Liang Buqing, Lesley Walter S, Robinson Timothy M, Chen Wencong, Benardete Ethan A, Huang Jason H
Department of Neurosurgery, Baylor Scott & White Health, Temple, TX, USA.
Texas A&M University HSC-COM, Temple, TX, USA.
Neurointervention. 2019 Sep;14(2):116-124. doi: 10.5469/neuroint.2019.00073. Epub 2019 Jul 15.
The Pipeline embolization device (PED) is approved in the USA for treating giant and large aneurysms arising from the petrous to superior hypophyseal segments of the internal carotid artery in patients older than 21 years of age. This study investigates off-label PED results in a large cohort.
Retrospective, single-center review of all patients who had off-label PED surgery.
Sixty-two aneurysms (48 patients) underwent off-label PED treatment from 2012- 2017. There were 44 females and four males (age 21 to 75 years; mean/median, 54.3/55.0 years). The most common presenting symptom was headache (47/62, 75.8%). All aneurysms were in the anterior circulation. Aneurysm size ranged from 1.4 to 25.0 mm (mean/median, 7.6/6.9 mm). Fifty-two aneurysms had post-operative imaging with total/near-complete occlusion of 84.6% (44/52). Aneurysm-based operative near-term complication rate was 9.7% while there were no permanent complications. For aneurysms and headache, 86.7% improved/resolved after embo-surgery, and were four times more likely to have a better clinical outcome (resolved or improved symptoms) after surgery (odds ratio [OR], 4.333; P=0.0325). Left-sided aneurysms had a higher occlusion rate (OR, 20; P=0.0073). Hypertension (OR, 4.2; P=0.0332) and smoking (OR, 7; P=0.0155) were more prone towards aneurysm occlusion. Patients without a family history were 14 times more likely to have favorable imaging outcome (P=0.0405). There is no difference of occlusion rates between untreated and previously treated aneurysms (P=0.6894). Overall, occlusion rate decreased by 14% with an increase of aneurysm size by 1 mm (P=0.0283).
For anterior circulation aneurysms, the off-label application of PED is as effective and safe as reported for on-label intracranial aneurysms.
管道栓塞装置（PED）在美国被批准用于治疗21岁以上患者起源于颈内动脉岩骨段至垂体上缘段的巨大和大型动脉瘤。本研究调查了一大群患者使用PED的非适应证治疗结果。
对所有接受PED非适应证手术的患者进行回顾性单中心研究。
2012年至2017年期间，62个动脉瘤（48例患者）接受了PED非适应证治疗。其中女性44例，男性4例（年龄21至75岁；平均/中位数，54.3/55.0岁）。最常见的症状是头痛（47/62，75.8%）。所有动脉瘤均位于前循环。动脉瘤大小范围为1.4至25.0mm（平均/中位数，7.6/6.9mm）。52个动脉瘤术后影像学检查显示完全/近完全闭塞率为84.6%（44/52）。基于动脉瘤的手术近期并发症发生率为9.7%，无永久性并发症。对于动脉瘤和头痛，86.7%在栓塞手术后改善/缓解，术后临床结局（症状缓解或改善）更佳的可能性是术前的4倍（优势比[OR]，4.333；P=0.0325）。左侧动脉瘤闭塞率更高（OR，20；P=0.0073）。高血压（OR，4.2；P=0.0332）和吸烟（OR，7；P=0.0155）更倾向于动脉瘤闭塞。无家族史的患者影像学结局良好的可能性高14倍（P=0.0405）。未治疗和先前治疗的动脉瘤闭塞率无差异（P=0.6894）。总体而言，动脉瘤大小每增加1mm，闭塞率下降14%（P=0.0283）。
对于前循环动脉瘤，PED的非适应证应用与已报道的适应证颅内动脉瘤应用一样有效且安全。
