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

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Date
2023-07-18
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Authors
Meuris, Bart ; Roussel, Jean-Christian ; Borger, Michael A. ; Siepe, Matthias ; Stefano, Pierluigi ; Laufer, Günther ; Langanay, Thierry ; Theron, Alexis ; Grabenwöger, Martin ; Binder, Konrad ; Demers, Philippe ; Pesotto, Renzo ; Leeuwen, Wouter van ; Bourguignon, Thierry ; Cánovas López, Sergio ; Mariscalco, Giovanni ; Coscioni, Enrico ; Dagenais, Francois ; Wendler, Olaf ; Polvani, Gianluca ; Eden, Matthias ; Botta, Beate ; Bramlage, Peter ; De Paulis, Ruggero
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Publisher
Oxford University Press
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DOI
https://doi.org/10.1093/icvts/ivad115
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Description
© The Author(s) 2023. 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 Interdisciplinary CardioVascular and Thoracic Surgery. To access the final edited and published work see https://doi.org/10.1093/icvts/ivad115
Abstract
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 cm2. CONCLUSIONS: The 1-year data from the INSPIRIS RESILIA valve demonstrate good safety and excellent haemodynamic performance as well as an early QoL improvement.
Citation
Interdisciplinary CardioVascular and Thoracic Surgery 2023, 37(4), ivad115
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