[Midterm and long-term angiographic outcomes and efficacy analysis of the Pipeline Embolization Device in the treatment of intracranial aneurysms]

Zhonghua Wai Ke Za Zhi. 2024 Nov 25;62(12):1113-1119. doi: 10.3760/cma.j.cn112139-20240613-00293. Online ahead of print.
[Article in Chinese]

Abstract

Objective: To investigate the midterm and long-term efficacy of flow-diverter device in treating intracranial aneurysms (IAs) and analyze its clinical outcomes in anterior circulation aneurysms and posterior circulation aneurysms. Methods: This is a retrospective case series study. The data of 566 intracranial aneurysm patients (681 aneurysms) treated with the flow-diverter device at Department of Neurosurgery, Beijing Neurosurgical Institute, Beijing Tiantan Hospital, Capital Medical University from January 2018 to January 2021 were retrospectively analyzed. There were 205 males and 361 females, with an age (M(IQR)) of 55 (14) years (range:18 to 77 years). Twelve patients (12 aneurysms) had ruptured aneurysms before surgery, and 75 patients (172 aneurysms) had multiple aneurysms. Preoperative modified Rankin scale (mRS) >2 points in 16 patients.There were 444 patients (552 aneurysms) in the anterior circulation group and 122 patients (129 aneurysms) in the posterior circulation group. Postoperative follow-up was conducted via outpatient visits or telephone calls at 3 to 12 months after the procedure. Baseline aneurysm parameters, surgical information, and imaging and clinical outcomes were collected. Univariate and multivariate Logistic regression analyses were used to identify independent factors associated with long-term incomplete aneurysm occlusion. Results: Intraoperative use of flow diverter-assisted coil embolization was performed in 221 patients (226 aneurysms), and balloon assistance was used in 20 patients (22 aneurysms).The intraoperative rupture rate was 0.5% (3/566), and the intraoperative thrombosis rate was 0.7% (4/566). The in-hospital mortality rate was 1.2% (7/566). Postoperative complications included subarachnoid hemorrhage in 5 patients (0.9%), intracerebral hemorrhage in 2 patients (0.4%), ischemic stroke in 19 patients (3.6%), and transient ischemic attack in 16 patients (3.0%). Imaging follow-up was available for 447 patients (548 aneurysms) with a follow-up duration of (16.7±6.7) months (range:3 to 45 months). Incomplete aneurysm occlusion occurred in 79 patients (95 aneurysms), accounting for 17.3% (95/548). Parent artery stenosis was observed in 63 patients (72 aneurysms), accounting for 13.1% (72/548). Clinical follow-up was available for 530 patients (644 aneurysms) with a follow-up duration of (29.4±11.3) months (range:3 to 54 months). One case of mRS score >2 points was observed in 18 patients, accounting for 3.4% (18/530). Among them, the rate of incomplete occlusion in the anterior and posterior circulation group was 16.9% (76/450) and 19.4% (19/98), respectively, and the rate of parent artery stenosis was 10.9% (49/450) and 23.5% (23/98), respectively; the rate of mRS score>2 points was 2.4% (10/415) and 7.0% (8/115), respectively. Univariate and multivariate Logistic regression analysis showed that aneurysm neck size (β=0.075,OR=1.08, P=0.028) and coil use (β=-1.070, OR=0.034, P=0.001) were independent factors influencing long-term aneurysm occlusion. Conclusions: The flow-diverter device demonstrates good safety and efficacy in the midterm and long-term treatment of overall IAs. However, further research is needed to focus on the midterm and long-term treatment outcomes of aneurysms with relatively wide neck and posterior circulation aneurysms.

目的: 探讨血流导向装置治疗颅内动脉瘤的中长期临床效果及动脉瘤中长期不完全闭塞的影响因素。 方法: 本研究为回顾性病例系列研究。回顾性分析2018年1月至2021年1月于首都医科大学附属北京天坛医院神经外科接受血流导向装置治疗的566例颅内动脉瘤患者(681个动脉瘤)的临床和影像学资料。男性205例,女性361例,年龄[M(IQR)]55(14)岁(范围:18~77岁)。12例(12个动脉瘤)为术前破裂动脉瘤,75例(172个动脉瘤)存在多发动脉瘤。术前改良Rankin量表(mRS)评分>2分的患者16例(2.8%)。前循环动脉瘤患者444例(552个动脉瘤),后循环动脉瘤患者122例(129个动脉瘤)。患者术后3~12个月于门诊或接受电话随访。收集患者动脉瘤基线参数、手术情况、随访中影像学及临床功能预后情况。通过单因素及多因素Logistics回归分析,确定动脉瘤中长期不完全闭塞的影响因素。 结果: 所有患者完成血流导向装置植入,术中辅助应用弹簧圈221例(226个动脉瘤),辅助应用球囊20例(22个动脉瘤)。3例患者术中发生动脉瘤破裂,占0.5%(3/566);4例患者发生术中血栓形成,占0.7%(4/566);7例患者住院期间死亡,占1.2%(7/566)。术后发生蛛网膜下腔出血5例(0.9%)、脑实质内出血2例(0.4%)、缺血性脑梗死19例(3.6%)、短暂性脑缺血发作16例(3.0%)。共447例患者(548个动脉瘤)获得影像学随访,随访时间(16.7±6.7)个月(范围:3~45个月)。末次随访时,动脉瘤不完全闭塞79例(95个动脉瘤),占17.3%(95/548);载瘤动脉狭窄63例(72个动脉瘤),占13.1%(72/548)。共530例患者(644个动脉瘤)获得临床随访,随访时间(29.4±11.3)个月(范围:3~54个月),mRS评分>2分18例,占3.4%(18/530)。其中前循环动脉瘤和后循环动脉瘤的随访动脉瘤不完全闭塞率分别为16.9%(76/450)和19.4%(19/98),载瘤动脉狭窄比例分别为10.9%(49/450)和23.5%(23/98),不良功能预后比例分别为2.4%(10/415)和7.0%(8/115)。多因素Logistics回归分析结果显示,动脉瘤瘤颈宽度(β=0.075,OR=1.08,P=0.028)和应用弹簧圈(β=-1.070,OR=0.034,P=0.001)是动脉瘤术后中长期闭塞的独立影响因素。 结论: 血流导向装置治疗颅内动脉瘤的中长期影像学及临床功能随访结果均良好,表现出较好的安全性和有效性,但在瘤颈宽度大的动脉瘤与后循环动脉瘤中的中长期治疗效果,需要进一步研究观察。.

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