Treatment algorithm

Please note that formulations/routes and doses may differ between drug names and brands, drug formularies, or locations. Treatment recommendations are specific to patient groups: see disclaimer

ONGOING

asymptomatic with low risk of thrombotic event (not in high risk occupation)

1st line – education and observation

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ONGOING
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asymptomatic with low risk of thrombotic event (not in high risk occupation)
1st line – 

education and observation

Patients with a small PFO and without a prior history of cerebrovascular accident do not require intervention. These patients are without an atrial septal aneurysm or have crossover of very few (<10) microbubbles on contrast injection. The PFO is generally an incidental finding. There is a low risk of paradoxical embolism and the risk-benefit ratio does not favor treatment. Education and observation for any evidence of a paradoxical embolism is all that is required.

asymptomatic with high risk of thrombotic event (not in high-risk occupation)

1st line – observation

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asymptomatic with high risk of thrombotic event (not in high-risk occupation)
1st line – 

observation

Factors denoting high risk of thrombosis are large PFOs with a large number of microbubble crossovers and/or an associated atrial septal aneurysm.[26][27]

Conservative treatment with education and observation for any evidence of a paradoxical embolism may be appropriate care in selected patients.

Consider – anticoagulation or antiplatelet therapy

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asymptomatic with high risk of thrombotic event (not in high-risk occupation)
Consider – 

anticoagulation or antiplatelet therapy

Treatment recommended for SOME patients in selected patient group

Initiation of antiplatelet therapy should be considered, especially in patients with larger PFO defects and associated atrial septal aneurysms.[25]

Usual recommendation is aspirin or clopidogrel rather than warfarin, unless anticoagulation is indicated. There are no clear guidelines on combined usage, although a combination is often used in patients with concomitant coronary artery disease.

Warfarin may be indicated in patients with atrial fibrillation or those with recurrent stroke despite being on antiplatelet therapy. The target international normalized ratio (INR) is 1.5 to 2.0.

Primary options

aspirin: 75-325 mg orally once daily

OR

clopidogrel: 75 mg orally once daily

Secondary options

warfarin: 2-5 mg orally once daily initially, adjust dose according to target INR

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cryptogenic stroke

1st line – percutaneous closure

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cryptogenic stroke
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candidate for percutaneous closure
1st line – 

percutaneous closure

In patients ages 18 to 60 years with established cryptogenic stroke and presence of PFO, it is reasonable to proceed with a percutaneous transcatheter PFO closure procedure along with postoperative antiplatelet therapy to prevent recurrent ischemic events, rather than antiplatelet therapy alone.[25] 

The benefit with PFO closure appears stronger in patients with high-risk features (i.e., large PFO, atrial septal aneurysm).[22]​ 

In patients with low-risk anatomic features of PFO, further risk stratification using the risk of paradoxical embolism (RoPE) score might be beneficial in identifying patients with PFO-related cryptogenic stroke. Factors in the score indicative of a higher likelihood of a PFO-related stroke are the absence of traditional risk factors such as hypertension and diabetes mellitus, prior stroke, cortical infarct on imaging, and younger age.[28]

Prior to percutaneous closure, patients receive antiplatelet therapy or anticoagulation. After PFO closure, antiplatelet therapy is typically recommended. For patients who have indications for chronic anticoagulation, PFO device closure is not indicated.

The PFO procedure is associated with a benefit of an absolute recurrent stroke risk reduction of 3.4% at 5 years, with a periprocedural complication risk of 3.9% and increased absolute rate of nonperiprocedural atrial fibrillation of 0.33% per year.[28]

Evidence is not as strong for PFO closure in patients younger than 18 years or older than 60 years with multiple cardiovascular risk factors. Guidelines support a multidisciplinary approach with involvement of neurology and cardiology teams, along with shared decision making with the patient, in formulating a management plan.[22][23]​​​ 

1st line – anticoagulation or antiplatelet therapy

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ONGOING
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cryptogenic stroke
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not a candidate for percutaneous closure
1st line – 

anticoagulation or antiplatelet therapy

Medical therapy with full anticoagulation is preferred over antiplatelet therapy to decrease recurrent ischemic events in patients with cryptogenic stroke who are not a candidate for a PFO closure procedure. This approach is associated with an increased risk of major bleeding. Careful evaluation of the bleeding profile of the patient and shared decision making is recommended in selecting antiplatelet versus anticoagulation therapy.[25]

If warfarin is used, the target international normalized ratio (INR) is 1.5 to 2.0.

Primary options

warfarin: 2-5 mg orally once daily initially, adjust dose according to target INR

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Secondary options

aspirin: 75-325 mg orally once daily

OR

clopidogrel: 75 mg orally once daily

high-risk occupation

1st line – anticoagulation or antiplatelet therapy

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ONGOING
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high-risk occupation
1st line – 

anticoagulation or antiplatelet therapy

High-risk occupations include deep sea divers, high altitude pilots, and astronauts.

Treatment with anticoagulation or antiplatelet therapy is generally recommended, along with behavioral prevention of decompression sickness.[29]

If warfarin is used, the target international normalized ratio (INR) is 1.5 to 2.0.

Primary options

aspirin: 75-325 mg orally once daily

OR

clopidogrel: 75 mg orally once daily

Secondary options

warfarin: 2-5 mg orally once daily initially, adjust dose according to target INR

More

Consider – percutaneous closure

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ONGOING
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high-risk occupation
Consider – 

percutaneous closure

Treatment recommended for SOME patients in selected patient group

Percutaneous closure of the PFO should be considered on an individual basis for professional scuba divers in whom behavioral prevention methods are not effective in preventing symptoms of decompression sickness.[30] It is unknown whether astronauts need to undergo closure. 

Open surgery is used if the PFO is discovered during open heart surgery for another indication such as bypass or valvular surgery.

Prior to percutaneous closure, patients receive antiplatelet therapy or anticoagulation. After PFO closure, antiplatelet therapy is typically recommended. For patients who have indications for chronic anticoagulation, PFO device closure is not indicated.

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Please note that formulations/routes and doses may differ between drug names and brands, drug formularies, or locations. Treatment recommendations are specific to patient groups. See disclaimer

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