Briganti Francesco, Leone Giuseppe, Marseglia Mariano, Cicala Domenico, Caranci Ferdinando, Maiuri Francesco
Unit of Interventional Neuroradiology, Department of Advanced Biomedical Sciences, "Federico II" University, Naples, Italy.
Division of Neurosurgery, Department of Neurosciences, Reproductive and Odontostomatological Sciences, "Federico II" University, Naples, Italy.
J Neurointerv Surg. 2016 Feb;8(2):173-80. doi: 10.1136/neurintsurg-2015-011743. Epub 2015 Apr 20.
BACKGROUND: Experience with the endovascular treatment of cerebral aneurysms by flow diverter devices (FDDs) is limited to four devices (Pipeline, Covidien; FRED, Microvention; Silk, Balt Extrusion; Surpass, Stryker), as reported in different studies. OBJECTIVE: To describe the initial experience and the technical innovations of a new-generation FDD (p64 Flow Modulation Device, Phenox, Bochum, Germany). METHODS: Between December 2014 and February 2015, six intracranial aneurysms in five patients (four women, one man; mean age 63 years) were treated with the p64 Flow Modulation Device. RESULTS: Immediate post-treatment angiography showed reduced flow into all aneurysms. No long-term angiographic data are available. The device may be easily deployed and totally retrieved with a unique mechanical detachment. No periprocedural technical complications occurred. No early or delayed aneurysm rupture, no ischemic or hemorrhagic complications, and no neurological morbidity or death were seen. CONCLUSIONS: Treatment of cerebral aneurysms with the p64 Flow Modulation Device is a safe procedure with no technical complications. The mechanical detachment and the 100% retrievability are significant advantages of this new device. However, large prospective studies with long-term clinical and angiographic follow-up are necessary to assess the role of the p64 in the endovascular treatment of intracranial aneurysms.
背景:不同研究报道,采用血流导向装置(FDD)进行脑动脉瘤血管内治疗的经验仅限于四种装置(Pipeline,柯惠公司;FRED,美敦力公司;Silk,巴尔挤压公司;Surpass,史赛克公司)。 目的:描述新一代FDD(p64血流调节装置,德国波鸿市菲尼克斯公司)的初步经验和技术创新。 方法:2014年12月至2015年2月期间,采用p64血流调节装置对5例患者(4例女性,1例男性;平均年龄63岁)的6个颅内动脉瘤进行了治疗。 结果:治疗后即刻血管造影显示所有动脉瘤的血流均减少。尚无长期血管造影数据。该装置易于部署,可通过独特的机械分离完全回收。未发生围手术期技术并发症。未观察到早期或延迟性动脉瘤破裂、缺血性或出血性并发症,也未出现神经功能障碍或死亡。 结论:使用p64血流调节装置治疗脑动脉瘤是一种安全的手术,无技术并发症。机械分离和100%可回收性是这种新装置的显著优点。然而,需要进行大规模前瞻性研究,并进行长期临床和血管造影随访,以评估p64在颅内动脉瘤血管内治疗中的作用。
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