What treatment options are available for a patient with a patent foramen ovale (PFO) and is intervention always required?

Patent Foramen Ovale Management: Intervention Is NOT Always Required

Intervention for patent foramen ovale (PFO) is NOT routinely required—treatment depends entirely on whether the patient has had a cryptogenic stroke and their age. Most people with PFO need no treatment at all.

When PFO Requires NO Intervention

For asymptomatic patients with incidentally discovered PFO, no intervention or medical therapy is indicated. 1 PFO is present in approximately 25% of the general adult population and does not increase stroke risk in asymptomatic individuals. 1, 2

Key Point on Asymptomatic PFO:

• No closure, no antiplatelet therapy, no anticoagulation needed 1
• PFO is a normal variant in these patients requiring only reassurance 3

When PFO DOES Require Intervention

Intervention is indicated specifically for patients under 60 years old with cryptogenic stroke after extensive workup excludes other stroke etiologies. 3, 4

Treatment Algorithm for Cryptogenic Stroke + PFO:

For patients <60 years with cryptogenic stroke:

1. If anticoagulation is contraindicated or declined:

   • STRONG recommendation: PFO closure + antiplatelet therapy 3
   • This provides substantial stroke reduction benefit 3
   • Procedure takes <2 hours, 1-day hospital stay, full recovery in weeks 3

2. If all treatment options are acceptable to the patient:

   • Weak recommendation: PFO closure + antiplatelet therapy over anticoagulation alone 3
   • PFO closure probably decreases major bleeding compared to anticoagulation 3
   • Trade-off: 5% absolute risk of persistent atrial fibrillation with closure 3

3. If PFO closure is contraindicated or declined:

   • Weak recommendation: Anticoagulation over antiplatelet therapy alone 3
   • Possible stroke reduction but increased bleeding risk 3

For patients ≥60 years with cryptogenic stroke:

• Antiplatelet therapy is preferred over PFO closure 4
• Benefits of closure are smaller and harms greater in older patients 3
• Fewer cryptogenic strokes are caused by paradoxical emboli in this age group 3

Risk Stratification Tools

Use the PASCAL classification system to determine if PFO likely caused the stroke: 2

• PASCAL "probable" (younger, no vascular risk factors, high-risk PFO features): 90% relative risk reduction with closure, 2.1% absolute risk reduction 2
• PASCAL "unlikely" (older, vascular risk factors present, no high-risk PFO features): No benefit from closure, only increased procedural risks 2

The RoPE score helps predict PFO causality—scores of 9-10 show 77% PFO prevalence vs 23% with scores <3 2

Special Circumstances

For paradoxical embolism causing MI or other non-cerebral events:

• No established guidelines exist 3
• Individualized approach to closure may be justified after careful consideration 3
• Presence of DVT/PE with PFO increases risk 10-fold for death and 5-fold for arterial thromboembolism 3

Evidence Quality Note

The 2018 BMJ guideline synthesized 6 trials with 3,560 patients showing annualized stroke incidence of 0.47% with closure vs 1.09% with medical therapy alone (hazard ratio 0.41). 2 However, the 2009 AHA/ASA advisory emphasized that randomized trial completion was critical, 3 and subsequent trials (CLOSE, REDUCE, RESPECT long-term, DEFENSE-PFO) published 2017-2018 now provide the high-quality evidence supporting these recommendations. 5, 6

Common Pitfalls to Avoid:

• Do not close PFO in asymptomatic patients—no benefit, only procedural risk 1
• Do not close PFO in patients >60 years without careful risk-benefit discussion 3, 4
• Do not assume all cryptogenic strokes with PFO are caused by PFO—use PASCAL/RoPE scoring 2
• Device-related adverse events occur in 3.6% of closures 3, 4