title: Community use of the amplatzer atrial septal defect occluder: results of the multicenter MAGIC atrial septal defect study.
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.
authors.affiliation: Department of Pediatrics, Johns Hopkins University, School of Medicine, Baltimore, MD 21287, USA. aeveret3@jhmi.edu
authors.forename: Allen D
authors.initials: AD
authors.lastname: Everett
authors.forename: Jacky
authors.initials: J
authors.lastname: Jennings
authors.forename: Erica
authors.initials: E
authors.lastname: Sibinga
authors.forename: Carl
authors.initials: C
authors.lastname: Owada
authors.forename: D Scott
authors.initials: DS
authors.lastname: Lim
authors.forename: John
authors.initials: J
authors.lastname: Cheatham
authors.forename: Ralf
authors.initials: R
authors.lastname: Holzer
authors.forename: Jeremy
authors.initials: J
authors.lastname: Ringewald
authors.forename: Rani
authors.initials: R
authors.lastname: Bandisode
authors.forename: Richard
authors.initials: R
authors.lastname: Ringel
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D021721:Balloon Occlusion / Q000295:instrumentation; D002648:Child; D002675:Child, Preschool; D004452:Echocardiography; D004621:Embolization, Therapeutic / Q000295:instrumentation*; D004867:Equipment Design; D005471:Fluoroscopy; D005500:Follow-Up Studies; D006344:Heart Septal Defects, Atrial / Q000175:diagnosis / Q000628:therapy*; D006764:Hospitals, Community / Q000706:statistics & numerical data*; D006801:Humans; D007223:Infant; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult