ArticleInterdisciplinary cardiovascular and thoracic surgery2025
Seven-Year Results for RESILIA Tissue in Bicuspid Aortic Valve Replacement Patients: Age and Valve Size Considerations.
Article in Interdisciplinary cardiovascular and thoracic surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01757665 (ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Aortic and Mitral Bioprostheses), which is not on this map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Aortic and Mitral Bioprostheses (Models 11000A and 11000M) With a New Tissue Treatment Platform (COMMENCE)
Who cites it
1 citing paper in PubMed.
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Authors and funding
13 authors.
Funding
Abstract
objectivesPatients with bicuspid aortic valve disease requiring surgical aortic valve replacement are often younger and want to avoid lifelong anticoagulation. A multicentre single-arm non-randomized study, the COMMENCE trial, studied outcomes of RESILIA tissue aortic valves in bicuspid aortic valve patients through 7 years of follow-up.
methodsOf 672 patients who underwent surgical replacement of native aortic valves, 214 had bicuspid and 458 had tricuspid aortic valves. Propensity score analyses with inverse probability of treatment weighting were utilized to minimize bias due to measured confounders. Linear mixed-effect models compared longitudinal changes in haemodynamic parameters.
resultsPatients with bicuspid were significantly younger than those with tricuspid aortic valves-mean age of bicuspid: 59.8 (12.4) vs tricuspid: 70.2 (9.5) years; P < .001; 39/214 (18%) bicuspid aortic valve patients were <50 years old. There was no evidence of structural valve deterioration in any bicuspid aortic valve patients over 7 years of follow-up. At 7 years, there was no significant difference between bicuspid and tricuspid aortic valve patients in propensity score- and age-adjusted survival (91.9% vs 88.1%, respectively; P = .35), stroke, or reoperation. Among bicuspid aortic valve patients <65 years of age, there was no significant difference in prosthetic valve effective orifice areas and mean gradients between 3 months and 7 years postoperatively.
conclusionsPatients with bicuspid aortic valves had excellent outcomes with RESILIA tissue valves at 7 years with no evidence of structural valve deterioration. These results suggest a durable alternative for carefully selected younger patients wishing to avoid anticoagulation. CLINICAL TRIAL REGISTRATION NUMBER: NCT01757665.
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