Evidence map›Paper›PMID 41099439›Full record

SynthesisInternational journal of stroke : official journal of the International Stroke Society2026

Outcomes of patent foramen ovale closure in patients over 60 years with cryptogenic stroke: A systematic review and meta-analysis.

Seyed Behnam Jazayeri, Cattien Phan, Sherief Ghozy, Soumya Ravichandran, Ana H Maleki, Oana M Dumitrascu, Kunal Agrawal, Royya Modir, Thomas Hemmen, Sven Poli and 5 more

Abstract readSystematic ReviewMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in International journal of stroke : official journal of the International Stroke Society, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. 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

15 authors.

Seyed Behnam JazayeriComprehensive Stroke Center, Department of Neurosciences, University of California San Diego, San Diego, CA, USA.ORCID 0000-0003-2860-6496
Cattien PhanComprehensive Stroke Center, Department of Neurosciences, University of California San Diego, San Diego, CA, USA.ORCID 0009-0002-8314-9734
Sherief GhozyDepartment of Radiology, Mayo Clinic, Rochester, MN, USA.
Soumya RavichandranComprehensive Stroke Center, Department of Neurosciences, University of California San Diego, San Diego, CA, USA.
Ana H MalekiNeuroscience Department, Loma Linda University, Loma Linda, CA, USA.
Oana M DumitrascuDepartment of Neurology, Mayo Clinic, Scottsdale AZ, USA.
Kunal AgrawalComprehensive Stroke Center, Department of Neurosciences, University of California San Diego, San Diego, CA, USA.
Royya ModirComprehensive Stroke Center, Department of Neurosciences, University of California San Diego, San Diego, CA, USA.ORCID 0000-0002-4782-0861
Thomas HemmenComprehensive Stroke Center, Department of Neurosciences, University of California San Diego, San Diego, CA, USA.
Sven PoliDepartment of Neurology and Stroke, Eberhard-Karls University, Tübingen, Germany.ORCID 0000-0002-0286-8781
Christine S ZuernDepartment of Neurology and Stroke, Eberhard-Karls University, Tübingen, Germany.
Daniela TrabattoniCentro Cardiologico Monzino, IRCCS, Milan, Italy.
Dawn MeyerComprehensive Stroke Center, Department of Neurosciences, University of California San Diego, San Diego, CA, USA.
Brett MeyerComprehensive Stroke Center, Department of Neurosciences, University of California San Diego, San Diego, CA, USA.ORCID 0000-0002-2877-1187
Bavarsad ShahripourComprehensive Stroke Center, Department of Neurosciences, University of California San Diego, San Diego, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn younger patients (<60 years) with cryptogenic stroke (CS) presumed to be patent foramen ovale (PFO)-related, the standard approach involves transcatheter PFO closure combined with antithrombotic therapy. However, due to their exclusion from randomized clinical trials (RCTs), no formal recommendations exist for patients ⩾60 years. This study had two objectives (1) to compare the efficacy and safety of PFO closure versus antithrombotic therapy alone (ATA) exclusively in older patients (⩾60 years) and (2) to assess the outcomes of PFO closure in patients ⩾ 60 years versus < 60 years.

methodsWe searched PubMed, Embase, Web of Science, and ScienceDirect databases to obtain articles in all languages from January 2004 until July 2025. The primary outcome was risk of recurrent stroke during follow-up. Secondary outcomes were risk of new-onset atrial fibrillation (AF), all-cause mortality, and in-hospital complications. PROSPERO registration ID: CRD420250652870.

resultsOnly one RCT (post hoc evaluation of the DEFENSE-PFO trial) and 11 observational studies were included. In patients aged ⩾ 60 years, risk of recurrent stroke was lower when PFO was closed compared with ATA (5.48% vs 10.05%, respectively, hazard ratio (HR) = 0.56, 95% confidence interval (CI) = 0.45-0.80, p < 0.001, I

conclusionBased on available data, which is predominantly derived from observational studies, PFO closure is associated with a reduced risk of recurrent stroke compared to ATA in patients over 60 years. However, these findings are subjected to limitations, including the potential for selection bias, unmeasured confounding, and insufficient long-term follow-up. Furthermore, long-term randomized trials are essential to definitively confirm efficacy and establish clinical guidelines for PFO closure in this older population.

Indexed as

Foramen Ovale, PatentIschemic StrokeStrokeAgedAtrial FibrillationFibrinolytic AgentsHumansMiddle AgedTreatment OutcomeFibrinolytic Agentsagedantithrombotic therapycryptogenic strokeESUSPFO closurestroke

Identifiers

PMID41099439
PMCPMC13197611

What OpenQuestion holds

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Registered trials

None linked

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.