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Updated: May 10, 2026

Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence
Published on: December 23, 2022
Patent foramen ovale: when is intervention warranted?
Michael J Landzberg1, Paul Khairy
1Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02115, USA. mlandzberg@partners.org
Insights
Patent foramen ovale (PFO) is common and often asymptomatic. Current evidence shows no benefit, and potential harm, from closing a PFO for stroke or migraine prevention.
Area of Science:
- Cardiology
- Neurology
- Medical Diagnostics
Background:
- The foramen ovale is a normal fetal structure that often remains patent (open) in a significant percentage of the population into adulthood.
- A patent foramen ovale (PFO) has been anecdotally linked to various pathologies, leading to interventions based on association rather than proven causality.
- Understanding the clinical significance of a PFO requires differentiating common anatomical variants from pathological conditions.
Purpose of the Study:
- To review the current best practices and evidence regarding the intervention on a patent foramen ovale (PFO).
- To evaluate the efficacy and safety of PFO closure based on recent randomized controlled trials (RCTs) and clinical guidelines.
- To provide a data-driven perspective on the decision-making process for altering the cardiovascular system by closing a PFO.
Main Methods:
- Systematic review of recent randomized controlled trials (RCTs) focusing on PFO closure.
- Analysis of current international practice guidelines for cardiovascular interventions.
- Evaluation of clinical outcomes related to stroke, transient ischemic attack (TIA), and migraine in patients with PFO.
Main Results:
- Current medical guidelines do not indicate PFO closure as a standard treatment, regardless of intervention method (transcatheter or surgical).
- Recent RCTs have failed to demonstrate a significant reduction in stroke or TIA risk for PFO closure.
- Intervention for PFO closure has shown increased adverse events without providing accrued benefits for stroke prevention or migraine elimination.
Conclusions:
- Intervention for patent foramen ovale (PFO) is not currently recommended by medical guidelines.
- Closing a PFO does not appear to reduce the risk of stroke or transient ischemic attack (TIA) and may increase harm.
- The decision to intervene on a PFO should be based on robust data and evidence, not on commonness or assumed causality.
Abstract:
In our desire to bring harmony to understanding of unexplained pathologies, we tend to relate commonly occurring entities and attempt to demonstrate meaningful association or causality. The foramen ovale is a universally present structure in utero, remaining patent in a substantial proportion of live births and through adulthood. In its commonness, it has been associated with many disease states and claims of causal inference. As we review the current state of best practice concerning patent foramen ovale (PFO) based on recent randomized controlled trials and practice guidelines, we are reminded that the human body, despite its medical frailties, remains an incredibly efficient machine; a decision to permanently alter its workings should demand knowledge gleaned from substantiated experience and validated data. Presently, no indications exist for PFO closure, whether via a transcatheter or surgical approach, within existing medical care guidelines. Recent randomized controlled trials examining reduction of risk for secondary prevention of stroke and/or transient ischemic attack and for elimination of migraine have underscored the message to restrain the temptation to intervene on a PFO; adversity appears to increase without accrued benefit from such an intervention.
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