Patent ductus arteriosus equipment and technique. Amplatzer duct occluder: intermediate-term follow-up and technical considerations

Between May 1997 and June 2000, 69 patients, ages 0.1 to 34 years, underwent attempted anterograde transcatheter closure of a patent ductus arteriosus (PDA) using the Amplatzer Duct Occluder (ADO). The ADO is a cone-shaped, self-centering, and repositionable occluder made of nitinol wire mesh. A 5Fr to 7Fr sheath was used for the delivery of the device. The mean PDA diameter (at the pulmonary end) was 4.6 +/- 1.9 mm (range 1 mm-8.5 mm). Sixty-seven of the 69 patients had successful device placement. The mean ADO smallest diameter was 6.9 +/- 1.8 mm (range 4 mm-12 mm). Complete angiographic closure occurred in 62 (92.5%) of 67 patients (95% confidence interval, 88.22%-98.77%). In five patients, there was a trivial residual shunt immediately after the procedure. At 24 hours, color Doppler flow imaging revealed complete closure in all 67 (100%) patients. The unsuccessful attempts occurred in two patients with a small, 1-mm diameter native PDA and residual PDA after surgical occlusion. Fluoroscopy time was 7.6 +/- 1.8 minutes (4 min-18 min). No complications were observed. At a median follow-up of 1.5 years (range 0.25 to 3.2 years), all patients had complete closure without complications. We conclude that transcatheter closure using the ADO is a highly effective and safe treatment for most patients with PDA.