When treating younger severe aortic stenosis patients, you will encounter patients with a bicuspid valve more frequently.1 The Evolut™ TAVI platform has been proven safe and effective in those patients in several trials.2-4
The self-expending supra-annular design results in a decoupling between the inflow at native annulus level and the leaflet level. The Evolut™ valve with its nitinol frame can conform to an elliptical native annulus while preserving circularity and expansion at the TAV leaflet level.2
In this multi-center registry Evolut™ demonstrates excellent performance. Stent frame under-expansion and ellipticity at the inflow level did not compromise stent frame geometry at the leaflet level, valve haemodynamics, or the risk of sub-clinical leaflet thickening.
The supra-annular positioning of the Evolut™ leaflets ensures reliable valve function despite anatomical complexities.
Impact of Evolut™ stent frame deformation at inflow level on stent frame expansion and ellipticity at leaflet level and valve performance
175 patients with bicuspid aortic valve undergoing TAVI with Evolut™
Valve performance
1 Tirado Conte G, Arslani K, Zaid S, et al. Stent Frame Deformation of Self-Expanding Transcatheter Heart Valves in Bicuspid Aortic Stenosis and Impact on Valve Performance. Eur Heart J Cardiovasc Imaging. Published online July 2, 2025. doi:10.1093/ehjci/jeaf195 30
Excellent hemodynamics with large implant effective orifice area and good clinical outcomes with a single digit mean gradient at 1 year follow-up. Sizing was defined either according to annular dimensions (n=77) or according to annular and supra-annular dimensions n=72).
Valve performance
at 30 days †:
95.3%
Freedom from severe patient-prosthesis mismatch (PPM) at 1 year:
96.2%
Freedom from moderate-to-severe AR at 1 year:
98.4%
† Defined as a mean aortic valve gradient <20 mmHg or peak velocity <3 m/s and no moderate or severe prosthetic valve regurgitation at 30 days.
1 Tchetche D, and al. Transcatheter aortic valve implantation with the Evolut platform for bicuspid aortic valve stenosis: the international, multicentre, prospective BIVOLUTX registry. EuroIntervention. 2023 May 18:EIJ-D-23-00021. doi: 10.4244/EIJ-D-23-00021. Epub ahead of print. PMID: 37203860.
Evolut™ design differentiation is at the root of the valve performance and durability that has been proven in randomized clinical trials.2,3
1 F. Vincent, J. Ternacle, T. Denimal, et al. Transcatheter aortic valve replacement in bicuspid aortic valve stenosis Circulation, 143 (2021), pp. 1043-1061
2 Tirado Conte G, Arslani K, Zaid S, et al. Stent Frame Deformation of Self-Expanding Transcatheter Heart Valves in Bicuspid Aortic Stenosis and Impact on Valve Performance. Eur Heart J Cardiovasc Imaging. Published online July 2, 2025. doi:10.1093/ehjci/jeaf195
3 Tchetche D, and al. Transcatheter aortic valve implantation with the Evolut platform for bicuspid aortic valve stenosis: the international, multicentre, prospective BIVOLUTX registry. EuroIntervention. 2023 May 18:EIJ-D-23-00021. doi: 10.4244/EIJ-D-23-00021. Epub ahead of print. PMID: 37203860.
4 Forrest, J. et al. Five-Year Outcomes from the Evolut Low Risk TAVR Bicuspid Study. Presented at EuroPCR 2025; Paris, France