TRANSCATHETER CLOSURE OF SECUNDUM ATRIAL SEPTAL-DEFECTS USING THE NEWSELF-CENTERING AMPLATZER SEPTAL OCCLUDER - INITIAL HUMAN-EXPERIENCE

Transcatheter closure of secundum atrial septal defect (ASD) using cla mshell or buttoned devices is accompanied by a high incidence of resid ual shunt. Recently, a new self-centering device, the Amplatzer septal occluder (ASO), has been evaluated in an animal model with very good results. Therefore, our purpose is to report on our initial clinical e xperience with this device. Thirty patients underwent an attempt at ca theter closure of their ASDs at a median age of 6.1 yr (range, 2.9-62. 4 yr) and median weight of 22 kg (range, 13-69 kg) using the ASO. The median ASD diameter measured by transesophageal echocardiography (IEE) was 12.5 mm (range, 5-21 mm), and the median ASD balloon stretched di ameter was 14 mm (range, 7-19 mm). All patients had right atrial and v entricular volume overload with a mean +/- SD Qp/Qs of 2.3 +/- 0.6. A7 F catheter was used for delivery of the device in all patients. The de vice was placed correctly in all patients. There was immediate and com plete closure (C) in 17/30 patients, 10 patients had trivial residual shunt (TS), and 3 had moderate residual shunt (MS). The median fluoros copy time was 15 min (range, 8-35 min), and the median total procedure time was 92.5 min (range, 40-135 min). There was no episode of device embolization or any other complication. Follow-up was performed using transthoracic echocardiography (TTE) 1 day, 1 mo, 3 mo, and yearly th ereafter. At 1 day, there was C of the ASD in 24/30 patients, 3 had TS , 1 had small shunt (SS), and 2 had MS. At a median follow-up interval of 6 mo, there have been no episodes of endocarditis, thromboembolism , or wire fracture. We conclude that the use of the new ASO is safe an d effective in complete closure of secundum ASDs up to a diameter of 2 1 mm in the majority of patients. Further clinical trials are underway . (C) 1997 Wiley-Liss, Inc.