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J. Neurol. Neurosurg. Psychiatr. · Aug 2013
Randomized Controlled Trial Multicenter Study Meta Analysis Comparative StudySafety and efficacy of gravitational shunt valves in patients with idiopathic normal pressure hydrocephalus: a pragmatic, randomised, open label, multicentre trial (SVASONA).
- 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, and Dirk Stengel.
- Department of Neurosurgery, Unfallkrankenhaus Berlin, Warener Str 7, Berlin 12683, Germany. johannes.lemcke@ukb.de
- J. Neurol. Neurosurg. Psychiatr.. 2013 Aug 1;84(8):850-7.
ObjectivesTo investigate whether gravitational valves reduce the risk of overdrainage complications compared with programmable valves in ventriculoperitoneal (VP) shunt surgery for idiopathic normal pressure hydrocephalus (iNPH).BackgroundPatients with iNPH may benefit from VP shunting but are prone to overdrainage complications during posture changes. Gravitational valves with tantalum balls are considered to reduce the risk of overdrainage but their clinical effectiveness is unclear.MethodsWe conducted a pragmatic, randomised, multicentre trial comparing gravitational with non-gravitational programmable valves in patients with iNPH eligible for VP shunting. The primary endpoint was any clinical or radiological sign (headache, nausea, vomiting, subdural effusion or slit ventricle) of overdrainage 6 months after randomisation. We also assessed disease specific instruments (Black and Kiefer Scale) and Physical and Mental Component Scores of the Short Form 12 (SF-12) generic health questionnaire.ResultsWe enrolled 145 patients (mean (SD) age 71.9 (6.9) years), 137 of whom were available for endpoint analysis. After 6 months, 29 patients in the standard and five patients in the gravitational shunt group developed overdrainage (risk difference -36%, 95% CI -49% to -23%; p<0.001). This difference exceeded predetermined stopping rules and resulted in premature discontinuation of patient recruitment. Disease specific outcome scales did not differ between the groups although there was a significant advantage of the gravitational device in the SF-12 Mental Component Scores at the 6 and 12 month visits.ConclusionsImplanting a gravitational rather than another type of valve will avoid one additional overdrainage complication in about every third patient undergoing VP shunting for iNPH.
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