Comparison of Programmable and Non-programmable CSF Shunts Among Adult Hydrocephalus Patients With Different Etiologies

Comparison of Benefit and Survival for Different Etiologies of Adult Patients With Hydrocephalus Between Programmable Cerebrospinal Fluid Ventricular Shunt and Non-programmable Cerebrospinal Fluid Ventricular Shunt

Programmable valve (PV) has been shown as a solution to the high revision rate in pediatric hydrocephalus patients, but it remains controversial among adults. This study is to compare the overall revision rate, revision cause, and revision-free survival between PV and non-programmable valve (NPV) in adult patients with different hydrocephalus etiologies.

Study Overview

• Status: Completed
• Conditions: Hydrocephalus; Ventriculoperitoneal Shunt Malfunction
• Intervention / Treatment: Device: Programmable valve; Device: Non-programmable valve

Detailed Description

Relatively high revision rates up to 32% of CSF shunting operations remained an unsolved problem for neurosurgeons. The cause of revisions were diverse, including overdrainage/underdrainage, shunting system obstruction, infection or technical skill related. Programmable valve (PV) has been shown as a solution to the high revision rate in pediatric hydrocephalus patients, but it remains controversial among adults. This study is to compare the overall revision rate, revision cause, and revision-free survival between PV and non-programmable valve (NPV) in adult patients with different hydrocephalus etiologies.

The investigators reviewed the chart of all patients with hydrocephalus receiving index ventricular CSF shunt operations conducted at a single institution in northern Taiwan from January 2017 to December 2017. Patients included in the study were followed up for at least five years. Statistical tests including independent t-test, Chi-square test and Fisher's exact test were used for comparative analysis, and Kaplan-Meier curve using log-rank test was performed to compare the revision-free survival between the PV and NPV groups

• Study Type: Observational
• Enrollment (Actual): 325

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult patients who received CSF ventricular shunting operations at Chang Gung Medical Foundation, Linkou Branch, a tertiary medical center in northern Taiwan, would be included in the study.

Description

Inclusion Criteria:

• received shunting operations at Chang Gung Medical Foundation, Linkou Branch from 2017/01/01~2017/12/31

Exclusion Criteria:

• Patients who received index ventricular CSF shunt at other hospitals,
• Patients who received index ventricular CSF shunt before January 1st 2017,
• Patients who were younger than 18

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Programmable valve(PV) group; Adult patients with hydrocephalus who received programmable ventricular CSF shunts operation.	Device: Programmable valve; Programmable valve used in the study included Medtronic Strata, B-Braun ProGav, Codman Certas.
Non-programmable valve(NPV) group; Adult patients with hydrocephalus who received non-programmable ventricular CSF shunts operation.	Device: Non-programmable valve; Non-programmable valve used in the study was Medtronic CSF-flow control valve.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial Shunt revision rate	the ratio of the total number of patients with at least one revision to the total number of patients included in this study	since the time of index operation until the initial revision or 2022/07/31
Total Shunt revision rate	the ratio of the total number of revisions to the total number of ventricular CSF shunt operations	since the time of index operation until the initial revision or 2022/07/31
The cause of shunt revision	the cause of the shunt malfunction warranting revision operation	since the time of index operation until the initial revision or 2022/07/31
Type of the revision operation	the detailed description of the revision operation	since the time of index operation until the initial revision or 2022/07/31
Revision-free survival	the interval between index operation and the initial revision	since the time of index operation until the initial revision or 2022/07/31

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shunt revision-free survival among different hydrocephalus etiologies	the individual interval between index operation and the initial revision among different hydrocephalus etiologies	since the time of index operation until the initial revision or 2022/07/31

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Collaborators: Ministry of Science and Technology, Taiwan
• Investigators: Principal Investigator: ZHUO HAO Liu, PhD, Department of Neurosurgery Chang Gung Memorial Hospital Chang Gung Medical College and University

Publications and helpful links

General Publications

• Reddy GK, Bollam P, Shi R, Guthikonda B, Nanda A. Management of adult hydrocephalus with ventriculoperitoneal shunts: long-term single-institution experience. Neurosurgery. 2011 Oct;69(4):774-80; discussion 780-1. doi: 10.1227/NEU.0b013e31821ffa9e.
• Li M, Wang H, Ouyang Y, Yin M, Yin X. Efficacy and safety of programmable shunt valves for hydrocephalus: A meta-analysis. Int J Surg. 2017 Aug;44:139-146. doi: 10.1016/j.ijsu.2017.06.078. Epub 2017 Jun 22.
• Rinaldo L, Bhargav AG, Nesvick CL, Lanzino G, Elder BD. Effect of fixed-setting versus programmable valve on incidence of shunt revision after ventricular shunting for idiopathic normal pressure hydrocephalus. J Neurosurg. 2019 Jun 7:1-9. doi: 10.3171/2019.3.JNS183077. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Long-term outcome; Hydrocephalus; Programmable shunt
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus
• Other Study ID Numbers: 202200775B0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes