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February 15, 2024

SNIS: New Randomized Trials Support Adjunctive MMA Embolization for Chronic Subdural Hematoma

February 15, 2024—Based on new results from several key trials, the Society of NeuroInterventional Surgery (SNIS) voiced its support of middle meningeal artery embolization (MMAE) as a beneficial adjunctive treatment for chronic subdural hematoma (CSH). MMAE with liquid agents represents a major shift in CSH management, the Society says, with many patients potentially being able to avoid open surgery.

The statement from SNIS comes after recent presentations of the EMBOLISE, MAGIC-MT, and STEM prospective randomized controlled trials showed that adjunctive MMAE significantly reduces the failure rates of standard management strategies.

SNIS summarized the findings as follows:

The effect sizes of adjunctive MMAE in patients in the nonsurgical arms of MAGIC-MT and STEM indicate that many patients may be able to avoid open surgery completely as MMAE substantially reduced the failure rates of nonsurgical management. For patients who required surgical drainage, EMBOLISE showed that adjunctive MMAE significantly reduced reoperation rates. The surgical management arm of the STEM trial showed a similar robust trend with MMAE cutting surgical failure rates by about half; however, STEM did not show differences in the nonsurgical and surgical subgroups separately, and as such, the surgical arm findings were not significant as a stand-alone subgroup.

Commenting in the Society’s announcement were STEM trial leads Adam Arthur, MD, MPH, and David Fiorella, MD, PhD.

“The presented data indicate that this novel adjunctive procedure represents an important advance as it reduces the failure rates of standard management strategies with a high margin of procedural safety," said Dr. Fiorella. “CSH is an exceedingly common problem, and these findings will be relevant to a large population of patients. We look forward to the final published results of all three studies. In many ways, these data are really just the beginning. There will be a tremendous amount of additional insight coming very soon. The MEMBRANE trial from Cerenovus just recently completed enrollment and a combined analysis of all four of these randomized controlled trials of MMAE is planned."

Dr. Fiorella, Professor of Neurosurgery at Stony Brook University, also noted that EMBOLISE and STEM were performed under investigational device exemptions within the context of FDA-regulated prospective clinical trials and that no liquid embolic agent currently has FDA clearance for MMAE; regulatory review is pending.

“It is incredible to see the fruits of our labor after 6 years of research,” added Dr. Arthur in the SNIS comments. Dr. Arthur is Chair of Neurosurgery at the University of Tennessee Health Sciences Center and Semmes-Murphey Clinic. “Together as neurointerventionalists and neurosurgeons, we are making a difference by providing evidenced-based, effective, and patient-centric minimally invasive alternatives to traditional treatment strategies. My SNIS colleagues are continually producing remarkable work to advance the field and I am eager to witness what is to come.”

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