November 22, 2004Catheterization and Cardiovascular Interventions
Erosion of Amplatzer septal occluder device after closure of secundum atrial septal defects: Review of registry of complications and recommendations to minimize future risk
Why the study?
What are the risk factors for device erosion following Amplatzer septal occluder placement for atrial septal defects?
Population
28 patients who developed hemodynamic compromise after Amplatzer septal occluder placement for secundum…
Comparison
Amplatzer septal occluder (ASO) placement vs Premarket approval data from FDA-approved…
Design
Case_series
Authors
Discussion
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Member takes
Implication
Supports caution with deficient aortic rim and device oversizing in ASD closure; leaves open prospective validation of erosion predictors.
Structured PICO
What are the risk factors for device erosion following Amplatzer septal occluder placement for atrial septal defects?
P
Population
28 patients who developed hemodynamic compromise (adverse events) after Amplatzer septal occluder (ASO) placement for secundum atrial septal defects, reported to AGA Medical Corporation.
I
Intervention
Amplatzer septal occluder (ASO) placement
C
Comparator
Premarket approval data from FDA-approved clinical trials
O
Outcome
Device erosion and development of pericardial effusion or hemodynamic compromisesafety
Deficient aortic rim, deficient superior rim, and oversized Amplatzer septal occluders are key risk factors for device erosion, which occurs in approximately 0.1% of cases in the US.
Cite This Study
Hijazi et al. (2004) studied this question.