{
  "abstract": "Objective Normal pressure hydrocephalus (NPH) is a neurological condition characterized by impaired gait, cognitive decline, and urinary incontinence. Endovascular shunting using the eShunt Implant diverts cerebrospinal fluid (CSF) from basal cisterns to the internal jugular vein via a transvenous, transfemoral procedure. We report initial eShunt safety data for treatment of NPH through 90 days in a prospective, multicenter, single-arm trial.Methods NPH participants indicated for endovascular shunt placement were included after exhibiting positive gait response to lumbar CSF withdrawal and candidate anatomy. NPH symptoms at baseline and following eShunt Implant placement were assessed using the Timed Up & Go (TUG) test for gait, Montreal Cognitive Assessment (MoCA) for cognition, and Neurogenic Bladder Symptom Score-Short Form (NBSS-SF) for urinary symptoms. The primary endpoint was the rate of device and/or procedure-related serious adverse events (SAE) at 90-day follow-up.Results Sixty-six participants were treated with the eShunt Implant without immediate or delayed cerebral hemorrhage, over-drainage, infection or device-related SAEs. Two procedure-related SAEs (3.0%) occurred, one sigmoid sinus thrombosis and one femoral artery pseudoaneurysm, both resolved without surgical intervention. Matched-pair analysis showed statistically significant improvements in TUG time (37.2%; P<0.0001), MoCA score (+2.3; P<0.0001), and NBSS-SF score (−2.1; P<0.002).Conclusions Endovascular shunting for NPH was feasible with a low rate of SAEs typically associated with conventional shunt surgery. An acceptable clinical response through 90 days was observed. These findings suggest further investigation of this minimally invasive, endovascular approach to NPH in a randomized controlled trial comparing to standard of care.Trial registration number ClinicalTrials.gov Identifiers: NCT05250505 and NCT05232838.",
  "authors": [
    {
      "affiliations": [
        "Interventional Neuroradiology, Clinical Institute ENERI, Buenos Aires, Argentina"
      ],
      "name": "Pedro Lylyk"
    },
    {
      "affiliations": [
        "Neurosurgery, Yale University, New Haven, Connecticut, USA"
      ],
      "name": "Charles C Matouk"
    },
    {
      "affiliations": [
        "Neurosurgery, Baptist Medical Center Jacksonville, Jacksonville, Florida, USA"
      ],
      "name": "Ricardo A Hanel"
    },
    {
      "affiliations": [
        "Neurosurgery, Virginia Commonwealth University, Richmond, Virginia, USA"
      ],
      "name": "John F Reavey-Cantwell"
    },
    {
      "affiliations": [
        "Neurosurgery, NYU, New York, New York, USA"
      ],
      "name": "Howard A Riina"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Montefiore Medical Center, Bronx, New York, USA"
      ],
      "name": "David J Altschul"
    },
    {
      "affiliations": [
        "Neurosurgery and Radiology and Canon Stroke and Vascular Research Center, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York, USA",
        "Neurosurgery, Gates Vascular Institute, Buffalo, New York, USA"
      ],
      "name": "Adnan H Siddiqui"
    },
    {
      "affiliations": [
        "Neurological Surgery, University of Kentucky, Lexington, Kentucky, USA"
      ],
      "name": "Justin F Fraser"
    },
    {
      "affiliations": [
        "Neurosurgery, Radiology, University of Kansas, Kansas City, Kansas, USA"
      ],
      "name": "Koji C Ebersole"
    },
    {
      "affiliations": [
        "Neurosurgery, University of Rochester Medical Center, Rochester, New York, USA"
      ],
      "name": "Tarun Bhalla"
    },
    {
      "affiliations": [
        "Neurosurgery, University of Rochester Medical Center, Rochester, New York, USA"
      ],
      "name": "Matthew T Bender"
    },
    {
      "affiliations": [
        "Neurosurgery, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA"
      ],
      "name": "Christopher S Ogilvy"
    },
    {
      "affiliations": [
        "Neurosurgery, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA"
      ],
      "name": "Philipp Taussky"
    },
    {
      "affiliations": [
        "Montefiore Medical Center, New York, New York, USA"
      ],
      "name": "Amanda Baker"
    },
    {
      "affiliations": [
        "Warren Alpert School of Medical at Brown University, Providence, Rhode Island, USA"
      ],
      "name": "Mahesh V Jayaraman"
    },
    {
      "affiliations": [
        "Clínica La Sagrada Familia, Buenos Aires, Argentina"
      ],
      "name": "Ivan Lylyk"
    },
    {
      "affiliations": [
        "Neuroradiology, Clinica Sagrada Familia, ENERI, Buenos Aires, Argentina"
      ],
      "name": "Nicolas Perez"
    },
    {
      "affiliations": [
        "Interventional Neuroradiology, Clinical Institute ENERI, Buenos Aires, Argentina"
      ],
      "name": "Carlos Bleise"
    },
    {
      "affiliations": [
        "Interventional Neuroradiology, Clinical Institute ENERI, Buenos Aires, Argentina",
        "Interventional Neuroradiology, Clinica Sagrada Familia, Buenos Aires, Argentina"
      ],
      "name": "Esteban Scrivano"
    },
    {
      "affiliations": [
        "Interventional Neuroradiology, Clinica Sagrada Familia, Buenos Aires, Argentina"
      ],
      "name": "Pedro N Lylyk"
    },
    {
      "affiliations": [
        "Neurosurgery, Yale University School of Medicine, New Haven, Connecticut, USA"
      ],
      "name": "Kamil W Nowicki"
    },
    {
      "affiliations": [
        "Neurosurgery, Yale School of Medicine, New Haven, Connecticut, USA"
      ],
      "name": "Andrew B Koo"
    },
    {
      "affiliations": [
        "Neurosurgery, Yale University, New Haven, Connecticut, USA"
      ],
      "name": "Joseph Antonios"
    },
    {
      "affiliations": [
        "CereVasc Inc, Charlestown, Massachusetts, USA"
      ],
      "name": "Brandon M Beneduce"
    },
    {
      "affiliations": [
        "Neurosurgery and Radiology and Canon Stroke and Vascular Research Center, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York, USA",
        "Neurosurgery, Gates Vascular Institute, Buffalo, New York, USA"
      ],
      "name": "Elad I Levy"
    },
    {
      "affiliations": [
        "Neurosurgery, Tufts Medical Center, Boston, Massachusetts, USA"
      ],
      "name": "Carl B Heilman"
    },
    {
      "affiliations": [
        "Neurosurgery, Tufts Medical Center, Boston, Massachusetts, USA"
      ],
      "name": "Adel M Malek"
    }
  ],
  "title": "Safety of endovascular shunting for normal pressure hydrocephalus from a prospective, multicenter, single-arm study",
  "uid": "d493eec4-c542-58a9-a4aa-9071d1b9dc10"
}