University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, Camden, NJ, USA.
J Vasc Surg. 2011 Jul;54(1):174-181.e1. doi: 10.1016/j.jvs.2010.11.109. Epub 2011 Jan 14.
Embolic stroke is a major cause of morbidity in aortic and cardiac interventional procedures. Although cerebral embolic protection devices have been developed for carotid interventions and for open heart surgery, a percutaneous device for cerebral embolic protection during aortic and cardiac interventions would be desirable.
The Embrella Embolic Deflector (Embrella Cardiovascular Inc, Wayne, Pa) is a percutaneously placed embolic protection device, inserted by a 6F access in the pig's right forelimb, and deployed in the aorta, covering the brachiocephalic vessel origins. The device functions by deflecting embolic debris downstream in the aortic circulation. A swine model (n = 3) was developed for testing the deployment, retrieval, and efficacy of the device using a carotid filtration circuit for collection of emboli. Human atheromatous material was prepared as embolization particles with diameters between 150 and 600 μm. Deflection efficiency of the device was calculated by comparing numbers of embolic particles in the carotid circulation during protected and unprotected injections.
The device was reliably deployed, positioned, and retrieved (n = 24). There was no significant drop in blood pressure across the membrane of the device to suggest reduction of cerebral blood flow. The device did not become occluded by embolic debris despite an embolic load many times that encountered in the clinical situation. Particles entering the carotid circulation after aortic injection of emboli were reduced from 19% of total (unprotected) to 1.3% (protected, P < .0001), with 98.7% of all injected particles being deflected downstream. There was no evidence of arterial injury related to the device found at necropsy.
The Embrella Embolic Deflector performs safely and reliably in the swine model of human atheroembolism. It effectively deflects almost all emboli downstream, away from the carotid circulation. The deflector shows promise as an aortic embolic protection device and merits further investigation.
在主动脉和心脏介入操作中，栓塞性中风是发病率的主要原因。尽管已经开发出用于颈动脉介入和心脏直视手术的脑栓塞保护装置，但在主动脉和心脏介入过程中使用经皮脑栓塞保护装置是可取的。
Embrella 栓塞防护器（Embrella Cardiovascular Inc，宾夕法尼亚州韦恩）是一种经皮放置的栓塞保护装置，通过猪右前肢的 6F 通道插入，并部署在主动脉中，覆盖头臂干血管起源。该装置通过将栓塞碎片在主动脉循环中向下游偏转来发挥作用。建立了猪模型（n=3），使用颈动脉过滤回路收集栓塞物来测试装置的部署、取回和功效。人类动脉粥样硬化物质被制备成直径在 150 至 600μm 之间的栓塞颗粒。通过比较保护和未保护注射时颈动脉循环中栓塞颗粒的数量来计算装置的偏转效率。
该装置可靠地部署、定位和取回（n=24）。装置膜上的血压没有明显下降，表明脑血流量没有减少。尽管栓塞负荷是临床情况下遇到的许多倍，但装置没有被栓塞碎片堵塞。在主动脉注射栓塞物后进入颈动脉循环的颗粒从未保护时的总颗粒数的 19%减少到保护时的 1.3%（P<0.0001），98.7%的所有注射颗粒都被向下游偏转。尸检未发现与装置相关的动脉损伤。
Embrella 栓塞防护器在人类动脉粥样栓塞的猪模型中安全可靠地运行。它有效地将几乎所有的栓塞物向下游偏转，远离颈动脉循环。该防护器作为主动脉栓塞保护装置具有潜力，值得进一步研究。
