Effective Date: 12/08/2010
Title: Mechanical Embolectomy in Stroke
Revision Date: 11/01/2017
CPT Code(s): 61645
will apply to all services performed on or after the above revision date which
will become the new effective date.
services referred to in this policy that were performed before the revision
date, contact customer service for the rules that would apply.
methods are purported to improve survival from acute ischemic strokes.
include mechanical Embolectomy using various techniques.
embolectomy with first-generation types of devices (such as the Merci Retriever
or the Penumbra System) is considered experimental/ investigative and is not
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.
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.
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:
If initiated within 12 hours after stroke
If the occlusion affects the internal
carotid or middle cerebral artery
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.
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
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.
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:
Accessed Sept 1, 2010.
González A, Mayol A, Martínez E, et al.
Mechanical Thrombectomy with snare in patients with acute ischemic stroke.
Neuroradiology. 2007; 49(4):365-372.
Smith WS. Technology insight: Recanalization
with drugs and devices during acute ischemic stroke. Nat Clin Pract Neurol.
Thomassen L, Bakke SJ. Endovascular
reperfusion therapy in acute ischaemic stroke. Acta Neurol Scand Suppl.
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.
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.
National Stroke Foundation. Clinical
guidelines for acute stroke management. Melbourne (Australia): National
Stroke Foundation; October, 2007. p. 6-15. Available at:
Accessed Sept. 1, 2010.
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.
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.
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.
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.
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.
National Institute for Health and Clinical
Excellence. Stroke: Diagnosis and initial management of acute stroke and
transient ischaemic attack (TIA). July. 2008. Available at:
Sept. 1, 2010.
Oliveira-Filho J, Koroshetz WJ, Samuels OB.
Fibrinolytic (thrombolytic) therapy for acute ischemic stroke. Up-to-date,
January 28, 2009.
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.
Broderick JP. Endovascular therapy for acute
ischemic stroke. Stroke. 2009; 40(3 Suppl):S103-S106.
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.
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.
Hoh BL, Ogilvy CS. Endovascular treatment of
cerebral vasospasm: Transluminal balloon angioplasty, intra-arterial
papaverine, and intra-arterial nicardipine. Neurosurg Clin N Am. 2005;
Brisman JL, Eskridge JM, Newell DW.
Neurointerventional treatment of vasospasm. Neurol Res. 2006; 28(7):769-776.
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:
. Accessed Sept. 1, 2010.
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.
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.
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.
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;
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.
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.
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.
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.
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.
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.