The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue.
Publication/Presentation Date
9-1-2017
Abstract
OBJECTIVES: The COMMENCE trial was conducted to evaluate the safety and effectiveness of a novel bioprosthetic tissue for surgical aortic valve replacement (AVR).
METHODS: Patients underwent clinically indicated surgical AVR with the Carpentier-Edwards PERIMOUNT™ Magna Ease™ aortic valve with RESILIA™ tissue (Model 11000A) in a prospective, multinational, multicentre (n = 27), single-arm, FDA Investigational Device Exemption trial. Events were adjudicated by an independent Clinical Events Committee; echocardiograms were analysed by an independent Core Laboratory.
RESULTS: Between January 2013 and February 2016, 689 patients received the study valve. Mean age was 67.0 ± 11.6 years; 71.8% were male; 26.3% were New York Heart Association Class III/IV. Mean STS PROM was 2.0 ± 1.8 (0.3-17.5). Isolated AVR was performed in 59.1% of patients; others had additional concomitant procedures, usually CABG. Thirty-day outcomes for all patients included all-cause mortality 1.2%, thromboembolism 2.2%, bleeding 0.9%, major paravalvular leak 0.1% and permanent pacemaker implantation 4.7%. Median intensive care unit and hospital length of stay were 2 (range: 0.2-66) and 7 days (3.0-121.0), respectively. At 2 years, New York Heart Association class improved in 65.7%, effective orifice area was 1.6 ± 0.5 cm2; mean gradient was 10.1 ± 4.3 mmHg; and paravalvular leak was none/trivial in 94.5%, mild in 4.9%, moderate in 0.5% and severe in 0.0%. One-year actuarial freedom from all-cause mortality for isolated AVR and for all patients was 98.2% and 97.6%, respectively. Two-year actuarial freedom from mortality in these groups was 95.3% and 94.3%, respectively.
CONCLUSIONS: These data demonstrate excellent early safety and effectiveness of aortic valve replacement with a novel bioprosthetic tissue (RESILIA™).
CLINICAL TRIAL REGISTRATION: clinicaltrials.gov: NCT01757665.
Volume
52
Issue
3
First Page
432
Last Page
439
ISSN
1873-734X
Published In/Presented At
Puskas, J. D., Bavaria, J. E., Svensson, L. G., Blackstone, E. H., Griffith, B., Gammie, J. S., Heimansohn, D. A., Sadowski, J., Bartus, K., Johnston, D. R., Rozanski, J., Rosengart, T., Girardi, L. N., Klodell, C. T., Mumtaz, M. A., Takayama, H., Halkos, M., Starnes, V., Boateng, P., Timek, T. A., … COMMENCE Trial Investigators (2017). The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue. European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery, 52(3), 432–439. https://doi.org/10.1093/ejcts/ezx158
Disciplines
Medicine and Health Sciences
PubMedID
28605428
Department(s)
Department of Surgery
Document Type
Article