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

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 ...