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Performance and complications associated with the synchromed 10-ml infusion pump for intrathecal baclofen
A Leland Albright1, Yasser Awaad, Michael Muhonen
1Department of Pediatric Neurosurgery, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA. Leland.Albright@chp.edu
Insights
The 10-ml intrathecal baclofen pump effectively treats cerebral spasticity in children, showing significant improvements in limb function. Complication rates are comparable to larger pumps, especially in younger patients.
Area of Science:
- Pediatric Neurology
- Neurosurgery
- Rehabilitation Medicine
Background:
- Cerebral spasticity significantly impacts children's motor function.
- Intrathecal baclofen pump (ITB) therapy is a treatment option for severe spasticity.
- The 10-ml pump offers a smaller volume option for pediatric patients.
Purpose of the Study:
- To evaluate the performance of a 10-ml ITB pump in treating pediatric cerebral spasticity.
- To monitor pump-related complications in this pediatric population.
- To investigate correlations between complications and patient body habitus.
Main Methods:
- Multicenter study involving 100 children with cerebral spasticity.
- ITB pump implantation with ages ranging from 1.4 to 16.8 years.
- Spasticity assessed using the Ashworth Scale; complications and BMI recorded.
Main Results:
- Significant reduction in upper and lower extremity spasticity at 6 and 12 months post-implantation (p < 0.001).
- Four catheter-related system complications and 32 procedure-related complications in 21 patients.
- Higher incidence of serious adverse events in children younger than 8 years; no BMI correlation with pocket complications/infections.
Conclusions:
- The 10-ml pump is suitable for pediatric use, offering advantages in smaller children (<40 lbs).
- Complication incidence with the 10-ml pump in younger children is similar to previous reports with larger pumps.
- ITB therapy with the 10-ml pump demonstrates efficacy in reducing spasticity in children.
Object:
The objectives of this multicenter study were to monitor the performance of a 10-ml pump infusing intrathecal baclofen to treat 100 children with cerebral spasticity, to monitor complications associated with the pump, and to correlate pump-related complications with body habitus.
Methods:
Age at implantation of the pump ranged from 1.4 to 16.8 years (mean 8.1 years). The effects of ITB on spasticity in the upper and lower extremities were evaluated using the Ashworth Scale. Data were collected regarding implant site, infection, complication, and body mass index (BMI). Ashworth Scale scores decreased significantly in the upper and lower extremities at 6 and 12 months after pump implantation (p < 0.001). There were four serious system-related complications, all specific to catheters. There were 32 serious procedure-related complications in 21 patients: 11 complications were infections that occurred in nine patients. Four of nine pump-induced infections were treated with pump removal and antibiotic therapy; five infections were treated successfully with antibiotic therapy alone, without pump removal. In children younger than 8 years of age there was a significantly higher incidence of serious procedure-related adverse events than in older children. There was no significant correlation between BMI and the incidence of pump pocket-related complications or infections.
Conclusions:
The 10-ml pump can be used therapeutically in small children, particularly those weighing less than 40 lbs, with greater ease and less wound tension, than the conventional 18-ml pump. The incidence of complications associated with the 10-ml pump in younger children appears to be similar to that previously reported with the 18-ml pump in larger-sized children.
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