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

doi:10.1056/NEJMoa2313472

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 JumaaPatrick 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

Research output: Contribution to journal › Article › peer-review

25 Scopus citations

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.)

Original language	English
Pages (from-to)	1890-1900
Number of pages	11
Journal	New England Journal of Medicine
Volume	391
Issue number	20
DOIs	https://doi.org/10.1056/NEJMoa2313472
State	Published - Nov 21 2024

Bibliographical note

Publisher Copyright:
© 2024 Massachusetts Medical Society.

Keywords

Allergy/Immunology
Anticoagulation/Thromboembolism
Anticoagulation/Thromboembolism
Cardiology
Cardiology General
Clinical Medicine
Clinical Medicine General
Coagulation
Critical Care
Emergency Medicine
Emergency Medicine General
Frailty
Geriatrics/Aging
Geriatrics/Aging General
Head Trauma
Hematology/Oncology
Hematology/Oncology General
Hospital-Based Clinical Medicine
Inflammatory Disease
Neurology/Neurosurgery
Neurology/Neurosurgery General
Pulmonary/Critical Care
Pulmonary/Critical Care General
Surgery
Surgery General
Trauma

ASJC Scopus subject areas

General Medicine

Access to Document

10.1056/NEJMoa2313472

Cite this

Davies, J. M., Knopman, J., Mokin, M., Hassan, A. E., Harbaugh, R. E., Khalessi, A., Fiehler, J., 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., Bernard, J. D., ... Siddiqui, A. H. (2024). Adjunctive Middle Meningeal Artery Embolization for Subdural Hematoma. New England Journal of Medicine, 391(20), 1890-1900. https://doi.org/10.1056/NEJMoa2313472

@article{1f0597260cae4073b8d04768b8bc4f9c,

title = "Adjunctive Middle Meningeal Artery Embolization for Subdural Hematoma.",

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.)",

keywords = "Allergy/Immunology, Anticoagulation/Thromboembolism, Anticoagulation/Thromboembolism, Cardiology, Cardiology General, Clinical Medicine, Clinical Medicine General, Coagulation, Critical Care, Emergency Medicine, Emergency Medicine General, Frailty, Geriatrics/Aging, Geriatrics/Aging General, Head Trauma, Hematology/Oncology, Hematology/Oncology General, Hospital-Based Clinical Medicine, Inflammatory Disease, Neurology/Neurosurgery, Neurology/Neurosurgery General, Pulmonary/Critical Care, Pulmonary/Critical Care General, Surgery, Surgery General, Trauma",

author = "Davies, {Jason M.} and Jared Knopman and Maxim Mokin and Hassan, {Ameer E.} and Harbaugh, {Robert E.} and Alexander Khalessi and Jens Fiehler 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 Patrick Youssef 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 Kathleen Dlouhy and Grossberg, {Jonathan A.} and Kellner, {Christopher P.} and Sahlein, {Daniel H.} and Justin Santarelli and Schirmer, {Clemens M.} and Justin Singer and Liu, {Jesse J.} and Majjhoo, {Aniel Q.} and Thomas Wolfe and Patel, {Neil V.} and Christopher Roark and Siddiqui, {Adnan H.}",

note = "Publisher Copyright: {\textcopyright} 2024 Massachusetts Medical Society.",

year = "2024",

month = nov,

day = "21",

doi = "10.1056/NEJMoa2313472",

language = "English",

volume = "391",

pages = "1890--1900",

number = "20",

}

Davies, JM, Knopman, J, Mokin, M, Hassan, AE, Harbaugh, RE, Khalessi, A, Fiehler, J, 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, P, Cress, MC, Chaudry, MI, Shakir, HJ, Lesley, WS, Billingsley, J, Jones, J, Koch, MJ, Paul, AR, Mack, WJ, Osbun, JW, Dlouhy, K, Grossberg, JA, Kellner, CP, Sahlein, DH, Santarelli, J, Schirmer, CM, Singer, J, Liu, JJ, Majjhoo, AQ, Wolfe, T, Patel, NV, Roark, C & Siddiqui, AH 2024, 'Adjunctive Middle Meningeal Artery Embolization for Subdural Hematoma.', New England Journal of Medicine, vol. 391, no. 20, pp. 1890-1900. https://doi.org/10.1056/NEJMoa2313472

TY - JOUR

T1 - Adjunctive Middle Meningeal Artery Embolization for Subdural Hematoma.

AU - Davies, Jason M.

AU - Knopman, Jared

AU - Mokin, Maxim

AU - Hassan, Ameer E.

AU - Harbaugh, Robert E.

AU - Khalessi, Alexander

AU - Fiehler, Jens

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

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

AU - Grossberg, Jonathan A.

AU - Kellner, Christopher P.

AU - Sahlein, Daniel H.

AU - Santarelli, Justin

AU - Schirmer, Clemens M.

AU - Singer, Justin

AU - Liu, Jesse J.

AU - Majjhoo, Aniel Q.

AU - Wolfe, Thomas

AU - Patel, Neil V.

AU - Roark, Christopher

AU - Siddiqui, Adnan H.

PY - 2024/11/21

Y1 - 2024/11/21

N2 - 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.)

AB - 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.)

KW - Allergy/Immunology

KW - Anticoagulation/Thromboembolism

KW - Cardiology

KW - Cardiology General

KW - Clinical Medicine

KW - Clinical Medicine General

KW - Coagulation

KW - Critical Care

KW - Emergency Medicine

KW - Emergency Medicine General

KW - Frailty

KW - Geriatrics/Aging

KW - Geriatrics/Aging General

KW - Head Trauma

KW - Hematology/Oncology

KW - Hematology/Oncology General

KW - Hospital-Based Clinical Medicine

KW - Inflammatory Disease

KW - Neurology/Neurosurgery

KW - Neurology/Neurosurgery General

KW - Pulmonary/Critical Care

KW - Pulmonary/Critical Care General

KW - Surgery

KW - Surgery General

KW - Trauma

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UR - http://www.scopus.com/inward/citedby.url?scp=85210340593&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa2313472

DO - 10.1056/NEJMoa2313472

M3 - Article

C2 - 39565988

AN - SCOPUS:85210340593

SN - 0028-4793

VL - 391

SP - 1890

EP - 1900

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 20

ER -

Adjunctive Middle Meningeal Artery Embolization for Subdural Hematoma.

Abstract

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Keywords

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