on August 14, 2008
Published online before print August 14, 2008, doi: 10.1161/STROKEAHA.108.513903
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Submitted on January 3, 2008
From the CardioVascular Center Frankfurt (H.S.), Sankt Katharinen, Frankfurt, Germany; the Faculty of Engineering (Y.G.), Tel-Aviv University, Tel-Aviv, Israel; MindGuard Ltd (Y.G., B.N., O.Y., D.H., Y.A., D.B.), Caesarea, Israel; Columbia University Medical Center (G.W.S.), New York, NY; Miami Cardiac & Vascular Institute (B.T.K.), Baptist Hospital, Miami, Fla; the University of California (R.H.), San Francisco Medical Center, San Francisco, Calif; the School of Medicine (A.K.W.), and Biomedical Engineering (B.B.L.), University of Miami, Miami, Fla; and Boston University Medical Center (A.N.), Boston, Mass. * To whom correspondence should be addressed. E-mail: ygael{at}eng.tau.ac.il.
Background and Purpose—The feasibility and safety of a novel endovascularly delivered tubular mesh designed to reroute emboli away from a critical artery as a means of ischemic stroke prevention was tested in vitro and in vivo. Methods—Emboli rerouting efficacy was assessed in vitro. Perfusion through the external femoral artery that was jailed by the device, cellular proliferation rate over the jailing mesh, and the resulting tissue coverage of the orifice were assessed in the swine iliofemoral bifurcation. Device-induced embolization was assessed in a swine kidney model. Results—In vitro experiments demonstrated that particles as small as 60% of the pore dimension can be rerouted by the device, although at low efficacy, and rerouting efficacy approached 100% as the particle size approached the pore dimension. Repeat assessment of flow preimplantation and at various follow-up times by Doppler ultrasound showed no significant changes in the perfusion ratio of the jailed branch to the parent artery or the jailed branch to the naive contralateral artery either as a result of device implantation or at the follow-up times. Tissue coverage over the jailed ostium was limited to approximately 12% after stabilization. Cellular proliferation rate gradually decreased to diminishing level approximately 22 weeks postimplantation. The devices implanted across the renal arteries did not demonstrate any device-induced embolization after 1 month. Conclusions—It is proposed that this device could be used to reroute emboli away from important intracranial vessels as a means of stroke prevention.
Revised on March 22, 2008
Accepted on April 10, 2008
A Novel Endovascular Device for Emboli Rerouting. Part I: Evaluation in a Swine Model
Ygael Grad PhD*;
Key words: carotid arteries • embolism • hemodynamics • prevention • stroke
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