Implementation of a new CSF dynamic device: a multicenter feasibility study in 562 patients

Area of Science:

• Neurosurgery
• Neurology
• Medical Devices

Background:

• The cerebrospinal fluid (CSF) infusion test is crucial for selecting hydrocephalus patients for shunt surgery.
• Limited data exists on the adverse events associated with this diagnostic procedure.

Purpose of the Study:

• To prospectively evaluate the feasibility and safety of the CSF infusion test.
• To document adverse events during and after the procedure.

Main Methods:

• A prospective study involving 562 patients undergoing CSF infusion testing.
• Standardized devices were used to measure CSF dynamics via lumbar puncture (LP).
• Adverse events and patient discomfort were systematically registered.

Main Results:

• The most common indication was normal-pressure hydrocephalus evaluation (63%).
• Lumbar puncture was successful in most cases, with 4.3% reporting major discomfort.
• 4% of patients experienced severe headache during infusion, and 15% reported headache at 24-h follow-up. No serious adverse events occurred.

Conclusions:

• The CSF infusion test is a safe procedure with a high success rate.
• The investigation is associated with expected mild to moderate discomfort, primarily headaches.