National Medical Policy Subject:

Endovascular Stent-graft Repair of Infrarenal Abdominal Aortic Aneurysm (AAA)

Policy Number:

NMP25

Effective Date*: September 2003 Updated:

October 2015

This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State's Medicaid manual(s), publication(s), citations(s) and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use

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Source National Coverage Determination (NCD) National Coverage Manual Citation Local Coverage Determination (LCD)*

Reference/Website Link

Non-coronary Vascular Stents:

http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx

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Article (Local)* Other None

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Instructions  Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions.  Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under “Reference/Website” and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2)

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 

If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance.

Current Policy Statement Health Net, Inc. considers elective endovascular repair of infrarenal abdominal aortic aneurysms (AAAs) and aortoiliac aneurysms medically necessary in patients with adequate iliac/femoral access and a reasonable life expectancy (> 1 year life expectancy) who meet all of the following: 1. Patient is > 65 years of age or, if < 65 years of age, represents a substantial operative risk because of severe medical co-morbidites; and 2. An abdominal aortic aneurysm meeting any of the following criteria: 

Aneurysm diameter of > 5.0 cm documented by ultrasound, conventional CT or spiral CT; or

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Aneurysm diameter of 4 to 4.9 cm with a documented expansion of > 0.5 cm in six months or > 1.0 cm in 12 months documented by ultrasound, conventional CT or spiral CT; or

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Aneurysm which is twice the diameter of the non-dilated proximal infrarenal neck documented by ultrasound, conventional CT or spiral CT; or

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A symptomatic AAA with pending rupture; and

3. Patient has all of the following suitable aneurysm morphology: 

Proximal neck diameter of 30mm or less; and

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Infrarenal non-aneurysmal neck length of greater than 1 cm at the proximal and distal ends of the aneurysm; and

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An inner vessel diameter approximately 10 to 20% smaller than the labeled device diameter; and

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An aortic neck angle < 45 degrees; and

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For aorto-iliac bypass, an iliac seal length of > 25 mm

OR 4. Any AAA with a > 3.0 cm aneurysmal iliac component Note: The catheter for endovascular grafting must be FDA approved (i.e., AneuRx, Ancure, Excluder). A vascular surgery team must be available at the institution performing endovascular grafting in the event that conversion to open surgical repair is required.

Investigational Health Net inc., considers the use of fenestrated endovascular stent graft devices (e.g. Zenith Fenestrated AAA Endovascular Graft) investigational due to insufficient data on the long-term safety and effectiveness of this device.

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Additional treatment after endovascular treatment should be strongly considered with any of the following complications: 1. Aneurysm growth > 5 mm ( or out leak) since last follow-up 2. Change in aneurysm pulsatility (or out growth or leak) 3. The appearance of a new endoleak 4. Evidence of perigraft flow 5. Persistent endoleak or out aneurysm growth 6. Stent-graft migration resulting in an inadequate seal zone Contraindications:                   



Ruptured AAAs Dissecting AAAs Distally embolizing aneurysms Inflammatory aneurysms Juxtarenal AAA Pararenal AAA Suprarenal or thoracoabdominal aneurysms An aortic neck angle > 45 degrees An iliac seal length of < 25 mm Less than 18 years old Presence of heavy circumferential calcification Iliac artery is severely tortuous and calcified Connective tissue disorder Hypercoagulability Mesenteric artery occlusive disease Morbidly obese patients whose weight exceeds 350 lbs (150 kg) because it may impede accurate fluoroscopic imaging Pregnant or nursing Active systemic infection Sensitivities or allergies to the device materials, which include polyethyleneterephthalete (PET), nickel, titanium, tantalum, stainless steel, polyetheresterblock-copolymer (Hytrel), polyetherblockamide (Pebax), polyetheretherketone (PEEK), platinum, ethyl cyanoacrylate, poly (methyl methacrylate), and hydroquinone. Preexisting renal insufficiency because use of this device requires administration of radiographic agents

Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures will be replaced by ICD-10 code sets. Health Net National Medical Policies will now include the preliminary ICD-10 codes in preparation for this

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transition. Please note that these may not be the final versions of the codes and that will not be accepted for billing or payment purposes until the October 1, 2015 implementation date.

ICD-9 Codes 441.01 441.2 901.0

Dissection of thoracic aorta Thoracic aneurysm without mention of rupture Injury to thoracic aorta

ICD-10 Codes I71.Ø1 I71.2 S25.ØØX-S25.09X

Dissection of thoracic aorta Thoracic aortic aneurysm, without rupture Unspecified injury of thoracic aorta, (initial, subsequent encounter or sequela)

CPT Codes 34800 34802 34803 34804 34805 34808 34812 34813 34820 34825 34826 34830 34831 34832 34833 34834 34841

Endovascular repair of infrarenal abdominal aortic aneurysm or dissection; using aorto-aortic tube prosthesis using modular bifurcated prosthesis (one docking limb) Endovascular repair of infrarenal abdominal aortic aneurysm or dissection; using modular bifurcated prosthesis (two docking limbs) using unibody bifurcated prosthesis Endovascular repair of infrarenal abdominal aortic aneurysm or dissection; using aorto-uniiliac or aorto-unifemoral prosthesis Endovascular placement of iliac artery occlusion device Open femoral artery exposure for delivery of aortic endovascular prosthesis, by groin incision, unilateral Placement of femoral-femoral prosthetic graft during endovascular aortic aneurysm repair Open iliac artery exposure for delivery of endovascular prosthesis or iliac occlusion during endovascular therapy, by abdominal or retroperitoneal incision, unilateral Placement of proximal or distal extension prosthesis for endovascular repair of infrarenal abdominal aortic or iliac aneurysm, false aneurysm, or dissection; initial vessel each additional vessel Open repair of infrarenal aortic aneurysm of dissection, plus repair of associated arterial trauma, following unsuccessful endovascular repair; tube prosthesis aorto-bi-iliac prosthesis aorto-bifemoral prosthesis Open iliac artery exposure creation of conduit for delivery of infrarenal aortic or iliac endovascular prosthesis, by abdominal or retroperitoneal incision, unilateral Open brachial artery exposure to assist in the deployment of infrarenal aortic or iliac endovascular prosthesis by arm incision, unilateral Endovascular repair of visceral aorta (e.g., aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) by deployment of a fenestrated visceral aortic endograft and all associated

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34842

34843

34844

34845

34846

34847

radiological supervision and interpretation, including target zone angioplasty, when performed; including one visceral artery endoprosthesis (superior mesenteric, celiac or renal artery) Endovascular repair of visceral aorta (e.g., aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) by deployment of a fenestrated visceral aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including two visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery(s) Endovascular repair of visceral aorta (e.g., aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) by deployment of a fenestrated visceral aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including three visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery(s) Endovascular repair of visceral aorta (e.g., aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) by deployment of a fenestrated visceral aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including four or more visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery(s) Endovascular repair of visceral aorta and infrarenal abdominal aorta (e.g., aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) with a fenestrated visceral aortic endograft and concomitant unibody or modular infrarenal aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including one visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery(s) Endovascular repair of visceral aorta and infrarenal abdominal aorta (e.g., aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) with a fenestrated visceral aortic endograft and concomitant unibody or modular infrarenal aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including two visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery(s) Endovascular repair of visceral aorta and infrarenal abdominal aorta (e.g., aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) with a fenestrated visceral aortic endograft and concomitant unibody or modular infrarenal aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including

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34848

34900 36140 36200 36245 36246 36247 75952 75953 0078T 0079T 0080T 0081T

three visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery(s) Endovascular repair of visceral aorta and infrarenal abdominal aorta (e.g., aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption) with a fenestrated visceral aortic endograft and concomitant unibody or modular infrarenal aortic endograft and all associated radiological supervision and interpretation, including target zone angioplasty, when performed; including four or more visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery(s) Endovascular repair of iliac artery (eg, aneurysm, pseudoaneurysm, arteriovenous malformation, trauma), using ilio-iliac tube endoprosthesis Introduction of needle or intracatheter; extremity artery Introduction of catheter, aorta Selective catheter placement, arterial system; each first order abdominal, pelvic or lower extremity artery branch, within a vascular family initial second order abdominal, pelvic or lower extremity artery branch, within a vascular family initial third order or more selective abdominal, pelvic, or lower extremity artery branch, within a vascular family Endovascular repair of infrarenal abdominal aortic aneurysm or dissection, radiological supervision and interpretation Placement of proximal or distal extension prosthesis for endovascular repair or infrarenal abdominal aortic aneurysm, radiological supervision and interpretation Endovascular repair of abdominal aortic aneurysm, pseudoaneurysm or dissection. (code deleted 12/2013) Placement of visceral extension prosthesis for endovascular repair of abdominal aortic aneurysm involving visceral vessels, each visceral branch. (code deleted 12/2013) Endovascular repair of abdominal aortic aneurysm, pseudoaneurysm or dissection involving visceral vessels using fenestrated bifurcated prosthesis. (code deleted 12/2013) Placement of visceral extension prosthesis for endovascular repair of abdominal aortic aneurysm involving visceral vessels, radiologic supervison and interpretation. (code deleted 12/2013)

HCPCS Codes N/A

Scientific Rationale – Update October 2015 The Zenith Fenestrated AAA Endovascular Graft is FDA approved and indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms that have an infrarenal aortic neck at least 4 mm in length. The device is proposed to provide an endovascular treatment option for some patients with abdominal aortic aneurysms who are not suitable for treatment with a currently-approved endovascular graft. Per the FDA approval:

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The Zenith Fenestrated AAA Endovascular Graft (Cook Inc) is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair, including: 

Adequate iliac/femoral access compatible with required introduction systems



Nonaneurysmal infrarenal aortic segment (neck) proximal to the aneurysms with:  Length >4 mm and unsuitable for a non-fenestrated graft  Diameter 19 mm  Angle 30 mm in length and between 7 – 21mm in diameter

Unlike the standard Zenith AAA Endovascular Graft, the Zenith Fenestrated AAA Endovascular Graft has fenestrations or scallops in the graft material, which allow the proximal edge of graft material to be placed above the renal arteries while still permitting blood flow to vessels accommodated by the fenestrations or scallops. In order to account for anatomical variation, each proximal body graft is made to order for a specific patient. The FDA based its approval of the device on a clinical study initially approved for 30 patients and use of available balloon-expandable stents in combination with the Fenestrated Graft. Following completion of the initial 30 patient enrollment, the study hypothesis and requirements for approval were agreed upon. The study was then expanded to include the Zenith Alignment Stent and enrollment of 12 additional patients, thus providing 42 total patients, which was the pre-specified study sample size. Patients were treated between January 2005 and August 2010. The database for the PMA supplement reflected data collected through June 2011 and included 42 patients. There were 7 investigational sites. The study was a prospective, multicenter, two-armed clinical study. One study arm consisted of investigational patients implanted with the Zenith Fenestrated AAA Endovascular Graft and the second arm consisted of historical, case- matched controls treated with the standard Zenith AAA Endovascular Graft. According to the FDA approval, the manufacturer must perform a post approval study. This prospective, observational, single-arm study will consist of continued follow-up of the premarket cohort, as well as newly enrolled subjects, and patients will be followed annually. The primary endpoint of the study is aneurysm-related mortality at 5 years. Aneurysm-related mortality is defined as:”Death from aneurysm rupture through 5 years; death from any cause occurring within 30 days of the initial procedure or a secondary intervention; or any death determined to be related to the aneurysm or its treatment.” Additional study endpoints will include rupture, conversion, morbidity, device integrity, device patency, changes in aneurysm size, endoleak, migration, and secondary interventions. In addition, the study will evaluate your training plan effectiveness as measured by the composite freedom from the following events at 30 days in up to the first 3patients from each site: technical failure, loss of patency (by core lab analysis), rupture, secondary intervention, conversion, and Type I or III endoleak (by core lab analysis).

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In order to evaluate the hypothesis for 5-year aneurysm related mortality 70 patients are needed to determine if the performance goal of 18% has been met. Allowing for 14% of patients who may withdraw or become lost to follow-up and 6 additional patients that refused to consent for long-term follow-up in the preapproval study, the total PAS number of enrolled subjects will be 88. The study population will consist of patients enrolled in the premarket study and de novo patients. Information on clinical outcomes is expected to be collected annually through 5 years post-procedure on at least 80% of patients enrolled (excluding those discontinued due to death). In addition, the manufacturer is required to perform “Evaluation of training program” :The study must be conducted as per agreement reached on April 2, 2012. This prospective, observational, single-arm registry study will consist of the evaluation of de novo subjects who have been treated by physicians who completed your training program. The primary endpoint for this study is technical success. Technical success is defined as: “Successfully completed procedure with endograft patency, preservation of all vessels targeted by fenestrations, and no Type I or II endoleaks at the time of deployment completion.” The study population will consist of the first patients (2 max) treated by at least 41 investigators who have completed the commercial training program. The rate of technical success in the registry will be statistically compared to a performance goal of 80%. The sample size for this study will be 82 subjects. Please be advised that the results from these studies should be included in the Peer review published literature evaluating the Zenith Fenestrated AAA Endovascular Graft is limited. Oderich et al (2014) reported the results of a prospective, multicenter trial designed to evaluate the safety and effectiveness of the Zenith fenestrated endovascular graft (Cook Medical, Bloomington, Ind) for treatment of juxtarenal abdominal aortic aneurysms (AAAs). Sixty-seven patients with juxtarenal AAAs were prospectively enrolled in 14 centers in the United States from 2005 to 2012. Custom-made fenestrated stent grafts were designed with one to three fenestrations on the basis of analysis of computed tomography data sets. Renal alignment was performed with balloon-expandable stents. Follow-up included clinical examination, laboratory studies, mesenteric-renal duplex ultrasound, abdominal radiography, and computed tomography imaging at hospital discharge and at 1 month, 6 months, and 12 months and yearly thereafter up to 5 years. There were 54 male and 13 female patients with a mean age of 74 ± 8 years enrolled. Mean aneurysm diameter was 60 ± 10 mm. A total of 178 visceral arteries required incorporation with small fenestrations in 118, scallops in 51, and large fenestrations in nine. Of these, all 118 small fenestrations (100%), eight of the scallops (16%), and one of the large fenestrations (11%) were aligned by stents. Technical success was 100%. There was one postoperative death within 30 days (1.5%). Mean length of hospital stay was 3.3 ± 2.1 days. No aneurysm ruptures or conversions were noted during a mean follow-up of 37 ± 17 months (range, 3-65 months). Two patients (3%) had migration ≥ 10 mm with no endoleak, both due to cranial progression of aortic disease. Of a total of 129 renal arteries targeted by a fenestration, there were four (3%) renal artery occlusions and 12 (9%) stenoses. Fifteen patients (22%) required secondary interventions for renal artery stenosis/occlusion in 11 patients, type II endoleak in three patients, and type I endoleak in one patient. At 5 years, patient survival was 91% ± 4%, and freedom from major adverse events was 79% ± 6%; primary and secondary patency of targeted renal arteries was 81% ± 5% and 97% ± 2%, freedom from renal function deterioration was 91% ± 5%, and freedom from secondary interventions was 63% ± 9%. The authors concluded the prospective study demonstrated that endovascular repair of juxtarenal AAAs with the Zenith fenestrated AAA stent graft is safe and

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effective. Mortality and morbidity are low in properly selected patients treated in centers with experience in these procedures. Canning et al (2015) reported that fenestrated endovascular aneurysm repair (FEVAR) provides an endovascular solution for patients with large abdominal aortic aneurysms and challenging neck anatomy in addition to repair of endoleaks and pseudoaneurysms. The authors reported the midterm outcomes of FEVAR from a single-tertiary referral centre in Ireland. From 2006 to 2012, nine consecutive asymptomatic patients with neck anatomy unfavorable for standard EVAR underwent endovascular repair with a customized fenestrated Zenith stent graft. An additional three patients had fenestrated grafts for repair of pseudoaneurysms (n = 2) following open AAA repair and a type I endoleak (n = 1). All patients were prospectively enrolled in a computerised database. Outcomes including mortality, morbidity, renal function, target vessel patency, endoleak and reintervention were analysed. The mean age and aneurysm size in the primary repair group were 74 years (65-84 years) and 6 cm (5-8.3 cm), respectively, and in the secondary repair group, the mean age was 66 years (61-75 years). No procedures required open conversion, and no visceral arteries were lost. On completion angiography, two patients in group 1 had a type I endoleak and one had a type III endoleak. There were no endoleaks in the secondary repair group. Follow-up ranged from 30 days to 6 years. There was one death within 30 days (8 %) and two deaths at 3 years from non-aneurysm-related causes. Six patients required secondary interventions. Three patients had a transient post-operative creatinine rise of >30 %. The authors oncluded the study supports FEVAR as a feasible and effective therapy in the management of patients with complex aortic aneurysms. Kitagawa et al (2013) reported the early clinical outcomes and experiences of Zenith pivot branch device (p-branch) standard fenestrated endovascular graft (Cook, Bloomington, Ind) for treating juxtarenal AAA originating below the superior mesenteric artery (SMA). A physician-sponsored investigational device exemption study was used to assess enrolled elective and emergency patients from August 2011 to September 2012 for treatment with an off-the-shelf Zenith p-branch device. Patients were included provided an anatomic seal could be established 4 mm below the SMA and the renal geometry fit the protocol based on reconstructed computed tomography data. The celiac artery was addressed with a scallop and the SMA with an 8-mm fenestration. The renal fenestrations were constructed as a modified design to allow a range of renal locations (7.5 mm radially from the center of the fenestration) to be acceptably treated with a single configuration. Two anatomic configurations were created for renal arteries (origins at the same level, or disparate renal arteries with left lower than right). Outcomes are reported in coherence with endovascular reporting standards documents. The study enrolled 16 patients (94% men; median age, 75 years [range, 59-87 years]) with a mean aneurysm size of 61 mm (range, 52-82 mm). Two were treated for aneurysm rupture. Technical success was achieved in all patients. The median fluoroscopy time was 62 minutes (range, 38-105 minutes), and the amount of contrast media was 69 mL (range, 31-121 mL). There were no aortic-related deaths, aneurysm ruptures, open surgical conversion, or type I/III endoleaks. One right renal artery occluded during follow-up in the setting of a conically shaped visceral aortic segment and was successfully treated with endovascular recanalization. The authors concluded the use of the p-branch device for aneurysms originating infra-SMA is associated with a high rate of technical success and minimal problems during the short follow-up duration. The off-the-shelf design allows for the treatment of ruptures and other urgent situations. Additional

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patients and more follow-up will be required to further define the risks and benefits of such a treatment strategy. England et al (2013) reported the incidence, timing, and related sequelae for proximal and distal migration of the Zenith Fenestrated AAA Endovascular Graft (Cook Medical, Bloomington, Ind) used to treat abdominal aortic aneurysms. A prospectively maintained database at a tertiary referral hospital was used to identify 83 patients who underwent endovascular repair using the Zenith fenestrated stent graft. Inclusion criteria included a postoperative computed tomography (CT) scan within 6 weeks of implantation and at least one additional follow-up CT scan (>5 months) available electronically at the single institution. Eligible patients underwent assessment of stent graft migration using a CT-based central luminal line (CLL) technique. The proximal and distal margins of the stent graft were measured using CLLs relative to vascular landmarks on all available follow-up CT scans. Migration was defined as stent graft movement ≥4 mm. Fifty-five patients were included in this study, mean age was 74 ± 7 years, and 89% were men. Mean preoperative aneurysm diameter was 67 ± 9 mm. In these 55 patients, fenestrations were applied to 162 target vessels with the commonest design accommodating two renal arteries (RAs) and the superior mesenteric artery (SMA). Median follow-up was 24 (range, 597) months; 80% of patients (n = 44) had both the proximal and two distal attachment sites assessed for evidence of migration. Twelve iliac limbs in 11 patients were excluded from analysis due to occlusion of one internal iliac artery precluding CLL assessment (n = 7), or image quality issues (n = 5). Using CLLs and based on those patients who exhibited migration, the median proximal and distal migration distances were +5.0 (range, +4.0 to +8.1) mm and -5.0 (range, -4.3 to -21.3) mm, respectively. Kaplan-Meier analysis for proximal migration revealed migration rates of 14% and 22% at 12 and 36 months, respectively. Distal migration rates were lower at 3% and 8%, respectively. There have been no incidences of late rupture or open conversion. Of the patients with proximal migration, two patients lost a single target vessel (two RAs) and three patients were reported to have target vessel stenosis (two SMAs, one RA). These cases did not require reintervention. The authors concluded both suprarenal fabric extension and visceral artery stenting are known to provide additional fixation for fenestrated aortic stent grafts. Despite this, minor proximal migration still occurs in up to one quarter of fenestrated endovascular repair patients by 4 years. We believe this is mainly due to the engagement of the barbs of the anchoring stent. Distal migrations occur with lower frequency. Greenberg et al (2009) reported the intermediate-term (24-month) outcomes of a prospective multicenter trial designed to evaluate the Zenith Fenestrated AAA Endovascular Graft (Cook Medical, Bloomington, Ind) for treating juxtarenal abdominal aortic aneurysms with short proximal necks. The study goals were to evaluate the safety and preliminary effectiveness of the device and refine patient selection criteria. Five centers in the United States enrolled 30 patients with juxtarenal aortic aneurysms with >or=50-mm diameter and short proximal necks. Devices were custom-designed for each patient based on measurements from reconstructed computed tomography (CT) data. Follow-up studies included physical examinations, laboratory studies, CT imaging, mesenteric-renal duplex ultrasound imaging, and abdominal flat plate radiographs at hospital discharge, at 1, 6, and 12 months, and yearly thereafter up to 5 years. During a 1-year period, 30 patients (80% men; mean age, 75 years) with a mean aneurysm size of 61.4 mm were enrolled. In these 30 patients, 77 visceral vessels were accommodated by fenestrations located within the sealing segment of the grafts. The most common

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design accommodated two renal arteries and the superior mesenteric artery (66.7%). All prostheses were implanted successfully. No visceral arteries were lost. Of the 30 patients treated, 27 were available for 12-month follow-up and 23 were available for 24-month follow-up. No aneurysm-related deaths, aneurysm ruptures, or conversions were observed through 24 months of follow-up. No type I or type III endoleaks were observed. Type II endoleaks were noted in six (26.1%) at 12 months and four (20.0%) at 24 months. No patients had aneurysm growth >5 mm. Aneurysm size decreased in 16 of 23 (69.6%) and was stable in the remaining patients at 24 months. Eight patients experienced a renal event (4 renal artery stenoses, 2 renal artery occlusions, and 2 renal infarcts). Five underwent secondary interventions. No renal failure developed requiring dialysis. The authors concluded the intermediate-term (24-month) results of the 30 patients in this multicenter study are concordant with previous single-center studies and support the concept that placement of fenestrated endovascular grafts is safe and effective at centers with experience in endovascular repair and renal/mesenteric stent placement. Several clinical trials evaluating fenestrated endovascular graft were identified on the clinicaltrial.gov website. For example, A Clinical Trial, “Fenestrated AAA Endovascular Graft Post-Approval Study” (NCT01990950) sponsored by Cook Inc, is ongoing but no longer recruiting participants. Another clinical trial sponsored by Cook Inc that is ongoing and no longer recruiting participants, “Zenith p-Branch and Zenith Fenestrated AAA Endovascular Graft Clinical Study (FENP)”, (NCT0165235), will study the safety and effectiveness of the Zenith p-Branch and Zenith Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic aneurysms. Another trial recruiting participants also sponsored by Cook Inc. (NCT01937949), “Complex Aortic Aneurysm Repair With Fenestrated Stent Grafts”, will compare two groups of subjects with complex abdominal aortic aneurysms. It will compare their clinical outcomes and quality of life measures. The group being treated in this study will have their aneurysms repaired by an endovascular approach using Zenith Fenestrated AAA Endovascular Graft. This group will be compared to a group of 461 patients (historical cohort) whose complex aneurysms were treated by open surgical repair.

Scientific Rationale – Update October 2014 Liu et al (2014) compared the perioperative outcome after endovascular repair (EVAR) of symptomatic abdominal aneurysms (S-AAAs) and elective nonsymptomatic AAAs (E-AAAs). From January 2008 to February 2013, a total of 230 non-ruptured AAA patients treated by EVAR met the inclusion criteria. S-AAAs were present in 43 (18.7%) patients, 40 patients were male, 3 patients were female, aged (69 ± 10) years and E-AAAs in 187 (81.3%) patients, 162 of which were male, the other 25 patients were female, aged (71 ± 9) years. Patients were followed up at 1 month after EVAR. The primary outcome of the study was perioperative mortality, secondary outcome included procedural data and major perioperative adverse events. At baseline, there were no differences in age, gender, American Society of Anesthesiologists classification score, and basic diseases. S-AAA patients had larger aneurysms on average (6.00 (1.97) cm vs. 5.10 (1.7) cm, Z = 2.51, P = 0.01). SAAA patients had shorter preoperative hospitalization (5.00 (5.0) days vs. 7.00 (4.0) days, Z = 1.86, P = 0.02). No differences in the perioperative mortality, respectively, 0 and 1.1% (P = 0.66). Technical success and clinical success were all 100% and the other procedure data was similar (P > 0.05). The occurrence of major adverse events, including mortality, within the 30-day after EVAR were similar between SAAA and E-AAA patients (0 vs. 2.1%, P = 0.43). The authors concluded there is no difference in perioperative outcome between S-AAA and elective E-AAA patients

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treated by EVAR. More study is needed to compare the middle and long-outcome between S-AAAs and E-AAAs after EVAR. Siracuse et al (2014) assessed perioperative outcomes of endovascular AAA repair (EVAR) and open surgical repair (OSR) in low-risk patients. Patients undergoing EVAR and OSR for infrarenal AAAs were identified in the 2007 to 2010 National Surgical Quality Improvement Program data sets. AAA-specific risk stratification, by the Medicare aneurysm scoring system, was used to create matched low-risk (score 150% of the size of the non-dilated proximal aortic segment, most often in the infrarenal portion. An estimated 1.5 million people in the United States have abdominal aortic aneurysms (AAAs) with more than 200,000 American diagnosed each year. The natural history of AAAs is to expand and rupture, accounting for an estimated 15,000 deaths per year. Thus, the major impetus for AAA repair is for prophylaxis against aneurysm-related death. The standard open surgical repair of AAAs is a well-established and durable procedure. However, as with all other major abdominal surgical operations, associated significant morbidity and mortality exist, along with prolonged recovery and various late complications. Furthermore, both mortality and morbidity increase significantly with advanced patient age and associated co-morbid disease states. As the incidence of AAA increases with age (34% in individuals aged 65 to 80 years are cited in the medical literature), it is recommended that asymptomatic males over 65 years of age, especially hypertensives, be screened for AAA on an annual basis using ultrasound. This has been shown to reduce mortality associated with rupture by 70%. Patients with small aneurysms should undergo regular surveillance, with repeated ultrasound every 6 months. Major complications of abdominal aortic aneurysm include rupture and dissection. The risk of rupture increases as the aneurysm expands. Overall, only 15% aneurysms ever rupture, but the 5 year risk of rupture are: 25% for 5.0 – 5.9 cm, 35% for 6.0 – 6.9 cm, and more than 75% for 7 cm or higher. Rupture is associated with high pre- and peri-operative mortality greater than 50%. Decision-making in regard to elective repair of abdominal aortic aneurysms (AAA) requires careful assessment of factors that influence rupture risk, operative mortality, and life expectancy. Individualized consideration of these factors in each patient is essential, and the role of patient preference is becoming of increasing importance. When warranted by the size, symptoms, or rate of expansion of the aneurysm, the existing standard of care is elective open surgical repair with replacement of the affected aortic segment with an inlay prosthetic graft. This may be approached transperitoneally, although the retroperitoneal approach is favored by some

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surgeons. The goal of surgical treatment is to prevent rupture. Such is best met in an elective procedure on a good surgical candidate with an asymptomatic AAA measuring 5.0 cm or more in diameter. Operating on smaller AAAs offers no longterm survival advantage over ultrasound surveillance, unless they are rapidly expanding in size. AAAs measuring less than 3.5 cm should be monitored by ultrasound yearly, and larger aneurysms, every 6 months. Very high-risk surgical patients should be monitored until the AAA is larger than 7.0 cm or becomes symptomatic, especially if endovascular repair is not possible. With intensive perioperative monitoring, even high-risk patients have undergone AAA repair with an operative mortality rate of less than 5%. Endovascular repair of abdominal aortic aneurysms with stent-grafts is a relatively new image-guided, catheter-based approach that provides a valuable alternative to standard open surgical repair, particularly in high-risk patients. The ultimate goal remains the same - complete exclusion of the aneurysm sac to prevent rupture. A stent-graft is an intraluminal device that consists of a supporting metal framework and synthetic graft material that is either self-expanding or balloon-expandable. Percutaneous delivery is made possible by compacting the device onto a catheter or compressing it into a sheath. The procedure involves the placement of the device in the lumen of the aorta and sometimes the iliac(s) via a femoral artery incision using a specialized delivery system under fluoroscopic guidance. Once the balloonexpandable or self-expandable attachment device is in position, it is released from the carrier and springs open in the aneurysm. The graft is implanted and the stents act to bolster the graft attachments to the proximal and distal necks of the aneurysm. Stent-grafts are available in three basic configurations - tube, bifurcated, and aorta-unilateral designs. Currently there are three devices approved by the FDA, the AneuRx Stent-graft, the Ancure Endograft and the Excluder. The primary sources of clinical evidence are the pivotal trials supporting FDA approval for each of these devices. In addition, several other stent-grafts are in development. About 60% of patients with abdominal aortic aneurysms are eligible for endovascular stent-graft repair. Most importantly, patients with extensive comorbid medical illnesses previously considered unsuitable for open repair and patients with a hostile abdomen or other technical factors that may complicate standard open repair can often receive treatment for aneurysms with endovascular techniques. Proper preprocedural imaging by the radiologist is an absolute necessity. This includes an intravenous contrast-enhanced computed tomographic (CT) scan and conventional angiography for the evaluation of the morphologic features of the aneurysm and branch vessels. Strict guidelines for patient eligibility depend on vascular anatomy. In more than 95% of procedures, successful insertion of an aortic stent-graft is possible. The most common cause of a failed procedure is the inability to insert the delivery device through diseased or tortuous iliac arteries. Endovascular repair has a number of advantages over open surgical techniques. The stent-graft procedure is less stressful to the patient and results in less blood loss and therefore fewer blood transfusions. If general anesthesia is used, the time to extubation is markedly reduced, stays in the intensive care unit are shorter, and ambulation without assistance occurs earlier. In most cases, patients quickly return to a regular diet, and hospital stay is reduced by two thirds. In large studies of stentgrafts, 30-day mortality rates ranged from 0.7% in low-risk populations to 15.7% in high-risk patients. This compares favorably with those associated with open surgical repair. Significant differences in the magnitude of complications were seen in patients having endovascular repair compared with those undergoing open surgery.

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Morbidity rates have been reported at 23% for surgery and 12% for endovascular repair. Death during the stent-graft procedure is rare, but complications do occur. Delayed rupture of abdominal aortic aneurysm has been a concern. However, results of endovascular repair in 669 patients showed that rupture also is rare, with an incidence of 0.4% over 4.5 years. Immediate aneurysm exclusion ranges from 66% to 87%, which compares poorly with results of the open surgical technique and its nearly 100% rate of exclusion. Follow-up studies performed in some patients who have undergone endovascular AAA treatment show progressive and clinically significant dilatation of untreated vascular segments proximal and distal to the graft. Thus, the potential exists for a delayed failure unless the endoprosthesis has the capability to continually expand. One important complication related to the use of endovascular stent-grafts is the problem of endoleaks, defined by persistence of blood flow outside the lumen of the endovascular graft, but within an aneurysm sac or adjacent vascular segment being treated. Endoleaks have been classified into 4 categories: (1) Type I are perigraft leaks, where blood escapes around the cuff of the stent and into the aneurysm; (2) Type II are retrograde endoleaks, where blood flows through collateral arteries in a retrograde fashion into the aneurysmal sac; (3) Type III endoleak is a leak through the graft because of tears, disconnection or disintegration of the fabric; and (4) Type IV endoleak occurs because of increased graft porosity. The occurrence of an endoleak suggests that the procedure has failed to exclude the aneurysm from the circulation. Such failure, especially if systemic arterial pressures are maintained within the aneurysm, may lead to continued expansion and subsequent rupture. Attachment site related endoleaks (Type I) are generally considered to warrant some form of intervention due to the belief that they represent a risk for future rupture. At present, there is little long-term follow-up information about the clinical significance of this type of problem. Therefore, it is unclear whether further intervention is warranted. In addition, more than 50% of endoleaks diagnosed at the time of initial placement of a stent-graft resolve spontaneously and need no further intervention. At present, there is no questions that endovascular repair is the best option in highrisk patients with suitable aneurysm morphology. In “average” patients undergoing endovascular repair, perioperative morbidity and recovery time are clearly reduced; however, there is a higher reintervention rate, increased surveillance burden, and a small but ongoing risk of AAA rupture. There is no justification at present for different indications for endovascular repair, such as earlier treatment of smaller AAA. The questions over the long-term durability of endovascular aneurysm surgery in preventing aneurysm rupture make it unsuitable for young patients. Until long-term outcome of endoluminal repair is better defined and results of randomized trials available, the choice between endovascular and open repair will continue to rely heavily on physician and patient preference. As technology continues to improve on the design of endovascular devices, this will only result in a progressive upward trend of this innovative method.

Review History September 2003 December 2005 January 2008 March 2011 November 2011 October 2012

Medical Advisory Council initial approval Update – no revisions Update – no revisions Update – no revisions Update. Added revised Medicare Table. Update – no revisions

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October 2013 October 2014 October 2015

Update – no revisions. Codes updated. Update – no revisions. Code updates. Update – Added the use of fenestrated endovascular stent graft devices as investigational

This policy is based on the following evidence-based guidelines: 1. 2. 3. 4. 5. 6. 7. 8.

9.

Geller SC and the members of the Society of Interventional Radiology Device Forum Imaging Guidelines for Abdominal Aortic Aneurysm Repair with Endovascular Stent Grafts. Imaging Guidelines for Abdominal Aortic Aneurysm Repair with Endovascular Stent. Grafts J Vasc Interv Radiol 2003; 14:S263–S264. Available at: http://www.sirweb.org/clinical/cpg/S263.pdf Society for Vascular Ultrasound. Vascular Technology Professional Performance Guidelines. 2002. Screening for abdominal aortic aneurysm: recommendation statement. Ann Intern Med 2005 Feb 1;142(3):198-202. National Institute for Health and Clinical Excellence (NICE). Endovascular stent grafts for the treatment of abdominal aortic aneurysm Technology Appraisal 167. London, UK: NICE; 2009 Feb. Available at: http://guidance.nice.org.uk/TA167 Hayes. Medical Technology Directory. Endovascular Repair of Abdominal Aortic Aneurysms. June 18, 2009. Updated June 22, 2012. Updated August 20, 2013. Updated August 2014. Update July 2015 Anderson JL, Halperin JL, Albert NM, et al. Management of patients with peripheral artery disease (compilation of 2005 and 2011 ACCF/AHA guideline recommendations): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;127(13):1425-1443. Walker TG, Kalva SP, Yeddula K, et al. Clinical practice guidelines for endovascular abdominal aortic aneurysm repair: written by the Standards of Practice Committee for the Society of Interventional Radiology and endorsed by the Cardiovascular and Interventional Radiological Society of Europe and the Canadian Interventional Radiology Association. J Vasc Interv Radiol. 2010 Nov;21(11):1632-55. Available at: http://www.sirweb.org/clinical/cpg/QI12.pdf

References – Update October 2015 1. 2. 3. 4. 5.

Canning C, Martin Z, Colgan MP, et al. Fenestrated endovascular repair of complex aortic aneurysms. Ir J Med Sci. 2015 Mar;184(1):249-55. England A, García-Fiñana M, Fisher RK, et al. Migration of fenestrated aortic stent grafts. J Vasc Surg. 2013 Jun;57(6):1543-52. Greenberg RK, Sternbergh WC 3rd, Makaroun M, et al. Intermediate results of a United States multicenter trial of fenestrated endograft repair for juxtarenal abdominal aortic aneurysms. J Vasc Surg. 2009 Oct;50(4):730-737.e1. Kitagawa A, Greenberg RK, Eagleton MJ, Mastracci TM. Zenith p-branch standard fenestrated endovascular graft for juxtarenal abdominal aortic aneurysms. J Vasc Surg. 2013 Aug;58(2):291-300. Oderich GS, Greenberg RK, Farber M, et al. Results of the United States multicenter prospective study evaluating the Zenith fenestrated endovascular graft for treatment of juxtarenal abdominal aortic aneurysms. J Vasc Surg. 2014 Dec;60(6):1420-8.e1-5.

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6. 7.

Zhang T, Jia X, Liu J, et al. Approach and efficacy of endovascular repair for abdominal aortic aneurysm with hostile proximal landing zone. Zhonghua Yi Xue Za Zhi. 2012 Dec 18;92(47):3329-32. U.S. Food and Drug Administration. Summary of Safety and Effectiveness Data. Zenitho Fenestrated AAA Endovascular Graft. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf2/p020018s040b.pdf

References – Update October 2014 1. 2. 3.

4. 5. 6. 7. 8.

9.

Garg T, Baker LC, Mell MW. Adherence to postoperative surveillance guidelines after endovascular aortic aneurysm repair among Medicare beneficiaries. J Vasc Surg. 2014 Jul 31. pii: S0741-5214(14)01294-4. Gupta PK, Ramanan B, Engelbert TL, et al. A comparison of open surgery versus endovascular repair of unstable ruptured abdominal aortic aneurysms. J Vasc Surg. 2014 Aug 4. Hicks CW, Black JH 3rd, Arhuidese I, et al. Early mortality variability after endovascular versus open abdominal aortic aneurysm repair in a large tertiary vascular center using a Medicare-derived risk prediction model. J Vasc Surg. 2014 Aug 21. pii: S0741-5214(14)01412-8. Liu J, Ge Y, Jia X, et al. Comparison of perioperative outcome after endovascular repair between symptomatic and asymptomatic abdominal aortic aneurysm. Zhonghua Wai Ke Za Zhi. 2014 May;52(5):342-5. Park KM, Kim DI, Kim YW, et al. Factors Affecting Anatomical Changes after Endovascular Abdominal Aortic Aneurysm Repair. Thorac Cardiovasc Surg. 2014 Sep 5. Piffaretti G, Mariscalco G, Riva F, et al. Abdominal aortic aneurysm repair: longterm follow-up of endovascular versus open repair. Arch Med Sci. 2014 May 12;10(2):273-82. Siracuse JJ, Gill HL, Graham AR, et al. Comparative safety of endovascular and open surgical repair of abdominal aortic aneurysms in low-risk male patients. J Vasc Surg. 2014 Jun 20. pii: S0741-5214(14)00999-9. Thomas D, Anderson D, Hulten E, et al. Open versus endovascular repair of abdominal aortic aneurysm: Incidence of cardiovascular events in 632 patients in a department of defense cohort over 6-year follow-up. Vascular. 2014 Aug 18. Verzini F, Isernia G, De Rango P, et al. Abdominal aortic endografting beyond the trials: a 15-year single-center experience comparing newer to older generation stent-grafts. J Endovasc Ther. 2014 Jun;21(3):439-47.

References – Update October 2013 1. 2. 3. 4. 5. 6.

de la Motte L, Jensen LP. Endovascular and open repair of abdominal aortic aneurysm are still both warranted -- a systematic review. Ugeskr Laeger. 2012;174(20):1376-1382. Linsen MA, Jongkind V, Nio D, et al. Pararenal aortic aneurysm repair using fenestrated endografts. J Vasc Surg. 2012;56(1):238-246. Cross J, Gurusamy K, Gadhvi V, et al. Fenestrated endovascular aneurysm repair. Br J Surg. 2012;99(2):152-159. Filardo G, Powell JT, Martinez MA, Ballard DJ. Surgery for small asymptomatic abdominal aortic aneurysms. Cochrane Database Syst Rev. 2012;3:CD001835. Lederle FA, Freischlag JA, Kyriakides TC, et al. Long-term comparison of endovascular and open repair of abdominal aortic aneurysm. N Engl J Med. 2012; 367(21):1988-1997. Qadura M, Pervaiz F, Harlock JA, et al. Mortality and reintervention following elective abdominal aortic aneurysm repair. J Vasc Surg. 2013;57(6):1676-1683.

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7.

Reimerink JJ, Hoornweg LL, Vahl AC, et al. Endovascular Repair Versus Open Repair of Ruptured Abdominal Aortic Aneurysms: A Multicenter Randomized Controlled Trial. Ann Surg. 2013; 8. United States Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH): Zenith Fenestrated AAA Endovascular Graft (with the adjunctive Zenith Alignment Stent). Cook, Inc. Summary of Safety and Effectiveness. No. P020018/S040. April 4, 2013. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num= P020018S040. 9. United States Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH): Valiant Thoracic Stent Graft with the Captivia Delivery System, Medtronic Vascular, Inc. Summary of Safety and Effectiveness. No. P100040/S008. October 26, 2012. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num= p100040s008. 10. Wang GJ, Fairman RM. Thoracic endovascular aneurysm repair. UpToDate. May 1, 2012.

References – Update October 2012 1.

2. 3. 4. 5. 6. 7. 8. 9.

Becquemin JP, Pillet JC, Lescalie F, et al. ACE trialists. A randomized controlled trial of endovascular aneurysm repair versus open surgery for abdominal aortic aneurysms in low- to moderate-risk patients. J Vasc Surg. 2011 May;53(5):1167-1173.e1. Epub 2011 Jan 26. Brown LC, Powell JT, Thompson SG, et al. The UK EndoVascular Aneurysm Repair (EVAR) trials: randomised trials of EVAR versus standard therapy. Health Technol Assess 2012; 16:1. Chaer RA. Endovascular repair of abdominal aortic aneurysm. UpToDate. August 3, 2012. Dillavou ED. Surgical and endovascular repair of ruptured abdominal aortic aneurysm. UpToDate. February 14, 2012. Jackson RS, Chang DC, Freischlag JA. Endovascular Repair of Abdominal Aortic Aneurysms. JAMA. 2012 Apr 18;307(15):1621-8. Jim J, Rubin BG, Geraghty PJ, et al. Outcome of endovascular repair of small and large abdominal aortic aneurysms. Ann Vasc Surg. 2011;25(3):306-314. Min SI, Min SK, Ahn S, et al. Comparison of costs of endovascular repair versus open surgical repair for abdominal aortic aneurysm in Korea. J Korean Med Sci 2012; 27:416. Morimae H, Maekawa T, Tamai H, et al. Cost disparity between open repair and endovascular aneurysm repair for abdominal aortic aneurysm: a single-institute experience in Japan. Surg Today 2012; 42:121. Riambau V, Zipfel B, Coppi G, et al. RELAY Endovascular Registry for Thoracic Disease RESTORE Investigators. Final operative and midterm results of the European experience in the RELAY Endovascular Registry for Thoracic Disease (RESTORE) study. J Vasc Surg. 2011;53(3):565-573.

References – Update November 2011 1. 2.

Baum RA, Fairman RA, Mohler ER. Endovascular repair of abdominal aortic aneurysms. UpToDate. 2011. De Bruin JL, Baas AF, Buth J, et al. DREAM Study Group. Long-term outcome of open or endovascular repair of abdominal aortic aneurysm. N Engl J Med. 2010 May 20;362(20):1881-9

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3. 4. 5.

Department of Veterans Affairs. Open versus Endovascular Repair (OVER) Trial for Abdominal Aortic Aneurysms. NLM Identifier: NCT00094575. Last updated May 3, 2011. Available at: http://clinicaltrials.gov/show/NCT00094575. Foster J, Ghosh J, Baguneid M. In patients with ruptured abdominal aortic aneurysm does endovascular repair improve 30-day mortality? Interact Cardiovasc Thorac Surg. 2010;10 (4):611-619. United Kingdom EVAR Trial Investigators; Greenhalgh RM, Brown LC, Powell JT,et al. Endovascular versus open repair of abdominal aortic aneurysm. N Engl J Med. 2010 May 20;362(20):1863-71. Epub 2010 Apr 11.

References – Update March 2011 1. 2. 3.

4. 5. 6.

Egorova N, Giacovelli JK, Gelijns A, et al. Defining high-risk patients for endovascular aneurysm repair. J Vasc Surg. 2009 Dec;50(6):1271-9.e1 Espinosa G, Ribeiro Alves M, Ferreira Caramalho M, et al. A 10-year singlecenter prospective study of endovascular abdominal aortic aneurysm repair with the talent stent-graft. J Endovasc Ther. 2009 Apr; 16(2):125-35. Holst J, Resch T, Ivancev K, et al. Early and intermediate outcome of emergency endovascular aneurysm repair of ruptured infrarenal aortic aneurysm: a single-centre experience of 90 consecutive patients. Eur J Vasc Endovasc Surg. 2009 Apr;37(4):413-9. Keefer A, Hislop S, Singh MJ, et al. The influence of aneurysm size on anatomic suitability for endovascular repair. J Vasc Surg. 2010 Oct;52(4):873-7. Tang XB, Chen Z, Wang S, et al. Comparison of open and endovascular repair for abdominal aortic aneurysm. Zhonghua Wai Ke Za Zhi. 2009 May 1;47(9):661-3 Wu XJ, Jin X, Zhang SY, Chong ZY, et al. Early and mid-term results of endovascular aneurysm repair for infrarenal abdominal aortic aneurysm. Zhonghua Yi Xue Za Zhi. 2010 Jul 6;90(25):1743-6.

References – Update January 2007 1.

2. 3. 4. 5. 6. 7.

De Rango P, Cao P, Parlani G, et al. Outcome after Endografting in Small and Large Abdominal Aortic Aneurysms: A Metanalysis. Eur J Vasc Endovasc Surg. 2007 Dec 7; : Hynes N, Sultan S.A Prospective Clinical, Economic, and Qualityof-Life Analysis Comparing Endovascular Aneurysm Repair (EVAR), Open Repair, and Best Medical Treatment in High-Risk Patients With Abdominal Aortic Aneurysms Suitable for EVAR: The Irish Patient Trial. J Endovasc Ther. 2007 Dec 1;14(6):763-776. Gawenda M, Brunkwall J.Renal Response to Open and Endovascular Repair of Abdominal Aortic Aneurysm: A Prospective Study. Ann Vasc Surg. 2007 Dec 3; Kapma MR, Groen H, Oranen BI, et al. Emergency Abdominal Aortic Aneurysm Repair With a Preferential Endovascular Strategy: Mortality and CostEffectiveness Analysis. J Endovasc Ther. 2007 Dec 1;14(6):777-784. Mutirangura P, Kruatrachue C, Ophasanond P, et al. Endovascular abdominal aortic aneurysm repair in high risk patients: outcomes of management. J Med Assoc Thai. 2007 Oct; 90(10):2080-9. Konig GG, Vallabhneni SR, Van Marrewijk CJ, et al. Procedure-related mortality of endovascular abdominal aortic aneurysm repair using revised reporting standards. Rev Bras Cir Cardiovasc. 2007 Mar;22(1):7-13; discussion 13-4. Collins JT, Boros MJ, Combs K. Ultrasound surveillance of endovascular aneurysm repair: a safe modality versus computed tomography. Ann Vasc Surg. 2007 Nov;21(6):671-5. Bown MJ, Fishwick G, Sayers RD, et al. Repair of ruptured abdominal aortic aneurysms by endovascular techniques. Adv Surg. 2007;41:63-80.

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8. 9.

10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20.

21. 22. 23. 24. 25.

Väärämäki S, Pimenoff G, Heikkinen M, et al. Ten-year outcomes after endovascular aneurysm repair (EVAR) and magnitude of additional procedures. Scand J Surg. 2007;96 (3):221-8. Feringa HH, Karagiannis S, Vidakovic R, et al. Comparison of the incidences of cardiac arrhythmias, myocardial ischemia, and cardiac events in patients treated with endovascular versus open surgical repair of abdominal aortic aneurysms. Am J Cardiol. 2007 Nov 1;100(9):1479-84. Epub 2007 Aug 27. de Donato G, Setacci C, Chisci E, et al. Abdominal aortic aneurysm repair in octogenarians: mith or reality? J Cardiovasc Surg (Torino). 2007 Dec;48(6):697703. Visser JJ, van Sambeek MR, Hamza TH, et al. Ruptured abdominal aortic aneurysms: endovascular repair versus open surgery--systematic review. Radiology. 2007 Oct;245(1):122-9. Jimenez JC, Moore WS, Quinones-Baldrich WJ. Acute and chronic open conversion after endovascular aortic aneurysm repair: a 14-year review.J Vasc Surg. 2007 Oct;46(4):642-7. Wilt TJ, Lederle FA, Macdonald R, et al. Comparison of endovascular and open surgical repairs for abdominal aortic aneurysm. Evid Rep Technol Assess (Full Rep). 2006 Aug;(144):1-113. van Herwaarden JA, van de Pavoordt ED, Waasdorp EJ, et al. Long-term singlecenter results with AneuRx endografts for endovascular abdominal aortic aneurysm repair. J Endovasc Ther. 2007 Jun;14(3):307-17. Hinchliffe RJ, Braithwaite BD. Ruptured abdominal aortic aneurysm: endovascular repair does not confer any long-term survival advantage over open repair. Vascular. 2007 Jul-Aug;15(4):191-6. Nagpal AD, Forbes TL, Novick TV, et al. Midterm results of endovascular infrarenal abdominal aortic aneurysm repair in high-risk patients. Vasc Endovascular Surg. 2007 Aug-Sep;41(4):301-9. Jean-Baptiste E, Hassen-Khodja R, Bouillanne PJ, et al. Endovascular repair of infrarenal abdominal aortic aneurysms in high-risk-surgical patients. Eur J Vasc Endovasc Surg. 2007 Aug;34(2):145-51. Lederle FA, Kane RL, MacDonald R, Wilt TJ. Systematic review: repair of unruptured abdominal aortic aneurysm. Ann Intern Med. 2007 May 15;146(10):735-41. Teufelsbauer H, Polterauer P, Lammer J, et al. Endovascular versus open surgical AAA exclusion techniques the importance of individual patient selection criteria. Acta Chir Belg. 2007 Mar-Apr;107(2):103-8. Hynes N, Sultan S. A Prospective Clinical, Economic, and Quality-of-Life Analysis Comparing Endovascular Aneurysm Repair (EVAR), Open Repair, and Best Medical Treatment in High-Risk Patients With Abdominal Aortic Aneurysms Suitable for EVAR: The Irish Patient Trial. J Endovasc Ther. 2007 Dec 1;14(6):763-776. Gawenda M, Brunkwall J. Renal Response to Open and Endovascular Repair of Abdominal Aortic Aneurysm: A Prospective Study. Ann Vasc Surg. 2007 Dec 3; De Rango P, Cao P, Parlani G, et al. Outcome after Endografting in Small and Large Abdominal Aortic Aneurysms: A Metanalysis. Eur J Vasc Endovasc Surg. 2007 Dec 7. Geraghty PJ. Minimally invasive approaches to vascular procedures in the elderly. Clin Geriatr Med. 2006 Aug;22(3):575-84. Upchurch GR Jr. Abdominal Aortic Aneurysm. Am Fam Physician. 2006 Apr; 73(7): 1198-204 Fleming C. Screening and Management of Abdominal Aortic Aneurysm: The Best Evidence. Am Fam Physician. 2006 Apr; 73(7): 1157-8

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References – Update December 2005 1. Brandt M, Walluscheck KP, Jahnke T, et al. Endovascular repair of ruptured abdominal aortic aneurysm: feasibility and impact on early outcome. J Vasc Interv Radiol. 2005 Oct;16(10):1309-12. 2. Puchner S, Bucek RA, Rand T, et al. Endovascular therapy of inflammatory aortic aneurysms: a meta-analysis. J Endovasc Ther. 2005 Oct;12(5):560-7. 3. May J, White GH, Harris JP. Complications of aortic endografting. J Cardiovasc Surg (Torino). 2005 Aug;46(4):359-69. 4. Leo E, Biancari F, Kechagias A, et al. Outcome after emergency repair of symptomatic, unruptured abdominal aortic aneurysm: results in 42 patients and review of the literature. Scand Cardiovasc J. 2005 Apr;39(1-2):91-5. 5. Drury D, Michaels JA, Jones L, Ayiku L. Systematic review of recent evidence for the safety and efficacy of elective endovascular repair in the management of infrarenal abdominal aortic aneurysm. Br J Surg. 2005 Aug;92(8):937-46. 6. Alsac JM, Kobeiter H, Becquemin JP, Desgranges P. Endovascular repair for ruptured AAA: a literature review. Acta Chir Belg. 2005 Apr;105(2):134-9. 7. Borioni R, Garofalo M, De Paulis R, et al. Abdominal Aortic dissections: anatomic and clinical features and therapeutic options. Tex Heart Inst J. 2005;32(1):70-3. 8. Sbarigia E, Speziale F, Ducasse E, et al. What is the best management for abdominal aortic aneurysm in patients at high surgical risk? A single-center review. Int Angiol. 2005 Mar;24(1):70-4. 9. Sakalihasan N, Limet R, Defawe OD. Abdominal aortic aneurysm. Lancet. 2005 Apr 30-May 6;365(9470):1577-89. 10. Lindsay TF; Canadian Society for Vascular Surgery. Canadian Society for Vascular Surgery consensus statement on endovascular aneurysm repair. CMAJ. 2005 Mar 29;172(7):867-8. 11. Diethrich EB. Stent grafts for the treatment of abdominal aortic aneurysms. Am Heart Hosp J. 2003 Winter;1(1):62-8.

References - Initial 1. Al-Omran M, Verma, Lindsay TF, et al. Clinical Decision Making for Endovascular Repair of Abdominal Aortic Aneurysm. Circulation. 2004;110:e517-e523. Available at: http://circ.ahajournals.org/cgi/content/full/110/23/e517 2. Hinchliffe RJ, Braithwaite BD, Hopkinson BR. The endovascular management of ruptured abdominal aortic aneurysms. Eur J Vasc Endovasc Surg. 2003 Mar;25(3):191-201. 3. Hansman MF, Neuzil D, Quigley TM, et al. A comparison of 50 initial endoluminal endograft repairs for abdominal aortic aneurysm with 50 concurrent open repairs. Am J Surg. 2003 May;185(5):441-4. 4. Jordan WD, Alcocer F, Wirthlin DJ, et al. Abdominal aortic aneurysms in "highrisk" surgical patients: comparison of open and endovascular repair. Ann Surg. 2003 May;237(5):623-9; discussion 629-30. 5. Hall SW. Endovascular repair of abdominal aortic aneurysms. AORN J. 2003 Mar;77(3):631-42. 6. Thompson MM. Infrarenal Abdominal Aortic Aneurysms. Curr Treat Options Cardiovasc Med. 2003 Apr;5(2):137-146. 7. Golzarian J. Imaging after endovascular repair of abdominal aortic aneurysm. Abdom Imaging. 2003 Mar-Apr;28(2):236-43. 8. Maldonado TS, Gagne PJ. Controversies in the management of type II "branch" endoleaks following endovascular abdominal aortic aneurysm repair. Vasc Endovascular Surg. 2003 Jan-Feb;37(1):1-12.

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9. Menard MT, Chew DK, Chan RK, et al. Outcome in patients at high risk after open surgical repair of abdominal aortic aneurysm. J Vasc Surg. 2003 Feb;37(2):28592. 10. Tonnessen BH, Conners MS 3rd, Sternbergh WC 3rd, et al. Mid-term results of patients undergoing endovascular aortic aneurysm repair. Am J Surg. 2002 Dec;184(6):561-6; discussion 567 11. Parodi JC, Ferreira LM, Beebe HG. Endovascular treatment of aneurysmal disease. Cardiol Clin. 2002 Nov;20(4):579-88, vii. 12. Kalman PG. What are the long-term results of conventional open surgical repair of abdominal aortic aneurysms? Acta Chir Belg. 2003 Apr;103(2):197-202. 13. Brewster DC, Cronenwett JL, Hallett JW JR, et al. Guidelines for the treatment of abdominal aortic aneurysms. Report of a subcommittee of the Joint Council of the American Association for Vascular Surgery and Society for Vascular Surgery. J Vasc Surg. 2003 May;37(5):1106-17. 14. Keith FJ, Tanquilut EM, Ohki T, et al. Conservative observational management with selective delayed repair for large abdominal aortic aneurysms in high risk patients. J Cardiovasc Surg. 2003 Jun;44(3):459-64. 15. Giannoni MF, Palombo G, Sbarigia E, et al. Contrast-enhanced ultrasound imaging for aortic stent-graft surveillance. J Endovasc Ther. 2003 Mar-Apr;10(2):208-17. 16. Maher MM, McNamara AM, MacEneaney PM, et al. Abdominal Aortic Aneurysms: Elective Endovascular Repair versus Conventional Surgery--Evaluation with Evidence-based Medicine Techniques. Radiology. 2003 Jul 17 17. Tanquilut EM, Ouriel K. Current outcomes in endovascular repair of abdominal aortic aneurysms. J Cardiovasc Surg (Torino). 2000 Aug;44(4):503-9. 18. Buth J, Harris PL, Van Marrewijk C, Fransen G. Endoleaks during follow-up after endovascular repair of abdominal aortic aneurysm. Are they all dangerous? J Cardiovasc Surg. 2000 Aug;44(4):559-66. 19. Tonnessen BH, Sternbergh WC, Money SR. Brave New World: the role for endovascular aneurysm repair in contemporary vascular surgery. J Cardiovasc Surg. 2000 Aug;44(4):535-42. 20. Bush RL, Lin PH, Lumsden AB. Endovascular management of abdominal aortic aneurysms. J Cardiovasc Surg. 2000 Aug;44(4):527-34. 21. Chuter TA. The choice of stent-graft for endovascular repair of abdominal aortic aneurysm. J Cardiovasc Surg. 2000 Aug;44(4):519-25. 22. Faries PL, Bernheim J, Kilaru S, et al. Selecting stent-grafts for the endovascular treatment of abdominal aortic aneurysms. J Cardiovasc Surg. 2000 Aug;44(4):511-8. 23. Hinchliffe RJ, Hopkinson BR. Current concepts and controversies in endovascular repair of abdominal aortic aneurysms. J Cardiovasc Surg. 2000 Aug;44(4):481502. 24. Bergqvist D. Management of small abdominal aortic aneurysms. Br J Surg 1999; 86: 433-434. 25. Hinchcliffe R J, Hopkinson B R. Endovascular repair of abdominal aortic aneurysm: current status. J R Coll Surg Ed 2002; 47: 523-527. 26. Lederle F A, Wilson S E, Johnson G R et al. Immediate repair compared surveillance of small abdominal aortic aneurysms. N Eng J Med 2002; 346: 1437-1444. 27. Lindbolt J S. Screening for abdominal aortic aneurysm. Br J Surg 2001; 88: 625-626. 28. The UK Small Aneurysm Trial Participants. Mortality results for randomised controlled trial of early elective surgery or ultrasonographic surveillance for small abdominal aortic aneurysms. Lancet 1998: 352: 1649-1655.

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29. Wilmirk T B, Quick C R, Hubbard C S, Kay D N. Influence of screening on the incidence of ruptured abdominal aortic aneurysm. J Vasc Surg 1999; 30: 203208. 30. Woodburn KR, May J, White GH. Endoluminal abdominal aortic aneurysm surgery. Br J Surg 1998: 85: 435-443 Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net’s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member’s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. states, prior notice or website posting is required before an amendment is deemed effective.

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No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member’s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member’s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member’s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member’s contract shall govern. The Policies do not replace or amend the Member’s contract.

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Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code 1367.63 requires health care service plans to cover reconstructive surgery. “Reconstructive surgery” means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean “cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code 1367.6 requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation.

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