Chronic subdural hematomas (CSH) are collections of blood in the subdural space. CSH are becoming the most common cranial neurosurgical condition among adults, and a significant public health problem, due to an increasing use of anticoagulant and antiplatelet medication in an ageing population. Symptomatic CSH, or CSH with a significant mass effect, are treated surgically. However, recurrences are common (10 to 20%). Conservative management (medical) is used in patients who are asymptomatic or have minor symptoms. However, therapeutic failures, requiring surgical treatment, are common. The pathophysiology of CSH involves inflammation, angiogenesis, and clotting dysfunction. Self-perpetuation and rebleeding is thought to be caused by neo-membranes from the inflammatory remodeling of the dura-mater mainly fed by the distal branches of the middle meningeal artery (MMA). There are 13 ongoing registered RCTs in CSH, with the most common covering application of steroids, surgical techniques and tranexamic acid. Further to this, there are trials running on other pharmacological agents, and peri-operative management. Some industrial or academic trials are or will enroll in France in the next year in France. But to our best knowledge, none of these trials will the eventual benefits of the MMA embolization in both cases of medical and/or surgical management, and none will focus on the use of cyanoacrylates (CYA) for this purpose.
Preliminary case series and nonrandomized retrospective studies have suggested that MMA embolization alone or as adjuvant therapy to surgery can decrease recurrences.
The investigators hypothesize that in both conditions of conservative or surgical managements, endovascular embolization of patients with CSH significantly reduces the risk of recurrence of CSH. The investigators choose the CYA as liquid embolic agent because of the pain and cost of the use of Ethylen Vinyl alcohol copolymer (EVOH) agents and its simplicity to be used.
Patient with a more than 10 mm CSH confirmed by NCCT
CSH localized to convexity
Patient aged 18 years or more at the time of the enrollment
Patient beneficiary from health insurance
Any contraindication as required per angiogram procedure (severe renal failure ≥ 4, allergy…)
Pre-existing severe disability resulting in baseline mRS score > 3
Life expectancy of less than 6 months due to another cause than CSH
Patient under legal protection or deprived of liberty by a judicial or administrative decision
Parallel
Medical treatment
Other interventionMedical treatment alone
Surgical treatment
Other interventionSurgical treatment alone
embolization of the MMA
Other interventionThe middle meningeal artery will be catheterized then embolized by cyanoacrylates until the occlusion of the MMA.
Number of CSH recurrence defined by the composite endpoint
CSH recurrence defined by the composite endpoint: * A symptomatic CSH during the 6 month FU period * A secondary surgical management during the 6 months FU period * A remaining or reaccumulated hematoma on NCCT at 6 months
Number of symptomatic CSH during the FU period
Number of symptomatic CSH during the FU period
Number of secondary surgical management during the FU period
Number of secondary surgical management during the FU period
Number of remaining or reaccumulated hematoma on NCCT
Number of remaining or reaccumulated hematoma on NCCT
Clinical efficacy
Mortality rate
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