The Asymmetric Vascular Stent: Efficacy in a Rabbit Aneurysm Model

Background and Purpose— Development of hemodynamic modifying devices to treat intracranial aneurysms is an active area of research. The asymmetrical vascular stent (AVS), a stent containing a low-porosity patch, is such device. We evaluate AVS efficacy in an in vivo intracranial aneurysm model. Methods— We created 24 elastase rabbit model aneurysms: 13 treated with the AVS, 5 treated with standard coronary stents, and 6 untreated controls. Four weeks after treatment, aneurysms underwent follow-up angiography, cone-beam micro-CT, histological evaluation, and selective electron microscopy scanning. Results— Four rabbits died early in the study: 3 during AVS treatment and 1 control (secondary to intraprocedural vessel injury and an unrelated tumor, respectively). AVS-treated aneurysms exhibited very weak or no aneurysm flow immediately after treatment and no flow in all aneurysms at follow-up. Standard stent-treated aneurysms showed flow both after treatment (5/5) and at follow-up (3/5). All control aneurysms remained patent during the study. Micro-CT scans showed: 9 of 9 scanned AVS aneurysms were occluded, 6 of 9 AVS were ideally placed, and 3 of 9 low-porosity region partially covered the aneurysm neck; standard stent-treated aneurysms were 1 of 5 occluded, 2 of 5 patent, and 2 of 5 partially patent. Histology results demonstrated: for AVS-treated aneurysms, advanced thrombus organization in the (9/9); for standard stent-treated aneurysms, (1/4) no thrombus, (2/4) partially thrombosed, and (1/4) fully thrombosed; for control aneurysms (4/4), no thrombus. Conclusion— The use of AVS shows promise as a viable new therapeutic in intracranial aneurysm treatment. These data encourage further investigation and provide substantial support to the AVS concept.

[1]  L. Solymosi,et al.  A new self-expanding nitinol stent (Enterprise) for the treatment of wide-necked intracranial aneurysms: initial clinical and angiographic results in 31 aneurysms , 2007, Neuroradiology.

[2]  David F. Kallmes,et al.  Creation of Saccular Aneurysms in the Rabbit , 2000 .

[3]  Adnan I Qureshi,et al.  Fate of Branch Arteries after Intracranial Stenting , 2003, Neurosurgery.

[4]  Stephen Rudin,et al.  Evaluation of an asymmetric stent patch design for a patient specific intracranial aneurysm using computational fluid dynamic (CFD) calculations in the computed tomography (CT) derived lumen , 2006, SPIE Medical Imaging.

[5]  J. Tardif,et al.  Biocompatibility aspects of new stent technology. , 1998, Journal of the American College of Cardiology.

[6]  C. Putman,et al.  Characterization of cerebral aneurysms for assessing risk of rupture by using patient-specific computational hemodynamics models. , 2005, AJNR. American journal of neuroradiology.

[7]  Kyehan Rhee,et al.  Changes of Flow Characteristics by Stenting in Aneurysm Models: Influence of Aneurysm Geometry and Stent Porosity , 2002, Annals of Biomedical Engineering.

[8]  Daniel R. Bednarek,et al.  Investigation of new flow modifying endovascular image-guided interventional (EIGI) techniques in patient-specific aneurysm phantoms (PSAPs) using optical imaging , 2008, SPIE Medical Imaging.

[9]  R. Rosenwasser,et al.  ENDOVASCULAR OCCLUSION OF WIDE-NECKED ANEURYSMS WITH A NEW INTRACRANIAL MICROSTENT (NEUROFORM) AND DETACHABLE COILS , 2004, Neurosurgery.

[10]  Howard A Riina,et al.  NEUROFORM STENT‐ASSISTED COIL EMBOLIZATION OF WIDE‐NECK INTRACRANIAL ANEURYSMS: STRATEGIES IN STENT DEPLOYMENT AND MIDTERM FOLLOW‐UP , 2007, Neurosurgery.

[11]  S. Akpek,et al.  Self-expandable stent-assisted coiling of wide-necked intracranial aneurysms: a single-center experience. , 2005, AJNR. American journal of neuroradiology.

[12]  Daniel R. Bednarek,et al.  Measurement of flow modification in phantom aneurysm model: comparison of coils and a longitudinally and axially asymmetric stent--initial findings. , 2004, Radiology.

[13]  Stephen Rudin,et al.  Asymmetric Vascular Stent: Feasibility Study of a New Low-Porosity Patch-Containing Stent , 2008, Stroke.

[14]  Stephen Rudin,et al.  Contrast settling in cerebral aneurysm angiography. , 2005, Physics in medicine and biology.

[15]  D. Fiorella,et al.  Usefulness of the Neuroform Stent for the Treatment of Cerebral Aneurysms: Results at Initial (3–6-mo) Follow-up , 2005, Neurosurgery.

[16]  R. Mericle,et al.  Use of gadolinium as an intraarterial contrast agent for pediatric neuroendovascular procedures. , 2004, Journal of neurosurgery.

[17]  A. Wakhloo,et al.  Stents for intracranial aneurysms: the beginning of a new endovascular era? , 1998, Neurosurgery.

[18]  Isabel Wanke,et al.  Double-stent method: therapeutic alternative for small wide-necked aneurysms. Technical note. , 2004, Journal of neurosurgery.

[19]  Daniel R. Bednarek,et al.  Cone-Beam Micro-CT System Based on LabVIEW Software , 2008, Journal of Digital Imaging.

[20]  David F. Kallmes,et al.  A New Endoluminal, Flow-Disrupting Device for Treatment of Saccular Aneurysms , 2007, Stroke.

[21]  Stephen Rudin,et al.  Flow modification in canine intracranial aneurysm model by an asymmetric stent: studies using digital subtraction angiography (DSA) and image-based computational fluid dynamics (CFD) analyses , 2006, SPIE Medical Imaging.

[22]  Baruch B. Lieber,et al.  Particle Image Velocimetry Assessment of Stent Design Influence on Intra-Aneurysmal Flow , 2002, Annals of Biomedical Engineering.

[23]  Daniel Roy,et al.  Endovascular Treatment of Unruptured Aneurysms , 2001, Stroke.

[24]  Carlos Miranda,et al.  Buenos Aires experience with the Neuroform self-expanding stent for the treatment of intracranial aneurysms. , 2005, Journal of neurosurgery.

[25]  B. Sellhaus,et al.  Long-term Histological and Scanning Electron Microscopy Results of Endovascular and Operative Treatments of Experimentally Induced Aneurysms in the Rabbit , 2006, Neurosurgery.

[26]  Ciprian N Ionita,et al.  Particle image velocimetry (PIV) evaluation of flow modification in aneurysm phantoms using asymmetric stents , 2004, SPIE Medical Imaging.

[27]  M. Gounis,et al.  The physics of endoluminal stenting in the treatment of cerebrovascular aneurysms , 2002, Neurological research.

[28]  D. Ku,et al.  Fluid mechanics of vascular systems, diseases, and thrombosis. , 1999, Annual review of biomedical engineering.

[29]  F Asakura,et al.  Evaluation of intraaneurysmal blood velocity by time-density curve analysis and digital subtraction angiography. , 1998, AJNR. American journal of neuroradiology.

[30]  D. Fiorella,et al.  Preliminary Experience Using the Neuroform Stent for the Treatment of Cerebral Aneurysms , 2004, Neurosurgery.

[31]  Daniel R. Bednarek,et al.  Angiographic analysis of blood flow modification in cerebral aneurysm models with a new asymmetric stent , 2004, SPIE Medical Imaging.

[32]  Chander Sadasivan,et al.  Angiographic quantification of contrast medium washout from cerebral aneurysms after stent placement. , 2002, AJNR. American journal of neuroradiology.

[33]  Daniel R. Bednarek,et al.  Microangiographic image-guided localization of a new asymmetric stent for treatment of cerebral aneurysms , 2005, SPIE Medical Imaging.

[34]  Thomas Schmitz-Rode,et al.  Treatment of Experimentally Induced Aneurysms with Stents , 2005, Neurosurgery.