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264 Other devices and how to use them
undesirability of placing stents in the tibial arter-
ies. When the balloon is inserted into the correct
location, it is inated slowly over the course of
approximately 30 to 60 seconds. is is done so
that the atherotomes or outer wires may correct
themselves and separate along the inner circum-
ference of the blood vessel wall. If further angio-
plasty is required, it is usually appropriate to follow
the scoring or cutting balloon with a standard
angioplasty balloon and to open the caliber of the
blood vessel further, since the cleavage planes have
been made within the plaque or within the scar tis-
sue that represents a lesion. Both scoring and cut-
ting balloons are a little larger in their prole than
plain balloons of equal caliber because the blades
or wires are on the outside of the balloon. Aer
balloon ination, the balloon catheter is aspirated
aggressively in an attempt to shrink it down to its
smallest possible size prior to removal.
Cryoplasty involves cooling of the inated
angioplasty balloon in an attempt to induce apop-
tosis. e idea behind cryoplasty is that cell divi-
sion can be interrupted and potentially even the
process of recurrent stenosis could be diminished
or prevented using cooling of the artery and the
surrounding tissues. ere is a substantial amount
of science behind this but whether or not it actu-
ally decreases long-term rates of recurrent steno-
sis has not been conclusively shown. Cryoplasty is
another potential option that may be used in loca-
tions where stenting is undesirable.
e cryoplasty apparatus includes a balloon
catheter that has multiple layers (Figure 20.9).
When the balloon is inated, the multiple layers
are designed to prevent leakage of nitrous oxide.
Because the balloon has multiple layers, the cali-
ber of the sheath required is either 6-Fr or 7-Fr
depending on the size of the balloon diameter that
A
B
C
Fig. 20.9 Apparatus for
performing cryoplasty.
(A)Amultilayered cryoplasty
balloon in its deflated and
inflated states. (B) The control
panel connects to the cryoplasty
catheter. (C) A nitrous oxide
canister is used to inflate the
balloon.
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Peripheral stent–grafts 265
is desired. e balloon catheter is connected to a
pump and when the balloon is located within the
lesion, the catheter is aspirated to clear the lumen
of any air or nitrogen that may be there. e pump
is then set into action at the press of a button.
Nitrous oxide is pumped into the balloon catheter
and then cooled to −10
o
C. e balloon is inated
gradually over the course of several seconds and is
inated to a very reproducible level of 8 atm. is
helps to decrease the likelihood that the balloon
could be punctured or ruptured and also helps to
achieve a very even type of dilation. Gradual ina-
tion and the very steady pressure increase over the
course of a couple of minutes helps to minimize
dissection. is minimization of dissection is
something that is apparent when using the cryo-
plasty apparatus. e other piece of the system is a
nitrous oxide canister, which may be placed within
the pump at the appropriate time. Aer angio-
plasty is completed, the catheter must be vented,
and aer it is vented a negative aspiration is drawn.
is helps to empty the balloon and as it empties
the blood ows around it and rewarms the balloon.
Once the balloon is rewarmed, it may be reposi-
tioned for an additional ination. Cryoplasty has
been used quite extensively in the lower extremi-
ties in the supercial femoral, popliteal, and tibial
arteries, especially in locations where stenting is
undesirable.
PERIPHERAL STENT–GRAFTS
Stent–gras have broad applications in relining the
aorta and iliac arteries when treating aneurysmal
disease. ere are several other conditions that
may require stent–gra placement. Stent–gras or
covered stents could be self-expanding or balloon-
expandable. Stent–gras available for peripheral
use include the Viabahn
™
stent–gra, the Fluency
™
stent–gra, t he Wa llgra
™
, the iCast
™
, the Viaba hn
®
balloon-expandable stent, and the Lifestream
®
bal-
loon-expandable covered stent. Allof these devices
have a bulkiness beyond standard stents and require
larger sheaths for placement. e uses for stent–
gras are being evaluated and their indications for
use in the treatment of occlusive disease of the lower
extremity are an active area of investigation. In gen-
eral, the lower extremity arteries may be treated
with self-expanding covered stents to accommodate
the exibility of these arteries. Self-expanding cov-
ered stents, usually Viabahn™, are used to treat pop-
liteal artery aneurysms. Either balloon-expandable
or self-expanding stents may be used in the aor-
toiliac segment to treat iliac occlusive disease or to
perform a completely covered aortoiliac reconstruc-
tion. Parallel gras used as branches in conjunction
with endovascular aortic aneurysm repair may be
performed with either balloon-expandable or self-
expanding gras. When self-expanding covered
stents are used as parallel gras, they are typically
reinforced with bare metal stents to avoid being
compressed.
e Viabahn
™
stent–gra has an indicationfor
use in the SFA (Figure 20.10). It is a nitinol mesh
stent–gra with a polytetrauoroethylene (PTFE)
covering. It is relatively exible and has low
chronicoutward force. It is deployed using a ripcord
style deployment system. Viabahn
™
stent–grasare
A
B
C
Fig. 20.10 Peripheral stent–graft. (A) This
self-expanding stent–graft has a nitinol
skeleton and a PTFE cover and is delivered
on a catheter (Viabahn™). The handle
of the catheter contains a ripcord type
mechanism, which is pulled to release the
graft. (B) After deployment, the graft is
self-expanding and somewhat flexible.
(C)Balloon-expandable covered stents are
also available. The balloon-expandable
stent segments are recognizable and
areheld together longitudinally with PTFE
and covered with PTFE.
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266 Other devices and how to use them
available in lengths from 5 to 20 cm. e diam-
eters in which they are available range from 4 to
10 mm. Viabahn
™
stent–gras require sheath sizes
anywhere from 6-Fr to 9-Fr and the sheath sizing
charts and specic catheter availability should be
consulted prior to any case. When treating a lesion
with Viabahn
™
stent– gras, the aim is to achieve
a seal within the artery and in a gra-to-gra fash-
ion of approximately 3 cm. Viabahn
™
stent–gras
may be oversized slightly, but if they are oversized
too much there will be wrinkling and corrugation
of the material within the area of the lumen of the
blood vessel. e Viabahn
™
stent–gra is prepack-
aged on a delivery catheter that is placed through
the sheath and then, when it is in its proper loca-
tion, the ripcord is pulled and the gra is deployed.
Appropriate measuring of both the length and the
width required should be performed prior to place-
ment of the gra. Viabahn
™
stent–gras have been
used to treat peripheral artery aneurysms through-
out the body including carotid, renal, visceral,
iliac, and popliteal vessels. ey have also been
used to treat occlusive disease in the SFA and the
iliac artery and, occasionally, in other locations.
Aer the stent–gra is placed, balloon angioplasty
is performed, including connections and at the
ends of the gra, to ensure that it is fully expanded.
Patients who are treated with stent–gras are typi-
cally maintained on antiplatelet agents or antico-
agulation and occasionally both.
Other types of stent–gras in the peripheral
arteries include the aforementioned gras. e
Fluency
®
gra is a nitinol stent covered with a
PTFE. It is stier than the Viabahn
™
stent–gra.
Because it is more rigid, it is useful for relatively
straighter conduit arteries. is is also a useful
device for iatrogenic or traumatic injuries to the
subclavian, supercial femoral, and other arter-
ies. e Wallgra™ is also somewhat rigid and has
handling and placement properties similar to the
Wallstent
™
, but its delivery is larger in caliber due
to the PTFE covering. ere is some length vari-
ability at the time of deployment since the nal
deployed length is dependent on the diameter to
which it is deployed. e contourability is poor as it
remains relatively rigid. e iCast
™
and Viabahn
™
VBX are balloon-expandable metal stents with a
gra material covering. ese are generally shorter
and more rigid than the self-expanding covered
stents and accuracy of placement is quite good
since it is balloon expandable. ey are useful for
vessel artery origin lesions such as the renal, subcla-
vian, or common carotid arteries. Even if vascular
trauma is not a signicant part of the work load, it
is a good idea to have some stent–gras available in
case an injury, traumatic or iatrogenic, presents in
the course of usual vascular practice.
THROMBECTOMY AND
THROMBOLYSIS
e intent with both chemical and mechani-
cal thrombolysis is the removal of thrombotic
material from the vascular system. In the case of
chemical thrombolysis, the thrombolytic agent is
delivered directly into the thrombus. Chemical
thrombolysis has been available for several
decades and has been through various iterations
with dierent agents and approaches. e devel-
opment of mechanical thrombectomy devices has
prompted eorts to optimize treatment by com-
bining chemical and mechanical thrombolysis in
each case for a faster and more complete throm-
bus removal.
Chemical thrombolysis calls for pulse spray
administration of thrombolytic agent directly into
the thrombus, followed by an infusion of the same
agent over a period of hours and up to 24 hours or,
occasionally, a little longer. In the case of mechani-
cal thrombolysis, there are various macerating,
churning, or aspirating type devices that may be
used to disrupt thrombus and remove it. e rela-
tive advantages of chemical thrombolysis are the
avoidance of injury to surrounding tissues and
access of the medication to the thrombus regard-
less of other nearby lesions. In general, this is a
more gentle process than mechanical thromboly-
sis, but it oen takes too long. Longer procedures
are not feasible in the setting of acute ischemic
pain or ischemic organ damage and they expose
the patient to longer intensive care stays, higher
doses of thrombolytic agents, and greater risk of
bleeding. e advantages of mechanical thrombol-
ysis are the ability to quickly debulk the clot bur-
den and restore ow, and to speed the procedure
along and avoid prolonged ischemia and prolonged
chemical thrombolysis sessions. e disadvan-
tages of mechanical thrombolysis are mostly
logistical: investment in equipment and time is
required; during the procedure larger sheaths are
needed; each device has its learning curve; and the
thrombus cannot always be reached. Very oen,
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Thrombectomy and thrombolysis 267
the mechanical thrombolysis debulks the throm-
bus but does not clear it completely. erefore,
thrombolysis procedures are oen performed with
a combination of both chemical and mechanical
thrombolysis; these two techniques are used in
concert to achieve a faster and safer result.
If thrombotic or embolic problems occur dur-
ing an endovascular procedure, the best initial
step to address the problem is aspiration throm-
bectomy (i.e., place a catheter in proximity to the
identied thrombus and aspirate). is is a use-
ful adjunct and is sometimes required on unan-
ticipated occasions. Aspiration may be performed
using a specically designed aspiration catheter or
a small sheath. Several companies make aspiration
catheters (e.g., Export
®
AP Aspiration catheter).
ese are typically 5-Fr or 6-Fr catheters with an
end-hole for aspiration and a monorail delivery.
Itis useful to have one of these on hand in case an
embolus occurs during a routine procedure.
A commonly used chemical thrombolytic
agent is tissue plasminogen activator (tPA). tPA is
mixed in normal saline at a specic concentration
and administered in a variety of ways. One com-
mon method is as follows. Place a sheath close to
the thrombus. Enter the thrombus with a guide-
wire and pass a catheter over the wire and through
the thrombus. Lace the clot with thrombolytic
agent using rapid injection of the agent directly
into the thrombus. is is performed with a 1-mL
syringe, injecting into multiple locations along the
length of a thrombus while gradually withdrawing
the catheter over the guidewire so that the throm-
bolytic agent can be evenly distributed. is is the
pulse spray technique. Aer this is performed, a
soaker hose-type catheter with multiple side holes
is advanced into the thrombus and the guidewire is
removed in exchange for an end-hole wire, which
can be used to infuse thrombolytic agent into the
distal runo (Fig u re 20.11). Put the guidewire
through the lumen of the soaker hose catheter.
is forces the thrombolytic agent out of the side
holes of the catheter. Two drip infusions are set
up: one through the soaker hose catheter itself and
one through the end-hole guidewire so that the
tip of the wire is also infusing tPA. e tip of the
guidewire is infused so that the runo blood ves-
sel, whether it is in the kidney, in the lower extrem-
ity, or in other locations, may be protected from
thrombus accumulation. Soaker hose catheters can
also be obtained that have a valve on the end so
that the lytic agent does not all runo into the dis-
tal vasculature and miss the thrombosed segment
of artery. Heparin is infused through the side arm
of the entry sheath at a subtherapeutic level to pre-
vent thrombus from accumulating in association
with the sheath.
During infusion with thrombolytic agent, the
patient undergoes intermittent laboratory analysis
including hematocrit, platelet level, thrombin level,
prothrombin time, and partial thromboplastin
time. If the thrombin level drops below 100 IU/mL,
the lytic agent should be stopped. e complica-
tions of chemical thrombolysis increase with the
time required for the infusion and the overall dose.
A typical dosing regimen for tPA for an occluded
lower extremity bypass is to lace the clot with
2–6mg of tPA then run the infusion at 1 mg/hour
for 4 hours and then decrease it to 0.5 mg/hour aer
that. Most of the improvement that can be expected
A B C D
Fig. 20.11 Chemical thrombolysis.
(A)An occlusion of the distal popliteal
and proximal tibial arteries is present.
(B)An antegrade sheath is placed and a
guidewire advanced across the thrombus.
(C) Through the sheath, a multiple side
hole soaker hose or thrombolytic therapy
catheter is placed. (D) Thrombolytic agent
is infusing through the side holes and
end hole of the catheter to help dissolve
the thrombus and also maintain patency
ofthe runoff vessel. Heparin is also infused
through the side arm of the sheath to help
prevent new thrombus from forming in the
area of the sheath or catheter.
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268 Other devices and how to use them
will be seen within the rst 8 hours. Typically, if
there is a change clinically or if several hours have
gone by, then it is time to repeat the angiography
and check the progress. Chemical thrombolysis
may be combined with aspiration thrombectomy.
A standard aspiration catheter may be placed over
the guidewire and used to aspirate any thrombus
that can be removed in this manner.
There are several devices available for
mechanical thrombolysis. One commonly used
device with a broad variety of applications
is the AngioJet
™
Peripheral Thrombectomy
System device (Figure20.12). When this device
is used, a rapid spray of heparinized saline is
infused and simultaneously aspirated. This cre-
ates a Bernoulli-type effect, which emulsifies
the clot, converts it into very small particulate,
and allows it to be removed with the effluent
from the catheter. The device has several differ-
ent types of catheters that are geared for blood
vessels of a variety of diameters. Care must be
taken to choose the appropriately sized catheter
and to advance it over the guidewire. As the
catheter approaches the thrombus, the machine
is engaged, the catheter advanced slowly, and the
clot gradually removed.
is device may be used alone or in conjunc-
tion with chemical thrombolysis to help remove
clot. Very oen, a thrombolysis case will be initi-
ated with pulse spray using the AngioJet
™
. is is
done by temporarily occluding the euent from
the catheter so that a small amount of infusion of
lytic agent is placed at high speed and eciency
directly into the clot. Aer waiting a pre-set time,
usually 15–30 minutes, the AngioJet
™
is passed
over the guidewire several times to remove throm-
bus. Aer several passes, interval arteriography
is performed. If thrombus removal is incomplete,
catheter-based chemical thrombolysis is estab-
lished. One major limitation of the AngioJet
™
A
B
Fig. 20.12 The Angiojet™ mechanical
thrombectomy catheter. (A) The
mechanical thrombectomy catheter
is passed over the guidewire.
(B) When engaged, the catheter
tip simultaneously provides
administration of fluid and aspiration
of effluent.
A B C
Fig. 20.13 Penumbra thrombus
aspiration device. (A) An occlusion
of the popliteal and proximal tibial
vessels is identified. (B) An antegrade
sheath is placed. The Penumbra
Aspiration Device catheter with
the soft tip is advanced to the
area of thrombus and the suction
mechanism is engaged. The catheter
can be gently advanced to chase
and aspirate the thrombus. (C) The
catheter is connected to a suction
pump that is specially designed to
accompany the catheter and remove
the thrombus.
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Distal embolic filters 269
is hemolysis; continued usage causes ongoing
damage to circulating red blood cells and this is
manifested by the patient’s blood-colored urine,
decreased hematocrit, and even hemodynamic
instability. e patient is maintained on full anti-
coagulation during mechanical thrombectomy.
e Penumbra Aspiration Device is a suction or
aspiration device. A smooth and well-engineered
catheter is advanced into the area of thrombus.
Extreme and continuous suction is applied to
remove the thrombus. ere is also the potential
to macerate the thrombus with an associated cath-
eter to help assist with aspiration. e catheter can
be moved to position it in the right location for
thrombus removal and the aspiration catheter tip
is gentle enough that it can be advanced into the
thrombus with minimal risk of arterial injury. is
is particularly useful when thrombus has formed
in a lower extremity artery and the patient is pro-
foundly ischemic, and the time to treat must be as
rapid as possible. ere are dierent sized cath-
eters, including 3-Fr, 6-Fr, and 9-Fr, for dierent
indications.
DISTAL EMBOLIC FILTERS
Distal protection devices, or embolic protection
devices , were developed for use in t he carotid vascu-
lar bed (Fig ure 2 0.14). Other applications include
protection during renal stenting or complex lower
extremity revascularization. Recanalizing or deb-
ulking an occluded SFA stent is another situation
in which a lter may be of value. Likewise, dur-
ing atherectomy of long or heavily calcied SFA
lesions, embolization is a risk and lters probably
play a role in making the procedure safer. Distal
protection devices have some risk and cost of their
own. In the carotid circulation, protection is con-
sidered mandatory during stenting, but distal l-
ters may not provide complete protection for the
brain. It is likely that the lters catch most major
emboli and this makes them useful for the lower
extremity. Distal protection devices were rst
approved for use in the coronary circulation when
there is stenosis within a previously placed coro-
nary vein gra. ere are several approved distal
protection devices for carotid stenting. Some of
Fig. 20.14 Distal embolic protection
devices. (A) The Emboshield NAV6™
is a free wire system comprised of a
0.014-inch guidewire with a 0.019-inch
knob on it near the tip and the self-
expanding filter held open with nitinol
struts. (B) The AngioGuard
®
is a fixed
wire system with a short landing zone
and an umbrella-like structure. (C) The
FilterWire EZ™ is a fixed wire system
with an eccentric nitinol hoop and a
windsock.
C
B
A
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270 Other devices and how to use them
them are approved for use along with a concur-
rently used stent such as the Emboshield NAV6
™
and the Accunet
®
. Other devices, such as the Spider
lter (SpiderFX
™
Embolic Protection Device), are
approved for use with any of the approved stents.
Distal protection devices function by being
placed beyond the lesion prior to treatment. ere
are two competing design concepts: one is a xed
wire system (lter is xed to the guidewire and
the wire and lter are placed together) and one is
a freewire system (wire and lter are separate; rst
the wire is placed and then the lter). e Accunet
®
and the FilterWire
™
are examples of xed wire
systems, where the lter is xed in place along a
guidewire. A short segment of so directional
wire, which is used to cross the lesion, extends
from the tip of where the lter is xed on the sha
of the guidewire. Once the tip of the wire is across
the lesion, the lter delivery catheter is advanced
until the lter, which is compacted tightly into the
lter delivery catheter, is also across the lesion.
Aer the lter has crossed the lesion, a covering
membrane is withdrawn and this allows the self-
expanding lter to deploy and set its position. e
alternative design, the free wire systems, includes
the Emboshield NAV6
™
and Spider lter. With the
Em b os hi e ld N AV6
™
, a specially designed guide-
wire is passed across the lesion. is guidewire
has a shapable tip and comes in several dierent
wire body strengths. ere is a 0.019-inch diam-
eter knob on the body of the 0.014-inch guidewire
close to the tip and this knob is used as a stop for
the lter to prevent it from going o the end of the
wire. In this case, the wire is placed rst, separate
from the lter. e guidewire behaves more likea
traditional guidewire, without the bulky lter
on the wire during passage. Aer the guidewire
is across the lesion, the lter delivery catheter is
advanced and the lter is deployed along the wire.
e Spider lter is dierent in that it allows the use
of any guidewire that is 0.014 inches in diameter.
Subsequently, a microcatheter is passed over the
initial guidewire of choice, the wire is removed,
and then the lter is placed through the micro-
catheter. e lter is then deployed. During the
procedure the lter is maintained in place. With
the free wire lter systems, it is possible to have
minor wire movement without signicant lter
movement. With the xed wire system, any move-
ment of the wire will also cause movement of the
lter. e xed wire systems permit crossing of the
lesion and placement of the lter in a single step,
whereas the free wire systems require separate
maneuvers for each of these steps.
In each of these systems there is some com-
ponent of nitinol scaolding, which provides for
the self-expanding properties of the lters. e
lters have a specic pore size or a range of pore
sizes. Ingeneral, most of the lters have pore sizes
between 110 microns and 400 microns. ere is a
range of expanded lter diameters, generally from
3 to 8mm, and a range of lter lengths. At the con-
clusion of the procedure the lter is recaptured.
In each case, the lter recapturing catheter is
larger than the delivery catheter, with the rationale
being that once the lesion is treated the lumen will
accommodate a somewhat larger catheter in order
to pass through and capture the lter. In addition,
it is not desirable to squeeze the lter into as small
a diameter as when it is an empty new lter, just in
case the lter is full of debris.
Filters may prevent a disastrous case of untreat-
able distal embolization. However, lters also have
pitfalls. ere is the potential that with the release
of embolic material, ltration will not be complete
or that the embolic material may spill out prior
to retrieval of the lter. An additional concern is
that if the pore sizes in the lter itself are too large,
embolic material may pass through the lter, but if
the pore sizes are too small, it will induce throm-
bus formation and may cause a slow ow situa-
tion. e support structure for the lter is in the
direction of the lesion. When a stent delivery cath-
eter is advanced over the guidewire, if the tip of
the catheter encounters the lter support system,
it may become entangled and irreversibly caught
and necessitate some other type of drastic action
to complete the procedure. Damage to the artery
may occur during lter placement for recapturing.
Placement of the lter delivery catheter itself could
cause embolization. Recapturing the lter may be
challenging in a tortuous anatomy.
Lesions of signicant complexity are being
revascularized using endovascular techniques in
many dierent vascular beds. e potential benet
of using lters in other locations is being explored.
Indications for lters may include renal angioplasty
and stenting, complex lower extremity revascular-
ization, atherectomy cases, subintimal angioplasty
cases, treatment of acute or chronic thrombus for-
mation with mechanical thrombectomy devices,
and during coil embolization cases to prevent distal
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Distal embolic filters 271
embolization of coils. ere is a risk:benet ratio
associated with the lter when used as an adjunct.
Most of the existing lters have been designed for
coronary or carotid circulations and have not been
designed for renal, lower extremity, or other appli-
cations. e lter systems are somewhat restrictive
with respect to the strength of the guidewire that
is used to support the lter. e lter has a length
that requires a specic landing zone, varying from
2 to 4 cm. is distance of nondiseased artery
distal to the lesion may not be available in every
anatomic bed. e diameter range for each lter
varies, but it is usually 4–7 mm to t with the dis-
tal internal carotid artery. Outside this diameter
range, there are no appropriate lters. e lter
itself may cause damage to the artery in the runo
bed and manipulation of the wire in this area may
also cause damage.
Most of the earlier discussion concerns distal
protection devices. ere are two other types of
protection devices, which are not lters but are
occlusive devices. ese devices provide protec-
tion by using occlusion to either stop prograde
cerebral ow or to reverse it. An example of a distal
occlusion device is the PercuSurge Guardwire
™
,
which is approved for coronary vein gras.
e guidewire is a hypotube with a lumen in it.
Aballoon is mounted on the tip of the wire and
passed across the lesion. Using a special device,
the hypotube is opened and uid administered to
ll the balloon until occlusion of the distal artery
is achieved. Treatment is undertaken and aer
this is done, an aspiration catheter is passed over
the guidewire with ow at a standstill. e area
is aspirated of any potentially embolic material.
Aer multiple aspirations, the balloon is deated
and the guidewire with the balloon on it removed.
ere is also a proximal occlusion balloon system
(the Mo.Ma
™
Ultra Proximal Cerebral Protection
Device), which may be combined with reversed
ow to achieve distal protection. is is performed
with a transfemoral sheath that is quite sizable, up
to 9-Fr to 11-Fr. e sheath is advanced into the
common carotid artery. e balloon is inated to
stop forward ow in the common carotid artery.
Backbleeding ow from the external carotid
artery is occluded with an occlusion balloon.
Prograde cerebral ow is stopped and the carotid
is aspirated vigorously aer the stent is placed but
before ow is restored.
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PART III
Therapy in specific vascular beds
21 Brachiocephalic interventions 275
22 Visceral and renal artery interventions 297
23 The infrarenal aorta, aortic bifurcation, and iliac arteries: Advice about balloon
angioplasty and stent placement
311
24 The infrainguinal arteries: Advice about balloon angioplasty and stent placement 329
25 Complex lower extremity revascularization 345
26 Salvage of previous reconstructions 373
27 Hybrid procedures 381
28 Technical aspects of treating aortic aneurysms 391
29 Coiling of peripheral aneurysms 419
30 Puncture site management 427
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