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- W2980696872 abstract "The aim of this study was to assess the safety and performance of a newly introduced transfemoral self-expanding supra-annular transcatheter heart valve.Transcatheter aortic valve replacement has become an established procedure, and newer transcatheter heart valves aim to supplement the current armamentarium.BIOVALVE-I is a prospective, single-center feasibility study enrolling 13 high-risk patients with severe aortic stenosis, and BIOVALVE-II is a multicenter pilot study enrolling a further 55 patients under the same protocol.Patients' mean age was 82.4 ± 5.3 years, 57.4% had concomitant coronary artery disease, 50.0% had renal insufficiency stage ≥3, 32.4% had diabetes mellitus, 29.4% had current anemia, 19.1% had chronic obstructive pulmonary disease, 19.1% were frail, and 17.6% had prior cerebrovascular events. The primary endpoint, early safety according to the Valve Academic Research Consortium-2 guidelines, was observed in 13 patients (19.1%). One patient (1.5%) died through 30 days of a noncardiac cause, and 4 patients (7.8%) died through 180 days. Disabling stroke occurred at 30 days in 1 patient (1.5%) and at 180 days in 2 patients (3.2%). New permanent pacemakers up to 30 days were implanted in 9 patients (13.4%). Two patients (3.8%) had moderate or severe paravalvular leakage at 30 days and 4 (9.1%) at 6 months, mean effective orifice area was 2.0 ± 0.4 cm2 and 1.9 ± 0.5 cm2, and mean gradient was 6.4 mm Hg at 30 days and 6 months.Clinical outcomes with the Biovalve self-expanding transcatheter heart valve were similar to those seen in other first-in-human studies with first-generation devices for severe aortic stenosis." @default.
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- W2980696872 date "2020-01-01" @default.
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- W2980696872 title "Safety and Performance Outcomes of a Self-Expanding Transcatheter Aortic Heart Valve" @default.
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- W2980696872 doi "https://doi.org/10.1016/j.jcin.2019.07.058" @default.
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