Korean Circulation Journal

The Korean Society of Cardiology (대한심장학회)
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Outcomes Associated with the Off-label Use of Medical Devices in Congenital Heart Disease at a Single Institute

  • Kong, Young Hwa (Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Song, Jinyoung (Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Huh, Jun (Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Kang, I-Seok (Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine)
  • Received : 2016.09.02
  • Accepted : 2016.12.29
  • Published : 2017.07.31
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Abstract

Background and Objectives: While the off-label use of implantable medical devices for treating congenital heart disease is not uncommon, the present conditions and outcomes of their off-label use have rarely been described. Therefore, this study evaluated the prevalence and results of using implantable devices off-label to treat congenital heart disease at a single institute. Subjects and Methods: This was a retrospective study based on the medical records of catheter-based interventions for congenital heart disease performed from July 1, 1995 to June 1, 2015. The inclusion criterion was the off-label use of an implantable device. Patient demographic data, procedural success, and follow-up status regarding late complications were investigated, and the results of the off-label use of each device were compared. Results: Off-label use occurred in 144 of 1730 interventions with device implantation, accounting for 8.3% of the interventions. The median patient age and mean body weight were 51.0 months and 16.3 kg, respectively. Immediate and late failures were found in 9 cases, and 3 cases of mortality were not directly related to the devices used. The overall success rate was 93.8%. There were no long-term complications of the off-label use of occlusion devices. No procedural failures resulted from stent implantation, but one case of stent malposition and two cases of stent fracture were identified after procedure completion. Conclusion: In general, the off-label use of implantable devices for treating congenital heart disease is safe and effective.

Keywords

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