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Background: Transcatheter closure for atrial septal defect (ASD) and patent foramen ovale (PFO) is a promising alternative to surgical closure or anticoagulant therapy. A potential complication is thrombus formation on the device after implantation. This study compared the incidence of thrombus formation at one month post implant between the two FDA approved devices.

Methods: From February 2001 through August 2003, 68 patients (50 PFO, 13 ASD and 5 fenestrated septum) were treated successfully with the Amplatzer device (19 septal and 18 PFO occluders) or the CardioSEAL device (30). Antiplatelet medication (aspirin and clopidogrel) was prescribed for 6 months after the procedure. Fifty-two patients had transesophageal echocardiography (TEE) one month after device implantation (26±9 days).

Results: No patient suffered a thromboembolic episode during the 30 month follow-up period. TEE revealed that …