In Vivo Evaluation of the First Dedicated Combined Flow-Restoration and Mechanical Thrombectomy Device in a Swine Model of Acute Vessel Occlusion

BACKGROUND AND PURPOSE: The use of self-expanding retrievable stents is an emerging and promising treatment strategy for acute stroke treatment. The concept combines the advantages of stent deployment with immediate flow-restoration and of mechanical thrombectomy with definitive thrombus removal. The present study was performed to gain more knowledge about the principle of combined flow restoration and thrombectomy in an established animal model using radiopaque thrombi evaluating efficiency, thrombus-device interaction and possible complications of the first dedicated flow-restoration and mechanical thrombectomy device. MATERIALS AND METHODS: The Solitaire FR (4 × 20 mm) was evaluated in 15 vessel occlusions in an established animal model in swine. Flow-restoration effect at T0, T5, and T10; recanalization rate after retrieval; thromboembolic events; and complications were assessed. Radiopaque thrombi (10-mm length) were used for visualization of thrombus-device interaction during application and retrieval. RESULTS: Immediate flow restoration was achieved in 80% of occlusions. Mean percentage of recanalization compared with the initial vessel diameter at T0 was 30.8%; at T5, 30.7%; and at T10, 25.4%. Re-occlusion occurred in 20.0% between T0 and T5 and in 13.3% between T5 and T10. Complete recanalization (TICI 3) after retrieval was achieved in 86.7%. In 2 cases (13.3%), partial recanalization was achieved, with the remaining thrombus in a side branch (TICI 2b). No thromboembolic event was observed. The assessment of thrombus-device interaction illustrated the compression of the thrombus against the vessel wall during deployment leading to partial flow restoration. During retrieval, the thrombus was retained by the stent struts even during the passage of vessel curvatures. CONCLUSIONS: The Solitaire FR is a safe and effective combined flow-restoration and thrombectomy device in vivo. Partial flow restoration is achieved by thrombus compression immediately after deployment, but flow restoration decreases afterward until final retrieval results in maximal recanalization.

[1]  G. Schroth,et al.  In Vivo Evaluation of the Phenox CRC Mechanical Thrombectomy Device in a Swine Model of Acute Vessel Occlusion , 2010, American Journal of Neuroradiology.

[2]  J. Mocco,et al.  First Food and Drug Administration-Approved Prospective Trial of Primary Intracranial Stenting for Acute Stroke: SARIS (Stent-Assisted Recanalization in Acute Ischemic Stroke) , 2009, Stroke.

[3]  J. Mocco,et al.  Temporary Endovascular Bypass: A Novel Treatment for Acute Stroke , 2009, American Journal of Neuroradiology.

[4]  G. Schroth,et al.  Percutaneous Transluminal Angioplasty and Stent Placement in Acute Vessel Occlusion: Evaluation of New Methods for Interventional Stroke Treatment , 2009, American Journal of Neuroradiology.

[5]  J. Serena,et al.  Use of the New Solitaire™ AB Device for Mechanical Thrombectomy When Merci Clot Retriever Has Failed to Remove the Clot , 2009, Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences.

[6]  Dong Ik Kim,et al.  Temporary stenting and retrieval of the self-expandable, intracranial stent in acute middle cerebral artery occlusion , 2009, Neuroradiology.

[7]  G. Schroth,et al.  Stent Placement in Acute Cerebral Artery Occlusion: Use of a Self-Expandable Intracranial Stent for Acute Stroke Treatment , 2009, Stroke.

[8]  J. Mocco,et al.  Navigability Trumps All: Stenting of Acute Middle Cerebral Artery Occlusions with a New Self-Expandable Stent , 2008, American Journal of Neuroradiology.

[9]  Rishi Gupta,et al.  Interventional Acute Ischemic Stroke Therapy With Intracranial Self-Expanding Stent , 2008, Stroke.

[10]  A. Furlan,et al.  Recanalization of an Acute Middle Cerebral Artery Occlusion Using a Self-Expanding, Reconstrainable, Intracranial Microstent as a Temporary Endovascular Bypass , 2008, Stroke.

[11]  Gerhard Schroth,et al.  Mechanical Thromboembolectomy for Acute Ischemic Stroke: Comparison of the Catch Thromboectomy Device and the Merci Retriever In Vivo , 2008, Stroke.

[12]  G. Schroth,et al.  Occlusion Length Is a Crucial Determinant of Efficiency and Complication Rate in Thrombectomy for Acute Ischemic Stroke , 2008, American Journal of Neuroradiology.

[13]  H. Woo,et al.  WINGSPAN IN‐STENT RESTENOSIS AND THROMBOSIS: INCIDENCE, CLINICAL PRESENTATION, AND MANAGEMENT , 2007, Neurosurgery.

[14]  H H Woo,et al.  Self-expanding stents for recanalization of acute cerebrovascular occlusions. , 2007, AJNR. American journal of neuroradiology.

[15]  Gerhard Schroth,et al.  Mechanical Thrombectomy for Acute Ischemic Stroke: Thrombus–Device Interaction, Efficiency, and Complications In Vivo , 2006, Stroke.

[16]  G. Schroth,et al.  A dedicated animal model for mechanical thrombectomy in acute stroke. , 2006, AJNR. American journal of neuroradiology.

[17]  E. Levy,et al.  Self-expanding stent-assisted middle cerebral artery recanalization: technical note , 2006, Neuroradiology.

[18]  E. Levy,et al.  Stent-assisted Intracranial Recanalization for Acute Stroke: Early Results , 2006, Neurosurgery.

[19]  R. Higashida,et al.  Trial Design and Reporting Standards for Intra-Arterial Cerebral Thrombolysis for Acute Ischemic Stroke , 2003, Stroke.

[20]  G. Cosnard,et al.  Vasospasm after subarachnoid hemorrhage: diagnosis with MR angiography. , 2000, AJNR. American journal of neuroradiology.