Indications for Patent Foramen Ovale (PFO) Closure
PFO closure has limited and controversial indications, with the strongest consideration being for cryptogenic stroke in carefully selected young patients (≤60 years) who have high-risk PFO features, though even this carries only a Class IIb recommendation with insufficient data to make definitive recommendations. 1
Primary Clinical Scenarios
Cryptogenic Stroke and TIA
Current guidelines state there are insufficient data to make a recommendation regarding PFO closure in patients with stroke and PFO (Class IIb; Level of Evidence C). 1
Despite this weak recommendation, recent evidence suggests benefit in specific subgroups:
Age ≤60 years with high-risk PFO features shows the most favorable outcomes, with recurrent stroke rates of 2.9% after closure versus 4% with medical therapy alone 2
High-risk PFO features that increase likelihood of benefit include:
Patients >60 years: The evidence is even weaker, with recurrence rates of 7% after closure versus 4% with medical therapy, suggesting no clear benefit 2
Important nuance: While intention-to-treat analysis of pooled trials (CLOSURE I, RESPECT, PC) showed no significant difference (3.7% closure vs 5.3% medical therapy, OR 0.70), as-treated analysis demonstrated benefit (3.6% vs 5.8%, OR 0.62, statistically significant) 1
Contraindications to Closure in Stroke Patients
Do not close PFO in patients with:
- Small deep infarcts (lacunar strokes) 3
- Small PFO without high-risk features 3, 2
- Indication for long-term anticoagulation 3
- Low-risk PFO (no atrial septal aneurysm, small shunt) - these patients had 0% recurrence with medical therapy alone 2
Migraine with Aura
There is insufficient evidence to recommend PFO closure for migraine with aura. 1
Decompression Sickness and High-Risk Occupations
Consider PFO closure only for multiple recurrences in individuals who must continue high-risk activities (high-volume divers, compressed-air tunnel workers, high-altitude aviators, astronauts) and only in centers maintaining closure registries or participating in trials. 1
Right-Sided Cardiac Disease with Elevated Pressures
Patients with right-sided cardiac disease and elevated right atrial pressures causing right-to-left shunting may warrant closure, but this decision must be highly individualized as PFO closure provides only intermediate-term palliation and may worsen RV function long-term. 1
Peripheral (Non-Cerebral) Paradoxical Embolism
There are no recommendations for PFO closure in peripheral embolism (MI, renal infarction, limb ischemia), as the presumptive causal connection lacks evidence-based medicine support. 1 The YAMIS study found no relationship between PFO and MI risk in young patients. 1
Risk Stratification Tools
Use the RoPE (Risk of Paradoxical Embolism) score and PASCAL (PFO-Associated Stroke Causal Likelihood) classification to predict recurrence risk - both are independent predictors of future neurologic events after closure. 4
History of prior neurological events increases recurrence risk 9.94-fold, making this a critical factor in decision-making. 4
Procedural Risks to Consider
- Major procedural complications: 2.4% 4
- New-onset atrial fibrillation: 3% long-term 4, with trend toward device-related AF inducibility noted in trials 1
- Age-related recurrence: Patients ≥45 years have 35% recurrence rate versus 0% in those <45 years after surgical closure 5
Long-Term Outcomes
Freedom from recurrent stroke/TIA/death at 10 years is 96.2% with transcatheter closure in selected patients, with an annualized recurrence rate of 0.38 per 100 patient-years. 4
The absolute annual stroke risk reduction is approximately 0.6%, but the lifetime cumulative benefit in young patients who have already experienced one stroke may be substantial. 3
Critical Diagnostic Requirements
Before attributing stroke to PFO, exclude:
- Atrial fibrillation 1
- Left-sided cardiac disease 1
- Severe atherosclerosis of thoracic aorta 1
- Alternative stroke mechanisms (PFO is present in 25% of general population) 3
Confirm presence of venous thrombosis or pulmonary embolism when possible to support paradoxical embolism diagnosis. 1