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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BORIS DOI
Date of Publication
October 4, 2023
Publication Type
Article
Division/Institute
Contributor
Meuris, Bart | |
Roussel, Jean-Christian | |
Borger, Michael A | |
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 |
Subject(s)
Series
Interdisciplinary cardiovascular and thoracic surgery
ISSN or ISBN (if monograph)
2753-670X
Publisher
Oxford University Press
Language
English
Publisher DOI
PubMed ID
37462612
Uncontrolled Keywords
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 (INDURE) 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
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%CI 97.1;99.6) and 81.8% were NYHA I vs. 21.9% at baseline. No patient developed structural valve deterioration Stage 3 (VARC-3). Mean aortic pressure gradient was 12.6 mmHg at 1 year and 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.
CLINICALTRIALS NUMBER
NCT03666741.
We report 1-year safety and clinical outcomes in patients <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 <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
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%CI 97.1;99.6) and 81.8% were NYHA I vs. 21.9% at baseline. No patient developed structural valve deterioration Stage 3 (VARC-3). Mean aortic pressure gradient was 12.6 mmHg at 1 year and 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.
CLINICALTRIALS NUMBER
NCT03666741.
File(s)
| File | File Type | Format | Size | License | Publisher/Copright statement | Content | |
|---|---|---|---|---|---|---|---|
| ivad115.pdf | text | Adobe PDF | 2.51 MB | accepted |