Department of Radiology, Mayo Clinic, Rochester, Minnesota.
Koru Hospital and Bayindir Hospitals, Ankara, Turkey; and.
J Neurosurg. 2017 Oct;127(4):775-780. doi: 10.3171/2016.8.JNS16467. Epub 2016 Oct 28.
OBJECTIVE The authors performed a pooled analysis of 3 studies-IntrePED (International Retrospective Study of the Pipeline Embolization Device), PUFS (Pipeline for Uncoilable or Failed Aneurysms Study), and ASPIRe (Aneurysm Study of Pipeline in an Observational Registry)-in order to assess angiographic outcomes and clinical safety of the Pipeline embolization device (PED). METHODS IntrePED was a retrospective study, while PUFS and ASPIRe were prospective studies. For each patient included in these studies, the authors collected baseline demographic data, aneurysm characteristics, and procedural details. The primary outcomes for this combined analysis were clinical outcomes, including neurological morbidity and mortality and major ipsilateral intracranial hemorrhage and ischemic stroke. The secondary outcomes were angiographic occlusion rates, which were available for ASPIRe and PUFS only. RESULTS A total of 1092 patients with 1221 aneurysms were included across the 3 studies. The mean aneurysm size was 12.0 ± 7.8 mm and the mean neck size was 6.6 ± 4.8 mm. The major ipsilateral ischemic stroke rate was 3.7% (40/1091). The major ipsilateral intracranial hemorrhage rate was 2.0% (22/1091). The major neurological morbidity rate was 5.7% (62/1091). The neurological mortality rate was 3.3% (36/1091). The combined major morbidity and neurological mortality rate was 7.1% (78/1091). The complete occlusion rates were 75.0% at 180 days (111/148) and 85.5% at 1 year (94/110). The overall aneurysm retreatment rate was 3.0% (33/1091) at a mean follow-up time of 10.2 ± 10.8 months. CONCLUSIONS Endovascular treatment of intracranial aneurysms with the PED is safe and effective. Angiographic occlusion rates progressed with follow-up. Rates of stroke, hemorrhage, morbidity and mortality, and retreatment were low, especially given the fact that the aneurysms treated were generally large and wide necked.
作者对 3 项研究——IntrePED（Pipeline 栓塞装置的国际回顾性研究）、PUFS（Pipeline for Uncoilable or Failed Aneurysms Study，用于不可解脱或失败的动脉瘤的 Pipeline 研究）和 ASPIRe（Pipeline 在观察性注册中的动脉瘤研究）——进行了汇总分析，以评估 Pipeline 栓塞装置（PED）的血管造影结果和临床安全性。方法：IntrePED 为回顾性研究，而 PUFS 和 ASPIRe 为前瞻性研究。对于这些研究中纳入的每位患者，作者收集了基线人口统计学数据、动脉瘤特征和手术细节。本联合分析的主要结局为临床结局，包括神经功能障碍和死亡率以及主要同侧颅内出血和缺血性卒中。次要结局为血管造影闭塞率，仅适用于 ASPIRe 和 PUFS。结果：在这 3 项研究中，共有 1092 例患者的 1221 个动脉瘤纳入研究。平均动脉瘤大小为 12.0±7.8mm，平均瘤颈大小为 6.6±4.8mm。同侧主要缺血性卒中发生率为 3.7%（40/1091）。同侧主要颅内出血发生率为 2.0%（22/1091）。主要神经功能障碍发生率为 5.7%（62/1091）。神经功能死亡率为 3.3%（36/1091）。主要发病率和神经功能死亡率的合并发生率为 7.1%（78/1091）。180 天时完全闭塞率为 75.0%（111/148），1 年时为 85.5%（94/110）。平均随访 10.2±10.8 个月时，总体动脉瘤再治疗率为 3.0%（33/1091）。结论：PED 血管内治疗颅内动脉瘤安全有效。血管造影闭塞率随随访而增加。卒中、出血、发病率、死亡率和再治疗率均较低，尤其是考虑到治疗的动脉瘤通常较大且瘤颈较宽。
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