BACKGROUND: Transcatheter closure of atrial septal defects (ASDs) has become an alternative to open surgical procedures. The Amplatzer septal occluder (ASO) has been approved since 2005 in Japan, but there are still many concerns about adverse events, and information about outcomes and complications is limited. The objective of this study was to assess the immediate and mid-term outcomes of device closure of secundum ASDs. METHODS AND RESULTS: From August 2005 to July 2011, 208 consecutive patients with a significant secundum ASD underwent percutaneous closure with the ASO [72 males, 136 females; median age, 7.3 years (range, 3.3-21.9 years)]. Follow-up was available for 206 (99%) patients. Device closure was successful in 203 (98%) patients. Device embolization occurred in 1 case within 1h of device implantation, but the device was surgically retrieved without any neurological sequelae. During the follow-up period, complete closure was observed in 202 of 203 patients. There were no cases of erosions, late embolization, thrombus formation, or death. CONCLUSIONS: Transcatheter closure of ASDs using the ASO is safe and effective, with excellent results during mid-term follow-up. Appropriate patient selection and accurate device selection is mandatory to avoid serious complications.
BACKGROUND: Transcatheter closure of atrial septal defects (ASDs) has become an alternative to open surgical procedures. The Amplatzer septal occluder (ASO) has been approved since 2005 in Japan, but there are still many concerns about adverse events, and information about outcomes and complications is limited. The objective of this study was to assess the immediate and mid-term outcomes of device closure of secundum ASDs. METHODS AND RESULTS: From August 2005 to July 2011, 208 consecutive patients with a significant secundum ASD underwent percutaneous closure with the ASO [72 males, 136 females; median age, 7.3 years (range, 3.3-21.9 years)]. Follow-up was available for 206 (99%) patients. Device closure was successful in 203 (98%) patients. Device embolization occurred in 1 case within 1h of device implantation, but the device was surgically retrieved without any neurological sequelae. During the follow-up period, complete closure was observed in 202 of 203 patients. There were no cases of erosions, late embolization, thrombus formation, or death. CONCLUSIONS: Transcatheter closure of ASDs using the ASO is safe and effective, with excellent results during mid-term follow-up. Appropriate patient selection and accurate device selection is mandatory to avoid serious complications.