使用Surpass流线型血流导向装置治疗大型和巨大型后交通动脉瘤：SCENT试验结果
Treatment of large and giant posterior communicating artery aneurysms with the Surpass streamline flow diverter: results from the SCENT trial.
作者信息
Kan Peter, Mohanty Alina, Meyers Philip M, Coon Alexander L, Wakhloo Ajay K, Marosfoi Miklos, Bain Mark, de Vries Joost, Ebersole Koji, Lanzino Giuseppe, Taussky Philipp, Hanel Ricardo A
机构信息
Department of Neurosurgery, The University of Texas Medical Branch at Galveston School of Medicine, Galveston, Texas, USA
Baylor College of Medicine Department of Neurosurgery, Houston, Texas, USA.
出版信息
J Neurointerv Surg. 2023 Jul;15(7):679-683. doi: 10.1136/neurintsurg-2021-018189. Epub 2022 May 12.
BACKGROUND
The Surpass flow diverter was developed to treat intracranial aneurysms not amenable to standard treatment. Indications for use allow placement in the internal carotid artery to the terminus, including the communicating artery segment.
METHODS
The Surpass Intracranial Aneurysm Embolization System Pivotal Trial to Treat Large or Giant Wide Neck Aneurysms (SCENT) trial is an international, multicenter, prospective, non-randomized trial comparing the outcomes of Surpass flow diverter treatment with historic control designed to evaluate the effectiveness and safety of Surpass for the treatment of wide neck (≥4 mm) large or giant intracranial aneurysms ≥10 mm. The primary effectiveness endpoint is the percentage of subjects with 100% aneurysm occlusion without significant stenosis of the parent artery and without retreatment of the target aneurysm at 12 months. The primary safety endpoint is the percentage of subjects experiencing neurologic death or major ipsilateral stroke at 12 months. We report the effectiveness and safety of flow diversion in the subgroup of posterior communicating artery (PComA) aneurysms.
RESULTS
Of the 180 patients treated, 38 harbored a PComA aneurysm. Mean aneurysm size was 12.2 mm and mean neck width was 4.8 mm. The mean number of Surpass devices used was 1.1 per procedure, with 94.7% of aneurysms treated with one flow diverter. The 12 month primary effectiveness rate was 73.7% (28/38). At 36 months, 68.4% (26/38) of aneurysms remained completely occluded. The 12 month major ipsilateral stroke or neurological death rate was 10.5%. No patients with PComA occlusion after flow diverter placement (54.5%) had clinical sequelae.
CONCLUSIONS
SCENT demonstrated acceptable 12 month effectiveness of flow diversion in PComA aneurysms. Despite associated PComA occlusions in many cases, arterial occlusions were clinically silent.
TRIAL REGISTRATION NUMBER
URL: https://www.
CLINICALTRIALS
gov. Unique identifier: NCT01716117.
背景
Surpass血流导向装置旨在治疗无法采用标准治疗方法的颅内动脉瘤。其使用指征允许放置于颈内动脉直至末端，包括交通动脉段。
方法
Surpass颅内动脉瘤栓塞系统治疗大型或巨大宽颈动脉瘤的关键试验（SCENT）是一项国际多中心前瞻性非随机试验，将Surpass血流导向装置治疗的结果与历史对照进行比较，旨在评估Surpass治疗宽颈（≥4毫米）、直径≥10毫米的大型或巨大颅内动脉瘤的有效性和安全性。主要有效性终点是在12个月时动脉瘤完全闭塞、载瘤动脉无明显狭窄且无需对目标动脉瘤再次治疗的受试者百分比。主要安全性终点是在12个月时发生神经源性死亡或同侧严重卒中的受试者百分比。我们报告后交通动脉（PComA）动脉瘤亚组中血流导向的有效性和安全性。
结果
在接受治疗的180例患者中，38例患有PComA动脉瘤。动脉瘤平均大小为12.2毫米，平均颈宽为4.8毫米。每次手术使用的Surpass装置平均数量为1.1个，94.7%的动脉瘤采用一个血流导向装置治疗。12个月时的主要有效率为73.7%（28/38）。在36个月时，68.4%（26/38）的动脉瘤仍完全闭塞。12个月时同侧严重卒中或神经源性死亡率为10.5%。在放置血流导向装置后PComA闭塞的患者中（54.5%），没有患者出现临床后遗症。
结论
SCENT显示在PComA动脉瘤中，血流导向在12个月时具有可接受的有效性。尽管在许多病例中伴有PComA闭塞，但动脉闭塞在临床上并无症状。
试验注册号
网址：https://www.
临床试验
gov。唯一标识符：NCT01716117。
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