Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma
Condition: Chronic Subdural Hematoma
MeSH terms: Hematoma, Subdural; Hematoma, Subdural, Chronic; Hematoma
Study type: Interventional

Summary: 
      Middle meningeal artery (MMA) embolization via a minimally invasive endovascular approach has
      been attempted with the goal of eliminating the arterial supply to the vascularized membrane.
      The investigators have recently presented the first known case series of MMA embolization as
      upfront treatment for cSDH in lieu of surgical evacuation (publication pending). Five
      patients underwent successful embolization of the MMA with subsequent reduction in size or
      complete resolution of cSDH with no peri-procedural complications.

      The purpose of this study will be to evaluate the safety and efficacy of MMA embolization
      compared to traditional surgical management for symptomatic, chronic, and medically
      refractory SDH. MMA embolization is an established procedure used routinely for treatment of
      tumors or vascular malformations; this study investigates the use of an established procedure
      for a new disease. The investigators hypothesize that MMA embolization will afford a
      particularly fragile patient population an alternative to invasive and morbid neurosurgical
      intervention.
    

Detailed description: 
      The purpose of this study will be to evaluate the safety and efficacy of middle meningeal
      artery (MMA) embolization compared to traditional surgical management for symptomatic,
      chronic, and medically refractory subdural hematoma (SDH). MMA embolization is an established
      procedure used routinely for treatment of tumors or vascular malformations; this study
      investigates the use of an established procedure for a new disease. The investigators
      hypothesize that MMA embolization will afford a particularly fragile patient population an
      alternative to invasive and morbid neurosurgical intervention.

      Since subjects being enrolled will be those that are symptomatic from chronic SDH,
      pre-procedural data such as clinical history, neurologic examination, and CT scans will
      already be available. The day after the embolization, subjects will undergo a clinical
      interview to assess change in symptoms. A neurologic exam and CT scan will also be performed
      prior to discharge. Telephone surveys will be used at intermittent time points to assess for
      change in clinical symptoms. The subjects will also present in clinic for a follow up
      clinical interview, neurologic exam, and CT scan at 2 and 6 weeks post-procedure. This follow
      up care including the CT scans is considered standard of care for patients undergoing surgery
      for chronic SDH and it will not expose them to any additional tests or imaging studies.

      MMA embolization is done under moderate sedation or general anesthesia using biplane
      fluoroscopy. Briefly, common femoral artery access is obtained, and a guide catheter is
      advanced into the external carotid artery. A microcatheter is then advanced into the internal
      maxillary artery and then the MMA. Particles are then injected. A post-procedure carotid
      angiography is performed to ensure no reflux of particles into the internal carotid artery
      circulation. The guide catheter is then removed and femoral hemostasis is obtained. Subjects
      recover from anesthesia and are observed overnight, undergo a non-contrast head CT the next
      day, and discharged if appropriate.
    

Intervention name(s): Middel Meningeal Artery Embolization
Intervention type(s): Procedure
Intervention description(s): Blood supply to the subdural hematoma via the middle meningeal artery is interrupted.
Other intervention name(s): MMA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Subdural Hematoma; Embolization; Middle meningeal artery