Transcatheter Atrial Septal Defect Closure Using Occlutech Figulla Device: A Two-Center Experience

Abstract

Background: Despite several reports regarding the use of the Occlutech Figulla® Flex septal occluder (OFFSO) in adults, there are few reports on its use in children. We sought to study the result of the transcatheter closure of atrial septal defect (ASD) using the OFFSO in children ≤ 12 years.
Methods: We enrolled 45 consecutive patients, ranging from 2.5 to 12 years of age, in two large pediatric cardiovascular centers. All the children underwent complete echocardiographic examination before the procedure. Defect/device ratio and device/weight ratio were measured. The device diameter to the cardiac diameter ratio (DD/CD ratio) in anteroposterior projection after device release and the DD/CD index were calculated by dividing the DD/CD ratio by the body surface area.
Results: Of the 45 enrolled patients, 25 (55%) were female. The range and mean ± standard deviation (SD) of age were2.5 to 12 years and 6.8 ± 2.5 years, respectively. The range and mean ± SD weight were 8.5 to 37.0 kg and 19.7 ± 7.2 kg, respectively. Successful implantation was performed in all the patients. No major complications occurred in any of the subjects. We encountered one cobra head deformity in one patient. Neither residual shunt nor conduction abnormality was observed in any of the cases.
Conclusion: Transcatheter ASD closure using the OFFSO was effective in our pediatric patients. Although this device needs relatively larger delivery sheaths, its use is safe while closing even large defects in children.