Trial reportEuropean journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery2024
Seven-year outcomes after surgical aortic valve replacement with a stented bovine pericardial bioprosthesis in over 1100 patients: a prospective multicentre analysis.
Trial report in European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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Who cites it
4 citing papers in PubMed.
- Real-World Early Outcomes of the Avalus Aortic Valve: Results From 1250 Patients in the Avalus Clinical confidencE Registry.Annals of thoracic surgery short reports · 2026Article
- Contemporary Management of Aortic Stenosis: Timing of Intervention and Lifetime Valve Management.European journal of clinical investigation · 2026Review
- Left Ventricular Outflow Tract Diameter Variability and Prosthesis-Patient Mismatch: A Simulation Study.Interdisciplinary cardiovascular and thoracic surgery · 2026Article
- VITTA TRIAL - safety and performance at 3-year follow-up after implantation of the VIVERE® aortic bioprosthesis.Frontiers in cardiovascular medicine · 2026Article
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15 authors.
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Abstract
objectivesSafety, efficacy and durability are important considerations when selecting a bioprosthesis for aortic valve replacement (AVR). This study assessed 7-year clinical outcomes and haemodynamic performance of the Avalus bioprosthesis.
methodsPatients indicated for surgical AVR were enrolled in this prospective, nonrandomized trial, conducted across 39 sites globally. The primary end-point of this analysis was freedom from surgical explant or percutaneous valve-in-valve reintervention due to structural valve deterioration (SVD) at 7 years of follow-up, determined using Kaplan-Meier (KM) analysis. We also evaluated a composite end-point of SVD and/or severe haemodynamic dysfunction requiring reintervention. Survival, valve-related safety events and haemodynamic performance were assessed. Deaths and safety events were adjudicated by an independent clinical events committee.
resultsA total of 1132 patients underwent surgical AVR. Mean age was 70 years; 854 patients (75%) were men. The mean STS risk of mortality was 2.0 ± 1.4%, and 659 patients (58%) had a New York Heart Association classification of I/II. One or more concomitant procedures were performed in 577 patients (51%). At 7 years, the Kaplan-Meier rate of freedom from SVD/severe haemodynamic dysfunction requiring reintervention was 1.2% (0.5-2.5%) with no cases adjudicated as SVD. The survival rate was 82.6% (79.5-85.0%). The KM event rate was 5.7% (4.3-7.7%) for reintervention, 6.3% (4.9-8.3%) for endocarditis and 0.4% (0.1-1.1%) for valve thrombosis. Mean aortic gradient, dimensionless velocity index and effective orifice area were 13.8 ± 5.9 mmHg, 0.42 ± 0.09 and 1.99 ± 0.53 cm2, respectively.
conclusionsThis analysis demonstrated excellent durability of the Avalus valve with good clinical outcomes and stable haemodynamic performance through 7 years of follow-up.
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