OBJECTIVES: The aim of this study was to demonstrate feasibility and short- and midterm clinical outcomes with a new self-expanding transcatheter heart valve and motorized delivery system.
BACKGROUND: Refining transcatheter aortic valve replacement with newly designed bioprostheses and delivery systems is anticipated to facilitate the procedure, reduce the risk of complications, improve outcomes, and widen applicability.
METHODS: The CENTERA valve (Edwards Lifesciences, Irvine, California) was implanted in 15 patients with symptomatic severe aortic stenosis via femoral or axillary arterial percutaneous access. Patients underwent transesophageal echocardiography during and transthoracic echocardiography and multidetector computed tomography before and after valve implantation. Clinical and echocardiographic follow-up was obtained at 30 days and for the initial 10 patients after 1 year.
RESULTS: All 15 device implants were successful. Aortic valve area increased from 0.7 ± 0.1 cm(2) to 1.6 ± 0.4 cm(2) post-procedure (p < 0.01) and 1.8 ± 0.3 cm(2) at 1 year. Mean transaortic gradient decreased from 36.3 ± 14.2 mm Hg to 10.6 ± 5.4 mm Hg post-procedure (p < 0.001) and 10.8 ± 4.1 mm Hg at 1 year. Paravalvular aortic regurgitation at 30-day follow-up was none/trivial in 3 (23%), mild in 9 (69%), and moderate in 1 (8%) patient. Four patients (27%) received a new permanent pacemaker. Survival was 87% at 30 days and 80% at 1 year. All surviving patients were in New York Heart Association functional class I (25%) or II (75%) at 1 year.
CONCLUSIONS: Transcatheter aortic valve replacement with the CENTERA transcatheter heart valve and motorized delivery system is feasible and can lead to good short- and midterm clinical and hemodynamic outcomes.