Rationale and methodology of the multicenter pediatric cerebrospinal sluid shunt design trial

Abstract

Cerebrospinal fluid shunt failure remains a common and at times overwhelming problem in pediatric patients with hydrocephalus. Two new shunt valve designs, the Orbis-Sigma (Cordis Corporation, Miami, Florida) and the Delta valve (PS Medical, Goletta, California), have flow/pressure characteristics dramatically different from those of standard differential pressure valves which have been used for over three decades. Both new designs reduce the siphoning effect in the upright position, and have been reported to reduce shunt failure rates in uncontrolled series, allegedly due to reduction in shunt overdrainage. Most mechanical shunt failure in the first 2 years after implantation is due to proximal shunt obstruction, overdrainage, and loculated ventricles. By reducing the incidence of slit ventricles associated with standard valves, both new designs could be envisioned as reducing the early mechanical complications. The improved results with both new valves could, however, also be to a large extent due to other confounding effects of shunt surgery, including patient selection, surgical technique, and specific configuration of the components of the shunt other than the valve. There are also theoretical reasons why these valve designs might be worse than their predecessors, including the narrow orifice and high resistance of the Orbis-Sigma, and the flexible membrane of the siphon control portion of the Delta valve, which may increase the ventricular pressure in the upright position or become blocked by encasing scar tissue. For this reason a randomized trial is required to determine efficacy, and a standard differential pressure valve is required as the control desing. A significant reduction in early shunt failure would dramatically improve the morbidity and mortality of pediatric hydrocephalic patients, as well as providing substantial savings to the health care system. Failure to determine any difference would focus attention on other issues surrounding shunt surgery, such as patient characteristics or surgical technique.