title: Transcatheter closure of large patent ductus arteriosus at high altitude with a novel nitinol device.
abstract: BACKGROUND
  Patent ducti arteriosi (PDAs) are more frequent and larger at high altitude than at sea level. A novel PDA closure device, the Nitocclud PDA-R, is designed specifically for both large and medium size PDAs. The initial clinical experience with a new nitinol-based device in high altitude patients with large PDAs is described.
  
  
  METHODS
  The Nitocclud PDA-R is a self-expandable, self-centering, repositionable occluder made of one nitinol wire without use of welding. It contains several polyester membranes, is delivered with a central guide wire and is released by retraction of the central wire into the delivery catheter. The efficacy of this device was evaluated at several high altitude centers.
  
  
  RESULTS
  Fifty-one patients without other congenital cardiac defects underwent transcatheter closure of PDA. Complete occlusion of the PDA was achieved in 98% of the patients. Nearly 49% of the patients had no shunt immediately after device implantation. Echocardiography revealed a complete closure rate by Doppler interrogation of 69% after 24 hr, 96% after 6 months, and 98% after 1 year. In two cases, device embolization was observed after release, and in both cases the device was easily retrieved with standard interventional techniques. There have been no episodes of delayed device migration, endocarditis, hemolysis, wire fracture, device disruption, or death.
  
  
  CONCLUSIONS
  The Nitocclud PDA-R device is safe and effective and can easily close very large PDAs. This device has a high rate of complete occlusion within 1 year and is easily retrieved if embolized.
authors.affiliation: Kardiozentrum, La Paz, Bolivia. draheath@gmail.com
authors.forename: Alexandra
authors.initials: A
authors.lastname: Heath
authors.forename: Nora
authors.initials: N
authors.lastname: Lang
authors.forename: Daniel S
authors.initials: DS
authors.lastname: Levi
authors.forename: Miguel
authors.initials: M
authors.lastname: Granja
authors.forename: Jorge
authors.initials: J
authors.lastname: Villanueva
authors.forename: Joaquin
authors.initials: J
authors.lastname: Navarro
authors.forename: Gabriel
authors.initials: G
authors.lastname: Echazú
authors.forename: Rainer
authors.initials: R
authors.lastname: Kozlik-Feldmann
authors.forename: Pedro
authors.initials: P
authors.lastname: del Nido
authors.forename: Franz
authors.initials: F
authors.lastname: Freudenthal
mesh_terms: D000293:Adolescent; D000328:Adult; D000497:Alloys; D000531:Altitude; D001118:Argentina; D001838:Bolivia; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D002648:Child; D002675:Child, Preschool; D020878:Device Removal; D004374:Ductus Arteriosus, Patent / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D018618:Echocardiography, Doppler, Color; D004867:Equipment Design; D005260:Female; D005548:Foreign-Body Migration / Q000209:etiology / Q000628:therapy; D006439:Hemodynamics; D006801:Humans; D007223:Infant; D008297:Male; D008567:Membranes, Artificial; D011091:Polyesters; D011446:Prospective Studies; D013812:Therapeutics; D013997:Time Factors; D055815:Young Adult
chemical_list: D000497:Alloys; D008567:Membranes, Artificial; D011091:Polyesters; C013616:nitinol