Further experience with catheter closure of patent ductus arteriosus using the new Amplatzer duct occluder in children.

The aim of the present study was to report our additional experience with transcatheter closure of the patent ductus arteriosus in 65 consecutive patients using the new Amplatzer duct occluder. The median patient age was 3.6 years (range 0.2to 12), and the median weight was 10.5 kg (range 4 to 38). The device was 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. It is delivered through a 4Fr to 5Fr delivery sheath. The device was permanently implanted in 62 of 65 patients. The mean patent ductus arteriosus diameter (at the pulmonary end) was 3.6 +/- 1.3 mm (range 0.5 to 5.5). The mean device diameter (waist diameter) was 4.2 +/- 1.5 mm (range 3 to 6). Complete echocardiographic closure of the PDA at 1 month follow-up was observed in 61 (98%) of 62 patients. Immediately after the procedure, mild left pulmonary stenosis (peak pressure gradient of 8, 10, and 12 mm Hg) in 3 of 63 patients. Device embolization in 1 patient was the main complication of the procedure. No other complications were observed. In conclusion, catheter closure using the Amplatzer duct occluder II is an effective and safe therapy for most patients with patent ductus arteriosus. Additional studies are required to document its efficacy, safety, and long-term results in a larger patient population.