title: Chronic hypobaric hypoxia, patent arterial duct and a new interventional technique to close it.
abstract: BACKGROUND
  Interventional closure of patent arterial duct has become an accepted alternative to surgical closure. Clinical trial with "Nit-Occlud® PDA-R".
  
  
  RESULTS
  To assess the safety and efficacy of the device, we performed a prospective clinical study between June, 2009 and December, 2010 in La Paz, Bolivia. In all, 29 - 22 female patients and 7 male patients - out of 59 patients were selected on the basis of inclusion criteria. The procedures were performed under sedation at an age and weight of 5.7 years and 22.7 kilograms, respectively, with 4-6 French arterial sheaths and 5-7 French venous sheaths. The minimal diameter of the duct was 3.5 millimetres. The procedure, fluoroscopy, and hospitalisation times were 96.4 minutes (55 to 145), 13.1 minutes (3 to 25.2), and 24 hours, respectively. The "Nit-Occlud® PDA-R" was successfully deployed in all patients. Immediate, 24-hour, 1-, 3-, and 6-month closure rates were 65.5%, 79.3%, 96.5%, and 100%, respectively. The systolic pulmonary pressure diminished from 37 millimetres of mercury (21 to 57) before the intervention to 31 millimetres of mercury (21 to 45) after the intervention. No early or late embolisation, haemolysis, left pulmonary artery, or descending aorta obstruction occurred.
  
  
  CONCLUSIONS
  We conclude that the "Nit-Occlud® PDA-R" device is safe and effective in closing patent arterial duct up to a diameter of 8 millimetres.
authors.affiliation: Department of Pediatric Cardiology, Kardiozentrum, University of San Andrés, La Paz, Bolivia.
authors.forename: Franz P
authors.initials: FP
authors.lastname: Freudenthal
authors.forename: Alexandra
authors.initials: A
authors.lastname: Heath
authors.forename: Jorge
authors.initials: J
authors.lastname: Villanueva
authors.forename: Janne
authors.initials: J
authors.lastname: Mendes
authors.forename: Ximena
authors.initials: X
authors.lastname: Vicente
authors.forename: Inge
authors.initials: I
authors.lastname: von Alvensleben
authors.forename: Gabriel
authors.initials: G
authors.lastname: Echazú
authors.forename: Joaquin
authors.initials: J
authors.lastname: Navarro
authors.forename: Nora
authors.initials: N
authors.lastname: Lang
authors.forename: Rainer
authors.initials: R
authors.lastname: Kozlik-Feldmann
mesh_terms: D000293:Adolescent; D000328:Adult; D000497:Alloys; D001838:Bolivia; D006328:Cardiac Catheterization / Q000379:methods*; D002648:Child; D002675:Child, Preschool; D002908:Chronic Disease; D004374:Ductus Arteriosus, Patent / Q000150:complications / Q000628:therapy*; D005260:Female; D005471:Fluoroscopy; D006801:Humans; D000860:Hypoxia / Q000150:complications; D007223:Infant; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D019736:Prostheses and Implants; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000497:Alloys; C013616:nitinol