National Medical Policy
National Medical Policy Subject: Endovascular Stent-graft Repair of Infrarenal Abdominal Aortic Aneurysm (AAA) Policy Number: NMP25 Effective Date*: September 2003 Updated: December 2005, January 2008, March 2011, November 2011 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use X Source National Coverage Determination (NCD) National Coverage Manual Citation Local Coverage Determination (LCD) Article (Local) Other None Reference/Website Link Endovascular Repair of Aortic Aneurysms: http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx Use Health Net Policy 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 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. Endovascular AAA Repair Nov 11 1 Current Policy Statement (Update November 2011 – A Medline search failed to reveal any studies that would cause Health Net, Inc. to change its current position) Elective endovascular repair of infrarenal abdominal aortic aneurysms (AAAs) and aortoiliac aneurysms is considered 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 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 Aneurysm which is twice the diameter of the non-dilated proximal infrarenal neck documented by ultrasound, conventional CT or spiral CT; or 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 Infrarenal non-aneurysmal neck length of greater than 1 cm at the proximal and distal ends of the aneurysm; and An inner vessel diameter approximately 10 to 20% smaller than the labeled device diameter; and An aortic neck angle < 45 degrees; and 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. 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 Endovascular AAA Repair Nov 11 2 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 ICD-9 Codes 093.0 441.4 747.69 442.2 Aneurysm of aorta, specified as syphilitic Abdominal aneurysm without mention of rupture Anomalies of other specified sites of peripheral vascular system Aneurysm of iliac artery 2005 CPT Codes 34803 Endovascular repair of infrarenal abdominal aortic aneurysm or dissection; using modular bifurcated prosthesis (two docking limbs) 34805 Endovascular repair of infrarenal abdominal aortic aneurysm or dissection; using aorto-uniiliac or aorto-unifemoral prosthesis CPT Codes 0001T Endovascular repair of infrarenal abdominal aortic aneurysm or dissection; modular bifurcated prosthesis (two docking limbs) (deleted 12/31/04) 0002T Aorto-uni-iliac or aorto-unifemoral prosthesis (deleted 12/31/04) Endovascular AAA Repair Nov 11 3 34800 Endovascular repair of infrarenal abdominal aortic aneurysm or dissection; using aorto-aortic tube prosthesis 34802 using modular bifurcated prosthesis (one docking limb) 34804 using unibody bifurcated prosthesis 34808 Endovascular placement of iliac artery occlusion device 34812 Open femoral artery exposure for delivery of aortic endovascular prosthesis, by groin incision, unilateral 34813 Placement of femoral-femoral prosthetic graft during endovascular aortic aneurysm repair 34820 Open iliac artery exposure for delivery of endovascular prosthesis or iliac occlusion during endovascular therapy, by abdominal or retroperitoneal incision, unilateral 34825 Placement of proximal or distal extension prosthesis for endovascular repair of infrarenal abdominal aortic or iliac aneurysm, false aneurysm, or dissection; initial vessel 34826 each additional vessel. 34830 Open repair of infrarenal aortic aneurysm of dissection, plus repair of associated arterial trauma, following unsuccessful endovascular repair; tube prosthesis 34831 aorto-bi-iliac prosthesis 34832 aorto-bifemoral prosthesis 34833 Open iliac artery exposure creation of conduit for delivery of infrarenal aortic or iliac endovascular prosthesis, by abdominal or retroperitoneal incision, unilateral 34834 Open brachial artery exposure to assist in the deployment of infrarenal aortic or iliac endovascular prosthesis by arm incision, unilateral 34900 Endovascular repair of iliac artery (eg, aneurysm, pseudoaneurysm, arteriovenous malformation, trauma), using ilio-iliac tube endoprosthesis (Code revised in 2011) 36140 Introduction of needle or intracatheter; extremity artery 36200 Introduction of catheter, aorta 36245 Selective catheter placement, arterial system; each first order abdominal, pelvic or lower extremity artery branch, in a vascular family 36246 initial second order abdominal, pelvic or lower extremity artery branch, in a vascular family 36247 initial third order or more selective abdominal, pelvic, or lower extremity artery branch, in a vascular family 75952 Endovascular repair of infrarenal abdominal aortic aneurysm or dissection, radiological supervision and interpretation 75953 Placement of proximal or distal extension prosthesis for endovascular repair or infrarenal abdominal aortic aneurysm, radiological supervision and interpretation 0078T Endovascular repair of abdominal aortic aneurysm, pseudoaneurysm or dissection. 0079T Placement of visceral extension prosthesis for endovascular repair of abdominal aortic aneurysm involving visceral vessels, each visceral branch. 0080T Endovascular repair of abdominal aortic aneurysm, pseudoaneurysm or dissection involving visceral vessels using fenestrated bifurcated prosthesis. 0081T Placement of visceral extension prosthesis for endovascular repair of abdominal aortic aneurysm involving visceral vessels, radiologic supervison and interpretation. HCPCS Codes Endovascular AAA Repair Nov 11 4 N/A Scientific Rationale – Update January 2008 Studies in the peer review medical literature continue to evaluate the long-term safety and efficacy of endovascular repair of AAA as compared with conventional open repair. Jean-Baptiste et al. (2007) evaluated initial and long-term results with endovascular AAA repair in high-risk-surgical patients. 115 patients with an AAA managed by an aortic endograft were entered in a registry. Data concerning diagnosis, operative risk, treatment, and follow-up were analyzed on an intention-totreat basis for all patients considered to be poor candidates for surgery. Patients with a ruptured AAA and those who were good surgical candidates were excluded from analysis. The main goal was evaluation of the operative mortality and the long-term survival of these patients. Secondary goals were determination of the frequency of secondary operations, the outcome of the aneurysm sac, and primary and secondary patency rates after aortic endograft placement. A total of 92 high-surgical-risk patients treated by an endograft were entered in this study. Sixty-seven patients (73%) were classed ASA III and 18 (20%) were ASA IV (20%). Mean aneurysm diameter was 58 mm+/-9 mm. The technical success rate was 99%. Operative mortality was 4.3% (4 cases). Four patients required re-intervention during the mean follow-up of 18 months. The survival rate at 3 yr was 85%. One type I endoleak (1%) and 9 type II endoleaks (9.7%) occurred during the follow-up period. Primary and secondary patency rates at 3 yr were respectively 96% and 100%. The investigators concluded that initial and long-term results with endograft repair of AAA in high-surgical-risk patients were satisfactory, noting that these results appear to justify endovascular repair for this patient population. Aune et al. (2007) compared risk factors, complications, operative mortality and relative survival of patients treated with endovascular aneurysm repair (EVAR) for asymptomatic abdominal aortic aneurysm (AAA) to that of those subjected to open operation. A total of 118 EVAR patients were compared with 386 with open repair in a single center retrospective study. The two groups had similar risk profiles. EVAR patients were older and had shorter hospital stays than those with open operation. Throughout follow-up, 45.8% of EVAR patients had complications, as compared to only 26% of open repairs. Operative mortality, long-term survival and relative survival did not differ significantly between the two groups. The investigators concluded that EVAR appears initially safe in selected patients. They report the complication rates after EVAR is high, but declines throughout the study period. They note that focus must still be on patient selection and device improvement to reduce complications. They note further that the question whether EVAR has improved AAA treatment remains to be answered. In the EUROSTAR study, reported by Hobo et al. (2007), 5183 patients who had endovascular aneurysm repair using a Talent, Zenith, or Excluder stent-graft were enrolled into the EUROSTAR registry. Incidence of proximal type I endoleak, stentgraft migration, proximal neck dilatation, aneurysm rupture, secondary interventions, and all-cause and aneurysm-related mortality were compared between patients with and without severe infrarenal neck angulation (>60 degrees angle between the infrarenal aortic neck and the longitudinal axis of the aneurysm). In the short term (before discharge), proximal type I endoleak and stent-graft migration were observed more frequently in patients with severe infrarenal neck angulation (SNA). Over the long term, higher incidences of proximal neck dilatation > or =4 mm, proximal type I endoleak and need for secondary interventions were seen in patients with SNA. All-cause mortality, aneurysm-related mortality, and rupture of Endovascular AAA Repair Nov 11 5 the aneurysm were similar in patients with and without severe neck angulation. In the subgroup of patients with an Excluder endograft, proximal endoleak at the completion angiogram and long-term proximal neck dilatation were more frequently observed in patients with SNA. In the Zenith subgroup, proximal endoleak at the completion angiogram and proximal stent-graft migration before discharge were more common in patients with SNA. In the Talent subgroup, long-term proximal endoleak, proximal neck dilatation and secondary interventions were more frequently observed in patients with SNA. The investigators concluded that severe infrarenal aortic neck angulation was clearly associated with proximal type I endoleak, while the relationship with stent-graft migration was not clear. Excluder, Zenith, and Talent stent-grafts perform well in patients with severe neck angulation, with only a few differences among devices. Hassen-Khodja et al. (2007) evaluated the feasibility and short-term results of endovascular repair of ruptured AAA at a single center. 17 patients were admitted for a ruptured AAA. Ten patients (59 %) underwent emergency endovascular repair and were included in this study (8 men and 2 women, mean age 81 years, range 5197). The mean duration of hospitalization was 19 days (range: 9-60). Mortality at day 30 was 20% (2 patients): one death occurred on day 2 due to multi-organ failure in an 80-year-old patient and another death occurred on day 2 owing to myocardial infarction in an 87-year-old patient. Mean follow-up was 6 months. Late mortality occurred in 2 cases. No endoleaks were observed during follow-up. The investigator concluded that initial results using endografts for the repair of ruptured AAA were satisfactory, with a feasibility of 59% and an operative mortality of 20%. The investigator noted that randomized studies are necessary to determine the true value of endovascular repair of ruptured AAA compared to conventional open repair. Hinchliffe and Braithwaite (2007) conducted a single-center retrospective study over a 10-year period (1994-2004) examining the long-term outcome of fifty-four patients who have undergone endovascular repair (EVAR) of ruptured AAA. The median age was 75 years; 42 (78%) patients were male. The perioperative mortality rate was 37%. During a median follow-up of 32 months (range 14-48 months), there were 5 aneurysm-related and 13 non-aneurysm-related deaths. Overall, the 3- and 5-year survival rates were 36% and 26%, respectively. The investigators reported that EVAR does not appear to confer any overall survival advantage in the mid- to long term compared with the published results for open repair. The reasons for this remain unclear. They suggest further, larger studies to confirm these results. Visser et al. (2007) performed a systematic review of studies in which endovascular repair was compared with open surgery in the treatment of patients with a ruptured abdominal aortic aneurysm (AAA). Inclusion criteria for studies were that they were about a comparison between patients who underwent endovascular repair and patients who underwent open surgery, that each treatment group included at least five patients, that information about patients' hemodynamic condition at presentation was reported, and that 30-day mortality was reported for each treatment group. Two reviewers independently extracted the data, and discrepancies were resolved by an arbiter. Random-effects models and meta-regression analysis were used to calculate crude and adjusted odds ratios (ORs) for endovascular repair versus open surgery. Ten studies, in which the results of 478 procedures (n=148 for endovascular repair, n=330 for open surgery) were reported, met the inclusion criteria. All studies were observational; no randomized controlled trials were found. The pooled 30-day mortality was 22% for endovascular repair and 38% for open surgery. The pooled rate for total systemic complications was 28% for endovascular Endovascular AAA Repair Nov 11 6 repair and 56% for open surgery. The crude OR for 30-day mortality for endovascular repair compared with open surgery was 0.45. After adjustment for patients' hemodynamic condition, the OR was 0.67. The reviewers concluded that after adjustment for patients' hemodynamic condition at presentation, a benefit in 30-day mortality for endovascular repair compared with open surgery for patients with a ruptured AAA was observed, but it was not statistically significant. Scientific Rationale – Update December 2005 Abdominal aortic aneurysms cause 1.3% of all deaths among men aged 65-85 years. These aneurysms are typically asymptomatic until the catastrophic event of rupture. Patients with small aneurysms (<6 cm), in whom the risk of death at 1-year due to comorbidities exceeds the risk of a ruptured aneurysm, all patients at high surgical risk (ASA class IV) benefit from AAA repair. Small aneurysms must undergo strict surveillance to assess growth and aneurysmal wall changes to prevent unexpected rupture. Repair of large or symptomatic aneurysms by open surgery or endovascular repair is recommended. Conventional management of asymptomatic infrarenal abdominal aortic aneurysm (AAA) is by open repair and is associated with a mortality rate of 2-6%. The overall anatomic suitability rates for endovascular repair (EVAR) of AAA reported suggest an applicability of 58% to 80% from an intent-to-treat experience. EVAR still remains an important interventional technology and continues to result in a significantly lower perioperative mortality rate compared with open repair. It has been a blessing for patients at high risk who were previously denied treatment for their aortic aneurysms. It does, however, have a substantial need for re-intervention for complications. Many of these complications including endoleak, endotension, migration, post implant syndrome and conversion to open repair are unique to endovascular aneurysm repair. Others including injury to the iliac arteries, graft limb thromboses and structural failure of prostheses occur with greater frequency in endovascular repair compared with open repair. Although EVAR is technically effective and safe with lower short-term morbidity and mortality rates than open surgery, there is a need for extended follow-up as the long-term success of EVAR in preventing aneurysm-related deaths is not yet known. Patient selection should be based on vascular anatomy, the availability of a suitable device, the patient's desire for a minimally invasive procedure, and a commitment to what is likely to be a lifetime of device surveillance. It is critical that physicians who evaluate and treat AAA patients have the information needed to make informed decisions on patient selection, device selection, and follow-up management. In a study contrasting retroperitoneal open repair with EVAR, there was no reported difference in mortality between those treated with an open surgical vs. an endovascular approach. Rigberg et al (2004) states that “While EVAR continues to yield a shorter hospital stay and fewer complications when compared with open repair, these benefits may be offset by the need for costly continual computed tomographic scan surveillance, the occasional need for late intervention or conversion to open repair, and the small but finite risk of late rupture.” Endovascular stents have been associated with perivascular leaks in about 25%. The long-term clinical significance of this issue as well as other potential long-term complications are still unknown. An endovascular approach may be most suitable for patients who are poor surgical candidates due to co-morbidities. The two devices have very different designs, and there are different reasons for the current concerns focused on each. Endovascular AAA Repair Nov 11 7 Open repair of ruptured abdominal aortic aneurysms (AAAs) still has a high associated mortality rate. The impact of the introduction of endovascular treatment on the early outcomes of ruptured AAAs, although limitedly reported, may significantly improved outcomes in ruptured AAAs and may, therefore, be beneficial in the overall treatment strategy in these patients. EVAR of inflammatory aortic aneurysms (IAA) is feasible, excludes the aneurysm effectively, and reduces perianeurysmal fibrosis (PAF) and renal impairment in most patients with very low periprocedural and midterm mortality and an acceptable reintervention rate. Isolated abdominal aortic dissections are rare events. Their anatomic and clinical features are different from those of atherosclerotic aneurysms. The Ancure system (Guidant) device has a flexible, unsupported fabric graft prosthesis that is actively fixed in place on the ends by wire hooks that penetrate the vascular tissue. On 3/16/01, Guidant suspended production and announced a recall of all existing inventory. The company reported to the FDA that they had failed to report many device malfunctions and adverse events, including severe vessel damage associated with problems with the deployment of the device. The manufacturer told FDA that an internal audit revealed problems with their complaint handling system, manufacturing quality systems, documentation procedures and training. The FDA is reviewing the firm’s Corrective Action Plan that addresses these problems. The AneuRx System (Medtronic AVE) device has a fabric graft supported along its entire length by a series of metal rings sutured to the graft. It is held in place by the radial force applied by the rings to the aorta. Aneurysm ruptures, as well as other serious adverse events have been reported. Factors associated with adverse events include: sub-optimal placement of the graft; endoleak (inadequate proximal seal, collateral vessel retrograde flow, persistent perigraft flow); migration of the main body of the device as well as any attachment cuffs, possibly associated with continuing aortic dilatation; problems with device integrity, due to metal frame fractures, suture breaks, or fabric tears; and aneurysm anatomy. Scientific Rationale - Initial The aorta is the major vascular conduit between the left ventricle and the systemic arterial bed. It is composed of 3 distinct layers: the intima, the media, and the adventitia. The media is a thick elastic layer intertwined with collagen and smooth muscle cells with sufficient elastic strength to withstand the pulsatile stress that occurs during the ejection of blood in ventricular systole. The elasticity allows the aorta to expand and contract and, in turn, contributes to the forward propulsion of blood through the systemic arterial bed. With normal aging, the elastic elements of the aorta degenerate, reducing distensibility. As a result, intra-arterial pressures may rise and increase the shear stress on the aortic wall. The continued phasic pressure changes make the aorta particularly vulnerable to mechanical trauma and injury over time. The aorta may become enlarged with a diameter exceeding 1.5 times the expected normal diameter. This enlargement of the aorta is called an aneurysm. Therefore, an abdominal aortic aneurysm (AAA) is defined as a focal dilation of the aorta > 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 Endovascular AAA Repair Nov 11 8 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 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, Endovascular AAA Repair Nov 11 9 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. 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. Endovascular AAA Repair Nov 11 10 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 Medical Advisory Council initial approval Update – no revisions Update – no revisions Update – no revisions Update. Added revised Medicare Table. Patient Education Websites English 1. MedlinePlus. Aneurysms. Available at: http://0www.nlm.nih.gov.csulib.ctstateu.edu/medlineplus/aneurysms.html 2. MedlinePlus. Abdominal aortic aneurysm. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/000162.htm 3. InteliHealth. Abdominal Aortic Aneurysm. Available at: http://www.intelihealth.com/IH/ihtIH/WSIHW000/9339/31040.html Spanish 1. MedlinePlus. Aneurismas. Available at: http://0www.nlm.nih.gov.csulib.ctstateu.edu/medlineplus/spanish/aneurysms.html 2. MedlinePlus. Aneurisma aórtico abdominal. Available at: http://www.nlm.nih.gov/medlineplus/spanish/ency/article/000162.htm 3. Enciclopedia médica en español. Aneurisma aórtico. Available at: http://www.nlm.nih.gov/medlineplus/spanish/ency/esp_imagepages/18072.htm This policy is based on the following evidence-based guidelines: 1. 2. Geller SC and the members of the Society of Interventional Radiology Device Forum Imaging Guidelines for Abdominal Aortic Aneurysm Repair with Endovascular Stent Endovascular AAA Repair Nov 11 11 3. 4. 5. 6. 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. Available at: http://www.svunet.org/about/positions/AAA_2002_11_26_02.pdf 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 Screening for abdominal aortic aneurysm: recommendation statement. Ann Intern Med 2005 Feb 1;142(3):198-202. Available at: http://www.guideline.gov/summary/summary.aspx?view_id=1&doc_id=6013 References – Update November 2011 1. 2. 3. 4. 5. Baum RA, Fairman RA, Mohler ER. Endovascular repair of abdominal aortic aneurysms. 2011. Available at: http://www.uptodate.com/contents/endovascular-repair-of-abdominal-aorticaneurysms?view=print 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 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. 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. Endovascular AAA Repair Nov 11 12 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 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. 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. Endovascular AAA Repair Nov 11 13 18. 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. 19. 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. 20. 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. 21. Gawenda M, Brunkwall J. Renal Response to Open and Endovascular Repair of Abdominal Aortic Aneurysm: A Prospective Study. Ann Vasc Surg. 2007 Dec 3; 22. 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. 23. Geraghty PJ. Minimally invasive approaches to vascular procedures in the elderly. Clin Geriatr Med. 2006 Aug;22(3):575-84. 24. Upchurch GR Jr. Abdominal Aortic Aneurysm. Am Fam Physician. 2006 Apr; 73(7): 1198-204 25. Fleming C. Screening and Management of Abdominal Aortic Aneurysm: The Best Evidence. Am Fam Physician. 2006 Apr; 73(7): 1157-8 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 Endovascular AAA Repair Nov 11 14 1. 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. 2. 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. 3. 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. 4. Hall SW. Endovascular repair of abdominal aortic aneurysms. AORN J. 2003 Mar;77(3):631-42. 5. Thompson MM. Infrarenal Abdominal Aortic Aneurysms. Curr Treat Options Cardiovasc Med. 2003 Apr;5(2):137-146. 6. Golzarian J. Imaging after endovascular repair of abdominal aortic aneurysm. Abdom Imaging. 2003 Mar-Apr;28(2):236-43. 7. 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. 8. 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. 9. 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 10. Parodi JC, Ferreira LM, Beebe HG. Endovascular treatment of aneurysmal disease. Cardiol Clin. 2002 Nov;20(4):579-88, vii. 11. 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. 12. 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. 13. 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. 14. Giannoni MF, Palombo G, Sbarigia E, et al. Contrast-enhanced ultrasound imaging for aortic stent-graft surveillance. J Endovasc Ther. 2003 MarApr;10(2):208-17. 15. 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 16. Tanquilut EM, Ouriel K. Current outcomes in endovascular repair of abdominal aortic aneurysms. J Cardiovasc Surg (Torino). 2000 Aug;44(4):503-9. 17. 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. 18. 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. 19. Bush RL, Lin PH, Lumsden AB. Endovascular management of abdominal aortic aneurysms. J Cardiovasc Surg. 2000 Aug;44(4):527-34. 20. Chuter TA. The choice of stent-graft for endovascular repair of abdominal aortic aneurysm. J Cardiovasc Surg. 2000 Aug;44(4):519-25. Endovascular AAA Repair Nov 11 15 21. 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. 22. Hinchliffe RJ, Hopkinson BR. Current concepts and controversies in endovascular repair of abdominal aortic aneurysms. J Cardiovasc Surg. 2000 Aug;44(4):481502. 23. Bergqvist D. Management of small abdominal aortic aneurysms. Br J Surg 1999; 86: 433-434. 24. Hinchcliffe R J, Hopkinson B R. Endovascular repair of abdominal aortic aneurysm: current status. J R Coll Surg Ed 2002; 47: 523-527. 25. 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. 26. Lindbolt J S. Screening for abdominal aortic aneurysm. Br J Surg 2001; 88: 625-626. 27. 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. 28. 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. 29. Woodburn KR, May J, White GH. Endoluminal abdominal aortic aneurysm surgery. Br J Surg 1998: 85: 435-443 Important Notice General Purpose. 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