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.