Transcatheter closure of secundum ASD using Occlutech Figulla-N device in symptomatic children younger than 2 years of age.

Background: Atrial septal defect (ASD) transcatheter occlusion techniques have become alternatives to surgical procedures. We evaluated the efficiency and safety of the Occlutech Figulla-N device in percutaneous closure of secundum ASDs in symptomatic children younger than 2 years of age.

Methods: The study included 17 patients (9 girls, 8 boys; mean age, 10.3 ± 2.1 months). Mean weight was 7.4 ± 1.3 kg, with secundum ASDs measuring more than 8 mm with a hemodynamically significant shunt, resulting in failure to thrive, right ventricular dilatation, and pulmonary hypertension. Two girls had fenestrated ASD secundum. Defect size and total interatrial septal length were estimated by transthoracic (TTE) and transesophageal (TEE) echocardiography in 3 views. Procedures were performed under fluoroscopic and TEE guidance. Patients were followed-up at 1, 3, 6, and 12 months with TTE.

Results: The mean defect size was 15.4 ± 2.7 mm on TTE and 17.1 ± 1.9 mm on TEE. The mean device size was 17.8 ± 3.6 mm (range, 10 to 24 mm). The mean pulmonary artery pressure was 54 ± 18 mm Hg. The device was placed successfully in all patients including fenestrated ASDs that were closed with a single device placement. No residual flow was seen after device placement in patients. Complications were seen in 2/17 patients (11.8%) in the form of sinus tachycardia in 1 patient and femoral vein hematoma in 1 patient. At 6 and 12 months, all the patients were asymptomatic. No cardiac perforation, device erosion, embolization, thrombus formation, or malposition of the device was observed. Three patients developed mild insignificant mitral regurgitation.

Conclusions: ASD closure in severely symptomatic children younger than 2 years of age using the Occlutech Figulla-N occluder is safe and efficient. Meticulous care to patient selection, adequate defect sizing, and device size selection are keys to lower incidence of complications.