gms | German Medical Science

62nd Annual Meeting of the German Society of Neurosurgery (DGNC)
Joint Meeting with the Polish Society of Neurosurgeons (PNCH)

German Society of Neurosurgery (DGNC)

7 - 11 May 2011, Hamburg

Results of the SVASONA study in idiopathic normal pressure hydrocephalus

Meeting Abstract

  • U. Meier - Department of Neurosurgery, Unfallkrankenhaus Berlin, Germany
  • J. Lemcke - Department of Neurosurgery, Unfallkrankenhaus Berlin, Germany
  • C. Müller - Department of Neurosurgery, Ernst-Moritz-Arndt-University of Greifswald, Germany
  • M.J. Fritsch - Department of Neurosurgery, Ernst-Moritz-Arndt-University of Greifswald, Germany
  • M. Kiefer - Department of Neurosurgery, Georg-August-University of Göttingen, Germany
  • R. Eymann - Department of Neurosurgery, Georg-August-University of Göttingen, Germany
  • U. Kehler - Department of Neurosurgery, Hospital Cologne-Merheim, Germany
  • N. Langer - Department of Neurosurgery, Hospital Cologne-Merheim, Germany
  • M. Schuhmann - Department of Neurosurgery, Asklepios Hospital Altona, Hamburg, Germany
  • A. Speil - Department of Neurosurgery, Asklepios Hospital Altona, Hamburg, Germany
  • F. Weber - Department of Neurosurgery, Saarland Medical University, Homburg/Saar, Germany
  • V. Remenez - Department of Neurosurgery, Saarland Medical University, Homburg/Saar, Germany
  • V. Rohde - Department of Neurosurgery, Eberhard-Karls-University of Tübingen, Germany
  • C. Ludwig - Department of Neurosurgery, Eberhard-Karls-University of Tübingen, Germany
  • D. Stengel - Center for Clinical Research, Dept of Trauma and Orthopaedics, Unfallkrankenhaus Berlin and Ernst-Moritz-Arndt-University of Greifswald, Germany

Deutsche Gesellschaft für Neurochirurgie. Polnische Gesellschaft für Neurochirurgen. 62. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie (DGNC), Joint Meeting mit der Polnischen Gesellschaft für Neurochirurgen (PNCH). Hamburg, 07.-11.05.2011. Düsseldorf: German Medical Science GMS Publishing House; 2011. DocMO.03.06

DOI: 10.3205/11dgnc006, URN: urn:nbn:de:0183-11dgnc0069

Published: April 28, 2011

© 2011 Meier et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.


Outline

Text

Objective: The supremacy of low-pressure valves (LPV) in the therapy of patients with idiopathic normal pressure hydrocephalus (iNPH) has been proven by Dutch NPH study. The downside of LPV is the high rate of over drainage complications. The goal of this prospective randomized controlled multicenter trial was to compare the rate of over-drainage complications after shunt surgery with programmable valves with or without a gravitational unit.

Methods: Patients suspected for iNPH with gait ataxia and one or two other symptoms of the hakim triad and enlarged ventricles in CCT or MRI underwent cerebrospinal fluid (CSF) infusion test, CSF tap test and/or continuous ICP measurement in seven experienced centres. If iNPH was diagnosed the patients were randomized to receive a ventriculoperitoneal shunt with a programmable valve with or without a gravitational unit. The patients were followed up 3, 6 and 12 month after surgery. The primary hypothesis of the study was that programmable valves with gravitational units would reduce the rate of over-drainage from 25% to 10%. The outcome measured by iNPH-specific outcome scales (Kiefer score, Black grading scale) and the generic quality of life (Short Form 12, SF12) was defined as secondary endpoint. To ensure safety and efficacy we performed a planned interim analysis halfway.

Results: From June 2006 to January 2009 133 patients were included in the study. Due to a massive advantage for the patient group with gravitational units the study was broken off after the planned interim analysis. The analysis of 112 patients with a complete 6 month follow-up at the time of the stop of the study showed a statistically significant (p<0.001) difference between the study groups. In the patients group with programmable valves without a gravitational unit over-drainage complications occurred in 38%, in the patient group with programmable valves with gravitational units over-drainage complications occurred in 3%. We expect these results being confirmed after final analysis of the complete follow-up data.

Conclusions: The clinical advantages of LPVs can be attained without a high rate of over-drainage complications if gravitational units are used. The study justifies gravitational units as a new standard of care for iNPH.