Improving Functional Outcomes after Intracerebral Hemorrhage
October 21, 2020
MIND study explores safety and efficacy of minimally invasive hematoma evacuation with Artemis device
Innovations in Neurology & Neurosurgery | Fall 2020
About 10 to 15 percent of all strokes are caused by intracerebral hemorrhages (ICHs), or acute bleeding inside the brain. ICH is the deadliest and most disabling subtype of stroke, with a one-year mortality rate of more than 50%.
The incidence of these hemorrhages is highest in elderly patients, making them even more devastating for patients and their families. Fewer than 20 percent of ICH survivors will be independent at six months. Most are left with severe disability and will require assistance in daily living.
“Current treatments can save your life, but patients end up in a nursing home or long-term care,” explains Yin Hu, MD, Division Chief of Neurological Surgery at University Hospitals Ahuja Medical Center, Clinical Associate Professor, Case Western Reserve University School of Medicine,
and principal investigator of a new UH study on minimally invasive hematoma evacuation. “We haven’t shown much improvement in functional outcomes.”
Fortunately, that trend is changing. Recent clinical trials have shown that patients undergoing minimally invasive hematoma evacuation may experience improved functional outcomes after one year.
UH was among the first in the country to get involved with initial trials for endovascular intracerebral hemorrhage evacuation, explains Abhishek Ray, MD, who completed his residency training and endovascular fellowship at the health system during that time.
“One of the first trials was ICES for brain hemorrhage,” recalls Dr. Ray, now a neurosurgeon in the Department of Neurological Surgery at University Hospitals Cleveland Medical Center, Assistant Professor of Neurological Surgery at the School of Medicine, and the sub-investigator in the new UH study. “That was exciting as a resident in training — to see how we could help patients with deep intracerebral hemorrhages who didn’t have an effective treatment available otherwise.”
IMPROVING FUNCTIONAL OUTCOMES
Even though the results of the ICES trial were not statistically significant, the trend toward improved functional outcomes was promising, Dr. Hu says. “So, that led to a process of us asking, ‘What will happen if we develop a process where we can make a small hole in the head to suck the clot out and minimize disruption of the surrounding brain tissue?’” he says.
That question is precisely what Dr. Hu and Dr. Ray hope to explore with “MIND: A Prospective, Multicenter Study of Artemis, a Minimally Invasive Neuro Evacuation Device, in the Removal of Intracerebral Hemorrhage,” which received Institutional Review Board (IRB) approval in November 2019. The primary objective of the multicenter, randomized controlled study is to compare the safety and efficacy of minimally invasive hematoma evacuation with the Artemis Neuro Evacuation Device to best medical management for the treatment of ICH.
Surgery for ICH is primarily meant to reduce secondary effects from the hemorrhage, such as brain swelling and damage to areas that haven’t yet been affected. With today’s approaches, surgeons will remove a large portion of the patient’s skull to go in and remove pressure or remove the clot.
“Whatever device you are using, the clot in the ICH is tough, and you need some way to suck it up and get a better evacuation,” Dr. Ray explains. “Our goal is not to get every drop of clot out, but to get the majority out.”
The emergence of new surgical devices, such as Penumbra Inc.’s Artemis device used in MIND, change that by taking a minimally invasive surgical approach. Dr. Hu describes Artemis as a slender suction that is hand-controlled with a sort of pulsatile aspiration on the end. A small agitator is used to break up and remove a clot without disrupting surrounding brain tissue, so patients can also avoid a bigger, more invasive surgery and the risks that come with it.
“This is the most minimally invasive trial so far,” he says. “We are inserting a hole in the brain maybe twice the size of a straw hole. So you will suck the clot, but you won't damage the brain. There’s nothing else out there like it.”
MIND participants will undergo 90-day and 180-day follow-up and post-op scans during their course of treatment. “Our primary objective with the trial is to determine if there is a difference in terms of functional outcomes for patients,” Dr. Hu says. “Additionally, we will test for secondary outcome measures, such as length of hospital stay, length of ICU stay, length of procedure time and more.”
Patient enrollment moves forward
After several years of preparation, UH is now recruiting patients for the MIND trial, with the first enrolled this spring — shortly before the COVID-19 pandemic. Dr. Hu says the goal is to complete the study by 2022, although he admits that patient enrollment is a challenge.
Enrolling patients for MIND is a large, coordinated team effort between neuro-interventionalists, stroke neurology teams, research coordinators, nurses and other staff to manage the full process — from screening to enrollment to follow-up care — and ensure patients meet strict inclusion criteria. For example, Dr. Hu says, “The patient must be highly functional before the hemorrhage.”
“A lot of times the patient is affected neurologically, so they cannot fully consent to the procedure,” Dr. Hu explains. “Also, patients and their families get nervous about being enrolled in a trial for brain surgery.”
Surgery with the Artemis also involves a novel device that requires multiple people to operate.
“During surgery, someone is stabilizing the sheet or the endoscope to make sure there isn’t a lot of maneuvering the device when you are suctioning the clot,” Dr. Ray explains. “It often requires at least four hands.”
With clinical trials like MIND, which involve surgery versus medical management, family members may feel disheartened if a relative is enrolled in a non-surgical form of treatment. Additionally, COVID-19 presents its own challenges for researchers who are focused on serious cases such as newly found brain tumors, traumatic spinal cord injuries and stroke.
“We’re used to talking to a room full of family and friends during the enrollment process, which we have not been able to do since February 2020” Dr. Ray says. “It’s challenging, because someone who is completely neurologically intact living their life can have devastating neurologic consequences, including being paralyzed on one side of their body, and their family and friends are struggling with that.”
The MIND team is now using virtual platforms such as Facetime, Zoom and WebEx to involve family members and help them with the decision for their relative.