What are the indications for patent foramen ovale (PFO) closure?

Indications for Patent Foramen Ovale Closure

PFO closure plus antiplatelet therapy is strongly recommended for patients under 60 years old with cryptogenic stroke when extensive workup excludes other stroke etiologies, particularly in those with high-risk PFO features such as atrial septal aneurysm. 1, 2

Primary Indication: Cryptogenic Stroke in Young Patients

Patient Selection Criteria

• Age ≤60 years with documented cryptogenic ischemic stroke after comprehensive evaluation excluding alternative causes 1, 2
• Must rule out atrial fibrillation through prolonged rhythm monitoring, aortic atherothrombosis via transesophageal echocardiography, and cerebrovascular disease through carotid imaging 1, 2
• Confirm absence of left-sided cardiac disease and severe thoracic aortic atherosclerosis 2

High-Risk PFO Features That Favor Closure

• Atrial septal aneurysm (>10mm excursion) increases stroke risk dramatically with an odds ratio of 15.59 in patients ≤55 years 3
• Large right-to-left shunt 2
• The combination of atrial septal aneurysm plus PFO carries substantially higher risk than either condition alone (OR 15.59 vs 6.14 for aneurysm alone vs 3.1 for PFO alone) 3

Treatment Algorithm for Cryptogenic Stroke Patients

When all treatment options are acceptable:

• Weak recommendation for PFO closure plus antiplatelet therapy over anticoagulation alone 1
• Number needed to treat is 20 over 5 years to prevent one recurrent stroke 3

When anticoagulation is contraindicated or declined:

• Strong recommendation for PFO closure plus antiplatelet therapy versus antiplatelet therapy alone 1, 3
• This represents the clearest evidence-based indication with pooled trial data showing 3.6% vs 5.8% recurrence rates (OR 0.62) 2

When PFO closure is contraindicated or declined:

• Weak recommendation for anticoagulation over antiplatelet therapy alone 1

Absolute Contraindications to PFO Closure

• Patients >60 years old should not undergo closure 2, 3
• Patients requiring long-term anticoagulation for other indications (e.g., atrial fibrillation) 2
• Small deep infarcts (lacunar strokes) suggesting small vessel disease rather than embolic mechanism 2
• Low-risk PFO without atrial septal aneurysm and with small shunt 2

Secondary Indications (Limited Evidence)

Decompression Sickness in High-Risk Occupations

• Consider closure only for multiple recurrences in individuals who must continue high-risk activities including high-volume divers, compressed-air tunnel workers, high-altitude aviators, or astronauts 2
• This is not a first-line indication but reserved for recurrent events despite occupational necessity 2

Right-Sided Cardiac Disease

• Patients with elevated right atrial pressures causing right-to-left shunting may warrant closure, but decisions must be highly individualized 2
• This represents a rare and complex scenario requiring careful hemodynamic assessment 2

Non-Indications (Insufficient Evidence)

Migraine with Aura

• Insufficient evidence to recommend PFO closure for migraine treatment 2
• Among 57 patients with migraine in one series, 73.7% reported relief, but this lacks controlled trial support 4

Peripheral Paradoxical Embolism

• No recommendation for closure in peripheral embolism (myocardial infarction, renal infarction, limb ischemia) 2
• The presumptive causal connection lacks evidence-based support despite theoretical plausibility 2

Post-Closure Management

Antiplatelet Therapy

• Dual antiplatelet therapy initially, transitioning to long-term single antiplatelet therapy 3
• Aspirin 75-325 mg daily is standard, with alternative antiplatelet agents acceptable 3

Expected Outcomes and Complications

• Procedure duration under 2 hours with 1-day hospitalization 3
• Device-related adverse events occur in 5.9% of cases 3
• Atrial fibrillation occurs in 4.6% post-closure 3
• Residual right-to-left shunt persists in 5.7% at follow-up 4
• Recurrent stroke rate of 1.2% and TIA rate of 3.6% during mean 1.9-year follow-up 5

Critical Diagnostic Requirements

Confirming Cryptogenic Stroke

• Prolonged cardiac rhythm monitoring to exclude atrial fibrillation 1
• Transesophageal echocardiography (higher sensitivity than transthoracic) to assess PFO characteristics and exclude left atrial appendage thrombus 3
• Valsalva maneuver during bubble study increases diagnostic sensitivity 3
• Carotid ultrasonography or advanced imaging to exclude significant cerebrovascular disease 1

Common Pitfall to Avoid

The most critical error is attributing stroke to PFO without excluding other etiologies—PFO is present in 25% of the general population, making it frequently an incidental finding rather than the stroke mechanism 6. The diagnosis of PFO-related cryptogenic stroke requires both presence of PFO and absence of alternative explanations after thorough investigation 1, 2.