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Updated: Sep 13, 2025

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Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
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Patent Foramen Ovale and Stroke: A Review
1Predictive Analytics and Comparative Effectiveness Center, Tufts Medical Center/Tufts University School of Medicine, Boston, Massachusetts.
JAMA
|July 28, 2025
Summary
Patent foramen ovale (PFO) closure significantly reduces stroke recurrence in select younger patients with cryptogenic stroke. Careful patient selection using the PASCAL system is crucial for optimizing outcomes and minimizing risks.
Area of Science:
- Cardiology
- Neurology
- Medical Devices
Background:
- Patent foramen ovale (PFO) is an atrial opening present in ~25% of adults, often implicated in paradoxical embolism and strokes, particularly in younger individuals.
- Cryptogenic strokes, especially in patients under 60, have a high prevalence of PFO (~50%), necessitating methods to determine PFO's causal role.
Purpose of the Study:
- To evaluate the efficacy of PFO closure in reducing recurrent stroke in patients with cryptogenic stroke.
- To assess the utility of the Risk of Paradoxical Embolism (RoPE) score and PFO-Associated Stroke Causal Likelihood (PASCAL) classification in guiding PFO closure decisions.
Main Methods:
- Analysis of pooled data from 6 trials involving 3740 patients comparing PFO closure with medical therapy.
- Utilized the RoPE score for initial risk stratification and the PASCAL system (combining RoPE score and echocardiographic findings) for detailed causal assessment.
Main Results:
- PFO closure reduced annualized stroke incidence (0.47% vs 1.09% with medical therapy) over a median of 57 months.
- Patients classified as PASCAL 'probable' (younger, no risk factors, high-risk PFO anatomy) showed a significant 90% relative risk reduction in recurrent stroke with PFO closure.
- PASCAL 'unlikely' patients did not benefit from closure and experienced higher adverse event rates.
Conclusions:
- Percutaneous PFO closure is effective in substantially reducing stroke recurrence in carefully selected patients (<60 years) with cryptogenic stroke.
- The PASCAL classification system aids in identifying patients most likely to benefit from PFO closure, distinguishing them from those at higher risk of complications without benefit.
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