Abstract

Objective: To study the long-term complications associated with chronic intrathecal baclofen (ITB) therapy in children with severe intractable hypertonia of cerebral or spinal origin. Design: Retrospective review of medical records. Setting: Multicenter outpatient pediatric rehabilitation medicine clinics. Participants: A total of 785 children with hypertonia of cerebral or spinal origin due to cerebral palsy, traumatic brain injury, or spinal cord injury who received ITB pumps for the management of hypertonia. Interventions: Not applicable. Main Outcome Measures: Complications associated with ITB pump use including catheter complications (disconnections, obstructions, migrations, tears, fractures), infections, pump failures, pump migrations, other pump problems requiring replacement of the pump, and deaths. Results: Catheter-related complications (disconnections, obstructions, migrations, tears, fractures) were the most common with 264 total catheter complications. Infection at the pump site occurred 68 times and replacement of the pump due to pump failure or pump migration 17 times. A total of 26 deaths occurred across 4 centers in 785 patients (mortality, 3.3%). Conclusions: Although ITB pump therapy has been shown to improve function, increase comfort, and increase ease of care provision in patients with severe hypertonia of cerebral or spinal origin, there are significant risks associated with this treatment. Further study is warranted to better define the complications so that points of intervention can be identified to decrease complications associated with ITB therapy, as well as to decrease the additional morbidity and mortality resulting from repeated surgery to correct the complications. Additional research is also needed to better examine deaths in children with ITB pump treatment to see if they are at an increased rate from a comparable population and how to intervene if possible.

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