TY - JOUR
T1 - Clinical outcomes of the Lotus Valve in patients with bicuspid aortic valve stenosis
T2 - An analysis from the RESPOND study
AU - Blackman, Daniel J.
AU - Van Gils, Lennart
AU - Bleiziffer, Sabine
AU - Gerckens, Ulrich
AU - Petronio, Anna Sonia
AU - Abdel-Wahab, Mohamed
AU - Werner, Nikos
AU - Khogali, Saib S.
AU - Wenaweser, Peter
AU - Wöhrle, Jochen
AU - Soliman, Osama
AU - Laborde, Jean Claude
AU - Allocco, Dominic J.
AU - Meredith, Ian T.
AU - Falk, Volkmar
AU - Van Mieghem, Nicolas M.
N1 - Publisher Copyright:
© 2019 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.
PY - 2019/5/1
Y1 - 2019/5/1
N2 - Aims: Patients with bicuspid valves represent a challenging anatomical subgroup for transcatheter aortic valve implantation (TAVI). This analysis evaluated the clinical outcomes of the fully repositionable and retrievable Lotus Valve System in patients with bicuspid aortic valves enrolled in the RESPOND post-market registry. Methods and Results: The prospective, open-label RESPOND study enrolled 1,014 patients at 41 centers in Europe, New Zealand, and Latin America, 31 (3.1%) of whom had bicuspid aortic valves. The mean age in the bicuspid patient cohort was 76.4 years, 64.5% were male, and the baseline STS score was 6.0 ± 10.2. Procedural success was 100%, with no cases of malpositioning, valve migration, embolization, or valve-in-valve. Repositioning was attempted in 10 cases (32.3%). There was one death (3.2%) and one stroke (3.2%) at 30-day follow-up. Mean AV gradient was reduced from 48.7 ± 17.0 mmHg at baseline to 11.8 ± 5.1 mmHg at hospital discharge (P < 0.001); mean effective orifice area (EOA) was increased from 0.6 ± 0.2 cm 2 to 1.7 ± 0.4 cm 2 (P < 0.001). There were no cases of moderate or severe paravalvular leak (PVL) adjudicated by the core laboratory; four subjects (13.8%) had mild PVL, 5 (17.2%) had trace PVL. The rate of pacemaker (PM) implantation for PM-naïve patients was 22.2% (6/27). Conclusions: Data from the RESPOND registry demonstrate good clinical and echocardiographic outcomes up to 1 year postimplantation in patients with bicuspid aortic valves using the repositionable Lotus Valve.
AB - Aims: Patients with bicuspid valves represent a challenging anatomical subgroup for transcatheter aortic valve implantation (TAVI). This analysis evaluated the clinical outcomes of the fully repositionable and retrievable Lotus Valve System in patients with bicuspid aortic valves enrolled in the RESPOND post-market registry. Methods and Results: The prospective, open-label RESPOND study enrolled 1,014 patients at 41 centers in Europe, New Zealand, and Latin America, 31 (3.1%) of whom had bicuspid aortic valves. The mean age in the bicuspid patient cohort was 76.4 years, 64.5% were male, and the baseline STS score was 6.0 ± 10.2. Procedural success was 100%, with no cases of malpositioning, valve migration, embolization, or valve-in-valve. Repositioning was attempted in 10 cases (32.3%). There was one death (3.2%) and one stroke (3.2%) at 30-day follow-up. Mean AV gradient was reduced from 48.7 ± 17.0 mmHg at baseline to 11.8 ± 5.1 mmHg at hospital discharge (P < 0.001); mean effective orifice area (EOA) was increased from 0.6 ± 0.2 cm 2 to 1.7 ± 0.4 cm 2 (P < 0.001). There were no cases of moderate or severe paravalvular leak (PVL) adjudicated by the core laboratory; four subjects (13.8%) had mild PVL, 5 (17.2%) had trace PVL. The rate of pacemaker (PM) implantation for PM-naïve patients was 22.2% (6/27). Conclusions: Data from the RESPOND registry demonstrate good clinical and echocardiographic outcomes up to 1 year postimplantation in patients with bicuspid aortic valves using the repositionable Lotus Valve.
KW - aortic regurgitation
KW - aortic valve stenosis
KW - bicuspid
KW - transcatheter aortic valve implantation
KW - transfemoral
UR - https://www.scopus.com/pages/publications/85061916620
U2 - 10.1002/ccd.28120
DO - 10.1002/ccd.28120
M3 - Article
SN - 1522-1946
VL - 93
SP - 1116
EP - 1123
JO - Catheterization and Cardiovascular Interventions
JF - Catheterization and Cardiovascular Interventions
IS - 6
ER -
