Treatment of hydrocephalus determined by the European Orbis Sigma Valve II survey: a multicenter prospective 5-year shunt survival study in children and adults in whom a flow-regulating shunt was used

Restricted access

Object. The goal of this study was to evaluate the long-term results of a flow-regulating shunt (Orbis Sigma Valve [OSV] II Smart Valve System; Integra NeuroSciences, Sophia Antipolis, France) in the treatment of hydrocephalus, whether it was a first insertion procedure or surgical revision of another type of shunt, in everyday clinical practice in a multicenter prospective study.

Methods. Patients of any age who had hydrocephalus underwent implantation of an OSV II system. The primary end point of the study was defined as any shunt-related surgery. The secondary end point was a mechanical complication (shunt obstruction, overdrainage, catheter misplacement, migration, or disconnection) or infection. The overall 5-year shunt survival rates and survival as it applied to different patient subgroups were assessed.

Five hundred fifty-seven patients (48% of whom were adults and 52% of whom were children) were selected for OSV II shunt implantation; 196 patients reached the primary end point. Shunt obstruction occurred in 75 patients (13.5%), overdrainage in 10 patients (1.8%), and infection in 46 patients (8.2%). The probability of having experienced a shunt failure—free interval at 1 year was 71% and at 2 years it was 67%; thereafter the probability remained quite stable in following years (62% at the 5-year follow-up examination). No difference in shunt survival was observed between the overall pediatric (≤ 16 years of age) and adult populations. In the pediatric age group, however, there was a significantly lower rate of shunt survival in children younger than 6 months of age (55% at the 5-year follow-up examination).

Conclusions. In this prospective study the authors demonstrate the effectiveness of flow regulation in the treatment of hydrocephalus both in children and in adults. Flow-regulating shunts limit the incidence of overdrainage and shunt-related complications. The overall 5-year shunt survival rate (62%) compares favorably with rates cited in other recently published series.

Article Information

Contributor Notes

Address reprint requests to: Patrick W. Hanlo, M.D., Ph.D., University Medical Center Utrecht, Wilhelmina's Children's Hospital, Home Mailbox KC.03.063.0, P.O. Box 85090, 3508 AB Utrecht, The Netherlands. email: p.hanlo-2@wkz.azu.nl.
Headings
References
  • 1.

    Aschoff AKremer PBenesch Cet al: Overdrainage and shunt technology. A critical comparison of programmable, hydrostatic and variable-resistance valves and flow-reducing devices. Childs Nerv Syst 11:1932021995Aschoff 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 11:193–202 1995

    • Search Google Scholar
    • Export Citation
  • 2.

    Choux M: Shunt complications. Monogr Neural Sci 8:161982Choux M: Shunt complications. Monogr Neural Sci 8:1–6 1982

  • 3.

    Collins PHockley ADWoollam DHM: Surface ultrastructure of tissues occluding ventricular catheters. J Neurosurg 48:6096131978Collins P Hockley AD Woollam DHM: Surface ultrastructure of tissues occluding ventricular catheters. J Neurosurg 48:609–613 1978

    • Search Google Scholar
    • Export Citation
  • 4.

    Czosnyka ZHCzosnyka MRichards HKet al: Laboratory evaluation of the Phoenix CRx diamond valve. Neurosurgery 48:6896942001Czosnyka ZH Czosnyka M Richards HK et al: Laboratory evaluation of the Phoenix CRx diamond valve. Neurosurgery 48:689–694 2001

    • Search Google Scholar
    • Export Citation
  • 5.

    Decq PBarat JLDuplessis Eet al: Shunt failure in adult hydrocephalus: flow-controlled shunt versus differential pressure shunts—a cooperative study in 289 patients. Surg Neurol 43:3333391995Decq P Barat JL Duplessis E et al: Shunt failure in adult hydrocephalus: flow-controlled shunt versus differential pressure shunts—a cooperative study in 289 patients. Surg Neurol 43:333–339 1995

    • Search Google Scholar
    • Export Citation
  • 6.

    Del Bigio MRDBruni JE: Reaction of rabbit lateral periventricular tissue to shunt tubing implants. J Neurosurg 64:9329401986Del Bigio MRD Bruni JE: Reaction of rabbit lateral periventricular tissue to shunt tubing implants. J Neurosurg 64:932–940 1986

    • Search Google Scholar
    • Export Citation
  • 7.

    Di Rocco CMarchese EVelardi F: A survey of the first complication of newly implanted CSF shunt devices for the treatment of nontumoral hydrocephalus. Cooperative survey of the 1991–1992 Education Committee of the ISPN. Childs Nerv Syst 10:3213271994Di Rocco C Marchese E Velardi F: A survey of the first complication of newly implanted CSF shunt devices for the treatment of nontumoral hydrocephalus. Cooperative survey of the 1991–1992 Education Committee of the ISPN. Childs Nerv Syst 10:321–327 1994

    • Search Google Scholar
    • Export Citation
  • 8.

    Drake JMKestle JRMiner Ret al: Randomized trial of cerebrospinal fluid shunt valve design in pediatric hydrocephalus. Neurosurgery 43:2943031998Drake JM Kestle JR Miner R et al: Randomized trial of cerebrospinal fluid shunt valve design in pediatric hydrocephalus. Neurosurgery 43:294–303 1998

    • Search Google Scholar
    • Export Citation
  • 9.

    Drake JMKestle JRTuli S: CSF shunts 50 years on—past, present and future. Childs Nerv Syst 16:8008042000Drake JM Kestle JR Tuli S: CSF shunts 50 years on—past present and future. Childs Nerv Syst 16:800–804 2000

    • Search Google Scholar
    • Export Citation
  • 10.

    Drake JMSainte-Rose C: The Shunt Book. Cambridge, MA: Blackwell Science1995 pp 121193Drake JM Sainte-Rose C: The Shunt Book. Cambridge MA: Blackwell Science 1995 pp 121–193

    • Search Google Scholar
    • Export Citation
  • 11.

    Engel MCarmel PWChutorian AM: Increased intraventricular pressure without ventriculomegaly in children with shunts: “normal volume” hydrocephalus. Neurosurgery 5:5495521979Engel M Carmel PW Chutorian AM: Increased intraventricular pressure without ventriculomegaly in children with shunts: “normal volume” hydrocephalus. Neurosurgery 5:549–552 1979

    • Search Google Scholar
    • Export Citation
  • 12.

    Epstein F: Increased intracranial pressure in hydrocephalic children with functioning shunts: a complication of shunt dependency in Shapiro KMarmarou APortnoy H (eds): Hydrocephalus. New York: Raven Press1984 pp 315321Epstein F: Increased intracranial pressure in hydrocephalic children with functioning shunts: a complication of shunt dependency in Shapiro K Marmarou A Portnoy H (eds): Hydrocephalus. New York: Raven Press 1984 pp 315–321

    • Search Google Scholar
    • Export Citation
  • 13.

    Epstein FMarlin AEWald A: Chronic headache in the shunt-dependent adolescent with nearly normal ventricular volume: diagnosis and treatment. Neurosurgery 3:3513551978Epstein F Marlin AE Wald A: Chronic headache in the shunt-dependent adolescent with nearly normal ventricular volume: diagnosis and treatment. Neurosurgery 3:351–355 1978

    • Search Google Scholar
    • Export Citation
  • 14.

    Fernell EVon Wendt LSerlo Wet al: Ventriculo-atrial or ventriculoperitoneal shunts in the treatment of hydrocephalus in children? Z Kinderchir 40 (Suppl 1):12141985Fernell E Von Wendt L Serlo W et al: Ventriculo-atrial or ventriculoperitoneal shunts in the treatment of hydrocephalus in children? Z Kinderchir 40 (Suppl 1):12–14 1985

    • Search Google Scholar
    • Export Citation
  • 15.

    Gower DJLewis JCKelly DL Jr: Sterile shunt malfunction. A scanning electron microscopic perspective. J Neurosurg 61:107910841984Gower DJ Lewis JC Kelly DL Jr: Sterile shunt malfunction. A scanning electron microscopic perspective. J Neurosurg 61:1079–1084 1984

    • Search Google Scholar
    • Export Citation
  • 16.

    Gruber R: Should “normalisation” of the ventricles be the goal of hydrocephalus therapy. Z Kinderchir 38 (Suppl 2):80831983Gruber R: Should “normalisation” of the ventricles be the goal of hydrocephalus therapy. Z Kinderchir 38 (Suppl 2):80–83 1983

    • Search Google Scholar
    • Export Citation
  • 17.

    Guiffré R: Choroidal and ependymal reactions. J Neurosurg Sci 20:1231291976 (Reference unverified)Guiffré R: Choroidal and ependymal reactions. J Neurosurg Sci 20:123–129 1976 (Reference unverified)

    • Search Google Scholar
    • Export Citation
  • 18.

    Hirsch JF: Surgery of hydrocephalus: past, present and future. Acta Neurochir 116:1551601992Hirsch JF: Surgery of hydrocephalus: past present and future. Acta Neurochir 116:155–160 1992

    • Search Google Scholar
    • Export Citation
  • 19.

    Hoffmann HJSmith MS: The use of shunting devices for cerebrospinal fluid in Canada. Can J Neurol Sci 13:81871986Hoffmann HJ Smith MS: The use of shunting devices for cerebrospinal fluid in Canada. Can J Neurol Sci 13:81–87 1986

    • Search Google Scholar
    • Export Citation
  • 20.

    Holness ROHoffman HJHendrick EB: Subtemporal decompression for the slit-ventricle syndrome after shunting in hydrocephalus children. Childs Brain 5:1371441979Holness RO Hoffman HJ Hendrick EB: Subtemporal decompression for the slit-ventricle syndrome after shunting in hydrocephalus children. Childs Brain 5:137–144 1979

    • Search Google Scholar
    • Export Citation
  • 21.

    Hyde-Rowan MDRekate HLNulsen FE: Reexpansion of previously collapsed ventricles: the slit ventricle syndrome. J Neurosurg 56:5365391982Hyde-Rowan MD Rekate HL Nulsen FE: Reexpansion of previously collapsed ventricles: the slit ventricle syndrome. J Neurosurg 56:536–539 1982

    • Search Google Scholar
    • Export Citation
  • 22.

    Kast JDuong DNowzari Fet al: Time-related patterns of ventricular shunt failure. Childs Nerv Syst 10:5245281994Kast J Duong D Nowzari F et al: Time-related patterns of ventricular shunt failure. Childs Nerv Syst 10:524–528 1994

    • Search Google Scholar
    • Export Citation
  • 23.

    Kestle JDrake JMilner Ret al: Long-term follow-up data from the shunt design trial. Pediatr Neurosurg 33:2302362000Kestle J Drake J Milner R et al: Long-term follow-up data from the shunt design trial. Pediatr Neurosurg 33:230–236 2000

    • Search Google Scholar
    • Export Citation
  • 24.

    Kestle JMilner RDrake J: The shunt design trial: variation in surgical experience did not influence shunt survival. Pediatr Neurosurg 30:2832871999Kestle J Milner R Drake J: The shunt design trial: variation in surgical experience did not influence shunt survival. Pediatr Neurosurg 30:283–287 1999

    • Search Google Scholar
    • Export Citation
  • 25.

    Kiekens RMortier WPothmann Ret al: The slit-ventricle syndrome after shunting in hydrocephalic children. Neuropediatrics 13:1901941982Kiekens R Mortier W Pothmann R et al: The slit-ventricle syndrome after shunting in hydrocephalic children. Neuropediatrics 13:190–194 1982

    • Search Google Scholar
    • Export Citation
  • 26.

    Kokkonen JSerlo WSaukkonen ALet al: Long-term prognosis for children with shunted hydrocephalus. Childs Nerv Syst 10:3843871994Kokkonen J Serlo W Saukkonen AL et al: Long-term prognosis for children with shunted hydrocephalus. Childs Nerv Syst 10:384–387 1994

    • Search Google Scholar
    • Export Citation
  • 27.

    Langley JMLeBlanc JCDrake Jet al: Efficacy of antimicrobial prophylaxis in placement of cerebrospinal fluid shunts: meta-analysis. Clin Infect Dis 17:981031993Langley JM LeBlanc JC Drake J et al: Efficacy of antimicrobial prophylaxis in placement of cerebrospinal fluid shunts: meta-analysis. Clin Infect Dis 17:98–103 1993

    • Search Google Scholar
    • Export Citation
  • 28.

    McGirt MJLeveque JCWellons JC IIIet al: Cerebrospinal fluid shunt survival and etiology of failures: a seven-year institutional experience. Pediatr Neurosurg 36:2482552002McGirt MJ Leveque JC Wellons JC III et al: Cerebrospinal fluid shunt survival and etiology of failures: a seven-year institutional experience. Pediatr Neurosurg 36:248–255 2002

    • Search Google Scholar
    • Export Citation
  • 29.

    McLaurin RL: Ventricular shunts: complications and results in McLaurin RLSchut LVenes JLet al (eds): Pediatric Neurosurgery: Surgery of the Developing Nervous Systemed 2. Philadelphia: WB Saunders1989 pp 219229 (Reference unverified)McLaurin RL: Ventricular shunts: complications and results in McLaurin RL Schut L Venes JL et al (eds): Pediatric Neurosurgery: Surgery of the Developing Nervous System ed 2. Philadelphia: WB Saunders 1989 pp 219–229 (Reference unverified)

    • Search Google Scholar
    • Export Citation
  • 30.

    Noetzel MJBaker RP: Shunt fluid examination: risks and benefits in the evaluation of shunt malfunction and infection. J Neurosurg 61:3283321984Noetzel MJ Baker RP: Shunt fluid examination: risks and benefits in the evaluation of shunt malfunction and infection. J Neurosurg 61:328–332 1984

    • Search Google Scholar
    • Export Citation
  • 31.

    Nulsen FESpitz EB: Treatment of hydrocephalus by direct shunt from ventricle to jugular vein. Surg Forum:3994031952Nulsen FE Spitz EB: Treatment of hydrocephalus by direct shunt from ventricle to jugular vein. Surg Forum:399–403 1952

    • Search Google Scholar
    • Export Citation
  • 32.

    Oberbauer RW: The significance of morphological details for developmental outcome in infantile hydrocephalus. Childs Nerv Syst 1:3293361985Oberbauer RW: The significance of morphological details for developmental outcome in infantile hydrocephalus. Childs Nerv Syst 1:329–336 1985

    • Search Google Scholar
    • Export Citation
  • 33.

    Oi SMatsumoto S: Morphological findings of postshunt slit-ventricle in experimental canine hydrocephalus. Aspects of causative factors of isolated ventricles and slit-ventricle syndrome. Childs Nerv Syst 2:1791841986Oi S Matsumoto S: Morphological findings of postshunt slit-ventricle in experimental canine hydrocephalus. Aspects of causative factors of isolated ventricles and slit-ventricle syndrome. Childs Nerv Syst 2:179–184 1986

    • Search Google Scholar
    • Export Citation
  • 34.

    Piatt JH JrCarlson CV: A search for determinants of cerebrospinal fluid shunt survival: retrospective analysis of a 14-year institutional experience. Pediatr Neurosurg 19:2332421993Piatt JH Jr Carlson CV: A search for determinants of cerebrospinal fluid shunt survival: retrospective analysis of a 14-year institutional experience. Pediatr Neurosurg 19:233–242 1993

    • Search Google Scholar
    • Export Citation
  • 35.

    Pollack IFAlbright ALAdelson PDet al: A randomized, controlled study of a programmable shunt valve versus a conventional valve for patients with hydrocephalus. Hakim-Medos Investigator Group. Neurosurgery 45:139914111999Pollack IF Albright AL Adelson PD et al: A randomized controlled study of a programmable shunt valve versus a conventional valve for patients with hydrocephalus. Hakim-Medos Investigator Group. Neurosurgery 45:1399–1411 1999

    • Search Google Scholar
    • Export Citation
  • 36.

    Rekate HL: Classification of slit-ventricle syndromes using intracranial pressure monitoring. Pediatr Neurosurg 19:15201993Rekate HL: Classification of slit-ventricle syndromes using intracranial pressure monitoring. Pediatr Neurosurg 19:15–20 1993

    • Search Google Scholar
    • Export Citation
  • 37.

    Sainte-Rose C: Shunt obstruction: a preventable complication? Pediatr Neurosurg 19:1561641993Sainte-Rose C: Shunt obstruction: a preventable complication? Pediatr Neurosurg 19:156–164 1993

    • Search Google Scholar
    • Export Citation
  • 38.

    Sainte-Rose CHoffman HJHirsch JF: Shunt failure. Concepts Pediatr Neurosurg 9:7201989Sainte-Rose C Hoffman HJ Hirsch JF: Shunt failure. Concepts Pediatr Neurosurg 9:7–20 1989

    • Search Google Scholar
    • Export Citation
  • 39.

    Sainte-Rose CHooven MDHirsch JF: A new approach in the treatment of hydrocephalus. J Neurosurg 66:2132261987Sainte-Rose C Hooven MD Hirsch JF: A new approach in the treatment of hydrocephalus. J Neurosurg 66:213–226 1987

    • Search Google Scholar
    • Export Citation
  • 40.

    Sainte-Rose CPiatt JHRenier Det al: Mechanical complications in shunts. Pediatr Neurosurg 17:291991/92Sainte-Rose C Piatt JH Renier D et al: Mechanical complications in shunts. Pediatr Neurosurg 17:2–9 1991/92

    • Search Google Scholar
    • Export Citation
  • 41.

    Scott RM: Preventing and treating shunt complications in Scott RM (ed): Hydrocephalus. Baltimore: Williams & Wilkins1990 pp 115121Scott RM: Preventing and treating shunt complications in Scott RM (ed): Hydrocephalus. Baltimore: Williams & Wilkins 1990 pp 115–121

    • Search Google Scholar
    • Export Citation
  • 42.

    Serlo WSaukkonen ALHeikkinen Eet al: The incidence and management of the slit ventricle syndrome. Acta Neurochir 99:1131161989Serlo W Saukkonen AL Heikkinen E et al: The incidence and management of the slit ventricle syndrome. Acta Neurochir 99:113–116 1989

    • Search Google Scholar
    • Export Citation
  • 43.

    Serlo WSaukkonen ALvon Wendt Let al: Incidence and management of the slit ventricle syndrome (SLVS) in Brock MBanerji AKSambasivan M (eds): Modern Neurosurgery 2. Berlin: WFNS1991 pp 441446Serlo W Saukkonen AL von Wendt L et al: Incidence and management of the slit ventricle syndrome (SLVS) in Brock M Banerji AK Sambasivan M (eds): Modern Neurosurgery 2. Berlin: WFNS 1991 pp 441–446

    • Search Google Scholar
    • Export Citation
  • 44.

    Vernet OCampiche RDe Tribolet N: Long-term results after ventriculo-atrial shunting in children. Childs Nerv Syst 11:1761791995Vernet O Campiche R De Tribolet N: Long-term results after ventriculo-atrial shunting in children. Childs Nerv Syst 11:176–179 1995

    • Search Google Scholar
    • Export Citation
  • 45.

    Zemack GRomner B: Seven years of clinical experience with the programmable Codman Hakim valve: a retrospective study of 583 patients. J Neurosurg 92:9419482000Zemack G Romner B: Seven years of clinical experience with the programmable Codman Hakim valve: a retrospective study of 583 patients. J Neurosurg 92:941–948 2000

    • Search Google Scholar
    • Export Citation
TrendMD
Cited By
Metrics

Metrics

All Time Past Year Past 30 Days
Abstract Views 270 252 8
Full Text Views 141 66 0
PDF Downloads 79 38 0
EPUB Downloads 0 0 0
PubMed
Google Scholar