From the Guidelines
PFO closure is recommended for carefully-selected patients aged 60 years or younger with an unexplained embolic stroke event who have a PFO and do not require chronic anticoagulant therapy for another reason. The treatment of patent foramen ovale (PFO) has evolved with recent trials providing evidence for its closure in specific patient populations. According to the Canadian Stroke Best Practice Recommendations [ 1 ], PFO closure has been shown to be superior to medical therapy for prevention of stroke recurrence in carefully-selected patients.
Key Considerations for PFO Closure
- The CLOSE trial [ 1 ] demonstrated a significant reduction in stroke rate with PFO closure compared to antiplatelet therapy alone, with a number needed to treat (NNT) of 20 to prevent 1 stroke in 5 years.
- The REDUCE trial [ 1 ] also showed a reduced rate of ischemic stroke with PFO closure, with an NNT of 28 to prevent 1 stroke in 2 years.
- The RESPECT trial [ 1 ] reported an extended follow-up with a reduced rate of recurrent ischemic stroke with PFO closure, particularly in patients with an atrial septal aneurysm or a substantial shunt size.
Patient Selection for PFO Closure
- Patients should be aged 60 years or younger with an unexplained embolic stroke event and a PFO.
- The presence of an atrial septal aneurysm or a large interatrial shunt increases the likelihood of PFO closure being beneficial.
- Patients should not require chronic anticoagulant therapy for another reason.
- Patient counseling and shared decision-making are crucial, taking into account patient values and preferences, as well as the benefits and risks of the procedure.
Alternative Treatment Options
- Antiplatelet therapy alone is recommended for patients who are not candidates for PFO closure, unless there is a separate evidence-based indication for anticoagulant therapy.
- Anticoagulation therapy may be prescribed for patients with PFO who are at high risk of stroke or have other indications for anticoagulation.
From the Research
Treatment Options for Patent Foramen Ovale (PFO)
- Medical treatment is often the primary approach for patients with cryptogenic stroke and PFO, as closure has restrictive eligibility criteria 2.
- Anticoagulation and antiplatelet treatment are two medical treatment options, with anticoagulation conveying no net benefit in prevention of recurrent stroke in most patients, but potentially benefiting those with high RoPE scores 2.
- PFO closure can be considered for the prevention of recurrent cryptogenic stroke in patients aged ≤60 years after a thorough evaluation and discussion about benefits and potential risks 3.
PFO Closure
- The cumulative evidence indicates that PFO closure reduces the risk of recurrent stroke in carefully selected young cryptogenic stroke patients, with an annualized risk reduction of ∼0.6% 4.
- The benefit of PFO closure is particularly evident in patients with embolic appearing strokes, large right-to-left shunt, or an associated atrial septal aneurysm 4.
- PFO closure is accompanied by a small risk of major procedural complication and atrial fibrillation 4, 3.
Anticoagulation Therapy
- Direct Oral Anticoagulants (DOACs) may be ineffective in preventing thrombus formation on device surfaces after PFO closure, and their use is not routinely recommended within the first 3 months after device implantation 5.
- Apixaban can be used as a secondary prophylaxis agent for PFO-associated stroke, and has been shown to be effective in preventing recurrent stroke and venous thromboembolism events 6.
Patient Selection
- The RoPE score can help identify patients with cryptogenic stroke and PFO who may benefit from PFO closure, with a score of 7,8, and 9-10 corresponding to a causal risk of 72%, 84%, and 88%, respectively 3.
- Patients with small deep infarcts, a small PFO, or an indication for long-term anticoagulation may not benefit from PFO closure 4.