Pediatric gravitational shunts: initial results from a prospective study.

Abstract

The authors' goal in this paper was to evaluate prospectively the efficacy and safety of a new pediatric gravitational shunt to determine whether it warrants inclusion in a randomized, controlled trial with other shunts. A total of 55 children between the ages of 0 and 6 years (median age 0.5 years, average age 4+/-6 years) underwent primary shunt implantation; all received the Miethke Paedi-GAV. The follow-up period ranged between 12 and 77 months (mean 47+/-21 months). The primary end point of the study was the first shunt failure necessitating revision. The 1- and 2-year shunt survival rates were 75 and 68%, respectively. The average failure-free shunt survival duration was 1423 +/- 641 days. Based on imaging findings, no slitlike ventricles occurred. The complication rate was 33%, and the median time to shunt failure was 45 days. Underdrainage occurred in one child (1.8%) and overdrainage in two children (3.6%). These preliminary results prove the Miethke Paedi-GAV to be a safe and effective pediatric shunt worthy of inclusion in a randomized comparison with other shunts in the pediatric population.