Minimally Invasive Technique Demonstrates Positive Surgical Outcome in Treatment of Hemorrhagic Strokes

By HospiMedica International staff writers
Posted on 27 Apr 2023

Image: The BrainPath family of products includes 13.5mm and 11mm diameter devices of various lengths (Photo courtesy of NICO)

Annually, hemorrhagic strokes affect two million people, representing the most lethal, expensive, and debilitating type of stroke. This kind of stroke occurs when a weakened blood vessel ruptures and bleeds into the brain, causing toxic blood to accumulate. Regrettably, nearly 50% of hemorrhagic stroke victims die within a month. Studies indicate that removing blood from the brain within 24 hours of the bleeding onset could minimize brain damage and fatalities. Currently, the standard treatment involves administering medication or adopting a "watch and see" approach, potentially prolonging blood presence in the brain and raising the risk of complications. Researchers have now announced promising results from a surgical treatment trial for hemorrhagic strokes, showing positive outcomes in treating intracerebral hemorrhage (ICH).

In the ENRICH (Early MiNimally-invasive Removal of ICH) randomized, multi-center clinical trial led by Emory University School of Medicine (Atlanta, GA, USA), researchers compared standard medical management to early minimally invasive parafascicular surgery (MIPS) using the BrainPath and Myriad technology from NICO Corporation (Indianapolis, IN, USA). The BrainPath device assists surgeons in reaching the bleeding site in the brain by delicately navigating through its folds and fibers, gently displacing brain tissue to create a pathway. Once at the site, the Myriad device, an automated suction and resection tool, removes the clot.

After six months, functional outcomes in ENRICH were assessed using the utility-weighted modified Rankin Scale (UWmRS), with scores above zero indicating improved results. The mean UWmRS score was 0.458 for the MIPS group and 0.374 for those receiving standard medical management, reflecting a 98.1% posterior probability of superiority. This difference fulfilled the primary endpoint, proving a statistically significant and clinically meaningful improvement in UWmRS for the MIPS group. The ENRICH study also determined MIPS to be safe, with an overall mortality rate of 21.7% at six months (20% for MIPS, 23.3% for the standard medical management group). In the MIPS group, median hematoma evacuation was 88%, with a median end-of-treatment volume (EOTV) of 7.2mL. Overall, 73% of patients achieved the EOTV goal of less than 15mL, considered the surgical standard in clot evacuation.

“The results of the ENRICH trial are revolutionary and represent an advancement for improving outcomes for the millions of people who suffer hemorrhagic strokes,” said Jim Pearson, president and CEO, NICO Corporation.

“ENRICH is the first, randomized clinical trial to meet its primary endpoint, while improving outcomes for these deadly strokes,” said Gustavo Pradilla, MD, co-lead investigator for ENRICH, associate professor of neurosurgery at Emory University School of Medicine and chief of neurosurgery for Grady Memorial Hospital. “This trial will help to change how we treat hemorrhagic stroke moving forward.”