2012 Volume 28 Issue 5 Pages 250-257
Background: Since the Amplatzer Septal Occluder (ASO) was approved in Japan on March 2005, more than 1000 procedures have been attempted as of July 2009. Meanwhile severe complications had occurred, including 2 erosion cases and 6 migrations.
Methods: To investigate the efficacy and the safety of percutaneous ASD closure, 115 cases of ASD closure with the ASO device between August 2006 and July 2009 were compared with 55 surgical closure cases retrospectively.
Results: The age was 9 ± 4 years for the device group and 6 ± 3 years for the surgical group (p < 0.0001). The body weight was 29 ± 15 kg for the device group and 19 ± 9 kg for the surgery group (p < 0.0001). The procedural attempt success rate of device closure was 98%. The defect size of ASD was 15 ± 4 mm measured with the sizing balloon and 18 ± 4 mm for the surgery group (p < 0.001). The success rate was 100% for both groups. The mean length of hospital stay was 5 days for the device group and 6 days for the surgery group (p < 0.001). The mean estimated cost per case was 1.4 ± 0.4 × 106 Japanese yen for the device closure group and 1.6 ± 0.3 × 106 Japanese yen for the surgery group. There was no erosion or severe complications among the device group. Mortality was 0% for both groups.
Conclusions: A total of 2/3 of the ASD cases that received transcatheter closure depended on the size of the defect and the rims. Transcatheter closure of secundum ASD using ASO is a safe and effective alternative therapy.