NEW research has shown that the ACURATE neo2 transcatheter aortic valve implantation (TAVI) system demonstrates favourable clinical outcomes and valve performance at 30 days in patients with severe bicuspid aortic valve (BAV) stenosis.
Severe BAV stenosis presents a unique challenge for TAVI, given the anatomical variability and risk of suboptimal valve positioning. The ACURATE neo2 is a contemporary TAVI system approved for the treatment of severe aortic stenosis in Europe, though its performance in BAV stenosis has not been extensively studied. This registry aimed to evaluate the safety and efficacy of ACURATE neo2 in this complex patient population across multiple European centres.
A retrospective analysis was conducted on 181 consecutive patients with severe BAV stenosis who underwent TAVI using ACURATE neo2 at 10 European centres. Imaging data from multislice computed tomography, echocardiography, and cinefluoroscopy were assessed by a core laboratory. The primary endpoints were device success and early safety at 30 days, as defined by Valve Academic Research Consortium 3 (VARC-3) criteria. The study found a high technical success rate of 95.6%, with device success achieved in 90.6% of cases. At 30 days, early safety was reported in 82.3% of patients, with a cardiovascular mortality rate of 2.2% (n=4) and stroke occurring in 1.6% (n=3). Echocardiographic assessment revealed an effective orifice area of 2.0 cm² (1.7-2.5) and a mean transvalvular gradient of 6.5 mmHg (4.6-9.0). Paravalvular leak was absent in 51.2% of cases, with moderate leak occurring in 4.3%. A new permanent pacemaker was required in 6.5% of patients (n=11).
These findings suggest that the ACURATE neo2 valve provides effective haemodynamic performance and procedural success in carefully selected BAV stenosis patients. The low rates of mortality, stroke, and significant paravalvular leak reinforce its potential as a viable treatment option. However, further studies are required to determine long-term durability and outcomes beyond 30 days. In clinical practice, patient selection, procedural technique, and post-TAVI management remain crucial to optimising results with this device. Future research should explore comparative data with other contemporary TAVI systems and evaluate strategies to further reduce complications, particularly the need for pacemaker implantation.
Katrina Thornber, EMJ
Reference
Ruck A et al. TAVI with the ACURATE neo2 in severe bicuspid aortic valve stenosis: the Neo2 BAV Registry. EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2025;21(2):e130-9.
