From the Department of Medical Imaging (A.A.D., V.M.P., T.K.), Toronto Western Hospital, University of Toronto, Toronto, Ontario, Canada
Neurosurgical Service (A.A.D., K.P., J.M.M., A.J.T.), Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
AJNR Am J Neuroradiol. 2019 Apr;40(4):591-600. doi: 10.3174/ajnr.A6006. Epub 2019 Mar 20.
Uptake of flow-diverting technology is rapidly outpacing the availability of clinical evidence. Most current usage is off-label, and the endovascular community is nearer the beginning than the end of the learning curve, given the number of devices in development. A comprehensive overview of technical specifications alongside key outcome data is essential both for clinical decision-making and to direct further investigations. Most-studied has been the Pipeline Embolization Device, which has undergone a transition to the Pipeline Flex for which outcome data are sparse or heterogeneous. Alternative endoluminal devices do not appear to be outperforming the Pipeline Embolization Device to date, though prospective studies and long-term data mostly are lacking, and between-study comparisons must be treated with caution. Nominal technical specifications may be unrelated to in situ performance, emphasizing the importance of correct radiologic sizing and device placement. Devices designed specifically for bifurcation aneurysms also lack long-term outcome data or have only recently become available for clinical use. There are no major studies directly comparing a flow-diverting device with standard coiling or microsurgical clipping. Data on flow-diverting stents are too limited in terms of long-term outcomes to reliably inform clinical decision-making. The best available evidence supports using a single endoluminal device for most indications. Recommendations on the suitability and choice of a device for bifurcation or ruptured aneurysms or for anatomically complex lesions cannot be made on the basis of current evidence. The appropriateness of flow-diverting treatment must be decided on a case-by-case basis, considering experience and the relative risks against standard approaches or observation.
血流导向装置的应用正在迅速超过临床证据的可获得性。大多数目前的应用都属于超适应证使用，考虑到正在开发的设备数量，血管内治疗领域还远未达到学习曲线的终点，而是处于早期阶段。全面了解技术规格和关键结果数据对于临床决策和指导进一步研究都是至关重要的。研究最多的是 Pipeline 栓塞装置，该装置已经过渡到 Pipeline Flex，但其结果数据稀疏或不一致。到目前为止，替代的腔内装置似乎没有优于 Pipeline 栓塞装置，尽管缺乏前瞻性研究和长期数据，而且必须谨慎对待研究之间的比较。标称技术规格可能与实际性能无关，这强调了正确的放射学测量和装置放置的重要性。专门为分叉动脉瘤设计的装置也缺乏长期结果数据，或者最近才开始用于临床。目前还没有直接比较血流导向装置与标准线圈栓塞或显微手术夹闭的大型研究。血流导向支架的长期结果数据非常有限，无法可靠地为临床决策提供信息。目前最好的证据支持在大多数情况下使用单一的腔内装置。鉴于目前的证据，无法针对分叉或破裂动脉瘤或解剖结构复杂的病变推荐使用哪种装置以及如何选择合适的装置。血流导向治疗的适当性必须根据具体情况决定，要考虑经验以及与标准方法或观察相比的相对风险。
