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Updated: Dec 25, 2025

Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
Patent foramen ovale closure versus medical therapy for cryptogenic stroke: An updated systematic review and
Sunny Goel1, Shanti Patel1, Elina Zakin2
1Department of Cardiology, Maimonides Medical Center, Brooklyn, NY, 11219, USA.
Insights
Patent foramen ovale (PFO) closure significantly reduces stroke risk in cryptogenic stroke patients compared to medical therapy. However, PFO closure increases the risk of atrial fibrillation.
Area of Science:
- Cardiology
- Neurology
- Interventional Cardiology
Background:
- The efficacy of patent foramen ovale (PFO) closure for preventing recurrent cryptogenic stroke (CS) remains debated.
- Medical management is the current standard, but its effectiveness in specific patient subgroups is under investigation.
Purpose of the Study:
- To compare the safety and efficacy of PFO closure versus medical therapy in patients with CS.
- To evaluate the impact of PFO closure on stroke recurrence and adverse events.
Main Methods:
- A systematic review and meta-analysis of randomized control trials (RCTs) were conducted.
- Searches included PubMed, EMBASE, Cochrane Library, and clinicaltrials.gov.
- Forest plots with random-effects models were used to compare event rates.
Main Results:
- Six RCTs with 3747 patients were analyzed, with follow-up ranging from 2 to 5.9 years.
- PFO closure significantly reduced stroke risk (RR=0.41) but increased atrial fibrillation risk (RR=5.29).
- No significant differences were found in major bleeding or mortality; device closure was effective in patients with large shunts.
Conclusions:
- PFO closure offers a significant stroke risk reduction compared to medical management for CS patients.
- Increased risk of atrial fibrillation is a key consideration with PFO closure.
- Device closure efficacy is particularly noted in patients with large shunt sizes.
Objectives:
The objective of this study was to compare safety and efficacy of patent foramen ovale (PFO) closure compared with medical therapy in patients with cryptogenic stroke (CS).
Background:
The role of PFO closure in preventing recurrent stroke in patients with prior CS has been controversial.
Methods:
We searched PubMed, EMBASE, the Cochrane Central Register of Controlled trials, and the clinical trial registry maintained at clinicaltrials.gov for randomized control trials that compared device closure with medical management and reported on subsequent stroke and adverse events. Event rates were compared using a forest plot of relative risk using a random-effects model assuming interstudy heterogeneity.
Results:
A total of 6 studies (n = 3747) were included in the final analysis. Mean follow-up ranged from 2 to 5.9 years. Pooled analysis revealed that device closure compared to medical management was associated with a significant reduction in stroke (risk ratio [RR] = 0.41, 95% CI = 0.20-0.83, I2 = 51%, P = 0.01). There was, however, a significant increase in atrial fibrillation with device therapy (RR = 5.29, 95% CI = 2.32-12.06, I2 = 38%, P < 0.0001). No effect was observed on major bleeding (P = 0.50) or mortality (P = 0.42) with device therapy. Subgroup analyses showed that device closure significantly reduced the incidence of the composite primary end point among patients who had large shunt sizes (RR = 0.35, 95% CI = 0.18-0.68, I2 = 27%, P = 0.002). The presence/absence of atrial septal aneurysm (P = 0.52) had no effect on the outcome.
Conclusion:
PFO closure is associated with a significant reduction in the risk of stroke compared to medical management. However, it causes an increased risk of atrial fibrillation.
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