Recent trends of treatment strategies and outcomes of basal ganglia hemorrhages at a single institution

Objective

The Early Minimally Invasive Removal of Intracerebral Hemorrhage (ENRICH) Trial was designed to evaluate the minimally invasive trans-sulcal parafascicular surgery (MIPS) approach, a technique advertised for safe access to deep brain structures and ICH removal using the BrainPath® and Myriad® devices (NICO Corporation, Indianapolis, IN). However, basal ganglia hemorrhages (BGHs) were determined to meet the a priori futility rule, resulting in exclusion from further trial enrollment consideration. Since screening for ICH is initiated immediately upon presentation of symptom bearing patients, treatment is curtailed to best preserve remaining neurological function. We sought to determine whether immediate exclusion from consideration of trial enrollment resulted in poorer patient outcomes despite best medical or surgical management.

Methods

A retrospective, observational, cohort analysis was performed on data extrapolated from our institution’s intracranial hemorrhage (ICH) screening log. All patients included in this study either (1) were excluded from the ENRICH trial for not meeting trial inclusion criteria or (2) presented on and after February 27^th, 2019 when BGHs. This inflection point in time was chosen based on the ENRICH trial’s decision to enact an a priori futility rule. Demographical, medical comorbities, presenting features, treatment characteristics, and outcomes were collected by chart review on all patients. These dichotimized groups were compared by univariate and multivariate statistical approaches. The main outcome of interest was functional status at 90 days as measured by the modified Rankin Scale.

Results

There were 52 patients with BGHs who presented before the interim exclusion decision, and 67 patients who presented after. The proportion of patients with intraventricular hemorrhage (IVH) occupying > 50 % of either lateral ventricle was higher in the “before” group (40.4 % vs 20.9 %, p = 0.026). There was a significant difference in the evacuation method used, with more patients in the “after” group undergoing craniotomy (10.5 % vs 0 %, p = 0.018). The 90-day mRS scores of 0–2 were significantly lower for patients who presented after the interim exclusion (16.4 % vs 36.5 %, p = 0.019). The 180-day mortality was not significantly different between the two groups (p = 0.56). In multivariate logistical regression, diabetes mellitus, hematoma volume at presentation, and presentation date were significant predictors of a “good” neurological outcome (90-day mRS score of 0–2). A 1 mL increase in hematoma volume at presentation was associated with a 4 % decrease in the likelihood of a good outcome (OR = 0.960, 95 % CI = 0.924–0.997, p = 0.033). Patients who presented after the interim exclusion had a 79.5 % lower likelihood of a “good” neurological outcome compared to those who presented before the interim exclusion (OR = 0.205, 95 % CI = 0.063–0.669, p = 0.009).

Conclusion

Those who presented after the interim decision had a significantly lower likelihood of achieving a 90-day mRS score of 0, 1, or 2, suggesting a possible change in care.