Outcomes Associated with the Off-label Use of Medical Devices in Congenital Heart Disease at a Single Institute
Korean Circulation Journal
;
: 509-515, 2017.
Article
in English
| WPRIM
| ID: wpr-195055
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 ANDMETHODS:
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Body Weight
/
Stents
/
Medical Records
/
Prevalence
/
Retrospective Studies
/
Follow-Up Studies
/
Mortality
/
Off-Label Use
/
Heart Defects, Congenital
Type of study:
Observational study
/
Prevalence study
/
Prognostic study
/
Risk factors
Limits:
Humans
Language:
English
Journal:
Korean Circulation Journal
Year:
2017
Type:
Article
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