Percutaneous atrial Septal Occluder devices and cardiac erosion: A review of the literature

Objective To systematically review all cases in the literature of erosion associated with Atrial Septal Defect (ASD) occluder devices. Background Delayed erosion of the aortic or atrial wall is an infrequent but potentially lethal complication of percutaneous septal defect closure using an ASD device. The epidemiology is poorly understood. Methods The MEDLINE database was searched for cases of ASD occluder device-associated erosion. Results Twenty-five articles present erosion events associated with the AMPLATZER (TM) Septal Occluder (ASO) device (March 2002June 2011), documenting 21 independent, surgically confirmed cases. Another 79 distinct events are reported in case series and review articles. Of all identified independent cases, 73 were reported in the United States. No articles associate the HELEX (TM) Septal occluder and erosions. Additional events are reported in association with FDA-unapproved percutaneous defect closure devices (n = 16). Estimation of ASO erosion incidence is unreliable because the numerator (number of erosion events) and denominator (number of patients with an implanted device) are unknown; estimates range from 0.1 to 0.3%. Conclusion Cardiac erosion is a rare but serious complication of the ASO device. Erosion events are most often ascribed to device over-sizing or deficient retro-aortic rims; however, both consensus and evidence for a cogent risk factor(s) is lacking. Further assessment of the root cause of erosion and true incidence of this complication is required; analyses using control patients and/or device registry establishment represent logical next steps. (C) 2012 Wiley Periodicals, Inc.