Early Minimally Invasive Surgery Enhances Stroke Outcomes

INDIANAPOLIS – Patients with an intracerebral hemorrhage have better medical outcomes when surgeons perform an early minimally invasive removal of a hematoma compared to those receiving the standard of care, according to a study published in the New England Journal of Medicine.

Indiana University School of Medicine faculty clinicians Mitesh Shah, MD, Bradley Bohnstedt, MD, Regg Singh, MD and Jason Allen, MD, PhD are co-authors on a paper that assessed the findings of the ENRICH trial, a randomized clinical trial aimed at evaluating the effectiveness, safety and economics of the intervention of a minimally invasive neurosurgery technique.

The study found that patients with an intracerebral hemorrhage — a type of stroke caused by bleeding inside the brain — who had minimally invasive surgical evacuation of a brain blood clot and guideline-based medical management within 24 hours had better survival rates and functional outcomes at 180 days compared to patients who only received medical management.

Neurosurgeons used BrainPath and Myrid devices developed by the NICO Corporation, based out of Carmel, Indiana, to perform the surgery. Surgeons create a path to the site of bleeding by gently moving aside brain tissue. Once the BrainPath device was placed, an automated suction and resection tool — the Myrid device — was used to remove the hematoma in the brain.

"We can offer early clot removal in patients with an intracerebral hemorrhage and tell our patients that they have better outcomes and survival. The families of the patients can ultimately see patients leave the hospital sooner," said Shah, chair of the Department of Neurological Surgery.

According to the World Stroke Organization, there are more than 3.4 million new intracerebral hemorrhages each year — and over 28% of all incident strokes are intracerebral hemorrhages. In the United States, more than half of patients die within 30 days of a hemorrhage.

The 300 patients in the ENRICH trial, set at 37 centers across the United States, either had a lobar (208 patients) or anterior basal ganglia hemorrhage (92 patients) with a hematoma volume of 30-80 mL and were randomized between the two surgical groups — surgery/medical management and medical management. IU School of Medicine and its health partner IU Health was one of the sites in the trial, where 14 patients received care.

Nearly three-fourths of the surgical group in the clinical trial saw the volume of their blood clot decrease to 15 mL or less after surgery was performed within 24 hours. At 30 days post-hemorrhage, 90.7% of surgery patients survived, while 82% of medical management patients survived.

"By evacuating the clot with this early intervention, we can increase survivability and reduce the number of days spent in critical care and reduce health care costs," Bohnstedt said.

About IU School of Medicine

The IU School of Medicine is the largest medical school in the U.S. and is annually ranked among the top medical schools in the nation by U.S. News & World Report. The school offers high-quality medical education, access to leading medical research and rich campus life in nine Indiana cities, including rural and urban locations consistently recognized for livability. According to the Blue Ridge Institute for Medical Research, the IU School of Medicine ranks No. 13 in 2023 National Institutes of Health funding among all public medical schools in the country.