Initial experience with implantation of novel dual layer flow-diverter device FRED.

Abstract

Flow-diverting stents can help treat complex and wide-necked cerebral aneurysms. The aim of the study was to evaluate initial experiences related to the safety and effectiveness of eight aneurysms treated with a new dual layer coverage designed flow-diverter device. In 2012 Fred flow-diverter devices were used to treat 8 unruptured wide neck (dome-neck ratio ≤ 1.5) and sidewall aneurysms in 6 patients. All aneurysms were located in the anterior circulation on the internal carotid artery (ICA). In 4 larger aneurysms (> 10 mm) one 3D coil in association with Fred was used to reduce potential incidence of postoperative subarachnoid haemorrhage (SAH). Dual antiplatelet therapy was administered before the procedure and continued for 3 months after it. Clinical parameters, aneurysm features and 3-month follow-up angiograms are presented. All 6 patients with 8 aneurysms were successfully stented with the Fred flow-diverter device and were discharged in generally good condition on dual-antiplatelet therapy. No complications were related to the procedure. In 5 cases digital subtraction angiography (DSA) control examination was performed after 3 months, showing complete occlusion of the aneurysms with patency of the parent artery. In 1 case thrombosis of the Fred occurred but without any clinical consequences because of cross-flow from the other side. Use of the Fred flow-diverter device was efficacious in all 8 treated cerebral aneurysms. The system seems to be promising as a flow diverter with certain characteristics, which allow for easy delivery and implantation. Further clinical evaluation with a larger group of patients is needed.