The MIND trial, sponsored by Penumbra, Inc., the manufacturer of the Artemis evacuation device, has demonstrated promising results in the field of minimally invasive surgery for intracerebral hemorrhage (ICH). Although the trial was halted early due to clinical equipoise after enrolling 236 patients, it provided valuable insights into the potential benefits of using the Artemis device. The primary endpoint focused on measuring the 180-day global disability through the ordinal modified Rankin score. This trial evaluated a novel surgical approach, utilizing a 14-mm burr hole for cranial access, which has shown significant promise in treating ICH.
The majority of participants in the MIND trial presented with ICH located deeply within the brain, accounting for 70% of cases, while the remaining 30% suffered from lobar bleeds. The median time from symptom onset to procedure was 27 hours. Remarkably, the Artemis evacuation device achieved excellent hematoma evacuation rates of approximately 80% across both deep and lobar ICH cases. The average procedure time stood at an impressive 27 minutes, with deep ICH requiring 37 minutes and lobar ICH taking only 25 minutes.
In terms of adverse outcomes, the surgical group experienced a lower rate of serious adverse events within 180 days, with 52% compared to 68% in the medical care group. Additionally, the conversion rate to craniotomy was notably low at just 1.4%. The trial also revealed that patients in the surgical group demonstrated more favorable clinical outcomes at 30 days. Although there was a numerical reduction in mortality for patients with lobar ICH using the surgical approach, it did not reach statistical significance. However, it was observed that this minimally invasive technique seemed to be more effective in patients with lobar ICH.
"This strategy is in the early stages of evolution. With more data from our study and future studies, we will get better at identifying the patients who will benefit from this approach, and I expect that practice will gradually change over time," – David Fiorella
The MIND trial's findings pointed to a lower rate of edema in the minimally invasive surgery arm, standing at 2.6% compared to 13.4% in patients receiving medical care alone. The trial highlighted substantial technical success with the Artemis neuro evacuation device, achieving significant hematoma reductions.
"Because of the early termination, the study is very underpowered, so the results are just descriptive. There are some trends toward benefit, but nothing significant." – Craig Anderson
"It can be challenging to incorporate new surgical techniques into routine practice. This is a complex intervention. Hospitals have to invest in the equipment, and surgeons have to train in the new procedure," – Craig Anderson
The MIND trial builds on the results from the ENRICH trial, showing positive effects without any indication of harm. According to Dr. David Fiorella, these findings underscore early benefits associated with minimally invasive surgical procedures. The results suggest a greater effect in patients with lobar ICH compared to those with deep ICH, providing an optimistic outlook for future studies of this technique.
"Our results build on those from the ENRICH trial, showing some positive effects, with no signal of harm," – David Fiorella
"We showed some early benefits with the minimally invasive surgical procedure. Consistent with the ENRICH trial, there appeared to be a greater effect in patients with lobar ICH vs those with deep ICH. These results are very encouraging for future studies of this technique," – David Fiorella
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