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Transcatheter Amplatzer device closure of atrial septal defect and patent foramen ovale in patients with presumed paradoxical embolism Khositseth A; Cabalka AK; Sweeney JP; Fortuin FD; Reeder GS; Connolly HM; Hagler DJMayo Clin Proc 2004[Jan]; 79 (1): 35-41OBJECTIVE: To review our experience with, and profile the safety and efficacy of, the Amplatzer PFO (patent foramen ovale) occluder (APO) and Amplatzer septal occluder (ASO) used to close PFO and/or atrial septal defect (ASD) in patients with paradoxical embolism (PE). PATIENTS AND METHODS: Between April 1998 and November 2002, 103 patients at the Mayo Clinic in Rochester, Minn, and Scottsdale, Ariz, mean age 52.4 years, with presumed PE (transient ischemic attack [n=22], stroke [n=77], or peripheral emboli [n=4]) underwent transcatheter device closure of PFO (n=81), ASD (n=12), and ASD/PFO (n=10) with 106 devices (APO [n=22] or ASO [n=84]). RESULTS: All devices deployed successfully, and no patients died. Procedural complications included atrial fibrillation (n=2), vessel injury (n=3), profound sinus node dysfunction (n=1), and device embolization with successful retrieval (n=1). At 3 months, 7 of 95 monitored patients had trivial residual shunt; at 12 months, 2 of 28 monitored patients had trivial residual shunt. Three patients had recurrent events--2 transient ischemic attacks and 1 retinal artery occlusion--at a mean +/- SD follow-up of 8.3 +/- 8.1 months (range, 1-34 months). None of these 3 patients had residual shunt or evidence of intracardiac thrombus. The average annual recurrence of all events was 3.6% at 23 months. The overall mean +/- SD freedom from recurrence of all events was 98.9% +/- 1.2% and 83.8% +/- 10.2% at 12 and 29 months of follow-up, respectively. CONCLUSIONS: Transcatheter device closure of PFO and/or ASD with use of APO/ASO in patients with presumed PE is effective and safe. Recurrent events may occur in the absence of a residual shunt.|*Prostheses and Implants[MESH]|Adult[MESH]|Aged[MESH]|Aged, 80 and over[MESH]|Arm/innervation[MESH]|Atrial Fibrillation/etiology[MESH]|Balloon Occlusion/adverse effects/*methods[MESH]|Echocardiography[MESH]|Embolism, Paradoxical/complications/diagnostic imaging/*therapy[MESH]|Female[MESH]|Heart Septal Defects, Atrial/complications/diagnostic imaging/*therapy[MESH]|Humans[MESH]|Hypesthesia/etiology[MESH]|Ischemic Attack, Transient/etiology[MESH]|Male[MESH]|Middle Aged[MESH]|Retinal Artery Occlusion/etiology[MESH]|Secondary Prevention[MESH]|Stroke/etiology[MESH]|Thromboembolism/etiology[MESH]|Treatment Outcome[MESH] |
