Infection risk for Bactiseal Universal Shunts versus Chhabra shunts in Ugandan infants: a randomized controlled trial

Restricted access

OBJECTIVE

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.

METHODS

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.

RESULTS

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).

CONCLUSIONS

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.

Clinical trial registration no.: PACTR201804003240177 (http://www.pactr.org/)

ABBREVIATIONS AIS = antibiotic-impregnated shunt; BUS = Bactiseal Universal Shunt; CCHU = CURE Children’s Hospital of Uganda; CNS = central nervous system; CSF = cerebrospinal fluid; HIC = high-income country; LMIC = low- and middle-income countries; NPIH = non-postinfectious hydrocephalus; PIH = postinfectious hydrocephalus; RCT = randomized controlled trial; WBC = white blood cell.

Article Information

Correspondence Benjamin C. Warf: Boston Children’s Hospital, Boston, MA. benjamin.warf@childrens.harvard.edu.

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.

© AANS, except where prohibited by US copyright law.

Headings

Figures

  • View in gallery

    CONSORT flow diagram for patient screening and randomization. Figure is available in color online only.

  • View in gallery

    Kaplan-Meier survival curves comparing time to shunt infection within 6 months (p = 0.29, Wilcoxon rank-sum test). BS = Bactiseal Universal Shunt; CS = Chhabra shunt. Figure is available in color online only.

  • View in gallery

    Kaplan-Meier survival curves comparing time to any outcome within 6 months, excluding shunt infection, according to shunt type (p = 0.17, Wilcoxon rank-sum test). Figure is available in color online only.

References

1

Ammirati MRaimondi AJ: 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 Syst 3:1061091987

2

Aryan HEMeltzer HSPark MSBennett RLJandial RLevy ML: Initial experience with antibiotic-impregnated silicone catheters for shunting of cerebrospinal fluid in children. Childs Nerv Syst 21:56612005

3

Attenello FJGarces-Ambrossi GLZaidi HASciubba DMJallo GI: Hospital costs associated with shunt infections in patients receiving antibiotic-impregnated shunt catheters versus standard shunt catheters. Neurosurgery 66:2842892010

4

Bayston RLambert E: Duration of protective activity of cerebrospinal fluid shunt catheters impregnated with antimicrobial agents to prevent bacterial catheter-related infection. J Neurosurg 87:2472511997

5

Blount JPCampbell JAHaines SJ: Complications in ventricular cerebrospinal fluid shunting. Neurosurg Clin N Am 4:6336561993

6

Borgbjerg BMGjerris FAlbeck MJBørgesen SE: Risk of infection after cerebrospinal fluid shunt: an analysis of 884 first-time shunts. Acta Neurochir (Wien) 136:171995

7

Demetriades AKBassi S: Antibiotic resistant infections with antibiotic-impregnated Bactiseal catheters for ventriculoperitoneal shunts. Br J Neurosurg 25:6716732011

8

Dewan MCRattani AMekary RGlancz LJYunusa IBaticulon RE: Global hydrocephalus epidemiology and incidence: systematic review and meta-analysis. J Neurosurg 27:1152018

9

Farber SHParker SLAdogwa OMcGirt MJRigamonti D: Effect of antibiotic-impregnated shunts on infection rate in adult hydrocephalus: a single institution’s experience. Neurosurgery 69:6256292011

10

Govender STNathoo Nvan Dellen JR: Evaluation of an antibiotic-impregnated shunt system for the treatment of hydrocephalus. J Neurosurg 99:8318392003

11

Hayhurst CCooke RWilliams DKandasamy JO’Brien DFMallucci CL: The impact of antibiotic-impregnated catheters on shunt infection in children and neonates. Childs Nerv Syst 24:5575622008

12

Kan PKestle J: Lack of efficacy of antibiotic-impregnated shunt systems in preventing shunt infections in children. Childs Nerv Syst 23:7737772007

13

Kiwanuka JBazira JMwanga JTumusiime DNyesigire ELwanga N: The microbial spectrum of neonatal sepsis in Uganda: recovery of culturable bacteria in mother-infant pairs. PLoS One 8:e727752013

14

Klimo P JrThompson CJBaird LCFlannery AM: 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 Pediatr 14 (Suppl 1):53592014

15

Konstantelias AAVardakas KZPolyzos KATansarli GSFalagas ME: Antimicrobial-impregnated and -coated shunt catheters for prevention of infections in patients with hydrocephalus: a systematic review and meta-analysis. J Neurosurg 122:109611122015

16

Kulkarni AVSchiff SJMbabazi-Kabachelor EMugamba JSsenyonga PDonnelly R: Endoscopic treatment versus shunting for infant hydrocephalus in Uganda. N Engl J Med 377:245624642017

17

Lane JDMugamba JSsenyonga PWarf BC: 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 Pediatr 13:1401442014

18

Lee JKSeok JYLee JHChoi EHPhi JHKim SK: Incidence and risk factors of ventriculoperitoneal shunt infections in children: a study of 333 consecutive shunts in 6 years. J Korean Med Sci 27:156315682012

19

Li LPadhi ARanjeva SLDonaldson SCWarf BCMugamba J: Association of bacteria with hydrocephalus in Ugandan infants. J Neurosurg Pediatr 7:73872011

20

McGirt MJWoodworth GCoon ALThomas GWilliams MARigamonti D: Diagnosis, treatment, and analysis of long-term outcomes in idiopathic normal-pressure hydrocephalus. Neurosurgery 57:6997052005

21

Odio CMcCracken GH JrNelson JD: CSF shunt infections in pediatrics. A seven-year experience. Am J Dis Child 138:110311081984

22

Parker SLAttenello FJSciubba DMGarces-Ambrossi GLAhn EWeingart J: Comparison of shunt infection incidence in high-risk subgroups receiving antibiotic-impregnated versus standard shunts. Childs Nerv Syst 25:7783 852009

23

Parker SLMcGirt MJMurphy JAMegerian JTStout MEngelhart L: 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 Neurosurg 122:4434482015

24

Parker SLMcGirt MJMurphy JAMegerian JTStout MEngelhart L: Cost savings associated with antibiotic-impregnated shunt catheters in the treatment of adult and pediatric hydrocephalus. World Neurosurg 83:3823862015

25

Pattavilakom AXenos CBradfield ODanks RA: Reduction in shunt infection using antibiotic impregnated CSF shunt catheters: an Australian prospective study. J Clin Neurosci 14:5265312007

26

Ritz RRoser FMorgalla MDietz KTatagiba MWill BE: Do antibiotic-impregnated shunts in hydrocephalus therapy reduce the risk of infection? An observational study in 258 patients. BMC Infect Dis 7:382007

27

Schiff SJKiwanuka JRiggio GNguyen LMu KSproul E: Separating putative pathogens from background contamination with principal orthogonal decomposition: evidence for Leptospira in the Ugandan neonatal septisome. Front Med (Lausanne) 3:222016

28

Schiff SJRanjeva SLSauer TDWarf BC: Rainfall drives hydrocephalus in East Africa. J Neurosurg Pediatr 10:1611672012

29

Sciubba DMMcGirt MJWoodworth GFCarson BJallo GI: Prolonged exposure to antibiotic-impregnated shunt catheters does not increase incidence of late shunt infections. Childs Nerv Syst 23:8678712007

30

Sciubba DMStuart RMMcGirt MJWoodworth GFSamdani ACarson B: Effect of antibiotic-impregnated shunt catheters in decreasing the incidence of shunt infection in the treatment of hydrocephalus. J Neurosurg 103 (2 Suppl):1311362005

31

Virella AAGalarza MMasterman-Smith MLemus RLazareff JA: Distal slit valve and clinically relevant CSF overdrainage in children with hydrocephalus. Childs Nerv Syst 18:15182002

32

Warf BC: Comparison of 1-year outcomes for the Chhabra and Codman-Hakim Micro Precision shunt systems in Uganda: a prospective study in 195 children. J Neurosurg 102 (4 Suppl):3583622005

33

Warf BC: 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 Neurosurg 103 (6 Suppl):4754812005

34

Warf BC: Hydrocephalus in Uganda: the predominance of infectious origin and primary management with endoscopic third ventriculostomy. J Neurosurg 102 (1 Suppl):1152005

35

Warf BCBhai SKulkarni AVMugamba J: Shunt survival after failed endoscopic treatment of hydrocephalus. J Neurosurg Pediatr 10:4634702012

TrendMD

Metrics

Metrics

All Time Past Year Past 30 Days
Abstract Views 156 156 156
Full Text Views 34 34 34
PDF Downloads 16 16 16
EPUB Downloads 0 0 0

PubMed

Google Scholar