Relative Risk Factors for Cardiac Erosion Following Transcatheter Closure of Atrial Septal Defects

Abstract

Background-Transcatheter closure of secundum atrial septal defects (ASD) using the Amplatzer septal occluder 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 Amplatzer septal occluder (cases) were compared with controls (matched 2:1) who underwent ASD closure but did not develop an erosion. A total of 125 erosions were reported between 2002 and 2014, 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 or superior vena cava rim deficiencies were more common in cases than in controls. In addition, larger balloon-sized ASD diameter, Amplatzer septal occluder 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 >5 mm 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 Amplatzer septal occluder device. To understand the mechanisms of and absolute risk factors for this uncommon but serious complication, an adequately powered prospective study with thorough echocardiographic evaluation will be critical.

Increasing propensity to pursue operative closure of atrial septal defects following changes in the instructions for use of the Amplatzer Septal Occluder device: An observational study using data from the Pediatric Health Information Systems database

“…This can only be accomplished by identifying subgroup(s) of patients with a significantly higher risk of erosion than the overall population risk. To date, the single consistent risk factor for device erosion is deficient retro-aortic rim(10,38). However, deficient retro-aortic rim is extremely prevalent in pediatric patients (between 40–60%)(30,39–41), and it is not clear that the current definition of deficient retro-aortic rim discriminates the patients at highest risk of device erosion.…”

“…However, deficient retro-aortic rim is extremely prevalent in pediatric patients (between 40–60%)(30,39–41), and it is not clear that the current definition of deficient retro-aortic rim discriminates the patients at highest risk of device erosion. There is recent evidence that patients with larger defects relative to body size and septal length and oversizing the device to the defect are more prevalent in erosions than in matched-controls(38). However, we must acknowledge that we have not yet been able to define a strata of patients in whom O-ASD is clearly favorable in terms of risk to TC-ASD.…”

Delayed Left Atrial Perforation Associated with Erosion After Device Closure of an Atrial Septal Defect

“…Most of the complications from erosion occur within 1 year of device closure, but more than 10% of the cases of erosion occurred more than 1 year after device closure [4]. With proper clinical follow-up, early erosion can be treated appropriately [5].…”

“…However, O ’Byrne et al [5] have argued that it is not associated with an increased risk of technical failure or early adverse events. On the other hand, McElhinney et al [4] have evaluated the relative risk factors and revealed that deficiency of any rim, the ratio of the size of the device to the size of the rim, and oversized devices are associated with erosion. A recent study has shown that absence of the aortic rim, poor posterior rim consistency, septal malalignment, and dynamic morphology of the ASD in echocardiographic findings can significantly increase the risk of erosion [6].…”

A Very Late Life-Threatening Complication After Percutaneous Closure of an Atrial Septal Defect

“…Furthermore, patients diagnosed with late erosion after implant are significantly older than those presenting earlier. 3 The reasons are not fully clear, but different tissue properties may have a potential role. As in our patient an ASD occluder was implanted in childhood and no signs of erosion were present at serial echoes, we can assume that further factors other than age at implant can contribute to the timing of onset of the erosion.…”