Transcatheter closure of atrial communications using the Amplatzer (TM) Septal Occluder

Certain types of atrial septal defects (ASDs) are amenable for transcathete r closure using various investigational devices. The use of the clamshell o r buttoned devices is accompanied with a high incidence of residual shunt. The experience of ASD closure using the Amplatzer(TM) Septal Occluder (ASO) is limited. Therefore, the purpose of this this article is to discuss the protocol of closure and report on the acute results using this device. Nine teen patients (17 ASD/2 fenestrated Fontan [FF]) underwent an attempt at ca theter closure of their defects at a median age of 13.3 years (range 5.5-67 .4 years) and a median weight of 49 kg (range 18-94 kgl using the ASO. The median ASI) diameter measured by transesophageal echocardiography (TEE) was 12 mm (range 6-23.8 mm) and the median defect balloon stretched diameter w as 17 mm (range 6-31 mm). All ASD patients had right atrial and ventricular volume overload with a mean +/- SD Qp/Qs of 2.4 +/- 0.9. A 7 to 8Fr cathet er was used for delivery of the device in all patients. The device was plac ed correctly in all but one patient. There were immediate and complete clos ures (C) in 13 of 18 patients; 3 patients had trivial residual shunts (TS), and 2 patients had small residual shunts (SS). In the two patients with FF , oxygen saturation improved from 85% to 95% and 88% to 96%, respectively. One patient received two devices for two separate defects. The median fluor oscopy time was 15.5 minutes (range 7.4-33.4 minutes), and the median total procedural time was 78 minutes (range 52-180 minutes). There was one episo de of device embolization in one patient. The device was successfully retri eved and 2 months later a second closure was performed successfully. Na oth er complications were encountered during or after the procedure. Follow-up was performed using transthoracic echocardiography (TTE) at 2 day and I mon th and by TEE at 3 months. At day 1, there was C of the defect in 15 of 19 patients and 4 had TS; 18 patients completed 1-month follow-up, 16 of 18 ha d C and 2 patients had TS. Eleven patients completed 3-month follow-up, all with C. So far there have been no episodes of endocarditis, thromboembolis m, or wire fracture. We conclude that the use of the new ASO is safe and ef fective in complete closure of atrial communications up to 23.8 mm in diame ter.