Does your competent? hospital have procedures in place to get research implemented into practice? Or don't you have a functioning stroke hospital? Are you sure you will be conscious enough to ask for this when you are in the ER? And hope they know how to do it by winging it?
Early Minimally Invasive Removal of Intracerebral Hemorrhage Shows Benefit
Outcomes appeared to be driven by lobar hemorrhage
In patients with acute intracerebral hemorrhage who had surgery within 24 hours, minimally invasive evacuation surgery combined with guideline-based medical management care yielded better functional outcomes at 180 days than medical management alone, the multicenter trial ENRICHopens in a new tab or window found.
Patients with supratentorial intracranial hemorrhages had a mean utility-weighted modified Rankin score (mRS) of 0.458 in the surgery group compared with 0.374 in the control group at 180 days (difference of 0.084, 95% Bayesian credible interval, 0.005-0.163), Gustavo Pradilla, MD, of the Emory University School of Medicine in Atlanta, and colleagues reported in the New England Journal of Medicineopens in a new tab or window. The utility-weighted mRS ranges from 0 to 1, with higher scores indicating better outcomes.
The posterior probability of superiority was 0.981, exceeding a prespecified threshold of 0.975, the researchers reported. "The result was apparently attributable to intervention for lobar supratentorial hemorrhages," they wrote.
"Patients who were treated with surgery -- including patients who were treated for deep hemorrhages -- the entire patient population showed a neurological benefit," Pradilla told MedPage Today.
Not only did more patients survive, "but they actually improved on their utility-weighted modified Rankin scale," he said.
Mean between-group difference in mRS scores at 180 days was 0.127 with lobar hemorrhages and -0.013 with anterior basal ganglia hemorrhages. At an interim analysis, the researchers stopped enrolling patients with anterior basal ganglia hemorrhage for futility.
Current guidelinesopens in a new tab or window support surgery for spontaneous intracerebral hemorrhage only as a last resort in most cases. A handful of trials that used different surgical techniques and a meta-analysis in which disability outcomes were known suggested a benefit for patients with small final hematoma volumes, observed A. David Mendelow, PhD, of Newcastle University in Newcastle upon Tyne in England, in an accompanying editorialopens in a new tab or window.
ENRICH, too, suggested patients had better outcomes with smaller hematoma volumes after surgery, Mendelow noted. "This implies that surgery needs to be effective at removing hematomas in order to achieve a good result, a conclusion that perhaps intuitive reasoning would suggest."
In ENRICH, the "benefits of surgery in patients with lobar hemorrhage were so great that the analysis of the primary end point in the total population (including those with anterior basal ganglia hemorrhage) showed a benefit from surgery," he continued.
The trial included patients 18-80 years old with CT evidence of supratentorial, spontaneous, acute intracerebral hemorrhage and a hematoma volume of 30 to 80 ml. Participants had scores of 5 to 14 on the Glasgow Coma Scaleopens in a new tab or window, more than 5 on the NIH stroke scaleopens in a new tab or window, and a score between 0 and 1 on the modified Rankin scaleopens in a new tab or window before the hemorrhage, representing little or no disability.
Patients were eligible if surgery could be started within 24 hours of the time they were last known to be well, and excluded if they had an uncorrectable coagulopathy or need for long term anticoagulation, among other criteria. Patients were assigned to undergo either minimally invasive trans-sulcal parafascicular surgery plus medical management or medical management alone.
A total of 300 patients from 37 U.S. centers were enrolled between 2016 and 2022, with a pause in 2020 due to the pandemic. Patients were a median age of 62-64, and around half were female. Ultimately, 92 patients had hemorrhage in the anterior basal ganglia location and 208 in the lobar location.
Fewer patients died in the surgery versus the control group at 30 days (9.3% vs 18%). Patients in the surgery group had shorter hospital and intensive care unit stays and fewer craniectomies performed. In the surgery group, 3.3% of patients had rebleeding associated with neurologic deterioration after surgery. Seizures and cerebral edema were more common in the control group.
The researchers were limited by the study's open-label design, and a lack of generalizability to patients with hematoma volumes less than 30 ml or more than 80 ml. Inferences of potential surgical benefit in basal ganglia hemorrhage patients were limited because few patients were enrolled. Methods of calculating hematoma volume were "crude," the authors noted.
The utility-rated weighted modified Rankin scale used as the primary endpoint had not been validated specifically for intracerebral hemorrhage, the authors noted.
![author['full_name']](https://clf1.medpagetoday.com/media/images/author/Putka_Resize_96.jpg)
Disclosures
Funding for this trial came from NICO.
Pradilla reported financial relationships with the NICO Corporation and Stryker Corporation.
Co-authors reported numerous financial relationships, including with industry.
Mendelow reported no financial relationships.
Primary Source
New England Journal of Medicine
Source Reference: opens in a new tab or windowPradilla G, et al "Trial of early minimally invasive removal of intracerebral hemorrhage" NEJM 2024; DOI: 10.1056/NEJMoa2308440.
Secondary Source
New England Journal of Medicine
Source Reference: opens in a new tab or windowMendelow AD, et al "New hope for adults with lobar intracerebral hemorrhage" NEJM 2024; DOI: 10.1056/NEJMe2401643.
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