Look before (and after) you plug: Moving slowly toward safer selection and management of patients at risk of device erosion

摘要

Device erosion after atrial septal defect (ASD) closure has hung over this procedure since the complication was first reported over a decade ago, and has been described to occur in up to 0.1%-0.3% of patients, presenting as late as eight years after deployment. The continued occurrence of erosion, embolic events, arrhythmias, and a host of uncommon but important peri-procedural complications has led to some reasonably rooted concerns about whether we have sufficient evidence base to unquestioningly accept the percutaneous approach [1]. The occurrence of erosions has led to prior recommendations by Amin et al. [2] that have been adopted by a significant segment of the implanting community, with revision of the Instructions for Use based on a review of device safety by the United States Food and Drug Administration (FDA) last year. Disturbingly, however, erosions continue to occur, albeit infrequently, but with high associated morbidity and mortality.