Relative Risk Factors for Cardiac Erosion Following Transcatheter Closure of Atrial Septal Defects: A Case-Control Study
Background—Transcatheter closure of secundum atrial septal defects (ASD) using the AMPLATZER septal occluder (ASO) is generally safe and effective, but erosion into the pericardial space or aorta has been described. Although the absolute risk of this complication is low, there has been no assessment of relative risk factors.
Methods and Results—All erosions reported to St. Jude Medical after ASD closure with an ASO (cases) were compared to controls (matched 2:1) who underwent ASD closure but did not develop an erosion. A total of 125 erosions were reported between 2002-14, including 95 with an available echocardiogram. The median duration from implant to erosion was 14 days, but was >1 year in 16 patients. Nine patients (all age ≥17 years) who died were more likely to have an oversized device, and to have erosion into the aorta, than survivors. Aortic and/or SVC rim deficiency were more common in cases than in controls. In addition, larger balloon-sized ASD diameter, ASO device size, and device size-ASD diameter difference, and smaller weight:device size ratio, were associated with erosion. On multivariable analysis, deficiency of any rim, device >5mm larger than ASD diameter, and weight:device size ratio were associated with erosion.
Conclusions—In addition to aortic rim deficiency, which was almost universal among erosion cases, there were several relative risk factors for erosion after ASD closure with the ASO device. To understand mechanisms of and absolute risk factors for this uncommon but serious complication, an adequately powered prospective study with thorough echocardiographic evaluation will be critical.
- Received October 19, 2015.
- Revision received February 18, 2016.
- Accepted March 14, 2016.