Zammar Samer G, Buell Thomas J, Chen Ching-Jen, Crowley R Webster, Ding Dale, Griessenauer Christoph J, Hoh Brian L, Liu Kenneth C, Ogilvy Christopher S, Raper Daniel M, Singla Amit, Thomas Ajith J, Cockroft Kevin M, Simon Scott D
Department of Neurosurgery, Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.
Department of Neurosurgery, University of Virginia, Charlottesville, Virginia, USA.
World Neurosurg. 2018 Jul;115:e200-e205. doi: 10.1016/j.wneu.2018.04.012. Epub 2018 Apr 19.
To examine outcomes of Pipeline embolization device (PED) use for treatment of intracranial aneurysms outside of U.S. Food and Drug Administration-approved indications.
Data from patients with aneurysms treated with off-label use of PED were pooled from 4 centers in a retrospective multicenter cohort study. Primary endpoints were decline in modified Rankin Scale score by at least 1 point and angiographic aneurysm occlusion at follow-up.
The study cohort comprised 109 patients. Mean aneurysm size was 8.4 ± 7.4 mm, 20.2% of aneurysms were located in the posterior circulation, and 11.9% of aneurysms were ruptured. The most common reasons for off-label use were aneurysm size (50.5%), aneurysm location (25.7%), and both size and location (10.1%). Mean follow-up was 9 months. Complete occlusion was achieved in 82.5% of cases at last angiographic follow-up. Modified Rankin Scale score decline was found in 18.8% of cases. On univariate analysis, age, aneurysm size, aneurysm morphology, aneurysm location, reason for off-label use, and rupture status were not associated with clinical decline or aneurysm occlusion on angiography. On multivariate analysis, treatment of a ruptured aneurysm with PED was found to be an independent predictor of postoperative decline in modified Rankin Scale score, and size as the only reason for off-label PED use was found to be an independent predictor of complete occlusion on final angiography.
Off-label use of PED has a reasonable risk-to-benefit profile for appropriately selected aneurysms. Posterior circulation location and fusiform morphology do not appear to be associated with worse clinical or angiographic outcomes.
研究在未获得美国食品药品监督管理局批准的适应症情况下，使用Pipeline栓塞装置（PED）治疗颅内动脉瘤的疗效。
在一项回顾性多中心队列研究中，汇总了4个中心使用PED进行非标签治疗的动脉瘤患者的数据。主要终点是改良Rankin量表评分至少下降1分以及随访时血管造影显示动脉瘤闭塞。
研究队列包括109例患者。动脉瘤平均大小为8.4±7.4毫米，20.2%的动脉瘤位于后循环，11.9%的动脉瘤破裂。非标签使用的最常见原因是动脉瘤大小（50.5%）、动脉瘤位置（25.7%）以及大小和位置均相关（10.1%）。平均随访时间为9个月。在最后一次血管造影随访时，82.5%的病例实现了完全闭塞。18.8%的病例出现改良Rankin量表评分下降。单因素分析显示，年龄、动脉瘤大小、动脉瘤形态、动脉瘤位置、非标签使用原因以及破裂状态与临床评分下降或血管造影显示的动脉瘤闭塞均无关。多因素分析显示，使用PED治疗破裂动脉瘤是改良Rankin量表评分术后下降的独立预测因素，而仅将大小作为PED非标签使用的原因是最终血管造影完全闭塞的独立预测因素。
对于适当选择的动脉瘤，PED的非标签使用具有合理的风险效益比。后循环位置和梭形形态似乎与较差的临床或血管造影结果无关。
