icon fsr

文献詳細

雑誌文献

Neurological Surgery 脳神経外科51巻6号

2023年11月発行

文献概要

総説

血管内治療におけるflow diverterの現状

著者: 尾崎友彦1

所属機関: 1大阪大学大学院医学系研究科脳神経外科学

ページ範囲:P.1133 - P.1148

文献購入ページに移動
Ⅰ はじめに
 Flow diverter(FD)は,本邦では2015年4月にPipelineTM Flex(Covidien,現Medtronic)が薬事承認され,その治療の歴史がスタートした.以降,『頭蓋内動脈ステント(脳動脈瘤治療用Flow Diverter)適正使用指針 第3版』1)に基づき治療が行われている.2023年現在,3種類のFDが使用可能となっており,FD導入前には治療困難であった大型動脈瘤や後方循環動脈瘤に対しても,安全に治療が行えるようになってきた.さらに近年,エビデンスの蓄積2-4)により,動脈瘤のサイズも10 mm以下の瘤にまで適応拡大されている.
 しかし,克服すべき課題も残されている.まず,母血管内に金属量の多いFDを留置することによる血栓性塞栓症,さらにそれを防止するための長期にわたる抗血小板薬内服の必要性が挙げられる.また,動脈瘤治癒までには数カ月を要するため,FD留置後の動脈瘤破裂,いわゆる遅発性破裂(delayed aneurysmal rupture)も課題である5).さらに,大きな分岐血管をもつ動脈瘤などの,FD留置後も瘤内血流停滞を得にくく瘤が治癒しないFD不応例にも考慮が必要である6)
 本稿では,FDの治療適応を含めた基本情報と,これまでのエビデンスに基づいた現状,さらには今後の展望に関して報告する.

参考文献

1)日本脳神経外科学会,他:頭蓋内動脈ステント(脳動脈瘤治療用Flow Diverter)適正使用指針 第3版.2020 http://jsnet.website/documents.php?id=109(2023年8月22日アクセス)
2)Arai S, et al:Pipeline Flex with Shield Technology placement for small- and medium-sized aneurysms achieves early complete occlusion. Neurol Med Chir(Tokyo)63:58-64, 2023
3)Hanel RA, et al:Prospective study on embolization of intracranial aneurysms with the pipeline device(PREMIER study):3-year results with the application of a flow diverter specific occlusion classification. J Neurointerv Surg 15:248-254, 2023
4)Hanel RA, et al:Prospective study on embolization of intracranial aneurysms with the pipeline device:the PREMIER study 1 year results. J Neurointerv Surg 12:62-66, 2020
5)Rouchaud A, et al:Delayed hemorrhagic complications after flow diversion for intracranial aneurysms:a literature overview. Neuroradiology 58:171-177, 2016
6)Bonney PA, et al:Failure of flow diverter therapy:predictors and management strategies. Neurosurgery 86(Suppl 1):S64-S73, 2020 doi:10.1093/neuros/nyz305
7)Girdhar G, et al:Thrombogenicity assessment of Pipeline Flex, Pipeline Shield, and FRED flow diverters in an in vitro human blood physiological flow loop model. J Biomed Mater Res A 106:3195-3202, 2018
8)Hagen MW, et al:Thrombogenicity of flow diverters in an ex vivo shunt model:effect of phosphorylcholine surface modification. J Neurointerv Surg 9:1006-1011, 2017
9)Matsuda Y, et al:Analysis of neointima development in flow diverters using optical coherence tomography imaging. J Neurointerv Surg 10:162-167, 2018
10)Becske T, 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. Neurosurgery 80:40-48, 2017
11)Becske T, et al:Pipeline for uncoilable or failed aneurysms:results from a multicenter clinical trial. Radiology 267:858-868, 2013
12)Kallmes DF, et al:International retrospective study of the pipeline embolization device:a multicenter aneurysm treatment study. AJNR Am J Neuroradiol 36:108-115, 2015
13)Lylyk I, et al:Pipeline embolization devices for the treatment of intracranial aneurysms, single-center registry:long-term angiographic and clinical outcomes from 1000 aneurysms. Neurosurgery 89:443-449, 2021
14)Chia GS, et al:Safety and Clinical Effectiveness of Pipeline Shield Device for Intracranial Aneurysms in an Australian Cohort(SCOPE-AUS). Stroke Vasc Interv Neurol 2:e000292, 2022 doi.org/10.1161/SVIN.121.000292
15)Rice H, et al:Periprocedural to 1-year safety and efficacy outcomes with the Pipeline Embolization Device with Shield technology for intracranial aneurysms:a prospective, post-market, multi-center study. J Neurointerv Surg 12:1107-1112, 2020
16)Martínez-Galdámez M, et al:Treatment of intracranial aneurysms using the pipeline flex embolization device with shield technology:angiographic and safety outcomes at 1-year follow-up. J Neurointerv Surg 11:396-399, 2019
17)Atasoy D, et al:Outcome Study of the Pipeline Embolization Device with Shield Technology in Unruptured Aneurysms(PEDSU). AJNR Am J Neuroradiol 40:2094-2101, 2019
18)Kallmes DF, et al:Safety and efficacy of the Pipeline embolization device for treatment of intracranial aneurysms:a pooled analysis of 3 large studies. J Neurosurg 127:775-780, 2017
19)Cortez GM, et al:Diffusion-weighted imaging lesions after intracranial aneurysm treatment with Pipeline Flex and Pipeline Flex with Shield technology:a retrospective cohort analysis. J Neurointerv Surg, 2023(Online ahead of print) doi:10.1136/jnis-2023-020250
20)Pikis S, et al:Diffusion weighted image documented cerebral ischemia in the postprocedural period following pipeline embolization device with shield technology treatment of unruptured intracranial aneurysms:a prospective, single center study. J Neurointerv Surg 12:407-411, 2020
21)Killer-Oberpfalzer M, et al:European multicenter study for the evaluation of a dual-layer flow-diverting stent for treatment of wide-neck intracranial aneurysms:the european flow-redirection intraluminal device study. AJNR Am J Neuroradiol 39:841-847, 2018
22)McDougall CG, et al:Safety and efficacy results of the Flow Redirection Endoluminal Device(FRED)stent system in the treatment of intracranial aneurysms:US pivotal trial. J Neurointerv Surg 14:577-584, 2022
23)Piano M, et al;FRED Italian Registry Group:FRED Italian registry:a multicenter experience with the flow re-direction endoluminal device for intracranial aneurysms. J Neurosurg 133:174-181, 2020
24)Pierot L, et al:SAFE study(Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment):1-year clinical and anatomical results. J Neurointerv Surg 11:184-189, 2019
25)Vivanco-Suarez J, et al:Safety and efficacy of the surpass streamline for intracranial aneurysms(SESSIA):a multi-center US experience pooled analysis. Interv Neuroradiol 29:589-598, 2023
26)Hanel RA, et al:Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide-Neck Aneurysms - SCENT:3-year outcomes. J Neurointerv Surg 15:1084-1089, 2023
27)Meyers PM, et al:SCENT Trial. Stroke 50:1473-1479, 2019
28)Wakhloo AK, et al;Surpass Study Group:Surpass flow diverter in the treatment of intracranial aneurysms:a prospective multicenter study. AJNR Am J Neuroradiol 36:98-107, 2015
29)Xia JL, et al:Flow-diverting device versus coil embolization for unruptured intracranial aneurysm:a meta-analysis. Medicine(Baltimore)100:e26351, 2021 doi:10.1097/MD.0000000000026351
30)Zhou G, et al:Flow-diverting devices versus coil embolization for intracranial aneurysms:a systematic literature review and meta-analysis. World Neurosurg 88:640-645, 2016
31)Chalouhi N, et al:Matched comparison of flow diversion and coiling in small, noncomplex intracranial aneurysms. Neurosurgery 81:92-97, 2017
32)Salem MM, et al:Pipeline embolization device versus stent-assisted coiling for intracranial aneurysm treatment:a retrospective propensity score-matched study. Neurosurgery 87:516-522, 2020
33)Nishimoto K, et al:Flow diverter stenting for symptomatic intracranial internal carotid artery aneurysms:clinical outcomes and factors for symptom improvement. Neurol Med Chir(Tokyo)63:343-349, 2023
34)Silva MA, et al:Vision outcomes in patients with paraclinoid aneurysms treated with clipping, coiling, or flow diversion:a systematic review and meta-analysis. Neurosurg Focus 42:E15, 2017 doi:10.3171/2017.3.FOCUS1718
35)Caroff J, et al;JENI Research Collaboration:Antithrombotic therapies for neurointerventional surgery:a 2021 French comprehensive national survey. J Neurointerv Surg 15:402-407, 2023
36)Enomoto Y, et al:Optimal duration of dual antiplatelet therapy for stent-assisted coiling or flow diverter placement. J Neurointerv Surg, 2023(Online ahead of print) doi:10.1136/jnis-2023-020285
37)Ajadi E, et al:Predictive value of platelet reactivity unit(PRU)value for thrombotic and hemorrhagic events during flow diversion procedures:a meta-analysis. J Neurointerv Surg 11:1123-1128, 2019
38)Taylor LI, et al:Platelet testing in flow diversion:a review of the evidence. Neurosurg Focus 42:E5, 2017 doi:10.3171/2017.3.FOCUS1746
39)Delgado Almandoz JE, et al:Pre-procedure P2Y12 reaction units value predicts perioperative thromboembolic and hemorrhagic complications in patients with cerebral aneurysms treated with the Pipeline embolization device. J Neurointerv Surg 5(Suppl 3):iii3-iii10, 2013 doi:10.1136/neurintsurg-2012-010582
40)Tsukagoshi E, et al:Delayed aneurysm rupture in a patient treated with flow redirection endoluminal device:a case report and literature review. Surg Neurol Int 13:506, 2022 doi:10.25259/SNI_783_2022
41)Hou K, et al:Delayed rupture of intracranial aneurysms after placement of intra-luminal flow diverter. Neuroradiol J 33:451-464, 2020
42)Akiyama T, et al:Pipeline flow diversion with adjunctive coil embolization for internal carotid artery aneurysms following an intradural component:results in 46 consecutive aneurysms from a Japanese single-center experience. Neurosurg Rev 45:2221-2230, 2022
43)Kulcsár Z, et al:Intra-aneurysmal thrombosis as a possible cause of delayed aneurysm rupture after flow-diversion treatment. AJNR Am J Neuroradiol 32:20-25, 2011
44)Cebral JR, et al:Aneurysm rupture following treatment with flow-diverting stents:computational hemodynamics analysis of treatment. AJNR Am J Neuroradiol 32:27-33, 2011
45)Chow M, et al:Delayed spontaneous rupture of a posterior inferior cerebellar artery aneurysm following treatment with flow diversion:a clinicopathologic study. AJNR Am J Neuroradiol 33:E46-E51, 2012 doi:10.3174/ajnr.A2532
46)Fox B, et al:Rupture of giant vertebrobasilar aneurysm following flow diversion:mechanical stretch as a potential mechanism for early aneurysm rupture. BMJ Case Rep 2014:bcr2014011325, 2014 doi:10.1136/bcr-2014-011325
47)Fischer S, et al:Pipeline embolization device(PED)for neurovascular reconstruction:initial experience in the treatment of 101 intracranial aneurysms and dissections. Neuroradiology 54:369-382, 2012
48)Kan P, et al:Early postmarket results after treatment of intracranial aneurysms with the pipeline embolization device:a U.S. multicenter experience. Neurosurgery 71:1080-1087;discussion 1087-1088, 2012
49)Park M, et al:Pipeline embolization device with or without adjunctive coil embolization:analysis of complications from the IntrePED registry. AJNR Am J Neuroradiol 37:1127-1131, 2016
50)Bender MT, et al:Predictors of cerebral aneurysm persistence and occlusion after flow diversion:a single-institution series of 445 cases with angiographic follow-up. J Neurosurg 130:259-267, 2018
51)Daou B, et al:Aneurysms with persistent filling after failed treatment with the Pipeline embolization device. J Neurosurg 130:1376-1382, 2018
52)Fujii T, et al:Outcome of flow diverter placement for intracranial aneurysm with dual antiplatelet therapy and oral anticoagulant therapy. Interv Neuroradiol 26:532-538, 2020
53)Fujii T, et al:Long-term follow-up results after flow diverter therapy using the Pipeline embolization device for large or giant unruptured internal carotid artery aneurysms:single-center retrospective analysis in the Japanese population. Neurol Med Chir(Tokyo)62:19-27, 2022
54)Tsang AC, et al:Failure of flow diverter treatment of intracranial aneurysms related to the fetal-type posterior communicating artery. Neurointervention 10:60-66, 2015
55)Xu C, et al:Incomplete occlusion and visual symptoms of peri-ophthalmic aneurysm after treatment with a pipeline embolization device:a multi-center cohort study. Acta Neurochir(Wien)164:2191-2202, 2022
56)Goertz L, et al:Retreatment strategies for recurrent and residual aneurysms after treatment with flow-diverter devices. Neuroradiology 62:1019-1028, 2020
57)Kim G, et al:Retreatment of a recurrent giant aneurysm of the internal carotid artery after treatment with a flow-diverting stent. J Cerebrovasc Endovasc Neurosurg 25:208-213, 2023
58)Yamasaki D, et al:Flow alteration therapy for impending rupture of intracranial giant aneurysm after flow diverter placement. Surg Neurol Int 13:323, 2022 doi:10.25259/SNI_437_2022
59)Bell RS, et al:Can a self-expanding aneurysm stent be clipped? Emergency proximal control options for the vascular neurosurgeon. Neurosurgery 68:1056-1062, 2011
60)Abla AA, et al:Optic chiasm compression from mass effect and thrombus formation following unsuccessful treatment of a giant supraclinoid ICA aneurysm with the Pipeline device:open surgical bailout with STA-MCA bypass and parent vessel occlusion. J Neurosurg Pediatr 14:31-37, 2014
61)Nakamura T, et al:Surgical trapping of a cavernous carotid aneurysm causing carotid cavernous fistula after flow diverter placement:technical note and literature review. World Neurosurg 177:31-38, 2023
62)Iosif C, et al:Middle cerebral artery bifurcation aneurysms treated by extrasaccular flow diverters:midterm angiographic evolution and clinical outcome. AJNR Am J Neuroradiol 38:310-316, 2017
63)Gavrilovic V, et al:Silk Vista Baby is a safe and technically feasible flow diverting stent for distal aneurysm treatment. Front Neurol 12:676749, 2021 doi:10.3389/fneur.2021.676749
64)Cagnazzo F, et al:Treatment of distal anterior cerebral artery aneurysms with flow-diverter stents:a single-center experience. AJNR Am J Neuroradiol 39:1100-1106, 2018
65)Cagnazzo F, et al:Treatment of unruptured distal anterior circulation aneurysms with flow-diverter stents:a meta-analysis. AJNR Am J Neuroradiol 40:687-693, 2019
66)Ravindran K, et al:Use of flow diversion for the treatment of distal circulation aneurysms:a multicohort study. World Neurosurg 118:e825-e833, 2018 doi:10.1016/j.wneu.2018.07.062
67)El Naamani K, et al:Treatment of cerebral aneurysms with the FRED Jr flow-diverting stent:a case series and meta-analysis. Clin Neurol Neurosurg 223:107483, 2022 doi:10.1016/j.clineuro.2022.107483
68)Jesser J, et al:Safety and efficacy of the FRED Jr flow re-direction endoluminal device for intracranial aneurysms:retrospective multicenter experience with emphasis on midterm results. Front Neurol 12:722183, 2021 doi:10.3389/fneur.2021.722183
69)Sivasankar R, et al:Experience with FRED junior flow diverter in treatment of cerebral aneurysms at or distal to the circle of Willis. J Clin Neurosci 69:166-169, 2019
70)Bhogal P, et al:The Silk Vista Baby - the UK experience. Interv Neuroradiol 28:201-212, 2022
71)Hanel RA, et al:Patient outcomes after treatment of brain aneurysm in small diameter vessels with the silk vista baby flow diverter:a systematic review. Interv Neuroradiol, 2022(Online ahead of print) doi:10.1177/15910199221091645
72)Alpay K, et al:Finnish flow diverter study:8 years of experience in the treatment of acutely ruptured intracranial aneurysms. J Neurointerv Surg 14:699-703, 2022
73)Vollherbst DF, et al:The FRESH study:treatment of intracranial aneurysms with the new FRED X flow diverter with antithrombotic surface treatment technology-first multicenter experience in 161 patients. AJNR Am J Neuroradiol 44:474-480, 2023
74)Monteiro A, et al:A systematic review and meta-analysis of the Derivo Embolization Device:a novel surface-modified flow diverter for intracranial aneurysm treatment. J Neurointerv Surg 14:1125-1129, 2022
75)Taschner CA, et al:Derivo embolization device in the treatment of unruptured intracranial aneurysms:a prospective multicenter study. J Neurointerv Surg 13:541-546, 2021
76)Ma Y, et al:Single antiplatelet regimen in flow diverter treatment of cerebral aneurysms:the drug matters. A systematic review and meta-analysis. Interv Neuroradiol, 2023(Online ahead of print) doi:10.1177/15910199231177745
77)Senol YC, et al:The safety profile of single antiplatelet therapy with flow diverters:systematic review and meta-analysis. Interv Neuroradiol, 2023(Online ahead of print) doi:10.1177/15910199231168669

掲載誌情報

出版社:株式会社医学書院

電子版ISSN:1882-1251

印刷版ISSN:0301-2603

雑誌購入ページに移動
icon up
あなたは医療従事者ですか?