On the method of a randomised comparison of programmable valves with and without gravitational units: the SVASONA study

Acta Neurochirurgica. Supplement
Johannes LemckeDirk Stengel

Abstract

The supremacy of low-pressure valves (LPV) in the therapy of patients with idiopathic normal pressure hydrocephalus (iNPH) has been proven by the Dutch NPH study. The downside of LPVs is the high rate of overdrainage complications. In the meantime gravitational units have been developed with the objective of minimising overdrainage complications. Do these gravitational units allow the same favourable outcomes as in the Dutch NPH study without overdrainage complications? The goal of this prospective randomised controlled multicentre trial is to compare the rate of overdrainage complications after shunt surgery with programmable valves with or without a gravitational unit. Patients suspected with iNPH with gait ataxia and one or two other symptoms of Hakim's triad and enlarged ventricles on CT or MRI underwent a cerebrospinal fluid (CSF) infusion test, CSF tap test and/or continuous ICP measurement in seven experienced centres. If iNPH was diagnosed the patients were randomised to receive a ventriculoperitoneal shunt with a programmable valve with or without a gravitational unit. The patients were followed up for 3, 6 and 12 months after surgery. The primary hypothesis of the study was that programmable valves with gravitational ...Continue Reading

Citations

Sep 21, 2013·Acta neurochirurgica·Florian StockhammerChristian Sprung
Jul 9, 2013·Child's Nervous System : ChNS : Official Journal of the International Society for Pediatric Neurosurgery·M PreussM Dengl
Aug 28, 2021·Journal of Clinical Medicine·Bienvenido RosMiguel Angel Arráez

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