Small and Medium-Sized Aneurysm Outcomes Following Intracranial Aneurysm Treatment Using the Pipeline Embolization Device: A Subgroup Analysis of the PLUS Registry
ObjectiveThe purpose of this work was to summarize the real-world safety and efficacy of Pipeline Embolization Device (PED) therapy for small and medium-sized intracranial aneurysms in China.MethodsPatients from the PED in China post-market multi-center registry study (PLUS) with aneurysms smaller t...
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Frontiers Media S.A.
2022-05-01
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author | Hongyun Zhang Hongyun Zhang Li Li Li Li Hongqi Zhang Hongqi Zhang Jianmin Liu Donglei Song Yuanli Zhao Sheng Guan Aisha Maimaitili Yunyan Wang Wenfeng Feng Yang Wang Jieqing Wan Guohua Mao Huaizhang Shi Bin Luo Qiuji Shao Qiuji Shao Kaitao Chang Kaitao Chang Qianqian Zhang Qianqian Zhang Yingkun He Yingkun He Peng Zhang Peng Zhang Xinjian Yang Tian xiao Li Tian xiao Li |
author_facet | Hongyun Zhang Hongyun Zhang Li Li Li Li Hongqi Zhang Hongqi Zhang Jianmin Liu Donglei Song Yuanli Zhao Sheng Guan Aisha Maimaitili Yunyan Wang Wenfeng Feng Yang Wang Jieqing Wan Guohua Mao Huaizhang Shi Bin Luo Qiuji Shao Qiuji Shao Kaitao Chang Kaitao Chang Qianqian Zhang Qianqian Zhang Yingkun He Yingkun He Peng Zhang Peng Zhang Xinjian Yang Tian xiao Li Tian xiao Li |
author_sort | Hongyun Zhang |
collection | DOAJ |
description | ObjectiveThe purpose of this work was to summarize the real-world safety and efficacy of Pipeline Embolization Device (PED) therapy for small and medium-sized intracranial aneurysms in China.MethodsPatients from the PED in China post-market multi-center registry study (PLUS) with aneurysms smaller than 12 mm were selected. Radiographic outcomes were assessed using digital subtraction angiography. Clinical outcomes included functional outcomes (modified Rankin Scale, MRS) in the early postoperative period ( ≤ 30 days) and early postoperative complications associated with PED therapy.ResultsA total of 652 patients with a combined 754 aneurysms were included in this study (mean age of 53.9 ± 10.3 years, 68.7% women). Mean aneurysm diameter was 6.78 ± 2.67 mm. Of the 687 stents deployed, 99.7% (685/689) were successfully deployed. In this study, 64.7% (488/754) of aneurysms were treated with only the PED, whereas 35.3% (266/754) were subjected to PED-assisted therapy. Radiographic outcome at the last follow-up (median time: seven months) was available for 64.3% (485/754) of the aneurysms. 82.5% (400/485) of aneurysms demonstrated complete occlusion (Raymond Roy Grade I). 81.4% (395/485) of aneurysms were found to meet the study's primary effectiveness outcome. At the early postoperative period, the mRS score was determined to be 0–2 vs. 3-6 in 98.2% (640/652) vs. 1.8% (12/652) of the cases, respectively. The combined major morbidity and mortality rate was 3.2% (21/652).ConclusionIn the largest study of PED therapy for small and medium-sized intracranial aneurysms to date, pipeline-assisted coil embolization was chosen more often than multiple stent implantation for aneurysm treatment, demonstrating good results, high surgical success rates, high occlusion rates, and low morbidity and mortality.Clinical Trial Registrationwww.ClinicalTrials.gov, identifier: NCT03831672. |
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spelling | doaj.art-3183373698c04ac182f4408681ab21c62022-12-22T03:36:10ZengFrontiers Media S.A.Frontiers in Neurology1664-22952022-05-011310.3389/fneur.2022.881353881353Small and Medium-Sized Aneurysm Outcomes Following Intracranial Aneurysm Treatment Using the Pipeline Embolization Device: A Subgroup Analysis of the PLUS RegistryHongyun Zhang0Hongyun Zhang1Li Li2Li Li3Hongqi Zhang4Hongqi Zhang5Jianmin Liu6Donglei Song7Yuanli Zhao8Sheng Guan9Aisha Maimaitili10Yunyan Wang11Wenfeng Feng12Yang Wang13Jieqing Wan14Guohua Mao15Huaizhang Shi16Bin Luo17Qiuji Shao18Qiuji Shao19Kaitao Chang20Kaitao Chang21Qianqian Zhang22Qianqian Zhang23Yingkun He24Yingkun He25Peng Zhang26Peng Zhang27Xinjian Yang28Tian xiao Li29Tian xiao Li30Cerebrovascular Department of Interventional Center, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Henan University People's Hospital, Zhengzhou, ChinaNeurosurgery Department of Stroke Center, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Henan University People's Hospital, Zhengzhou, ChinaCerebrovascular Department of Interventional Center, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Henan University People's Hospital, Zhengzhou, ChinaNeurosurgery Department of Stroke Center, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Henan University People's Hospital, Zhengzhou, ChinaDepartment of Neurosurgery, International Neuroscience Institute (China-INI), Xuanwu Hospital, Capital Medical University, Beijing, ChinaDepartment of Interventional Neuroradiology, Xuanwu Hospital, Capital Medical University, Beijing, ChinaChanghai Hospital Affiliated to Naval Medical University, Shanghai, ChinaShanghai Donglei Brain Hospital, Shanghai, ChinaPeking University International Hospital, Beijing, ChinaFirst Affiliated Hospital of Zhengzhou University, Zhengzhou, ChinaFirst Affiliated Hospital of Xinjiang Medical University, Ürümqi, China0Qilu Hospital of Shandong University, Jinan, China1Nanfang Hospital, Southern Medical University, Guangzhou, China2First Affiliated Hospital of Nanchang University, Nanchang, China3School of Medicine, Renji Hospital, Shanghai Jiao Tong University, Shanghai, China4Second Affiliated Hospital of Nanchang University, Nanchang, China5First Affiliated Hospital of Harbin Medical University, Harbin, China6Beijing Neurosurgical Institute, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaCerebrovascular Department of Interventional Center, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Henan University People's Hospital, Zhengzhou, ChinaNeurosurgery Department of Stroke Center, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Henan University People's Hospital, Zhengzhou, ChinaCerebrovascular Department of Interventional Center, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Henan University People's Hospital, Zhengzhou, ChinaNeurosurgery Department of Stroke Center, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Henan University People's Hospital, Zhengzhou, ChinaCerebrovascular Department of Interventional Center, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Henan University People's Hospital, Zhengzhou, ChinaNeurosurgery Department of Stroke Center, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Henan University People's Hospital, Zhengzhou, ChinaCerebrovascular Department of Interventional Center, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Henan University People's Hospital, Zhengzhou, ChinaNeurosurgery Department of Stroke Center, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Henan University People's Hospital, Zhengzhou, ChinaDepartment of Neurosurgery, International Neuroscience Institute (China-INI), Xuanwu Hospital, Capital Medical University, Beijing, ChinaDepartment of Interventional Neuroradiology, Xuanwu Hospital, Capital Medical University, Beijing, China6Beijing Neurosurgical Institute, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaCerebrovascular Department of Interventional Center, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Henan University People's Hospital, Zhengzhou, ChinaNeurosurgery Department of Stroke Center, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Henan University People's Hospital, Zhengzhou, ChinaObjectiveThe purpose of this work was to summarize the real-world safety and efficacy of Pipeline Embolization Device (PED) therapy for small and medium-sized intracranial aneurysms in China.MethodsPatients from the PED in China post-market multi-center registry study (PLUS) with aneurysms smaller than 12 mm were selected. Radiographic outcomes were assessed using digital subtraction angiography. Clinical outcomes included functional outcomes (modified Rankin Scale, MRS) in the early postoperative period ( ≤ 30 days) and early postoperative complications associated with PED therapy.ResultsA total of 652 patients with a combined 754 aneurysms were included in this study (mean age of 53.9 ± 10.3 years, 68.7% women). Mean aneurysm diameter was 6.78 ± 2.67 mm. Of the 687 stents deployed, 99.7% (685/689) were successfully deployed. In this study, 64.7% (488/754) of aneurysms were treated with only the PED, whereas 35.3% (266/754) were subjected to PED-assisted therapy. Radiographic outcome at the last follow-up (median time: seven months) was available for 64.3% (485/754) of the aneurysms. 82.5% (400/485) of aneurysms demonstrated complete occlusion (Raymond Roy Grade I). 81.4% (395/485) of aneurysms were found to meet the study's primary effectiveness outcome. At the early postoperative period, the mRS score was determined to be 0–2 vs. 3-6 in 98.2% (640/652) vs. 1.8% (12/652) of the cases, respectively. The combined major morbidity and mortality rate was 3.2% (21/652).ConclusionIn the largest study of PED therapy for small and medium-sized intracranial aneurysms to date, pipeline-assisted coil embolization was chosen more often than multiple stent implantation for aneurysm treatment, demonstrating good results, high surgical success rates, high occlusion rates, and low morbidity and mortality.Clinical Trial Registrationwww.ClinicalTrials.gov, identifier: NCT03831672.https://www.frontiersin.org/articles/10.3389/fneur.2022.881353/fullendovascularpipeline embolization devicesmall and medium-sizedintracranial aneurysmmulti-center studycomplications |
spellingShingle | Hongyun Zhang Hongyun Zhang Li Li Li Li Hongqi Zhang Hongqi Zhang Jianmin Liu Donglei Song Yuanli Zhao Sheng Guan Aisha Maimaitili Yunyan Wang Wenfeng Feng Yang Wang Jieqing Wan Guohua Mao Huaizhang Shi Bin Luo Qiuji Shao Qiuji Shao Kaitao Chang Kaitao Chang Qianqian Zhang Qianqian Zhang Yingkun He Yingkun He Peng Zhang Peng Zhang Xinjian Yang Tian xiao Li Tian xiao Li Small and Medium-Sized Aneurysm Outcomes Following Intracranial Aneurysm Treatment Using the Pipeline Embolization Device: A Subgroup Analysis of the PLUS Registry Frontiers in Neurology endovascular pipeline embolization device small and medium-sized intracranial aneurysm multi-center study complications |
title | Small and Medium-Sized Aneurysm Outcomes Following Intracranial Aneurysm Treatment Using the Pipeline Embolization Device: A Subgroup Analysis of the PLUS Registry |
title_full | Small and Medium-Sized Aneurysm Outcomes Following Intracranial Aneurysm Treatment Using the Pipeline Embolization Device: A Subgroup Analysis of the PLUS Registry |
title_fullStr | Small and Medium-Sized Aneurysm Outcomes Following Intracranial Aneurysm Treatment Using the Pipeline Embolization Device: A Subgroup Analysis of the PLUS Registry |
title_full_unstemmed | Small and Medium-Sized Aneurysm Outcomes Following Intracranial Aneurysm Treatment Using the Pipeline Embolization Device: A Subgroup Analysis of the PLUS Registry |
title_short | Small and Medium-Sized Aneurysm Outcomes Following Intracranial Aneurysm Treatment Using the Pipeline Embolization Device: A Subgroup Analysis of the PLUS Registry |
title_sort | small and medium sized aneurysm outcomes following intracranial aneurysm treatment using the pipeline embolization device a subgroup analysis of the plus registry |
topic | endovascular pipeline embolization device small and medium-sized intracranial aneurysm multi-center study complications |
url | https://www.frontiersin.org/articles/10.3389/fneur.2022.881353/full |
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