{
  "abstract": "Introduction The Woven EndoBridge (WEB) Embolization System is the first intrasaccular device developed for the treatment of wide-necked bifurcation aneurysms (WNBAs). Here we report the 1-year outcomes for the unruptured aneurysm cohort of the WISE Study (WEB Implant Safety and long-term Effectiveness) database, a pooled analysis of subject-level data from seven prospective WEB trials.Methods Individual subject-level data from seven prospective, multicenter, core laboratory adjudicated, externally monitored studies evaluating the WEB device for the treatment of unruptured WNBAs were pooled. The included aneurysms had a mean dome width of 6.5 mm. All studies shared the same core laboratory, and five of the seven shared the same clinical events committee. Subject demographic and aneurysm characteristics, procedural data, and effectiveness and safety outcomes were combined and evaluated as a single population. Adequate occlusion was defined as complete occlusion or residual neck on core laboratory assessment.Results A total of 449 unruptured aneurysms were successfully treated within WISE. The 1-year rates of complete occlusion and adequate occlusion were 54.7% (223/408) and 82.8% (338/408), respectively. Aneurysm recurrence was 6.4% (19/298) and the retreatment rate was 2.5% (11/449). All-cause morbidity was 1.2% (5/416) and treatment-related morbidity (device- and/or procedure-related) was 0.5% (2/416) at 12 months. No ruptures were observed after WEB treatment through 1 year. Complete occlusion was less likely for anterior circulation aneurysms, larger aneurysm height and width, and wider neck. Complete occlusion was less likely for anterior circulation aneurysms and for aneurysms with larger height, width, and neck size (all p<0.05). Greater WEB lateral compression was associated with higher rates of complete occlusion (OR 1.289 for absolute difference and OR 7.042 for ratio, p≤0.0066), and with higher rates of adequate occlusion (OR 1.288 and 8.846, respectively). Retreatment was associated with larger aneurysm height and width, and smoking history.Conclusion The WEB device is safe and effective for the treatment of unruptured intracranial aneurysms with high rates of adequate occlusion, low rates of recurrence and retreatment, and reliable protection from rupture.",
  "authors": [
    {
      "affiliations": [
        "Department of Neurosurgery, Stony Brook Medicine, Stony Brook, New York, USA"
      ],
      "name": "David Fiorella"
    },
    {
      "affiliations": [
        "Radiology, University Hospital Reims, Reims, France"
      ],
      "name": "Laurent Pierot"
    },
    {
      "affiliations": [
        "Neurointerventions, National Institute of Neurosciences, Budapest, Hungary"
      ],
      "name": "Istvan Szikora"
    },
    {
      "affiliations": [
        "Neurosurgery, Xuanwu Hospital, Beijing, China"
      ],
      "name": "Hongqi Zhang"
    },
    {
      "affiliations": [
        "Diagnostic and Therapeutic Neuroradiology, Hôpital Purpan, Toulouse, France"
      ],
      "name": "Christophe Cognard"
    },
    {
      "affiliations": [
        "The Second Military Medical University, Shanghai, China"
      ],
      "name": "Jianmin Liu"
    },
    {
      "affiliations": [
        "NEURI The Brain Vascular Center, Bicetre Hospital Interventional Neuroradiology, Le Kremlin-Bicetre, France",
        "Paris-Saclay University Faculty of Medicine, Le Kremlin-Bicetre, France"
      ],
      "name": "Laurent Spelle"
    },
    {
      "affiliations": [
        "Semmes-Murphey Neurologic and Spine Institute, Memphis, Tennessee, USA",
        "Neurosurgery, University of Tennessee Health Science Center, Memphis, Tennessee, USA"
      ],
      "name": "Adam S Arthur"
    },
    {
      "affiliations": [],
      "name": "on behalf of the WISE Investigators"
    }
  ],
  "title": "The WISE Study - WEB Implant Safety and long-term Effectiveness: a pooled analysis of seven clinical trials – 1-year unruptured aneurysm results",
  "uid": "6737f93f-6599-5f16-970c-13bfc9306891"
}