University of Oulu

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.

Hemodynamic comparison of transcatheter aortic valve replacement with theSAPIEN3 Ultra versusSAPIEN3 : the HomoSAPIEN registry

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Author: Moriyama, Noriaki1,2; Lehtola, Heidi3; Miyashita, Hirokazu1;
Organizations: 1Department of Cardiology, Heart and Lung Center, Helsinki University and Helsinki University Central Hospital, Helsinki, Finland
2Department of Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Kamakura, Japan
3Department of Cardiology, Oulu University Hospital, Oulu, Finland
Format: article
Version: published version
Access: open
Online Access: PDF Full Text (PDF, 2 MB)
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Language: English
Published: John Wiley & Sons, 2021
Publish Date: 2021-08-25


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.

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Series: Catheterization and cardiovascular interventions
ISSN: 1522-1946
ISSN-E: 1522-726X
ISSN-L: 1522-1946
Volume: 97
Issue: 7
Pages: E982 - E991
DOI: 10.1002/ccd.29281
Type of Publication: A1 Journal article – refereed
Field of Science: 3121 General medicine, internal medicine and other clinical medicine
Funding: This study did not receive any form of financial support.
Copyright information: © 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.