Case Report: An Unexpected Complication of Intrathecal Therapy.

Traditionally, intrathecal therapy has been used for pain amelioration in cancer patients, but now has indications for nonmalignant chronic pain conditions. Due to its expanding use, it is imperative to understand the risks and management of intrathecal pump implantation. This case illustrates a series of uncommon intrathecal pump complications in a 52-year-old woman with complex regional pain syndrome. Considering the complications outlined in this case, there is a need to conduct retrospective studies and establish guidelines to address when it is optimal to remove a chronically placed catheter as well as the proper technique for removal.

Treatment of Intrathecal Drug Pump Flipping Using Fascial Flaps: A Technical Description and Case Series.

BACKGROUND AND OBJECTIVES: Intrathecal drug therapy is a common treatment for dystonia, pain, and spasticity using implanted pump and catheter systems. Standardized management of intrathecal drug pump (ITDP) migration and flipping has not been well established in the literature. This study reports the use of soft tissue to address less common pump complications such as pump flipping, migration, and difficulty in medication refill. METHODS: A retrospective chart review of intrathecal pump cases performed by two surgeons between February 2020 and August 2022 was conducted. Patients with complications such as pump flipping, migration, or challenges in medication refill treated with soft tissue flaps were included. Patient demographics, comorbidities, and perioperative data were collected. RESULTS: A total of five patients with ITDP complicated by pump flipping, migration, malposition, or difficulty in medication refill that were treated using fascial flaps were included in the study. Three technical considerations when revising ITDP complications are secure pump anchoring, reliable wound closure, and ease of pump medication refill. Cases 1 and 2 demonstrate the technique of secure pump anchoring with a rectus fascial flap. Cases 3 and 4 show a technique to achieve reliable vascularized wound closure, and case 5 describes a technique to solve an uncommon problem of a thick subcutaneous abdominal tissue preventing the refill of the ITDP medication. CONCLUSION: Soft tissue flaps may serve as a treatment option for patients with uncommon ITDP complications. De-epithelialized dermal fasciocutaneous or fascial flaps may be developed to anchor the pump more securely. Cross-discipline collaboration may further delineate the technique, benefits, and outcomes of this approach.

Safety and efficacy of intrathecal baclofen trials for the treatment of hypertonia: a retrospective cohort study.

OBJECTIVE: Intrathecal baclofen (ITB) is an effective treatment for refractory hypertonia in children. ITB has long been effective for the treatment of spasticity, and indications have naturally evolved to include dystonia and mixed pediatric movement disorders (PMDs). The established uses for ITB trials are insurance prerequisite, mixed tone, and family request. Despite agreement for ITB therapy by a multidisciplinary group of subspecialists in a complex PMD program, insurance companies often require an ITB trial be performed. A longitudinal cohort was identified to determine the safety and efficacy of ITB trials and to determine the utility of test dosing in this population. METHODS: Retrospective data analysis was performed for patients with hypertonia who underwent ITB bolus trials at the authors' institution between 2021 and 2023. Nonmodifiable risk factors and clinical variables were collected. RESULTS: Thirty-one patients (11 female) underwent 32 ITB trials. Of these patients, 67.7% had a diagnosis of mixed hypertonia, 32.3% pure spasticity, and 9.1% secondary dystonia. The mean age at test dose was 12.8 years, and 58.1% of patients were born premature. The mode Gross Motor Function Classification System score was 5. The mean difference in Barry-Albright Dystonia Scale (BADS) scores was -7.33 points (p = 0.01) at 2.5 hours postoperatively. The mean difference in upper-extremity modified Ashworth Scale (mAS) scores was -5.36 points (p = 0.003), and that for lower-extremity mAS scores was -6.61 (p < 0.001). In total, 21.9% of patients developed a post-dural puncture headache. Conversion to a permanent baclofen pump was performed in 22/32 (68.8%) patients. Of those who did not pursue pump placement, 1 patient had high surgical risk, 1 had an ineffective response, 1 had a bad reaction to the test dose and cited both regression and increased discomfort, and 2 declined despite an effective trial owing to family preferences. CONCLUSIONS: ITB trials require hospitalization in some form and carry risks of procedural complications. The decision to pursue a trial should be made on a case-by-case basis by clinicians and should not be determined by insurance companies. The complication rate of ITB trials is high, and a test dose is unnecessary in this fragile population.

Baclofen pumps do not increase risk of complications following spinal fusion.

PURPOSE: To assess the complication risks associated with intrathecal baclofen (ITB) pumps in cerebral palsy (CP) patients undergoing posterior spinal fusion (PSF) and to determine if timing of pump implantation before or during PSF impacts the risk of complications. METHODS: A prospectively collected multicenter database was retrospectively reviewed to identify CP patients undergoing PSF from 2008 to 2023. Patients were divided into 2 cohorts: those with an ITB pump (ITB cohort) and those without (non-ITB cohort). The ITB cohort was further categorized by placement of the pump prior to or during PSF. Cohorts were then compared in terms of postoperative complications, perioperative complications, and need for revision surgery. RESULTS: Four hundred six patients (ITB n = 79 [53 prior to, 26 during PSF], non-ITB n = 326) were included in this analysis. At an average follow-up of 4.0 years (range 2-10 years), there were no significant differences between the ITB and non-ITB cohorts in the rate of perioperative complications (5.0% vs 6.5%, p = 0.80), revision surgeries (2.5% vs 4.6%, p = 0.54), or any complication type, regardless of whether pumps were placed prior to or during PSF, aside from longer surgical times in the latter group. CONCLUSION: Complication rates are similar for ITBs placed prior to and during PSF. Patients with spastic CP may safely be treated with ITB pumps without increased risks of complication or further reoperation/revision following PSF. LEVEL OF EVIDENCE: Level III.

The presence of Candida parapsilosis with intrathecal baclofen pump in a person with high cervical spinal cord injury; infection or colonization? A Case Report.

INTRODUCTION: Intrathecal baclofen (ITB) therapy is an effective method of treating spasticity in persons with spasticity due to spinal cord injury (SCI), but complications are not rare and can include spinal fluid leaks, infection, and catheter/pump malfunction. CASE PRESENTATION: This study presents information related to an adult male patient with traumatic SCI and a history of two prior ITB pump pocket infections that required removal due to pump infection. The patient then developed skin erosion over the third pump, and the fluid around the pump grew methicillin-sensitive Staphylococcus aureus, diphtheroids, and Candida parapsilosis. The patient was initially treated with antibiotics and anti-fungal medication without removal of the ITB pump. The ITB pump was eventually removed 27 months later, and the fourth pump was implanted 10 months later. DISCUSSION: ITB pumps can be an effective treatment modality for spasticity in people with SCI; however, complications, including infection, can occur and require pump removal. This case illustrates a case of possible Candida colonization of the ITB pump, which was eventually removed.

Characteristics of Changes in Intrathecal Baclofen Dosage over Time due to Causative Disease.

Intrathecal baclofen (ITB) therapy effectively treats spasticity caused by brain or spinal cord lesions. However, only a few studies compare the course of treatment for different diseases. We investigated the change in daily dose of baclofen per year and its associated adverse events in patients presenting with the three most common etiologies at our institute: hereditary spastic paraplegia, cerebral palsy, and spinal cord injury. The ITB pumps were implanted from July 2007 to August 2019, with a mean follow-up period of 70 months. In patients with hereditary spastic paraplegia, baclofen dosage was reduced after eight years following ITB introduction, and the treatment was terminated in one patient owing to disease progression. In patients with cerebral palsy, the dosage increased gradually, and became constant in the 11th year. Patients with spinal cord injury gradually increased their baclofen dosage throughout the entire observation period. Severity and adverse event rates were higher in patients with cerebral palsy than in others. The degree and progression of spasticity varied depending on the causative disease. Understanding the characteristics and natural history of each disease is important when continuing ITB treatment.

Twenty years of intrathecal baclofen therapy in Slovenia: a retrospective single-center analysis of complications.

Since the first implantation in July 2001, the intrathecal baclofen (ITB) therapy for patients with generalized spasticity has been used in Slovenia for 20 years. The aim of this retrospective study was to evaluate the rates of different complications, especially if catheter-related complications were less frequent after the introduction of the coated catheter type in February 2013, and the potential correlation between higher baclofen doses and the incidence of complications. We retrospectively collected data from all patients in the registry during the period from 3 July 2001 to 31 December 2021. Among 138 patients (48 females), 120 patients had the first ITB system implanted at the University Medical Centre Ljubljana. Forty-three complications were reported in 38 patients (27%), with a total complication rate of 0.203/1000 days or 0.074/pump year. The most frequent was catheter-related (0.083/1000 days or 0.030/pump year), followed by skin-related (0.063/1000 days or 0.023/pump year) and pump-related complication (0.026/1000 days or 0.009/pump year). The incidence of catheter-related complications decreased significantly since the use of Ascenda type catheter: 14/7 complications per 88/147 implantations ( P  = 0.008). Patients with complications had a statistically significantly higher dose of baclofen: median 400 µg/24h vs. median 300 µg/24h ( P  = 0.016). Our retrospective analysis confirmed a significant decrease of catheter-related complications after the implementation of Ascenda type catheter in February 2013. Patients with a higher ITB dose had a statistically significantly higher incidence of complications. The total complication rate was a bit higher as previously reported in other studies, which is consistent with a long follow-up time.

Intrathecal Drug Delivery Systems for Cancer Pain Control: Insights on Current Contemporary Practices in the US.

OBJECTIVES: Among patients with cancer with moderate to severe, intractable pain, intrathecal drug delivery using an intrathecal drug delivery system (IDDS) offers effective pain control. In this study, we evaluate the trends of IDDS therapy among patients with cancer, associated comorbidities, complications, and outcomes, using a large representative US administrative inpatient data base. MATERIALS AND METHODS: The Nationwide Inpatient Sample (NIS) data base contains data from 48 states and the District of Columbia. The NIS was used to identify patients with cancer who underwent IDDS implantation between 2016 and 2019. Patients with cancer with intrathecal pumps for the treatment of chronic pain were identified using administrative codes. Baseline demographics, hospital characteristics, type of cancer associated with IDDS implantation, palliative care encounters, hospitalization costs, length of stay, and prevalence of bone pain were evaluated in the study. RESULTS: A total of 22,895 (0.32%) individuals with hospital admission for IDDS surgery were included for analysis among 7.06 million individuals with cancer in the final cohort. The IDDS cohort consisted of patients predominantly in the 65-to-79 years age group (40.49%), female sex (50.42%), and Caucasian ethnicity (75.82%). The top five cancers in patients receiving IDDS were lung (27.15%), colorectal (24.9%), liver (16.44%), bone (8.01%), and liver (7.99%) cancer. In addition, the length of stay was six days (interquartile range [IQR] four-nine days) and the median cost of hospital admission was $29,062 (IQR $19,413-$42,261) in the patients who received an IDDS. These factors were greater than those in patients without IDDS. CONCLUSIONS: A very few patients with cancer received IDDS in the US during the study period. Despite recommendations supporting its use, there are significant racial and socioeconomic disparities in IDDS use.

Management of high-dose intrathecal baclofen pump explant: A case report.

BACKGROUND: Intrathecal baclofen (ITB) is a proven, effective treatment for refractory spasticity and chronic pain, with applications ranging from spinal cord injury to amyotrophic lateralsclerosis (ALS). Despite its effectiveness, the withdrawal syndrome of intrathecal baclofen can be life-threatening. CASE REPORT: This case describes the treatment of a patient with chronic spasticity related to ALS with an ITB pump infection requiring explant and a prolonged period of antibiotics before reimplantation. A 62-year-old man with ALS-related spasticity maintained on high-dose ITB for 20 years presented to the emergency department with one week of fever, confusion, and localized erythema to the R-side of his abdomen. Laboratories indicated a mild leukocytosis 12.9 K/uL and imaging showed a 2.9-cm fluid collection with fat stranding surrounding the ITB pump. The pack was explanted, and the patient started on intravenous antibiotics. Due to the high baclofen dosage, our pain service recommended PO (per os) baclofen 30 mg every 6 h via gastrostomy and PO diazepam 10 mg every 6 h via gastrostomy. These doses were titrated carefully to avoid oversedation while preventing withdrawal symptoms. On Day 23 postexplant, the patient had the baclofen pump reimplanted and baclofen titrated over three days to his previous dose of ITB. CONCLUSION: This case demonstrates a successful approach to avoiding severe baclofen withdrawal using PO baclofen combined with PO diazepam. The high dose of maintenance ITB (1188.8 mcg/day), the inability to reinsert the patient's intrathecal pump, and the high risk of intubation in a patient with severe neuromuscular dysfunction all made this a challenging case.

Use of intraoperative topical antibiotics to reduce intrathecal baclofen pump surgical site infections: a single institution's experience over 24 years.

OBJECTIVE: Patients requiring intrathecal baclofen (ITB) therapy are at high risk for surgical site infections (SSIs) given their poor functional status. After years of a nominal infection rate, there was an inexplicable increase in ITB pump infections at the authors' institution and multiple investigations offered no solution. Use of intraoperative topical antibiotics is well-documented in the orthopedic literature and was considered for ITB pump insertion. In this study, the authors investigated whether intraoperative vancomycin and tobramycin powder at the ITB pump site could reduce SSIs. METHODS: Operative and infection data were collected and analyzed retrospectively to determine the efficacy of this change. Patients were stratified into three cohorts (1998-2009, 2010-2012, and 2013-2021) to better understand the trends before and after implementation of intraoperative topical antibiotics. Each cohort had similar demographics. RESULTS: One hundred fifty-four patients underwent 272 ITB pump procedures between 1998 and 2021 (131 in 1998-2009, 49 in 2010-2012, and 92 in 2013-2021) for cerebral palsy (69.5%), spastic quadriparesis due to traumatic brain injury (7.1%), anoxic brain injury (6.5%), and other causes (16.9%). Infection rates were reduced from a high of 32% in 2010-2011 to 3.8% over the last 2.5 years (p = 0.0094). There were no adverse effects from the use of topical antibiotics. CONCLUSIONS: In the setting of an intractable rise in ITB pump infections, the addition of intraoperative topical antibiotics significantly reduced postoperative infections in a high-risk population. One could appreciate a significant drop each year in the rate of infections after the institution of intraoperative topical antibiotics. The reduction in SSIs significantly improved the long-term outcomes for these patients.

Intrathecal pain pumps in pain relief.

Chronic pain is a significant global health issue, described as a bio-psychosocial phenomenon that hampers the integration of body, mind, and social functions. To relieve chronic intractable pain, intrathecal drug-delivery devices (IDDDs) are the last resort after conventional treatment options have been exhausted. This article outlines the indications, pharmacological agents, types, techniques, preparation of the patient, and complications of IDDDs for the management of challenging chronic pain (non-neoplastic and cancer-related pain) conditions in patients who have not responded well to a commonly used conventional line of treatment.

Effectiveness and Safety of Intrathecal Drug Delivery Systems for the Management of Cancer Pain: A Systematic Review and Meta-Analysis.

OBJECTIVES: Intrathecal drug delivery systems (IDDS) and spinal cord stimulation (SCS) have been proposed and assessed for the management of cancer pain; however, such treatments remain underused. We conducted a systematic review to evaluate the effectiveness and safety of IDDS and SCS for cancer pain. MATERIALS AND METHODS: Electronic databases MEDLINE, CENTRAL, EMBASE, and WikiStim were searched from 1988 to March 2021. Randomized controlled trials and observational studies of adults with pain related to cancer or its treatment who received an implantable IDDS or SCS were eligible for inclusion. The primary outcome of the review was change in pain intensity from baseline to the last available follow-up, measured using a visual analog scale or numerical rating scale. The protocol for this review is registered on PROSPERO (CRD42021240717). RESULTS: A total of 22 studies (24 reports) included a total of 3043 participants who received either IDDS or SCS for cancer pain. Eight studies reporting data for 405 participants with an IDDS could be included in the meta-analysis of pain intensity that showed a statistically significant reduction at the latest posttreatment follow-up time compared with baseline (mean difference [MD], -3.31; 95% CI, -4.18 to -2.45; p < 0.001). Six studies reporting data for 325 participants with an IDDS could be included in the meta-analysis of pain intensity that showed a statistically significant reduction up to one month after treatment compared with baseline (MD, -3.53; 95% CI, -4.06 to -3.00; p < 0.001). A meta-analysis including studies of participants with either an IDDS or an SCS device showed similar results. Improvements in other outcomes following implantation of IDDS also were observed. Postdural puncture headache was the most reported complication, whereas urinary retention, nausea, and vomiting were commonly reported side effects. CONCLUSION: Our findings suggest that IDDS is effective in reducing pain intensity for patients with cancer pain when compared with pretreatment.

Intrathecal Baclofen and Opioid Therapy: Cerebrospinal Fluid Leak and Infection Incidence, Risk Factors, and Outcomes.

BACKGROUND: Intrathecal drug therapy treats medically refractory spasticity and pain. cerebrospinal fluid (CSF) leak or infection can limit efficacy and increase morbidity. We aim to evaluate risk factors and outcomes after CSF leaks and infections requiring reoperation. MATERIALS AND METHODS: We retrospectively analyzed our 7-year experience of intrathecal baclofen and opioid operations using a protocol designed to limit CSF leakage and infections. Postoperative complication incidence and risk factors for reoperation were compared with published reports. We assessed outcomes after these complications. RESULTS: We analyzed 282 intrathecal baclofen (ITB) and intrathecal opioid (ITO) therapy operations (mean 2.27-year follow-up). 21% developed CSF leaks overall with similar incidences in ITB and ITO patients (19% vs. 25%, p0.3). Overall, 5% of patients developed deep infections with similar incidences between ITB and ITO cohorts (6% vs. 4%, p0.6). Tobacco use and age <50 years were significantly associated with CSF leak in ITO operations. Underweight body mass index, immunosuppression, tobacco use, and primary implantation were associated with infection. When CSF leak or infection occurred, patients suffered more perioperative adverse events and had elevated 90-day readmission rate compared with those without these complications. CONCLUSIONS: Our 7-year ITB and ITO therapy using the 8781 Ascenda intrathecal catheter highlights a higher reoperation rate for CSF leak and similar infection incidence to reports using traditional catheters. Multiple modifiable risk factors for CSF leak include recent tobacco use among ITO patients. Body mass index optimization and immunosuppressant elimination may reduce reoperation for infection.

Loss of effectiveness with an implanted drug delivery system for intrathecal pain therapy due to corrosion.

INTRODUCTION: Intrathecal drug delivery is an established invasive treatment option. Most common complication is catheter malfunction, which can lead to overdose or withdrawal. CASE PRESENTATION: A 61-year-old female patient underwent an elective replacement of an intrathecal drug delivery pump. The patient complained about a loss of effectiveness over the past 2 years. Intraoperatively, a white mass corresponding to morphine precipitation in the pump pocket was found, which appeared to be due to corrosion at the pump-catheter connection site. CONCLUSIONS: Recommendations on how to deal with the decreasing effectiveness of intrathecal drug delivery and on intraoperative catheter handling are provided.

[Intrathecal Baclofen Therapy for Spastic Paralysis].

Intrathecal baclofen therapy(ITB)is a recognized treatment for spastic paralysis. Direct injection of baclofen into the intrathecal space through a catheter from a battery-loaded pump implanted in the abdomen allows effective administration of the drug at much lower doses than oral administration. ITB therapy is indicated for patients with severe spastic paraparesis that do not respond sufficiently to first-line medical therapy or in whom the side effects complicate treatment. A pump implantation is considered in cases where spasticity is improved after intrathecal infection of a small amount of baclofen. Postoperative complications include CSF leakage, infection and device malfunction. Postoperatively, the patient requires baclofen refills every 2-3 months and pump replacement surgery every 6-7 years. Currently, ITB therapy is not widespread in Japan, although further popularization is expected.

Hepatic Artery Infusion Pumps: A Surgical Toolkit for Intraoperative Decision-Making and Management of Hepatic Artery Infusion-Specific Complications.

BACKGROUND: Hepatic artery infusion (HAI) is a liver-directed therapy that delivers high-dose chemotherapy to the liver through the hepatic arterial system for colorectal liver metastases and intrahepatic cholangiocarcinoma. Utilization of HAI is rapidly expanding worldwide. OBJECTIVE AND METHODS: This review describes the conduct of HAI pump implantation, with focus on common technical pitfalls and their associated solutions. Perioperative identification and management of common postoperative complications is also described. RESULTS: HAI therapy is most commonly performed with the surgical implantation of a subcutaneous pump, and placement of its catheter into the hepatic arterial system for inline flow of pump chemotherapy directly to the liver. Intraoperative challenges and abnormal hepatic perfusion can arise due to aberrant anatomy, vascular disease, technical or patient factors. However, solutions to prevent or overcome technical pitfalls are present for the majority of cases. Postoperative HAI-specific complications arise in 22% to 28% of patients in the form of pump pocket (8%-18%), catheter (10%-26%), vascular (5%-10%), or biliary (2%-8%) complications. The majority of patients can be rescued from these complications with early identification and aggressive intervention to continue to deliver safe and effective HAI therapy. CONCLUSIONS: This HAI toolkit provides the HAI team a reference to manage commonly encountered HAI-specific perioperative obstacles and complications. Overcoming these challenges is critical to ensure safe and effective pump implantation and delivery of HAI therapy, and key to successful implementation of new programs and expansion of HAI to patients who may benefit from such a highly specialized treatment strategy.

Intrathecal Pumps.

Intrathecal drug delivery systems are a well-established intervention for chronic pain. The localized delivery of analgesics allows for reduced side effect profiles and pain scores in patients with chronic pain. Given their proven benefits and the development of novel intrathecal medications, intrathecal drug delivery systems are being used earlier in chronic pain management treatment pathways. Success is reliant on proper patient selection and mitigating the risks of various adverse events stemming from the implantation procedure, medications, and the device itself. This article discusses patient selection criteria, medication selection, risks, complications, supporting data, and future directions of intrathecal drug delivery systems.

Intrathecal baclofen overdose mimicking brainstem death during deep brain stimulation surgery for pain.

We describe a unique case of intrathecal baclofen overdose mimicking brainstem death, during bilateral anterior cingulate cortex deep brain stimulation (DBS) for pain. A 37-year-old man with chronic regional pain syndrome requiring an intrathecal baclofen pump underwent DBS under general anaesthesia and experienced an intraoperative generalised tonic-clonic seizure on dural opening. Once the operation was completed, the patient was noted to have fixed, dilated pupils bilaterally and was transferred for an emergency computed tomography scan of the head, which did not reveal any acute intracranial pathology. The patient was transferred to the intensive care unit for management of concurrent hypotension, bradycardia and supportive management of his low Glasgow Coma Scale (GCS) score. A trial of atropine to counter the bradycardia was unsuccessful. Intrathecal baclofen toxicity was suspected as a diagnosis of exclusion, necessitating urgent aspiration of the baclofen pump. The patient's GCS score improved after pump aspiration and he was discharged home several days later. It was noted that the intrathecal baclofen pump had been refilled several days previously and the patient had reported intermittent episodes of somnolence. In perioperative patients with intrathecal baclofen pumps in situ, baclofen toxicity should always be considered as a differential in perioperative complications, even if it is considered a rare event.

Behavioral dysregulation exacerbated by intrathecal baclofen in an adolescent with severe traumatic brain injury.

This is a case of a 19-year-old male with a history of remote severe traumatic brain injury (TBI) with an intrathecal baclofen (ITB) pump for dystonia management. Given concern for lack of efficacy despite increasing doses of ITB, his catheter was evaluated and found to be epidural rather than intrathecal. The baclofen dose was down-titrated and he underwent catheter revision. Post-op, his baclofen dose was up-titrated and complicated by significant behavioral changes including aggressive physical and verbal behaviors resulting in hospitalization. Work-up was negative for infection, new neurologic pathology, and epileptic activity. Psychiatric medications were adjusted but the behaviors persisted. Due to concern that the increased baclofen dose was causing his mood instability, his pump was down-titrated. As the dosage decreased, the frequency of outbursts also decreased. Throughout these dose adjustments, his dystonia remained stable and overall functional status improved. This is one of the first cases demonstrating that ITB may exacerbate mood instability in patients with TBI.