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.

Transthoracic echocardiography is a safe alternative for assessment and guidance of transcatheter closure of secundum atrial septal defect in children

“…Our successful ASD device implant rate of 96.7% was similar to procedural success rates of 95.7% in the IMPACT Registry, 96% in the MAGIC report, 95% in the C3PO report, and 95.7% in the Amplatzer Septal Occluder FDA study (2,29,37,38). Major adverse events were observed in 1.3% in our study.…”

“…Major adverse events were observed in 1.3% in our study. This rate compares with 1.2% in IMPACT patients, 1.1% in MAGIC patients, 4.7% in C3PO patients and 1.6% in the FDA study (2,29,37,38). As previously described, device embolization was successfully managed percutaneously in most cases (34).…”

“…Echo guidance of ASD closure TEE was required in the pivotal trial of the ASO device and continues to be the most widely used technology for ASD assessment, device selection, and guidance during implantation (2,28,29). However the rational to consider TTE guidance as an alternative is driven by some rare reports of TEE-related esophageal perforation in adults and children (6)(7)(8), as well as the fact that TTE-guidance may allow to shorten both procedure time and fluoroscopy time (30) and to avoid general anesthesia and orotracheal intubation in spontaneously breathing children (30,31).…”

Historical developments of atrial septal defect closure devices: what we learn from the past

“…Major and total adverse event rates were 1.6% and 7.2%, both significantly smaller than after surgical repair. The subsequent IMPACT Registry and MAGIC study reported similar success and complication rates [42,43]. ASO embolization is the most frequent adverse event as reported by the FDA Manufacturer and User Facility Device Experience database, accounting for 51% of events with a rate of 0.2-1.1%.…”

Perkütan Cribriform Tip Atriyal Septal Defekt Kapatma İşlemi Sonrası Acil Cerrahi: Olgu Sunumu

“…Fakat perkütan kapatma işleminde, geniş ya da multipl defekte sahip olan hastalar ile 1'den fazla occluder device kullanılan hastalarda rezidüel shunt oranı daha fazladır 8 .…”