When the Stars Align: Trained Surgeon + New Technology & Early Intervention Save Life of Patient with Hemorrhagic Stroke
Being away from home on that foggy, rainy winter day on Jan. 12 was not that unusual. Cathy visited her mom quite often. But this trip would end very different from past visits.
“She went to get up from the table and the plate she was holding dropped to the floor,” said Cathy’s mom, Lorre Andryszczyk. “There were no symptoms, no complaints, no signs of anything being wrong. Then she said, ‘I hope I’m not having a stroke.’ I immediately called 9-1-1.”
Cleveland’s mobile stroke unit responded to the call and Cathy had her first brain scan before reaching the hospital that was only minutes away. She arrived at the emergency department awake, but confused and with difficulty speaking and moving the right side of her body.
Cathy had a hemorrhagic stroke with what a Cleveland hospital neurosurgeon called a medium to moderate size hemorrhage located deep in the basil ganglia area on the left side of her brain.
“This is an area where we have typically not been able to do surgery due to the deep location,” the neurosurgeon said. “But Cathy was absolutely the ideal candidate for a new surgical approach we had been using for about two years.”
Before surgery could begin, however, the neurosurgeon would need the approval of Cathy’s husband. Mike recalls the telephone conversation being very direct. “The options were to do nothing or consent to a new kind of brain surgery for stroke using new technology called BrainPath.
“If they didn’t do the BrainPath procedure, I knew the outcome would not be good and this story would have a completely different ending,” Mike said. “So I agreed to the surgery. The nurse promised they would take really good care of Cathy, and I jumped on a plane for Cleveland.”
The neurosurgeon had performed more than 60 surgeries using the BrainPath Approach, a minimally-disruptive kind of brain surgery that uses the NICO BrainPath to access the hematoma by creating a path through the natural folds of the brain to evacuate the clot. More than 5,000 surgical procedures have been performed using the technology, and this local hospital was among the first in the country to have the technology.
“I had very pessimistic thoughts during my time in flight,” Mike remembers. “I didn’t have any experience with stroke, but I knew this was serious. I wondered if I would ever see my wife alive again.”
As with any kind of stroke, time was precious. It was just over two hours after Cathy’s stroke when she was wheeled into the OR. The surgeon said before the availability of BrainPath, patients like Cathy would have been stabilized in the ICU and then a “watch and wait” approach would have been taken to allow the brain to absorb the blood.
“Many times this resulted in a long and drawn out recovery with complications that included brain swelling, possible surgery because of swelling and longer ICU stays,” said the surgeon. “Hemorrhagic stroke, even today, is not considered a surgical disease. But the BrainPath has given us the option to go after this kind of clot.
“We didn’t operate before,” he added. “Five years ago, I would not have operated at all on this kind of stroke. It’s taken us two years of using the system and getting comfortable. Now we’ve seen the results with BrainPath, and it’s really changing our thinking on this.”
Cathy’s surgery was completed in less than two hours. Cathy’s mom said the nurse gave her two thumbs up when they wheeled Cathy out of surgery.
“Cathy immediately smiled at us. She was talking and she recognized us,” Lorre said. “I knew then that my daughter would be fine.”
After surgery, the surgeon said he was really amazed at how well and how quickly Cathy was recovering. “As soon as she woke up, she was brighter and started to speak immediately.
“Hemorrhagic stroke is a very, very difficult disease,” the surgeon said. “Some of the brain is always affected. Recovery of 100 percent is a lofty goal, but certainly, that’s what we are here to do.”
Cathy was in the hospital for nine days and rehabilitation for 17 days. “There hasn’t been one person who hasn’t been impressed and astonished at how well I’m doing,” Cathy said. “People say they don’t even know I’ve had a stroke.”
Mike attributes Cathy’s survival and recovery to a perfect alignment of the stars that day in January. If she wasn’t in Cleveland or if she had already left on the drive from Cleveland to Columbus – it’s nothing short of a miracle, he said.
“There’s no disputing that without the BrainPath procedure, our life would have been completely different – and not in a positive way,” Mike added. “The more I’ve checked into the procedure and talked about it, it’s fascinating to me. I take a look at Cathy today and we’re so blessed.”
Cathy is continuing therapy and goes once a week for rehabilitation. She says they tell her it will take one to two years to reach her plateau. But that’s not what Cathy believes.
“I’m going to set the new norm,” she said. “I’m on the road to normal. I’m living more independently than I thought I would. I’m really grateful for what I have, and it’s only been four months.”
Cathy has healed cosmetically, too. The small, one-inch incision has healed to be invisible, she said.
“As traumatic as this has been, it’s really quite fascinating,” Mike said. “If it happens to a loved one of yours, pray that you’re at a place that can do this for you. Literally, it’s that simple.
“I don’t want to sound cliché, but this technology and the choice to have surgical intervention has to become more available – this just has to become a more accepted procedure.”
For more patient stories on NICO BrainPath visit www.niconeuro.com/patients/.
Hemorrhagic Stroke Clinical TrialTwenty four healthcare institutions including a prominent Cleveland hospital, are participating in a randomized controlled trial evaluating the clinical effectiveness of early surgical intervention using BrainPath following spontaneous intracerebral hemorrhage (ICH), the deadliest, costliest and most debilitating form of stroke.
The ENRICH (Early MiNimally-invasive Removal of ICH) trial is designed to determine the procedural safety, as well as the economic and functional benefit, of early surgical removal of intracerebral hemorrhage using the BrainPath Approach compared to the medical management standard of care. The BrainPath Approach uses a combination of technologies, including the FDA-cleared NICO BrainPath® or non-disruptive access and NICO Myriad® to achieve the goal of maximum clot evacuation.
The BrainPath device is used to access the hemorrhage site by navigating through the natural folds and fiber tracks of the brain, displacing brain tissue as it creates a corridor to the hemorrhage site and evacuating the clot, all through an opening the size of a dime. Ideal trial candidates are spontaneous supratentorial ICH patients with a good clinical chance of benefiting from the surgical treatment based on well-defined criteria for study enrollment.
This trial will build on current peer-reviewed clinical data on the BrainPath Approach including the results1 of a multi-center pilot study presented at the 2015 International Stroke Conference. The study was on the safety and efficacy of hematoma evacuation using a trans-sulcal surgical approach with BrainPath and showed “statistically significant” improvement in patients’ neurological state associated with early intervention. This improvement was reported in 35 patients at 10 centers with outcomes showing 89 percent clot evacuation and no new surgical deficits or deaths and was cited as a breakthrough in the treatment of hemorrhagic stroke.
“We are hoping this trial is positive so we can be more aggressive about how we care for people with intracerebral hemorrhage,” said Dr. Bain, the principle site investigator for the ENRICH trial. “We deal with this disease so conservatively now, and we can do better. We want to change the paradigm and treatment of this disease. A standardized approach and better technology is really going to help us.”
For more information about the ENRICH trial and to learn more about patient criteria for the trial, visit www.ENRICHtrial.com. Learn more about the NICO BrainPath and its use for accessing hemorrhagic stroke by visiting the website at www.NICOneuro.com. Procedure videos showing atraumatic access with BrainPath can be found on YouTube at NICOneuroCorp.
1Labib M, et al. The safety and efficacy of image-guided trans-sulcal radial corridors for hematoma evacuation: a multicenter study. Late breaking oral presentation LB12 at: 2015 International Stroke Conference; February 11-13, 2015; Nashville, TN.
The 411 on Hemorrhagic StrokeHemorrhagic stroke results from a weakened vessel that ruptures and bleeds into the surrounding brain. Studies show that early removal of the blood can potentially mitigate brain injury.1 However, the current standard of care calls for medical management of the patient or a “watch and see” protocol that often allows blood to remain in the brain2. Hemorrhagic stroke (ICH), impacts more than 160,000 people in the U.S. and 3.4 million people worldwide.
The Deadliest Form of Stroke
• Accounts for 10-15 percent of all strokes (or ~1/10)
• Early Mortality (30 days) can be up to 50 percent (30-50 percent)
• Only 20 percent of survivors are functionally independent
*All cited: Adeoye, O. and Broderick, J.P. Nat. Rev. Neurol. 6, 593-601 (2010);published online 28 September 2010; doi:10.1038/nrneurol.2010.146
New Outcomes with BrainPath
• Zero surgical related mortalities
• Immediate, post-procedure improvement in level of consciousness
• 63 percent of patients living functionally independent
(Labib,MA, et al. The Safety and Feasibility of Image-Guided BrainPath-Mediated Transsulcul Hematoma Evacuation: A Multicenter Study, Neurosurgery (2017) 80 (4): 515-524. DOI: https://doi.org/10.1227/NEU.0000000000001316
The National Stroke Association provides educational information about treatments for post-stroke issues through real-life stories. Promotion of these stories does not imply endorsement of any product or service and it is recommended that patients ask a healthcare professional before using any product, medicine, or therapy.