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Updated: Feb 13, 2026

Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
Percutaneous closure versus medical therapy for stroke with patent foramen Ovale: a systematic review and
Xin-Lin Zhang1, Li-Na Kang1, Lian Wang1
1Department of Cardiology, Affiliated Drum Tower Hospital, Nanjing University School of Medicine, 321 Zhongshan Road, Nanjing, 210008, China.
Insights
Patent foramen ovale (PFO) closure significantly reduces stroke risk in cryptogenic stroke patients but increases risks for atrial fibrillation and pulmonary embolism compared to medical therapy.
Area of Science:
- Cardiology
- Neurology
- Interventional Medicine
Background:
- Patent foramen ovale (PFO) is a potential cause of cryptogenic stroke.
- PFO closure is considered for secondary stroke prevention.
- Comparative data on PFO closure versus medical therapy for stroke is limited.
Purpose of the Study:
- To evaluate the comparative efficacy and safety of PFO closure versus medical therapy in patients with PFO and cryptogenic stroke.
- To synthesize evidence from randomized controlled trials (RCTs) and observational studies.
Main Methods:
- Systematic review and meta-analysis of 20 studies (5 RCTs, 15 observational).
- Included studies compared PFO closure with medical therapy.
- Minimum 20 patients in the closure arm and 1-year follow-up required.
Main Results:
- PFO closure significantly reduced the composite outcome of ischemic stroke, transient ischemic attack (TIA), or all-cause death (OR 0.57).
- Stroke incidence was significantly lower with PFO closure (OR 0.39).
- PFO closure increased risks for atrial fibrillation/flutter (OR 5.74) and pulmonary embolism (OR 3.03).
Conclusions:
- PFO closure is effective in reducing stroke recurrence and a composite of stroke, TIA, or death.
- Increased risks of atrial fibrillation/flutter and pulmonary embolism necessitate careful patient selection and monitoring.
- Evidence suggests PFO closure is a viable secondary prevention strategy with a specific risk profile.
Background:
Patent foramen ovale (PFO) closure has emerged as a secondary prevention option in patients with PFO and cryptogenic stroke. However, the comparative efficacy and safety of percutaneous closure and medical therapy in patients with cryptogenic stroke and PFO remain unclear.
Methods:
Randomized controlled trials (RCTs) and comparative observational studies that compared PFO closure against medical therapy, each with a minimal of 20 patients in the closure arm and 1-year follow-up were included.
Results:
We analyzed 6961 patients from 20 studies (5 RCTs and 15 observational studies) with a median follow-up of 3.1 years. Moderate-quality evidence showed that PFO closure was associated with a significantly lower incidence of the composite outcome of ischemic stroke, transient ischemic attack (TIA), or all-cause death (odds ratio [OR]: 0.57; 95% confidence interval [CI]: 0.38 to 0.85; P = 0.006), mainly driven by lower incidence of stroke (OR: 0.39; 95% CI: 0.24 to 0.63; P < 0.001). The numbers needed to treat were 43 and 39 for the composite outcome and recurrent ischemic stroke respectively. PFO closure increased the risks for atrial fibrillation or atrial flutter (OR: 5.74; 95% CI: 3.08 to 10.70; P < 0.001; high-quality evidence) and pulmonary embolism (OR: 3.03; 95% CI: 1.06 to 8.63; P = 0.038; moderate-quality evidence), with the numbers needed to harm being 30 and 143 respectively. The risks for TIA, all-cause death, and major bleeding were not statistically different. Analyses limited to RCTs showed similar findings, as did a series of other subgroup analyses.
Conclusion:
In conclusion, PFO closure reduced the incidences of stroke and the composite outcome of ischemic stroke, TIA, or all-cause death, but increased risks for atrial fibrillation or atrial flutter and pulmonary embolism compared with medical therapy.
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