Safety and efficacy of gravitational shunt valves in patients with idiopathic normal pressure hydrocephalus: A pragmatic, randomised, open label, multicentre trial (SVASONA)

Journal of Neurology, Neurosurgery and Psychiatry

Volumn 84, Issue 8, 2013, Pages 850-857

  Lemcke, Johannes ^a   Meier, Ullrich ^a   Müller, Cornelia ^b   Fritsch, Michael J ^b   Kehler, Uwe ^c   Langer, Niels ^c   Kiefer, Michael ^d   Eymann, Regina ^d   Schuhmann, Martin U ^e   Speil, Andreas ^e   Weber, Friedrich ^f   Remenez, Victor ^f   Rohde, Veit ^g   Ludwig, Hans Christoph ^g   Stengel, Dirk ^a,h  

^a UNFALLKRANKENHAUS BERLIN   (Germany)

^b UNIVERSITY OF GREIFSWALD   (Germany)

^c ASKLEPIOS KLINIK ALTONA   (Germany)

^d SAARLAND UNIVERSITY   (Germany)

^e UNIVERSITY OF TÜBINGEN   (Germany)

^f KRANKENHAUS MERHEIM   (Germany)

^g UNIVERSITY OF GÖTTINGEN   (Germany)

^h CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; AGED; ARTICLE; BRAIN HEMORRHAGE; BRAIN VENTRICLE DILATATION; CEREBROSPINAL FLUID DRAINAGE; CLINICAL EFFECTIVENESS; CLINICAL FEATURE; CONTROLLED STUDY; FEMALE; GRAVITATIONAL SHUNT VALVE; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICAL DEVICE COMPLICATION; NORMOTENSIVE HYDROCEPHALUS; OUTCOME ASSESSMENT; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; SCORING SYSTEM; SHORT FORM 12; SUBDURAL EFFUSION; SURGICAL INFECTION; TREATMENT WITHDRAWAL; VALVE; VENTRICULOATRIAL SHUNT;

EID: 84879950057     PISSN: 00223050     EISSN: 1468330X     Source Type: Journal    
DOI: 10.1136/jnnp-2012-303936     Document Type: Article

References (35)

1. Hakim CA, Hakim R, Hakim S. Normal-pressure hydrocephalus. Neurosurg Clin N Am 2001;12:761-73. (Pubitemid 32924279)
2. Greitz D. Radiological assessment of hydrocephalus: new theories and implications for therapy. Neurosurg Rev 2004;27:145-65. (Pubitemid 38937033)
3. Brean A, Fredo HL, Sollid S, et al. Five-year incidence of surgery for idiopathic normal pressure hydrocephalus in Norway. Acta Neurol Scand 2009;120:314-16.
4. Gangemi M, Maiuri F, Buonamassa S, et al. Endoscopic third ventriculostomy in idiopathic normal pressure hydrocephalus. Neurosurgery 2004;55:129-34. (Pubitemid 38859090)
5. Bergsneider M, Black PM, Klinge P, et al. Surgical management of idiopathic normal-pressure hydrocephalus. Neurosurgery 2005;57:S29-39.
6. Cage TA, Auguste KI, Wrensch M, et al. Self-reported functional outcome after surgical intervention in patients with idiopathic normal pressure hydrocephalus. J Clin Neurosci 2011;18:649-54.
7. Boon AJ, Tans JT, Delwel EJ, et al. Dutch Normal-Pressure Hydrocephalus Study: randomized comparison of low- and medium-pressure shunts. J Neurosurg 1998;88:490-5. (Pubitemid 28114722)
8. Lemcke J, Meier U, Müller C, et al. Is it possible to minimize overdrainage complications with gravitational units in patients with idiopathic normal pressure hydrocephalus? Protocol of the randomized controlled SVASONA trial (ISRCTN51046698). Acta Neurochir Suppl 2010;106:113-15.
9. Lemcke J, Meier U. Improved outcome in shunted iNPH with a combination of a Codman Hakim programmable valve and an Aesculap-Miethke Shunt Assistant. Cen Eur Neurosurg 2010;71:113-16.
10. Kiefer M, Meier U, Eymann R. Gravitational valves: relevant differences with different technical solutions to counteract hydrostatic pressure. Acta Neurochir Suppl 2006;96:343-7.
11. Adams RD, Fisher CM, Hakim S, et al. Symptomatic occult hydrocephalus with "normal" cerebrospinal fluid pressure. A treatable syndrome. N Engl J Med 1965;273:117-26.
12. Evans WA. An encephalographic ratio for estimating ventricular enlargement and cerebral atrophy. Arch Neurol Psychiatry 1942;47:931-7.
13. Meier U, Bartels P. The importance of the intrathecal infusion test in the diagnosis of normal pressure hydrocephalus. J Clin Neurosci 2002;9:260-7.
14. Bech-Azeddine R, Gjerris F, Waldemar G, et al. Intraventricular or lumbar infusion test in adult communicating hydrocephalus? Practical consequences and clinical outcome of shunt operation. Acta Neurochir (Wien) 2005;147:1027-35.
15. Brean A, Eide PK. Assessment of idiopathic normal pressure patients in neurological practice: the role of lumbar infusion testing for referral of patients to neurosurgery. Eur J Neurol 2008;15:605-12. (Pubitemid 351677513)
16. Kahlon B, Sundbarg G, Rehncrona S. Lumbar infusion test in normal pressure hydrocephalus. Acta Neurol Scand 2005;111:379-84. (Pubitemid 40705308)
17. Kahlon B, Sundbarg G, Rehncrona S. Comparison between the lumbar infusion and CSF tap tests to predict outcome after shunt surgery in suspected normal pressure hydrocephalus. J Neurol Neurosurg Psychiatry 2002;73:721-6. (Pubitemid 35448859)
18. Tans JT. Differentiation of normal pressure hydrocephalus and cerebral atrophy by computed tomography and spinal infusion test. J Neurol 1979;222:109-18. (Pubitemid 10209281)
19. Damasceno BP, Carelli EF, Honorato DC, et al. The predictive value of cerebrospinal fluid tap-test in normal pressure hydrocephalus. Arq Neuropsiquiatr 1997;55:179-85. (Pubitemid 127509251)
20. Marmarou A, Young HF, Aygok GA, et al. Diagnosis and management of idiopathic normal-pressure hydrocephalus: a prospective study in 151 patients. J Neurosurg 2005;102:987-97. (Pubitemid 43193966)
21. Sand T, Bovim G, Grimse R, et al. Idiopathic normal pressure hydrocephalus: the CSF tap-test may predict the clinical response to shunting. Acta Neurol Scand 1994;89:311-16.
22. Wikkelso C, Andersson H, Blomstrand C, et al. Normal pressure hydrocephalus. Predictive value of the cerebrospinal fluid tap-test. Acta Neurol Scand 1986;73:566-73. (Pubitemid 16057825)
23. Aschoff A, Kremer P, Benesch C, et al. Overdrainage and shunt technology. A critical comparison of programmable, hydrostatic and variable-resistance valves and flow-reducing devices. Childs Nerv Syst 1995;11:193-202.
24. Aschoff A, Kremer P, Hashemi B, et al. The scientific history of hydrocephalus and its treatment. Neurosurg Rev 1999;22:67-93. (Pubitemid 29493079)
25. Klinge P, Marmarou A, Bergsneider M, et al. Outcome of shunting in idiopathic normal-pressure hydrocephalus and the value of outcome assessment in shunted patients. Neurosurgery 2005;57:S40-52.
26. Relkin N, Marmarou A, Klinge P, et al. Diagnosing idiopathic normal-pressure hydrocephalus. Neurosurgery 2005;57:S4-16.
27. Kiefer M, Eymann R, Komenda Y, et al. A grading system for chronic hydrocephalus. Zentralbl Neurochir 2003;64:109-15.
28. Zemack G, Romner B. Seven years of clinical experience with the programmable Codman Hakim valve: a retrospective study of 583 patients. J Neurosurg 2000;92:941-8. (Pubitemid 30346511)
29. Copeland KT, Checkoway H, McMichael AJ, et al. Bias due to misclassification in the estimation of relative risk. Am J Epidemiol 1977;105:488-95. (Pubitemid 8112070)
30. Benzel EC, Pelletier AL, Levy PG. Communicating hydrocephalus in adults: prediction of outcome after ventricular shunting procedures. Neurosurgery 1990;26:655-60. (Pubitemid 20120715)
31. Black PM. Idiopathic normal-pressure hydrocephalus. Results of shunting in 62 patients. J Neurosurg 1980;52:371-7.
32. Black PM, Ojemann RG, Tzouras A. CSF shunts for dementia, incontinence, and gait disturbance. Clin Neurosurg 1985;32:632-51.
33. Hellstrom P, Klinge P, Tans J, et al. The neuropsychology of iNPH: findings and evaluation of tests in the European multicentre study. Clin Neurol Neurosurg 2012;114:130-4.
34. Trigg R, Jones RW, Skevington SM. Can people with mild to moderate dementia provide reliable answers about their quality of life? Age Ageing 2007;36:663-9. (Pubitemid 350258977)
35. Seymour DG, Ball AE, Russell EM, et al. Problems in using health survey questionnaires in older patients with physical disabilities. The reliability and validity of the SF-36 and the effect of cognitive impairment. J Eval Clin Pract 2001;7:411-18. (Pubitemid 33086249)