Andreas Rück; Won-Keun Kim; Paolo Alberto Del Sole; Max Wagener; Angela McInerney; Magdi Yacoub; Elfatih Hasabo; Cagri Ayhan; Hesham Elzomor; Dina Neiroukh; Abdul Amir; Nawzad Saleh; Magnus Settergren; Rickard Lindler; Dinos Verouhis; Samuel Sossalla; Matthias Renker; Matteo Montorfano; Barbara Bellini; Xavier Suarez; Victoria Vilalta Del Olmo; Federico De Marco; Matteo Biroli; Helge Möllmann; Eckel Enno; Giuseppe Tarantini; Tommaso Fabris; Alfonso Ielasi; Giuliano Costa; Marco Barbanti; Osama Soliman; Darren Mylotte

doi:10.4244/EIJ-D-24-00869

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

Andreas Ruck¹, MD; Won-Keun Kim²^,³, MD; Paolo Alberto Del Sole⁴, MD; Max Wagener⁴^,⁵, MD; Angela McInerney⁴, MD; Magdi S. Yacoub⁴^,⁶, MD; Elfatih A. Hasabo⁴^,⁶, MD; Cagri Ayhan⁴^,⁶, MD; Hesham Elzomor⁴^,⁶, MD; Dina Neiroukh⁴^,⁶, MD; Abdul Amir¹, MD; Nawzad Saleh¹, MD, PhD; Magnus Settergren¹, MD, PhD; Rickard Lindler¹, MD, PhD; Dinos Verouhis¹, MD, PhD; Samuel Sossalla²^,³, MD; Matthias Renker²^,³, MD; Matteo Montorfano⁷^,⁸, MD; Barbara Bellini⁸, MD; Xavier Carrillo Suarez⁹, MD; Victoria Vilalta Del Olmo⁹, MD; Federico De Marco¹⁰, MD, PhD; Matteo Biroli¹⁰, MD; Helge Mollmann¹¹, MD; Eckel Clemens Enno¹¹, MD; Giuseppe Tarantini¹², MD, PhD; Tommaso Fabris¹², MD; Alfonso Ielasi¹³, MD; Giuliano Costa¹⁴, MD; Marco Barbanti¹⁵, MD, PhD; Osama Soliman⁴^,⁶, MD, PhD; Darren Mylotte⁴, MB, MD, PhD

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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