Hemodynamic comparison of transcatheter aortic valve replacement with theSAPIEN3 Ultra versusSAPIEN3 : the HomoSAPIEN registry
Moriyama, Noriaki; Lehtola, Heidi; Miyashita, Hirokazu; Piuhola, Jarkko; Niemelä, Matti; Laine, Mika (2020-09-23)
Moriyama, N, Lehtola, H, Miyashita, H, Piuhola, J, Niemelä, M, Laine, M. Hemodynamic comparison of transcatheter aortic valve replacement with the SAPIEN 3 Ultra versus SAPIEN 3: The HomoSAPIEN registry. Catheter Cardiovasc Interv. 2021; 97: E982– E991. https://doi.org/10.1002/ccd.29281
© 2020 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
https://creativecommons.org/licenses/by/4.0/
https://urn.fi/URN:NBN:fi-fe2021082544150
Tiivistelmä
Abstract
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 mm²). 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 < 0.001, and the cohort excluding 29-mm valve: 4.0 vs. 21.4%, p = 0.03) 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 = 0.05) 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.
Kokoelmat
- Avoin saatavuus [31941]