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146
What is the
INPACT trial?
The IN.PACT SFA trial was a prospective
multicenter randomized controlled trial that
involved 331 patients to compare drug-coated
balloon (DCB) angioplasty with traditional
percutaneous transluminal angioplasty (PTA) in
the treatment of superficial femoral artery (SFA)
and proximal popliteal artery disease. There were
many other clinical trials that addressed similar
goals, including the LEVANT and the RAPID
trials; however, the INPACT trial was the largest
prospective, multicenter, randomized trial.
What are the
results of the
INPACT trial?
The IN.PACT SFA trial showed that DCB was
superior to PTA in improvement of patient
outcomes for peripheral arterial disease and that
they had a favorable safety profile when treating
femoropopliteal arterial disease.
How were
the results
demonstrated
in functional
outcomes?
Functional outcomes for both investigational
and control groups were unchanged from
baseline in terms of quality of life. Both groups
also demonstrated improvement from baseline
in terms of walking impairment in a period of
12months; there was no statistical difference in
both groups.
So then, how
are DCBs
more effective
than PTAs?
Three- and five-year data shows patients
that underwent DCB had better primary
vessel patency and a marked reduction for
revascularization and retreatment of the target
lesion. This means that DCBs were able to keep
areas of critical stenosis open longer and reduced
the need for retreatment of the area down the
road. Although functional outcomes were similar
across both groups, DCB proved to be safer and
with less complications.
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147
Common Questions
What is
the pre-
procedure
status for a
patient?
Patients should not eat or drink anything at least
4–6hours before their procedure. Patients who
take medications should discuss with their doctor
which medication can and cannot be taken the
day of the procedure and, also importantly, when
certain medications can be stopped and resumed
after the procedure.
Why is
patient
follow-up
important?
It is important to monitor results of the
intervention performed and to prevent further
disease progression.
Is there a
standardized
imaging
technique
or protocol
when it
comes to
patient
follow-up?
There has not been much vigorous research
and trials in regard to the timeline for patient
follow-up and what imaging study should be used
to evaluate the patient. There is an agreement that
the same imaging modality should be used when
following patients to have stable comparisons.
What is the
modality
of choice
for imaging
follow-up?
The modality of choice for follow-up is
ultrasound. There are many advantages to this
modality such as being noninvasive, low cost,
wide availability, and lack of radiation. The
major disadvantages are its operator dependent
and artifacts on imaging which can happen with
calcifications and stents.
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Peripheral Arterial Disease
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148
What other
modalities
are used for
follow-up?
Other imaging modalities include computer
tomography angiography or CTA and magnetic
resonance angiography or MRA.CTA is a
noninvasive imaging modality that is widely
available, is not significantly operator dependent,
can be rapidly performed, and can accurately
evaluate the complications of PAD intervention.
Disadvantages of CTA are ionizing radiation
and the risk of contrast-induced contrast injury.
MRA is another noninvasive imaging modality
that can be used to evaluate PAD interventions.
Limitations include artifacts such as susceptibility
and flow-related.
What
are some
important
actions after
a procedure
is done?
Patients are usually advised and encouraged
to stop smoking. Patients are also started on
antiplatelet therapy; most patients are started on
aspirin and Plavix. Patients are also encouraged
to exercise and eat healthy food. These are just as
important as the procedure in ensuring long-term
success.
When should
a person
be seen
for clinical
follow-up?
Patients are usually seen in clinic for the first time
1month after their intervention. Imaging should
have been done before the visit. A good history
and physical should be performed including
examination of the affected extremity.
Further Reading
Bokhari MR, Bokhari SRA.Renal artery stenosis. [Updated 2019
Dec 12]. In: StatPearls [Internet]. Treasure Island: StatPearls
Publishing; 2020. Available from: https://www.ncbi.nlm.nih.gov/
books/NBK430718/.
Cherian M, Mehta P, Kalyanpur T, Gupta P.Review: interventional
radiology in peripheral vascular disease. Indian J Radiol Imaging
[Internet]. Wolters Kluwer– Medknow Publications; 2008 [cited
2018 Aug 22];18(2):150. Available from: http://www.ijri.org/text.
asp?2008/18/2/150/40301.
O. Ajibola and A. Mousa
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149
Conte MS, et al. Global vascular guidelines on the manage-
ment of chronic limb-threatening ischemia. J Vasc Surg.
2019;69(6S):3S–125S.
Health Quality Ontario. Stenting for peripheral artery disease of
the lower extremities: an evidence-based analysis. Ont Health
Technol Assess Ser. 2010;10(18):1–88.
Karimi A, de Boer SW, van den Heuvel DA, et al. Randomized
trial of Legflow® paclitaxel eluting balloon and stenting versus
standard percutaneous transluminal angioplasty and stent-
ing for the treatment of intermediate and long lesions of the
superficial femoral artery (RAPID trial): study protocol for
a randomized controlled trial. Trials. 2013;14:87.
https://doi.
org/10.1186/1745-
6215- 14- 87.
Kaufman J. Vascular and interventional radiology: the requisites.
2nd ed. Philadelphia: Saunders; 2014.
Krankenberg H, Zeller T, Ingwersen M, Schmalstieg J, Gissler HM,
Nikol S, Baumgartner I, Diehm N, Nickling E, Müller- Hülsbeck
S, Schmiedel R, Torsello G, Hochholzer W, Stelzner C, Brechtel
K, Ito W, Kickuth R, Blessing E, Thieme M, Nakonieczny J, Nolte
T, Gareis R, Boden H, Sixt S. Self-
Expanding versus balloon-
expandable stents for iliac artery occlusive disease. J Am Coll
Cardiol Intv. 2017;10(16):1694–704.
Liistro F, Angioli P, Porto I, Ricci L, Ducci K, Grotti S, Falsini G,
Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Paclitaxel-
eluting balloon vs. standard angioplasty to reduce recur-
rent restenosis in diabetic patients with in-stent restenosis of
the superficial femoral and proximal popliteal arteries: The
DEBATE-ISR Study. J Endovasc Ther. 2014;21(1):1–8.
Mauro MA, Murphy KPJ, Thomson KR, Venbrux AC, Morgan
RA.Image-guided interventions. 2nd ed. Philadelphia: Saunders;
2014.
Michalska M, Kazimierczak W, Leszczyński W, Nadolska K,
Bryl Ł. Contemporary follow-up imaging after endovascular
repair of lower extremity atherosclerotic lesions. Pol J Radiol.
2018;83:e634–42. Published 2018 Dec 9.
https://doi.org/10.5114/
pjr.2018.80348.
Mujoomdar M, Russell E, Dionne F, etal. Optimizing health system
use of medical isotopes and other imaging modalities [Internet].
Ottawa: Canadian Agency for Drugs and Technologies in
Health; 2012. APPENDIX 2.18, Evaluation of Renovascular
Hypertension. Available from: https://www.ncbi.nlm.nih.gov/
books/NBK174860/.
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150
Patel MR, Conte MS, Cutlip DE, etal. Evaluation and treatment of
patients with lower extremity peripheral artery disease: consen-
sus definitions from Peripheral Academic Research Consortium
(PARC). J Am Coll Cardiol. 2015;65(9):931–41. https://doi.
org/10.1016/j.jacc.2014.12.036
.
Santoro D, Benedetto F, Mondello P, Pipitò N, Barillà D, Spinelli F,
etal. Vascular access for hemodialysis: current perspectives. Int
J Nephrol Renovasc Dis [Internet]. Dove Press; 2014 [cited 2018
Aug 22];7:281–94. Available from: http://www.ncbi.nlm.nih.gov/
pubmed/25045278
.
Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers
M, Tepe G, Naisbitt S, Rosenfield K.The LEVANT I (Lutonix
Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal
Restenosis) trial for femoropopliteal revascularization: first-
in-human randomized trial of low-dose drug-
coated balloon
versus uncoated balloon angioplasty. JACC: Cardiovasc Interv.
2014;7(1):10–9. ISSN 1936-8798. https://doi.org/10.1016/j.
jcin.2013.05.022
.
Schillinger M, Minar E.Percutaneous treatment of peripheral artery
disease: novel techniques. Circulation. 2012;126(20):2433–40.
https://doi.org/10.1161/CIRCULATIONAHA.111.036574.
Sos T. Brachial and axillary arterial access. Endovasc Today.
2010;5:55–8.
Tepe G, Laird J, Schneider P, et al. Drug-coated balloon versus
standard percutaneous transluminal angioplasty for the treat-
ment of superficial femoral and popliteal peripheral artery
disease: 12-month results from the IN.PACT SFA randomized
trial. Circulation. 2015;131(5):495–502. https://doi.org/10.1161/
CIRCULATIONAHA.114.011004.
Valji K.The practice of interventional radiology. 2nd ed. Philadelphia:
Saunders; 2012.
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151© Springer Nature Switzerland AG 2022
R. Chand et al. (eds.), Essential Interventional Radiology
Review, https://doi.org/10.1007/978-3-030-84172-0_21
Evaluating Patient
Acute venous
thromboembolic
(VTE) disease includes
which two entities?
Deep vein thrombosis (DVT) and
pulmonary embolism (PE)
What is a deep vein
thrombosis (DVT)?
Deep vein thrombosis refers to the
presence of thrombus, or blood clot,
within veins of deep compartments of the
body, most commonly within the lower
extremities. Thrombi within superficial
veins are not DVT but are a part of a
separate more benign entity known as
superficial thrombophlebitis.
Chapter 21
Acute Venous
Thromboembolic Disease
SabeehaChowdhury andPeytonCramer
S. Chowdhury (*)
Department of Interventional Radiology, Medstar Georgetown
University Hospital, Washington, DC, USA
P. Cramer
Department of Radiology, New York Presbyterian Hospital Weill
Cornell Medicine, New York, NY, USA
McGovern Medical School, UT Health Science Center at Houston,
Houston, TX, USA
e-mail: peyton.m.cramer@uth.tmc.edu
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How does an acute
DVT present?
Most will have symptoms at the site of
thrombus such as swelling, warmth, pain,
tenderness, or skin redness.
How are DVTs
classified?
By the duration of symptoms:
Acute: 0–14days
Subacute: 15–28days
Chronic: Greater than 28days
What is a
pulmonary
embolism (PE)?
A pulmonary embolism refers to the
intravascular migration of a venous
thrombus to a pulmonary artery through
the process of clot fragmentation and
embolization.
What is the
difference between
a low-risk,
intermediate-risk,
and high-risk PE?
A low-risk PE is defined by the absence
of right heart strain (as indicated on
imaging as a RV:LV<0.9), a PESI score
less than 1, or a patient lacking significant
clinical symptoms. An intermediate-risk
PE is defined by right heart dysfunction
(RV:LV≥0.9) or PESI score≥1in the
setting of normal systemic blood pressure.
Intermediate-risk PE is further divided into
intermediate low risk and intermediate
high risk based on the absence or presence,
respectively, of elevated cardiac biomarkers.
A high-risk PE indicates that there is
severe right heart dysfunction resulting
in sustained hypotension (systolic blood
pressure < 90mmHg for at least 15minutes
or requiring inotropic support).
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What is the
Pulmonary
Embolism Severity
Index (PESI) and
how is it used in PE
management?
The PESI score is a risk stratification
tool that can be used to determine risk
of mortality and long-term morbidity in
patients with newly diagnosed PE.This
score takes into account 11 clinical criteria
including age, gender, history of malignancy,
history of heart failure, history of chronic
lung disease, heart rate≥110, systolic
blood pressure < 90, respiratory rate≥30,
temperature < 36°C, altered mental status
(AMS), and oxygen saturation (SpO2)
< 90. Various points are given for each
clinical feature (with the heaviest weight
placed on AMS, history of malignancy, and
hypotension) to place patients into risk
categories. These categories are associated
with the following 30-day mortality rates:
Very low risk: 0–1.6%
Low risk: 1.7–3.5%
Intermediate risk: 3.2–7.1%
High risk: 4.0–11.4%
Very high risk: 10.0–24.5%
This tool can also aid in distinguishing
which patients can be treated as an
outpatient and which require higher level
of care. Very low- and low-risk patients are
often considered for outpatient treatment
of PE (anticoagulation and follow-up care
in the PE/DVT clinic, with a primary care
physician, and hematology); however, the
decision ultimately takes into account the
entire clinical scenario.
What is the utility
of echocardiogram
in evaluation
of pulmonary
embolism patients?
Echocardiogram provides very useful data
in the evaluation of right heart strain and
cardiac physiology, including potential
identification of a PFO.
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What symptoms
should raise the
suspicion for
a pulmonary
embolism?
Rapid onset dyspnea, pleuritic chest pain,
hypoxia, tachycardia, and an increased
alveolar-arterial oxygen gradient without
another obvious explanation
What is May-
Thurner syndrome?
May-Thurner syndrome is an anatomic
variant in which the left common iliac
vein is compressed by the right common
iliac artery against the lumbar spine.
This compression may result in left lower
extremity thrombus formation related to
the altered flow mechanics in this disease
state.
What is a
paradoxical
embolism?
A venous thromboembolism that traverses
through an intracardiac or pulmonary
(right-to-left) shunt and embolizes into the
systemic circulation. Depending on the site
of embolization, this can lead to stroke,
myocardial infarction, gastrointestinal
ischemia, renal infarction, or ischemic
extremities.
What is post-
thrombotic
syndrome (PTS)?
PTS is a chronic condition related to
venous outflow obstruction, inflammation
and valve destruction, and negative
remodeling of the veins. It is characterized
by high venous pressures and can present
clinically as varicose veins, venous stasis
dermatitis, venous stasis ulcers, and venous
claudication. Venous hypertension and
inflammation can lead to increased vessel
permeability and lymphedema.
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High Yield History
What is Virchow’s
triad?
Three factors that predispose to
thrombus formation: slow blood flow,
hypercoagulability, and endothelial
damage.
What are some
genetic causes of
hypercoagulable states?
Factor V Leiden (most common),
antithrombin III deficiency, protein
C deficiency, protein S deficiency,
hyperhomocysteinemia, and
prothrombin G20210A mutation
What are some
acquired causes of
hypercoagulable states?
Surgery, trauma, malignancy,
immobilization, smoking, obesity,
nephrotic syndrome, and oral
contraception pills
What is a Wells score? The Wells score is a noninvasive
scoring system to determine the pretest
probability of having an acute PE.A
score of four or less makes a PE
“unlikely,” whereas a score of greater
than four points makes a PE “likely.”
What factors are
incorporated into the
Wells score?
Clinical signs and symptoms of
DVT, heart rate >100bpm, previous
immobilization or surgery, previous
PE or DVT, hemoptysis, or recent
malignancy
What is the best test
for a patient with low
probability of having
VTE?
D-dimer is often used because of its
high sensitivity. A negative test can
rule out acute thrombus; however, a
positive test is inconclusive because it is
nonspecific.
What is the best test
for a patient with a
high probability of
having a DVT?
Ultrasound with Doppler. The four
signs seen on ultrasound include non-
compressibility of the vein, intraluminal
echogenicity, loss of flow, and loss
of augmentation response. The most
specific sign is non-compressibility of
the vein.
(continued)
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