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6 Arterial Revascularization
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for open TMA amputation if it is being considered in the early weeks after DVA creation.
6.24.3.10 Wound Care
Wound care for DVA patients requires a dedicated team that ideally includes an angiologist,
cardiologist, radiologist, vascular interventionalist, plastic surgeon, endocrinologist, podiatrist,
social worker, a home health team, a nurse navigator, infectious disease expert, nephrologist, primary care physician, and family support for
successful outcomes. The team should be able to
provide tension-free debridement and amputa-
tion without using tourniquets to prevent occlusion of the circuit and the arterialized veins.
Utilization of dermal substitutes, split thick skin
grafts, allografts, vacuum-assisted therapy, and
rotational skin aps can improve and accelerate
wound healing after revascularization.
6.24.4 When toNever Perform Deep
Venous Arterialization
tancy. DVA should not be offered to patients
who continue to smoke.
• Lastly it cannot be performed on a patient
with thrombosed pedal veins.
6.24.4.2 Clinical Experience
andExpert Opinion
The goal of DVA is limb salvage to improve both
longevity and quality of life as compared to
patients who would otherwise undergo amputation. While this procedure has the potential to
save limbs, it is not without signicant sacrice
including healthcare cost and resource utilization
and prolonged radiation exposure to the vascular
specialist and support staff. Since many factors
contribute to positive outcomes following deep
venous arterialization, a comprehensive evaluation of all determinants of health should be utilized to enhance patient selection and overall
success.
6.24.5 What IWish IKnew About DVA
Reuben Perez McCon, RT Ahmad Omar Hallak,
MDZola N’Dandu, MD
6.24.4.1 Patient Selection Process
DVA should be considered for no-option CLTI
patients who have had multiple failed interventions whether surgical or endovascular without
an available standard revascularization option to
perfuse a desert foot. The foot should not be
severely infected to salvage a functional limb.
Appropriate patient selection is critical for the
successful outcome of DVA. Not every critical
limb ischemia patient is a candidate for DVA.
• DVA should not be performed on a patient
with extensive infection where the foot cannot
be salvaged or whenever a patient cannot tol-
erate antiplatelet therapy or anticoagulation,
which is required for the patency of the
conduit.
• Additionally, it should not be performed on a
patient with less than one-year life expec-
ReubenPerezMcConRT, AhmadOmarHallak
and ZolaN’Dandu
6.24.5.1 New Information/Lack
ofInformation
Although currently dual integrated therapy or
oral anticoagulation is used, there is no consensus thus far on the ideal or proven post-procedure
regimen. With the worldwide interest in providing advanced treatment options for end-stage
critical limb ischemia and more clinical trials,
hopefully there will be more evidence-based
information needed to perform these procedures
with successful outcomes.
6.24.5.2 Clinical Experience
andExpert Opinion
Not everyone involved in post-patient care will
know the dos and don’ts of postoperative DVA
care. Education on the concepts of DVA is important to both the patient/family and the entire team
of providers caring for no-option CLTI patients.
218
I. Ali et al.
6.24.6 What toTell thePatient,
Family Member, and/or
Referring Provider
SreekumarMadassery
Percutaneous deep vein arterialization (p-DVA,
DVA, TADV) is still in its infancy, and clear
understanding of long-term effects, outcomes,
and how to optimize it are still yet to be claried.
However, as a growing body of evidence that it
provides yet another limb preservation option,
many operators have adopted this procedure.
With that, it is important to have a frank and honest discussion with the patient, family, and other
providers based on the short- term understandings
noted thus far.
When discussing the potential for DVA option,
it is important to bring the topic early in the discussions with any CLI/CLTI patient and family,
so that they have heard the term in their journey of
limb preservation. They should be told that if it is
found that there is microvascular disease pattern
on angiogram in the foot, also referred to as SAD
(small arterial disease), DVA may be the only
option for them if revascularization is needed. The
following should also be considered:
• It must be stated that the long-term outcomes,
the sequelae of true cardiac impact, venous
complications, and other matters are not well
understood. It is known that small subset of
patients may develop high-output cardiac fail-
ure, which is a reason why DVA should not
offered to patients with severe heart failure, or
potentially the DVA may need to be emboli-
zed/ligated.
• Patients with signicant preexisting venous
insufciency and edema may have negative
impact from the venous hypertension that
develops with DVA, which is why some oper-
ators try to perform distal DVA(dDVA) in
these patients or avoid the procedure.
• All involved must be told that creation of DVA
could hasten the time to major amputation,
which may be due to increased venous hyper-
tension causing blistering wounds and pro-
gression of infection, or with the process
turning stable gangrene into wet gangrene.
• If there is an underlying infection, there is
concern with infecting the implanted stent
grafts that are used in DVA procedures, so this
must be discussed as well.
• It is important to clearly inform that from
what is known thus far, the true benets of the
arterialization may take 6–8weeks to be realized. Therefore, everyone involved must be
aware that pain relief and wound healing will
not be immediate, and the wound needs to be
stable and continually monitored during this
time. It has been noted that some wounds may
appear worsened (especially with a recent
TMA), before it starts improving.
– However, it is not uncommon for some
wound healing to be seen in the early weeks
post-DVA, with granulation seen during
wound care, and with pain improvement.
• Once the DVA is created, it is possible that
repeat interventions may be needed, to treat
stenoses, thrombosis, collateral vein embolization, etc., until maturation is achieved.
Therefore, giving patients this warning is prudent to prevent any surprises.
• Patients and teams should understand that if
the DVA occludes after the initial few months,
the operator may choose to leave it alone, as
the arterialization should have already commenced and shown its benet. It could be
futile to perform an exhaustive attempt to
revascularize the DVA.
– This does not hold true for the rst two
months, where it seems benecial to
address any issues noted on noninvasive
imaging, physical examination, or direct
angiogram.
Additional concerns to keep in mind are that
minor amputation, particularly TMAs, should be
delayed, if possible, until the DVA has had time
to mature. The best estimates are between 4 and
8weeks and based on thorough evaluation by the
operator in follow-up. If the amputation is necessary in the interim, recommend tension-free
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amputation to allow the tissue to progressively
heal.
In the end, as long as an upfront and honest
conversation is had between the operator and the
patient and family, with clear setting of expectations and unknowns, this procedure can be very
successful technique to save limbs. Giving constant updates to the other providers only helps to
improve outcomes, as the operator will be made
aware of any important changes that happen, so
timely intervention can be performed.
6.25 Hybrid Deep Vein
Arterialization
JillSommersetJorgeMiranda, and
MiguelMonteroBaker
6.25.1 Denition ofNo Option
In the treatment of CLTI, the therapeutic goal is
restoration of blood ow and perfusion; however,
there is a segment of the CLTI population where
standard surgical and endovascular revascularization attempts do not sufce, leaving no option
for further treatment. The term “no-option CLTI”
is an evolving concept that lacks a standardized
denition by scientic consensus. Broadly speaking, no-option CLTI represents patients, which
have no viable options for arterio-arterial reconstructions. Objective denitions and classication have been proposed in the past and include
patients with extensive tissue loss, “desert foot”
pedal anatomy, and the inability to revascularize
the limb, but there is not yet broad adoption of
any one denition by the medical community
[373, 374].
6.25.2 MAC Classication
The main histopathological driver of no-option
CLTI is severe below-the-ankle calcium burden.
This burden can be graded via medial artery cal-
cication (MAC) scoring. Ferraresi et al. proposed a risk classication of MAC, which divides
patients into three groups based on distribution of
MAC as evaluated by plain radiographic study of
the foot [375]. The higher the MAC score, the
worse the clinical results, including vascular and
podiatric unplanned reinterventions and major
adverse limb events.
6.25.3 Venous Arterialization
Though conventional revascularization
approaches have been unsuccessful in no-option
CLTI, the concept of venous arterialization as a
solution has been hypothesized and attempted in
various iterations for the last century. As previously discussed, arterialization of the veins retroperfuses the capillary bed in the ischemic foot by
diverting oxygenated blood ow from diseased
artery into non-diseased vein. The results have
been heterogeneous and difcult to compare
owing to the drastic differences in technical
approaches and advances in technology. The
absence of consistency has led to limited reported
cohorts and poor adoption of the procedure.
Miranda et al. have shown clinical success
with two main techniques: Transcatheter deep
venous arterialization (TADV, aka deep vein arterialization/DVA) and hybrid supercial venous
arterialization (HYSA) [376].
6.25.3.1 Selecting TADV vs HYSA
• TADV/DVA is a purely endovascular proce-
dure that involves placing PTFE-covered
stents across an anastomosis from the poste-
rior tibial artery (ideally) to the posterior tibial
vein and lining the PTV to divert arterial ow
into the lateral plantar vein, where the venous
valves have been lysed.
• Hybrid endovascular and surgical approach to
this procedure is also performed. The HYSA
procedure involves making an in situ open
surgical anastomosis from the greater saphe-
nous vein to the popliteal artery followed by
valve lysis and distal endovascular focaliza-
tion of ow.
220
Fig. 6.96 Occlusive pattern of the forefoot. This pattern is best suited to perform a HSYA.During a HYSA procedure,
there is no disruption of the PTA inow as the anastomosis is done end-to-side
I. Ali et al.
Fig. 6.97 Occlusive pattern of the hindfoot, also called orphan heel. This pattern is best suited to perform a TADV.Using
the PTA as inow would not alter baseline hemodynamics
• The decision to perform either primarily
depends on the anatomical distribution of disease: In patients with an occluded anterior
tibial artery and suitable GSV (>3.0 mm),
HYSA is preferred. On the contrary, patients
with an (Fig. 6.96) occluded posterior tibial
artery regardless of GSV status, TADV/DVA
is more suitable (Fig.6.97).
• Early prospective studies of HYSA have
shown very promising results, with Ferraresi
et al. reporting limb salvage of 69% and
wound healing in 44% of limbs at a mean follow- up of 10.8months in a 35-patient cohort
of no-option CLTI patients [377].
• TADV/DVA results in no-option CLTI patients
have been reported in several patient cohorts
including the experience of Kum etal., Del
6.25.3.2 Data
There is a growing body of evidence for both
approaches, as technical advances allow for
increased availability of appropriate devices for
performing the procedures and as the procedure
continues to be standardized.
Giudice etal., Clair etal., and Schmidt etal.,
all of which reported consistent amputationfree survival rates at 12months of 57–74%
[370, 378–380].
• In addition to fully percutaneous TADV/DVA,
Miranda etal. reported 81% limb salvage in a
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cohort of 41 patients who underwent HYSA
or TADV/DVA [376].
6.25.4 LimFlow System forVenous
Arterialization
SreekumarMadassery
LimFlow (LimFlow Inc.) system for deep vein
arterilization(DVA) is a proprietary system used
currently only in trials globally. The system has
the necessary main components for DVA creation
including ultrasound-based arterial and venous
catheters to create the AV stula, tapered covered
stent graft, and an over-the-wire valvulotome.
LimFlow has thus far underdone two trials:
• PROMISE I, which had 32 patients followed
for 1 year, reported in 2020, with 70%
amputation- free survival (AFS) and 75%
wounds healed/healing at 12months.
• PROMISE II, which followed 105 patients,
and the 6-month follow-up results were
released on October 2022 at VIVA
conference.
• The recent results were very promising, with
66% AFS (compared to 54% in the general
population performance goal in these patients),
and 76% limb salvage rate with >75% of
wounds healed/healing at 6months [381].
The results of these trials are incredibly promising, as these are the most complex and limbthreatening cohorts in the PAD population. While
the proprietary system in under trials and awaiting commercial use, many operators globally
have been performing DVA off the shelf for several years. The data for this are very difcult to
generalize as there is no standardization of the
techniques, and only retrospective reviews are
currently reported. Recently, there was a retrospective review of 42 patient non-LimFlow DVA
review, with 33 successful arterializations, and
overall AFS at 6 months was ~61% for 25
patients, and 16 patients with minor amputations
[382]. There will be far more retrospective studies reported in the coming years and hopefully
more prospective and randomized studies so that
a better understanding can be attained in this
complex patient population. In the meantime, for
patients truly with no options, and ambulatory
status, venous arterialization may be the only
option that still exists and still better than major
amputation if avoidable.
6.26 No-Option Aortoiliac
Patients Still Have Options
MuratOsman and BulentArslan
Historically, aortoiliac occlusive disease has
been primarily managed with an open surgical
approach. However, over the past several decades
advents in interventional techniques and tools
have allowed for hybrid and completely interventional/endovascular options to become possible. Open repair of aortoiliac disease is
associated with higher operative mortality/morbidity, net cost, and longer length of stay when
compared to hybrid and/or completely interventional repair [383, 384]. Hybrid and percutaneous approaches are especially better suited for
patients who are deemed high risk for open surgery. Ultimately, appropriate selection of management should be based on center experience
with open and endovascular procedures and
patient factors such as age, comorbidities, and
vascular anatomy.
We present a 77-year-old man with severe
lifestyle-limiting claudication (> 50feet) involving bilateral thighs and calves for approximately
15 years. He has a complex medical history
including 40+ pack year smoking history, systolic heart failure s/p CABG in 1999 with two
occluded coronary bypass grafts (LIMA to LAD
patent), and previously placed bilateral external
iliac artery (EIA) and renal artery stents. The
patient was offered open only surgical revascularization at several major academic institutions,
with a high mortality/morbidity risk due to his
comorbidities. He declined those options and
presented to our institution for a “fth” opinion.
Pertinent physical examination ndings include
non-palpable femoral, popliteal, dorsalis pedis
(DP), and posterior tibial (PT) pulses bilaterally.
222
abc
I. Ali et al.
d
Fig. 6.98 Preprocedure coronal CTA 3D rendering (a, b)
and axial planes (a, b) of the abdomen and pelvis demonstrate multilevel atherosclerotic disease and multilevel
aortoiliac occlusions. (a) Note critical stenosis of the
infrarenal aorta (blue arrow) and occlusion of the bilateral
CIA stents and occluded EIA (red arrow). (b) Coronal 3D
runoff demonstrates dominant high-grade atherosclerotic
Initial ABI study was notable for ABI/TBI of
0.26/0.21 on the right and 0.29/0.12 on the left with
biphasic PT/DP bilaterally. CTA of the abdomen/
pelvis with runoffs demonstrated occlusion of the
distal aorta below the IMA, bilateral common iliac
(CIA), external iliac (EIA), common (CFA), and
supercial femoral arteries (SFA) (Fig. 6.98a).
Only the bilateral deep femoral branches and tibial
arteries were patent, which were primarily fed by
collaterals (Fig.6.98b). The SMA and celiac artery
were occlusive and were reconstituted through
IMA collaterals (Fig.6.98c, d). The bilateral renal
artery stents were patent. Preprocedural aortography from a left brachial artery approach conrmed
these ndings (Fig.6.99).
After considering patient’s preference on forgoing any open abdominal surgery, a hybrid
approach was planned, which aimed at recanalizing the distal aorta, L CIA/EIA arteries into the
occlusive L CFA. This would be followed by
immediate surgical repair of the bilateral CFAs
and placement of a femoral–femoral bypass graft
in one procedural setting.
stenosis in the bilateral common and supercial femoral
arteries (arrowheads), with one vessel runoff to the R foot
via a reconstituted PT and L foot via reconstituted AT and
PT arteries. (c) There is post-stenotic dilation of the IMA
(blue arrow) and occlusive stenosis of the celiac origin
(d), with complete occlusion of the SMA (not shown)
Case Technical Description:
• First, left groin dissection with exposure of the
left CFA was performed and access was
obtained directly into the occlusive L CFA
with a micropuncture system. Then, a 5 Fr
pinnacle sheath was advanced with its tip into
the occlusive EIA.
– Through this sheath, an 0.035″
GLIDEWIRE and a Berenstein catheter
were used to cross the occlusive segments
to access the patent segment of the distal
aorta.
• Then, the GLIDEWIRE was exchanged with
an Amplatz wire, and over the wire, a 12 Fr
introducer sheath was placed. Initial aortogram was performed (Fig.6.100a) and angioplasty of the L CIA and EIA was performed
(Fig.6.100b).
• A 10mm x15cm Viabahn stent was advanced
and placed from the mid-portion of the L CIA
extending into the proximal CFA segment
(Fig.6.100c).
cd
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ab
223
Fig. 6.99 Preprocedure aortogram (a) performed via L
brachial access conrms ndings of preprocedure CTA,
with multilevel stenosis of the aorta just below the level of
the renal arteries (red arrow) and occlusion of the aorta
below the IMA (blue arrow). The bilateral renal artery
stents are patent; however, no signicant lling of the
– This would allow the surgeon to access
the distal stent and suture it into the surgically created femoral patch (i.e.,
conduit).
• At the proximal end of the stent construct, a
Viabahn VBX balloon-expandable stent was
placed to bridge the self-expanding Viabahn
stents and the patent aorta (Fig. 6.100d).
During placement of the VBX balloonexpendable stent, attention was paid not to
push the plaque to the origin of the IMA.
– The restricted space in the distal aorta at
the origin of the IMA was also a reason to
recanalize only the left iliac system instead
of both right and left.
• Post-deployment angiography demonstrated
re-established arterial inow to the L CFA;
however, the IMA was no longer visualized
(Fig.6.100e). This was due to displacement of
atherosclerotic plaque near the IMA ostium
by the VBX stent graft.
• Subsequently, the VBX stent was pulled down
a few millimeters by inating a balloon inside
it and applying a downward force (images not
available). Repeat angiogram demonstrated
improved ow to the IMA but persistent, suboptimal ow (Fig.6.100f).
• Steps were then taken to ensure optimal ow
to the IMA.A steerable sheath was advanced
and positioned near the origin of the IMA
proximal celiac artery was visualized. Selective angiography (b) demonstrates hypertrophic IMA with large rectal
artery collaterals (arrowhead). Pelvic and lower extremity
angiography (c, d) demonstrates occlusions of the bilateral CIA, EIA, and CFA, and SFAs with prominent
collaterals
(Fig. 6.101a). Using a Berenstein catheter
with a 0.018 wire was advanced, and the IMA
was successfully catheterized. Over the 0.018
wire, angioplasty of the IMA was performed,
which resulted in rupture of the balloon
(Fig.6.101b, c).
– A snare was advanced over the existing
system to retrieve the ruptured balloon
fragment (Fig. 6.102a). After this, it was
recognized that the balloon separated into
two pieces.
• Although the proximal fragment was successfully removed, the distal fragment migrated
into the distal IMA, adjacent to the arc of
Riolan (Fig. 6.102b). To retrieve the distal
fragment and optimize the IMA ow, rst a
5 mm × 2.2 cm drug-eluting stent was
deployed into the origin of the IMA
(Fig.6.102c). Through the stent, a snare was
advanced, and the distal balloon was retrieved
(Fig.6.102d).
– After retrieval, residual spasm was noted
secondary to instrumentation, which slowly
resolved (Fig.6.102e).
• Subsequently, a 10mm×4cm balloon was
inated left within the stented L EIA to temporarily obstruct ow and allow for repair of
bilateral CFA and placement of a fem-fem
bypass graft (Fig.6.102f), which was successfully completed.
224
bc
a
bc
de f
I. Ali et al.
Fig. 6.100 Sequential uoroscopic images demonstrating
recanalization of the occluded left CIA.After obtaining initial aortogram (a), uoroscopic image demonstrates serial
dilation of the previous chronically occluded L EIA stent
(arrow) and occlusive segments (b) prior to placement of
Viabahn stent grafts extending to the proximal L CFA (c).
Deployment of the proximal VBX stent graft (d) with post-
dilation of the stent construct. Following deployment of the
VBX stent, repeat angiogram (e) demonstrates diminished
ow to the IMA (arrow). Following attempts to mechanically
pull down the VBX stent with a balloon (f) and ow through
the IMA improved however suboptimal ow persisted
a
Fig. 6.101 Sequential uoroscopic images demonstrating angioplasty of stenotic IMA origin and balloon rupture. Angiogram (a) demonstrating advancement of a
steerable sheath with redemonstrated diminished ow.
Sequential uoroscopic images (b and c) demonstrate
rupture of the balloon during ination, as demonstrated by
presence of contrast leaking outside the contours of the
balloon (blue arrow)
bc
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a
de f
225
Fig. 6.102 Sequential uoroscopic images demonstrating retrieval of the ruptured balloon. A snare was advanced
through the existing system, and the retained balloon was
successfully retrieved (a). Following snare retrieval,
repeat angiography of the IMA demonstrates a radioopaque density and surrounding lling defect in the distal
IMA (b), representing an embolized fragment of the balloon. A drug-eluting stent was rst deployed at the IMA
The patient was ultimately discharged on
POD #7. The patient’s claudication symptoms
resolved on one-month follow-up, with follow up ABI demonstrating improved ABI/TBI bilaterally 0.60/0.43 on the right and 0.59/0.43 on the
left with improved biphasic DP/PT waveform
origin (c) followed by retrieval of the distal balloon fragment with a snare (d). Subsequent aortography demonstrates improved and patent ow through the proximal and
distal IMA (e). Note residual spasms of the mid-distal
IMA (green arrow). At the end of the case, a balloon was
left inated within the stented L EIA to aid in the placement of a surgical bifemoral bypass (f)
and palpable bilateral common femoral arteries.
Several follow-up CTA studies at two months
through 4 years demonstrate continued patency
of the IMA, stent graft construct, and bifemoral
bypass with no recurrence of claudication symptoms (Fig.6.103).
226
ac
Fig. 6.103 Four-year
follow-up CTA of the
abdomen/pelvis with
runoff in the axial plane
(a, b) and 3D volume
rendering (c)
demonstrate patent
bifemoral bypass graft
(blue arrow) and surgical
changes related to
endarterectomy and
patch angioplasty of the
L EIA to the CFA
bifurcation (red arrow).
The stented IMA is
patent (b)
I. Ali et al.
b
6.27 Inequalities inLimb
Preservation
There is a paucity of data available on Hispanic
Americans, Native Americans, Asian Americans,
and other races within the USA.Lastly, this secJordanTaylor, NicoleKeefe, GloriaSalazar
and MaureenKohi
tion will explore the differences in disease bur-
den and demographics in the global health
setting, understanding that each country and
geographical landscape provide vastly different
6.27.1 Introduction
epidemiological data and management is usually
limited by the infrastructure available to these
Peripheral artery disease affects an extensive and
diverse patient population both domestically and
abroad in the global health setting. There is
strong evidence that supports major gaps in
equality regarding the affected population and
the involved diagnosis, treatment, and management. These gaps result in racial and gender disparities that increase the disease burden, severity
at initial presentation, and ultimately result in a
greater number of lower extremity amputations.
countries.
The authors of this chapter recognize that race
and ethnicity are a social construct without a biological basis with somewhat arbitrary ofcial
denitions, which continue to change over time.
With that understanding, the authors have based
conclusions using racial guidelines dened by
the US Census Bureau, the US Ofce of
Management and Budget, and the World Health
Organization Racial and Ethnic Categories.
This section will address racial, gender, and geographic disparities. The majority of the literature
available focuses on Black Americans and non-
6.27.2 Racial Disparities inPAD
Hispanic Whites. The current studies evaluating
gender disparities focus on white females with a
limited amount of data involving black females.
The overall prevalence of peripheral artery disease (PAD) among individuals over age 40in the
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