Neurothrombectomy devices for the treatment of acute ischemic stroke: State of the evidence

Annals of Internal Medicine

Volumn 154, Issue 4, 2011, Pages 243-252

  Baker, William L ^a   Colby, Jennifer A ^b   Tongbram, Vanita ^b   Talati, Ripple ^b   Silverman, Isaac E ^b   Michael White, C ^b   Kluger, Jeffrey ^b   Coleman, Craig I ^b  

^a UNIVERSITY OF CONNECTICUT   (United States)

^b UNIVERSITY OF CONNECTICUT   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACUTE ISCHEMIC STROKE; AGING; BLOOD VESSEL PERFORATION; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; CASE REPORT; CLINICAL EVALUATION; CLINICAL STUDY; CLINICAL TRIAL; COCHRANE LIBRARY; DATA EXTRACTION; DISEASE SEVERITY; HUMAN; INFORMATION RETRIEVAL; MAJOR CLINICAL STUDY; MEDLINE; NEUROTHROMBECTOMY DEVICE; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECANALIZATION; REVIEW; RISK FACTOR; STROKE; SURGICAL EQUIPMENT; TREATMENT INDICATION;

EID: 79951619033     PISSN: 00034819     EISSN: 15393704     Source Type: Journal    
DOI: 10.7326/0003-4819-154-4-201102150-00306     Document Type: Review

References (62)

1. Lopez AD, Mathers CD, Ezzati M, Jamison DT, Murray CJ. Global and regional burden of disease and risk factors, 2001: systematic analysis of population health data. Lancet. 2006;367:1747-1757. [PMID: 16731270]
2. Lloyd-Jones D, Adams R, Carnethon M, De Simone G, Ferguson TB, Flegal K, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics-2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2009;119:480-486. [PMID: 19171871]
3. Smith WS, Tsao JW, Billings ME, Johnston SC, Hemphill JC 3rd, Bonovich DC, et al. Prognostic significance of angiographically confirmed large vessel intracranial occlusion in patients presenting with acute brain ischemia. Neurocrit Care. 2006;4:14-17. [PMID: 16498189]
4. Centers for Disease Control and Prevention (CDC). Prevalence of disabilities and associated health conditions among adults-United States, 1999. MMWR Morb Mortal Wkly Rep. 2001;50:120-125. [PMID: 11393491]
5. Centers for Disease Control and Prevention (CDC). Outpatient rehabilitation among stroke survivors-21 States and the District of Columbia, 2005. MMWR Morb Mortal Wkly Rep. 2007;56:504-507. [PMID: 17522589]
6. Fischer U, Arnold M, Nedeltchev K, Brekenfeld C, Ballinari P, Remonda L, et al. NIHSS score and arteriographic findings in acute ischemic stroke. Stroke.2005;36:2121-2125. [PMID: 16151026]
7. Nogueira RG, Liebeskind DS, Sung G, Duckwiler G, Smith WS; MERCI. Predictors of good clinical outcomes, mortality, and successful revascularization inpatients with acute ischemic stroke undergoing thrombectomy: pooled analysis of the Mechanical Embolus Removal in Cerebral Ischemia (MERCI) and Multi MERCI Trials. Stroke. 2009;40:3777-3783. [PMID: 19875740]
8. Rha JH, Saver JL. The impact of recanalization on ischemic stroke outcome: a meta-analysis. Stroke. 2007;38:967-973. [PMID: 17272772]
9. Zangerle A, Kiechl S, Spiegel M, Furtner M, Knoflach M, Werner P, et al. Recanalization after thrombolysis in stroke patients: predictors and prognostic implications. Neurology. 2007;68:39-44. [PMID: 17200490]
10. Wolpert SM, Bruckmann H, Greenlee R, Wechsler L, Pessin MS, del Zoppo GJ. Neuroradiologic evaluation of patients with acute stroke treated with recombinant tissue plasminogen activator. The rt-PA Acute Stroke Study Group. AJNR Am J Neuroradiol. 1993;14:3-13. [PMID: 8427107]
11. Thomassen L, Bakke SJ. Endovascular reperfusion therapy in acute ischaemic stroke. Acta Neurol Scand Suppl. 2007;187:22-29. [PMID: 17419824]
12. Becker KJ, Brott TG. Approval of the MERCI clot retriever: a critical view. Stroke. 2005;36:400-403. [PMID: 15653576]
13. Nogueira RG, Schwamm LH, Hirsch JA. Endovascular approaches to acute stroke, part 1: Drugs, devices, and data. AJNR Am J Neuroradiol. 2009;30:649-661. [PMID: 19279271]
14. Lutsep HL. Mechanical endovascular recanalization therapies. Curr Opin Neurol. 2008;21:70-75. [PMID: 18180654]
15. U.S. Food and Drug Administration 510(k) Premarket Notification. Accessed at www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfPMN/pmn.cfm on 25 August 2010.
16. Baker WL, Colby JA, Tongbram V, Talati RA, Silverman IE, White CM, et al. Neurothrombectomy devices for treatment of acute ischemic stroke. (Prepared by the University of Connecticut/Hartford Hospital Evidence-based Practice Center under contract 290-2007-10067-I with the Agency for Healthcare Research and Quality.) Rockville, MD: Agency for Healthcare Research and Quality; 2010. Accessed at www.effectivehealthcare.ahrq.gov on 16 December 2010.
17. Guidance for Industry and FDA Staff: Pre-Clinical and Clinical Studies for Neurothrombectomy Devices. Silver Spring, MD: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health; 18 June 2007. Accessed at: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071403.htm on 25 August 2010.
18. Gupta R. Arterial vasospasm during mechanical thrombectomy for acute stroke. J Neuroimaging. 2009;19:61-64. [PMID: 18801002]
19. Stead LG, Gilmore RM, Bellolio MF, Rabinstein AA, Decker WW. Percutaneousclot removal devices in acute ischemic stroke: a systematic review and meta-analysis. Arch Neurol. 2008;65:1024-1030. [PMID: 18695052]
20. Smith WS, Sung G, Starkman S, Saver JL, Kidwell CS, Gobin YP, et al; MERCI Trial Investigators. Safety and efficacy of mechanical embolectomy in acute ischemic stroke: results of the MERCI trial. Stroke. 2005;36:1432-1438. [PMID: 15961709]
21. Smith WS, Sung G, Saver J, Budzik R, Duckwiler G, Liebeskind DS, et al; Multi MERCI Investigators. Mechanical thrombectomy for acute ischemic stroke: final results of the Multi MERCI trial. Stroke. 2008;39:1205-1212. [PMID: 18309168]
22. Nichols C, Carrozzella J, Yeatts S, Tomsick T, Broderick J, Khatri P. Isperi-procedural sedation during acute stroke therapy associated with poorer functional outcomes? J Neurointerv Surg. 2010;2:67-70. [PMID: 20431708]
23. Kelly ME, Furlan AJ, Fiorella D. Recanalization of an acute middle cerebral artery occlusion using a self-expanding, reconstrainable, intracranial microstent as a temporary endovascular bypass. Stroke. 2008;39:1770-1773. [PMID: 18388338]
24. Suh SH, Lee KY, Hong CK, Kim BM, Kim CH, Chung TS, et al. Temporary stenting and retrieval of the self-expandable, intracranial stent in acute middle cerebral artery occlusion. Neuroradiology. 2009;51:541-544. [PMID: 19424689]
25. Hauck EF, Mocco J, Snyder KV, Levy EI. Temporary endovascular bypass: a novel treatment for acute stroke. AJNR Am J Neuroradiol. 2009;30:1532-1533. [PMID: 19279279]
26. Castaño C, Serena J, Dávalos A. Use of the new Solitaire (TM) AB device for mechanical thrombectomy when Merci Clot Retriever has failed to remove the clot. A case report. Interv Neuroradiol. 2009;15:209-214. [PMID: 20465901]
27. Henkes H, Liebig T, Miloslavski E, Guethe T, Schmid E, Wiethoelter H. Endovascular acute ischemic stroke treatment using the self-expanding and fully retrievable Solitaire stent [Abstract]. Stroke. 2009;40:E247-E248.
28. Castaño C, Dorado L, Guerrero C, Millán M, Gomis M, Perez de la Ossa N, et al. Mechanical thrombectomy with the Solitaire AB device in large artery occlusions of the anterior circulation: a pilot study [Letter]. Stroke. 2010;41: 1836-1840. [PMID: 20538693]
29. Loh Y, Jahan R, McArthur DL, Shi ZS, Gonzalez NR, Duckwiler GR, et al. Recanalization rates decrease with increasing thrombectomy attempts. AJNR Am J Neuroradiol. 2010;31:935-939. [PMID: 20075091]
30. Devlin TG, Baxter BW, Feintuch TA, Desbiens NA. The Merci Retrieval System for acute stroke: the Southeast Regional Stroke Center experience. NeurocritCare. 2007;6:11-21. [PMID: 17356186]
31. Kim D, Jahan R, Starkman S, Abolian A, Kidwell CS, Vinuela F, et al. Endovascular mechanical clot retrieval in a broad ischemic stroke cohort. AJNR Am J Neuroradiol. 2006;27:2048-2052. [PMID: 17110664]
32. Gobin YP, Starkman S, Duckwiler GR, Grobelny T, Kidwell CS, Jahan R, et al. MERCI 1: a phase 1 study of Mechanical Embolus Removal in Cerebral Ischemia. Stroke. 2004;35:2848-2854. [PMID: 15514171]
33. Lin R, Vora N, Zaidi S, Aleu A, Jankowitz B, Thomas A, et al. Mechanical approaches combined with intra-arterial pharmacological therapy are associated with higher recanalization rates than either intervention alone in revascularization of acute carotid terminus occlusion. Stroke. 2009;40:2092-2097. [PMID: 19390066]
34. Jo KD, Saver JL, Starkman S, Kim D, Ali LK, Ovbiagele B, et al. Predictors of recanalization with mechanical thrombectomy for acute ischemic stroke [Abstract]. Stroke. 2008;39:599.
35. Madison MT, Goddard JK. III, Lassig JP, Meyers ME. Single center experience with combined (thrombolytics and mechanical thrombectomy) intraarterial intervention in 112 consecutive patients with angio-graphically confirmed large vessel thromboembolic ischemic stroke (1-6 hours post symptom onset) from 2003 to 2007 [Abstract]. Stroke. 2008;39:547.
36. Kidwell CS, Latour L, Saver JL, Alger JR, Starkman S, Duckwiler G, et al; UCLA Thrombolysis Investigators. Thrombolytic toxicity: blood brain barrier disruption in human ischemic stroke. Cerebrovasc Dis. 2008;25:338-343. [PMID: 18303253]
37. Kulcsár Z, Bonvin C, Pereira VM, Altrichter S, Yilmaz H, Lövblad KO, et al. Penumbra system: a novel mechanical thrombectomy device for large-vessel occlusions in acute stroke. AJNR Am J Neuroradiol. 2010;31:628-633. [PMID: 20019113]
38. Penumbra Pivotal Stroke Trial Investigators. The Penumbra Pivotal Stroke Trial: safety and effectiveness of a new generation of mechanical devices for clot removal in intracranial large vessel occlusive disease. Stroke. 2009;40:2761-2768. [PMID: 19590057]
39. Grunwald IQ, Walter S, Papanagiotou P, Krick C, Hartmann K, Dautermann A, et al. Revascularization in acute ischaemic stroke using the penumbra system: the first single center experience. Eur J Neurol. 2009;16:1210-1216. [PMID: 19659754]
40. Bose A, Henkes H, Alfke K, Reith W, Mayer TE, Berlis A, et al; Penumbra Phase 1 Stroke Trial Investigators. The Penumbra System: a mechanical device for the treatment of acute stroke due to thromboembolism. AJNR Am J Neuroradiol. 2008;29:1409-1413. [PMID: 18499798]
41. Struffert T, Köhrmann M, Engelhorn T, Nowe T, Richter G, Schellinger PD, et al. Penumbra Stroke System as an "add-on" for the treatment of large vessel occlusive disease following thrombolysis: first results. Eur Radiol. 2009;19: 2286-2293. [PMID: 19350248]
42. Tarr R, Alfke K, Stingele R, Jansen O, Frei D, Bellon R, et al. Initial post-market experience of the Penumbra System: revascularization of large vessel occlusion in acute ischemic stroke in the United States and Europe [Abstract]. Stroke. 2009;40:e151.
43. Frei D, Bellon R. Mechanical thrombectomy in acute stroke patients who were refractory to intravenous thrombolytic therapy [Abstract]. Stroke. 2009;40: E250.
44. Liebig T, Reinartz J, Guethe T, Roth C, Milosiavski M. Early clinical experiences with a new thrombectomy device for the treatment of ischemic stroke [Abstract]. Stroke. 2008;39:608-609.
45. Tomsick T, Broderick J, Carrozella J, Khatri P, Hill M, Palesch Y, et al; Interventional Management of Stroke II Investigators. Revascularization results in the Interventional Management of Stroke II trial. AJNR Am J Neuroradiol. 2008;29:582-587. [PMID: 18337393]
46. Mahon BR, Nesbit GM, Barnwell SL, Clark W, Marotta TR, Weill A, et al. North American clinical experience with the EKOS MicroLysUS infusion catheter for the treatment of embolic stroke. AJNR Am J Neuroradiol. 2003;24: 534-538. [PMID: 12637311]
47. González A, Mayol A, Martínez E, González-Marcos JR, Gil-Peralta A. Mechanical thrombectomy with snare in patients with acute ischemic stroke. Neuroradiology. 2007;49:365-372. [PMID: 17262195]
48. Mayer TE, Hamann GF, Schulte-Altedorneburg G, Brückmann H. Treatment of vertebrobasilar occlusion by using a coronary waterjet thrombectomy device: a pilot study. AJNR Am J Neuroradiol. 2005;26:1389-1394. [PMID: 15956504]
49. Berlis A, Lutsep H, Barnwell S, Norbash A, Wechsler L, Jungreis CA, et al. Mechanical thrombolysis in acute ischemic stroke with endovascular photoacoustic recanalization. Stroke. 2004;35:1112-1116. [PMID: 15017011]
50. Mayer TE, Hamann GF, Brueckmann HJ. Treatment of basilar artery embolism with a mechanical extraction device: necessity of flow reversal. Stroke. 2002;33:2232-2235. [PMID: 12215592]
51. Clark RA, Bryant AL, Pua Y, McCrory P, Bennell K, Hunt M. Validity and reliability of the Nintendo Wii Balance Board for assessment of standing balance. Gait Posture. 2010;31:307-310. [PMID: 20005112]
52. Nogueira RG, Smith WS; MERCI and Multi MERCI Writing Committee. Safety and efficacy of endovascular thrombectomy in patients with abnormal hemostasis: pooled analysis of the MERCI and multi MERCI trials. Stroke. 2009;40:516-522. [PMID: 19095994]
53. Nogueira RG, Yoo AJ, Buonanno FS, Hirsch JA. Endovascular approaches to acute stroke, part 2: a comprehensive review of studies and trials. AJNR Am J Neuroradiol. 2009;30:859-875. [PMID: 19386727]
54. Meyers PM, Schumacher HC, Alexander MJ, Derdeyn CP, Furlan AJ, Higashida RT, et al; American Academy of Neurology. Performance and training standards for endovascular ischemic stroke treatment. J Neurosurg. 2010;113: 149-152. [PMID: 20035576]
55. Connors JJ 3rd, Sacks D, Black CM, McIff EB, Stallmeyer MJ, Cole JW, et al; Society of Interventional Radiology. Training guidelines for intra-arterialcatheter-directed treatment of acute ischemic stroke: a statement from a special writing group of the Society of Interventional Radiology. J Vasc Interv Radiol. 2009;20:1507-1522. [PMID: 19944980]
56. Khatri P, Abruzzo T, Yeatts SD, Nichols C, Broderick JP, Tomsick TA; IMS I and II Investigators. Good clinical outcome after ischemic stroke with successful revascularization is time-dependent. Neurology. 2009;73:1066-1072. [PMID: 19786699]
57. Smith WS, Lev MH, English JD, Camargo EC, Chou M, Johnston SC, et al. Significance of large vessel intracranial occlusion causing acute ischemic stroke and TIA. Stroke. 2009;40:3834-3840. [PMID: 19834014]
58. Josephson SA, Saver JL, Smith WS; Merci and Multi Merci Investigators. Comparison of mechanical embolectomy and intraarterial thrombolysis in acute ischemic stroke within the MCA: MERCI and Multi MERCI compared to PROACT II. Neurocrit Care. 2009;10:43-49. [PMID: 19030784]
59. Alexandrov AV, Grotta JC. Arterial reocclusion in stroke patients treated with intravenous tissue plasminogen activator. Neurology. 2002;59:862-867. [PMID: 12297567]
60. Gralla J, Schroth G, Remonda L, Nedeltchev K, Slotboom J, Brekenfeld C. Mechanical thrombectomy for acute ischemic stroke: thrombus-device interaction, efficiency, and complications in vivo. Stroke. 2006;37:3019-3024. [PMID: 17053185]
61. Khatri P, Hill MD, Palesch YY, Spilker J, Jauch EC, Carrozzella JA, et al; Interventional Management of Stroke III Investigators. Methodology of the Interventional Management of Stroke III Trial. Int J Stroke. 2008;3:130-137. [PMID: 18706007]
62. Mauldin PD, Simpson KN, Palesch YY, Spilker JS, Hill MD, Khatri P, et al; Interventional Management of Stroke III Investigators. Design of the economic evaluation for the Interventional Management of Stroke (III) trial. Int J Stroke. 2008;3:138-144. [PMID: 18706008]