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Updated: Mar 21, 2026
Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
Patent foramen ovale: indications for closure and techniques
Maurizio Taramasso1, Fabian Nietlispach, Francesco Maisano
1UniversitätsSpital Zurich, University Heart Center, Zurich, Switzerland.
Insights
Patent foramen ovale (PFO) closure is safe and may prevent strokes and migraines. More research is needed, but current data suggest benefits, potentially expanding PFO closure indications.
Area of Science:
- Cardiology
- Neurology
- Vascular Medicine
Background:
- Non-surgical patent foramen ovale (PFO) closure is a well-established procedure with a strong safety record.
- Current indications for PFO closure are limited, often lacking robust randomized trial data.
- PFOs are implicated in paradoxical embolism, stroke, myocardial infarction, and other ischemic events, as well as migraine and sleep apnea.
Purpose of the Study:
- To evaluate the safety and efficacy of non-surgical PFO closure.
- To review the existing randomized data supporting PFO closure for specific conditions.
- To discuss the potential for expanded indications, including primary prevention.
Main Methods:
- Review of existing literature and randomized controlled trials on PFO closure.
- Analysis of data regarding PFO closure for secondary prevention of cerebral attacks and migraine.
- Discussion of the long-term safety and potential benefits of PFO closure.
Main Results:
- PFO closure has demonstrated a strong safety profile in approximately one million procedures worldwide.
- Randomized data, particularly for secondary prevention of stroke and migraine, show a numerical advantage for PFO closure.
- Sub-analyses in key trials indicate statistically significant benefits in specific patient subgroups.
Conclusions:
- Despite limited randomized data, the safety and potential benefits of PFO closure warrant consideration for broader application.
- The documented safety of PFO closure suggests a proactive approach in upcoming guidelines.
- The potential for primary prevention in high-risk PFO cases should be explored.
Abstract:
Non-surgical closure of the patent foramen ovale (PFO) has been possible for 40 years and proved safe in probably a million cases performed worldwide. Nonetheless, indications are still restricted as only a few are supported by randomised data. Paradoxical embolism through a PFO causes stroke, myocardial infarction, and visceral or peripheral ischaemia. The PFO is a likely mediator of migraine, diving or high altitude sickness, dyspnoea, and sleep apnoea problems. As untoward effects of a PFO are rare and spaced widely timewise, large cohorts and long follow-ups are required to prove unequivocally that PFO closure is bene-ficial and appropriate in comparison to no treatment or medical therapy. The most compelling respective randomised data have been gathered so far in the realm of secondary prevention of cerebral attacks and migraine. Invariably they showed a numerical advantage of PFO closure with significant difference in sub-analyses. Evidence-based medicine carries a danger of underutilising valuable therapies while accumulating further data. PFO closure is an example. Its documented innocuousness invites a more proactive reflection in upcoming guidelines. At worst, PFO closure may not convey the projected amount of benefit. This even opens the door for primary prevention in some PFOs with high-risk characteristics.
