A novel treatment approach combining surgery and embolization for subdural hematomas significantly reduces the risk of recurrence, according to a study by researchers at Weill Cornell Medicine and University at Buffalo. The EMBOLISE study, a multi-center, randomized clinical trial, demonstrated the benefits of adding middle meningeal artery (MMA) embolization to standard surgical care.
The findings, published in the New England Journal of Medicine, indicate that hematoma recurrence or progression requiring subsequent surgery occurred in approximately 4% of patients who received MMA embolization in conjunction with surgery, compared to over 11% of those treated with surgery alone. This suggests a substantial improvement in patient outcomes with the combined approach.
The EMBOLISE Trial
The EMBOLISE trial, sponsored by Medtronic, involved 400 adult patients with chronic subdural hematomas across 39 medical centers. The mean age of participants was 72 years. Patients were randomly assigned to receive either MMA embolization plus surgery (197 patients) or surgery alone (203 patients).
"This trial provides evidence that adding MMA embolization should be a new standard of care for one of the most common neurosurgical conditions we see," said Dr. Jared Knopman, director of Cerebrovascular Surgery and Interventional Neuroradiology at Weill Cornell Medicine and co-lead author of the study.
Addressing a Critical Need
Chronic subdural hematomas are increasingly prevalent, particularly among older adults, and are projected to become the most common cranial neurosurgical disease by 2030. Symptoms, including weakness, headaches, and confusion, can develop gradually after a head injury. Traditional treatment involves surgical drainage of the hematoma, but recurrence rates are high, often necessitating repeat surgeries.
"For the last century, doctors have treated symptomatic subdural hematomas the same way; with surgery to create a small hole in the skull or removing a small section of skull to drain the blood," Dr. Knopman said. However, recurrence after surgical drainage occurs in approximately 15% of cases.
MMA embolization, developed by Dr. Knopman and colleagues, involves threading a catheter into the middle meningeal artery to deliver an embolic agent that blocks blood vessels feeding the hematoma. This reduces the likelihood of recurrence and the need for additional surgeries.
Implications for Patient Care
The EMBOLISE study results suggest that MMA embolization plus surgery should be considered as a new standard of care for chronic subdural hematomas. The procedure can reduce hospital readmissions and improve overall health outcomes, especially for the aging patient population.
Serious adverse events attributed to MMA embolization occurred in 2% of patients receiving the treatment. Researchers are now exploring the potential of upfront MMA embolization for patients with smaller hematomas to potentially avoid surgery altogether.
"In addition to demonstrating the role that the middle meningeal artery plays in the formation and recurrence of subdural hematomas, we have discovered an entirely new facet about the brain that has gone unknown and untreated for decades," Dr. Knopman added.
