Department of Neurosurgery, National Hospital Organization Osaka National Hospital.
Department of Neurosurgery, Hanwa Memorial Hospital.
Neurol Med Chir (Tokyo). 2024 Aug 15;64(8):316-322. doi: 10.2176/jns-nmc.2024-0034. Epub 2024 Jun 19.
There is a lack of data regarding the safety and effectiveness of implanting the Pipeline Embolization Device with Shield technology (PED-Shield) compared with the previous generation of Pipeline (PED-Flex). This retrospective single-center study aimed to compare treatment outcomes between the PED-Shield and PED-Flex for treating unruptured internal carotid artery aneurysms. The PED-Flex was used in 62 procedures (67 aneurysms, 59 patients) and the PED-Shield in 53 procedures (59 aneurysms, 58 patients). The mean aneurysm diameter was significantly lower in the PED-Shield group than in the PED-Flex group (11.9 ± 7.0 mm vs. 15.2 ± 6.9 mm, p < 0.001). At the 12-month follow-up, the complete angiographic occlusion rate was 72.1% and 72.3% in the PED-Flex and PED-Shield groups, respectively (p = 0.9808). Limited to aneurysms larger than 10 mm, 70.6% and 68.0%, respectively (p = 0.8175). The incidence of more than three high signal intensity areas on diffusion-weighted imaging after treatment was significantly lower in the PED-Shield group than in the PED-Flex group (27.7% vs. 67.7%; p < 0.001). Limited to aneurysms larger than 10 mm, 41.1% and 69.6%, respectively (p < 0.0117). Symptomatic ischemic complications occurred within 30 days of four PED-Flex procedures (6.5%) and one PED-Shield procedure (2.0%) (p = 0.2315). Limited to aneurysms larger than 10 mm, 1.8% and 3.2%, respectively (p = 0.6677). The incidence of mRS score worsening at 6 months was 3.2% and 1.9% in the PED-Flex and PED-Shield groups, respectively (p = 0.6534). The PED-Shield can achieve outcomes equivalent to or better than the PED-Flex. Further large-scale studies are warranted to confirm our findings.
与上一代 Pipeline（PED-Flex）相比，关于植入具有 Shield 技术的 Pipeline 栓塞装置（PED-Shield）的安全性和有效性的数据有限。这项回顾性单中心研究旨在比较 PED-Shield 和 PED-Flex 治疗未破裂颈内动脉动脉瘤的治疗结果。PED-Flex 用于 62 例（67 个动脉瘤，59 例患者），PED-Shield 用于 53 例（59 个动脉瘤，58 例患者）。PED-Shield 组的平均动脉瘤直径明显小于 PED-Flex 组（11.9 ± 7.0mm 比 15.2 ± 6.9mm，p<0.001）。在 12 个月的随访中，PED-Flex 和 PED-Shield 组的完全血管造影闭塞率分别为 72.1%和 72.3%（p=0.9808）。仅限于直径大于 10mm 的动脉瘤，分别为 70.6%和 68.0%（p=0.8175）。治疗后弥散加权成像上出现超过三个高信号强度区的发生率在 PED-Shield 组明显低于 PED-Flex 组（27.7%比 67.7%；p<0.001）。仅限于直径大于 10mm 的动脉瘤，分别为 41.1%和 69.6%（p<0.0117）。4 例 PED-Flex 手术（6.5%）和 1 例 PED-Shield 手术（2.0%）在 30 天内发生症状性缺血性并发症（p=0.2315）。仅限于直径大于 10mm 的动脉瘤，分别为 1.8%和 3.2%（p=0.6677）。PED-Flex 和 PED-Shield 组在 6 个月时 mRS 评分恶化的发生率分别为 3.2%和 1.9%（p=0.6534）。PED-Shield 可以获得与 PED-Flex 相当或更好的结果。需要进一步的大规模研究来证实我们的发现。
