Intrathecal Pump Research Articles

Intrathecal baclofen pump exchange in multiple sclerosis. Factors affecting baclofen efficacy and dose adjustement. A case report

Multiple sclerosis is a neurological disease that presents with various symptoms; in some cases it is progressive and highly disabling, requiring invasive techniques to treat pain and spasticity. The use of intrathecal baclofen infusions is an effective and safe alternative for patients with severe and refractory spasticity. The therapy can improve quality of life, but must be performed in a pain unit by medical staff trained in the technique, its indications, pharmacology, and the potential risks of both the implant and the drug. The treatment can be individualized and patients must be followed up periodically.

Microsurgical DREZotomy in Spastic Cerebral Palsy: Poor Man's Baclofen Pump

Using an intrathecal baclofen (ITB) pump for severe refractory spastic cerebral palsy is not a viable option in resource-constraint settings. Therefore authors assessed the role of microsurgical dorsal root entry zone-otomy (MDT) as an alternative for patients in whom the circumstances did not allow ITB pump placement. A prospective clinical study was conducted from August 2016 to July 2020. All patients of spastic cerebral palsy (with III-IV Ashworth grade) who underwent MDT were included. Preoperative and postoperative Ashworth grade and Gross Motor Function Classification System level were assessed along with any change in power, sensation, and bladder functions postoperatively. At last follow-up, the patients' main care providers were asked to rate the effect of surgery (on scale of 0-5) on ease of providing care related to 6 activities of daily living. Seven patients (5 males, 2 females) of spastic cerebral palsy with an age range of 6-21 years underwent MDT over the study period. Six patients had spastic diplegia, and 1 had spastic hemiplegia. Preoperative Ashworth grade in all patients was 3-4 in various involved muscle groups. Four patients with spastic diplegia underwent MDT at L3-S1 level bilaterally, 2 patients with spastic diplegia and spastic bladder underwent MDT at L3-S4 level bilaterally, and 1 patient with right-sided spastic hemiplegia underwent MDT at C5-T1 level and L3-S1 level on the right side. Postoperative Ashworth grade in all patients improved to 0-1. The improvement in mean Ashworth grade was from 3.14 ± 0.378 preoperatively to 0.29 ± 0.488 (P value= 0.000). Most care providers reported improvement in their ability to do physiotherapy, position, clothe, ambulate, and maintain patient's personal hygiene. Care providers of 6 patients reported that they were likely to recommend MDT to another similar patient. MDT is a cost-effective tool in deceasing limb spasticity in spastic cerebral palsy, especially for those who cannot afford ITB placement.

Education and training of nurses in the use of advanced medical technologies in home care related to patient safety: A cross-sectional survey

BackgroundTo use advanced medical technologies (AMTs) correctly and safely requires both specialist knowledge and skills, and an awareness of risks and how those can be minimized. Reporting safety concerns about AMTs in home care can contribute to an improved quality of care. The extent to which a health care organization has integrated the reporting, evaluation and learning from incidents is a key element of that organization's patient safety culture. ObjectivesTo explore nurses' experiences regarding the education followed in the use of AMTs in the home setting, and their organizations' systems of reporting. DesignDescriptive cross-sectional design. Methods209 home care nurses from across the Netherlands who worked with infusion therapy, parenteral nutrition and/or morphine pumps responded to the online questionnaire between July 2018 and February 2019. The analysis of the data was mainly descriptive. ResultsEducational interventions that are most often used to learn how to use AMTs were, as an average over the three AMTs, instruction by a nurse (71%), practical training in the required skills (71%) and acquiring information to increase theoretical knowledge (69%). Considerable attention is paid to patient safety (88%) and the home setting (89%). However, a substantial proportion of the nurses (up to 29%) use AMTs even though they had not been tested on their skills. 95% of the respondents were well acquainted with the incident reporting protocol of their organization, but only 49% received structural or regular feedback on any actions taken as a result of event reporting. ConclusionsThis study revealed aspects of nurses' education that imply risk factors for patient safety. Practical training is not always given, additional or retraining is often voluntary, and the required skills are not always tested. However, the results show that nurses do have a good awareness of patient safety. Incidents are mainly discussed within the team, but less at the organizational level.

Evaluation of the cognitive benefits of intrathecal baclofen pump implantation in people with intractable multiple sclerosis related spasticity

BackgroundSpasticity is a common problematic symptom in Multiple Sclerosis with over one third of patients failing first line therapies. Intrathecal baclofen is a safe and efficacious option for treatment resistant spasticity. Anecdotally patients report improved concentration/cognitive performance when switching to intrathecal baclofen (ITB) from systemic medications. AimTo explore whether subjects who proceed with ITB pump implantation for spasticity management and reduce oral anti-spasticity agents will have improved cognitive function. MethodsSubjects were admitted for trial of ITB via lumbar puncture and subsequent pump implantation. Spasticity and cognitive measures before ITB trial and 3 months post implant were recorded. Paired t-test or Wilcoxon Signed Ranks test was used for within subject change and effect sizes (Cohen's dz) were calculated. Subgroup analysis of those on ≥2, or ≤ 1 spasticity medications at baseline was performed. Results27 subjects with MS completed per protocol. Mean age 46 years [26 – 56], disease duration 15 years [6 – 26], RRMS = 3, SPMS = 17 and PPMS=7. The majority were on multiple spasticity medications. Spasticity scores significantly improved post pump implant. Mean ITB dose at 3 months was 143 mcg / day and 19 discontinued all other treatments for spasticity. There was no deterioration on any cognitive or mood measure. An improvement of moderate effect size was found in Backwards Digit Span (d=0.41, p=0.059) and HADS – anxiety (d=0.37, p=0.097). Fatigue Severity Scale score decreased substantially (d=0.81, p=0.005). Small improvements in Symbol Digit Modalities Test score (d=0.24) and Sustained Attention to Response Task response time (d=0.23) were non-significant. Performance on other measures did not change. Effect sizes were larger in subgroup on ≥2 oral spasticity medications at baseline, compared to the group on ≤1 medication (SDMT, d=0.42 vs d=0.07; Backwards digit span 0.45 vs 0.28; HADS-anxiety 0.39 vs 0.32; HADS-depression d=0.32 vs 0.05 and FSS, d= 1.14 vs 0.42). ConclusionsIn a pilot study exploring the impact of ITB on cognition, spasticity scores improved universally and beneficial effects on some measures of fatigue, anxiety, auditory attention and verbal working memory were found. Improvement of speed of processing in those withdrawing higher doses of oral medication was also demonstrated suggesting that switching to ITB has added cognitive and psychological benefits for people with MS.

Mothballs, status dystonicus and critical care: an unusual case of G6PD deficiency

Glucose 6 Phosphate Dehydrogenase (G6PD) is a critical enzyme in the pentose phosphate pathway, a pathway that acts to provide reducing energy to cells. G6PD deficiencies are X-linked inherited disorders, in which the G6PD on red blood cells (RBCs) is defective. This case report will focus on an G6PD deficient individual of Thai descent, Sill, who was exposed to moth balls at an early age. The damage left him with severe dystonic Cerebral Palsy (CP), a permanent movement disorder, causing him to constantly display asymmetric posturing and opisthotonic movements. This article follows Sill through his admission, initially for GJ Tube re-insertion, then for hypoxemia. Sill is seen by several services, who attempt various forms of medication and procedures. This case ends with the insertion of an Intrathecal Baclofen pump; a potential remedy for Sill's current symptoms. Lastly, we discuss the implications of screening for conditions that are typically benign, such as G6PD deficiencies, but can have lethal outcomes.

New modalities and directions for dystonia care.

Dystonia is an abnormal involuntary movement or posture owing to sustained or intermittent muscle contraction. Standard treatment for dystonia includes medications, such as levodopa, anticholinergic and antiepileptic drugs, botulinum toxin, and baclofen pump, and surgeries, such as lesioning surgery and deep-brain stimulation. New treatment modalities aimed toward improving dystonia care in the future are under investigation. There are two main axes to improve dystonia care; one is non-invasive neuromodulation, such as transcranial magnetic stimulation, transcranial electrical stimulation, and transcutaneous electrical nerve stimulation. The other is a quantitative evaluation of dystonia using a wearable device and motion-capturing system, which can be empowered by artificial intelligence. In this article, the current status of these axes will be reviewed.

Outcomes Associated With Infection of Chronic Pain Spinal Implantable Electronic Devices: Insights From a Nationwide Inpatient Sample Study

ObjectivesChronic pain spinal implantable electronic devices (CPSIEDs) include devices that provide spinal cord stimulation and intrathecal drug therapy. In this study, we sought to evaluate the trends of CPSIED infections, related complications, and outcomes following the treatment of infection. Materials and MethodsThe Nationwide Inpatient Sample database contains data from 48 states, and the District of Columbia was used to identify patients with a primary diagnosis of CPSIED infection during the years 2005–2014. Patients with intrathecal pumps for the treatment of spasticity were excluded to limit the study population to patients with chronic pain disorders. Treatments were categorized as: 1) without device removal, 2) pulse generator or pump only removal, 3) intrathecal pump system removal, and 4) spinal cord stimulation system removal. Complications associated with CPSIED infections were identified using administrative billing codes. ResultsDuring the study period 2005–2014, a total of 11,041 patients were admitted to the hospital with CPSIED infections. The majority of the patients were treated without surgical intervention (56%), and a smaller proportion underwent complete system explantation (22.7%). In-hospital mortality or permanent disability due to paralysis after CPSIED infection was around 1.83% and 2.77%, respectively. Infectious complications such as meningitis, abscess formation, and osteomyelitis occurred in 4.93%, 5.08%, and 1.5%, respectively. The median cost of hospitalization was around US $14,118.00, and the median length of stay was approximately six days (interquartile range = 4–13 days). ConclusionsThe complications of CPSIED infection were higher among patients that did not undergo device removal.

A Retrospective Analysis of Intrathecal Catheter Tip Position in Plain Radiography: How Much Do We Agree?

To assess interrater and intrarater reliability of postoperative plain radiographs, which are routinely performed to confirm the correct placement of the catheter tip after intrathecal drug delivery systems (IDDS) implantation. This was a retrospective analysis of plain radiographs obtained from patients implanted with intrathecal catheters and morphine pumps. Each plain radiograph was assessed independently by three raters with varying expertise, at three different time points, to confirm the position of the intrathecal catheter tip. Krippendorff?s alpha coefficient was used to calculate both the interrater and intrarater reliability. There was a high level of agreement among the three raters and the three reviews of each rater separately when assessing the location of intrathecal catheter tips in plain radiographs from 126 patients. This was evidenced by the Krippendorff?s alpha value being > 0.99 in all cases, which was greater than the cutoff threshold value of 0.8. The interrater and intrarater reliability of plain radiographs for determination of catheter tip position after IDDS implantation was high. The experience and expertise of the raters did not significantly affect the assessments.

Acute Pain Management of Chronic Pain Patients in Ambulatory Surgery Centers.

With the widespread growth of ambulatory surgery centers (ASCs), the number and diversity of operations performed in the outpatient setting continue to increase. In parallel, there is an increase in the proportion of patients with a history of chronic opioid use and misuse undergoing elective surgery. Patients with such opioid tolerance present a unique challenge in the ambulatory setting, given their increased requirement for postoperative opioids. Guidelines for managing perioperative pain, anticipating postoperative opioid requirements and a discharge plan to wean off of opioids, are therefore needed. Expert guidelines suggest using multimodal analgesia including non-opioid analgesics and regional/neuraxial anesthesia whenever possible. However, there exists variability in care, resulting in challenges in perioperative pain management. In a recent study of same-day admission patients, anesthesiologists correctly identified most opioid-tolerant patients, but used non-opioid analgesics only half the time. The concept of a focused ambulatory pain specialist on site at each ASC has been suggested, who in addition to providing safe anesthesia, could intervene early once problematic pain issues are recognized. This review focuses on perioperative pain management in three subsets of patients who exhibit opioid tolerance: those on large doses of opioids (including abuse-deterrent formulations) for chronic non-malignant or malignant pain; those who have ongoing opioid misuse; and those who were prior addicts and are now on methadone/suboxone maintenance. We also discuss perioperative pain management for patients who have implanted devices such as spinal cord stimulators and intrathecal pain pumps.

Virtual reality to reduce pain intensity and anxiety during intrathecal pump refills in children with cerebral palsy

Virtual reality to reduce pain intensity and anxiety during intrathecal pump refills in children with cerebral palsy

Complications of intrathecal baclofen pump treatment in children with spastic cerebral palsy. A comparative analysis of patients weighing over or under 20 kg at the time of implantation.

The purpose of this study was to investigate the incidence of complications in pediatric spastic cerebral palsy (CP) patients weighing less than 20 kg at the time of intrathecal baclofen (ITB) pump implantation and to compare it with spastic CP patients heavier than 20 kg. Twenty-seven patients with spastic CP (14 males) treated with ITB implantation at our institution between January 2002 and January 2018 were retrospectively reviewed. Eight of the 27 patients had a bodyweight below 20 kg (group A) and 19 had weight above 20 kg (group B). Group A had a significantly more important proportion of patients with the Gross Motor Function Classification System V compared to group B (88 vs. 42%). The median follow-up was respectively 2.5 (1.8-4.6) and 4.6 (1.9-10.0) years in groups A and B. Median age at the time of ITB implantation was 7.4 (2.8-12.8) and 13.7 (6.5-16.8) years in groups A and B (P = 0.002). The proportion of patients with complications or reoperation was NS between groups A and B (P > 0.05). No postoperative infections were recorded in any of the groups. During follow-up, five patients died (63%) in group A and three (16%) in group B (P = 0.049) within 3.8 years on average after ITB implantation. ITB therapy in spastic CP patients weighing less than 20 kg seems to be as well tolerated and effective as it is in heavier (>20 kg) pediatric patients.

Cost Comparison Among Punctate Midline Myelotomy, Intrathecal Pain Pump, and Spinal Cord Epidural Stimulator

Background Invasive pain procedures can be valuable tools to manage chronic pain. Here, we compared the costs of three procedures used to address chronic pain; punctate midline myelotomy (PMM), placement of a spinal cord stimulator (SCS), or placement of an intrathecal pain pump (ITPP). Case Description This retrospective chart review yielded 9 patients with chronic pain syndromes; 3 had PMM, 3 had SCS, and 3 had ITPP procedures. Variables studied included; pain type, the procedures performed, and the cost of each procedure. The Wilcoxon rank-sum and one-way analysis of variance were used to compare the three groups (P < 0.05). PMM was performed for patients with chronic nonmalignant visceral pain and SCS was utilized for failed back syndrome, while ITPP was placed in two patients with chronic visceral cancer pain and one patient with chronic somatic cancer pain. The mean length of stay was significant shorter for SCS and PMM versus ITPP (e.g., 1, 3.6 ± 0.6 and 15 ± 5.6 days). The mean procedure costs were significantly higher for SCS versus PMM and ITPP (105,234, $71,087, and $79,333); for the latter PMM and ITPP, procedural costs were not significantly different. Conclusion For the three pain procedures discussed in this report, PMM is the most cost-effective as it obviates the need for efficacy trials, and there are: no implant device costs, no medication refills, no maintenance costs, and no complication management costs.

Low Rate of Intrathecal Baclofen Pump Catheter-Related Complications

Low Rate of Intrathecal Baclofen Pump Catheter-Related Complications

Response to: Managing Intrathecal Drug Delivery Devices in a Global Pandemic

Response to: Managing Intrathecal Drug Delivery Devices in a Global Pandemic

Allergic Skin Reactions to Baclofen Pump: A Case Report

US was a 37-year old man who presented with generalized skin rashes of two years duration. He had a history of cervicothoracic (C6/T1) spine injury seven years earlier and for which he was managed conservatively at a secondary level hospital. He had Baclofen Pump inserted intrathecally in India four years following the spinal injury resulting in persistent spastic paralysis of both lower limbs. He was scheduled for intermittent Baclofen refill at India. Three months after the second drug refill, he developed generalized skin rashes. His vital signs were stable on presentation. He had wide-spread skin rashes. There was a bulge on the anterior abdominal wall on the right hypochondrial region due to the presence of the metallic implant. The dermatological review suggested foreign body reaction to exclude Acquired Ichthyosis was made. The patient had an explantation done and thereafter, showed remarkable improvement three months after the removal of the Intrathecal Baclofen Pump with healing and disappearance of the skin rash.

Epidural catheter placement in children with baclofen pumps.

Children with cerebral palsy often suffer from increased tone, which can be treated with intrathecal baclofen via implanted pump. Additionally, they often require major orthopedic surgery for hip reconstruction; however, the presence of an intrathecal baclofen pump is a relative contraindication to regional anesthesia due to concerns about damaging the intrathecal baclofen pump system. (a) To evaluate adverse events related to placing epidural catheters in children with intrathecal baclofen pumps and (b) describe our multidisciplinary approach to the care of these complex patients. Children with cerebral palsy and intrathecal baclofen pump in situ who underwent hip reconstruction between 2010 and 2019 and had a perioperative epidural placed were reviewed retrospectively. Charts were assessed for adverse events or intrathecal baclofen complications. Fluoroscopic images were reviewed to evaluate the proximity between epidural and intrathecal baclofen catheters. The process of coordinating multiple services was examined. Sixteen children met the inclusion criteria. There were no major complications following epidural placement. Postoperative pump interrogation was normal for all patients. Fluoroscopy was utilized for 9/16 (56%) epidural procedures. Epidurogram was used to confirm 11/16 catheters (68%). Children with an intrathecal baclofen pump were identified by orthopedic surgeons at the time of surgical booking and referred to the regional anesthesia team for review. The neurosurgical, pain, and regional anesthesia teams determined the appropriateness and safety of approaching the neuraxis. Pain and/or regional anesthesiologists with competency in spine fluoroscopy were scheduled on the day of surgery for fluoroscopically guided epidural placement. Postoperatively, catheters were managed by the acute pain team. Intrathecal baclofen pumps were interrogated by the baclofen pump team prior to patient discharge. In this case series, not only was epidural placement feasible but also there were no observed complications. This work highlights the importance of a multidisciplinary approach to complex regional anesthetic techniques, as well as the importance of basic competency in spine fluoroscopy for regional anesthesiologists.

Utility of intrathecal baclofen pump in primary lateral sclerosis

Primary lateral sclerosis is a disorder categorized by insidious onset of progressive upper motor neuron dysfunction without lower motor neuron involvement. PLS often presents with gradual-onset, progressive lower extremity stiffness and pain due to muscle spasticity. Intrathecal Baclofen pumps (ITB) have been used to effectively treat spasticity in several neurologic conditions including MS and spinal cord injury. This study aimed at reviewing a cohort of PLS patients with spasticity requiring ITB to assess the clinical course, benefits, and complications in these patients. A series of 5 patients were identified who were diagnosed with PLS and received ITB as treatment for spasticity. The average age of the patients at the time of ITB insertion was 56.4 years. The average length of treatment was 10.4 years with a range of 4–15 years. All patients reported improvement in spasticity as measured by clinical examinations and Ashworth scores; 1/5 had complications with the pump related to migration of catheter. No patients required permanent removal of the ITB. ITB is a safe and effective treatment for spasticity in PLS and should be considered in other patients.

Managing a National Intrathecal Pump Service During the COVID-19 Pandemic

ObjectiveThe healthcare and social disruption caused by the COVID-19 pandemic could pose significant risk to patients with intrathecal pump (ITP) who may miss refill or replacement appointments. In some cases, this could be life-threatening. We designed and piloted a novel refill protocol to assess its efficacy and safety.Materials and MethodsScreening of our ITP database for patients most at risk of harm was conducted. These patients were risk-assessed for COVID-19 infection and were enrolled in a protocol to optimize the safety and efficiency of their pump replacement or refill.ResultsOf note, 31 of 51 database patients were deemed to be high risk of ITP failure during the pandemic. Thirty patients were successfully refilled with only one patient refusing to leave their house for refill. There were no significant adverse outcomes.ConclusionOur protocol offers a safe and efficient pathway for ITP management during a pandemic.

Surgical treatment of spasticity: intrathecal baclofen pump implantation under subarachnoid block.

Most patients with spasticity, rigidity, and other symptoms of the upper motor neuron syndrome respond effectively to surgical treatment with an intrathecal baclofen pump when their symptoms become intractable to nonsurgical measures. Baclofen administered into the lumbar subarachnoid space produces a locally high concentration at the spinal level and a low concentration supraspinally, avoiding most of the central side effects associated with a high oral dose, such as drowsiness and confusion.The aim of surgical treatment is to provide the appropriate volume and concentration of the drug in the subarachnoid space, avoiding the main surgical complications, that is, infections, skin erosion, and catheter displacement.The video can be found here: https://youtu.be/HetelPwwwak

Reducing Intrathecal Baclofen Related Infections: Service Evaluation and Best Practice Guidelines

Intrathecal baclofen (ITB) pumps are an effective treatment for spasticity; however infection rates have been reported in 3-26% of patients in the literature. The multidisciplinary ITB service has been established at The National Hospital for Neurology and Neurosurgery, UCLH, Queen Square, London for over 20 years. Our study was designed to clarify the rate of infection in our ITB patient cohort and secondly, to formulate and implement best practice guidelines and to determine prospectively, whether they effectively reduced infection rates. Clinical record review of all patients receiving ITB pre-intervention; January 2013-May 2015, and following practice changes; June 2016-June 2018. Four of 118 patients receiving ITB during the first time period (3.4%, annual incidence rate of infection 1.4%) developed an ITB-related infection (three following ITB pump replacement surgery, one after initial implant). Infections were associated with 4.2% of ITB-related surgical procedures. Three of four pumps required explantation. Following change in practice (pre-operative chlorhexidine skin wash and intraoperative vancomycin wash of the fibrous pocket of the replacement site), only one of 160 ITB patients developed infection (pump not explanted) in the second time period (0.6%, annual incidence rate 0.3%). The infection rate related to ITB surgical procedures was 1.1%. In cases of ITB pump replacement, the infection rate was reduced to 3.3% from 17.6%. This study suggests that a straightforward change in clinical practice may lower infection rates in patients undergoing ITB therapy.