What is the initial management approach for patients with a patent foramen ovale (PFO)?

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Last updated: June 3, 2025View editorial policy

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From the Guidelines

The initial management approach for patients with a patent foramen ovale (PFO) should prioritize antiplatelet therapy, with PFO closure considered for carefully selected patients under 60 years with cryptogenic stroke and high-risk PFO features. For asymptomatic patients with incidentally discovered PFOs, observation without specific treatment is typically recommended as these defects carry minimal risk [ 1 ]. For patients who have experienced a cryptogenic stroke with a PFO, antiplatelet therapy with aspirin (81-325 mg daily) is often the first-line treatment [ 1 ]. In cases of recurrent stroke despite antiplatelet therapy, or in patients with high-risk PFO features (large shunt, atrial septal aneurysm), anticoagulation with warfarin or direct oral anticoagulants may be considered [ 1 ]. Some key points to consider in the management of PFO include:

  • PFO closure via percutaneous device placement is reserved for patients under 60 years with cryptogenic stroke and high-risk PFO features who have failed medical therapy [ 1 ].
  • Lifestyle modifications including smoking cessation and maintaining healthy blood pressure are also important components of management.
  • Patient counseling and shared decision-making, taking into account patient values and preferences, are important considerations [ 1 ].
  • The benefits and risks of PFO closure, including the risk of procedural complications such as atrial fibrillation, should be carefully weighed [ 1 ]. Recent studies, including the CLOSE trial [ 1 ] and the REDUCE trial [ 1 ], have demonstrated the effectiveness of PFO closure in preventing recurrent stroke in carefully selected patients. However, the decision to proceed with PFO closure should be made on a case-by-case basis, taking into account the individual patient's risk factors and medical history [ 1 ].

From the Research

Initial Management Approach for Patients with Patent Foramen Ovale (PFO)

The initial management approach for patients with a patent foramen ovale (PFO) depends on various factors, including the presence of cryptogenic stroke, atrial septal aneurysm, or large interatrial shunt.

  • The optimal antithrombotic strategy is still unclear, but studies suggest that anticoagulation may not convey a net benefit in prevention of recurrent stroke compared to antiplatelet treatment 2.
  • PFO closure plus antiplatelet therapy may result in a substantial reduction in ischemic stroke recurrence compared to antiplatelet therapy alone, especially in patients with high-risk features such as atrial septal aneurysm or large interatrial shunt 3, 4, 5.
  • Anticoagulation may reduce the risk of ischemic stroke recurrence, but it also increases the risk of major bleeding 3, 5.
  • The choice of management strategy should be individualized based on patient characteristics, risk factors, and the presence of contraindications to certain treatments.

Comparison of Management Strategies

  • PFO closure vs. antiplatelet therapy: PFO closure may be associated with a lower risk of recurrent stroke, but it also increases the risk of procedural complications and atrial fibrillation 4, 5.
  • PFO closure vs. anticoagulation: PFO closure may be associated with a lower risk of major bleeding, but the difference in stroke recurrence is uncertain 3, 5.
  • Anticoagulation vs. antiplatelet therapy: Anticoagulation may reduce the risk of ischemic stroke recurrence, but it also increases the risk of major bleeding 2, 3, 5.

Patient Selection and Risk Stratification

  • The RoPE score may help in selecting patients who would benefit from anticoagulation 2.
  • Patients with high-risk features such as atrial septal aneurysm or large interatrial shunt may benefit from PFO closure or anticoagulation 3, 4, 5.
  • Further studies are needed to delineate the risk/benefit profile of different management strategies and to develop personalized treatment approaches for patients with PFO.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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