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6 Arterial Revascularization
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147
Medication: Alteplase (TPA)
1 Mechanism of action: Thrombolytic (converts
plasminogen to plasmin to degrade brin and
brinogen).
2 Intra- or post-procedural anticoagulation:
(a) Bolus: operator discretion. Typically, <
5mg.
(b) Continuous infusion: 0.05–0.1 mg/kg/hr.
via infusion catheter.
• Laboratory monitoring: brinogen
levels.
6.9.2.5 Thrombolysis Protocol
There is a wide variability in concurrent anticoagulation administration, interval of brinogen
monitoring, and changing thrombolytic dose during thrombolysis [132]. An example protocol for
patients with suspected HIT is provided:
Example thrombolysis with anticoagulation
protocol in setting of HIT/HITT used at our
institution:
• 0.5 mcg/kg/min argatroban + alteplase
0.5–1mg/h.
• Fibrinogen monitored every 4h.
(a) If brinogen <100, decrease alteplase by
50% and recheck in 2h.
(b) If brinogen <75, decrease alteplase by
50% and administer 2units of FFP.
(c) If brinogen <50, discontinue alteplase
and administer 2 units of FFP.
Initiate normal saline through infusion
catheter.
6.10 Tibial Calcium Management
6.10.1 Device Selection
Omar Chohan, MD
6.10.1.1 Tibial Disease
1. Big artery disease (BAD) = below knee/above
ankle (Figs.6.51 and 6.52).
(a) Transmitting vessels – sends blood
through to feet.
(b) Disease affects tibial vessels to pedal
loop.
(c) Atherosclerotic disease.
ab c
Fig. 6.51 (a–c) Left lower extremity runoff demonstrates
BAD; Flush occlusion of the posterior tibial artery and
distal occlusion of the anterior tibial artery. Peroneal
artery reconstitutes to supply foot distally and opacies
the pedal loop, large digital arteries, and small vessels
with poor distribution to tissue (blue arrow). Patient was
scheduled for trans-metatarsal amputation
148
ab c
I. Ali et al.
Fig. 6.52 (a–c) Left lower extremity runoff demonstrates
BAD following orbital atherectomy and angioplasty;
revascularization of anterior and posterior tibial artery
2. Small artery disease (SAD) = blow ankle
(Fig.6.53).
(a) Distribution vessels – delivers blood to
feet tissue.
(b) Disease affects distal metatarsal arteries
and capillary outow.
(c) DM; medial artery calcication (MAC).
Often see tram-track calcium.
(d) Often “no-option” CLI patients, or “des-
ert foot.”
(e) Calcium morphology.
• Atherosclerosis.
– Luminal plaque; soft or calcied.
– Can be of various lengths and sizes.
• Medial artery calcication.
– Intramural plaque contained within
media.
– Often diffuse and appears as “rail-
road tracks” on CT, X-ray, or
uoroscopy.
(f) Approach to device selection.
• Stenosis or occlusion length.
• Calcium density and location.
• Thrombus.
• In-stent restenosis.
provides inline ow to pedal loop, large digital arteries,
and small vessels distributing ow to tissue (red arrow).
No amputation was required
Fig. 6.53 Right lower extremity runoff demonstrates
SAD.Posterior tibial artery supplies pedal loop, however,
thready digital arteries and essentially nonexistent small
vessels. Revascularization would not improve distribution. This patient required amputation
6 Arterial Revascularization
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Table 6.3 Device types and their uses
Atherectomy Directional Rotational Photoablative Orbital IVL
Device Hawk Jetstream Rotablator Excimer Auryon Diamondback Shockwave
Focal Ca ++ + +
Diffuse Ca + + + ++ +
Thrombosis + +
BTK + + + + + +
ISR + + +
CTO ++ + ++ + + ++
149
3. Device types (Table6.3).
(a) Atherectomy.
• Orbital.
– Diamondback.
Eccentric crown mounted on
wire rotating at high speeds.
Can achieve luminal gain larger
than crown size due to orbital
rotation resulting in plaque
removal and differential sanding.
Useful in heavy calcium and
long-length segments.
Sands calcium into debris less
than blood cell, however caution
or avoid when using with
chunky/coral reef type calcium.
• Rotational.
– Jetstream.
Front cutting tip and aspiration
ports.
Useful for mixed plaque morphologies and thrombus.
Not useful for BTK.
– Rotablator.
Rotating burr centrally mounted.
Sands and removes plaques.
Useful in heavy calcium and
long-length segments.
– Phoenix.
Front cutting tip.
Not useful for BTK.
• Directional.
– HawkOne.
Cutting blade contained in tubular housing.
Can be turned and directed
toward plaque to exercise.
DEFINTIVE LE study – 800
patients.
• ~90% success.
• 3% distal embolization.
• 12-month freedom from
major amputation 95%.
• Laser.
– Excimer.
High-energy monochromatic
light beam vaporizes plaque.
Can penetrate proximal brous
cap in CTO.
Can be used for in-stent
restenosis.
LACI trial.
• 93% limb salvage rate at
6months.
– Auryon.
Laser photoablation like
Excimer.
Has an aspiration port on larger
catheter sizes which can be
used in mixed plaque and
thrombus.
• Intravascular Lithotripsy (IVL).
– Shockwave.
Semi-compliant balloon
mounted on a catheter delivering
ultrasonic waves.
Uses low pressure compared to
POBA.
Softens and remodels dense calcium improving luminal gain
and recoil.
Can be used in conjunction with
traditional atherectomy or
alone.
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I. Ali et al.
6.10.2 Non-POBA Balloons
MicahWatts
Improved intraprocedural imaging, including
routine use of IVUS, has increased the awareness
of arterial dissection after PTA [133]. It is
believed that treatment failure including restenosis or thrombosis may result from untreated or
undiagnosed dissections.
• The theorized mechanism of this is a combination of ow limitation due to luminal
obstruction and exposure of the thrombogenic
subintimal layers of the vessel.
• Dissections can be treated with prolonged balloon angioplasty, stenting, or an endovascular
tack device. Prolonged angioplasty is not
always effective.
• Stenting and Tack (Philips Inc.) placement
causes either continuous outward force or
inammatory stimulus that may accelerate
restenosis.
• Any method of treating a dissection will accelerate neointimal hyperplasia accelerating the
rate of restenosis.
• Preventing dissections by decreasing barotrauma during angioplasty has become the
goal in development of multiple endovascular
devices [134].
6.10.2.1 Cutting andScoring
Balloons
Cutting balloon (Boston Scientic) angioplasty
has been available in the United States since 2005
and was the rst device designed to dilate brotic
stenoses at lower atmospheric pressure. Three or
four atherotomes, or small blades, are mounted
onto a noncompliant angioplasty balloon. When
the balloon is inated, these blades score the
plaque to allow for lower pressure angioplasty.
Small studies demonstrated superiority regarding
restenosis with cutting balloon vs conventional
balloon in femoropopliteal angioplasty [135].
The original cutting balloons were limited to
short lengths and required relatively large sheath
sizes. The technology was updated, although
without blades, with the release of AngioSculpt
(Philips medical), which is available in tibial
artery sizes from 2.0 to 4.0mm and lengths up to
100 cm delivered via a 5F or 6F sheath. The
AngioSculpt balloon is a semi-compliant balloon
wrapped in a helical conguration with three
rectangular exible nitinol struts, which grip the
artery to prevent slipping and concentrate the
force of the angioplasty 15 to 25 times that of
conventional angioplasty along the struts [136].
Multiple small studies demonstrated excellent
primary patency with low rates of clinically signicant dissection or bailout stenting when using
AngioSculpt as a primary treatment modality
[137, 138]. Other scoring balloons have been
released subsequently from other medical device
companies and function similarly.
6.10.2.2 Chocolate
The chocolate balloon (Medtronic) is a semicompliant angioplasty balloon mounted inside a
nitinol restraining cage. When the balloon is
inated, the constraining cage creates a series of
pillows and grooves, which interact with the vessel wall. The pillows are balloon segments that
extend from the cage and provide gentle focal
force to the arterial wall. The appearance of the
pillows constrained by a nitinol grid gives the
appearance of a classic chocolate bar divided into
rectangular segments. The design of the balloon
is to encourage uniform ination pressures and
allow the balloon “pillows” to exert the force on
the arterial wall, while the metallic cage elements
brace the balloon to the wall and act as a barrier
to dissection propagation. The restraining cage
also helps prevent overination and excessive
barotrauma while protecting the vessel from the
torsional forces inherent in unfolding a traditional angioplasty balloon during ination [139].
The chocolate balloon is designed to treat both
above and below-the-knee arteries with diameters as low as 2.5mm and lengths up to 120mm
via a 5 Fr sheath. It is designed to be sized 1:1 to
the normal vessel lumen to result in fewer dissections and bailout stents and less neointimal
hyperplasia.
• Chocolate BAR, a post-market multicenter
registry focusing on safety and efcacy fol-
6 Arterial Revascularization
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151
lowed 226 patients with tibial artery chocolate
balloon interventions showing excellent
12-month results in freedom from bailout
stenting and freedom from target lesion revascularization (TLR) [140].
6.10.2.3 Intravascular Lithotripsy
Adapting technology from urologic extracorporeal lithotripsy, the Shockwave intravascular
lithotripsy (IVL) device delivers sonic energy to
the vessel wall via a balloon inated to sub-nominal pressures. An electric generator sends small
electric charges through the mixture of saline
and contrast in the balloon, which vaporizes the
uid and creates a rapidly expanding and contracting pressure wave. The pressure wave passes
through soft tissue and preferentially impacts
hard tissue including both intimal calcium and
medial calcium. The sonic pressure causes
microfractures along the calcium, thus increasing vessel compliance. The more compliant vessel is then ready for denitive therapy to
maximize luminal expansion. Shockwave IVL
catheters are available in femoropopliteal sizes
from 3.5 to 8mm in 6cm lengths and in tibial
sizes ranging from 2.5 to 4mm in 4cm lengths.
The balloons are available on an 0.014″ platform
[141]. Femoropopliteal balloons are routinely
used off-label in the iliac arteries. The DISRUPT
PAD and DISRUPT PAD studies were discussed
in prior sections. Early results seem very positive for IVL [82].
6.10.2.4 Serranator
The Serranator PTA serration balloon catheter
(Cagent Vascular, Wayne, PA) is the latest specialty balloon to enter the market. The Serranator
is a semi-compliant angioplasty balloon with
three or four embedded metallic strips with serrated scoring elements designed to apply greater
than one thousand times the force to the vessel
wall compared to POBA.
• This focal force creates an interrupted line
along the vessel surface allowing for plaque
modication and controlled expansion at low
pressures. Those two factors combine to create fewer dissections and less recoil with the
ability to more effectively and safely treat calcied, highly brotic, and complex lesions.
• Serranator PTA balloons are available for
above and below the knee. Below-the-knee
sizes range from 2.5 to 3.5 mm and lengths
range from 40 to 120mm. These have three
metallic strips. Above-the-knee sizes range
from 4 to 6mm and lengths range from 40 to
120mm. These are equipped with four metallic strips.
• Long-term data are still lacking as Serranator
is new to the market, but safety and efcacy
have been proven in the PRELUDE studies.
The PRELUDE ATK studies enrolled 25
patients with femoropopliteal lesions and
demonstrated very low residual stenosis at
very low ination pressures, the majority of
which measured less than 6atm.
• The PRELUDE BTK study showed similar
luminal gain at low pressures with minimal
bailout stenting. Results in both studies
included qualitative core laboratory review of
IVUS or OCT, which consistently demonstrated the focal perforations from the metallic
strips [142, 143].
6.10.2.5 Tips
• Very long percutaneous old balloon angioplasty (POBA) balloons (up to and exceeding
300mm) are available for tibial angioplasty.
With the rare exception of complete tibial
artery occlusion, these apply forces unevenly
to different portions of the vessel.
– If using a long balloon, it can be inated to
nominal pressure and examined for remaining as it is. If waists are present, deate the
balloon and pretreat that area with a specialty balloon to decrease the pressure
applied to that spot, and in turn, to the unaffected arterial wall touched by the balloon.
• Drug-coated balloon technology for the tibial
arteries has been slow in development.
Specialty balloons can improve the outcome
of tibial angioplasty without the use of
medication.
– Though many studies have subsequently
shown no denite increase in the risk of
death after the use of paclitaxel bearing
152
I. Ali et al.
devices, some may still wish to avoid drug
delivery when possible.
• Debulking atherectomy can similarly decrease
required angioplasty pressures, but may
increase the risk of complication including
downstream embolization in certain lesions.
• As data continue to show positive results with
tibial stenting and as new tibial stents are
being designed and released, effective lowpressure angioplasty in calcied lesions may
improve stent expansion and allow for optimal
results after tibial artery stenting.
• Shockwave IVL is routinely used in heavily
calcied iliac arteries to aid in the delivery of
large sheaths for structural heart procedures
and growing use in the infrainguinal arteries
down to the tibials.
– A stent that has been deployed into heavy
calcium and has poorly expanded can be
treated with Shockwave IVL to attempt
better expansion by fracturing the calcium
that is constraining the stent.
• Predilation with a scoring balloon may perforate the intima and allow for a larger-sized
POBA balloon to treat the lesion at a lower
pressure.
• “No stent zones” include the P2 segment of
the popliteal artery and the common femoral
artery, making these excellent places to use
specialty balloons to minimize the risk of dissection and necessity for bailout stenting.
Stenting in these areas has been performed
however lack signicant data as of yet.
in FDA-approved clinical trials, there are multiple dedicated below-the- knee tibial stents that
are showing promise.
6.10.3.1 Indications forBelow-theKnee Stenting
1. Critical limb ischemia (Rutherford criteria
4–6).
2. Severe vessel recoil (>50% reference vessel)
following balloon angioplasty.
3. Long-segment CTO occlusions unlikely to
respond to angioplasty alone.
4. Lesions involving the proximal 2/3 tibial ves-
sels (for current technology using balloonexpandable coronary drug-eluting stents).
5. Flow-limiting dissections.
6. Bailout for vessel perforation with active
extravasation.
6.10.3.2 Contraindications forBelowthe- Knee Stenting
There are few if any ABSOLUTE contraindications in the setting of critical limb ischemia. There
are, however, RELATIVE contraindications:
1. Contraindication or intolerance to antiplate-
let/anticoagulant therapy.
2. Contrast dye reaction.
6.10.3 Tibial Scaold Options
JesseMartin and RobertBeasley
Currently, there are no FDA-approved stents for
use below the knee. For many years, balloonexpandable coronary drug-eluting stents have
been used as a bailout for failed tibial angioplasty with good outcomes (Figs. 6.54 and
6.55). One limitation is areas of external com-
pression, such as below the calf level, limits use
of these stents. Past trials looking at selfexpanding stents for below-the-knee use have
not had favorable results [144]. However, now
Fig. 6.54 Normal anatomy for standard tibial artery
stenting procedures. Image courtesy of Robert E.Beasley,
MD, Palm Vascular Centers
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abc
Fig. 6.55 (a) Post-SAFARI and angioplasty of the right anterior tibial artery resulting in signicant dissection (red
arrow). (b) Coronary drug-eluting bare metal stent placement. (c) Completion angiogram with resolution of dissection
6.10.3.3 Current Tibial Scaold Options
withTrial Data andFuture
Tibial Stent Platforms
1. In the ACHILLES Trial that took place at 17
European centers, balloon-expandable coronary drug-eluting stents were randomized to
plain balloon angioplasty for treatment of
tibial lesions in patients with CLI.
(a) DES showed signicantly lower resteno-
sis rates (22.4% versus 41.9%), higher
patency (75.0% versus 41.9%), and
improved Rutherford classication at
12months [145].
2. In the Yukon-BTK trial, 161 patients were
randomized to receive balloon-expandable
coronary drug-eluting stents versus balloonexpandable coronary bare metal stents.
(a) The DES showed signicantly higher pri-
mary patency (80.6% versus 55.6%) and
improved Rutherford class [146].
3. In the XCELL registry, which evaluated the
Xpert self-expanding bare metal stent (Abbott
Vascular), 120 patients were enrolled in a
multicenter trial.
(a) Signicant binary in-stent restenosis was
seen with a rate of 68.5% at 6months and
only 49% had complete wound healing at
6months [144].
4. Future stent possibilities at the time of this
writing include three tibial stents that are currently in the FDA IDE trial.
(a) The Microstent (Micro Medical solu-
tions) is a tightly woven nitinol stent that
is currently being studied in the STAND
trial.
(b) The Eluvia stent (Boston Scientic) is a
drug-coated self-expanding nitinol stent
that is currently being studied in the
SAVAL trial.
• Results of this study were released at
CIRSE meeting in Barcelona 2022
showing it did not meet is primary
safety and efcacy endpoints.
(c) The ESPRIT stent (Abbott Vascular) is a
drug-eluting bioresorbable scaffold that is
currently being studied in the LIFE-BTK
trial.
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a bcd
I. Ali et al.
Fig. 6.56 (a) Post-angioplasty of the left anterior tibial
artery resulted in focal subtle dissection (red arrow). (b)
IVUS color ow image showing signicant dissection
TACK Dissection Repair
The TACK (Philips Inc.) endovascular dissection
repair is a Self-Expanding scaffold with low outward radial force, with the only intent of tacking
up the dissection aps post-intervention, which
otherwise can be a source of restenosis or thrombosis (Fig.6.56). These small stents, with minimal metal component, come preloaded on
catheters for above-the-knee and below-the-knee
sizes, from 1.5mm up to 8mm vessel diameters.
These are not intended for stenosis recoil management, which are reserved for conventional
stents/scaffolds. In using this device, one can
avoid using unnecessary stent material, which
itself can induce more downstream or follow-up
stenosis.
• The TOBA II BTK study has followed 233
patients out to 3 years with below-the-knee
application and showed approximately 70%
K-M Freetom from CD-TLR and~94% K-M
target limb salvage.
• Most operators prefer to use drug-coated balloon angioplasty before TACK placement to
assist in reducing restenosis.
ap (white arrow). (c) Deployment of two tack dissection
repair scaffolds. (d) Completion angiogram with satisfactory tacking of dissection ap
6.11 Distal Popliteal
andTrifurcation Disease
Management
IbrahimAli, UmanJaffer, and PrakashKrishnan
We know that there is signicant elastic recoil in
the tibial vessels with balloon angioplasty alone,
and oftentimes, prolonged balloon inations are
needed for better vessel patency. To date, however, our only bailout scaffold for recoil, residual
stenosis, ow-limiting dissection, or perforation
of the tibial vessels are stents.
Various trials evaluating below-the-knee arterial disease management are summarized below
and in Table6.4:
• Bare metal stents (BMSs), both balloon-
expandable and self-expandable, have been
compared with PTA and have shown no
clinical benet with regard to 1-year primary
patency or TLR [147].
– Additionally, BMSs have a high rate of
restenosis [147].
6 Arterial Revascularization
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Table 6.4 Results over various trials evaluating below–the- knee arterial disease management
Trial Randomization groups Number of patients Primary outcome Lesions
Yukon-
Btk
Destiny XIENCE everolimus-eluting
Achilles Sirolimus-eluting stent vs
Ideas DESs (zotarolimus/
Padi Paclitaxel-eluting stent vs
Sirolimus-eluting stent vs
BMS
stent vs BMS
standard PTA
sirolimus/everolimus stents)
vs paclitaxel drug-coated
balloons (DCBs)
PTA/BMS
161 CLI and
Claudication
Rutherford 2–5
140 CLI
Rutherford 4–5
200 CLI
Rutherford 3–5
50 CLI
Rutherford 3–6
137 CLI
Rutherford 4–6
12-month patency
(80.6% vs 55.6%;
P=0.004)
12-month patency
(85.2% vs 54.4%;
P=0.0001)
12-month restenosis by
angiography (22.4% vs
41.9%; P=0.019)
6-month angiographic
restenosis (28% vs
57.9%; P=0.046)
5-year amputation-free
survival (31.8% vs
20.4%; P=0.041)
Single de novo, <5mm
Maximum of two focal
lesions. Total lesion
length <40mm. Excluded
bifurcations
Total lesion length
<120mm. Excluded
bifurcations
Single lesions >70mm
Single lesion <60mm
155
• In contrast, the emerging evidence for the use
of drug-eluting stents (DESs) in infrapopliteal
disease is promising [145, 146, 148, 149].
– Therefore, we suggest using DES, includ-
ing coronary DES, in all bifurcation lesions
when, and if, a scaffold is required, with an
effort to minimize the amount of stented
area [150, 151].
– It is important to keep in mind there are
little to no data on the long-term patency on
drug-eluting stents in bifurcation lesions
below the knee. Our recommendations are
based on DES performance in single
lesions [151].
• A non-drug-eluting tibial stent, the MircoStent
(Micromedical Inc.), which is a closed-cell
nitinol self-expanding stent currently under
trials, may hold future promise as well [152].
• Treatment of bifurcation lesions may evolve
to include bioresorbable vascular scaffolds
(BVS), as to leave no footprint. In a recent
registry publication analyzing the Absorb
BVS by Abbott, the BVS showed freedom
from restenosis of 86.6% at 24 months.
Additionally, we await the results of the LIFEBTK randomized trial [152].
In complex bifurcation lesions of the tibial
vessels, we have primarily adapted coronary
bifurcation techniques to tackle these lesions.
• Primary techniques are provisional, culotte,
T-stenting, mini-crush, and kissing stents.
Below, we explain each [150].
6.11.1 Single Stent Technique/
Provisional (Fig.6.57)
• Preferred, least complex.
• Typically, a side branch is not involved.
• Steps: Wire placed down main branch and
stent is deployed into main vessel with side
branch jailed (i.e., stent from TP trunk into
peroneal artery jailing the posterior tibial). If
signicant dissection in a side branch, one
156
No double layers
•
Least amount of
•
stent
I. Ali et al.
Double layer of stent
Fig. 6.58 Culotte technique
Fig. 6.57 Single stent technique
would need to rewire side branch via stent
struts from main vessel stent and balloon
ostium of the side branch with nal KBI (kissing balloon ination).
6.11.2 Culotte Technique (Fig.6.58)
• Good technique for true bifurcation lesions
with similar size of two branches (main branch
and side branch).
• Side branch ostium will denitely be covered;
however, two layers of metal will be left in the
proximal main vessel (prior to bifurcation).
• Steps: Wire main branch and side branch.
Stent the more angulated branch rst. Then,
cross into the side branch via struts of main
branch stent and dilate struts open. Deploy the
second stent into side branch with proximal
portion of the stent in the main vessel overlapped with rst stent. Re-cross the rst stent
in the main branch and then perform KBI.
Uncovered area
Fig. 6.59 T-stenting technique
• No overlap between main branch and side
branch stents so less metal left behind proximally prior to bifurcation.
• Steps: Wire main branch and stent main
branch. Next, cross the main branch stent
struts into side branch with wire and deploy
stent in the proximal portion of the side
branch. Perform KBI to complete.
6.11.4 Mini-Crush Technique
(Fig.6.60)
6.11.3 T-Stenting (Fig.6.59)
• This is a relatively less complex bifurcation
technique, which is great for lesions that do
not involve the side branch ostium due to difculty in fully covering side branch ostium.
• Variation of the T-stenting which addresses
inherent lack of side branch ostium coverage
with T-stent technique.
• Good for bifurcations with side branch ostial
involvement as ostium is always covered. In
addition, unlike culotte technique only a sin-
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