Tan Peter Shuangyue, Li Charles, Williams Cameron, Chong Winston, Chung Carlos, Houlihan Conor, Madan Anoop
Department of Interventional Neuroradiology, Alfred Hospital, Melbourne, Victoria, Australia.
Faculty of Medicine, Nursing and Health Sciences, Central Clinical School, Monash University, Melbourne, Victoria, Australia.
J Med Imaging Radiat Oncol. 2025 Jun;69(4):484-490. doi: 10.1111/1754-9485.13857. Epub 2025 Apr 14.
The FRED X flow diverter features antithrombotic surface treatment to reduce thrombogenicity. This study evaluated the safety and efficacy of FRED X in treating intracranial aneurysms in the Australian setting.
Clinical, procedural and imaging data were retrospectively reviewed for a consecutive series of patients at a single Australian neurovascular centre. Follow-up imaging was performed with a combination of MRA and IV-DSA imaging.
A total of 39 consecutive patients (21% presenting with acute rupture) with 52 aneurysms treated with 40 FRED X devices between June 2021 and September 2024 were included in this study. Aneurysms were predominantly saccular (88%) and located in the ICA (82%), with a median size of 5.1 mm (IQR 2.4-8). Satisfactory wall apposition was achieved in 98% of cases. Additional coiling was performed in 20%, and balloon angioplasty in 5%. At a median follow-up of 28 weeks, complete aneurysm occlusion was achieved in 74% of cases, with adequate occlusion (> 90%) in 86%. Minor adverse events occurred in 10% and major adverse events in 5%. Overall mortality was 5%, exclusively in acute subarachnoid haemorrhage cases.
The FRED X demonstrates favourable safety and efficacy profiles, with high technical success rates and satisfactory occlusion outcomes in an Australian setting. Thrombotic complications were rare, possibly reflecting the benefits of the antithrombotic coating, though larger studies with longer-term follow-up are needed for confirmation.
FRED X血流导向装置采用抗血栓表面处理以降低血栓形成倾向。本研究评估了FRED X在澳大利亚环境下治疗颅内动脉瘤的安全性和有效性。
对澳大利亚一个神经血管中心连续一系列患者的临床、手术和影像学数据进行回顾性分析。采用MRA和IV-DSA成像相结合的方式进行随访成像。
本研究纳入了2021年6月至2024年9月期间连续39例患者(21%为急性破裂),共52个动脉瘤,使用了40个FRED X装置进行治疗。动脉瘤主要为囊状(88%),位于颈内动脉(82%),中位大小为5.1毫米(四分位间距2.4 - 8)。98%的病例实现了满意的壁贴合。20%的病例进行了额外的弹簧圈栓塞,5%的病例进行了球囊血管成形术。中位随访28周时,74%的病例实现了动脉瘤完全闭塞,86%的病例实现了充分闭塞(>90%)。10%的患者发生了轻微不良事件,5%的患者发生了严重不良事件。总体死亡率为5%,仅发生在急性蛛网膜下腔出血病例中。
FRED X在澳大利亚环境下显示出良好的安全性和有效性,技术成功率高,闭塞效果令人满意。血栓形成并发症罕见,这可能反映了抗血栓涂层的益处,不过需要更大规模、长期随访的研究来证实。