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Multicenter Study
. 2025 Jan 20;21(2):e130-e139.
doi: 10.4244/EIJ-D-24-00869.

TAVI with the ACURATE neo2 in severe bicuspid aortic valve stenosis: the Neo2 BAV Registry

Andreas Ruck  1 , Won-Keun Kim  2   3 , Paolo Alberto Del Sole  4 , Max Wagener  4   5 , Angela McInerney  4 , Magdi S Yacoub  4   6 , Elfatih A Hasabo  4   6 , Cagri Ayhan  4   6 , Hesham Elzomor  4   6 , Dina Neiroukh  4   6 , Abdul Amir  1 , Nawzad Saleh  1 , Magnus Settergren  1 , Rickard Lindler  1 , Dinos Verouhis  1 , Samuel Sossalla  2   3 , Matthias Renker  2   3 , Matteo Montorfano  7   8 , Barbara Bellini  8 , Xavier Carrillo Suarez  9 , Victoria Vilalta Del Olmo  9 , Federico De Marco  10 , Matteo Biroli  10 , Helge Mollmann  11 , Eckel Clemens Enno  11 , Giuseppe Tarantini  12 , Tommaso Fabris  12 , Alfonso Ielasi  13 , Giuliano Costa  14 , Marco Barbanti  15 , Osama Soliman  4   6 , Darren Mylotte  4
Affiliations
Multicenter Study

TAVI with the ACURATE neo2 in severe bicuspid aortic valve stenosis: the Neo2 BAV Registry

Andreas Ruck et al. EuroIntervention. .

Abstract

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: Among 181 patients with BAV stenosis treated with the ACURATE neo2, the mean age was 77.5±7.2 years, 58.0% were female, and the Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score was 2.3% (1.6-3.7%). Most procedures were transfemoral, and predilatation was performed in all cases. A second valve was required in 4 cases (2.2%). VARC-3-defined technical success was 95.6%. The primary endpoints of device success and early safety occurred in 90.6% and 82.3%, respectively. At 30 days, cardiovascular death occurred in 2.2% (N=4) and stroke in 1.6% (N=3). Core laboratory-adjudicated echocardiography reported an effective orifice area of 2.0 (1.7-2.5) cm2 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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Conflict of interest statement

A. Rück reports grants and personal fees from Boston Scientific; and personal fees from Edwards Lifesciences, Abbott, and Anteris Technologies. W.-K. Kim reports proctor/speaker fees/advisory board participation for Abbott, Boston Scientific, Edwards Lifesciences, and Meril Life Sciences. M. Wagener received educational support from Medtronic. A. McInerney has received speaker fees from Shockwave Medical, Boston Scientific, and Novartis. M. Montorfano received consultant fees from Abbott, Boston Scientific, Kardia, and Medtronic. B. Bellini received consultant fees from Medtronic. H. Möllmann receives grants, consulting and lecture fees from Abbott, Boston Scientific, Edwards Lifesciences, Meril Life Sciences, and Medtronic; and support for attending meetings/travel from Boston Scientific, Abbott, and Edwards Lifesciences. G. Tarantini has received honoraria for lectures and consulting from Medtronic, Edwards Lifesciences, Boston Scientific, GADA group, and Abbott. M. Barbanti is a consultant for Edwards Lifesciences, Boston Scientific, and Medtronic. O. Soliman received institutional research grants, committee membership and chairmanship from Abbott, Biosensors, Boston Scientific, Cardiawave, and Meril Life Sciences. D. Mylotte reports institutional research grants from Boston Scientific and Medtronic; and is a consultant for Boston Scientific, Medtronic, and MicroPort. The other authors have no conflicts of interest to declare in relation to this manuscript. The Guest Editor reports consultancy fees from Novartis and Meril Life Sciences; speaker honoraria from Boston Scientific, Amgen, Daiichi Sankyo, and Meril Life Sciences; reports speaker honoraria paid to his institution from BMS/Pfizer, Daiichi Sankyo, Boston Scientific, Siemens, and Amgen; and research grants paid to his institution from Boston Scientific and Abbott.

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