Treatment of hydrocephalus determined by the European Orbis Sigma Valve II survey: a multicenter prospective 5-year shunt survival study in children and adults in whom a flow-regulating shunt was used: a multicenter prospective 5-year shunt survival study in children and adults in whom a flow-regulating shunt was used

Patrick W. Hanlo, Giuseppe Cinalli, W. Peter Vandertop, Joop A. J. Faber, Lars Bøgeskov, Svend E. Børgesen, Jürgen Boschert, Paul Chumas, Hans Eder, Ian K. Pople, Willy Serlo, Eckehard Vitzthum

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OBJECT: The goal of this study was to evaluate the long-term results of a flow-regulating shunt (Orbis Sigma Valve [OSV] II Smart Valve System; Integra NeuroSciences, Sophia Antipolis, France) in the treatment of hydrocephalus, whether it was a first insertion procedure or surgical revision of another type of shunt, in everyday clinical practice in a multicenter prospective study. METHODS: Patients of any age who had hydrocephalus underwent implantation of an OSV II system. The primary end point of the study was defined as any shunt-related surgery. The secondary end point was a mechanical complication (shunt obstruction, overdrainage, catheter misplacement, migration, or disconnection) or infection. The overall 5-year shunt survival rates and survival as it applied to different patient subgroups were assessed. Five hundred fifty-seven patients (48% of whom were adults and 52% of whom were children) were selected for OSV II shunt implantation; 196 patients reached the primary end point. Shunt obstruction occurred in 75 patients (13.5%), overdrainage in 10 patients (1.8%), and infection in 46 patients (8.2%). The probability of having experienced a shunt failure-free interval at 1 year was 71% and at 2 years it was 67%; thereafter the probability remained quite stable in following years (62% at the 5-year follow-up examination). No difference in shunt survival was observed between the overall pediatric ( <or = 16 years of age) and adult populations. In the pediatric age group, however, there was a significantly lower rate of shunt survival in children younger than 6 months of age (55% at the 5-year follow-up examination). CONCLUSIONS: In this prospective study the authors demonstrate the effectiveness of flow regulation in the treatment of hydrocephalus both in children and in adults. Flow-regulating shunts limit the incidence of overdrainage and shunt-related complications. The overall 5-year shunt survival rate (62%) compares favorably with rates cited in other recently published series
Original languageEnglish
Pages (from-to)52-57
Number of pages6
JournalJournal of neurosurgery
Issue number1
Publication statusPublished - Jul 2003


  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anthropometry
  • Cerebral Ventricles/anatomy & histology
  • Cerebrospinal Fluid Shunts/instrumentation
  • Child
  • Child, Preschool
  • Female
  • Follow-Up Studies
  • Humans
  • Hydrocephalus/surgery
  • Infant
  • Infant, Newborn
  • Male
  • Middle Aged
  • Prospective Studies
  • Surveys and Questionnaires
  • Survival Rate

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