Masanori Yamamoto; Fumiaki Yashima; Shinichi Shirai; Norio Tada; Toru Naganuma; Masahiro Yamawaki; Futoshi Yamanaka; Kazuki Mizutani; Masahiko Noguchi; Hiroshi Ueno; Kensuke Takagi; Yohei Ohno; Masaki Izumo; Hidetaka Nishina; Hiroto Suzuyama; Kazumasa Yamasaki; Kenji Nishioka; Daisuke Hachinohe; Yasushi Fuku; Toshiaki Otsuka; Masahiko Asami; Yusuke Watanabe; Kentaro Hayashida; on behalf of the OCEAN-TAVI investigators

doi:10.4244/EIJ-D-23-00996

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

The reference multimedia journal in interventional cardiology

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

1. Department of Cardiology, Toyohashi Heart Center, Toyohashi, Japan; 2. Department of Cardiology, Nagoya Heart Center, Nagoya, Japan; 3. Department of Cardiology, Gifu Heart Center, Gifu, Japan; 4. Department of Cardiology, Saiseikai Utsunomiya Hospital, Utsunomiya, Japan; 5. Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan; 6. Department of Cardiology, Sendai Kosei Hospital, Sendai, Japan; 7. Department of Cardiology, New Tokyo Hospital, Chiba, Japan; 8. Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan; 9. Department of Cardiology, Shonan Kamakura General Hospital, Kamakura, Japan; 10. Department of Medicine, Division of Cardiology, Kindai University, Osaka, Japan; 11. Department of Cardiology, Tokyo Bay Urayasu Ichikawa Medical Center, Urayasu, Japan; 12. Second Department of Internal Medicine, Toyama University Hospital, Toyama, Japan; 13. Department of Cardiology, National Cerebral and Cardiovascular Center, Osaka, Japan; 14. Department of Cardiology, Tokai University School of Medicine, Isehara, Japan; 15. Department of Cardiology, St Marianna University School of Medicine, Kawasaki, Japan; 16. Department of Cardiology, Tsukuba Medical Center Hospital, Tsukuba, Japan; 17. Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan; 18. Department of Cardiology, Sapporo Higashi Tokushukai Hospital, Sapporo, Japan; 19. Department of Cardiology, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan; 20. Cardiovascular Medicine, Sapporo Heart Center, Sapporo Cardiovascular Clinic, Sapporo, Japan; 21. Department of Cardiovascular Medicine, Kurashiki Central Hospital, Kurashiki, Japan; 22. Department of Hygiene and Public Health, Nippon Medical School, Tokyo, Japan; 23. Center for Clinical Research, Nippon Medical School Hospital, Tokyo, Japan; 24. Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan; 25. Department of Cardiology, Teikyo University School of Medicine, Tokyo, Japan; 26. Department of Cardiology, Keio University School of Medicine, Tokyo, Japan

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...

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Volume 20 Number 9

May 10, 2024