Low Rate of Intrathecal Baclofen Pump Catheter-Related Complications: Long-Term Study in Over 100 Adult Patients Associated With Reinforced Catheter.

OBJECTIVES: Intrathecal baclofen (ITB) is a cost-effective therapy for patients with severe spasticity. The most common complications are catheter-related complications (CRCs) including kinking/occlusion, blockage, migration, fracture, disconnection, and CSF leak. Our objective was to determine the CRC rate in a large cohort of adults with newly implanted ITB pump systems with polymer reinforced silicone catheters. MATERIALS AND METHODS: This is a retrospective study of a prospectively maintained database consisting of patients who had undergone implantation of ITB pump systems with Ascenda (Medtronic, Minneapolis) catheters from 2013 to 2020. Over this seven-year period, 141 patients underwent ITB pump system implantations; 126 of which had a minimum of one-year follow-up. RESULTS: The 126 patients with a minimum of one year follow-up (average 43 month; range 12-89), had an average age of 51 years (63% male). Severe spasticity was due to spinal cord injury (38%), traumatic brain injury (15%), cerebral palsy (13%), multiple sclerosis (11%), stroke (10%), and other (13%). Nine (7.1%) CRCs occurred in 7 (5.6%) patients (median 6 mo. post-implant): 5 intrathecal catheter occlusions (range 3-52 months post-implant), two fractures in one patient (6 months), one disconnection at the catheter pump interface (2 months), and one due to kinking at 84 months No migrations occurred. CONCLUSIONS: Reported CRCs have been high for ITB pump systems. Ours is the first large cohort, long-term study of CRCs related to reinforced catheters; additionally, our low CRC rate compares favorably to previously published data. Thus, implantation of reinforced catheters may be associated with a low CRC rate.

Intrathecal Baclofen Therapy in Patients With Multiple Sclerosis: Improved Outcomes and Reduced Costs Through Identification of Catheter Malfunction.

INTRODUCTION: Two patients previously implanted with intrathecal Baclofen (ITB) pumps for management of intractable spasticity due to multiple sclerosis (MS) were referred to our center for ongoing management of their spasticity. Initial evaluation of these patients revealed high levels of spasticity in the presence of ITB doses 10 times the average daily dose of our other MS patients. CLINICAL FACTS: High doses of ITB required frequent clinical visits and result in high drug and procedure costs. Both patients' daily doses were greater than 1000 mcg/day resulting in clinical visits every 1-2 months with drug and procedure costs ranging from 16 to 23 thousand dollars annually based on Medicare national average pricing for physician's office. Of the 59 MS patients receiving ITB therapy at our institution, the mean, median, and mode daily doses for ITB are 184, 115, and 159 mcg/day, respectively. The high ITB doses in these patients and poor spasticity control raised suspicion for pump/catheter malfunction and prompted immediate troubleshooting. FINDINGS: One patient's catheter was found to be disconnected from the pump and the other's catheter tip was outside the intrathecal space. In both cases, the patients were not receiving the therapy. After pump/catheter replacement, both patients received excellent clinical benefits from ITB at significantly lower daily doses. This reduction in dose resulted in decreased frequency of medication refills (twice annually) which resulted in decreased cost of care (12-19 thousand dollars savings annually per patient). DISCUSSION: These cases illustrate the need for early ITB pump troubleshooting to identify catheter problems, improve efficacy, and avoid unnecessary healthcare costs.

Intrathecal Baclofen Dosing Regimens: A Retrospective Chart Review.

OBJECTIVES: To examine dosing patterns in patients receiving baclofen via intrathecal baclofen pumps to assess for common patterns by diagnosis, ambulation ability, and affected limbs distribution. MATERIALS AND METHODS: This trial study included 25 patients with baclofen pumps selected from the 356 patients enrolled in our center's baclofen pump program. Selection was done by splitting all patients into diagnostic categories of stroke, multiple sclerosis, traumatic/anoxic brain injury, cerebral palsy, and spinal cord injury, and then, five patients were randomly selected from each diagnosis.A systematic chart review was then conducted for each patient from Jan 1, 2008, through September 16, 2013, to look at factors including mean daily dose at end of study, and among those implanted during the study mean initial stable dose and time to initial stable dose. RESULTS: Analysis of mean daily dose across diagnoses found significant differences, with brain injury, cerebral palsy, and spinal cord injury patients having higher doses while multiple sclerosis and stroke patients required lower doses. Nonambulatory patients strongly trended to have higher daily doses than ambulatory patients. Similar trends of mean initial stable dose being higher in a similar pattern as that of end mean daily dose were seen according to diagnoses and ambulatory status, although statistical significance could not be achieved with the small sample size. CONCLUSION: Significant differences in dosing were found between diagnoses and trended to differ by ambulatory status at the end of the study, and similar trends could be observed in achieving initial stable dose.

Best Practices for Intrathecal Baclofen Therapy: Dosing and Long-Term Management.

INTRODUCTION: Intrathecal baclofen (ITB) therapy aims to reduce spasticity and provide functional control. METHOD: An expert panel consulted on best practices. RESULTS: Pump fill and drug delivery can be started intraoperatively, with monitoring for at least eight hours. Initiate with the 500 mcg/mL concentration. The starting daily dose should be twice the effective bolus screening dose, or the screening dose if the patient had a prolonged response (greater than eight hours) or negative reactions. Oral antispasmodics can be weaned, one drug at a time beginning with oral baclofen after ITB begins. Assessment should occur within 24 hours of a dose change. For adults, daily dose increases may be 5% to 15% once every 24 hours for cerebral-origin spasticity and 10% to 30% once every 24 hours for spinal-origin spasticity. Daily dose increases can be 5% to 15% once every 24 hours for children. Inpatients should be assessed at least every 24 hours and receive rehabilitation. Step dosing can be used for outpatients who cannot return daily. Dosing options include simple continuous dosing, variable 24-hour flex dosing, or regularly scheduled boluses. Patients/caregivers should understand the care plan, responsibilities, and possible side-effects. Low-reservoir alarm dates and refill schedules should be written down, along with emergency contact information. A higher concentration at refill can extend refill intervals, and a bridge bolus must be programmed. Time changes may affect flex dosing. Pump replacement should be scheduled at least three months in advance. CONCLUSIONS: ITB dosing is multistep and individualized.

Building PRM in sub-Saharan Africa.

It is estimated that about 50% of people in low- and middle- income countries who require rehabilitation do not get it. Multidisciplinary rehabilitation services led by Physical and Rehabilitation Medicine (PRM) physicians have been shown to improve functioning, independence and the quality of life of persons with reduced functioning or disability. However, there is a dearth of PRM physicians in low to middle income countries (LMICs), particularly in sub-Saharan Africa. One potential solution to this lack of specialists is the establishment of PRM training programs, which are currently lacking. The International Rehabilitation Forum (IRF) developed and implemented a fellowship program to train physicians in rehabilitation medicine and has been successful in Ghana, Ethiopia and Cameroon, all LMICs in sub-Saharan Africa. However, ongoing challenges include inadequate PRM trainers, availability of logistics and services for hands on experience, and funding. The fellowship program has a promising future and an ultimate goal of having locally trained fellows leading the program and expanding it to other LMICs. There has however been no publication of the process followed to achieve this or of a similar process undertaken anywhere in Africa. The process followed in this publication highlights the journey from engaging stakeholders to the admission of new and current fellows in training.

Digital rectal stimulation as an intervention in persons with spinal cord injury and upper motor neuron neurogenic bowel. An evidenced-based systematic review of the literature.

Context: Need for evidential support of practice guideline recommendations for management of neurogenic bowel management in adults with spinal cord injury.Objective: To determine evidence for digital rectal stimulation (DRS) as an intervention in the management of upper motor neuron neurogenic bowels (UMN-NB) in persons with spinal cord injury (SCI).Methods: A systematic review of the literature including research articles and practice guidelines evaluating upper motor neuron neurogenic bowel treatments and the use of digital rectal stimulation was performed using OvidMedline, PubMed and the Cochrane database and included research articles and practice guidelines. Limitations were made related to English language, patient age and focus on spinal cord injured patients. Strength of evidence was assessed using the Johns Hopkins Nursing evidence-based practice model.Results: Eleven articles were included in the systematic review. Only one used DRS as a primary intervention. There was moderate evidence for DRS in persons with SCI and UMN-NB. There was evidence of the physiologic effect of DRS and support for combining DRS with other treatment regimens.Conclusion: There is insufficient evidence to promote any one intervention for the management of UMN-NB. The promotion of DRS, and education as to the proper technique for DRS should remain an emphasis of education of home management of UMN-NB in persons with SCI. Future research should focus on the use of standardized, validated tools to evaluate management techniques for UMN-NB.

Incidence and identification of intrathecal baclofen catheter malfunction.

OBJECTIVE: A retrospective chart review was undertaken of cases of intrathecal baclofen (ITB) pump/catheter malfunction and the diagnostic tests performed to identify the problem. An internal review was performed to develop a diagnostic flow chart to have a systematic method for identifying ITB pump and catheter complications. DESIGN: Retrospective chart review. SETTING: Tertiary care hospital. PARTICIPANTS: A total of 167 adult patients currently followed in outpatient clinic with intractable spasticity and ITB pump implanted between January 1994 and May 2009. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Catheter malfunction was identified either by anterior/posterior and lateral thoracic/lumbar radiographs, fluoroscopic guided side port access, contrast agent injection followed by CT (fluoro/CT) scan, or indium radionuclide studies. RESULTS: During the study period, 33 patients had 37 catheter revisions. Radiographs were obtained in all cases; fluoro/CT studies in 22, and indium studies in 6. Four cases had both fluoro/CT and indium studies. A total of 13 cases (35.1%) were diagnosed with radiographs; 9 cases (24.3%) were diagnosed by inability to withdraw cerebral spinal fluid from the side port; 13 cases (35.1%) were diagnosed with fluoro/CT studies; and 2 cases (5.4%) were diagnosed with indium studies. Fluoro/CT studies demonstrated subdural catheter location in 7 cases. A total of 2 of 4 cases with both fluoro/CT and indium studies had normal-appearing indium scans and an abnormal fluoro/CT study confirming subdural catheter placement. CONCLUSIONS: On the basis of an internal review of the diagnostic studies used to identify patients with suspected ITB pump/catheter malfunction, a troubleshooting flow chart was developed. Timely identification and correction of potential ITB complications could improve the clinical effectiveness of ITB and may reduce unnecessary health-care costs.