Long-term follow-up data from the shunt design trial

John Kestle, J. Drake, R. Milner, C. Sainte-Rose, G. Cinalli, Frederick Boop, J. Piatt, S. Haines, S. Schiff, D. Cochrane, P. Steinbok, N. MacNeil

Research output: Contribution to journalArticle

249 Citations (Scopus)

Abstract

Background: A previously reported multicenter randomized trial assessed whether 2 new shunt valve designs would reduce shunt failure rates compared to differential pressure valves. The study did not show a significant difference in the time to first shunt failure. Patients entered the trial between October 1, 1993, and October 31, 1995. The primary results were based on the patients' status as of October 31, 1996 (a minimum follow-up of 1 year). This report describes the late complications based on the patients' most recent follow-up. Methods: Three hundred and forty-four hydrocephalic children at 12 North American and European centers were randomized to 1 of 3 valves: a standard differential pressure valve; a Delta valve (PS Medical-Medtronic) or a Sigma valve (NMT Cordis). Patients were followed until their first shunt failure. Shunt failure was defined as shunt surgery for obstruction, overdrainage, loculation or infection. If the shunt did not fail, follow-up was continued until August 31, 1999. Results: One hundred and seventy-seven patients had shunt failure. Shunt obstruction occurred in 131, overdrainage in 13, loculated ventricles in 2 and infection in 29. The overall shunt survival was 62% at 1 year, 52% at 2 years, 46% at 3 years, 41% at 4 years. The survival curves for the 3 valves were similar to those from the original trial and did not show a survival advantage for any particular valve. Conclusions: Prolonged follow-up to date does not alter the primary conclusions of the trial: there does not appear to be one valve that is clearly the best for the initial treatment of pediatric hydrocephalus.

Original languageEnglish (US)
Pages (from-to)230-236
Number of pages7
JournalPediatric Neurosurgery
Volume33
Issue number5
DOIs
StatePublished - Dec 1 2000
Externally publishedYes

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Survival
Pressure
Hydrocephalus
Infection
Multicenter Studies
Pediatrics
Therapeutics

All Science Journal Classification (ASJC) codes

  • Pediatrics, Perinatology, and Child Health
  • Clinical Neurology

Cite this

Kestle, J., Drake, J., Milner, R., Sainte-Rose, C., Cinalli, G., Boop, F., ... MacNeil, N. (2000). Long-term follow-up data from the shunt design trial. Pediatric Neurosurgery, 33(5), 230-236. https://doi.org/10.1159/000055960

Long-term follow-up data from the shunt design trial. / Kestle, John; Drake, J.; Milner, R.; Sainte-Rose, C.; Cinalli, G.; Boop, Frederick; Piatt, J.; Haines, S.; Schiff, S.; Cochrane, D.; Steinbok, P.; MacNeil, N.

In: Pediatric Neurosurgery, Vol. 33, No. 5, 01.12.2000, p. 230-236.

Research output: Contribution to journalArticle

Kestle, J, Drake, J, Milner, R, Sainte-Rose, C, Cinalli, G, Boop, F, Piatt, J, Haines, S, Schiff, S, Cochrane, D, Steinbok, P & MacNeil, N 2000, 'Long-term follow-up data from the shunt design trial', Pediatric Neurosurgery, vol. 33, no. 5, pp. 230-236. https://doi.org/10.1159/000055960
Kestle J, Drake J, Milner R, Sainte-Rose C, Cinalli G, Boop F et al. Long-term follow-up data from the shunt design trial. Pediatric Neurosurgery. 2000 Dec 1;33(5):230-236. https://doi.org/10.1159/000055960
Kestle, John ; Drake, J. ; Milner, R. ; Sainte-Rose, C. ; Cinalli, G. ; Boop, Frederick ; Piatt, J. ; Haines, S. ; Schiff, S. ; Cochrane, D. ; Steinbok, P. ; MacNeil, N. / Long-term follow-up data from the shunt design trial. In: Pediatric Neurosurgery. 2000 ; Vol. 33, No. 5. pp. 230-236.
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AU - Drake, J.

AU - Milner, R.

AU - Sainte-Rose, C.

AU - Cinalli, G.

AU - Boop, Frederick

AU - Piatt, J.

AU - Haines, S.

AU - Schiff, S.

AU - Cochrane, D.

AU - Steinbok, P.

AU - MacNeil, N.

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N2 - Background: A previously reported multicenter randomized trial assessed whether 2 new shunt valve designs would reduce shunt failure rates compared to differential pressure valves. The study did not show a significant difference in the time to first shunt failure. Patients entered the trial between October 1, 1993, and October 31, 1995. The primary results were based on the patients' status as of October 31, 1996 (a minimum follow-up of 1 year). This report describes the late complications based on the patients' most recent follow-up. Methods: Three hundred and forty-four hydrocephalic children at 12 North American and European centers were randomized to 1 of 3 valves: a standard differential pressure valve; a Delta valve (PS Medical-Medtronic) or a Sigma valve (NMT Cordis). Patients were followed until their first shunt failure. Shunt failure was defined as shunt surgery for obstruction, overdrainage, loculation or infection. If the shunt did not fail, follow-up was continued until August 31, 1999. Results: One hundred and seventy-seven patients had shunt failure. Shunt obstruction occurred in 131, overdrainage in 13, loculated ventricles in 2 and infection in 29. The overall shunt survival was 62% at 1 year, 52% at 2 years, 46% at 3 years, 41% at 4 years. The survival curves for the 3 valves were similar to those from the original trial and did not show a survival advantage for any particular valve. Conclusions: Prolonged follow-up to date does not alter the primary conclusions of the trial: there does not appear to be one valve that is clearly the best for the initial treatment of pediatric hydrocephalus.

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