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Korean Circ J. 2017 Jul;47(4):509-515. doi: 10.4070/kcj.2016.0311. Epub 2017 Jul 27.

Outcomes Associated with the Off-label Use of Medical Devices in Congenital Heart Disease at a Single Institute.

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1
Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

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:

Congenital heart defects; Medical device; Off-label; Transcatheter therapy

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