Relative Risk Factors for Cardiac Erosion Following Transcatheter Closure of Atrial Septal Defects: A Case-Control
Doff B McElhinney1, Michael D Quartermain1, Damien Kenny1
1From Department of Cardiothoracic Surgery, Lucille Packard Children's Hospital, Stanford University, CA (D.B.M.); Department of Pediatrics, Wake Forest University School of Medicine, Winston-Salem, NC (M.D.Q.); Our Lady's Hospital for Sick Children, Crumlin, Dublin, Ireland (D.K.); Division of Pediatric Cardiology, Banner Children's Specialists, Mesa, AZ (E.A.); and Department of Pediatrics, Children's Hospital of Georgia, Georgia Regents University, Augusta (Z.A.).
Insights
Transcatheter closure of atrial septal defects (ASD) using the Amplatzer septal occluder has rare but serious erosion risks. Key factors include aortic rim deficiency and oversized devices, necessitating further research into risk mitigation.
Area of Science:
- Cardiology
- Medical Devices
- Interventional Cardiology
Background:
- Transcatheter closure of secundum atrial septal defects (ASD) using the Amplatzer septal occluder is a common procedure.
- While generally safe and effective, rare complications like device erosion into the pericardial space or aorta have been reported.
- Previous studies have not thoroughly assessed the relative risk factors for these erosions.
Purpose of the Study:
- To identify relative risk factors associated with device erosion after transcatheter closure of ASD.
- To compare cases of erosion with controls who underwent successful closure without complications.
Main Methods:
- A retrospective analysis of reported erosions to St. Jude Medical following Amplatzer septal occluder implantation for ASD closure.
- Cases of erosion were matched 2:1 with controls who had ASD closure without erosion.
- Multivariable analysis was used to identify significant risk factors.
Main Results:
- Aortic rim deficiency was a near-universal finding in erosion cases.
- Factors associated with erosion included larger ASD diameter, oversized Amplatzer device, and smaller weight-to-device size ratio.
- Device size exceeding ASD diameter by >5 mm and any rim deficiency were significant independent risk factors.
Conclusions:
- Aortic rim deficiency and specific device/patient size discrepancies are significant relative risk factors for erosion.
- Further prospective studies with detailed echocardiographic assessments are needed to elucidate absolute risk factors and mechanisms.
- Understanding these factors is crucial for improving patient safety during transcatheter ASD closure.
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.
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