Safety and Performance Outcomes of a Self-Expanding Transcatheter Aortic Heart Valve: The BIOVALVE Trials

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 -