Is an elderly male with a history of transient ischemic attack (TIA) and a small patent foramen ovale (PFO) with right-to-left shunt a candidate for a PFO closure device?

PFO Closure in Elderly Male with TIA

In an elderly male with TIA and small PFO, closure is NOT recommended based on current guidelines, which restrict device closure to patients aged 18-60 years. 1, 2

Age as the Primary Exclusion Criterion

The most critical factor determining candidacy is age. Current guidelines explicitly limit PFO closure to patients between 18 and 60 years old with cryptogenic stroke or TIA. 1, 2 This age cutoff is based on the major randomized trials that excluded patients over 60, and guideline-writing bodies have not extended recommendations beyond this age range despite emerging evidence. 2

Why Guidelines Restrict Closure in Elderly Patients

• Insufficient trial data: The landmark trials demonstrating benefit (REDUCE, RESPECT, CLOSE) specifically enrolled patients ≤60 years, creating an evidence gap for older populations. 2
• Competing stroke mechanisms: Elderly patients have higher rates of atherosclerosis, atrial fibrillation, and other stroke etiologies that make PFO less likely to be the true culprit. 1, 3
• Risk-benefit uncertainty: Procedural risks (atrial fibrillation 4.6-6.6%, device-related complications 1.4-5.9%) may outweigh benefits when stroke recurrence risk from PFO alone is uncertain. 2

The Emerging Evidence Contradiction

However, recent high-quality research directly challenges this age restriction. A 2024 Korean multicenter study of 437 patients aged ≥60 years (mean age 68.1) with cryptogenic stroke and PFO found that device closure significantly reduced recurrent ischemic stroke or TIA compared to medical therapy alone (HR 0.45,95% CI 0.24-0.84, p=0.012). 4 In the high-risk PFO subgroup (those with atrial septal aneurysm or large shunt), closure reduced ischemic stroke alone by 53% (HR 0.47,95% CI 0.23-0.95, p=0.035). 4

Additionally, a 2020 population-based study demonstrated that stroke recurrence risk in elderly patients with PFO increases with age, reaching 3.27 per 100 patient-years in those ≥60 years—higher than younger cohorts—suggesting elderly patients may actually derive greater benefit from closure. 5

Practical Decision Algorithm for This Patient

Step 1: Confirm cryptogenic nature of TIA

• Exclude atrial fibrillation through prolonged cardiac monitoring (minimum 30 days). 1, 2
• Rule out significant carotid stenosis, left atrial thrombus, and severe thoracic aortic atherosclerosis. 1, 2
• Confirm cortical symptoms or positive neuroimaging consistent with embolic mechanism. 6

Step 2: Assess PFO risk features

• Determine shunt size (small shunts visible only with Valsalva have lower attributable risk). 2
• Evaluate for atrial septal aneurysm (increases stroke risk 15-fold in younger patients, likely similar in elderly). 2
• Search for deep vein thrombosis or pulmonary embolism to support paradoxical embolism diagnosis. 1, 6

Step 3: Apply guideline-based recommendation

• If patient is >60 years: Closure is NOT recommended per current guidelines; initiate medical therapy with antiplatelet agent (aspirin or clopidogrel). 1, 2, 6
• Consider anticoagulation only if venous thromboembolism or hypercoagulable state is documented. 6

Step 4: Consider off-guideline closure in highly selected cases

• If patient has high-risk PFO features (atrial septal aneurysm or large shunt), discuss with multidisciplinary team including interventional cardiologist and neurologist. 1
• Counsel patient that closure in elderly patients is off-label, lacks guideline support, but has emerging evidence of benefit. 4
• If closure pursued, ensure no contraindications: no need for long-term anticoagulation, no lacunar stroke pattern, acceptable procedural risk profile. 2

Critical Pitfalls to Avoid

• Do not assume PFO is causal without excluding other mechanisms: Elderly patients have multiple competing stroke etiologies, and PFO may be an incidental finding. 1, 3
• Do not close small PFOs without high-risk features: Small shunts visible only with Valsalva in elderly patients have uncertain benefit and definite procedural risk. 2
• Do not proceed with closure if patient requires anticoagulation: The benefit of mechanical closure is negated when anticoagulation is already indicated. 2
• Do not use dual antiplatelet therapy: Guidelines recommend single antiplatelet agent or anticoagulation, not DAPT, for PFO-associated stroke. 6

Recommended Management for This Patient

Initiate single antiplatelet therapy (aspirin 81-325 mg daily or clopidogrel 75 mg daily) as the guideline-concordant approach. 6 If the patient has high-risk PFO features (atrial septal aneurysm or large shunt documented on echocardiography), present the emerging evidence for closure to the patient and consider referral to a center with expertise in PFO closure in elderly patients, acknowledging this represents off-guideline practice with Class IIb evidence at best. 2, 4

The recurrence rate on medical therapy in elderly patients with PFO is approximately 2-3% per year, which may justify more aggressive intervention in highly selected cases, but current guidelines do not support routine closure based on age alone. 5, 4