|
KMID : 0368120170470040509
|
|
Korean Circulation Journal
2017 Volume.47 No. 4 p.509 ~ p.515
|
|
|
Outcomes Associated with the Off-label Use of Medical Devices in Congenital Heart Disease at a Single Institute
|
|
Kong Young-Hwa
Song Jin-Young
Huh June
Kang I-Seok
|
|
|
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.
|
|
|
KEYWORD
|
|
|
Off-label, Medical device, Transcatheter therapy, Congenital heart defects
|
|
|
FullTexts / Linksout information
|
|
|
|
|
Listed journal information
|
|
   
|
|