Department of Neurosurgery and Toshiba Stroke and Vascular Research Center, University at Buffalo, State University of New York, Buffalo, New York 14203, USA.
Neurosurgery. 2012 Dec;71(6):1080-7; discussion 1087-8. doi: 10.1227/NEU.0b013e31827060d9.
The pipeline embolization device (PED) is the latest technology available for intracranial aneurysm treatment.
To report early postmarket results with the PED.
This study was a prospective registry of patients treated with PEDs at 7 American neurosurgical centers subsequent to Food and Drug Administration approval of this device. Data collected included clinical presentation, aneurysm characteristics, treatment details, and periprocedural events. Follow-up data included degree of aneurysm occlusion and delayed (> 30 days after the procedure) complications.
Sixty-two PED procedures were performed to treat 58 aneurysms in 56 patients. Thirty-seven of the aneurysms (64%) treated were located from the cavernous to the superior hypophyseal artery segment of the internal carotid artery; 22% were distal to that segment, and 14% were in the vertebrobasilar system. A total of 123 PEDs were deployed with an average of 2 implanted per aneurysm treated. Six devices were incompletely deployed; in these cases, rescue balloon angioplasty was required. Six periprocedural (during the procedure/within 30 days after the procedure) thromboembolic events occurred, of which 5 were in patients with vertebrobasilar aneurysms. There were 4 fatal postprocedural hemorrhages (from 2 giant basilar trunk and 2 large ophthalmic artery aneurysms). The major complication rate (permanent disability/death resulting from perioperative/delayed complication) was 8.5%. Among 19 patients with 3-month follow-up angiography, 68% (13 patients) had complete aneurysm occlusion. Two patients presented with delayed flow-limiting in-stent stenosis that was successfully treated with angioplasty.
Unlike conventional coil embolization, aneurysm occlusion with PED is not immediate. Early complications include both thromboembolic and hemorrhagic events and appear to be significantly more frequent in association with treatment of vertebrobasilar aneurysms.
血流导向装置（PED）是治疗颅内动脉瘤的最新技术。
报告 PED 的早期上市后结果。
本研究是在美国 7 家神经外科中心进行的一项前瞻性注册研究，对该装置获得食品和药物管理局批准后接受 PED 治疗的患者进行研究。收集的数据包括临床表现、动脉瘤特征、治疗细节和围手术期事件。随访数据包括动脉瘤的闭塞程度和迟发性（术后>30 天）并发症。
共进行了 62 例 PED 手术，治疗了 56 名患者的 58 个动脉瘤。接受治疗的动脉瘤中，37 个（64%）位于颈内动脉海绵窦至垂体上动脉段；22%位于该段远端，14%位于椎基底动脉系统。共植入 123 个 PED，每个治疗的动脉瘤平均植入 2 个。6 个装置未完全展开，需要进行球囊血管成形术抢救。6 例发生围手术期（手术期间/术后 30 天内）血栓栓塞事件，其中 5 例发生在椎基底动脉瘤患者中。术后发生 4 例致命性出血（2 例为基底动脉主干巨大动脉瘤，2 例为大型眼动脉动脉瘤）。主要并发症发生率（围手术期/迟发性并发症导致的永久性残疾/死亡）为 8.5%。在 19 名接受 3 个月随访血管造影的患者中，68%（13 名）患者的动脉瘤完全闭塞。2 例患者出现迟发性支架内血流受限狭窄，经血管成形术成功治疗。
与传统的线圈栓塞不同，PED 治疗后的动脉瘤闭塞不是即刻发生的。早期并发症包括血栓栓塞和出血事件，并且似乎与椎基底动脉瘤的治疗密切相关，其发生率明显更高。
