Background: Intrathecal baclofen (ITB) effectively reduces muscle hypertonia; however, associated complications influence its utility and acceptance.
Objective: To systematically review the literature on procedure- and device-related complications associated with ITB infusion therapy for adult muscle hypertonia of spinal or cerebral origin.
Methods: The authors searched the PubMed database for full-length articles published in English that reported ITB-associated complications in adults. Of 147 articles retrieved, 32 full-length manuscripts and 10 case reports were reviewed in detail.
Results: Overall, 558 complications were reported after 1362 pump implants (0.41 per implant).
Method: s for characterizing complications varied greatly between studies, as did complication rates, ranging from 0 to 2.24 per implant. Of the 558 complications, 148 (27%) were related to surgical procedures, 39 (7%) to pump problems, and 369 (66%) to catheter malfunctions. The overall complication rate was higher for studies that followed patients for more than 18 months on average (mean 0.56/implant) versus studies with shorter follow-up (0.23/implant, P < .05). Although correlation between the number of implants and the number of complications was significant (r = .58), the goodness of linear fit was poor because of clusters with varied complication rates.
Conclusions: Catheter problems are relatively common and more frequent than pump or surgical procedure complications after ITB pump implantation. Higher complication rates should be expected in centers that follow patients for a longer period of time. Standardized data collection and complication-reporting procedures along with appropriate training should be implemented in centers offering ITB treatment for management of muscle hypertonia.