Infectious Complications and Operative Management of Intrathecal Baclofen Pumps in the Pediatric Population: A Systematic Review and Meta-Analysis of 20 Years of Pooled Experience

Nuru, Mohammed; Maglinger, Benton; Vessell, Meena; J, Simon; Daniels, Michael W.; Anderson, Douglas; Mutchnick, Ian

doi:10.1016/j.wneu.2022.02.078

Cited by 7 publications

(5 citation statements)

References 40 publications

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“…The complication rate in our patient cohort is similar to that of previously published reports. In a recent meta-analysis comprising 2264 patients, the incidence of device-related infection (7.28%), catheter malfunction (9.13%), CSF leak (3.21%), and pump malfunction (1.23%), 11 was similar to our observation (6%, 14%, 2.3%, and 7.3%, respectively; see Table 2). Importantly, our study encompassed patients with both Indura and Ascenda catheters, which should be taken in consideration when interpreting the results.…”

Section: Discussionsupporting

confidence: 89%

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

Tiefenbach,

Machado,

Bethoux

2024

Neurosurgical Focus

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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.

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Section: Discussionsupporting

confidence: 89%

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

Tiefenbach,

Machado,

Bethoux

2024

Neurosurgical Focus

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Section: Complications-catheter Relatedsupporting

confidence: 90%

“…The frequency of complications in our study was similar to what has been reported in Japan (37%) [7]. The literature review shows that 20-50% of patients with ITB can have ITB-related complications [18][19][20][21][22].…”

Section: Complicationssupporting

confidence: 89%

“…Catheter-related complications remain the most common cause of ITB-related problems, which can occur in up to 40% of patients with ITB [18,21,23]. Catheter malfunction constituted 33% of the ITB-related complications in our study, which is similar to what was published (37%) in a meta-analysis of 2264 patients [18]. This raises a high suspicion of catheter-related problems while investigating ITB-related concerns but does not necessitate the need for a catheter workup as the first step during ITB troubleshooting.…”

Section: Complications-catheter Relatedmentioning

confidence: 99%

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Complications of Intrathecal Baclofen Pump Therapy: An Institutional Experience from Saudi Arabia

Qureshi,

Shacfe,

Ilyas

et al. 2023

Healthcare

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The intrathecal baclofen pump (ITB) is one of the advanced treatment options in the management of spasticity. This retrospective cohort study was conducted to identify the complications of ITB treatment at a tertiary care rehabilitation facility. Various demographic and technical factors were analyzed, which are less often reported in the literature. All patients with ITB who had their refill at the ITB clinic between November 2019 and March 2020 were included. Of 48 patients, 17 patients had 18 (37.5%) ITB-related complications. Catheter-related complications were most common, whereas loss of efficacy (16.7%) and baclofen withdrawal (14.5%) were the most common outcomes of complications. Only catheter occlusion had a significant relationship with the pattern of spastic quadriparesis (p = 0.001). Gender, rehabilitation diagnosis, patients’ residence, and facility of ITB placement did not have significant association. Similarly, age, distance from hospital, disease onset, ITB therapy duration, and baclofen dose were not statistically significant in relation to ITB-related complications.

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“…1,9 The pump delivers a constant rate of baclofen at lower doses than necessary via enteral dosing, thus minimizing systemic adverse effects including paresthesia, nausea, and confusion. 10,11 ITB therapy is favored by patients and caregivers in many instances due to minimal maintenance requirements, low adverse effect profile, and reported improvements in daily activities, quality of life, and overall comfort. 12 A major benefit of ITB therapy is that it can be trialed to discern the patient's response prior to implantation of the pump and catheter.…”

mentioning

confidence: 99%

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

Abdelmageed,

Horak,

Mossner

et al. 2024

Journal of Neurosurgery: Pediatrics

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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.

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Infectious Complications and Operative Management of Intrathecal Baclofen Pumps in the Pediatric Population: A Systematic Review and Meta-Analysis of 20 Years of Pooled Experience

Cited by 7 publications

References 40 publications

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

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

Complications of Intrathecal Baclofen Pump Therapy: An Institutional Experience from Saudi Arabia

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

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