What constitutes a sufficient stroke to consider patent foramen ovale (PFO) closure?

Criteria for PFO Closure in Stroke Patients

PFO closure is recommended for carefully-selected patients aged 18-60 years with a non-lacunar embolic ischemic stroke or TIA attributed to a PFO after thorough evaluation has excluded alternative etiologies. 1, 2

Patient Selection Criteria

PFO closure should be considered when ALL of the following criteria are met:

1. Age: 18-60 years
2. Stroke type: Confirmed non-lacunar embolic ischemic stroke or TIA with positive neuroimaging or cortical symptoms
3. Causality: PFO determined to be the most likely cause after thorough evaluation excluding alternate etiologies
4. No indication for chronic anticoagulation for another reason 1

High-Risk PFO Features That Strengthen Indication for Closure

• Atrial septal aneurysm (excursion >10 mm)
• Large interatrial shunt (>30 microbubbles in the left atrium within three cardiac cycles)
• Substantial right-to-left shunt (spontaneous or during Valsalva maneuver) 1, 2

Evaluation Process to Determine PFO Causality

A thorough evaluation must exclude alternative stroke etiologies through:

• Prolonged rhythm monitoring to exclude atrial fibrillation
• Transoesophageal echocardiography or alternative imaging of the aorta and left atrial appendage to rule out aortic atherothrombosis or left atrial clot
• Carotid ultrasonography, CT, or MRI to rule out cerebrovascular disease 1

Patients Who Should NOT Receive PFO Closure

• Patients >60 years of age (unless exceptional circumstances)
• Patients with small deep infarcts (lacunar strokes)
• Patients with an identified alternative cause for stroke
• Patients with a small PFO without high-risk features
• Patients requiring long-term anticoagulation for another indication 1, 3

Evidence Supporting These Recommendations

The benefit of PFO closure is well-established in carefully selected patients:

• CLOSE trial: Stroke rate 0% in PFO-closure group vs. 6.0% in antiplatelet-only group (NNT = 20 over 5 years)
• REDUCE trial: Ischemic stroke rate 1.4% in closure group vs. 5.4% in antiplatelet-only group (NNT = 28 over 2 years)
• RESPECT trial: Recurrent ischemic stroke rate 3.6% in PFO closure group vs. 5.8% in medical therapy group (NNT = 42 over 5 years) 1

Potential Complications and Considerations

• Procedural complications rate: 5.9%
• Atrial fibrillation: 4.6-6.6% (mostly transient)
• Serious device-related adverse events: 1.4% 1, 2

Management Algorithm

1. Confirm cryptogenic stroke: Rule out all other potential causes through comprehensive workup
2. Confirm PFO: Preferably with transesophageal echocardiography with bubble contrast and Valsalva maneuver
3. Assess PFO characteristics: Determine shunt size and presence of atrial septal aneurysm
4. Evaluate patient age and stroke characteristics: Confirm non-lacunar, embolic pattern
5. Determine if PFO is the most likely cause: Consider RoPE score >8 with clinical risk factors
6. Proceed with closure if all criteria met: Use device closure plus antiplatelet therapy
7. If criteria not met: Use antiplatelet therapy alone (unless separate indication for anticoagulation exists) 1, 2

PFO closure provides significant reduction in recurrent stroke risk when properly selected, with an annualized risk reduction of approximately 0.6% 3. The benefit is particularly pronounced in younger patients with high-risk PFO features and truly cryptogenic strokes.