TY - JOUR
T1 - Bioprosthetic aortic valve replacement in patients under 60 years - 3-year safety results from the indure registry
AU - de Paulis, Ruggero
AU - Roussel, Jean-Christian
AU - Borger, Michael
AU - Kueri, Sami
AU - Stefano, Pierluigi
AU - Andreas, Martin
AU - Langanay, Thierry
AU - Théron, Alexis
AU - Kainz, Frieda Maria
AU - Grabenwöger, Martin
AU - Demers, Philippe
AU - Pessotto, Renzo
AU - van Leeuwen, Wouter
AU - Bourguignon, Thierry
AU - Canovas, Sergio
AU - Mariscalco, Giovanni
AU - Coscioni, Enrico
AU - Dagenais, Francois
AU - Deshpande, Ranjit
AU - Penza, Eleonora
AU - Eden, Matthias
AU - Bramlage, Peter
AU - Botta, Beate
AU - Zimmermann, Lena
AU - Trushina, Nataliya
AU - Meuris, Bart
N1 - © The Author(s) 2026. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.
PY - 2026/7/29
Y1 - 2026/7/29
N2 - OBJECTIVES: We report three-year safety and clinical outcomes in patients younger than 60 years undergoing bioprosthetic surgical aortic valve intervention.METHODS: The INSPIRIS RESILIA Durability Registry (INDURE) is a prospective, multicentre registry to assess clinical outcomes of patients under 60 years. Patients with planned surgical aortic valve replacement 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 three years were assessed.RESULTS: The study cohort included 415 patients with a mean age of 53.5 years, 76.9% being male and 27.1% in New York Health Association (NYHA) class III/IV. Outcomes after three years included cardiovascular-related mortality (0.4%), thromboembolic events (0.6%), valve-related bleeding (0.0%) and new permanent pacemaker implantation (0.4%). QoL increased over the time course of the study from baseline to three-year follow-up. Three-year freedom from all-cause mortality was 95.4% (95% CI 93.3-97.6), and 84.5% were NYHA I versus 22.0% at baseline. No patient developed haemodynamic valve deterioration stage 3. The mean aortic pressure gradient was 13.7 mmHg at three years, and the mean effective orifice area was 1.8 cm.CONCLUSIONS: The three-year data from the INSPIRIS RESILIA valve demonstrate reassuring safety findings and stable haemodynamic performance as well as a high QoL.
AB - OBJECTIVES: We report three-year safety and clinical outcomes in patients younger than 60 years undergoing bioprosthetic surgical aortic valve intervention.METHODS: The INSPIRIS RESILIA Durability Registry (INDURE) is a prospective, multicentre registry to assess clinical outcomes of patients under 60 years. Patients with planned surgical aortic valve replacement 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 three years were assessed.RESULTS: The study cohort included 415 patients with a mean age of 53.5 years, 76.9% being male and 27.1% in New York Health Association (NYHA) class III/IV. Outcomes after three years included cardiovascular-related mortality (0.4%), thromboembolic events (0.6%), valve-related bleeding (0.0%) and new permanent pacemaker implantation (0.4%). QoL increased over the time course of the study from baseline to three-year follow-up. Three-year freedom from all-cause mortality was 95.4% (95% CI 93.3-97.6), and 84.5% were NYHA I versus 22.0% at baseline. No patient developed haemodynamic valve deterioration stage 3. The mean aortic pressure gradient was 13.7 mmHg at three years, and the mean effective orifice area was 1.8 cm.CONCLUSIONS: The three-year data from the INSPIRIS RESILIA valve demonstrate reassuring safety findings and stable haemodynamic performance as well as a high QoL.
U2 - 10.1093/icvts/ivag208
DO - 10.1093/icvts/ivag208
M3 - Journal article
C2 - 42523170
SN - 2753-670X
JO - Interdisciplinary cardiovascular and thoracic surgery
JF - Interdisciplinary cardiovascular and thoracic surgery
ER -