Indications for Patent Foramen Ovale (PFO) Closure
PFO closure is indicated for carefully selected patients aged 18-60 years with cryptogenic embolic stroke and high-risk PFO features (atrial septal aneurysm or moderate-to-large shunt), after excluding other stroke etiologies including atrial fibrillation, left-sided cardiac disease, and severe aortic atherosclerosis. 1
Primary Indication: Cryptogenic Stroke in Young Patients
The strongest evidence supports closure in patients ≤60 years with cryptogenic stroke and high-risk PFO anatomical features. 1 This recommendation carries a Class IIb designation from the American Heart Association and American College of Cardiology, though Canadian guidelines have upgraded this to Level A for carefully-selected patients. 1
High-Risk PFO Features That Favor Closure:
- Atrial septal aneurysm (increases stroke risk with OR 15.59 in patients ≤55 years) 1
- Moderate shunt (6-25 microbubbles on bubble study) or large shunt (>25 microbubbles) 1
- Young age (<45 years shows better outcomes with 0% recurrence vs 35% in those ≥45 years) 2
- High RoPE score (9-10 indicates 77% likelihood PFO caused the stroke) 3
Expected Benefit:
Pooled trial data demonstrates closure reduces stroke recurrence from 5.8% to 3.6% (OR 0.62), with annualized stroke rates of 0.47% vs 1.09% over median 57-month follow-up. 1, 3 In PASCAL "probable" patients (younger, no vascular risk factors, high-risk PFO features), closure provides 90% relative risk reduction (absolute risk reduction 2.1%). 3
Absolute Contraindications to Closure:
Do not close PFO in patients with: 1
- Indication for long-term anticoagulation (benefit unclear in this population)
- Small deep infarcts/lacunar strokes (suggests small vessel disease, not paradoxical embolism)
- Low-risk PFO (no atrial septal aneurysm, small shunt visible only with Valsalva in older patients)
- Age >60 years (uncertain benefit, complications may outweigh benefits)
Critical Pre-Closure Diagnostic Requirements:
Before attributing stroke to PFO, you must exclude: 1
- Atrial fibrillation (extended cardiac monitoring)
- Left-sided cardiac disease (thrombus, valvular disease)
- Severe atherosclerosis of thoracic aorta
- Large artery atherosclerosis causing stroke
Ideally confirm: 1
- Presence of venous thrombosis or pulmonary embolism (supports paradoxical embolism mechanism)
- Cortical infarct pattern on imaging (not lacunar)
Special Populations Where Closure May Be Considered:
Decompression Sickness:
Consider closure only for multiple recurrences in individuals who must continue high-risk activities (high-volume divers, compressed-air tunnel workers, high-altitude aviators, astronauts). 1
Right-Sided Cardiac Disease:
Patients with elevated right atrial pressures causing right-to-left shunting may warrant closure, but this requires highly individualized assessment. 1
Insufficient Evidence/Not Recommended:
- Migraine with aura: Insufficient evidence to recommend closure 1
- Peripheral paradoxical embolism (MI, renal infarction, limb ischemia): No recommendations due to lack of evidence-based support 1
- Small PFO visible only with Valsalva in patients >60 years: Uncertain benefit 1
Procedural Risks to Discuss:
Patients must understand: 1
- Atrial fibrillation: 4.6-6.6% incidence
- Serious device-related adverse events: 1.4-5.9%
- Late complications: Pericardial effusion, device erosion, thrombus formation
- Procedural success rate: 98.9%
- Residual shunt: 5.7% at follow-up 4
Common Pitfalls to Avoid:
Do not close PFO without: 1
- Thorough neurological evaluation excluding other stroke causes
- Transesophageal echocardiography confirming PFO and assessing anatomical features
- Consideration of patient age (benefit diminishes significantly after age 45-60) 2
- Shared decision-making discussion about risks vs benefits
The PASCAL classification system (combining RoPE score with anatomical features) helps identify patients most likely to benefit: "probable" patients show substantial benefit, while "unlikely" patients have higher procedural risks without clear benefit. 3