Transcatheter closure of atrial septal defects in children & adults using the Amplatzer Septal Occluder
1Department of Pediatrics, Section of Pediatric Cardiology, University of Chicago Children's Hospital, Pritzker School of Medicine, Chicago, Illinois, USA.
Insights
The Amplatzer Septal Occluder (ASO) effectively closes atrial septal defects (ASDs) in patients of all ages. This worldwide study shows high success rates and minimal complications for ASO device implantation.
Area of Science:
- Cardiology
- Medical Devices
- Pediatric Cardiology
Background:
- Atrial septal defects (ASDs) are common congenital heart conditions requiring intervention.
- Transcatheter device closure has emerged as a primary treatment modality for ASDs.
- The Amplatzer Septal Occluder (ASO) is a widely used device for ASD closure.
Purpose of the Study:
- To report worldwide experience with the Amplatzer Septal Occluder (ASO) for atrial septal defect (ASD) closure.
- To evaluate the safety and efficacy of ASO in pediatric and adult populations.
- To assess short- and long-term outcomes and complication rates associated with ASO implantation.
Main Methods:
- A retrospective analysis of 3580 procedures performed in 3535 patients worldwide using the ASO device.
- Outcome measures included immediate success by transesophageal echocardiography (TEE), short- and long-term follow-up (up to 3 years) by transthoracic echocardiography (TTE), and complication incidence.
- Patient demographics, ASD characteristics, device sizes, and fluoroscopy times were recorded.
Main Results:
- Immediate success rate for ASD closure was 97.4%, increasing to 99.2% at 3 months and 100% at 3 years.
- Minor complications occurred in 2.8% of procedures, with serious complications in less than 0.3%.
- No device-related deaths were reported. The ASO was effective for ASDs up to 40 mm stretched diameter.
Conclusions:
- The Amplatzer Septal Occluder (ASO) is a safe and highly effective device for transcatheter closure of small to large atrial septal defects (ASDs).
- The device demonstrates excellent short-, medium-, and long-term success rates with a low complication profile in both children and adults.
- ASO implantation represents a successful therapeutic option for a broad range of ASDs, minimizing the need for surgical intervention.
Abstract:
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.
