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/ZeitungSCORING: ZeitschriftenaufsätzeForschungBegutachtung

Harvard

Schäfer, U, Kempfert, J, Verheye, S, Maisano, F, Thiele, H, Landt, M, Haude, M, Rudolph, TK, Ince, H, Kische, S, Treede, H, Tonino, P & Conradi, L 2020, 'Safety and Performance Outcomes of a Self-Expanding Transcatheter Aortic Heart Valve: The BIOVALVE Trials', JACC-CARDIOVASC INTE, Jg. 13, Nr. 2, S. 157-166. https://doi.org/10.1016/j.jcin.2019.07.058

APA

Schäfer, U., Kempfert, J., Verheye, S., Maisano, F., Thiele, H., Landt, M., Haude, M., Rudolph, T. K., Ince, H., Kische, S., Treede, H., Tonino, P., & Conradi, L. (2020). Safety and Performance Outcomes of a Self-Expanding Transcatheter Aortic Heart Valve: The BIOVALVE Trials. JACC-CARDIOVASC INTE, 13(2), 157-166. https://doi.org/10.1016/j.jcin.2019.07.058

Vancouver

Bibtex

@article{6003636645424ab99ca3994c33b1262c,
title = "Safety and Performance Outcomes of a Self-Expanding Transcatheter Aortic Heart Valve: The BIOVALVE Trials",
abstract = "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.",
keywords = "aortic stenosis, Biovalve, self-expanding, supra-annular, transcatheter heart valve, transfemoral",
author = "Ulrich Sch{\"a}fer and J{\"o}rg Kempfert and Stefan Verheye and Francesco Maisano and Holger Thiele and Martin Landt and Michael Haude and Rudolph, {Tanja K} and H{\"u}seyin Ince and Stephan Kische and Hendrik Treede and Pim Tonino and Lenard Conradi",
note = "Copyright {\textcopyright} 2020. Published by Elsevier Inc.",
year = "2020",
month = jan,
day = "27",
doi = "10.1016/j.jcin.2019.07.058",
language = "English",
volume = "13",
pages = "157--166",
journal = "JACC-CARDIOVASC INTE",
issn = "1936-8798",
publisher = "Elsevier Inc.",
number = "2",

}

RIS

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 - aortic stenosis

KW - Biovalve

KW - self-expanding

KW - supra-annular

KW - transcatheter heart valve

KW - transfemoral

UR - http://www.scopus.com/inward/record.url?scp=85077653344&partnerID=8YFLogxK

U2 - 10.1016/j.jcin.2019.07.058

DO - 10.1016/j.jcin.2019.07.058

M3 - SCORING: Journal articles

C2 - 31629751

VL - 13

SP - 157

EP - 166

JO - JACC-CARDIOVASC INTE

JF - JACC-CARDIOVASC INTE

SN - 1936-8798

IS - 2

ER -