Device-related complications of long-term intrathecal drug therapy via implanted pumps

Flückiger, B; Knecht, Hans; Grossmann, Samuel; Felleiter, Peter

doi:10.1038/sc.2008.24

Cited by 65 publications

(44 citation statements)

References 18 publications

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“…This is at the lower end of the range of complication rates reported by others, varying between 7 and 20%. 10,11,22 The drug-related side effects were mostly mild and the annual risk of 13.8% per year of treatment was also within the range reported by others.…”

Section: Discussionsupporting

confidence: 59%

The incidence and management of tolerance in intrathecal baclofen therapy

et al. 2009

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Study design: Retrospective study. Objectives: To study the incidence and management of tolerance in patients treated with intrathecal baclofen (ITB) therapy. Setting: Department of neurology and neurosurgery, University Medical Center Groningen, The Netherlands. Methods: Medical records of all patients who had received an implantable ITB pump at our clinic during 1991-2005 were reviewed. Results: A total of 37 patients (representing 116 pump years) were included. Mean follow-up time was 38 months (range 3-120 months). Baclofen dose increased in the first 18 months after implantation (Po0.05), and then stabilized around a mean dose of 350 mg per day. Eight patients (22%) developed tolerance, defined as a dose increase of 4100 mg per year. No predictive factors for development of tolerance could be determined. Three different treatment regimens for tolerant patients were analyzed. Altering the infusion mode from simple to complex continuous (n ¼ 6) had no effect on the development of tolerance. Pulsatile bolus infusion (n ¼ 1) and a drug holiday (n ¼ 2) were both effective in reducing the daily baclofen dose. Patients who needed surgical revision of the pump system because of mechanical failures (n ¼ 11) showed a significant dose decrease during the first month after revision, indicating that the preoperative dose increase most likely had been caused by the pump failure. Pumprelated complications occurred once per 10.5 years of ITB treatment. Drug-related side effects had an annual risk of 13.8%. The reported events were mostly mild. Conclusions: ITB therapy is effective and safe, also in the long term and causes tolerance in only 22% of the treated patients.

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Section: Discussionsupporting

confidence: 59%

The incidence and management of tolerance in intrathecal baclofen therapy

et al. 2009

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“…5 The most common catheter-related complications are catheter leakage, dislocation of the catheter tip, disconnection at the pump, catheter occlusion, and granuloma formation at the catheter tip. 5 In a prospective study involving 209 patients undergoing implantation of lumbar intrathecal catheter drug delivery systems for pain or spasticity, 7 (3.3%) catheter-related complications were reported. 6 Three patients (1.4%) had leakage, cuts, or breaks in the catheter, and only 2 patients (0.9%) had catheter dislodgement or migration.…”

Section: Discussionmentioning

confidence: 99%

Migrating lumbar intrathecal catheter fragment associated with intracranial subarachnoid hemorrhage

Hnenny

Sabry

Raskin

et al. 2015

SPI

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Intrathecal catheter placement into the lumbar cistern has varied indications, including drug delivery and CSF diversion. These Silastic catheters are elastic and durable; however, catheter-associated malfunctions are well reported in the literature. Fractured catheters are managed with some variability, but entirely intradural retained fragments are often managed conservatively with observation. The authors describe a case of a 70-year-old man with an implanted intrathecal morphine pump for failed back surgery syndrome who presented to an outside hospital with a history of headache, neck pain, nausea, and photophobia of 3 days' duration. He also described mild weakness and intermittent numbness of both legs. Unenhanced head CT demonstrated subarachnoid hemorrhage (SAH). A right C-5 hemilaminectomy was performed. This case is unique in that there was no indication that the lumbar intrathecal catheter had fractured prior to the patient's presentation with SAH. This case demonstrates that intrathecal catheter fragments are mobile and can precipitate intracranial morbidity. Extrication of known fragments is safe and should be attempted to prevent further neurosurgical morbidity.

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“…However, ITB trials might be useful in ambulant patients and those with complex hyperkinetic movement disorders, where benefits of ITB therapy are less well documented. The ITB trial may remain a useful tool to help patients/families make an informed decision, particularly given the high rate of complications from baclofen pumps 2,9,14,16,[18][19][20]24,27 and the long-term commitment to meticulous follow-up for pump refills. Additionally, the level of response to the test dose guides the initial ITB daily infusion rate, usually calculated as twice the effective trial dose.…”

Section: Discussionmentioning

confidence: 99%

“…It works as an agonist of the inhibitory neurotransmitter g-aminobutyric acid. 10 Unfortunately, its effectiveness when taken orally is limited due to poor crossing of the blood-brain barrier, leading to high doses being required to combat spasticity or dystonia and concomitant side effects.Intrathecal baclofen (ITB) has been used since the 1980s for treatment of high tone, especially in the lower limbs.2,11 Pump delivery systems allow a patient to receive lower doses of baclofen at a constant rate with fewer side effects than the enteral route.5 Placement of an ITB pump is an invasive procedure associated with significant complications; 2,9,14,16,[18][19][20]24,27 therefore, high-quality patient selection is vital. A common stage of a presurgical workup for the ITB pump is the delivery of an ITB test dose.…”

mentioning

confidence: 99%

“…2,11 Pump delivery systems allow a patient to receive lower doses of baclofen at a constant rate with fewer side effects than the enteral route. 5 Placement of an ITB pump is an invasive procedure associated with significant complications; 2,9,14,16,[18][19][20]24,27 therefore, high-quality patient selection is vital. A common stage of a presurgical workup for the ITB pump is the delivery of an ITB test dose.…”

mentioning

confidence: 99%

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Intrathecal baclofen trials: complications and positive yield in a pediatric cohort

Sayer

Lumsden

Perides

et al. 2016

PED

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OBJECT Intrathecal baclofen (ITB) is an effective management option for childhood hypertonia. Given the potential complications of implanted ITB pumps, trials of ITB are usually performed as part of the workup for ITB pumps. Two methods are used for ITB trials, lumbar puncture (LP) and catheter insertion into the intrathecal space. Little has been written to date on the number of positive trials and complications in trials. This study aimed to report the outcomes and complications in ITB trials for childhood hypertonia (dystonia, spastic, or mixed). METHODS A retrospective case notes review was conducted of all patients who underwent ITB trials at the Evelina London Children’s Hospital between 2005 and 2012 (inclusive). Positive trials were defined as a reduction in Modified Ashworth Scale by a minimum of 1 point in at least 2 muscle groups and improvement reported by the caregivers in the areas of goals agreed upon between professionals and the families. RESULTS Our patient group comprised children with dystonia (n = 7), mixed spasticity/dystonia (n = 29), spasticity (n = 4), and pain (n = 1). A total of 47 trials were attempted in 41 children. Forty trials were successfully completed, with 39 being positive. Thirty-three were catheter trials, and 14 were LPs. The overall complication rate in the 47 attempted trials was 53%: 61% in catheter trials, and 36% in LP trials. This difference was not statistically significant. The most common complications were vomiting (n = 9) and CSF leak (n = 4). The most serious complication was meningitis (n = 1) in a catheter trial. No patients experienced a permanent injury. CONCLUSIONS There is a high risk of minor self-limiting complications with ITB trials, which needs to be factored into the decision process of progression to trials. The rate of positive trials in this study was 98%, of which 21% did not progress to pump implantation. While the authors would still advocate for ITB trials prior to ITB pump insertion to aid parental decision-making, this figure suggests that with good patient selection, ITB pumps could be placed without a preceding trial.

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Device-related complications of long-term intrathecal drug therapy via implanted pumps

Cited by 65 publications

References 18 publications

The incidence and management of tolerance in intrathecal baclofen therapy

The incidence and management of tolerance in intrathecal baclofen therapy

Migrating lumbar intrathecal catheter fragment associated with intracranial subarachnoid hemorrhage

Intrathecal baclofen trials: complications and positive yield in a pediatric cohort

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