Safety and Efficacy of Aneurysm Treatment With WEB: Results of the WEBCAST Study

J Neurosurg. 2016 May;124(5):1250-6. doi: 10.3171/2015.2.JNS142634. Epub 2015 Sep 18.

Abstract

OBJECT WEB is an innovative intrasaccular treatment for intracranial aneurysms. Preliminary series have shown good safety and efficacy. The WEB Clinical Assessment of Intrasaccular Aneurysm Therapy (WEBCAST) trial is a prospective European trial evaluating the safety and efficacy of WEB in wide-neck bifurcation aneurysms. METHODS Patients with wide-neck bifurcation aneurysms for which WEB treatment was indicated were included in this multicentergood clinical practices study. Clinical data including adverse events and clinical status at 1 and 6 months were collected and independently analyzed by a medical monitor. Six-month follow-up digital subtraction angiography was also performed and independently analyzed by a core laboratory. Success was defined at 6 months as complete occlusion or stable neck remnant, no worsening in angiographic appearance from postprocedure, and no retreatment performed or planned. RESULTS Ten European neurointerventional centers enrolled 51 patients with 51 aneurysms. Treatment with WEB was achieved in 48 of 51 aneurysms (94.1%). Adjunctive implants (coils/stents) were used in 4 of 48 aneurysms (8.3%). Thromboembolic events were observed in 9 of 51 patients (17.6%), resulting in a permanent deficit (modified Rankin Scale [mRS] Score 1) in 1 patient (2.0%). Intraoperative rupture was not observed. Morbidity (mRS score > 2) and mortality were 2.0% (1 of 51 patients, related to rupture status on entry to study) and 0.0% at 1 month, respectively. Success was achieved at 6 months in 85.4% of patients treated with WEB: 23 of 41 patients (56.1%) had complete occlusion, 12 of 41 (29.3%) had a neck remnant, and 6 of 41 (14.6%) had an aneurysm remnant. CONCLUSIONS The WEBCAST study showed good procedural and short-term safety of aneurysm treatment with WEB and good 6-month anatomical results.

Keywords: ACoA = anterior communicating artery; BA = basilar artery; CCT = Cerecyte Coil Trial; DSA = digital subtraction angiography; ICA = internal carotid artery; ITT = intention to treat; MCA = middle cerebral artery; WEB; WEBCAST = WEB Clinical Assessment of Intrasaccular Aneurysm Therapy; endovascular treatment; flow-diverter device; intracranial aneurysms; mRS = modified Rankin Scale; vascular disorders.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Alloys*
  • Angiography, Digital Subtraction
  • Cause of Death
  • Combined Modality Therapy
  • Diffusion Chambers, Culture
  • Embolization, Therapeutic / instrumentation*
  • Embolization, Therapeutic / methods*
  • Endovascular Procedures / instrumentation*
  • Endovascular Procedures / methods*
  • Female
  • Follow-Up Studies
  • Humans
  • Intracranial Aneurysm / diagnostic imaging
  • Intracranial Aneurysm / mortality
  • Intracranial Aneurysm / surgery*
  • Male
  • Middle Aged
  • Outcome and Process Assessment, Health Care
  • Patient Safety
  • Platelet Aggregation Inhibitors / administration & dosage
  • Postoperative Complications / diagnostic imaging
  • Postoperative Complications / mortality
  • Prospective Studies
  • Prostheses and Implants*
  • Stents*
  • Thromboembolism / diagnostic imaging
  • Thromboembolism / mortality
  • Thromboembolism / prevention & control
  • Treatment Outcome

Substances

  • Alloys
  • Platelet Aggregation Inhibitors
  • nitinol