Comparison of Programmable and Non-programmable CSF Shunts Among Adult Hydrocephalus Patients With Different Etiologies
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- Initial Shunt revision rate [since the time of index operation until the initial revision or 2022/07/31]
the ratio of the total number of patients with at least one revision to the total number of patients included in this study
- Total Shunt revision rate [since the time of index operation until the initial revision or 2022/07/31]
the ratio of the total number of revisions to the total number of ventricular CSF shunt operations
- The cause of shunt revision [since the time of index operation until the initial revision or 2022/07/31]
the cause of the shunt malfunction warranting revision operation
- Type of the revision operation [since the time of index operation until the initial revision or 2022/07/31]
the detailed description of the revision operation
- Revision-free survival [since the time of index operation until the initial revision or 2022/07/31]
the interval between index operation and the initial revision
Secondary Outcome Measures
- Shunt revision-free survival among different hydrocephalus etiologies [since the time of index operation until the initial revision or 2022/07/31]
the individual interval between index operation and the initial revision among different hydrocephalus etiologies
Eligibility Criteria
Criteria
Inclusion Criteria:
- received shunting operations at Chang Gung Medical Foundation, Linkou Branch from 2017/01/01~2017/12/31
Exclusion Criteria:
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Patients who received index ventricular CSF shunt at other hospitals,
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Patients who received index ventricular CSF shunt before January 1st 2017,
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Patients who were younger than 18
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Chang Gung Memorial Hospital
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- 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.
- 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. [Epub ahead of print]
- 202200775B0