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
Hauptverfasser: 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
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container_issue 2
container_start_page 1198
container_title Neurotherapeutics
container_volume 18
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
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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 (&lt; 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 &gt; 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. 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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 &gt; 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. 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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 (&lt; 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 &gt; 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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identifier ISSN: 1933-7213
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1878-7479
1878-7479
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source MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; Alma/SFX Local Collection; SpringerLink Journals - AutoHoldings
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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