Trial results support benefits of minimally invasive therapy in treating chronic subdural hematoma

New research by Society of Neurolnterventional Surgery (SNIS) members found that adjunctive middle meningeal artery embolization (MMAE) for the treatment of chronic subdural hematoma resulted in a lower risk of treatment failure than standard treatment alone, without resulting in an increased incidence of disabling stroke or death in the short term.

Following preliminary findings presented at the International Stroke Conference, the final results of the Squid Trial for the Embolization of the Middle Meningeal Artery for the Treatment of Chronic Subdural Hematoma (STEM) published in the New England Journal of Medicine (NEJM) demonstrate MMAE to be a beneficial adjunctive treatment for chronic subdural hematoma, cutting the overall rate of failure from 36% to 16%.

In light of these findings, SNIS is urging the field to consider MMAE as they plan treatment protocols, ensuring eligible chronic subdural hematoma patients have access to this safe and effective treatment.

Chronic subdural hematoma is associated with significant morbidity and mortality, resulting in a tremendous healthcare resource burden in the U.S. This disorder refers to the gradual accumulation of blood over the surface of the brain, primarily affecting elderly patients. As the U.S. population continues to age, studies show that chronic subdural hematoma may be the most prevalent neurosurgical diagnosis that requires treatment within the next decade.

The existing standard of care for treating chronic subdural hematoma has a high rate of surgical failure. It involves either drilling holes into the skull to drain the blood (i.e., surgical management) or watchful waiting with various medical interventions (i.e., non-surgical management) for patients who do not require early surgical intervention and/or are poor surgical candidates. However, an average of 10% to 30% of patients experience recurrence of chronic subdural hematoma after surgery, often necessitating reoperation. Studies like STEM show these surgical failure rates are higher among elderly patients, and failure rates among patients initially managed non-surgically are reported to be even higher.

The technically straightforward and minimally invasive MMAE procedure is performed using small catheters inserted through a blood vessel in the arm or leg. These small catheters are then navigated into the middle meningeal artery and liquid agents are injected into these blood vessels, solidifying within them (like a glue), blocking them off and stopping the chronic bleeding into the subdural space.

Adjunctive MMAE with liquid agents started in 2018 with two members of SNIS who went on to lead the pivotal STEM trial (sponsored by BALT USA) — former SNIS President Adam Arthur MD MPH and David Fiorella MD PhD.

“The final results of STEM demonstrate the positive impact that adjunctive MMAE can have in the lives of chronic subdural hematoma patients, giving them the best possible odds of a successful treatment,” said Dr. Fiorella, professor of neurosurgery at Stony Brook University. “This is a significant achievement for the field of neurointerventional surgery.”

It is important to acknowledge that STEM was performed under investigational device exemptions within the context of an FDA-regulated prospective clinical trial. No liquid embolic agent currently has FDA clearance for MMAE and regulatory review is pending.

“This treatment represents a major shift in the management of this disease,” said Dr. Arthur, chair of neurosurgery at the University of Tennessee Health Sciences Center and Semmes-Murphey Clinic. “As neurointerventionalists and neurosurgeons, we strive to provide the best for our patients through evidence-based, effective and minimally invasive strategies. My SNIS colleagues are continually working together to challenge the status quo and advance the field. There are other important studies of this treatment underway and we hope to do a combined analysis in the near future. I look forward to what’s to come.”

Source: News Release
Society of NeuroInterventional Surgery
November 21, 2024