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(Stroke. 2009;40:952.)
© 2009 American Heart Association, Inc.

Original Contributions

An Original Flow Diversion Device for the Treatment of Intracranial Aneurysms

Evaluation in the Rabbit Elastase-Induced Model

Chander Sadasivan, PhD; Liliana Cesar, DVM; Jaehoon Seong, PhD; Audrey Rakian, MSc; Qing Hao, MSc; Fermin O. Tio, MD; Ajay K. Wakhloo, MD, PhD Baruch B. Lieber, PhD

From the Department of Biomedical Engineering (C.S., B.B.L., A.R., Q.H.), the Department of Radiology (B.B.L.), and the Endovascular Research Center, Vascular Biology Institute (L.C.), University of Miami, Coral Gables, Fla; the Department of Engineering and Physics (J.S.), University of Central Oklahoma, Edmond; the Department of Radiology (A.K.W.), University of Massachusetts Medical School, Worcester; and the Department of Medicine (F.O.T.), University of Texas Health Science Center, San Antonio.

Correspondence to Baruch B. Lieber, PhD, Professor of Biomedical Engineering and of Radiology, 1251 Memorial Drive, Coral Gables, FL 33146. E-mail blieber{at}miami.edu

Background and Purpose— The potential for successful treatment of intracranial aneurysms by flow diversion is gradually being recognized in the clinical setting; however, the devices currently available (stents) are not designed for flow diversion. We evaluate the long-term response of an appropriately designed flow diversion device in producing thrombotic occlusion of experimental aneurysms.

Methods— Three different configurations of an original flow diversion device were implanted across thirty elastase-induced aneurysm models in rabbits. Ten animals per device configuration were followed-up for 3 weeks (n=3), 3 months (n=3), or 6 months (n=4), and tissue explanted postsacrifice was sent for histology. The temporal variation in angiographic contrast intensity within each aneurysm was fitted with a mathematical model to quantify the alteration in local hemodynamics caused by the implanted device. A predictive index, called the washout coefficient, was constructed to estimate long-term aneurysm occlusion probabilities immediately after treatment with any flow diversion device.

Results— The device with a porosity of 70% and pore density of 18 pores/mm² performed better at occluding aneurysms than devices with 70% porosity, 12 pores/mm² and 65% porosity, 14 pores/mm². A value of the washout coefficient less than 30 predicted greater than 97% angiographic aneurysm occlusion over a period of 6 months with a sensitivity of 73% and specificity of 82%.

Conclusions— The flow diversion devices effected successful and stable aneurysm occlusion. Pore density, rather than porosity, may be the critical factor modulating efficacy of such devices.

Key Words: stents • histology • scanning electron microscopy • washout coefficient • side-branch patency

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