Safety and efficacy of gravity shunt valves in patients with idiopathic normal pressure hydrocephalus: a pragmatic, randomized, open-label, multicenter trial (SVASONA)
Study SVASONA is a randomized, open-label, multicenter clinical trial designed to evaluate the efficacy of gravity shunt valves in patients with idiopathic normal pressure hydrocephalus (iNPH). A total of 145 patients were included who underwent ventriculoperitoneal (VP) shunt surgery using either gravity or programmable valves. The primary objective of the study was to determine the incidence of overdrainage complications 6 months after surgery.
The results showed that the incidence of hyperdrainage in the programmable valve group was 29 cases, whereas in the group of gravity valves only 5 cases (risk difference -36%, 95% CI: -49% to -23%; p < 0.001). These data led to early termination of patient recruitment to the study. Secondary outcomes included improvement in quality of life measures in patients who received gravity valves, including the mental component of the SF-12 at 6 and 12 months.
Article Details
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Name: Safety and Efficacy of Gravitational Shunt Valves in Patients with Idiopathic Normal Pressure Hydrocephalus: A Pragmatic, Randomised, Open Label, Multicentre Trial (SVASONA)
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Authors: Johannes Lemcke, Ullrich Meier, Cornelia Müller, Michael J. Fritsch, Uwe Kehler, Niels Langer, Michael Kiefer, Regina Eymann, Martin U. Schuhmann, Andreas Speil, Friedrich Weber, Victor Remenez, Veit Rohde, Hans-Christoph Ludwig, Dirk Stengel
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Institutions: Several university clinics in Germany
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Magazine: Journal of Neurology, Neurosurgery & Psychiatry, 2013
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Publication date: March 1, 2013
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License: Creative Commons Attribution Non-Commercial (CC BY-NC 3.0)
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Annotation: The study examines the impact of different shunt types on outcomes in patients with iNPH, including the incidence of overdrainage and quality of life after surgery.
