Neurosurgery
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Randomized Controlled Trial Multicenter Study Clinical Trial
A randomized, controlled study of a programmable shunt valve versus a conventional valve for patients with hydrocephalus. Hakim-Medos Investigator Group.
A multicenter prospective randomized controlled study was performed to assess the safety and efficacy of a Codman Hakim programmable shunt valve (Codman/Johnson & Johnson, Raynham, MA) versus a conventional valve system of the surgeon's choice for the treatment of patients with hydrocephalus. ⋯ Safety and efficacy of the Codman Hakim programmable shunt valve is comparable to conventional valves in the overall population of patients with hydrocephalus. However, the current study was not designed to assess the efficacy of programmable versus conventional valves in the management of individual hydrocephalus problems, and it had insufficient statistical power to support such comparisons. This study provides a rationale for examining whether the theoretical advantages of a programmable valve for managing challenging hydrocephalus problems can translate into meaningful improvements in shunt and valve survival.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Change in ventricular size and effect of ventricular catheter placement in pediatric patients with shunted hydrocephalus.
The multicenter, randomized pediatric cerebrospinal fluid shunt valve design trial found no difference in the rate of shunt failure between a standard valve, a siphon-reducing valve (Delta; Medtronic PS Medical, Goleta, CA), and a flow-limiting valve (Orbis Sigma; Cordis, Miami, FL); however, the valves were expected to have different effects on ultimate ventricular size. Also, the catheter position or local environment of the ventricular catheter tip might have affected shunt failure. Therefore, we performed a post hoc analysis to understand what factors, other than valve design, affected shunt failure and to identify strategies that might be developed to reduce shunt failure. ⋯ Decline of ventricular size over time is not affected by these different shunt valve designs. This suggests that the mechanical models of hydrocephalus on which the designs were based are inadequate. Ventricular catheter tip location and ventricular catheter environment are important. Techniques to accurately place ventricular catheters and new valve designs that effectively control ventricular size might reduce shunt malfunction.