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Flow Diverters for Intracranial Aneurysms

DOI: 10.1155/2014/415653

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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. 1. Introduction During recent decades, endovascular treatment of cerebrovascular aneurysms has evolved to include unassisted coil embolization techniques, whose efficacy and safety are supported by class-1-evidence, assisted coil embolization techniques, and newly developed techniques using flow diverters [1]. While the various coil embolization techniques, including balloon assisted and stent assisted coiling, are targeted towards the aneurysm sac, flow diverters represent a paradigm shift with the intervention carried out in the parent artery [2, 3]. Flow diverter aneurysm embolization can be combined with coil embolization, further expanding the options available to clinicians and patients [3]. Flow diverters were first tested in untreatable aneurysms or those that had failed previous endovascular therapy [2]. With the approval of these devices in the USA, Europe, and other countries experience with “off-label” uses is evolving. In this paper we review the use of flow diverters for treatment of intracranial cerebral aneurysms. We review the putative mechanism of action, the technical features of devices and their uses, and the evidence for efficacy and safety of flow diverters for intracranial aneurysms. 2. Flow Diversion and Mechanism of Action Flow diverters are stent-like devices that are deployed endovascularly to treat aneurysms. Conceptually, flow diverters allow

References

[1]  A. J. Molyneux, R. S. Kerr, L.-M. Yu et al., “International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion,” The Lancet, vol. 366, no. 9488, pp. 809–817, 2005.
[2]  T. Becske, D. F. Kallmes, I. Saatci, et al., “Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial,” Radiology, vol. 267, no. 3, pp. 858–868, 2013.
[3]  P. K. Nelson, P. Lylyk, I. Szikora, S. G. Wetzel, I. Wanke, and D. Fiorella, “The pipeline embolization device for the intracranial treatment of aneurysms trial,” American Journal of Neuroradiology, vol. 32, no. 1, pp. 34–40, 2011.
[4]  D. F. Kallmes, Y. H. Ding, D. Dai, R. Kadirvel, D. A. Lewis, and H. J. Cloft, “A new endoluminal, flow-disrupting device for treatment of saccular aneurysms,” Stroke, vol. 38, no. 8, pp. 2346–2352, 2007.
[5]  K. Yavuz, S. Geyik, I. Saatci, and H. S. Cekirge, “Endovascular treatment of middle cerebral artery aneurysms with flow modification with the use of the pipeline embolization device,” American Journal of Neuroradiology, vol. 35, no. 3, pp. 529–535, 2014.
[6]  J. Berge, T. Tourdias, J.-F. Moreau, X. Barreau, and V. Dousset, “Perianeurysmal brain inflammation after flow-diversion treatment,” American Journal of Neuroradiology, vol. 32, no. 10, pp. 1930–1934, 2011.
[7]  P. Lylyk, C. Miranda, R. Ceratto et al., “Curative endovascular reconstruction of cerebral aneurysms with the pipeline embolization device: the Buenos Aires experience,” Neurosurgery, vol. 64, no. 4, pp. 632–643, 2009.
[8]  R. C. Puffer, D. F. Kallmes, H. Y. J. Cloft, and G. E. Lanzino, “Patency of the ophthalmic artery after flow diversion treatment of paraclinoid aneurysms: clinical article,” Journal of Neurosurgery, vol. 116, no. 4, pp. 892–896, 2012.
[9]  T. J. Phillips, J. D. Wenderoth, C. C. Phatouros, et al., “Safety of the pipeline embolization device in treatment of posterior circulation aneurysms,” American Journal of Neuroradiology, vol. 33, pp. 1225–1231, 2012.
[10]  T. E. Darsaut, F. Bing, A. Makoyeva, et al., “Flow diversion to treat aneurysms: the free segment of stent,” Journal of NeuroInterventional Surgery, vol. 5, no. 5, pp. 452–457, 2013.
[11]  J. de Vries, J. Boogaarts, A. Van Norden, and A. K. Wakhloo, “New generation of Flow Diverter (surpass) for unruptured intracranial aneurysms: a prospective single-center study in 37 patients,” Stroke, vol. 44, pp. 1567–1577, 2013.
[12]  A. Makoyeva, F. Bing, T. E. Darsaut, I. Salazkin, and J. Raymond, “The varying porosity of braided self-expanding stents and flow diverters: an experimental study,” American Journal of Neuroradiology, vol. 34, pp. 596–602, 2013.
[13]  F. Bing, T. E. Darsaut, I. Salazkin, A. Makoyeva, G. Gevry, and J. Raymond, “Stents and flow diverters in the treatment of aneurysms: device deformation in vivo may alter porosity and impact efficacy,” Neuroradiology, vol. 55, no. 1, pp. 85–92, 2013.
[14]  L. Augsburger, M. Farhat, P. Reymond et al., “Effect of flow diverter porosity on intraaneurysmal blood flow,” Clinical Neuroradiology, vol. 19, no. 3, pp. 204–214, 2009.
[15]  B. B. Lieber, A. P. Stancampiano, and A. K. Wakhloo, “Alteration of hemodynamics in aneurysm models by stenting: influence of stent porosity,” Annals of Biomedical Engineering, vol. 25, no. 3, pp. 460–469, 1997.
[16]  S. Fischer, Z. Vajda, M. A. Perez, et al., “Pipeline Embolization Device (PED) for neurovascular reconstruction: initial experience in the treatment of 101 intracranial aneurysms and dissections,” Neuroradiology, vol. 54, no. 4, pp. 369–382, 2012.
[17]  A. Consoli, S. Nappini, L. Renieri, et al., “Treatment of two blood blister-like aneurysms with flow diverter stenting,” Journal of NeuroInterventional Surgery, vol. 4, article e4, 2012.
[18]  I. Szikora, Z. Berentei, Z. Kulcsar et al., “Treatment of intracranial aneurysms by functional reconstruction of the parent artery: the Budapest experience with the pipeline embolization device,” American Journal of Neuroradiology, vol. 31, no. 6, pp. 1139–1147, 2010.
[19]  O. I. Tahtinen, H. I. Manninen, R. L. Vanninen, et al., “The silk flow-diverting stent in the endovascular treatment of complex intracranial aneurysms: technical aspects and midterm results in 24 consecutive patients,” Neurosurgery, vol. 70, pp. 617–624, 2012.
[20]  S. Maimon, L. Gonen, E. Nossek, I. Strauss, R. Levite, and Z. Ram, “Treatment of intra-cranial aneurysms with the SILK flow diverter: 2 years' experience with 28 patients at a single center,” Acta Neurochirurgica, vol. 154, no. 6, pp. 979–987, 2012.
[21]  S. B. Murthy, S. Shah, A. Shastri, C. P. V. Rao, E. M. Bershad, and J. I. Suarez, “The SILK flow diverter in the treatment of intracranial aneurysms,” Journal of Clinical Neuroscience, vol. 21, no. 2, pp. 203–206, 2014.
[22]  W. Brinjikji, M. H. Murad, G. Lanzino, H. J. Cloft, and D. F. Kallmes, “Endovascular treatment of intracranial aneurysms with flow diverters: a meta-analysis,” Stroke, vol. 44, pp. 442–447, 2013.
[23]  Stryker Neurovascular, “The surpass intracranial aneurysm embolization system pivotal trial to treat large or giant wide neck aneurysms (SCENT trial),” in ClinicalTrials.Gov, NCT01716117, National Library of Medicine (US), Bethesda, Md, USA, 2000, https://clinicaltrials.gov/ct2/show/NCT01716117.
[24]  J. Berge, A. Biondi, P. Machi, et al., “Flow-diverter silk stent for the treatment of intracranial aneurysms: 1-year follow-up in a multicenter study,” American Journal of Neuroradiology, vol. 33, pp. 1150–1155, 2012.
[25]  N. Sambu, A. Radhakrishnan, H. Dent et al., “Personalised antiplatelet therapy in stent thrombosis: observations from the Clopidogrel Resistance in Stent Thrombosis (CREST) registry,” Heart, vol. 98, no. 9, pp. 706–711, 2012.
[26]  J. Comin and D. F. Kallmes, “Platelet-function testing in patients undergoing neurovascular procedures: caught between a rock and a hard place,” American Journal of Neuroradiology, vol. 34, pp. 730–734, 2013.
[27]  M. D. Schleinitz, I. Olkin, and P. A. Heidenreich, “Cilostazol, clopidogrel or ticlopidine to prevent sub-acute stent thrombosis: a meta-analysis of randomized trials,” American Heart Journal, vol. 148, no. 6, pp. 990–997, 2004.
[28]  J.-W. Suh, S.-P. Lee, K.-W. Park et al., “Multicenter randomized trial evaluating the efficacy of cilostazol on ischemic vascular complications after drug-eluting stent implantation for coronary heart disease: results of the CILON-T (influence of cilostazol-based triple antiplatelet therapy on ischemic complication after drug-eluting stent implantation) trial,” Journal of the American College of Cardiology, vol. 57, no. 3, pp. 280–289, 2011.
[29]  D. J. Angiolillo, P. Capranzano, S. Goto et al., “A randomized study assessing the impact of cilostazol on platelet function profiles in patients with diabetes mellitus and coronary artery disease on dual antiplatelet therapy: results of the OPTIMUS-2 study,” European Heart Journal, vol. 29, no. 18, pp. 2202–2211, 2008.
[30]  M. E. Bertrand, H.-J. Rupprecht, P. Urban, and A. H. Gershlick, “Double-blind study of the safety of clopidogrel with and without a loading dose in combination with aspirin compared with ticlopidine in combination with aspirin after coronary stenting: the Clopidogrel Aspirin Stent International Cooperative study (CLASSICS),” Circulation, vol. 102, no. 6, pp. 624–629, 2000.
[31]  M. Kamran, J. Yarnold, I. Q. Grunwald, and J. V. Byrne, “Assessment of angiographic outcomes after flow diversion treatment of intracranial aneurysms: a new grading schema,” Neuroradiology, vol. 53, no. 7, pp. 501–508, 2011.
[32]  Z. Kulcsár, U. Ernemann, S. G. Wetzel et al., “High-profile flow diverter (Silk) implantation in the basilar artery: efficacy in the treatment of aneurysms and the role of the perforators,” Stroke, vol. 41, no. 8, pp. 1690–1696, 2010.
[33]  S. Marinkovic, M. Milisavljevic, and M. Kovacevic, “Interpeduncular perforating branches of the posterior cerebral artery. Microsurgical anatomy of their extracerebral and intracerebral segments,” Surgical Neurology, vol. 26, no. 4, pp. 349–359, 1986.
[34]  S. V. Marinkovic, H. Gibo, A. L. Rhoton, and S. J. Peerless, “The surgical anatomy of the perforating branches of the basilar artery,” Neurosurgery, vol. 33, no. 1, pp. 80–87, 1993.
[35]  J. V. Byrne, R. Beltechi, J. A. Yarnold, J. Birks, and M. Kamran, “Early experience in the treatment of intra-cranial aneurysms by endovascular flow diversion: a multicentre prospective study,” PLoS ONE, vol. 5, no. 9, Article ID e12492, 2010.
[36]  R. Navarro, J. Yoon, T. Dixon, D. A. Miller, R. A. Hanel, and R. G. Tawk, “Retrograde trans-anterior communicating artery rescue of unopened Pipeline Embolization Device with balloon dilation: complication management,” Journal of NeuroInterventional Surgery, 2014.
[37]  U.S. Food and Drug Administration, “Instructions for use (IFU): Pipeline embolization device,” 2011, http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100018c.pdf.
[38]  D. Hammoud, P. Gailloud, A. Olivi, and K. J. Murphy, “Acute vasogenic edema induced by thrombosis of a giant intracranial aneurysm: a cause of pseudostroke after therapeutic occlusion of the parent vessel,” American Journal of Neuroradiology, vol. 24, no. 6, pp. 1237–1239, 2003.
[39]  N. F. Fanning, R. A. Willinsky, and K. G. TerBrugge, “Wall enhancement, edema, and hydrocephalus after endovascular coil occlusion of intradural cerebral aneurysms,” Journal of Neurosurgery, vol. 108, no. 6, pp. 1074–1086, 2008.
[40]  J. J. Shankar, R. Vandorpe, G. Pickett, and W. Maloney, “SILK flow diverter for treatment of intracranial aneurysms: initial experience and cost analysis,” Journal of NeuroInterventional Surgery, vol. 5, supplement 3, pp. iii11–iii15, 2013.
[41]  J. P. Cruz, M. Chow, C. O'Kelly et al., “Delayed ipsilateral parenchymal hemorrhage following flow diversion for the treatment of anterior circulation aneurysms,” American Journal of Neuroradiology, vol. 33, no. 4, pp. 603–608, 2012.
[42]  G. P. Colby, L. M. Lin, and A. L. Coon, “Revisiting the risk of intraparenchymal hemorrhage following aneurysm treatment by flow diversion,” American Journal of Neuroradiology, vol. 33, article E107, 2012.
[43]  B. Turowski, S. MacHt, Z. Kulcsár, D. H?nggi, and W. Stummer, “Early fatal hemorrhage after endovascular cerebral aneurysm treatment with a flow diverter (SILK-Stent): do we need to rethink our concepts?” Neuroradiology, vol. 53, no. 1, pp. 37–41, 2011.
[44]  Z. Kulcsár, E. Houdart, A. Bonafé et al., “Intra-aneurysmal thrombosis as a possible cause of delayed aneurysm rupture after flow-diversion treatment,” American Journal of Neuroradiology, vol. 32, no. 1, pp. 20–25, 2011.
[45]  H. W. Chan, N. Haliasos, S. Derakhshani, R. Vindlacheruvu, and S. Chawda, “Delayed caroticocavernous fistula after stent-assisted coil embolization of intracavernous carotid aneurysm: should we manage conservatively?” Acta Neurochirurgica, vol. 153, no. 6, pp. 1291–1295, 2011.
[46]  J. Raymond, T. E. Darsaut, A. Makoyeva, F. Bing, and I. Salazkin, “Endovascular treatment with flow diverters may fail to occlude experimental bifurcation aneurysms,” Neuroradiology, vol. 55, no. 11, pp. 1355–1363, 2013.
[47]  T. E. Darsaut, F. Bing, I. Salazkin, G. Gevry, and J. Raymond, “Flow diverters failing to occlude experimental bifurcation or curved sidewall aneurysms: an in vivo study in canines,” Journal of Neurosurgery, vol. 117, no. 1, pp. 37–44, 2012.
[48]  Centre Hospitalier de l'Université de Montréal (CHUM), “A randomized trial comparing flow diversion and best-standard treatment—the FIAT trial,” in ClinicalTrials.Gov, NCT01349582, National Library of Medicine (US), Bethesda, Md, USA, 2000, http://www.clinicaltrials.gov/ct2/show/NCT01349582.
[49]  D. Fiorella, P. Lylyk, I. Szikora et al., “Curative cerebrovascular reconstruction with the Pipeline Embolization Device: the emergence of definitive endovascular therapy for intracranial aneurysms,” Journal of NeuroInterventional Surgery, vol. 1, no. 1, pp. 56–65, 2009.
[50]  Balt International, “Multicenter randomized trial on selective endovascular aneurysm occlusion with coils versus parent vessel reconstruction using the SILK flow diverter (MARCO POLO post-market clinical investigation),” in ClinicalTrials.Gov, NCT01084681, National Library of Medicine (US), Bethesda, Md, USA, 2000, http://www.clinicaltrials.gov/ct2/show/NCT01084681.
[51]  Hospices Civils de Lyon, “Multicenter randomized study for medico-economic evaluation of embolization with flow diverter stent in the endovascular treatment of unruptured saccular wide-necked intracranial aneurysms,” in ClinicalTrials.Gov, NCT01811134, National Library of Medicine (US), Bethesda, Md, USA, 2000, http://clinicaltrials.gov/ct2/show/record/NCT01811134.
[52]  Medical University of South Carolina, “LARGE aneurysm randomized trial: flow diversion versus traditional endovascular coiling therapy,” in ClinicalTrials.Gov, NCT01762137, National Library of Medicine (US), Bethesda, Md, USA, 2000, http://clinicaltrials.gov/ct2/show/record/NCT01762137.
[53]  S. P. Ferns, M. E. S. Sprengers, W. J. van Rooij et al., “Coiling of intracranial aneurysms: a systematic review on initial occlusion and reopening and retreatment rates,” Stroke, vol. 40, no. 8, pp. e523–e529, 2009.
[54]  J. Raymond, F. Guilbert, A. Weill et al., “Long-term angiographic recurrences after selective endovascular treatment of aneurysms with detachable coils,” Stroke, vol. 34, no. 6, pp. 1398–1403, 2003.
[55]  Centre Hospitalier de l'Université de Montréal (CHUM), “International subarachnoid aneurysm trial II comparing clinical outcomes of surgical clipping and endovascular coiling for ruptured intracranial aneurysms not included in the original ISAT study,” in ClinicalTrials.Gov, NCT01668563, National Library of Medicine (US), Bethesda, Md, USA, 2000, http://clinicaltrials.gov/ct2/show/record/NCT01668563.
[56]  J. Xu, B. Deng, Y. Fang et al., “Hemodynamic changes caused by flow diverters in rabbit aneurysm models: comparison of virtual and realistic FD deployments based on micro-CT reconstruction,” PLoS ONE, vol. 8, no. 6, Article ID e66072, 2013.

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