Abstract

PURPOSE: Complex wide-necked bifurcation aneurysms by using a single-stent and double (X and Y) stenting remain challenging. The purpose of the French Barrel™ Prospective Registry, an intention to treat study, is to evaluate the safety and probable benefit of the Barrel VRD when used to facilitate endovascular coiling of wide-neck bifurcating. METHODS: The Barrel VRD was intended for use with embolic coils for the treatment of wide-neck bifurcating intracranial aneurysms arising from a parent vessel with a diameter of ≥ 2mm and ≤ 4 mm. A wide-neck is defined as having a neck width ≥ 4 mm or a dome-to-neck ratio < 2. Patients (all harboring unruptured aneurysms) were placed on a double anti-platelet protocol (Clopidogrel and ASA) prior to treatment. RESULTS: From December 2013 to June 2014, 18 patients harboring 18 aneurysms (7 MCA, 4 basilar tip, 4 AcoA, 3 ICA termination) were enrolled within the French Barrel Registry thus far. One patient was enrolled, but not treated due to being a low anti-platelet responder. Aneurysm necks ranged from 3.1 to 8.0 mm (mean: 4.8) and dome/neck ratio ranged from 0.6 to 1.7 (mean : 1.2). Trans-cell microcatheter placement was obtained in all cases. Technical success was 88.2% (15/17). In 1 case, 2 coil loops protruded outside the Barrel within the parent vessel, in another case the Barrel moved slightly during coil delivery microcatheter placement into the sac. Discharge mRS was 0 for all but 1 patients (this patient was mRS 2 at admission). Adverse events included 1 groin hematoma, and 1 aneurysm coil perforation, related to the procedure, but not the Barrel VRD. CONCLUSIONS: The initial French Barrel Registry results demonstrate that the Barrel VRD device is new tool for the endovascular treatment of wide neck bifurcation aneurysms.

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