Evidence map›Paper›PMID 39101119›Full record

ArticleJACC. Asia2024

Initial Results of Intra-Annular Self-Expandable Valves: Insights From the OCEAN-TAVI Registry.

Shinichi Shirai, Masanori Yamamoto, Fumiaki Yashima, Hirofumi Hioki, Toshinobu Ryuzaki, Toru Morofuji, Toru Naganuma, Futoshi Yamanaka, Kazuki Mizutani, Masahiko Noguchi and 14 more

Abstract read
In one paragraph

Article in JACC. Asia, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

  1. Article
  2. Prosthesis-Patient Mismatch in All-Comer Patients Undergoing Newer-Generation Self-Expanding Transcatheter Aortic Valve Replacement.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2026
    Article
  3. Article
  4. Review
  5. Pacemaker Implantation Rates With the Self-Expandable Navitor Valve.Journal of the American Heart Association · 2026
    Article
  6. Article
  7. Article
  8. Review
  9. 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
  10. Article
  11. Article
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.

Shinichi ShiraiDepartment of Cardiology, Kokura Memorial Hospital, Kokura, Japan.
Masanori YamamotoDepartment of Cardiology, Toyohashi Heart Center, Toyohashi, Japan.
Fumiaki YashimaDepartment of Cardiology, Saiseikai Utsunomiya Hospital, Tochigi, Japan.
Hirofumi HiokiDepartment of Cardiology, IMS Tokyo Katsushika General Hospital, Tokyo, Japan.
Toshinobu RyuzakiDepartment of Cardiology, Keio University School of Medicine, Tokyo, Japan.
Toru MorofujiDepartment of Cardiology, Kokura Memorial Hospital, Kokura, Japan.
Toru NaganumaDepartment of Cardiology, New Tokyo Hospital, Chiba, Japan.
Futoshi YamanakaDepartment of Cardiology, Shonan Kamakura General Hospital, Kanagawa, Japan.
Kazuki MizutaniDivision of Cardiology, Department of Medicine, 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, Oasaka, Japan.
Yohei OhnoDepartment of Cardiology, Tokai University School of Medicine, Isehara, Japan.
Masaki IzumoDepartment of Cardiology, St. Marianna University School of Medicine, Tokyo, 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.
Daisuke HachinoheCardiovascular Medicine, Sapporo Heart Center, Sapporo Cardio Vascular 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.
OCEAN-TAVI Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Navitor, an intra-annular self-expanding heart valve (IA-SEV), is the third transcatheter heart valve introduced in Japan (in April 2022) as the next generation of the Portico valve ahead of other Asian countries. Objectives: The purpose of this study was to assess the patient-prosthesis mismatch (PPM) after IA-SEV implantation in Asian patients. Methods: All clinical data were collected from the database of an ongoing prospective Japanese multicenter registry (OCEAN-TAVI [Optimised Catheter Valvular Intervention transcatheter aortic valve implantation]). The primary endpoint was the rate of no PPM; the secondary endpoint included the rate of in-hospital mortality and hemodynamics after IA-SEV implantation. Results: A total of 463 patients (median age 86; 69.7% female) were enrolled in the registry. The percentages of implanted valves sized 23 mm, 25 mm, 27 mm, and 29 mm were 26.1% (n = 121), 41.7% (n = 193), 22.9% (n = 106), and 9.3% (n = 43), respectively. The primary endpoint of no PPM was achieved in 91.7% of the entire cohort and in 87.3%, 94.2%, 91.4%, and 93.0% of each valve size. The rate of in-hospital mortality was 1.9%. Postprocedural mean pressure gradient was 8.3 ± 4.3 mm Hg. The overall rate of pacemaker implantation was 9.7%; the incidence of pacemaker rate tended to be reduced when dividing the first and second half of operator experiences (13.0% vs. 8.0%; Conclusions: The initial results for the IA-SEV were excellent regarding hemodynamics and reduction of paravalvular leakage regardless of valve size. The IA-SEV is a useful transcatheter heart valve, especially for Asian patients with a high prevalence of small annulus.

Indexed as

intra-annularlearning curvePPMself-expandable valveTAVR

Identifiers

PMID39101119
PMCPMC11291339

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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.