1. Multicenter nit-occlud® PDA-R patent. Ductus arteriosus occlusion device trial: initial and six-month results.
- Author
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Granja MA, Trentacoste L, Rivarola M, Barbosa JD, Lucini V, Peirone A, and Spillman A
- Subjects
- Adolescent, Argentina, Cardiac Catheterization adverse effects, Child, Child, Preschool, Ductus Arteriosus, Patent diagnosis, Ductus Arteriosus, Patent physiopathology, Female, Hemodynamics, Humans, Infant, Male, Pilot Projects, Prospective Studies, Prosthesis Design, Radiography, Interventional, Time Factors, Treatment Outcome, Cardiac Catheterization instrumentation, Ductus Arteriosus, Patent therapy, Septal Occluder Device
- Abstract
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., (© 2015 Wiley Periodicals, Inc.)
- Published
- 2015
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