Coverage Policy Manual
Policy #: 2002014
Category: Surgery
Initiated: August 2002
Last Review: October 2018
  Extracranial-Intracranial Bypass Surgery in Cerebrovascular Disease

Description: Extracranial/intracranial (EC/IC) artery bypass surgery has been proposed as treatment for patients with internal cerebral artery stenosis or stenosis or occlusion of the middle cerebral artery.  Prior to the mid 1980's the procedure was done throughout the world with many claims of improved medical outcomes.  In the late 1970's, a multicenter randomized trial was begun which recruited 1,377 patients from three continents over eight years.  Patients with symptomatic atherosclerosis of the internal carotid or middle cerebral arteries were randomized to medical care alone or to EC/IC bypass with continuing medical care.  The study was reported in 1985, and patients in the EC/IC arm of the study were found to have transient worsening of functional status in the initial 6 month post-operative period, and no difference in medical outcomes between the medically treated and the surgically treated groups were identified after six months.  No decrease in risk of subsequent stroke was identified in the surgically treated group.  Criticism of the trial methods occurred because it was discovered that patients at some of the trial centers had been operated on without having been randomized.  A subsequent removal from the trial data of the clinical results of these patients did not change the results of the study.  The goal of the surgery (to reduce repeated strokes) was not documented.

Recently, the procedure has been revisited: neuroimaging (PET with O16 tagged radioisotope) have made it possible to evaluate cerebral hemodynamics associated with carotid occlusion.  Studies have shown that patients with symptomatic carotid artery occlusion who have increased oxygen extraction fraction (OEF) measured by positron emission tomography also have a high rate of subsequent stroke within the next two years if they are maintained on medical therapy.  A national randomized controlled trial, known as the Carotid Occlusion Surgery Study, funded by the National Institute of Neurological Disorders and Stroke, is ongoing to again test the hypothesis of benefit of EC-IC bypass for patients with atherosclerotic obstruction in the subset of patients with increased OEF.  Patients with non-atherosclerotic carotid vascular disease are excluded from this study.

Policy/
Coverage:
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
EC-IC bypass meets primary coverage criteria for effectiveness and is covered for treatment of cerebral ischemia due to obstruction of the external-internal cerebral arteries secondary to tumor, in surgical conditions that require removal of major arterial vessels included in removal of diseased tissue, or scarring associated with radiation injury or other injury in patients with demonstrated cerebral oxygen deprivation in the region supplied by the obstructed vessel, and for treatment of cerebral aneurysm.
 
Indirect bypass using the technique of encephaloduroarteriomyosynangiosis (EDMAS) for treatment of childhood moyamoya disease meets primary coverage criteria for effectiveness and is covered.
 
Direct EC-IC bypass (e.g., STA-MCA) for treatment of ischemic moyamoya disease in adults meets primary coverage criteria for effectiveness and is covered.
 
EC-IC bypass for flow replacement in planned vessel sacrifice (i.e., treatment of inoperable intracranial aneurysms or excision of skull base tumors) meets primary coverage criteria for effectiveness and is covered.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Direct EC-IC bypass (e.g., STA-MCA) for treatment of hemorrhagic moyamoya disease in adults does not meet member benefit certificate primary coverage criteria as this treatment is understudy in a prospective randomized trial. For members without primary coverage criteria, direct EC-IC (e.g., STA-MCA) for treatment of hemorrhagic moyamoya disease in adults is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
EC-IC for the treatment of atherosclerotic disease, including, but not limited to, the treatment of ischemia in the setting of carotid occlusion or to treat cerebrovascular occlusive disease does not meet member certificate of benefit Primary Coverage Criteria. For members without primary coverage criteria, EC-IC for the treatment of atherosclerotic disease, including, but not limited to, the treatment of ischemia in the setting of carotid occlusion or to treat cerebrovascular occlusive disease adults is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
The Excimer Laser Assisted Non-Occlusive Anastomosis (ELANA) procedure does not meet member certificate of benefit Primary Coverage Criteria.  For members without primary coverage criteria, Excimer Laser Assisted Non-Occlusive Anastomosis (ELANA) is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
EC-IC for any other indication, not specifically listed as covered above, including but not limited to, treatment of cerebral ischemia secondary to arteriosclerotic/thrombotic obstruction of carotid arteries does not meet member benefit certificate primary coverage criteria. For contracts without primary coverage criteria, EC-IC for any other indication not specifically listed as covered, including but not limited to, treatment of cerebral ischemia secondary to arteriosclerotic/thrombotic obstruction of carotid arteries is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
 

Rationale:
Member benefit contracts exclude coverage of procedures being studied in Phase 1, II or III trials or otherwise under study to determine effectiveness.
 
2011 Update
The Carotid Occlusion Surgery Study (COSS) randomized 195 patients with atherosclerotic internal carotid artery occlusion to receive either extracranial-intracranial bypass surgery or no surgery.  Forty-nine clinical centers and 18 positron emission tomography (PET) centers in the United States and Canada participated in the trial. The primary outcome for participants in the surgical group was all stroke and death from surgery through 30 days after surgery and ipsilateral ischemic stroke within 2 years of randomization.  For those participants not receiving surgery the primary outcome was all stroke and death from randomization to randomization plus 30 days and ipsilateral ischemic stroke within 2 years of randomization. Two year rates for the primary end point were 21 % for the surgical group and 22.7 % for the surgical group. The authors report, “the results of the COSS showed that EC-IC bypass surgery provided no additional benefit over medical therapy for preventing recurrent stroke” (Powers, 2011).
 
2012 Update
A literature search was conducted through September 2012.  There was no new literature identified that would prompt a change in the coverage statement.
 
2014 Update
A literature search conducted through September 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
To evaluate the value of time-of-flight MR angiography (TOF MRA) for the assessment of extracranial-intracranial (EC-IC) bypass in Moyamoya disease in comparison with computed tomography angiography (CTA) Chen and colleagues (Chen, 2014) studied a consecutive series of 23 patients with Moyamoya disease were analyzed retrospectively. Twenty three patients underwent 25 procedures of extracranial-intracranial bypass. Cranial CTA was performed within one week after the surgery to assess bypass patency. Then TOF MRA was scanned within 24 h after CTA on a 3T MRI system. Using 5-point scales (0 = poor to 4 = excellent), two radiologists rated the image quality and vessel integrity of bypass for three segments (extracranial, trepanation, intracranial). Image quality was high in both CTA and TOF MRA (mean quality score 3.84 ± 0.37 and 3.8 ± 0.41), without statistical difference (p = 0.66). Mean scores of TOF MRA with respect to bypass visualization were higher than CTA in the intracranial segment (p = 0.026). No significant difference of bypass visualization regarding the extracranial and trepanation segments was found between TOF MRA and CTA (p = 0.66 and p = 0.34, respectively). For the trepanation segment, TOF MRA showed pseudo lesions in 2 of all 25 cases.
 
3T TOF MRA, a non-contrast technique not exposing the patients to radiation, proved to be at least equal to CTA for the assessment of EC-IC bypass, and even superior to CTA with respect to the intracranial segment. In addition, readers should be aware of a potential overestimation showing focal pseudo lesions of the bypass at the trepanation segment in TOF MRA.
 
2015 Update
A literature search conducted through September 2015 did not reveal any new information that would prompt a change in the coverage statement.
Aba and Lawton retrospectively reviewed a consecutive, single-surgeon experience with ACA aneurysms and bypasses over a 16 year period (Aba, 2014). Bypasses for ACA aneurysms reported in the literature were also reviewed. Ten patients had aneurysms that were treated with ACA bypass as part of their surgical intervention. Four patients presented with subarachnoid hemorrhage and 3 patients with mass effect symptoms from giant aneurysms; 1 patient with bacterial endocarditis had a mycotic aneurysm, and 1 patient's meningioma resection was complicated by an iatrogenic pseudoaneurysm. One patient had his aneurysm discovered incidentally. There were 2 pre-communicating aneurysms (A1 segment of the ACA), 5 communicating aneurysms (ACoA), and 3 post-communicating (A2-A3 segments of the ACA). In situ bypasses were used in 4 patients (A3-A3 bypass), interposition bypasses in 4 patients, reimplantation in 1 patient (pericallosal artery-to-callosomarginal artery), and reanastomosis in 1 patient (pericallosal artery). Complete aneurysm obliteration was demonstrated in 8 patients, and bypass patency was demonstrated in 8 patients; one bypass thrombosed, but 4 years later. There were no operative deaths, and permanent neurological morbidity was observed in 2 patients. At last follow-up, 8 patients (80%) were improved or unchanged. In a review of the 29 relevant reports, the A3-A3 in situ bypass was used most commonly, extracranial (EC)-IC interpositional bypasses were the second most common, and reanastomosis and reimplantation were used the least. Anterior cerebral artery aneurysms requiring bypass are rare and can be revascularized in a variety of ways. Anterior cerebral artery aneurysms, more than any other aneurysms, require a thorough survey of patient-specific anatomy and microsurgical options before deciding on an individualized management strategy. The authors' experience demonstrates a preference for IC-IC reconstruction, but EC-IC bypasses are reported frequently in the literature. The authors conclude that ACA bypass with indirect aneurysm occlusion is a good alternative to direct clip reconstruction for complex ACA aneurysms.
 
A total of 18 devices have been distributed in the U.S since HDE approval, although the device has been successfully used in only one subject at the time of this Executive Summary. In two other subjects, intent to use the ELANA was aborted and the device was not used in the subjects. All three subjects (the one successful use and two intended use) were adults and these three were enrolled in the post-approval study. Only one new article has been published since last year’s literature review in which it provided no new information on the safety or effectiveness of the ELANA device. In large part due to the limited use of the device since approval, no new safety issues have been identified. (FDA, 2014)
 
The Manufacturer and User Facility Device Experience (MAUDE) database was searched August 1st, 2014, to identify any Medical Device Reports (MDRs) associated with the Excimer Laser Assisted Non-occlusive Anastomosis (ELANA) device which had been reported to FDA. The first MAUDE search criteria included Brand name (Variations of %Elana% and %Exicmer%Laser%) and did not identify any reports associated with the Elana Arteriotomy KitHUD. A second MAUDE search was performed using Manufacturer name (Variations of %Elana%) which also did not identify any reports associated with the Elana device. Based on these MAUDE searches, there are currently no MDRs within the MAUDE database associated with the Elana device.
 
Miyamoto and colleagues documented a multi-centered, prospective, randomized, controlled trial conducted by 22 institutes in Japan. Adult patients with moyamoya disease who had experienced intracranial hemorrhage within the preceding year were given either conservative care or bilateral extracranial-intracranial direct bypass and were observed for 5 years. Primary and secondary end points were defined as all adverse events and rebleeding attacks, respectively. Eighty patients were enrolled (surgical, 42; nonsurgical, 38). Adverse events causing significant morbidity were observed in 6 patients in the surgical group (14.3%) and 13 patients in the nonsurgical group (34.2%). Kaplan-Meier survival analysis revealed significant differences between the 2 groups (3.2%/y versus 8.2%/y; P=0.048). The hazard ratio of the surgical group calculated by Cox regression analysis was 0.391 (95% confidence interval, 0.148-1.029). Rebleeding attacks were observed in 5 patients in the surgical group (11.9%) and 12 in the nonsurgical group (31.6%), significantly different in the Kaplan-Meier survival analysis (2.7%/y versus 7.6%/y; P=0.042). The hazard ratio of the surgical group was 0.355 (95% confidence interval, 0.125-1.009).
 
2018 Update
A literature search was conducted through September 2018.  There was no new information identified that would prompt a change in the coverage statement.  

CPT/HCPCS:
61711Anastomosis, arterial, extracranial-intracranial (eg, middle cerebral/cortical) arteries

References: Abla AA, Lawton MT.(2014) Anterior cerebral artery bypass for complex aneurysms: an experience with intracranial-intracranial reconstruction and review of bypass options. J Neurosurg. 2014 Jun;120(6):1364-77.

Alexander MJ, Perna J.(2005) Endoscopic saphenous vein graft harvest for estracranial-intracranial bypass procedures. Surg Neurol 2005; 63(6):565-8.

Amin-Hanjani S, Charbel FT.(2006) Is extracranial-intracranial bypass surgery effective in certain patients? Neurologic Clin, 2006; 24:729-43.

Awad IA, Spetzler RF.(1986) Extracranial-intracranial bypass surgery: a critical analysis in light of the International Cooperative Study. Neurosurgery 1986; 19:655-664.

Carotid Occlusion Surgery Study. Clinical Trials.gov; 2002.

Chen Q, Qi R, Cheng X, Zhou C et al.(2014) Assessment of extracranial-intracranial bypass in Moyamoya disease using 3T time-of-flight MR angiography: comparison with CT angiography. Vasa. 2014 Jul;43(4):278-83. doi: 10.1024/0301-1526/a000363

De Rango P, Brown MM, leys D et al.(2013) Management of carotid stenosis in women: consensus document. Neurology 2013; 80(24):dd58-68.

Derdeyn CP, Gage BF, Grubb RL, et al.(2000) Cost-effectiveness analysis of therapy for symptomatic carotid occlusion: PET screening before selective extracranial-to-intracranial bypass versus medical treatment. J Nucl Med 2000; 41:800-07.

FDA(2014) FDA Executive Summary Prepared for the September 23, 2014 meeting of the Pediatric Advisory Committee H080005 Elana, Inc. Elana Surgical KitHUD http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/pediatricadvisorycommittee/ucm413884.pdf

Grubb RL Jr.(2004) Extracranial-intracranial artrial bypass for treatment of occlusion of the internal carotid artery. Curr Neurol Neurosci Rep 2004; 4(1):23-30.

Grubb RL, Powers WJ.(2001) Risks of stroke and current indications for cerebral revascularization in patients with carotid occlusion. Neurosurg Clin N Am 2001; 12:613-24.

Hallemeier CL, Rich KM, et al.(2006) Clinical features and outcomes in North American adults with moyamoya phenomenon. Stroke, 2006; 37:1490-6.

Haynes RB, Mukherjee J, Sackett DL, et al.(1987) Functional status changes following medical or surgical treatment for cerebral ischemia. Results of the extracranial-intracranial bypass study. JAMA 1987; 257:2043-46.

Houkin K, Kamiyama H, et al.(1996) Surgical therapy for adult moyamoya disease. Can surgical revascularization prevent the recurrence of intracerebral hemorrhage. Stroke, 1996; 27:1342-6.

Jennett B.(1989) Surgery to prevent stroke. High hopes and deep disappointment. Int J Technol Assess Health Care 1989; 5:443-57.

Mendelowitsch A, Taussky P, Rem JA, et al.(2004) Clinical outcome of standard extracranial-intracranial bypass surgery in patients with symptomatic atherosclerotic occlusion of the internal carotid artery. Acta Neurochir (Wien) 2004; Feb; 146(2):95-101.

Miyamoto S, Yoshimoto T, Hashimoto N, et al.(2014) Effects of extracranial-intracranial bypass for patients with hemorrhagic moyamoya disease: results of the Japan Adult Moyamoya Trial. Stroke. 2014 May;45(5):1415-21.

Neff KW, Horn P, Dinter D, et al.(2004) Extracranial-intracranial arterial bypass surgery improves total brain blood supply in selected symptomatic patients with unilateral internal carotid artery occlusion and insufficient collaterization. Neuroradiology 2004; 46(9):730-7.

Powers WJ, Clark MR, Grubb RL, et al.(2011) Extracranial-intracranial bypass surgery for stroke prevention in hemodynamic cerebral ischemia: The Carotid Occlusion Surgery Study Randomized Trial. JAMA 2011 Nov 9; 306:1983-1992.

Sasoh M, Ogasawara K, Kuroda K, et al.(2003) Effects of EC-IC bypass surgery on cognitive impairment in patients with hemodynamic cerebral ischemia. Surg Neurol 2003;59(6):455-60.

The EC/IC Bypass Group, Barnett HJM, Sackett DL, Taylor DW, et al.(1985) Failure of extracranial-intracranial artery bypass to reduce the risk of ischemic stroke. Results of an international randomized trial. NEJM 1985; 313:1191-1200.

the Japan Adult Moyamoya Trial Group.(2004) Study design for a prospective randomized trial of extracranial-intracranial bypass surgery for adults with moyamoya disease and hemorrhagic onset. Neurologia Medico-Chirurgica 2004; 44(4):218-9.

Tummala RP, Chu RM, Nussbaum ES.(2003) Extracranial-intracranial bypass for symjptomatic occlusive cerebrovascular disease not amenable to carotid endarterectomy. Neurosurg Focus 2003; 14(3):e8.

van Doormaal TP, van der Zwan A, Redegeld S, et al.(2011) Patency, flow, and endothelialization of the sutureless Excimer Laser Assisted Non-occlusive Anastomosis (ELANA) technique in a pig model. J Neurosurg. 2011 Dec;115(6):1221-30. Epub 2011 Jul 22.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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