A breakthrough clinical trial in Atlanta found that a surgical technique to remove blood clots not only did so effectively, but also cut recovery times in some cases to days – allowing patients who suffered the worst kinds of previously fatal strokes to be released from hospitals soon after surgery.
“It’s a paradigm shift,” Gustavo Pradilla, a neurosurgeon at Emory University who led the study, told The Atlanta Journal-Constitution. “We were able to achieve 88% removal, the highest clot removal to date.”
It was no small feat for a branch of brain surgery that had, up until now, achieved much lower odds of removing blood clots without damaging brain tissue.
The study was published this week in the New England Journal of Medicine. The researchers at Emory University School of Medicine and Grady Memorial Hospital, along with doctors from 37 hospitals nationwide, based their trial on a simple theory: that a tool surgeons have used for years to remove tumors, but not blood clots, could help doctors act fast to remove clots and stop swelling.
The study confirmed researchers’ theory, and should lead to widespread adoption of a technique that will improve stroke outcomes for hospitals in Southeastern states, otherwise known as “the stroke belt” for having some of the highest rates of stroke in America.
Each year, about 2 million people suffer hemorrhagic strokes, which are considered the deadliest, most costly and debilitating form of stroke. Hemorrhagic stroke occurs when a weakened vessel ruptures and bleeds into the surrounding brain. The buildup of blood inside the skull can crush brain tissue and cause damage.
Up to 50% of people who suffer from hemorrhagic strokes will die within 30 days. But research suggested that removal of blood from the brain within 24 hours after bleeding starts could reduce brain damage and death.
Dan Barrow, a neurosurgeon at Emory who developed the protocol with Pradilla, said removing blood clots from the brain sounds, intuitively, like the right thing to do. But until their study, known as the “Trial of Early Minimally Invasive Removal of Intracerebral Hemorrhage,” or ENRICH study, the efficacy of such a procedure had not been proven.
“With intracerebral hemorrhage, there have been multiple studies going back to the 1960s trying to demonstrate a benefit for removing a hemorrhage from the brain,” Barrow told the AJC. “None showed a statistical benefit until now. Developing less invasive and more precise operations seems to be the key to cracking the nut.”
Credit: Photo provided by Emory University
Credit: Photo provided by Emory University
The ENRICH study used two medical devices made by Indianapolis-based Nico Corporation, which also funded the study. One tool, called the BrainPath, looks like a screw and essentially moves brain tissue to the side to avoid damage. A second tool, known as the meniGLIDE, removes the hard bits of blood via suction.
The study found that the procedure was most effective if performed within 24 hours of stroke. That’s because the brain recognizes blood clots as foreign bodies — and in seeking to remove them, the brain essentially attacks the clot, leading to inflammation in the brain that creates pressure in the skull and, in many cases, death.
Pradilla said he has trained 300 surgeons in the technique, and that over 1,000 others have adopted the method. The ultimate aim, he said, is to phase out conventional craniotomy, which entails a large skin incision, removal of a portion of the skull to access the brain, and a long recovery time.
According to the Georgia Department of Health, Georgia is in the “stroke belt,” an area in the Southeastern U.S. with stroke death rates that are approximately 30% higher than the rest of the U.S. The coastal plains of Georgia are in the “buckle” of the Stroke Belt, an area with stroke death rates about 40% higher than the rest of the nation.
Pradilla said he thinks the technique can reduce ICU stays for stroke recovery at Grady, where stays can sometimes stretch beyond two weeks.
Perry J. LeBlanc III, a financial advisor in Atlanta, was one of the first metro area residents to receive the new procedure.
The 56-year-old was diagnosed with prehypertension, but hadn’t yet been prescribed blood-pressure-lowering medication. He suffered an intracerebral hemorrhage while watching a varsity boys soccer game at Whitfield Academy, and was taken to Northside Hospital, then Emory University Hospital, where the procedure was performed within 24 hours.
“That procedure allowed me to not only survive the hemorrhage, but to do so with very little rehabilitation,” he told the AJC.
Stephan Mayer, a New York Medical College neurointensivist and ICH researcher who was not involved in the study, said the ENRICH trial will reduce mortality and stimulate more research.
“ICH is the most brutal form of stroke,” Mayer told the AJC. “To demonstrate that even for a subset of patients you can get a consistent shift towards more favorable recovery is really important and meaningful.”
