载瘤动脉栓塞装置治疗未破裂颅内动脉瘤：一项前瞻性多中心研究。

Derivo embolization device in the treatment of unruptured intracranial aneurysms: a prospective multicenter study.

机构信息

Department of Neuroradiology, Faculty of Medicine, Medical Center-University of Freiburg, University of Freiburg, Freiburg im Breisgau, Germany

Department of Intracranial Endovascular Therapy, Alfried Krupp Krankenhaus Essen, Essen, Germany.

出版信息

J Neurointerv Surg. 2021 Jun;13(6):541-546. doi: 10.1136/neurintsurg-2020-016303. Epub 2020 Sep 8.

DOI:10.1136/neurintsurg-2020-016303

PMID:32900908

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8142444/

Abstract

BACKGROUND

Flow diverters (FD) are used regularly for the endovascular treatment of unruptured intracranial aneurysms. We aimed to assess the safety and effectiveness of the Derivo embolization device (DED) with respect to long-term clinical and angiographic outcomes.

METHODS

A prospective multicenter trial was conducted at 12 centers. Patients presenting with modified Rankin Score (mRS) of 0-1, treated for unruptured intracranial aneurysms with DED were eligible. Primary endpoint was the mRS assessed at 18 months with major morbidity defined as mRS 3-5. Satisfactory angiographic occlusion was defined as 3+4 on the Kamran scale.

RESULTS

Between July 2014 and February 2018, 119 patients were enrolled. Twenty-three patients were excluded. Ninety-six patients, 71 (74%) female, mean age 54±12.0 years, were included in the analysis. Mean aneurysm size was 14.2±16.9 mm. The mean number of devices implanted per patient was 1.2 (range 1-3). Clinical follow-up at 18 months was available in 90 (94%) patients, resulting in a mean follow-up period of 14.8±5.2 months. At last available follow-up of 96 enrolled patients, 91 (95%) remained mRS 0-1. The major morbidity rate (mRS 3-5) was 3.1% (3/96), major stroke rate was 4.2% (4/96), and mortality was 0%. Follow-up angiographies were available in 89 (93%) patients at a median of 12.4±5.84 months with a core laboratory adjudicated satisfactory aneurysm occlusion in 89% (79/89).

CONCLUSION

Our results suggest that DED is a safe and effective treatment for unruptured aneurysms with high rates of satisfactory occlusion and comparably low rates of permanent neurological morbidity and mortality.

TRIAL REGISTRATION

DRKS00006103.

摘要

背景

血流导向装置（FD）常用于未破裂颅内动脉瘤的血管内治疗。我们旨在评估 Derivo 栓塞装置（DED）在长期临床和血管造影结果方面的安全性和有效性。

方法

在 12 个中心进行了一项前瞻性多中心试验。符合条件的患者为改良Rankin 量表（mRS）评分为 0-1，接受 DED 治疗未破裂颅内动脉瘤。主要终点是 18 个月时 mRS 的评估，主要发病率定义为 mRS 3-5。满意的血管造影闭塞定义为 Kamran 量表上的 3+4。

结果

2014 年 7 月至 2018 年 2 月期间，共纳入 119 例患者。23 例患者被排除在外。96 例患者（71 例女性，平均年龄 54±12.0 岁）纳入分析。平均动脉瘤大小为 14.2±16.9mm。每位患者平均植入的器械数量为 1.2 个（范围 1-3 个）。90 例（94%）患者可获得 18 个月的临床随访，平均随访时间为 14.8±5.2 个月。在 96 例入组患者的最后一次随访中，91 例（95%）患者 mRS 仍为 0-1。主要发病率（mRS 3-5）为 3.1%（3/96），主要卒中率为 4.2%（4/96），死亡率为 0%。89 例（93%）患者可获得中位随访时间为 12.4±5.84 个月的随访血管造影，89%（79/89）经核心实验室裁决为满意的动脉瘤闭塞。