Bioprosthetic aortic valve replacement in patients under 60 years – 3-year safety results from the indure registry

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.