Uncovering the rate and risk factors of intrathecal baclofen pump-associated complications in the adult population.

OBJECTIVE: The aim of this study was 1) to describe the rate of intrathecal baclofen (ITB)-associated complications at a large tertiary center, and 2) to evaluate the impact of patient-related factors on the likelihood of developing such complications. METHODS: A retrospective single-center study was carried out. A total of 301 eligible patients were included in the analysis. Univariate regression models were used to evaluate the impact of age, sex, diagnosis, ambulation status, modified Ashworth scale score, body mass index, diabetes status, and pain level on the likelihood of developing a device-related infection, pump malfunction, catheter malfunction, and other clinically significant complications. RESULTS: Overall, 27% of patients experienced an ITB-related complication. The most common complications included infection (6%, 18/301), pump malfunction (7.3%, 22/301), and catheter malfunction (14%, 42/301). The univariate analyses revealed that the patient's ambulatory status had a significant impact on the likelihood of developing a catheter-related malfunction. Furthermore, a trend toward significance was identified between patients' preoperative body mass index and device-related infection. Finally, the risk of suffering any ITB-related complications was statistically correlated with the number of years that had passed since the initial pump implantation. CONCLUSIONS: The authors' analysis reveals a previously underrecognized association between ambulatory status at the time of ITB pump implantation and the incidence of catheter-related complications, and confirms the impact of time since surgery on the risk of developing any ITB-related complication. The patient's age, sex, diagnosis, diabetes status, or pain level at baseline were not associated with the risk of complications. Collectively, these insights contribute novel information to the existing literature, providing practical value for physicians in guiding patient selection for ITB therapy.

Spinal catheter revision in pediatric intrathecal baclofen pumps: risk factors and postoperative outcomes.

OBJECTIVE: Intrathecal baclofen (ITB) pumps are commonly used in pediatric patients with cerebral palsy (CP) and medically refractory spasticity. However, catheter malfunction and associated risk factors are not well understood. The aim of this study was to examine potential risk factors for spinal catheter malfunction and characterize postoperative follow-up to understand the clinical consequences. METHODS: Patients who received ITB pump replacement or revision at Boston Children's Hospital between 2010 and 2023 were retrospectively reviewed. The spinal catheter revision cohort (SCRC) included patients whose spinal catheter was occluded requiring lumbar catheter revision. The second cohort included abdominal pump replacements only (APRC). Between-group comparisons and multivariable regression identified factors associated with catheter revision and postoperative outcomes. RESULTS: Forty-one (33.6%) patients underwent spinal catheter revision and were compared with 81 patients (66.4%) who underwent abdominal pump replacement only. Younger age at surgery and an elevated preoperative lower-extremity modified Ashworth scale grade were associated with spinal catheter revision (p < 0.05). Catheter model type, tip location, and history of spinal fusion were not associated with obstruction. Postoperatively, SCRC patients experienced a higher rate of infection (17.1%) relative to APRC patients (0%) within 30 days from their ITB pump replacement procedure (p < 0.05) and greater likelihood of subsequent ITB system removal compared with the APRC (24.4% vs 7.4%, p < 0.05). Although not differing preoperatively, SCRC patients had lower postoperative ITB doses when compared with the APRC group (median dose 143 vs 350 µg/day, p < 0.05) at hospital discharge and remained statistically different at the 6-month and 1-year follow-ups (p < 0.05). There were no postoperative differences in baclofen overdose, withdrawal, or median number of hospital readmissions within 30 days. Overall, 31.7% of spinal catheter revisions were unanticipated by the clinical team at time of surgery. CONCLUSIONS: Younger age at surgery and increased preoperative lower-extremity tone may be risk factors for catheter obstruction, resulting in a higher rate of postoperative infection and subsequent ITB pump removal compared with pump replacement alone. Spinal catheter occlusion can complicate revision or replacement procedures, especially when unanticipated. Routine clinical assessment may be inadequate for diagnosing insidious catheter malfunction. Catheter occlusion deserves further study, and routine assessment of catheter patency may be warranted to prevent suboptimal tone therapy.

Brief pump externalization without ITB wean to treat a probable pocket infection.

BACKGROUND AND IMPORTANCE: Intrathecal baclofen (ITB) pumps are an effective management tool for spasticity and dystonia. In the pediatric population, ITB complications including infection are common, and strategies to minimize their impact are important. Current standard of care for pump infection involves a wean of the ITB therapy followed by explantation of the hardware, which can be a three to 6-month process. CLINICAL PRESENTATION: We present a 20-year-old female who developed an pump pocket infection after revision. The pump was removed from the body but left connected. The pocket was debrided, thoroughly washed, and packed with multiple microbicidal agents. Nine days later, a new pump and proximal catheter was re-implanted without complications or interruption of medication administered intrathecally. One year later, the patient is doing well without any infectious problems. CONCLUSION: To our knowledge, this is the first report of an externalized pump and expedited reimplantation without a break in ITB therapy. Further studies are required in order to best characterize this technique as a potential alternative for infected baclofen pump pockets.

Intracerebroventricular baclofen therapy improves function and quality of life in a child with severe cerebral palsy.

Limited therapies are available for severe cerebral palsy children (CP) with complex movement disorders, especially when both dystonia and spasticity are present. In this publication, we present the improvement of a child with severe CP after intracerebroventricular baclofen therapy. The treatment can impact not just the movement disorders but also on the quality of life of the child and caregivers. Global functional improvements can be observed on the 6-month follow-up.

The patients with intrathecal baclofen pump in the age of COVID-19: a single center study.

PURPOSE: Intrathecal baclofen pump treatment is employed in the treatment of various diseases. Despite the benefits of intrathecal baclofen pump, patients may occasionally encounter severe complications. These complications may necessitate urgent assessment or intervention for patients with intrathecal baclofen pumps. This study aimed to evaluate the intrathecal baclofen pump-related problems, the utilization of health services, physical-psychosocial status, and the quality of life of patients with intrathecal baclofen pumps during the coronavirus disease 2019 pandemic. MATERIALS AND METHODS: We conducted a cross-sectional, phone-based survey study between 1 June 2021 and 15 July 2021 with a sample of 23 patients with intrathecal baclofen pumps. The patients' quality of life before the implantation of the pump, after one year of implantation, and during the pandemic was evaluated with the 3-level version of EQ-5D. RESULTS: Catheter migration developed in one of the patients, after which the pump was changed. While the dose of baclofen was altered in eight (38.1%) patients during the pandemic period, the filling period was modified in three (14.3%) patients. While 61.9% of the patients reported that their general health, mobility, spasticity and joint mobility were worse than before the pandemic, 90.5% of the patients stated that their communication and mood were worse than before the pandemic. The 3-level version of EQ-5D and EQ-Visual Analogue Scale scores of the patients were significantly decreased during pandemic (p < .05). CONCLUSIONS: Due to the complications of the intrathecal baclofen pump, its management should continue uninterruptedly during the pandemic period.

Staphylococcus Aureus Swabbing and Decolonization Before Neuromodulation Procedures: A Systematic Review and Meta-Analysis.

INTRODUCTION: Staphylococcus aureus (S aureus) is the foremost bacterial cause of surgical-site infection (SSI) and is a common source of neuromodulation SSI. Endogenous colonization is an independent risk factor for SSI; however, this risk has been shown to diminish with screening and decolonization. MATERIALS AND METHODS: A systematic review was performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines using the PubMed, Cochrane Library, and Embase data bases from inception to January 1, 2022, for the purposes of identifying all studies reporting on the use of S aureus swabbing and/or decolonization before neuromodulation procedures. A random-effects meta-analysis was performed using the metaphor package in R to calculate odds ratios (OR). RESULTS: Five observational cohort studies were included after applying the inclusion and exclusion criteria. The average study duration was 6.6 ± 3.8 years. Three studies included nasal screening as a prerequisite for subsequent decolonization. Type of neuromodulation included spinal cord stimulation in two studies, deep brain stimulation in two studies, intrathecal baclofen in one study, and sacral neuromodulation in one study. Overall, 860 and 1054 patients were included in a control or intervention (ie, screening and/or decolonization) group, respectively. A combination of nasal mupirocin ointment and a body wash, most commonly chlorhexidine gluconate soap, was used to decolonize throughout. Overall infection rates were observed at 59 of 860 (6.86%) and ten of 1054 (0.95%) in the control and intervention groups, respectively. Four studies reported a significant difference. The OR for intervention (screen and/or decolonization) vs no intervention was 0.19 (95% CI, 0.09-0.37; p < 0.001). Heterogeneity between studies was nonsignificant (I2 = 0.43%, τ2 = 0.00). CONCLUSIONS: Preoperative S aureus swabbing and decolonization resulted in significantly decreased odds of infection in neuromodulation procedures. This measure may represent a worthwhile tool to reduce neuromodulation SSI, warranting further investigation.

[Surgical procedures for treatment of spasticity]. / Chirurgische Verfahren zur Therapie von Spastik.

BACKGROUND: The causes of spasticity are various and include cerebral palsy, spinal cord injury, stroke, multiple sclerosis or other congenital or acquired lesions of the central nervous system (CNS). While there is often a partial functional component, spasticity also results in varying degrees of impairment of the quality of life. OBJECTIVE: A review of surgical treatment options for spasticity. MATERIAL AND METHODS: A systematic PubMed review of the literature on epidemiology and treatment options with a focus on neurosurgical interventions for spasticity and developments in the last 20 years as well as inclusion of still valid older landmark papers was carried out. Illustration of indications, technique, follow-up, and possible pitfalls of the different methods for the surgical treatment of spasticity. RESULTS: Depending on the affected region, the number of muscle groups, and the extent of spasticity, focal (selective peripheral neurotomy, nerve transfer), regional (selective dorsal rhizotomy), or generalized (baclofen pump) procedures can be performed. The indications are usually established by an interdisciplinary team. Conservative (physiotherapy, oral medications) and focally invasive (botulinum toxin injections) methods should be performed in advance. In cases of insufficient response to treatment or only short-term relief, surgical methods can be evaluated. These are usually preceded by test phases with, for example, trial injections. CONCLUSION: Surgical methods are a useful adjunct in cases of insufficient response to conservative treatment in children and adults with spasticity.

Efficacy of Selective Dorsal Rhizotomy and Intrathecal Baclofen Pump in the Management of Spasticity.

BACKGROUND: Neurosurgical indications and interventions provided in the management of spasticity have evolved significantly over time. Selective dorsal rhizotomy (SDR) and intrathecal baclofen (ITB) pumps have been used to improve mobility, reduce lower extremity spasticity, and increase quality of life in patients with various diagnoses. METHODS: Studies describing ITB and SDR outcomes in adult and pediatric patients were identified from Medline and Embase databases. Only publications between January 1990 to January 2021 were included. Combinations of search terms 'Selective Dorsal Rhizotomy', 'Selective Posterior Rhizotomy', 'functional posterior rhizotomy', 'intrathecal baclofen pump', and 'spasticity' were used. Only studies in English language and those that included parameters for lower extremity outcome (i.e., spasticity, ambulation) were included. Only studies describing follow-up 12 months or greater were included. Case reports, reviews without primary data, or inaccessible publications were excluded. RESULTS: Two hundred and ninety publications between January 1990 to January 2021 were identified. Of these, 62 fit inclusion and exclusion criteria for a total of 1291 adult and 2263 patients. Etiologies in adult and pediatric populations varied substantially with multiple sclerosis, cerebral palsy, and trauma comprising the majority of causes for spasticity in adult patients. In pediatric patients, cerebral palsy was the predominant etiology of spasticity. While outcomes after SDR and ITB varied, both are effective for long-term tone reduction. SDR appeared to have a greater effect on function compared to baseline when comparing relatively similar subgroups. The complication rates for either intervention were significant; ITB had a much greater incidence of wound and hardware adverse events, whereas SDR was associated with a not insignificant incidence of new bladder or sensory deficit. CONCLUSION: ITB and SDR have demonstrated efficacy and utility for tone reduction in a variety of conditions. The selection of a specific intervention may have a variety of determining features including the etiology of spasticity, age of patient, as well as balancing benefit and complication profiles of each technique. Appropriate patient selection is essential for providing optimal patient outcomes.

Baclofen Withdrawal With Reversible Posterior Leukoencephalopathy Syndrome: Bacterial Meningitis Mimicker.

BACKGROUND: The intrathecal baclofen (ITB) pump is an effective treatment for patients with spasticity unresponsive to oral medication. CASE REPORT: A 31-year-old woman with spinal cord injury sequelae was admitted to the emergency department due to sudden headache and excessive confusion. The patient was on ITB for lower limb spasticity. On presentation, her vital signs revealed blood pressure of 171/106 mm Hg, heart rate of 141 beats/min, and temperature of 39.0°C. Antibiotics were promptly administered intravenously for suspicion of bacterial meningitis. Based on magnetic resonance imaging and cerebrospinal fluid findings, as well as clinical signs such as marked lower limb spasticity, the final diagnosis was determined to be baclofen withdrawal syndrome complicated by reversible posterior leukoencephalopathy syndrome (RPLS). Improved consciousness was quickly achieved on blood pressure control. Resolution of spasticity was achieved after intravenous midazolam and intrathecal baclofen via lumbar puncture. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: Baclofen withdrawal syndrome is the leading differential diagnosis for impaired consciousness and fever among patients using ITB pumps. Moreover, baclofen withdrawal syndrome mimics a wide variety of conditions, including sepsis. This unique case was complicated by intrathecal baclofen withdrawal syndrome coexisting with RPLS, thus presenting more similarly to bacterial meningitis than the usual baclofen withdrawal, due to marked headache, altered consciousness, and generalized convulsive symptoms. In addition to general withdrawal management, commencement of antihypertensive therapy for RPLS may have an immediate effect on the improvement of impaired consciousness.

Baclofen pump with pre-brainstem catheter tip placement: technical note and case series.

PURPOSE: This study aims to describe a new baclofen pump implantation technique with pre-brainstem catheter placement and to demonstrate the benefits that this procedure has in treating spasticity and dystonia. METHODS: We described a new technique to place a baclofen pump catheter anterior to the brainstem. To illustrate the technique, we presented five patients with both spasticity and dystonia in whom conventional treatment was not effective. They each received a baclofen pump with a pre-brainstem catheter. We evaluated the results using the Ashworth scale for spasticity, the Barry-Albright scale for dystonia, and the PedsQL for quality of life assessment. Each patient was evaluated before a surgery and after 6 months of follow-up. RESULTS: There were statistically significant differences in all the physical examination evaluated areas using the Barry-Albright and modified Ashworth scales between the preoperative and the postoperative period. The same applies to the results of the PedsQL quality of life scale. CONCLUSION: We presented an innovative baclofen pump implantation technique with pre-brainstem catheter placement that could be a therapeutic alternative in patients with dystonia and spastic quadriparesis for whom conventional therapy is not effective.

Unusual mechanical failures of intrathecal baclofen pump systems: symptoms, signs, and trouble shooting.

INTRODUCTION: Although intrathecal baclofen (ITB) therapy is an effective treatment for spasticity, it has several disadvantages and a risk of complications. METHODS: We present six pediatric patients who suffered from unusual mechanical failures of intrathecal baclofen pump systems. RESULTS: With these case-vignettes, we provide a systematic approach on how to interpret the symptoms of ITB complications and an advice which further diagnostic and therapeutic steps to follow. We underline the seriousness of baclofen overdose, underdosing or withdrawal.

Epidural catheter placement in children with baclofen pumps.

BACKGROUND: 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. AIMS: (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. METHODS: 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. RESULTS: 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. DISCUSSION: 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.

Pediatric Intrathecal Baclofen Pumps: A Descriptive Analysis of Hospital Course and Associated Costs.

INTRODUCTION: The purpose of this study was to identify predictors of increased cost and postoperative length-of-stay (LOS) following intrathecal baclofen pump (ITBP) placement. METHODS: Patients were derived from the 2009/2012 kids' inpatient database. Inclusion criteria were selected for patients with ICD-9 codes 343.X (infantile cerebral palsy), 86.06 (infusion pump insertion), 03.90 (spinal catheter insertion), and elective hospitalizations. Nonparametric univariate analysis and subsequent gamma log-link general linear modeling were used to identify significant predictors of cost/LOS (p < 0.05). RESULTS: 529 unweighted patients (787 with survey weights applied) met criteria. Median LOS was 3.00 days, and median cost was USD 23,284. Following multivariate modeling, predictors of increased LOS (in days) included increased hospital ITBP volume (p = 0.027), small hospital size (+0.55, p = 0.004), device complications (+0.95, p < 0.001), procedural complications (+1.40, p < 0.001), additional procedures (+0.86, p < 0.001), electrolyte abnormalities (+3.74, p < 0.001), and neurological comorbidities (+1.60, p < 0.001). Factors associated with decreased LOS were paralysis (-0.53, p < 0.001), Northeastern hospital region (-0.55, p = 0.018), and investor-owned hospital status (-0.75, p = 0.001). Similarly, predictors of increased cost included race of Hispanic (+USD 1,156, p = 0.033) or "other" (+USD 2,158, p = 0.001), Northeast hospital region (+USD 4,120, p < 0.001), small (+USD 4,139, p < 0.001) or medium (+USD 3,368, p < 0.001) hospital sizes, additional procedures (+USD 1,649, p < 0.001), neurological comorbidities (+USD 3,222, p = 0.003), and increased LOS (p < 0.001). Factors associated with decreased cost included Western hospital region (-USD 1,594, p = 0.001), government hospitals (-USD 1,391, p = 0.019), and investor-owned hospitals (-USD 2,057, p = 0.021). CONCLUSION: This study found multiple variables associated with increased cost/LOS following ITBP placement. Broadly, this analysis demonstrates national trends associated with increased cost following ITBP placement.

Intrathecal Baclofen Pump Infection With Meningitis: Effective Treatment by Radical Debridement and Intrareservoir Baclofen-Vancomycin Co-Infusion.

OBJECTIVES: Intrathecal baclofen pump associated central nervous system (CNS) infection and meningitis is a rare but serious complication and may have dire consequences. Due to bacterial biofilm formation, the optimal treatment strategy is usually for removal of the pump, followed by systemic antibiotics for treatment of local and CNS infection. We describe this case of a patient with recurrent Staphylococcus aureus pump site empyema and meningitis leading to status dystonicus, who was successfully managed with radical debridement and intrareservoir baclofen-vancomycin co-infusion. MATERIALS AND METHODS: We retrospectively report a case of infected intrathecal baclofen pump with meningitis and provide a full review of literature. CONCLUSIONS: To the best of our knowledge, this is the first reported case of intrathecal baclofen (ITB)-associated pump site empyema and meningitis successfully treated with this technique. In selected cases where surgical explantation is deemed not feasible, this method can provide clinicians with an additional option for pump salvage and retention, while eradicating CNS infection and maintaining optimal control of spasticity and dystonia.

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

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

Intrathecal baclofen therapy for treatment of spasticity in infants and small children under 6 years of age.

PURPOSE: The aim of this study is to prove the efficacy and safety of intrathecal baclofen therapy in infants and children below 6 years of age by retrospective analysis of our pediatric cohort of 135 primary pump implantations. METHODS: Between 2007 and 2018, 17 patients with pump implantations were below 6 years of age. Data were acquired retrospectively with a follow-up of 12 months to 11 years regarding complications. RESULTS: The youngest infant was 11 months at implantation with a bodyweight of 6, 4 kg, and 63 cm length. Surgical complications were comparable to published literature and mainly involved the catheter (2 catheter dislocations and 1 catheter transection) and one pump infection resulting in 4 revision surgeries in 3 patients. One baclofen-related apnea during titration and an overdose after refill were treated conservatively. Using a subfascial implantation technique, we observed neither skin ulceration nor pump infection since 2007. In a growing child, catheter slides are common and related to growth, scoliosis, spine surgery, and surgical failure. CONCLUSION: Intrathecal baclofen therapy in infants and small children is as safe and effective as published for older pediatric patients; therefore, intrathecal baclofen can be considered in all infants as long as an 8-cm incision fits into the triangle of the anterior superior iliac spine, costal margin of the 10th rib, and navel. We suggest the utilization of subfascial surgical technique for implantation pump and catheter. Titration of intrathecal baclofen should be performed slowly to avoid bradycardia in infants. This is a retrospective study (level of evidence 4).

Screening Intrathecal Baclofen Pump Systems for Catheter Patency via Catheter Access Port Aspiration.

OBJECTIVES: To screen all of our patients being treated with intrathecal baclofen (ITB) therapy for catheter patency. METHOD: Catheter patency was examined by performing a catheter access port study in 91 pediatric and adult patients undergoing ITB therapy at our institution. RESULTS: Despite no preoperative clinical suspicion of a problem with the ITB system in all but one case, 16.5% of the catheters in our patient population were not patent. After replacement, prerevision and stable postrevision dosage was examined to determine the impact system replacement had on the daily dosage. There was a significant 65% reduction in the daily ITB dosage from before catheter exploration (M = 823.8 mcg/day, SD = 390.51) to stable post replacement/revision dosage after catheter replacement or revision (M = 289.43 mcg/day, SD = 187.76), t11 = 4.09, p = .002, 95% CI [246.80, 822.00]. CONCLUSIONS: These results suggest that catheters need to be routinely screened for patency. Routine maintenance and screening can minimize or more quickly detect nonpatent systems and ensure proper functioning of the ITB system.

Hyperbaric Oxygen Therapy as Adjuvant Treatment for Hardware-Related Infections in Neuromodulation.

BACKGROUND: In neuromodulation therapies, hardware-related infections are a major challenge often leading to hardware removal. OBJECTIVE: To investigate the role of adjuvant hyperbaric oxygen therapy (HBOT) in hardware-related infections. METHODS: Fourteen hardware-related infection events in 12 consecutive patients between 2002 and 2015 were treated with antibiotics and adjuvant HBOT at the Karolinska University Hospital (Stockholm, Sweden). Two time-independent infection events related to hardware replacements occurred in 2 patients. Infection resolution and the need for hardware removal were assessed. RESULTS: Twelve out of 14 events of hardware-related infection were successfully treated without hardware removal (86%). The 2 patients treated twice with HBOT on 2 time-independent occasions could retain their hardware in both cases. Hardware was removed following HBOT failure in 2 infection events, with long-term infection control achieved in all patients. Further, an intrathecal pump malfunction caused by HBOT at 2.8 bars was observed, leading to a change in the manufacturer's guidelines. CONCLUSIONS: This study indicates a potential benefit of adjuvant HBOT in the treatment of hardware-related infections in neuromodulation, diminishing the need for hardware removal and treatment interruption. Prospective studies are warranted to establish the role of adjuvant HBOT in the treatment of hardware-related infections in neuromodulation.

Neuromodulation in multiple sclerosis.

Neuromodulation, or the utilization of advanced technology for targeted electrical or chemical neuronal stimulation or inhibition, has been expanding in several neurological subspecialties. In the past decades, immune-modulating therapy has been the main focus of multiple sclerosis (MS) research with little attention to neuromodulation. However, with the recent advances in disease-modifying therapies, it is time to shift the focus of MS research to neuromodulation and restoration of function as with other neurological subspecialties. Preliminary research supports the value of intrathecal baclofen pump and functional electrical stimulation in improving spasticity and motor function in MS patients. Deep brain stimulation can improve MS-related tremor and trigeminal neuralgia. Spinal cord stimulation has been shown to be effective against MS-related pain and bladder dysfunction. Bladder overactivity also responds to sacral neuromodulation and posterior tibial nerve stimulation. Despite limited data in MS, transcranial magnetic stimulation and brain-computer interface are promising neuromodulatory techniques for symptom mitigation and neurorehabilitation of MS patients. In this review, we provide an overview of the available neuromodulatory techniques and the evidence for their use in MS.

Impact of antibiotic prophylaxis for intrathecal baclofen pump surgery in pediatric patients.

OBJECT This study explored antibiotic prophylaxis (AP) in pediatric patients undergoing intrathecal baclofen pump (ITBP) surgery and factors associated with perioperative AP compliance with clinical guidelines. METHODS Data were obtained from the Pediatric Health Information System. The study cohort comprised patients who underwent ITBP surgery within 3 days of admission, between July 1, 2004, and March 31, 2014, with a minimum prior screening period and follow-up of 180 days. Exclusion criteria were prior infection, antibiotic use within 30 days of admission, and/or missing financial data. Chi-square tests and multivariate logistic regressions were used to determine factors associated with compliance with AP guidelines in ITBP surgeries. RESULTS A total of 1,534 patients met the inclusion criteria; 91.5% received AP and 37.6% received dual coverage or more. Overall bundled compliance comprised 2 components: 1) perioperative antibiotic administration and 2) < 24-hour postoperative antibiotic course. The most frequently used antibiotics in surgery were cefazolin (n = 873, 62.2%) and vancomycin (n = 351, 25%). Documented bundled AP compliance rates were 70.2%, 62.0%, 66.0%, and 55.2% in West, South, Midwest, and Northeast regions of the US, respectively. Compared with surgeries in the Northeast, procedures carried out in the West (OR 2.0, 95% C11.4-2.9, p < 0.001), Midwest (OR 1.6, 95% C11.1-2.3, p = 0.007), and South (OR 1.5, 95% C11.1-2.0, p = 0.021) were more likely to have documented AP compliance. Black (OR 0.74, 95% CI 0.55-1.00, p = 0.05) and Hispanic (OR 0.63, 95% CI 0.47-0.86, p = 0.004) patients were less likely to have documented AP compliance in ITBP surgeries than white patients. There were no significant differences in compliance rate by age, sex, type of insurance, and diagnosis. AP process measures were associated with shorter length of stay, lower hospitalization costs, and lower 6-month rates of surgical infection/complication. One of the 2 noncompliance subgroups, missed preoperative antibiotic administration, was correlated with a significantly higher 6-month surgical complication/infection rate (27.03%) compared with bundled compliance (20.00%, p = 0.021). For the other subgroup, prolonged antibiotic use > 24 hours postoperatively, the rate was insignificantly higher (22.00%, p = 0.368). Thus, of direct relevance to practicing clinicians, missed preoperative antibiotics was associated with 48% higher risk of adverse complication/infection outcome in a 6-month time frame. Adjusted hospitalization costs associated with baclofen pump surgery differed significantly (p < 0.001) with respect to perioperative antibiotic practices: 22.83, 29.10, 37.66 (× 1000 USD) for bundled compliance, missed preoperative antibiotics, and prolonged antibiotic administration, respectively. CONCLUSIONS Significant variation in ITBP antibiotic prophylaxis was found. Documented AP compliance was associated with higher value of care, showing favorable clinical and financial outcomes. Of most impact to clinical outcome, missed preoperative antibiotics was significantly associated with higher risk of 6-month surgical complication/infection. Prolonged antibiotic use was associated with significantly higher hospital costs compared with those with overall bundled antibiotic compliance. Future research is warranted to examine factors associated with practice variation and how AP compliance is associated with outcomes and quality, aiming for improving delivery of care to pediatric patients undergoing ITBP procedures.