Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA
Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA.
J Neurointerv Surg. 2023 Mar;15(3):248-254. doi: 10.1136/neurintsurg-2021-018501. Epub 2022 Mar 15.
The pipeline embolization device (PED; Medtronic) has presented as a safe and efficacious treatment for small- and medium-sized intracranial aneurysms. Independently adjudicated long-term results of the device in treating these lesions are still indeterminate. We present 3-year results, with additional application of a flow diverter specific occlusion scale.
PREMIER (prospective study on embolization of intracranial aneurysms with pipeline embolization device) is a prospective, single-arm trial. Inclusion criteria were patients with unruptured wide-necked intracranial aneurysms ≤12 mm. Primary effectiveness (complete aneurysm occlusion) and safety (major neurologic event) endpoints were independently monitored and adjudicated.
As per the protocol, of 141 patients treated with a PED, 25 (17.7%) required angiographic follow-up after the first year due to incomplete aneurysm occlusion. According to the Core Radiology Laboratory review, three (12%) of these patients progressed to complete occlusion, with an overall rate of complete aneurysm occlusion at 3 years of 83.3% (115/138). Further angiographic evaluation using the modified Cekirge-Saatci classification demonstrated that complete occlusion, neck residual, or aneurysm size reduction occurred in 97.1%. The overall combined safety endpoint at 3 years was 2.8% (4/141), with only one non-debilitating major event occurring after the first year. There was one case of aneurysm recurrence but no cases of delayed rupture in this series.
The PED device presents as a safe and effective modality in treating small- and medium-sized intracranial aneurysms. The application of a flow diverter specific occlusion classification attested the long-term durability with higher rate of successful aneurysm occlusion and no documented aneurysm rupture.
NCT02186561.
Pipeline 栓塞装置(PED;美敦力)已被证明是治疗小型和中型颅内动脉瘤的安全有效的治疗方法。该设备治疗这些病变的独立裁决长期结果仍不确定。我们报告了 3 年的结果,并额外应用了一种特定的血流转向器闭塞分级。
PREMIER(Pipeline 栓塞装置栓塞颅内动脉瘤的前瞻性研究)是一项前瞻性、单臂试验。纳入标准为未破裂的宽颈颅内动脉瘤≤12mm。主要有效性(完全动脉瘤闭塞)和安全性(主要神经事件)终点由独立监测和裁决。
根据方案,141 例接受 PED 治疗的患者中,由于不完全动脉瘤闭塞,25 例(17.7%)在第一年需要进行血管造影随访。根据核心放射学实验室的评估,其中 3 例(12%)患者进展为完全闭塞,3 年总体完全动脉瘤闭塞率为 83.3%(115/138)。进一步使用改良的 Cekirge-Saatci 分类进行血管造影评估显示,完全闭塞、颈部残留或动脉瘤缩小的比例为 97.1%。3 年总体联合安全性终点为 2.8%(4/141),仅在第一年之后发生 1 例非致残性重大事件。本系列中无动脉瘤复发,但有 1 例动脉瘤迟发性破裂。
PED 装置在治疗小型和中型颅内动脉瘤方面是一种安全有效的方法。应用特定的血流转向器闭塞分类证明了长期的耐久性,具有更高的成功闭塞动脉瘤的比例,且无记录的动脉瘤破裂。
NCT02186561。