Pipeline Embolization Device for Intracranial Aneurysms in a Large Chinese Cohort: Complication Risk Factor Analysis
During intracranial aneurysm embolization with the Pipeline embolization device (PED), ischemic and hemorrhagic complications have been observed in cases among Western populations. The postmarket multicenter registry study on the embolization of intracranial aneurysms with the PED in China, i.e., th...
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Veröffentlicht in: | Neurotherapeutics 2021-04, Vol.18 (2), p.1198-1206 |
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creator | Kang, Huibin Zhou, Yu Luo, Bin Lv, Nan Zhang, Hongqi Li, Tianxiao Song, Donglei Zhao, Yuanli Guan, Sheng Maimaitili, Aisha Wang, Yunyan Feng, Wenfeng Wang, Yang Wan, Jieqing Mao, Guohua Shi, Huaizhang Yang, Xinjian Liu, Jianmin |
description | During intracranial aneurysm embolization with the Pipeline embolization device (PED), ischemic and hemorrhagic complications have been observed in cases among Western populations. The postmarket multicenter registry study on the embolization of intracranial aneurysms with the PED in China, i.e., the PLUS study, was performed to assess real-world predictors of complications and functional outcomes in patients treated with the PED in a Chinese population. All patients with intracranial aneurysms who underwent embolization using the PED between November 2014 and October 2019 across 14 centers in China were included. The study endpoints included preoperative and early postoperative ( 10 mm, distal anterior circulation aneurysms, and adjunctive coiling were found to be independent predictors of delayed aneurysm rupture, distal intraparenchymal hemorrhage, and neurological compression symptoms, respectively. The rate of PED-related complications in the PLUS study was similar to that in Western populations. The PLUS study identified successful deployment after adjustment or unsuccessful device deployment and the degree of immediate postoperative occlusion as novel independent predictors of PED-related ischemic stroke in a Chinese population.
ClinicalTrial.gov
Identifier: NCT03831672 |
doi_str_mv | 10.1007/s13311-020-00990-8 |
format | Article |
fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8423892</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2478583984</sourcerecordid><originalsourceid>FETCH-LOGICAL-c474t-e99f5d82f57c2dada5ac2427f22825e828b36fec821fc14699461ee0eb69d3143</originalsourceid><addsrcrecordid>eNp9kU1v1DAQhi1ERT_gD3BAlrhwCfgrsc0BabW0pdJKRQjOlteZ7Lok9mInlZZfj5eUQjn0NJbmmXfm9YvQS0reUkLku0w5p7QijFSEaE0q9QSdUCVVJYXUT8tbc15JRvkxOs35hpCac62eoWPORSGIOEHjZ7-D3gfA58M69v6nHX0M-CPcege4iwlfhTFZl2zwtseLAFPa5yFjH7DFK5s2gJfbMp9LjduYxvelDrveu1npi8_f8YV1Y5FaBNvvs8_P0VFn-wwv7uoZ-nZx_nX5qVpdX14tF6vKCSnGCrTu6laxrpaOtba1tXVMMNkxplgNiqk1bzpwitHOUdFoLRoKQGDd6JZTwc_Qh1l3N60HaB0crPRml_xg095E683DTvBbs4m3RgnGlWZF4M2dQIo_JsijGXx20Pc2QJyyYUKqWpU_Pex6_R96E6dUDBeqbnTBBNGFYjPlUsw5QXd_DCXmEKqZQzUlVPM7VKPK0Kt_bdyP_EmxAHwGcmmFDaS_ux-R_QV3ga6i</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2569858409</pqid></control><display><type>article</type><title>Pipeline Embolization Device for Intracranial Aneurysms in a Large Chinese Cohort: Complication Risk Factor Analysis</title><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>PubMed Central</source><source>Alma/SFX Local Collection</source><source>SpringerLink Journals - AutoHoldings</source><creator>Kang, Huibin ; Zhou, Yu ; Luo, Bin ; Lv, Nan ; Zhang, Hongqi ; Li, Tianxiao ; Song, Donglei ; Zhao, Yuanli ; Guan, Sheng ; Maimaitili, Aisha ; Wang, Yunyan ; Feng, Wenfeng ; Wang, Yang ; Wan, Jieqing ; Mao, Guohua ; Shi, Huaizhang ; Yang, Xinjian ; Liu, Jianmin</creator><creatorcontrib>Kang, Huibin ; Zhou, Yu ; Luo, Bin ; Lv, Nan ; Zhang, Hongqi ; Li, Tianxiao ; Song, Donglei ; Zhao, Yuanli ; Guan, Sheng ; Maimaitili, Aisha ; Wang, Yunyan ; Feng, Wenfeng ; Wang, Yang ; Wan, Jieqing ; Mao, Guohua ; Shi, Huaizhang ; Yang, Xinjian ; Liu, Jianmin</creatorcontrib><description>During intracranial aneurysm embolization with the Pipeline embolization device (PED), ischemic and hemorrhagic complications have been observed in cases among Western populations. The postmarket multicenter registry study on the embolization of intracranial aneurysms with the PED in China, i.e., the PLUS study, was performed to assess real-world predictors of complications and functional outcomes in patients treated with the PED in a Chinese population. All patients with intracranial aneurysms who underwent embolization using the PED between November 2014 and October 2019 across 14 centers in China were included. The study endpoints included preoperative and early postoperative (< 30 days) functional outcomes (modified Rankin scale [mRS] scores) and complications related to PED treatment at early postoperative and follow-up time points (3–36 months). Multivariate analysis was performed to identify risk factors for complications. A total of 1171 consecutive patients (mean age, 53.9 ± 11.4; female, 69.6% [813/1171]) with 1322 aneurysms were included in the study. Hypertension, basilar artery aneurysms, and successful deployment after adjustment or unsuccessful device deployment were found to be independent predictors of ischemic stroke, while the use of the Flex PED and incomplete occlusion immediately after treatment were protective factors. An aneurysm size > 10 mm, distal anterior circulation aneurysms, and adjunctive coiling were found to be independent predictors of delayed aneurysm rupture, distal intraparenchymal hemorrhage, and neurological compression symptoms, respectively. The rate of PED-related complications in the PLUS study was similar to that in Western populations. The PLUS study identified successful deployment after adjustment or unsuccessful device deployment and the degree of immediate postoperative occlusion as novel independent predictors of PED-related ischemic stroke in a Chinese population.
ClinicalTrial.gov
Identifier: NCT03831672</description><identifier>ISSN: 1933-7213</identifier><identifier>ISSN: 1878-7479</identifier><identifier>EISSN: 1878-7479</identifier><identifier>DOI: 10.1007/s13311-020-00990-8</identifier><identifier>PMID: 33447904</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Adult ; Aged ; Aneurysm ; Aneurysms ; Biomedical and Life Sciences ; Biomedicine ; Cerebral Angiography - trends ; China - epidemiology ; Cohort Studies ; Compression ; Dual Anti-Platelet Therapy - adverse effects ; Dual Anti-Platelet Therapy - trends ; Embolization ; Embolization, Therapeutic - adverse effects ; Embolization, Therapeutic - trends ; Endovascular coiling ; Factor analysis ; Female ; Follow-Up Studies ; Hemorrhage ; Humans ; Intracranial Aneurysm - diagnostic imaging ; Intracranial Aneurysm - epidemiology ; Intracranial Aneurysm - therapy ; Ischemia ; Male ; Middle Aged ; Multivariate analysis ; Neurobiology ; Neurology ; Neurosciences ; Neurosurgery ; Occlusion ; Original ; Original Article ; Patients ; Population studies ; Risk Assessment ; Risk Factors ; Self Expandable Metallic Stents - adverse effects ; Self Expandable Metallic Stents - trends ; Stroke ; Stroke - diagnostic imaging ; Stroke - epidemiology ; Stroke - etiology</subject><ispartof>Neurotherapeutics, 2021-04, Vol.18 (2), p.1198-1206</ispartof><rights>The American Society for Experimental NeuroTherapeutics, Inc. 2021</rights><rights>2021. The American Society for Experimental NeuroTherapeutics, Inc.</rights><rights>The American Society for Experimental NeuroTherapeutics, Inc. 2021.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c474t-e99f5d82f57c2dada5ac2427f22825e828b36fec821fc14699461ee0eb69d3143</citedby><cites>FETCH-LOGICAL-c474t-e99f5d82f57c2dada5ac2427f22825e828b36fec821fc14699461ee0eb69d3143</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8423892/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8423892/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,723,776,780,881,27903,27904,41467,42536,51297,53769,53771</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33447904$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kang, Huibin</creatorcontrib><creatorcontrib>Zhou, Yu</creatorcontrib><creatorcontrib>Luo, Bin</creatorcontrib><creatorcontrib>Lv, Nan</creatorcontrib><creatorcontrib>Zhang, Hongqi</creatorcontrib><creatorcontrib>Li, Tianxiao</creatorcontrib><creatorcontrib>Song, Donglei</creatorcontrib><creatorcontrib>Zhao, Yuanli</creatorcontrib><creatorcontrib>Guan, Sheng</creatorcontrib><creatorcontrib>Maimaitili, Aisha</creatorcontrib><creatorcontrib>Wang, Yunyan</creatorcontrib><creatorcontrib>Feng, Wenfeng</creatorcontrib><creatorcontrib>Wang, Yang</creatorcontrib><creatorcontrib>Wan, Jieqing</creatorcontrib><creatorcontrib>Mao, Guohua</creatorcontrib><creatorcontrib>Shi, Huaizhang</creatorcontrib><creatorcontrib>Yang, Xinjian</creatorcontrib><creatorcontrib>Liu, Jianmin</creatorcontrib><title>Pipeline Embolization Device for Intracranial Aneurysms in a Large Chinese Cohort: Complication Risk Factor Analysis</title><title>Neurotherapeutics</title><addtitle>Neurotherapeutics</addtitle><addtitle>Neurotherapeutics</addtitle><description>During intracranial aneurysm embolization with the Pipeline embolization device (PED), ischemic and hemorrhagic complications have been observed in cases among Western populations. The postmarket multicenter registry study on the embolization of intracranial aneurysms with the PED in China, i.e., the PLUS study, was performed to assess real-world predictors of complications and functional outcomes in patients treated with the PED in a Chinese population. All patients with intracranial aneurysms who underwent embolization using the PED between November 2014 and October 2019 across 14 centers in China were included. The study endpoints included preoperative and early postoperative (< 30 days) functional outcomes (modified Rankin scale [mRS] scores) and complications related to PED treatment at early postoperative and follow-up time points (3–36 months). Multivariate analysis was performed to identify risk factors for complications. A total of 1171 consecutive patients (mean age, 53.9 ± 11.4; female, 69.6% [813/1171]) with 1322 aneurysms were included in the study. Hypertension, basilar artery aneurysms, and successful deployment after adjustment or unsuccessful device deployment were found to be independent predictors of ischemic stroke, while the use of the Flex PED and incomplete occlusion immediately after treatment were protective factors. An aneurysm size > 10 mm, distal anterior circulation aneurysms, and adjunctive coiling were found to be independent predictors of delayed aneurysm rupture, distal intraparenchymal hemorrhage, and neurological compression symptoms, respectively. The rate of PED-related complications in the PLUS study was similar to that in Western populations. The PLUS study identified successful deployment after adjustment or unsuccessful device deployment and the degree of immediate postoperative occlusion as novel independent predictors of PED-related ischemic stroke in a Chinese population.
ClinicalTrial.gov
Identifier: NCT03831672</description><subject>Adult</subject><subject>Aged</subject><subject>Aneurysm</subject><subject>Aneurysms</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Cerebral Angiography - trends</subject><subject>China - epidemiology</subject><subject>Cohort Studies</subject><subject>Compression</subject><subject>Dual Anti-Platelet Therapy - adverse effects</subject><subject>Dual Anti-Platelet Therapy - trends</subject><subject>Embolization</subject><subject>Embolization, Therapeutic - adverse effects</subject><subject>Embolization, Therapeutic - trends</subject><subject>Endovascular coiling</subject><subject>Factor analysis</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Hemorrhage</subject><subject>Humans</subject><subject>Intracranial Aneurysm - diagnostic imaging</subject><subject>Intracranial Aneurysm - epidemiology</subject><subject>Intracranial Aneurysm - therapy</subject><subject>Ischemia</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Multivariate analysis</subject><subject>Neurobiology</subject><subject>Neurology</subject><subject>Neurosciences</subject><subject>Neurosurgery</subject><subject>Occlusion</subject><subject>Original</subject><subject>Original Article</subject><subject>Patients</subject><subject>Population studies</subject><subject>Risk Assessment</subject><subject>Risk Factors</subject><subject>Self Expandable Metallic Stents - adverse effects</subject><subject>Self Expandable Metallic Stents - trends</subject><subject>Stroke</subject><subject>Stroke - diagnostic imaging</subject><subject>Stroke - epidemiology</subject><subject>Stroke - etiology</subject><issn>1933-7213</issn><issn>1878-7479</issn><issn>1878-7479</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp9kU1v1DAQhi1ERT_gD3BAlrhwCfgrsc0BabW0pdJKRQjOlteZ7Lok9mInlZZfj5eUQjn0NJbmmXfm9YvQS0reUkLku0w5p7QijFSEaE0q9QSdUCVVJYXUT8tbc15JRvkxOs35hpCac62eoWPORSGIOEHjZ7-D3gfA58M69v6nHX0M-CPcege4iwlfhTFZl2zwtseLAFPa5yFjH7DFK5s2gJfbMp9LjduYxvelDrveu1npi8_f8YV1Y5FaBNvvs8_P0VFn-wwv7uoZ-nZx_nX5qVpdX14tF6vKCSnGCrTu6laxrpaOtba1tXVMMNkxplgNiqk1bzpwitHOUdFoLRoKQGDd6JZTwc_Qh1l3N60HaB0crPRml_xg095E683DTvBbs4m3RgnGlWZF4M2dQIo_JsijGXx20Pc2QJyyYUKqWpU_Pex6_R96E6dUDBeqbnTBBNGFYjPlUsw5QXd_DCXmEKqZQzUlVPM7VKPK0Kt_bdyP_EmxAHwGcmmFDaS_ux-R_QV3ga6i</recordid><startdate>20210401</startdate><enddate>20210401</enddate><creator>Kang, Huibin</creator><creator>Zhou, Yu</creator><creator>Luo, Bin</creator><creator>Lv, Nan</creator><creator>Zhang, Hongqi</creator><creator>Li, Tianxiao</creator><creator>Song, Donglei</creator><creator>Zhao, Yuanli</creator><creator>Guan, Sheng</creator><creator>Maimaitili, Aisha</creator><creator>Wang, Yunyan</creator><creator>Feng, Wenfeng</creator><creator>Wang, Yang</creator><creator>Wan, Jieqing</creator><creator>Mao, Guohua</creator><creator>Shi, Huaizhang</creator><creator>Yang, Xinjian</creator><creator>Liu, Jianmin</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7TK</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20210401</creationdate><title>Pipeline Embolization Device for Intracranial Aneurysms in a Large Chinese Cohort: Complication Risk Factor Analysis</title><author>Kang, Huibin ; Zhou, Yu ; Luo, Bin ; Lv, Nan ; Zhang, Hongqi ; Li, Tianxiao ; Song, Donglei ; Zhao, Yuanli ; Guan, Sheng ; Maimaitili, Aisha ; Wang, Yunyan ; Feng, Wenfeng ; Wang, Yang ; Wan, Jieqing ; Mao, Guohua ; Shi, Huaizhang ; Yang, Xinjian ; Liu, Jianmin</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c474t-e99f5d82f57c2dada5ac2427f22825e828b36fec821fc14699461ee0eb69d3143</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aneurysm</topic><topic>Aneurysms</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Cerebral Angiography - trends</topic><topic>China - epidemiology</topic><topic>Cohort Studies</topic><topic>Compression</topic><topic>Dual Anti-Platelet Therapy - adverse effects</topic><topic>Dual Anti-Platelet Therapy - trends</topic><topic>Embolization</topic><topic>Embolization, Therapeutic - adverse effects</topic><topic>Embolization, Therapeutic - trends</topic><topic>Endovascular coiling</topic><topic>Factor analysis</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Hemorrhage</topic><topic>Humans</topic><topic>Intracranial Aneurysm - diagnostic imaging</topic><topic>Intracranial Aneurysm - epidemiology</topic><topic>Intracranial Aneurysm - therapy</topic><topic>Ischemia</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Multivariate analysis</topic><topic>Neurobiology</topic><topic>Neurology</topic><topic>Neurosciences</topic><topic>Neurosurgery</topic><topic>Occlusion</topic><topic>Original</topic><topic>Original Article</topic><topic>Patients</topic><topic>Population studies</topic><topic>Risk Assessment</topic><topic>Risk Factors</topic><topic>Self Expandable Metallic Stents - adverse effects</topic><topic>Self Expandable Metallic Stents - trends</topic><topic>Stroke</topic><topic>Stroke - diagnostic imaging</topic><topic>Stroke - epidemiology</topic><topic>Stroke - etiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kang, Huibin</creatorcontrib><creatorcontrib>Zhou, Yu</creatorcontrib><creatorcontrib>Luo, Bin</creatorcontrib><creatorcontrib>Lv, Nan</creatorcontrib><creatorcontrib>Zhang, Hongqi</creatorcontrib><creatorcontrib>Li, Tianxiao</creatorcontrib><creatorcontrib>Song, Donglei</creatorcontrib><creatorcontrib>Zhao, Yuanli</creatorcontrib><creatorcontrib>Guan, Sheng</creatorcontrib><creatorcontrib>Maimaitili, Aisha</creatorcontrib><creatorcontrib>Wang, Yunyan</creatorcontrib><creatorcontrib>Feng, Wenfeng</creatorcontrib><creatorcontrib>Wang, Yang</creatorcontrib><creatorcontrib>Wan, Jieqing</creatorcontrib><creatorcontrib>Mao, Guohua</creatorcontrib><creatorcontrib>Shi, Huaizhang</creatorcontrib><creatorcontrib>Yang, Xinjian</creatorcontrib><creatorcontrib>Liu, Jianmin</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Neurosciences Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest Psychology</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Neurotherapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kang, Huibin</au><au>Zhou, Yu</au><au>Luo, Bin</au><au>Lv, Nan</au><au>Zhang, Hongqi</au><au>Li, Tianxiao</au><au>Song, Donglei</au><au>Zhao, Yuanli</au><au>Guan, Sheng</au><au>Maimaitili, Aisha</au><au>Wang, Yunyan</au><au>Feng, Wenfeng</au><au>Wang, Yang</au><au>Wan, Jieqing</au><au>Mao, Guohua</au><au>Shi, Huaizhang</au><au>Yang, Xinjian</au><au>Liu, Jianmin</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pipeline Embolization Device for Intracranial Aneurysms in a Large Chinese Cohort: Complication Risk Factor Analysis</atitle><jtitle>Neurotherapeutics</jtitle><stitle>Neurotherapeutics</stitle><addtitle>Neurotherapeutics</addtitle><date>2021-04-01</date><risdate>2021</risdate><volume>18</volume><issue>2</issue><spage>1198</spage><epage>1206</epage><pages>1198-1206</pages><issn>1933-7213</issn><issn>1878-7479</issn><eissn>1878-7479</eissn><abstract>During intracranial aneurysm embolization with the Pipeline embolization device (PED), ischemic and hemorrhagic complications have been observed in cases among Western populations. The postmarket multicenter registry study on the embolization of intracranial aneurysms with the PED in China, i.e., the PLUS study, was performed to assess real-world predictors of complications and functional outcomes in patients treated with the PED in a Chinese population. All patients with intracranial aneurysms who underwent embolization using the PED between November 2014 and October 2019 across 14 centers in China were included. The study endpoints included preoperative and early postoperative (< 30 days) functional outcomes (modified Rankin scale [mRS] scores) and complications related to PED treatment at early postoperative and follow-up time points (3–36 months). Multivariate analysis was performed to identify risk factors for complications. A total of 1171 consecutive patients (mean age, 53.9 ± 11.4; female, 69.6% [813/1171]) with 1322 aneurysms were included in the study. Hypertension, basilar artery aneurysms, and successful deployment after adjustment or unsuccessful device deployment were found to be independent predictors of ischemic stroke, while the use of the Flex PED and incomplete occlusion immediately after treatment were protective factors. An aneurysm size > 10 mm, distal anterior circulation aneurysms, and adjunctive coiling were found to be independent predictors of delayed aneurysm rupture, distal intraparenchymal hemorrhage, and neurological compression symptoms, respectively. The rate of PED-related complications in the PLUS study was similar to that in Western populations. The PLUS study identified successful deployment after adjustment or unsuccessful device deployment and the degree of immediate postoperative occlusion as novel independent predictors of PED-related ischemic stroke in a Chinese population.
ClinicalTrial.gov
Identifier: NCT03831672</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>33447904</pmid><doi>10.1007/s13311-020-00990-8</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Adult Aged Aneurysm Aneurysms Biomedical and Life Sciences Biomedicine Cerebral Angiography - trends China - epidemiology Cohort Studies Compression Dual Anti-Platelet Therapy - adverse effects Dual Anti-Platelet Therapy - trends Embolization Embolization, Therapeutic - adverse effects Embolization, Therapeutic - trends Endovascular coiling Factor analysis Female Follow-Up Studies Hemorrhage Humans Intracranial Aneurysm - diagnostic imaging Intracranial Aneurysm - epidemiology Intracranial Aneurysm - therapy Ischemia Male Middle Aged Multivariate analysis Neurobiology Neurology Neurosciences Neurosurgery Occlusion Original Original Article Patients Population studies Risk Assessment Risk Factors Self Expandable Metallic Stents - adverse effects Self Expandable Metallic Stents - trends Stroke Stroke - diagnostic imaging Stroke - epidemiology Stroke - etiology |
title | Pipeline Embolization Device for Intracranial Aneurysms in a Large Chinese Cohort: Complication Risk Factor Analysis |
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