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Transcatheter atrial septal defect closure using occlutech figulla device: a two-center experience
Hojat Mortezaeian1, Keyhan Sayadpour Zanjani2, Elaheh Malakan Rad2
1Rajaie Cardiovascular, Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran.
The Journal of Tehran Heart Center
|May 26, 2015
Summary
Transcatheter closure of atrial septal defect (ASD) using the Occlutech Figulla® Flex septal occluder (OFFSO) is safe and effective in pediatric patients up to 12 years old. This study demonstrates successful outcomes with no major complications in children undergoing ASD closure.
Area of Science:
- Pediatric Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Limited data exists on the Occlutech Figulla® Flex septal occluder (OFFSO) use in pediatric populations.
- Previous studies primarily focused on adult patients.
Purpose of the Study:
- To evaluate the efficacy and safety of transcatheter closure of atrial septal defects (ASDs) using the OFFSO in children aged 12 years and younger.
- To assess procedural outcomes and complications in this pediatric cohort.
Main Methods:
- A prospective study involving 45 consecutive pediatric patients (age 2.5-12 years) undergoing ASD closure with the OFFSO.
- Echocardiographic assessments were performed pre-procedure, and device/defect ratios were calculated.
- Device diameter to cardiac diameter (DD/CD) ratio and index were analyzed.
Main Results:
- Successful OFFSO implantation was achieved in all 45 pediatric patients.
- No major complications, residual shunts, or conduction abnormalities were reported.
- One instance of cobra head deformity was noted, with no significant adverse events.
Conclusions:
- Transcatheter ASD closure with the OFFSO is an effective and safe treatment option for pediatric patients.
- The device demonstrates successful closure of even large defects in children, despite requiring larger delivery sheaths.
