Article

OBJECTIVE: To assess the frequency and types of adverse events (AEs) related to
intrathecal baclofen (ITB) therapy in adults, and associated risk factors.
DESIGN: A prospective, observational cohort study of adults followed up from
January 1 to December 31, 2010. SETTING: A neurologic rehabilitation department
in a university hospital. PARTICIPANTS: All consecutive adult subjects (N=158)
receiving ITB via a pump, either implanted or followed up during the study
period. INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: Frequency and type
of AEs. RESULTS: In 2010, 158 subjects were followed up for ITB therapy, of whom
128 were implanted before 2010 (nonsurgical subjects), and 30 underwent
implantation in 2010 (surgical subjects). Of these 30 subjects, 20 were "newly
implanted" and 10 were "replacements." The most frequent pathologic disorders
were spinal cord injury (42%) and multiple sclerosis (28%). Twenty-eight subjects
(18%) experienced a total of 38 AEs. The rate of AEs was .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 adverse 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=.009). No significant association between occurrence of an AE and subject
characteristics (age, gait capacity, spinal vs cerebral spasticity, duration of
ITB therapy follow-up) was found. Nearly half of the AEs were serious, extending
admission time by a mean of 16 days. No AE induced long-term morbidity or death.
CONCLUSIONS: The 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.
CI - Copyright (c) 2014 American Congress of Rehabilitation Medicine. Published by
Elsevier Inc. All rights reserved.

Langue : ANGLAIS