J Neurosurg. 2023 Aug 25;140(2):436-440. doi: 10.3171/2023.7.JNS23981. Print 2024 Feb 1.
The object of this study was to compare the efficacy and safety profile of the Pipeline embolization device (PED)/Pipeline Flex embolization device (PED Flex) with that of the Pipeline Flex embolization device with Shield Technology (PED Shield). After introducing the first-generation PED and the second-generation PED Flex with its updated delivery system, the PED Shield was launched with a synthetic layer of phosphorylcholine surface modification to reduce thrombogenicity.
This is a retrospective review of unruptured aneurysms treated with PED/PED Flex versus PED Shield between 2017 and 2022 at the authors' institution. Patients with ruptured aneurysms, adjunctive treatment, failed flow diverter deployment, and prior treatment of the target aneurysm were excluded. Baseline characteristics were collected for all patients, including age, sex, past medical history (hypertension, hyperlipidemia, diabetes mellitus), smoking status, aneurysm location, and aneurysm dimensions (neck, width, height) and morphology (saccular, nonsaccular). The primary outcome was procedural and periprocedural complication rates.
The study cohort comprised 200 patients with 200 aneurysms, including 150 aneurysms treated with the PED/PED Flex and 50 treated with the PED Shield. With respect to intraprocedural and periprocedural complications, length of stay, length of follow-up, and functional outcome at discharge, there was no significant difference between the two cohorts. At the midterm follow-up, the rate of in-stent stenosis (PED/PED Flex: 14.2% vs PED Shield: 14.6%, p = 0.927), aneurysm occlusion (complete occlusion: 79.5% vs 80.5%, respectively; neck remnant: 4.7% vs 12.2%; dome remnant: 15.7% vs 7.3%; p = 0.119), and the need for retreatment (5.3% vs 0%, p = 0.097) were comparable between the two cohorts.
This study suggests that, as compared to first- and second-generation PED and PED Flex, the third-generation PED Shield offers similar rates of complications, aneurysm occlusion, and in-stent stenosis at the midterm follow-up.
本研究旨在比较 Pipeline 栓塞装置（PED）/Pipeline Flex 栓塞装置（PED Flex）与具有 Shield 技术的 Pipeline Flex 栓塞装置（PED Shield）的疗效和安全性。在介绍第一代 PED 和第二代具有更新输送系统的 PED Flex 之后，推出了具有磷酸胆碱合成层表面改性以降低血栓形成的 PED Shield。
这是一项回顾性研究，比较了 2017 年至 2022 年在作者所在机构接受 PED/PED Flex 与 PED Shield 治疗的未破裂动脉瘤患者。排除破裂动脉瘤患者、辅助治疗、失败的血流导向装置放置以及目标动脉瘤的先前治疗。收集了所有患者的基线特征，包括年龄、性别、既往病史（高血压、高血脂、糖尿病）、吸烟状况、动脉瘤位置以及动脉瘤尺寸（颈部、宽度、高度）和形态（囊状、非囊状）。主要结局是程序和围手术期并发症发生率。
研究队列包括 200 名患者的 200 个动脉瘤，其中 150 个动脉瘤接受了 PED/PED Flex 治疗，50 个动脉瘤接受了 PED Shield 治疗。在术中及围手术期并发症、住院时间、随访时间和出院时的功能结局方面，两组之间没有显著差异。在中期随访中，支架内狭窄率（PED/PED Flex：14.2%比 PED Shield：14.6%，p=0.927）、动脉瘤闭塞率（完全闭塞：79.5%比 80.5%；颈部残留：4.7%比 12.2%；瘤顶残留：15.7%比 7.3%；p=0.119）和需要再次治疗的比例（5.3%比 0%，p=0.097）在两组之间相似。
本研究表明，与第一代和第二代 PED 和 PED Flex 相比，第三代 PED Shield 在中期随访中具有相似的并发症、动脉瘤闭塞和支架内狭窄发生率。
