Erosion by the Amplatzer Septal Occluder: Experienced Operator Opinions at Odds With Manufacturer Recommendations?

Background: Device erosion is a very rare but potentially fatal complication of ASD occlusion by the Amplatzer Septal Occluder (ASO). After reviewing cases of device erosion, recommendations for ASD sizing and device selection were revised by a small group of "experts" and adopted by the device manufacturer in 2004. These revisions, which recommend use of smaller devices, which do not straddle the aorta, remain controversial. Objective: The aim of our study is to help define an expanded expert consensus with respect to the causes and preventive strategies for erosions. Methods: We report a case of device erosion in which the 2004 revisions were carefully followed; and a survey of the members of the Congenital Cardiovascular Interventional Study Consortium (CCISC) soliciting experiences with and opinions about device erosion. Results: In our case, the device disk appeared to protrude into the aortic root but not straddle, and had motion independent of cardiac movement. Of 57 survey responders having a total experience of 12,006 ASO implants, 12 members reported 14 erosions among 3,010 implants. Ninety percent of erosions occurred in patients with deficit aortic rim. Of 53 patients, 38 (71.7%) responded that devices, which are undersized and do not straddle the aorta are at highest risk of erosion. Of 52 patients, 44 (84%) responded that motion of the device relative to the heart may cause erosion. Conclusion: Both the survey results and our single case experience suggest that operator opinions (and perhaps also device sizing practices) are at odds with the 2004 revisions. Further study and focus on this issue is needed. (C) 2009 Wiley-Liss, Inc.