Complications of intrathecal drug delivery therapy (ITDD): A retrospective study of 231 implantations between 1999 and 2014

Objective: Determination of types and frequencies of complications related to ITDD therapy, and assessment of possible risk factors for such complications. Methods: Retrospective study (1999-2014) including all ITDD-implantations at one regional center in Sweden. Descriptors comprised: sex; age; medical condition; body weight index; preoperative ASA-grade; presence of indwelling urinary catheters, feeding tubes, and/or daily urinary or anal incontinence; primary or reimplantation; type of pump and catheter; drug delivered; weekday of surgery; surgical procedure time; surgeon; experience of surgeon; surgical theater; and type of antibiotic prophylaxis. All deaths during the study period were assessed as regards possible relation to ITDD. Data were analyzed with SPSS 25, using Chi(2) test for correlations between descriptors and complications. Results: 231 ITDD pump implantations/re-implantations occurred in 159 patients. Seventy-eight (34%) instances of complications were found: 33 catheter-associated; 6 pump-associated; and 29 infection-associated, where 16 were surgical site infections. A higher infection rate occurred in pump re-implantations, as compared to primary implantations (p = 0.002), and in patients with traumatic spinal cord injury (TSCI) as compared to other diagnoses (p = 0.02). Cloxacillin as antibiotic prophylaxis correlated with a higher infection risk (p = 0.005) relative to other antibiotic prophylaxis. Prolonged surgical procedure time in re-implantations correlated positively with increased catheter-associated complications (p = 0.006). Conclusion: Complications in ITDD therapy were common, comprising catheter-, infection-, and pump-associated mishaps. A comprehensive system of care needs to be present for managing complications. Future studies may show less complications due to improved protocols and equipment.

Automated summary

This retrospective study analyzed complications related to ITDD therapy in a regional center in Sweden from 1999 to 2014, finding common mishaps including catheter-, infection-, and pump-associated complications. Risk factors for complications included pump re-implantation, traumatic spinal cord injury (TSCI) diagnosis, and the use of cloxacillin as antibiotic prophylaxis. Prolonged surgical procedure time in re-implantations was also found to correlate with increased catheter-associated complications.