Chronic subdural hematoma (cSDH) is a common neurological affliction which affects mostly frail and elderly patients. Surgical evacuation by using burr hole craniostomy (BHC) is the most frequently used treatment but carries a recurrence rate varying between 10-30% in the literature. Especially in this frail population re-operation is undesirable. Embolization of the middle meningeal artery is an adjuvant treatment which has been reported in multiple case reports and larger case series, showing a beneficial effect on recurrence rate, reducing it to \<5%, without complications.
Objectives: Primary: To evaluate whether additional embolization of the middle meningeal artery after surgery for cSDH reduces the recurrent surgery rate. Secondary: to evaluate whether the use of middle meningeal artery embolization after surgical treatment in symptomatic cSDH patients increases quality of life (SF-36 and the EQ-5D-5L), performance in activities of daily living (AMC Linear Disability Score), functional outcome (mRS), cognitive functioning (MOCA) and reduces mortality, occurrence of complications, recurrence rate, size and volume of the hematoma, neurological impairment (mNIHSS, Markwalder score) and the use of care and health-related costs (iMCQ and iPCQ).
Study design: Multicenter, randomized controlled open-label superiority trial. Study population: Patients diagnosed with a cSDH who require surgery. Intervention: The intervention group will receive embolization in addition to standard surgical treatment. The control group will receive surgery only.
Main study endpoint: The number of patients who require reoperation within 24 weeks after the intervention.
Symptomatic cSDH patients will undergo peri-operative embolization of the middle meningeal artery until 72 hours after surgical treatment. Complications are monitored during hospital admission and follow-up. Radiological and clinical follow-up is at eight, 16 and 24 weeks post-intervention with a CT-scan of the head and assessment of mRS, MOCA, mNIHSS, Markwalder score, SF-36, EQ-5D-5L, ALDS, iMCQ and iPCQ. Standard care after surgery entails outpatient follow-up with on average two CT-scans, indicated by clinical signs and symptoms.
· CT-confirmed diagnosis of chronic Subdural Hematoma;
Primary surgical treatment based on clinical symptoms (progressive neurological deficits).
· Significant contraindication to angiography (eg. allergy for contrast);
Structural causes for subdural hemorrhage, e.g. arachnoid cysts, cortical vascular malformations and a history of cranial surgery in the previous 365 days;
Inability to obtain informed consent from the patient or legal representative (when the patient has a depressed level of consciousness), including language barrier;
Monocular blindness on contralateral side of the hematoma;
Parallel
embolization of the middle meningeal artery
Procedure/SurgeryThe embolization procedure will be as follows: first femoral artery access will be obtained by using a 5 French micropuncture kit and common carotid and external carotid angiography is performed using a standard 5 French diagnostic catheter. A microcatheter is then advanced selectively under roadmap guidance into the middle meningeal artery (MMA), and MMA angiography is performed to evaluate for potential dangerous anastomoses such as the orbital branch to the ophthalmic artery. Embolization is performed using polyvinyl alcohol particles (100 microns in diameter) under blank fluoroscopic roadmap while carefully avoiding reflux. Particles are infused until lack of anterograde flow into the MMA branches is demonstrated on angiography, and the catheters are removed \[31\]. The procedure is performed under local anesthesia.
Reoperation
Number of patients who require a reoperation for recurrent cSDH
Reoperation
Number of patients who require a reoperation for recurrent cSDH
Reoperation
Number of patients who require a reoperation for recurrent cSDH
Hematoma volume reduction
hematoma volumes are measured on CT-scan of the head and compared to pre-operative volume
Hematoma volume reduction
hematoma volumes are measured on CT-scan of the head and compared to pre-operative volume
Hematoma volume reduction
hematoma volumes are measured on CT-scan of the head and compared to pre-operative volume
Complications
Number of complications will be monitored
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