Transcatheter closure of atrial septal defects in children & adults using the Amplatzer Septal Occluder

We are reporting the worldwide experience in closing atrial septal defects (ASDs) in children and adults using the Amplatzer Septal Occluder (ASO) as of July 2000. The outcome measures were safety and efficacy with special emphasis on: (1) immediate success of the ASD closure as measured by transesophageal echocardiography (TEE), (2) short- and medium-term follow-up at 24 hours and 1 and 3 months and long-term follow-up at 1, 2, and 3 years as assessed by transthoracic echocardiography (TTE); and (3) the incidence of complications. In all, 3580 procedures were performed in 3535 patients. In 75 patients, the device was not implanted for variety of reasons; 3460 patients received a single ASO device and 45 received two devices for multiple ASDs. The median age of the patients was 12.1 year, (range, 10 days-88 years, the median weight was 41.0 kg (range, 2.4-137 kg) and the median Qp/Qs ratio was 2 (range, 0.3-10). The median size of ASD by TEE was 14 mm (range, 1-38 mm) and the median stretched diameter was 18 mm (range, 4-44 mm). The median size of device implanted was 18 mm (range, 4-40 mm). The median fluoroscopy time was 17.1 minutes (range, 0.0-194.0 minutes). The immediate success rate including those patients with complete closure, trivial residual shunt, or with small residual shunt was 97.4%. This increased to 99.2% and 100% at 3 months and 3 years, respectively. Minor complications were encountered in 2.8% of procedures, while serious complications occurred in less than 0.3% of the cases. There were no device related deaths. We conclude that the ASO is a safe and effective device for catheter closure of small to large ASDs up to a stretched diameter of 40 mm in children and adults with very high short-, medium, and long-term success rates.