Abstract
Objective
To assess the frequency and types of adverse events (AEs) related to intrathecal baclofen
(ITB) therapy in adults, and associated risk factors.
Design
A prospective, observational cohort study of adults followed up from January 1 to
December 31, 2010.
Setting
A neurologic rehabilitation department in a university hospital.
Participants
All consecutive adult subjects (N=158) receiving ITB via a pump, either implanted
or followed up during the study period.
Intervention
Not applicable.
Main Outcome Measures
Frequency and type of AEs.
Results
In 2010, 158 subjects were followed up for ITB therapy, of whom 128 were implanted
before 2010 (nonsurgical subjects), and 30 underwent implantation in 2010 (surgical
subjects). Of these 30 subjects, 20 were “newly implanted” and 10 were “replacements.”
The most frequent pathologic disorders were spinal cord injury (42%) and multiple
sclerosis (28%). Twenty-eight subjects (18%) experienced a total of 38 AEs. The rate
of AEs was .023 per month of ITB treatment. AEs were related to the surgical procedure
in 53% of cases, to the device in 29% (predominantly catheter dysfunctions), and to
adverse effects of baclofen in 18%. AEs related to the surgical incision (scar complications
and collections) were more frequent in replacement than newly implanted subjects (P=.009). No significant association between occurrence of an AE and subject characteristics
(age, gait capacity, spinal vs cerebral spasticity, duration of ITB therapy follow-up)
was found. Nearly half of the AEs were serious, extending admission time by a mean
of 16 days. No AE induced long-term morbidity or death.
Conclusions
The AE rate was relatively low in this cohort. This has to be balanced against the
clinical, functional, and quality-of-life improvements, which are expected from ITB
therapy.
Keywords
List of abbreviations:
AE (adverse event), CI (confidence interval), CSF (cerebrospinal fluid), ITB (intrathecal baclofen), MS (multiple sclerosis), OR (odds ratio), SCI (spinal cord injury)To read this article in full you will need to make a payment
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References
- Drug treatments for spasticity.Ann Phys Rehabil Med. 2009; 52: 746-756
- Continuous intrathecal baclofen for severe spasticity.Lancet. 1985; 2: 125-127
- Intrathecal baclofen therapy for severe spasticity: analysis on a series of 112 consecutive patients and future prospectives.Clin Neurol Neurosurg. 2012; 114: 321-325
- Rising complication rates after intrathecal catheter and pump placement in the pediatric population: analysis of national data between 1997 and 2006.Pain Physician. 2012; 15: 65-74
- Intrathecal baclofen administration for control of severe spinal spasticity: functional improvement and long-term follow-up.Arch Phys Med Rehabil. 1996; 77: 35-39
- Treatment of spasticity with intrathecal baclofen administration: long-term follow-up, review of 40 patients.Spinal Cord. 2004; 42: 686-693
- Intrathecal baclofen in the treatment of painful, disabling spasms in Friedreich's ataxia.Mov Disord. 2005; 20: 758-759
- Cost-effectiveness modeling of intrathecal baclofen therapy versus other interventions for disabling spasticity.Neurorehabil Neural Repair. 2009; 23: 546-552
- Intrathecal baclofen for treatment of spasticity of multiple sclerosis patients.Mult Scler. 2006; 12: 101-103
- Comparison of long-term outcomes of patients with severe traumatic or hypoxic brain injuries treated with intrathecal baclofen therapy for dysautonomia.Brain Inj. 2012; 26: 1451-1463
- Intrathecal baclofen for spasticity management: a comparative analysis of spasticity of spinal vs cortical origin.J Spinal Cord Med. 2010; 33: 16-21
- Complications of intrathecal baclofen pump: prevention and cure.ISRN Neurol. 2012; 2012: 575168
- Intrathecal baclofen therapy over 10 years.J Neurosci Nurs. 2004; 36: 322-327
- A clinical study of intrathecal baclofen using a programmable pump for intractable spasticity.Arch Phys Med Rehabil. 2005; 86: 2165-2171
- A review of the complications of intrathecal baclofen in patients with cerebral palsy.NeuroRehabilitation. 2007; 22: 383-395
- Adverse drug reactions: definitions, diagnosis, and management.Lancet. 2000; 356: 1255-1259
- Evidence of tolerance to baclofen in treatment of severe spasticity with intrathecal baclofen.Clin Neurol Neurosurg. 2002; 104: 142-145
- Procedure- and device-related complications of intrathecal baclofen administration for management of adult muscle hypertonia: a review.Neurorehabil Neural Repair. 2010; 24: 609-619
- The incidence and management of tolerance in intrathecal baclofen therapy.Spinal Cord. 2009; 47: 751-756
- Intrathecal baclofen in cerebral palsy. A retrospective study of 25 wheelchair-assisted adults.Ann Phys Rehabil Med. 2011; 54: e16
- The use of intrathecal baclofen pump implants in children and adolescents: safety and complications in 200 consecutive cases.J Neurosurg. 2007; 107: 32-35
- Incidence and identification of intrathecal baclofen catheter malfunction.PM R. 2010; 2: 751-756
- A benefit-risk assessment of baclofen in severe spinal spasticity.Drug Saf. 2004; 27: 799-818
- Microsurgical drezotomy for the treatment of spasticity of the lower limbs.Neurochirurgie. 1998; 44 ([French]): 209-218
- Continuous intrathecal baclofen for children with spasticity and/or dystonia: goal attainment and complications associated with treatment.J Paediatr Child Health. 2009; 45: 720-726
- Management of increase in spasticity in patients with intrathecal baclofen pumps.Ann Readapt Med Phys. 2007; 50: 93-99
- Efficacy of intrathecal baclofen therapy in children with intractable spastic cerebral palsy: a randomised controlled trial.Eur J Paediatr Neurol. 2009; 13: 240-246
- Death after acute withdrawal of intrathecal baclofen: case report and literature review.Arch Phys Med Rehabil. 1999; 80: 1600-1604
- [Spasticity in non-walking child with cerebral palsy: control by the delivery of intrathecal baclofen: about 11 cases] [French].Revue de Chirurgie Orthopédique et Traumatologique. 2009; 95: 101-106
- Intrathecal baclofen. Literature review of the results and complications.Neurochirurgie. 2003; 49 ([French]): 276-288
Article info
Publication history
Published online: January 08, 2014
Footnotes
No commercial party having a direct financial interest in the results of the research supporting this article has conferred or will confer a benefit on the authors or on any organization with which the authors are associated (Borrini, Thiebaut, Hugeron, Rech, Jourdan).
A commercial party having a direct financial interest in the results of the research supporting this article has conferred or will confer a financial benefit on the author or 1 or more of the authors. Bensmail has received consulting fees or remuneration from Medtronic for teaching courses delivered to physicians about intrathecal baclofen therapy.
Identification
Copyright
© 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.
