Background: To assess the safety and efficacy of percutaneous patent foramen ovale (PFO) closure for the prevention of recurrent stroke in high-risk patients.
Methods and results: Between January 2002 and March 2005, 40 patients (65% female), mean (SD) age 43 (10) years were identified using the following inclusion criteria: <60 years, recent brain infarction (<3 months), combination of PFO plus atrial septal aneurysm (ASA) and exclusion of any other thromboembolic cause. Percutaneous PFO closure was performed under general anaesthesia and under the guidance of transoesophageal echocardiography (TEE). Aspirin and clopidogrel were given for three months after PFO closure, followed by aspirin alone. Neurological examination was performed every three months.
Results: PFO closure was successful in all patients, using all devices: INTRASEPT in 34 cases, STARFlex in 5 cases and AMPLATZER in one case. At day one, transthoracic echocardiography (TTE) excluded malpositioning of the device or pericardial effusion. At 6 months, TTE and TEE confirmed satisfactory implantation of the device, with no spontaneous shunt. No device related thrombi was observed. Mean patient follow-up was 17+/-7 months (range 12-38) and was 100% complete. No patients suffered from recurrent stroke (neither transient ischaemic attack nor brain infarction).
Conclusion: This preliminary experience is encouraging for PFO closure with a 0% risk of stroke recurrence rate in a high-risk subset of patients (< 60 years, recent cryptogenic stroke, PFO plus ASA) and is safe using the current technology. Larger series with longer follow-up and randomised studies are still necessary in this setting before the completion of guidelines.