Intrathecal baclofen pump complications in adults: rates, risk factors, and spinal cord injury insights from a longitudinal cohort study.

Abstract

This study analyzed a cohort of adult patients who underwent intrathecal baclofen (ITB) pump and catheter implantation at a large tertiary neurorehabilitation center. The objectives were 1) to describe the rate and types of ITB-associated complications in patients with diverse neurological conditions, 2) to compare baseline clinical and demographic characteristics between patients with spinal cord injury (SCI) who experienced a complication and those who did not, and 3) to identify potential risk factors associated with the occurrence of complications in patients with SCI. This retrospective cohort study included patients who underwent ITB implantation at a single center (1989-2025). Patients with SCI who had complications were compared with those without complications across multiple baseline variables, including age, sex, ambulation status, BMI, diabetes status, neurological level of injury, American Spinal Injury Association Impairment Scale (AIS) grade, and motor Functional Independence Measure (FIM). Cox proportional hazards models were used to assess the association between patient-related factors and the risk of experiencing a first complication event. Among 281 patients (205 male, mean age 43.1 years) who underwent ITB pump implantation, the most prevalent conditions were SCI (203/281, 72.2%), multiple sclerosis (29/281, 10.3%), and cerebrovascular accident (16/281, 5.7%). Overall, 22.4% of patients experienced an ITB-related complication. Complications included device erosion (20/281, 7.1%), catheter malfunction (16/281, 5.7%), infection (14/281, 5.0%), CSF leakage (10/281, 3.6%), and pump malfunction (8/281, 2.8%). Additionally, 28 patients (10.0%) had "other" complications, which included a range of issues (e.g., seromas and hematomas). Among the patients with SCI, those with a complication (25.1%) were significantly younger at the time of implantation (mean age 38.1, SD 14.4, years) compared with those without a complication (mean age 45.3, SD 15.7, years; p = 0.004). No significant differences were observed between groups in terms of AIS grade, ambulation, diabetes, BMI, or neurological level. Patients who developed complications had a higher motor FIM score at baseline (mean 51.3 [SD 24.9] vs 44.4 [SD 25.0]), although this difference did not reach statistical significance (p = 0.056). Multivariable Cox proportional hazards analysis identified younger age at implantation as the only significant predictor of complication risk (HR 0.97 [95% CI 0.95-0.99], p = 0.013; C-index = 0.714). One in four patients with SCI had complications, half of which occurred within the first year. Younger patients were at higher risk, likely due to increased activity, emphasizing the need for early monitoring and targeted prevention strategies.