Safety of percutaneous patent ductus arteriosus closure: an unselected multicenter population experience

J Am Heart Assoc. 2013 Nov 27;2(6):e000424. doi: 10.1161/JAHA.113.000424.

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.

Methods and 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.

Keywords: PDA; adverse events; complications; interventional catheterization; safety.

Publication types

  • Comparative Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Age Factors
  • Body Weight
  • Cardiac Catheterization* / adverse effects
  • Cardiac Catheterization* / instrumentation
  • Child
  • Child, Preschool
  • Ductus Arteriosus, Patent / diagnosis
  • Ductus Arteriosus, Patent / therapy*
  • Female
  • Humans
  • Infant
  • Male
  • Patient Safety
  • Patient Selection
  • Practice Patterns, Physicians'
  • Prospective Studies
  • Registries
  • Risk Factors
  • Treatment Outcome
  • United States