RESUMEN
BACKGROUND: The non-homogenous flow of the cerebrospinal fluid within the ventricular catheter is one of the causative factors in shunt obstructions during the treatment of hydrocephalus. Previously, we studied the flow in ventricular catheters under the steady and pulsatile boundary conditions by means of computational fluid dynamics (CFD) in three-dimensional paradigms. Subsequently, several catheter designs with homogeneous flow patterns were developed out of which one prototype was chosen after a validation study. OBJECTIVE: To test the effectiveness of the flow ventricular catheter in a prospective, multicenter, comparative study. METHODS: Eligible centers were three pediatric hospitals: two with sole adult practice and one a mixed pediatric-adult. Standard silicone material was used to develop a parametric catheter model with homogenous flow characteristics. The flow catheters were inserted in pediatric (n = 30) and adult (n = 10) patients with all types of hydrocephalus. Simultaneously, regular ventricular catheters were inserted in another 43 control patients in the participating centers. Catheter positioning was standardized according to the Schaumann and Thomale classification. RESULTS: All ventricular catheters had a cephalad grade I or II positioning, and caudally, its extension had a peritoneal location. Programmable valves were utilized in 70% and antisiphon devices in 20% of the cases. Regular differential pressure valves were utilized in the remaining. No case of flow catheter obstruction was identified during a mean follow-up period of 2 years at the time of this writing. There were four catheter obstructions in the control cohort, all pediatric cases, during the first year. Shunt infections occurred in two cases in the control group, while there was one recurrent case of adult ventriculitis in the flow catheter group. CONCLUSIONS: This prototype model represents the next generation of ventricular catheters with a homogeneous flow pattern. The flow catheter can be inserted safely in hydrocephalic patients, and this preliminary prospective comparative study showed a possible obstruction-free functionality.