The efficiency and safety of percutaneous closure of secundum atrial septal defects with the Occlutech Figulla device: initial clinical experience.

Results : The mean defect size was 20.3±2.1 mm on TTE, 22.1±1.9 mm on TEE, and 24.2±2.4 mm on balloon sizing. The mean device size was 26.8±3.6 mm (range 6 to 36 mm). The mean procedure time was 44.7±21.4 minutes. The device was placed successfully in all the patients. A small residual flow was seen immediately after device placement in three patients (10.7%), which disappeared in two patients at three months, and in one patient at six months. During the procedure, complications were seen in four patients (14.3%), including transient sinus tachycardia in three patients (10.7%) and acute atrial fibrillation in one patient (3.6%). At six months, all the patients were asymptomatic. No ischemic stroke, cardiac perforation, device erosion, embolization, thrombus formation, or malposition of the device were observed. Conclusion: The Occlutech Figulla occluder is a safe and efficient device to close secundum ASDs. It may be preferred especially in patients with a high risk for thrombus formation.