title: Multicenter nit-occlud® PDA-R patent. Ductus arteriosus occlusion device trial: initial and six-month results.
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.
authors: Hospital de Niños Pedro Elizalde, Servicio de hemodinamia, Ciudad Autónoma de Buenos Aires, Argentina.
authors: Miguel A
authors: MA
authors: Granja
authors: Hospital de Niños Ricardo Gutiérrez, Ciudad Autónoma de Buenos Aires, Argentina.
authors: Luis
authors: L
authors: Trentacoste
authors: Hospital de Niños Ricardo Gutiérrez, Ciudad Autónoma de Buenos Aires, Argentina.
authors: Marcelo
authors: M
authors: Rivarola
authors: Hospital de Niños Pedro Elizalde, Servicio de hemodinamia, Ciudad Autónoma de Buenos Aires, Argentina.
authors: Jesus Damsky
authors: JD
authors: Barbosa
authors: Hospital de Niños Pedro Elizalde, Servicio de hemodinamia, Ciudad Autónoma de Buenos Aires, Argentina.
authors: Victorio
authors: V
authors: Lucini
authors: Hospital de Niños Santísima Trinidad, Servicio de Hemodinamia, Córdoba, Córdoba, Argentina.
authors: Alejandro
authors: A
authors: Peirone
authors: Hospital de Niños Santísima Trinidad, Servicio de Hemodinamia, Córdoba, Córdoba, Argentina.
authors: Ana
authors: A
authors: Spillman
mesh_terms: D000293:Adolescent; D001118:Argentina; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D002648:Child; D002675:Child, Preschool; D004374:Ductus Arteriosus, Patent / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D005260:Female; D006439:Hemodynamics; D006801:Humans; D007223:Infant; D008297:Male; D010865:Pilot Projects; D011446:Prospective Studies; D011474:Prosthesis Design; D015641:Radiography, Interventional; D055989:Septal Occluder Device; D013997:Time Factors; D016896:Treatment Outcome
keywords: PDA-R occluder; patent ductus arteriosus; percutaneus closure