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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Hydrocephalus, Ventriculoperitoneal Shunt Malfunction

Intervention / Treatment
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* Device: Programmable valve
* Device: Non-programmable valve


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydrocephalus, Programmable shunt, Long-term outcome