EMBOLISE randomized surgical trial for subdural hematoma: Clinical benefits beyond reoperation with middle meningeal artery embolization

Jared Knopman, Neurological Surgery, NewYork-Presbyterian Weill Cornell Medical Center, New York, New York, USA.
Jason M. Davies, Neurosurgery and Bioinformatics and Canon Stroke and Vascular Research Center, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York, USA jdavies@ubns.com.
Maxim Mokin, Neurosurgery and Brain Repair, University of South Florida, Tampa, Florida, USA.
Ameer E. Hassan, Neuroscience, University of Texas Rio Grande Valley, Harlingen, Texas, USA.
Robert E. Harbaugh, Neurosurgery and Engineering Science & Mechanics, Penn State University, Hershey, Pennsylvania, USA.
Alexander Khalessi, Neurological Surgery, Surgery, Radiology, and Neurosciences, University of California San Diego, La Jolla, California, USA.
Jens Fiehler, Diagnostic and Interventional Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Elad I. Levy, Neurosurgery, Gates Vascular Institute, Buffalo, New York, USA.
Bradley A. Gross, Neurosurgery, University of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania, USA.
Ramesh Grandhi, Department of Neurosurgery, University of Utah Health, Salt Lake City, Utah, USA.
Jason Tarpley, Radiology, Providence Little Company of Mary Medical Center San Pedro, Torrance, California, USA.
Walavan Sivakumar, Neurosurgery, Providence Little Company of Mary Medical Center Torrance, Torrance, California, USA.
Mark Bain, Cerebrovascular Center, Cleveland Clinic, Cleveland, Ohio, USA.
R Webster Crowley, Neurosurgery, Rush University, Chicago, Illinois, USA.
Thomas W. Link, Neurosurgery, North Shore University Hospital, Great Neck, New York, USA.
Justin F. Fraser, Neurological Surgery, Neurology, Radiology, Otolaryngology, and Neuroscience, University of Kentucky, Lexington, Kentucky, USA.
Michael R. Levitt, Neurological Surgery, Radiology, Neurology, Mechanical Engineering, and Stroke & Applied Neuroscience Center, University of Washington School of Medicine, Seattle, Washington, USA.
Peng Roc Chen, Neurosurgery, Memorial Hermann Texas Medical Center, Houston, Texas, USA.
Ricardo A. Hanel, Cerebrovascular Surgery, Baptist Neurological Institute, Lyerly Neurosurgery, Jacksonville, Florida, USA.
Joe D. Bernard, Neuroendovascular Surgery, Neuroradiology, Atrium Health Carolinas Medical Center, Charlotte, North Carolina, USA.
Mouhammad Jumaa, Neurology and Interventional Neurology, The University of Toledo Medical Center, Toledo, Ohio, USA.
Patrick P. Youssef, Neurological Surgery, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Marshall C. Cress, Orlando Health Neuroscience Institute Neurosurgery Group, Orlando Health Orlando Regional Medical Center, Orlando, Florida, USA.
Mohammad Imran Chaudry, Diagnostic Radiology and Neuroradiology, Prisma Health, Greenville, South Carolina, USA.
Hakeem J. Shakir, Department of Neurosurgery, The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.
Walter S. Lesley, Neurosurgery, Baylor Scott & White Health, Temple, Texas, USA.
Joshua Billingsley, Advocate Health - MidwestFollow
Jesse Jones, Neurosurgery and Radiology, The University of Alabama at Birmingham Heersink School of Medicine, Birmingham, Alabama, USA.
Matthew J. Koch, Department of Neurosurgery, University of Florida, Gainesville, Florida, USA.
Alexandra R. Paul, Neurosurgery, Albany Medical Center, Albany, New York, USA.
et al

Affiliations

Advocate Lutheran General Hospital

Abstract

Background: Randomized clinical trials have demonstrated that middle meningeal artery embolization (MMAe) reduces reoperation rates in surgically treated patients with subacute/chronic subdural hematoma (SDH). The effect of embolization on outcomes beyond reoperation remains to be determined. We analyzed the impact of reoperation and healthcare encounters among patients enrolled in the EMBOLISE trial.

Methods: Symptomatic subacute/chronic SDH patients were randomized to surgical evacuation alone (control) or surgical evacuation plus Onyx MMAe (treatment). Changes in modified Rankin Scale (mRS) scores, frequency of unscheduled follow-up visits, and radiographic evolution of hematomas in patients with versus without reoperation were analyzed.

Results: A total of 197 patients were randomly assigned to the treatment group and 203 to the control group. Patients who required reoperation compared with those who did not exhibited a ~threefold higher incidence of mRS >2 (37.0% vs 12.9%, P=0.0025) and an ~2.5 fold increase in mRS worsening (22.2% vs 9.5%, P=0.0503) at 180 days. In patients who did not receive MMAe, there was a ~threefold fold increase in rate of SDH recurrence/progression even among those who did not require reoperation (14.3% vs 5.3%, P=0.0045) and a ~twofold increase in unscheduled physician follow-up visits (27.1% vs 14.7%, P=0.0031).

Conclusion: Among patients with symptomatic subacute/chronic SDH, reoperation was associated with increased rates of mRS worsening and higher mRS scores at follow-up. Adjunctive Onyx MMAe resulted in lower rates of hematoma recurrence/progression and fewer unscheduled physician follow-up visits. Thus, in addition to reducing surgical reoperation rates, adjunctive MMAe led to improved clinical outcomes and reduced healthcare encounters.

Document Type

Article

PubMed ID

41444014

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