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Updated: May 10, 2026
Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence
Published on: December 23, 2022
Stroke prevention by percutaneous closure of patent foramen ovale: a systematic review and meta-analysis
Mathias Wolfrum1, Georg M Froehlich, Guido Knapp
1Department of Internal Medicine, Spital Zollikerberg, Zollikerberg, Switzerland.
Insights
Percutaneous closure of patent foramen ovale (PFO) for cryptogenic stroke is not superior to medical therapy based on current randomized data. However, further research is encouraged due to potential benefits, despite increased atrial fibrillation risk.
Area of Science:
- Cardiology
- Neurology
- Interventional Cardiology
Background:
- The efficacy of percutaneous closure of patent foramen ovale (PFO) for cryptogenic stroke remains controversial due to limited evidence.
- Cryptogenic strokes account for a significant portion of ischemic strokes, highlighting the need for effective secondary prevention strategies.
Purpose of the Study:
- To conduct a systematic review and meta-analysis comparing percutaneous PFO closure with best medical therapy (BMT) for secondary stroke prevention.
- To evaluate the impact of PFO closure on stroke recurrence, bleeding risk, mortality, and atrial fibrillation incidence.
Main Methods:
- A comprehensive literature search was performed up to May 2013 to identify relevant controlled clinical trials (randomized and non-randomized).
- Data from 14 studies involving 4335 patients were analyzed using a random effects model to calculate pooled relative risks (RR) and 95% confidence intervals (CIs).
- Stroke was the primary endpoint, with secondary analyses including bleeding, mortality, and atrial fibrillation.
Main Results:
- Randomized controlled trials (RCTs) showed no significant difference in stroke reduction between PFO closure and BMT (RR 0.66, p=0.171).
- Non-randomized studies suggested a stroke reduction with PFO closure (RR 0.37, p<0.001), and a combined time-to-event analysis indicated borderline significance (HR 0.58, p=0.047).
- PFO closure was associated with a significantly higher incidence of new-onset atrial fibrillation (RR 3.50, p=0.005) but no significant differences in bleeding or mortality.
Conclusions:
- Current randomized data do not support percutaneous PFO closure as superior to BMT for secondary stroke prevention in cryptogenic stroke patients.
- The procedure is linked to an increased risk of atrial fibrillation, but potential benefits warrant further investigation.
- Strong encouragement for additional research is recommended to clarify the role of PFO closure in cryptogenic stroke management.
Context:
The role of percutaneous closure of patent foramen oval (PFO) in patients with cryptogenic stroke has been very controversial for years due to a lack of clear evidence.
Objective:
Systematic review and meta-analysis of the effect of percutaneous PFO closure for secondary prevention of cryptogenic strokes as compared to best medical therapy (BMT).
Data Sources:
Trials were identified through a literature search until 28 May 2013.
Study Selection:
Controlled clinical trials (randomised and non-randomised) comparing percutaneous PFO closure with BMT.
Data Extraction And Synthesis:
Main end point of interest was stroke. A random effects model was used to calculate the pooled relative risks (RR) with 95% CIs.
Results:
A total of 14 studies (three randomised controlled trials (RCT) and 11 non-randomised observational studies (non-RCT)), and a total of 4335 patients were included for this analysis. There was no significant treatment effect of PFO closure regarding stroke among the RCT (RR 0.66, 95% CI 0.37 to 1.19, p=0.171). However, among non-RCT stroke was reduced (RR 0.37, 95% CI 0.20 to 0.67, p<0.001) after PFO closure. A time-to-event (stroke) analysis, combining all three RCT and the two non-RCT which applied strict multivariate adjustments, showed a borderline significant risk reduction after PFO closure (HR 0.58, 95% CI 0.33 to 0.99, p=0.047). Neither risk of bleeding nor mortality differed significantly between the groups. However, there was a higher incidence of new onset atrial fibrillation in the closure group (RR 3.50, 95% CI 1.47 to 8.35, p=0.005).
Conclusions:
Percutaneous closure of PFO in patients with cryptogenic stroke does not appear superior to medical therapy according to currently available randomised data. Furthermore, it is associated with an increased incidence of atrial fibrillation. However, there are signals pointing towards a potential benefit and more research should be strongly encouraged.
