Community Use of the Amplatzer Atrial Septal Defect Occluder: Results of the Multicenter MAGIC Atrial Septal Defect Study
- 18 November 2008
- journal article
- research article
- Published by Springer Science and Business Media LLC in Pediatric Cardiology
- Vol. 30 (3), 240-247
- https://doi.org/10.1007/s00246-008-9325-x
Abstract
The objective of this study was to determine the initial safety and results of unrestricted multi-institution routine community use of the Amplatzer Septal Occluder (ASO) for atrial septal defect (ASD) closure. A multicenter, nonrandomized prospective study was performed in 13 pediatric cardiology centers from November 2004 to September 2007. Data were collected at the time of cardiac catheterization and 1 day postimplant. Four hundred seventy-eight patients underwent cardiac catheterization for ASO device closure of an ASD. The median age was 6 years (range, <1–83 years), and the mean weight was 37.2 kg (range, 2.6–148 kg). Procedural success was 96% (458/478 patients), with deficient rims being the major single reason for failed implantation (9/20). Major and minor complication rates were 1.1% and 4.8%, respectively, and were not different between simple and complex ASD groups. Success at 24 h was 99.4% (333/335) in the simple ASD group and 100% (120/120) in the complex ASD group. The presence of large defects, the presence of multiple defects, the use of multiple devices, and a weight <8 kg were significantly associated with a residual shunt (small to moderate) at 24 h. In conclusion, the ASO device in routine clinical practice for simple and complex ASD closure has an immediate safety and effectiveness profile equal to that reported in the initial pivotal FDA trial for simple ASDs. Based on the evolution in care posed by the ASO and the lack of consensus on patient selection in complex ASDs, this study points out the need to redefine the optimal patient and possibly broaden the indications for device closure of ASDs.Keywords
This publication has 14 references indexed in Scilit:
- Percutaneous Device Closure of Atrial Septal Defect in a Premature Infant With Rapid Improvement in Pulmonary StatusPEDIATRICS, 2007
- Development of the MAGIC Congenital Heart Disease Catheterization Database for Interventional Outcome StudiesJournal of Interventional Cardiology, 2006
- Transcatheter closure of atrial septal defect in young children: Results and follow-upJournal of the American College of Cardiology, 2003
- Experience with transcatheter closure of secundum atrial septal defects using the Amplatzer septal occluder: a single centre study in 236 consecutive patientsHeart, 2003
- Choice of Device Size and Results of Transcatheter Closure of Atrial Septal Defect Using the Amplatzer Septal OccluderJournal of Interventional Cardiology, 2002
- Comparison between transcatheter and surgical closure of secundum atrial septal defect in children and adults: Results of a multicenter nonrandomized trialJournal of the American College of Cardiology, 2002
- Results of transvenous occlusion of secundum atrial septal defects with the fourth generation buttoned device: comparison with first, second and third generation devicesJournal of the American College of Cardiology, 2000
- Experimental atrial septal defect closure with a new, transcatheter, self-centering device.Circulation, 1993
- Echocardiographic follow-up of atrial septal defect after catheter closure by double-umbrella device.Circulation, 1993
- Double-umbrella closure of atrial defects. Initial clinical applications.Circulation, 1990