Percutaneous closure of secundum atrial septal defect with a new self centring device (“angel wings”)
Why the study?
Is transcatheter closure using the 'angel wings' device safe and effective in patients with secundum atrial septal defect or persistent foramen ovale?
Population
105 patients evaluated, closure attempted in 75 patients. Inclusion criteria: defects with an occlusive…
Design
Cohort
Follow-up
1-17 months
Authors
Discussion
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Member takes
Implication
Supports feasibility of percutaneous ASD/PFO closure; leaves open safety concerns necessitating device modifications.
Structured PICO
Is transcatheter closure using the 'angel wings' device safe and effective in patients with secundum atrial septal defect or persistent foramen ovale?
P
Population
105 patients evaluated, closure attempted in 75 patients (35 children and 15 adults with secundum atrial septal defect [ASD II], 25 adults with persistent foramen ovale [PFO]). Inclusion criteria: defects with an occlusive diameter of ≤ 20 mm and a surrounding rim of > 4 mm; body weight > 10 kg; and an indication for surgical closure of ASD II or compassionate indication for PFO closure.
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Intervention
Transcatheter closure using a self-centering device ('angel wings') consisting of two square frames made of superelastic nitinol wire covered by elastic polyester fabric.
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Outcome
Safety, efficacy, and clinical application of the device (including procedural success, residual shunts, and complications)safety
Percutaneous closure of ASD and PFO with the 'angel wings' device is feasible and effective, but design modifications are necessary due to a 4% rate of serious complications.
Cite This Study
Rickers et al. (1998) studied this question.