Adjunctive Middle Meningeal Artery Embolization for Subdural Hematoma

Jason M Davies; Jared Knopman; Maxim Mokin; Ameer E Hassan; Robert E Harbaugh; Alexander Khalessi; Jens Fiehler; Bradley A Gross; Ramesh Grandhi; Jason Tarpley; Walavan Sivakumar; Mark Bain; R Webster Crowley; Thomas W Link; Justin F Fraser; Michael R Levitt; Peng Roc Chen; Ricardo A Hanel; Joe D Bernard; Mouhammad Jumaa; Patrick Youssef; Marshall C Cress; Mohammad Imran Chaudry; Hakeem J Shakir; Walter S Lesley; Joshua Billingsley; Jesse Jones; Matthew J Koch; Alexandra R Paul; William J Mack; Joshua W Osbun; Kathleen Dlouhy; Jonathan A Grossberg; Christopher P Kellner; Daniel H Sahlein; Justin Santarelli; Clemens M Schirmer; Justin Singer; Jesse J Liu; Aniel Q Majjhoo; Thomas Wolfe; Neil V Patel; Christopher Roark; Adnan H Siddiqui; EMBOLISE Investigators

doi:10.1056/NEJMoa2313472

Adjunctive Middle Meningeal Artery Embolization for Subdural Hematoma

N Engl J Med. 2024 Nov 21;391(20):1890-1900. doi: 10.1056/NEJMoa2313472.

Authors

Jason M Davies¹, Jared Knopman¹, Maxim Mokin¹, Ameer E Hassan¹, Robert E Harbaugh¹, Alexander Khalessi¹, Jens Fiehler¹, Bradley A Gross¹, Ramesh Grandhi¹, Jason Tarpley¹, Walavan Sivakumar¹, Mark Bain¹, R Webster Crowley¹, Thomas W Link¹, Justin F Fraser¹, Michael R Levitt¹, Peng Roc Chen¹, Ricardo A Hanel¹, Joe D Bernard¹, Mouhammad Jumaa¹, Patrick Youssef¹, Marshall C Cress¹, Mohammad Imran Chaudry¹, Hakeem J Shakir¹, Walter S Lesley¹, Joshua Billingsley¹, Jesse Jones¹, Matthew J Koch¹, Alexandra R Paul¹, William J Mack¹, Joshua W Osbun¹, Kathleen Dlouhy¹, Jonathan A Grossberg¹, Christopher P Kellner¹, Daniel H Sahlein¹, Justin Santarelli¹, Clemens M Schirmer¹, Justin Singer¹, Jesse J Liu¹, Aniel Q Majjhoo¹, Thomas Wolfe¹, Neil V Patel¹, Christopher Roark¹, Adnan H Siddiqui¹; EMBOLISE Investigators

Collaborators

EMBOLISE Investigators:
Joshua Billingsley, Alexandra R Paul, Daniel H Sahlein, Joe D Bernard, Thomas Wolfe, Ricardo A Hanel, Joshua W Osbun, Walter S Lesley, Jason M Davies, Mark Bain, Clemens M Schirmer, Jonathan A Grossberg, Michael R Levitt, Neil V Patel, Aniel Q Majjhoo, Peng Roc Chen, Jared Knopman, Thomas W Link, Hakeem J Shakir, Jesse J Liu, Marshall C Cress, Mohammad Imran Chaudry, Mouhammad Jumaa, Jason Tarpley, Walavan Sivakumar, R Webster Crowley, Justin Singer, Maxim Mokin, Christopher P Kellner, Patrick Youssef, Matthew J Koch, Jesse Jones, Christopher Roark, Kathleen Dlouhy, Justin F Fraser, Bradley A Gross, William J Mack, Ramesh Grandhi, Ameer E Hassan, Justin Santarelli

Affiliation

¹ From the Departments of Neurosurgery (J.M.D., A.H.S.), Biomedical Informatics (J.M.D.), and Radiology (A.H.S.), Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, the Department of Neurological Surgery, New York Presbyterian Hospital-Weill Cornell Medical Center (J.K.), and the Department of Neurosurgery, Icahn School of Medicine at Mount Sinai (C.P.K.), New York, the Department of Neurosurgery, North Shore University Hospital at Northwell Health, Great Neck (T.W.L.), the Department of Neurosurgery, Albany Medical Center, Albany (A.R.P.), and the Department of Neurosurgery, Westchester Medical Center at New York Medical College, Valhalla (J. Santarelli) - all in New York; the Department of Neurosurgery and Brain Repair, University of South Florida, and Tampa General Hospital, Tampa (M.M.), Lyerly Neurosurgery, Baptist Medical Center Jacksonville, Jacksonville (R.A.H.), the Orlando Health Neuroscience Institute, Division of Neurosurgery, Orlando Health, Orlando Regional Medical Center, Orlando (M.C.C.), and the Department of Neurosurgery, University of Florida, Gainesville (M.J.K.) - all in Florida; the Department of Neuroscience, Valley Baptist Medical Center, and the Department of Neurology, University of Texas Rio Grande Valley, Harlingen (A.E.H.), the Department of Neurosurgery, Memorial Hermann-Texas Medical Center, Houston (P.R.C.), and the Department of Neurosurgery, Baylor Scott and White Health, Temple (W.S.L.) - all in Texas; the Departments of Neurosurgery and Engineering Science and Mechanics, Penn State University, Hershey (R.E.H.), the Department of Neurosurgery, University of Pittsburgh Medical Center, Pittsburgh (B.A.G.), and the Department of Neurosurgery, Geisinger and Geisinger Commonwealth School of Medicine, Wilkes-Barre (C.M.S.) - all in Pennsylvania; the Departments of Neurological Surgery, Surgery, Radiology, and Neurosciences, University of California, San Diego, La Jolla (A.K.), the Departments of Radiology (J.T.) and Neurosurgery (W.S.), Providence Little Company of Mary Medical Center, Torrance, Pacific Neuroscience Institute, Santa Monica (J.T., W.S.), and the Department of Neurological Surgery, Keck School of Medicine, University of Southern California, Los Angeles (W.J.M.) - all in California; the Department of Diagnostic and Interventional Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (J.F.); the Department of Neurosurgery, University of Utah School of Medicine, Salt Lake City (R.G.); the Cerebrovascular Center, Cleveland Clinic, Cleveland (M.B.), the Department of Neurology, ProMedica Toledo Hospital-University of Toledo College of Medicine and Life Sciences, Toledo (M.J.), and Wexner Medical Center, Ohio State University, Columbus (P.Y.) - all in Ohio; the Department of Neurosurgery, Rush University, Chicago (R.W.C.), and the Department of Neurosciences, Advocate Lutheran General Hospital, Park Ridge (J.B.) - both in Illinois; the Departments of Neurological Surgery, Neurology, Radiology, Otolaryngology, and Neuroscience, University of Kentucky, Lexington (J.F.F.); the Departments of Neurological Surgery, Radiology, Neurology, and Mechanical Engineering and the Stroke and Applied Neuroscience Center, University of Washington, Seattle (M.R.L.); the Department of Neurosurgery, Atrium Health Carolinas Medical Center, and Carolina Neurosurgery and Spine Associates - both in Charlotte, NC (J.D.B.); the Department of Diagnostic Radiology and Neuroradiology, Prisma Health Southeastern Neurosurgical and Spine Institute, Greenville, SC (M.I.C.); the Department of Neurosurgery, University of Oklahoma Health Sciences Center, Oklahoma City (H.J.S.); the Departments of Neurosurgery and Radiology, University of Alabama School of Medicine, Birmingham (J.J.); the Departments of Neurosurgery, Radiology, and Neurology, Washington University in St. Louis, St. Louis (J.W.O.); the Department of Neurosurgery, University of Iowa Hospitals and Clinics, Iowa City (K.D.); the Department of Neurosurgery, Emory University School of Medicine, Atlanta (J.A.G.); the Department of Neurointerventional Radiology, Goodman Campbell Brain and Spine, Indianapolis (D.H.S.); the Department of Neurosurgery, Michigan State University College of Human Medicine, Grand Rapids (J.S.), the Department of Neurology, McLaren Flint Hospital, Flint (A.Q.M.), and McLaren Macomb Hospital, Mount Clemens (A.Q.M.) - all in Michigan; the Department of Neurological Surgery, Oregon Health and Science University, Portland (J.J.L.); Aurora Neuroscience Innovation Institute, Milwaukee (T.W.); the Division of Neurointerventional Radiology, Department of Radiology, Beth Israel Lahey Health, Lahey Hospital and Medical Center, Burlington, MA (N.V.P.); and the Department of Neurosurgery, University of Colorado, Denver (C.R.).

PMID: 39565988
DOI: 10.1056/NEJMoa2313472

Abstract

Background: Subacute and chronic subdural hematomas are common and frequently recur after surgical evacuation. The effect of adjunctive middle meningeal artery embolization on the risk of reoperation remains unclear.

Methods: In a prospective, multicenter, interventional, adaptive-design trial, we randomly assigned patients with symptomatic subacute or chronic subdural hematoma with an indication for surgical evacuation to undergo middle meningeal artery embolization plus surgery (treatment group) or surgery alone (control group). The primary end point was hematoma recurrence or progression that led to repeat surgery within 90 days after the index treatment. The clinical secondary end point was deterioration of neurologic function at 90 days, which was assessed with the modified Rankin scale in a noninferiority analysis (margin for risk difference, 15 percentage points).

Results: A total of 197 patients were randomly assigned to the treatment group and 203 to the control group. Surgery occurred before randomization in 136 of 400 patients (34.0%). Hematoma recurrence or progression leading to repeat surgery occurred in 8 patients (4.1%) in the treatment group, as compared with 23 patients (11.3%) in the control group (relative risk, 0.36; 95% confidence interval [CI], 0.11 to 0.80; P = 0.008). Functional deterioration occurred in 11.9% of the patients in the treatment group and in 9.8% of those in the control group (risk difference, 2.1 percentage points; 95% CI, -4.8 to 8.9). Mortality at 90 days was 5.1% in the treatment group and 3.0% in the control group. By 30 days, serious adverse events related to the embolization procedure had occurred in 4 patients (2.0%) in the treatment group, including disabling stroke in 2 patients; no additional events had occurred by 180 days.

Conclusions: Among patients with symptomatic subacute or chronic subdural hematoma with an indication for surgical evacuation, middle meningeal artery embolization plus surgery was associated with a lower risk of hematoma recurrence or progression leading to reoperation than surgery alone. Further study is needed to evaluate the safety of middle meningeal artery embolization in the management of subdural hematoma. (Funded by Medtronic; EMBOLISE ClinicalTrials.gov number, NCT04402632.).

Publication types

Randomized Controlled Trial
Multicenter Study

MeSH terms

Aged
Aged, 80 and over
Combined Modality Therapy / adverse effects
Combined Modality Therapy / methods
Disease Progression
Drainage* / adverse effects
Drainage* / methods
Drainage* / statistics & numerical data
Embolization, Therapeutic* / adverse effects
Embolization, Therapeutic* / methods
Female
Hematoma, Subdural, Chronic* / mortality
Hematoma, Subdural, Chronic* / therapy
Humans
Male
Meningeal Arteries* / surgery
Middle Aged
Prospective Studies
Recurrence
Reoperation / statistics & numerical data
Stroke / epidemiology
Stroke / etiology

Associated data

ClinicalTrials.gov/NCT04402632