Randomized trial of cerebrospinal fluid shunt valve design in pediatric hydrocephalus

James M. Drake, John R.W. Kestle, Ruth Milner, Giuseppe Cinalli, Frederick Boop, Joseph Piatt, Stephen Haines, Steven J. Schiff, D. Douglas Cochrane, Paul Steinbok, Nancy MacNeil

Research output: Contribution to journalArticle

491 Citations (Scopus)

Abstract

OBJECTIVE: Forty percent of standard cerebrospinal fluid shunts implanted for the treatment of pediatric hydrocephalus fail within the first year. Two new shunt valves designed to limit excess flow, particularly in upright positions, were studied to compare treatment failure rates with those for standard differential-pressure valves. METHODS: Three hundred-forty-four hydrocephalic children (age, birth to 18 yr) undergoing their first cerebrospinal fluid shunt insertion were randomized at 12 North American or European pediatric neurosurgical centers. Patients received one of three valves, i.e., a standard differential-pressure valve; a Delta valve (Medtronic PS Medical, Goleta, CA), which contains a siphon-control component designed to reduce siphoning in upright positions; or an Orbis-Sigma valve (Cordis, Miami, FL), with a variable-resistance, flow-limiting component. Patients were monitored for a minimum of 1 year. Endpoints were defined as shunt failure resulting from shunt obstruction, overdrainage, loculations of the cerebral ventricles, or infection. Outcome events were assessed by blinded independent case review. RESULTS: One hundred-fifty patients reached an endpoint; shunt obstruction occurred in 108 (31.4%), overdrainage in 12 (3.5%), loculated ventricles in 2 (0.6%), and infection in 28 (8.1%). Sixty- one percent were shunt failure-free at 1 year and 47% at 2 years, with a median shunt failure-free duration of 656 days. There was no difference in shunt failure-free duration among the three valves (P = 0.24). CONCLUSION: Cerebrospinal fluid shunt failure, predominantly from shunt obstruction and infection, remains a persistent problem in pediatric hydrocephalus. Two new valve designs did not significantly affect shunt failure rates.

Original languageEnglish (US)
Pages (from-to)294-305
Number of pages12
JournalNeurosurgery
Volume43
Issue number2
DOIs
StatePublished - Aug 1 1998

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Cerebrospinal Fluid Shunts
Hydrocephalus
Pediatrics
Infection
Pressure
Cerebral Ventricles
Treatment Failure
Parturition
Therapeutics

All Science Journal Classification (ASJC) codes

  • Surgery
  • Clinical Neurology

Cite this

Drake, J. M., Kestle, J. R. W., Milner, R., Cinalli, G., Boop, F., Piatt, J., ... MacNeil, N. (1998). Randomized trial of cerebrospinal fluid shunt valve design in pediatric hydrocephalus. Neurosurgery, 43(2), 294-305. https://doi.org/10.1097/00006123-199808000-00068
Drake, James M. ; Kestle, John R.W. ; Milner, Ruth ; Cinalli, Giuseppe ; Boop, Frederick ; Piatt, Joseph ; Haines, Stephen ; Schiff, Steven J. ; Cochrane, D. Douglas ; Steinbok, Paul ; MacNeil, Nancy. / Randomized trial of cerebrospinal fluid shunt valve design in pediatric hydrocephalus. In: Neurosurgery. 1998 ; Vol. 43, No. 2. pp. 294-305.
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abstract = "OBJECTIVE: Forty percent of standard cerebrospinal fluid shunts implanted for the treatment of pediatric hydrocephalus fail within the first year. Two new shunt valves designed to limit excess flow, particularly in upright positions, were studied to compare treatment failure rates with those for standard differential-pressure valves. METHODS: Three hundred-forty-four hydrocephalic children (age, birth to 18 yr) undergoing their first cerebrospinal fluid shunt insertion were randomized at 12 North American or European pediatric neurosurgical centers. Patients received one of three valves, i.e., a standard differential-pressure valve; a Delta valve (Medtronic PS Medical, Goleta, CA), which contains a siphon-control component designed to reduce siphoning in upright positions; or an Orbis-Sigma valve (Cordis, Miami, FL), with a variable-resistance, flow-limiting component. Patients were monitored for a minimum of 1 year. Endpoints were defined as shunt failure resulting from shunt obstruction, overdrainage, loculations of the cerebral ventricles, or infection. Outcome events were assessed by blinded independent case review. RESULTS: One hundred-fifty patients reached an endpoint; shunt obstruction occurred in 108 (31.4{\%}), overdrainage in 12 (3.5{\%}), loculated ventricles in 2 (0.6{\%}), and infection in 28 (8.1{\%}). Sixty- one percent were shunt failure-free at 1 year and 47{\%} at 2 years, with a median shunt failure-free duration of 656 days. There was no difference in shunt failure-free duration among the three valves (P = 0.24). CONCLUSION: Cerebrospinal fluid shunt failure, predominantly from shunt obstruction and infection, remains a persistent problem in pediatric hydrocephalus. Two new valve designs did not significantly affect shunt failure rates.",
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Drake, JM, Kestle, JRW, Milner, R, Cinalli, G, Boop, F, Piatt, J, Haines, S, Schiff, SJ, Cochrane, DD, Steinbok, P & MacNeil, N 1998, 'Randomized trial of cerebrospinal fluid shunt valve design in pediatric hydrocephalus', Neurosurgery, vol. 43, no. 2, pp. 294-305. https://doi.org/10.1097/00006123-199808000-00068

Randomized trial of cerebrospinal fluid shunt valve design in pediatric hydrocephalus. / Drake, James M.; Kestle, John R.W.; Milner, Ruth; Cinalli, Giuseppe; Boop, Frederick; Piatt, Joseph; Haines, Stephen; Schiff, Steven J.; Cochrane, D. Douglas; Steinbok, Paul; MacNeil, Nancy.

In: Neurosurgery, Vol. 43, No. 2, 01.08.1998, p. 294-305.

Research output: Contribution to journalArticle

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T1 - Randomized trial of cerebrospinal fluid shunt valve design in pediatric hydrocephalus

AU - Drake, James M.

AU - Kestle, John R.W.

AU - Milner, Ruth

AU - Cinalli, Giuseppe

AU - Boop, Frederick

AU - Piatt, Joseph

AU - Haines, Stephen

AU - Schiff, Steven J.

AU - Cochrane, D. Douglas

AU - Steinbok, Paul

AU - MacNeil, Nancy

PY - 1998/8/1

Y1 - 1998/8/1

N2 - OBJECTIVE: Forty percent of standard cerebrospinal fluid shunts implanted for the treatment of pediatric hydrocephalus fail within the first year. Two new shunt valves designed to limit excess flow, particularly in upright positions, were studied to compare treatment failure rates with those for standard differential-pressure valves. METHODS: Three hundred-forty-four hydrocephalic children (age, birth to 18 yr) undergoing their first cerebrospinal fluid shunt insertion were randomized at 12 North American or European pediatric neurosurgical centers. Patients received one of three valves, i.e., a standard differential-pressure valve; a Delta valve (Medtronic PS Medical, Goleta, CA), which contains a siphon-control component designed to reduce siphoning in upright positions; or an Orbis-Sigma valve (Cordis, Miami, FL), with a variable-resistance, flow-limiting component. Patients were monitored for a minimum of 1 year. Endpoints were defined as shunt failure resulting from shunt obstruction, overdrainage, loculations of the cerebral ventricles, or infection. Outcome events were assessed by blinded independent case review. RESULTS: One hundred-fifty patients reached an endpoint; shunt obstruction occurred in 108 (31.4%), overdrainage in 12 (3.5%), loculated ventricles in 2 (0.6%), and infection in 28 (8.1%). Sixty- one percent were shunt failure-free at 1 year and 47% at 2 years, with a median shunt failure-free duration of 656 days. There was no difference in shunt failure-free duration among the three valves (P = 0.24). CONCLUSION: Cerebrospinal fluid shunt failure, predominantly from shunt obstruction and infection, remains a persistent problem in pediatric hydrocephalus. Two new valve designs did not significantly affect shunt failure rates.

AB - OBJECTIVE: Forty percent of standard cerebrospinal fluid shunts implanted for the treatment of pediatric hydrocephalus fail within the first year. Two new shunt valves designed to limit excess flow, particularly in upright positions, were studied to compare treatment failure rates with those for standard differential-pressure valves. METHODS: Three hundred-forty-four hydrocephalic children (age, birth to 18 yr) undergoing their first cerebrospinal fluid shunt insertion were randomized at 12 North American or European pediatric neurosurgical centers. Patients received one of three valves, i.e., a standard differential-pressure valve; a Delta valve (Medtronic PS Medical, Goleta, CA), which contains a siphon-control component designed to reduce siphoning in upright positions; or an Orbis-Sigma valve (Cordis, Miami, FL), with a variable-resistance, flow-limiting component. Patients were monitored for a minimum of 1 year. Endpoints were defined as shunt failure resulting from shunt obstruction, overdrainage, loculations of the cerebral ventricles, or infection. Outcome events were assessed by blinded independent case review. RESULTS: One hundred-fifty patients reached an endpoint; shunt obstruction occurred in 108 (31.4%), overdrainage in 12 (3.5%), loculated ventricles in 2 (0.6%), and infection in 28 (8.1%). Sixty- one percent were shunt failure-free at 1 year and 47% at 2 years, with a median shunt failure-free duration of 656 days. There was no difference in shunt failure-free duration among the three valves (P = 0.24). CONCLUSION: Cerebrospinal fluid shunt failure, predominantly from shunt obstruction and infection, remains a persistent problem in pediatric hydrocephalus. Two new valve designs did not significantly affect shunt failure rates.

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