| Coverage Policy Manual | |
| Policy #: | 2000022 |
| Category: | Surgery |
| Initiated: | May 2000 |
| Last Review: | January 2024 |
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| Percutaneous Transluminal Endovascular Graft for Abdominal Aortic Aneurysm | |
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| Description: |
Conventional management of a clinically significant abdominal aortic aneurysm (AAA) consists of surgical excision with the placement of a sutured woven graft. Surgical excision is associated with a perioperative mortality rate between 1% and 5%. Perioperative morbidity and mortality are highest in older female patients with cardiac, pulmonary, or kidney disease; the most common cause of death is multisystem organ failure.
Due to the high mortality rate, endovascular prostheses have been developed as a less risky and minimally invasive, catheter-based alternative to open surgical excision of AAAs. These devices are deployed across the aneurysm such that the aneurysm is effectively "excluded" from the circulation with subsequent restoration of normal blood flow.
The main potential advantage of endovascular grafts for an AAA is that they offer a less invasive and less risky approach to the repair of abdominal aneurysms. While the use of an endovascular approach has the potential to reduce the relatively high perioperative morbidity and mortality associated with open AAA repair, use of endovascular grafts also has potential disadvantages. In particular, there are concerns about the durability of the anchoring system, aneurysm expansion, and other late complications related to the prosthetic graft. Aneurysm expansion may result from perivascular leaks, also known as endoleaks, which are a unique complication of endoprostheses. Perivascular leaks may result from an incompetent seal at one of the graft attachment sites, blood flow in aneurysm tributaries (these tributaries are ligated during open surgery), or perforation of graft fabric (Blum, 1997; Ernst, 1997; White, 1997; Zarins, 1999).
Several types of grafts are currently in use: straight grafts, in which both ends are anchored to the infrarenal aorta, and bifurcated grafts, in which the proximal end is anchored to the infrarenal aorta and the distal ends are anchored to the iliac arteries. Fenestrated grafts have also been investigated. These grafts are designed with openings in the wall that can be placed across the renal or celiac arteries while still protecting vessel patency through these critical arteries. In addition, extensions can be placed from inside the main endograft body into the visceral arteries to create a hemostatic seal.
Regulatory Status
A large number of endovascular grafts have been approved by the U.S. Food and Drug Administration (FDA) through the premarket approval (PMA) process for the treatment of AAAs. They are listed below. Most of the stents have undergone device modification, name changes, and have approved supplements since the original PMA.
FDA product code MIH.
Abdominal Aortic Stent Grafts Approved by the FDA
Coding
The overall procedure essentially involves 4 steps: establishment of vascular access, the introduction of catheters and guidewires into the arterial system, deployment of the endoprosthesis, and radiologic supervision.
1. The following CPT codes describe the establishment of vascular access; either the femoral or iliac arteries are used.
34812: Open femoral artery exposure for delivery of endovascular prosthesis, by groin incision; unilateral
34820: Open iliac artery exposure for delivery of endovascular prosthesis or iliac occlusion during endovascular therapy, by abdominal or retroperitoneal incision; unilateral
2. Introduction of catheters and guidewires
CPT code 36200 (introduction of catheter, aorta) may be used. Sometimes the renal arteries are catheterized to ensure that the renal arteries are not obstructed by the prosthesis. If this is the case, CPT code 36245 (selective catheter placement, arterial system, each first-order abdominal branch) may be used.
3. The following CPT codes describe the deployment of the prosthesis:
34701: Endovascular repair of infrarenal aorta by deployment of an aorto-aortic tube endograft including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, all endograft extension(s) placed in the aorta from the level of the renal arteries to the aortic bifurcation, and all angioplasty/stenting performed from the level of the renal arteries to the aortic bifurcation; for other than rupture (eg, for aneurysm, pseudoaneurysm, dissection, penetrating ulcer)
34702: for rupture including temporary aortic and/or iliac balloon occlusion, when performed (eg, for aneurysm, pseudoaneurysm, dissection, penetrating ulcer, traumatic disruption)
34703: Endovascular repair of infrarenal aorta and/or iliac artery(ies) by deployment of an aorto-uni-iliac endograft including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, all endograft extension(s) placed in the aorta from the level of the renal arteries to the iliac bifurcation, and all angioplasty/stenting performed from the level of the renal arteries to the iliac bifurcation; for other than rupture (eg, for aneurysm, pseudoaneurysm, dissection, penetrating ulcer)
34704: for rupture including temporary aortic and/or iliac balloon occlusion, when performed (eg, for aneurysm, pseudoaneurysm, dissection, penetrating ulcer, traumatic disruption)
34705: Endovascular repair of infrarenal aorta and/or iliac artery(ies) by deployment of an aorto-bi-iliac endograft including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, all endograft extension(s) placed in the aorta from the level of the renal arteries to the iliac bifurcation, and all angioplasty/stenting performed from the level of the renal arteries to the iliac bifurcation; for other than rupture (eg, for aneurysm, pseudoaneurysm, dissection, penetrating ulcer)
34706: for rupture including temporary aortic and/or iliac balloon occlusion, when performed (eg, for aneurysm, pseudoaneurysm, dissection, penetrating ulcer, traumatic disruption)
34707: Endovascular repair of iliac artery by deployment of an ilio-iliac tube endograft including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, and all endograft extension(s) proximally to the aortic bifurcation and distally to the iliac bifurcation, and treatment zone angioplasty/stenting, when performed, unilateral; for other than rupture (eg, for aneurysm, pseudoaneurysm, dissection, arteriovenous malformation)
34708: for rupture including temporary aortic and/or iliac balloon occlusion, when performed (eg, for aneurysm, pseudoaneurysm, dissection, arteriovenous malformation, traumatic disruption)
34709: Placement of extension prosthesis(es) distal to the common iliac artery(ies) or proximal to the renal artery(ies) for endovascular repair of infrarenal abdominal aortic or iliac aneurysm, false aneurysm, dissection, penetrating ulcer, including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, and treatment zone angioplasty/stenting, when performed, per vessel treated (List separately in addition to code for primary procedure)
34710: Delayed placement of distal or proximal extension prosthesis for endovascular repair of infrarenal abdominal aortic or iliac aneurysm, false aneurysm, dissection, endoleak, or endograft migration, including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, and treatment zone angioplasty/stenting, when performed; initial vessel treated
34711: each additional vessel treated (List separately in addition to code for primary procedure)
4. The following new CPT codes describe radiologic supervision
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 of infrarenal abdominal aortic aneurysm, radiological supervision, and interpretation.
It is estimated that less than 5% of patients will be unsuccessfully treated with endovascular techniques to the extent that the patient must undergo urgent or emergent open surgical aneurysm repair. The following CPT codes have been introduced to describe this situation:
34830: Open repair of infrarenal aortic aneurysm or dissection, plus repair of associated arterial trauma, following unsuccessful endovascular repair; tube prosthesis
34831: aorto-bi-iliac prosthesis
34832: aorto-bifemoral prosthesis
Effective January 2015, CPT 34839 was released to report the physician planning and sizing for a patient-specific fenestrated visceral aortic endograft. Code 34839 may only be reported when the physician spends a minimum of 90 total minutes performing patient-specific fenestrated endograft planning. Planning includes but is not limited to: review of CT, CTA or MRI, utilization of 3D software for iterative modeling of the aorta and device in multiplanar views and center line of flow analysis. The physician planning time does not need to be continuous but should be clearly documented in the patient record.
Effective in 2014, there are category I codes for the use of fenestrated endografts to repair the visceral aorta (34841-34844) and the visceral aorta and infrarenal abdominal aorta (34845-34848). These codes replace the category III codes 0078T-0081T which were deleted.
34841: 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 one visceral artery endoprosthesis (superior mesenteric, celiac or renal artery)
34842: including two visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s])
34843: including three visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s])
34844: including four or more visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s])
34845: 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 endoprosthesis (superior mesenteric, celiac or renal artery)
34846: including two visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s])
34847: including three visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s])
34848: including four or more visceral artery endoprostheses (superior mesenteric, celiac and/or renal artery[s])
Before 2014, there were category III CPT codes that specifically identified the use of fenestrated grafts that allow extensions to be added into the visceral branches of the abdominal aorta. The use of visceral extension prosthesis is reported separately from the use of the fenestrated graft because the number of visceral extensions may vary from 1 to 4, based on the aneurysm anatomy.
Category III Codes
There are also category III CPT codes that specifically identify the use of fenestrated grafts that allow extensions to be added into the visceral branches of the abdominal aorta. The use of visceral extension prosthesis is reported separately from the use of the fenestrated graft since the number of visceral extensions may vary from 1 to 4, based on the aneurysm anatomy.
0078T: Endovascular repair of abdominal aortic aneurysm, pseudoaneurysm or dissection, abdominal aorta involving visceral vessels.
0079T: Placement of visceral extension prosthesis for endovascular repair of abdominal aortic aneurysm involving visceral vessels, each visceral branch.
Codes 0080T and 0081T describe the radiologic supervision of 0078T and 0079T, respectively.
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Policy/ Coverage: |
Effective June 2015
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Endoprostheses of abdominal aortic aneurysms meets primary coverage criteria that there be scientific evidence of effectiveness for the treatment of abdominal aortic aneurysms in any of the following clinical situations:
Individual consideration for coverage is extended for aneurysms smaller than five cm in women or small individuals.
Physician planning and sizing for a patient-specific fenestrated visceral aortic endograft meets member benefit certificate primary coverage criteria and is covered provided there is clear documentation of a minimum of 90 total minutes of planning. Planning may include but is not limited to review of CT, CTA or MRI and/or utilization of 3D software for iterative modeling of the aorta and device in multiplanar views and center line of flow analysis.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Any other use of endovascular grafts for abdominal aortic aneurysm does not meet Primary Coverage Criteria that there be scientific evidence of effectiveness.
For contracts without Primary Coverage Criteria, any other use endovascular grafts for abdominal aortic aneurysm is considered investigational and is not covered. Investigational services are an exclusion in the member benefit certificate.
Effective March 2010 – May 2015
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Endoprostheses of abdominal aortic aneurysms meets primary coverage criteria that there be scientific evidence of effectiveness for the treatment of abdominal aortic aneurysms in any of the following clinical situations:
Individual consideration for coverage is extended for aneurysms smaller than five cm in women or small individuals.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Any other use of endovascular grafts for abdominal aortic aneurysm does not meet Primary Coverage Criteria that there be scientific evidence of effectiveness.
For contracts without Primary Coverage Criteria, any other use endovascular grafts for abdominal aortic aneurysm is considered investigational and is not covered. Investigational services are an exclusion in the member benefit certificate.
Effective June 2000 – February 2010
Endoprostheses of abdominal aortic aneurysms meets primary coverage criteria that there be scientific evidence of effectiveness for the treatment of abdominal aortic aneurysms measuring five cm or more in diameter.
Individual consideration for coverage is extended for:
Any other use of endovascular grafts for abdominal aortic aneurysm does not meet Primary Coverage Criteria that there be scientific evidence of effectiveness.
For contracts without Primary Coverage Criteria, any other use endovascular grafts for abdominal aortic aneurysm is considered investigational and is not covered. Investigational services are an exclusion in the member benefit certificate.
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| Rationale: |
“Due to the detail of the rationale, the complete document is not online. If you would like a hardcopy print, please email: codespecificinquiry@arkbluecross.com”
Particular concerns regarding endovascular prostheses for abdominal aortic aneurysms include the durability of the anchoring system and aneurysm expansion. Aneurysm expansion may result from perivascular leaks, which are a unique complication of endoprostheses. Perivascular leaks may result from an incompetent seal at one of the graft attachment sites, blood flow in aneurysm tributaries (these tributaries are ligated during open surgery), or perforation of graft fabric. The following results were reported to the FDA as part of the premarket approval application. The data from both companies were based on prospective multicenter clinical trials in which the results of endoprosthesis implantation were compared with either concurrent or historical open surgical controls. The studies were not randomized.
Endovascular grafts originally received FDA approval based on nonrandomized comparative studies that demonstrated potential improvements in outcomes. For the Guidant Endovascular Grafting System (Ancure),data were presented on 88 control patients treated surgically, 118 receiving a straight endoprosthesis, and 162 receiving bifurcated grafts. The mean diameter of the aneurysm was 5.2 cm. Controls were those patients who were not candidates for the endoprosthesis due to anatomic considerations, i.e., the vessels were too small for the catheter or the aneurysm extended too close to the renal arteries. The 30-day and long-term mortality were not significantly different among all 3 groups. The rate of significant complications (i.e., cardiac, respiratory, renal, GI, etc.) in the endoprostheses groups was half of that of the control group. Other immediate benefits experienced in the endoprosthesis group included shorter hospital stays, decreased operative blood loss, and opportunity to use regional anesthesia. Leaking around the graft was reported in about 25% of patients at 1 year, although only 10% showed aneurysm enlargement.
For the AneuRx Bifurcated Endovascular Endoprosthesis System, data were presented on 53 patients treated surgically and 199 patients treated with an endoprosthesis. The control group consisted of candidates for aneurysm repair just prior to the introduction of the endoprosthesis. Therefore, the patient selection criteria for the 2 groups were the same. There was no difference in perioperative or late mortality between the 2 groups. The risk of severe treatment-related adverse events was significantly lower in the endoprosthesis group. There were also decreases in anesthesia time, blood loss, earlier ambulation, and resumption of normal diet. The duration of ICU time decreased from 3.5 days in the surgical group to 0.9 days in the endoprosthesis group. Leaking around the graft was detected in about 25% of patients. Similar to the Guidant system, there was a lack of correlation with clinically significant complications.
This policy is also supported by a 2001 Blue Cross Blue Shield Association Technology Evaluation Center Assessment.
2003 Update
A review of the peer-reviewed literature on MEDLINE for the period of 2001 through February 2003 found several clinical trial reports that support the use of endovascular grafts for abdominal aortic aneurysm and demonstrate lowered treatment-related adverse events. While the risk of graft leakage may require reintervention, rupture-free survival rates are similar to patients receiving open repair. Therefore, the policy statement is unchanged.
2008 Update
In April 2008 the FDA approved the Talent Abdominal Graft System by Medtronic (P070027). This graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement with certain anatomical critera. The initial study enrolled 166 patients at 13 sites though only 162 received the stent graft. The primary safety data from the Talent Abdominal study showed that, through 30 days, patients who received the Talent Abdominal Stent Graft experienced a lower rate of MAE's than patients treated with open surgery, as well as generally lower rates of mortality and morbidity. Clinical utility measures of the Talent Abdominal Stent Graft are improved as compared to surgery with respect to procedure duration, blood loss, length of time in the ICU and hospital, and usage of general anesthesia. Effectiveness of the aneurysm treatment using the Talent Abdominal Stent Graft System was greater than 90%. The Talent Abdominal Stent Group was 99.2% migration-free at 12 months and had I100% stent graft patency at 12 months. Additionally, there were no aneurysm ruptures or conversions to surgery at 12 months. Data beyond the 1 year endpoints continues to support device safety and efficacy.
2009 Update
In 2006, the ACC/AHA, in conjunction with other societies, published guidelines on peripheral arterial disease. Recommendations for surgical vs. endovascular intervention for AAA included the following:
While insertion of an endovascular stent graft generally carries less morbidity than does open surgical repair, concerns remain about radiation exposure, endoleaks, the need for serial radiographic follow-up, post-implantation syndrome, and device migration. In 2001, the FDA issued a public health notice about two approved products, and they were withdrawn from the market. In 2002, the Medical Devices Agency of the UK issued alerts for three additional devices (Powell, 2003). The short-term risk appears lower with endovascular repair than with surgery, but at present, there are no clear data demonstrating long-term superiority of endovascular repair (Harris, 2000; Blankensteijn, 2005). The majority of studies have been from nonrandomized trials which are subject to selection bias (Teufelsbauer, 2002). In long-term follow-up, the there is no mortality benefit of endovascular repair versus surgery (Cao, 2004; Goueffic, 2005). The entire field has been tainted by a report that one manufacturer had threatened legal action to block publication of a negative paper (Cronenwett, 2004). The coverage policy remains unchanged.
2010 Update
The use of endovascular techniques in elective repair of abdominal aneurysms continues to gradually increase. A number of studies and reviews presented data on the use of this technique. As noted in the publications, for patients with ruptured AAA to be candidates for endovascular repair, the lesions need to be suitable for the endovascular devices and patients need to be sufficiently stable to undergo CT evaluation. The conclusions of publications since the last policy update indicate that endovascular repair has at least comparable outcomes to open repair, and may have advantages in some subsets of patients. In a Cochrane Review, Dillon and colleagues concluded that while there are no randomized trials, data suggest that endovascular repair is feasible in selected patients with outcomes comparable to best conventional open surgical repair for ruptured AAA (Dillon, 2007). Using a Nationwide Inpatient Sample, McPhee and colleagues found that rates of endovascular treatment of ruptured AAA increased from 6% in 2001 to 19% in 2006 (McPhee, 2009). They found that EVAR had a lower overall in-hospital mortality rate than open repair (32% vs. 41%), and that the effect was amplified when stratified by institutional volume. Based on analysis of data from Medicare beneficiaries, Egorova and colleagues found that EVAR repair of ruptured AAA had a protective effect (hazard ratio 0.86, p=0.0061) on long-term survival controlling for comorbidities, demographics, and volume. Thus, based on these finding, in suitable patients (able to undergo CT scan and with an aneurysm that can be corrected using an FDA-approved endoluminal device), endovascular repair of a ruptured abdominal aortic aneurysm meets primary coverage criteria of effectiveness in improving health outcomes. Thus, the policy statement is changed.
June 2010 Update
Since the last update, two randomized trials comparing open surgery versus endovascular repair of AAA have been published. In both trials, early mortality was lower in the patients treated with endovascular repair. However, over time, equivalent long term survival was seen in both groups (Kent, 2010).
The EVAR-1 trial, conducted by the United Kingdom Endovascular Aneurysm Repair investigators, randomized 1252 patients with AAA (>/= 5.5 cm) to either open surgical repair or endovascular repair (United Kingdom EVAR Trial Investigators, 2010). Patients were enrolled from 1999 through 2004 at 37 centers and were followed until the end of 2009. The mortality rate 30-days post-op was 1.8% in the endovascular repair group and 4.3% in the open surgical repair group. However, at the end of the study there was no statistical difference in the overall total mortality or the overall aneurysm-related mortality between the two groups. During the 8 years of follow-up, over-all graft-related complications were higher in the endovascular repair group (85%) than in the open repair group (48%). A higher rate of reintervention was also seen in the endovascular repair group, contributing to an overall higher cost of aneurysm-related procedures in the endovascular group.
In the DREAM trial, 351 patients were randomized to undergo either an open surgical repair or an endovascular repair (De Bruin, 2010). Patients were followed post-operatively for a period of six years. Again, in this trial, patients in the endovascular group had an initial survival benefit over the open surgical repair group. But, this benefit was no longer seen after 2-years of follow-up. The survival rates after six years were 68.9% for patients undergoing endovascular repair and 69.9% for open repair. Again, a higher rate of reintervention was seen in the endovascular group compared to open surgical repair.
In another randomized trial, the EVAR-2 Trial, patients with large AAA that were considered physically ineligible for open surgical repair were randomized to endovascular repair or no repair (United Kingdom EVAR Trial Investigators, 2010). In this trial, although a lower rate of aneurysm-related mortality was seen in the endovascular repair group, there was not a reduction seen in all-cause mortality. Once again, the cost for aneurysm-related procedures was higher in the endovascular group ($20,124) than in the control group ($6,759).
An editorial accompanying the publications of these trials points out that although endovascular repair provides an early advantage there is more to consider. Patients that have endovascular repair require long-term monitoring and additional interventions are sometimes necessary. Endovascular repair is more costly and further evaluation of cost-effectiveness is needed (Kent, 2010).
2011 Update
A literature search was performed for the period of February 2010 through March 2011. Three major areas of research were identified that are relevant to this policy review: 1) Endovascular aneurysm repair (EVAR) as an alternative to open repair for elective treatment of abdominal aortic aneurysms (AAAs) that meet current criteria for surgery; 2) EVAR as an alternative to open repair for ruptured aneurysms; and 3) EVAR as treatment for smaller aneurysms that do not meet current size criteria for surgery. For each category, comparative studies of EVAR that reported on relevant clinical outcomes were reviewed.
EVAR as an alternative to open repair for elective treatment of AAAs
Several RCTs compared outcomes of EVAR with open repair for elective treatment of AAAs. These studies generally corroborated previous evidence on this question, i.e., that early complications related to the procedure are less with EVAR but that long-term complications are more common with EVAR, and there is no difference in long-term outcomes between the two procedures.
The U.K. EVAR Investigators published a RCT of EVAR versus open repair in patients who were candidates for open repair (UK EVAR Trial Investigators, 2010). A total of 1,252 patients with aneurysms 5.5 cm or larger were randomized to EVAR or open repair. The perioperative mortality was lower in the EVAR group compared to open repair (1.8% vs. 4.3%, respectively; p=0.02). After 8 years of follow-up, there was no difference in survival between the groups (HR: 1.03; 95% confidence interval [CI]: 0.86-1.23). The authors concluded that the early survival advantage of EVAR was lost over time due to late endograft ruptures, which were often fatal.
De Bruin et al. randomized 351 patients with AAAs of at least 5 cm to EVAR or open repair (De Bruin, 2010). The primary outcomes were all-cause mortality and reinterventions. After 6 years of follow-up, the survival rates were similar between the EVAR and open repair groups (68.9% vs. 69.9%, respectively; 95% CI for the difference: -8.8 to 10.8; p=0.97). Reinterventions were more common in the EVAR group. Freedom from reinterventions was 70.4% for EVAR compared to 81.9% for open repair (95% CI for difference: 2.0 to 21.0; p=0.03).
Becquemin et al. performed a RCT of EVAR versus open repair in low- to moderate-risk patients. Low-to-moderate risk was defined by a score of 0-2 on the comorbidity scale of the Society of Vascular Surgery and by the lack of high-risk features on imaging (Becquemin, 2011). A total of 316 patients with aneurysms larger than 5 cm was randomized to EVAR or open repair. In-hospital mortality was low for both the EVAR and open repair group, with no significant difference between groups (0.6% vs. 1.3%, respectively; p=1.0). At 3 years of follow-up, there was no difference between the EVAR and open group in the percent of patients surviving free of major adverse events (82.4% +/- 3.7% vs. 85.1% +/- 4.5%, respectively; p=0.09). Aneurysm-related mortality also did not differ between the EVAR and open groups (4% vs. 0.7%, respectively; p=0.12). There were significantly more reinterventions in the EVAR group (16% vs. 2.4%, respectively; p<0.0001).
EVAR as an alternative to open repair for ruptured aneurysms
One comparative, nonrandomized study was identified that compared EVAR and open repair for ruptured aneurysms at one institution. Ten Bosch et al performed a retrospective comparison of 25 patients who underwent EVAR with 79 patients who underwent open repair. EVAR was performed if the EVAR-trained vascular surgeon was on call and the patient was suitable for EVAR; otherwise open repair was performed (Ten Bosch, 2010). Perioperative mortality was 4.0% in the EVAR group compared to 6.1% in the open repair group (p>0.99). At 30 days, mortality was lower for the EVAR group (20.0% vs. 45.5%, respectively; p=0.04), and this survival advantage was maintained at 6 months (28% vs. 54.5%, respectively; p=0.04). Median length of stay was also lower with EVAR (9.5 days vs. 17.0 days, respectively, p=0.03).
While this trial reported superior outcomes for the EVAR group, it has several methodologic limitations and is therefore not definitive for establishing the superiority of EVAR. The study was retrospective, thus limiting the quality of the data available for analysis. It was nonrandomized, with group assignment based largely on surgeon availability, and therefore prone to selection bias. The baseline characteristics of patients showed numerous numerical imbalances. There were small numbers of patients in the EVAR group (n=25), and the groups were not balanced in terms of numbers (25 vs. 79 in open repair group). The outcomes were analyzed in univariate fashion only, there was no multivariate analysis.
EVAR versus no surgery for smaller aneurysms that do not meet current size criteria for surgery, or for patients who are ineligible for open surgery
The Caesar trial compared the use of EVAR for small AAAs, which did not meet the current thresholds recommended for intervention, with active surveillance (Cao, 2011). The study enrolled 360 patients, 50-79-yearsold, with aneurysms of 4.1-5.4 cm. Patients were randomized to early EVAR treatment or surveillance by ultrasound and/or CT. In the surveillance group, surgery was performed only after the AAA met current recommendations for intervention (≥5.5 cm, growth 1 cm/year, or symptomatic). If repair was indicated, EVAR was performed unless the anatomy of the AAA was unsuitable for EVAR, in which case open repair was performed. Patients were followed for a median of 32.4 months for the primary outcome of all-cause mortality.
The primary outcome occurred at a lower rate than anticipated, thus limiting the power to detect a difference. At final follow-up, there was no significant difference in the main endpoint. Kaplan-Meier estimates of all-cause mortality were 10.1% for the surveillance group compared with 14.5% for the EVAR group (HR 0.76; 95% CI: 0.30-1.93). Aneurysm-related mortality, aneurysm rupture, and major morbidity rates were also similar between groups. For patients in the surveillance group, the Kaplan-Meier estimate of undergoing aneurysm repair was 59.7% at 36 months and 84.5% at 54 months.
A second trial by Ouriel et al. randomly assigned 728 patients with AAAs of 4-5 cm to early EVAR or ultrasound surveillance (Ouriel, 2010). Patients were followed for a mean 20 +/- 12 months for the primary outcomes of aneurysm rupture, aneurysm-related death, and overall mortality. At the final follow-up, overall mortality was the same in both groups at a rate of 4.1%. Aneurysm rupture or aneurysm-related death occurred at a low rate and was also the same between groups at a rate of 0.6%. The hazard ratio for the primary outcome measures was 0.99 (95% CI: 0.14-7.06).
The U.K. EVAR Investigators published a RCT of EVAR versus no treatment of AAAs 5.5 cm or larger, but in whom surgery was not an option due to prohibitive surgical risk or patient preference (UK EVAR Trial Investigators, 2010). A total of 404 patients were randomized to EVAR or no treatment. Perioperative mortality in the EVAR group was 7.3%. After 8 years of follow-up, aneurysm-related mortality was lower in the EVAR group, but overall mortality did not differ (HR 0.99; 95% CI: 0.78-1.27). There was a high rate of long-term complications in the EVAR group, with 48% of patients having a graft-related complication, and 27% of patients requiring reintervention for complications.
Summary
New evidence from randomized, controlled trials comparing EVAR to open repair for elective treatment of aneurysm corroborates previous studies on this question, with neither approach being clearly superior to the other. These trials report on longer term outcomes, greater than 5 years after surgery, and continue to show comparable survival for EVAR compared to open repair at these longer time points. The early advantage of EVAR is balanced out by the higher rate of long-term complications. One trial of patients who were of low to moderate surgical risk reported that the early benefit of EVAR was not evident in this population.
Several randomized, controlled trials have evaluated EVAR versus no surgical intervention in patients who were not eligible for open repair. These trials do not report superior outcomes with EVAR and thus do not support use of EVAR in these patients. One nonrandomized trial compared EVAR with open repair for ruptured aneurysms and reported that survival at 30 days and 6 months was superior for the EVAR group. However, this study had numerous methodologic limitations and is not definitive for establishing the superiority of EVAR.
This new evidence is not sufficient to warrant any changes in the policy statements, which remain unchanged.
Technology Assessments, Guidelines, and Position Statements
Guidelines for the use of EVAR were developed jointly by the Society of Interventional Radiology, the Cardiovascular and Interventional Radiological Society of Europe, and the Canadian Interventional Radiology Association (Walker, 2010). These guidelines state that:
2012 Update
A search of the MEDLINE database was conducted through September 2012. There was no new information identified that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
The EVAR-1 trial, which was discussed in a previous update, had another follow-up publication which focused on cardiovascular morbidity and mortality at five years’ post-treatment (Brown, 2011). The EVAR group had a lower total cardiovascular event rate at all follow-up time points, but the difference over the course of the study did not reach statistical significance (hazard ratio [HR] 0.83, 95% CI 0.62-1.10). During the period of 6-24 months post-surgery, the EVAR group had a higher rate of cardiovascular events (HR 1.44, 95% CI 0.79-2.62), which attenuated the early benefit of EVAR and led to convergence of events between the two procedures. Cardiovascular mortality over the course of the trial was similar between the groups (HR 1.06, 95% CI 0.83-1.36).
ACE trial
The ACE trial (Becquemin, 2011) compared EVAR to open surgical repair in patients who were low to moderate surgical risk. A total of 306 patients were randomized from 25 clinical centers in France. Inclusion criteria included a Society of Vascular Surgery comorbidity score of 0-2 and suitable anatomy for EVAR without high-risk features. There were 17 crossovers from open surgery to EVAR (11%) and four crossovers from EVAR to open surgery (3%). Median follow-up was three years.
Peri-operative mortality was 1.3% for the EVAR group and 0.6% for the open surgery group (p=0.12). Survival at one year was 95.2% for EVAR and 96.5% for open surgery (p=0.24). At three years, survival remained similar at 86.3% for EVAR and 86.7% for open surgery. Major adverse cardiovascular events were present in 6.7% of EVAR patients compared to 4.0% of open surgery, a difference that was also not significant. Re-interventions were more common in the EVAR group compared to open surgery (16% vs. 2.7%, p<0.0001).
Endoleaks were identified on follow-up CT scanning in 27% of EVAR patients (41/150). There were a total of 10 type I endoleaks; five were treated by endoluminal procedures, two were treated with open surgery and three were treated by observation. There were a total of 31 type II endoleaks; eight of these were treated with coil embolization and 23 were left untreated.
Systematic Reviews
A systematic review of nonrandomized studies that compared EVAR versus open surgery in elderly patients 80 years or older was published in 2011 (Biancari, 2011). This analysis included observational studies of elderly patients who had undergone EVAR, and compared results with observational studies of elderly patients undergoing open repair. Pooled analysis revealed that operative mortality was lower in the EVAR group (2.3%) compared to the open surgery group (8.6%), and that EVAR also had lower rates of postoperative cardiac, pulmonary and renal complications. Survival at three years was not different between patients undergoing EVAR and open repair (Risk ratio 1.10, 95% CI 0.77-1.57).
A Cochrane Review summarized the evidence on interventions for small aneurysms, 4.0-5.5cm in size, either by open surgery or EVAR (Filardo, 2012). There were a total of four RCTs identified, including the two RCTs on EVAR included in this policy review (Cao, 2011; Ouriel, 2010) and an additional two RCTs on open surgical repair. Combined analysis of the two EVAR trials revealed no difference in mortality at one year (Odds ratio 1.15, 95% CI 0.59-2.25). There was also no survival benefit for the trials of open surgery, nor was there any benefit apparent when all four trials were combined.
2013 Update
A search of the MEDLINE database was conducted through September 2013. There was no new information identified that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
EVAR as an alternative to open repair for elective treatment of AAAs
Long-term results of the OVER trial were published by Lederle et al. in 2012 (Lederle, 2012). In this trial, 881 patients with asymptomatic AAAs from multiple Veterans Administration medical centers were randomized to EVAR versus open repair and followed up for a mean of 5.2 years. An early survival advantage was reported for EVAR of up to 3 years, but at final follow-up, mortality was similar between groups (hazard ratio [HR]: 0.97, 95% confidence interval [CI]: 0.77-1.22, p=0.81). On subgroup analysis, differences in mortality were noted according to age. For patients younger than 70 years, mortality was increased in the EVAR group (HR: 1.31, 95% CI: 0.99-1.73), while for patients older than 70 years, mortality was reduced in the EVAR group (HR: 0.65, 95% CI: 0.43-0.98).
A systematic review of RCTs was published in 2012 (Dangas, 2012). This review included 6 trials involving a total of 2,899 patients. Combined analysis revealed a lower 30-day mortality rate for the EVAR group (relative risk [RR]: 0.35, 95% CI: 0.19-0.64). At the longest follow-up, there was not difference in overall mortality (RR: 0.99, 95% CI: 0.85-1.15), or in abdominal aortic aneurysm (AAA)-related mortality (RR: 1.58, 95% CI: 0.20-12.74). There were more reinterventions in the EVAR group at both short-term and long-term follow-up. The relative risk for reinterventions at the longest follow-up was 2.24 (95% CI: 1.58-4.08).
EVAR as an alternative to open repair for ruptured aneurysms
In 2012, Saqib et al. published a retrospective comparison of EVAR versus open surgery from a single institution using propensity score matching (Saqib, 2012). Out of a sample of 312 patients undergoing repair for a ruptured aneurysm, 37 cases of EVAR were matched with 111 cases of open surgery. Operative mortality rates were numerically lower in the EVAR group, but did not reach statistical significance (22% vs. 32%, p=0.40). Similarly, complications were somewhat lower in the EVAR group, but the difference was not statistically significant (54% vs. 66%, p=0.23). Overall survival at 1 year (50% vs. 54%), 2 years (50% vs. 52%), and 3 years (42% vs. 47%) was similar between the EVAR and open surgery groups (p=0.66 for overall trend).
Mehta et al. compared 120 patients who underwent EVAR with 163 patients who underwent open surgery (Mehta, 2013). Thirty-day mortality was lower in the EVAR group (24.2% vs. 44.2%, p<.005). The survival advantage for EVAR was maintained up to 5 years post-treatment. Approximately one-fourth of EVAR patients required secondary interventions over this time period.
2014 Update
A literature search conducted through March 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
A 2014 Cochrane review assessed the evidence on the effectiveness of EVAR compared with open surgery for patients considered fit for surgery (Paravastus, 2012). The authors identified 4 trials considered high quality that compared EVAR with open repair (ACE, DREAM, OVER, 1 trials described above; N=2790 patients). In a pooled analysis, short-term mortality (30-day or in-hospital mortality) was significantly lower in patients treated with EVAR (1.4% vs 4.2%, OR=0.33, 95% CI, 0.2 to 0.55, P<0.0001). There were no significant differences in mortality between EVAR and open repair groups at intermediate-term follow-up.
Stather et al conducted a systematic review and meta-analysis of studies of EVAR compared with open surgical repair for AAA with the goal of evaluating longer-term outcomes (Stather, 2013). The authors included RCTs and validated age-sex matched nonrandomized cohort studies of AAAs that met the following characteristics: compared EVAR with open surgery; contained more than 200 patients for RCTs or more than 2000 patients for cohort studies; and reported on 30-day and longer-term mortality. The final analysis included 11 studies: 9 articles that reported the outcomes from 4 RCTs at different follow-up time points, and 2 nonrandomized studies. The RCTs included 1393 patients who underwent EVAR and 1390 who underwent open surgical repair. The nonrandomized studies included age- and sex-matched cohorts of 23,685 patients who had EVAR and 25,752 who had open repair. Overall, the short-term (30-day or in-hospital) mortality was lower in the EVAR groups (OR=0.36, 95% CI, 0.21 to 0.61). However, at longer term follow up, there were no significant mortality differences between groups (2-year all-cause mortality OR=0.87, 95% CI, 0.72 to 1.06; 4-year or greater all-cause mortality OR=1.11, 95% CI, 0.91 to 1.35). Rates of reintervention were significantly higher in patients treated with EVAR (OR=2.08, 95% CI, 1.27 to 3.39). Similarly, rates of aneurysm rupture were higher in patients treated with EVAR (OR=5.94, 95% CI, 2.33 to 15.14). However, the this result may have been driven by a higher rate of rupture in the EVAR 1 trial than the other RCTs and the nonrandomized trials, which may have reflected surgeon inexperience, along with the fact that the OVER trial used a significant proportion of the Medtronic AneurX devices, which were associated with worsened survival rates.
EVAR as an alternative to open repair for ruptured aneurysms
Emergency EVAR (eEVAR) for ruptured AAAs is being studied as a potential method to decrease the high mortality rate associated with open surgical repair. RCTs are difficult in this area due to the emergent or semiemergent nature of treatment for ruptured aneurysms. As a result, until 2013, the most relevant evidence on this question is from nonrandomized, comparative studies of EVAR versus open surgery. However, there is a high risk for selection bias in uncontrolled studies. Aneurysms that meet the anatomic criteria for EVAR tend to be smaller and less complex than aneurysms that do not meet criteria for EVAR, resulting in the highest risk patients being preferentially treated with open surgery. Some studies have attempted to identify the degree to which selection bias may contribute to apparent favorable outcomes in endovascular EVAR repair by comparing outcomes for patients who underwent open repair in patients who met eligibility for EVAR compared with those who did not. In a study by Krenzien et al, (Krenzien, 2013) those who were suitable for EVAR had a significantly lower prevalence of in-hospital deaths compared with patients unsuitable for EVAR (25% vs 53%, p=0.02). In contrast, in an observational cohort of 279 patients who underwent open repair of suspected ruptured AAA who were enrolled in parallel to the Amsterdam Acute Aneurysm Trial previously described, 30-day morbidity was not lower among the 71 patients who met criteria for EVAR compared with the 208 patients who did not meet criteria for EVAR (38% vs 30%, p=0.23) (van Beek, 2014). Because of the possibility of selection bias, several nonrandomized studies have used patient matching or other methods to reduce selection bias.
RCTs of EVAR compared with open repair for ruptured AAA. In 2013, the IMPROVE investigators reported 30-day follow up results for The Immediate Management of Patients with Rupture: Open Versus Endovascular Repair (IMPROVE) trial. This study randomized 623 patients at 30 centers (29 in the UK, 1 in Canada) with a clinical diagnosis of a ruptured AAA to either an endovascular strategy of immediate CT and eEVAR, with open repair for patients anatomically unsuitable for EVAR (endovascular strategy group), or to the standard treatment of emergency open repair (open repair group) (IMPROVE, 2014). Patients were excluded if they had a previous aneurysm repair, rupture of an isolated internal iliac aneurysm, aorto-caval or aorto-enteric fistulae, recent anatomic assessment of the aorta (for example, awaiting elective EVAR), a diagnosis of connective tissue disorder, or if intervention was considered futile. The study protocol permitted inclusion of hemodynamically unstable patients. Ten patients who were randomized were excluded from data analysis due to breach of inclusion criteria. Three hundred sixteen patients were randomized to EVAR, 275 (87%) of whom had a confirmed diagnosis of ruptured AAA and 174 (64%) were considered anatomically suitable for EVAR. EVAR was attempted in 154 patients, 4 of whom were converted to open repair. Open repair was attempted in 112 other patients (84 anatomically unsuitable for EVAR, 28 crossovers). Sixteen patients died before repair, and 1 patient refused repair and was discharged. Two hundred seventy nine patients were randomized to open repair, 261 (88%) of whom had a confirmed diagnosis of ruptured AAA. Of the open repair randomization group, open repair was attempted in 220 patients (80%), EVAR was attempted in 36 patients (13%), and 19 patients died before repair.
A different approach to the problem of selection bias was taken by an industry-sponsored study that enrolled 100 consecutive patients across 10 institutions to determine the percentage of patients for whom eEVAR was applicable and to compare mortality and morbidity between the 2 groups (Peppelenbosch, 2006). Open surgical repair was performed in 51 patients; in 80% of cases, this was due to a configuration of the neck that was unfavorable for endovascular repair. Patients with severe hemodynamic instability also received open surgical repair. This study found no difference between the 2 groups in either in-hospital (35% to 39%, respectively) or 3-month mortality (40% in the eEVAR group and 42% in the open repair group). Blood loss, time in intensive care, and the duration of mechanical ventilation were lower in patients treated by eEVAR than in those treated by open surgery. Identical mortality rates (53%) were also found in a pilot study with 32 patients randomized to eEVAR or open surgical repair by intention-to-treat analysis (Hinchliffe, 2006). In addition, endovascular repair requires long-term monitoring and possible reintervention due to endoleaks, graft migration, and aneurysm enlargement. Paraplegia resulting from spinal cord ischemia during eEVAR has also been reported (Peppelenbosch, 2005).
One study attempted to address the issue of selection bias by assessing the overall mortality rate in a unit where eEVAR has become the treatment of choice and comparing it with the overall mortality rate of historical controls treated with open surgical repair (Arya, 2006). For a 2-year period between 2002 and 2004, patients received eEVAR unless they presented with shock or cardiac arrest during transportation to the hospital or if the CT scan indicated an unfavorable anatomic configuration of the aortic neck (short, conical, wide). Fifty-one patients (17 eEVAR and 34 open repair) were treated during the study period; they were compared with a group of 41 patients treated in the previous 2-year period in the same unit and by the same vascular surgeons. The study found a decrease in length of stay in intensive care (5.5 vs 0 days, respectively) and a trend toward a decrease in mortality (59% vs 39%, respectively; p=0.065) with eEVAR. However, the study also found that patients who were considered too unstable for eEVAR had a 77% mortality rate, while those who were considered unsuitable for eEVAR due to unsuitable aortic neck anatomy had a 19% mortality rate. These results suggest that the favorable mortality rates found in uncontrolled eEVAR studies are due to selection bias.
Systematic reviews of EVAR compared with open repair for ruptured AAA.
Qin et al reported results of a systematic review and meta-analysis of emergent EVAR compared with open repair for ruptured AAAs that included 2 RCTs, 5 prospective comparative studies, and 11 retrospective comparative studies (Qin, 2014). The authors included English-language studies that evaluated outcomes between emergent open and endovascular ruptured AAA repair, with the intervention at the time of the emergency. In a pooled analysis, for the primary outcome of perioperative mortality, the patients who underwent EVAR had significantly lower mortality rates than those who underwent open repair (pooled OR=0.62, 95% CI, 0.58 to 0.67, p<0.001). There was significant heterogeneity in the studies.
In another systematic review and meta-analysis of emergent EVAR compared with open repair for ruptured AAAs that had less stringent inclusion criteria, Antoniou et al evaluated 41 studies, including all types of comparative studies (prospective or retrospective observational studies or RCTs) (Antoniou, 2013). Two RCTs were included. The meta-analysis included a total of 59,941 patients, 8201 who underwent EVAR and 51,740 who underwent open repair. In a pooled analysis, patients who underwent EVAR had significantly lower in-hospital mortality than those who underwent open repair (pooled OR=0.56, 95% CI, 0.50 to 0.64, p<0.01). There was a trend toward shorter length of stay in the EVAR group, but the difference was not significant.
Updated guidelines for the management of AAAs were released by the American College of Cardiology and the American Heart Association in 2011 as a focused update to the 2005 guidelines on the management of patients with peripheral artery disease (Rooke, 2011). These guidelines state that:
2016 Update
A literature search conducted through April 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Nonrandomized Comparative Studies
Schermerhorn and colleagues published a propensity-matched study of EVAR versus open repair in 79,932 Medicare patients (Schermerhorn. 2015). Matching was based on demographic and clinical variables available for 2 years prior to the index procedure. Analysis of Medicare data showed that patients treated with EVAR had lower perioperative mortality (1.6% vs 5.2% p<0.001) and improved survival through the first 3 years of follow-up compared to patients treated with open repair. Survival rates between 3 and 8 years of follow-up did not differ between groups. Reasons for interventions through 8 years of follow-up differed, and were related to the management of the aneurysm after EVAR versus laparotomy after open repair. Aneurysm rupture occurred in a significantly greater proportion of patients after endovascular repair (5.4%) than in patients who had open repair (1.4%) through 8-year follow-up (p<0.001). Interpretation of these data is limited by the potential for selection bias. While this study used propensity matching to reduce selection bias, the potential for bias in selecting patients for EVAR remains.
Two RCTs were published in 2013 and 2014 that compare short-term results following endovascular versus open repair for ruptured aneurysms. One-year follow-up from 1 of the trials (IMPROVE, described next) was published in 2015. Thirty-day and 1-year follow-up for a pseudo-randomized trial that compared EVAR with open surgical repair in patients who qualified for EVAR was published in 2015.
RCTs of EVAR Compared With Open Repair for Ruptured AAAs
Immediate Management of Patients With Rupture: Open Versus Endovascular Repair Trial
Thirty-day follow up results for the Immediate Management of Patients with Rupture: Open Versus Endovascular Repair (IMPROVE) trial. One-year outcomes were reported in 2015 (IMPROVE, 2015). This study randomized 623 patients at 30 centers (29 in the U.K., 1 in Canada) with a clinical diagnosis of a ruptured AAA to either an endovascular strategy of immediate CT and eEVAR, with open repair for patients anatomically unsuitable for EVAR (endovascular strategy group), or to the standard treatment of emergency open repair (open repair group) (IMPROVE, 2014). Patients were excluded if they had a previous aneurysm repair, rupture of an isolated internal iliac aneurysm, aorto-caval or aorto-enteric fistulae, recent anatomic assessment of the aorta (for example, awaiting elective EVAR), a diagnosis of connective tissue disorder, or if intervention was considered futile. The study protocol permitted inclusion of hemodynamically unstable patients. Ten patients who were randomized were excluded from data analysis due to breach of inclusion criteria. Three hundred sixteen patients were randomized to EVAR, 275 (87%) of whom had a confirmed diagnosis of ruptured AAA and 174 (64%) were considered anatomically suitable for EVAR. EVAR was attempted in 154 patients, 4 of whom were converted to open repair. Open repair was attempted in 112 other patients (84 anatomically unsuitable for EVAR, 28 crossovers). Sixteen patients died before repair, and 1 patient refused repair and was discharged. Two hundred seventy nine patients were randomized to open repair, 261 (88%) of whom had a confirmed diagnosis of ruptured AAA. Of the open repair randomization group, open repair was attempted in 220 patients (80%), EVAR was attempted in 36 (13%) patients, and 19 patients died before repair.
Endovasculaire ou Chirgurgie dan les Aneuvysmes aorto-iliaques Rompus
Desgranges and colleagues reported the 30-day and 1-year results of the multicenter Endovasculaire ou Chirgurgie dan les Aneuvysmes aorto-iliaques Rompus (ECAR) pseudo-randomized trial (Desgranges, 2015). A total of 107 patients were assigned by alternating weeks to EVAR (n=56) or open repair (n=51). Power analysis indicated that 80 patients per group would be required to detect a 20% reduction in mortality; however, enrollment for the trial was terminated after 5 years. Patients were included if they had a ruptured aortic, aorto-iliac, or iliac aneurysm, met clinical and anatomic criteria for both EVAR and open repair, and were hemodynamically stable. Assignment also included the availability of a qualified surgeon (≥15 EVAR procedures) and facilities. During the study period 417 patients were treated for ruptured aorto-iliac aneurysms, of which 32% qualified for EVAR (56 included, 116 not included). Baseline characteristic were similar between the EVAR and open repair study groups. There was no significant difference between EVAR and open repair group for the primary outcome of mortality at 30 days (18% vs 24%, p=0.239) or at 1 year (30% vs 35%, respectively, 0.296), although the study was underpowered to detect a difference of this magnitude. The lower than expected mortality in the open repair group may have been due to the exclusion of patients with hemodynamic instability or unfavorable anatomic criteria. In spite of a longer delay to repair with EVAR compared to open surgery (2.9 hours vs 1.3 hours, p<0.005), EVAR resulted in a reduction in respiratory support time (59.3 hours vs 180.3 hours, p=0.007), pulmonary complications (15.4% vs 41.5%, p=0.05), total blood transfusion (6.8 units vs 10.9 units, p=0.020), and duration of intensive care unit stay (7 days vs 11.9 days, p=0.010).
Systematic Reviews of EVAR Compared With Open Repair for Ruptured AAAs
Sweeting and colleagues published a patient-level meta-analysis of 3 RCTs (total N=836 patients) that compared EVAR with open repair for ruptured AAAs (Sweeting, 2015). To have a more uniform comparison, 90-day data from only the patients who were anatomically suitable for EVAR from the IMPROVE trial were analyzed along with patient-level data from the AAA and ECAR trials (described above). There was no survival benefit from EVAR in pooled analysis at 90 days (OR=0.85; 95% CI, 0.64 to 1.13). However, pooled analysis confirmed the finding from IMPROVE that women benefited more than men from an endovascular strategy (ratio of OR=0.49; 95% CI, 0.24 to 0.99). Pooled analysis also confirmed the individual findings of the 3 trials that hospital length of stay was shorter after EVAR than after open repair (HR=1.24; 95% CI, 1.04 to 1.47).
2017 Update
A literature search conducted using the MEDLINE database through May 2016 did not reveal any new information that would prompt a change in the coverage statement.
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2018. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Endovascular Aneurysm Repair As An Alternative To Open Repair For Elective Treatment Of AAAS
Ulug et al published a systematic review of 5 studies of men and women who underwent intact AAA repair, either through open repair or EVAR (Ulug, 2017). Three separate meta-analyses were conducted to address 3 issue areas. One meta-analysis included 5 studies and compared morphologic eligibility for EVAR between men and women. There was a greater likelihood that men were deemed eligible for EVAR. Another meta-analysis assessed the likelihood of nonintervention in women compared with men. Four studies were included (1365 men, 247 women) and the likelihood of nonintervention in women was 34% vs 19% in men. The third meta-analysis included 9 studies (52,018 men, 11,076 women) and evaluated 30-day mortality rate after EVAR. The 30-day mortality rate for women was 2.3% and 1.4 % for men. Reviewers noted that their analysis was limited by inconsistent reporting of confounders such as age, aneurysm diameter, and comorbidities. Overall, fewer women were offered EVAR than men, and, for both EVAR and open repair, women had a higher incidence of mortality following the procedure.
Nonrandomized Comparative Studies
Liang et al analyzed data from 2641 patients who were 65 or younger being treated for AAA with EVAR or open repair; patients were drawn from the Vascular Quality Initiative, a national registry (Liang, 2017). The majority of patients were treated with EVAR (73%), and 13% (n=337) of patients were female. The primary outcomes included perioperative, short-term mortality, and complications in younger patients with few comorbidities. Exclusions included patients with open pararenal or thoracoabdominal repair, patients unfit for open repair, and patients with EVAR for isolated iliac aneurysms. Unadjusted re-intervention rates were five (open repair) and seven (EVAR) reinterventions per 100 person-years. Unadjusted 1-year survival rates were not significantly different between the two interventions (both open repair and EVAR, 3.0%; p< .98). Propensity weighted survival and re-intervention rates did not differ between the two methods of repair. There is a risk of selection bias as registry participation in the Vascular Quality Initiative is voluntarily. The data is self-reported with incomplete 1-year follow-up results. The short-term survival advantage of EVAR was not demonstrated in the younger age cohort.
EVAR as an Alternative to Open Repair for Ruptured AAAs Systematic Reviews
Sweeting et al published a patient-level meta-analysis of 3 RCTs that compared EVAR with open repair for ruptured AAAs al (Sweeting, 2015). To have a more uniform comparison, 90-day data from only the patients who were anatomically suitable for EVAR who participated in the IMPROVE trial were analyzed along with patient-level data from the AJAX and ECAR trials There was no survival benefit from EVAR in pooled analysis at 90 days. However, pooled analysis confirmed findings from IMPROVE that women benefited more than men from an endovascular strategy. Pooled analysis also confirmed the individual findings of the 3 trials that hospital length of stay was shorter after EVAR than after open repair.
The most recent relevant Cochrane review, by Badger et al, reported on 4 RCTs (AJAX, ECAR, Hinchliffe et al [2006], and IMPROVE) which evaluated short- and mid-term outcomes of 868 patients with ruptured AAA treated with emergency EVAR or open repair (Badger, 2017). For the primary outcome, short-term mortality (defined as 30-day or in-hospital mortality), there was no significant difference between EVAR and open repair. Secondary outcomes (endoleak events, 30-day complication rates, 6-month mortality) were not assessed in all studies. Reductions in bowel ischemia (a secondary outcome) were more significant in the EVAR group than in the open repair group. Using data from the AJAX trial (n=116), reviewers found no 6-month survival advantage for patients treated with emergency EVAR.
Practice Guidelines and Position Statements
Society for Vascular Surgery
In 2018, the Society for Vascular Surgery published guidelines for the treatment of AAAs (Chaikof, 2018). As in previous publications, these guidelines indicated that open surgery and EVAR are options for patients with aneurysms that meet the current treatment threshold.
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2019. No new literature was identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2020. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
A 2019 systematic review by Li et al included 73 studies (N=299 784 patients) that compared EVAR (n=151,092) and open repair (n=148,692) outcomes for long-term (5-9 y) and very long-term (≥10 y) all-cause mortality, reintervention, and secondary rupture rates (Li, 2019). The study years ranged from 1999 to 2018 and included 3 RCTs (5 articles) and 68 observational studies. Follow-up ranged from 5 to 15 years. EVAR was associated with higher long-term all-cause mortality, reintervention, and secondary rupture rates compared with OSR. In the very long-term, EVAR was also associated with higher reintervention and secondary rupture rates but mortality rates were seen to improve over time.
Lederle et al reported on the 14-year extended follow-up for the OVER trial. The primary outcome was all-cause mortality. Of the 444 patients assigned to EVAR, 302 (68.0%) had died, and of the 437 open-repair patients, 306 (70.0%) had died (HR = 0.96; 95% CI, 0.82-1.13; P =.61). Deaths associated with AAA were seen in 12 (2.7%) EVAR patients and 16 (3.7%) open repair (95% CI, -3.3 to 1.4). Of those deaths, 2 EVAR patients died either during hospitalization or within 30 days after repair; 11 open-repair patients died during that same period. Of the EVAR group, 117 out of 439 (26.7%) patients underwent a secondary procedure compared with 85 of 429 (19.8%) patients in the open repair group (95% CI, 2.0-17.5). During the first 4 years of follow-up, overall survival appeared to be higher with endovascular repair than with open repair; from year 4 through year 8, overall survival was higher in the open-repair group; and after 8 years, overall survival was once again higher in the endovascular-repair group (hazard ratio for death, 0.94; 95% CI, 0.74 to 1.18). None of these trends were significant.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Yokoyama et al published a meta-analysis evaluating longer-term outcomes from the 4 key RCTs included in previous meta-analyses (OVER, DREAM, EVAR-1, ACE) plus 7 propensity-matched cohort studies (N=106243); one of the included cohort studies had not previously been included in a pooled analysis (Yokoyama, 2020). Overall, EVAR reduced mortality versus OSR during the perioperative period, but increased mortality versus open surgical repair (OSR) during the post-operative periods that include 1 to 24 months and 2 to 6 years after repair. There were no significant differences in mortality between groups when evaluating the following postoperative periods: 0 to 2 years, 6 to 10 years, ≥10 years.
Antoniou published a meta-analysis comparing outcomes of fenestrated or branched EVAR with open repair for juxta/para/suprarenal or thoraco-AAAs (Antoniou, 2021). Eleven observational studies were included (N=7061). Fenestrated or branched EVAR did not significantly lower peri-operative mortality (OR, 0.56; 95% CI, 0.28 to 1.12; p =.10) or increase overall mortality (HR, 1.25; 95% CI, 0.93 to 1.67; p = 0.14) versus open repair. However, reintervention was significantly more likely after EVAR (HR, 2.11; 95% CI 1.39 to 3.18; p <.001).
An update of the 2015 Cochrane Review was attempted in 2020, but no new studies were identified for inclusion (Ulug, 2020).
Recommendations for the diagnosis and management of AAAs were published by the National Institute for Health and Care Excellence (NICE) in March 2020 (NICE, 2020). Recommendations for repairing unruptured aneurysms include:
Recommendations for repairing ruptured aneurysms include:
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Khoury et al assessed outcomes after EVAR via the utilization of more contemporary post-EVAR2 data from the Vascular Quality Initiative database of the Society of Vascular Surgery (2003 to 2020). Patients were categorized as unfit (n=4435) or suitable (n=27036) for open AAA repair (Khoury, 2022). The primary outcome of the study was 30-day mortality. Secondary outcomes included length of stay, major adverse cardiovascular events (MACE), and 1-year mortality. Patients deemed unfit for open repair had significantly higher 30-day mortality (0.8% vs. 0.4%; p<.001), more perioperative MACE (5.1% vs. 2.2%; p<.001), and longer lengths of stay (p<.001) as compared to suitable patients. Unfit patients were also found to have worse 1-year survival as compared to suitable patients per Kaplan-Meier analysis (p<.001). However, unfit and suitable patients had significantly improved actual 1-year mortality with EVAR compared with predicted 1-year mortality without EVAR: 9.5% vs. 15.6% (p<.001) and 4.0% vs. 11.7% (p<.001), respectively. The mortality benefit after EVAR in patients deemed unfit was primarily restricted to those with smaller Gagne indices and larger aneurysm diameters. Those deemed unsuitable for open repair due to frailty or multiple reasons had worse 1-year cumulative survival compared with all other unfit patients. Limitations of this study included its retrospective design, lack of data regarding specifics of aneurysm anatomy, and lack of objective definition of what classifies a patient as "unfit".
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