Long term follow up after percutaneous closure of PFO in 357 patients with paradoxical embolism: Difference in occlusion systems and influence of atrial septum aneurysm.

BACKGROUND: Percutaneous transcatheter closure of patent foramen ovale (PFO) in cryptogenic stroke or TIA is an alternative to medical therapy especially in patients with atrial septal aneurysm (ASA). The differences in time to complete occlusion for various closure devices in PFO alone and PFO plus ASA are of natural interest.

METHODS AND RESULTS: Between January, 1st 1998 and November, 30th 2006 percutaneous PFO closure was performed in 357 patients with a history of > or =1 paradoxical embolism using three different devices: Amplatzer PFO-(n=199), Starflex-(n=48) and Helex Occluder (n=110). All patients were assigned to a post-interventional protocol with contrast-enhanced transesophageal echocardiography (TOE) at 1 and 6 months and every 6 to 12 months in case of incomplete closure. Definite closure was confirmed in at least two consecutive TOE studies. The closure time curves between the three devices were significantly different (p=0.0072). Devices of 25 mm or less had a better occlusion rate. The difference between the closure time curves of PFO and PFO+ASA concerning each device type was significant for Helex (p=0.006) and Starflex (p=0.030). In regard to the occlusion time for large devices Helex succeeded later than Amplatzer and Starflex (p=0.0029). Concerning the cumulative follow up period of 1265 patient years the recurrence/re-event rate of cerebral and peripheral thromboembolic events was 0.7% per patient year. No relation to residual PFO shunting or to thrombus formation was seen. There were no peri-interventional technical complications. In five patients of the Starflex group thrombi were detected in the four week TOE controls.

CONCLUSION: The closure rate is dependent on occluder size and type plus the occurrence of an atrial septum aneurysm.