Trial of Early Minimally Invasive Removal of Intracerebral Hemorrhage.

BACKGROUND: Trials of surgical evacuation of supratentorial intracerebral hemorrhages have generally shown no functional benefit. Whether early minimally invasive surgical removal would result in better outcomes than medical management is not known. METHODS: In this multicenter, randomized trial involving patients with an acute intracerebral hemorrhage, we assessed surgical removal of the hematoma as compared with medical management. Patients who had a lobar or anterior basal ganglia hemorrhage with a hematoma volume of 30 to 80 ml were assigned, in a 1:1 ratio, within 24 hours after the time that they were last known to be well, to minimally invasive surgical removal of the hematoma plus guideline-based medical management (surgery group) or to guideline-based medical management alone (control group). The primary efficacy end point was the mean score on the utility-weighted modified Rankin scale (range, 0 to 1, with higher scores indicating better outcomes, according to patients' assessment) at 180 days, with a prespecified threshold for posterior probability of superiority of 0.975 or higher. The trial included rules for adaptation of enrollment criteria on the basis of hemorrhage location. A primary safety end point was death within 30 days after enrollment. RESULTS: A total of 300 patients were enrolled, of whom 30.7% had anterior basal ganglia hemorrhages and 69.3% had lobar hemorrhages. After 175 patients had been enrolled, an adaptation rule was triggered, and only persons with lobar hemorrhages were enrolled. The mean score on the utility-weighted modified Rankin scale at 180 days was 0.458 in the surgery group and 0.374 in the control group (difference, 0.084; 95% Bayesian credible interval, 0.005 to 0.163; posterior probability of superiority of surgery, 0.981). The mean between-group difference was 0.127 (95% Bayesian credible interval, 0.035 to 0.219) among patients with lobar hemorrhages and -0.013 (95% Bayesian credible interval, -0.147 to 0.116) among those with anterior basal ganglia hemorrhages. The percentage of patients who had died by 30 days was 9.3% in the surgery group and 18.0% in the control group. Five patients (3.3%) in the surgery group had postoperative rebleeding and neurologic deterioration. CONCLUSIONS: Among patients in whom surgery could be performed within 24 hours after an acute intracerebral hemorrhage, minimally invasive hematoma evacuation resulted in better functional outcomes at 180 days than those with guideline-based medical management. The effect of surgery appeared to be attributable to intervention for lobar hemorrhages. (Funded by Nico; ENRICH ClinicalTrials.gov number, NCT02880878.).

Early Minimally Invasive Removal of Intracerebral Hemorrhage (ENRICH): Study protocol for a multi-centered two-arm randomized adaptive trial.

Background: Intracerebral hemorrhage (ICH) is a potentially devastating condition with elevated early mortality rates, poor functional outcomes, and high costs of care. Standard of care involves intensive supportive therapy to prevent secondary injury. To date, there is no randomized control study demonstrating benefit of early evacuation of supratentorial ICH. Methods: 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 for safe access to deep brain structures and ICH removal using the BrainPath® and Myriad® devices (NICO Corporation, Indianapolis, IN). ENRICH is a multi-centered, two-arm, randomized, adaptive comparative-effectiveness study, where patients are block randomized by ICH location and Glasgow Coma Score (GCS) to early ICH evacuation using MIPS plus standard guideline-based management vs. standard management alone to determine if MIPS results in improved outcomes defined by the utility-weighted modified Rankin score (UWmRS) at 180 days as the primary endpoint. Secondary endpoints include clinical and economic outcomes of MIPS using cost per quality-adjusted life years (QALYs). The inclusion and exclusion criteria aim to capture a broad group of patients with high risk of significant morbidity and mortality to determine optimal treatment strategy. Discussion: ENRICH will result in improved understanding of the benefit of MIPS for both lobar and deep ICH affecting the basal ganglia. The ongoing study will lead to Level-I evidence to guide clinicians treatment options in the management of acute treatment of ICH. Trial registration: This study is registered with clinicaltrials.gov (Identifier: NCT02880878).

Monitored anesthesia care during mechanical thrombectomy for stroke: need for data-driven and individualized decisions.

BACKGROUND: The optimal anesthesia management for patients with stroke undergoing mechanical thrombectomy (MT) during the COVID-19 pandemic has become a matter of controversy. Some recent guidelines have favored general anesthesia (GA) in patients perceived as high risk for intraprocedural conversion from sedation to GA, including those with dominant hemispheric occlusions/aphasia or baseline National Institutes of Health Stroke Scale (NIHSS) score >15. We aim to identify the rate and predictors of conversion to GA during MT in a high-volume center where monitored anesthesia care (MAC) is the default modality. METHODS: A retrospective review of a prospectively maintained MT database from January 2013 to July 2020 was undertaken. Analyses were conducted to identify the predictors of intraprocedural conversion to GA. In addition, we analyzed the GA conversion rates in subgroups of interest. RESULTS: Among 1919 MT patients, 1681 (87.6%) started treatment under MAC (median age 65 years (IQR 55-76); baseline NIHSS 16 (IQR 11-21); 48.4% women). Of the 1677 eligible patients, 26 (1.6%) converted to GA including 1.4% (22/1615) with anterior and 6.5% (4/62) with posterior circulation strokes. The only predictor of GA conversion was posterior circulation stroke (OR 4.99, 95% CI 1.67 to 14.96, P=0.004). The conversion rates were numerically higher in right than in left hemispheric occlusions (1.6% vs 1.2%; OR 1.37, 95% CI 0.59 to 3.19, P=0.47) and in milder than in more severe strokes (NIHSS ≤15 vs >15: 2% vs 1.2%; OR 0.62, 95% CI 0.28 to 1.36, P=0.23). CONCLUSIONS: Our study showed that the overall rate of conversion from MAC to GA during MT was low (1.6%) and, while higher in posterior circulation strokes, it was not predicted by either hemispheric dominance or stroke severity. Caution should be given before changing clinical practice during moments of crisis.

Outcomes and implications of a single brain death examination policy on organ donation outcomes at a high-volume trauma center.

BACKGROUND: Despite current neurological guidelines that a single brain death examination (SBDE) is sufficient to determine brain death, a vast majority of hospitals still use a two brain death examination (TBDE) policy based on historical practice. The purpose of this study was to analyze the outcomes and implications of an SBDE policy compared with a TBDE policy with respect to organ donation outcomes. METHODS: We retrospectively reviewed all adult patients declared dead by neurological criteria between 2010 and 2018 at a high-volume trauma center. The study population was divided into SBDE and TBDE cohorts. Primary outcomes included time to organ donation, terminal donor creatinine and bilirubin, and number of procured and transplanted organs. RESULTS: A total of 327 patients comprised the study population: 66.7% SBDE (n = 218 of 327 patients) and 33.3% TBDE (n = 109 of 327 patients). The SBDE group had a shorter median time from examination to procurement (38 vs. 44 hours, p = 0.02) as well as lower terminal donor creatinine (1.1 vs. 1.35 mg/dL, p = 0.004) and bilirubin (0.8 vs. 1.1 mg/dL, p = 0.04). Furthermore, the SBDE group had a significantly greater proportion of kidneys (90.6% vs. 81.6%, p = 0.02), lungs (11.8% vs. 4.6%, p = 0.02), and total organs (58.2% vs. 46.6%; p = 0.0001) procured with intent to transplant and a greater proportion of total organs transplanted (53.1% vs. 42.4%, p = 0.0004). Multivariable regression analysis confirmed that SBDE was independently associated with a shorter time to procurement, lower terminal creatinine, and increased number of procured organs. CONCLUSION: These data highlight the potential benefit of an SBDE policy with regards to organ donation outcomes at a high-volume trauma center and should facilitate future randomized prospective studies to more rigorously test this hypothesis. LEVEL OF EVIDENCE: Therapeutic/Care Management, level IV.

Minimally Invasive Parafascicular Surgery (MIPS) for Spontaneous Intracerebral Hemorrhage Compared to Medical Management: A Case Series Comparison for a Single Institution.

OBJECTIVE: We compared the safety and effectiveness of minimally invasive parafascicular surgery (MIPS) as a frontline treatment for spontaneous supratentorial ICH to medical management. Patients. The sample consisted of 17 patients who underwent MIPS from January 2014 to December 2016 and a comparison group of 23 patients who were medically managed from June 2012 to December 2013. All had an International Classification of Disease (ICD) diagnosis of 431 and were treated at Grady Memorial Hospital, an urban, public, safety-net hospital. METHODS: The primary endpoint was risk of inpatient mortality. Secondary endpoints were rates of inpatient infection and favorable discharge status, defined as discharge to home or rehabilitation facility. Demographics and pre- and postclinical outcomes were compared using t-tests, the Mann-Whitney test, and chi-squared tests for continuous, ordinal and categorical measures, respectively. Cox proportional hazard models were used to estimate the time to inpatient death. Logistic regression analyses were used to determine treatment effects on secondary outcomes. We also conducted exploratory subgroup analyses which compared MIPS to two medical management subgroups: those who had surgery during their hospitalization and those that did not. RESULTS: Two patients (12%) died in the MIPS group compared to three (12%) in the medical management group. MIPS did not increase the risk of inpatient mortality relative to medical management. Rates of inpatient infection did not differ significantly between the two groups; eight MIPS patients (47%) and 13 medically managed patients (50%) contracted infections. MIPS significantly increased the likelihood of favorable discharge status (odds ratio (OR) 1.77; 95% CI, 1.12-21.9) compared to medical management. No outcome measures were significantly different between MIPS and the medical management subgroup without surgery, while rates of favorable discharge were higher among the MIPS patients compared to the medical management group with surgery. CONCLUSIONS: These data suggest that MIPS, as a frontline treatment for spontaneous ICH, versus medical management for spontaneous ICH warrants further investigation.

Initial and intermediate-term treatment of the phantom thrombus (primary non-occlusive mural thrombus on normal arteries).

An embolic event originating from thrombus on an otherwise un-diseased or minimally diseased proximal artery (Phantom Thrombus) is a rare but significant clinical challenge. All patients from a single center with an imaging defined luminal thrombus with a focal mural attachment site on an artery were evaluated retrospectively. We excluded all patients with underlying anatomic abnormalities of the vessel at the attachment site. Six patients with a mean age of 62.5 years were identified over a 2.5-year period. All patients had completed treatment for or had a current diagnosis of malignancy and none were on antiplatelets or other anticoagulants. Four thrombi originated in the aorta proximal to the renal arteries and one originated distal. One thrombus was found in the common carotid artery and one was in an arterialized vein graft. Mean follow-up was 22 months. None of the patients underwent removal or exclusion of the embolic source. With systemic anticoagulation, four of the phantom thrombi were resolved on imaging within 8 weeks, one resolved after 72 weeks. One phantom thrombus reoccurred after 6 months on reduced anticoagulant dosing. There was one acute and one death in follow-up (26 months). One patient required a partial foot amputation secondary to tissue necrosis from the initial thromboembolic event. Arterial thrombi forming on otherwise normal vessels are a distinct clinical entity. In patients with a phantom thrombus, a strategy of therapeutic anticoagulation for management of the embolic source seems to be safe and effective over both the short and intermediate-term.