Transcatheter Atrial Septal Defect Device Erosion
What are risk factors for erosion of the AMPLATZER septal occluder into the pericardial space or aorta?
A case-control study was performed. Erosions (cases) included all device erosions reported to the manufacturer as well as those identified by the manufacturer via literature review. Control subjects (matched with cases 2:1) were drawn from the post-approval study performed between 2008 and 2012. Available echocardiograms from cases and controls were reviewed by echocardiographers blinded to the study group and clinical outcomes. Echocardiographic parameters included presence and length of atrial septal defect (ASD) rims and ASD diameter, among others.
A total of 125 erosions were reported between 2002 and 2014, of which 95 had an available echocardiogram. The median duration from implant to erosion was 14 days, but was >1 year in 16 patients. Nine patients (all ages ≥17 years) who died were more likely to have an oversized device, and to have erosion into the aorta, than survivors. Aortic and/or superior vena cava rim deficiency were more common in cases than in controls. On multivariable analysis, deficiency of any rim, device >5 mm larger than ASD diameter, and weight:device size ratio were associated with erosion.
In addition to aortic rim deficiency, there were several relative risk factors for ASD device erosion. A large prospective study will be required to understand mechanisms and absolute risk factors related to device erosion.
Device erosion is a rare, but potentially catastrophic complication of device closure of ASD. It has been well established that deficient or absent aortic rims are a risk factor for erosion, prompting a temporary listing of a deficient aortic rim as a contraindication to device closure. This is currently considered a high-risk feature as opposed to an absolute contraindication. It will be important to better understand which subgroups of patients with deficient aortic rims will be at the highest risk of erosion. A post-market surveillance study with a target neuroma of 8,000 patients is expected to conclude in 2019. The rarity of this complication will continue to make it difficult to identify absolute risk factors for device erosion.
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