An adjustable gravitational valve for initial VP-shunt treatment in hydrocephalic preterm neonates and infants below 1 year of age

Abstract

Objective: Shunt treatment for hydrocephalus in children should aim for sustainable flexibility in regard to optional, perspective pressure level adjustment during advancing physical and mental development. Gravitation-assisted shunt valves are designed to prevent hydrostatic over-drainage frequently observed in the long course of shunt-treated hydrocephalus. We prospectively studied and analyzed the implication, safety, and feasibility for an adjustable gravitational unit combined with a fixed differential-pressure (DP) valve for neonates and infants primary shunted within the first 12 months of life. Methods: Clinical course of hydrocephalic neonates and infants who received initial VP-shunt insertion in the early post-natal phase were monitored prospectively on the basis of our digital institutional Hydrocephalus & Shunt Registry. All patients were equipped with a fixed DP valve combined with a programmable gravitational unit activated in upright body position. Patients with a minimum shunt follow-up of 24 months were considered for further statistical analysis regarding hydrocephalus etiology, surgical setting, pre- and post-operative ventricular enlargement, head circumference, valve pressure setting, implication for the adjustment option of the gravitational unit, type and number of shunt complications, and revision-free shunt and valve survival. Results: Seventy-eight pediatric patients received primary VP-shunt insertion at a mean age of 10 weeks with age gestationally corrected for preterm neonates. Hydrocephalus was related to perinatal IVH (64%), CNS malformation (11%), spina bifida (9%), congenital aqueductal stenosis (9%), and idiopathic (4%) or post-infectious etiology (3%). Fifty-two patients (70%) presented with history of prematurity (gestational age 23–36 weeks). Regular follow-up carried out for a mean period of 63 months demonstrated that ventricular enlargement decreased significantly after applied treatment and excessive head growth could be counteracted effectively. At least one pressure level adjustment was performed in 31% of all patients after 12 months, in 42% after 24 months, and in 64% at the time of last clinical follow-up since initial shunt insertion. Pressure level adjustments were successful in cases of clinical or radiographic signs of under- or over-drainage for individual patients of various ages during entire clinical course. Mean pressure setting for upright position was 24.1 cm H2O at the time of initial shunt insertion and increased to 26.4 cmH2O at the time of last clinical follow-up. Revision-free shunt-survival rates after 12 and 24 months were 79% and 70% and valve-survival rates 91% and 90%, respectively. Conclusion: The combination of a fixed DP valve with an adjustable gravitational unit utilized as first-line shunt regimen was feasible and safe in a highly vulnerable subgroup of hydrocephalic infants. The adjustment option for the gravitational unit showed frequent and increasing implication over time and was beneficial even during the very early developmental stage of limited autonomous mobility. To our knowledge this is the first ever reported long-term investigation of an age-consistent pediatric patient collective primary shunted with an adjustable gravitational valve system.