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FiberNet - A new embolic protection device for carotid artery stenting

机译:FiberNet-一种用于颈动脉支架置入术的新型栓塞保护装置

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Background Though distal filter protection during carotid stenting reduces the risk of cerebrovascular events, periprocedural stroke remains a risk despite their broad usage. This observation may be related to the pore size of common filters. The FiberNet distal filter system is unique by its very small pore size (40 μm) as well as its low profile and flexibility. Little data is available regarding the clinical performance and safety of this device. Purpose The aim was the evaluation of the safety of the FiberNet embolic protection system during carotid artery stenting. Methods All consecutive patients treated with carotid stenting at our institution using the FiberNet device were systematically followed. Primary endpoint was the rate of all death and stroke within 30 days of the procedure. Results Carotid artery stenting using the FiberNet embolic protection system was performed in 54 patients. The procedure was technical successful in all patients. Three patients (5.5%) had a TIA. Amauosis fugax occurred in two patients (3.7%). One patient (1.9%) had a minor stroke with hemiparesis of the left arm and face which resolved completely within 48 hr after the procedure. No patient died or suffered a major stroke. Conclusion The safety and feasibility of the FiberNet distal protection system appears to be at least equivalent to that reported in studies using conventional distal filter protection.
机译:背景技术尽管在颈动脉支架置入术期间进行远端滤器保护可以降低发生脑血管事件的风险,但是尽管其使用范围广泛,但围手术期中风仍然是一种风险。该观察结果可能与常见过滤器的孔径有关。 FiberNet远端过滤器系统的独特之处在于其非常小的孔径(40μm)以及低矮的外形和灵活性。关于该设备的临床性能和安全性的数据很少。目的目的是评估在颈动脉支架置入术中FiberNet栓塞保护系统的安全性。方法对我院采用FiberNet装置进行颈动脉支架置入术治疗的所有连续患者进行系统随访。主要终点是手术后30天内所有死亡和中风的发生率。结果54例患者使用FiberNet栓塞保护系统进行了颈动脉支架置入术。该程序在所有患者中均获得技术成功。三名患者(5.5%)患有TIA。 2例患者发生了胎盘松软(3.7%)。一名患者(1.9%)发生轻度卒中,左臂和面部偏瘫,在手术后48小时内完全消退。没有患者死亡或中风。结论FiberNet远端保护系统的安全性和可行性似乎至少与使用常规远端过滤器保护的研究报告的安全性和可行性相同。

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