Objectives The aim of this study was to report 1-year experience with 51 patients who underwent attempted transcatheter closure of a PDA using the new Amplatzer duct occluder (ADO II).
Methods The mean age of the patients was 7.5 ± 7.8 years (range 0.3 to 45 years). The device is a modified Amplatzer duct occluder made of fabric-free fine Nitinol wire net in to 2 very low profile disks with an articulated connecting waist. Both disks are 6 mm larger than the diameter of the connecting waist. Connecting waist diameters and device lengths range from 3-6 mm and 4-6 mm, respectively. The ADO II is appropriate for closure of very small to moderate- large (up to 5.5 mm) PDAs of any morphological type.
Results The mean PDA diameter was 3.5±1.6 mm (range, 0.5 to 5.4 mm). The mean device diameter (waist diameter) was 4.2 ± 1.3 mm (range 3 to 6 mm). The device was permanently implanted in 49 patients. Complete angiographic closure was observed in 47/49 (96%) patients. At 24 hours color Doppler flow imaging revealed complete closure in 48/49 (98%) patients. Major complications included device embolization and significant hemodynamic obstruction of the aorta in one patient (infants 3 and 4 kg, respectively), respectively. No other complications were observed.
Conclusions The ADO II is a highly effective prosthesis that can be safely applied in most patients with small to moderate-large PDA of any anatomical type. Further studies are required to establish long-term results in a larger patient population.