Blocking artery plus surgery offers hope for reducing reoperations in brain hematoma patients

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Injecting a substance to block arteries feeding the dura (the protective sac around the brain) and draining pooled blood lowers the risk of surgery and patients needing repeat surgery compared to surgical drainage alone, according to early-breaking Science presented today. In American Stroke Association International Stroke Conference 2024. The meeting held in person in Phoenix on Feb. 7 – 9, 2024, a world premier meeting for researchers and clinicians dedicated to the science of stroke and brain health.

A subdural hematoma occurs when one of the thin blood vessels that stretches between the surface of the brain and the overlying membrane that protects the brain is torn. A subdural hematoma can be caused by a physical injury such as a car accident, but it can develop slowly within days or weeks of the injury. This study looked at the treatment of subacute or chronic subdural hematoma. Subacute subdural hematoma occurs after a less severe injury, such as a concussion – accompanied by weakness, numbness, convulsions, convulsions, headache, confusion or dizziness that develops hours or days after the event. Chronic subdural hematoma can result from slow bleeding after minimal trauma that the patient may not even notice – symptoms may be subtle and/or take weeks to become noticeable enough to require treatment.

Chronic subdural hematoma is one of the most common neurosurgical conditions and may increase in the future as we have an older population, many on blood thinners to manage various medical conditions. These hematomas often form in the elderly because as we age, the brain shrinks and moves away from the inside of the skull, dilating the veins that form a bridge between the dura and the brain, making them more likely to rupture after a minor injury. And blood leaks into the dura, the protective space between the brain and skull.”

Jason Davis, MD, Ph.D., Study co-authors, Associate Professor of Neurosurgery and Biomedical Informatics at State University of New York, Buffalo

Treatment of a subacute or chronic subdural hematoma may include a surgical procedure to drain the pooled blood from the area or close monitoring of symptoms to determine if and when intervention may be necessary. The challenge is that even with surgery, up to 20% of cases of subdural hematomas may require repeat surgery.

The EMBOLISE clinical trial examined whether a subacute or chronic subdural hematoma would require additional surgery if, in addition to surgical drainage, a substance was injected to block or embolize one of the arteries supplying blood to the dura. onyxTM The liquid embolic system, tested in this experiment, is already used before surgery to reduce bleeding in people undergoing surgery to correct an abnormal connection between an artery and vein in the brain.

Between December 2020 and August 2023, researchers enrolled 400 adults (mean age 72; 27% female) at 39 centers (including both community and academic hospitals). All were undergoing surgery for subacute or chronic subdural hematoma and were considered capable of self-care and expected to survive at least one year. Patients were randomly assigned to receive either surgery or surgery plus embolization using a liquid embolic system to reduce progression or recurrence of subdural hematoma.

The primary outcome was how often the blood recurred (a recurrence) requiring surgical drainage within 90 days.

The analysis found:

  • Subsequent subdural hematoma within 90 days and requiring surgical drainage occurred in 4.1% of patients who underwent surgery plus embolization and 11.3% of those who underwent surgery alone.
  • At 90 days after surgery, cumulative disability and neurological dysfunction were found to be comparable (statistically the same) in both groups, 11.9% of patients who underwent surgery plus embolization and 9.8% of patients who underwent surgery alone.
  • Serious adverse events attributable to embolization occurred in 2% of patients who received it.

“The EMBOLISE trial showed that patients who were treated with surgery and embolization had an almost 3-fold reduction in reoperation,” Davis said. “Fewer trips to the operating room mean less potential for pain, complications, recovery, and expense for the patient. Moreover, we could see that the complications associated with the embolization procedure were lower and there was no increase in neurological complications.”

Study Details and Background:

  • EMBOLISE (EMBOLIZATION OF MIDDLE MENINGEAL ARTERY WITH ONYXTM The Liquid Embolic System in the Treatment of Subacute and Chronic Subdural Hematoma) study was conducted at multiple hospitals and health centers in the United States.
  • Liquid embolic system treatment begins as an injectable soft solid, flows as a liquid when force is applied, and then returns to a soft solid to stop the blood vessels from leaking.
  • Other arms of the EMBOLISE study, in which patients did not undergo surgery and were randomized to receive the liquid embolic system, are ongoing and will not be presented at ISC 2024.
  • Additional measures measuring the success of fluid embolic system treatment included the number of hospitalizations; Hematoma (blood clot) change in volume or thickness; and changes in midline shift (when a hematoma pushes brain tissue out of alignment), assessed 90 days after treatment.
  • Safety endpoints included the incidence of neurologic death or serious adverse events at 30, 90, and 180 days after treatment.

The main limitation was a relatively high loss to follow. “One of the challenges of conducting this trial was dealing with a frail elderly population, especially in the midst of a pandemic. Tracking patients for follow-up is always a challenge, and it was compounded by the various COVID-era restrictions that many of our sites faced,” Davis said.

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