Why the study?
Does the Cardioseal/Starflex device compared to the Amplatzer device increase major complications in adults undergoing percutaneous closure of secundum-type ASD?
Population
133 adult patients with secundum-type atrial septal defect (ASD), mean age 46.8 years, 36 men.
Comparison
Percutaneous ASD closure using the… vs Percutaneous ASD closure using the Amplatzer ASD…
Design
Cohort
Follow-up
mean 3.4 ± 2.8 years
Authors
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May warrant avoiding Cardioseal/Starflex for ASD closure due to embolization risk; leaves open confirmation in randomized trials.
Does the Cardioseal/Starflex device compared to the Amplatzer device increase major complications in adults undergoing percutaneous closure of secundum-type ASD?
Percutaneous ASD closure in adults is safe and effective with the Amplatzer device, whereas the Cardioseal/Starflex device is associated with a significantly higher rate of major complications, specifically embolization.
Luermans et al. (2010) studied this question.
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