The DERIVO®2 Embolization Device in the treatment of ruptured and unruptured intracranial aneurysms: A multicenter analysis.

IF 1.7 4区医学 Q3 Medicine

Interventional Neuroradiology Pub Date : 2024-10-01 Epub Date: 2022-12-25 DOI:10.1177/15910199221142643

Maximilian Thormann, Nele Sillis, Taina Thoma, Jens Altenbernd, Björn Berger, Andrea Cioltan, Christian Loehr, Georg Bohner, Eberhard Siebert, Hannes Nordmeyer, Anastasios Mpotsaris, Daniel Behme

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引用次数: 0

Abstract

Background: Flow diverters are an increasingly used treatment option for intracranial aneurysms. A recent addition to the European market is the DERIVO®2 Embolization Device (DED2), promising improved radiopacity. We aimed to assess the safety and efficacy of the DED2 regarding angiographic and clinical outcomes in ruptured and unruptured cerebral aneurysms.

Methods: We performed a multicenter trial at six interventional centers. Data were prospectively collected and all patients treated with the DED2 were included. The primary endpoint was angiographic aneurysm occlusion at 6 months as assessed by the O'Kelly Marotta (OKM) grading scale with a favorable outcome definition of OKM C + D. Clinical outcome was evaluated according to the modified Rankin scale (mRS).

Results: Between August 2020 and July 2021, 37 patients were treated with the DED2 and were included in our analysis. Five patients presented with ruptured aneurysms. Median age was 60 years, 27 patients were female, and 10 male. Median mRS was 0 (range 0-4). Mean aneurysm size was 8.9 ± 7.1 mm with a mean neck size of 6.5 ± 6.1. The DED2 fully opened at deployment in all cases. Clinical follow-up was available for 30 patients (81%). Twenty-five (83%) had an mRS of 0 or 1. Three patients with ruptured aneurysms died during the follow-up period. No treatment-related major morbidity was observed. Follow-up imaging was available in 27 (90%) patients, with 23 patients (85%) showing satisfactory aneurysm occlusion OKM grade C-D.

Conclusion: In this small cohort, the DED2 provided safe and effective treatment of ruptured and unruptured intracranial aneurysms.

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DERIVO®2 栓塞装置用于治疗破裂和未破裂的颅内动脉瘤：多中心分析。

背景：血流分流器越来越多地被用于治疗颅内动脉瘤。最近，欧洲市场上出现了一种有望改善放射能力的栓塞装置--DERIVO®2（DED2）。我们的目的是评估 DED2 在破裂和未破裂脑动脉瘤的血管造影和临床结果方面的安全性和有效性：我们在六个介入中心进行了一项多中心试验。方法：我们在六个介入中心进行了多中心试验，前瞻性地收集了数据，并纳入了所有接受 DED2 治疗的患者。主要终点是 6 个月时的血管造影动脉瘤闭塞情况，由 O'Kelly Marotta（OKM）分级表评估，OKM C + D 为良好结果定义。临床结果根据改良兰金量表（mRS）进行评估：2020年8月至2021年7月期间，37名患者接受了DED2治疗，并纳入了我们的分析。5名患者出现动脉瘤破裂。中位年龄为 60 岁，27 名患者为女性，10 名患者为男性。mRS 中位数为 0（范围 0-4）。动脉瘤平均大小为 8.9 ± 7.1 毫米，平均颈部大小为 6.5 ± 6.1 毫米。所有病例的 DED2 在部署时均完全打开。有 30 名患者（81%）接受了临床随访。25例患者（83%）的mRS为0或1。三名动脉瘤破裂患者在随访期间死亡。没有观察到与治疗相关的主要发病率。27名患者（90%）接受了随访成像，其中23名患者（85%）的动脉瘤闭塞情况令人满意，OKM评级为C-D：结论：在这一小批患者中，DED2 能安全有效地治疗破裂和未破裂的颅内动脉瘤。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Interventional Neuroradiology 医学-核医学

CiteScore

2.80

自引率

11.80%

发文量

192

审稿时长

6-12 weeks

期刊介绍： Interventional Neuroradiology (INR) is a peer-reviewed clinical practice journal documenting the current state of interventional neuroradiology worldwide. INR publishes original clinical observations, descriptions of new techniques or procedures, case reports, and articles on the ethical and social aspects of related health care. Original research published in INR is related to the practice of interventional neuroradiology...