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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 12/08/2010 Title: Mechanical Embolectomy in Stroke
Revision Date: 11/01/2017 Document: BI283:00
CPT Code(s): 61645
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Several methods are purported to improve survival from acute ischemic strokes.

2)    These include mechanical Embolectomy using various techniques.

3)    Mechanical embolectomy with first-generation types of devices (such as the Merci Retriever or the Penumbra System) is considered experimental/ investigative and is not covered.

4)    Mechanical embolectomy with second-generation devices (such as the Solitaire FR Revascularization Device or the Trevo XP ProVue Retriever) is covered if clinical criteria are met.


Medical Statement
  1. Mechanical embolectomy by means of first-generation types of devices (such as the Merci Retriever or the Penumbra System) is considered experimental and investigational for the treatment of acute ischemic stroke because its effectiveness has not been established.  These have a Hayes D rating.
  2. Mechanical embolectomy with second-generation devices (such as the Solitaire FR Revascularization Device or the Trevo XP ProVue Retriever—all of which have a Hayes B rating) are covered if clinical criteria are met:
    1. If initiated within 12 hours after stroke onset AND
    2. If the occlusion affects the internal carotid or middle cerebral artery

Background

Traditional treatment entails the use of anti-coagulants and/or aspirin.  Within the appropriate time-window, various endovascular approaches have been employed to manage patients with AIS.  Endovascular therapy comprises a number of pharmacological and mechanical procedures.  Intravenous (IV) thrombolysis including the use of tissue plasminogen activator (TPA) is an accepted treatment for AIS administered within 3 hours of onset.  Mechanical procedures using first generation devices (e.g., the mechanical embolus removal in cerebral ischemia [MERCI] device or the Penumbra System) offer the promise of effective treatment for patients in whom pharmacological thrombolysis is contraindicated or might be ineffective.  However, the clinical value of mechanical embolectomy using first-generation devices in improving health outcomes of patients with AIS has not been established.

With changes in technology and the introduction of second-generation devices (such as the Solitaire FR Revascularization Device or the Trevo XP ProVue Retriever), there is now evidence from randomized controlled trials that this is superior to conventional treatment if intervention is initiated within 12 hours for patients with ischemic stroke due to occlusion of the internal carotid or middle cerebral arteries.


Reference
  1. Smith WS, Sung G, Starkman S, et al; MERCI Trial Investigators. Safety and efficacy of mechanical embolectomy in acute ischemic stroke: Results of the MERCI trial. Stroke 2005; 36(7):1432-1438.
  2. No authors listed. Emerging technology list. Device for treatment of ischemic stroke. Canadian Coordinating Office for Health Technology Assessment. No. 27, March, 2005. Available at: http://cadth-acmts.ca/media/pdf/152_No27_merci_retriever_etech_e.pdf. Accessed Sept 1, 2010.
  3. González A, Mayol A, Martínez E, et al. Mechanical Thrombectomy with snare in patients with acute ischemic stroke. Neuroradiology. 2007; 49(4):365-372.
  4. Smith WS. Technology insight: Recanalization with drugs and devices during acute ischemic stroke. Nat Clin Pract Neurol. 2007; 3(1):45-53.
  5. Thomassen L, Bakke SJ. Endovascular reperfusion therapy in acute ischaemic stroke. Acta Neurol Scand Suppl. 2007; 187:22-29.
  6. No authors listed. Use of the Merci retriever for the emergent treatment of acute ischemic stroke. California Technology Assessment Forum. October 17, 2007. Available at: http://ctaf.org/content/assessment/detail/770. Accessed Sept. 1, 2010.
  7. Adams HP Jr, del Zoppo G, Alberts MJ, et al; American Heart Association, American Stroke Association Stroke Council, Clinical Cardiology Council. Guidelines for the early management of adults with ischemic stroke: A guideline from the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups. Stroke 2007; 38(5):1655-1711.
  8. National Stroke Foundation. Clinical guidelines for acute stroke management. Melbourne (Australia): National Stroke Foundation; October, 2007. p. 6-15. Available at: http://www.guidelines.gov/summary/summary.aspx?doc_id=12926&nbr=006640&string=acute+AND+ischemic+AND+stroke. Accessed Sept. 1, 2010.
  9. Bose A, Henkes H, Alfke K; 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(7):1409-1413.
  10. Smith WS, Sung G, Saver J, et al. Mechanical Thrombectomy for acute ischemic stroke: Final results of the Multi MERCI trial. Stroke. 2008; 39(4):1205-1212.
  11. Kobayashi A, Czepiel W, Dowzenko A, Członkowska A. Mechanical embolectomy in acute ischaemic stroke -- report of the first two cases. Neurol Neurochir Pol. 2008; 42(5):451-457.
  12. Sugiura S, Iwaisako K, Toyota S, Takimoto H. Simultaneous treatment with intravenous recombinant tissue plasminogen activator and endovascular therapy for acute ischemic stroke within 3 hours of onset. AJNR Am J Neuroradiol. 2008; 29(6):1061-1066.
  13. Stead LG, Gilmore RM, Bellolio MF, et al. Percutaneous clot removal devices in acute ischemic stroke: A systematic review and meta-analysis. Arch Neurol. 2008; 65(8):1024-1030.
  14. National Institute for Health and Clinical Excellence. Stroke: Diagnosis and initial management of acute stroke and transient ischaemic attack (TIA). July. 2008. Available at: http://www.nice.org.uk/nicemedia/pdf/CG68NICEGuideline.pdf.  Accessed Sept. 1, 2010.
  15. Oliveira-Filho J, Koroshetz WJ, Samuels OB. Fibrinolytic (thrombolytic) therapy for acute ischemic stroke. Up-to-date, January 28, 2009.
  16. Josephson SA, Saver JL, Smith WS; Merci and Multi Merci Investigators. Comparison of mechanical embolectomy and intra-arterial thrombolysis in acute ischemic stroke within the MCA: MERCI and Multi MERCI compared to PROACT II. Neurocrit Care. 2009; 10(1):43-49.
  17. Broderick JP. Endovascular therapy for acute ischemic stroke. Stroke. 2009; 40(3 Suppl):S103-S106.
  18. Meyers PM, Schumacher HC, Higashida RT; American Heart Association. Indications for the performance of intracranial endovascular neurointerventional procedures: A scientific statement from the American Heart Association Council on Cardiovascular Radiology and Intervention, Stroke Council, Council on Cardiovascular Surgery and Anesthesia, Interdisciplinary Council on Peripheral Vascular Disease, and Interdisciplinary Council on Quality of Care and Outcomes Research. Circulation. 2009; 119(16):2235-2249.
  19. Elliott JP, Newell DW, Lam DJ, et al. Comparison of balloon angioplasty and papaverine infusion for the treatment of vasospasm following aneurysmal subarachnoid hemorrhage. J Neurosurg. 1998; 88(2):277-284.
  20. Hoh BL, Ogilvy CS. Endovascular treatment of cerebral vasospasm: Transluminal balloon angioplasty, intra-arterial papaverine, and intra-arterial nicardipine. Neurosurg Clin N Am. 2005; 16(3):501-516.
  21. Brisman JL, Eskridge JM, Newell DW. Neurointerventional treatment of vasospasm. Neurol Res. 2006; 28(7):769-776.
  22. No authors listed. Acute stroke management. Management of subarachnoid and intracerebral hemorrhage. In: Canadian best practice recommendations for stroke care: 2006. Ottawa (ON): Canadian Stroke Network, Heart & Stroke Foundation of Canada; 2006. p. 61-63. Available at: http://www.guidelinecentral.com/guidelines-author/canadian-stroke-network-guidelines .  Accessed Sept. 1, 2010.
  23. Abdennour L, Lejean L, Bonneville F, et al. Endovascular treatment of vasospasm following subarachnoid aneurysmal hemorrhage. Ann Fr Anesth Reanim. 2007; 26(11):985-989.
  24. Platz J, Baráth K, Keller E, Valavanis A. Disruption of the blood-brain barrier by intra-arterial administration of papaverine: A technical note. Neuroradiology. 2008; 50(12):1035-1039.
  25. Grech R, Mizzi A, Pullicino R, Thornton J, Downer J. Functional outcomes, and recanalization rates of stent retrievers in acute ischaemic stroke: a systematic review and meta-analysis. Neuroradiol J. 2015; 28(2):152-171.
  26. Ganesalingam J, Pizzo E, Morris S, Sunderland T, Ames D, Lobotesis K. Cost-utility analysis of mechanical thrombectomy using stent retrievers in acute ischemic stroke. Stroke. 2015; 46(9):2591-2598.
  27. Goyal M, Demchuk AM, Menon BK, et al.; ESCAPE Trial Investigators. Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med. 2015; 372(11):1019-1030.
  28. Berkhemer OA, Fransen PS, Beumer D, et al.; Mr. Clean Investigators. A randomized trial of intra-arterial treatment for acute ischemic stroke. N Engl J Med. 2015; 372(1):11-20.
  29. Jovin TG, Chamorro A, Cobo E, et al.; REVASCAT Trial Investigators. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med. 2015; 372(24):2296-2306.
  30. Osanai T, Pasupuleti V, Deshpande A, et al. Acute endovascular reperfusion therapy in ischemic stroke: a systematic review and meta-analysis of randomized controlled trials. PLoS One. 2015; 10(4):e0122806.
  31. Saver JL, Goyal M, Bonafe A, et al.; SWIFT PRIME Investigators. Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. N Engl J Med. 2015; 372(24):2285-2295.

Addendum:

Effective 01/01/2017: Policy updated to deny for medical records and cover intervention with second-generation devices if clinical criteria met (based on Hayes “B” rating).


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
This policy has recently been updated. Please use the index above or enter policy title in search bar for the latest version.