Which stroke patients with a Patent Foramen Ovale (PFO) would benefit from PFO closure and who would not?

PFO Closure in Stroke Patients: Who Benefits and Who Does Not

PFO closure plus antiplatelet therapy is strongly recommended for carefully selected patients aged 18-60 years with cryptogenic embolic stroke when the PFO is determined to be the most likely cause, but should not be performed in patients over 60 years or when the PFO is likely incidental. 1, 2

Patients Who BENEFIT from PFO Closure

Essential Selection Criteria (All Must Be Met)

• Age 18-60 years - This is a strict cutoff; older patients derive minimal benefit with greater procedural risks 1, 2
• Confirmed nonlacunar embolic stroke on imaging - Lacunar strokes are excluded as they suggest small vessel disease, not paradoxical embolism 1
• Cryptogenic stroke after thorough evaluation - Must exclude atrial fibrillation (prolonged rhythm monitoring), carotid disease (ultrasonography/imaging), aortic atherothrombosis, and left atrial clot (transesophageal echocardiography) 1, 3
• Cortical infarct pattern - Suggests embolic mechanism rather than lacunar/small vessel disease 1
• No indication for long-term anticoagulation - If anticoagulation is required for another reason, closure benefit is unclear 1, 2

High-Risk Anatomical Features That Increase Benefit

Patients with these PFO characteristics derive the greatest benefit from closure:

• Large right-to-left shunt - Defined as >20 microbubbles on bubble study with Valsalva maneuver 1, 4
• Atrial septal aneurysm - This combination increases stroke risk 15-fold and shows the strongest benefit from closure 1, 2, 4
• Substantial shunt size - Grade 3 shunts show greater benefit in subgroup analyses 1

Clinical Risk Stratification Tools

RoPE Score >8 identifies patients most likely to have PFO-related stroke 1, 3:

• Younger age (higher points)
• Absence of hypertension, diabetes, prior stroke/TIA
• Cortical infarct on imaging
• No smoking history

The PASCAL classification system combines RoPE score with anatomical features to categorize PFO as "probable," "possible," or "unlikely" cause of stroke 4, 5. Patients classified as PASCAL "probable" show 90% relative risk reduction with closure (absolute risk reduction 2.1% at 2 years) 5.

Expected Benefit

• Number needed to treat: 20-28 patients over 5 years to prevent one recurrent stroke 1, 2
• Annualized stroke rate: 0.47% with closure vs 1.09% with medical therapy alone 5
• Hazard ratio for recurrent stroke: 0.23-0.41 depending on patient selection 1, 5

Patients Who Do NOT Benefit (or Are Harmed)

Absolute Contraindications to PFO Closure

Age >60 years - This is a critical exclusion 1, 2:

• Older patients have competing stroke mechanisms (atherosclerosis, atrial fibrillation)
• Procedural risks outweigh minimal benefits
• The procedure "should rarely be performed in older patients and only in very unusual clinical circumstances" 1

Lacunar stroke pattern - Small deep infarcts suggest small vessel disease, not paradoxical embolism; all trials showing benefit excluded lacunar strokes 1

Alternative stroke mechanism identified - If prolonged monitoring reveals atrial fibrillation, significant carotid stenosis (>40%), or other definite cause, the PFO is incidental 1, 2

Requirement for long-term anticoagulation - Patients needing anticoagulation for atrial fibrillation, mechanical valve, or other indication should receive anticoagulation alone; closure decision remains unclear 1, 2

Low-Risk PFO Features (Likely Incidental)

PASCAL "unlikely" classification 4, 5:

• Older patients with vascular risk factors
• Small PFO without atrial septal aneurysm
• Small shunt size
• RoPE score <3 (PFO prevalence similar to general population at 23%) 5

Presence of competing vascular risk factors 1:

• Hypertension, diabetes, hyperlipidemia
• Proximal large artery disease with 40% stenosis
• These suggest alternative stroke mechanisms

Procedural Risks to Consider

• Atrial fibrillation: 4.6-6.6% incidence post-procedure (vs 0.4% with medical therapy) 1, 2
• Device-related adverse events: 5.9% of cases 2
• Serious complications: Rare but include device embolization, cardiac perforation, thrombus formation 1

Management Algorithm

For Patients Meeting Closure Criteria (Age 18-60, Cryptogenic, High-Risk Features)

1. PFO closure plus antiplatelet therapy is the recommended approach 1, 2, 3
2. Post-procedure: Dual antiplatelet therapy for 1-3 months, then single antiplatelet for 6 months minimum 3
3. Long-term cardiac monitoring for atrial fibrillation detection 4

For Patients NOT Meeting Closure Criteria

1. Antiplatelet therapy alone (aspirin 75-325 mg daily) 2, 3
2. Anticoagulation (warfarin INR 2.0-3.0) if deep vein thrombosis identified or other indication exists 1, 2
3. No evidence supports anticoagulation over antiplatelet therapy for PFO alone without DVT 1

Critical Pitfalls to Avoid

Do not assume PFO is causative without excluding alternatives - PFO is present in 25% of the general population; thorough workup is mandatory 6, 5

Do not close PFO in patients >60 years - This age group has minimal benefit and greater harm 1, 2

Do not close small PFOs in patients with vascular risk factors - These patients likely have alternative stroke mechanisms 1, 5

Do not perform closure for primary prevention - There is no indication for closure in asymptomatic patients 1

Ensure multidisciplinary evaluation - Both stroke neurology and cardiovascular expertise are required for proper patient selection 1, 3