Effectiveness and safety of cervical catheter tip placement in intrathecal baclofen treatment of spasticity: A systematic review.

OBJECTIVE: To evaluate the effectiveness and safety of intrathecal baclofen treatment of spasticity, administered via a cervical catheter tip. DESIGN: A review of PubMed and the Cochrane Library up to September 2020. No restriction in study design. Two reviewers independently evaluated eligibility, extracted data and evaluated risk of bias. Studies were included in which patients were treated with intrathecal baclofen for spasticity, with the catheter tip at or above the first thoracic level, independent of diagnosis and age. RESULTS: Thirteen studies were eligible, with a moderate to critical risk of bias. Improvement in spasticity was seen only in the upper extremity in 6% of subjects, only in the lower extremity in 2%, in both upper and lower extremities in 50% and without specification of location in 41%. Upper extremity function improved in 88% of cases. Neither drug-related (1%) nor technical (21%) complications occurred more often than in lower placement of the tip. Effects on respiratory function and sleep apnoea were not investigated. CONCLUSION: Cervically administered intrathecal baclofen seems to improve upper extremity spasticity and function, without causing more complications than thoracolumbar intrathecal baclofen. However, the mainly drug-related complications have not been thoroughly investigated and the available literature is of poor methodological quality. Further research is needed to confirm the efficacy and safety of this procedure.

The Rate of Infectious Complications After Intrathecal Drug Delivery System Implant for Cancer-Related Pain Is Low Despite Frequent Concurrent Anticancer Treatment or Leukopenia.

BACKGROUND: The efficacy of intrathecal drug delivery (IDD) for cancer-related pain is well established. Cancer therapies are often associated with immunosuppression and increased risk of infection, and the rate of infection after intrathecal drug delivery system (IDDS) implant in cancer patients has been reported as 2.4%-6.3%. Our objective is to report on the rate of surgical site infections (SSI) in patients implanted with IDDS for cancer-related pain and to provide a data-driven discussion on the relationship between antineoplastic treatment, leukopenia, and other clinical or demographic characteristics and SSI. METHODS: Following local institutional review board approval, we conducted a retrospective chart review of IDDS implants from May 2014 through December 2018. Data collected included demographic data, health status, prophylactic antibiotic administration, surgery duration, presence of leukopenia (white blood cell [WBC] count of <4.0 K/µL) or moderate neutropenia (absolute neutrophil count [ANC] of <1000/µL) within the 30 days before IDDS implant, and details of antineoplastic treatment or systemic corticosteroid use in the perioperative period. This information was assessed in relation to SSI incidence up to 6 months following implant. RESULTS: Two hundred seventeen IDDS implants were identified. A majority of patients (79.3%) received ≥1 form of antineoplastic therapy within 30 days before or after implant, and 42.4% received multiple forms of antineoplastic therapy. Therapies included chemotherapy in 46.5%, immunotherapy in 28.6%, systemic steroids in 32.3%, and radiation therapy in 28.1%. One-quarter of patients (25.8%) were leukopenic within 30 days before implant, with 3.2% having moderate neutropenia. There were 2 infectious complications representing an infection rate of 0.9% (95% CI, 0.1%-3.3%), with limited shared characteristics between those experiencing SSI. CONCLUSIONS: SSI risk after IDDS placement for cancer pain is low, despite frequent concurrent antineoplastic therapy and leukopenia in the perioperative period. Concomitant cancer therapies should not be a barrier to the implementation of IDD for cancer pain.

Intrathecal Baclofen Infusion Pumps in the Treatment of Spasticity: A Retrospective Cohort Study in a Portuguese Centre.

INTRODUCTION: Spasticity is a complex problem in patients with neurological disorders and may distress their quality of life. Intrathecal baclofen infusion pumps reduce spasticity with low doses and minimal side effects but are not free from complications. We aimed to evaluate the efficacy and safety of intrathecal baclofen infusion pumps as well as patients' satisfaction. MATERIAL AND METHODS: Retrospective cohort study including all intrathecal baclofen infusion pumps placed up to December 2015. Demographic characteristics, clinical diagnoses, date of placement or withdrawal/replacement of intrathecal baclofen infusion pumps, baclofen dosage and complications of intrathecal baclofen infusion pumps were collected. Assessments from the Ashworth and Penn's scales, Katz index and patients' global satisfaction were analysed. RESULTS: In 19 years we placed 251 intrathecal baclofen infusion pumps in 155 patients. The mean age was 41.1 ± 15.8 years. The most frequent conditions were: trauma (34%), cerebral palsy (14%), multiple sclerosis (12%) and stroke (12%). Eighty-five patients (55%) required a second pump, and eleven (7%) a third one. The lifetime of the first pump was 72 (36 - 89) and the total follow-up time was 96 (9 - 132) months. The causes of withdrawal/replacement were: battery failure (57%), catheter migration/kinking (24%), infection (14%) and pump displacement/exteriorization (7%). The complication rate was 0.21 events/month. There was a significant improvement in the Ashworth and Penn's scales after the placemen of intrathecal baclofen infusion pumps (p < 0.001 for all diagnoses) and the patients were satisfied with the treatment. DISCUSSION: The incidence of complications was within range of other international studies despite our long follow-up time. Events per month, loss to follow-up, re-intervention rate, incidence of infection and mortality were similar to other studies. CONCLUSION: Intrathecal baclofen infusion pumps are safe and effective in the treatment of spasticity. Infusion pumps provide a high level of satisfaction regarding treatment and quality of life.

Introdução: A espasticidade é um problema complexo em doentes com distúrbios neurológicos influenciando a sua qualidade de vida. As bombas perfusoras intratecais de baclofeno reduzem a espasticidade com doses baixas e efeitos laterais mínimos, mas não estão livres de complicações. Pretendemos avaliar a eficácia, segurança e satisfação dos doentes com bombas perfusoras intratecais de baclofeno. Material e Métodos: Estudo de coorte retrospetivo, incluindo todas as bombas perfusoras intratecais de baclofeno colocadas até dezembro de 2015. Foram avaliadas as características demográficas, diagnósticos, data de colocação ou retirada/substituição e complicações das bombas perfusoras intratecais de baclofeno. Analisaram-se as escalas Ashworth, Penn, Katz e satisfação dos doentes. Resultados: Durante 19 anos colocaram-se 251 bombas perfusoras intratecais de baclofeno em 155 doentes. A idade média foi 41,1 ± 15,8 anos. As patologias mais freqüentes foram: traumatismo (34%), paralisia cerebral (14%), esclerose múltipla (12%) e acidente vascular cerebral (12%). Oitenta e cinco doentes (55%) precisaram de uma segunda e onze (7%) de uma terceira bomba. A semi-vida da primeira bomba foi 72 (36 ­ 89) e o tempo total de seguimento 96 (9 ­ 132) meses. As causas de retirada/substituição foram: falha de bateria (57%), migração/kinking do cateter (24%), infeção (14%) e deslocamento/exteriorização da bomba (7%). A taxa de complicações foi 0,21 eventos/mês. Houve uma melhoria significativa nas escalas de Ashworth e Penn após colocação das bombas perfusoras intratecais de baclofeno (p < 0,001 para todos os diagnósticos) e os doentes ficaram satisfeitos com o tratamento. Discussão: A incidência de complicações situou-se dentro do intervalo reportado por outros estudos internacionais, apesar do longo tempo de seguimento. Número de eventos por mês, perda de seguimento, taxas de re-intervenção ou infecção e mortalidade foram semelhantes a outros estudos. Conclusão: As bombas perfusoras intratecais de baclofeno são seguras e eficazes no tratamento da espasticidade e oferecem um alto nível de satisfação quanto ao tratamento e qualidade de vida.

Removal of Intrathecal Catheters Used in Drug Delivery Systems.

INTRODUCTION: Implanted intrathecal drug delivery systems (IDDS) are increasingly used in the treatment of spasticity and in patients with refractory pain. Literature discussing complications associated with intrathecal pump placement is widely available. However, reports of complications following the removal of chronically placed catheters are scarce. We reviewed our series of patients who had surgery to remove the intrathecal catheter. METHODS: Retrospective review was performed for all patients who underwent surgery to remove a catheter linked to an IDDS between 2010 and 2016. Patients older than 18 years were included in final analysis. Demographic (including age at removal, sex, BMI, and comorbidities) and etiologic characteristics (indications of IDDS implant and explant, interval between implant and explant, and concomitant surgery) were analyzed. Simple logistic regression was performed to seek any potential predictor of complications. RESULTS: Fifty-nine patients underwent removal of their intrathecal catheter after variable periods (mean interval of 189 months). On eight occasions, patients developed complications after catheter removal (mean interval between implant and explant was 76 months for these cases). Retained catheter was the cause of complications in half of these occasions. Persistent cerebrospinal fluid leak was the next most common complication, with requirement of an external ventricular drain and lumbar drain to facilitate wound healing on two separate occasions. CONCLUSION: Removal of an intrathecal catheter from IDDS systems may cause complications that in some cases require additional surgery.

Novel Association Between Intrathecal Drug Administration and Arachnoiditis Ossificans.

BACKGROUND: We present a case of delayed progression of adhesive arachnoiditis to arachnoiditis ossificans (AO) in a patient being treated with a high-dose polypharmaceutical intrathecal regimen. CASE DESCRIPTION: The patient is a 39-year-old Caucasian male who was implanted with an intrathecal pump in 2006 to control severe low back pain and administered intrathecal pain medication for a period of 10 years. In 2016, he developed new-onset radicular pain and worsened sensation in his lower extremities. Computed tomography scan of the lumbar spine at that time demonstrated profound calcification of the arachnoid consistent with a diagnosis of AO. It was presumed that prolonged high-dose intrathecal medication precipitated this condition, and his intrathecal medications were titrated down with removal of the pump. CONCLUSIONS: It is unlikely that his condition occurred as a result of prior surgery, with the more likely cause being hyperplasia of the spinal arachnoid, leading to scarring and calcification, due to the high-dose intrathecal regimen. This case highlights the delayed progression from stable arachnoiditis to AO concurring with a regimen of high-dose intrathecal medications. Clinicians should closely monitor patients undergoing intrathecal drug administration, particularly at elevated doses, for indications of damage to the spinal arachnoid mater.

Unique Intradural Inflammatory Mass Containing Precipitated Morphine: Confirmatory Analysis by LESA-MS and MALDI-MS.

Opioids are often used for analgesia via continuous intrathecal delivery by implantable devices. A higher concentration and daily dose of opioid have been postulated as risk factors for intrathecal granuloma formation. We present a 42-year-old female patient with chronic abdominal pain from refractory pancreatitis, with an intrathecal drug delivery device implanted 21 years prior, delivering continuous intrathecal morphine. After many years without concerning physical signs or complaints, with gradual increases in daily morphine dose, she presented with rapidly progressive neurologic deficits, including lower extremity, bladder, and bowel symptoms. These symptoms were determined to be secondary to mass effect and local inflammation related to an intrathecal catheter tip granuloma, detected on magnetic resonance imaging of the spine. The mass was urgently resected. On histopathologic examination, this granuloma was found to be unique, in that in addition to the expected inflammatory components, it appeared to contain precipitated nonpolarizable crystals. These were identified as precipitated morphine using liquid extraction surface analysis-tandem mass spectrometry (LESA-MS/MS) and matrix-assisted laser desorption ionization-Fourier transform ion cyclotron resonance-mass spectrometry imaging (MALDI-FTICR-MSI). In addition to the unique finding of precipitated morphine crystals, the long-term follow-up of both morphine concentration and daily dose increases provides insight into the formation of intrathecal granulomas.

An investigation of the relationship between autonomic dysreflexia and intrathecal baclofen in patients with spinal cord injury.

OBJECTIVE: To study the relationship between autonomic dysreflexia and intrathecal baclofen in patients with spinal cord injury. DESIGN: Retrospective chart review. SETTING: Inpatient and outpatient acute rehabilitation facility. PARTICIPANTS: Thirty-four subjects. INTERVENTIONS: We reviewed patients' medical records to ascertain the presence of symptomatic autonomic dysreflexia (AD) prior to and after implantation of an intrathecal baclofen (ITB) pump for spasticity in spinal cord injury patients. We recorded risk factors for autonomic dysreflexia including kidney and bladder stones, heterotopic ossification (HO), and ischial / sacral pressure ulcers. OUTCOME MEASURES: Presence of autonomic dysreflexia pre and post-intrathecal baclofen pump placement, presence of risk factors associated with autonomic dysreflexia including (1) kidney or bladder stones, (2) heterotopic ossification, and (3) pressure ulcers. RESULTS: Of the 34 subjects, 25 (73.5%) experienced AD prior to ITB pump placement and only 2 (5.9%) after placement. Four subjects (11.8%) had kidney or bladder stones, of which, all had AD prior to placement and none had AD afterwards. Twenty-six subjects (76.5%) had pressure ulcers, of which, all experienced AD prior to placement and only one (0.02%) afterwards. Six patients (17.6%) had HO, of which 5 (83%) had AD prior to placement and none afterwards. Additionally, three patients (8.8%) had at least 2 of the above risk factors, of which, all had AD prior to ITB placement and none afterwards. CONCLUSION: This study showed a significant reduction of symptomatic episodes of autonomic dysreflexia after spinal cord injury, even in those with additional risk factors for development of autonomic dysreflexia.

Colonic perforation by an intrathecal baclofen pump catheter causing delayed Escherichia coli meningitis.

Intrathecal baclofen (ITB) delivery via an implanted pump is frequently used for the treatment of spasticity. This is an effective and safe neurosurgical and pharmacological intervention associated with an improvement in patient quality of life. There is, however, a risk of device-related infection. We present a patient with pump-site infection and Escherichia coli meningitis secondary to transcolonic perforation of an intrathecal baclofen pump catheter. While this is rare, we review the intraoperative precautions and best practices that should be taken to prevent and manage this unusual complication.

[Complications of intrathecal baclofen therapy]. / Oslozhneniya intratekal'noi terapii baklofenom.

AIM: To analyze complications of intrathecal baclofen therapy and identify high-risk groups. MATERIAL AND METHODS: We implanted 52 pumps to spastic patients for chronic intrathecal baclofen infusion. Two groups of patients were distinguished: 23 patients with spinal spasticity (group 1) and 29 patients with cerebral spasticity (group 2). The mean patient age was 37.2±14.6 years in group 1 and 17.3±10.3 years in group 2. Surgery was performed according to a standard procedure. A Medstream (Codman) pump was implanted in 10 cases, and a Synchromed II (Medtronic) pump was implanted in the remaining 42 cases. RESULTS AND DISCUSSION: Complications developed in 12 (23%) patients. We divided complications into 3 groups: baclofen underdose, baclofen overdose, and others. Insufficiency of intrathecal therapy was observed in 7 cases, which was caused by catheter migration (5 cases) and pump dysfunction (2 cases). In one case, baclofen overdose was observed after air travel. Other complications included 4 cases of persistent peri-implant seroma and infectious complications. Groups with a high risk of complications were identified based on an analysis of the results. Patients with severe dystonia of the trunk muscles have an increased risk of spinal catheter migration. Pronounced communicating hydrocephalus is associated with the risk of cerebrospinal fluid leak through a catheter shaft channel. Weakness of the axial musculature can lead to progression of scoliotic deformity. CONCLUSION: In some cases, chronic intrathecal baclofen therapy can be accompanied by various complications. This technique should be carefully used in patients from high-risk groups.

High-Resolution Three-Dimensional Computed Tomography for Assessing Complications Related to Intrathecal Drug Delivery.

BACKGROUND: The assessment of the functionality of intrathecal drug delivery (IDD) systems remains difficult and time-consuming. Catheter-related problems are still very common, and sometimes difficult to diagnose. OBJECTIVES: The aim of the present study is to investigate the accuracy of high-resolution three-dimensional computed tomography (CT) in order to detect catheter-related pump dysfunction. STUDY DESIGN: An observational, retrospective investigation. SETTING: Academic medical center in Germany. METHODS: We used high-resolution three dimensional (3D) computed tomography with volume rendering technique (VRT) or fluoroscopy and conventional axial-CT to assess IDD-related complications in 51 patients from our institution who had IDD systems implanted for the treatment of chronic pain or spasticity. RESULTS: Twelve patients (23.5%) presented a total of 22 complications. The main type of complication in our series was catheter-related (50%), followed by pump failure, infection, and inappropriate refilling. Fluoroscopy and conventional CT were used in 12 cases. High-resolution 3D CT VRT scan was used in 35 instances with suspected yet unclear complications. Using 3D-CT (VRT) the sensitivity was 58.93% - 100% (CI 95%) and the specificity 87.54% - 100% (CI 95%).The positive predictive value was 58.93% - 100% (CI 95%) and the negative predictive value: 87.54% - 100% (CI 95%).Fluoroscopy and axial CT as a combined diagnostic tool had a sensitivity of 8.3% - 91.7% (CI 95%) and a specificity of 62.9% - 100% (CI 95%). The positive predictive value was 19.29% - 100% (CI 95%) and the negative predictive value: 44.43% - 96.89% (CI 95%). LIMITATIONS: This study is limited by its observational design and the small number of cases. CONCLUSION: High-resolution 3D CT VRT is a non- invasive method that can identify IDD-related complications with more precision than axial CT and fluoroscopy.

Evaluation of intrathecal baclofen delivery system malfunction by computed tomography scan.

AIM: To describe the computed tomography (CT) findings encountered when catheter patency is questionable. The role of CT in directing treatment is evaluated. METHOD: Records of children with intrathecal baclofen pump management were reviewed. Only patients with CT evaluation who had revision pump/catheter surgery were included. RESULTS: From 295 patients, 27 had CT contrast study; in three of them, baclofen could not be aspirated and the procedure was stopped, eight had normal scan and did not need surgery and 16 patients were reported. Four patients had normal CT (free contrast formed a perfect crescent shape), and had surgery because the pump battery was close to expiration. Five patients had inadequate fluid pooling (fluid was seen without a crescent shape). Five patients had fluid leak (fluid was seen around the pump or in the lumbar canal below catheter entrance level or outside the canal in the lumbar region). Two patients had catheter occlusion (fluid loculation around the catheter tip with no free flow). INTERPRETATION: CT contrast study is safe and effective for locating defects in intrathecal baclofen delivery system. When catheter patency is questionable, CT plays an important role in directing the next step of management.

Infection as a Complication of Intrathecal Baclofen Treatment in Children With Cerebral Palsy.

BACKGROUND: Children with cerebral palsy (CP) and spasticity are often managed with intrathecal baclofen treatment (ITB). Complications of ITB include infection at the pump or catheter site and late complications as well as revisions of the pump and catheter because of events such as battery expiration or implant malfunction. The goal of this study is to report the short-term and long-term incidence, risk factors, and treatment outcomes of ITB infections in children. METHODS: This was a retrospective review of 294 children with CP. The number of ITB surgeries per patient, risk of infection for primary and secondary ITB-related procedures, microorganisms responsible, and associated factors, such as concurrent orthopaedic interventions, medical comorbidities, and subsequent management of ITB-related infections, were evaluated. RESULTS: Infection occurred in 28/294 patients (9.5%) with a 4.9% rate per procedure. There were 14 acute (within 90 d of surgery) and 14 late infections. The infection risk per ITB procedure was 2.4%. Risk of late infection over 5-year mean follow-up was 0.95% per year. Pump removal with acute contralateral implantation was the most successful treatment of infections. Gross Motor Function Classification System level V and G-tube were the main risk factors for infection. A total of 133 concurrent orthopaedic procedures were performed during 277 ITB procedures with no increased risk of infection. CONCLUSIONS: ITB in children with CP has a relatively low and manageable risk of infection. It is important to always consider infection as a complication with ITB because with prompt treatment the positive impact of ITB is still possible. It is safe to perform concurrent orthopaedic procedures with ITB procedures. LEVELS OF EVIDENCE: Level III-therapeutic study.

Catheter-tip Granulomas Associated with Intrathecal Drug Delivery--A Two-Center Experience Identifying 13 Cases.

BACKGROUND: Intrathecal (IT) drug therapy with implanted pumps is an effective treatment modality for chronic pain and/or spasticity, especially after non-invasive treatment has failed. Long-term use of intrathecal opioids may cause formation of inflammatory masses at the tip of intrathecal catheters, possibly leading to neurological deficits and/or catheter revision. OBJECTIVE: We aimed to identify risk factors for catheter-tip granuloma (CG) formation. STUDY DESIGN: Retrospective study. SETTING: Tertiary Spine Centers in Germany and Switzerland. METHODS: We retrospectively reviewed data at 2 Swiss centers (Kantonsspital St. Gallen, Swiss Paraplegic Centre Nottwil) between 01/1994 and 10/2013. Collected data were age at operation, gender, smoking status, previous spinal operations, spinal level of catheter-tip, clinical symptoms, catheter testing with contrast agent, applied drugs, drug concentration, as well as cumulative daily drug dosages. RESULTS: Thirteen patients with a mean age of 52.6 years and CG formation after a mean of 6.9 years of follow-up were identified and compared to 54 patients of similar age and length of follow-up (48.6 years, P = 0.535; follow-up 5.3 years, P = 0.236) without CG. In the analysis of risk factors, catheter ending in the middle thoracic spine (Th4-8; 38.5 vs. 6.5%; P = 0.010), previous spinal surgery (75 vs. 41%; P = 0.051), and chronic pain as an underlying primary symptom for IT drug therapy (100 vs. 56%, P = 0.003) were associated with CG formation. IT drug therapy for spasticity appeared to be much less associated with CG formation (0 vs. 44%, P = .0003). As the symptomatology is closely related to the medical treatment applied, patients with CG were more likely to be treated with IT morphine (77 vs. 20%; P < 0.001), and as tendency with IT clonidine (54 vs. 26%; P = 0.092) and IT bupivacaine (46 vs. 20%; P = 0.077). Average in-pump morphine concentration (30.3 vs. 19.5 mg/mL; P = 0.05) as well as average daily dose of morphine (12.5 vs. 6.2 mg/d; P = 0.037) were significantly higher in the CG group. Smoking could not be identified as risk factor for CG formation. LIMITATIONS: Limitations include the retrospective approach, the limited group size of granuloma patients, as well as missing data in the investigated patient groups. CONCLUSION: Our patient cohort with CG differed in some features, of which some like catheter localization, choice, dosage, and the concentration of drugs are potentially modifiable. These results could contribute to the prevention of CG in the future.

Use Of External Intrathecal Infusion Pumps In The Management Of Septic Complications: A Case Report.

Spasticity is a motor disorder with an increased muscle tone, typically associated with spasms, weakness and lack of coordination. It is an invalidating and debilitating pathology, characterized by pain, limited autonomy in activities of daily living, development of severe lesions. Spasticity can be adequately treated with physiotherapy, muscle relaxants drugs or topical treatment with botulinic toxin type A. Intrathecal baclofen therapy is very effective in the treatment of severe and generalized spasticity. Sometimes, soft tissues adjacent to the implant intrathecal infusion become infected; removing intrathecal infusion and systemic antibiotic therapy are best solution for clinical cure. However, removing intrathecal baclofen therapy could increase muscle spasticity with enhancement of pain and clonus that can worsen quality of life. In this study, we evaluated clinical improvement after complete healing of the septic focus and implantation of a new infuser.

Intrathecal analgesia: time to consider it for your patient?

When systemic analgesics or antispasmodics fail to control chronic pain or cause intolerable adverse effects, an intrathecal drug delivery system may be the best bet.

Effects of massage therapy on pain and anxiety arising from intrathecal therapy or bone marrow aspiration in children with cancer.

Cancer and its treatment are stressful and reduce the quality of life in children. The aim of this study was to investigate the effect of massage therapy on pain and anxiety arising from intrathecal therapy or bone marrow aspiration in children with cancer. We conducted a controlled pretest/posttest quasi-experimental study at a paediatric oncology unit in Turkey. Twenty-five children were enrolled in this study. Their pain and anxiety were determined using a visual analogue scale. When the pretest and posttest pain and anxiety levels of the groups were compared, no statistically significant difference was found (P > 0.05). It was determined that pain and anxiety levels in the experimental group decreased significantly. This study provides preliminary evidence for the effectiveness in children of massage in reducing pain and anxiety arising from intrathecal therapy or bone marrow aspiration.

Fibrin glue to treat spinal fluid leaks associated with intrathecal drug systems.

Intrathecal drug delivery systems (IDDSs) are used to treat resistant pain states as well as intractable spasticity via medication delivery into the spinal fluid. Risks associated with implantation of these devices include infection, bleeding, intrathecal granuloma formation, and neurologic sequelae similar to other neuraxial procedures. Intrathecal catheter placement creates the additional risk of persistent spinal fluid leak, which can lead to postdural puncture headaches as well as seroma formation and may require subsequent surgical exploration or explantation. This retrospective case series examines 3 patients at a single institution with persistent spinal fluid leak after IDDS placement (and explantation in one case) resulting in headache and/or seroma formation that were treated with epidural fibrin glue. Three patients underwent IDDS implantation with baclofen for spasticity. In 1 patient, a cerebral spinal fluid leak developed at 1-week postoperatively. After several unsuccessful epidural blood patches and surgical exploration with a catheter revision, she was ultimately treated successfully with a fibrin glue patch. The second patient received an IDDS and did well until a seroma developed 1 year later. He was likewise treated with an epidural fibrin glue patch after 2 failed blood patches. In a third patient, a spinal fluid leak developed after explantation of an IDDS and was treated with an epidural fibrin glue patch as initial therapy.

Intrathecal baclofen in multiple sclerosis and spinal cord injury: complications and long-term dosage evolution.

OBJECTIVE: To investigate the long-term dosage evolution and complication rate of intrathecal baclofen use in multiple sclerosis and spinal cord injury patients, based on a large population with a long follow-up. DESIGN: Retrospective data analysis. SETTING: Academic hospital. SUBJECTS: Patients with multiple sclerosis (n = 81) or spinal cord injury (n = 49) having an intrathecal baclofen pump implanted at the University Hospitals Leuven between 1988 and 2009. INTERVENTION: Medical records review of included patients in August 2010. MAIN MEASURES: Complications linked to intrathecal baclofen therapy. Daily baclofen dosage after 3 and 6 months, and yearly thereafter. Data on dosage evolution were analysed using a mixed-effect linear model. RESULTS: In 130 patients with a mean follow-up of 63 months, comprising 797 pump years, 104 complications were recorded. This corresponds to a complication rate of 0.011 per month, equally divided among both groups. Seventy-eight of these complications were catheter related. The mean dosage of baclofen stabilizes two years after implantation at 323 µg/day in the multiple sclerosis population. In spinal cord injury patients the daily dose only stabilizes after five years at a significantly higher dosage (504 µg/day). No significant increase in dosage is seen in the long term. CONCLUSIONS: In multiple sclerosis and spinal cord injury patients, intrathecal baclofen therapy has a complication rate of 1% per month. Complications are mainly due to catheter-related problems (74%). The intrathecal baclofen dosage stabilizes in the long term, indicating that long-term tolerance, defined as progressive diminution of the susceptibility to the effects of a drug, is not present.

Rising complication rates after intrathecal catheter and pump placement in the pediatric population: analysis of national data between 1997 and 2006.

BACKGROUND: Intrathecal delivery of baclofen (ITB) is effective at controlling spasticity. However, it requires the placement of a catheter into the intrathecal space, and a pump with a reservoir for the medication. The process of placing the catheter and pump are prone to complications. OBJECTIVES: The objective of this paper is to determine factors contributing to rising complication rates after intrathecal catheter/pump placement in a national sample of pediatric patients. STUDY DESIGN: This was a retrospective observational database study. METHODS: We queried the Kids' Inpatient Database for all children greater than 4 years old and under 20 years old for the years 1997, 2000, 2003, and 2006 who had an intrathecal catheter and pump placed. We then compared demographics and hospital characteristics of patients with and without complications. We performed univariate and multivariate analyses to determine the relative contribution of various factors to the development of complications. RESULTS: We identified 2,843 patients who met our criteria, and 514 of these patients had one or more complications after placement of intrathecal pump/catheter. There were 1.14 complications per patient. The complication rate was 10.2% in 1997, and increased to 21.9% in 2006. Mechanical complications were the most common type of complication in this population, account for nearly two-thirds of all complications occurring. Age, hospital type, hospital size, and admission source were independent predictors of complications. LIMITATIONS: We did not have access to ASA status, operative details, and access to patient charts. CONCLUSIONS: Complication rates after placement of intrathecal pump/catheters have increased in the pediatric population between 1997 and 2006 mainly due to an increase in mechanical complications.