Abstract
OBJECTIVES: To investigate 3-year outcomes of surgical aortic valve replacement using the INSPIRIS RESILIA aortic valve bioprosthesis in patients with severe aortic stenosis. METHODS: IMPACT registry is a prospective, multicentre, international registry with a 5-year follow-up. After 3 years, haemodynamic performance, all-cause mortality, and valve-related mortality were determined. RESULTS: A total of 556 patients who underwent surgical aortic valve replacement with the INSPIRIS RESILIA aortic valve were enrolled between December 2019 and June 2021. The mean age was 63.4 ± 8.5 years, 29.0% were female, with a EuroSCORE II of 2.2 ± 2.5% and an STS score of 1.7 ± 2.2%. Hypertension (66.2%), coronary artery disease (34.7%), and diabetes (18.4%) were the most common comorbidities. A total of 49.3% of patients underwent full sternotomy, 58.3% isolated aortic valve replacement. The most commonly implanted valve sizes were 23 mm (35.4%) and 25 mm (30.9%). At 3 years, overall survival was 91.0%, freedom from valve-related mortality was 97.5%, from prosthetic endocarditis 96.0%, from stroke 91.5%, from valve-related dysfunction 98.0%, from reintervention 96.2%, from structural valve deterioration stage 2 96.8%, and from stage 3 99.4%. The mean transvalvular gradient was 11.9 mmHg at 3 years, with an indexed effective orifice area of 0.8 cm2/m2. Functional class improved from 41.2% class III or IV at baseline to 5.7% at 3 years. CONCLUSIONS: Three-year outcomes, including survival and haemodynamic and functional status after surgical aortic valve replacement using the INSPIRIS RESILIA bioprosthetic aortic valve, were reported in a real-world patient population with severe aortic stenosis. CLINICALTRIALS.GOV: NCT04053088.