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Published Online
on January 15, 2009

Stroke. 2009
Published online before print January 15, 2009, doi: 10.1161/STROKEAHA.108.533760
A more recent version of this article appeared on March 1, 2009
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Submitted on August 4, 2008
Accepted on August 26, 2008

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; and 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.

* To whom correspondence should be addressed. 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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