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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
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in ALL regions.
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determinations for your region
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contained in the NCD or National Coverage Manual.
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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
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4. Evidence of perigraft flow
5. Persistent endoleak or out aneurysm growth
6. Stent-graft migration resulting in an inadequate seal zone
Contraindications:
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





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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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2.
3.
4.
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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
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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
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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
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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
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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
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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
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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
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