Evidence map›Paper›PMID 41368845›Full record

Observational studyJournal of the American Heart Association2025

Safety and Prognostic Implications of Mechanical Circulatory Support-Assisted Transcatheter Edge-to-Edge Repair: The OCEAN-Mitral Registry.

Shuhei Tanaka, Teruhiko Imamura, Ryuichi Ushijima, Makiko Nakamura, Nobuyuki Fukuda, Hiroshi Ueno, Koichiro Kinugawa, Masanori Yamamoto, Shunsuke Kubo, Yuki Izumi and 19 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Journal of the American Heart Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

29 authors.

Shuhei TanakaSecond Department of Internal Medicine University of Toyama Japan.ORCID 0000-0001-7551-3431
Teruhiko ImamuraSecond Department of Internal Medicine University of Toyama Japan.ORCID 0000-0002-7294-7637
Ryuichi UshijimaSecond Department of Internal Medicine University of Toyama Japan.ORCID 0000-0002-4543-596X
Makiko NakamuraSecond Department of Internal Medicine University of Toyama Japan.
Nobuyuki FukudaSecond Department of Internal Medicine University of Toyama Japan.
Hiroshi UenoSecond Department of Internal Medicine University of Toyama Japan.ORCID 0000-0001-9747-2511
Koichiro KinugawaSecond Department of Internal Medicine University of Toyama Japan.
Masanori YamamotoDepartment of Cardiology Toyohashi Heart Center Toyohashi Japan.ORCID 0000-0001-5210-6382
Shunsuke KuboDepartment of Cardiology Kurashiki Central Hospital Kurashiki Japan.ORCID 0000-0003-4794-7843
Yuki IzumiDepartment of Cardiology Sakakibara Heart Institute Tokyo Japan.ORCID 0000-0002-4542-5809
Mike SajiDepartment of Cardiology Sakakibara Heart Institute Tokyo Japan.ORCID 0000-0003-2057-109X
Masahiko AsamiDivision of Cardiology Mitsui Memorial Hospital Tokyo Japan.ORCID 0000-0002-2102-033X
Yusuke EntaDepartment of Cardiology Sendai Kosei Hospital Sendai Japan.ORCID 0000-0003-1931-1012
Shinichi ShiraiDepartment of Cardiology Kokura Memorial Hospital Kitakyushu Japan.ORCID 0000-0002-4764-8205
Masaki IzumoDivision of Cardiology St. Marianna University School of Medicine Hospital Kawasaki Japan.ORCID 0000-0001-8597-1479
Shingo MizunoDepartment of Cardiology Shonan Kamakura General Hospital Kamakura Kanagawa Japan.
Yusuke WatanabeDepartment of Cardiology Teikyo University School of Medicine Tokyo Japan.ORCID 0000-0003-2297-5303
Makoto AmakiDepartment of Heart Failure and Transplant Division of Heart Failure National Cerebral and Cardiovascular Center Suita Japan.ORCID 0000-0001-5132-5129
Kazuhisa KodamaDivision of Cardiology Saiseikai Kumamoto Hospital Cardiovascular Center Kumamoto Japan.
Hisao OtsukiDepartment of Cardiology Tokyo Woman's Medical University Tokyo Japan.
Toru NaganumaDepartment of Cardiology New Tokyo Hospital Chiba Japan.
Hiroki BotaDepartment of Cardiology Sapporo Higashi Tokushukai Hospital Sapporo Japan.
Yohei OhnoDepartment of Cardiology Tokai University School of Medicine Isehara Japan.ORCID 0000-0003-4203-7613
Masahiro YamawakiDepartment of Cardiology Saiseikai Yokohama City Eastern Hospital Yokohama Japan.
Gaku NakazawaDivision of Cardiology, Department of Medicine Kindai University Faculty of Medicine Osaka Japan.ORCID 0000-0002-6721-1342
Daisuke HachinoheDivision of Cardiovascular Medicine Sapporo Heart Center, Sapporo Cardiovascular Clinic Sapporo Japan.ORCID 0000-0003-4828-1836
Toshiaki OtsukaDepartment of Hygiene and Public Health Nippon Medical School Tokyo Japan.ORCID 0009-0004-7994-7594
Kentaro HayashidaDepartment of Cardiology Keio University School of Medicine Tokyo Japan.ORCID 0000-0002-1750-1982
OCEAN‐Mitral investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTranscatheter edge-to-edge repair of the mitral valve (M-TEER) has demonstrated promising outcomes for patients with mitral regurgitation who are unsuitable for surgical intervention. However, the clinical implications of M-TEER in patients requiring mechanical circulatory support (MCS) for unstable hemodynamics remains unclear. This study aimed to evaluate the outcomes of MCS-assisted M-TEER in critically ill patients.

methodsConsecutive patients who underwent M-TEER for significant mitral regurgitation were identified from the Japanese multicenter OCEAN-Mitral (Optimized Catheter Valvular Intervention-Mitral) registry. All-cause death was compared between the cohort undergoing MCS-assisted M-TEER and a virtual control group receiving MCS alone without undergoing M-TEER, estimated using the Seattle Heart Failure Model. Additionally, logistic regression analysis was conducted to identify factors associated with in-hospital death following MCS-assisted M-TEER.

resultsA total of 3764 patients were included in the analysis (mean age, 81 years; 54.9% men; 70.1% with secondary mitral regurgitation), of whom 105 underwent MCS-assisted M-TEER. Procedure success exceeded 95%, irrespective of MCS use. The 1-year mortality rate in the MCS-assisted M-TEER group was lower than the estimated mortality rate in the virtual control group (43.2% versus 69.5%). Factors associated with in-hospital death included frailty, inflammation, and hypoalbuminemia. In a landmark analysis starting from discharge date, there was no statistically significant difference in cardiovascular death or heart failure hospitalization between the groups with or without the use of MCS (hazard ratio, 1.45 [95% CI, 0.93-2.26];

conclusionsMCS-assisted M-TEER appears to be a viable and effective therapeutic strategy for carefully selected patients with significant mitral regurgitation and unstable hemodynamics. REGISTRATION: URL: https://www.umin.ac.jp/ctr/; Unique identifier: UMIN-ID: UMIN000023653.

Indexed as

Cardiac CatheterizationHeart Valve Prosthesis ImplantationMitral ValveMitral Valve InsufficiencyAgedAged, 80 and overFemaleHemodynamicsHospital MortalityHumansJapanMalePrognosisRegistriesRetrospective StudiesRisk Factorsmechanical circulatory supportmitral regurgitationtranscatheter edge‐to‐edge repair

Identifiers

PMID41368845
PMCPMC12826929

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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.