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

Objectives: We evaluated the efficiency and safety of the Occlutech Figulla device in percutaneous closure of secundum atrial septal defects (ASD). Study design: The study included 28 patients (17 women, 11 men; mean age 43 years) who underwent percutaneous transcatheter closure using the Occlutech Figulla device for secundum ASDs causing a hemodynamically significant shunt. Defect size was estimated by transthoracic (TTE) and transesophageal (TEE) echocardiography, and also by balloon sizing in nine patients. The patients were followed-up for six months and were examined by TTE. 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.