WISE study: 1 year outcomes of Woven EndoBridge treatment for ruptured wide neck bifurcation aneurysms

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Abstract
Introduction: The WISE (WEB Implant Safety and long term Efficacy: A pooled analysis of seven clinical trials) study combines data from seven fully adjudicated clinical trials totaling 601 enrolled patients, of which 143 were ruptured aneurysms. This analysis evaluates the safety and effectiveness of the Woven EndoBridge (WEB) device for the treatment of wide neck bifurcation aneurysms in the ruptured aneurysm cohort. Methods: WISE is a pooled analysis that combined patient level data from seven prospective multicenter WEB studies, each conducted with independent core laboratory review of imaging and independent adjudication of adverse events. Patients treated for ruptured aneurysms were identified, and baseline characteristics, procedural details, and 12 month clinical and angiographic outcomes were evaluated. Safety events, including thromboembolic and hemorrhagic complications, vasospasm, and hydrocephalus were assessed. Results: Among 143 patients with ruptured aneurysms, technical success was achieved in 97.2% of cases. Adequate occlusion was achieved in 87.5% of patients with available imaging, including 60.0% with complete occlusion. Retreatment up to 12 months occurred in 6.5% of patients. No rebleeding of WEB treated aneurysms was reported. Safety events up to 12 months included procedural thromboembolic events in 13.3% and stroke events in 8.4% of patients, with low 12 month mortality (1.4%) and morbidity (6.4%), mostly related to the initial aneurysm rupture. Conclusions: WEB treatment provided complete protection against rebleeding and is a safe and effective option for patients with ruptured wide neck bifurcation aneurysms.
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  • Terumo Neuro (NA)

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