Middle Meningeal Artery Embolization With n-Butyl Cyanoacrylate in Patients With Chronic Subdural Hematoma
27 affiliations
- 1Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York
- 2Department of Neuroradiology, Rockefeller Neuroscience Institute, West Virginia University, Morgantown
- 3Department of Neurosurgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia
- 4Department of Interventional Neurology, WellStar Health System, Marietta, Georgia
- 5Department of Neurosurgery, Miller School of Medicine, University of Miami, Miami, Florida
- 6Department of Neurology and Neurosurgery, Westchester Medical Center, Valhalla, New York
- 7Department of Neurosurgery, Yale University School of Medicine, New Haven, Connecticut
- 8Department of Neurosurgery, John Muir Health, Walnut Creek, California
- 9Department of Neurosurgery, Vanderbilt University Medical Center, Nashville, Tennessee
- 10Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
- 11Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
- 12Department of Neurosurgery, University of Alabama, Birmingham
- 13Texas Stroke Institute, Dallas-Fort Worth
- 14Department of Neurosurgery, University of Utah, Salt Lake City
- 15Neuroscience Institute, Allegheny Health Network, Pittsburgh, Pennsylvania
- 16Department of Neurosurgery, Oregon Health & Science University, Portland
- 17University of Maryland School of Medicine, Baltimore
- 18Nanjing Drum Tower Hospital, Jiangsu Province, Nanjing, China
- 19Department of Interventional Neuroradiology, Swedish Medical Center, Englewood, Colorado
- 20Department of Neurosurgery, University of Cincinnati, Cincinnati, Ohio
- 21Division of Neurointerventional Radiology, Lahey Hospital & Medical Center, Burlington, Massachusetts
- 22Neuroscience and Stroke Program, Bon Secours Mercy Health St Vincent Hospital, Toledo, Ohio
- 23Neurological Institute of Savannah, Savannah, Georgia
- 24University of Virginia, Charlottesville
- 25Department of Neurology, Hartford Hospital, Hartford, Connecticut
- 26for the MEMBRANE Study Group
- 27JFK University Medical Center, Edison, New Jersey
Abstract
Importance: Middle meningeal artery embolization (MMAE) is a minimally invasive adjunctive treatment for chronic subdural hematoma (cSDH). The TRUFILL n-butyl cyanoacrylate (n-BCA) liquid embolic system is indicated for embolization of cerebral arteriovenous malformations for presurgical devascularization and may be appropriate for MMAE in patients with cSDH. Objective: To evaluate safety and effectiveness of the study device for MMAE plus standard of care vs standard of care alone in patients with cSDH. Design, Setting, and Participants: The Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL n-BCA (MEMBRANE) trial was a prospective, multicenter, open-label, randomized clinical trial conducted from May 27, 2021, to February 6, 2024, at 30 hospitals (28 in the United States and 2 in China). Participants aged 18 to 90 years with symptomatic cSDH and a modified Rankin Scale score of 3 or less were enrolled. Interventions: Site physicians determined whether each patient required surgical or nonsurgical management. Participants in the surgical and nonsurgical cohorts were then randomized 1:1 to receive MMAE plus standard of care or standard of care alone. Main Outcomes and Measures: The primary effectiveness end point was residual or re-accumulation of hematoma (>10 mm; assessed by an independent core laboratory) at 6 months or requiring a surgical procedure on the cSDH within 6 months (conducted as an intention-to-treat analysis). The primary safety end point was incidence of adverse events through 6 months (conducted as an as-treated analysis). Results: A total of 376 participants (188 in MMAE plus standard of care and 188 in standard of care alone) were included. In the MMAE plus standard of care and standard of care alone groups, the mean (SD) age was 70.9 (10.6) and 70.3 (12.1) years, and 45 (23.9%) and 49 (26.1%) were female, respectively. Primary effectiveness end point events occurred in 17 of 146 participants receiving MMAE plus standard of care (11.6%) and 29 of 131 receiving standard of care alone (22.1%) (final estimate of common odds ratio: 0.53 [90% CI, 0.31-0.91]; P = .04), indicating statistically significant benefit for MMAE plus standard of care vs standard of care alone. Adverse events occurred in 130 of 181 participants in the MMAE plus standard of care group (71.8%) and 124 of 190 in the standard of care alone group (65.3%) through 6 months. MMAE plus standard of care treatment was noninferior to standard of care alone based on analysis of good functional outcome at 3 months, as assessed by the modified Rankin Scale. Conclusions and Relevance: In this randomized clinical trial, MMAE plus standard of care significantly reduced rates of recurrence and reoperation vs standard of care alone, without a significant increase in adverse events. Trial registration: ClinicalTrials.gov Identifier, NCT04816591.
Related
- Embolization of the middle meningeal artery for non‐acute subdural hematoma
- Determining the Number of Chronic Subdural Hematoma Potentially Eligible for Middle Meningeal Artery Embolization: A Population-Based Study
- Standalone Middle Meningeal Artery Embolization Versus Surgical Evacuation for Nontraumatic Subdural Hematoma: A Propensity-Matched Multicenter Real-World Study
- Comparative outcomes of middle meningeal artery embolization, burr hole drainage, and neuroendoscopic-assisted evacuation with MMA disconnection for chronic subdural haematoma: a multicenter retrospective cohort study
- Neuro-endoscopic assisted small bone window treatment for acute subdural hematoma in young and middle aged patients: preliminary experience and techniques exploration of 6 cases
BibTeX
@article{kellner2026middle,
title = {{Middle Meningeal Artery Embolization With n-Butyl Cyanoacrylate in Patients With Chronic Subdural Hematoma}},
author = {Christopher Paul Kellner and Ansaar Rai and Hazem Shoirah and Visish Mani Srinivasan and Rishi Gupta and Robert M. Starke and Fawaz Al‐Mufti and Charles C. Matouk and Benjamin Yim and Matthew R. Fusco and Jieqing Wan and Elizabeth J. Liptrap and Parita Bhuva and Ramesh Grandhi and Russell Cerejo and Jesse J. Liu and JJ Cherian and Q Y Zhang and Ian Kaminsky and Charles Joseph Prestigiacomo and Emanuele Orrù and Eugene I. Lin and Jay Howington and Avery Evans and Tapan Mehta and SoHyun Boo and Ira J. Finch and T M Liu and Rohan V Chitale and Shahram Majidi and Brian Thomas Jankowitz and MEMBRANE Study Group and Ronald Budzik and Michael Stiefel and Richard Williamson and Dimitri G. Sigounas and Frank Hellinger and Erik Friedrich Hauck and Bharathidasan Jagadeesan and Ricardo Hanel and AL Coon and Lucas Elijovich and Ryan Turner and Phong Vu and M Czaplicki and Reade Andrew De Leacy and Johanna Fifi and Tomoyoshi Shigematsu and Michael Travis Caton and Benjamin I. Rapoport and Gregory Lock and Thomas James Oxley and Pouria Moshayedi and Krisztina Moldovan and Natalie Hall and Anne Yanda and Sarah Baggette and Osama O. Zaidat and Wayne M. Clark and Parker Miller},
journal = {JAMA Neurology},
year = {2026},
month = jun,
doi = {10.1001/jamaneurol.2026.1542},
url = {https://doi.org/10.1001/jamaneurol.2026.1542},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Middle Meningeal Artery Embolization With n-Butyl Cyanoacrylate in Patients With Chronic Subdural Hematoma
AU - Christopher Paul Kellner
AU - Ansaar Rai
AU - Hazem Shoirah
AU - Visish Mani Srinivasan
AU - Rishi Gupta
AU - Robert M. Starke
AU - Fawaz Al‐Mufti
AU - Charles C. Matouk
AU - Benjamin Yim
AU - Matthew R. Fusco
AU - Jieqing Wan
AU - Elizabeth J. Liptrap
AU - Parita Bhuva
AU - Ramesh Grandhi
AU - Russell Cerejo
AU - Jesse J. Liu
AU - JJ Cherian
AU - Q Y Zhang
AU - Ian Kaminsky
AU - Charles Joseph Prestigiacomo
AU - Emanuele Orrù
AU - Eugene I. Lin
AU - Jay Howington
AU - Avery Evans
AU - Tapan Mehta
AU - SoHyun Boo
AU - Ira J. Finch
AU - T M Liu
AU - Rohan V Chitale
AU - Shahram Majidi
AU - Brian Thomas Jankowitz
AU - MEMBRANE Study Group
AU - Ronald Budzik
AU - Michael Stiefel
AU - Richard Williamson
AU - Dimitri G. Sigounas
AU - Frank Hellinger
AU - Erik Friedrich Hauck
AU - Bharathidasan Jagadeesan
AU - Ricardo Hanel
AU - AL Coon
AU - Lucas Elijovich
AU - Ryan Turner
AU - Phong Vu
AU - M Czaplicki
AU - Reade Andrew De Leacy
AU - Johanna Fifi
AU - Tomoyoshi Shigematsu
AU - Michael Travis Caton
AU - Benjamin I. Rapoport
AU - Gregory Lock
AU - Thomas James Oxley
AU - Pouria Moshayedi
AU - Krisztina Moldovan
AU - Natalie Hall
AU - Anne Yanda
AU - Sarah Baggette
AU - Osama O. Zaidat
AU - Wayne M. Clark
AU - Parker Miller
PY - 2026
DA - 2026/06/15
JO - JAMA Neurology
DO - 10.1001/jamaneurol.2026.1542
UR - https://doi.org/10.1001/jamaneurol.2026.1542
AB - Importance: Middle meningeal artery embolization (MMAE) is a minimally invasive adjunctive treatment for chronic subdural hematoma (cSDH). The TRUFILL n-butyl cyanoacrylate (n-BCA) liquid embolic system is indicated for embolization of cerebral arteriovenous malformations for presurgical devascularization and may be appropriate for MMAE in patients with cSDH. Objective: To evaluate safety and effectiveness of the study device for MMAE plus standard of care vs standard of care alone in patients with cSDH. Design, Setting, and Participants: The Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL n-BCA (MEMBRANE) trial was a prospective, multicenter, open-label, randomized clinical trial conducted from May 27, 2021, to February 6, 2024, at 30 hospitals (28 in the United States and 2 in China). Participants aged 18 to 90 years with symptomatic cSDH and a modified Rankin Scale score of 3 or less were enrolled. Interventions: Site physicians determined whether each patient required surgical or nonsurgical management. Participants in the surgical and nonsurgical cohorts were then randomized 1:1 to receive MMAE plus standard of care or standard of care alone. Main Outcomes and Measures: The primary effectiveness end point was residual or re-accumulation of hematoma (>10 mm; assessed by an independent core laboratory) at 6 months or requiring a surgical procedure on the cSDH within 6 months (conducted as an intention-to-treat analysis). The primary safety end point was incidence of adverse events through 6 months (conducted as an as-treated analysis). Results: A total of 376 participants (188 in MMAE plus standard of care and 188 in standard of care alone) were included. In the MMAE plus standard of care and standard of care alone groups, the mean (SD) age was 70.9 (10.6) and 70.3 (12.1) years, and 45 (23.9%) and 49 (26.1%) were female, respectively. Primary effectiveness end point events occurred in 17 of 146 participants receiving MMAE plus standard of care (11.6%) and 29 of 131 receiving standard of care alone (22.1%) (final estimate of common odds ratio: 0.53 [90% CI, 0.31-0.91]; P = .04), indicating statistically significant benefit for MMAE plus standard of care vs standard of care alone. Adverse events occurred in 130 of 181 participants in the MMAE plus standard of care group (71.8%) and 124 of 190 in the standard of care alone group (65.3%) through 6 months. MMAE plus standard of care treatment was noninferior to standard of care alone based on analysis of good functional outcome at 3 months, as assessed by the modified Rankin Scale. Conclusions and Relevance: In this randomized clinical trial, MMAE plus standard of care significantly reduced rates of recurrence and reoperation vs standard of care alone, without a significant increase in adverse events. Trial registration: ClinicalTrials.gov Identifier, NCT04816591.
SN - 2168-6149
SN - 2168-6157
ER -