What is the treatment (Tx) of a patent foramen ovale (PFO)?

Treatment of Patent Foramen Ovale (PFO)

For patients under 60 years old with cryptogenic stroke and PFO, strongly recommend PFO closure plus antiplatelet therapy over antiplatelet therapy alone. 1

Treatment Algorithm Based on Clinical Scenario

For Cryptogenic Stroke Patients <60 Years Old

When all treatment options are acceptable:

• Weakly recommend PFO closure + antiplatelet therapy over anticoagulation alone 1
• This approach probably decreases major bleeding compared to anticoagulation 1

When anticoagulation is contraindicated or declined:

• Strongly recommend PFO closure + antiplatelet therapy over antiplatelet therapy alone 1
• Number needed to treat is 20 over 5 years to prevent one stroke 2
• Evidence quality is high for this recommendation 1

When PFO closure is contraindicated or declined:

• Weakly recommend anticoagulation therapy over antiplatelet therapy alone 1

For Patients ≥60 Years Old

Antiplatelet therapy alone is preferred over PFO closure 1, 3

• In older patients, fewer cryptogenic strokes are caused by paradoxical emboli 1
• Benefits of PFO closure are smaller and harms are greater in this age group 1
• Applicability to patients with traditional cerebrovascular risk factors (diabetes, hypertension, hyperlipidemia) is uncertain 1

Special High-Risk Scenario: PFO with Concurrent DVT

This fundamentally changes management approach:

• Immediately initiate therapeutic anticoagulation with bridging heparin or LMWH while transitioning to warfarin (target INR 2.0-3.0) for minimum 3 months 4
• The DVT requires treatment regardless of PFO management decisions 4
• Do not close PFO acutely - active thrombotic state is a relative contraindication to device placement 4
• Consider PFO closure after completing initial anticoagulation course for DVT 4
• Complete hypercoagulable workup - if hypercoagulable state identified, consider long-term anticoagulation beyond initial 3 months 4

High-Risk Anatomic Features: PFO with Atrial Septal Aneurysm

This combination significantly increases stroke risk:

• Odds ratio of 15.59 for ischemic stroke in patients <55 years (compared to 6.14 for atrial septal aneurysm alone and 3.1 for PFO alone) 2
• Strongly recommend PFO closure + antiplatelet therapy over antiplatelet therapy alone in patients <60 years with cryptogenic stroke 2
• Atrial septal aneurysm (>10mm excursion) is a marker of increased embolic risk 2

Procedural Details for PFO Closure

Practical considerations:

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

Device-related risks:

• Device-related adverse events occur in 3.6-5.9% of cases 1, 2
• Atrial fibrillation occurs in 4.6% of patients undergoing closure 2

Medical Therapy Specifications

Post-closure antiplatelet therapy:

• Dual antiplatelet therapy initially after PFO closure, then transition to long-term single antiplatelet therapy 2

Antiplatelet therapy alone (when closure not performed):

• Aspirin 75-325 mg daily 3, 2
• Alternative antiplatelet agents are acceptable 2

Anticoagulation therapy (when indicated):

• Warfarin with target INR 2.0-3.0 3

Diagnostic Approach

Initial screening:

• Transthoracic echocardiography with color Doppler can identify PFO by visualizing flow between atria 3, 2
• Valsalva maneuver during bubble study increases sensitivity 3, 2

When closure is planned:

• Transesophageal echocardiography (TEE) has higher sensitivity than transthoracic imaging 3, 2
• TEE is recommended in younger adults with unexplained cerebrovascular events for detailed visualization of atrial septal anatomy 3, 2

Asymptomatic/Incidental PFO

No intervention required:

• Patients with incidentally discovered PFO require only reassurance 4
• PFO is a normal variant in asymptomatic individuals (present in ~25% of adult population) 4, 5

Critical Pitfalls to Avoid

Do not close PFO in:

• Patients ≥60 years old 2
• Patients where PFO is likely incidental 2
• Patients requiring chronic anticoagulation for other indications (e.g., atrial fibrillation) 3, 2
• Patients with active thrombotic state (defer until after completing DVT treatment) 4

Do not discharge patients with concurrent DVT without anticoagulation:

• The DVT requires treatment regardless of PFO management decisions 4

Recognize uncertainty in older literature:

• Earlier trials (pre-2018) showed insufficient data for PFO closure recommendations 1
• Intention-to-treat analysis was negative, but as-treated analysis showed benefit (recurrent events 3.6% with closure vs 5.8% with medical therapy) 1

Non-Stroke Indications (Insufficient Evidence)

Not routinely recommended for:

• Migraine with aura - insufficient evidence 1, 6
• Decompression sickness in divers - may warrant closure only with multiple recurrences in high-volume divers wishing to continue diving 1, 6
• Platypnea-orthodeoxia syndrome - individualized approach may be justified 6
• Non-cerebral paradoxical embolism (MI, renal infarction, limb ischemia) - no support from evidence-based medicine for routine closure 1, 6