Antibiotic-impregnated shunt catheters led to fewer infections than standard catheters in this study, although the overall rate of shunt revision remained about the same.
In hydrocephalus, a shunt is a device consisting in part of a long catheter (a tube) that relieves the raised pressure of fluid in the ventricles of the brain. It is inserted internally and works by simply draining the fluid, most commonly, to the abdomen. These shunts may need revision because of infection or mechanical failure (for example, blockage), so shunt catheters are impregnated with silver or an antibiotic to try and reduce the risk of infection.
This large NIHR-funded trial found that 2% of patients with antibiotic shunt catheters needed revisions because of infection, compared with 6% for standard or silver shunt catheters. The overall revision rate was about 25% for all types.
By using antibiotic-impregnated shunt catheters, about 4% of people avoided infection they may otherwise have developed. This trial supports the use of these shunt catheters in UK practice.
Why was this study needed?
Hydrocephalus affects around 88 in 100,000 children, 11 in 100,000 adults and 175 in 100,000 adults over 65. A peritoneal shunt is one of the most common treatments for the condition, but 7% to 15% of shunts fail because of infection, and more fail from other causes.
Infection with a shunt in place requires reoperation for revision, and a potentially lengthy hospital stay for antibiotic treatment. Infection affects survival, as well as the quality of life and cognitive function.
Previous systematic reviews concluded there was insufficient evidence that either silver or antibiotic-impregnated shunt catheters reduced the rate of infection. This study was set up to answer the question as to which type of shunt catheter was more clinically and cost-effective.
What did this study do?
The trial was undertaken in 21 regional neurosurgery centres in the UK and Ireland and randomised 1,605 adults and children to standard, silver or antibiotic shunt systems (catheters impregnated with rifampicin and clindamycin), and followed them for an average 22 months.
The patients had hydrocephalus from any cause and were due to receive their first ventriculoperitoneal shunt. Patients were excluded if they had active infection at the time of insertion.
The randomised controlled trial (BASICS) allocated participants to receive standard, silver or antibiotic-impregnated shunt catheters, with treatment allocation revealed only in the operating theatre and withheld from the outcome assessors and most of the surgeons managing the suspected infection. Researchers followed patients for up to 24 months (mean follow-up 22 months). Where the surgeon thought a revision was due to infection, a review panel (blinded to shunt allocation) checked the data on clinical presentation and treatment given. The primary outcome was time to infection, and revision rates and cost-effectiveness were also assessed.
What did it find?
- Shunt catheters were removed for an infection in 6% of participants with standard catheters, 2% with antibiotic catheters and 6% with silver catheters.
- Shunt catheter removal or revision for any cause occurred in 24% of participants with standard catheters, 25% with antibiotic catheters and 26% with silver catheters.
- The antibiotic shunt catheters delayed any infection compared with the standard catheter (hazard ratio (HR) 0.38, 97.5% confidence interval (CI) 0.18 to 0.80). The silver catheter was no better than a standard catheter (HR 0.99, 95% CI 0.56 to 1.74).
- Children were more likely to need shunt revision due to infection than adults. Some 8% of 592 children, 5% of 499 adults under 65 and 1% of 503 adults aged 65 and over required revision due to infection.
- Average costs for the duration of the study period (24 months) were £18,707 for standard catheter shunts, £14,192 for antibiotic catheters and £17,385 for silver catheters.
What does current guidance say on this issue?
A 2014 guideline from the American Association of Neurological Surgeons said: “Antibiotic-impregnated shunt (AIS) tubing may be associated with a lower risk of shunt infection compared with conventional silicone hardware and thus is an option for children who require placement of a shunt.”
At the time, the authors of this guideline said the evidence was Level III, meaning an unclear degree of clinical certainty.
What are the implications?
The results of the BASICS study suggest that antibiotic-impregnated shunt catheters should be the first choice for people having a first ventriculoperitoneal shunt inserted for treatment of hydrocephalus, regardless of age or cause of illness.
Although antibiotic-impregnated shunt catheters may not reduce the numbers of revisions required for any cause, infections in the cerebrospinal fluid cause significant morbidity and require longer and more expensive treatment as well as revision compared with just revision for mechanical failure.
The increased price of these shunt catheters could be expected to be recovered by the reduction in treatment for shunt infection.
Citation and Funding
Mallucci CL, Jenkinson MD, Conroy EJ et al. Antibiotic or silver versus standard ventriculoperitoneal shunts (BASICS): a multicentre, single-blinded, randomised trial and economic evaluation. Lancet 2019;394:1530-9.
The study was funded by the NIHR Health Technology Assessment Programme (project number 10/104/30).
Flannery AM. Comparing antibiotic, silver, and standard ventriculoperitoneal shunts. Lancet 2019;394:1485-6.
Klimo Jr P, Clinton J, Baird LC and Flannery 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 Pediatrics (Suppl). 2014;14:53-9.
Produced by the University of Southampton and Bazian on behalf of NIHR through the NIHR Dissemination Centre