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Updated: Jun 13, 2026

Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence
Published on: December 23, 2022
Patent foramen ovale and stroke: Should PFOs be closed in otherwise cryptogenic stroke?
David A Carpenter1, Andria L Ford, Jin-Moo Lee
1Department of Neurology, Washington University School of Medicine, St. Louis, MO 63110, USA. carpenterd@wustl.edu
Abstract:
Since initial reports of its association with ischemic stroke appeared in 1988, there has been continued controversy regarding the existence and strength of the association between patent foramen ovale (PFO) and ischemic stroke. Many case-control studies have reported an association between incident cryptogenic ischemic stroke and PFO, yet population-based studies have failed to confirm this association. Studies of the risk of recurrent stroke in patients with cryptogenic stroke with or without PFO have not shown an increased risk of recurrent stroke in patients with PFO. Meanwhile, use of devices to close PFOs and atrial septal defects percutaneously has increased dramatically since their introduction. Completion of the randomized clinical trials of PFO closure currently in progress is vital to determine if the benefits of PFO closure in cryptogenic stroke outweigh its risks.
Insights
The link between patent foramen ovale (PFO) and ischemic stroke remains controversial. Current evidence does not support PFO as a cause of recurrent stroke, necessitating further trials on PFO closure effectiveness.
Area of Science:
- Cardiology
- Neurology
- Medical Devices
Background:
- The association between patent foramen ovale (PFO) and ischemic stroke has been debated since 1988.
- While case-control studies suggest a link, population-based studies have not confirmed it.
- Recurrent stroke risk in patients with cryptogenic stroke is not elevated by the presence of a PFO.
Purpose of the Study:
- To evaluate the controversial association between PFO and ischemic stroke.
- To assess the risk of recurrent stroke in patients with PFO.
- To determine the necessity of ongoing randomized clinical trials for PFO closure.
Main Methods:
- Review of case-control and population-based studies on PFO and ischemic stroke.
- Analysis of studies examining recurrent stroke risk in patients with and without PFO.
- Consideration of trends in percutaneous closure device utilization.
Main Results:
- Case-control studies report an association, but population-based studies do not confirm it.
- No increased risk of recurrent stroke was found in patients with PFO.
- Percutaneous PFO closure device use has significantly increased.
Conclusions:
- The link between PFO and ischemic stroke requires further investigation.
- Evidence does not currently support PFO as a cause of recurrent stroke.
- Randomized trials are crucial to ascertain the benefits versus risks of PFO closure.
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