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P. T. Skummer et al.
• No high-quality randomized control trials
exist comparing DUS to other screening
modalities nor evaluating the benet and longterm outcomes of prophylactic intervention
after EVT.A threshold of recurrent severe stenosis (>70%) has been suggested for re-intervention on asymptomatic patients to avoid the
potential risk of intervening on a smaller area
of stenosis that may have had an otherwise
benign course [19].
• Patients who may benet most from close surveillance and early re-intervention include
those with failed prior open or surgical interventions, as well as patients presenting with
severe ischemia, persistent wounds/tissue
loss, new stenotic lesions post-intervention,
poor runoff, and/or long-segment treatments
[3, 19, 20].
10.1.4 Bypass Follow-Up
The ofcial suggestion from SVS is patients who
were treated for intermittent claudication are part
of a clinical surveillance program that consists of
an interval history to detect new symptoms,
ensure compliance with medical therapies, record
subjective functional improvements, pulse
examination, and measurement of resting and, if
possible, post-exercise ABIs [2].
• Arterial disease treated with bypass should be
evaluated with physical examination, ABI,
and DUS within the rst month of treatment to
establish a baseline, then again at 6months,
12months, and annually if there are no new
symptoms [8].
• A 3-month follow-up should be included with
infra-inguinal vein bypass grafts. Angiogram
with possible intervention should be performed should PSV >300cm/s or Vr >3.5 [3].
• Cross-sectional imaging should be performed
if there is a decrease in ABI >0.15 or mid-graft
velocity decrease to PSV <45 cm/s without
obvious cause on DUS. Closer follow-up
should be performed within 6–12 weeks in
patients with moderately elevated PSV (200–
300cm/s) or Vr (3.5>Vr>2) [3, 21].
• Patients with a worsening clinical vascular
examination, return of rest pain, nonhealing
wounds, or new tissue loss should undergo
DUS at any time point.
10.1.5 EVT Patients
• Post-EVT patients should be evaluated with
physical examination, ABI, and DUS within
the rst month of treatment to establish a
baseline, 6months, 12months, and then annually if there are no new symptoms [8].
• Continued surveillance at 3months and then
every 6months is indicated for the endovascular interventions using stents because of the
potential increased difculty of treating an
occlusive or stenotic in-stent lesion [8].
• Also, 3 and 6 months follow-up is recommended for those who have undergone angioplasty or atherectomy to treat critical limb
ischemia because of an increased risk of
recurrent rest pain or tissue loss should the
intervention fail as well as those who have had
any tibial artery intervention [8].
• Those patients with a worsening clinical vascular examination, return of rest pain, nonhealing wounds, or new tissue loss should
undergo repeated DUS or possible crosssectional arterial imaging (6, 3), especially if
decrease in ABI >0.15 [8].
• Angiogram with re-intervention should be
considered in patients with DUS-detected restenosis >70%, as dened as PSV >300cm/
second or PSV ratio >3.5 [3, 14].
• Recurrence of symptoms such as rest pain
or new/worsening wounds should prompt
DUS, regardless of time from intervention.
Suggested follow-up intervals with DUS
and recommended next steps based on DUS
ndings are summarized in Tables 10.1 and
10.2.
10 Long-Term Imaging
Table 10.1 Follow-up intervals
Baseline (within
1month) 3months 6months
Peripheral arterial disease
Intermittent claudication x
Lower extremity bypass x x x x
Endovascular therapy
Treatment with critical limb ischemia x x x x
Deep venous disease
Pharmaco-mechanical catheter-directed
thrombolysis
Left iliac vein stenting/Iliocaval reconstruction x x x x
a
Consideration can be given to annual surveillance in patients with stable examinations, particularly in those without
stent grafts
Table 10.2 Abnormalities on DUS or Exam (Peripheral Arterial Disease)
Elevated PSV (200–300cm/s) or
Vr (3.5>Vr>2)
PSV>300cm/s or Vr>3.5 Angiogram with possible intervention
ABI decrease >0.15 Correlate with DUS, if no evident abnormality, then further work-up with CT
PSV<45cm/s in bypass graft Correlate with DUS, if no evident abnormality, then further work-up with CT
Change in vascular examination,
rest pain, nonhealing wounds, or
new tissue loss
PAA stent narrowing 50% or more Catheter angiogram
DUS Duplex ultrasound, PSV peak systolic velocity, VR velocity ratio, ABI Ankle brachial index, CT computed tomog-
raphy, MR magnetic resonance
a
Repeat DUS in 6–12weeks, resume surveillance timing if no signicant
change or angiogram with possible intervention if worsen
or MR angiogram or catheter angiogram with possible intervention
or MR angiogram or catheter angiogram with possible intervention
Perform DUS then treatment based upon ndings as described above
x x x x
x x x x
Every
12months
Every
6months
301
10.2 How toFollow Venous
Wounds?
PhilipT.Skummer, MatthewJ.Scheidt,
and ParagJ.Patel
10.2.1 Venous
10.2.1.1 Deep Venous Diseases
Deep venous disease exists on a spectrum regarding the presence and extent of thrombus, type of
intervention required, and chronicity of thrombus. Venous DUS, CT/MR venography, and
Direct Catheter Venography can play an important role in pre-procedure planning and followup in select cases. Surgical or endovascular
intervention for deep venous thrombosis (DVT)
is primarily driven by the location of the thrombus, with the main goal of prevention, or reducing severity of post-thrombotic syndrome (PTS).
The Acute Venous Thrombosis: Thrombus
Removal with Adjunctive Catheter-Directed
Thrombolysis (ATTRACT) Trial was a major
multi-centered, prospective, randomized, assessor-blinded clinical trial evaluating the relationship between endovascular therapy for acute
(14days or less) proximal (femoral through iliac
vein) DVT, that included evaluation of PTS, and
quality of life [22].
• This study demonstrated that pharmacomechanical catheter-directed thrombolysis
resulted in lower clot burden at 1month and
302
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P. T. Skummer et al.
common femoral vein non-compressibility
was associated with greater incidence and
severity of PTS.
• The follow-up imaging regimen in this trial
included DUS at baseline, 1 month, and
12months post-procedure with reux DUS at
12months.
• Post-procedure success can be dened with
objective scoring to grade residual thrombus, such as the Venous Clinical Severity
Scoring, Villalta scoring system, or venous
registry index, with post-procedure success
considered >50% clearance of luminal clot
burden [23].
Similar to PAD, there is a paucity of high-
quality studies to evaluate the optimal timing of
imaging follow-up on patients after intervention.
Long-term patient-centered outcomes such as
quality of life scores and absence of PTS symptoms, are key components of post- intervention
follow-up [23].
• One potential metric to be considered with
long-term imaging follow-up is the presence
of venous reux on DUS.
• Comparison between both lower extremities
can be used as a functional surrogate measure
for presence of clinically relevant PTS [23].
• New/worsening symptoms or wounds should
prompt DUS, regardless of time from
intervention.
• Suggested follow-up intervals with DUS and
recommended next steps based upon DUS
ndings are summarized in Tables 10.1 and
10.3.
10.2.1.2 May-Thurner Syndrome
May-Thurner Syndrome (MTS), also known as
iliac vein compression syndrome, is secondary to
extrinsic compression of the left common iliac
vein by the right common iliac artery, resulting in
luminal narrowing, which can potentially lead to
acute thrombosis. Patients with acute thrombosis
often undergo catheter-directed thrombolysis as
this can lead to chronic, more difcult to treat,
occlusion when not addressed. The standard of
care for treating patients with clinically relevant
iliac vein compression syndrome pathology is
stenting of the left common iliac vein, particularly now with dedicated venous stents. Several
studies have evaluated the efcacy of treatment
protocols for MTS, both in the acute and chronic
setting, as well as if DVT is present.
In May-Thurner syndrome, routine clinical
follow-up consists of a physical exam, screening
DUS, and determining CEAP (clinical, etiological, anatomical, and pathophysiological) classication, venous clinical severity score (VCSS),
and venous claudication score. Particular attention on post-treatment surveillance DUS is made
for any extrinsic stent compression, in-stent stenosis, and stent integrity.
• Various follow-up schedules were proposed by
different authors with most agreeing on early
post-procedure clinic visits and DUS at
2–6 weeks, then 6 months, 12 months, and
annually [24, 25]. Evidence of ow limiting in-
stent stenosis or thrombosis on DUS, as well as
worsening symptoms, should prompt diagnos-
tic venography with possible intervention.
10.2.2 Iliocaval Stent Reconstruction
Table 10.3 Abnormalities on DUS or Exam (Deep
Venous Disease)
Unable to evaluate
iliac vein patency
In-stent stenosis or
thrombus >50%
Recurrent
symptoms
DUS Duplex ultrasound, CT computed-tomography, MR
magnetic resonance
CT or MR venogram
Catheter venogram
Perform DUS then treatment
based upon ndings as
described above
Iliocaval Stent reconstruction serves as an adjunct
to iliocaval or iliofemoral thrombosis and as part
of the treatment of MTS.Most studies regarding
follow-up for iliocaval reconstruction are institution dependent, reported as part of publications
describing the technical factors related to the procedure, with a heterogenous patient population
involving both acute and chronic thrombus, as
well as thrombosis secondary to an inferior vena
10 Long-Term Imaging
303
cava lter. Imaging follow-up should not happen
in isolation and patients should be clinically evaluated at similar time points, to determine symptomatic improvement. Clinical evaluation
includes:
• Obtaining objective data points such as CEAP
classication.
• Physical exam to evaluate for skin changes or
ulceration.
• Leg circumference measurements.
• Record of patient compliance regarding the
use of compression garments and medication
adherence [26].
The Cardiovascular and Interventional
Radiological Society of Europe (CIRSE)
developed practice guidelines for iliocaval
stenting and recommended post-procedural
monitoring with physical examination and
assessment of CEAP classication, as well as
DUS to identify stent thrombosis or in-stent stenosis requiring intervention.
• Suggested surveillance intervals by CIRSE
were 1 month, 3 months, 6 months, and
12 months post-procedure then annually
afterward [27].
• Hage et al. conducted a survey of providers
performing iliocaval reconstruction with
approximately 95% of responders performing
imaging follow-up with either DUS or CT
venogram within the rst month then a
majority repeating relevant imaging at
6months intervals afterward [28].
• This follow-up regimen was similar to many
of the published articles at individual
institutions, with early acquisition of baseline
examination with DUS obtained immediately
post-procedure through the rst month, at
6months, and then annually [29, 30].
• Recurrent luminal obstruction of greater than
50% on post-intervention imaging warrants
further evaluation with dedicated catheterdirected venography. Catheter-directed intervention is warranted for stent thrombosis or
in-stent stenosis of at least 50% [26].
10.2.3 Chronic Venous Disease
Chronic venous disease is typically the sequela of
DVT resulting in venous insufciency, reux,
and hypertension. Endovenous thermal ablation
(EVTA) can be utilized to treat these incompetent
veins and re-distribute blood through more
functional venous drainage pathways. Successful
treatment can be documented by DUS showing
acute venous wall thickening then complete
occlusion and ultimately obliteration of the
treated venous segments [26].
• One study had a seven visit, 8-month followup schedule to assess treated veins at 2days,
1week, 2weeks, 1month, 3months, 5months,
and 8months [31]. Such a detailed follow-up
program may not be required for all patients
as the average time to essential venous obliteration is less than 6months [31].
• A multi-society consensus statement on supercial venous insufciency with EVTA dened
the endpoint in DUS surveillance as the time
when the treated vein is no longer sonographically visualized.
• In addition, follow-up DUS should be performed if new varicosities develop to determine if recurrent reux in a previously treated
vein or a new venous pathway is responsible
for the clinical symptoms [32].
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Long-Term Medical Management
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IanDel Conde andSreekumarMadassery
11
11.1 Arterial Disease Management
IanDel Conde
Peripheral arterial disease (PAD) is highly prevalent in the general population, and these patients
are at elevated risk of cardiovascular morbidity
and mortality.
• With decreasing ankle-brachial indices below
0.9, the event rate of cardiovascular endpoints
rapidly rises.
• In patients with an ankle-brachial index below
0.7, the 5-year risk of major cardiac events is
approximately 19%, which is higher than the
highest risk category of the Framingham risk
score [1] (Fig.11.1).
• At 5 years, mortality rates of PAD are similar
to those seen in more readily recognized lethal
conditions such as colorectal cancer or
Hodgkin’s disease. Even with contemporary
medical management, patients with PAD have
high rates of major cardiovascular events.
In addition to high cardiovascular morbidity
and mortality, patients with PAD and claudication have a markedly diminished quality of life.
Using validated tools such as the SF 36 questionnaire, patients with intermittent claudication have
a quality of life that is at par with conditions such
as congestive heart failure or chronic lung disease. Additionally, PAD patients experience
major adverse limb events, such as amputation.
In a recent study, 6.8% of real-world patients
with PAD underwent amputation [2]. In 2009, the
hospital costs associated with amputation or staggering totaled over $8.3 billion [3].
11.1.1 Medical Management of PAD
The management of patients with PAD follows a
three-pronged approach focused on:
• The prevention of major adverse cardiac
events, including myocardial infarction,
stroke, and death.
• Improving function and quality of life.
• Preventing limb loss (Fig.11.2).
I. Del Conde
Miami Cardiac and Vascular Institute, Baptist Health
South Florida, Miami, FL, USA
e-mail: iand@baptisthealth.net
S. Madassery (*)
Department of Vascular and Interventional Radiology,
Rush University Medical Center, Chicago, IL, USA
© The Author(s), under exclusive license to Springer Nature Switzerland AG 2023
S. Madassery, A. Patel (eds.), Limb Preservation for the Vascular Specialist,
https://doi.org/10.1007/978-3-031-36480-8_11
Every patient with peripheral arterial disease
should be prescribed:
• Complete smoking cessation
• Antithrombotic therapy
• Aggressive lipid management
307
308
I. Del Conde and S. Madassery
Fig. 11.1 Coronary
heart disease (CHD)
outcomes plotted against
ankle: brachial index
(ABI)
Fig. 11.2 Threepronged approach to the
medical management of
patients with PAD
Framingham “ High Risk” = 20% at 10 years
4
3
2
per Year (%)
1
CHD Event Outcomes*
0
*Fatal or nonfatal MI
Prevent limb loss
Every PAD
patient is at
“very high risk”
1.4%
>1.1
1.1–1.01 1.0–0.91 0.9–0.71 <0.7
Management of
ABI
Prevent MI,
Stroke, and
Death
the Patient with
PA D
5-year risk=
10%
2%
PAD
5-year risk=
19%
3.8%
Improve function
and QOL
• Blood pressure control
• Diabetes control
• Regular exercise
• Foot care
11.1.2 Walking Program
There is ample evidence that a walking or exercise program improves the ability to walk in
patients with claudication, even to a greater
degree compared to drug therapies such as
cilostazol. In a meta-analysis, an exercise
program led to 120% increase in walking distance
among patients with claudication, which was
superior compared to all other noninvasive
interventions [4].
The current PAD guidelines provide a class Ia
recommendation for a supervised exercise program
to improve functional status and quality of life and
to reduce leg symptoms [5]. It should be noted that
as of May 2017, the Centers for Medicare and
Medicaid Services have approved reimbursement
for supervised exercise training, only if the therapy
meets specic criteria, such as sessions lasting
30–60min delivered by certied personnel.
11.1.3 Antithrombotic Therapy
inStable PAD
Even though antiplatelet therapy is widely
accepted as a standard in patients with peripheral
arterial disease, in a well-performed meta- analysis,
Berger etal. found little data to support the use of
aspirin for the prevention of major adverse cardiac
events among patients with PAD [6].
• Notwithstanding, antiplatelet therapy receives
a class Ia recommendation in the current PAD
11 Long-Term Medical Management
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309
guidelines and should be used in all patients
with peripheral arterial disease.
There are reasons to believe the ADP receptor
antagonist Clopidogrel may be superior to
aspirin. In the CAPRIE trial, in which aspirin and
clopidogrel were compared head-to-head
amongst patients with a prior history of stroke,
myocardial infarction, or PAD, the PAD subgroup
derived particular benet from clopidogrel with a
24% relative risk reduction in the occurrence of
stroke myocardial infarction or cardiovascular
death [7].
• Despite the absence of data replicating these
ndings, some clinicians have interpreted the
CAPRIE study as an indication that clopidogrel
should be the preferred antiplatelet drug in
patients with PAD.Although there were hopes
that the third-generation P2Y12 inhibitor
ticagrelor would be superior to clopidogrel in
patients with peripheral internal disease in the
prevention of cardiovascular endpoints, the
EUCLID trial failed to demonstrate any
outcomes advantage of ticagrelor over
clopidogrel [8].
There is limited data to support the use of dual
antiplatelet therapy in patients for the medical
management of stable peripheral arterial disease
(i.e., excluding patients with recent endovascular
revascularization).
• In the CHARISMA study, dual antiplatelet
therapy with aspirin and clopidogrel resulted
in slightly lower rates of myocardial infarction
and hospitalization compared to aspirin alone,
at the cost of increased minor bleeding [9].
Vorapaxar is an antiplatelet drug that blocks
the thrombin receptor on the platelet surface as
well as on endothelial cells. It is not an
anticoagulant. Thrombin is the most potent
platelet agonist known and is particularly relevant
in invivo platelet activation and aggregation.
• In a large, randomized control trial looking at
secondary prevention of cardiovascular
disease, vorapaxar led to a lower risk of
hospitalization for acute limb ischemia as well
as for peripheral revascularization compared
to placebo among patients with PAD [10].
More recently, the combination of aspirin plus
ultra-low-dose rivaroxaban at 2.5mg twice daily
has been studied in patients with stable CAD or
PAD in the COMPASS trial.
• The combination of low-dose rivaroxaban and
aspirin led to a 28% relative risk reduction in
the composite endpoint of cardiovascular
death, myocardial infarction, or stroke
compared to aspirin alone, and was also
associated with a 46% relative reduction in the
composite of major adverse limb events
comprised of acute limb ischemia, critical
limb ischemia, and amputation [11].
• Additionally, the combination arm was associ-
ated with a statistically signicant 18%
decreased risk of all-cause mortality compared
to aspirin.
11.1.4 Antithrombotic Therapy
Post-Revascularization
The optimal duration of dual antiplatelet therapy
in patients who have undergone endovascular
revascularization for lower extremity peripheral
arterial disease has not been well dened. Several
factors contribute to the difculty in establishing
an optimal antithrombotic regimen, including a
broad range of complexity and anatomical considerations of the peripheral arterial disease itself, and
the various devices, procedures, and technologies
used to treat the disease. For example, tibioperoneal disease treated with a coronary drug-eluting
stent carries a higher risk of stent thrombosis than
a large stent used in the iliac segments.
• In practice, the duration of dual antiplatelet
therapy in patients undergoing endovascular
revascularization is guided by the manufactur-
ers of the revascularization devices them-
selves, which in turn is extrapolated from the
coronary literature.
310
I. Del Conde and S. Madassery
• Most instructions for use (IFUs) recommend
anywhere from 1 to 6months of dual antiplatelet therapy following revascularization.
One of the most recent investigations to help
dene the duration of dual antiplatelet therapy
after endovascular revascularization was led by
Choo and colleagues [12]. The study involved
693 patients who received dual antiplatelet
therapy for either less than 6 months or over
6months.
• Dual antiplatelet therapy for over 6 months
duration was associated with decreased 5-year
major adverse cardiovascular and major
adverse limb events, with no signal toward
increased major bleeding.
• Major adverse cardiac events occurred less
frequently in the DAPT group for ≥6months
group than in the DAPT for <6months (17.3%
vs 31.3%; hazard ratio, 0.44; 95% condence
interval, 0.3–0.65; P<0.001). Major adverse
limb events also occurred less frequently in
the DAPT for ≥6 months group than the
DAPT for <6months group (21.5% vs 43.7%;
hazard ratio, 0.42; 95% CI, 0.3–0.58;
P<0.001).
• One important caveat of this study is that it
looked at patients who were treated between
2008 and 2013, thereby not fully reecting
current devices and adjunct pharmacotherapies
that have become standard in the management
of PAD.
As mentioned earlier in the chapter, a more
recent large PAD randomized controlled trial, the
COMPASS trial, suggested that the addition of
ultra-low dose rivaroxaban may decrease the rate
of serious limb events following revascularization compared to the standard of care. The multicenter VOYAGER PAD trial tested the efcacy
and safety of low-dose rivaroxaban (2.5mg twice
daily) compared to placebo on a background of
aspirin therapy in 6564 patients who had previously undergone surgical (35%) or endovascular
(65%) revascularization for symptomatic peripheral artery disease within the past 10days [13].
Use of clopidogrel on top of aspirin/rivaroxaban
or aspirin/placebo was allowed at the discretion
of the investigators for up to 6months. The primary outcome (a composite of cardiovascular
death, acute limb ischemia, major amputation,
myocardial infarction, or stroke) occurred in
15.5% of the rivaroxaban + aspirin arm compared
to 17.8% of the placebo+aspirin arm, representing a 15% relative risk reduction in the primary
outcome (p=0.009). Although the rate of major
bleeding occurred more frequently among
patients in the combination arm of rivaroxaban+aspirin (1.9% vs. 1.35%, P=0.07), there
were no excess events of intracerebral hemorrhage or fatal bleeding.
• The ndings of VOYAGER PAD conrm the
notion of the role of very low-dose
anticoagulation (specically with rivaroxaban)
added on top of antiplatelet therapy with
aspirin in patients with atherosclerotic
peripheral arterial disease, both in the stable
phase as well as post-revascularization.
11.1.5 Putting It Together
• A reasonable general antithrombotic strategy
in patients following endovascular revascularization is to treat with dual antiplatelet
therapy with aspirin and clopidogrel per IFU
of the device used, which is generally for
1–3 months, and possibly longer (up to
6 months) with more complex disease at
higher risk of thrombosis.
• If the patient is considered to have an acceptable bleeding risk prole (without specic
risk factors for life-threatening bleeding), then
rivaroxaban 2.5mg twice daily can be added
to the regimen. Once clopidogrel is stopped,
the risk-benet of long-term aspirin 81 mg
daily plus rivaroxaban 2.5mg twice daily can
be considered.
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