Publication: Durability of bioprosthetic aortic valves in patients under the age of 60 years – rationale and design of the international INDURE registry
Authors
Meuris, Bart ; Borger, Michael A. ; Bourguignon, Thierry ; Siepe, Matthias ; Grabenwöger, Martin ; Laufer, Günther ; Binder, Konrad ; Polvani, Gianluca ; Stefano, Pierluigi ; Coscioni, Enrico ; Leeuwen, Wouter van ; Demers, Philippe ; Dagenasis, Francois ; Cánovas López, Sergio ; Theron, Alexis ; Langanay, Thierry ; Roussel, Jean Christian ; Wendler, Olaf ; Mariscalco, Giovanni ; Pesotto, Renzo ; Botta, Beate ; Bramlage, Peter ; Paulis, Ruggero de
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Publisher
BMC
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DOI
https://doi.org/10.1186/s13019-020-01155-6
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info:eu-repo/semantics/article
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
Abstract
Background
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.
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Citation
Journal of Cardiothoracic Surgery, 2020, Vol. 15: 119
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Este ítem está sujeto a una licencia Creative Commons. http://creativecommons.org/licenses/by/4.0/