- 期刊
- OpenAccess
最新兩代血流導向裝置治療動脈瘤的比較
Comparison of two generations Pipeline Embolization Device in the treatment of intracranial aneurysms
摘要
目的：通過比較單一中心連續使用第二代血流導向裝置Pipeline Embolization Device（PED）Flex同第三代PED Shield治療顱內未破裂動脈瘤的情況，評價兩代產品在使用上的安全性及有效性。方法：回顧鏡湖醫院2015年1月～2019年3月間分別使用PED Flex及PED Shield治療顱內未破裂動脈瘤的患者，分析兩種方法治療病例的栓塞率、圍手術期及術後中期併發症發生率及近期預後情況進行分析。結果：兩組共42例，其中Flex治療26例26個動脈瘤，Shield治療16例17個動脈瘤。PED Flex及PED Shield完全閉塞率分別是84.6%,88.2%；術中技術性併發症發生率分別是3.8%,6.2%；術後併發症發生率分別是3.8%,0%；載瘤動脈或穿支血管閉塞發生率分別是7.6%,0；近期療效（mRS:0-2）96.2%,100%。隨訪1年後，兩組患者無動脈瘤再破裂，無遲發出血或梗塞、死亡病例。經統計學檢驗未顯示出兩代產品在治療效果及併發症的統計學差異。結論：顱內未破裂動脈瘤使用PED治療是安全及有效的，PED Flex存在的栓塞事件在PED Shield上得到改進。
並列摘要
Objective: To evaluate the safety and effectiveness of endovascular treatment of unruptured intracranial aneurysms by two generations flow divertive device (FDD), namely the Flex and Shield Pipeline Embolization Devices (PED). Methods: Clinical data of unruptured cerebral aneurysm cases that had been admitted to the department of neurosurgery of the Kiang Wu Hospital Macau and treated with PED between January 2015 and March 2019 were reviewed. The study end points were angiographic evidence of complete aneurysm occlusion, occlusion of the parent artery or perforator, and clinical and radiological evidence of brain ischemia or bleed. Periprocedural and mid-term results were also analyzed. Results: The records of 42 patients harboring 43 cerebral aneurysms (26by Flex, 17by Shield) were included. 26 cases treated with Flex and 16 cases treated with Shield. Complete occlusion of Flex and Shield PED was achieved in 22 and 15 (84.6% and 88.2%) aneurysms respectiv; partial occlusion in 4 and 3 (15.3% and 11.8%) respectively; occlusion of the parent artery or perforator in 2 and 0 ( 7.6% and 0%) respectively. Intraprocedural technical complications occurred in 1 and 1 patients (3.8%and 6.2%). Postprocedural complications occurred in 1 and 0 patients (3.8% and 0%) respectively. Between the third month and one year follow-up, there were no reports of any delayed aneurysm rupture, subarachnoid hemorrhage, ischemic complications, or procedure- or device-related deaths. There is no significance difference between the two generations of PED regarding mid-term clinical outcome. Conclusion: Endovascular treatment with a PED is a safe treatment for unruptured cerebral aneurysms, resulting in a high rate of occlusion. Data in this study also suggest that ischemic complications occur in Flex cases has been improved by the Shield device.