Objectives The study aims to compare the hemodynamic and clinical outcomes of the SAPIEN 3 Ultra (S3-Ultra) with the SAPIEN 3 (S3) system in patients who underwent transfemoral transcatheter aortic valve replacement (TF-TAVR). Background The new balloon-expandable S3-Ultra system incorporates new features to reduce paravalvular leakage (PVL). However, the data after the S3-Ultra implantation is very limited. Methods A total of 282 consecutive patients who underwent TF-TAVR with the S3-Ultra and the S3 were evaluated. The primary outcome of this study was to compare the incidence of >= mild PVL after the S3-Ultra and S3 implantation. Results Between June 2017 and November 2019, 141 patients with the S3-Ultra and 141 patients with the S3 were identified with similar baseline and preprocedural imaging characteristics (mean age: 79.6 +/- 6.7 years and mean aortic annulus area: 492.5 +/- 91.2 mm(2)). In total, 83 patients (29.4%) were treated with 29-mm valve. Predischarge echocardiography demonstrated a significantly lower incidence of >= mild PVL (the total cohort: 7.2 vs. 22.3%,p = mild PVL compared with the S3 system in multivariate analysis. There were no significant differences in clinical outcomes at 30-day between these groups, except for the lower incidence of major vascular complication (4.5 vs. 11.4%,p= .05) in patients with the S3-Ultra. Conclusions In this registry, the S3-Ultra system performed superiorly to the S3, as demonstrated by reduced >= mild PVL, with comparable safety.Peer reviewe
