Clinical and economic repercussions of ventricular shunt infections are magnified in low-resource countries. The efficacy of antibiotic-impregnated shunts in this setting is unclear. A previous retrospective cohort study comparing the Bactiseal Universal Shunt (BUS) and the Chhabra shunt provided clinical equipoise; thus, the authors conducted this larger randomized controlled trial in Ugandan children requiring shunt placement for hydrocephalus to determine whether there was, in fact, any advantage of one shunt over the other.
Between April 2013 and September 2016, the authors randomly assigned children younger than 16 years of age without evidence of ventriculitis to either BUS or Chhabra shunt implantation in this single-blind randomized controlled trial. The primary outcome was shunt infection, and secondary outcomes included reoperation and death. The minimum follow-up was 6 months. Time to outcome was assessed using the Kaplan-Meier method. The significance of differences was tested using Wilcoxon rank-sum, chi-square, Fisher’s exact, and t-tests.
Of the 248 patients randomized, the BUS was implanted in 124 and the Chhabra shunt in 124. There were no differences between the groups in terms of age, sex, or hydrocephalus etiology. Within 6 months of follow-up, there were 14 infections (5.6%): 6 BUS (4.8%) and 8 Chhabra (6.5%; p = 0.58). There were 14 deaths (5.6%; 5 BUS [4.0%] vs 9 Chhabra [7.3%], p = 0.27) and 30 reoperations (12.1%; 15 BUS vs 15 Chhabra, p = 1.00). There were no significant differences in the time to primary or secondary outcomes at 6 months’ follow-up (p = 0.29 and 0.17, respectively, Wilcoxon rank-sum test).
Among Ugandan infants, BUS implantation did not result in a lower incidence of shunt infection or other complications. Any recommendation for a more costly standard of care in low-resource countries must have contextually relevant, evidence-based support.
Correspondence Benjamin C. Warf: Boston Children’s Hospital, Boston, MA. firstname.lastname@example.org.
INCLUDE WHEN CITING Published online January 4, 2019; DOI: 10.3171/2018.10.PEDS18354.
Disclosures All BUS systems were provided at no cost by Codman, which also provided funding support. Chhabra shunts were provided at no cost by the nonprofit group the International Federation for Spina Bifida and Hydrocephalus (www.ifglobal.org). Neither entity had any role in the design of the study, collection or analysis of the data, data interpretation, or writing or editing the manuscript. The corresponding author had full access to the data and final responsibility for the submission of the manuscript for publication. None of the authors has any conflicts of interest to report, financial or otherwise.
AmmiratiMRaimondiAJ: Cerebrospinal fluid shunt infections in children. A study on the relationship between the etiology of hydrocephalus, age at the time of shunt placement, and infection rate. Childs Nerv Syst3:106–1091987
AttenelloFJGarces-AmbrossiGLZaidiHASciubbaDMJalloGI: Hospital costs associated with shunt infections in patients receiving antibiotic-impregnated shunt catheters versus standard shunt catheters. Neurosurgery66:284–2892010
KlimoPJrThompsonCJBairdLCFlanneryAM: Pediatric hydrocephalus: systematic literature review and evidence-based guidelines. Part 7: antibiotic-impregnated shunt systems versus conventional shunts in children: a systematic review and meta-analysis. J Neurosurg Pediatr14 (Suppl 1):53–592014
KonstanteliasAAVardakasKZPolyzosKATansarliGSFalagasME: Antimicrobial-impregnated and -coated shunt catheters for prevention of infections in patients with hydrocephalus: a systematic review and meta-analysis. J Neurosurg122:1096–11122015
LaneJDMugambaJSsenyongaPWarfBC: Effectiveness of the Bactiseal Universal Shunt for reducing shunt infection in a sub-Saharan African context: a retrospective cohort study in 160 Ugandan children. J Neurosurg Pediatr13:140–1442014
ParkerSLAttenelloFJSciubbaDMGarces-AmbrossiGLAhnEWeingartJ: Comparison of shunt infection incidence in high-risk subgroups receiving antibiotic-impregnated versus standard shunts. Childs Nerv Syst25:77–83 852009
ParkerSLMcGirtMJMurphyJAMegerianJTStoutMEngelhartL: Comparative effectiveness of antibiotic-impregnated shunt catheters in the treatment of adult and pediatric hydrocephalus: analysis of 12,589 consecutive cases from 287 US hospital systems. J Neurosurg122:443–4482015
ParkerSLMcGirtMJMurphyJAMegerianJTStoutMEngelhartL: Cost savings associated with antibiotic-impregnated shunt catheters in the treatment of adult and pediatric hydrocephalus. World Neurosurg83:382–3862015
SchiffSJKiwanukaJRiggioGNguyenLMuKSproulE: Separating putative pathogens from background contamination with principal orthogonal decomposition: evidence for Leptospira in the Ugandan neonatal septisome. Front Med (Lausanne)3:222016
SciubbaDMStuartRMMcGirtMJWoodworthGFSamdaniACarsonB: Effect of antibiotic-impregnated shunt catheters in decreasing the incidence of shunt infection in the treatment of hydrocephalus. J Neurosurg103 (2 Suppl):131–1362005
WarfBC: Comparison of endoscopic third ventriculostomy alone and combined with choroid plexus cauterization in infants younger than 1 year of age: a prospective study in 550 African children. J Neurosurg103 (6 Suppl):475–4812005