Middle Meningeal Artery Embolization (MMAE) Outcomes for Chronic Subdural Hematoma (cSDH)

Study Overview
=================
Brief Summary
-----------------
This multi-center retrospective cohort study aims to investigate the real-world outcomes of chronic subdural hematoma treated with MMAE, including clinical effectiveness, recurrence rates, and safety profile.

Detailed Description
-----------------
Chronic subdural hematoma (cSDH) is a prevalent neurosurgical condition marked by the accumulation of blood in the subarachnoid space. Primarily affecting elderly individuals, cSDH is associated with significant morbidity and mortality rates. Current standard treatments for cSDH involve surgical evacuation through burr hole craniotomy or twist-drill craniotomy; however, recent research has illuminated the potential significance of the middle meningeal artery (MMA) in cSDH pathogenesis, suggesting an innovative minimally invasive treatment avenue. The investigator team is attempting to determine whether MMA embolization has demonstrated a favorable safety profile with a low incidence of treatment-related complications.

Official Title
-----------------
Outcomes of Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma; Middle Meningeal Artery Embolization for Chronic Subdural Hematoma (MESH)

Conditions
-----------------
Chronic Subdural Hematoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive adult patients (18 yrs. of age or older) Endovascular embolization of middle meningeal artery using any embolization material: PVA particles; Onyx, nBCA glue; dimethyl sulfoxide, microcoils, PVA with microcoils Exclusion Criteria: Endovascular embolization of middle meningeal artery using any other embolization material

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaccumulation of Hematoma | The percentage of patients who were determined to have a reaccumulation of their hematoma will be tabulated and reported | Within 1 month post MMAE | 
| Rescue surgical evacuation | The percentage of patients who were determined to require rescue surgical evacuation of their hematoma will be tabulated and reported | Between 1-3 months post MMAE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaccumulation of Hematoma | The percentage of patients who were determined to have a reaccumulation of their hematoma will be tabulated and reported. Reaccumulation of the hematoma will be determined by measuring the hematoma thickness at a given time point and comparing it to the thickness measured at the previous time point. | Between 1-3 months post MMAE | 
| Reaccumulation of Hematoma | The percentage of patients who were determined to have a reaccumulation of their hematoma will be tabulated and reported. Reaccumulation of the hematoma will be determined by measuring the hematoma thickness at a given time point and comparing it to the thickness measured at the previous time point. | Between 3-6 months post MMAE | 
| Reaccumulation of Hematoma | The percentage of patients who were determined to have a reaccumulation of their hematoma will be tabulated and reported. Reaccumulation of the hematoma will be determined by measuring the hematoma thickness at a given time point and comparing it to the thickness measured at the previous time point. | Between 6-12 months post MMAE | 
| Reaccumulation of Hematoma | The percentage of patients who were determined to have a reaccumulation of their hematoma will be tabulated and reported. Reaccumulation of the hematoma will be determined by measuring the hematoma thickness at a given time point and comparing it to the thickness measured at the previous time point. | Between 12-24 months post MMAE | 
| Clinical Outcome at Follow-up Clinical outcome at follow-up | Clinical outcome at follow-up will be assessed using a variant of the modified Rankin Scale (mRS) for neurologic disability. The classic mRS is a 6-point disability scale with possible scores ranging from 0-5. mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Higher scores are generally associated with less favorable outcomes. For this study patients with an mRS score of 0-2 will be determined to have had a favorable outcome to the procedure and patients with an mRS score of 3-5 will have been determined to have had an unfavorable outcome. Scoring will also include a 6 to identify patients who have expired. | Upon study discharge, 1-4 weeks | 
| Clinical Outcome at Follow-up Clinical outcome at follow-up | Clinical outcome at follow-up will be assessed using a variant of the modified Rankin Scale (mRS) for neurologic disability. The classic mRS is a 6-point disability scale with possible scores ranging from 0-5. mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Higher scores are generally associated with less favorable outcomes. For this study patients with an mRS score of 0-2 will be determined to have had a favorable outcome to the procedure and patients with an mRS score of 3-5 will have been determined to have had an unfavorable outcome. Scoring will also include a 6 to identify patients who have expired. | Within 1 month post MMAE | 
| Clinical Outcome at Follow-up Clinical outcome at follow-up | Clinical outcome at follow-up will be assessed using a variant of the modified Rankin Scale (mRS) for neurologic disability. The classic mRS is a 6-point disability scale with possible scores ranging from 0-5. mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Higher scores are generally associated with less favorable outcomes. For this study patients with an mRS score of 0-2 will be determined to have had a favorable outcome to the procedure and patients with an mRS score of 3-5 will have been determined to have had an unfavorable outcome. Scoring will also include a 6 to identify patients who have expired. | Between 1-3 months post MMAE | 
| Clinical Outcome at Follow-up Clinical outcome at follow-up | Clinical outcome at follow-up will be assessed using a variant of the modified Rankin Scale (mRS) for neurologic disability. The classic mRS is a 6-point disability scale with possible scores ranging from 0-5. mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Higher scores are generally associated with less favorable outcomes. For this study patients with an mRS score of 0-2 will be determined to have had a favorable outcome to the procedure and patients with an mRS score of 3-5 will have been determined to have had an unfavorable outcome. Scoring will also include a 6 to identify patients who have expired. | Between 3-6 months post MMAE | 
| Clinical Outcome at Follow-up Clinical outcome at follow-up | Clinical outcome at follow-up will be assessed using a variant of the modified Rankin Scale (mRS) for neurologic disability. The classic mRS is a 6-point disability scale with possible scores ranging from 0-5. mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Higher scores are generally associated with less favorable outcomes. For this study patients with an mRS score of 0-2 will be determined to have had a favorable outcome to the procedure and patients with an mRS score of 3-5 will have been determined to have had an unfavorable outcome. Scoring will also include a 6 to identify patients who have expired. | Between 6-12 months post MMAE | 
| Clinical Outcome at Follow-up Clinical outcome at follow-up | Clinical outcome at follow-up will be assessed using a variant of the modified Rankin Scale (mRS) for neurologic disability. The classic mRS is a 6-point disability scale with possible scores ranging from 0-5. mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Higher scores are generally associated with less favorable outcomes. For this study patients with an mRS score of 0-2 will be determined to have had a favorable outcome to the procedure and patients with an mRS score of 3-5 will have been determined to have had an unfavorable outcome. Scoring will also include a 6 to identify patients who have expired. | Between 12-24 months post MMAE | 
| Complications following MMAE | Complications following MMAE will be identified and tabulated as either permanent or transient in nature | Following the procedure, up to 4 weeks | 
| Timing of Complications | Complications will be categorized and tabulated as having occurred perioperatively or postoperatively | Following the procedure, up to 4 weeks | 
| Relatedness of Complications | Complications will be assessed as to whether or not they were related to the surgical procedure | Following the procedure, up to 4 weeks | 
| Duration of Hospital Stay | The median duration of hospital stay will be tabulated and reported | Upon study discharge, up to 24 months | 
| Clinical outcome at discharge | Clinical outcome at discharge will be assessed using the modified Rankin Scale (mRS) for neurologic disability. The mRS being used is a 7-point scale with possible scores ranging from 0-6. mRS measures the degree of disability or dependence in the daily activities of people who have suffered neurological disability. Scoring ranges from 0 (no residual symptoms) to 5 (severe neurologic disability). A patient who has expired (during or after discharge from hospital) is assigned a score of 6. Scores will be averaged and reported. Higher mRS scores are associated with progressively less favorable outcomes. | Upon study discharge, up to 24 months | 
| Disposition After Discharge | Disposition upon discharge will be categorized as either discharged to home; discharged to home with health service, discharged to rehabilitation facility, or death | Upon study discharge, up to 24 months | 
| Rescue surgical evacuation | The percentage of patients who were determined to require rescue surgical evacuation of their hematoma will be tabulated and reported | Between 3-12 months post MMAE | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Middle meningeal artery embolization, Endovascular Embolization