Transcatheter Amplatzer device closure of atrial septal defect and patent foramen ovale in patients with presumed paradoxical embolism.
OBJECTIVE
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).


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.
Khositseth
Anant
A
Division of Pediatric Cardiology, Mayo Clinic College of Medicine, Rochester, Minn 55905, USA.
Cabalka
Allison K
AK
Sweeney
John P
JP
Fortuin
F David
FD
Reeder
Guy S
GS
Connolly
Heidi M
HM
Hagler
Donald J
DJ
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001132:Arm / Q000294:innervation; D001281:Atrial Fibrillation / Q000209:etiology; D021721:Balloon Occlusion / Q000009:adverse effects / Q000379:methods*; D004452:Echocardiography; D019320:Embolism, Paradoxical / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D005260:Female; D006344:Heart Septal Defects, Atrial / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D006801:Humans; D006987:Hypesthesia / Q000209:etiology; D002546:Ischemic Attack, Transient / Q000209:etiology; D008297:Male; D008875:Middle Aged; D019736:Prostheses and Implants; D015356:Retinal Artery Occlusion / Q000209:etiology; D055502:Secondary Prevention; D020521:Stroke / Q000209:etiology; D013923:Thromboembolism / Q000209:etiology; D016896:Treatment Outcome