What are the guidelines for patent foramen ovale (PFO) closure in a patient with a history of embolic stroke?

Guidelines for PFO Closure in Embolic Stroke

For carefully-selected patients aged 18-60 years with cryptogenic embolic stroke attributed to PFO, PFO closure plus antiplatelet therapy is strongly recommended over antiplatelet therapy alone. 1

Patient Selection Criteria

All of the following criteria must be met before recommending PFO closure: 1

• Age 18-60 years (benefits uncertain and likely smaller in patients >60 years due to fewer cryptogenic strokes caused by paradoxical emboli) 1
• Confirmed embolic stroke on imaging - specifically a non-lacunar embolic ischemic stroke or TIA with positive neuroimaging or cortical symptoms 1
• Thorough etiological evaluation completed to exclude alternative stroke mechanisms including:
  • Prolonged rhythm monitoring to exclude atrial fibrillation 1
  • Transoesophageal echocardiography or alternative imaging of aorta and left atrial appendage to rule out atherothrombosis or left atrial clot 1
  • Carotid ultrasonography, CT, or MRI to rule out cerebrovascular disease 1
• PFO determined to be the most likely cause by a neurologist or clinician with stroke expertise 1
• Evaluation by multidisciplinary team with both stroke and cardiovascular expertise 1

Treatment Algorithm

When All Options Are Acceptable:

PFO closure plus antiplatelet therapy is recommended over anticoagulation therapy (weak recommendation), as most patients prefer avoiding long-term bleeding risk from anticoagulation over the relatively small procedural risks. 1

When Anticoagulation is Contraindicated or Declined:

PFO closure plus antiplatelet therapy is strongly recommended over antiplatelet therapy alone (strong recommendation), with high-quality evidence showing substantial stroke reduction benefit. 1

When PFO Closure is Contraindicated or Declined:

Either antiplatelet or anticoagulant therapy is recommended for patients aged ≤60 years, unless there is a separate evidence-based indication for chronic anticoagulation. 1, 2 The American Heart Association recommends antiplatelet therapy as the primary option, with anticoagulation reserved for specific high-risk scenarios. 2

Expected Benefits and Risks

Benefits of PFO Closure:

• Absolute recurrent stroke risk reduction of 3.4% at 5 years 3
• Relative risk reduction of recurrent stroke: 46-100% 4
• Annualized absolute stroke reduction: 0.49-1.32% per year 4
• Number needed to treat: 18-44 patients to prevent one stroke recurrence over 2-10 years 5

Risks of PFO Closure:

• Periprocedural complication rate: 3.9% (serious but infrequent) 3
• Increased atrial fibrillation risk: 0.33% per year (non-periprocedural) 3
• Procedure duration: under 2 hours with 1-day hospital stay and full recovery within weeks 1

Special Populations and Contraindications

Higher Risk Patients (Consider Medical Therapy Instead):

• Patients with identified higher-risk alternative stroke mechanism should not routinely undergo PFO closure 3
• Patients with small deep (lacunar) infarcts may have little or no benefit 6
• Patients with small PFO without atrial septal aneurysm may have minimal benefit 6
• Patients requiring long-term anticoagulation for other indications - decision remains unclear and should be based on individual risk-benefit profile 1

Patients Who Benefit Most:

• Embolic-appearing strokes 3
• Large right-to-left shunt 6
• Associated atrial septal aneurysm 6
• High RoPE (Risk of Paradoxical Embolism) score >8 with at least one clinical risk factor 1, 7

Post-Closure Management

Dual antiplatelet therapy (DAPT) for 1-3 months, followed by single antiplatelet therapy for 6 months is recommended, though antiplatelet therapy may be continued indefinitely or discontinued after this period. 1, 7

Critical Caveats

• PFO is present in approximately 25% of the general population and may be an incidental finding rather than the stroke cause 1, 6, 3
• Certainty of causation is impossible to determine - clinicians must counsel patients that it is difficult to establish with certainty whether the PFO caused their stroke 1, 3
• Timing of closure should be as early as possible after stroke, as evidence for late closure is limited 7
• Patients with evidence of deep vein thrombosis or venous thromboembolism require anticoagulation regardless of PFO status 1