Thirty-Day Data Published for Edwards' Centera Transcatheter Aortic Valve System
December 21, 2017—The 30-day safety and efficacy results from the pivotal CENTERA-2 trial of the Centera transcatheter aortic valve system (Edwards Lifesciences) for symptomatic high-risk patients with severe aortic stenosis were published by Hermann Reichenspurner, MD, et al in Journal of the American College of Cardiology (JACC;2017;70;3127–3136). Centera is a low-profile, self-expanding nitinol valve made from bovine pericardial tissue that is 14-F compatible with a motorized delivery system allowing for repositionability.
The primary endpoint in the CENTERA-2 trial was all-cause mortality at 30 days. The investigators assessed clinical and echocardiographic outcomes at baseline, discharge, and 30 days. Major events were adjudicated by an independent clinical events committee. Echocardiograms and computed tomography scans were reviewed by core laboratories.
As summarized in JACC, the study was composed of 203 patients treated by transfemoral valve implantation at 23 centers between March 25, 2015 and July 5, 2016. The patients had severe symptomatic aortic stenosis and were at increased surgical risk, as determined by the heart team. The patients' mean age was 82.7 ± 5.5 years, 67.5% were female, and 68% were New York Heart Association functional class III/IV.
The investigators reported that at 30 days, mortality was 1%, disabling stroke occurred in 2.5% of patients, and New York Heart Association functional class I/II was observed in 93% of patients.
Additionally, the investigators found that the effective orifice area increased from 0.71 ± 0.20 cm2 to 1.88 ± 0.43 cm2 (P < .001). The mean aortic transvalvular gradient decreased from 40.5 ± 13.2 mm Hg to 7.2 ± 2.8 mm Hg at 30 days postprocedure (P < .001). Paravalvular aortic regurgitation at 30 days was moderate or higher in 0.6% of patients. A new permanent pacemaker was implanted in 4.5% of patients receiving the Centera valve (4.9% for patients at risk).
The Centera transcatheter aortic valve system is safe and effective at 30 days with low mortality, significant improvements in hemodynamic outcomes, a low incidence of adverse events, and a low incidence of permanent pacemaker implantations, concluded the investigators in JACC.
In May, Edwards Lifesciences announced that the 30-day results were presented by Didier Tchétché, MD, as late-breaking data at the EuroPCR 2017 conference in Paris, France. At that time, the company advised that the Centera valve is an investigational device not yet available commercially in any country and that European CE Mark approval is anticipated to be received during the fourth quarter of 2017.