Review: Procedure- and Device-Related Complications of Intrathecal Baclofen Administration for Management of Adult Muscle Hypertonia: A Review

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). Methods 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.