Objectives Long-term follow-up after percutaneous closure of patent foramen ovale (PFO) in patients with cryptogenic stroke is not well established.
Design Prospective cohort study.
Setting Single tertiary care centre.
Participants 525 consecutive patients (age 51±12 years; 56% male).
Interventions Percutaneous PFO closure without intra-procedural echocardiography.
Main outcome measures Freedom form recurrent embolic events.
Results There were 1.7±1.0 clinically apparent embolic events per patient, and 186 patients (35%) had >1 event. An atrial septal aneurysm was associated with the PFO in 161 patients (31%). All patients were followed prospectively for up to 11 years. The implantation procedure failed in 2 patients (0.4%). There were 13 procedural complications (2.5%) without any long-term sequelae. Contrast transesophageal echocardiography at 6 months showed complete closure in 86% of patients, and a minimal, moderate, or large residual shunt in 9%, 3%, and 2%, respectively. Patients with small occluders (<30 mm; n=429) had less residual shunts (small 11% vs. large 27%; p<0.0001). During a mean follow-up of 2.9±2.2 years (median 2.3 years; total 1,536 patient-years), 6 ischemic strokes, 9 TIAs and 2 peripheral emboli occurred. Freedom from recurrent stroke, TIA, or peripheral embolism was 98% at 1 year, 97% at 2 years, and 96% at 5 and 10 years, respectively. A residual shunt (HR 3.4; 95%CI 1.3 to 9.2) was a risk factor for recurrence.
Conclusions This study attests to the long-term safety and efficacy of percutaneous PFO closure guided by fluoroscopy only for secondary prevention of paradoxical embolism in a large cohort of consecutive patients.
- atrial septal aneurysm
- cerebral ischemia
- patent foramen ovale
- secondary stroke prevention
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