Background: Intrathecal baclofen (ITB) therapy effectively reduces severe spasticity but is associated with complications that can be serious. The evolution of these complications over time and their predictive factors are not well known.
Objectives: The primary aim was to describe the incidence of ITB complications in adults with neurological disorders and disabling spasticity. The secondary aims were to describe the complications and the time-course of their incidence, to identify factors associated with complications, and to evaluate ITB effectiveness.
Method: We conducted a retrospective, single-centre, longitudinal observational study of data from people implanted with an ITB pump between 1995 and 2023. We calculated the incidence of complications overall and per category, and their evolution over the study period. Factors associated with complications were searched among demographic, clinical, device-related, and ITB dose characteristics. Effectiveness of ITB therapy was assessed using a goal-achievement scale.
Results: Data from 170 individuals were included (1577 years of ITB therapy); 198 complications were reported. Complication incidence was 0.13 events per pump-year and rate was 0.63 events per implantation. 49 % of complications were device related, 31 % procedure related and 20 % drug related. Surgical intervention was required for 63 % of complications. The main risk factors were walking capacity with odds ratio (OR) 3.12 (95 % CI 1.14 to 9.10, P = 0.030), and pre-Ascenda catheters with OR 3.36 (95 % CI 1.28 to 9.10, P = 0.014). Synchromed II pumps were associated with a higher risk of procedure-related complications: OR 3.41 (95 % CI 1.14 to 12.12, P = 0.039). Complication incidence decreased continuously during the study period, mainly because of a reduction in the number of device-related complications. Goals were partially achieved in 51 % of participants and achieved in 37 %.
Conclusions: The incidence of complications associated with ITB therapy was high, and complications were mostly serious (requiring hospitalisation and/or life threatening). We recommend thorough examination of the benefits and risks of ITB therapy for each individual and systematic screening for dysfunctions at follow-up visits.
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