ArticleInterdisciplinary cardiovascular and thoracic surgery2026
Three-Year Outcomes After Surgical Aortic Valve Replacement With a Bioprosthetic Valve from the Multi-Centre IMPACT Registry.
Article in Interdisciplinary cardiovascular and thoracic surgery, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04053088 (Surgical Aortic Valve Replacement), which is not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Surgical Aortic Valve Replacement: IMPACT of Pre-existing Comorbidities on Patient Outcomes and Prosthetic Valve Performance in a Real-world Setting.
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29 authors.
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Abstract
objectivesTo investigate 3-year outcomes of surgical aortic valve replacement using the INSPIRIS RESILIA aortic valve bioprosthesis in patients with severe aortic stenosis.
methodsIMPACT 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.
resultsA 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.
conclusionsThree-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.
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