Short- and intermediate-term results of transcatheter closure of atrial septal defect with the Amplatzer Septal Occluder

Background The Amplatzer Septal Occluder (ASO) (AGA Medical Corp, Golden Valley, Minn) has gained wide acceptance for transcatheter closure of atrial septal defect (ASD). We conducted this study to evaluate the short-and intermediate-term results of ASD closure with the ASO and to determine the impact of deficient rim on the results. Methods Between March 1999 and February 2003, 197 patients underwent attempted transcatheter closure of ASD with the ASO. The size of the selected device either equaled or was 1 to 2 mm larger than the stretched diameter of the defect. Transesophageal echocardiography was used to monitor the implantation procedure. One hundred and fourteen patients (58%) with a deficiency in 1 rim (<5 mm) were included as group I, and the remaining 83 patients with adequate rims comprised group II. Results The mean stretched diameter measured with the balloon catheter was 18.6 +/- 6.7 mm (range 7.1-37.2 mm). Deployment of the ASO was successful in 191 (97%) patients and failed in 6. There was no significant difference between the 2 groups in the success rate for ASD closure (110/114 vs 81/83). Repositioning of the device was required in 28 patients: 21 in group I and 7 in group II (21/114 vs 7/83, P > .05) The mean stretched diameter of the defect in these 28 patients was significantly larger than that in those who did not require repositioning of the device (27.3 +/- 5.7 vs 17.1 +/- 5.5 mm, P < .01). Three patients experienced severe complications: 1 had transient complete atrioventricular block, 1 had tamponade requiring drainage, and 1 had dislodgement of the device requiring emergent operation. One had a distal embolism to a fingertip. Echocardiography at 1 day, 3 months, 6 months, 12 months, and 24 months after the procedure showed residual shunts in 37/191 (19%), 15/189 (8%), 11/176 (6%), 7/131 (5%), and 3/72 (4%) patients, respectively. Conclusions The ASO is a safe and effective device for the transcatheter closure of ASD. Deficiency in 1 rim, particularly the superior anterior rim, does not influence the success rate of ASD closure.