title: Safety of percutaneous patent ductus arteriosus closure: an unselected multicenter population experience.
abstract: BACKGROUND
  The technique and safety of transcatheter patent ductus arteriosus (PDA) closure have evolved during the past 20 years. We sought to report a multicenter experience of PDA closure with a focus on the rate of adverse events (AE) and a review of institutional practice differences.
  
  
  RESULTS
  Outcome data on transcatheter PDA closure were collected at 8 centers prospectively using a multicenter registry (Congenital Cardiac Catheterization Project on Outcome Registry). Between February 2007 and June 2010, 496 PDA closures were recorded using a device in 338 (68%) or coils in 158 (32%). Most patients had an isolated PDA (90%). Fifty percent of patients were between 6 months and 3 years old, with only 40 patients (8%) <6 months old. Median minimum PDA diameter was 2.5 mm (range 1 to 12 mm; IQR 2 to 3 mm) for device closure and 1 mm (range 0.5 to 6 mm; IQR 1 to 2 mm) for coil closure (P<0.001). A device rather than coil was used in patients <3 years, weight <11 kg, and with a PDA minimum diameter >2 mm (all P<0.001). Three of 8 centers exclusively used a device for PDAs with a diameter >1.5 mm. In 9% of cases (n=46), an AE occurred; however, only 11 (2%) were classified as high severity. Younger age was associated with a higher AE rate. Coil-related AEs were more common than device-related AEs (10% versus 2%, P<0.001).
  
  
  CONCLUSIONS
  PDA closure in the present era has a very low rate of complications, although these are higher in younger children. Technical intervention-related events were more common in coil procedures compared with device procedures. For PDAs ≤2.5 mm in diameter, institutional differences in preference for device versus coil exist.
authors.affiliation: Rady Children's Hospital, San Diego, CA.
authors.forename: Howaida G
authors.initials: HG
authors.lastname: El-Said
authors.forename: Andras
authors.initials: A
authors.lastname: Bratincsak
authors.forename: Susan R
authors.initials: SR
authors.lastname: Foerster
authors.forename: Joshua J
authors.initials: JJ
authors.lastname: Murphy
authors.forename: Julie
authors.initials: J
authors.lastname: Vincent
authors.forename: Ralf
authors.initials: R
authors.lastname: Holzer
authors.forename: Diego
authors.initials: D
authors.lastname: Porras
authors.forename: John
authors.initials: J
authors.lastname: Moore
authors.forename: Lisa
authors.initials: L
authors.lastname: Bergersen
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D001835:Body Weight; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation; D002648:Child; D002675:Child, Preschool; D004374:Ductus Arteriosus, Patent / Q000175:diagnosis / Q000628:therapy*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D061214:Patient Safety; D018579:Patient Selection; D010818:Practice Patterns, Physicians'; D011446:Prospective Studies; D012042:Registries; D012307:Risk Factors; D016896:Treatment Outcome; D014481:United States
keywords: PDA; adverse events; complications; interventional catheterization; safety