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COPYRIGHT 2004 American Association of Neuroscience Nurses
Abstract: Intrathecal baclofen (ITB) therapy has evolved into a standard treatment for severe spasticity. After this therapy had been provided for 10 years, a retrospective chart review on 50 patients, representing a total 2,922 patient months of ITB service, was done. These patients suffered severe spasticity from a number of disease processes including multiple sclerosis, cerebral palsy, and brain injury. The average dosage for the total group was 463 micrograms per day ([micro]g/day), and 32% used a simple infusion mode. Pump refills occurred every 3 months for 58% of the group. Three evolving trends in ITB therapy were identified from clinical trial to current management: (a) higher catheter tip placement, (b) use of more complex infusion modes, and (c) a decreased complication rate.
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The Decade of the Brain saw advances in treatment for neurological disorders, especially chronic conditions. One example is intrathecal baclofen (ITB) therapy, a technique introduced in the 1980s. Baclofen (Lioresal intrathecal) infused long term directly into the intrathecal space using the Synchromed Infusion System was approved by the Food and Drug Administration in 1992 for spinal origin spasticity and in 1996 for cerebral origin spasticity. It is now accepted internationally as standard care for severe spasticity (Albright, Gilmartin, Swift, Krach, Ivanhoe, & McLaughlin, 2003; Awaad, Tayem, Munoz, Ham, Michon, & Awaad, 2003; Emery, 2003; Gilmartin, et al. 2000; Ivanhoe, Tilton, & Francisco, 2001; Meythaler, Guin-Renfroe, Brunner, & Hadley, 2001).
Across the United States, ITB is offered at a number of settings by various team members. To offer this therapy locally and fulfill a community need, the Neuroscience Implant Program (NIP) was developed within a tertiary-care regional medical center of a rural state. This unique advanced practice nurse-managed program accepted referrals for patients considered as candidates for implanted devices for neurological disorders. ITB was the first therapy offered through this program, but vagus nerve stimulation and deep brain stimulation treatments were added later. All therapies were managed in collaboration with the patient's neurologist. This allowed each neurologist the opportunity to offer treatment with implanted devices without the expense and time necessary to acquire the specific skills and equipment, and yet continue their role as healthcare provider for their patients with a chronic condition. In addition, NIP staff members collaborated with other physicians and medical center departments such as rehabilitation, nursing units, surgery, and radiology as needed. Consequently, development of the NIP allowed all residents of the rural state access to these innovative therapies with an experienced team.
A database was developed to track ITB patient demographics, dosing, and complications. After this therapy had been offered for 10 years, changes in ITB management were noted using the database. This article provides a retrospective review of 50 patients treated with ITB for up to 10 years with comparison to published reports and practices of national experts.
Patient Population
Over 10 years, beginning during the original multi-center clinical trial, 140 people were referred for evaluation for potential screening trial, implantation, and management of ITB therapy. Of these, 17 patients were not appropriate candidates and were not screened. Five patients completed screening trials but were not deemed appropriate for long-term therapy. Consequently, 118 patients were implanted with the Synchromed Infusion System by a pain management specialist or neurosurgeon for chronic ITB infusion. In addition, 12 patients who were implanted with the system at other sites were referred; four were seen only for system evaluation. Therefore, 126 implanted patients were followed by the author for at least 1 year. Of these, 35 were lost to follow-up or referred to a pain specialist for addition of a second drug, morphine, for example, to their baclofen for intrathecal infusion. Fourteen died from causes unrelated to ITB. Two were explanted because of complications (specifically, repeat catheter malfunction). Five patients, 4 adults, and 1 child with cerebral palsy (CP) were explanted because of dissatisfaction with the therapy. Seventy patients with ITB continued with the NIP.
Method
During the winter of 2002-2003, the first 50 patients to sign consents were interviewed and a retrospective chart review was conducted. The project, including consent, received institutional review board approval. Database expansion continued, but this report includes only the first 50 patients.
Results
These 50 patients represented an...
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