title: Reliability and clinical utility of an implanted intraspinal catheter used in the treatment of spasticity and pain.
abstract: Objectives. To examine the performance and reliability of a redesigned implantable intrathecal catheter. Materials and Methods. A total of 212 catheters were implanted in 202 patients in this 22-center prospective study of an implantable catheter/pump system used to deliver intrathecal drugs for the treatment of pain and spasticity. Along with physician assessments of ease of use, the rates of common catheter complications (dislodgments, disconnections, fractures, and kinks) experienced during the study were analyzed in relation to implant conditions (catheter entry site, tip position, and anchoring method). Results. A cumulative total of 3112.8 months of patient experience (average: 15.4 months; range: 0-30.2 months per catheter) revealed an overall catheter-caused complication rate of 0.3% per patient month. Physician assessments were favorable with 89% rating this catheter as better than previously used intraspinal catheters. A measure of catheter survival estimates (Kaplan-Meier) at nine months was 89% including all complications. Comparison of data relating to implant techniques demonstrated a variety of catheter implant techniques (entry, positioning, anchoring) with no correlation between any one technique and the common complications. Conclusions. Performance data and physician assessments indicate that this catheter is an improvement over the previously available catheter.
authors.affiliation: *Pacific Pain Treatment Centers, San Francisco, California;                               †Carolina Pain Center, Columbia, South Carolina;                               ‡8703 W Catheter Study Group Physicians and Locations are listed in Appendix                  A.
authors.forename: E S
authors.initials: ES
authors.lastname: Krames
authors.forename: I
authors.initials: I
authors.lastname: Chapple