Key result
Lotus valve TAVI achieves 83% device success in bicuspid aortic stenosis.
Why the study?
Prior experience with first-generation TAVI devices in bicuspid aortic valve stenosis showed disappointing results mainly due to an increased prevalence of aortic regurgitation.
Is transcatheter aortic valve implantation using the Lotus device safe and effective in patients with bicuspid aortic valve stenosis?
Observational (n=24)
Yes
Is transcatheter aortic valve implantation using the Lotus device safe and effective in patients with bicuspid aortic valve stenosis?
TAVI using the mechanically expanded Lotus device in selected patients with bicuspid aortic valve stenosis is feasible with encouraging mid-term clinical outcomes and low rates of severe aortic regurgitation.
Supports Lotus TAVI feasibility in selected bicuspid AS; leaves open randomized comparisons to contemporary valves.
BACKGROUND: The aim of this study was to evaluate the outcomes of transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BiAV) stenosis using a mechanically expanded Lotus™ device. The prior experience with first-generation devices showed disappointing results mainly due to increased prevalence of aortic regurgitation (AR) that exceeded those observed in tricuspid stenosis. METHODS AND One in-hospital death was observed secondary to aortic perforation. There was no severe AR and the rate of moderate AR equalled 9% at 30 days (n = 2). Device success was achieved in 83% and the 30-day safety endpoint was 17%. In the 2-year follow-up, the overall mortality was 12.5% and the 2-year composite clinical efficacy endpoint was met in 25% of the patients (n = 6) CONCLUSIONS: The TAVI in selected BiAV patients using the Lotus™ is feasible and characterized by encouraging valve performance and mid-term clinical outcomes.
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Kochman et al. (2019) conducted an observational in Bicuspid aortic valve stenosis (n=24). Transcatheter aortic valve implantation (TAVI) using Lotus valve was evaluated on Device success (VARC-2 criteria). Transcatheter aortic valve implantation using the Lotus valve in patients with bicuspid aortic valve stenosis achieved an 83% device success rate and a 17% 30-day safety composite endpoint.
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