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- Title
The COMMENCE trial: 2-year outcomes with an aortic bio prosthesis with BRASILIA tissue.
- Authors
Puskas, John D.; Bavaria, Joseph E.; Svensson, Lars G.; Blackstone, Eugene H.; Griffith, Bartley; Gammie, James S.; Heimansohn, David A.; Sadowski, Jerzy; Bartus, Krzysztof; Johnston, Douglas R.; Rozanski, Jacek; Rosengart, Todd; Girardi, Leonard N.; Klodell, Charles T.; Mumtaz, Mubashir A.; Takayama, Hiroo; Halkos, Michael; Starnes, Vaughn; Boateng, Percy; Timek, Tomasz A.
- Abstract
OBJECTIVES: The COMMENCE trial was conducted to evaluate the safety and effectiveness of a novel bio prosthetic tissue for surgical aortic valve replacement (AR). METHODS: Patients underwent clinically indicated surgical AR with the Carpentier-Edwards PERIMOUNTTM Magna EaseTM aortic valve with RESILIATM 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™).
- Subjects
AORTIC valve surgery; BIOPROSTHESIS; PULMONARY valve; MITRAL valve surgery; SURGERY
- Publication
European Journal of Cardio-Thoracic Surgery, 2017, Vol 52, Issue 3, p432
- ISSN
1010-7940
- Publication type
Article
- DOI
10.1093/ejcts/ezx158