EuroPCR 2018: Low incidence of cardiovascular mortality with Centera self-expanding valve at one year

Hermann Reichenspurner

Hermann Reichenspurner (Departments of Cardiovascular Surgery and General and Interventional Cardiology, University Heart Center, Hamburg, Germany) at EuroPCR (22 May—25 May, Paris, France) reported that the Centera self-expanding transcatheter aortic valve implantation (TAVI) device is associated with both a low rate of cardiovascular mortality (4.6%) and a low rate of disabling stroke (4.1%) at one year for the management of aortic stenosis in patients at high surgical risk.

According to Reichenspurner, the valve has a short frame height, the same bovine pericardial tissue that is used in Edwards Lifesciences’ Sapien valve family, Resilia tissue technology “that allows the valve to be stored dry”, and a “unique contoured frame designed to anchor and seal within the annulus for low paravalvular leak rates”.

The primary endpoint of the CENTERA study was to evaluate the rate of 30-day all-cause mortality in patients who received the valve. The 30-day results were presented at last year’s EuroPCR and showed a high survival rate (99%) and a low rate of disabling stroke (2.5%). The aim of the present analysis was to review the one-year follow-up outcomes for patients who received the valve.

Of the 203 patients initially enrolled in the study, follow-up data were available for 179 patients. The all-cause mortality rate was 9%, the rate of disabling stroke was 4.1%, and the rate of cardiac-related hospitalisation was 6.8%. Additionally, the rate of cardiac mortality was 4.6% and the rate of need for a new permanent pacemaker 6%. No patients had severe or moderate aortic regurgitation at one year, with most (71.4%) having none or trace (28.6% had mild aortic regurgitation).

Between baseline and 30-day follow-up, in the overall study population, there was a significant improvement in New York Heart Association (NYHA) Class (p<0.0001). However, there were no differences in NYHA class between 30 days and six months or between 30 days and one year. At one year, the majority of patients were in Class I or II.

Reichenspurner told Cardiovascular News that Centera offers “excellent early and one-year outcome with low mortality, minimal evidence of paravalvular leakage and low rates of necessary pacemaker implantation”.


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