Piano Mariangela, Valvassori Luca, Lozupone Emilio, Pero Guglielmo, Quilici Luca, Boccardi Edoardo
1ASST Grande Ospedale Metropolitano Niguarda, Milan; and.
2UOC Radiologia e Neuroradiologia, Dipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
J Neurosurg. 2019 May 10;133(1):174-181. doi: 10.3171/2019.1.JNS183005. Print 2020 Jul 1.
The introduction of flow-diverter devices (FDDs) has revolutionized the endovascular treatment of intracranial aneurysms. Here the authors present their Italian multicenter experience using the flow re-direction endoluminal device (FRED) in the treatment of cerebral aneurysms, evaluating both short- and long-term safety and efficacy of this device.
Between February 2013 and December 2014, 169 consecutive aneurysms treated using FRED in 166 patients were entered into this study across 30 Italian centers. Data collected included patient demographics, aneurysm location and characteristics, baseline angiography, adverse event and serious adverse event information, morbidity and mortality rates, and pre- and posttreatment modified Rankin Scale scores, as well as angiographic and cross-sectional CT/MRI follow-up at 3-6 months and/or 12-24 months per institutional standard of care. All images were reviewed and adjudicated by an independent core lab.
Of the 169 lesions initially entered into the study, 4 were later determined to be extracranial or nonaneurysmal by the core lab and were excluded, leaving 165 aneurysms in 162 patients treated in 163 procedures. Ninety-one (56.2%) patients were asymptomatic with aneurysms found incidentally. Of the 165 aneurysms, 150 (90.9%) were unruptured. One hundred thirty-four (81.2%) were saccular, 27 (16.4%) were fusiform/dissecting, and the remaining 4 (2.4%) were blister-like. One hundred thirty-seven (83.0%) arose from the anterior circulation.FRED deployment was impossible in 2/163 (1.2%) cases, and in an additional 4 cases (2.5%) the device was misdeployed. Overall mortality and morbidity rates were 4.3% and 7.3%, respectively, with rates of mortality and morbidity potentially related to FRED of up to 2.4% and 6.2%, respectively. Neuroimaging follow-up at 3-6 months showed complete or nearly complete occlusion of the aneurysm in 94% of cases, increasing to 96% at 12-24 months' follow-up. Aneurysmal sac shrinkage was observed in 78% of assessable aneurysms.
This preliminary experience using FRED for endovascular treatment of complex unruptured and ruptured aneurysms showed a high safety and efficacy profile that is comparable to those of other FDDs currently in use.
血流导向装置（FDD）的引入彻底改变了颅内动脉瘤的血管内治疗。本文作者介绍了他们在意大利多中心使用血流再定向腔内装置（FRED）治疗脑动脉瘤的经验，评估了该装置的短期和长期安全性及有效性。
2013年2月至2014年12月期间，意大利30个中心的166例患者连续接受了169例使用FRED治疗的动脉瘤被纳入本研究。收集的数据包括患者人口统计学资料、动脉瘤位置和特征、基线血管造影、不良事件和严重不良事件信息、发病率和死亡率，以及治疗前后改良Rankin量表评分，以及按照各机构的标准护理在3 - 6个月和/或12 - 24个月进行的血管造影和横断面CT/MRI随访。所有图像均由独立的核心实验室进行审查和判定。
最初纳入研究的169个病变中，有4个后来被核心实验室确定为颅外病变或非动脉瘤性病变，予以排除，最终162例患者的165个动脉瘤接受了163次治疗。91例（56.2%）患者无症状，动脉瘤为偶然发现。165个动脉瘤中，150个（90.9%）未破裂。134个（81.2%）为囊状，27个（16.4%）为梭形/夹层型，其余4个（2.4%）为水泡样。137个（83.0%）起源于前循环。在163例中有2例（1.2%）无法植入FRED，另有4例（2.5%）植入不当。总体死亡率和发病率分别为4.3%和7.3%，与FRED可能相关的死亡率和发病率分别高达2.4%和6.2%。3 - 6个月的神经影像学随访显示，94%的病例动脉瘤完全或几乎完全闭塞，在12 - 24个月随访时增至96%。在78%可评估的动脉瘤中观察到瘤囊缩小。
使用FRED对复杂未破裂和破裂动脉瘤进行血管内治疗的初步经验显示，其安全性和有效性较高，与目前使用的其他FDD相当。
