Al Kasab Sami, Guerrero Waldo R, Nakagawa Daichi, Samaniego Edgar A, Ortega-Gutierrez Santiago, Hasan David
Department of Neurology, University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA.
Department of Neurosurgery, University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA.
Interv Neurol. 2020 Jan;8(2-6):83-91. doi: 10.1159/000495074. Epub 2019 Jan 16.
The use of Pipeline Embolization Device (PED) is approved by the US Food and Drug Administration (FDA) to treat aneurysms located between the petrous and superior hypophyseal segments of the internal carotid artery. The purpose of this study is to evaluate the feasibility and efficacy of treating aneurysms outside the FDA approved anatomical locations. Furthermore, we analyze the safety of our antiplatelet protocol.
Data on all patients treated with PED at our center from March 2015 to December 2017 were reviewed. Only patients with aneurysms treated with PED as off label use were included. Procedural complications and long-term functional outcome measured by modified Rankin Scale (mRS) were recorded. Tirofiban maintenance infusion was administered intravenously after PED deployment. None of the patients had platelet function testing.
A total of 36 patients harboring 36 aneurysms were included in the study. Mean age was 58.2 years ±14.6. Nineteen were women (52.8%) and most aneurysms were unruptured (80.6%). There were no intraoperative complications. Five patients experienced postoperative complications - 4 ischemic strokes and one groin hematoma. None led to any significant disability at follow-up. Thirty-one patients (86.1%) achieved an mRS of 0-2 at follow-up. A Raymond-Roy classification of 1 was achieved in 78.9% of patients.
The use of PED to treat aneurysms located outside the circle of Willis is feasible and effective. Our novel antiplatelet protocol did not require platelet function assay testing and did not lead to a higher rate of thrombo-embolic events compared to what has been previously reported.
管道栓塞装置（PED）的使用已获美国食品药品监督管理局（FDA）批准，用于治疗位于颈内动脉岩骨段与垂体上动脉段之间的动脉瘤。本研究的目的是评估在FDA批准的解剖位置以外治疗动脉瘤的可行性和疗效。此外，我们分析了我们的抗血小板方案的安全性。
回顾了2015年3月至2017年12月在我们中心接受PED治疗的所有患者的数据。仅纳入将PED作为超适应证使用治疗动脉瘤的患者。记录手术并发症和采用改良Rankin量表（mRS）测量的长期功能结局。在PED植入后静脉内给予替罗非班维持输注。所有患者均未进行血小板功能检测。
本研究共纳入36例患有36个动脉瘤的患者。平均年龄为58.2岁±14.6岁。19例为女性（52.8%），大多数动脉瘤未破裂（80.6%）。术中无并发症。5例患者出现术后并发症——4例缺血性卒中，1例腹股沟血肿。随访时均未导致任何严重残疾。31例患者（86.1%）随访时mRS评分为0 - 2分。78.9%的患者达到Raymond - Roy 1级分类。
使用PED治疗 Willis 环以外的动脉瘤是可行且有效的。我们的新型抗血小板方案不需要进行血小板功能检测，与先前报道相比，血栓栓塞事件发生率并未更高。
