Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation (MEMBRANE)

Status:

completed 03/2026

Aims:

Primary aim of this project was to reduce the rate of treatment-requiring recurrences of surgically treated chronic subdural hematomas (cSDH) by additional endovascular embolization of the frontal and parietal branches of the middle meningeal artery (MMA). The primary endpoint was the occurrence of cSDH recurrence following surgical treatment. The primary hypothesis stated that adjunctive MMA embolization would reduce the recurrence rate of surgically treated cSDH within a 3-month follow-up period. A reduction in recurrence risk was expected to prevent recurrence-associated complications such as neurological deficits, coma, or death. Furthermore, avoiding repeat surgeries for cSDH evacuation could reduce morbidity and mortality. Patients of working age might therefore return to work earlier and with a lower risk of long-term disability.

Activities/Methods:

In this randomized controlled trial, patients were randomly assigned to either the control or intervention group. While patients in the control arm received standard treatment, those in the intervention arm additionally underwent MMA embolization using digital subtraction angiography. Eligible participants were adult patients undergoing burr-hole surgery for first-time cSDH at ukb. Based on published data, a 20% difference in recurrence rates between groups within 3 months was assumed. With 80% power and a significance level of 5%, a sample size of 138 evaluable patients (69 per group) was calculated. After recruitment of half the target sample, a prespecified interim analysis according to the O'Brien-Fleming approach was performed. The study was to be terminated early in case of either significant superiority of the intervention or a substantially smaller treatment effect than expected.

Results:

Of the 93 randomized patients, 64 were available for analysis of the primary endpoint at interim analysis. Mean age was 74.6 ± 13.3 years, and 66.7% of patients were male. In the intervention group, 5 of 26 patients (19.2%) developed recurrent cSDH compared with 9 of 38 patients (23.7%) in the control group (p = 0.672). No revision surgeries were required in the intervention group, whereas four patients (10.5%) in the control group underwent reoperation (p = 0.140). No adverse events related to MMA embolization occurred. The small risk difference observed between study groups at interim analysis led to premature termination of the trial. Despite its limitations, the MEMBRANE study provides preliminary evidence regarding the safety of MMA embolization and its potential role in preventing cSDH recurrence in routine clinical practice. Thus, we implemented regular evaluation of the indication for additional MMAE in routine clinical practice. For patients with pre-existing conditions treated with anticoagulants, an increase in treatment safety through MMAE is foreseeable.

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