1-Year Outcomes of the CENTERA-EU Trial Assessing a Novel Self-Expanding Transcatheter Heart Valve.

OBJECTIVES The purpose of this study is to report the 1-year results of the CENTERA-EU trial. BACKGROUND The CENTERA transcatheter heart valve (THV) (Edwards Lifesciences, Irvine, California) is a low-profile (14-F eSheath compatible), self-expanding nitinol valve, with a motorized delivery system allowing for repositionability. The 30-day results of the CENTERA-EU trial demonstrated the short-term safety and effectiveness of the valve. METHODS Implantations were completed in 23 centers in Europe, Australia, and New Zealand. Transfemoral access was used in all patients. Echocardiographic outcomes were adjudicated by a core laboratory at baseline, discharge, 30 days, 6 months, and 1 year. Major adverse clinical events were adjudicated by an independent clinical events committee. RESULTS Between March 2015 and July 2016, 203 high-risk patients (age 82.7 ± 5.5 years, 67.5% women, 68.0% New York Heart Association functional class III or IV, Society of Thoracic Surgeons score 6.1 ± 4.2%) with severe, symptomatic aortic stenosis underwent transcatheter aortic valve replacement with the CENTERA THV. The primary endpoint of the study was 30-day mortality (1.0%). At 1 year, overall mortality was 9.1%, cardiovascular mortality was 4.6%, disabling stroke was 4.1%, new permanent pacemakers were implanted in 6.5% of patients at risk, and cardiac-related rehospitalization was 6.8%. Hemodynamic parameters were stable at 1 year, with a mean aortic valve gradient of 8.1 ± 4.7 mm Hg, a mean effective orifice area of 1.7 ± 0.42 cm2, and no incidences of severe or moderate aortic regurgitation. CONCLUSIONS The CENTERA-EU trial demonstrated mid-term safety and effectiveness of the CENTERA THV, with low mortality, sustained improvements in hemodynamic performances, and low incidence of permanent pacemaker implantations in high-risk patients with symptomatic aortic stenosis. (Safety and Performance of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve [CENTERA-2]; NCT02458560)