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Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years — 1-year follow-up from the prospective INDURE registry

OBJECTIVES: We report 1-year safety and clinical outcomes in patients <60 years undergoing bioprosthetic surgical aortic valve intervention. METHODS: The INSPIRIS RESILIA Durability Registry is a prospective, multicentre registry to assess clinical outcomes of patients <60 years. Patients with...

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Autores principales: Meuris, Bart, Roussel, Jean-Christian, Borger, Michael A, Siepe, Matthias, Stefano, Pierluigi, Laufer, Günther, Langanay, Thierry, Theron, Alexis, Grabenwöger, Martin, Binder, Konrad, Demers, Philippe, Pessotto, Renzo, van Leeuwen, Wouter, Bourguignon, Thierry, Canovas, Sergio, Mariscalco, Giovanni, Coscioni, Enrico, Dagenais, Francois, Wendler, Olaf, Polvani, Gianluca, Eden, Matthias, Botta, Beate, Bramlage, Peter, De Paulis, Ruggero
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10576637/
https://www.ncbi.nlm.nih.gov/pubmed/37462612
http://dx.doi.org/10.1093/icvts/ivad115
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author Meuris, Bart
Roussel, Jean-Christian
Borger, Michael A
Siepe, Matthias
Stefano, Pierluigi
Laufer, Günther
Langanay, Thierry
Theron, Alexis
Grabenwöger, Martin
Binder, Konrad
Demers, Philippe
Pessotto, Renzo
van Leeuwen, Wouter
Bourguignon, Thierry
Canovas, Sergio
Mariscalco, Giovanni
Coscioni, Enrico
Dagenais, Francois
Wendler, Olaf
Polvani, Gianluca
Eden, Matthias
Botta, Beate
Bramlage, Peter
De Paulis, Ruggero
author_facet Meuris, Bart
Roussel, Jean-Christian
Borger, Michael A
Siepe, Matthias
Stefano, Pierluigi
Laufer, Günther
Langanay, Thierry
Theron, Alexis
Grabenwöger, Martin
Binder, Konrad
Demers, Philippe
Pessotto, Renzo
van Leeuwen, Wouter
Bourguignon, Thierry
Canovas, Sergio
Mariscalco, Giovanni
Coscioni, Enrico
Dagenais, Francois
Wendler, Olaf
Polvani, Gianluca
Eden, Matthias
Botta, Beate
Bramlage, Peter
De Paulis, Ruggero
author_sort Meuris, Bart
collection PubMed
description OBJECTIVES: We report 1-year safety and clinical outcomes in patients <60 years undergoing bioprosthetic surgical aortic valve intervention. METHODS: The INSPIRIS RESILIA Durability Registry is a prospective, multicentre registry to assess clinical outcomes of patients <60 years. Patients with planned SAVR with or without concomitant replacement of the ascending aorta and/or coronary bypass surgery were included. Time-related valve safety, haemodynamic performance and quality of life (QoL) at 1 year were assessed. RESULTS: A total of 421 patients were documented with a mean age of 53.5 years, 76.5% being male and 27.2% in NYHA class III/IV. Outcomes within 30 days included cardiovascular-related mortality (0.7%), time-related valve safety (VARC-2; 5.8%), thromboembolic events (1.7%), valve-related life-threatening bleeding (VARC-2; 4.3%) and permanent pacemaker implantation (3.8%). QoL was significantly increased at 6 months and sustained at 1 year. Freedom from all-cause mortality at 1 year was 98.3% (95% confidence interval 97.1; 99.6) and 81.8% were NYHA I versus 21.9% at baseline. No patient developed structural valve deterioration stage 3 (VARC-3). The mean aortic pressure gradient was 12.6 mmHg at 1 year and the effective orifice area was 1.9 cm(2). CONCLUSIONS: The 1-year data from the INSPIRIS RESILIA valve demonstrate good safety and excellent haemodynamic performance as well as an early QoL improvement. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov: NCT03666741.
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spelling pubmed-105766372023-10-15 Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years — 1-year follow-up from the prospective INDURE registry Meuris, Bart Roussel, Jean-Christian Borger, Michael A Siepe, Matthias Stefano, Pierluigi Laufer, Günther Langanay, Thierry Theron, Alexis Grabenwöger, Martin Binder, Konrad Demers, Philippe Pessotto, Renzo van Leeuwen, Wouter Bourguignon, Thierry Canovas, Sergio Mariscalco, Giovanni Coscioni, Enrico Dagenais, Francois Wendler, Olaf Polvani, Gianluca Eden, Matthias Botta, Beate Bramlage, Peter De Paulis, Ruggero Interdiscip Cardiovasc Thorac Surg Valvular Heart Disease OBJECTIVES: We report 1-year safety and clinical outcomes in patients <60 years undergoing bioprosthetic surgical aortic valve intervention. METHODS: The INSPIRIS RESILIA Durability Registry is a prospective, multicentre registry to assess clinical outcomes of patients <60 years. Patients with planned SAVR with or without concomitant replacement of the ascending aorta and/or coronary bypass surgery were included. Time-related valve safety, haemodynamic performance and quality of life (QoL) at 1 year were assessed. RESULTS: A total of 421 patients were documented with a mean age of 53.5 years, 76.5% being male and 27.2% in NYHA class III/IV. Outcomes within 30 days included cardiovascular-related mortality (0.7%), time-related valve safety (VARC-2; 5.8%), thromboembolic events (1.7%), valve-related life-threatening bleeding (VARC-2; 4.3%) and permanent pacemaker implantation (3.8%). QoL was significantly increased at 6 months and sustained at 1 year. Freedom from all-cause mortality at 1 year was 98.3% (95% confidence interval 97.1; 99.6) and 81.8% were NYHA I versus 21.9% at baseline. No patient developed structural valve deterioration stage 3 (VARC-3). The mean aortic pressure gradient was 12.6 mmHg at 1 year and the effective orifice area was 1.9 cm(2). CONCLUSIONS: The 1-year data from the INSPIRIS RESILIA valve demonstrate good safety and excellent haemodynamic performance as well as an early QoL improvement. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov: NCT03666741. Oxford University Press 2023-07-18 /pmc/articles/PMC10576637/ /pubmed/37462612 http://dx.doi.org/10.1093/icvts/ivad115 Text en © The Author(s) 2023. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Valvular Heart Disease
Meuris, Bart
Roussel, Jean-Christian
Borger, Michael A
Siepe, Matthias
Stefano, Pierluigi
Laufer, Günther
Langanay, Thierry
Theron, Alexis
Grabenwöger, Martin
Binder, Konrad
Demers, Philippe
Pessotto, Renzo
van Leeuwen, Wouter
Bourguignon, Thierry
Canovas, Sergio
Mariscalco, Giovanni
Coscioni, Enrico
Dagenais, Francois
Wendler, Olaf
Polvani, Gianluca
Eden, Matthias
Botta, Beate
Bramlage, Peter
De Paulis, Ruggero
Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years — 1-year follow-up from the prospective INDURE registry
title Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years — 1-year follow-up from the prospective INDURE registry
title_full Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years — 1-year follow-up from the prospective INDURE registry
title_fullStr Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years — 1-year follow-up from the prospective INDURE registry
title_full_unstemmed Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years — 1-year follow-up from the prospective INDURE registry
title_short Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years — 1-year follow-up from the prospective INDURE registry
title_sort durability of bioprosthetic aortic valve replacement in patients under the age of 60 years — 1-year follow-up from the prospective indure registry
topic Valvular Heart Disease
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10576637/
https://www.ncbi.nlm.nih.gov/pubmed/37462612
http://dx.doi.org/10.1093/icvts/ivad115
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