Multicenter nit-occlud® PDA-R patent. Ductus arteriosus occlusion device trial: initial and six-month results.

BACKGROUND:Transcatheter closure of a moderate to large patent ductus arteriosus (PDA) using conventional techniques is challenging. The Nit-Occlud® PDA-R trial can close a PDA up to 8 mm in diameter. We sought to report procedural and six-month efficacy and safety results of the multicenter Nit-Occlud® PDA-R trial. METHODS:From June 2010 to February 2011, 43 patients were enrolled in three centers from Argentina. Median age was 4.5 (range 1.4-18.4 years) years old at catheterization, 70% were females and weight was 17.7 (range 10-67 kg). RESULTS:PDAs mean diameter was 2.98 ± 1.03 and ranged from 2 to 6.19 mm. About 11.6% were large (≥4 mm), whereas 32.6% were <2.5 mm. Median pulmonary artery mean pressure was 17 mm Hg (range 9-26 mm Hg). The device was implanted successfully in all patients. By echocardiography, trivial residual shunt was observed in 42% at the end of the procedure, in 28% at 24 hr, in 12.1% at one week, and none at three-months. There was one case of embolization (due to undersizing), that was treated successfully with a larger study device. There were no major short- or long-term complications. CONCLUSIONS:PDAs ranging from 2 to 6 mm can be effectively and safely closed using the Nit-Occlud® PDA-R device, with good procedural and six-month results. The Nit-Occlud® PDA-R emerges as an optimal alternative for closure of small to moderate PDAs.