Evidence map›Paper›PMID 38726714›Full record

ArticleEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2024

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

Masanori Yamamoto, Fumiaki Yashima, Shinichi Shirai, Norio Tada, Toru Naganuma, Masahiro Yamawaki, Futoshi Yamanaka, Kazuki Mizutani, Masahiko Noguchi, Hiroshi Ueno and 14 more

Abstract read
In one paragraph

Article in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

26 citing papers in PubMed.

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  18. Intra- versus supra-annular self-expanding transcatheter heart valves in small aortic annuli.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025
    Article
  19. The challenge of interpreting comparative TAVI studies.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025
    Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors.

Masanori YamamotoDepartment of Cardiology, Toyohashi Heart Center, Toyohashi, Japan.
Fumiaki YashimaDepartment of Cardiology, Saiseikai Utsunomiya Hospital, Utsunomiya, Japan.
Shinichi ShiraiDepartment of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan.
Norio TadaDepartment of Cardiology, Sendai Kosei Hospital, Sendai, Japan.
Toru NaganumaDepartment of Cardiology, New Tokyo Hospital, Chiba, Japan.
Masahiro YamawakiDepartment of Cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan.
Futoshi YamanakaDepartment of Cardiology, Shonan Kamakura General Hospital, Kamakura, Japan.
Kazuki MizutaniDepartment of Medicine, Division of Cardiology, Kindai University, Osaka, Japan.
Masahiko NoguchiDepartment of Cardiology, Tokyo Bay Urayasu Ichikawa Medical Center, Urayasu, Japan.
Hiroshi UenoSecond Department of Internal Medicine, Toyama University Hospital, Toyama, Japan.
Kensuke TakagiDepartment of Cardiology, National Cerebral and Cardiovascular Center, Osaka, Japan.
Yohei OhnoDepartment of Cardiology, Tokai University School of Medicine, Isehara, Japan.
Masaki IzumoDepartment of Cardiology, St Marianna University School of Medicine, Kawasaki, Japan.
Hidetaka NishinaDepartment of Cardiology, Tsukuba Medical Center Hospital, Tsukuba, Japan.
Hiroto SuzuyamaDivision of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.
Kazumasa YamasakiDepartment of Cardiology, Sapporo Higashi Tokushukai Hospital, Sapporo, Japan.
Kenji NishiokaDepartment of Cardiology, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.
Daisuke HachinoheCardiovascular Medicine, Sapporo Heart Center, Sapporo Cardiovascular Clinic, Sapporo, Japan.
Yasushi FukuDepartment of Cardiovascular Medicine, Kurashiki Central Hospital, Kurashiki, Japan.
Toshiaki OtsukaDepartment of Hygiene and Public Health, Nippon Medical School, Tokyo, Japan.
Masahiko AsamiDivision of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan.
Yusuke WatanabeDepartment of Cardiology, Teikyo University School of Medicine, Tokyo, Japan.
Kentaro HayashidaDepartment of Cardiology, Keio University School of Medicine, Tokyo, Japan.
On Behalf Of The Ocean-Tavi Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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

aimsWe aimed to assess the clinical outcomes, including valve performance, of the S3UR.

methodsRegistry 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.

resultsThe 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).

conclusionsThe 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.

Indexed as

Aortic ValveAortic Valve StenosisHeart Valve ProsthesisRegistriesTranscatheter Aortic Valve ReplacementAgedAged, 80 and overFemaleHemodynamicsHospital MortalityHumansMalePostoperative ComplicationsProsthesis DesignTreatment Outcome

Identifiers

PMID38726714
PMCPMC11067722

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.