ArticleJTCVS open2023
Mid-term outcomes of the COMMENCE trial investigating mitral valve replacement using a bioprosthesis with a novel tissue.
Article in JTCVS open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. 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 9 papers.
What it found
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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
9 citing papers in PubMed, 7 citations in OpenAlex.
- Early Degeneration of a Next-Generation Mitral Bioprosthesis in the Tricuspid Position Treated With Valve-in-Valve.JACC. Case reports · 2026Article
- Clinical Outcomes of First-Time and Redo Mitral Valve Replacement Using MITRIS RESILIA Bioprosthesis.Annals of thoracic surgery short reports · 2026Article
- Bovine Pericardial Versus Porcine Mitral Valve Replacement: A Propensity-Matched Analysis of Mid-Term Durability Outcomes.Interdisciplinary cardiovascular and thoracic surgery · 2026Article
- Survival and Cost Analysis of Surgical Mitral Valve Replacement With Different Prostheses: A Nationwide Cohort Study in Taiwan.Medical science monitor : international medical journal of experimental and clinical research · 2025Article
- Minimally Invasive Mitral Valve Replacement in the Gray Zone: Bioprosthetic vs. Mechanical Valves in Patients Aged 50-69 Years.Journal of clinical medicine · 2025Article
- Early Haemodynamic Performance and Clinical Outcomes of a Novel Bioprosthetic Mitral Valve.Interdisciplinary cardiovascular and thoracic surgery · 2025Article
- Case Series of First Microinvasive Fully Endoscopic Use of a New Mitral Prosthesis.Journal of clinical medicine · 2024Article
- Three-year outcomes of surgical valve replacement with Dafodil™ pericardial bioprosthesis: Dafodil™-1 trial.Frontiers in cardiovascular medicine · 2024Article
- Mitral valve replacement in young patients: review and current challenges.Future cardiology · 2024Review
Corrections and comments
- Erratum issued
Authors and funding
10 authors at 7 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objective: Novel tissue leaflets (RESILIA tissue) may improve durability of bioprosthetic heart valves. The COMMENCE trial is an ongoing prospective study to evaluate valve replacement using RESILIA tissue. This report describes mid-term outcomes in the mitral cohort of COMMENCE. Methods: Adult patients requiring mitral valve replacement were enrolled in a prospective, single-arm trial at 17 sites in the United States and Canada. An independent clinical events committee adjudicated safety events using definitions from established guidelines, and hemodynamic performance was evaluated by an independent echocardiographic core laboratory. Results: Eighty-two patients (median age 70 years) successfully underwent mitral valve replacement with the study valve. Five-year event-free probabilities for all-cause mortality, structural valve deterioration, and reoperation were 79.9%, 98.7%, and 97.1%, respectively. Hemodynamic valve function measurements were stable through the 5-year follow-up period; valvular leaks were infrequently observed and primarily clinically insignificant/mild. Conclusions: Mitral valve replacement patients implanted with a RESILIA tissue bioprosthesis had a good safety profile and clinically stable hemodynamic performance.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.