Schwab Roland, Kabbasch Christoph, Goertz Lukas, Kaschner Marius, Weiss Daniel, Loehr Christian, Wensing Hauke, Bester Maxim, Simgen Andreas, Kemmling André, Wendl Christina, Fuchs Erelle, Thormann Maximilian, Behme Daniel, Nordmeyer Hannes
University Clinic for Neuroradiology, Medical Faculty and University Hospital, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.
Research Campus STIMULATE, Otto-von-Guericke University Magdeburg, Magdeburg, Germany.
Clin Neuroradiol. 2025 Mar;35(1):25-34. doi: 10.1007/s00062-024-01446-8. Epub 2024 Aug 22.
The use of flow diverting stents in the treatment of intracranial aneurysms is associated with a risk of neurological morbidity due to their thrombogenicity. To reduce this risk different surface modifications have been developed. The Derivo 2 Embolization Device (Acandis, Pforzheim, Germany) has proven to be a safe and effective flow diverter. To overcome the risk of thrombo-embolism, the device was modified by adding an anti-thrombogenic fibrin-heparin coating. We aimed to assess the safety and effectiveness of the Derivo 2 heal Embolization Device.
Retrospective multicenter data from nine German neurovascular centers between February 2022 until December 2023 were used. Patients treated with the Derivo 2 heal Embolization Device for unruptured or ruptured intracranial aneurysms were included. Peri- and postprocedural adverse events, clinical outcomes, and angiographic follow-up results were evaluated.
84 patients (73.8% female; mean age 58.7 years) with 89 aneurysms (mean size 9.8 mm) were included. 87.6% were located in the anterior circulation. Most of them were sidewall aneurysms (88.8%). 96 flow diverters were used. 99.0% were successfully implanted. An in-stent balloon angioplasty was performed in 6.0% of the cases. An additional coiling was performed in 28.6%. Technical difficulties were present in 12.0% of the cases. Thrombotic events occurred in 4.8% with no neurological sequelae. Mortality and morbidity were 0 and 1.2% respectively. Adequate aneurysm occlusion was achieved in 80.7% with a mean follow-up time of 6.6 months.
The Derivo 2 heal Embolization Device showed a satisfying aneurysm occlusion and safety with a low rate of neurological morbidity.
由于其血栓形成性，血流导向支架在颅内动脉瘤治疗中的应用与神经功能障碍风险相关。为降低此风险，已开发出不同的表面改性方法。Derivo 2栓塞装置（德国普福尔茨海姆的Acandis公司）已被证明是一种安全有效的血流导向装置。为克服血栓栓塞风险，该装置通过添加抗血栓形成的纤维蛋白-肝素涂层进行了改进。我们旨在评估Derivo 2 heal栓塞装置的安全性和有效性。
使用了来自9个德国神经血管中心在2022年2月至2023年12月期间的回顾性多中心数据。纳入了使用Derivo 2 heal栓塞装置治疗未破裂或破裂颅内动脉瘤的患者。评估了围手术期和术后不良事件、临床结局以及血管造影随访结果。
纳入了84例患者（女性占73.8%；平均年龄58.7岁），共89个动脉瘤（平均大小9.8毫米）。87.6%位于前循环。其中大多数为侧壁动脉瘤（88.8%）。使用了96个血流导向装置。99.0%成功植入。6.0%的病例进行了支架内球囊血管成形术。28.6%的病例进行了额外的弹簧圈栓塞。12.0%的病例存在技术困难。血栓形成事件发生率为4.8%，无神经后遗症。死亡率和发病率分别为0和1.2%。平均随访时间为6.6个月时，80.7%实现了动脉瘤的充分闭塞。
Derivo 2 heal栓塞装置显示出令人满意的动脉瘤闭塞效果和安全性，神经功能障碍发生率较低。
