Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2019
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
_version_ 1783471809389133824
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
work_keys_str_mv AT giordanoarturo comparativeonemonthsafetyandeffectivenessoffiveleadingnewgenerationdevicesfortranscatheteraorticvalveimplantation
AT corcionenicola comparativeonemonthsafetyandeffectivenessoffiveleadingnewgenerationdevicesfortranscatheteraorticvalveimplantation
AT ferraropaolo comparativeonemonthsafetyandeffectivenessoffiveleadingnewgenerationdevicesfortranscatheteraorticvalveimplantation
AT morelloalberto comparativeonemonthsafetyandeffectivenessoffiveleadingnewgenerationdevicesfortranscatheteraorticvalveimplantation
AT contesirio comparativeonemonthsafetyandeffectivenessoffiveleadingnewgenerationdevicesfortranscatheteraorticvalveimplantation
AT testaluca comparativeonemonthsafetyandeffectivenessoffiveleadingnewgenerationdevicesfortranscatheteraorticvalveimplantation
AT bedognifrancesco comparativeonemonthsafetyandeffectivenessoffiveleadingnewgenerationdevicesfortranscatheteraorticvalveimplantation
AT iadanzaalessandro comparativeonemonthsafetyandeffectivenessoffiveleadingnewgenerationdevicesfortranscatheteraorticvalveimplantation
AT bertisergio comparativeonemonthsafetyandeffectivenessoffiveleadingnewgenerationdevicesfortranscatheteraorticvalveimplantation
AT regazzolidamiano comparativeonemonthsafetyandeffectivenessoffiveleadingnewgenerationdevicesfortranscatheteraorticvalveimplantation
AT romagnolienrico comparativeonemonthsafetyandeffectivenessoffiveleadingnewgenerationdevicesfortranscatheteraorticvalveimplantation
AT tranicarlo comparativeonemonthsafetyandeffectivenessoffiveleadingnewgenerationdevicesfortranscatheteraorticvalveimplantation
AT burzottafrancesco comparativeonemonthsafetyandeffectivenessoffiveleadingnewgenerationdevicesfortranscatheteraorticvalveimplantation
AT pepemartino comparativeonemonthsafetyandeffectivenessoffiveleadingnewgenerationdevicesfortranscatheteraorticvalveimplantation
AT fratigiacomo comparativeonemonthsafetyandeffectivenessoffiveleadingnewgenerationdevicesfortranscatheteraorticvalveimplantation
AT biondizoccaigiuseppe comparativeonemonthsafetyandeffectivenessoffiveleadingnewgenerationdevicesfortranscatheteraorticvalveimplantation
AT comparativeonemonthsafetyandeffectivenessoffiveleadingnewgenerationdevicesfortranscatheteraorticvalveimplantation