Evidence map›Paper›PMID 40820980›Full record

Observational studyJournal of the American Heart Association2025

Impact of Peridevice Leak on Clinical Outcomes After Left Atrial Appendage Closure: The OCEAN-LAAC Registry.

Tetsuya Saito, Hikaru Tsuruta, Akiyoshi Kajino, Juri Iwata, Shingo Sakata, Toshinobu Ryuzaki, Mitsuru Sago, Shuhei Tanaka, Ryuki Chatani, Daisuke Hachinohe and 18 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 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

10 citing papers in PubMed.

  1. Review
  2. Article
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  7. Review
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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

28 authors.

Tetsuya SaitoDepartment of Cardiology Keio University School of Medicine Tokyo Japan.ORCID 0000-0001-5356-9477
Hikaru TsurutaDepartment of Cardiology Keio University School of Medicine Tokyo Japan.ORCID 0009-0006-8645-0281
Akiyoshi KajinoDepartment of Cardiology Keio University School of Medicine Tokyo Japan.
Juri IwataDepartment of Cardiology Keio University School of Medicine Tokyo Japan.ORCID 0000-0002-6809-5259
Shingo SakataDepartment of Cardiology Keio University School of Medicine Tokyo Japan.ORCID 0009-0002-0362-8584
Toshinobu RyuzakiDepartment of Cardiology Keio University School of Medicine Tokyo Japan.ORCID 0000-0002-6450-860X
Mitsuru SagoDepartment of Cardiology Toyohashi Heart Center Toyohashi Japan.
Shuhei TanakaSecond Department of Internal Medicine Toyama University Hospital Toyama Japan.ORCID 0000-0001-7551-3431
Ryuki ChataniDepartment of Cardiology Kurashiki Central Hospital Kurashiki Japan.ORCID 0009-0009-7622-8494
Daisuke HachinoheDepartment of Cardiology Sapporo Higashi Tokushukai Hospital Sapporo Japan.ORCID 0000-0003-4828-1836
Toru NaganumaDepartment of Cardiology New Tokyo Hospital Chiba Japan.
Yohei OhnoDepartment of Cardiology Tokai University School of Medicine Isehara Japan.ORCID 0000-0003-4203-7613
Tomoyuki TaniDepartment of Cardiology Sapporo East Tokushukai Hospital Sapporo Japan.
Hideharu OkamatsuDivision of Cardiology Saiseikai Kumamoto Hospital Cardiovascular Center Kumamoto Japan.ORCID 0000-0001-8122-3561
Kazuki MizutaniDivision of Cardiology, Department of Medicine Kinki University Faculty of Medicine Osaka Japan.ORCID 0000-0001-7206-4538
Yusuke WatanabeDepartment of Cardiology Teikyo University School of Medicine Tokyo Japan.ORCID 0000-0003-2297-5303
Masaki IzumoDivision of Cardiology St. Marianna University School of Medicine Hospital Kawasaki Japan.ORCID 0000-0001-8597-1479
Mike SajiDepartment of Cardiology Sakakibara Heart Institute Tokyo Japan.ORCID 0000-0003-2057-109X
Shingo MizunoDepartment of Cardiology Shonan Kamakura General Hospital Kamakura Kanagawa Japan.
Hiroshi UenoDepartment of Cardiology National Cerebral and Cardiovascular Center Suita Japan.ORCID 0000-0001-9747-2511
Shunsuke KuboDepartment of Cardiology Kurashiki Central Hospital Kurashiki Japan.ORCID 0000-0003-4794-7843
Shinichi ShiraiDivision of Cardiology Kokura Memorial Hospital Kitakyushu Japan.ORCID 0000-0002-4764-8205
Masaki NakashimaDepartment of Cardiology Sendai Kosei Hospital Sendai Japan.ORCID 0000-0001-5245-1573
Masahiko AsamiDivision of Cardiology Mitsui Memorial Hospital Tokyo Japan.ORCID 0000-0002-2102-033X
Masanori YamamotoDepartment of Cardiology Toyohashi Heart Center Toyohashi Japan.ORCID 0000-0001-5210-6382
Masaki IedaDepartment of Cardiology Keio University School of Medicine Tokyo Japan.ORCID 0000-0003-4724-3299
Kentaro HayashidaDepartment of Cardiology Keio University School of Medicine Tokyo Japan.ORCID 0000-0002-1750-1982
OCEAN‐LAAC investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe impact of peridevice leak (PDL) at device implantation on clinical outcomes after percutaneous left atrial appendage closure (LAAC) is unknown. This study aimed to investigate the association between PDL and clinical outcomes after LAAC.

methodsUsing data from the OCEAN-LAAC (Optimized Catheter Valvular Intervention-Left Atrial Appendage Closure) Japanese multicenter registry, we examined 1397 patients who underwent LAAC between September 2019 and December 2022. The primary outcome was transient ischemic attack, ischemic stroke, or systemic embolism within 2 years of LAAC. Clinical outcomes were compared between patients with and without PDL at device implantation using Fine and Gray multivariable regression analyses and propensity score matching. Additional analyses were performed by categorizing PDL into 2 groups: ≤3 mm and >3 mm but ≤5 mm.

resultsOf 1397 patients who underwent LAAC, 84 (6.0%) had PDL, of whom 73 (86.9%) had ≤3 mm PDL. Patients with PDL had a larger left atrium and higher CHADS2 scores than those without PDL. Multivariable analyses showed that PDL was significantly associated with a higher risk of transient ischemic attack, ischemic stroke, or systemic embolism (adjusted subdistribution hazard ratio [sHR], 4.25 [95% CI, 1.91-9.44];

conclusionsPDL was associated with a higher risk of transient ischemic attack, ischemic stroke, or systemic embolism, even PDL ≤3 mm. Therefore, it may be necessary to aim for no PDL as much as possible.

Indexed as

Atrial AppendageAtrial FibrillationPostoperative ComplicationsAgedAged, 80 and overEmbolismFemaleHumansIschemic Attack, TransientIschemic StrokeJapanLeft Atrial Appendage ClosureMaleMiddle AgedPropensity ScoreRegistriesatrial fibrillationpercutaneous left atrial appendage closurepropensity score matching

Identifiers

PMID40820980
PMCPMC12748067

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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.