A multicenter prospective cohort study of the Strata valve for the management of hydrocephalus in pediatric patients.

OBJECT: Previous reports suggest that adjustable valves may improve the survival of cerebrospinal fluid shunts or relieve shunt-related symptoms. To evaluate these claims, the authors conducted a prospective multicenter cohort study of children who underwent placement of Strata valves.
METHODS: Patients undergoing initial shunt placement (Group 1) or shunt revision (Group 2) were treated using Strata valve shunt systems. Valves were adjustable to five performance level settings by using an externally applied magnet. The performance levels were checked using an externally applied hand tool and radiography. Patients were followed for 1 year or until they underwent shunt revision surgery. Between March 2000 and February 2002, 315 patients were enrolled in the study. In Group 1 (201 patients) the common causes of hydrocephalus were myelomeningocele (16%), aqueductal stenosis (14%), and hemorrhage (14%). The overall 1-year shunt survival was 67%. Causes of shunt failure were obstruction (17%), overdrainage (1.5%), loculated ventricles (2%), and infection (10.6%). Patients in Group 2 (114 patients) were older and the causes of hydrocephalus were similar. Among patients in Group 2 the 1-year shunt survival was 71%. There were 256 valve adjustments. Symptoms completely resolved (26%) or improved (37%) after 63% of adjustments. When symptoms improved or resolved, they did so within 24 hours in 89% of adjustments. Hand-tool and radiographic readings of valve settings were the same in 234 (98%) of 238 assessments.
CONCLUSIONS: The 1-year shunt survival for the Strata valve shunt system when used in initial shunt insertion procedures or shunt revisions was similar to those demonstrated for other valves. Symptom relief or improvement following adjustment was observed in 63% of patients. Hand-tool assessment of performance level settings reliably predicted radiographic assessments.