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New Drugs and Technologies

Endovascular Repair of Abdominal and Thoracic


Aortic Aneurysms
Barry T. Katzen, MD; Michael D. Dake, MD; Alexandra A. MacLean, MD; David S. Wang, MD

ortic aneurysms remain a challenging problem for patients and physicians. There have been major advances
in the treatment of large-vessel aneurysms during the past 10
years. The surgical armamentarium used to treat these aneurysms now includes an endovascular approach that allows the
insertion of a graft to exclude the aneurysm sac from blood
flow. The endovascular repair of abdominal and thoracic
aortic aneurysms has become a viable alternative to open
repair and is often the approach of choice for high-risk
patients. In this review, we examine the endovascular treatment of abdominal and thoracic aortic aneurysms.

Endovascular Repair of Abdominal


Aortic Aneurysms
Abdominal aortic aneurysms (AAAs) are a formidable diagnosis for patients. This is a life-threatening condition that
mandates consideration of repair. A ruptured AAA has a
mortality rate approaching 90%; however, when an AAA is
repaired electively, the mortality drops to less than 5%.13
There is, therefore, a clear advantage to treating these
aneurysms before they rupture. Because this disease affects
4% to 7% of adults over the age of 65 years, with a far greater
prevalence in males than females, clinicians will encounter
this problem more frequently as the population ages.4
AAAs usually develop in patients with a history of arteriosclerosis or smoking. Patients present for repair when it is
discovered that there is a dilation of their abdominal aorta to
a diameter 1.5 times normal. The result is a weakened aortic
wall that is at increased risk of rupture. The pathogenesis of
this aortic wall change likely involves enzymes responsible
for elastin and collagen breakdown.5 Recent research has
focused on the role of metalloproteinase-9 (MMP-9). Aneurysm presence and size have been correlated with MMP-9
levels. Other investigators are looking into the inflammatory
and autoimmune mechanisms involved in aneurysmal disease.6 Another area of research is in the molecular genetics of
AAAs, because these aneurysms have a well-recognized
familial nature. There is also an interest in the analysis of
aortic wall stress distribution from a biomechanical approach.
Ongoing studies have found that peak wall stress can predict
those patients who will experience AAA rupture.7,8
Patients with symptomatic aneurysms should be offered
repair, after careful consideration of comorbidities, even if

the aneurysm is not of usual elective operative size. For


patients with asymptomatic AAAs, there are guidelines to
help plan further surveillance or operative repair. The size of
the aneurysm is one factor, and the operative approach is
another. In the past, the fitness of patients for a transabdominal or retroperitoneal operation was of paramount concern.
High-risk patients faced the choice of a morbid operation
with a not insignificant mortality rate or the risk of rupture.
The treatment option for this population was not satisfactory,
and the development of a lower-risk operation was a necessity to adequately treat this population.
Over the past 15 years, the management of AAAs has
changed dramatically because of the development of the
technique of endovascular aneurysm repair (EVAR; Figures 1
and 2). Patients and physicians have embraced EVAR as the
method of choice to treat high-risk patients with AAAs.
EVAR has great appeal for this older population because it
leads to faster recovery with fewer systemic complications
than open repair.9 14
Parodi et al15 reported the first endovascular repair of an
AAA in a human in 1991 using a graft fashioned from
prosthetic vascular grafts and expandable stents. Current
estimates are that more than 20 000 EVAR procedures take
place each year in the United States, which represents 36%
of all AAA repairs. The estimate is that 12% of all
procedures in Europe are with EVAR, and expected annual
growth is 15% at this time (Medtronic Marketing Department, personal communication, 2004). EVAR is the method
of choice in high-risk older patients because of its minimal
incisions, shorter operating time, and reduced blood loss.
Three EVAR devices are available commercially in the
United States at this time, and several more are under
evaluation in clinical trials. The Food and Drug Administration (FDA), well aware of the many confounding variables
in an EVAR-to-surgery comparison, permitted the use of
concurrent surgical controls. The large deposit of multicenter, prospectively collected data on the European
EVAR experience also provides a great source for analyses: the EUROSTAR (EUROpean collaborators on Stentgraft Techniques for abdominal aortic Aneurysm Repair)
Registry (4392 patients, 1996 to 2002).1720
In the present review, we will address EVAR indications,
contraindications, devices, outcomes, complications, en-

From the Baptist Cardiac and Vascular Institute (B.T.K., A.A.M.), Miami, Fla; University of Virginia Health System (M.D.D.), Charlotteville ; and
Stanford University School of Medicine (D.S.W.), Stanford, Calif.
Correspondence to Barry T. Katzen, MD, Founder and Medical Director, 8900 N Kendall Dr, Miami, FL 33176-2197. E-mail barryk@baptisthealth.net
(Circulation. 2005;112:1663-1675.)
2005 American Heart Association, Inc.
Circulation is available at http://www.circulationaha.org

DOI: 10.1161/CIRCULATIONAHA.105.541284

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Circulation

September 13, 2005

Figure 1. 3D rendering of 6-cm AAA.

dograft surveillance, and future directions. This is an exciting


time for the management of AAAs, because there are many
more options for high-risk patients. The field is rapidly
evolving, and patients expect to be informed of the current
technology.

Indications for AAA Treatment


Most asymptomatic AAAs are discovered serendipitously,
often on imaging examinations for other complaints. Increasing evidence indicates that there is value to screening patients
for AAAs, and it is likely that screening will be approved in
the near future.21 Once the diagnosis of AAA is made, 2
critical questions need to be answered: when to intervene and
how to intervene. The availability of EVAR has made these
decisions somewhat more complex while adding a significant
treatment option.
Recent studies have questioned whether aneurysms smaller
than 5 cm should be treated.22 However, in general, the
clinical recommendation remains to offer treatment for aneu-

Figure 2. 3D rendering of AAA 1 year after therapy with the


trivascular stent graft (treated [or evaluated] under a phase I
investigational device exemption clinical trial); note shrinkage of
sac.

rysms between 5 and 5.5 cm, depending on the results of


clinical trials.23 An exception to this guideline is that intervention should be offered despite the size of the aneurysm if
symptoms develop or the aneurysm increases in size by 1 cm
per year.24 In addition, if the patient is a woman with smaller
native vessels, the relative size that represents aneurysmal
disease may be less than the conventional 5 to 5.5 cm range.

Clinical and Anatomic Selection Factors


Patient selection has emerged as the most important factor
related to successful EVAR. The assessment begins with
consideration of the body habitus and sex of the patient; small
body size and female sex have been associated with a higher

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Katzen et al
TABLE 1.

Evaluation for EVAR

Endovascular Aneurysm Report

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ists can deal with some of these challenges, but morphological features of the aneurysm and access vessels may preclude
EVAR.
Currently, we use EVAR primarily to treat patients at high
surgical risk. We are confident that EVAR protects patients
from aneurysm rupture, but we cannot yet extend the offer of
EVAR to young, healthy patients, because we do not have
data on long-term durability to support this practice.

CT scan assessment for EVAR eligibility


Proximal neck: diameter, length, angle, presence or absence of thrombus
Distal landing zone: diameter and length
Iliac arteries: presence of aneurysms and occlusive disease
Access arteries: diameter, presence of occlusive disease
Contraindications for EVAR
Short proximal neck

Devices

Thrombus presence in proximal landing zone

Endografts have developed from simple tube grafts suitable


for a small subset of aneurysms to complex bifurcated grafts
with a range of sizing and extensions that can be used to treat
the morphological challenges of aneurysmal disease. The
language used to describe the devices has also evolved over
time.
There are 2 types of device bodies: unibody and modular.
The former comes in 1 piece, and although easy to deploy, it
requires contralateral occlusion and bypass grafting. Modular
devices are composed of more than 1 piece, and the components are deployed through both groins. There is greater
flexibility associated with the modular devices, and they
dominate the market. The endograft fabric is either a woven
polyester or PTFE (polytetrafluoroethylene). The difference
between these is the degree of porosity (PTFE woven
polyester), and some believe this affects the rate of type IV
endoleaks.
The key features of endovascular repair of AAAs that
determine procedural success and long-term outcomes are
proximal and distal fixation and sealing. Various device
modifications and designs address this need; there are now 3
FDA-approved endografts and several others in various
stages of development (Table 2). Early devices were secured
proximally and distally with the aid of expandable stents.
Now, most of the devices use a metal skeleton throughout the
graft that is made from stainless steel, nitinol, or Elgiloy.
Attachment is facilitated by the use of hooks or radial force.
Once the graft is inserted through the sheath, it can be
deployed by a self-expanding mechanism or balloon expansion. Some grafts attach superior to the renal arteries (suprarenal attachment), whereas most of the devices require at least
15 mm of proximal neck to achieve fixation and sealing in the

Conical proximal neck


Greater than 120 angulation of the proximal neck
Critical inferior mesenteric artery
Significant iliac occlusive disease
Tortuosity of iliac vessels

risk of procedure abortion.25,26 In addition, the comorbidities


of the patients must be assessed, with careful attention to
cardiac, pulmonary, and renal conditions. In general, open
surgical repair is advocated for younger, lower-risk patients,
and EVAR is preferred for older, higher-risk patients. Open
surgical repair of AAA has proven long-term durability;
EVAR follow-up is now at 10 years. The use of risk
stratification to analyze outcomes clearly indicates that survival for those at low to minimal risk is excellent over 10
years; those at highest risk succumb to cardiac disease or
cancer, and for those patients, survival is poorest.27 EVAR
has shown a reduction in 30-day mortality relative to that
achieved with open repair (1.2% versus 4.6%). Further study
is required to determine whether there is a long-term survival
advantage. Risk stratification determines survival in general
and shows that both open surgery and EVAR decrease the
risk of death from AAA rupture.28
The characteristics of the aneurysm must be matched to the
most suitable device; this has a direct impact on outcomes
and the complication profile of the procedure. The aneurysm
is evaluated from a 3D reconstruction CT scan or aortography
with a calibrated catheter. There are at least 4 important
features that must be assessed before one determines a
patients eligibility for EVAR, and this analysis leads to a list
of contraindications29 (Table 1). Experienced interventionalTABLE 2.

Endograft Devices
FDA Approval

Main Body
Diameter, mm

Fixation

Profile

Ancure (Guidant)/off-market 2003

September 1999

2026

Infrarenal

21F

AneuRx (Medtronic)/worldwide

September 1999

2228

Infrarenal

21F

Excluder (Gore)/worldwide

November 1999

2331

Infrarenal

18F

Device (Company)/Market

Fortron (Cordis)/Europe

No

2634

Suprarenal

NA

Lifepath (Edwards)/Europe, Australia

No

2129

Infrarenal

21F

Powerlink (Endologix)/Europe

No

2534

Infrarenal; suprarenal

21F

Stentor/Vanguard (Boston Scientific)/off-market 1999

No

2226

Infrarenal

21F

Talent (Medtronic)/Europe, Australia, Asia

No

2434

Suprarenal

22F/24F

Trivascular (Boston Scientific)/in research

No

1626

Infrarenal

16F

May 2003

2232

Suprarenal

18F/20F

Zenith (Cook)/worldwide

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TABLE 3.

Circulation

September 13, 2005

EVAR Outcomes
EVAR Cases, n

Conversion Rate

Endoleak

Delayed Rupture

Mortality

Ancure/EGS (Guidant),
compared with open surgery12

Device (Company)

309 Patients; 5-year


follow-up

2.80%

25.60% at 60 months

1.7% 30-Day rate

AneuRx (Medtronic)13

1192 Patients; 4-year


follow-up

93% Freedom from


open conversion at 3
years

13% at 1 month

99.5% Freedom from


rupture at 3 years

2% 30-Day rate

Excluder (Gore), compared with


open surgery10

235 patients; 2-year


follow-up

20% at 2 years

1% 30-Day rate

Fortron (Cordis)
study results not yet available

NA

NA

NA

NA

NA

Lifepath (Edwards)30

227 Patients; 11
months (mean)
follow-up

2.20%

5.90% at 6 months

1.3% Perioperative

Powerlink (Endologix)31

118 Patients; 16
months (mean)
follow-up

3.30%

5.90% at 30 days

0.8% Perioperative

23 Patients; 3-year
(median) follow-up

30%

65%

NA

NA

Talent (Medtronic), compared


with open surgery9

240 Patients; 406 days


(mean) follow-up

2.50%

10% at 12 months

0.8% 30-Day rate

Trivascular (Boston Scientific),


study results not yet available

NA

NA

NA

NA

NA

Zenith (Cook), compared with


open surgery14

200 Patients

1.50%

7.40% at 12 months

98.9% Freedom from


rupture at 1 year

0.5% 12 Months

Stentor/Vanguard (Boston
Scientific)32

infrarenal position. The grafts also differ in their profile or


the size of the delivery system. Low-profile devices permit
access through smaller arteries.
The importance of choosing the appropriate device to fit
the characteristics of the aneurysm cannot be overemphasized. With a short proximal neck, the suprarenal Talent
device proves useful, and when small access arteries are
encountered (especially in females), the low-profile Excluder
endograft is appealing. The Lifepath device has been used
with some success in the difficult angulated neck.

Outcomes
Table 3 describes the published literature from large devicespecific series.9,10,1214,30 32 Some of the series compare the
EVAR data with that obtained from open surgical repair.
Recently, a prospective, randomized trial of EVAR and open
repair demonstrated a two thirds reduction in early mortality
with EVAR.33 All studies have shown excellent rupture-free
survival and significant reduction in blood loss, cardiovascular events, and intensive care unit stay. High-volume institutions with experience using multiple types of endografts are
able to optimize the matching of the device to the characteristics of the aneurysm.

Complications
Most of the complications associated with EVAR are minor
and can be watched carefully or treated easily with additional
interventional procedures. Some complications occur during
or soon after the procedure, whereas others are only noticed
during graft surveillance (Table 4).34 A study by Ohki et al35
analyzed complication and death rates within 30 days of
EVAR and found the major complication and death rates

were 17.6% and 8.5%, respectively. This remains an active


and important area of EVAR research, and standards have
been developed to facilitate reporting of endovascular abdominal aortic repair complications.36
Endoleaks can have substantial clinical significance because of an increased risk of becoming symptomatic or
leading to aneurysm rupture. Endoleak describes the continuation of blood flow into the extragraft portion of the
aneurysm; this flow increases the size of the aneurysmal
sac.37 Endoleaks occur in either the acute setting during graft
implantation or during the postoperative surveillance period.
The majority of procedural endoleaks will disappear without
intervention.
Endoleaks are either graft-related or nongraft-related, and a
classification system has been developed (Table 5).38 Type I
endoleaks occur when the attachment is not complete, either
proximally or distally; blood is able to flow into the aneurysmal sac and is not completely occluded by endograft
attachment to the arterial wall. Type II endoleaks result from
continued back flow from aortic branches such as the inferior
mesenteric artery and lumbar arteries. This flow occurs
retrograde into the aneurysmal sac around the endograft.
Type III endoleaks are caused by defects in the endograft
structure that lead to leakage of blood flow from inside the
endograft to the aneurysmal sac. Finally, type IV endoleaks
are noted early after endograft placement and resolve when
the fabric porosity is decreased by clotted blood. Because
endovascular repair uses a relatively new technology, graft
surveillance for complications such as endoleaks is essential.
Endoleaks are diagnosed by a variety of techniques: arteriography, pressure monitoring during or after the procedure, CT
scan, and duplex scanning. The preferred method of detecting

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Katzen et al
TABLE 4.

EVAR Complications
Deployment related
Failed deployment
Bleeding
Hematoma
Lymphocele
Infection
Embolization
Perforation
Arterial rupture
Dissection
Device related
Structural failure
Implant related
Endoleaks
Limb occlusion/stent-graft kink
Sac enlargement/proximal neck dilatation
Stent migration
AAA rupture
Infection
Buttock/leg claudication
Systemic
Cardiac
Pulmonary
Renal insufficiency
Cerebrovascular
Deep vein thrombosis
Pulmonary embolus
Coagulopathy
Bowel ischemia
Spinal cord ischemia
Erectile dysfunction

endoleaks is by CT scanning, An analysis of 2463 patients


from the EUROSTAR registry revealed that 171 had an
endoleak by the time of their first-month postoperative
evaluation, and 317 patients developed one at a later date.39
TABLE 5.

Classification of Endoleaks

I: Attachment site leaks


A: Proximal end of endograft
B: Distal end of endograft
C: Iliac occluder (plug)
II: Branch leaks (without attachment site connection)
A: Simple or to-and-fro (from only 1 patent branch)
B: Complex or flow-through (with 2 or more patent branches)
III: Graft defect
A: Junctional leak or modular disconnect
B: Fabric disruption (midgraft hole)
Minor (2 mm; eg, suture holes)
Major (2 mm)
IV: Graft wall (fabric) porosity (30 days after graft placement)

Endovascular Aneurysm Report

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Of these, 7.8% had a type II endoleak, and 12% had a type I,


type III, or combination of endoleaks.
There are many different ways to treat endoleaks, including
coil embolization, placement of stent-graft cuffs and extensions, laparoscopic ligation of inferior mesenteric and lumbar
arteries, open surgical repair, and EVAR redo procedures.
Type I and III endoleaks require fairly urgent intervention,
because blood flow and sac pressure will continue to increase
and lead to rupture. Type IV endoleaks usually resolve on
their own.
The management of type II endoleaks is more controversial, because some of them will thrombose on their own,
whereas others will lead to sac enlargement. There are 2
critical questions that must be addressed at this juncture: (1)
Should an intervention be entertained, and (2) when should
the intervention be performed?40 One approach is to monitor
the patient with a postprocedure 6-month CT scan, and if the
aneurysm has increased in size, then a plan for intervention is
formulated. There are at least 3 approaches to manage type II
endoleaks: transarterial, translumbar embolization, and laparoscopic ligation.41 Another approach to eliminate endoleaks
is to perform preoperative embolization of feeding arteries. A
study by Bonvini et al42 analyzed 23 consecutive patients who
underwent preoperative embolization to reduce type II endoleaks. They monitored the patients for a mean of 17 months
and found 1 type II endoleak (4.5%). During a consensus
conference in 2000, 23 of 26 international leaders in EVAR
disagreed with the preoperative approach to endoleaks.38

Surveillance
Endograft surveillance is important to document normal and
abnormal morphological changes in the repair and the involved vessels. This process is vital for the detection of
endoleaks, increased aneurysm diameter, and possible device
migration.43 The study by Corriere et al43 showed that 24% of
the patients had an endoleak detected during surveillance that
averaged 19 months. In that study, 3 endoleaks were detected
2 years after repair, with 1 at 7 years. Other findings,
including perigraft air, accompanied by leukocytosis and
fever, can be detected after repair and have been shown to be
nonspecific and not indicative of graft infection.44
The recommended surveillance routine is for a CT scan at
1, 6, and 12 months and annually thereafter. If an endoleak is
detected, the frequency of the scans increases to every 6
months until resolution of the endoleak is detected. Investigators have compared duplex ultrasound with CT scan for
surveillance and found that CT scan is superior for endoleak
detection.45 MRI can also be used for graft surveillance,
especially in older patients with decreased renal function.46 A
recent development for endograft surveillance is the monitoring of sac pressure within treated aneurysms through an
implanted sensor device.47,48 Trials with this implanted sensor
are currently being conducted.
The use of EVAR technology has led to a greater understanding of the basic science of aneurysmal disease. For
example, Curci and Thompson6 have been studying the
relationship between the secretion of matrix metalloproteinases (MMPs) and AAAs. They have measured increased
levels in the aneurysmal rather than the normal arterial wall.

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TABLE 6.

Indications for TAA Repair

60-mm diameter or 2 transverse diameter of an adjacent normal


aortic segment
Symptomatic regardless of size
Growth rate of aneurysm to 3 mm/y

This finding may lead to a simple test for increased aneurysm


sac growth after endograft repair.49 Advances in the basic
science of aneurysm disease are helping us better manage this
disease.

Future Directions
EVAR has clear benefits, especially in high-risk patients.
After long-term durability studies have been completed, we
will have a better idea of the role of EVAR in young, healthy
patients. The future of EVAR is exciting, with many new
developments on the horizon. The next generation of endografts will have smaller delivery systems that will permit
the application of this technology to a broader group of
patients. There are endograft designs in development that will
allow us to better treat aneurysms with short proximal necks
and tortuous iliac arteries. The results of ongoing clinical
trials will help elucidate the role of branched endografts that
facilitate treatment of suprarenal aneurysms. A new implantable sac pressuremonitoring device is being studied, and the
utility of this device in the surveillance of the endovascular
repair may help decrease the frequency of follow-up CT
scans. The EVAR story is still being written. This technology
is helpful to a segment of the population of patients with
AAAs, and more study will only broaden its application.

Endovascular Repair of Thoracic


Aortic Aneurysms
Aortic aneurysms, both thoracic and abdominal, generally
occur in the elderly and have thus been increasing in
incidence as the population ages and diagnostic capabilities
advance.50 With an incidence of 6 to 10 per 100 000 personyears, thoracic aortic aneurysms (TAAs) are less common
than AAAs but remain life-threatening.50,51 The natural history of TAAs is one of progressive expansion and weakening
of the aortic wall, leading to eventual rupture.5254 With an
associated mortality rate of 94%, TAA rupture is usually a
fatal event.51,55 The 5-year survival rate of unoperated TAA
patients approximates 13%, whereas 70% to 79% of those
who undergo elective surgical intervention are alive at 5
years.56 58 The risk of rupture mandates consideration for
surgical treatment in all patients who are suitable candidates
for operation. Specific indications for operative repair are
listed in Table 6. The use of endovascular stent grafts for
repair of TAAs is emerging as a promising, less invasive
therapeutic alternative to conventional surgical treatment.
Endovascular treatment of aortic aneurysms is achieved by
transluminal placement of 1 or more stent-graft devices
across the longitudinal extent of the lesion (Figure 3). The
prosthesis bridges the aneurysmal sac to exclude it from
high-pressure aortic blood flow, thereby allowing for sac
thrombosis around the endograft and possible remodeling of
the aortic wall. Although the advent and ensuing rapid

Figure 3. Stent-graft repair of thoracic aortic pseudoaneurysm.


A, Thoracic aortogram illustrates large aneurysm in a 58-yearold man who had surgery 22 years earlier to repair a traumatic
aortic injury from a motor vehicle accident. B, Aortogram after
stent-graft placement shows widely patent device without evidence of contrast media endoleak into the aneurysm sac.

evolution of endovascular aortic repair occurred initially in


the abdominal aorta, efforts to adapt this technology for the
thoracic aorta are ongoing. As is the case for AAA, a less
invasive approach to TAA repair is highly desirable, because
the patient population tends to be elderly and harbors multiple
comorbidities.54,58,59 Continued development of endovascular
therapy for thoracic aneurysms, however, is likely to provide
greater benefits in patient outcomes than those observed with
AAAs. Conventional surgical treatment of TAA is physio-

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Katzen et al
logically more demanding and carries a greater operative risk.
It mandates open thoracotomy, aortic cross-clamping, resection of the aneurysm, and replacement with a prosthetic graft,
and it often requires cardiopulmonary bypass.60 Despite
advances in operative technique, intraoperative monitoring,
and postoperative care, the mortality and morbidity of surgery
remain substantial and less favorable than outcomes for open
AAA repair. Mortality for TAA surgical repair ranges from
5% to 20% in elective cases and to 50% in emergent
situations.58,61 63 Major complications associated with surgical TAA treatment include renal and pulmonary failure,
visceral and cardiac ischemia, stroke, and paraplegia. Paraplegia is a particularly devastating complication nearly unique
to the surgical treatment of thoracic aneurysms, occurring in 5%
to 25% of cases versus 1% for AAAs.56,58,64 67 For these
reasons, a significant population of TAA patients are not
candidates for open repair and have been without a treatment
option until recently.
Endovascular aneurysm repair of the thoracic aorta is
currently focused on the descending portion, defined as being
distal to the left subclavian artery. Approximately half of
TAAs are located in the descending thoracic aorta.51,59
Anatomically, this aortic segment provides a substrate more
amenable for endovascular stent-graft repair given its avoidance of the great vessels proximally and major visceral
branches and aortic bifurcation distally. Despite these anatomic advantages and the ability to draw from early experiences with endovascular AAA repair, the development of
stent grafting in the thoracic aorta has progressed more
slowly than that of its infrarenal counterpart. The thoracic
aorta poses several unique challenges that have impeded
simple adaptation of endovascular devices and techniques
developed for the abdominal aorta.68 First, the hemodynamic
forces of the thoracic aorta are significantly more aggressive
and place greater mechanical demands on thoracic endografts. The potential for device migration, kinking, and late
structural failures are important concerns. Second, greater
flexibility is required of thoracic devices to conform to the
natural curvature of the proximal descending aorta and to
lesions with tortuous morphology. Third, because larger
devices are necessary to accommodate the diameter of the
thoracic aorta, arterial access is more problematic. This is an
important concern given the greater proportion of TAA
patients, relative to AAA patients, who are women, in whom
access vessels tend to be smaller. Fourth, as with conventional open TAA repair, paraplegia remains a potential
complication in the endovascular approach despite the absence of aortic cross-clamping.69,70 Lastly, the extent of
TAAs can often extend beyond the boundaries of the descending thoracic aorta and involve more proximal or distal
TABLE 7.

TAG (Gore)
Talent (Medtronic)

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Figure 4. Current thoracic stent grafts undergoing US clinical


trials. Left, TAG device manufactured by WL Gore & Associates,
Inc is composed of PTFE graft material and nitinol stent forms.
Middle, Talent thoracic graft from Medtronic, Inc is fabricated
from nitinol and polyester graft. Right, TX2 Zenith device created by Cook, Inc is a 2-component endograft with stainless
steel stent bodies and polyester graft material.

aorta than desired. Management of the left subclavian artery,


in particular, has gained considerable attention.7173
With these challenges in mind, significant progress has
been achieved since the first stent graft was deployed for
TAA exclusion in 1992.69,74 Although the development of
thoracic stent-graft technology remains in its adolescent
stages, the cumulative clinical experience with an estimated
5000 implants worldwide has yielded short- to mid-term data
that demonstrate promising results. This review will provide
an update on the current state of endovascular management of
aneurysms in the descending thoracic aorta.

Devices
Early clinical experiences with stent grafting of the thoracic
aorta were based on the use of first-generation, homemade
devices that were rigid and required large delivery systems
(24F to 27F).74,75 Fortunately, several commercial manufacturers of abdominal endografts have created derivatives for
the thoracic aorta with dramatic improvements over homemade devices. To date, none have been approved for use in
the United States, but 3 are undergoing clinical trials for FDA
approval (Figure 4; Table 7): TAG (W.L. Gore and Associates, Inc), Talent (Medtronic, Inc), and TX2 (Cook, Inc).
Although each device has unique features, all 3 employ the
same basic structural design. The endoprostheses are composed of a stent (nitinol or stainless steel) covered with fabric
(polyester or PTFE). The modular design of the TX2 system
renders it less flexible than the TAG but more so than the
Talent. The TAG device uses a delivery system that is
specifically designed to limit distal migration. The design of

Devices Undergoing FDA Review for TAA Repair

Device (Company)

TX2 (Cook)

Endovascular Aneurysm Report

Stent/Graft Material

Delivery Profile

Nitinol/PTFE

20F to 24F

Unique Properties
Flexible

Nitinol/polyester

22F to 27F

Uncovered proximally

Stainless steel/polyester

20F to 22F

Fixation barbs

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TABLE 8.
of TAA

Circulation

September 13, 2005

Anatomic Requirements for Endovascular Repair

A proximal neck at least 15 to 25 mm from the origin of the left subclavian


artery
A distal neck at least 15 to 25 mm proximal to the origin of the celiac
artery
Adequate vascular access: absence of severe tortuosity, calcification, or
atherosclerotic plaque burden involving the aortic or pelvic vasculature
The transverse diameter of the proximal and distal neck should be within
the range that available devices can appropriately accommodate

common iliac or abdominal aorta. Additionally, severe stenosis and tortuosity of the abdominal and thoracic aorta distal
to the target are contraindications for endovascular repair.
In spite of the use of these criteria, treatment failures can
occur, but the specific contributing factors and frequencies
are currently unknown, particularly over the long-term. Thus,
follow-up surveillance with serial CT scans at 1, 6, and 12
months and annually thereafter is recommended to monitor
changes in aneurysm morphology, identify device failures,
and detect endoleaks.

Clinical Experience
the proximal and distal ends varies, and some of the stents are
uncovered proximally and distally (TX2), whereas others
have an uncovered proximal end (Talent). In addition, the
TX2 stent uses barbs to facilitate fixation proximally and
distally. Ultimately, each device has its advantages and
disadvantages.

Requirements for Endovascular Repair


The evaluation of a patient for repair of their TAA considers
their overall risk profile, evidence of rapid enlargement of the
aneurysm, diameter 6 cm, or presence of symptoms. The
suitability of the patient for endovascular repair is based on
both clinical and anatomic considerations. Clinical parameters indicating a preference for the endovascular approach
over the traditional approach remain to be defined but should
be based on comparison of respective risk-benefit ratios.
Although data from long-term follow-up studies and randomized, controlled trials are pending, endovascular stent grafting
is currently reserved for high-surgical-risk and nonoperative
patients who have suitable anatomic features.
General consensus has been established for anatomic
prerequisites for endovascular repair (Table 8). Thorough
preprocedural imaging is essential to fully characterize the
lesion and access route. Detailed imaging evaluation can be
obtained with spiral CT or MRI; however, without the
availability of high resolution 3D renderings of the aorta,
catheter-based angiography remains the gold standard.
Measurements from imaging data are used to select the
appropriate device diameter and length.
Determination of aneurysm location in relation to the left
subclavian artery and celiac axis is of upmost importance.
Successful TAA exclusion requires normal segments of
native aorta at both ends of the lesion (the so-called landing
zone or neck) of at least 15 to 25 mm to ensure adequate
endoprosthesisaortic wall contact and formation of a tight
circumferential seal. Landing zones that are markedly angled
or conical or that contain thrombus can result in poor fixation.
Devices are oversized by 10% to 20% in diameter to provide
sufficient radial force for adequate fixation.
The vascular access route for device introduction and
delivery to the pathological target must be of sufficient size
and of suitable morphology. Stent grafts are most commonly
introduced through the femoral artery. Small-diameter, tortuous, and excessively calcified iliac arteries may preclude such
access, requiring more proximal retroperitoneal exposure and
direct cannulation of or creation of a graft conduit to the

The literature on thoracic stent grafting consists mostly of


small to medium-sized case series with short- to mediumterm follow-up (Table 9). Nevertheless, these studies illustrate a consensual pattern of outcomes when viewed in
aggregate. Overall, successful device deployment is achieved
in 85% to 100% of cases, and periprocedural mortality ranges
from 0% to 14%, falling within or below elective surgery
mortality rates of 5% to 20%.68,7590 As expected, outcomes
have improved over time with accumulated technical expertise, use of commercially manufactured devices, and improved patient selection criteria. The recently published
collective experiences of the EUROSTAR and United Kingdom Thoracic Endograft registries, the largest series to date
(n249), demonstrate successful deployment in 87% of
cases, 30-day mortality of 5% for elective cases, and paraplegia and endoleak rates of 4%.90 FDA phase II trial data
from exclusive deployment of the Gore TAG endograft in
142 TAA patients reveal similar results: technical success in
98%, 30-day mortality of 1.5%, paraplegia in 3.5%, and
endoleak in 8.8%.89
These results cannot be directly compared with the
outcomes of contemporary surgical studies. The majority
of TAA patients who were repaired by the endovascular
approach in these studies were older and sicker, having
been deemed either high risk or not suitable for open
surgical repair. For example, 52% of patients in the combined
EUROSTAR and United Kingdom registries were preoperatively classified as ASA 3 or above (American Society of
Anesthesiologists physical status classification that predicts
procedural risk: 1 to 2 indicates low risk; 3, intermediate risk;
4 to 5, high risk; and 6, organ donor).90 In light of these
patient substrate differences, endovascular TAA repair will
likely play a substantial role in the management of high-risk
patients. Furthermore, the applications of this less invasive
therapeutic modality may broaden if endograft studies with
lower-risk surgical candidates result in favorable mortality
and morbidity gains, particularly as devices and techniques
continue to evolve.
True comparisons between conventional therapy and the
endovascular alternative can only be achieved after the
completion of prospective, randomized, controlled trials.
Although such trials are under way, a few studies have
compared endovascular treatment with anatomically similar
open-surgery historic controls. As part of the phase II Gore
Excluder study, 19 TAA patients who were candidates for
open repair received stent-graft therapy and were compared
with a nonrandomized cohort of 10 patients who had under-

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Katzen et al
TABLE 9.

Endovascular Aneurysm Report

1671

Summary Data on Studies of Endovascular Repair of TAA

First Author and Year


of Study Publication

Mean
Follow-Up,
mo

30-Day Mortality,
%

Long-Term
Survival, %

Paraplegia,
%

83% Complete thrombosis

73 (Actuarial 2 year)

80% Complete thrombosis

10

NA

20

3.1

15.4
14.3

Devices

Technical Success

Homemade
Talent

Dake 199875

103

Ehrlich 199876

10

NA

Cartes-Zumelzu 200077

32

16

Excluder, Talent

90.6%

22

9.4

90.6 (32 Months)

Grabenwoger 200078

21

NA

Talent, Prograft

100%

9.5

NA

Greenberg 200079

25

15.4

Homemade

NA

20 (12.5 for elective,


33 for emergent)

NA

12

Temudom 200080

14

5.5

Homemade, Vanguard,
Excluder

78.6%

14.3

NA

7.1

Endoleak,
%
24

12
14.3

Najibi 200281

24

12

Excluder, Talent

94.7%

5.3

89.5 (1 Year)

Heijmen 200282

28

21

Talent, AneuRx, Excluder

96.4%

96.4 (Mean 21 months)

28.6

Schoder 200383

28

22.7

Excluder

100%, 89.3% Complete


exclusion

96.1 (1 Year), 80.2 (3 years)

25

Marin 200384

94

15.4

Excluder, Talent

85.1%

NA

NA

NA

24

Lepore 200385

21

12

Excluder, Talent

100%

9.5

76.2 (1 Year)

4.8

19

Sunder-Plassman 200386

45

21

Corvita, Stenford, Vanguard,


AneuRx, Talent, Excluder

NA

6.7

NA

2.2

22.2

Ouriel 200368

31

Excluder, Talent,
Other commercial

NA

12.9

81.6 (1 Year)

6.5

32.3

Bergeron 200387

33

24

Excluder, Talent

NA

9.1

75.8 (Mean 24 months)

Czerny 200488

54

38

Excluder, Talent

94.4%

9.3

63 (3 Years event free)

27.8

Makaroun 200489

142

29.6

TAG

97.9%

1.5

75 (2-Year freedom from death)

Leurs 200490

249

160

Excluder, Talent,
Zenith, Endofit

87%

10.4 (5.3 for elective,


27.9 for emergent)

80.3 (1 Year)

gone open repair before the availability of thoracic stent


grafts.81 All aneurysms met the same inclusion/exclusion
criteria for anatomic involvement. One-year survival was
89.5% in the endovascular group and 70% in the operative
group. As expected, mean hospital stay (6.2 versus 16.3 days)
and length of intervention (155 versus 256 minutes) were
significantly less among those treated endovascularly. In a
similar study, Ehrlich and colleagues found decreased 30-day
mortality (10% versus 31%), mean hospital stay (6 versus 10
days), and mean intervention time (150 versus 325 minutes)
in the endovascular group; the paraplegia rate was also
decreased (0% versus 12%).76

Complications
With the avoidance of aortic cross-clamping and prolonged
iatrogenic hypotension, endovascular TAA repair was expected to result in lower incidences of paraplegia relative to
conventional treatment. Indeed, this has held true, with
paraplegia rates generally ranging from 0% to 5% in endovascular studies,68,7590 whereas paraplegia occurs in 5% to
25% of open repair cases.56,58,64,65 Although low, these rates
remain significant, especially because it is impossible to
reimplant intercostal arteries in this setting. Some evidence
suggests that the occurrence of paraplegia is associated with
concomitant or prior surgical AAA repair and increased
exclusion length because of the absence of lumbars and
hypogastric collateral circulation.79,91 Adjunctive measures to
further reduce spinal cord ischemic complication rates in
endovascular TAA repair are being investigated.92
Endoleaks are the most prevalent of TAA stent-graft
treatment complications. However, their observed frequency
is substantially less than that reported for AAA endograft

3.5

8.8

4.2

repair.93 Interestingly, the distribution of endoleak types also


differs. TAA endoleaks occur more commonly at the proximal or distal attachment sites (type I endoleak), whereas the
majority of AAA endoleaks are type II.94 It is generally
accepted that type I endoleaks are more serious and require
expeditious intervention because they represent direct communications between the aneurysm sac and aortic blood
flow.95 Treatment options include transcatheter coil or glue
embolization, balloon angioplasty, placement of endovascular graft extensions, and open repair.96,97
Despite the hostile hemodynamic conditions of the thoracic
aorta, the anticipated complications of device migration and
kinking have occurred infrequently and have been observed
primarily with homemade devices and those with unsupported mid-graft segments.70 For both homemade and commercial endografts, however, questions about device durability and stability over the long term remain unanswered.

Future Directions
The cumulative worldwide experience with endovascular
repair of thoracic aneurysms has highlighted not only its
potential as an advance in treatment but also its limitations.
Efforts are under way to expand the applicability of endovascular stent-graft technology in the thoracic aorta, challenging
current anatomic constraints and clinical indications. A variety of exciting strategies are being explored and deserve
mention.
Although current anatomic criteria limit thoracic stentgraft exclusion to lesions located at least 15 to 25 mm away
from the origin of the left subclavian artery and celiac trunk,
it is common for descending TAAs to be located within the
proximal or distal neck length necessary for adequate fixa-

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1672

Circulation

September 13, 2005

tion. At the proximal end, the landing zone can be extended


by prophylactic left subclavian to left carotid artery transposition or bypass graft placement.69 Alternatively, the uncovered proximal portion of the Talent endograft can be placed
across the left subclavian origin to achieve fixation without
blocking flow. However, because case reports of inadvertent
coverage of the left subclavian artery origin found no resulting complications,98 subsequent studies determined that such
maneuvers may not be necessary as long as there is no
obstruction of the right vertebral or carotid artery and the left
internal mammary artery is not used as a coronary bypass
conduit.7173 Complications such as left arm ischemia were
found to be rare, possibly owing to collateral blood supply via
retrograde left vertebral flow. This is commonly referred to as
the subclavian steal phenomenon. Most centers now intentionally cover the left subclavian origin when necessary and
reserve secondary revascularization procedures for when
related symptoms develop.69
For even more proximal thoracic aneurysms involving the
aortic arch, branched and fenestrated stent grafts are being
developed to accommodate perfusion through the great vessels.99,100 Although feasibility has been demonstrated, it is
already apparent that the required implantation techniques
would have to be highly complex and demand considerable
technical expertise. Some centers have thus been investigating techniques to create fenestrations intraoperatively after
device deployment and coverage of critical branches.101
In contrast, there are no easy management strategies to deal
with a short distal neck. In this setting as well, fenestrated and
branched grafts have been used in isolated cases, but the
overall experience is very limited. Intentional coverage of the
celiac artery is not recommended given the risk of hepatic and
visceral ischemia. Although a normal superior mesenteric
artery may provide collateral flow, no methods exist to
predetermine whether such collateral supply would be sufficient. Furthermore, the celiac trunk may serve as a prominent
source of retrograde endoleak if covered without adjunctive
transcatheter occlusion. In distal aneurysms that involve both
the descending thoracic and abdominal aorta, combined open
AAA repair and endovascular TAA exclusion is a novel
treatment approach under investigation.
Stent grafts are also being used to treat patients with diffuse
aneurysmal disease involving the entire thoracic aorta. In
such patients, the traditional surgical treatment is a 2-staged
procedure named the elephant trunk technique.102 In the
first stage, the ascending aorta and aortic arch are repaired via
a median sternotomy, and an extra-long graft is used for
reconstruction, which leaves the excess portion of the graft,
the elephant trunk, dangling within the lumen of the remaining diseased aorta. In the second stage, the lesion in the
descending aorta is repaired via a left thoracotomy, and the
graft replacement is connected to the elephant trunk proximally. To bypass the need for thoracotomy, a few centers
have successfully deployed thoracic stent grafts into the
elephant trunk extension, altogether replacing the second
stage of the traditional elephant trunk procedure.103
Following closely on the heels of early clinical experiences
with stent grafting for TAA repair, experimental application
of this less invasive approach has been extended to a growing

number of other pathologies of the thoracic aorta. Most


noteworthy among these are aortic dissection,104 traumatic
aortic injury,105 penetrating atherosclerotic ulcer,106 and aortic rupture.107 Some investigators believe that thoracic stentgraft technology may eventually yield the greatest impact on
clinical care in the management of aortic dissections, because
current treatment standards are far from optimal.

Conclusions
The emergence of endovascular stent grafting as an alternative therapy to open surgical repair of abdominal and thoracic
aneurysms is an exciting advance. Although it is apparent that
high-operative-risk patients will benefit from this technology,
the exact role of stent grafting remains to be defined as we
continue to accumulate long-term data and experience and as
devices and techniques evolve. Instead of replacing conventional surgical treatment, endovascular repair will likely play
a complementary role and offer a less invasive option in our
treatment armamentarium. It is clear that the limitations of
both approaches are distinct. Although what is considered
high risk for surgery is defined by clinical parameters in terms
of comorbidities and physiological reserve, contraindications
for endovascular stent-graft treatment are defined by anatomical constraints. In this regard, each may fulfill the treatment
gaps left by the other.

Disclosures
Dr Dake has received research grants from Cook and W.L. Gore; has
served on the speakers bureau of Cook; and has consulted for W.L.
Gore. Dr Katzen has consulted for and received educational grants
from Cook, Boston Scientific, W.L. Gore, and Medtronic.

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Endovascular Repair of Abdominal and Thoracic Aortic Aneurysms


Barry T. Katzen, Michael D. Dake, Alexandra A. MacLean and David S. Wang
Circulation. 2005;112:1663-1675
doi: 10.1161/CIRCULATIONAHA.105.541284
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