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Durability of bioprosthetic aortic valves in patients under the age of 60 years – rationale and design of the international INDURE registry

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dc.contributor.authorMeuris, Bart
dc.contributor.authorBorger, Michael A.
dc.contributor.authorBourguignon, Thierry
dc.contributor.authorSiepe, Matthias
dc.contributor.authorGrabenwöger, Martin
dc.contributor.authorLaufer, Günther
dc.contributor.authorBinder, Konrad
dc.contributor.authorPolvani, Gianluca
dc.contributor.authorStefano, Pierluigi
dc.contributor.authorCoscioni, Enrico
dc.contributor.authorLeeuwen, Wouter van
dc.contributor.authorDemers, Philippe
dc.contributor.authorDagenasis, Francois
dc.contributor.authorCánovas López, Sergio
dc.contributor.authorTheron, Alexis
dc.contributor.authorLanganay, Thierry
dc.contributor.authorRoussel, Jean Christian
dc.contributor.authorWendler, Olaf
dc.contributor.authorMariscalco, Giovanni
dc.contributor.authorPesotto, Renzo
dc.contributor.authorBotta, Beate
dc.contributor.authorBramlage, Peter
dc.contributor.authorPaulis, Ruggero de
dc.contributor.departmentCirugía, Pediatría y Obstetricia y Ginecología
dc.date.accessioned2024-07-18T11:22:37Z
dc.date.available2024-07-18T11:22:37Z
dc.date.issued2020-05-27
dc.description© The Author(s) 2020. This manuscript version is made available under the CC-BY 4.0 license http://creativecommons.org/licenses/by/4.0/ This document is the Published version of a Published Work that appeared in final form in Journal of Cardiothoracic Surgery. To access the final edited and published work see https://doi.org/10.1186/s13019-020-01155-6
dc.description.abstractBackground There is an ever-growing number of patients requiring aortic valve replacement (AVR). Limited data is available on the long-term outcomes and structural integrity of bioprosthetic valves in younger patients undergoing surgical AVR. Methods The INSPIRIS RESILIA Durability Registry (INDURE) is a prospective, open-label, multicentre, international registry with a follow-up of 5 years to assess clinical outcomes of patients younger than 60 years who undergo surgical AVR using the INSPIRIS RESILIA aortic valve. INDURE will be conducted across 20–22 sites in Europe and Canada and intends to enrol minimum of 400 patients. Patients will be included if they are scheduled to undergo AVR with or without concomitant root replacement and/or coronary bypass surgery. The primary objectives are to 1) determine VARC-2 defined time-related valve safety at one-year (depicted as freedom from events) and 2) determine freedom from stage 3 structural valve degeneration (SVD) presenting as morphological abnormalities and severe haemodynamic valve degeneration at 5 years. Secondary objectives include the assessment of the haemodynamic performance of the valve, all stages of SVD, potential valve-in-valve procedures, clinical outcomes (in terms of New York Heart Association [NYHA] function class and freedom from valve-related rehospitalisation) and change in patient quality-of-life. Discussion INDURE is a prospective, multicentre registry in Europe and Canada, which will provide much needed data on the long-term performance of bioprosthetic valves in general and the INSPIRIS RESILIA valve in particular. The data may help to gather a deeper understanding of the longevity of bioprosthetic valves and may expand the use of bioprosthetic valves in patients under the age of 60 years.es
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dc.identifier.citationJournal of Cardiothoracic Surgery, 2020, Vol. 15: 119
dc.identifier.doihttps://doi.org/10.1186/s13019-020-01155-6
dc.identifier.issnElectronic: 1749-8090
dc.identifier.urihttp://hdl.handle.net/10201/143204
dc.languageenges
dc.publisherBMC
dc.relationThis work was supported with a research grant provided by Edwards Lifesciences (Nyon, Switzerland) to the sponsor Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.es
dc.relation.publisherversionhttps://cardiothoracicsurgery.biomedcentral.com/articles/10.1186/s13019-020-01155-6#Fun
dc.rightsinfo:eu-repo/semantics/openAccesses
dc.rightsAtribución 4.0 Internacional*
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/*
dc.subjectAortic valve diseasees
dc.subjectSurgical aortic valve replacementes
dc.subjectSAVRes
dc.subjectStructural valve degenerationes
dc.subjectValve durabilityes
dc.titleDurability of bioprosthetic aortic valves in patients under the age of 60 years – rationale and design of the international INDURE registryes
dc.typeinfo:eu-repo/semantics/articlees
dspace.entity.typePublicationes
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