TY - JOUR
T1 - Anterior versus posterior entry site for ventriculoperitoneal shunt insertion
T2 - a randomized controlled trial by the Hydrocephalus Clinical Research Network
AU - Whitehead, William E.
AU - Cambrin, Jay Riva
AU - Wellons, John C.
AU - Kulkarni, Abhaya V.
AU - Limbrick, David D.
AU - Wall, Vanessa L.
AU - Rozzelle, Curtis J.
AU - Hankinson, Todd C.
AU - McDonald, Patrick J.
AU - Krieger, Mark D.
AU - Pollack, Ian F.
AU - Tamber, Mandeep S.
AU - Pindrik, Jonathan
AU - Hauptman, Jason S.
AU - Naftel, Robert P.
AU - Shannon, Chevis N.
AU - Chu, Jason
AU - Jackson, Eric M.
AU - Browd, Samuel R.
AU - Simon, Tamara D.
AU - Holubkov, Richard
AU - Reeder, Ron W.
AU - Jensen, Hailey
AU - Koschnitzky, Jenna E.
AU - Gross, Paul
AU - Drake, James M.
AU - Kestle, John R.W.
N1 - Funding Information:
Research reported in this work was funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (CER-1403-13857). The statements in this work are solely the responsibility of the authors and do not necessarily represent the views of PCORI, its Board of Governors, or Methodology Committee. We thank our colleagues for their past and ongoing support of HCRN: D. Brockmeyer, M. Walker, R. Bollo, S. Cheshier, J. Blount, J. Johnston, B. Rocque, L. Acakpo-Satchivi, W. J. Oakes, P. Dirks, J. Rutka, M. Taylor, P. Dirks, D. Curry, G. Aldave, A. Jea, S. Lam, H. Weiner, S. McCluggage, R. Ellenbogen, J. Ojemann, A. Lee, A. Avellino, S. Greene, E. Tyler-Kabara, T. Abel, T. S. Park, J. Strahle, S. McEvoy, M. Smyth, N. Tulipan, A. Singhal, P. Steinbok, D. Cochrane, W. Hader, C. Gallagher, M. Benour, E Kiehna, J. G. McComb, P. Chiarelli, A. Robison, A. Alexander, M. Handler, B. O’Neill, C. Wilkinson, L. Governale, A. Drapeau, J. Leonard, E. Sribnick, A. Shaikhouni, E. Ahn, A. Cohen, M. Groves, S. Robinson, C. M. Bonfield, and C. Shannon. In addition, our work would not be possible without the outstanding support of the dedicated personnel at each clinical site and the DCC. Special thanks go to L. Holman, J. Clawson, P. Martello, N. Tattersall, and T. Bach (Salt Lake City); A. Arynchyna and A. Bey (Birmingham); H. Ashrafpour, M. Lamberti-Pasculli, and L. O’Connor (Toronto); E. Sanchez, E. Santisbon, S. Martinez, and S. Ryan (Houston); C. Gangan, A. Anderson, and G. Bowen (Seattle); K. Diamond and A. Luther (Pittsburgh); A. Morgan, H. Botteron, D. Morales, M. Gabir, D. Berger, and D. Mercer (St. Louis); A. Wiseman, J. Stoll, D. Dawson, and S. Gannon (Nashville); A. Cheong and R. Hengel (British Columbia); R. Rashid and S. Ahmed (Calgary); A. Loudermilk and J. Yea (Baltimore); N. Rea and C. Cook (Los Angeles); S. Staulcup (Colorado); A. Sheline (Columbus); and N. Nunn, M. Langley, D. Austin, B. Conley, V. Freimann, L. Herrera, and B. Miller (Utah DCC). Thank you to all the members of the Patient Partner Committee who have supported this work from the beginning: Katie Cook, Jennifer Johnston, Jamie Wright, Sarah Ann Whitbeck, Karima Roumila, Brenda Bell Ennis, Laurel Fleming, Mia Padron, Matt Pope, Jennifer Pope, David Browdy, Amanda Garzon, Michael Schwab, and Robin Ennis.
Publisher Copyright:
© 2022 American Association of Neurological Surgeons. All rights reserved.
PY - 2022/3
Y1 - 2022/3
N2 - OBJECTIVE The primary objective of this trial was to determine if shunt entry site affects the risk of shunt failure. METHODS The authors performed a parallel-design randomized controlled trial with an equal allocation of patients who received shunt placement via the anterior entry site and patients who received shunt placement via the posterior entry site. All patients were children with symptoms or signs of hydrocephalus and ventriculomegaly. Patients were ineligible if they had a prior history of shunt insertion. Patients received a ventriculoperitoneal shunt after randomization; randomization was stratified by surgeon. The primary outcome was shunt failure. The planned minimum follow-up was 18 months. The trial was designed to achieve high power to detect a 10% or greater absolute difference in the shunt failure rate at 1 year. An independent, blinded adjudication committee determined eligibility and the primary outcome. The study was conducted by the Hydrocephalus Clinical Research Network. RESULTS The study randomized 467 pediatric patients at 14 tertiary care pediatric hospitals in North America from April 2015 to January 2019. The adjudication committee, blinded to intervention, excluded 7 patients in each group for not meeting the study inclusion criteria. For the primary analysis, there were 229 patients in the posterior group and 224 patients in the anterior group. The median patient age was 1.3 months, and the most common etiologies of hydrocephalus were postintraventricular hemorrhage secondary to prematurity (32.7%), myelomeningocele (16.8%), and aqueductal stenosis (10.8%). There was no significant difference in the time to shunt failure between the entry sites (log-rank test, stratified by age < 6 months and ≥ 6 months; p = 0.061). The hazard ratio (HR) of a posterior shunt relative to an anterior shunt was calculated using a univariable Cox regression model and was nonsignificant (HR 1.35, 95% CI, 0.98–1.85; p = 0.062). No significant difference was found between entry sites for the surgery duration, number of ventricular catheter passes, ventricular catheter location, and hospital length of stay. There were no significant differences between entry sites for intraoperative complications, postoperative CSF leaks, pseudomeningoceles, shunt infections, skull fractures, postoperative seizures, new-onset epilepsy, or intracranial hemorrhages. CONCLUSIONS This randomized controlled trial comparing the anterior and posterior shunt entry sites has demonstrated no significant difference in the time to shunt failure. Anterior and posterior entry site surgeries were found to have similar outcomes and similar complication rates.
AB - OBJECTIVE The primary objective of this trial was to determine if shunt entry site affects the risk of shunt failure. METHODS The authors performed a parallel-design randomized controlled trial with an equal allocation of patients who received shunt placement via the anterior entry site and patients who received shunt placement via the posterior entry site. All patients were children with symptoms or signs of hydrocephalus and ventriculomegaly. Patients were ineligible if they had a prior history of shunt insertion. Patients received a ventriculoperitoneal shunt after randomization; randomization was stratified by surgeon. The primary outcome was shunt failure. The planned minimum follow-up was 18 months. The trial was designed to achieve high power to detect a 10% or greater absolute difference in the shunt failure rate at 1 year. An independent, blinded adjudication committee determined eligibility and the primary outcome. The study was conducted by the Hydrocephalus Clinical Research Network. RESULTS The study randomized 467 pediatric patients at 14 tertiary care pediatric hospitals in North America from April 2015 to January 2019. The adjudication committee, blinded to intervention, excluded 7 patients in each group for not meeting the study inclusion criteria. For the primary analysis, there were 229 patients in the posterior group and 224 patients in the anterior group. The median patient age was 1.3 months, and the most common etiologies of hydrocephalus were postintraventricular hemorrhage secondary to prematurity (32.7%), myelomeningocele (16.8%), and aqueductal stenosis (10.8%). There was no significant difference in the time to shunt failure between the entry sites (log-rank test, stratified by age < 6 months and ≥ 6 months; p = 0.061). The hazard ratio (HR) of a posterior shunt relative to an anterior shunt was calculated using a univariable Cox regression model and was nonsignificant (HR 1.35, 95% CI, 0.98–1.85; p = 0.062). No significant difference was found between entry sites for the surgery duration, number of ventricular catheter passes, ventricular catheter location, and hospital length of stay. There were no significant differences between entry sites for intraoperative complications, postoperative CSF leaks, pseudomeningoceles, shunt infections, skull fractures, postoperative seizures, new-onset epilepsy, or intracranial hemorrhages. CONCLUSIONS This randomized controlled trial comparing the anterior and posterior shunt entry sites has demonstrated no significant difference in the time to shunt failure. Anterior and posterior entry site surgeries were found to have similar outcomes and similar complication rates.
KW - CSF shunts
KW - hydrocephalus
KW - pediatric
KW - shunt entry site
KW - ventricular catheter
KW - ventriculoperitoneal shunt
UR - http://www.scopus.com/inward/record.url?scp=85127249035&partnerID=8YFLogxK
U2 - 10.3171/2021.9.PEDS21391
DO - 10.3171/2021.9.PEDS21391
M3 - Article
C2 - 34798600
AN - SCOPUS:85127249035
SN - 1933-0707
VL - 29
SP - 257
EP - 267
JO - Journal of Neurosurgery: Pediatrics
JF - Journal of Neurosurgery: Pediatrics
IS - 3
ER -