A Reality Check for Minimally Invasive Evacuation Surgery on Sudden Brain Bleeds

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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