Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years - 1-year follow-up from the prospective INDURE registry
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 (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.
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Date
2023-07-18
Type
Article
Subject
Surgical aortic valve replacement, Structural valve degeneration, Valve durability
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Citation
Meuris, B., Roussel, J. C., Borger, M. A., Siepe, M., Stefano, P., Laufer, G., Langanay, T., Theron, A., Grabenwöger, M., Binder, K., Demers, P., Pessotto, R., van Leeuwen, W., Bourguignon, T., Canovas, S., Mariscalco, G., Coscioni, E., Dagenais, F., Wendler, O., Polvani, G., … De Paulis, R. (2023). Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years - 1-year follow-up from the prospective INDURE registry. Interdisciplinary cardiovascular and thoracic surgery, ivad115. Advance online publication. https://doi.org/10.1093/icvts/ivad115