The Amplatzer duct occluder: Experience in 209 patients

OBJECTIVES The aim of the study was to assess the safety and efficacy of th e Amplatzer ductal occluder (ADO) in transcatheter occlusion of patent duct us arteriosus (PDA). BACKGROUND Transcatheter closure of small to moderate sized PDAs is an esta blished procedure. The ADO is a self-expandable device with a number of sal utary features, notably its retrievability, ease of delivery via small 5F t o 7F catheters and a range of sizes suitable even for the larger PDAs. METHODS Between November 1997 and August 1999, the ADO was successfully imp lanted in 205 of 209 patients with PDA. The inclusion criteria for this dev ice occlusion method were patients with clinical and echocardiographic feat ures of moderate to large PDA, weighing greater than or equal to3.5 kg as w ell as asymptomatic adolescents and adults with PDA measuring greater than or equal to5.0 mm on two-dimensional (2D) echocardiogram. Occlusion was ach ieved via the antegrade venous approach. Follow-up evaluations were perform ed with 2D echocardiogram, color-flow mapping and Doppler measurement of th e descending aorta and left pulmonary artery velocity at 24 h and 1, 3, 6 a nd 12 months after implantation. RESULTS Two hundred and five patients had successful PDA occlusion using th is device. The patients were between two months and 50 years (median 1.9) a nd weighed between 3.4 kg and 63.2 (median 8.4). Infants made up 26% of the total patients. The PDA measured from 1.8 to 12.5 mm (mean 4.9) at the nar rowest diameter. Forty-four percent of patients achieved immediate complete occlusion. On color Doppler the closure rates at 24 h and 1 month after im plant were 66% and 97%, respectively. At 6 and 12 months all except one pat ient attained complete occlusion. Device embolization occurred in three pat ients; in two this was spontaneous, and in the other it was due to catheter manipulation during postimplant hemodynamic measurement. Mild aortic narro wing was seen in an infant. CONCLUSIONS Patent ductus arteriosus occlusion using ADO is safe and effica cious. It is particularly useful in symptomatic infants and small children with relatively large PDA. Embolization can be minimized by selection of ap propriate sized devices, and caution should be exercised in infants <5 kg. (J Am Coil Cardiol 2001;37:258-61) (C) 2001 by the American College of Card iology.