Original Research

DOI: 10.4244/EIJ-D-23-00996

Performance and outcomes of the SAPIEN 3 Ultra RESILIA transcatheter heart valve in the OCEAN-TAVI registry

Masanori Yamamoto1,2,3, MD; Fumiaki Yashima4, MD; Shinichi Shirai5, MD; Norio Tada6, MD; Toru Naganuma7, MD; Masahiro Yamawaki8, MD; Futoshi Yamanaka9, MD; Kazuki Mizutani10, MD; Masahiko Noguchi11, MD; Hiroshi Ueno12, MD; Kensuke Takagi13, MD; Yohei Ohno14, MD; Masaki Izumo15, MD; Hidetaka Nishina16, MD; Hiroto Suzuyama17, MD; Kazumasa Yamasaki18, MD; Kenji Nishioka19, MD; Daisuke Hachinohe20, MD; Yasushi Fuku21, MD; Toshiaki Otsuka22,23, MD; Masahiko Asami24, MD; Yusuke Watanabe25, MD; Kentaro Hayashida26, MD; on behalf of the OCEAN-TAVI investigators

Abstract

BACKGROUND: Data on the performance of the latest-generation SAPIEN 3 Ultra RESILIA (S3UR) valve in patients who undergo transcatheter aortic valve replacement (TAVR) are scarce.

AIMS: We aimed to assess the clinical outcomes, including valve performance, of the S3UR.

METHODS: Registry data of 618 consecutive patients with S3UR and of a historical pooled cohort of 8,750 patients who had a SAPIEN 3 (S3) valve and underwent TAVR were collected. The clinical outcomes and haemodynamics, including patient-prosthesis mismatch (PPM), were compared between the 2 groups and in a propensity-matched cohort.

RESULTS: The incidence of in-hospital death, vascular complications, and new pacemaker implantation was similar between the S3UR and the S3 groups (allp>0.05). However, both groups showed significant differences in the degrees of paravalvular leakage (PVL) (none-trivial: 87.0% vs 78.5%, mild: 12.5% vs 20.5%, ≥moderate: 0.5% vs 1.1%; p<0.001) and the incidence of PPM (none: 94.3% vs 85.1%, moderate: 5.2% vs 12.8%, severe: 0.5% vs 2.0%; p<0.001). The prevalence of a mean pressure gradient ≥20 mmHg was significantly lower in the S3UR group (1.6% vs 6.2%; p<0.001). Better haemodynamics were observed with the smaller 20 mm and 23 mm S3UR valves. The results were consistent in a matched cohort of patients with S3UR and with S3 (n=618 patients/group).

CONCLUSIONS: The S3UR has equivalent procedural complications to the S3 but with lower rates of PVL and significantly better valve performance. The better valve performance of the S3UR, particularly in smaller valve sizes, overcomes the remaining issue of balloon-expandable valves after TAVR.

Sign in to read
the full article

Forgot your password?
No account yet?
Sign up for free!

Create my pcr account

Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from PCRonline.com

Volume 20 Number 9
May 10, 2024
Volume 20 Number 9
View full issue


Key metrics

Suggested by Cory

Editorial

10.4244/EIJ-E-23-00009 Apr 24, 2023
SAPIEN 3 Ultra: better sealing, reduced paravalvular leak and a move in the right direction?
Reardon MJ and Goel SS
free

Clinical research

10.4244/EIJ-D-22-00164 Jan 23, 2023
ACURATE neo2 versus SAPIEN 3 Ultra for transcatheter aortic valve implantation
Pellegrini C et al
free

10.4244/EIJV15I14A219 Feb 20, 2020
Going ultra!
Lefèvre T
free
Trending articles
152.9

Clinical research

10.4244/EIJ-D-20-01125 Oct 20, 2021
An upfront combined strategy for endovascular haemostasis in transfemoral transcatheter aortic valve implantation
Costa G et al
free
47.8

NEW INNOVATION

10.4244/EIJ-D-15-00467 Feb 20, 2018
Design and principle of operation of the HeartMate PHP (percutaneous heart pump)
Van Mieghem NM et al
free
39.1

Clinical research

10.4244/EIJ-D-22-00558 Feb 6, 2023
Permanent pacemaker implantation and left bundle branch block with self-expanding valves – a SCOPE 2 subanalysis
Pellegrini C et al
free
38.95

State-of-the-Art

10.4244/EIJ-D-23-00912 Oct 7, 2024
Optical coherence tomography to guide percutaneous coronary intervention
Almajid F et al
free
X

The Official Journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI)

EuroPCR EAPCI
PCR ESC
Impact factor: 7.6
2023 Journal Citation Reports®
Science Edition (Clarivate Analytics, 2024)
Online ISSN 1969-6213 - Print ISSN 1774-024X
© 2005-2024 Europa Group - All rights reserved