ABSTRACT
OBJECTIVES: The objective of this study was to evaluate the accuracy, reliability, safety, and efficacy of the Codman Model 3000 Constant Flow Implantable Infusion Pump for intrathecal baclofen delivery as a therapeutic option for the treatment of severe spasticity. The distinctive features of this pump include a raised, easily palpable septum, a safety valve protecting the bolus pathway, no programmer needed, and no battery to fail. DESIGN: A total of 17 patients with spinal cord injury, multiple sclerosis, or cerebral palsy were implanted with this pump. The accuracy of the pump and drug treatment efficacy was determined at each visit and adjustments to the dosages were made as required. All the intrathecal drug delivery system complications were reviewed. RESULTS: The expected efficacy was achieved. The accuracy of the implanted pumps ranged from 90-97% (average 94%). There were no complications due to primary pump problems. The complications reported are similar to other implantable infusion devices and include dehiscence of the suture line, pressure ulcer development, formation of seroma, inversion of the pump, baclofen overdose, and catheter failures. CONCLUSION: The Codman Model 3000 Constant Flow Implantable Infusion Pump is an accurate, reliable, and convenient option for patients needing intrathecal baclofen therapy, with complications similar to other available pumps.
Subject(s)
Baclofen/administration & dosage , Evaluation Studies as Topic , Infusion Pumps, Implantable , Muscle Relaxants, Central/administration & dosage , Muscle Spasticity/drug therapy , Adolescent , Adult , Child , Female , Humans , Injections, Spinal , Male , Middle Aged , Outcome Assessment, Health Care , Prospective Studies , Reproducibility of Results , Retrospective StudiesABSTRACT
OBJECTIVE: To review the outcomes of surgical management of spinal cord injury (SCI) patients with severe pressure ulcers and to examine likely risk factors for recurrence of pressure ulcers. DESIGN: A retrospective medical record review. SETTING: An SCI unit in a tertiary care facility. PATIENTS: All admissions to the SCI unit for grade 4 pressure ulcers from 1976 to 1996. INTERVENTION: Surgical repair of pressure ulcers. MAIN OUTCOME MEASURE: Complication and recurrence rates of pressure ulcers. RESULTS: Of 598 pressure ulcers, 468 were pelvic area ulcers, of which 431 (92%) were treated surgically. Fifty-three had split-thickness skin grafting, and 380 were treated with 421 surgical procedures (253 fasciocutaneous or cutaneous flaps, 93 muscle or musculocutaneous flaps, 75 primary closures). One hundred eight (26%) of these procedures required some bone work. Suture line dehiscence occurred in 130 (31%), with 45 (11%) requiring reconstruction and 8 (2%) requiring skin grafting to heal. At discharge, 38 (9%) of these pelvic ulcers had not healed. Recurrent admissions occurred in 90 (54%) of the patients. Recurrence of ulcers at the same site occurred in 31% of the total number of ulcers and at a different site in 21%. At the time of the 415 admissions, 336 (81%) of the patients were unemployed; 159 (38%) had grade 8 or lower level of education; and 226 (55%) lived alone or with family but were independent in self-care. Of the 168 patients studied, 45 (27%) were aboriginal (Canadian native), and 59 (35%) had a history of drug or alcohol abuse. CONCLUSIONS: The vast majority of severe pressure ulcers were surgically treated. Complication and recurrence rates are similar to previous reports. Psychosocial problems (unemployment, low level of education, drug or alcohol abuse, poverty in the native communities) appear to increase the risk for pressure ulcer development.
