Transfemoral aortic valve implantation with new-generation devices: the repositionable Lotus vs. the balloon-expandable Edwards Sapien 3 valve.

ABSTRACT

BACKGROUND: New-generation transcatheter heart valves have been developed to reduce complications of transcatheter aortic valve implantation (TAVI). With this study we sought to compare procedural and 30-day outcomes of the new-generation repositionable Boston Scientific Lotus (Lotus) and the balloon-expandable Edwards Sapien 3 (ES3) transcatheter heart valves. METHODS: A total of 315 patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI with Lotus or ES3 included in two large Italian registries were considered for this analysis. After propensity matching, 93 matched pairs of patients were included. Outcomes were evaluated according to Valve Academic Research Consortium-2 definition at discharge and 30 days. RESULTS: There were no differences in baseline characteristics, except for lower mean aortic gradient and larger mean aortic annulus in the ES3-treated patients. Valve Academic Research Consortium-2 defined device success was high and comparable between groups (97.8 for Lotus vs. 98.9% for ES3, P = 0.09). The frequency of moderate/severe paravalvular leak was low and similar for both devices (2.2 vs. 1.1%, P = 0.10). At 30 days, both groups showed low all-cause mortality (5.4 vs. 1.1%, P = 0.10) and rates of disabling stroke (3.2 vs. 1.1%, P = 0.31). New pacemaker implantation was more common after Lotus deployment (31.7 vs. 10.5%, P < 0.001). CONCLUSION: Transfemoral TAVI with both Lotus and ES3 resulted in favorable clinical and hemodynamic procedural and 30-day outcomes. Rates of significant paravalvular leak were low with both devices. The Lotus valve was associated with higher risk of pacemaker implantation.