Objectives: This study sought to evaluate the safety, efficacy and valve performance of different types of transcatheter aortic valve (TAV) devices (self-expending, balloon-expendable and mechanically-expanding) in patients with severe bicuspid aortic valve (BAV) stenosis undergoing transcatheter aortic valve implantation (TAVI).  

Background: TAVI proved to be a safe and efficient treatment option in patients with tricuspid aortic stenosis. However, data concerning the feasibility and hemodynamic performance of different TAV types in patients with severe BAV stenosis are limited.  

Methods: We retrospectively evaluated all patients treated with TAVI for severe symptomatic aortic stenosis at the Heart Center Leipzig over a 3 year period and who were enrolled in the Leipzig TAVI registry. BAV morphology was classified according to the Sievers and Schmidtke classification method. All study relevant outcomes were assigned according to the Valve Academic Research Consortium (VARC)-3 criteria.

Results: In total 2,690 patients were included in the present analysis. Of these, 128 patients had BAV morphology on multi-detector computed tomography angiography. BAV patients undergoing TAVR were younger, had less frequently concomitant coronary artery disease and had a lower Society of Thoracic Surgeons score compared to patients with tricuspid aortic valve morphology. A total of 87 BAV patients were treated with the balloon-expendable Sapien 3 valve (68%), 28 patients with the self-expending Evolut R/Pro valve (22%) and 13 patients with the mechanically-expanding Lotus valve (10%). There were no differences concerning in-hospital mortality (1% in Sapien 3 group vs. 0% in Evolut R/Pro group and vs. 0% in Lotus group, p=0.79), stroke (6% in Sapien 3 group vs. 4% Evolut R/Pro group and vs. 23% in Lotus group, p=0.06), acute myocardial infarction (0% in Sapien 3 group vs. 4% in Evolut R/Pro group and vs. 0% in Lotus group, p=0.17) and permanent pacemaker implantation after TAVI (17% in Sapien 3 group vs. 15% in Evolut R/Pro group and vs. 30% in Lotus group, p=0.33) between BAV patients treated with different types of current generation TAVs. Patients treated with the Lotus valve experienced more frequently TAV thrombosis than BAV patients treated with the Sapien 3 valve or the EvolutR/Pro valves (23% in Lotus vs. 0% in other valves, p=0.001). BAV patients treated with the Evolut R/Pro valve had a significantly lower mean pressure gradient across TAV (9.1±2.9 mmHg vs. 11.9±3.4 mmHg in Sapien 3 group [p=0.001] and vs. 17.1±8.6 mmHg in Lotus group [p=0.001]) and larger effective orifice after TAVI compared to BAV patients treated with other TAV types (1.9±0.4 mm² vs. 1.6±0.3 mm² in Sapien 3 group [p=0.001] and vs. 1.5±0.4 mm² in Lotus group [p=0.003]). BAV patients had lower rates of moderate and severe prosthesis-patient mismatch (PPM) after implantation of the EvolutR/Pro valve (11.1% and 0%) in comparison to Sapien 3 (40.2% and 3.5%, p=0.32 and p=0.005, respectively) and Lotus valves (38.4% and 25%, p=0.007 and p=0.04, respectively).

Conclusion: TAVI with current generation TAV devices is feasible, safe and effective in BAV patients. The Evolut R/Pro valve exhibits a superior hemodynamic profile and lower rates of moderate and severe PPM in comparison to the Sapien 3 and the Lotus valve.