Hemodynamic comparison of transcatheter aortic valve replacement with the SAPIEN 3 Ultra versus SAPIEN 3: The HomoSAPIEN registry

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 < .001, and the cohort excluding 29‐mm valve: 4.0 vs. 21.4%, p = .03) for the S3‐Ultra. The S3‐Ultra system, especially 20‐, 23‐, and 26‐mm valve, was associated with significantly lower risk of ≥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.