Evidence map›Paper›PMID 28939677›Full record

Trial reportStroke2017

Safety Outcomes After Percutaneous Transcatheter Closure of Patent Foramen Ovale.

Alexander E Merkler, Gino Gialdini, Shadi Yaghi, Peter M Okin, Costantino Iadecola, Babak B Navi, Hooman Kamel

Abstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Stroke, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 3 pooled it
–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

30 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Outcomes of patent foramen ovale closure in patients over 60 years with cryptogenic stroke: A systematic review and meta-analysis.International journal of stroke : official journal of the International Stroke Society · 2026
    Pooled it
  2. New-onset atrial fibrillation following percutaneous closure of patent foramen ovale: a systematic review and meta-analysis.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2021
    Pooled it
  3. Pooled it
  4. Review
  5. Article
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  11. Article
  12. Atrial Fibrillation After Patent Foramen Ovale Closure: Innocuous Passerby or Propagating Substrate.Journal of the Society for Cardiovascular Angiography & Interventions · 2024
    Article
  13. Incidence of Atrial Fibrillation or Arrhythmias After Patent Foramen Ovale Closure.Journal of the Society for Cardiovascular Angiography & Interventions · 2024
    Article
  14. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Alexander E MerklerFrom the Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute (A.E.M., G.G., C.I., B.B.N., H.K.), Department of Neurology (A.E.M., C.I., B.B.N., H.K.), and Division of Cardiology (P.M.O.), Weill Cornell Medicine, New York; and Department of Neurology, the Warren Alpert Medical School of Brown University, Providence, RI (S.Y.). alm9097@med.cornell.edu.
Gino GialdiniFrom the Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute (A.E.M., G.G., C.I., B.B.N., H.K.), Department of Neurology (A.E.M., C.I., B.B.N., H.K.), and Division of Cardiology (P.M.O.), Weill Cornell Medicine, New York; and Department of Neurology, the Warren Alpert Medical School of Brown University, Providence, RI (S.Y.).
Shadi YaghiFrom the Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute (A.E.M., G.G., C.I., B.B.N., H.K.), Department of Neurology (A.E.M., C.I., B.B.N., H.K.), and Division of Cardiology (P.M.O.), Weill Cornell Medicine, New York; and Department of Neurology, the Warren Alpert Medical School of Brown University, Providence, RI (S.Y.).
Peter M OkinFrom the Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute (A.E.M., G.G., C.I., B.B.N., H.K.), Department of Neurology (A.E.M., C.I., B.B.N., H.K.), and Division of Cardiology (P.M.O.), Weill Cornell Medicine, New York; and Department of Neurology, the Warren Alpert Medical School of Brown University, Providence, RI (S.Y.).
Costantino IadecolaFrom the Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute (A.E.M., G.G., C.I., B.B.N., H.K.), Department of Neurology (A.E.M., C.I., B.B.N., H.K.), and Division of Cardiology (P.M.O.), Weill Cornell Medicine, New York; and Department of Neurology, the Warren Alpert Medical School of Brown University, Providence, RI (S.Y.).
Babak B NaviFrom the Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute (A.E.M., G.G., C.I., B.B.N., H.K.), Department of Neurology (A.E.M., C.I., B.B.N., H.K.), and Division of Cardiology (P.M.O.), Weill Cornell Medicine, New York; and Department of Neurology, the Warren Alpert Medical School of Brown University, Providence, RI (S.Y.).
Hooman KamelFrom the Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute (A.E.M., G.G., C.I., B.B.N., H.K.), Department of Neurology (A.E.M., C.I., B.B.N., H.K.), and Division of Cardiology (P.M.O.), Weill Cornell Medicine, New York; and Department of Neurology, the Warren Alpert Medical School of Brown University, Providence, RI (S.Y.).

Funding

Overexpression of the amyloid precursor protein and cerebrovascular regulationR01NS037853 · NINDS · WEILL MEDICAL COLL OF CORNELL UNIV · PI Costantino Iadecola · 1998 to 2026
$10.6M
NO SYNTHASE GENE EXPRESSION AND CEREBRAL ISCHEMIC DAMAGER01NS034179 · NINDS · WEILL MEDICAL COLL OF CORNELL UNIV · PI IADECOLA, COSTANTINO · 1995 to 2021
$5.5M
Hypertension and neurovascular dysfunctionR37NS089323 · NINDS · WEILL MEDICAL COLL OF CORNELL UNIV · PI IADECOLA, COSTANTINO · 2015 to 2021
$3.1M
CHRONIC INTERMITTENT HYPOXIA, NEUROVASCULAR DYSFUNCTION AND STROKER01NS073666 · NINDS · WEILL MEDICAL COLL OF CORNELL UNIV · PI IADECOLA, COSTANTINO · 2011 to 2015
$1.8M
NO SYNTHASE GENE EXPRESSION AND CEREBRAL ISCHEMIC DAMAGER37NS034179 · NINDS · WEILL MEDICAL COLLEGE OF CORNELL UNIV · PI IADECOLA, COSTANTINO · 1999 to 2005
$1.8M
Left Atrial abNormality, ThromboEmbolism, and Race: Novel risk factors for stroke (LANTERN)R01NS097443 · NINDS · WEILL MEDICAL COLL OF CORNELL UNIV · PI KAMEL, HOOMAN · 2016 to 2019
$1.5M
Cancer And Risk Of Ischemic StrokeK23NS091395 · NINDS · WEILL MEDICAL COLL OF CORNELL UNIV · PI NAVI, BABAK BENJAMIN · 2015 to 2019
$945k
Atrial Fibrillation Precursors May Be Novel Stroke Risk FactorsK23NS082367 · NINDS · WEILL MEDICAL COLL OF CORNELL UNIV · PI KAMEL, HOOMAN · 2013 to 2017
$937k
NINDS NIH HHS K23 NS082367NINDS NIH HHS K23 NS091395NINDS NIH HHS R01 NS034179NINDS NIH HHS R01 NS037853NINDS NIH HHS R01 NS073666NINDS NIH HHS R01 NS097443NINDS NIH HHS R37 NS034179NINDS NIH HHS R37 NS089323
6 · The paper itself

Abstract

background and purposeWe sought to evaluate the real-world rate of safety outcomes after patent foramen ovale (PFO) closure in patients with ischemic stroke or transient ischemic attack (TIA).

methodsWe performed a retrospective cohort study using administrative claims data on all hospitalizations from 2005 to 2013 in New York, California, and Florida. Using

resultsWe identified 1887 patients who underwent PFO closure after ischemic stroke or TIA. The rate of any adverse outcome during the hospitalization for PFO closure was 7.0% (95% confidence interval [CI], 5.9%-8.2%). Rates of adverse outcomes varied by age and type of preceding cerebrovascular event. In patients >60 years of age, the rate of adverse outcomes was 10.9% (95% CI, 8.6%-13.6%) versus 4.9% (95% CI, 3.8%-6.3%) in patients ≤60 years of age. The rate of adverse outcomes was 9.9% (95% CI, 7.3%-12.5%) in patients with preceding ischemic stroke versus 5.9% (95% CI, 4.7%-7.1%) after TIA.

conclusionsApproximately 1 in 14 patients who underwent percutaneous transcatheter PFO closure after ischemic stroke or TIA experienced a serious periprocedural adverse outcome or death. The risk of adverse outcomes was highest in older patients and in those with preceding ischemic stroke.

Indexed as

AdultAgedAge FactorsBrain IschemiaCardiac CatheterizationFemaleForamen Ovale, PatentHumansMaleMiddle AgedPostoperative ComplicationsRetrospective StudiesRisk FactorsStrokeatrial fibrillationoutcomes researchpatent foramen ovalepatent foramen ovale closurestroketransient ischemic attack

Identifiers

PMID28939677
PMCPMC5699514

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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.