Adverse effects associated with an intrathecal baclofen pump

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Occurrence of adverse events in chronic intrathecal baclofen infusion: a one-year follow-up study of 158 adults. Borrini L, Bensmail D, Thiebaut JB, Hugeron C, Rech C, Jourdan C.
Arch Phys Med Rehabil. 2014 Jan 6. pii: S0003-9993(14)00003-3. doi: 10.1016/j.apmr.2013.12.019. [Epub ahead of print]


OBJECTIVE: To assess the frequency and types of adverse events (AEs) related to intrathecal baclofen (ITB) therapy in adults, and associated risk factors.
PARTICIPANTS:All consecutive adult subjects (n = 158) receiving ITB via a pump, implanted or followed during the study period.
RESULTS: 158 subjects were followed for ITB therapy in 2010. 128 were implanted prior to this (“non-surgical” subjects), 30 underwent implantation in 2010 (“surgical subjects”), with 20 “newly implanted” and 10 “replacements”. Most frequent pathologies were spinal cord injury (42%) and multiple sclerosis (28%). Twenty-eight subjects (18%) experienced a total of 38 AEs. The rate of AEs was 0.023 per month of ITB treatment. AEs were related to the surgical procedure in 53% of cases, to the device in 29% (predominantly catheter dysfunctions) and to side effects of baclofen in 18%. AEs related to the surgical incision (scar complications and collections) were more frequent in “replacement” than “newly-implanted” subjects (p=0.009). No significant association between occurrence of an AE and subject characteristics (age, gait capacity, spinal vs. cerebral spasticity and duration of ITB therapy follow-up) was found. Nearly half of the AEs were serious, extending admission time by a mean 16 days. No AE induced long-term morbidity.
CONCLUSION: AE rate was relatively low in this cohort. This has to be balanced against the clinical, functional and quality of life improvements, which are expected from ITB therapy.
Intrathecal baclofen can be very effective at controlling spasticity but every procedure has side effects potential.

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