Comparison of the clinical outcomes in high-risk patients with severe aortic stenosis undergoing transfemoral aortic Valve implantation using SAPIEN XT and LOTUS Valve

Abstract

Objective: The aim of this study was to compare the procedural, 30-day, and one-year follow-up Valve Academic Research Consortium-2 (VARC-2) defined outcomes using either the LOTUS valve or the conventional the SAPIEN XT valve. Material and Methods: 50 patients (25 with LOTUS and 25 with SAPIEN XT) with severe symptomatic aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) were included in this study. We evaluated the procedural outcomes, early safety, and clinical efficacy endpoints of patients who were treated with the LOTUS or the SAPIEN XT valve delivered via the transfemoral route. Results: Accordingly, the Valve Academic Research Consortium-2-defined safety endpoints within 30 days and combined efficacy endpoints at one-year follow-up were the same in both groups (p=0.569, p=0.529, respectively). The need for permanent pacemaker implantation in the LOTUS group was higher than in the SAPIEN XT group at 30 days (20% vs. 8%, p=0.221, respectively) and at one-year (24.0% vs. 16%, p=0.480, respectively). Echocardiography upon discharge demonstrated that trivial or mild paravalvular leakage in SAPIEN XT patients was significantly higher than in LOTUS patients (52% vs. 24%, p=0.041, respectively). Moderate or severe paravalvular leakage was observed in only one patient in a SAPIEN group. Conclusion: 30 days and one-year follow-up results according to Valve Academic Research Consortium-2 were similar in both groups. The permanent pacemaker rate was higher in LOTUS group despite an insignificant difference between the groups. LOTUS was associated significantly lower rate of trivial or mild paravalvular leakage compared with the SAPIEN XT. TAVI with LOTUS valve was associated with no moderate or severe paravalvular leakage and a low rate of mild paravalvular leakage.