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

Indications for Patent Foramen Ovale (PFO) Closure

PFO closure is primarily indicated for patients aged 18-60 years with cryptogenic stroke or TIA attributed to a PFO after thorough evaluation has excluded alternative etiologies. 1

Primary Indications for PFO Closure

Cryptogenic Stroke/TIA

• Strong indication (Class A evidence) when ALL of the following criteria are met 2:
  • Age 18-60 years
  • Confirmed non-lacunar embolic ischemic stroke or TIA with positive neuroimaging or cortical symptoms
  • PFO determined to be the most likely cause after thorough evaluation excluding alternate etiologies
  • Presence of high-risk PFO features (moderate to large right-to-left shunt or associated atrial septal aneurysm)

Other Potential Indications (Individualized Decision-Making Required)

• Decompression sickness/Professional divers 2, 1:

  • Multiple recurrences in high-volume divers, compressed-air tunnel workers, high-altitude aviators, astronauts
  • Particularly those who wish to continue their high-risk occupations
  • Should be performed in centers maintaining closure registries or participating in trials

• Right-sided cardiac disease 2, 1:

  • Patients with elevated right-sided filling pressures predisposed to right-to-left shunting
  • Consider when significant hypoxemia is present due to right-to-left shunting
  • Note: May provide intermediate-term palliation, but longer-term worsening of RV function may occur

• Peripheral embolism 2:

  • Documented paradoxical embolism to peripheral arteries
  • After exclusion of other potential sources

Conditions Where PFO Closure is NOT Recommended

• Patients >60 years with incidental PFO 2, 1
• Migraine with aura (insufficient evidence) 2
• Primary stroke prevention 1
• Asymptomatic PFO 1

Risk Stratification for PFO Closure Decision

Higher likelihood of benefit from closure if:

• Young age (18-60 years) 2, 1
• Substantial right-to-left shunt (>25 microbubbles) 2, 3
• Presence of atrial septal aneurysm 2, 4
• No alternative explanation for stroke/TIA 1

Diagnostic Evaluation Before Considering Closure

• Transesophageal echocardiography with contrast and Valsalva maneuver (preferred method) 1
• Complete evaluation to exclude:
  • Atrial fibrillation
  • Aortic atherothrombosis or left atrial clot
  • Cerebrovascular disease
  • Other potential causes of stroke/TIA

Outcomes and Complications

• PFO closure reduces recurrent stroke risk compared to medical therapy alone:
  • NNT = 28 to prevent 1 stroke in 2 years 2
  • NNT = 42 to prevent 1 stroke in 5 years 2
• Potential complications:
  • Serious device-related adverse events: 1.4% 2
  • Post-procedure atrial fibrillation: 6.6% (mostly transient) 2

Special Considerations

• For patients requiring long-term anticoagulation for other reasons, the benefit of PFO closure is less clear 2
• Real-world data suggests PFO closure may be beneficial in selected high-risk patients >60 years, though randomized evidence is lacking 4
• Low-risk PFOs (small shunt, no atrial septal aneurysm) may be adequately managed with medical therapy alone 4

Common Pitfalls to Avoid

• Recommending PFO closure in patients >60 years despite lack of proven benefit
• Assuming PFO causality without thorough evaluation for other stroke etiologies
• Overtreatment of incidentally found PFOs without history of cryptogenic stroke
• Failing to recognize that small PFOs carry lower risk than those with large shunts or associated atrial septal aneurysm 1