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Updated: Jul 21, 2025
Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
Effectiveness of Transcatheter Closure of Patent Foramen Ovale in Clinical Practice
Mohamad Alkhouli1, Holly K Van Houten2,3, Xiaoxi Yao1,3
1Department of Cardiovascular Medicine Mayo Clinic Rochester MN USA.
Insights
Transcatheter closure of patent foramen ovale (PFO) did not reduce recurrent stroke in real-world practice, unlike in clinical trials. However, PFO closure was associated with lower mortality, suggesting benefits beyond stroke prevention.
Area of Science:
- Cardiovascular Medicine
- Neurology
- Interventional Cardiology
Background:
- Randomized trials show transcatheter closure of patent foramen ovale (PFO) reduces recurrent stroke risk in cryptogenic stroke patients.
- The effectiveness of PFO closure in routine clinical practice remains uncertain.
Purpose of the Study:
- To evaluate the association of PFO closure with recurrent ischemic stroke or systemic embolization in contemporary US practice.
- To compare secondary outcomes, including mortality and bleeding events, between PFO closure and medical therapy.
Main Methods:
- Retrospective analysis of the OptumLabs database, identifying patients with PFO and prior ischemic stroke or TIA.
- Propensity-matched comparison of 6668 patients undergoing PFO closure (n=4111) versus medical therapy (n=2557).
- Primary endpoint: recurrent ischemic stroke or systemic embolization. Secondary endpoints: mortality, all stroke, TIA, major bleeding.
Main Results:
- No significant difference in the primary endpoint of recurrent stroke or systemic embolization between PFO closure and medical therapy (HR 0.85, P=0.13).
- PFO closure was associated with significantly lower mortality (HR 0.69, P=0.002).
- Increased non-intracranial hemorrhage bleeding observed in patients on oral anticoagulation post-PFO closure (HR 0.69, P=0.043).
Conclusions:
- In current US clinical practice, PFO closure is not associated with reduced rates of recurrent ischemic stroke or systemic embolization compared to medical therapy.
- PFO closure demonstrated a significant reduction in mortality, indicating potential benefits beyond stroke prevention.
- Discrepancies between trial and real-world data warrant further investigation into factors influencing PFO closure outcomes.
Abstract:
Background Transcatheter closure of patent foramen ovale (PFO) has reduced the risk of recurrent stroke in patients with cryptogenic strokes in randomized clinical trials. Whether PFO closure in clinical practice is associated with similar benefit remains unknown. Methods and Results We identified patients with PFO and a history of ischemic stroke or transient ischemic attack who were treated with PFO closure or medical therapy in the OptumLabs database. The primary end point was recurrent ischemic stroke or systemic embolization. Secondary outcomes included mortality, all stroke, transient ischemic attack, and major bleeding. A total of 6668 propensity-matched patients were included (PFO closure n=4111; medical therapy n=2557). The incidence of stroke or systemic embolization per 100 person-years was 2.38 after PFO cohort and 2.99 with medical therapy (hazard ratio [HR], 0.85 [95% CI, 0.68-1.05], P=0.13). Mortality was lower in the PFO closure cohort (1.78 versus 2.59 per 100 person-years: HR, 0.69 [95% CI, 0.55-0.87], P=0.002). Falsification end points showed that this difference is unlikely to be completely explained by residual confounders. There were no significant differences between the groups in secondary end points including intracranial hemorrhage and major bleeding except for an increase in nonintracranial hemorrhage bleeding among patients treated with oral anticoagulation (1.42 versus 2.16 per 100 person-years: HR, 0.69 [95% CI, 0.48-0.99], P=0.043). The main end point was consistent in subanalyses including patients <60 years of age, patients with prior stroke, and those treated after the publication of the positive PFO trials in 2017. Conclusions In contemporary US practice, PFO closure is not associated with lower rates of recurrent ischemic stroke or systemic embolization compared with medical therapy. Potential reasons for this discrepancy warrant further investigation.
