LOS ANGELES -- A strategy of minimally
invasive surgery (MIS) for spontaneous intracerebral hemorrhage (ICH)
failed to meet expectations in the MIND trial.
Patients who underwent MIS with the Artemis NeuroEvacuation device
ended up with virtually the same modified Rankin Scale (mRS) score at
180 days as peers who had medical management alone, supported by both
intention-to-treat (mean OR 1.03, 95% CI 0.62-1.72) and by per-protocol
analysis (mean OR 1.29, 95% CI 0.76-2.20), according to David Fiorella,
MD, PhD, of Stony Brook Medical Center in New York.
There
had been some early clinical benefit detected at the 30-day mark (OR
4.23, 95% CI 2.36-7.57) that applied to deep and lobar bleeds -- but
this did not persist to 90 or 180 days, Fiorella told the audience here
at the International Stroke Conference.
Fiorella maintained that in MIND, hematoma evacuation with MIS was
beneficial for patients with deep and lobar ICH as it produced
substantial hemorrhage reductions with an 80.7% evacuation rate.
Notably, the MIND trial had been stopped early due to diminishing odds
of success, and was left underpowered for the main analysis of treatment
size.
As for safety, the trial saw low 30-day mortality overall, reaching a similar 9.8% with medical management and 7.2% with MIS (P=0.6167) on an as-treated basis.
The goal of MIS is controlled aspiration of tissue and/or fluid from a
brain bleed. The concept of MIS had been validated previously in a
high-profile trial using another device. That study, ENRICH,
had shown neurological benefit to MIS for patients with acute ICH,
particularly lobar supratentorial hemorrhages, at 180 days. The
researchers had stopped enrolling patients with anterior basal ganglia
hemorrhage for futility.
ENRICH
operators had been told to evacuate bleeds with suction and the Myriad
device. In contrast, MIND tested the Artemis NeuroEvacuation device
designed to target an area markedly narrower than the device used in
ENRICH.
"While safe and effective at removing hematomas, minimally invasive
surgery for non-traumatic intracerebral hemorrhage did not improve
overall outcomes in the MIND study. These data are in line with ENRICH
in that evacuation of deep ICH is not currently clinically beneficial,"
commented Alexander Merkler, MD, MS, neurologist at Weill Cornell
Medicine in New York City.
Bleeds represented in MIND were mostly deep (70.8%), otherwise lobar
(29.2%). The deep bleeds tended to affect younger patients, more men,
and people with more comorbidities; they were also associated with more
severe stroke symptoms and smaller ICH volumes at presentation.
Merkler told MedPage Today that "given the safety and
efficacy of hematoma evacuation, I look forward to future studies
perhaps targeting earlier hematoma evacuation as a means to improve
outcomes."
MIND
was a prospective, open-label trial that enrolled adults up to 80 years
old with moderate-large (20-80 mL) supratentorial ICH, presenting
within 24 hours of symptom onset, with an NIH Stroke Scale score of at
least 6, and who had previously been living with no or minimal
disability.
Participants were randomized 2:1 to MIS or medical management alone
of their brain bleeds. The MIS patients had their procedures within 72
hours of the ictus/bleed.
Fiorella explained that MIND had started with 200 patients and passed
an interim analysis before the data threw clinical equipoise into
question. Investigators eventually stopped randomizing lobar ICHs, and
enrollment paused due to a protocol amendment. Later, an independent
feasibility analysis suggested low probability of statistical difference
between study arms in the deep ICH cohort. In the end, the group had a
final sample of 236 individuals -- too few for a powered analysis of
the primary endpoint.
Participants
had a median age of 60 years, and under 40% were women. NIH Stroke
Scale score was 18 at baseline. Time to randomization was 19.5 hours for
the control group and 22 hours for the MIS group. Baseline ICH volume
was around 40 mL. Hemphill scores were about 80% in the 0-2 range, and
GCS scores about 55% in the 5-12 range.
Subgroup comparisons did not show that MIS resulted in any better or worse survival in deep or lobar brain bleeds.
Yet serious adverse events -- particularly symptomatic evolution of
perihematomal edema -- were less frequent in the MIS arm compared
with medical management, a finding that was consistent between the two
ICH locations.
Stays in the hospital and ICU were about equally long whether
patients received MIS or not. Only the secondary endpoint of intubation
at 30 days appeared to favor MIS (3.6% vs 12.1%, P=0.047).
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Nicole Lou is a reporter for MedPage Today, where she covers cardiology news and other developments in medicine. Follow
Disclosures
The study was sponsored by Penumbra.
Fiorella
disclosed relationships with Medtronic, Stryker, BALT USA, Cerenovus,
RAPID.ai, RAPID Medical, Q'Apel, Phenox, MENTICE, Microvention,
Scientia, Arsenal, and Elixir.
Merkler had no disclosures.
Primary Source
International Stroke Conference
Source Reference: Fiorella
D "Procedural, safety, and functional outcomes following minimally
invasive surgery for deep and lobar intracranial hemorrhages: 180-day
MIND study results" ISC 2025.