BAlloon expandable vs. SElf expanding transcatheter vaLve for degenerated bioprosthesIs

Detalhes bibliográficos
Autor(a) principal: Nuis, Rutger Jan
Data de Publicação: 2023
Outros Autores: van Belle, Eric, Teles, Rui, Blackman, Daniel, Veulemans, Verena, Santos, Ignacio Amat, Pilgrim, Thomas, Tarantini, Giuseppe, Saia, Francesco, Iakovou, Ioannis, Mascherbauer, Julia, Vincent, Flavien, Geleijnse, Marcel, Sathananthan, Janarthanan, Wood, David, Makkar, Raj, Van Mieghem, Nicolas M.
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10362/151020
Resumo: Funding Information: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Publisher Copyright: © 2022 The Author(s)
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spelling BAlloon expandable vs. SElf expanding transcatheter vaLve for degenerated bioprosthesIsdesign and rationale of the BASELINE trialCardiology and Cardiovascular MedicineFunding Information: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Publisher Copyright: © 2022 The Author(s)Background: Surgical aortic valve bioprostheses may degenerate over time and require redo intervention. Transcatheter aortic valve replacement (TAVR) is a less invasive alternative to redo surgery. The BAlloon Expandable vs. SElf Expanding Transcatheter VaLve for Degenerated BioprosthesIs (BASELINE) trial was designed to compare the performance of the balloon-expandable SAPIEN-3 Ultra and the self-expanding EVOLUT PRO+ valve systems in symptomatic patients with a failing surgical bioprosthesis. Methods: The BASELINE trial is an investigator-initiated, non-funded, prospective, randomized, open-label, superiority trial enrolling a total of 440 patients in up to 50 sites in 12 countries in Europe and North-America. The primary endpoint is device success at 30-days defined by the Valve Academic Research Consortium-3 Criteria as the composite of technical success, freedom from mortality, freedom for surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication with an intended performance of the valve (mean gradient <20 mmHg and less than moderate aortic regurgitation). The co-primary endpoint at 1 year is defined as the composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems. Independent Core Laboratories will conduct uniform analyses of echocardiography (pre-, post-, 1-year post-procedure), multi-sliced computed tomography (pre-, and if available post-procedure) and cine-fluoroscopy studies. Conclusions: The BASELINE trial is a head-to-head comparative trial investigating the 2 most used contemporary transcatheter heart valves for the treatment of a failing surgical aortic bioprosthesis. (ClinicalTrials.gov number NCT04843072).NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)RUNNuis, Rutger Janvan Belle, EricTeles, RuiBlackman, DanielVeulemans, VerenaSantos, Ignacio AmatPilgrim, ThomasTarantini, GiuseppeSaia, FrancescoIakovou, IoannisMascherbauer, JuliaVincent, FlavienGeleijnse, MarcelSathananthan, JanarthananWood, DavidMakkar, RajVan Mieghem, Nicolas M.2023-03-21T22:27:56Z2023-022023-02-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article9application/pdfhttp://hdl.handle.net/10362/151020eng0002-8703PURE: 56515115https://doi.org/10.1016/j.ahj.2022.11.013info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2024-03-11T05:33:27Zoai:run.unl.pt:10362/151020Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T03:54:25.366264Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv BAlloon expandable vs. SElf expanding transcatheter vaLve for degenerated bioprosthesIs
design and rationale of the BASELINE trial
title BAlloon expandable vs. SElf expanding transcatheter vaLve for degenerated bioprosthesIs
spellingShingle BAlloon expandable vs. SElf expanding transcatheter vaLve for degenerated bioprosthesIs
Nuis, Rutger Jan
Cardiology and Cardiovascular Medicine
title_short BAlloon expandable vs. SElf expanding transcatheter vaLve for degenerated bioprosthesIs
title_full BAlloon expandable vs. SElf expanding transcatheter vaLve for degenerated bioprosthesIs
title_fullStr BAlloon expandable vs. SElf expanding transcatheter vaLve for degenerated bioprosthesIs
title_full_unstemmed BAlloon expandable vs. SElf expanding transcatheter vaLve for degenerated bioprosthesIs
title_sort BAlloon expandable vs. SElf expanding transcatheter vaLve for degenerated bioprosthesIs
author Nuis, Rutger Jan
author_facet Nuis, Rutger Jan
van Belle, Eric
Teles, Rui
Blackman, Daniel
Veulemans, Verena
Santos, Ignacio Amat
Pilgrim, Thomas
Tarantini, Giuseppe
Saia, Francesco
Iakovou, Ioannis
Mascherbauer, Julia
Vincent, Flavien
Geleijnse, Marcel
Sathananthan, Janarthanan
Wood, David
Makkar, Raj
Van Mieghem, Nicolas M.
author_role author
author2 van Belle, Eric
Teles, Rui
Blackman, Daniel
Veulemans, Verena
Santos, Ignacio Amat
Pilgrim, Thomas
Tarantini, Giuseppe
Saia, Francesco
Iakovou, Ioannis
Mascherbauer, Julia
Vincent, Flavien
Geleijnse, Marcel
Sathananthan, Janarthanan
Wood, David
Makkar, Raj
Van Mieghem, Nicolas M.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)
RUN
dc.contributor.author.fl_str_mv Nuis, Rutger Jan
van Belle, Eric
Teles, Rui
Blackman, Daniel
Veulemans, Verena
Santos, Ignacio Amat
Pilgrim, Thomas
Tarantini, Giuseppe
Saia, Francesco
Iakovou, Ioannis
Mascherbauer, Julia
Vincent, Flavien
Geleijnse, Marcel
Sathananthan, Janarthanan
Wood, David
Makkar, Raj
Van Mieghem, Nicolas M.
dc.subject.por.fl_str_mv Cardiology and Cardiovascular Medicine
topic Cardiology and Cardiovascular Medicine
description Funding Information: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Publisher Copyright: © 2022 The Author(s)
publishDate 2023
dc.date.none.fl_str_mv 2023-03-21T22:27:56Z
2023-02
2023-02-01T00:00:00Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10362/151020
url http://hdl.handle.net/10362/151020
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 0002-8703
PURE: 56515115
https://doi.org/10.1016/j.ahj.2022.11.013
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 9
application/pdf
dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron:RCAAP
instname_str Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron_str RCAAP
institution RCAAP
reponame_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
collection Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository.name.fl_str_mv Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
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