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 VRD™ Prospective Registry, an intention to treat study, was to evaluate the safety and probable benefit of the device when used to facilitate endovascular coiling of wide-neck bifurcating aneurysms.
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 ≥ 2 mm 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. Patient enrollment was initiated in December 2013 and terminated in December 2014. The study is ongoing and data presented includes 12-month follow-up data. Specific variables that were evaluated in this study include: the ability of the device to facilitate endovascular coiling, the occurrence and frequency of adverse events and unanticipated adverse device, angiographic assessment of aneurysm occlusion grade, and occlusion durability. Occlusion grade and parent vessel compromise were assessed by DSA after the procedure as well as on the 12-month angiogram.
Results Twenty patients harboring 20 bifurcation aneurysms (8 MCA, 4 basilar tip, 4 AcoA, 4 ICA termination) were enrolled within the French Barrel Registry. One patient was enrolled, but not treated due to being a low anti-platelet responder. Patient enrollment was completed on December 2014. Aneurysm necks ranged from 3.1 to 8.0 mm (mean: 5.6) and dome/neck ratio ranged from 0.6 to 1.9 (mean: 1.2). All but 2 aneurysms were virgin unruptured aneurysms, 2 aneurysms were recurring aneurysms after previous endovascular treatment. Trans-cell microcatheter placement was obtained in all cases. Technical success was 100% (19/19). The mean overall performance of the device was 3.1 (on a 0 to 5 scale). Discharge mRS was 0 for all but 1 patient (this patient was mRS 2 at admission). Four serious adverse events were deplored in 3 patients: an ischemic stroke ipsilateral to the stent following low blood pressure after orthopedic surgery 9 months after stent implantation (mRS 3), a SAH during procedure due to perforation of the dome with the coil delivery microcatheter (mRS 0), a groin hematoma requiring prolonged hospital stay and transfusion, a pseudo-aneurysm of the femoral artery requiring surgical repair. At the end of the procedure, Raymond grade 1 occlusion was obtained in 9 cases, grade 2 in 5 cases, and grade 3 in 5 cases. To date, one-year angiographic follow-up was obtained in 5 (25.0%) patients, showing Raymond grade 1 occlusion in 3/5, grade 2 in 1/5, grade 3 in 1/5. There were neither parent vessel occlusion nor stenosis.
Conclusions The results demonstrate that the Barrel VRD device is new, effective tool for the endovascular treatment of wide neck bifurcation aneurysms. The main advantage of the Barrel VRD™ is to avoid the use of 2 stents in a Y-configuration for bifurcation aneurysm neck reconstruction.
Disclosures M. Piotin: 2; C; Covidien, Microvention, Stryker. 4; C; Lazarus Effect. J. Berge: None. F. Turjman: None. R. Blanc: None.
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