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

Jared Knopman; Jason M. Davies; Maxim Mokin; Ameer E. Hassan; Robert E. Harbaugh; Alexander Khalessi; Jens Fiehler; Elad I. Levy; 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 P. 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 M. Dlouhy; Jonathan A. Grossberg; Christopher P. Kellner; Daniel H. Sahlein; Justin Santarelli; Clemens M. Schirmer; Paul Mazaris; Jesse J. Liu; Aniel Q. Majjhoo; Thomas Wolfe; Neil V. Patel; Christopher D. Roark; Adnan H. Siddiqui

doi:10.1136/jnis-2025-024587

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

Jared Knopman
, Jason M. Davies
, Maxim Mokin
, Ameer E. Hassan
, Robert E. Harbaugh
, Alexander Khalessi
, Jens Fiehler
, Elad I. Levy
, 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 P. 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 M. Dlouhy, Jonathan A. Grossberg, Christopher P. Kellner, Daniel H. Sahlein, Justin Santarelli, Clemens M. Schirmer, Paul Mazaris, Jesse J. Liu, Aniel Q. Majjhoo, Thomas Wolfe, Neil V. Patel, Christopher D. Roark, Adnan H. Siddiqui

Producción científica: Article › revisión exhaustiva

2 Citas (Scopus)

Resumen

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 ~2.5fold 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 ~threefoldfold 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 ~twofoldincrease 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.

Idioma original	English
Publicación	Journal of NeuroInterventional Surgery
DOI	https://doi.org/10.1136/jnis-2025-024587
Estado	Accepted/In press - 2025

Nota bibliográfica

Publisher Copyright:
© Author(s) (or their employer(s)) 2025. No commercial re-use. See rights and permissions. Published by BMJ Group.

Financiación

JK – Equity holder: Neuro Technology Investments; Financial interest: Hyperion, Serenity; Consultant/Proctor: Medtronic, Stryker, MicroVention, Phenox, Kaneka; National PI/Steering Committee: EMBOLISE. JMD - Research Grants: NIH R21/R01, NSF SBIR, UB-CAT, Buffalo Translational Consortium, Cummings Foundation, nVidia, Google; Financial Interest: QAS.ai, Rist Neurovascular, Cerebrotech, Synchron, Hyperion, Kandu, Radical Catheter Technologies, ASCEND; Consultant/Advisory Board: Medtronic, MicroVention (Terumo Neuro), Imperative Care, Xenter, RapidPulse, Rapid Medical, Canon, J&J; National PI/Steering Committees: StrokeNET DSMB, EMBOLISE, SUCCESS, RapidPulse, SBIR/STTR, NIH NINDS/NLM Study sections. MM - Ownership/stock: Serenity Medical, Synchron, VICIS; Consultant: Canon Medical, Medtronic; NIH grant support R21NS109575 (Principal Investigator). AEH – Consultant/Speaker: Medtronic, Microvention, Stryker, Penumbra, Cerenovus, Genentech, GE Healthcare, Scientia, Balt, Viz.ai, Insera Therapeutics, Proximie, NeuroVasc, NovaSignal, Vesalio, Rapid Medical, Imperative Care, Galaxy Therapeutics, Route 92 and Perfuze; Principal Investigator: COMPLETE study – Penumbra, LVO SYNCHRONISE – Viz.ai, MARRS - Perfuze, RESCUE - ICAD – Medtronic; Steering Committee/Publication committee member: SELECT, DAWN, SELECT 2, EXPEDITE II, EMBOLISE, CLEAR, ENVI, DELPHI, DISTALS; Data and Safety Monitoring Board: COMAND trial. REH – None. AK – Consultant: Medtronic, Synaptive, Ospitek, Proximie. JF – Director: Eppdata; Consultant: Medtronic, Cerenovus, MicroVention, Penumbra, Phenox, Roche, Stryker, TG Med, Tonbridge; Stockholder: Eppdata, Tegus Medical, Vastrax. EIL – Consultant: Clarion, GLG Consulting, Guidepoint Global, Medtronic (formerly Covidien Neurovascular), Mosaic, StimMed; Honorarium for training and lectures: Integra, Medtronic (formerly Covidien Neurovascular), Penumbra, Terumo Neuro/MicroVention; Patent: Ultrasonic Surgical Blade; Shareholder or ownership interest: Claret Medical, Cognition Medical, Dendrite, Imperative Care (formerly the Stroke Project), Kaneka, Longeviti, NeXtGen Biologics, Q’Apel, RAPID Medical, StimMed, Three Rivers Medical; National PI: Medtronic SHIELD, Medtronic (formerly Covidien Neurovascular); Steering Committees for SWIFT Prime and SWIFT Direct Trials, Penumbra THUNDER; Site PI Study: Medtronic (formerly Covidien Neurovascular) STRATIS Study – Sub I, Terumo Neuro/MicroVention CONFIDENCE Study; Coprincipal Investigator: COMMAND Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis; Chief Medical Officer: Haniva Medical Technology; Advisory Board: Cognition Medical, IRRAS AB-Consultant/Advisory Board, NeXtGen Biologics; Leadership or Fiduciary Role (Other board, society, committee, or advocacy groups-paid or unpaid): ABNS-American Board of Neurological Surgery, CNS-Congress of Neurological Surgeons, UBNS-University at Buffalo Neurosurgery; Medical-Legal Review: Expert witness rendering medical-legal opinions. BG – Consultant: Medtronic, MicroVention, and Stryker. RG – Consultant: Balt Neurovascular, Medtronic Neurovascular, Cerenovus, Stryker Neurovascular, Integra, Rapid Medical. JT – None provided. WS – Consultant: Stryker. MB – None provided. RWC – Proctor: Medtronic, MicroVention; Consultant: Koswire; Shareholder: Von Medical, Hyperion. TL – None provided. JFF – Trainer: Medtronic. ML – Grants: Stryker and Medtronic; Equity interests: Proprio, Synchron, Stroke Diagnostics, Apertur, Hyperion Surgical, Fluid Biomed; Consulting: Metis Innovative, Aeaean Advisers, Stereotaxis, Apertur; Data safety monitoring board: Arsenal Medical; Editorial board: Journal of NeuroInterventional Surgery. PRC – None provided. RAH – Research Funding: NIH, Interline Endowment, MicroVention, Stryker, CNX; Consulting for Medtronic, Stryker, Cerenovus, MicroVention, Balt, Phenox, Rapid Medical, Q’Apel; Advisory Board: MiVI, eLum, Three Rivers Medical, Inc, Shape Medical, Corindus; Investor/Stockholder: InNeuroCo, Cerebrotech, eLum, Endostream, Three Rivers Medical, Inc., Scientia, RisT, BlinkTBI, Corindus, NTI. JB – None. MJ – None provided. PPY – None provided. MC – Consultant: Xenix Medical, Smith and Nephew, MicroVention, Rapid Medical, Medtronic. MIC – None provided. HJS – None provided. WSL –Niekro Aneurysm & AVM Foundation, Board of Directors. JB – Consultant: Q’Apel Medical. JJ – Consultant: Cerenovus, MIVI, Protara, TG Medical; Stockholder: Piraeus. MJK – None. ARP – Consultant: MicroVention, Penumbra, IRRAS, GT Medical, NICO. WM – Consultant: Rebound Therapeutics, Viseon Imperative Care, Integra, Q’Apel, Stream Biomedical, Spartan Micro, Egret. Investor: Cerebrotech, Q’ Apel, Endostream, Viseon, Rebound, Truvic, Radical Catheters, Vastrax, Borvo, Stream Biomedical, Spartan Micro, Egret; Site Principal Investigator: Medtronic EMBOLISE trial; Core lab: Stryker FEAT trial. JO – None provided. KMD – Consultant: Medtronic, Penumbra, Stryker. JAG – Research Funding: Georgia Research Alliance, Emory Medical Care Foundation, Emory Neurosurgery Catalyst, NIH 1R01NS130036-01, Uniformed Services University-Surgical Critical Care Initiative; Consultant: Cognition Medical, Imperative Care, Equity NTI. CPK – Institution receives research grant support from Medtronic (for participation in this study), Integra, Penumbra, Viz.AI, Siemens, Minnetronix, Longeviti, Irras, ICE Neurosystems, CVAID, Endostream, and Microtransponder; Equity in Precision Recovery, Borealis, E8, Borvo, and Metis Innovative. Metis Innovative is an investment group that has coordinated investments in Synchron, Proprio, Fluid Biomed, Von Vascular, and Precision Recovery. DHS – None provided. JS – None provided. CMS – Research Funding: NIH/NINDS, Penumbra, Medtronic, Balt, Stryker, MicroVention, Cerenovus, MIVI, Route 92; Consulting/Speakers fee: Werfen, Medtronic, Viz.ai, Balt, Stryker, MicroVention; Ownership: NTI, Reist. PM – Consultant: Stryker Neurovascular and Kaneka Neurovascular. JJL – None. AQM – Consultant: Medtronic; Proctor: Pipeline. TW – Part Owner: Galaxy Therapeutics. NVP – None. CR – None provided. AHS - Current Research Grants: Co-investigator for NIH - 1R01EB030092-01, Project Title: High Speed Angiography at 1000 frames per second; Mentor for Brain Aneurysm Foundation Carol W. Harvey Chair of Research, Sharon Epperson Chair of Research, Project Title: A Whole Blood RNA Diagnostic for Unruptured Brain Aneurysm: Risk Assessment Prototype Development and Testing; Financial Interest/Investor/Stock Options/Ownership: 3N Endovascular, Adona Medical, Inc, Basecamp Vascular SAS, Bend IT Technologies, Ltd, BlinkTBI, Inc, Borvo Medical, Inc, CerebrovaKP, Code Zero Medical, Inc, Cognition Medical, Collavidence, Inc, Contego Medical, Inc, CVAID Ltd, E8, Inc, Endostream Medical, Ltd, FreeOx Biotech, SL, Galaxy Therapeutics, Inc, Hyperion Surgical, Inc, Imperative Care, Inc, InspireMD, Ltd, Instylla, Inc, IRRAS, AB, Launch NY, Inc, Neurolutions, Inc, Neurovascular Diagnostics, Inc, NeXtGen Biologics, Peijia Medical, PerFlow Medical, Ltd, Physician X, LLC, Piraeus Medical, Inc, Prometheus Therapeutics, Inc, PUMA Venture Capital Fund I, LP, Q’Apel Medical, Inc, QAS.ai, Inc, Radical Catheter Technologies, Inc, ReNiva, Inc, Rist Neurovascular, Inc (purchased 2020 by Medtronic), Sense Diagnostics, Inc, Serenity Medical, Inc, Silk Road Medical, Sim & Cure, Spinnaker Medical, Inc, Stent’Up, StimMed, LLC, Synchron, Inc, Tegus Medical, GmbH, T.G. Medical, Inc, Tulavi Therapeutics, Inc, Vastrax, LLC, Viseon, Inc, Viz.ai, Whisper Medical, Inc, Willow Medtech, Inc. Consultant/Advisory Board: Abbott Laboratories, Acandis, Asahi Intecc Co Ltd, Canon Medical Systems USA, Inc, Carotix Medical, LLC, CerebrovaKP, Cerenovus, Contego Medical, Inc, Cordis, Endostream Medical, Ltd, FreeOx Biotech, SL, Hyperfine Operations, Inc, Imperative Care, InspireMD, Ltd, IRRAS AB, Medtronic, Minnetronix Neuro, Inc, Peijia Medical, Perflow Medical, Ltd, Piraeus Medical, Inc, Prometheus Therapeutics, Inc, Q’Apel Medical, Inc, Serenity Medical, Inc, Shockwave Medical, Inc, StimMed, LLC, Stryker Neurovascular, Synchron Australia Pty Ltd, Tegus Medical, GmbH, T.G. Medical, Inc, Terumo Neuro (Formerly MicroVention), Vastrax, LLC, Vesalio, Viz.ai, Inc, WL Gore; National PI/Steering Committees: Cerenovus EXCELLENT and ARISE II Trial; Medtronic SWIFT PRIME, VANTAGE, EMBOLISE and SWIFT DIRECT Trials; Terumo Neuro (formerly MicroVention) FRED Trial & CONFIDENCE Study; MUSC POSITIVE Trial; Penumbra 3D Separator Trial, COMPASS Trial, INVEST Trial, MIVI neuroscience EVAQ Trial; Rapid Medical SUCCESS Trial; InspireMD C-GUARDIANS IDE Pivotal Trial; Patent: Patent No. US 11,464,528 B2, Date: October 11, 2022, CLOT RETRIEVAL SYSTEM FOR REMOVING OCCLUSIVE CLOT FROM A BLOOD VESSEL, Applicant and Assignee: Neuravi Limited (Galway), Role: Co-Inventor. This study was funded by Medtronic.

Financiadores	Número del financiador
UB-CAT
Cummings Foundation
NASA SBIR
Georgia Research Alliance
NSF
Google
NIH STTR
Basecamp Vascular SAS
Buffalo Translational Consortium
Medtronic
NIH/NINDS
NIH	R21/R01
NIH/NLM	R21NS109575
Emory Medical Care Foundation	1R01NS130036-01, 1R01EB030092-01

ASJC Scopus subject areas

Surgery
Clinical Neurology

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10.1136/jnis-2025-024587

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Knopman, J., Davies, J. M., Mokin, M., Hassan, A. E., Harbaugh, R. E., Khalessi, A., Fiehler, J., Levy, E. I., Gross, B. A., Grandhi, R., Tarpley, J., Sivakumar, W., Bain, M., Crowley, R. W., Link, T. W., Fraser, J. F., Levitt, M. R., Chen, P. R., Hanel, R. A., ... Siddiqui, A. H. (Aceptado/En prensa). EMBOLISE randomized surgical trial for subdural hematoma: clinical benefits beyond reoperation with middle meningeal artery embolization. Journal of NeuroInterventional Surgery. https://doi.org/10.1136/jnis-2025-024587

@article{146f9a3081574e23b3b4ef1057bfbf6d,

title = "EMBOLISE randomized surgical trial for subdural hematoma: clinical benefits beyond reoperation with middle meningeal artery embolization",

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 \textasciitilde{}threefold higher incidence of mRS >2 (37.0\% vs 12.9\%, P=0.0025) and an \textasciitilde{}2.5fold 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 \textasciitilde{}threefoldfold 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 \textasciitilde{}twofoldincrease 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.",

keywords = "Liquid Embolic Material, Subdural, Technique, Technology",

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

note = "Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2025. No commercial re-use. See rights and permissions. Published by BMJ Group.",

year = "2025",

doi = "10.1136/jnis-2025-024587",

language = "English",

}

Knopman, J, Davies, JM, Mokin, M, Hassan, AE, Harbaugh, RE, Khalessi, A, Fiehler, J, Levy, EI, Gross, BA, Grandhi, R, Tarpley, J, Sivakumar, W, Bain, M, Crowley, RW, Link, TW, Fraser, JF, Levitt, MR, Chen, PR, Hanel, RA, Bernard, JD, Jumaa, M, Youssef, PP, Cress, MC, Chaudry, MI, Shakir, HJ, Lesley, WS, Billingsley, J, Jones, J, Koch, MJ, Paul, AR, Mack, WJ, Osbun, JW, Dlouhy, KM, Grossberg, JA, Kellner, CP, Sahlein, DH, Santarelli, J, Schirmer, CM, Mazaris, P, Liu, JJ, Majjhoo, AQ, Wolfe, T, Patel, NV, Roark, CD & Siddiqui, AH 2025, 'EMBOLISE randomized surgical trial for subdural hematoma: clinical benefits beyond reoperation with middle meningeal artery embolization', Journal of NeuroInterventional Surgery. https://doi.org/10.1136/jnis-2025-024587

TY - JOUR

T1 - EMBOLISE randomized surgical trial for subdural hematoma

T2 - clinical benefits beyond reoperation with middle meningeal artery embolization

AU - Knopman, Jared

AU - Davies, Jason M.

AU - Mokin, Maxim

AU - Hassan, Ameer E.

AU - Harbaugh, Robert E.

AU - Khalessi, Alexander

AU - Fiehler, Jens

AU - Levy, Elad I.

AU - Gross, Bradley A.

AU - Grandhi, Ramesh

AU - Tarpley, Jason

AU - Sivakumar, Walavan

AU - Bain, Mark

AU - Crowley, R. Webster

AU - Link, Thomas W.

AU - Fraser, Justin F.

AU - Levitt, Michael R.

AU - Chen, Peng Roc

AU - Hanel, Ricardo A.

AU - Bernard, Joe D.

AU - Jumaa, Mouhammad

AU - Youssef, Patrick P.

AU - Cress, Marshall C.

AU - Chaudry, Mohammad Imran

AU - Shakir, Hakeem J.

AU - Lesley, Walter S.

AU - Billingsley, Joshua

AU - Jones, Jesse

AU - Koch, Matthew J.

AU - Paul, Alexandra R.

AU - Mack, William J.

AU - Osbun, Joshua W.

AU - Dlouhy, Kathleen M.

AU - Grossberg, Jonathan A.

AU - Kellner, Christopher P.

AU - Sahlein, Daniel H.

AU - Santarelli, Justin

AU - Schirmer, Clemens M.

AU - Mazaris, Paul

AU - Liu, Jesse J.

AU - Majjhoo, Aniel Q.

AU - Wolfe, Thomas

AU - Patel, Neil V.

AU - Roark, Christopher D.

AU - Siddiqui, Adnan H.

PY - 2025

Y1 - 2025

N2 - 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 ~2.5fold 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 ~threefoldfold 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 ~twofoldincrease 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.

AB - 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 ~2.5fold 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 ~threefoldfold 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 ~twofoldincrease 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.

KW - Liquid Embolic Material

KW - Subdural

KW - Technique

KW - Technology

UR - https://www.scopus.com/pages/publications/105026309629

UR - https://www.scopus.com/pages/publications/105026309629#tab=citedBy

U2 - 10.1136/jnis-2025-024587

DO - 10.1136/jnis-2025-024587

M3 - Article

C2 - 41444014

AN - SCOPUS:105026309629

SN - 1759-8478

JO - Journal of NeuroInterventional Surgery

JF - Journal of NeuroInterventional Surgery

ER -

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

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