Treatment for Patent Foramen Ovale (PFO) After Cryptogenic Stroke
For patients under 60 years old with PFO and cryptogenic stroke, PFO closure plus antiplatelet therapy is strongly recommended over antiplatelet therapy alone when anticoagulation is contraindicated or declined. 1
Treatment Algorithm Based on Patient Eligibility
When All Treatment Options Are Acceptable
- Weak recommendation for PFO closure plus antiplatelet therapy over anticoagulation therapy in patients under 60 years with cryptogenic stroke after extensive workup excludes other stroke etiologies 1, 2
- PFO closure probably results in substantial reduction in ischemic stroke recurrence compared to antiplatelet therapy alone (87 fewer strokes per 1000 patients over 5 years) 3
When Anticoagulation is Contraindicated or Declined
- Strong recommendation for PFO closure plus antiplatelet therapy versus antiplatelet therapy alone 1, 2
- This represents the strongest evidence-based recommendation in the treatment algorithm 1
When PFO Closure is Contraindicated or Declined
- Weak recommendation for anticoagulation therapy over antiplatelet therapy alone 1
- Anticoagulation may reduce ischemic stroke recurrence risk by 71 per 1000 patients compared to antiplatelet therapy, though evidence certainty is low 3
Critical Patient Selection Criteria
Age Considerations
- These recommendations specifically apply to patients under 60 years old 1, 2
- For patients over 60 years, antiplatelet therapy is recommended as first-line treatment rather than PFO closure 2
- In older patients, fewer cryptogenic strokes are caused by paradoxical emboli, making PFO closure benefits smaller and harms potentially greater 1
Required Diagnostic Workup
- Extensive evaluation must exclude other stroke etiologies before attributing stroke to PFO 1, 2
- Transesophageal echocardiography is recommended for detailed visualization of atrial septal anatomy when PFO closure is planned 2
- Sensitivity for PFO detection increases with Valsalva maneuver during imaging 2
Procedural Details and Recovery
PFO Closure Procedure
- Procedure duration: under 2 hours 1, 2
- Hospital stay: typically one day 1, 2
- Return to activities: most activities within a few days 1, 2
- Full recovery: within a few weeks 1
Risks and Complications
Device-Related Adverse Events
- Absolute risk of device-related adverse events: 3.6% 1, 2
- High-quality evidence supports this risk estimate 1
Atrial Fibrillation Risk
- PFO closure probably increases risk of persistent atrial fibrillation (18 additional cases per 1000 patients) 3
- Atrial fibrillation occurred in 6.6% of patients after PFO closure in one major trial 4
- Atrial fibrillation requiring treatment was documented in 1.7% of patients in long-term follow-up 5
Bleeding Risk with Anticoagulation
- Anticoagulation probably increases major bleeding risk by 12 per 1000 patients compared to antiplatelet therapy 3
- PFO closure has lower major bleeding risk compared to anticoagulation (20 fewer events per 1000 patients) 3
Medical Therapy Options
Antiplatelet Therapy
- Aspirin 75-325 mg daily is recommended 2
- May be continued indefinitely or discontinued some months after PFO closure 1
Anticoagulation Therapy
- Warfarin with target INR 2.0-3.0 when anticoagulation is indicated 2
- Warfarin was superior to antiplatelet therapy in preventing recurrences in observational data 6
Clinical Outcomes Data
Stroke Recurrence Rates
- PFO closure resulted in 1.4% stroke recurrence versus 5.4% with antiplatelet therapy alone over median 3.2 years follow-up 4
- Hazard ratio for stroke recurrence with PFO closure: 0.23 (95% CI 0.09-0.62) 4
- Long-term follow-up showed recurrent stroke rate of 0.5% (0.55 per 100 person-years) after PFO closure 5
Important Caveats
Applicability Limitations
- Applicability to patients over 60 and those with traditional cerebrovascular risk factors (diabetes, hypertension, hyperlipidemia) is more uncertain 1
- If concurrent atrial fibrillation exists, anticoagulation is indicated regardless of PFO status 2