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Clinical Trial
. 2017 Sep 1;52(3):432-439.
doi: 10.1093/ejcts/ezx158.

The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue

John D Puskas  1 , Joseph E Bavaria  2 , Lars G Svensson  3 , Eugene H Blackstone  4 , Bartley Griffith  5 , James S Gammie  6 , David A Heimansohn  7 , Jerzy Sadowski  8 , Krzysztof Bartus  8 , Douglas R Johnston  4 , Jacek Rozanski  9 , Todd Rosengart  10 , Leonard N Girardi  11 , Charles T Klodell  12 , Mubashir A Mumtaz  13 , Hiroo Takayama  14 , Michael Halkos  15 , Vaughn Starnes  16 , Percy Boateng  17 , Tomasz A Timek  18 , William Ryan  19 , Shuab Omer  20 , Craig R Smith  21 ; COMMENCE Trial Investigators
Affiliations
Clinical Trial

The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue

John D Puskas et al. Eur J Cardiothorac Surg. .

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.

Keywords: Aortic valve replacement; Bioprosthetic valves; RESILIA™; tissue.

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