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

PFO Closure Guidelines for Cryptogenic Stroke

For patients under 60 years old with cryptogenic stroke and patent foramen ovale (PFO), PFO closure followed by antiplatelet therapy is strongly recommended over antiplatelet therapy alone to reduce recurrent stroke risk. 1

Patient Selection Criteria

Recommended for PFO Closure:

• Age under 60 years
• Cryptogenic ischemic stroke (after extensive workup for other stroke etiologies is negative)
• Confirmed PFO on echocardiography
• No contraindications to the procedure or antiplatelet therapy

High-Risk PFO Features (Stronger Benefit from Closure):

• PFO with atrial septal aneurysm
• Large shunt size (≥2 mm separation between septum primum and secundum)
• Hypermobile septum (phasic septal excursion ≥10 mm) 2

Treatment Algorithm

1. If patient is open to all options:

   • Weak recommendation for PFO closure plus antiplatelet therapy over anticoagulation therapy 1
   • Discuss both options with patient

2. If anticoagulation is contraindicated or declined:

   • Strong recommendation for PFO closure plus antiplatelet therapy over antiplatelet therapy alone 1
   • Meta-analyses show significant reduction in recurrent stroke with PFO closure (RR=0.36,95% CI: 0.17-0.79) 3

3. If PFO closure is contraindicated or declined:

   • Weak recommendation for anticoagulant therapy over antiplatelet therapy 1

Procedural Considerations

• Procedure typically takes under 2 hours
• In-hospital stay is usually one day
• Most activities can be resumed within a few days
• Full recovery expected within a few weeks 1

Benefits of PFO Closure

• Significantly reduces recurrent stroke risk compared to medical therapy alone
• The effect is more pronounced in patients with high-risk anatomical features:
  • Patients with atrial septal aneurysm or large shunt: RR=0.27 (95% CI: 0.11-0.70)
  • Patients without these features: RR=0.80 (95% CI: 0.43-1.47) 3

Potential Complications and Risks

• New-onset atrial fibrillation:

  • More frequent with PFO closure (RR=4.33,95% CI: 2.37-7.89) 3
  • Usually occurs within first year after procedure 1

• Device-related adverse events:

  • Occur in approximately 2.40% of procedures (95% CI: 1.03-4.25) 3
  • May include pericardial effusion and pseudoaneurysm 2

Important Caveats

• Age limitation: Benefits are less certain in patients over 60 years
• Comorbidities: Benefits are less certain in patients with traditional cerebrovascular risk factors (diabetes, hypertension, hyperlipidemia)
• Rationale: In older patients, fewer cryptogenic strokes are caused by paradoxical emboli, so benefits of PFO closure would likely be smaller and harms potentially greater 1

Follow-up Management

• After PFO closure, patients should receive antiplatelet therapy
• Regular follow-up to monitor for device-related complications and atrial fibrillation
• Ongoing management of other stroke risk factors

Evidence Quality

The recommendation for PFO closure in appropriate patients is supported by multiple randomized controlled trials and meta-analyses showing consistent benefit in reducing recurrent stroke risk, particularly in younger patients with high-risk PFO features 1, 3, 4, 5.