Skip to main content

Lund University Publications

LUND UNIVERSITY LIBRARIES

Swedish trial on embolization of middle meningeal artery versus surgical evacuation in chronic subdural hematoma (SWEMMA)—a national 12-month multi-center randomized controlled superiority trial with parallel group assignment, open treatment allocation and blinded clinical outcome assessment

Drake, Mattias LU ; Ullberg, Teresa LU ; Nittby, Henrietta LU ; Marklund, Niklas LU orcid and Wassélius, Johan LU (2022) In Trials 23(1).
Abstract

Background: Chronic subdural hematoma (cSDH) is one of the most common neurosurgical disorders and the incidence is rising. The routine treatment is neurosurgical hematoma evacuation, which is associated with recurrence rates up to 10–25%. In recent years, endovascular embolization of the middle meningeal artery (eMMA) has garnered much attention due to recurrence rates as low as < 5%. Several randomized controlled trials are planned or ongoing. In most of these trials, conventional neurosurgical treatment with or without adjunctive endovascular embolization is compared. The proposed trial aims to conduct a head-to-head comparison between neurosurgical and endovascular treatment as stand-alone treatments. Methods: The trial is... (More)

Background: Chronic subdural hematoma (cSDH) is one of the most common neurosurgical disorders and the incidence is rising. The routine treatment is neurosurgical hematoma evacuation, which is associated with recurrence rates up to 10–25%. In recent years, endovascular embolization of the middle meningeal artery (eMMA) has garnered much attention due to recurrence rates as low as < 5%. Several randomized controlled trials are planned or ongoing. In most of these trials, conventional neurosurgical treatment with or without adjunctive endovascular embolization is compared. The proposed trial aims to conduct a head-to-head comparison between neurosurgical and endovascular treatment as stand-alone treatments. Methods: The trial is academically driven and funded within existing public healthcare systems and infrastructure. Patients with uni- or bilateral cSDH, presenting with mild-to moderate symptoms, and admitted to neurosurgery on clinical grounds will be offered participation. Subjects are randomized 1:1 between conventional neurosurgical treatment (control) and endovascular embolization of the middle meningeal artery (intervention). Primary endpoint is reoperation due to clinically and/or radiologically significant recurrence within 3 months. Secondary endpoints include safety, technical success rate, neurological disability, and quality of life. Discussion: There are mounting retrospective data suggesting eMMA, as sole treatment or as an adjunctive to neurosurgery for cSDH, is safe and effective with a reoperation rate lower than neurosurgical hematoma evacuation alone. If randomized controlled trials confirm these findings, there is a potential for a paradigm shift in the treatment of cSDH where a minimally invasive procedure can replace open surgery in a large and oftentimes old and fragile patient cohort. Trial registration: ClinicalTrials.gov, ClinicalTrials.gov Identifier NCT05267184. Registered March 4, 2022.

(Less)
Please use this url to cite or link to this publication:
author
; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Burr hole, Chronic subdural hematoma, Embolization, Endovascular, Middle meningeal artery, Neurosurgery
in
Trials
volume
23
issue
1
article number
926
publisher
BioMed Central (BMC)
external identifiers
  • scopus:85141367325
  • pmid:36348417
ISSN
1745-6215
DOI
10.1186/s13063-022-06842-4
language
English
LU publication?
yes
id
c982661e-66db-48c6-97ea-2fb5ae64a370
date added to LUP
2022-12-05 12:46:57
date last changed
2024-06-13 21:00:43
@article{c982661e-66db-48c6-97ea-2fb5ae64a370,
  abstract     = {{<p>Background: Chronic subdural hematoma (cSDH) is one of the most common neurosurgical disorders and the incidence is rising. The routine treatment is neurosurgical hematoma evacuation, which is associated with recurrence rates up to 10–25%. In recent years, endovascular embolization of the middle meningeal artery (eMMA) has garnered much attention due to recurrence rates as low as &lt; 5%. Several randomized controlled trials are planned or ongoing. In most of these trials, conventional neurosurgical treatment with or without adjunctive endovascular embolization is compared. The proposed trial aims to conduct a head-to-head comparison between neurosurgical and endovascular treatment as stand-alone treatments. Methods: The trial is academically driven and funded within existing public healthcare systems and infrastructure. Patients with uni- or bilateral cSDH, presenting with mild-to moderate symptoms, and admitted to neurosurgery on clinical grounds will be offered participation. Subjects are randomized 1:1 between conventional neurosurgical treatment (control) and endovascular embolization of the middle meningeal artery (intervention). Primary endpoint is reoperation due to clinically and/or radiologically significant recurrence within 3 months. Secondary endpoints include safety, technical success rate, neurological disability, and quality of life. Discussion: There are mounting retrospective data suggesting eMMA, as sole treatment or as an adjunctive to neurosurgery for cSDH, is safe and effective with a reoperation rate lower than neurosurgical hematoma evacuation alone. If randomized controlled trials confirm these findings, there is a potential for a paradigm shift in the treatment of cSDH where a minimally invasive procedure can replace open surgery in a large and oftentimes old and fragile patient cohort. Trial registration: ClinicalTrials.gov, ClinicalTrials.gov Identifier NCT05267184. Registered March 4, 2022.</p>}},
  author       = {{Drake, Mattias and Ullberg, Teresa and Nittby, Henrietta and Marklund, Niklas and Wassélius, Johan}},
  issn         = {{1745-6215}},
  keywords     = {{Burr hole; Chronic subdural hematoma; Embolization; Endovascular; Middle meningeal artery; Neurosurgery}},
  language     = {{eng}},
  number       = {{1}},
  publisher    = {{BioMed Central (BMC)}},
  series       = {{Trials}},
  title        = {{Swedish trial on embolization of middle meningeal artery versus surgical evacuation in chronic subdural hematoma (SWEMMA)—a national 12-month multi-center randomized controlled superiority trial with parallel group assignment, open treatment allocation and blinded clinical outcome assessment}},
  url          = {{http://dx.doi.org/10.1186/s13063-022-06842-4}},
  doi          = {{10.1186/s13063-022-06842-4}},
  volume       = {{23}},
  year         = {{2022}},
}