Institute of Neurological Sciences, Prince of Wales Hospital, Randwick, New South Wales, Australia.
Department of Interventional Neuroradiology, Liverpool Hospital, Liverpool, New South Wales, Australia.
J Neurointerv Surg. 2019 Jul;11(7):694-698. doi: 10.1136/neurintsurg-2018-014363. Epub 2018 Dec 14.
The Pipeline Embolisation Device with Shield technology (PED-Shield) is suggested to have reduced thrombogenicity. This reduced thrombogenicity may make it possible to use safely in the acute treatment of aneurysmal subarachnoid haemorrhage (aSAH) on single antiplatelet therapy (SAPT).
To evaluate the safety and efficacy of the off-label use of PED-Shield with SAPT for the acute treatment of aSAH.
Patients who underwent acute treatment of ruptured intracranial aneurysms with the PED-Shield with SAPT were retrospectively identified from prospectively maintained databases at three Australian neurointerventional centres. Patient demographics, aneurysm characteristics, clinical and imaging outcomes were reviewed.
Fourteen patients were identified (12 women), median age 64 (IQR 21.5) years. Aneurysm morphology was saccular in seven, fusiform in five, and blister in two. Aneurysms arose from the anterior circulation in eight patients (57.1%). Six (42.9%) patients were poor grade (World Federation of Neurological Societies grade ≥IV) SAH. Median time to treatment was 1 (IQR 0.5) day. Complete or near complete aneurysm occlusion (Raymond-Roy <3) was achieved in 12 (85.7%) patients at the end of early-acute follow-up (median day 7 after SAH). Permanent, treatment-related morbidity occurred in one (7.1%) patient and one (7.1%) treatment-related death occurred. The use of a postoperative heparin infusion (n=5) was associated with a higher rate of all complications (80.0% vs 11.1%, p=0.023) and symptomatic complications (60% vs 0.0%, p=0.028). No symptomatic ischaemic or haemorrhagic complications were observed in the patients who did not receive a post-operative heparin infusion. Nine (64.3%) patients were functionally independent on discharge from the treatment centre.
The PED-Shield may be safe to use in the acute treatment of ruptured intracranial aneurysms with SAPT. Further investigation with a formal treatment registry is needed.
Pipeline 栓塞装置 Shield 技术（PED-Shield）被认为具有降低血栓形成的特性。这种降低血栓形成的特性可能使其能够在急性蛛网膜下腔出血（aSAH）的单一抗血小板治疗（SAPT）中安全使用。
评估 PED-Shield 联合 SAPT 用于急性治疗 aSAH 的安全性和有效性。
从澳大利亚三个神经介入中心前瞻性维护的数据库中回顾性确定接受 PED-Shield 联合 SAPT 急性治疗破裂颅内动脉瘤的患者。回顾患者的人口统计学、动脉瘤特征、临床和影像学结果。
共确定了 14 名患者（12 名女性），中位年龄 64（IQR 21.5）岁。7 例动脉瘤形态为囊状，5 例为梭形，2 例为疱状。8 例患者（57.1%）动脉瘤起源于前循环。6 例（42.9%）患者为差级（世界神经外科学会分级≥IV 级）aSAH。中位治疗时间为 1（IQR 0.5）天。在早期急性随访结束时（SAH 后第 7 天中位数），12 例（85.7%）患者达到完全或接近完全的动脉瘤闭塞（Raymond-Roy<3）。1 例（7.1%）患者出现永久性、与治疗相关的并发症，1 例（7.1%）患者出现与治疗相关的死亡。使用术后肝素输注（n=5）与更高的总并发症发生率（80.0% vs. 11.1%，p=0.023）和症状性并发症发生率（60% vs. 0.0%，p=0.028）相关。未接受术后肝素输注的患者中未观察到症状性缺血或出血性并发症。9 例（64.3%）患者在离开治疗中心时具有独立的功能。
PED-Shield 联合 SAPT 治疗急性破裂颅内动脉瘤可能是安全的。需要进一步的正式治疗登记研究。
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