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International Infant Hydrocephalus Study: initial results of a prospective, multicenter comparison of endoscopic third ventriculostomy (ETV) and shunt for infant hydrocephalus

Child's Nervous System volume 32, pages 1039–1048 (2016)Cite this article

Abstract

Introduction

The IIHS is an international, prospective, multicenter study to compare endoscopic third ventriculostomy (ETV) and shunt in infants (<24 months old) with symptomatic triventricular hydrocephalus from aqueductal stensosis. Recruitment started in 2004, and here, we present the first results of IIHS.

Methods

IIHS utilized a prospective comprehensive cohort design, which contained both a randomized and a non-randomized arm. Patients received either an ETV or shunt, based on randomization or parental preference. Patients were followed prospectively for time to treatment failure, defined as the need for repeat CSF diversion procedure (shunt or ETV) or death due to hydrocephalus. Survival analysis was used to compare time to failure for ETV versus shunt. The trial was registered at clinicaltrials.gov (NCT00652470).

Results

A total of 158 patients met eligibility criteria (median age at surgery 3.6 months, IQR 1.6–6.6 months) across 27 centers in 4 continents. Since only 52 patients (32.9 %) were randomized, all 158 patients were analyzed together (115 ETV, 43 shunt). Actuarial success rates for ETV vs shunt at 3, 6, and 12 months were as follows: 68 vs 95 %, 66 vs 88 %, and 66 vs 83 %. The 6-month ETV success rate of 66 % was slightly higher than would have been predicted by the ETV Success Score (57 %).The hazard ratio for time to treatment failure favored shunt over ETV (3.17, 95 % CI 1.45–6.96, p = 0.004), after adjusting for age at surgery, history of previous hemorrhage or infection, continent, and randomization status. Patients younger than 6 months of age appeared to do relatively worse with ETV than older patients.

Conclusions

The IIHS has provided the first prospective direct comparison of ETV and shunt for infant hydrocephalus. These initial results suggest that shunting has a superior success rate compared to ETV, although the success rate for both was relatively high. This patient cohort continues to be followed, and we will await the results of the important primary outcome of health status at 5 years of age.

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Acknowledgments

The authors would like to extend special thanks to Adina Sherer, who ran the organizational logistics of this study and without whom the IIHS would not have been possible.

Author information

Authors and Affiliations

  1. The Hospital for Sick Children, University of Toronto, 555 University Avenue, Suite 1503, Toronto, Ontario, M5G 1X8, Canada

    Abhaya V. Kulkarni

  2. Department of Pediatric Neurosurgery, Mitera Children’s Hospital, University of Athens Medical School, Athens, Greece

    Spyros Sgouros

  3. Department of Pediatric Neurosurgery, Dana Children’s Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv University, Tel Aviv, Israel

    Shlomi Constantini

Authors
  1. Abhaya V. Kulkarni
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  2. Spyros Sgouros
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  3. Shlomi Constantini
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Consortia

IIHS Investigators

Corresponding author

Correspondence to Shlomi Constantini.

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Conflict of interest

The members of the Steering Committee have no conflicts of interest with respect to this work.

Additional information

See “Appendix” for full list of study investigators

Appendix: IIHS personnel

Appendix: IIHS personnel

Steering Committee: Shlomi Constantini (Principal Investigator), Spyros Sgouros, Abhaya V. Kulkarni

Consultant Neurologist: Yael Leitner

Data Safety Monitoring Committee: John RW Kestle (Chair), Douglas D Cochrane, Maurice Choux, Fleming Gjerris

Coordinating Administrator: Adina Sherer

Participating investigators (in parentheses are the number of eligible patients contributed to the study by each investigator)

Medical Center IIHS participants # of patients
Ankara, Turkey
Hacettepe University Hospital 		Nejat Akalan, Burçak Bilginer (12)
Barcelona, Spain
Hospital Sant Joan de Deu 		Ramon Navarro
(currently at Cleveland Clinic Abu Dhabi, UAE) 		(7)
Belgrade, Serbia
Clinical Center of Serbia, Belgrade, Neurosurgery Division 		Ljiljana Vujotic (8)
Berlin, Germany
Charité—Universitätsmedizin Berlin 		Hannes Haberl, Ulrich-Wilhelm Thomale (4)
Birmingham, UK
Birminghan Children’s Hospital 		Spyros Sgouros
(currently at “Mitera” Childrens Hospital) 		(1)
Buenos Aires, Argentina
Hospital De Pediatria Prof. Dr. J.P. Garrahan 		Graciela Zúccaro, Roberto Jaimovitch (21)
Chicago, USA
The University of Chicago Comer Children’s Hospital 		David Frim, Lori Loftis (3)
Dallas, USA
Children’s Medical Center of Dallas 		Dale M. Swift, Brian Robertson, Lynn Gargan (6)
Debrecen, Hungary
University of Debrecen, Clinical Center, Department of Neurosurgery 		László Bognár, László Novák, Georgina Cseke (5)
Genova, Italy
Giannina Gaslini Hospital, Gaslini Children Institute 		Armando Cama, Giuseppe Marcello Ravegnani (3)
Giessen/Leipzig
University Hospital Gießen and Marburg 		Matthias Preuß
Currently at University Hospital Leipzig 		(4)
Greifswald, Germany
Ernst-Moritz-Arndt-Universität Klinik für Neurochirurgie 		Henry W. Schroeder, Michael Fritsch, Joerg Baldauf (2)
Katowice, Poland Medical University of Silesia Marek Mandera, Jerzy Luszawski, Patrycja Skorupka (9)
Liverpool, UK
Alder Hey Children’s Hospital 		Conor Mallucci, Dawn Williams (4)
Lodz, Poland
Polish Mother’s Memorial Hospital, Research Institute 		Krzysztof Zakrzewski, Emilia Nowoslawska (2)
Lucknow (KGMC), India
CSM Medical University (KGMC) 		Chhitij Srivastava (4)
Lucknow (SGPGI), India
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGI) 		Ashok K. Mahapatra, Raj Kumar, Rabi Narayan Sahu (8)
Moscow, Russia
Burdenko Neurosurgical Institute 		Armen G. Melikian (Армен Меликян), Anton Korshunov (Антон Евгеньевич Коршунов), Anna Galstyan (Анна Галстян) (11)
New Delhi, India
All India Institute of Medical Sciences 		Ashish Suri, Deepak Gupta (12)
Nijmegen, The Netherlands
Radboud University Medical Center 		J. André Grotenhuis, Erik J. van Lindert (9)
Nova Lima, Brazil
Neurocirurgia Infantil, Biocor Instituto 		José Aloysio da Costa Val (5)
Rome, Italy
Pediatric Neurosurgery, Policlinico Universitario “A. Gemelli” 		Concezio Di Rocco, Gianpiero Tamburrini (4)
São Paulo, Brazil
Escola Paulista de Medicina, UNIFESP 		Samuel Tau Zymberg, Sergio Cavalheiro (3)
Shanghai, China
Xinhua Hospital, Shanghai JiaoTong University School of Medicine 		Ma Jie, Jiang Feng (3)
Tel Aviv, Israel
Dana Children’s Hospital, Tel Aviv Medical Center 		Shlomi Constantini, Orna Friedman (20)
Toronto, Canada
Hospital for Sick Children 		Abhaya V. Kulkarni (5)
Warsaw, Poland
Children’s Memorial Health Institute 		Marcin Roszkowski, Slawomir Barszcz (7)

The following centers (and investigators) participated in the IIHS, but did not enroll any patients: Baltimore, MD, USA (George Jallo); Gainesville, FL, USA (David W. Pincus, Bridget Richter); Kiel, Germany (HM Mehdorn, Susan Schultka); London, ON, Canada (Sandrine de Ribaupierre); London, UK (Dominic Thompson, Silvia Gatscher); Mainz, Germany (Wolfgang Wagner, Dorothee Koch); Reggio Calabria, Italy (Saverio Cipri, Claudio Zaccone); Winnipeg, MB, Canada (Patrick McDonald)

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Kulkarni, A.V., Sgouros, S., Constantini, S. et al. International Infant Hydrocephalus Study: initial results of a prospective, multicenter comparison of endoscopic third ventriculostomy (ETV) and shunt for infant hydrocephalus. Childs Nerv Syst 32, 1039–1048 (2016). https://doi.org/10.1007/s00381-016-3095-1

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  • DOI: https://doi.org/10.1007/s00381-016-3095-1

Keywords

  • Endoscopic third ventriculostomy
  • Triventricular hydrocephalus
  • ETV Success Score