Intrathecal drug therapy using the Codman Model 3000 Constant Flow Implantable Infusion Pumps: experience with 17 cases.

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.

Surgical treatment of pressure ulcers: 20-year experience.

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.

Urinary and gastrointestinal systems medications.

This article reviews the medical management of the neurogenic bladder and bowel. The drugs discussed specifically affect detrusor instability, detrusor weakness, high urethral pressure, low urethral closure pressure, inflammatory cystitis, and chronic constipation.

Intravenous pamidronate attenuates bone density loss after acute spinal cord injury.

OBJECTIVE: To compare the effects of a 6-month treatment with intravenous pamidronate (30-mg infusion once per month) to conventional rehabilitation without pamidronate on bone density of the spine and leg bones and on the excretion rate of N-telopeptide, a urinary marker of bone catabolism, in acutely spinal cord injured patients. DESIGN: A nonrandomized control trial in which 24 spinal cord injured subjects entered the study within 6 weeks of their injury. Fourteen subjects received pamidronate; 10 did not. OUTCOME MEASURES: Bone density measurements by dual x-ray absorptiometry were performed before the initial treatment (within 6 weeks of the injury) and at 3, 6, and 12 months postinjury and was the primary efficacy parameter. Urine for N-telopeptide levels was the secondary efficacy parameter. RESULTS: After acute spinal cord injury, patients treated with intravenous pamidronate had significantly less bone density loss compared with those who did not receive pamidronate (parametric ANOVA, p<.02). Also, ambulatory subjects had significantly less bone density loss over the study period (p<.05) than nonambulatory subjects. In general, a high excretion level of the urinary bone-breakdown product N-telopeptide was found before intravenous pamidronate treatment, followed by a dramatic reduction in excretion after pamidronate treatment. Ambulatory subjects excreted significantly less N-telopeptide than motor-complete subjects at all time points. CONCLUSION: Intravenous pamidronate treatment and ambulatory ability in the first 6 months after an acute spinal cord injury prevents bone density loss.

Intrathecal baclofen therapy for adults with spinal spasticity: therapeutic efficacy and effect on hospital admissions.

A prospective trial to demonstrate the efficacy of intrathecal baclofen therapy by implanted pump for adults with spasticity due to spinal cord injury or multiple sclerosis was initiated in our hospital. Of the 140 patients assessed, 7 met the following criteria for inclusion in the study: a modified Ashworth score > 3, a spasm frequency score > 2, and an inadequate response to oral anti-spasticity drugs, (i.e., baclofen, clonidine and cyproheptadine). All patients responded to intrathecal bolus injection of baclofen in the double blind, placebo-controlled screening phase (mean bolus dose = 42.8 micrograms). Programmable Medtronic pumps were implanted in 4 patients while 3 patients received non-programmable Infusaid pumps. Post-implantation, a marked decrease in spasticity occurred with a significant reduction of the Ashworth score (mean = 1.8, p < .005), a reduced spasm score (mean = 0.8, p < .005), and an improved leg swing in the pendulum test. These effects were maintained during a follow-up of 24-41 months (average infusion dose = 218.7 micrograms/day). The gross cost-savings due to reduced hospitalizations related to spasticity was calculated by comparing the cost for the two year period before pump implantation to the same period after treatment for 6 of the 7 patients. The cost of in-hospital implantation as well as the cost of the pumps were deducted from the gross savings. There was a net cost-saving of $153,120. Our findings agree with the reported efficacy and safety of intrathecal baclofen treatment, and illustrate the cost-effectiveness of this treatment.