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Endovascular vs conservative treatment in patients with chronic subdural hematomas and mild symptoms: a study
Giancarlo Salsano1, Pietro Fiaschi2, Giorello Laura3
1Department of Radiology and Interventional Radiology, Neuroradiology Unit, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi, 10, 16132, Genoa, Italy. giancarlo.salsano@yahoo.it.
Insights
Middle meningeal artery embolization may reduce chronic subdural hematoma progression. This randomized trial will compare embolization to conservative management to assess effectiveness and safety, potentially changing clinical practice.
Area of Science:
- Neurosurgery
- Interventional Radiology
- Clinical Trials
Background:
- Chronic subdural hematoma (cSDH) is common in the elderly, lacking clear management guidelines.
- Current strategies vary, with conservative management for asymptomatic or mildly symptomatic cases.
- Middle meningeal artery (MMA) embolization shows promise in reducing cSDH recurrence and progression.
Purpose of the Study:
- To evaluate the superiority of MMA embolization over conservative treatment for cSDH.
- To determine the effectiveness and safety of endovascular embolization for cSDH.
- To assess if MMA embolization reduces progression rate and surgical rescue events compared to conservative care.
Main Methods:
- A multicenter, prospective, randomized clinical trial (PROBE design) with 300 patients.
- Patients randomized 1:1 to MMA embolization or conventional treatments.
- Primary outcome: treatment failure (incomplete resolution or surgical rescue within 6 months).
Main Results:
- This section is not applicable as the study is ongoing and results are not yet available.
Conclusions:
- A randomized trial is necessary to assess MMA embolization's benefit-risk ratio for cSDH.
- Positive results could lead to guideline changes and altered clinical practice.
- Further confirmatory trials may follow if MMA embolization proves superior.
Background:
Chronic subdural hematoma (cSDH) is a common neurosurgical condition that is prevalent in elderly patients. There are no well-defined guidelines for cSDH and management strategies vary widely among physicians and institutions, and this variability is expressed in the literature. In general, conservative management is reserved to patients who are asymptomatic or have minor symptoms with mild mass effect. Spontaneous resolution of cSDH is an unusual phenomenon and middle meningeal artery (MMA) embolization seems to reduce the recurrence and progression rate of SDH compared to conventional treatments in multiple cohort studies. A randomized controlled trial is warranted to determine the effectiveness and safety of endovascular embolization for cSDH and whether MMA embolization is superior to conservative management in reducing the progression rate and surgical rescue event.
Methods:
This is an Italian multicenter prospective randomized clinical trial with open-label treatment and blinded outcome assessment (PROBE design) to assess the superiority of MMA embolization compared to conservative treatment. A total of 300 patients are planned to be randomized 1:1 to receive MMA embolization (intervention) or conventional treatments (control). The primary outcome is the treatment arm failure which is defined as a composite of incomplete hematoma resolution or surgical rescue within 6 months follow-up. Incomplete hematoma resolution is defined as a reduction of the cSDH thickness ≤50% at follow-up compared to the hematoma thickness measured at the time of randomization. Surgical rescue is intended as hematoma removal for relief or symptoms that developed with continuous growth of the cSDH. In case of bilateral cSDH, the treatment failure occurred when primary outcomes criteria are satisfied for at least one of the two hematomas.
Discussion:
This multi-centre randomized controlled trial is needed to evaluate the benefit-to-risk ratio of primary embolization of the MMA to facilitate resolution and prevent rescue surgical evacuation of cSDH. If MMA embolization turns out to be superior to conservative management in this trial, this may prompt further confirmatory trials and, at best, may change clinical practice and guideline recommendations.
Trial Registration:
ClinicalTrials.gov. Identifier: NCT06274580, Registered on 6 February 2024. This protocol was developed in accordance with the SPIRIT Checklist and by use of the structured study protocol template provided by BMC Trials.
