Key result
Amplatzer septal occluder perforations uniquely involve anterosuperior atrial walls and aorta, with ~67% occurring post-discharge.
Why the study?
Amplatzer septal occluder-associated cardiac perforation at the authors' institution prompted this review, as cardiac perforation is a rare complication following transcatheter ASD closure.
Observational (n=24)
Yes
Cardiac perforation after ASD closure with the Amplatzer septal occluder is a rare but serious complication that often occurs late (post-discharge) and predominantly involves the anterosuperior atrial walls and adjacent aorta.
No takes yet. Share an insight, caveat, or question.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Nonetheless, we think there should be some re-assessment in terms of doing re-analysis of the data, with 2 points in mind. The first is going back to the drawing board and having a broader view, not focusing so carefully on the anatomy, which would seem to be the most likely explanation, but to consider other factors in this re-analysis.”
“We respect the role of the FDA and share their goal of protecting patient safety. St. Jude Medical's Amplatzer Septal Occluder remains a safe and reliable option for atrial septal defect closure and is the most studied pediatric intra-cardiac, percutaneous device in the market, with over 225,000 ASO devices sold worldwide.”
Warrants post-discharge vigilance for anterosuperior atrial-aortic perforation after ASO; leaves open mechanistic and device optimization questions for prospective study.
Divekar et al. (2005) conducted an observational in Atrial septal defect (n=24). Amplatzer septal occluder (ASO) was evaluated on Characteristics and timing of cardiac perforation events. Amplatzer septal occluder-associated cardiac perforation uniquely involves the anterosuperior atrial walls and adjacent aorta, with 66.6% of events occurring late (post-discharge).
Synapse has enriched 4 closely related papers on similar clinical questions. Consider them for comparative context: