{
  "abstract": "Introduction NeoCast is a novel, solvent-free, non-adhesive, shear-thinning liquid embolic agent designed to achieve reproducible distal penetration. We report the three-month follow-up data for 24 subjects enrolled in EMBO-02, the first-in-human trial of NeoCast for Middle Meningeal Artery embolization (MMAE) in subjects with chronic subdural hematoma (cSDH).Methods The EMBO-02 study (ACTRN12624000659505) is an open-label, multicenter, prospective, externally monitored, core lab adjudicated, feasibility clinical trial. The primary safety endpoint is device related disabling stroke or neurological death within 30 days of embolization. The primary feasibility endpoint is successful injection of NeoCast, resulting in complete occlusion at, or distal to, the point of injection. Inclusion criteria included cSDH thickness ≥ 10 mm, a pre-morbid mRS ≤ 2, and planned MMAE as part of standard management. Assessments included mRS and hematoma volume at 6 weeks, 3 months, and 6 months as well as a post embolization usability questionnaire. Imaging assessments were completed by the core lab (Oculus Imaging, Knoxville TN).Results Twenty-four subjects (average age 74 years old, 19 male and 5 female) were enrolled across three sites and six operators. Average baseline hematoma thickness was 16.7 ± 5.3 mm and volume of 67.0 ± 35.5 ml. Most subjects (79%, 19/24) underwent standalone embolization and 42% (10/24) were treated under conscious sedation with a shift in preference toward conscious sedation in the last cohort of patients. A total of 45 NeoCast injections were completed (six treated bilaterally). All target MMA vessels were successfully embolized with NeoCast. Distal penetration was achieved in all subjects. Operators were satisfied or very satisfied with NeoCast’s overall performance in 92% of the cases; none were dissatisfied. All subjects successfully passed the 30-day safety endpoint with no device-related adverse events. At 6 weeks and 3 months, 66% and 93% of hematomas, respectively, demonstrated a >50% reduction in volume. Subjects had good functional outcomes (mRS 0-2) in 96% of the cases at 3 months with 67% improved from baseline.Conclusion To date, MMAE with NeoCast has been feasible and safe across multiple procedural contexts, including adjunctive and standalone embolization, utilizing both general anesthesia and conscious sedation. Successful embolization of the distal vasculature was achieved in all subjects with high levels of operator satisfaction. There was significant reduction in hematoma volume and good function outcomes in most patients at 3 month follow-up.Disclosures D. Fiorella: 2; C; Arsenal Medical. 4; C; Arsenal Medical. L. Slater: 1; C; Arsenal Medical. T. Phillips: 1; C; Arsenal Medical. L. de Villiers: 1; C; Arsenal Medical. J. Groom: 4; C; Arsenal Medical. 5; C; Arsenal Medical.Abstract O-027 Figure 1(A) Selective angiography prior to embolization, blue arrow indicates proximal catheter position. (B) Fluoroscopic image during NeoCast embolization, yellow arrows indicate NeoCast material, note distal penetration",
  "authors": [
    {
      "affiliations": [
        "SUNY SB, Stony Brook, NY"
      ],
      "name": "D Fiorella"
    },
    {
      "affiliations": [
        "Monash university, Aspendale, Australia"
      ],
      "name": "L Slater"
    },
    {
      "affiliations": [
        "Sir Charles Gairdner Hospital, Perth, Australia"
      ],
      "name": "T Phillips"
    },
    {
      "affiliations": [
        "Gold Coast University Hospital, Southport, Australia"
      ],
      "name": "L de Villiers"
    },
    {
      "affiliations": [
        "Arsenal Medical, Waltham, MA"
      ],
      "name": "J Groom"
    }
  ],
  "title": "O-027 Three month outcomes of middle meningeal artery embolization using neocast™ liquid embolic",
  "uid": "9c3d9f35-560d-5f00-8870-b0fd3df2c9ca"
}