Minimally invasive endoscopic surgery may be an effective and safe treatment for patients with intracerebral hemorrhage, the most severe type of stroke, according to results from a recent clinical trial published in JAMA Neurology.
“This trial shows this procedure is safe, effective, generalizable and surgeons can offer it. It will certainly help in terms of getting patients out of the ICU faster,” said Babak Jahromi, MD, PhD, professor of Neurological Surgery and a co-author of the study, who was principal investigator for the Northwestern Medicine clinical trial site.
“Hemorrhagic stroke is the one place where we still don’t have good surgical treatments, and this is why this study is so important because it’s finally showing that there is hope on the horizon,” said Jahromi, who is also a professor in the Ken and Ruth Davee Department of Neurology and of Radiology.
Intracerebral hemorrhage — when a blood vessel ruptures in the brain and bleeds into surrounding brain tissue — accounts for approximately 15 percent of all strokes and has the highest mortality rate of any stroke type, according to a recent guideline from the American Heart Association and American Stroke Association.
Both non-surgical and surgical interventions are used to stop bleeding, remove blood clots and relieve pressure on the brain. Current surgical procedures are considered “maximally invasive,” in which they require removing a large portion of the skull and making an incision into the brain.
While these procedures have been shown to improve mortality in patients, they have not yet been shown to improve patients’ ability to perform daily tasks and overall cognitive function after surgery, according to Jahromi.
“Such procedures were shown to save life but not necessarily improve function,” Jahromi said. “Until about a year ago, it was demonstrated that a minimally invasive procedure could be of help for such brain hemorrhages if they were superficial, as in closer to the surface of the brain or if they involved a large lobe of the brain.”
In the current multicenter clinical trial, Jahromi and his collaborators aimed to determine if a minimally invasive endoscopic surgical approach could remove an intracerebral hemorrhage without disturbing surrounding brain tissue and, ultimately, improve functional outcomes in patients.
Specifically, the procedure involves drilling a small hole in the skull (no larger than a dime) and then using computer-assisted navigation to direct the endoscope through the brain and to the site of the hemorrhage.
A total of 236 participants from 32 clinical trial sites around the world with spontaneous supratentorial intracerebral hemorrhage were randomized 2:1 to either undergo the surgical procedure within 72 hours of symptom onset and receive medical management or receive medical management alone.
The average age of participants was 60 years; 36.9 percent were female, 69.5 percent had deep tissue bleeds and 30.5 percent had lobar bleeds (bleeding in the cerebral lobes).
The investigators found that minimally invasive surgery within 72 hours did not significantly reduce mortality 30 days post-surgery or improve disability 180 days post-surgery compared to medical management alone. However, patients who underwent surgery did show an improvement in disability 30 days post-surgery and a reduction in serious adverse events 180 days post-surgery.
The findings show that endoscopic evacuation can be effective and safe treatment approach for intracerebral hemorrhage, according to Jahromi.
“When we compare the patients that were treated with an endoscopic evacuation versus patients that were treated purely with medical means at 30 days, the patients who had this endoscopic evacuation did much better,” Jahromi said. “What’s interesting is that the benefit doesn’t hold up at 90 days or 180 days; it seems that eventually the medical group begins to recover and catch up. But what this study showed for the first time is that endoscopic evacuation is very effective and safe.”
Jahromi said future clinical trials will aim to identify which patient groups may benefit from the procedure beyond 30 days and narrow down the optimal time of when to surgically intervene.
“This trial takes us one step towards identifying the appropriate substrate of patients that should be enrolled in the next trial, and I think it gives us an idea that the target for [hemorrhage] evacuation should likely be earlier,” Jahromi said.
This study was supported by Penumbra, Inc.
