Abstract
BackgroundThe 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 resultsWe collected baseline, in-hospital, 30-day and 2-year follow-up data from a prospective, multicentre registry of patients with BiAV undergoing TAVI using Lotus™ valve. Safety and efficacy endpoints were assessed according to VARC-2 criteria. The study group comprised 24 patients. The mean age was 73.5 years and the mean EuroSCORE 2 was 4.35 ± 2.56%. MDCT analysis revealed Type 1 BiAV in 75% of patients. The mean gradient decreased from 60.1 ± 18.3 to 15 ± 6.4 mm Hg, the AVA increased from 0.6 ± 0.19 to 1.7 ± 0.21 cm2. 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)ConclusionsThe TAVI in selected BiAV patients using the Lotus™ is feasible and characterized by encouraging valve performance and mid-term clinical outcomes.Graphic abstract
Highlights
A bicuspid aortic valve (BiAV) is the most common congenital heart defect reported in up to 2% of the general population [1, 2]
Unfavourable anatomy with heavily calcified and asymmetrical aortic valve cusps accompanied by annular eccentricity and aortopathy were perceived as features that could lead to prosthesis dysfunction and periprocedural complications
The device is fully repositionable and resheatable even in the expanded position, before final release. It is equipped with a surrounding flexible membrane designed to seal the paravalvular gaps between the prosthesis and native annulus, which aims to reduce the risk of significant paravalvular leaks (PVLs) [12,13,14]
Summary
A bicuspid aortic valve (BiAV) is the most common congenital heart defect reported in up to 2% of the general population [1, 2]. 20% octogenarians who underwent surgical AVR had an underlying BiAV pathology [4] As these individuals are characterized by an increased operative risk, they might be suitable candidates for transcatheter aortic valve implantation (TAVI). Unfavourable anatomy with heavily calcified and asymmetrical aortic valve cusps accompanied by annular eccentricity and aortopathy were perceived as features that could lead to prosthesis dysfunction and periprocedural complications These concerns were further strengthened by results of few small TAVI registries that showed a higher rate of moderate-to-severe aortic regurgitation (AR) than in tricuspid valves [8,9,10,11].
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