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.
OBJECTIVE
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.
Hanlo
Patrick W
PW
Department of Neurosurgery, Utrecht University Medical Center, Wilhelmina's Children's Hospital, Utrecht, The Netherlands. p.hanlo-2@wkz.azu.nl
Cinalli
Giuseppe
G
Vandertop
W Peter
WP
Faber
Joop A J
JA
Bøgeskov
Lars
L
Børgesen
Svend E
SE
Boschert
Jürgen
J
Chumas
Paul
P
Eder
Hans
H
Pople
Ian K
IK
Serlo
Willy
W
Vitzthum
Eckehard
E
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000886:Anthropometry; D002552:Cerebral Ventricles / Q000033:anatomy & histology / Q000601:surgery; D002557:Cerebrospinal Fluid Shunts / Q000295:instrumentation / Q000401:mortality; D002648:Child; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006849:Hydrocephalus / Q000601:surgery*; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D015996:Survival Rate