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
em En
| WPRIM
| ID: wpr-195055
Biblioteca responsável:
WPRO
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.
Palavras-chave
Texto completo:
1
Índice:
WPRIM
Assunto principal:
Peso Corporal
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Stents
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Prontuários Médicos
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Prevalência
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Estudos Retrospectivos
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Seguimentos
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Mortalidade
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Uso Off-Label
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Cardiopatias Congênitas
Tipo de estudo:
Observational_studies
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Prevalence_studies
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Prognostic_studies
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Risk_factors_studies
Limite:
Humans
Idioma:
En
Revista:
Korean Circulation Journal
Ano de publicação:
2017
Tipo de documento:
Article