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Valiant®
THORACIC STENT GRAFT. DESIGNED TO CONFORM.
Now available in
22mm diameters.
Expanding the dimension
of conformability
C O N F O R M A B I L I T Y. D U R A B I L I T Y. D E L I V E R E D W I T H S I M P L I C I T Y
Not for distribution in the USA. © 2008 Medtronic, Inc. All rights reserved. UC200903416EE
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E N DU R A N T
E VO L U T I ON
A A A
S T E N T
G R A F T
S Y S T E M
FROM 1000'S OF DIFFERENT ANATOMIES AND 1000'S OF DIFFERENT
TREATMENT CHALLENGES, A 12 YEAR EVOLUTIONARY CYCLE HAS
PROVIDED A SOLUTION - A SUPER SPECIES OF STENT GRAFT.
I T I S M E DT R O N I C ' S U LT I M AT E E V O L U T I O N .
EN DURANT
AAA Stent Graft System
IT IS...
N AT U R A L S E L E C T I O N
Xcelerant®
Hydro Delivery
System:
Hydrophilic
coating
Resilient:
©2008 Medtronic, Inc. All rights reserved. UC200900638EE
Multifilament
polyester
fabric
Talent™ AAA
Stent Graft:
Xcelerant®
Delivery
System:
Trackability /
Flexibility
Ease of use
Valiant®
Stent Graft:
Conformability
Laser-cut
nitinol
stent
Suprarenal
fixation /
UniDOC
technology
*
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I
he Endurant® Stent Graft
System evolved from the
work of a collection of
engineers and physicians spanning
several regions worldwide. The
development of the stent graft
that eventually became known as
“Endurant” actually began in 2001
as a Talent II project in Sunrise,
Florida (the old World Medical
Headquarters), which included an
M-shaped proximal sealing stent
and a tip capture system. However,
the Talent II project had barely
begun when it was postponed and,
in 2003, it restarted as the Endurant
project in Santa Rosa, California
(Vascular Headquarters). Over the
next several months, the technical
design work continued sporadically
as the team focused on customer
input requirements.
In May 2004, the development
of the Endurant device continued
in earnest. For the first time, active
fixation and flexibility were included
as design targets. To help refine and
finalise designs of the Endurant
Stent Graft and Delivery System,
the project team sought feedback
from several physicians. In fact, by
the time the Endurant design was
frozen, more than 200 physicians
worldwide had been surveyed.
With the help of engineers from
Medtronic’s facility in Galway,
Ireland, the initial effort for the
stent-graft design was concentrated
on the suprarenal and sealing
region. The design team started by
separating the stent design from the
active fixation design and developed
three suprarenal/sealing concepts:
n Connected proximal stent
– one-piece, integrated suprarenal and infrarenal stent;
n Single element stent – single
stent sewn to the proximal
fabric edge; and
n Separated stents – two
different stent structures at the
proximal fabric edge.
Several designs of each concept
were developed and analysed for
radial force, short neck sealing,
angulated neck sealing, flexibility,
durability and crossing profile.
After these evaluations, the team
selected the “separated” design
because it performed the best.
Similarly, three concepts for
active fixation were developed:
n Single pin – one anchor pin
attached to each suprarenal
apex;
n Connected pin – two pins
originating from an apex but
merging to form one pin; and
n Separate pins – two pins
originating from an apex and
remaining separate.
Several concepts from each
group were developed and analysed
in proximal migration resistance
tests, including straight and
angulated performance in silicone
tubes and straight pull-out tests in a
bovine aorta. Because of its superior
fixation strength, the “separate pin”
design was selected.
Various designs were considered
for the body and limb stents,
including wire and laser-cut stents
with differing numbers of stent
apices. The main design criteria
for body stents were flexibility,
durability and conformability.
Wire-formed stents demonstrated
improved radial fatigue performance and were less abrasive
to the fabric than laser-cut stents,
whereas shorter stents with more
of apices were more flexible. As a
result, the Endurant body stent
design included short, wire-formed
stents with 10 to 12 apices and the
Endurant limb stents included
short, wire-formed stents with six
to eight apices.
In developing the tip capture
delivery system, both “pull-down”
and “push-up” designs were
evaluated. The spindle and
“push-up” sleeve design was
eventually chosen because of
its improved deployment
accuracy compared with the
“pull-down” method.
After three years of development
and testing, the first patient was
treated with an Endurant device
in November 2007, as part of the
Endurant CE Mark Clinical Trial.
The trial encompassed 10 sites
in Germany and the Netherlands
and treated 80 patients. Hence
Verhagen, the CE Mark Trial
Principal Investigator, said:
“This next-generation device has
performed exceptionally well in
the treatment of abdominal aortic
aneurysms. The Endurant System
has the potential to expand the
applicability of EVAR to more
AAA patients who have been
considered especially difficult to
treat.” As of the mid-January 2009,
approximately 1660 patients have
been treated with the Endurant
Stent Graft and many are soon to
follow since the Endurant device
was commercial released on 12
August 2008.
As a member of the
Endovascular Innovations
team since 2000, it is especially
rewarding for me to see the next
platform of AAA Stent Graft come
to market and fulfill the Medtronic
Mission of alleviating pain,
restoring health and extending life.
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EDA>8A>C>8D86G:<<>!;ADG:C8:!>I6AN
I
he development of
endovascular aneurysm
repair (EVAR) of abdominal
aortic aneurysms (AAA) has led to
a major change in treatment for
patients with aortic aneurysms.
The number of endovascular
procedures for AAA treatment has
substantially increased after the
publication of EVAR1 and DREAM2
randomised trials 1,2 and EVAR has
now become a widely accepted
alternative option to standard
open repair. Moreover, studies
have shown that EVAR is safe and
effective in both the medium and
long term.3–5
Nevertheless, anatomic
difficulties continue to pose serious
challenges to aortic endografting.
The continual need to find less
invasive means to manage AAA has
resulted in a continuous evolution
of materials6, 7 that aim to treat
patients with difficult vascular
access and complex attachment
site geometry, since the proximal
aneurysm neck is a well recognised
risk factor of early failure.8, 9
Medtronic has recently released
on the European market the
Endurant® Abdominal Stent Graft
System: a new, high-flexible and
low-profile stent graft that is
specifically designed to improve
conformability and trackability in
patients with complex anatomies.
The main improved features of
the design are a short M-shaped
proximal sealing stent to enhance
flexibility and sealing performance
in the angulated neck, and
anchoring pins to ensure proximal
fixation. The graft has been
assessed in the European clinical
trial of the Endurant Stent Graft
System at 10 different centres in
the Netherlands and Germany, with
encouraging results.
We describe the case of a
patient with an asymptomatic
AAA, who was unfit for open
repair because of high clinical
risk and had severe angulations
and extensive external iliac artery
stenosis. He underwent successful
endovascular treatment with the
new Endurant Abdominal Stent
Graft.
obesity (body-mass index
31·1 kg/m2) and chronic
obstructive pulmonary disease
(forced expiratory volume in 1 sec
65%). Thoracic and abdominal CT
angiography (CTA) confirmed the
duplex scan findings and showed
the presence of two remarkable
angulations and circumferential
calcification and stenoses of
bilateral external iliac arteries, a
proximal neck of 20 mm diameter
with a length of 20 mm, a common
iliac artery diameter of 15 on the
right and 12 mm on the left, and
a 5 mm diameter of the bilateral
proximal external iliac arteries at
calcification level (figures 1 and
2). However, the high clinical risk
of the patient emphasised the
indication for an endovascular
approach, and we chose the
Endurant Abdominal Stent Graft
8VhZgZedgi
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A 77-year-old man was referred to
our vascular clinic with a duplex
scan diagnosis of a 7 cm AAA. The
patient had many comorbidities
including smoking, hypertension,
dyslipidaemia, chronic coronary
artery disease (previous myocardial
infarction that was treated with
coronary artery bypass graft),
,
8DC;DGB67>A>IN:6HN688:HH
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'
System because of its specific
features and benefits.
We undertook the operation
using local anaesthesia and mild
sedation with use of a mobile
C-arm (OEC 9800, GE Healthcare,
USA). Because of substantial
calcification of the common
femoral arteries (CFA) we decided
not to proceed with a percutaneous
access, and a surgical exposure of
both CFA was done. After we had
undertaken a preoperative digital
subtraction angiography (DSA)
with a calibrated pigtail catether
(figure 3), an ENBF2513C170EE
18F main body was introduced
through the left CFA to follow
the aorta axis, and was deployed
just below the origin of the
renal arteries (figure 4). The low
profile and hydrophilic coating
of the delivery system allowed the
severely calcified and stenotic
iliac axis to be easily tracked. The
smooth Xcelerant release system
combined with the new capture
tip, holding the suprarenal stent
closed inside the delivery system,
allowed a very precise deployment
in the tortuous proximal aortic
neck. Furthermore, the proximal
M-shaped stent conformation
allowed the graft to closely
adapt to the severe angulated
+
)
*
aortic neck. To increase passive
columnar strength, we deployed
the main body in cross-leg manner.
The suprarenal stent was then
released and the stent graft was
actively fixed to the aorta with the
anchoring pins (figure 5).
The contralateral gate was
cannulated with standard
technique and we deployed an
iliac limb ENLW1616C120EE.
After ballooning the proximal and
distal landing zones and the graft
junctions with a Reliant® balloon,
a completion DSA showed normal
patency of the stent graft,
visceral and iliac vessels, and
no evidence of any endoleak
(figure 6).
We observed the patient 24h
in the intensive-care unit and
subsequently discharged
him without any major
complication.
Postoperative follow-up at one
month included X-ray, duplex
scan, and CTA. The duplex showed
no evidence of endoleak and the
absence of sac pulsatility with Mmode. The CTA was reconstructed
and a post-processing vessel
analysis done with 3surgery 4.0
software. The proximal fixation
of the endograft in the proximal
part and its adaptability to the
Figure 1 & 2
Figure 5
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Figure 6
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Figures 7 & 8
(9edhi"
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tortuosity of the neck were at an
optimum (figures 7 and 8), and
we confirmed the absence of any
endoleak.
9^hXjhh^dc
This case shows how the Endurant
Abdominal Stent Graft System
is technically feasible and offers
good early results even in presence
of unfavourable anatomy that
would have typically precluded an
endovascular approach. However,
since the patient was unfit for open
surgery because of the multiple
severe comorbidities, an alternative
to open repair was mandatory.
The Endurant Abdominal Stent
Graft System was considered the
best option because of its specific
characteristics in terms of proximal
graft configuration, reduced device
profile, and hydrofilic coating of the
delivery system. Proximal fixation
in such an angulated neck was the
major issue; adaptability of the
main body and precise deployment
was essential to prevent early
failure of the procedure.
Development of newer
generations of devices seems
to increase the feasibility of
endovascular repair. However,
until further data show long-term
durability of these endografts in
such challenging anatomies, we
would continue to recommend
this approach only in very selected
patients who are at high risk for
open surgery.
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The opinion and experience expressed by Giovanni
Pratesi, Aaron Fargion and Carlo Pratesi are under
their sole responsibility.
Use of Endurant Stent Graft outside the scope of the
IFU is under sole responsibility of Giovanni Pratesi,
Aaron Fargion, Carlo Pratesi.
Produced with educational grant from Medtronic
CardioVascular.
.
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Figure 1
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Figure 2
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6
n 83-year-old male
patient presented with an
abdominal aortic aneurysm
(AAA) of 78 mm diameter. He had
several previous surgeries and
comorbidities and suffered from
atrial fibrillation, which was treated
with Sintrom. The patient was also
treated for bilateral inguinal hernia
and varicose veins on both legs,
and had a prostatectomy.
A CT scan was done (GE, GE
Medical Systems, Salt Lake City,
Utah, USA) and images were
analysed on a GE AW workstation
with advanced blood vessel
analysis. The patient had an
infrarenal proximal neck of 24 mm
in diameter and 13 mm in length.
The infrarenal angulation of the
neck was measured at 70°. Both
common iliac arteries were ectatic,
24 mm on the right side and
15 mm with a remarkable angulation on the left side. The femoral
and external iliac arteries were of
good quality (figure 1).
We decided to implant an
Endurant® Bifurcated Stent Graft
with a right-side approach. We used
an EN2813C145EE1 main body with
an ENLW1620C120EE2 contralateral
limb and an ENLW 1628C120EE3
iliac extension on the ipsilateral
side. The operation was undertaken
percutaneously with a Prostar
(Abbott Vascular Devices, Redwood
City, CA, USA), on each side.
The Endurant main body was
introduced via the right groin per-
&
'
cutaneous approach and advanced
through the vasculature without
difficulty until it was positioned at
the level of the renal arteries. It was
then deployed, placing the proximal
radiopaque markers immediately
below the left renal artery (figure
2). The positioning was precise and
the stent graft conformed very well
to the angulation of the aorta, thus
maximising the sealing zone on the
full length of the neck.
After the release of the suprarenal
bare stent with anchoring pins,
the spindle of the delivery system
was pressed against the aortic wall
because of the sharp angulation of
the neck. It was therefore important
to gently rotate and advance the
delivery system 2–3 cm proximally
before recapturing the tip and
retrieve the delivery system
(figure 3).
The contralateral limb was
advanced without difficulty despite
a tortuous iliac artery. It was then
deployed, adapting perfectly to the
arterial anatomy. The 28 mm iliac
extension on the ipsilateral side was
released, adapting well to the iliac
ectasia. Overlapping zones between
the different components were
ballooned with the Reliant® balloon
from Medtronic.
The final angiography showed a
perfect exclusion of the aneurysm,
with no presence of endoleaks.
There were no postoperative events
and the patient was discharged 48h
after the procedure (figure 4).
(
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Difficulties in advancing the
endoprosthesis via the iliac arteries
is one of the most common and
difficult challenges faced in the
endovascular treatment of AAAs.
The low profile of the Endurant
Delivery System with hydrophilic
coating helped with the treatment
of this patient with challenging
vasculature and difficult access.
Another noteworthy aspect of
the Endurant endoprosthesis is
its great adaptability to the
patient’s anatomy, thanks to its new
design, which makes it flexible and
conformable. This case involved a
short, highly angulated proximal
neck. The Endurant Stent Graft
achieved a perfect seal. Despite the
sharp angulation, retrieving the
spindle was not difficult.
We consider the Endurant endoprosthesis to be an improvement
in the treatment of AAAs. It
offers an endovascular treatment
opportunity in cases involving
complex anatomies, although the
medium-term to long-term results
must be awaited.
The opinion and experience
expressed by Dr M de Blas and
Dr J M Egaña is under their sole
responsibility. Use of Endurant
Stent Graft outside the scope of
the IFU is under sole responsibility
of Dr M de Blas and Dr J M Egaña.
Produced with educational grant
from Medtronic CardioVascular.
)
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D
n 15 October 2008,
Bonn’s local newspaper
(Bonner General-Anzeiger)
reported the following news story.
Mr Otto Carl, a former translator
at the Federal Press Office in
Germany, has set a precedent in
medicine. To date, at the age of 98,
Carl is the oldest person in whom
an Endurant® AAA Stent Graft has
been implanted.
For Mr Carl, an endovascular
procedure with stent grafts
that were already available on
the market was not an option
because of the severe condition
of his access vessels, iliac arteries
and abdominal aorta. Mr Carl’s
abdominal aortic aneurysm was
7 cm in diameter, and both he
and his son, Helge, were aware
of the risk of rupture and the
seriousness of his life-threatening
condition. When his family doctor
LeftBgDiid
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:cYjgVciHiZci
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learned of the new, less invasive
endovascular procedure, Mr Carl
and his son found a physician
– Dr Wolf Schare – who was
willing to risk the operation at
Marienhospital in Bonn, Germany.
Dr Schare considered a
suitable approach using the latest
generation of stent graft technology
developed by Medtronic, the
9gHX]VgZhZaZXiZYi]Z
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Endurant Stent Graft. After
consultation of the Indications
and Instructions for Use, Dr
Schare selected the Endurant
device because of its low profile
delivery system, high flexibility
and adaptability to tortuous and
challenging anatomies, and ease
of use. The implantation was very
successful and Mr Carl recovered
quickly after the operation, thanks
to his healthy lifestyle and what
he calls the good genes that give
his family longevity. Dr Schare
also described his patient as being
“incredibly fit” for his age.
Otto Carl has not regretted
his decision to undertake the
procedure. On the contrary: he is
committed to coming back for his
follow-up visit when he has reached
“at least 105 years of age” with the
Endurant Stent Graft.
&&
I=DG68>88DC;DGB67>A>IN
:[[ZXid[hiZci\gV[i
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igZVibZciVcYgZhjaih
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i]ZXdbbZgX^VaanVkV^aVWaZi]dgVX^XhiZci\gV[ih
7N>6CAD;IJH!HI<:DG<:ÉHK6H8JA6G>CHI>IJI:!HI<:DG<:ÉH
=:6AI=86G:C=HIGJHI!ADC9DC!J@
9
ifferences in the usability
and performance of the
commercially available
thoracic stent grafts are clear.
Direct comparison of device
specific outcomes, however, is
difficult, since few comparative
and certainly no randomised
studies have been done. This is
explained partly by the fact that
indication to treat and device
selection depends to an extent on
patient-related and anatomical
criteria. Although most of the
available devices are suitable for
anatomically straightforward
aneurysms, unfavourable anatomy
shows the technical restrictions of
some of the devices on the market.
Until recently, thoracic
endograft design and manufacture
has not kept up with clinical
ambition. Early thoracic stent
grafts were derived from designs
intended for the infrarenal aorta.
As experience with thoracic
endografting grows, the case mix
has become increasingly complex,
with indications for stent grafts
expanding. The thoracic aorta
poses substantial and specific
challenges in endograft delivery,
deployment and fixation.
These challenges include:
n The ability of endografts to
conform to the anatomy of
the aortic arch. Nonconformability of grafts can
cause a device to sit proud in
the arch, making it inherently
unstable. Grafts that do not
oppose to the curvature of the
arch can be prone to migration,
collapse and pseudo-coarctation.
n The ability of long delivery
systems to track through
tortuous, calcified vessels. This
can lead to excessive force in
device delivery, risking cerebral
or distal embolisation, or trauma
to the aortic wall.
n The ability to provide secure
fixation and long-term durability.
Recent evidence has drawn
attention to the incidence
of long-term endoleak and
graft migration, and a definite
incidence of late aortic-related
death.
n The accuracy of deployment,
particularly in the aortic arch,
where high forces might lead
to inaccurate deployment,
excessive device manipulation,
great vessel occlusion or
proximal endoleaks.
The ideal stent graft should be
able to conform to the anatomy
of the aortic arch with satisfactory
apposition to both greater and
lesser curves, the ability to provide
durable proximal fixation, and
a durable stent design. These
properties should be delivered in
a device that can track through
narrow tortuous vessels and
deploy accurately.
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hjWhiVci^VaX]VaaZc\Zh
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Devices available at present use
different stent-graft constructions
with inherent differences in rigidity,
conformability and durability.
Different fixation devices create
varying security of fixation and
potential for aortic-wall trauma.
Furthermore, the delivery device
and system of deployment create
different challenges in terms
of accuracy of deployment and
trackability.
The Gore TAG® endoprosthesis
consists of an ePTFE graft that is
supported by an external nitinol
stent. A sealing cuff is present
at each end, along with a device
spring flare for radial force fixation.
Delivery starts in the middle of
the device and enables rapid
deployment. However, the speed
of deployment can compromise
accuracy of deployment, especially
in the aortic arch. In the phase II
Pivotal and Confirmatory Studies1,
Gore showed favourable results
compared with open surgery.
However, trial entry criteria were
strict and the data are probably
not indicative of present thoracic
endovascular practice. Concerns
have also been raised about device
integrity and long-term durability.
Despite design modifications
during the initial studies, modified
devices have been noted to contain
stent fractures that are consistent
with fatigue failure.2
The TAG device has been
increasingly used for the treatment
of a diverse range of thoracic aortic
pathologies. Some studies have
shown that complication rates have
&'
I=DG68>88DC;DGB67>A>IN
Figure 1
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risen as a reflection of this practice
and have expressed caution in the
use of the device in complex arch
anatomy3 (figure 1).
The Cook Zenith TX2® stent
graft consists of a dacron graft
covered by stainless steel modified
Gianturco Z-stents. Both the
proximal and distal components
comprise a tubular stent graft with
an uncovered bare stent, with barbs
incorporated in the lower segment
of the distal endograft device.
The proximal device incorporates
fixation barbs made of stainless
steel to provide proximal fixation.
Device deployment is achieved by
withdrawing an external sheath.
The proximal end of the graft is
held to the delivery system with
use of trigger wires that keep the
proximal end of the graft in position
relative to the target anatomy.
Matsumara and colleagues4
have recently reported results from
a prospective, non-randomised,
multinational trial involving
42 centres and 230 patients
undergoing repair of descending
thoracic aortic aneurysms with
the Zenith TX2 device. The 30-day
survival rate was comparable with
open repair (98.1% and 94.3%
respectively) as was the reintervention rate, but the morbidity
score at 30 days was significantly
lower in the endovascular
group. Follow-up showed at 12
months aneurysm growth in
7.1% of patients, endoleak in
3.9% and migration in 2.8%.4
Again, allocation to endovascular
treatment or the surgical control
group was based on strict
anatomical criteria. The TX2 device
is a substantial improvement on
the predecessor, but bench test
conformability remains a problem
in the aortic arch8 and the delivery
system is also fairly complex.
The Bolton Relay® device consists
of self-expanding nitinol stents
sutured to a polyester graft. A spiral
nitinol wire provides longitudinal
support and can potentially
affect on stent conformability
in the angulated arch. However,
reasonable results in terms of
aneurysm exclusion have recently
been published in a registry
series of 150 cases5, in which
additional procedures – including
subclavian bypass/transposition
– were required in 30% of cases. Of
concern, however, is the fact that
there were three migrations and
one kinked device5. Furthermore,
most required only one stent,
suggesting that this cohort
represents a fairly straightforward
anatomical group.
The Medtronic Valiant®
endoprosthesis is an evolution
from the Talent™ TAA graft that
incorporated modifications to
stent design, delivery sheath,
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graft configuration, deployment
methodology and markers.6 A
nitinol eight peak proximal spring
provides radial force for secure
proximal fixation and apposition to
the vessel wall. The proximal stent
graft has a Free Flo configuration,
and the distal stent graft a closed
web configuration. The body of the
graft can be straight or tapered, and
the distal fixation can be closed web
or have a bare-spring configuration.
The graft is manufactured
without a connecting bar, which
is designed to enhance flexibility.
Early experience of the device
demonstrated a substantial
improvement in wall apposition,
even in challenging arch anatomy
(figures 3a-3b). The delivery
device incorporates an integrated
handle for deployment, providing
a mechanical advantage and a
reduced user-sensed deployment
force. The graft cover of the system
has been improved to provide
improved trackability and lower
force of deployment.
In a recently published registry
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I=DG68>88DC;DGB67>A>IN
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of initial experience with the
Valiant system,7 180 patients were
studied from seven European
centres. Pre-emptive open surgical
procedures before covering
aortic branches included three
ascending aortic bypasses to the
brachiocephalic and left common
carotid arteries, 17 carotid-carotid
bypasses, 14 carotid-subclavian
revascularisations, 18 visceral
bypasses and 11 access procedures.
More than one device was deployed
in 50% of procedures compared
with 30% in the Talent study,
despite the longer length of the
Valiant device. Although the
Valiant Registry had a much more
complex anatomical group than
the Talent Registry did, the primary
technical success rate was 95%. The
30-day/inpatient mortality rate was
7.2%. Excluding hybrid procedures,
the 30-day mortality and paraplegia
rates were 3% and 1.3%.7
Recent work from Canaud and
co-workers8 has shown a clear
difference in the fixation forces of
the four commercially available
stent grafts. In a bench top pulsatile
flow model, the Valiant device
remained apposed to the aortic
wall, with increasing increments
of arch angulation and degree of
oversizing. The Relay, TAG and
Zenith devices lacked apposition
over 80°, 90° and 70°, respectively.8
This finding is reflected in clinical
(W
practice, on which conformability
and apposition of the Valiant device
even in pronounced arch angulation
are secure and predictable. This is
likely to reflect a combination of the
distribution of radial force, device
flexibility, and open stent design of
the proximal stent.
In summary, trials for regulatory
purposes often use strict
anatomical criteria for inclusion
that are unrepresentative of
clinical practice. Multi-centre
registry data could offer the best
opportunity for assessment of
new endovascular grafts and
techniques, since many cases
can be collected in fairly short
periods of time, and reflect modern
practice. Initial experience with
the Valiant stent graft suggests
that there are substantial design
improvements over previous
devices as discussed in this article,
and these have been reflected
in increasing clinical ambition
regarding complexity of case.
The opinion and experience
expressed by Ian Loftus are under
his sole responsibility. Use of
Valiant Stent Graft outside the
scope of the IFU is under sole
responsibility of Ian Loftus.
Produced with educational grant
from Medtronic CardioVascular.
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I
horacic endovascular aortic
repair (TEVAR) was introduced to the clinical arena
by the Ukrainian surgeon Nicolas
Volodos, who first implanted a
membrane-covered homemade
stent-graft device in a patient with a
traumatic aortic pseudoaneurysm
in 1986.1 In 1994, Michael Dake
from Stanford University in
California reported the first results
of TEVAR for the treatment of
13 patients with thoracic aortic
aneurysms in the New England
Journal of Medicine.2
In 1999, Michael Dake3 and
Christoph Nienaber4 from the
University of Rostock, Germany,
simultaneously published results
of TEVAR for the treatment of
patients with acute and chronic
descending aortic dissections
(type B dissection according to
the Stanford classification). Since
then, TEVAR has been increasingly
used as a less invasive treatment
option.5, 6 Acute results of TEVAR
are promising, and the risk of
neurologic complications seems
to compare favourably with open
surgery. Paraplegia rates range
between 1% and 2% whereas stroke
is encountered in 2-5% of patients.6, 7
This article discusses the
technical and procedural considerations to undertake a successful
TEVAR procedure.
GVi^dcVaZd[I:K6G^cVdgi^X
Y^hhZXi^dc
Previous studies have consistently
identified persisting perfusion of
the false lumen via a proximal entry
tear in the descending thoracic
aorta to be the major predictor
of adverse long-term outcome in
patients with type B dissection8, 9.
Conversely, spontaneous complete
thrombosis of the false lumen is
associated with improved prognosis. However, in clinical practice,
thrombosis of the false lumen
occurs only rarely (<4% of patients).9
Patients can develop partial
thrombosis of the false lumen, but
recent data from the International
Registry on Aortic Dissection (IRAD)
suggests that partial false lumen
thrombosis is associated with
adverse outcome.10
TEVAR aims at non-surgical
reconstruction of the dissected
aorta by implantation of a membrane-covered stent graft across
the proximal entry tear to obliterate
flow into and depressurise the false
lumen. Subsequent false lumen
thrombosis will eventually induce a
process of aortic remodelling with
enlargement of the true lumen and
shrinkage of the false lumen.
EVi^ZcihZaZXi^dc
Selection of the appropriate
patient candidate for TEVAR
provides the basis for undertaking
a successful procedure. At present
there is general consensus that
TEVAR is indicated in patients
with acute aortic dissections that
are complicated by impending or
contained rupture, malperfusion
syndrome, refractory hypertension,
recurrent pain, or early enlargement
of the aortic diameter. Conversely,
TEVAR indications for patients who
survive the initial event and enter
a stable clinical course are as yet
unclear. A multicentre randomised
trial (Investigations of Stent-Grafts
in Aortic Dissection – INSTEAD)11
which, so far, has been presented at
scientific meetings but has not yet
been published, compared optimal
medical treatment with TEVAR in
patients with subacute stable type
B dissection with no complications.
Follow-up results at one year
suggested that TEVAR might not be
better than a conservative medical
strategy in this specific patient
cluster. Therefore, a primarily
conservative approach is advised
for patients with stable subacute
dissection, reserving TEVAR for
evolving complications.
A recent consensus statement12
from international TEVAR
experts chaired by Lars Svensson
from the Cleveland Clinic in
Ohio, USA, considered the
following indications for TEVAR in
patients with chronic (>14 days
after impact) dissections in
analogy to open surgical criteria:
persisting perfusion of the false
lumen via a proximal entry tear
amenable for TEVAR and aortic
diameter >5.5 cm, documented
aortic expansion >1 cm per year,
resistant hypertension despite
antihypertensive combination
therapy, recurrent episodes of
chest or back pain that cannot be
attributed to another cause, or
chronic malperfusion syndrome.12
In addition to dissection-specific
criteria, the general clinical health
of the patient has also to be taken
into careful consideration when a
TEVAR procedure is contemplated.
Analyses from the Stanford group13
and from our group14 have suggested that the general health status
of the patient is the most important
predictor of long-term outcome.
Patients who are not candidates
from open surgery because of their
reduced health status might not
benefit from TEVAR in the long
term (table 1).
&*
I:K6GI=:G6EN
Table 1: >cY^XVi^dch[dgI:K6G^ceVi^Zcihl^i]IneZ7
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Once the indication for TEVAR is
present in an individual patient,
careful preinterventional planning
is paramount for a successful
procedure. Failure to adequately
plan is planning to eventually fail.
Careful imaging is crucial in
the preinterventional planning.
In my experience, I prefer
contrast-enhanced computerised
tomography (CT). The CT should
include the entire aorta and should
also cover the proximal part of the
head vessels down to the femoral
artery bifurcation. A maximum
slice thickness of 3 mm is
acceptable, with 1 mm being the
preferred thickness.
Multiplanar reconstructions
(MPR) are very useful, particularly
for diameter measurements in the
proximal landing zone within the
aortic arch. Therefore, I request
sagital and transverse MPR in
every patient who is considered
for TEVAR, but admittedly most
of the measurements are done on
the source axial images. Personally
I find that 3D-volume-rendering
techniques are more time
consuming than helpful in patients
with aortic dissection.
Magnetic resonance imaging
(MRI) also provides comprehensive
imaging of the entire aorta and
can be used for preinterventional
planning. Transesophageal
echocardiography (TEE) alone is not
sufficient for planning of an elective
TEVAR procedure and should be
used in conjunction with CT or
MRI. TEE is very useful during the
procedure itself; however, it usually
requires general anaesthesia
because of the discomfort of the
probe with the patient in a supine
position. Invasive angiography
is only rarely required for taking
preinterventional measurements,
but should be undertaken in
patients with suspicion of coronary
artery disease to exclude or treat
significant coronary artery stenoses.
Further indications for invasive
angiography are borderline femoral
artery dimensions or significant
kinking of the iliac axis.
Images should be assessed for
the location of the proximal entry
tear. When the tear is in close
vicinity to the offtake of the left
subclavian artery (LSA), intentional
occlusion of the LSA should be contemplated to avoid proximal type I
endoleak. I prefer stent grafts with
a free-flow proximal bare spring
when approaching the aortic arch,
although anecdotal reports suggest
higher risk of retrograde dissection
of the ascending aorta associated
with first generation Thoracic stent
grafts. In most patients, occlusion
of the LSA can be done without
prior surgical revascularisation. The
occurrence of ischaemic symptoms
of the arm is rather low.15 However,
there is a risk of severe neurological
complications.15 Therefore it is
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advisable to perform magnetic resonance angiography of the vertebral
arteries and the intracranial arteries
preintervention15.
In case of dominance of the
left vertebral artery or incomplete
formation of the basilar artery from
the right vertebral artery, surgical
transposition or bypass surgery of
the LSA is advised before TEVAR
to avoid posterior/cerebellar
infarction. A rare indication for
preinterventional surgical transposition or bypass surgery is an
isolated offtake of the left vertebral
artery directly from the aortic
arch. Therefore, CT images should
also be carefully assessed for any
anatomic abnormality of the origin
of the head vessels.
The entry tear location also
affects the choice of method
to lower blood pressure during
stent-graft deployment. When the
tear is close to the LSA and the stent
graft has to be placed with the bare
spring across the left common
carotid artery, transvenous rapid
pacing at 180–220 per min is
recommended during stent-graft
deployment. A more distal position
of the tear might allow less strict
blood pressure lowering with use of
sodium nitroprusside.
The stent-graft diameter
should be selected on the basis of
measurements of the “healthy”
non-dissected aorta. Measurements
should be done in 2 axes: on the
axial CT images and on the sagital
MPR reconstruction. For dissection
I do not apply oversizing but select
a stent-graft diameter that comes
closest to the measurement.
Generally, 30–34 mm endografts are
sufficient. A 38–40 mm diameter
should raise suspicion for erroneous measurement and should
prompt careful remeasurement.
For the Valiant® device, the
diameter step from 32 to 34 mm is
associated with an increase of the
size of the delivery system (22 to
24 French). In a 32/33 mm aortic
diameter and in case of borderline
femoral artery dimensions, I would
select a 32 mm endoprosthesis. For
dissections I generally recommend
a stent-graft length of 20–25 cm.
&+
8A>C>86AJE96I:
Figure 1
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6
In our early experience we only
used stent grafts of 10 cm since we
were afraid of an increased risk of
paraplegia with longer stent grafts
because of the coverage of several
intercostals arteries. However,
growing clinical experience has
shown that the risk of paraplegia is
low and is not increased with longer
stent grafts.6, 7 Analyses of aortic
remodelling have further shown
that false-lumen thrombosis occurs
mainly in the stented segment of
the aorta,16 therefore we changed
our policy towards longer stent
grafts. Nevertheless, when possible,
I prefer to use only a single, but long
stent-graft piece during the initial
procedure. In small women, stent
grafts of 20–25 cm can reach down
to the celiac trunk, and occlusion
should be prevented. During the
procedure, a graduated pigtail
catheter (which usually has markers
in 1 cm increments over 20 cm)
can be used for initial angiography
if there are doubts regarding the
correct device length.
Evaluation of the access vessels
is crucial during preinterventional
planning. The common femoral
artery should measure at least 8 mm
in diameter. Heavy calcifications are
associated with an increased risk
of failure to advance the stent graft
and access complications. In case of
elongation and kinking of the iliac
vessels, heavy calcifications can also
prevent vessel straightening by the
7
stiff wire. Generally, if there is only
minor concern about the suitability
of the femoral artery as the primary
access vessel, a different access
vessel should be considered. In
these cases, surgical approach to
the common iliac artery or even
directly to the abdominal aorta
might be needed.
I:K6GegdXZYjgZ
In our department we prefer
surgical cutdown to the common
femoral artery. In most of our
cases we use general anaesthesia,
however, aiming at extubation
immediately after the TEVAR
procedure with the patient still on
the table. Therefore use of shortlasting analgesic or sedative drugs
and a close communication with
the anaesthesiologist are required.
TEVAR can also be undertaken as a
percutaneous procedure in sedation
avoiding intubation (eg, in patients
with severe COPD) with postprocedural closure of the access site using
sutured-mediated closure devices
(eg, Prostar by Abbott). However,
surgical cutdown, in our experience,
allows better bleeding control of
the access vessel, which is usually
severely atherosclerotic.
In dissections I always
recommend using an angiography
catheter, which is introduced via
the aortic arch. I prefer left radial
artery access (sheath size 4F)
with introduction of a 4F pigtail
8
catheter into the LSA. The brachial
approach can also be used. I use
this catheter for preinterventional
aortic arch angiography and for
intraprocedural angiography during
stent-graft deployment. Before
actual deployment of the stent graft,
the pigtail catheter is withdrawn
into the ostium of the LSA to mark
the offtake of the LSA with its pigtail
end. Even if the entry tear is located
in sufficient distance to the LSA, I
would recommend covering the LSA
with the bare spring (“trans-LSA”
fixation is analogous to EVAR
transrenal fixation). This position
provides much better alignment
and scaffolding of the stent graft to
the distal aortic arch. Implantation
of the stent graft distal to the LSA
with the bare spring beginning in
the curve of the distal arch (“no
man’s landing zone”) will result in a
very steep angle of the bare springs
against the arch.
During deployment, angiography
can be undertaken over the LSA
pigtail to modify the position of the
stent graft to preserve perfusion of
the LSA. The advantage of left-sided
access over right-sided access is the
ability to undertake angiography of
the LSA after intentional occlusion.
Angiography will eventually show
perfusion of the false lumen via the
LSA (type 2 endoleak). In this case
the radial access can be immediately
used to place an Amplatzer vascular
plug with the use of a 6 French
&,
I:K6GI=:G6EN
guiding catheter into the LSA
ostium to occlude the endoleak.
After surgical exposure of
the common femoral artery, we
undertake open puncture and
introduce an 8F sheath. A pigtail
catheter is advanced into the
ascending aorta with a standard
soft 0.035” guidewire. Particular
care must be taken that the pigtail
catheter is advanced within the true
lumen of the aorta. A false-lumen
position of the pigtail will thwart
later stent graft placement. TEE can
be helpful to identify the correct
position of the pigtail within the
true lumen. If the guidewire enters
the false lumen, for example in the
abdominal aorta, the wire should
be withdrawn to a position that
is definitively in the true lumen.
Advancement of the pigtail without
the guidewire can be helpful to
maintain the true lumen position.
After the pigtail catheter is in the
ascending aorta, a stiff guidewire
is introduced. We prefer to use the
Backup-Meier (Boston Scientific,
Natick, MA, USA) guidewire. The
soft tip of the wire should be
positioned in a circle onto the aortic
valve. Advancement of the stiff
guidewire without a pigtail catheter
can injure the fragile dissection
membrane and is strongly
discouraged. The endoprosthesis
is then advanced over the stiff
guidewire.
The first angiography is done
over the radially placed pigtail
catheter only when the delivery
system is already advanced to the
landing zone to conserve on the
use of contrast media and decrease
the risk of contrast nephropathy.
We always undertake an initial
aortogram in digital subtraction
angiography (DSA) technique with
breath-hold. Aortic angiography
for determination of landing zones
is done with 35 mL at a flow of
14 mL/s. Additional angiography
might be needed to locate the
perfect landing zone. These are
usually undertaken with 20 mL at a
flow of 10 mL/s. During deployment
I recommend digital overlay
technique of the angiography.
However, the table should not be
<gdl^c\Xa^c^XVa
ZmeZg^ZcXZ]Vhh]dlc
i]Vii]Zg^h`d[eVgVeaZ\^V
^hadlVcY^hcdi^cXgZVhZY
l^i]adc\ZghiZci\gV[ih
moved during fluoroscopy.
For the Valiant device, it is crucial
to advance the delivery system
3–4 cm proximal to the intended
position of the stent graft. With the
first two springs carefully released,
the stent graft is slowly retracted
until the correct position is reached.
Intraprocedural angiography can
be undertaken. When the correct
position is reached, the entire
prosthesis is released. We deploy
the Valiant stent graft within the
aortic arch always using transvenous rapid pacing at 180–220/
min. In my experience, pacing
ensures optimum deployment
since pulsatile flow is completely
abolished with pacing but not with
sodium nitroprusside. Rapid pacing
is very safe generally and the risk of
induction of ventricular fibrillation
is low. Nevertheless, critical
coronary artery disease should be
excluded beforehand.
Patients with reduced left
ventricular ejection fraction less
than 30% have an increased risk
of ventricular fibrillation after
rapid pacing. In these patients,
alternative methods to lower blood
pressure should be contemplated.
Patients in whom rapid pacing is
undertaken receive patch electrodes
connected to a defibrillator to
provide shocks as soon as possible
in the event of ventricular fibrillation. With sodium nitroprusside,
blood pressure should be lowered
to 50 mm Hg systolic when the
stent graft is released into the
aortic arch. If the intended landing
zone is more distal, a less severe
blood pressure lowering should be
sufficient. Nevertheless, I would
recommend a systolic blood
pressure <80 mm Hg. I personally
do not use adenosine for temporary
cardiac arrest during deployment
since re-onset is not predictable and
premature ventricular contractions
can result in distal dislodgement of
the endoprosthesis.
After deployment of the
endograft, completion angiography
is done to check for proximal
type I endoleak. I do not recommend performing balloon
dilatation of the stent graft,
particularly in patients with acute
aortic dissection due to the fragility
of the dissecting membrane and
the risk of membrane rupture.
Analyses of aortic remodelling
from our group have shown that
the stent graft, even if it initially
seems somewhat underexpanded,
will expand over time because of its
self-expanding properties. As mentioned above, angiography of the
LSA via the radially placed catheter
is very useful for exclusion of type
II endoleak. Usually angiography
of the proximal and distal landing
zone in two views is sufficient.
In patients with malperfusion
syndrome, extension of the stent
graft distally using uncovered selfexpanding stent grafts should be
considered (PETTICOAT concept),
since closure of the proximal entry
tear might not suffice to depressurise the false lumen immediately
and restore visceral and distal
limb perfusion.17
Edhi^ciZgkZci^dcVaXVgZ
Extubation should be done immediately after the procedure to prevent
extended mechanical ventilation,
which increases the risk of
complications. In our department,
patients are extubated on the
operating room table. After the
procedure, patients are transferred
to the intensive-care unit, usually
until the next day. Close blood
pressure monitoring is required
since blood pressure crises can
occur. Nevertheless, maintaining
a blood pressure around 140 mm
Hg systolic is advisable and phases
of hypotension should be avoided.
Lowering the blood pressure too
low could increase the risk of
paraplegia. On the intensive-care
unit, patients are closely monitored
&8A>C>86AJE96I:
for any signs of paraparesis
or paraplegia. In the event of
paraparesis, immediate spinal
drainage to 10 mm Hg is recommended to eventually reverse the
neurologic deficit.18 Generally,
antiplatelet or anticoagulation
therapy is not required after TEVAR.
I personally recommend ASA plus
clopidogrel for four weeks if a bare
spring is placed across the origin of
a head vessel.
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dgVci^XdV\jaVi^dc
i]ZgVen^hcdigZfj^gZY
V[iZgI:K6G
GZ[ZgZcXZh
1
KdadYdhCA!
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H]Z`]Vc^c
K:!Igd^VcK>!
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2
For postinterventional imaging
we prefer contrast-enhanced CT.
This should be done on the second
to fourth postoperative day in the
stable patient. But, if the patient
has recurrent pain or evidence of
stroke, CT can also be done earlier.
However, if CT is undertaken too
early it can show incomplete or even
absence of false lumen thrombosis
despite angiographically successful
TEVAR procedure due to the
prolonged effect of heparin and
membrane porosity.
After discharge the first follow-up
CT is done after three to six months
in our department. We then change
to MRI for further imaging because
of the radiation exposure associated
with CT. Imaging is done 12 months
after the procedure and then every
year. After two years of stable
course, follow-up intervals can be
extended to two years.
3
4
The opinion and experience
expressed by Holger Eggebrecht is
under his sole responsibility.
Use of Valiant Stent Graft outside
the scope of the IFU is under sole
responsibility of Holger Eggebrecht.
Produced with educational grant
from Medtronic CardioVascular.
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Strength or Flexibility.
Which is more important ?
Both.
RACER RX
Renal Stent System
Why compromise strength for flexibility–
or flexibility for strength–when you don't
need to? The Racer stent has both.
And that's not all.
Advanced cobalt chromium
• High radial strength, thin struts
and a lower profile
• Immediate postprocedure MR imaging,
under appropriate conditions
Exclusive modular stent design
• Supportive scaffolding helps minimize
tissue prolapse
• Low recoil for enhanced lumen patency
and precise deployment
Rapid-exchange delivery system
• Low crossing profile for easy deliverability
• Optimal balloon-stent interface for minimal
overhang and added security during delivery
So why compromise?
Available in stent diameters of 4, 5, 6 and 7 mm, stent lengths of
12 and 18 mm, and shaft lengths of 80 and 130 cm.
Tel: +41.21.802.7111, www.Medtronic.com
© 2006 Medtronic, Inc. All rights reserved. UC200701419EE 8/06
For international use only. Not for distribution in the USA.
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7N?JA>:C76>HH6I!B6G@:I>C<B6C6<:G!B:9IGDC>8>CI:GC6I>DC6A
I
he theory of evolution by
natural selection put forth by
Charles Darwin in The Origin
of Species in 1859 suggests that if a
population of organisms contains
multiple hereditary variants, and if
one of these variants with favorable
traits successfully contributes more
offspring to the next generation
than the other variants do, these
advantaged traits become more
prevalent in subsequent generations and the overall composition of
the population changes, triggering
the continuous process of evolution.
Looking back over the past few
years, this is how the Endurant® AAA
Stent Graft developed. Medtronic
has learned a lot from 12 years
of experience in working closely
with the medical community.
During this period, more than
150,000 patients have been treated
worldwide with Medtronic’s various
aortic stent graft technologies,
providing valuable insights into
performances and necessary
improvements. Medtronic spent five
years developing the Endurant Stent
Graft System, which incorporates
all the key features that make the
endovascular treatment available to
a wider range of patients (figure 1).
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At Medtronic, first we have learned
that only a highly conformable stent
graft could satisfy the broad range
of anatomies in patients with an
abdominal aortic aneurysm (AAA).
So, how do we facilitate fixation and
sealing in the infrarenal neck even
when it is short or angulated? The
proximal transrenal bare stent on
the Endurant Stent Graft provides
acute fixation in an area that is
known to be healthier than below
the renal arteries. The proximal
covered M-shaped stent reinforces
the radial force on the proximal
neck and achieves
sealing even in
angulated and short
necks, thanks to the
smaller amplitude
of the stent design.
Distally, the stents in
the Endurant legs are
shorter and are positioned to follow curvatures
and to avoid kinks in
the iliac arteries.
Medtronic designed
the Endurant Stent
Graft to conform to
the natural tortuosity
of the vessels.
6XXjgVXnVcYXdcigda
Treatment of an AAA with
a stent graft requires a very
precise placement and
controlled deployment,
not only in short and
angulated necks,
but also in easier
anatomies to achieve
successful long-term
outcomes. The
Endurant Delivery System
makes the deployment
easy and precise. After the first
three proximal covered stents are
deployed, their position can be
adjusted upward or downward to
achieve optimum placement below
the renal arteries.
The four proximal radiopaque
markers, one of them with an
e-shape, assist with the anteriorposterior view to align the edge
of the graft with respect to the
central axis of the lumen of the
aorta. Finally, the tip capture
mechanism allows a controlled
deployment of the suprarenal
stent with anchoring pins.
With the Endurant Stent Graft
System, you are in control at
every step.
:VhnVXXZhh
Looking at the published work, we also
learned that vascular
access was still one
of the main issues
faced by endovascular
specialists. Between 5%
and 15% of patients with
an AAA are denied EVAR
because of difficulties
with access.1 These
difficulties lead to perioperative complications in 13% of EVAR
patients, 1% of which
lead to conversions
with increased risk of
mortality, morbidity and
costs.2,3 The hydrophilic
coating, which helps reduce
friction, was already
introduced with
the Talent™ Stent
Graft last year. The
Endurant Delivery
System incorporates
the same hydrophilic
coating. Moreover,
it has an inner nitinol
tube designed for increased
flexibility, kink resistance
and improved trackability. More
importantly, the profile has been
substantially reduced compared
with previous generation stent
grafts, as shown in table 1.
Bjai^eaZdei^dch[dgeVi^Zci
Xjhidb^hVi^dc
The treatment of more patients
has been made possible not only
with a smaller profile, but also
with the new range of available
configurations. The Endurant Stent
Graft comes in bifurcated mainbody
with straight and flared limbs;
contralateral limb with tapered,
straight, and flared limbs; iliac
extension; aortic extension; and
abdominal tube. AUI configuration
is also available.
9jgVW^a^in
The durability of stent grafts
has always been a concern to
physicians, especially in the
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treatment of younger patients.
Although any conclusion about longterm outcomes of using the Endurant
Stent Graft cannot yet be made, it has
been designed with materials that
are known for their durability. The
proximal suprarenal bare stent is a
one-piece, laser-cut nitinol stent. The
anchoring pins are not soldered but
are part of the structure of the stent.
This design avoids breakage that was
noticed in clinical practice with other
stent grafts.4
We learned from experience
that the connection between the
transrenal stent and the graft fabric
is the point that is under the highest
constraint. 4, 5,6 We therefore used
an ultra-high molecular weight
polyethylene suture at that point,
Table 1: I]Z:cYjgVciHiZci<gV[iadlXgdhh^c\egdÒaZ
7^[jgY^VbZiZg
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which is three times stronger than
are normal surgical sutures.7 The
graft material is made of highdensity multifilament polyester with
a low porosity.
Finally, the nitinol used is electropolished, providing extra resistance
to long-term fatigue. Throughout its
Figure 3: I]Z:cYjgVci
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development, the Endurant Stent
Graft has been tested extensively to
demonstrate 10 years of durability.
8a^c^XVaZ[ÒXVXn
Medtronic is also committed to
evidence-based medicine. A strong
clinical programme has been
established to generate and collect
data about the device and provide
additional support to physicians
who are eager to expand the option
of endovascular treatment to their
patients.
Before European and international commercialisation, a
prospective multicentre trial was
undertaken, which continues to
assess one-year safety and performance in 80 patients. To obtain
FDA approval, a prospective
multicentre trial has been initiated
in the USA to enroll 200 patients.
Finally, a postmarket global
study is about to be started
to generate real-world device
performance data with a five-year
follow-up period.
From thousands of different
anatomies and thousands of
different treatment challenges,
a 12-year evolutionary cycle has
provided a solution: a super species
of stent graft. It is Medtronic’s latest
evolution, it is … the Endurant Stent
Graft, an AAA stent graft designed
to provide endovascular specialists
with the ease of use and confidence
to enhance performance in more
patients with AAAs with both
straightforward and challenging
anatomies.
5
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8
urrent commercially
available stent grafts such
as the Talent™ Abdominal
Stent Graft have proven to be safe
and effective in most patients
with an abdominal aortic
aneurysm (AAA). However, severe
angulations at the proximal
aneurysm neck and tortuous or
small iliacs are recognised as
important contra-indications
for endovascular repair of AAA.
Patients with these difficult
anatomies could benefit from a
flexible, conformable, low-profile
stent graft.
Medtronic’s new generation
stent graft system, Endurant®,
is specifically designed to treat
patients with straightforward and
challenging anatomies, including
severe infrarenal angulations
of the neck up to and including
75°. New design characteristics
enable physicians to treat difficult anatomies and to improve
operative handling, allowing a
broader group of patients to be
given endovascular stent grafts.
DW_ZXi^kZ
The objective of the first-in-man
Endurant CE Mark clinical study
was to assess the clinical safety
and performance of the Endurant
Stent Graft System within the
first 30 days after the study device
was implanted. The safety and
performance data were part of the
clinical file that was submitted to
obtain a CE Mark.
HijYnYZh^\c
The Endurant clinical trial was
a prospective, non-randomised,
single-group, multicentre trial in
The Netherlands and Germany.
Forty patients were enrolled and
followed up for 30 days after
implantation. Six patients were
selected on the basis of an infrarenal angle between 60° and 75°.
Clinical study outcomes included
a comprehensive range of relevant
measures, including:
n The primary efficacy endpoint,
which was defined as acute
delivery and deployment success
CZlYZh^\c
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e]nh^X^VchidigZViY^[ÒXjai
VcVidb^ZhVcYid^begdkZ
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(±6 mm at intended site);
n The primary safety endpoint,
clinical success, defined as
freedom from all-cause mortality
within 30 days;
n Technical success within 30
days, defined as absence of type
I/III endoleaks, loss of device
integrity, graft infections,
thrombosis or occlusions,
conversions to open repair, ruptured aneurysm and secondary
endovascular procedure; and
n Standard safety measures, such
as adverse events.
GZhjaih
This clinical investigation showed
that, in this study population, the
Table 1: :cYjgVci8:BVg`ig^Va^ckZhi^\Vidgh
=ZcXZ?BKZg]V\Zc
9ZeVgibZcid[KVhXjaVg
Hjg\Zgn
:gVhbjhBZY^XVa8ZciZg
GdiiZgYVb
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<^dkVcc^IdghZaad
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9ZeVgibZcid[
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?ZVc"EVjaEBYZKg^Zh
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9ZeVgibZcid[
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I]ZCZi]ZgaVcYh
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9ZeVgibZcid[KVhXjaVg
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9gZhYZc!
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9^Zg`HX]Z^cZgi
EVg`"@gVc`Zc]VjhAZ^eo^\"
H“Ydhi<bW=
@a^c^`[“g>ccZgZBZY^o^c
>$6c\^dad\^Z!@VgY^dad\^Z
AZ^eo^\!<ZgbVcn
=Vch"=Zcc^c\:X`hiZ^c
BZY^XVa8ZciZgÆB“cX]Zc
gZX]ihYZg>hVgÇBG>
IZX]c^XVaJc^kZgh^inBjc^X]!
9Zeid[KVhXjaVgHjg\Zgn$
KVhXjaVg8ZciZg
B“cX]Zc!<ZgbVcn
?ddhi6kVc=ZglVVgYZc
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8ZcigjbJigZX]i
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'(
:C9JG6CI
Endurant Stent Graft System
can be delivered and deployed
safely (delivery and deployment
success rate of 100%). The primary
safety endpoint (freedom from
all-cause mortality within 30
days) was achieved in 97.4% of
patients, with only one death
within 30 days. Furthermore,
no device-related deaths were
reported.
Technical success was achieved
in 90.3% of patients, with no
reported type I/III endoleaks; no
loss of device integrity; no graft
infections; thromboses or occlusions; no conversions to open
repair; and no ruptured aneurysms.
A 9.1% rate of secondary endovascular procedure was recorded,
all related to access site bleeding
complications.
This finding indicates that the
graft configuration performed
suitably within 30 days after the
index procedure. Careful review
of the adverse events during this
clinical investigation shows an
acceptable good profile of the
Endurant Stent Graft System for
endovascular abdominal aortic
stent grafting.
8dcXajh^dc
The Endurant Stent Graft System
examined in this CE Mark study can
be delivered and deployed safely and
effectively, even in highly angulated
anatomy. No device-related death
or device-related serious adverse
events were noted during the first
follow-up period. This new stent
graft may potentially enlarge the
patient population who are suitable
for endovascular AAA repair.
8jggZcihiVijh
The Endurant trial has been
extended to 80 patients and
one-year follow-up to collect more
clinical evidence with the Endurant
device. Medtronic is aiming
to publish the full results after
one-year follow-up.
:cYjgVciœHiZci<gV[iHnhiZb^c
GZVaLdgaY666EVi^Zcih
:C<6<:\adWVagZ\^hign
7N6CID>C:8J>?E:GH!8A>C>86AG:H:6G8=B6C6<:G!B:9IGDC>876@@:CG:H:6G8=8:CI:G!
B66HIG>8=I!I=:C:I=:GA6C9H
Figure 1: 8
linical safety and
performance data for the
Endurant® Stent Graft
System have been collected
recently during the European
market trial, contributing to its
market release with the CE Mark.
A premarket trial of this type is
well controlled, highly regulated
and intended to enrol a homogeneous patient population. Thus
an extensive list of well defined
inclusion and exclusion criteria
is established and, as a result, the
outcome of device-performance
assessment might not include
particular groups of patients (eg
outlier patients) who would be
implanted in a post-market phase.
Additionally, this type of trial
tends to have a large set of study
requirements and well selected
tests to be followed in an identical
manner to avoid information
and treatment bias. Therefore,
premarket trials might prove to
be too restrictive for physicians to
be indicative of typical, real-world
clinical practice; therefore the
trial outcomes might not be as
applicable to the general real-world
population, nor can they be
assumed to apply to subpopulations
who are excluded from the trial.
ENGAGE, the Endurant Stent
<Zd\gVe]^XVa
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Graft Natural Selection Global Postmarket Registry, has been initiated
to expand the clinical knowledge
base to include real- world patients.
This patient group might better
represent the patient profile
treated in actual clinical practice,
without selection for subgroups
of particular low or high risk or
exclusion of specific diseases, nor
is ENGAGE expected to impose
protocol-required study procedures
affecting clinical practice.
Table 2: I^bZa^cZ[dgeVi^ZciZcgdabZci
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Patients who are diagnosed with
AAAs and who are candidates for
endovascular repair can participate
in ENGAGE. Patient enrolment is
expected to continue until 1,200
patients are implanted with an
Endurant Stent Graft, followed by a
five-year follow-up period.
Approximately 80 enrolling sites
across Western Europe, Central
and Eastern Europe, Greece and
Israel (CEEGI), Asia, South Africa,
Middle East, Latin America and
Canada are expected to participate;
these are regions in which the
Endurant Stent Graft is either
currently commercially available
or anticipated to be commercially
available.
An Executive Committee will
be established with investigator
representatives from the
different regions.
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EGD;:HHDGC>8@8=:H=>G:!9:E6GIB:CID;K6H8JA6GHJG<:GN!>BE:G>6A8DAA:<:HIB6GNÉH
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K
ascular surgery has
undergone substantial
developments in the
past several years, with the
introduction of endovascular
therapy and the subsequent
widespread application of this
technique for the repair of aortic
aneurysms. As a result, training
for vascular surgeons has also
had to undergo changes to
ensure that they are now skilled
in endovascular procedures.
Endovascular stent grafting has
an intense learning curve, and
a continuous development in
interventional skills and patient
management is needed.
At St George’s Teaching
Hospital and Imperial College
(St Mary’s Campus), London, UK,
we have always taken training for
vascular surgeons very seriously
and have tried to provide a solution
for the increasing requests
that we receive for guidance in
endovascular techniques.
In 2005, after the publication of
EVAR 1 and DREAM studies, we
started the London Endovascular
G^\]iI]Z
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XdjghZ^cXajYZh
aZXijgZhVcYXVhZ
Y^hXjhh^dch
Course (LEC), which was aimed
at consultants and senior SpRs
who were interested in gaining
practical knowledge and
expertise in endovascular repair
of abdominal aortic aneurysms
(AAAs). The course was ideal
for clinicians who had recently
started an endovascular AAA
programme, who wished to hone
their skills with endovascular
simulators or silicone AAA
models, and to gain practical
knowledge about choice of
equipment, patient selection and
procedure planning.
The format of the two-day
course was a mixture of lectures,
case discussions, practical
sessions and live cases. It was
very interactive and allowed
ample time for discussions of
the cases.
Around 130 physicians
attended the six AAA LECs
that we have held so far, with
attendees coming mainly from
the UK and Nordic countries.
The feedback that we received
has always been extremely
I]ZViiZcY^c\YZaZ\ViZh
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VcYi]ZbVcV\ZbZci
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positive; the attending delegates
found learning about endovascular
aneurysm repair (EVAR) and the
management of AAA from the
experienced multidisciplinary
teams at St George’s and St Mary’s
hospitals particularly interesting
and incredibly useful.
Since EVAR has naturally evolved
with time, we want to widen our
educational programme to fully
reflect the needs of vascular
surgeons and radiologists, and
share with our peers and colleagues
our experience by introducing the
next level of endovascular training.
The new Advanced London
Endovascular Course (Advanced
LEC) is intended for consultants
and senior SpRs who already
have substantial endovascular
experience in EVAR and who wish
to expand their level of expertise
to incorporate more challenging
cases, anatomies and procedures.
The format of the one-day
course includes a mix of recorded
procedural cases that focus on
specific anatomical challenges,
case discussions, practical tips,
techniques and troubleshooting
to overcome the technological
limitations and to provide
attendees with the ability to offer
EVAR to a wider range of patients.
The programme allows ample
'*
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ZcYdkVhXjaVgXdjghZ
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');ZWgjVgn'%%.
AdXVi^dc/=^aidcBZigdedaZ!
AdcYdcEVYY^c\idc!J@
;VXjainBZbWZgh/
?cf[h_Wb9ebb[][
IjCWhoÊi9Wcfki/
Egd[C^X`8]Zh]^gZ!
9ZeVgibZcid[KVhXjaVg
Hjg\Zgn0
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d[KVhXjaVgHjg\Zgn0VcY
9gBd=VbVYn!9ZeVgibZci
d[GVY^dad\n#
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time for delegates to discuss
present practices, and they are
given the opportunity to present
their own cases. This discussion
is led by the endovascular teams
of St George’s Teaching Hospital
and Imperial College (St Mary’s
Campus).
The teams also present on:
n Challenging cases that we can
tackle with technology that is
presently available, including:
– Challenging necks
– Challenging vascular access
– Challenging clinical status
n Imaging and technological
requirements that are needed to
successfully treat these difficult
cases
n Tips and tricks to prevent
complications in such
challenging cases
partner to launch and develop
this new and innovative training
programme. Medtronic’s
experience in endovascular
education comes from a longestablished partnership with
physicians. Their aim was to
develop tailored educational
solutions that can satisfy the
different educational needs of
endovascular practitioners.
We appreciate that the Medtronic
Endovascular Innovations has
made physician training and
education a primary focus of their
organisation, and has continuously
been innovating these programmes
to strengthen the content
and increase the variety of its
educational offering.
The organisation of this
educational activity requires a
great deal of time and dedication
and, in our experience, Medtronic
is a very trustworthy partner that
provides a great deal of assistance
in these courses.
n Follow-up requirements for
these cases
We have chosen the Medtronic
Endovascular Innovations
Academia Team as our trusted
The opinion and experience
expressed by Nick Cheshire and
Matt Thompson are under their
sole responsibility.
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6
t Medtronic, service extends
well beyond delivery of
the device to the hospital.
Whenever a physician chooses
Medtronic products, he or she
chooses to work with a company
that looks at the entire range of
needs to deliver the best possible
procedural results.
Medtronic responds to these
needs by providing an integrated
training service that includes
therapy development and training,
physician proctoring, case selection
and support that is given by
certified clinical specialists. Since
1997, when Medtronic started the
commercialisation of the AneuRx
Stent Graft, a team of dedicated
clinical specialists has devoted
their time and energy to furthering
their endovascular knowledge and
expertise to assist with endovascular
procedures in newly opened centres.
Working alongside the most
experienced physicians and
attending a substantial number of
cases, Medtronic clinical specialists
have developed a consistent
technical and clinical knowledge
about the endovascular aneurysm
repair (EVAR) and thoracic endovascular aorbic repair (TEVAR) procedures and product-related issues.
They show proven clinical skills
within the operating theatre or cath
lab, have experience of supporting
surgeons and radiologists during
Medtronic endovascular implant
procedures, and deliver product
presentations and product training,
working with surgeons, radiologists and other hospital staff at key
institutions.
The main tasks of Medtronic
clinical specialists are assisting
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i]ZgZ[dgZVc^cYZeZcYZci
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doctors in case screening, case
planning and device selection,
and providing technical support
during clinical cases. This set of
skills and knowledge is not easily
achieved. Therefore an intensive
training programme at Medtronic
has been set up, followed by a
certification process to assess the
expertise and competencies of the
clinical specialists.
The training is an intensive
programme of practical and
theoretical experience, lasting
for at least one year. The new
hire representatives go through a
three-month orientation period,
attend endovascular cases, practise
on case screening and selection
under the mentorship of an expert
clinical specialist and attend specific
training sessions. Lectures, case
studies and specific training material
have been specially designed to help
develop their knowledge and skills.
Their role is crucial and Medtronic
wants to provide the best-in-class
support; therefore, an independent
endovascular MD expert assesses
and certifies their knowledge and
expertise.
Dr Jos C van den Berg has been
involved in the certification process
of Medtronic clinical specialists
since 2001. He has interviewed and
assessed skills and expertise of
more than 100 Medtronic clinical
specialists and he undertakes
examination sessions on average
every three months.
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WZXdbZ^ckdakZY^cZcYdkVhXjaVg
666igZVibZciVcYi]ZBZYigdc^X
igV^c^c\egd\gVbbZ4
Dr van den Berg: At the end of
1996, we started the endovascular
AAA programme in my former
hospital (St Antonius Hospital,
Nieuwegein, Netherlands). Dr Frans
Moll (now professor of Vascular
Surgery at UMC, Utrecht) and I did
the first European implants of the
AneuRx device in November 1996,
and from then on the collaboration
with Medtronic has strengthened.
When the AneuRx stent graft
was commercialised in mid-1997,
',
8A>C>86AHE:8>6A>HI8:GI>;>86I>DC
both physicians and Medtronic
clinical specialists needed to be
trained. In Nieuwegein (and other
European centres), we developed a
training programme together with
Medtronic, focusing on imaging
studies, preprocedural planning,
case selection, the procedure itself
and the follow-up of patients.
All clinical specialists from
Medtronic from the early days
(some of whom have attended and
assisted at thousands of cases)
received most of their training in
film reading from me. Proctor visits
were also made to help centres that
were starting their endovascular
programme in undertaking their
first cases (the proctor was present
on site during the implants).
Later, after the acquisition of
AVE by Medtronic (and with that
World Medical), the Talent™
Stent Graft was included in the
training programme. This inclusion
also allowed extension towards
TAA treatment, which a separate
training programme was then set
up for (together with cardiothoracic
surgeons Dr Marc Schepens and Dr
Robin Heijmen).
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They must have good knowledge of
vascular anatomy and basic understanding of diagnostic imaging.
Product knowledge is crucial for
cases in which unforeseen events
occur, and clinical specialists
should be trained to provide tips
and tricks to help the physician.
To provide the best possible clinical
outcome they should understand that accurate planning is
mandatory.
Additionally, clinical specialists
should be able to provide good
support during the stent-graft
procedure. You have to keep
in mind that, because clinical
specialists serve many different
hospitals, they generally have seen
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more cases of endovascular AAA
treatment than the local interventionalist who is doing the actual
procedure. In straightforward cases
this fact might not be significant, but
when troubleshooting is necessary
it can become a decisive factor for
obtaining a successful outcome.
=dlYdndj_jY\Zi]Z`cdlaZY\Z
VcYZmeZgi^hZd[BZYigdc^X
Xa^c^XVaheZX^Va^hih4
Medtronic clinical specialists have
to pass a written examination on
endovascular AAA therapy with
more than 120 questions, and then
they need to discuss and assess
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two or three cases during an
interview with me. During the
practical part of the examination,
sizing evaluation obviously plays
a major part. However, problemsolving is also tested, as well as
the candidate’s ability to foresee
potential problems.
This examination is not easy,
but the clinical specialists come
very well prepared and they take
their job very seriously. It is rare
for them not to fulfil expectations
and fail. In these situations, extra
attention is given to the candidate’s
weak points, which usually results
in a major improvement of their
knowledge and skills level (thus
allowing them to pass the practical
test in a second attempt).
I must say that the clinical
specialists go through a very intense
and effective training programme
(that is split into two levels). I
believe Medtronic is the only
company in the endovascular field
with such an intensive preparation
and training programme, offering
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and guaranteeing a high quality of
the service provided.
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I will list several items that are,
in my opinion, of added value.
Medtronic is able to:
n Assist in the learning process;
n Share experiences of other
centres;
n Provide technical troubleshooting, tips and tricks;
n Offer support in the operating
room or cath lab;
n Offer support in case selection
and sizing;
n Provide help in staff training
(hands-on product knowledge);
n Provide latest educational
material and key literature
update.
The opinion and experience
expressed by Jos Van den Berg is
under his sole responsibility.
Produced with educational grant
from Medtronic CardioVascular.
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Endovascular
e-Training
www.endovasculartraining.net
In an effort to further develop and advance
our educational initiatives, we are pleased
to announce an innovative and unique online training program aimed at strengthening
physicians endovascular skills and knowledge!
LESSON 1:
LESSON 2:
LESSON 3:
LESSON 4:
The EVAR golden
rule: failing to plan
is planning to fail
How to ensure
durable sealing?
How to ensure
limb patency?
Speakers: Prof F. Moll
& Prof H. Verhagen
Speakers: Prof V.
Riambau
& Prof S. Müller-Hülsbeck
What evidence
do we have on
EVAR long term
outcomes?
Speakers: Prof JP
Becquemin
& Dr J. Van den Berg
Speakers: Prof G. Torsello
& Prof PG Cao
Please log on to the web site and take on-line courses on endovascular treatment of Abdominal Aortic Aneurysms.
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=Vh:K6GWZXdbZi]ZhiVcYVgYd[
XVgZ[dg666eVi^Zcih4
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G:>B7JGH:B:CI9>G:8IDG!86G9>DK6H8JA6G!L:HI:GC:JGDE:
I
he UK National Institute
for Health and Clinical
Excellence (NICE) is one of
the most advanced bodies for health
technology assessment (HTA) in the
world. In addition to its key role in
the UK healthcare system, its effect is
felt outside the UK as organisations
and individual physicians in other
countries monitor its conclusions.
NICE’s recommendations, as
contained in the Final Appraisal
Determination (FAD) on the use of
endovascular stent grafts for the
treatment of AAA, were posted on
NICE’s website on 20 November
2008. The FAD will soon form the
Institute’s guidance for the use of
endovascular stent grafts for the
treatment of abdominal aortic
aneurysm (AAA).
The positive recommendations
from the FAD read as follows:
n Endovascular stent grafts are
recommended as a treatment
option for patients with unruptured
infrarenal AAA, for whom surgical
intervention (open surgical repair
or endovascular aneurysm repair
[EVAR]) is considered appropriate.
n The decision about whether EVAR
is preferred over open surgical
repair should be made jointly by
the patient and their clinician after
assessment of factors including:
• aneurysm size and morphology;
• patient age, general life expec
tancy and fitness for open surgery;
• the short-term and long-term
benefits and risks of the procedures, including aneurysmrelated mortality and operative
mortality.
n EVAR should only be undertaken in
specialist centres by clinical teams
experienced in the management
of AAA. The teams should have
appropriate expertise in all aspects
of patient assessment and the use of
endovascular aortic stent grafts.
n Endovascular aortic stent grafts are
not recommended for patients with
ruptured aneurysms except in the
to produce an estimate of the
technology’s clinical and costeffectiveness for a specific
indication. Strengths, weaknesses,
uncertainty around certain parameters and gaps in the evidence are
also identified.
The judgemental appraisal then
considers the reports and analyses
produced in the assessment phase
within the context of additional information supplied by consultees,
commentators, clinical specialists,
patient experts and the general
public.
:cYdkVhXjaVghiZci
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VhVigZVibZcidei^dc[dg
C>8:ÉH;69DC:K6G
eVi^Zcihl^i]jcgjeijgZY
The FAD on the use of endovascular
^c[gVgZcVa666![dgl]db stent grafts for the treatment of
hjg\^XVa^ciZgkZci^dc
AAAs is divided into six distinctive
sections:
deZchjg\^XVagZeV^gdg
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1. Guidance
gZeV^g:K6G^hXdch^YZgZY 2. Clinical need and practice
(an overview of the disease or
Veegdeg^ViZ
context of research. Given the
difficulties of undertaking
randomised controlled trials, it is
recommended that data should be
collected through existing registries
to enable further research.
=I66HH:HHB:CIK:GHJH
6EEG6>H6A
HTA by NICE follow a two-stage
process. First, the scientific
assessment – ie, the systematic
evaluation of all the relevant
evidence available for a technology
– is undertaken with the aim
condition – in this case
AAAs – epidemiology and
pathophysiology, etc.)
3. The technologies (a brief
description of the intervention
under assessment – ie, abdominal
stent grafts, their place in the
pathway of care for AAAs – and
relevant alternative treatments and
comparators).
4. Evidence and interpretation
(an outline of the evidence of
clinical and cost-effectiveness and,
when appropriate, clarification
and critique of the economic
models received from stakeholders, as well as identification of
important issues for the Appraisal
(&
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VXXdjciZY[dg^ci]ZXdhi"
Z[[ZXi^kcZhhVcVanh^h
E>8IJG:/>HID8@
Committee to consider to help with
the discussion).
5. Implementation.
6. Recommendations for further
research.
Section 4 is of particular interest
to understand how the Appraisal
Committee derived its recommendations directly from the evidence
base, together with statements from
consultees and commentators,
and the views expressed by clinical
specialists and patient experts at the
Committee meeting.
8JGG:CI8A>C>86AEG68I>8:
Section 4.3.2 of the EVAR FAD
mentions that the Committee heard
from clinical specialists that EVAR
is now routinely regarded as part
of the management of infrarenal
AAAs and that identification of
patients for whom EVAR is appropriate should consider not only
the size of the aneurysm but also
other factors such as physiological
measures of the person’s fitness for
surgery, aneurysm morphology and
patient choice. When examining
the clinical effectiveness for EVAR
for patients with unruptured
infrarenal aneurysms for whom
elective surgical repair is considered
appropriate (section 4.3.3), the
Committee concurred the rates
reported in the randomised trials
such as EVAR1 and DREAM for
long-term aneurysm-related death,
complications and reinterventions
after EVAR were higher than those
seen currently in UK clinical practice.
Indeed, the trials used older stent
grafts, the technology has substantially improved since the randomised
controlled trials were done and
clinical expertise in the assessment
of patients’ suitability for EVAR and
in undertaking the procedure has
improved with more widespread use
of the technology.
In summary, the benefits of
EVAR compared with open repair in
current clinical practice are likely to
be greater than those recorded in the
randomised controlled trials.
G>H@"H8DG>C<HNHI:BH
The Committee considered how
fitness for surgical intervention
(EVAR or open surgical repair)
should be assessed, with the aim to
understand whether the definitions
of fitness used by the Assessment
Group in the economic model were
clinically meaningful and could be
implemented nationally.
Local protocols exist between
clinicians and commissioners for
how to assess patients’ fitness for
surgery, and these assessments
are based on objective measures as
well as clinical opinion. However,
because no nationally agreed definitions of fitness for surgery have
been set and there is no difference
in the relative risk of operative
mortality for patients with “good
fitness” and those with “moderate
and poor fitness”, the Committee
concluded exclusion of a specific
subgroup of patients would be
inappropriate because there was no
clear distinction between the patient
subgroups based on differing levels
of fitness.
In conclusion, the decision as
to whether EVAR is preferred over
open repair should be made jointly
between the patient and their
clinician after assessment of several
factors including aneurysm size and
morphology, patient age, general life
expectancy, and the short-term and
long-term benefits and risks of the
two procedures, including aneurysmrelated mortality and operative
mortality (section 4.3.15).
DE:G6I>K:BDGI6A>IN
In discussion of the various sensitivity analyses undertaken by the
Assessment Group when using
moderate, poor fitness and good
fitness, the Committee noted that
for the patients with moderate and
poor fitness, the operative mortality
rate for EVAR and open surgery was
assumed in the model to be 4% and
11%, respectively. For good fitness,
those with the operative mortality
for EVAR and open surgical repair
was assumed to be 1% and 3%,
respectively (section 4.3.14). Thus,
the relative differences in operative
mortality is three times higher for
open surgery than for EVAR for
patients with good fitness, and those
with moderate and poor fitness.
:8DCDB>8BD9:AA>C<
GZhdjgXZjhZYjg^c\^c^i^VaegdXZYjgZ
When considering the differential
costs of the initial procedures, the
Committee noted that the resource
use and costs for operating theatre
time, intensive care and ward stay
for EVAR that were used in the
Assessment Group’s model were
('
=:6AI=:8DCDB>8H
based on the actual costs and
resources used in the EVAR1 trial;
however, the Committee also heard
from the clinical specialists that the
length of stay in the intensive-care
unit and on the ward after EVAR have
been reduced since the trials were
undertaken, and these variations
have a large effect on the cost-effectiveness estimates for the procedure.
In this connection, a postal
survey was administered in January,
2008, to UK hospitals to investigate
whether the length of hospital
stay has changed since the EVAR1
trial. The survey found that the
difference in length of stay in the
intensive-care unit and in general
wards between the two interventions
is now greater than was estimated in
the EVAR1 trial.
Most importantly, the survey drew
attention to the fact that the mean
length of stay might not represent the
full opportunity cost of these facilities,
as some centres require an ICU bed
to be available before commencing a
procedure, in case it is needed; 86%
of surgical teams would cancel an
open repair procedure if such a bed
were not available compared with
22% who would cancel an EVAR
procedure. (Assessment Report,
completed by CRD/CHE Technology
Assessment Group of the University
of York in April 2008, also posted on
NICE’s website.)
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Just as for the initial procedure, the
Committee noted that the rates used
by the Assessment Group in their
cost-effectiveness model for reintervention after EVAR had been derived
from the EVAR1 trial. The clinical
specialists explained that clinicians
are less inclined to reintervene in
current UK clinical practice than
was the case during the period when
the randomised controlled trials
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were undertaken. This is particularly
true for type II endoleaks, which
comprised most re-interventions in
the trials.
The Committee concluded that
a smaller rate of reinterventions
(corresponding to a hazard ratio
for reinterventions of 1.5) would be
appropriate to use in the cost-effectiveness analysis.
clinical teams who are experienced
in the management of AAAs is
based on statements from clinical
specialists. They explained that
outcomes after EVAR were better for
patients undergoing the procedure
in specialist units because of the
greater numbers of cases treated
and therefore the increased clinical
expertise.
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The Committee also considered
the costs of follow-up after EVAR. It
heard testimony from the clinical
specialists that for patients undergoing EVAR, duplex ultrasound
scanning has largely replaced the
need for CT. The Committee was
therefore persuaded that a considerably lower yearly cost for follow-up
after EVAR could be accounted for
(average of £54) in the cost-effectiveness analyses.
Medtronic has always played an
innovative role in the stent-graft
industry and has been strongly
committed to EVAR therapy development for more than a decade.
Therefore Medtronic is delighted to
see that the EVAR FAD is a result of
careful consideration of the evidence
as well as of comments received
during consultation and further
economic modelling.
As such, NICE recommends
endovascular stent grafts as a
treatment option for patients
with unruptured infrarenal AAAs,
for whom surgical intervention
(open surgical repair or EVAR) is
considered appropriate.
Medtronic appreciates that
re-evaluation is a key component
of the HTA process to maintain the
accuracy of assessments, ideally to
reduce uncertainty encountered for
specific parameters during the initial
valuation process and to ensure that
the most appropriate products are on
the market.
Medtronic therefore remains
committed to the further
advancement of the endovascular
technology, not only by developing
new generation devices like Talent
HydroTM and Endurant® but also
by actively contributing to the
generation of additional evidence.
Medtronic will carefully consider
the recommendations for future
research that were contained in
the last paragraph of the EVAR
FAD (eg, research to measure
the extent to which the relative
treatment effect of EVAR on
operative mortality can be assumed
constant across subgroups of
patients, and research into how to
incorporate the best available riskscoring systems for the management
of AAA into decision-making in
routine clinical practice).
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The Committee discussed the
treatment options for patients
considered unfit for open surgical
repair, but who could receive EVAR.
It was aware of the little evidence
base for EVAR in this situation and of
the limitations of the model emphasised by the Assessment Group
in the original assessment report
(crossovers, delays and absence of a
watchful waiting protocol in EVAR2
trial made the results difficult to use
directly to identify the most costeffective form of management).
The Committee decided that,
given its conclusion that EVAR
was a cost-effective treatment for
patients with moderate and poor
fitness, then it was plausible that
the cost-effectiveness estimate
for EVAR for patients of very poor
fitness would be similar. The
Committee therefore concluded
that EVAR would be an acceptable
use of NHS resources in patients
who were considered unfit for open
surgical repair and when EVAR was
considered appropriate.
:ME:GI>H:
The Committee’s decision regarding
the fact that EVAR using endovascular stent grafts should only be
undertaken in specialist centres by
((
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B6G>:C=6JH8A>C>8!6=GL:>A:G!<:GB6CN
I
he Marienhaus Clinic in
Ahrweiler was the venue
for an information event,
held on 12 December 2007, which
was aimed at presenting the latest
developments in the treatment of
infrarenal and thoraco-abdominal
aortic aneurysms. The clinic’s chief
of vascular surgery, Dr Christian
Sprenger (pictured above), invited
Prof Michael Jacobs, professor of
vascular surgery at the European
Vascular Centre in Aachen, to
speak at the event, which attracted
around 100 private practice
doctors from across the region. Dr
Sprenger reports on the event.
Prof Jacobs is widely acknowledged as an expert in the treatment
of aortic disease, having previously
worked alongside renowned
vascular surgeon Dr D A Coly at
Houston’s Texas Heart Institute
in the USA. From 1990 to 1993,
Prof Jacobs worked in the vascular
surgery department at University
Hospital Maastricht before being
appointed successor to Prof
Dongen in the Department of
Vascular Surgery at the Academic
Medical Center of the University
of Amsterdam. He is currently
director of the surgical department
at University Hospital Maastricht
and heads the European Vascular
Centre Aachen-Maastricht.
The aim of the Marienhaus event
was to provide referring doctors
with information about the latest
developments in the diagnosis
and treatment of infrarenal
aortic aneurysms. It began with a
presentation of the current situ-
ation in relation to the treatment
and diagnosis of aortic aneurysms,
and from this presentation it was
apparent that the clinical picture
is still not completely clear for
referrers and patients. For example,
reference was made to the frequent
diagnosis of incidental findings
as part of preventative urological
examinations. Despite the fact
that abdominal aortic aneurysm
(AAA) is the 12th most common
cause of death in Western Europe, a
targeted strategy to eradicate aortic
disease rarely exists.
This situation is reflected in
current statistics: of the more than
40,000 patients in Germany with
AAA with a diameter of greater than
5 cm, only a quarter are detected
and receive treatment. Of these
patients, 70% are treated by means
of open procedures and 30% by
means of endovascular procedures.
(Source: DGG, BIBA).
According to various sources,
the prevalence in the primary risk
group for this type of aneurysm
(male patients aged older than 60
years with arterial hypertension) is
somewhere between
4% and 8%.
The presentation also described
the therapeutic methods available
for present treatment of aortic
aneurysms, including both open
surgical procedures and endovascular repair methods. Interestingly,
it emerged during the discussion
that there is still as yet no widescale awareness of endovascular
methods for treatment of infrarenal
aortic aneurysms among referring
physicians and that, particularly
in rural areas, there is no comprehensive information available
about centres at which both types
of procedure are provided.
Thanks to the event and the
information materials provided by
Medtronic, attendees learned about
the latest techniques and methods
for treatment of aortic aneurysms.
Particular attention was given to
the advantages of endovascular
repair techniques compared with
open surgical approaches for
specific indications, and attendees
learned that endovascular methods
eliminate the need to clamp the
aorta, require a much smaller
incision and can be performed
under local anaesthetic.
In its participation in the event,
the Department of Vascular Surgery
at the Marienhaus Clinic presented
itself as a centre that undertakes
both open and endovascular
procedures.
The opinion and experience
expressed by Christian Sprenger is
under his sole responsibility.
Produced with educational grant
from Medtronic CardioVascular.
()
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n 1955, Albert Einstein was
diagnosed with a ruptured
abdominal aortic aneurysm
(AAA). He refused treatment and
thus we lost one of the greatest
minds in history.
Since then, open surgical repair
has evolved substantially, offering
much better clinical results than
it did 60 years ago. Moreover, with
the development of endovascular
technologies over the past 15 years,
the treatment of AAA has become
much less invasive, with excellent
clinical outcomes for a large
proportion of patients.
Despite these improvements,
many people with an AAA remain
undiagnosed; ultimately, many
die, since the chance of surviving
a ruptured AAA is less than 20%.1
If a patient has a ruptured AAA,
he is lucky to arrive at the hospital
alive. Then he needs to survive the
operation to repair it. The operative
mortality of a patient with a
ruptured aneurysm, which is about
40%,2 which is significantly higher
than for a patient with a diagnosed
AAA whose operative mortality is
between 2% to 5% or even lower
in case of the EVAR. Hence, better
diagnosis is urgently needed.3,4
2
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Thanks to the pioneering activity
of Medtronic, which worked
to prove the effectiveness of a
screening programme and supported the activity of the SAAAVE
Act, a national AAA screening
programme voted into law by the
US Congress in 2006, US citizens
now have the opportunity to be
diagnosed. Some countries, such
as the UK where an initiative is still
pending parliamentary approval,
are following in the footsteps of
the USA. In many other countries,
vascular surgery societies are
working to raise awareness of the
opportunity for screening of AAA
and other vascular diseases.
Medtronic is deeply committed
to promotion of the screening
of patients with AAAs. Several
screening programmes are
sponsored locally5 with the aim to
show the cost-effectiveness of these
programmes. These are positive
initiatives, but it will take time
for national healthcare
healthca systems
to implem
implement broad
sscreening for
patients with
an AAA.
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In the meantime, how can the
diagnosis and referral of patients to
vascular specialists be improved?
Communication and therapy
awareness between referring
physicians is key. Medtronic
has developed a set of tools to
help vascular surgeons educate
referring physicians about AAA,
its diagnosis and the treatment
options that are available.
A comprehensive guide has been
designed to help vascular surgeons
organise information sessions
or workshops with front-line
physicians who can potentially
refer patients with AAAs. This guide
includes a set of templates that can
be customised, such as invitations
and thank you letters. The guide
also recommends key actions
that, if taken, ensure a successful
meeting: good attendance coupled
with effective communication of its
educational objectives.
A PowerPoint presentation is also
available, providing key data for the
incidence of AAA, risk factors, different therapies with advantages and
disadvantages, and what happens to
patients when diagnosed.
Lastly, a leaflet has been
developed so physicians can
provide their patients with
information about the disease and
the treatment options.
Endovascular practitioners
should contact their Medtronic
representative to learn more about
these tools and how they can
improve diagnosis and referral for
patients with AAAs.
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NAT U R A L
SELECTION
Endurant
AAA Stent Graft System
LATIN NAME:
Rex Graft Stenti
(Stent Graft King)
Abdominal aortic or
aorto-iliac aneurysms.
Highly adaptable,
bred to survive and succeed
in challenging environments.
Thrives in complicated situations.
ENDURANT
AAA Stent Graft System
N AT U R A L S E L E C T I O N
©2008 Medtronic, Inc. All rights reserved. UC200900630EE
HABITAT:
Over 150,000 EVAR patients treated globally
In partnership with Medtronic, physicians have treated more EVAR patients globally than with anyone else.
© 2007 Medtronic, Inc. Not for distribution or use in the US. Data on file at Medtronic. UC200704581EE