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Chapter 6 Patient Selection Criteria for Endovascular Aortic Aneurysm Repair 109
straight and free of thrombus or irregular calcified plaques. This situation provides
for proper fixation and sealing of the graft and decreases the likelihood of
endoleak or graft migration. Unfortunately, such an aortic neck rarely exists
and when the neck is not ideal, alterations in graft design and fixation systems
have been developed to address this issue. These design enhancements include
fixation hooks/barbs, suprarenal attachment stents, balloon expandable stent
components, more precise deployment mechanisms, and fenestrated/scalloped
graft designs.
Suprarenal attachment graft designs have a bare-stent segment above the
level of the graft material and the proposed advantage is better fixation and
prevention of early and late stent graft migration. Current generation endog-
rafts are being increasingly and safely used for shorter and wider necks with
good results.
93
For individuals with a normal aortic segment at and above the
level of renal arteries but with not so suitable infrarenal neck, fenestrated and
multibranched endografts are being used in current clinical trials.
94–
97
Symptomatic and Ruptured AAA
EVAR is being increasingly used in many institutions to treat patients with
symptomatic or ruptured AAA who are generally treated with open surgical
techniques.
98–
104
The numbers of patients with ruptured AAAs that are being
treated with aortic endografts has steadily increased over the last several years,
driven primarily by the improved survival rates reported in the literature.
6
Unfortunately, the proportion of patients with ruptured AAAs who are suitable
for EVAR seems to be lower compared with asymptomatic AAAs because
ruptured AAAs tend to have larger neck diameters and shorter neck length.
103
EVAR utility varies from 40% to 80% in patients with ruptured AAAs.
103–
105
The preoperative investigations used to assess patients before endovascular
ruptured aneurysm repair (EVrAR) have varied among institutions. Whenever
possible, thin slice contrast-enhanced CT using CT angiogram protocol on the
way to operating room is useful in selecting patients for EVrAR. The old idea
that patients with a suspected ruptured AAA should go straight to the operat-
ing room rather than the CT scanner is hardly applicable in today’s world of
helical CTA with scanning times in seconds and rarely is a patient transferred
to the author’s institution with a ruptured AAA without a CT scan. If the
patient is too profoundly unstable to undergo CT scanning, an aortogram may
be performed through brachial or femoral approach to decide the candidacy
for EVrAR. In general, anatomical criteria to be considered for EVrAR of
ruptured AAA are similar to that of asymptomatic AAA.
Although the basic techniques for endograft implantation in ruptured
aneurysms are the same as for the elective situation, different strategies have
been applied. Aortobi-iliac, aortouni-iliac, and aortouni-femoral grafts have
all been used to a variable extent. Some centers have routinely used aortouni-
iliac grafts for acute cases, whereas others have favored bifurcated devices,
the choice of device depends upon the individual institution (device availability
and experience). An aortouni-iliac device has the advantage of relatively
rapid deployment of the primary graft, whereas it also requires implantation
of a contralateral occlusion plug into the iliac artery and revascularization
by a femorol–femoral crossover bypass. Rupture kits are being marketed by
various manufacturers which enable most aneurysms to be repaired with a
minimal amount of stock. Certain supplementary techniques such as placing
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110 V.N. Krishnamurthy and J.E. Rectenwald
occlusion balloon in the proximal abdominal aorta over a guide wire may also
be required during EVrAR of ruptured AAAs to control hemorrhage.
Several single-center studies have reported significantly improved outcomes
(morbidity, mortality, and length of hospital stay) in the short-term follow-up
compared with open repair. Ohki et al. reported the use of an aortouni-iliac
device in combination with an occlusion balloon placed via brachial artery
approach for treating ruptured AAA with a survival of 61% over a mean
follow-up of 15.6 months.
106
The mean survival duration in this study was
significantly longer for EVrAR than survival in patients treated by open surgical
repair (7.9 months).
Recently, Greco et al. reported a mortality rate of 39.3% for EVrAR com-
pared with 47.7% for open repair.
107
There were significant reductions in
pulmonary, renal, and bleeding complications. An analysis of the National US
Medicare database (1999–2003) showed that this early survival benefit disap-
peared at 6 month follow-up and stayed nonsignificant on continued follow-up
out to 2.5 years.
108
In conclusion, development of a successful EVrAR program should include
the treatment of ruptured or symptomatic AAA and requires the ready avail-
ability of an experienced endovascular team, a range of device sizes and
ancillary equipment, the capability to perform rapid preoperative imaging
(particularly CT), and excellent procedural imaging equipment in the operat-
ing room environment.
Aneurysms That Involve and Extend Above the Renal Artery:
Juxtarenal/Suprarenal AAAs and Thoraco-Abdominal Aneurysms
The AAA that involves renal arteries, visceral branches, and/or extend into
the thoracic aorta has complex anatomy making surgical repair challenging.
The mortality rates associated with conventional surgical treatment are higher
than the infrarenal AAA and range from 5% to 34%.
109–
112
In addition, there is
a significant incidence of major postoperative complications associated with
these aneurysms such as paraplegia, cardiopulmonary issues, and renal failure
resulting in a rate of hemodialysis that approaches 8% in some series.
113
The
successful application of EVAR as a less invasive treatment option to this
group of patients may provide improved outcomes compared to open surgery
for these complex aneurysms than typical infrarenal AAA.
The intricacy of designing and implanting endografts for aneurysms that
involve the visceral segment is more complex than infrarenal endografts. At
present, three designs of endografts have been developed and are currently
being evaluated for treating these complex aneurysms – fenestrated, reinforced
fenestrated, and directional branch grafts.
114
Fenestrated Endografts
These are the earliest endografts developed for juxtarenal aneurysms. These
grafts are custom designed and have holes that are synchronized to visceral
branches. A balloon expandable stent is then placed through the customized
fenestration once the main body graft has been aligned with the target visceral
ostia and deployed. The balloon is inflated to the size of the target vessel
and further flared with a larger balloon to rivet the visceral stent against the
graft and aortic wall. This is then repeated for the desired number of visceral
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Chapter 6 Patient Selection Criteria for Endovascular Aortic Aneurysm Repair 111
vessels. These are mainly applied in the endovascular treatment of juxtarenal
aneurysms.
94,
95,
97,
115,
116
Reinforced Fenestrated Endografts
This design is similar to the fenestrated endograft described above but with
the addition of the nitinol ring to support the circumference of the customized
fenestration, and the uncovered stent is substituted with a covered stent.
The reinforced fenestrated endograft design can be used to treat aneurysms
that involve the renal arteries or aneurysms involving all of the visceral vessels.
This device implantation is more challenging than a simple fenestrated device
as there exists a space between the fenestration and branch ostium which can
complicate cannulation. The use of covered stents rather than bare stents for
the visceral vessels requires longer and larger (less flexible delivery system)
balloon-expandable stent grafts. This type of graft design makes the branch
vessel origin relatively narrow and right-angled and this may make the renal
and visceral perfusion less physiological.
Directional Branch Endografts
This type of endograft is designed to overcome many of the shortcomings
seen in the reinforced fenestrated graft design. The directional branches are
constructed in a manner to optimize the flow dynamics between the aorta
and its branches. The branch allows more angulations between the aorta and
the visceral branch to be accommodated, avoiding the steep angles seen in
the reinforced fenestrated design. The length of the seal between the aortic
component and the visceral branch graft in this device is longer than the joint
within a reinforced fenestrated device (where the entire sealing region consists
of a nitinol ring surrounding the fenestration). One limitation of this design
is that these longer branches and sealing zones between the main body graft
and the visceral branches take up space within the aneurysm as well as the
delivery system making the device bulky (delivery device may be up to 24 F
sheath compared with 18–20 F for fenestrated grafts). In addition, the more
complicated visceral cannulations associated with branched endografts require
extensive fluoroscopy exposure, contrast load, and significant proficiency with
catheter and wire techniques.
Selection of patients for EVAR when the aneurysm involves and extends
above the level of renal artery origin is a difficult and complex problem. It
is heavily dependent on the availability of the various fenestrated grafts and
experienced endovascular surgeons. Recent studies have demonstrated the
mid-term safety and efficacy of fenestrated endografts.
116–
118
In the largest
series from the Cleveland Clinic, in which data on 119 patients was reported,
the perioperative (30 day) mortality was under 2%, and survival at 12, 24,
and 36 months was 92%, 83%, and 79%, respectively. Aneurysm sac shrink-
age was noted in 79% at 12 months. Endoleaks were uncommon and noted
in 9% of patients at 30 days (all type II), and 4%, 6%, and 3% at 12, 24, and
36 months, respectively. Results on the safety and efficacy of directional
branched endografts are still evolving. Early reports show favorable out-
comes.
119–
121
Long-term durability is not known and therefore, as in infrar-
enal EVAR, long-term, indefinite imaging and clinical follow-up is essential.
Thus, only those patients who can comply with the recommended follow-up
protocol should be selected for EVAR of aneurysms that involve visceral seg-
ment and thoracoabdominal aneurysms.
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112 V.N. Krishnamurthy and J.E. Rectenwald
Conclusions
EVAR is a landmark contribution in the management of AAAs providing
acceptable outcomes with a significant decrease in perioperative morbidity
and mortality rate compared to open surgical repair. There has been a signifi-
cant increase in the number of patients being selected for EVAR of AAAs over
the last decade. In recent years, the use of EVAR in the management of infra-
renal AAAs has increased to approximately 45–80%.
76,
80,
122,
123
This increased
use of EVAR has been attributed to increased familiarity and improved clinical
experience with endovascular techniques and significant technical advances in
the graft design.
Early results show reduced operative mortality rates, but randomized clini-
cal trials of EVAR versus open repair have not yet demonstrated differences
in survival or quality of life over 4 years of follow-up.
124–
126
More important,
EVAR is associated with a unique set of complications, secondary interven-
tions, and life-long imaging surveillance, leading to increased expense to
society.
127–
132
Adverse anatomy of the infrarenal neck/proximal attachment site remains
the most common reason for exclusion from EVAR repair, although recent
developments, such as fenestrated endografts, are beginning to address this
issue. Other common exclusion factors include severe bilateral iliac artery
disease and female gender (generally due to smaller ilio-femoral/conduit arteries)
but these issues will likely be addressed by decreasing the diameters of the
delivery catheters and development of more flexible endografts.
133,
134
One
issue surrounding successful treatment of AAAs with EVAR that is unlikely
to change is the fact that proper patient selection for EVAR will always remain
the key to a successful outcome.
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