title: The adjustable proGAV shunt: a prospective safety and reliability multicenter study.
abstract: OBJECTIVE
  To evaluate the reliability of the gravitation-assisted adjustable proGAV shunt system with a prospective multicenter study conducted in 10 German hospitals.
  
  
  METHODS
  Enrollment for this observational study began in April 2005 and concluded in February 2006. The protocol required re-examinations 3 and 6 months postoperatively and fixed the endpoint of follow-up at 12 months after implantation. Patients with different types of adult, juvenile, and pediatric hydrocephalus were included and 165 patients were enrolled; 9 died and 12 had incomplete follow-up.
  
  
  RESULTS
  Of the assessable 144 patients, 130 completed the protocol after 12 months, whereas 14 failed because of the need to explant the device, mainly because of infection. In 12 patients, components of the shunt, not the valve, were revised. In 65 of the 144 patients, there were 102 readjustments of the valve in 67 incidences because of underdrainage and in 35 because of overdrainage. In 1 case, readjustment was not possible. Determination of pressure level with the verification instrument was safe and corresponded to the required x-ray controls after adjustments. No unintended readjustments were noted.
  
  
  CONCLUSIONS
  The proGAV is a safe and reliable device.
authors.affiliation: Department of Neurosurgery, Universitätsmedizin Berlin-Charité, Berlin, Germany. christian.sprung@charite.de
authors.forename: Christian
authors.initials: C
authors.lastname: Sprung
authors.forename: Hans-Georg
authors.initials: HG
authors.lastname: Schlosser
authors.forename: Johannes
authors.initials: J
authors.lastname: Lemcke
authors.forename: Ullrich
authors.initials: U
authors.lastname: Meier
authors.forename: Martina
authors.initials: M
authors.lastname: Messing-Jünger
authors.forename: Hans Axel
authors.initials: HA
authors.lastname: Trost
authors.forename: Friedrich
authors.initials: F
authors.lastname: Weber
authors.forename: Christoph
authors.initials: C
authors.lastname: Schul
authors.forename: Veit
authors.initials: V
authors.lastname: Rohde
authors.forename: Hans-Christian
authors.initials: HC
authors.lastname: Ludwig
authors.forename: Jürgen
authors.initials: J
authors.lastname: Höpfner
authors.forename: Abolghassem
authors.initials: A
authors.lastname: Sepehrnia
authors.forename: M Javad
authors.initials: MJ
authors.lastname: Mirzayan
authors.forename: Joachim K
authors.initials: JK
authors.lastname: Krauss
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002557:Cerebrospinal Fluid Shunts / Q000295:instrumentation* / Q000379:methods*; D002648:Child; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006801:Humans; D006849:Hydrocephalus / Q000401:mortality / Q000601:surgery*; D007223:Infant; D008297:Male; D008875:Middle Aged; D019370:Observation; D011446:Prospective Studies; D012189:Retrospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome; D055815:Young Adult