A percutaneous aortic device for cerebral embolic protection during cardiovascular intervention

Abstract

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.