), and permanent pacemaker implantation (favoring Acurate, p < 0.001). Propensity score-adjusted analyses showed lower rates of major adverse events with Evolut and Portico (p < 0.05), major vascular complications with Lotus and Portico (p < 0.05), renal failure with Sapien3 (p < 0.05) and permanent pacemaker implantation with Acurate (p < 0.05). In conclusion, new-generation TAVI devices have different profiles of early comparative safety and efficacy. These findings should be taken into account for individualized decision making and patient management. |
format | Online Article Text |
id | pubmed-6864033 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Nature Publishing Group UK |
record_format | MEDLINE/PubMed |
spelling | pubmed-68640332019-12-03 Comparative one-month safety and effectiveness of five leading new-generation devices for transcatheter aortic valve implantation Giordano, Arturo Corcione, Nicola Ferraro, Paolo Morello, Alberto Conte, Sirio Testa, Luca Bedogni, Francesco Iadanza, Alessandro Berti, Sergio Regazzoli, Damiano Romagnoli, Enrico Trani, Carlo Burzotta, Francesco Pepe, Martino Frati, Giacomo Biondi-Zoccai, Giuseppe Sci Rep Article Transcatheter aortic valve implantation (TAVI) for aortic stenosis is becoming an appealing alternative to surgical aortic valve replacement in high-risk patients and to medical therapy for inoperable ones. Several new-generation TAVI devices have been recently introduced, but comparative analyses are lacking. We aimed to compare 1-month outcomes associated with such five leading new-generation TAVI devices exploiting data collected in the prospective observational RISPEVA (Registro Italiano GISE sull’impianto di Valvola Aortica Percutanea) Study. We queried the dataset of the ongoing RISPEVA study to retrieve baseline, procedural and 1-month outcome details of patients undergoing TAVI with Acurate, Evolut, Portico, Lotus, and Sapien3. Analysis was based on unadjusted and propensity score-adjusted methods. We included 1976 patients, 234 (11.8%) treated with Acurate, 703 (35.6%) with Evolut, 151 (7.6%) with Lotus, 347 (17.6%) with Portico, and 541 (27.4%) with Sapien3. Unadjusted analysis for baseline features highlighted several significant differences, and other discrepancies were found for procedural features. Despite these differences, device and procedural success were similarly high (ranging from 98.0% to 99.4%, p > 0.05). However, procedural valve migration appeared more common with Acurate (p = 0.007), and major bleeding with Sapien3 (p = 0.002). Unadjusted analysis for 1-month outcomes also highlighted significant differences in the composite of death, stroke, myocardial infarction, major vascular complication, major bleeding, or renal failure (favoring Portico, p < 0.001), major vascular complications (favoring Lotus, p < 0.001), renal failure (favoring Portico, p = 0.035), and permanent pacemaker implantation (favoring Acurate, p < 0.001). Propensity score-adjusted analyses showed lower rates of major adverse events with Evolut and Portico (p < 0.05), major vascular complications with Lotus and Portico (p < 0.05), renal failure with Sapien3 (p < 0.05) and permanent pacemaker implantation with Acurate (p < 0.05). In conclusion, new-generation TAVI devices have different profiles of early comparative safety and efficacy. These findings should be taken into account for individualized decision making and patient management. Nature Publishing Group UK 2019-11-19 /pmc/articles/PMC6864033/ /pubmed/31745198 http://dx.doi.org/10.1038/s41598-019-53081-w Text en © The Author(s) 2019 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Article Giordano, Arturo Corcione, Nicola Ferraro, Paolo Morello, Alberto Conte, Sirio Testa, Luca Bedogni, Francesco Iadanza, Alessandro Berti, Sergio Regazzoli, Damiano Romagnoli, Enrico Trani, Carlo Burzotta, Francesco Pepe, Martino Frati, Giacomo Biondi-Zoccai, Giuseppe Comparative one-month safety and effectiveness of five leading new-generation devices for transcatheter aortic valve implantation |
title | Comparative one-month safety and effectiveness of five leading new-generation devices for transcatheter aortic valve implantation |
title_full | Comparative one-month safety and effectiveness of five leading new-generation devices for transcatheter aortic valve implantation |
title_fullStr | Comparative one-month safety and effectiveness of five leading new-generation devices for transcatheter aortic valve implantation |
title_full_unstemmed | Comparative one-month safety and effectiveness of five leading new-generation devices for transcatheter aortic valve implantation |
title_short | Comparative one-month safety and effectiveness of five leading new-generation devices for transcatheter aortic valve implantation |
title_sort | comparative one-month safety and effectiveness of five leading new-generation devices for transcatheter aortic valve implantation |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6864033/ https://www.ncbi.nlm.nih.gov/pubmed/31745198 http://dx.doi.org/10.1038/s41598-019-53081-w |
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