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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Clinical outcomes of the Lotus Valve in patients with bicuspid aortic valve stenosis: An analysis from the RESPOND study
Catheterization and Cardiovascular Interventions, Volume 93, No. 6, Year 2019
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Description
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. © 2019 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.
Authors & Co-Authors
Blackman, Daniel James
United Kingdom, Leeds
Leeds General Infirmary
Bleiziffer, Sabine
Germany, Bochum
Ruhr-universitat Bochum
Petronio, Anna Sonia
Italy, Pisa
Azienda Ospedaliero Universitaria Pisana
Abdel-Wahab, Mohamed Kader
Germany, Leipzig
Herzzentrum Leipzig
Khogali, Saib S.
United Kingdom, Wolverhampton
The Royal Wolverhampton Nhs Trust
Wöhrle, Jochen
Germany, Ulm
Universität Ulm
Soliman, O. I.I.
Netherlands, Rotterdam
Erasmus Mc
Falk, Volkmar
Germany, Berlin
Deutsches Herzzentrum Berlin
Van Mieghem, Nicolas M.D.A.
Netherlands, Rotterdam
Erasmus Mc
Statistics
Citations: 14
Authors: 9
Affiliations: 13
Identifiers
Doi:
10.1002/ccd.28120
ISSN:
15221946
Research Areas
Health System And Policy
Noncommunicable Diseases
Study Design
Cohort Study
Participants Gender
Male