Safety and Performance Outcomes of a Self-Expanding Transcatheter Aortic Heart Valve: The BIOVALVE Trials
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Safety and Performance Outcomes of a Self-Expanding Transcatheter Aortic Heart Valve: The BIOVALVE Trials. / Schäfer, Ulrich; Kempfert, Jörg; Verheye, Stefan; Maisano, Francesco; Thiele, Holger; Landt, Martin; Haude, Michael; Rudolph, Tanja K; Ince, Hüseyin; Kische, Stephan; Treede, Hendrik; Tonino, Pim; Conradi, Lenard.
in: JACC-CARDIOVASC INTE, Jahrgang 13, Nr. 2, 27.01.2020, S. 157-166.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Safety and Performance Outcomes of a Self-Expanding Transcatheter Aortic Heart Valve: The BIOVALVE Trials
AU - Schäfer, Ulrich
AU - Kempfert, Jörg
AU - Verheye, Stefan
AU - Maisano, Francesco
AU - Thiele, Holger
AU - Landt, Martin
AU - Haude, Michael
AU - Rudolph, Tanja K
AU - Ince, Hüseyin
AU - Kische, Stephan
AU - Treede, Hendrik
AU - Tonino, Pim
AU - Conradi, Lenard
N1 - Copyright © 2020. Published by Elsevier Inc.
PY - 2020/1/27
Y1 - 2020/1/27
N2 - OBJECTIVES: The aim of this study was to assess the safety and performance of a newly introduced transfemoral self-expanding supra-annular transcatheter heart valve.BACKGROUND: Transcatheter aortic valve replacement has become an established procedure, and newer transcatheter heart valves aim to supplement the current armamentarium.METHODS: 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.RESULTS: 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.CONCLUSIONS: 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.
AB - OBJECTIVES: The aim of this study was to assess the safety and performance of a newly introduced transfemoral self-expanding supra-annular transcatheter heart valve.BACKGROUND: Transcatheter aortic valve replacement has become an established procedure, and newer transcatheter heart valves aim to supplement the current armamentarium.METHODS: 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.RESULTS: 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.CONCLUSIONS: 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.
KW - Aged
KW - Aged, 80 and over
KW - Aortic Valve/diagnostic imaging
KW - Aortic Valve Stenosis/diagnostic imaging
KW - Feasibility Studies
KW - Female
KW - Heart Valve Prosthesis
KW - Hemodynamics
KW - Humans
KW - Male
KW - Pilot Projects
KW - Prospective Studies
KW - Prosthesis Design
KW - Recovery of Function
KW - Risk Assessment
KW - Risk Factors
KW - Severity of Illness Index
KW - Time Factors
KW - Transcatheter Aortic Valve Replacement/adverse effects
KW - Treatment Outcome
U2 - 10.1016/j.jcin.2019.07.058
DO - 10.1016/j.jcin.2019.07.058
M3 - SCORING: Journal article
C2 - 31629751
VL - 13
SP - 157
EP - 166
JO - JACC-CARDIOVASC INTE
JF - JACC-CARDIOVASC INTE
SN - 1936-8798
IS - 2
ER -