title: Implementation of a new CSF dynamic device: a multicenter feasibility study in 562 patients.
abstract: OBJECTIVE
  The cerebrospinal fluid (CSF) infusion test is frequently used when selecting hydrocephalus patients for shunt surgery. Very little has been reported regarding adverse events. We present a prospective feasibility study.
  
  
  METHODS
  Standardized devices for measuring CSF dynamics were built and 562 patients investigated: Needles were placed by lumbar puncture (LP). An automatic CSF infusion protocol was performed. Course of events during the investigation as well as adverse events were registered.
  
  
  RESULTS
  Preoperative evaluation of normal-pressure hydrocephalus was the most common indication (63%), followed by evaluation of shunt function (23%) and intracranial pressure recordings (14%). The LP was successfully performed in all but nine cases with 24 patients (4.3%) reporting major discomfort. Ringer infusion was performed in 474 investigations, and a valid measurement of the outflow resistance was received in 439 (93%). During the infusion phase, 17 (4%) patients reported severe headache. Infusion volume was significantly higher in patients having subjective symptoms during the infusion phase compared with those without adverse events. During 269 preoperative CSF tap tests, six (2%) patients had severe headache. Post-investigational headache was reported by 83 (15%) patients at the 24-h follow-up. No serious adverse events were observed.
  
  
  CONCLUSIONS
  Infusion testing was safe and without serious adverse events with a high rate of successful procedures. The investigation was associated with expected mild to moderate discomfort.
authors.affiliation: Department of Clinical Neuroscience, Umeå University, Sweden. jan.malm@neuro.umu.se
authors.forename: J
authors.initials: J
authors.lastname: Malm
authors.forename: N
authors.initials: N
authors.lastname: Sundström
authors.forename: K G
authors.initials: KG
authors.lastname: Cesarini
authors.forename: M
authors.initials: M
authors.lastname: Edsbagge
authors.forename: B
authors.initials: B
authors.lastname: Kristensen
authors.forename: G
authors.initials: G
authors.lastname: Leijon
authors.forename: A
authors.initials: A
authors.lastname: Eklund
mesh_terms: D015170:Cerebrospinal Fluid Pressure / Q000502:physiology*; D002557:Cerebrospinal Fluid Shunts / Q000009:adverse effects / Q000295:instrumentation* / Q000592:standards; D003955:Diagnostic Tests, Routine / Q000295:instrumentation / Q000379:methods; D005240:Feasibility Studies; D006801:Humans; D006849:Hydrocephalus / Q000175:diagnosis* / Q000503:physiopathology / Q000601:surgery*; D007260:Infusion Pumps / Q000592:standards / Q000639:trends*; D008365:Manometry / Q000379:methods; D011446:Prospective Studies; D015203:Reproducibility of Results