RESUMO
BACKGROUND: The CENTERA transcatheter heart valve (THV) 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. OBJECTIVES: The pivotal study evaluated safety and efficacy of this THV in high-surgical-risk study patients with severe symptomatic aortic stenosis. METHODS: Implantations were completed in 23 centers. Clinical and echocardiographic outcomes were assessed 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. The primary endpoint was all-cause mortality at 30 days. RESULTS: Between March 25, 2015 and July 5, 2016, 203 patients with severe symptomatic aortic stenosis and increased surgical risk, as determined by the heart team, were treated by transfemoral THV implantation (age 82.7 ± 5.5 years, 67.5% female, 68.0% New York Heart Association functional class III/IV). 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 93.0% of patients. Effective orifice area increased from 0.71 ± 0.20 cm2 to 1.88 ± 0.43 cm2 (p < 0.001). Mean aortic transvalvular gradient decreased from 40.5 ± 13.2 mm Hg to 7.2 ± 2.8 mm Hg at 30 days post-procedure (p < 0.001). 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 THV (4.9% for patients at risk). CONCLUSIONS: The herein described THV is safe and effective at 30 days with low mortality, significant improvements in hemodynamic outcomes, and low incidence of adverse events. Of particular interest is the low incidence of permanent pacemaker implantations. (Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve [CENTERA-2]; NCT02458560).