Outcomes Associated with the Off-label Use of Medical Devices in Congenital Heart Disease at a Single Institute.
- Author:
Young Hwa KONG
1
;
Jinyoung SONG
;
Jun HUH
;
I Seok KANG
Author Information
- Publication Type:Original Article
- Keywords: Off-label; Medical device; Transcatheter therapy; Congenital heart defects
- MeSH: Body Weight; Follow-Up Studies; Heart Defects, Congenital*; Humans; Medical Records; Mortality; Off-Label Use*; Prevalence; Retrospective Studies; Stents
- From:Korean Circulation Journal 2017;47(4):509-515
- CountryRepublic of Korea
- Language:English
- 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.
