ICH has surgical Clot removal that is superior to Meds alone

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The ENRICH trial, showing improved functional outcomes with surgical clot evacuation plus medical management, has now been published in The New England Journal of Medicine.
The mean utility-weighted modified Rankin score at 180 days, the primary efficacy endpoint, was 0.458 in the surgery group and 0.374 in the control group.
The mean between-group difference was 0.127 among those with lobar hemorrhages (95% CI, 0.035-0.219) and -0.013 among those with basal ganglia hemorrhages (95% CI, -0.147 to 0.116).
At the final 180-day follow-up, 30 patients (20%) in the surgery group and 35 patients (23%) in the control group had died from any cause.
In the surgery group, one or more serious adverse events occurred in 95 patients (63.3%), and five patients had rebleeding associated with neurologic deterioration after surgery.
In the control group, 118 patients (78.7%) had one or more serious adverse events.
The average length of ICU stay fell from 9.7 days among controls to 6.9 in the surgical group and overall hospital stay dropped from 18.1 days to 14.9 days, respectively.
In addition, 30 patients in the control group required decompressive hemicraniectomy compared with five in the surgical group, Padilla said.

NEUTRAL

Recently, The New England Journal of Medicine published a study called ENRICH that demonstrated better functional outcomes when surgical clot evacuation was combined with medical management.

According to a report from Medscape Medical News at the time, the trial results were initially presented at the American Association of Neurological Surgeons (AANS) 2023 Annual Meeting.

The current paper was published online on April 10 and highlights the lack of support from current guidelines for routinely using conventional craniotomy surgery to improve outcomes following an intracerebral hemorrhage (ICH).

While meta-analyses have indicated potential benefits for minimally invasive surgery (MIPS) techniques, the MISTIE-III trial found that functional outcomes were improved at one year with minimally invasive catheter-based evacuation plus alteplase.

The researchers reported that a significant amount of hematoma has been successfully and safely removed by minimally invasive trans-sulcal parafascicular ICH evacuation, which is accessed through a port in a sulcus oriented along the long axis of the white-matter tracts.

Using the BrainPath minimal access port, Myrid aspiration device, suction, and guideline-directed medical management alone or in combination with early trans-sulcal MIPS, the ENRICH trial directly compared treatment for 300 patients with a supratentorial ICH. Federal approval has been granted to NICO Corporation’s two devices.

Patients met the eligibility criteria if their Glasgow Coma Scale score fell between 5 and 14, if their hematoma volume was between 30 and 80 mL, and if surgery could be completed within 24 hours of the patient’s last known normal. Thirty-seven percent had anterior basal ganglia hemorrhages, and seventy-four percent had lobar hemorrhages. Only those patients who had experienced lobar hemorrhages were enrolled after the first 175 patients, due to the activation of an adaptation rule.

At the 180-day mark, the primary efficacy endpoint, the surgery group’s mean utility-weighted modified Rankin score was 0.458, while the control group’s was 0.374.

With a between-group difference of at least 0.075, the difference between the groups was 0.084 (Bayesian 95 percent CI, 0.005-0.163), indicating a clinically meaningful effect.

Between those who had lobar hemorrhages (95 percent CI: 0.035-0.219) and those who had basal ganglia hemorrhages (95 percent CI: -0.147 to 0.116), the mean between-group difference was 0.127 as well as -0.013 respectively.

Gustavo Pradilla, MD, of Emory University School of Medicine in Atlanta, Georgia, who led the study, told Medscape Medical News, “We found a powerful effect for lobar hemorrhages.”. We stopped enrolling patients with basal ganglia, and the sample size consists of only roughly 100 patients with basal ganglia, so we are unsure if this will be helpful for them. Thus, we are unable to make inferences from that sample. “.

Novel Investigative and Secondary Examinations.

Pradilla pointed out that the current paper offers fresh information on a number of outcomes, such as the primary safety endpoint of 30-day mortality, which was almost cut in half in the surgery group (between-group difference, -8.7; Bayesian 95 percent CI, -16.4 to -1.0) from 18% with medical treatment alone to 93%.

Thirty patients (20%) in the surgery group and thirty-five patients (23%), in the control group, had passed away at the final 180-day follow-up for any reason.

Five patients experienced rebleeding following surgery, which was linked to neurologic decline, and 95 patients (63.3%) experienced one or more major adverse events. One or more significant adverse events were reported by 118 patients (78.7%) in the control group.

The average length of hospital stay decreased from 18 points1 days to 14 points9 days, and the average length of ICU stay decreased from 9 points 7 days among controls to 6 points9 days in the surgical group.

Pradilla stated, “ICU stays in this specific disease are really important because about half of the patients who survive the ICH event and make it to the hospital will die from complications related to the ICU, such as pneumonia, sepsis, [pulmonary embolisms], and deep vein thromboses.”. “Therefore, the daily rate in the compounded intensive care unit increases. ****.

Surgical patients spent fewer days on ventilation (5.3 vs. 8.8), according to exploratory analyses, but mechanical ventilation was more common after surgery than after medical therapy alone (58.7 percent vs. 52 percent).

In addition, Padilla reported that compared to five patients in the surgical group, 30 patients in the control group needed decompressive hemicraniectomy.

“A Pleasant Discovery”.

In a statement to Medscape Medical News, Larry Goldstein, MD, Ruth L. Works Professor and chair of the University of Kentucky, Lexington Department of Neurology stated: “The improvement in functional outcome is a positive finding supporting the intervention, but it is limited to patients chosen and managed according to the study protocol, with the benefit typically limited to patients with more superficial bleeding rather than bleeding in deeper parts of the brain. “.

A non-participant in the research, Goldstein pointed out that only 300 out of the 11,600 patients screened for eligibility were assigned at random. Additionally, the participants’ treatment group was known to the accessors.

Goldstein noted that the intervention was only available to patients who could have the surgery within 24 hours of the onset of symptoms and that it was not compared to other surgical methods. “It is unknown whether more delayed interventions would be beneficial and whether the results would be similar using other techniques,” the speaker stated.

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