国产血流导向装置Repath治疗颅内动脉瘤的安全性及有效性研究Safety and efficiency of domestic flow diverter Repath in the treatment of intracranial aneurysms
付晓杰;徐浩文;权涛;郭新宾;袁永杰;刘朝;王子博;管生;
摘要(Abstract):
目的初步探讨国产血流导向装置Repath治疗颅内动脉瘤的安全性及有效性。方法本研究为前瞻性、单中心、单臂临床前期试验,共纳入10例颅内动脉瘤患者并完成Repath血流导向装置植入,描述性分析Repath支架植入技术成功率、手术并发症及6个月动脉瘤闭塞率。结果 10例颅内动脉瘤患者(13个动脉瘤)纳入本研究,共植入11枚Repath血流导向装置,Repath支架植入技术成功率100%。术后1个月、3个月、6个月随访,除1例无症状性脑梗死外无器械及责任血管相关不良事件,9例患者完成6个月影像学随访,动脉瘤闭塞率75%(9/12动脉瘤)。结论血流导向装置Repath在治疗颅内动脉瘤中具有较高的安全性及有效性,但仍需大型、多中心、随机对照研究进一步证实。
关键词(KeyWords): 脑动脉瘤;蛛网膜下腔出血;血流导向装置;弹簧圈;介入栓塞
基金项目(Foundation): 河南省医学科技攻关计划联合共建项目(编号:LHGJ20190076)
作者(Authors): 付晓杰;徐浩文;权涛;郭新宾;袁永杰;刘朝;王子博;管生;
参考文献(References):
- [1]SAIGLE V,ASAD S,PRESSEAU J,et al.Do patientreported outcome measures for SAH include patient,family,and caregiver priorities?A scoping review[J].Neurology,2019,92(6):281-295.DOI:10.1212/WNL.0000000000006883.
- [2]MARCOLINI E,STRETZ C,DEWITT K M.Intracranial Hemorrhage and Intracranial Hypertension[J].Emerg Med Clin North Am,2019,37(3):529-544.DOI:10.1016/j.emc.2019.04.001.
- [3]ROUANET C,SILVA G S.Aneurysmal subarachnoid hemorrhage:current concepts and updates[J].Arq Neuropsiquiatr,2019,77(11):806-814.DOI:10.1590/0004-282X20190112.
- [4]VLAK M H,ALGRA A,BRANDENBURG R,et al.Prevalence of unruptured intracranial aneurysms,with emphasis on sex,age,comorbidity,country,and time period:a systematic review and meta-analysis[J].Lancet Neurol,2011,10(7):626-636.DOI:10.1016/S1474-4422(11)70109-0.
- [5]LI M H,CHEN S W,LI Y D,et al.Prevalence of unruptured cerebral aneurysms in Chinese adults aged 35to 75 years:a cross-sectional study[J].Ann Intern Med,2013,159(8):514-521.DOI:10.7326/0003-4819-159-8-201310150-00004.
- [6]WANG Y J,LI Z X,GU H Q,et al.China Stroke Statistics 2019 Writing Committee.China Stroke Statistics2019:A Report From the National Center for Healthcare Quality Management in Neurological Diseases,China National Clinical Research Center for Neurological Diseases,the Chinese Stroke Association,National Center for Chronic and Non-communicable Disease Control and Prevention,Chinese Center for Disease Control and Prevention and Institute for Global Neuroscience and Stroke Collaborations[J].Stroke Vasc Neurol,2020,5(3):211-239.DOI:10.1136/svn-2020-000457.
- [7]DONG Y,GUO Z N,LI Q,et al.Chinese Stroke Association Stroke Council Guideline Writing Committee.Chinese Stroke Association guidelines for clinical management of cerebrovascular disorders:executive summary and 2019 update of clinical management of spontaneous subarachnoid haemorrhage[J].Stroke Vasc Neurol,2019,4(4):176-181.DOI:10.1136/svn-2019-000296.
- [8]BROWN R D JR,BRODERICK J P.Unruptured intracranial aneurysms:epidemiology,natural history,management options,and familial screening[J].Lancet Neurol,2014,13(4):393-404.DOI:10.1016/S1474-4422(14)70015-8.
- [9]SUZUKI T,TAKAO H,RAPAKA S,et al.Rupture Risk of Small Unruptured Intracranial Aneurysms in Japanese Adults[J].Stroke,2020,51(2):641-643.DOI:10.1161/STROKEAHA.119.027664.
- [10]ALGRA A M,LINDGREN A,VERGOUWEN M D I,et al.Procedural Clinical Complications,Case-Fatality Risks,and Risk Factors in Endovascular and Neurosurgical Treatment of Unruptured Intracranial Aneurysms:A Systematic Review and Meta-analysis[J].JAMANeurol,2019,76(3):282-293.DOI:10.1001/jamaneurol.2018.4165.
- [11]RINKEL G J E.Management of patients with unruptured intracranial aneurysms[J].Curr Opin Neurol,2019,32(1):49-53.DOI:10.1097/WCO.0000000000000642.
- [12]ABECASSIS I J,ZEESHAN Q,GHODKE B V,et al.Surgical Versus Endovascular Management of Ruptured and Unruptured Intracranial Aneurysms:Emergent Issues and Future Directions[J].World Neurosurg,2020,136:17-27.DOI:10.1016/j.wneu.2019.12.127.
- [13]BRIGANTI F,LEONE G,MARSEGLIA M,et al.Endovascular treatment of cerebral aneurysms using flowdiverter devices:A systematic review[J].Neuroradiol J,2015,28(4):365-375.DOI:10.1177/1971400915602803.
- [14]KANNATH S K,MOHIMEN A,RAMAN K T,et al.Single centre experience of flow diverter treatment of complex intracranial aneurysms from South India:Intermediate and long-term outcomes[J].Neurol India,2019,67(3):797-802.DOI:10.4103/0028-3886.263195.
- [15]SHANKAR J J,TAMPIERI D,IANCU D,et al.SILKflow diverter for complex intracranial aneurysms:a Canadian registry[J].J Neurointerv Surg,2016,8(3):273-278.DOI:10.1136/neurintsurg-2015-011708.
- [16]NURMINEN V,RAJ R,NUMMINEN J,et al.Flow diversion for internal carotid artery aneurysms:Impact of complex aneurysm features and overview of outcome[J].Clin Neurol Neurosurg,2020,193:105782.DOI:10.1016/j.clineuro.2020.105782.
- [17]DANDAPAT S,MENDEZ-RUIZ A,MART NEZ-GALDMEZ M,et al.Review of current intracranial aneurysm flow diversion technology and clinical use[J].J NeuroInterv Surg,2020,2020:015877.
- [18]范锋,管生,郭新宾,等.血流导向装置治疗复发性颅内动脉瘤的初步经验[J].中国实用神经疾病杂志,2020,23(13):1110-1115.DOI:10.12083/SYSJ.2020.13.253.
- [19]DMYTRIW A A,PHAN K,MOORE J M,et al.On Flow Diversion:The Changing Landscape of Intracerebral Aneurysm Management[J].AJNR Am J Neuroradiol,2019,40(4):591-600.
- [20]NELSON P K,MAROSF I M,BERENTEI Z,et al.Long-Term Clinical and Angiographic Outcomes Following Pipeline Embolization Device Treatment of Complex Internal Carotid Artery Aneurysms:Five-Year Results of the Pipeline for Uncoilable or Failed Aneurysms Trial[J].Neurosurgery,2017,80(1):40-48.DOI:10.1093/neuros/nyw014.
- [21]PATEL P D,CHALOUHI N,ATALLAH E,et al.Offlabel uses of the Pipeline embolization device:a review of the literature[J].Neurosurg Focus,2017,42(6):E4.DOI:10.3171/2017.3.FOCUS1742.
- [22]LIMBUCCI N,LEONE G,RENIERI L,et al.Expanding Indications for Flow Diverters:Distal Aneurysms,Bifurcation Aneurysms,Small Aneurysms,Previously Coiled Aneurysms and Clipped Aneurysms,and Carotid Cavernous Fistulas[J].Neurosurgery,2020,86(Supplement_1):S85-S94.
- [23]LIU J M,ZHOU Y,LI Y,et al.Parent Artery Reconstruction for Large or Giant Cerebral Aneurysms Using the Tubridge Flow Diverter:A Multicenter,Randomized,Controlled Clinical Trial (PARAT)[J].Am JNeuroradiol,2018,39(5):807-816.DOI:10.3174/ajnr.A5619.
- [24]SWEID A,ATALLAH E,HERIAL N,et al.Pipelineassisted coiling versus pipeline in flow diversion treatment of intracranial aneurysms[J].J Clin Neurosci,2018,58:20-24.DOI:10.1016/j.jocn.2018.10.081.
- [25]SIDDIQUI A H,LEVY E I,SNYDER K V,et al.Use of Coils in Conjunction With the Pipeline Embolization Device for Treatment of Intracranial Aneurysms[J].Neurosurgery,2015,76(2):142-149.DOI:10.1227/NEU.0000000000000579.