Title
Case-Control Analysis of Endoscopic Intracerebral Hemorrhage Evacuation vs Medical Management
Christopher P Kellner, MD; J Mocco, MS, MD
Background
While intracerebral hemorrhage (ICH) accounts for only 10-15% of strokes, high mortality rates and poor functional outcomes make ICH an important target for novel therapeutic interventions (1, 2). While randomized trials of open surgery for supratentorial ICH have been performed, few benefits in mortality or functional outcomes have been seen (3, 4). However, endoscopic surgery in recent years has become more popular (5), with the Stereotactic Intracerebral Hemorrhage Underwater Blood Aspiration (SCUBA) technique being utilized at several centers (6). As randomized trials studying endoscopic techniques are currently enrolling, there is a dearth of literature currently comparing patients who underwent minimally-invasive ICH evacuation to those who received medical management. Our objective with this study will be to perform a propensity-matched analysis comparing patients who received minimally-invasive ICH evacuation to those who received medical management.
Hypotheses
Our hypothesis is that patients who underwent endoscopic evacuation will have better functional outcomes at 3 months as assessed via the modified Rankin Scale (mRS), lower rates of mortality, shorter hospital length of stay, and lower rates of decompressive hemicraniectomy.
Methods
Our study will consist of two cohorts from unique data sources. The primary interventional (endoscopic evacuation) cohort will be queried from the Mount Sinai Health System intracerebral hemorrhage registry. The control (medical management) cohort will be queried from the VISTA-ICH datasets. The inclusion criteria will include patients that had supratentorial ICH, were >18 years old at the time of hemorrhage, and had spontaneous ICH (no alternative source of bleeding found). Patients with traumatic ICH or who required immediate decompressive hemicraniectomy will be excluded.
Variables queried will include age, gender, premorbid mRS, ICH volume (as quantified by ABC/2), NIH Stroke Scale upon arrival, and baseline ICH score (7). The primary outcome will be good functional outcome (defined as mRS of 0-3) at 3 months, with secondary outcomes including mRS at discharge and 3 months, in-hospital and 3-month mortality, discharge disposition, decompressive hemicraniectomy rates, and hospital and intensive care unit (ICU) length of stay.
A propensity score will be constructed using logistic regression, with an outcome of receiving surgical vs. medical management and baseline characteristics as predictors. A 1:3 (surgical-to-medical) match using nearest neighbors to within 0.2 standard deviations of the logit of the propensity score will then be performed between the cohorts. Baseline characteristics and all outcomes will then be compared between the propensity-matched surgical and medical cohorts. A sensitivity analysis comparing the cohorts before propensity matching will also be performed.
References
1. Mozaffarian D, Benjamin EJ, Go AS, et al. Heart disease and stroke statistics – 2015 update: a report from the American Heart Association. Circulation 2015;131:e29–322.
2. Qureshi AI, Mendelow AD, Hanley DF. Intracerebral haemorrhage. Lancet 2009;373:1632–44.
3. Mendelow AD, Gregson BA, Rowan EN, et al. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial lobar intracerebral haematomas (STICH II): a randomised trial. Lancet 2013;382:397–408.
4. Hemphill JC, Greenberg SM, Anderson CS, et al. Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke 2015;46:2032–60.
5. Fiorella D, Arthur A, Bain M, et al. Minimally invasive surgery for Intracerebral and intraventricular hemorrhage: rationale, review of existing data and emerging technologies. Stroke 2016;47:1399–406.
6. Kellner CP, Chartrain AG, Nistal DA, et al. The Stereotactic Intracerebral Hemorrhage Underwater Blood Aspiration (SCUBA) technique for minimally invasive endoscopic intracerebral hemorrhage evacuation. Journal of NeuroInterventional Surgery. 2018;10(8):771-776. doi:10.1136/neurintsurg-2017-013719
7. Hemphill JC, Bonovich DC, Besmertis L, Manley GT, Johnston SC. The ICH score: a simple, reliable grading scale for intracerebral hemorrhage. Stroke. 2001;32(4):891-897. doi:10.1161/01.str.32.4.891
Funding Arrangements
We understand the cost and are prepared to pay the fee.