Intrathecal Pump Research Articles

Comparison of intrathecal baclofen pump insertion and selective dorsal rhizotomy for nonambulatory children with predominantly spastic cerebral palsy.

In nonambulatory children with predominantly spastic cerebral palsy (CP), the authors compared care needs, symptom burden, and complications after surgical treatment with either intrathecal baclofen (ITB) pump insertion or selective dorsal rhizotomy (SDR). The patients were treated at two Canadian centers with variability in practice pertaining to these surgical options. The authors performed a retrospective analysis of nonambulatory children with predominantly spastic quadriplegic or diplegic CP who underwent treatment with ITB or SDR. These two strategies were retrospectively assessed by comparing patient data from the two treatment groups for demographic characteristics, outcomes, and complications. A partial least-squares analysis was performed to identify patient phenotypes associated with outcomes. Thirty patients who underwent ITB and 30 patients who underwent SDR were included for analysis. Patients in the ITB group were older and had lower baseline functional status, with greater burdens of spasticity, dystonia, pain, deformity, bladder dysfunction, and epilepsy than patients in the SDR group. In addition, children who underwent SDR had lower Gross Motor Function Classification System (GMFCS) levels and were less likely to experience complications than those who underwent ITB. However, children treated with SDR had fewer improvements in pain than children treated with ITB. A single significant latent variable explaining 88% of the variance in the data was identified. Considerable baseline differences exist within this pediatric CP patient population. Factors specific to individual children must be taken into account when determining whether ITB or SDR is the appropriate treatment.

Use of Antibacterial Envelopes for Prevention of Infection in Intrathecal Pump Implantation

Intrathecal pumps for targeted delivery of baclofen for spasticity or morphine/hydromorphone for chronic pain are attractive treatment options for a variety of conditions, with increasing utilization. Placement of these devices carries a historic infection rate as high as 12%. Treatment of pump-related infection includes removal of the system, potentially leading to dangerous medication withdrawal. TYRX antibacterial envelopes (Medtronic Inc., Minneapolis, MN), which are absorbable mesh envelopes that elute minocycline and rifampin, have been used in implantable cardiac devices with substantial risk reduction for infection.

Myth and Truth in Opioid Consumption with Intrathecal Morphine Pump Implantation in Chronic Pain: A Retrospective Cohort Study with Claims Database in South Korea.

To investigate the opioid consumption and the healthcare resource utilization in patients with the intrathecal drug delivery system (IDDS) therapy and the comprehensive medical management (CMM) alone. A retrospective cohort study with a customized claims database. In a university-based hospital. Patients with complex regional pain syndrome, post-laminectomy syndrome, and fibromyalgia. Using propensity score matching (1:3), we selected patients with morphine infusion through IDDS (IDDS group) and CMM alone (CMM group). The primary endpoints were comparisons of average morphine equivalents daily dosages (MEDD, mg/day) for 6 and 12 months from an index date. The number of emergency room (ER) visits and hospitalizations and the total medical expenditures were compared as secondary outcomes. In total, 82 patients (N = 23 in the IDDS group and N = 59 in the CMM group) were analyzed. Although a 6-month average MEDD did not reach statistical significance, a 12-month average MEDD was significantly decreased in the IDDS group compared to the CMM group (53.2 ± 46.3 vs 123.9 ± 176.4, respectively; P = 0.008). ER visits were more frequent in the IDDS group than the CMM group at baseline (5.4 vs 0.5, respectively; P = .002), which was maintained for 12 months (P < 0.001). Otherwise, the number of hospitalization and the medical expenditures for pain management were not different between the groups for 12 months. The combined IDDS therapy had some benefits in reducing opioid consumption for 1-year follow-up compared to the CMM alone in chronic noncancer pain patients.

Results of Intrathecal Baclofen Treatment in Sixteen Spasticity Patients According to Four Different Measurement Scales:A Retrospective Analysis.

IntroductionSpasticity is a motor disorder characterized by a velocity-dependent increase in tonic stretch reflexes. It occurs as a result of overstimulation of the stretch reflex and is a component of the upper motor neuron syndrome. Intrathecal Baclofen (ITB) pump administration in patients with a diagnosis of spasticity may be a suitable option for reducing the complaints of the patients and increasing their quality of life. The aim of this study is to analyze clinically and statistically the diagnosis, treatment criteria, and post-treatment results of patients with spasticity who were treated in our clinic.Materials and MethodSixteen patients who were diagnosed with spasticity and placed on an intrathecal Baclofen pump between January 2015 and December 2020 were included in this study. An intrathecal Baclofen trial was first applied to patients who were candidates for the Baclofen pump. The spasticity levels of the patients who decided to have an intrathecal Baclofen pump were scored according to the modified Ashworth scale (MAS) and Penn spasm frequency scale (PSFS). In addition, the scaling of the patients' own conditions according to the visual analogue scale (VAS) and ambulation status according to the modified functional ambulation classification (MFAC) were recorded. All these evaluations were repeated in the preoperative, early postoperative, and follow-up periods.ResultsThe sex distribution of the patients included in the study was equal to eight women and eight men. The age distribution was between 18 and 76. The average age was 40.62 (standard deviation ±17.79). The average preoperative modified Ashworth scale score was 3.73, and the average Penn spasm frequency scale score of the patients was 3.67. The average preoperative modified functional ambulation classification score was 1.87, and the average visual analogue scale score was 6.67. At the end of the second postoperative week, the average modified Ashworth scale score was 1.80 and the average Penn spasm frequency scale score was 1.67. The modified functional ambulation classification score was 2.60 and the visual analogue scale score was 4.58. The average follow-up period of the patients was 64 months. At the end of the follow-up periods, the average late-period modified Ashworth scale score was 1.87, and the Penn spasm frequency scale score was 1.67. The average modified functional ambulation classification score was 3.00, and the average visual analogue scale score was 4.50. Statistically, there was a significant difference between preoperative and postoperative results in both modified Ashworth scale and Penn spasm frequency scale scores (P<0.05). Modified functional ambulation classification preoperative and postoperative comparison results (P<0.05) and visual analogue scale results (P<0.05) were also statistically significant. No significant difference was found between the early postoperative period and the late postoperative period in all measurements (P=1.00).ConclusionIntrathecal Baclofen administration is one of the many treatment options for spasticity. In this way, it has been shown that greater Baclofen efficacy is achieved and its side effects are reduced. It should always be remembered that the process of this treatment is teamwork that requires the participation of more than one specialty branch. Physical therapists, neurologists, pediatricians, and neurosurgeons should be included in this teamwork.

ID:16343 Managing Chronic Spinal Cord Stimulation in the Cerebral Palsy Population: A Case Report

This is the case of a 58 year old female with a history of congenital Cerebral palsy complicated by spastic quadriplegia treated with a Intrathecal Baclofen pump. Her course had been complicated by a long history of painful bilateral peripheral neuropathy that had been relieved with a Spinal Cord stimulator five years prior. She also received periodic Botulinim toxin injections in her bilateral upper and lower extremities for spasticity. The patient presented to Rehabilitation clinic with persistent worsening bilateral leg pain after total knee surgery and physical therapy.

ID:16258 Chronic Pain Management in a Parturient With an Implanted Intrathecal Drug Delivery System

AB is a 38 year old G2P0 with history of gastric bypass, retinal detachment, local anesthetic allergy, and complex regional pain syndrome (CRPS) of the left lower extremity. Her CRPS had been managed with a spinal cord stimulator (SCS), but the generator failed following an MRI. She underwent intrathecal pump implantation with SCS generator removal. The SCS leads were left in place for potential future use. Her pain was controlled on intrathecal fentanyl 245mcg basal dose, with 10 boluses/day, 30mcg each, up to a maximum of 542mcg/day.

Preoperative evaluation of coagulation status in neuromodulation patients.

The incidence of hemorrhage in patients who undergo deep brain stimulation (DBS) and spinal cord stimulation (SCS) is between 0.5% and 2.5%. Coagulation status is one of the factors that can predispose patients to the development of these complications. As a routine part of preoperative assessment, the authors obtain prothrombin time (PT), partial thromboplastin time (PTT), and platelet count. However, insurers often cover only PT/PTT laboratory tests if the patient is receiving warfarin/heparin. The authors aimed to examine their experience with abnormal coagulation parameters in patients who underwent neuromodulation. Patients who underwent neuromodulation (SCS, DBS, or intrathecal pump implantation) over a 9-year period and had preoperative laboratory values available were included. The authors determined abnormal values on the basis of a clinical protocol utilized at their practice, which combined the normal ranges of the laboratory tests and clinical relevance. This protocol had cutoff values of 12 seconds and 39 seconds for PT and PTT, respectively, and < 120,000 platelets/μl. The authors identified risk factors for these abnormalities and described interventions. Of the 1767 patients who met the inclusion criteria, 136 had abnormal preoperative laboratory values. Five of these 136 patients had values that were misclassified as abnormal because they were within the normal ranges at the outside facility where they were tested. Fifty-one patients had laboratory values outside the ranges of our protocol, but the surgeons reviewed and approved these patients without further intervention. Of the remaining 80 patients, 8 had known coagulopathies and 24 were receiving warfarin/heparin. The remaining 48 patients were receiving other anticoagulant/antiplatelet medications. These included apixaban/rivaroxaban/dabigatran anticoagulants (n = 22; mean ± SD PT 13.7 ± 2.5 seconds) and aspirin/clopidogrel/other antiplatelet medications (n = 26; mean ± SD PT 14.4 ± 5.8 seconds). Eight new coagulopathies were identified and further investigated with hematological analysis. New anticoagulants and antiplatelet medications are not monitored with PT/PTT, but they affect coagulation status and laboratory values. Although platelet function tests aid in a subset of medications, it is more difficult to assess the coagulation status of patients receiving novel anticoagulants. PT/PTT may provide value preoperatively.

National survey of health services provided by pediatric post-acute care facilities in the US.

The need for pediatric post-acute facility care (PAC) is growing due to technological advances that extend the lives of many children, especially those with complex medical needs. The objectives were to describe [1] the types and settings of PAC; [2] the clinical characteristics of the pediatric patients requiring PAC; and [3] perceptions of PAC care delivery by clinical staff. An online survey was administered between 6/2018 to 12/2018 to administrative leaders in PAC facilities that have licensed beds for children and who were active members of the Pediatric Complex Care Association. Survey topics included types of health services provided; pediatric patient characteristics; clinical personnel characteristics; and perceptions of pediatric PAC health care delivery. Leaders from 26 (54%) PAC facilities in 16 U.S. states completed the survey. Fifty-four percent identified as skilled nursing facility/long-term care, 19% intermediate care facilities, 15% respite and medical group homes, and 12% post-acute rehabilitation facilities. Sixty-nine percent of facilities had a significant increase in the medical complexity of patients over the past 10 years. Most reported capability to care for children with tracheostomy/invasive ventilation (100%), gastrostomy tubes (96%), intrathecal baclofen pump (89%), non-invasive positive pressure ventilation (85%), and other medical technology. Most facilities (72%) turned away patients for admission due to bed unavailability occasionally or always. Most facilities (62%) reported that insurance reimbursement to cover the cost of providing PAC to children was not acceptable, and most reported that it was difficult to hire clinical staff (77%) and retain staff (58%). PAC in the U.S. is provided to an increasingly medically-complex population of children. There is a critical need to investigate financially-viable solutions for PAC facilities to meet the patient demands for their services and to sufficiently reimburse and retain staff for the challenging and important care that they provide.

ID:15921 Treating Spasticity in a Stroke Patient

The patient was a 60-year-old woman who had a stroke in 2005. She presented at the Culicchia Neurological Clinic in 2013 with right hemiparesis and global spasticity in her right upper and lower extremities. She had no visible spasms, took 30 mg of oral baclofen a day, and managed pain with acetaminophen as needed. In 2014, she was implanted with an intrathecal pump (SynchroMed® II, Medtronic) and started at a dose of 50.04 μg/day programmed as simple continuous, titrated to 54.98 μg/day a few days later.

P.166 Subcutaneous intrathecal catheter and port implants for administration of Nusinersen in patients with Spinal Muscular Atrophy

Background: Until recently, no effective treatment was available for spinal muscular atrophy (SMA). In 2017, Health Canada approved intrathecal Nusinersen a medication that prevents degeneration of the motor neurons in the spinal cord. The administration is intrathecally most commonly via lumbar puncture (LP) to have a direct effect on the motor neurons of the spinal cord.Many older patients with SMA and concomitant spinal deformities present technical challenges to access the thecal sac. Different routes have been described for delivery of the medication. These techniques may require sedation, are associated with radiation exposure, and demand experience personnel. Methods: A new surgical technique has been proposed to overcome these obstacles by combining two Health Canada approved devices: 1) an intrathecal catheter designed for intrathecal baclofen pumps and 2) an implantable subcutaneous port designed for intravascular medication administration Results: We describe the technical nuances and outline the clinical outcomes of six patients with complex spine deformities who have undergone such an implant for administration of Nusinersen. Conclusions: We discuss the benefits of the procedure which includes: 1) administration in the outpatient setting without sedation, 2) avoidance of costly imaging and experienced personnel, and 3) placement of the catheter in the cervicothoracic junction.

ID:15850 Identification of a Pump Inversion by Radiotelemetry

Implanted intrathecal pumps can flip over in the pocket, a condition that can have serious consequences. Not only can a filled pump not be refilled but the dynamic movement can cause damage to the catheter. Some devices are designed so that the programmer can communicate with the implanted pump regardless of position. In this case, pump inversion was detected by a failure to obtain radiotelemetry communication between the pump and programmer.

ID:15841 A Case of Prolonged Psychosis With Intrathecal Ziconotide

Chronic refractory pain can be difficult to manage. Intrathecal Ziconotide has proven to be effective at treating refractory nociceptive and neuropathic pain. Ziconotide’s analgesic effect is via selective blockade of N-type calcium channels. Ziconotide is trialed with a bolus of 3 mcg or 5 mcg. After intrathecal pump implant, therapy is initiated at 1.2-2.4 mcg/day. After 7-14 days the medication is exchanged and the dose kept the same. Subsequently, the dose is titrated every 7-14 days by 0.5-1.2 mcg/day.

Infected Intrathecal Pump Exchange with Preservation of Original Catheter in a Cancer Patient.

Infected Intrathecal Pump Exchange with Preservation of Original Catheter in a Cancer Patient.

Intrathecal Drug Delivery Systems Survey: Trends in Utilization in Pain Practice.

BackgroundThe use of intrathecal drug delivery for chronic and cancer pain medicine has been established for decades. However, optimization and utilization of this technique still lag behind other modalities for pain control. Some of this may be due to variability of surgical technique, medication usage and education. It is currently unclear on whether or not practitioners follow available algorithms for the use of intrathecal drug delivery systems.MethodsA survey developed by the American Society of Pain and Neuroscience (ASPN) was sent to its members via email using the cloud-based SurveyMonkey. After 30 days of being available, 159 different providers responded to the survey that consisted of 31 various multiple choice and free response questions. Each question was not required and the number of responses to each varied from 128 to 159.ResultsApproximately 9% of those who successfully received and opened the email containing the survey responded, likely due to a small number of providers working with intrathecal drug delivery systems. Eighty-six of respondents practice medicine in the United States, and 87% of the respondents were attending physicians. A majority of respondents, approximately 74%, were board certified in pain medicine with 69% of respondents being train in anesthesiology. The first and second most used medications for intrathecal pump trial were morphine and fentanyl, respectively. Most respondents, approximately 96%, provide pre-operative/intra-operative antibiotics. The most common first-choice medication for implanted intrathecal pumps was also morphine with the most common implanted location being the abdomen.ConclusionInterestingly, there is currently fairly substantial variation in the way providers utilize intrathecal pump delivery for both chronic and cancer pain. There is variation from the training background of the providers providing care, to the pre-implantation trial medications, to where the pump is implanted for each patient, to if the patient has the option to give themselves boluses once implanted. Further research is needed to elucidate current and best practices for intrathecal drug delivery system trials, implantations, and utilization.

Look Before You Leap: When ITB Pumps Fail

A 32-year-old male presented with uncontrolled hip flexor spasms. He suffered a spinal cord injury and was put on an intrathecal baclofen pump. Despite escalating doses, his spasticity was not controlled. On further investigation, femur neck fractures were found. One should find all the triggers for spasticity before inserting a pump.

Management of severe spasticity with and without dystonia with intrathecal baclofen in the pediatric population: a cross-sectional study.

To investigate the differences in delivery mode, daily dose, and catheter tip location in pediatric patients using intrathecal baclofen (ITB) pumps with spasticity plus dystonia versus spasticity alone. A single-center, cross-sectional study was performed by collecting retrospective data from electronic medical records. Demographic and diagnostic information was obtained, comparing patients with spasticity with or without dystonia. The data were analyzed for group differences using a two-tailed Student's t-test. Categorical data were analyzed for group differences using Pearson's χ2 test. A total of 137 patients met the criteria. The majority (114) had spasticity plus dystonia whereas only 23 were documented as spasticity alone. Simple continuous dosing was the most common delivery mode, but flex dosing was used more than twice as frequently with spasticity plus dystonia compared with spasticity alone (42% vs 17%). Patients with spasticity plus dystonia also had more rostral catheter tip locations. While it has been discussed anecdotally, this study confirms the supposition that patients with spasticity plus dystonia have increased dose requirements when compared with those with spasticity alone. Although there are no clear standards of care when managing these patients, they are often on higher daily dosages, are more likely to require flexed dosing method, and have higher catheter placements. Still, there are few studies that demonstrate improvements in dystonia with the use of ITB. In general, these patients would benefit from the development of universal standardizations as well as the confirmation that this is an appropriate treatment.

Perioperative Management of Spinal Cord Stimulators and Intrathecal Pain Pumps.

Spinal cord stimulators (SCSs) and intrathecal pain pumps (IPPs) are implantable devices used in the management of chronic pain or spasticity. Complications, such as infection, lead migration/failure, cerebrospinal fluid leak, neurologic injury, and other medical complications, can occur after placement and may require surgical intervention. Orthopaedic surgeons may encounter patients with these devices and should have a basic understanding of their function. In addition, they should be aware that patients may have residual stenosis or deformity contributing to their symptoms; thus, spine surgery referral may be indicated. If a patient with a SCS or IPP is undergoing revision spinal surgery, a preoperative discussion regarding retention versus removal of the device is imperative because indications for device retention, revision, and removal are complex. This review summarizes potential complications and intraoperative considerations concerning the proper perioperative management of SCSs/IPPs and will provide evidence-based data regarding management strategies for these devices.

Attainment of personal goals in the first year of intrathecal baclofen treatment in dyskinetic cerebral palsy: a prospective cohort study

Purpose To assess attainment of individual treatment goals one year after intrathecal baclofen (ITB) pump implantation in individuals with dyskinetic cerebral palsy (CP). Materials and methods A multi-center prospective cohort study was conducted including 34 non-walking individuals with severe dyskinetic CP, classified as Gross Motor Function Classification System (GMFCS) IV/V, aged 4–24 years, 12 months after pump implantation. The main outcome measure was Goal Attainment Scaling (GAS). Predictors of GAS results were analyzed. Complications were registered systematically. Results Seventy-one percent of individuals with dyskinetic CP fully achieved one or more treatment goals. One or more treatment goals were partially achieved in 97% of individuals. Two factors were found to be associated with attainment of goals: Dyskinesia Impairment Scale (DIS) score at baseline and the difference in pain score between baseline and follow-up. These two variables explain 30% of the variance in the outcome. Conclusions Intrathecal baclofen is effective in achieving individual treatment goals in children and young adults with dyskinetic CP after nine to 12 months of ITB treatment. A positive outcome on treatment goals is, for a small part, associated with higher severity of dystonia at baseline and with improvement of pain during treatment. Clinical trial registration number Dutch Trial Register, number NTR3642. Implications for rehabilitation Intrathecal baclofen treatment is effective in attainment of personal treatment goals, one year after pump implantation in patients with dyskinetic cerebral palsy. A positive outcome on treatment goals is, for a small part, related to higher severity of dystonia at the start and on improvement of pain during treatment.

Neuraxial anesthesia for post-operative pain control after hip surgery in children with cerebral palsy and pre-existing intrathecal baclofen pumps.

The purpose of this study is to describe the efficacy and adverse events of neuraxial anesthesia for post-operative pain control in non-ambulatory children with cerebral palsy with pre-existing intrathecal baclofen (ITB) pumps undergoing hip reconstructive or palliative surgery. Twelve children (mean age 11.25 years) were included in the study with the following neuraxial anesthesia methods: indwelling epidural catheter (8 patients), neuraxial opioids administered through the side port of the ITB pump (3 patients), and single injection spinal anesthetic (1 patient). Observational pain scores and opioid requirements were quantified for all patients. There were no ITB pump or surgical complications at a mean follow-up of 2.2 years. The average length of stay was 6 days. Patients had good post-operative pain control with a mean observational pain score of 0.7 and mean morphine equivalent use of 0.26mg/kg/day. Four patients required anti-emetics to control nausea and three patients had urinary retention requiring repeat catheterization, but all medical complications resolved prior to discharge. Neuraxial anesthesia can effectively control post-operative pain in children with a pre-existing ITB pump. Utilizing the side port of the ITB pump for administration of neuraxial opioids is an option when epidural or spinal anesthesia is not possible.

Spinal anesthesia for cesarean section in a woman with an intrathecal baclofen pump

BackgroundIntrathecal baclofen pumps are commonly used for the management of lower extremity spasticity in the setting of spinal cord injury. There have been no reports of the performance of spinal anesthesia in patients with a pre-existing intrathecal baclofen pump.Case presentationA 29-year-old parturient presented for cesarean section. She had a history of spinal cord injury due to fractures of the thoracic vertebrae with lower extremity spasticity, which had been treated with an intrathecal baclofen pump inserted through lumbar (L) 3-L4 intervertebral space. Preoperative lumbosacral ultrasound was performed to identify the L4-5 interspace, and spinal anesthesia was performed through that space with a 25-gauge 3.5-inch-long Whitacre spinal needle. Thoracic (T) 4 dermatomal level anesthesia was achieved, and the patient underwent the cesarean section without requiring additional intravenous analgesic adjuncts.ConclusionsSpinal anesthesia can be successfully performed in patients with intrathecal baclofen pumps. Existing intrathecal catheters can be located with preoperative imaging, and ultrasound can be used to determine the vertebral levels below the intrathecal catheter through which spinal anesthesia can be performed safely.