Key result
TAVI with the ACURATE neo2 in severe bicuspid aortic valve stenosis resulted in a mean transvalvular gradient of 6.5 mmHg, 4.3% moderate paravalvular leak, and a 6.5% new pacemaker rate at 30 days.
Why the study?
The ACURATE neo2 TAVI system is approved for severe aortic stenosis in Europe but has not been evaluated in bicuspid aortic valve stenosis.
Does TAVI with ACURATE neo2 improve VARC-3-defined 30-day procedure safety and efficacy in patients with severe bicuspid aortic valve stenosis?
Cohort
Yes
Does TAVI with ACURATE neo2 improve VARC-3-defined 30-day procedure safety and efficacy in patients with severe bicuspid aortic valve stenosis?
TAVI with the ACURATE neo2 system demonstrates favorable 30-day safety and bioprosthetic valve performance in selected patients with severe bicuspid aortic valve stenosis.
Answers are grounded in this paper and cite their sources.
Supports ACURATE neo2 in selected BAV stenosis; extends tricuspid data but leaves randomized confirmation open.
BACKGROUND: The ACURATE neo2 is a contemporary transcatheter aortic valve implantation (TAVI) system approved for the treatment of severe aortic stenosis in Europe. The ACURATE neo2 has not been evaluated in bicuspid aortic valve (BAV) stenosis. AIMS: We sought to evaluate the safety and efficacy of ACURATE neo2 in patients with BAV stenosis. METHODS: We retrospectively analysed consecutive severe BAV stenosis patients undergoing TAVI with ACURATE neo2 at 10 European centres. Imaging data from preprocedural multislice computed tomography, pre- and postprocedural echocardiography, and procedural cinefluoroscopy were evaluated by a core laboratory. Valve Academic Research Consortium 3 (VARC-3)-defined 30-day procedure safety and efficacy were the primary endpoints. Adverse events were site-reported according to VARC-3 criteria. RESULTS: and a mean transvalvular gradient of 6.5 (4.6-9.0) mmHg. Half of all cases (51.2%) had no paravalvular leak, while moderate leak occurred in 4.3%. A new permanent pacemaker was required in 11 patients (6.5%). CONCLUSIONS: The ACURATE neo2 demonstrated favourable clinical outcomes and bioprosthetic valve performance at 30 days in selected patients with severe BAV stenosis.
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Rück et al. (2025) conducted a cohort in severe bicuspid aortic valve stenosis. ACURATE neo2 was evaluated on Valve Academic Research Consortium 3 (VARC-3)-defined 30-day procedure safety and efficacy. TAVI with the ACURATE neo2 in severe bicuspid aortic valve stenosis resulted in a mean transvalvular gradient of 6.5 mmHg, 4.3% moderate paravalvular leak, and a 6.5% new pacemaker rate at 30 days.
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