| Literature DB >> 24967131 |
Yazan J Alderazi1, Darshan Shastri1, Tareq Kass-Hout1, Charles J Prestigiacomo1, Chirag D Gandhi1.
Abstract
Flow diverters (pipeline embolization device, Silk flow diverter, and Surpass flow diverter) have been developed to treat intracranial aneurysms. These endovascular devices are placed within the parent artery rather than the aneurysm sac. They take advantage of altering hemodynamics at the aneurysm/parent vessel interface, resulting in gradual thrombosis of the aneurysm occurring over time. Subsequent inflammatory response, healing, and endothelial growth shrink the aneurysm and reconstruct the parent artery lumen while preserving perforators and side branches in most cases. Flow diverters have already allowed treatment of previously untreatable wide neck and giant aneurysms. There are risks with flow diverters including in-stent thrombosis, perianeurysmal edema, distant and delayed hemorrhages, and perforator occlusions. Comparative efficacy and safety against other therapies are being studied in ongoing trials. Antiplatelet therapy is mandatory with flow diverters, which has highlighted the need for better evidence for monitoring and tailoring antiplatelet therapy. In this paper we review the devices, their uses, associated complications, evidence base, and ongoing studies.Entities:
Year: 2014 PMID: 24967131 PMCID: PMC4054970 DOI: 10.1155/2014/415653
Source DB: PubMed Journal: Stroke Res Treat
Figure 3Arterial phase angiograms in (a) oblique and (b) lateral projections of a large (20 mm) left supraclinoid internal carotid artery aneurysm that had recanalized after previous coil embolization. Follow-up angiogram 8 months after placement of pipeline embolization device, (c) oblique and (d) lateral projections, demonstrating complete occlusion of the aneurysm and patency of the ophthalmic artery that was covered by the flow diverter.
Figure 1Computational fluid dynamics simulation based on micro-CT metal coverage measurement with in vivo flow diverter deployment. Inflow stream of the aneurysm sac and streamlines in <35% metal coverage ((a) and (b)) and >35% metal coverage ((c) and (d)) situations demonstrating lower mean inflow velocity with high metal coverage. Modified from [56].
Figure 2(a) The Silk flow diverter which is made of 48 braided nitinol strands with its flared ends. (b) The Surpass flow diverter which is made of cobalt-chromium alloy; also note the inner body that functions as a delivery wire. Reproduced with permission from (1) Balt Extrusion, Montmorency, France, and (2) Stryker Neurovascular.
Ongoing clinical trials involving flow diverters for intracranial aneurysms.
| Trial name | Patient population | Intervention | Comparison | Outcome |
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| Flow diversion in intracranial aneurysm treatment (FIAT) trial | Any patient with a “difficult” intracranial aneurysm in whom flow diversion is considered an appropriate if not the best yet unproved therapeutic option by the participating clinician | Flow diversion | Standard treatment of any of the following: (1) conservative management, (2) coil embolization with or without high porosity stent, (3) parent vessel occlusion, or (4) surgical clipping | Rate of successful therapy at 12 months. |
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| LARGE aneurysm randomized trial: flow diversion versus traditional endovascular coiling therapy (LARGE) | Patients aged 21–75 internal carotid artery aneurysms (petrous, cavernous, and paraophthalmic) with neck and fundus morphologies amenable to either traditional endovascular treatments using coils or reconstruction with the flow diversion. | Flow diversion | Endovascular coil embolization | Noninferiority with regard to efficacy and safety at 180 days after procedure. |
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| Endovascular treatment of intracranial aneurysm with pipeline versus coils with or without stents (EVIDENCE) trial | Unruptured saccular intracranial aneurysms larger than 7 mm | Pipeline embolization device | Endovascular coil embolization with or without balloon remodeling, with or without stent assistance | Angiographic aneurysm complete occlusion rates at 12 months |
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| Complete occlusion of coilable intracranial aneurysms (COCOA) trial | “Coilable” aneurysms of the petrous, cavernous, and supraclinoid segments of the internal carotid artery | Pipeline embolization device | Endovascular coil embolization | Complete angiographic occlusion of the target aneurysm 180 days after treatment |
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| Multicentre randomised trial on selective endovascular aneurysm occlusion with coils versus parent vessel reconstruction using the SILK flow diverter (MARCO POLO) | Patients with at least one documented untreated, unruptured intracranial aneurysm suitable for occlusion with an intracranial device | SILK flow diverter without coils | Endovascular coil embolization with or without balloon remodeling or stent assistance | Angiographic aneurysm complete occlusion rates at 12 months |
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| The Surpass intracranial aneurysm embolization system pivotal trial to treat large or giant wide neck aneurysms (SCENT trial) | 19–80-year-old patients with single targeted wide neck, large, or giant intracranial aneurysms of the internal carotid artery up to the terminus | Surpass flow diverter | None | Complete aneurysm occlusion without clinically significant stenosis (>50%) of parent artery at 12 months. |
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| International subarachnoid aneurysm trial II (ISAT II) | Ruptured intracranial aneurysms not included in the original ISAT study: | Endovascular therapy with use of coils, balloon remodeling, stents, or flow diverters as per physician performing treatment | Surgical management, surgical clipping with or without bypass, and other surgical flow redirecting methods as per physician performing treatment | Poor clinical outcomes; modified Rankin scale >2 at 12 months |
Figure 4Arterial phase lateral view angiograms of a right cavernous internal carotid artery aneurysm, (a) initial pretreatment angiogram, (b) immediate contrast stasis within the aneurysm at the end of deployment of two telescoping pipeline embolization devices, and (c) carotid cavernous fistula on angiogram at 4 months after treatment done for symptoms of right eye pain, swelling, and vision loss. Note filling of aneurysm sac in (c) as well as venous drainage in the enlarged superior ophthalmic vein (arrow) and the pterygoid venous plexus (double arrows).
On-label indications for flow diverters.
| Flow diverter | Indication in USA | Indication in Europe |
|---|---|---|
| Pipeline embolization device (PED; ev3/Covidien, Irvine, California) | Patients aged 22 and older with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to superior hypophyseal segments | The endovascular embolization of cerebral aneurysms |
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| Silk flow diverter (SILK; Balt Extrusion, Montmorency, France) | Not yet FDA approved | The treatment of intracranial aneurysms in association with embolization coils |
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| Surpass flow diverter (SURPASS; Stryker Neurovascular, Fremont, CA) | Not yet FDA approved | Saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter of ≥2 mm and ≤5.3 mm |