Five-year Outcomes of the COMMENCE Trial Investigating Aortic Valve Replacement With RESILIA Tissue.
Publication/Presentation Date
6-1-2023
Abstract
BACKGROUND: The COMMENCE trial was conducted to evaluate the safety and effectiveness of aortic valve replacement using a bioprosthesis with novel RESILIA tissue (Edwards Lifesciences). RESILIA tissue is incorporated in the INSPIRIS RESILIA aortic valve (Edwards Lifesciences).
METHODS: Patients underwent clinically indicated surgical aortic valve replacement with a bovine pericardial bioprosthesis (model 11000A; Edwards Lifesciences) in a prospective, multinational, multicenter (n = 27), US Food and Drug Administration Investigational Device Exemption trial. Events were adjudicated by an independent clinical events committee, and echocardiograms were analyzed by an independent core laboratory. Outcomes through an observational period of 5 years are reported.
RESULTS: Between January 2013 and March 2016, 689 patients received the study valve. Mean patient age was 66.9 ± 11.6 years; Society of Thoracic Surgeons Predicted Risk of Mortality was 2.0% ± 1.8%; and 23.8%, 49.9%, and 24.4% of patients were New York Heart Association functional class I, II, and III at baseline, respectively. Through December 11, 2020 the follow-up duration was 4.3 ± 1.4 years, and the completeness of follow-up over the observational period was 95.5%. Early (<30 >days) all-cause mortality was 1.2%, stroke 1.6%, and major paravalvular leak 0.1%. Five-year actuarial freedom from all-cause mortality, structural valve deterioration, and all-cause reintervention were 89.2%, 100%, and 98.7%, respectively. At 5 years the effective orifice area was 1.6 ± 0.5 cm
CONCLUSIONS: The safety and hemodynamic performance of this aortic bioprosthesis with RESILIA tissue through 5 years are encouraging, with clinically stable hemodynamics, minimal regurgitation, and no evidence of structural valve deterioration.
Volume
115
Issue
6
First Page
1429
Last Page
1436
ISSN
1552-6259
Published In/Presented At
Bavaria, J. E., Griffith, B., Heimansohn, D. A., Rozanski, J., Johnston, D. R., Bartus, K., Girardi, L. N., Beaver, T., Takayama, H., Mumtaz, M. A., Rosengart, T. K., Starnes, V., Timek, T. A., Boateng, P., Ryan, W., Cornwell, L. D., Blackstone, E. H., Borger, M. A., Pibarot, P., Thourani, V. H., … COMMENCE Trial Investigators (2023). Five-year Outcomes of the COMMENCE Trial Investigating Aortic Valve Replacement With RESILIA Tissue. The Annals of thoracic surgery, 115(6), 1429–1436. https://doi.org/10.1016/j.athoracsur.2021.12.058
Disciplines
Medicine and Health Sciences
PubMedID
35065065
Department(s)
Department of Surgery
Document Type
Article