What is the management approach for a patient with a patent foramen ovale (PFO) and does the size of the PFO matter?

Management of Patent Foramen Ovale

For patients under 60 years old with cryptogenic stroke and PFO, PFO closure plus antiplatelet therapy is strongly recommended over antiplatelet therapy alone when anticoagulation is contraindicated or declined. 1

Does PFO Size Matter?

Yes, PFO size significantly impacts stroke risk and treatment decisions. The presence of a large right-to-left shunt substantially increases the benefit of closure, while small PFOs may provide little to no benefit from intervention. 2

High-Risk PFO Features That Matter:

• Large right-to-left shunt increases the likelihood that PFO is pathogenic and predicts greater benefit from closure 2
• Associated atrial septal aneurysm (>10mm excursion) dramatically increases stroke risk with an odds ratio of 15.59 in patients under 55 years, compared to 3.1 for PFO alone 3
• Embolic-appearing strokes on imaging suggest PFO as the mechanism and predict better outcomes with closure 2

Management Algorithm by Clinical Scenario

For Patients <60 Years with Cryptogenic Stroke:

When all treatment options are acceptable:

• Weak recommendation for PFO closure plus antiplatelet therapy over anticoagulation alone 1
• This approach probably decreases major bleeding compared to anticoagulation 4

When anticoagulation is contraindicated or declined:

• Strong recommendation for PFO closure plus antiplatelet therapy versus antiplatelet therapy alone 1
• Number needed to treat is 20 over 5 years to prevent one recurrent stroke 3

When PFO closure is contraindicated or declined:

• Weak recommendation for anticoagulation over antiplatelet therapy alone 1

For Patients ≥60 Years with Cryptogenic Stroke:

• Antiplatelet therapy alone is preferred over PFO closure 4
• Benefits of closure are smaller and harms greater in older patients 4
• PFO closure is not recommended in this age group 3

For Asymptomatic PFO (Incidental Finding):

• Reassurance only—no intervention required 4
• PFO is a normal variant present in approximately 25% of the general population 5, 2

Special Clinical Scenarios

PFO with Concurrent Deep Vein Thrombosis:

This fundamentally changes management and represents a high-risk scenario for paradoxical embolism. 4

• Immediate therapeutic anticoagulation for minimum 3 months to treat the DVT (target INR 2.0-3.0) 4
• Complete hypercoagulable workup during anticoagulation period 4
• Consider PFO closure after completing initial anticoagulation course for the acute thrombotic event 4
• Do not close PFO acutely—active thrombotic state is a relative contraindication to device placement 4
• If hypercoagulable disorder identified, continue long-term anticoagulation beyond initial 3 months 4

PFO with Atrial Septal Aneurysm:

• PFO closure plus antiplatelet therapy is strongly recommended for patients under 60 with cryptogenic stroke 3
• This combination increases stroke risk 15-fold compared to neither condition 3
• Atrial septal aneurysm is a marker of increased embolic risk and often associated with septal fenestrations 3

Diagnostic Workup Requirements

Before attributing stroke to PFO, extensive workup must exclude other etiologies. 1

Imaging Approach:

• Transthoracic echocardiography with color Doppler as initial test, with Valsalva maneuver during bubble study to increase sensitivity 3, 6
• Transesophageal echocardiography (TEE) has higher sensitivity and is recommended in younger adults with unexplained cerebrovascular events 3, 6
• TEE is mandatory when PFO closure is planned for detailed visualization of atrial septal anatomy 6

Risk Stratification Tool:

• Use the Risk of Paradoxical Embolism (RoPE) score to predict probability of pathogenic PFO 7

PFO Closure Procedural Details

The procedure typically takes under 2 hours with 1-day hospital stay. 3, 6

Expected Recovery:

• Most activities resumed within days 3, 6
• Full recovery within weeks 3, 6

Complication Rates:

• Device-related adverse events: 5.9% 3
• Atrial fibrillation: 4.6% 3
• Major procedural complications are small but present 2

Post-Procedure Antiplatelet Therapy:

• Dual antiplatelet therapy initially after closure 3
• Transition to long-term single antiplatelet therapy 3
• Aspirin 75-325 mg daily is standard, with alternative antiplatelet agents acceptable 3, 6

Medical Therapy Specifications

Antiplatelet Therapy Alone:

• Aspirin 75-325 mg daily 3, 6
• Alternative antiplatelet agents acceptable 3

Anticoagulation Therapy:

• Warfarin with target INR 2.0-3.0 when indicated 6
• Direct oral anticoagulants (DOACs) have not been studied in randomized trials for this indication 7

Critical Pitfalls to Avoid

Do not close PFO in these situations:

• Patients over 60 years old 3, 4
• Patients where PFO is likely incidental (small deep infarcts, small PFO without high-risk features) 3, 2
• Patients requiring chronic anticoagulation for other indications (e.g., atrial fibrillation) 3, 6
• Active thrombotic state (defer until after DVT treatment) 4

Do not assume PFO is causative without thorough workup:

• PFO is present in 1 in 4 adults and should not be considered the stroke cause until alternative mechanisms are excluded 2
• Small deep infarcts suggest alternative mechanisms and may derive little benefit from closure 2

Do not discharge patients with concurrent DVT without anticoagulation:

• The DVT requires treatment regardless of PFO management decisions 4