Related Experiment Video
Updated: Oct 21, 2026
Neuronavigation and Laparoscopy Guided Ventriculoperitoneal Shunt Insertion for the Treatment of Hydrocephalus
Published on: October 14, 2022
Rationale and methodology of the multicenter pediatric cerebrospinal fluid shunt design trial. Pediatric
Insights
New cerebrospinal fluid shunt valves may reduce failure rates in pediatric hydrocephalus patients by preventing overdrainage. Further randomized trials are needed to confirm efficacy and compare them to standard differential pressure valves.
Area of Science:
- Neurosurgery
- Pediatric Neurology
- Biomedical Engineering
Background:
- Cerebrospinal fluid (CSF) shunt failure is a significant challenge in pediatric hydrocephalus management.
- Standard differential pressure valves have been used for decades, but complications like overdrainage and proximal obstruction persist.
- New valve designs, Orbis-Sigma and Delta, offer different flow/pressure characteristics to potentially mitigate these issues.
Purpose of the Study:
- To evaluate the efficacy of two novel cerebrospinal fluid shunt valve designs (Orbis-Sigma and Delta) in pediatric hydrocephalus.
- To compare the performance of these new valves against standard differential pressure valves in reducing shunt failure rates.
- To investigate the potential impact of new valve designs on early mechanical complications and overall patient outcomes.
Main Methods:
- The study proposes a randomized trial to compare the Orbis-Sigma and Delta valves against a standard differential pressure valve.
- The trial aims to assess shunt failure rates, focusing on early mechanical complications such as proximal obstruction and overdrainage.
- Confounding factors like patient selection, surgical technique, and shunt component configuration will be considered.
Main Results:
- Uncontrolled series suggest new valve designs may reduce shunt failure rates, potentially by decreasing overdrainage and slit ventricles.
- Theoretical concerns exist regarding the Orbis-Sigma's narrow orifice and the Delta valve's siphon control membrane.
- A randomized trial is necessary to definitively determine the efficacy of these novel valves.
Conclusions:
- Novel cerebrospinal fluid shunt valves show promise in reducing early mechanical complications in pediatric hydrocephalus.
- Randomized controlled trials are essential to validate the efficacy of Orbis-Sigma and Delta valves and establish their superiority over standard designs.
- Confirming reduced shunt failure could significantly improve patient morbidity and mortality while offering healthcare cost savings.
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 design. 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.
