What are the indications for patent foramen ovale (PFO) closure in patients with cryptogenic stroke?

Indications for Patent Foramen Ovale Closure in the Setting of Stroke

PFO closure is strongly recommended for patients under 60 years with cryptogenic stroke and a patent foramen ovale (PFO) when extensive workup for other stroke etiologies is negative, particularly in those with high-risk PFO features. 1

Patient Selection Algorithm

Step 1: Confirm Cryptogenic Stroke

• Rule out alternative stroke etiologies through:
  • Prolonged cardiac rhythm monitoring to exclude atrial fibrillation
  • Transoesophageal echocardiography or alternative imaging of aorta and left atrial appendage
  • Carotid ultrasonography, CT, or MRI to rule out cerebrovascular disease
  • Evaluation for traditional stroke risk factors (hypertension, hyperlipidemia, diabetes)

Step 2: Confirm PFO Presence and Characterize

• Transoesophageal echocardiography is preferred over transthoracic for PFO detection 1
• Perform saline contrast study with Valsalva maneuver to increase detection sensitivity
• Document high-risk PFO features:
  • Atrial septal aneurysm (excessive bulging of atrial septal fossa ovalis)
  • Moderate to large interatrial shunt
  • Right-to-left shunting

Step 3: Assess Patient-Specific Factors

• Age: Strong evidence supports PFO closure in patients <60 years 1
• RoPE Score: Consider PFO closure in patients with RoPE score >8 plus at least one clinical risk factor 1
• Absence of traditional stroke risk factors: Patients without hypertension, diabetes, or hyperlipidemia are more likely to benefit

Evidence-Based Recommendations

For Patients Open to All Treatment Options:

• PFO closure plus antiplatelet therapy is recommended over antiplatelet therapy alone (strong recommendation) 1, 2
  • Reduces recurrent ischemic stroke risk by 87 per 1000 patients over 5 years 2
  • Number needed to treat to prevent one stroke is approximately 11 patients

For Patients with Contraindications to Anticoagulation:

• PFO closure plus antiplatelet therapy is strongly recommended over antiplatelet therapy alone 1
  • Reduces stroke recurrence by 77% compared to antiplatelet therapy alone 3

For Patients with Contraindications to PFO Closure:

• Anticoagulation is recommended over antiplatelet therapy alone (weak recommendation) 1
  • May reduce recurrent stroke risk compared to antiplatelet therapy
  • Increases risk of major bleeding (approximately 12 per 1000 patients) 2

Important Considerations and Caveats

Procedural Risks

• Device-related adverse events occur in approximately 36 per 1000 patients 1
• New-onset atrial fibrillation occurs in approximately 6.6% of patients following PFO closure 3
• Most procedure-related complications are transient and resolve within weeks

Age Considerations

• Evidence primarily supports PFO closure in patients under 60 years
• Recent data suggests older patients (≥60 years) with PFO and cryptogenic stroke may have higher recurrence risk (3.27 per 100 patient-years) 4
• Benefit of PFO closure in older patients remains uncertain and requires larger trials

Common Pitfalls to Avoid

1. Inadequate stroke workup: Ensure thorough investigation to confirm truly cryptogenic etiology
2. Overestimating PFO causality: Not all PFOs in stroke patients are pathogenic; consider RoPE score
3. Underestimating procedural risks: Counsel patients about potential complications including atrial fibrillation
4. Neglecting antiplatelet therapy post-closure: Continued antiplatelet therapy remains important after PFO closure

Practical Implementation

• PFO closure procedure typically takes under 2 hours
• Hospital stay usually one day
• Most activities can be resumed within days
• Full recovery expected within weeks 1

Recent meta-analyses confirm that PFO closure significantly reduces recurrent stroke risk (OR 0.41; 95% CI 0.19-0.90) compared to medical therapy alone, though it increases risk of new-onset atrial fibrillation (OR 4.74; 95% CI 2.33-9.61) 5.