Reporting standards of the Society for Vascular

Surgery for endovascular treatment of chronic

lower extremity peripheral artery disease
Michael C. Stoner, MD,a Keith D. Calligaro, MD,b Rabih A. Chaer, MD,c Alan M. Dietzek, MD,d
Alik Farber, MD,e Raul J. Guzman, MD,f Allen D. Hamdan, MD,f Greg J. Landry, MD,g and
Dean J. Yamaguchi, MD,h on behalf of the Society for Vascular Surgery, Rochester, NY; Philadelphia
and Pittsburgh, Pa; Danbury, Conn; Boston, Mass; Portland, Ore; and Greenville, NC

Peripheral arterial disease (PAD) represents a spectrum from asymptomatic stenosis to limb-threatening ischemia. The last
decade has seen a tremendous increase in the variety of endovascular devices and techniques to treat occlusive disease. Like
many evolving technologies, the literature surrounding therapy for endovascular arterial disease consists of mixed-quality
manuscripts without clear standardization. Accordingly, critical evaluation of the reported results may be problematic. As
such, providers and their patients make treatment decisions without the full benefit of a comparative effectiveness
framework. The purpose of this document is to provide a summary for the reporting of endovascular revascularization
techniques in the setting of chronic disease. Much of the work in this document is based on prior publications and
standards proposed by the Society for Vascular Surgery. We have also made recommendations based on current literature
and have attempted to acknowledge shortcomings and areas for future research. The various sections contain summaries of
required reporting standards and should serve as a guide for the design of clinical trials and as reference for journal editors
and reviewers when considering scientific work pertaining to endovascular therapy for chronic lower extremity arterial
disease. An Appendix is provided with commonly used abbreviations in this document. (J Vasc Surg 2016;64:e1-e21.)

TABLE OF CONTENTS 3. Preintervention assessment and nonanatomical

treatment
1. Claudication 3.1. Patient factors
1.1. Ankle-brachial index 3.1.1. Required reporting standards
1.2. Medical therapy 3.2. Medical therapy
1.3. Functional assessment 3.2.1. Required reporting standards
1.4. Quality of life 3.3. Diagnostic imaging
1.5. Classification 3.3.1. Duplex ultrasound
1.6. Required reporting standards 3.3.2. Magnetic resonance angiography
2. Critical limb ischemia 3.3.3. Computed tomography angiography
2.1. Clinical presentation 3.3.4. Digital subtraction angiography
2.2. Physiologic testing 3.4. Anatomic characterization
2.3. Classification of tissue loss and wounds 3.4.1. Bollinger score
2.4. Required reporting standards 3.4.2. TASC grade
3.4.3. Runoff score
3.4.4. Calcium score
From the Division of Vascular Surgery, University of Rochester, Rochestera;
3.4.5. Lesion length
the Section of Vascular Surgery, Pennsylvania Hospital, Philadelphiab; the
Division of Vascular Surgery, University of Pittsburg, Pittsburghc; the Di- 3.4.6. Required reporting standards
vision of Vascular Surgery, Danbury Hospital, Danburyd; the Division of 4. Intervention
Vascular Surgery, Boston Medical Center,e and the Division of Vascular 4.1. Angioplasty
Surgery, Beth Israel Deaconess Medical Center,f Boston; the Division 4.1.1. Drug-eluting balloons
of Vascular Surgery, Oregon Health Science University, Portlandg; and
the Division of Vascular Surgery, East Carolina University, Greenville.h
4.1.2. Required reporting standards
Author conflict of interest: none. 4.2. Stents
Correspondence: Michael C. Stoner, MD, Division of Vascular Surgery, 4.2.1. Required reporting standards
University of Rochester, 601 Elmwood Ave, Rochester, NY 14642 4.3. Atherectomy devices
(e-mail: michael_stoner@urmc.rochester.edu).
4.3.1. Required reporting standards
Independent peer-review and oversight has been provided by members of the
SVS Document Oversight Committee: Peter Gloviczki, MD (Chair), 4.4. Other adjuncts
Michael Conte, MD, Mark Eskandari, MD, Thomas Forbes, MD, Glenn 4.5. Embolic protection and thrombectomy devices
LaMuraglia, MD, Gregory Moneta, MD, Amy Reed, MD, Russell Samson, 4.6. Radiation reporting
MD, Piergiorgio Settembrini, MD. 4.7. Contrast
0741-5214
Copyright Ó 2016 by the Society for Vascular Surgery. Published by
4.8. Pharmacology
Elsevier Inc. 5. Outcome measuresdprocedural
http://dx.doi.org/10.1016/j.jvs.2016.03.420 5.1. Definition of technical and procedural success

e1

e2 Stoner et al
5.2. Hemodynamic success
5.3. Patency
5.4. Primary, primary assisted, and secondary patency
5.5. Vessel specific reporting
5.6. Duplex ultrasound, CTA, and other imaging
5.7. Target lesion revascularization
5.8. Required reporting standards
6. Outcome measuresddisease specific
6.1. Required reporting standards
7. Complications
7.1. Required reporting standards
8. References
9. Appendix
CLAUDICATION
“Classic” claudication, as defined by the San Diego
Population Study, is defined by pain in the calf region
with walking, not occurring with sitting or standing, which
does not disappear during the walk and causes the subject
to stop or slow down, and is relieved within 10 minutes of
walking cessation.1 Although symptoms are most
frequently localized to the calf, the thigh or buttocks may
also be affected. In the multicenter PAD Awareness, Risk
and Treatment: New Resources for Survival study of
6417 adult primary care patients, 29% of patients in general
medical practices had peripheral arterial occlusive disease
(PAD), with only 11% presenting with classic intermittent
claudication, over half with atypical symptoms, less than
half asymptomatic.2
Ankle-brachial index. The most useful initial test to
evaluate for PAD is the ankle-brachial limb-specific index
(ABI) at rest and after exercise. Resting ABI alone may
not be not sufficient to confirm or rule out a vasculogenic
etiology for exertional leg symptoms. Although the ABI does
not always correlate specifically with walking distance,
it strongly correlates with the presence of PAD, future
cardiovascular events, and mortality in this patient popu-
lation.3 The American Heart Association released guide-
lines to standardize the examination and its interpretation,
which should be followed in all clinical trials.4 The ABI
should be calculated separately for each leg, with the lower
value of the two legs reported at the patient level and
the limb-specific index ABI reported when evaluating a
specific intervention.
An ABI #0.90 is the threshold for the diagnosis of
PAD. As stated in the recently published Society for
Vascular Surgery (SVS) guidelines, when the ABI is
borderline or normal (>0.9) and symptoms of claudication
are suggestive, we recommend exercise ABI.5 If patients
cannot perform exercise studies due to medical comorbid-
ities or other conditions preventing brisk walking, then
treatment for arterial claudication should not be considered
unless these conditions are temporary.
When the ABI is >1.40 but clinical suspicion of PAD
exists, alternate modalities should be used to document
PAD. Suggested tests and their thresholds for diagnosis
of PAD include a toe-brachial index #0.7, a systolic peak
JOURNAL OF VASCULAR SURGERY
July 2016
posterior tibial artery flow velocity <10 cm/s, or a resting
toe pressure <40 mm Hg,6 or alternatively, pulse volume
recordings (PVRs) can provide useful information.
Medical therapy. Medications prescribed specifically
for the treatment of intermittent claudication (eg, pentox-
ifylline, cilostazol) should be recorded. Guidelines for
reporting of additional medications are included in the
“Critical limb ischemia” section.
Functional assessment. The initial evaluation of pa-
tients with intermittent claudication ideally includes func-
tional assessment of walking abilities. A postexercise ABI
should conventionally be performed on a treadmill at a 12%
grade at 2 miles per hour (mph) for 5 minutes or until leg
pain prohibits further walking. A postexercise ABI decrease
of >20% is considered diagnostic for PAD. In graded tread-
mill testing, the workload is progressively increased during
the test by increasing the speed, incline, or both. The Hiatt
et al7 and Gardner et al8 protocols have both been vali-
dated in the PAD population. The speed in both protocols is
fixed at 2 mph with an increase in grade every 3 minutes in the
Hiatt protocol and 2% every 2 minutes in the Gardner pro-
tocol. Regardless of protocol used, the distance at which the
patient first experiences muscle group pain (initial claudica-
tion distance) and at which point the patient stops walking
(absolute claudication distance) should be recorded.
Most contemporary studies use a graded protocol, which
is associated with significantly reduced variability and accom-
modates subjects with a broader range of claudication
symptoms. Contemporary studies should therefore use the
graded protocol to assess patients’ initial functional abilities
and to follow changes over time. Standardized testing also
allows for valid comparisons of procedures in clinical trials.9
Although treadmill testing is historically the primary
method of measuring walking abilities, recent studies
have indicated that hallway walking exercises may be a
more accurate reflection of a patient’s true community
walking abilities10 and should be incorporated into clinical
trials involving interventions in patients with intermittent
claudication. In the timed 6-minute walk test (6MWT), pa-
tients are instructed to walk back and forth in a 100-foot-
long hallway. The distance covered in 6 minutes is
recorded in linear meters. This test has been validated
against treadmill walking and is a more reliable reflection
of walking abilities as well as being less anxiety provoking
than treadmill walking.11 Other tests, such as the short phys-
ical performance battery may be useful but are likely outside
the scope of most claudication studies.12 Daily physical ac-
tivity can be measured using a vertical accelerometer, such
as the Caltrac accelerometer (Muscle Dynamics Fitness
Network, Inc, Torrence, Calif), which has been validated
for use in patients with PAD.13
Quality of life. A number of general and disease-
specific quality of life questionnaires have been used in
studies of patients with PAD. General questionnaires are
important in defining and quantifying patients’ overall
health status and also in allowing comparison of disability
across disease states. Disease-specific questionnaires are
important in focusing on patients’ walking abilities.14
JOURNAL OF VASCULAR SURGERY
Volume 64, Number 1
Reports of endovascular interventions for claudication
should include at least one validated general and one vali-
dated disease-specific quality of life questionnaire.
Of the general health questionnaires, the Medical Out-
comes Study 36-Item Short Form (SF-36) Health Survey is
most frequently used and has been validated for PAD.
Additional general health questionnaires that have been
validated in the PAD population include the SF-12 (a
shorter version of the SF-36), European Quality of Life
Questionnaire (EuroQOL), Nottingham Health Profile
(NHP), World Health Organization Quality of Life Assess-
ment Instrument 100 (WHOQUOL-100), and the
McMaster Health Index Questionnaire (MHIQ).
Of the disease-specific questionnaires, the Walking
Impairment Questionnaire (WIQ) is the oldest and most
extensively used in patients with intermittent claudica-
tion.15 Other disease-specific questionnaires that have
been used and validated in patients with intermittent clau-
dication include the German Claudication Scale (CLAU-
S), Peripheral Artery Occlusive Disease 86 (PAVK-86),
Walking Estimated Limitation Calculated by History
(WELCH), Vascular Quality of Life (VascuQOL), Periph-
eral Artery Questionnaire (PAQ), and Intermittent Claudi-
cation Questionnaire (ICQ).
Classification. The suggested classification for grading
the severity of PAD is the Rutherford classification, listed in
Table I.6 The classification for intermittent claudication is
based on treadmill walking and ankle pressures. Although
the Rutherford classification remains the standard method
of reporting, a revised Rutherford classification system is
warranted to add clarity, particularly in CLI patients, in
which a broad range of foot lesions are incorporated into a
single category (category 5). The Fontaine classification is
historical in nature and should be avoided.
Required reporting standardsdclaudication.
d Resting or exercise ABI to support the diagnosis of
PAD
d Rutherford classification
d Baseline functional assessment with a preference for
the 6MWT
d A validated disease-specific quality of life measure
CRITICAL LIMB ISCHEMIA
Critical limb ischemia (CLI) is defined as rest pain, ul-
cer, or gangrene attributable to objectively proven arterial
occlusive disease.16,17 In reports of patients with CLI, it
is important to consider the broad range of patients
captured by these criteria. By necessity, the current defini-
tion includes patients with a variety of clinical presenta-
tions, risk factors, and most importantly, significantly
different risks of amputation and death. Reports on CLI
populations must therefore include detailed clinical, hemo-
dynamic, and imaging data in order to make the best com-
parisons among patient populations. At minimum, studies
of CLI patients should include a description of the clinical
presentation (rest pain, ulcer, or gangrene), and hemody-
namic parameters from noninvasive tests (ankle and toe
Stoner et al e3
Table I. Rutherford classification of peripheral arterial
occlusive disease
Category Clinical description Objective criteria
0 Asymptomatic Normal treadmill test
1 Mild claudication Completes treadmill test,
ankle pressure
postexercise >50 mm Hg
but at least 20 mm Hg
below resting value
2 Moderate claudication Between categories 1 and 3
3 Severe claudication Cannot complete treadmill
test and ankle pressure
postexercise <50 mm Hg
4 Ischemic rest pain Resting ankle pressure <60
mm Hg, toe pressure <40
mm Hg
5 Minor tissue Resting ankle pressure <40
lossdnonhealing mm Hg, toe pressure <30
ulcer, focal gangrene mm Hg
6 Major tissue Same as category 5
lossdextending above
transmetatarsal level
pressures, transcutaneous pressure of oxygen [transcuta-
neous oximetry). Risk factors, including diabetes, tobacco
history, hypercholesterolemia, hypertension, and renal sta-
tus, should be documented and assessed.
It is also important to understand that there is some
controversy surrounding the use of the term CLI because
there is no accepted threshold for ischemia based on clinical
criteria or noninvasive testing. To address this issue, the
SVS has published a classification system intended to
permit more meaningful analysis of outcomes for various
forms of therapy. We recommend using the WIfI classifica-
tion, based on wound, ischemia, and foot infection, that
has been recently validated and correlates with risk of major
amputation and time to wound healing.18-20
Clinical presentation. Ischemic rest pain commonly
occurs at night and is localized to the metatarsal area of
the foot. In more severe cases, it can occur during the
day and characteristically is made worse with elevation
and improved by placing the limb in a dependent position.
It may be intermittent or continuous. Other entities in the
differential diagnosis, such as diabetic neuropathy, nerve
root compression, and inflammatory conditions, should
be excluded. Patients with tissue loss should not be
included in cohorts with rest pain.
CLI patients with ulcers can present at any stage of
wound progression. Ulcers may be superficial and involve
only the tips of the toes or extend down to bone and
involve the more proximal foot. They may be infected or
associated with abscess at the time of presentation, and
they may or may not be large. The ulcer volume and area
are not considered in standard scoring systems, but newer
systems may include this information.
Patients with gangrene of the foot present the most
challenging subgroup and are at the highest risk for ampu-
tation. The gangrene may be associated with surrounding
infection, and these patients may have other areas of

e4 Stoner et al
ulceration that are not infected or gangrenous. Usually, the
most severe clinical manifestation of ischemia is used to
assign a patient’s Rutherford category.6
Physiologic testing. Reports on CLI populations
should include noninvasive arterial testing to confirm pedal
ischemia.17 The most widely used method for confirming
pedal ischemia is arterial pressure assessment at the ankle and
toe. In patients with rest pain, an ankle pressure <40 mm
Hg, ABI <0.4, or toe pressure <30 mm Hg is sufficient to
substantiate the diagnosis. For patients with ulcers or
gangrene, a higher ankle pressure of <70 mm Hg or toe
pressure <50 mm Hg are accepted to meet criteria. It is
understood that full consensus on these limits does not exist
and is somewhat arbitrary.6 Furthermore, in patients with
calcified arterial circulation, even toe pressures can be inac-
curate. Dampened or flat PVR at the metatarsal or toe can
also be used to identify patients with CLI.
Although not in the aforementioned guidelines, trans-
cutaneous oximetry measurements of <30 mm Hg have
been used as a substitute of ankle and toe pressures, and
this appears justified. As previously noted, the problem
with deciding entry criteria is that the risk of continuing tis-
sue necrosis and rest pain varies widely from patient to pa-
tient, and therefore, the risks of requiring a major
amputation also vary.16
Classification of tissue loss and wounds. Several
scoring systems have been developed to assist in categoriz-
ing foot wounds, each with advantages and disadvantages.21
For studies that use exclusive criteria, such as those confined
to patients in Rutherford category 5, designation of a
wound category is recommended. This is to ensure that
patient populations can be compared across studies. Early
scoring systems involved assessment of the wound, whereas
more recent scoring systems have incorporated an assess-
ment of ischemia, neuropathy, and infection.
As mentioned, the SVS has recently introduced a compre-
hensive threatened limb staging system, WIfI (Appendix II),
which uses three components to classify severity: grading of
the wound (W), presence of ischemia (I) and foot infection
(fI).18 This classification system takes into account multiple
causes of ulceration and wound formation and allows for
discrimination of ischemic and nonischemic cases. Similar to
a TNM approach, four stages of limb threat are described
that are suggested to correlate with the risk of major amputa-
tion. Use of the WIfI system for comparing patients across
different populations, institutions, and practices is strongly
recommended. As experience grows with assigning patients
to individual WIfI stages, it is expected to become a robust
reporting measure and prognostic factor.
Methods of wound care should be described in suffi-
cient detail, with comparator cohorts receiving identical
wound care treatment protocols and podiatric care. The
importance of controlling for wound care cannot be
overstated. For studies concerned with this subset of pa-
tients, quantification of area of tissue loss is appropriate,
in addition to a grade, as mentioned above. One final
note is the importance of delineating between ischemic
tissue loss and neuropathic ulceration. Although most
JOURNAL OF VASCULAR SURGERY
July 2016
patients with limb threat have both, those with purely
neuropathic distribution ulceration without physiologic
basis for CLI can obscure data obtained from revascular-
ization trials.
Required reporting standardsdCLI.
d Documented ankle or toe pressure consistent with the
diagnosis of CLI
d Rest pain and tissue loss patients should be reported
separately
d WIfI classification
d Documented standardized wound care protocol for
patients with tissue loss
PREINTERVENTION ASSESSMENT AND
NONANATOMIC TREATMENT
The following section outlines reporting standards
regarding patient factors and pretreatment documentation.
Adherence to guidelines ensures similar comparator co-
horts of patients and aids with the assessment of the
external validity of a study.
Patient factors
In general, all conditions presumed to affect reported
outcomes should be recorded and reported in any study
or trial. The comorbidities and scoring systems are mainly
intended to represent systemic factors that are likely to
affect major morbidity and mortality associated with
lower extremity revascularization. Although this may not
be necessary in all instances, unifying the reporting of
comorbidities will facilitate future analyses and comparisons
of different studies.
Standardization of reporting patient comorbidities is
critical to ensure applicability and external validity of any
lower extremity endovascular study. Suggested reporting
standards, modified from prior SVS scoring systems, are
listed below, summarized in Table II, and should not be
considered exhaustive. These comorbidities are known to
correlate with both complications (systemic and local)
and effectiveness of endovascular interventions. Further-
more, a particular study may not record all of the docu-
mented comorbidities; however, inclusion of these data
does increase the chance that the study can be used to
address future comparative effectiveness questions.
Diabetes mellitus. 0 ¼ none, 1 ¼ controlled, not
requiring insulin, 2 ¼ controlled by insulin, 3 ¼ type 1 dia-
betes or uncontrolled diabetes. Diabetes mellitus has been
described as a correlate of endovascular revascularization
patency, wound healing, limb salvage, and overall patient
outcomes, although conflicting data do exist.20-24 Further
characterization of longitudinal glycemic control can be
provided via reporting glycosylated hemoglobin.
Tobacco use. 0 ¼ none (or remote >10 years ago),
1 ¼ quit 1 to 10 years ago, 2 ¼ current within the last
year, smoking <1 pack per day, 3 ¼ current within the
last year, smoking >1 pack per day. Dose-product can be
reported as pack-years. Smoking is a known epidemiologic
JOURNAL OF VASCULAR SURGERY
Volume 64, Number 1 Stoner et al e5

Table II. Grading system for nonanatomic patient variables

Categories/grade Description

Diabetes
0 None
1 Not requiring insulin
2 Controlled by insulin
3 Type 1 or uncontrolled
Tobacco use
0 None or remote (>10 years ago)
1 Quit 1-10 years ago
2 Current within the last year, smoking <1 pack per day
3 Current within the last year, smoking >1 pack per day
Hypertension
0 None
1 Controlled with 1 drug
2 Controlled with 2 drugs
3 Requiring >2 drugs or uncontrolled
Renal status
0 Normal
1 Evidence of renal disease, GFR >90 mL/min/1.73 m2
2 GFR 60-89 mL/min/1.73 m2
3 GFR 30-59 mL/min/1.73 m2
4 GFR 15-29 mL/min/1.73 m2
5 GFR <15 mL/min/1.73 m2 or dialysis
Hyperlipidemia
0 None
1 Elevated without drug treatment
2 Elevated with dietary treatment
3 Elevated with drug and diet treatment
Cardiac status
0 Asymptomatic, with normal electrocardiogram
1 Asymptomatic but with remote myocardial infarction by history (6 months) or occult myocardial infarction
2 Any one of the following: stable angina, no angina but significant reversible perfusion defect on dipyridamole
thallium scan, significant silent ischemia (1% of time) on Holter monitoring, ejection fraction 25% to 45%,
controlled ectopy or asymptomatic arrhythmia, or history of congestive heart failure that is now well
compensated
3 Any one of the following: unstable angina, symptomatic or poorly compensated or recurrent congestive heart
failure, ejection fraction <25%, myocardial infarction #6 months
Pulmonary status
0 Normal
1 Asymptomatic or mild dyspnea
2 Between 1 and 3
3 Vital capacity less than 1.85 liters, FEV1 <1.2 liters or <35% of predicted, maximal voluntary ventilation <50% of
predicted, PCO2 >45 mm Hg, supplemental oxygen use medically necessary, or pulmonary hypertension
Functional status
0 No impairment
1 Impaired, but able to carry out ADL without assistance
1 Needs some assistance to carry out ADL or ambulatory assistance
2 Requiring total assistance for ADL or nonambulatory

ADL, Activities of daily living; FEV1, forced expiratory volume in 1 second; GFR, glomerular filtration rate; PCO2, partial pressure of carbon dioxide.

agent in the development of PAD and an important factor
in long-term outcomes and mortality.25
Hypertension. 0 ¼ none (normotensive), 1 ¼
controlled with one drug, 2 ¼ controlled with two drugs,
3 ¼ requires more than two drugs or is uncontrolled.
Renal status. Serum creatinine is often reported but
may be an inaccurate measure because of the influence of
age, body mass, and other issues. As such, the Kidney Dis-
ease Outcomes Quality Initiative chronic kidney disease
stage system is recommended: 0 ¼ normal, 1 ¼ evidence
of renal dysfunction, glomerular filtration rate (GFR in
mL/min/1.73 m2) >90, 2 ¼ GFR 60 to 89, 3 ¼ GFR
30 to 59, 4 ¼ GFR 15 to 29, 5 ¼ GFR <15 or patient
on dialysis.26 Alternatively, GFR for patients not on renal
replacement therapy can reported as a continuous variable.
GFR will typically be calculated via the Cockcroft-Gault
calculation, and the method of deriving this should be
noted in the Methods section of the particular study. Use
of renal replacement therapy should be noted.
Hyperlipidemia. 0 ¼ none (low-density lipoprotein,
total cholesterol, and triglyceride levels within normal
reference range for age), 1 ¼ elevated without drug treat-
ment, 2 ¼ elevated requiring dietary treatment, 3 ¼
elevated requiring dietary and drug treatment. The class

e6 Stoner et al
of drug should be noted and reported because several phar-
macologic agents have been shown to influence vascular
surgery outcomes and overall vascular morbidity and mor-
tality in high-risk patients (see “Preintervention assess-
ment” and “Nonanatomic treatment” sections).27
Cardiac status. 0 ¼ asymptomatic, with normal elec-
trocardiogram, 1 ¼ asymptomatic but with remote myocar-
dial infarction by history (6 months) or occult myocardial
infarction (by electrocardiographic diagnosis), 2 ¼ any one
of the following: stable angina, no angina but significant
reversible perfusion defect on dipyridamole thallium scan,
significant silent ischemia (1% of time) on Holter moni-
toring, ejection fraction 25% to 45%, controlled ectopy or
asymptomatic arrhythmia, or history of congestive heart fail-
ure that is now well compensated, 3 ¼ any one of the
following: unstable angina, symptomatic or poorly controlled
ectopy/arrhythmia (chronic/recurrent), poorly compen-
sated or recurrent congestive heart failure, ejection fraction
of less <25%, myocardial infarction #6 months. Stratification
by other risk scoring systems, such as the Lee index and New
York Heart Association Functional Classification of heart fail-
ure, may be applicable in studies examining cardiac safety of
certain interventions.28-30
Pulmonary status. 0 ¼ asymptomatic with normal-
appearing chest X-ray and pulmonary function tests (PFT)
within normal reference ranges, 1 ¼ asymptomatic or mild
dyspnea, PFT 65% to 80% of predicted value, 2 ¼ between 1
and 3, 3 ¼ vital capacity of <1.85 liters, forced expiratory
volume in 1 second <1.2 liters or <35% of predicted,
maximal voluntary ventilation <50% of predicted, partial
pressure of carbon dioxide >45 mm Hg, supplemental ox-
ygen use medically necessary, or pulmonary hypertension.
Functional status. 0 ¼ no impairment, able to
perform all activities of daily living (ADL) without assis-
tance, 1 ¼ impaired, but able to perform ADL without
assistance, 2 ¼ impaired, needs some assistance (via medical
devices or persons) to perform ADL or ambulatory assis-
tance, 3 ¼ impaired requiring total assistance for ADL or
nonambulatory. Patient functional status represents a sum-
mation of individual comorbidities and has been shown to
be an independent predictor of success after an endovascu-
lar intervention.31
Socioeconomic, gender, and racial factors strongly in-
fluence procedural safety and efficacy measures.32-34 Cate-
gorization of these factors is possible using simple scoring
systems for highest level of education and household in-
come stratified by multiples of the federal poverty line.
Full characterization of these factors will likely be outside
of the scope of most device and modality-centric endovas-
cular studies but is something for authors to consider, espe-
cially in large-scale longitudinal outcome studies.
Nonrevascularization adjuncts that may affect inter-
ventional outcomes also warrant reporting. This is
especially true in cases of CLI with tissue loss, where
wound care and mechanical off-loading strategies can
be quite variable and no true standard of care exists.
Manuscripts that center on tissue loss CLI must clearly
delineate wound care strategies and ensure they are
JOURNAL OF VASCULAR SURGERY
July 2016
equally applied to study and control patient cohorts.
Operative débridement should always be recorded and
note salient variables such as surface area, and use of inci-
sional vs excisional débridement, tissue flap techniques,
and biologic dressings. Hyperbaric oxygen use should
always be noted, including treatment time and frequency.
Wound characterization is further delineated in the
Clinical Presentationd“Critical limb ischemia” section
of this document.
Required reporting standardsdpatient factors
d Patient factors reported in compliance with grading
system
d Gender, race, age, diabetes, hypertension, tobacco use,
renal function, and hyperlipidemia should be reported
in all study populations
Medical therapy
Grading risk factors in severity with uniform defini-
tions, such as the SVS 0 to 3 scoring scale, allows severity
indices to be calculated for subgroup comparison.6,35 The
SVS medical comorbidity grading system is adopted from
the comorbid scoring system used in reports on lower ex-
tremity ischemia (see “Patient factors” section).35
Clinical reports that evaluate lower extremity endovas-
cular (LE-EV) revascularization, particularly those that
compare different treatment methods, may be difficult to
interpret when differences in factors that can affect
outcome are not identified and characterized. A grading
of such factors by severity and intensity of medical therapy,
with uniform definitions for (1) mild, (2) moderate, and
(3) severe, had been previously proposed (Table III).6,35
Antiplatelet therapy. Whether patients are receiving
any antiplatelet therapy, with single or dual agents, should
be noted. The agents should be identified, including
dosage. If a particular study protocol mandates antiplatelet
therapy, this should be noted in the Methods section of the
manuscript.
Lipid-lowering therapy. All patients with PAD need
to be considered for lipid-lowering therapy. Suggested
reporting of lipid-lowering therapy: 0 ¼ on a statin with
lipid testing within therapeutic range; 1 ¼ on a statin but
lipid levels not optimal; 2 ¼ on a high-dose statin or
requiring supplemental lipid medications; 3 ¼ statin
intolerant or patient with familial hypercholesterolemia.
Antithrombotic therapy. Documentation of a hyper-
coagulable state should be considered, especially in patients
with no clear risk factors for PAD and patients with prema-
ture PAD occurring in those aged #50 years. Documenta-
tion of whether such a state exists should be recorded as:
0 ¼ no known hypercoagulable state; 1 ¼ unknown;
2 ¼ low-risk hypercoagulable state (eg, heterozygous fac-
tor V Leiden); 3 ¼ high-risk hypercoagulable state (eg, ho-
mozygous factor V Leiden or multiple hypercoagulable
factors). All anticoagulants (low-molecular-weight heparin,
warfarin, or other) and antiplatelet medications should
be recorded.
JOURNAL OF VASCULAR SURGERY
Volume 64, Number 1 Stoner et al e7

Table III. Standardized reporting for preintervention medical therapy

Therapy Scoring scale Intervention

Antiplatelet therapy 0 ¼ none; 1 ¼ single agent, 3 ¼ dual therapy Aspirin, clopidogrel, other
Lipids 0 ¼ normal; 1 ¼ mild elevation, diet controlled; 2 ¼ moderate elevation, Statin, fibrate, other
strict diet; 3 ¼ severe elevation, strict diet, and drugs
Lipid-lowering 0 ¼ on a statin with lipid testing within therapeutic range; 1 ¼ on a statin
therapy but lipid levels not optimal; 2 ¼ on a high-dose statin or requiring
supplemental lipid medications; 3 ¼ statin intolerant or patient with
familial hypercholesterolemia
Anticoagulation 0 ¼ no hypercoagulable state; Warfarin, low-molecular-weight
1 ¼ unknown; 2 ¼ low risk hypercoagulable state (eg, heterozygous factor heparin, other
V Leiden); 3 ¼ high-risk hypercoagulable state (eg, homozygous factor V
Leiden or multiple hypercoagulable factors
Hypertension 0 ¼ normotensive for age without need for antihypertensive; 1 ¼ controlled b-blocker, ACE inhibitor,
with 1 drug; 2 ¼ controlled with 2 drugs; 3 ¼ requires >2 drugs or is angiotensin receptor blocker,
uncontrolled calcium channel blocker, diuretic
therapy, other agents
Diabetes 0 ¼ none; 1 ¼ adult onset, controlled by diet or oral agents; 2 ¼ adult Diet, oral agent, insulin, other
onset, insulin controlled; 3 ¼ juvenile onset

ACE, Angiotensin converting enzyme.

Antihypertensive therapy. Arterial hypertension in pa-
tients should be controlled adequately with diet and lifestyle
changes as well as with pharmacotherapy. In the Heart Out-
comes Prevention Evaluation (HOPE) trial, angiotensin-
converting enzyme inhibitor treatment significantly reduced
cardiovascular events in patients with symptomatic PAD.36
In addition, the use of the angiotensin-converting enzyme
inhibitor ramipril for 24 weeks has been suggested to
significantly improve symptoms of claudication and quality of
life.37 Other agents can be used for hypertension control and
should be noted. Basic categories are: 0 ¼ normotensive for
age, without need for antihypertensive; 1 ¼ controlled with
one drug; 2 ¼ controlled with two drugs; 3 ¼ requires more
than two drugs or is uncontrolled.
Smoking cessation therapy. Observational studies
have found that the risk of death, myocardial infarction,
and amputation is substantially greater and lower extremity
angioplasty and open surgical revascularization patency
rates are lower in individuals with PAD who continue to
smoke than in those who stop smoking.38-40 Strategies
for smoking cessation include physician advice, formal
counseling, and pharmacologic therapy. It should be
particularly noted whether patients received individualized
counseling or are on nicotine replacement, bupropion,
varenicline, or other agents, or both.
Required reporting standardsdmedical therapy
d Pertinent pharmacotherapy for all patients should be
reported
d Study-specific mandatory therapy should be noted in
the Methods
Diagnostic imaging
An accurate anatomic diagnosis can be established in
patients with peripheral vascular disease with the use of
modern noninvasive vascular diagnostic techniques, which
include physiologic testing with arterial Doppler and
duplex ultrasound (DUS) imaging.41-44 These tests will
usually provide adequate information for creation of a ther-
apeutic plan.
DUS imaging. DUS imaging can establish the lower
extremity PAD diagnosis, establish anatomic localization,
and define severity of focal lower extremity arterial steno-
ses. It is, however, operator dependent and can be of
limited value in proximal aortoiliac occlusive disease in
overweight patients and in severely diseased or calcified
vessels. DUS imaging provides anatomic datadbut not
functional datadand may thus have limited utility in clau-
dication studies. In addition, DUS imaging is also limited
in the below-the-knee outflow vessels, which may affect
on outcomes of any intervention in any stage.
DUS reporting should specify the peak systolic velocity
(PSV) and the ratio of adjacent PSVs. The phasic nature of
flow should also be recorded. The criteria used should be
explicitly described for native and stented vessels. Validated
criteria should be used as outlined by the Intersocietal Accred-
itation Commission (Vascular) guidelines.45 If a different
method for determining the degree of stenosis is used, it
should be validated, reported, and described in detail.
Magnetic resonance angiography. Magnetic reso-
nance angiography (MRA) is useful to assess PAD anatomy
and presence of significant stenoses and to select patients
who are candidates for endovascular or surgical revascular-
ization. However, MRA may be inaccurate in arteries
treated with metal stents and cannot be used in patients
with contraindications (eg, patients with renal failure, pace-
makers, defibrillators, intracranial metallic stents, clips,
coils, and other devices).43,46,47
The specific examination protocols should be outlined
and the technique for determining measurements and the
degree of stenosis specified in the Methods section of the

e8 Stoner et al
reports. The accuracy and correlation with DUS evaluation
or conventional angiographic imaging, including intraob-
server and interobserver variability, should be reported
and discussed whenever possible.
Computed tomography angiography. Computed
tomography (CT) angiography (CTA) is useful to assess
anatomy, presence of significant stenoses, and to select pa-
tients who are candidates for endovascular or surgical revas-
cularization. Scan times are significantly faster than for
MRA. However, CTA requires iodinated contrast and
ionizing radiation. Its use is therefore limited in individuals
with established renal dysfunction. Visualization can also
be limited by severe calcification, especially in the infrapo-
pliteal tibial and crural distribution. CTA can also overesti-
mate the degree of stenosis.
The specific examination protocols should be
outlined and the technique for determining measure-
ments and the degree of stenosis specified in the Methods
section of the reports. The accuracy and correlation
with DUS evaluation or conventional angiographic imag-
ing, including intraobserver and interobserver variability,
should be reported.
Digital subtraction angiography. Digital subtraction
angiography (DSA) remains the gold standard to deter-
mine the degree of stenosis and establish an anatomic road-
map. This is the definitive method for anatomic evaluation
of PAD when revascularization is planned.
Complete evaluation of the inflow and outflow is typi-
cally performed. Appropriate oblique imaging, such as
contralateral oblique to image the iliac bifurcation and
the ipsilateral oblique to image the femoral bifurcation,
should be obtained and reported in the Methods section.
The lesion should be imaged in two different oblique views
and the highest degree of stenosis reported.
Imaging of the pedal runoff should also be reported in
two different oblique views, if needed, and the number of
outflow vessels noted. Although this is particularly empha-
sized for patients enrolled in clinical trials, clinical judg-
ment regarding the need for multiple oblique images
should be exercised, based on the adequacy of single runoff
views as well as on the patient’s renal function and risk for
contrast-induced nephropathy. Lesion length, occlusion,
or degree of stenosis should be noted and reported.
Reporting of superficial femoral artery (SFA) disease
should also note a flush occlusion if present, the relation
to the ostium of the SFA, and the relation to the adductor
hiatus. Popliteal disease location should be reported in the
P1 (suprageniculate), P2 (retrogeniculate), or P3 (infrage-
niculate) segment.
Other angiographic findings at the index lesions, such as
calcification (see calcium score, below), thrombus (nonoc-
clusive or occlusive thrombus), vessel tortuosity
(mild <30 angulation; moderate 30 -60 angulation from
the straight segment above it; or severe hairpin loop with
>60 angulation from the straight segment above it), pres-
ence of plaque ulceration, and other lesion characteristics,
should be described as outlined below.
JOURNAL OF VASCULAR SURGERY
July 2016
Anatomic characterization
Anatomic characteristics of the index lesion affect dura-
bility, outcomes, and response to endovascular interven-
tions. Anatomic (angiographic) disease description in
PAD patients also requires a scoring system that is sensitive
to differences in femoropopliteal and infrapopliteal artery
disease.
Bollinger score. The Bollinger scoring system consists
of an additive score describing the severity of the lesions
visualized on angiography within each study segment
(Table IV).48 The lesions are categorized in four groups:
complete occlusion of the lumen, stenosis encompassing
>50% of the diameter of the vessel, stenosis narrowing the
lumen between 25% and 50%, and plaques resulting in
#25% stenosis. The score assigned is higher when the lesion
is more severe. The Bollinger score takes into account the
most severe lesion and dictates that in the presence of
occlusions, other lesions should not be considered; similarly,
when both categories of stenoses (<50% and >50%) are
present, milder lesions, such as plaques, are not scored.
The Bollinger system appears well suited for detecting
the difference between femoropopliteal and infrapopliteal
disease. A recent analysis of the Bypass vs Angioplasty in
Severe Ischaemia of the Leg (BASIL) trial showed the
below-knee Bollinger score appeared to discriminate better
between individuals than the above-knee score.49 The
TransAtlantic Inter-Society Consensus for the Manage-
ment of Peripheral Arterial Disease (TASC II) classification
appears to have significant limitations in this patient group
due to lack of reproducibility and definition of crural
disease.
TASC II grade. The TASC II classification largely re-
stricts itself to the aortoiliac and femoropopliteal segments
and has been widely used to classify disease severity in that
distribution.17 TASC II scores do not take into account
the extent of the disease in the more distal segments,
specifically in the tibial arteries. Aortoiliac and femo-
ropopliteal disease is currently classified based on the
TASC II classification (Tables V and VI). However, limi-
tations of the TASC II scoring system and the lack of
universal endorsement limit future applicability of this
classification.
Runoff score. The severity and extent of PAD, taking
into account the variability in the runoff, can be gauged by
using the modified SVS runoff score. The modified SVS
runoff score is calculated from angiographic images.6,50
This score ranges from 0 to 19, with a higher score indi-
cating more severe disease, and is calculated by assessing the
patency and degree of stenosis/occlusion in the popliteal
artery and the three tibial vessels. A score of 0 is assigned to a
vessel with <20% stenosis, a score of 1 for a 21% to 49%
stenosis, 2 for 50% to 99% stenosis, 2.5 for a vessel occluded
over an area less than half its length, and 3 for an occlusion
greater than half the vessel length. The score for the popliteal
artery is multiplied by 3 and a value of 1 is added before
adding all 4 vessel scores together, giving a range of possible
popliteal artery scores from 1 to 10.
JOURNAL OF VASCULAR SURGERY
Volume 64, Number 1 Stoner et al e9

Table IV. Bollinger scoring matrixa Table VI. TransAtlantic Inter-Society Consensus for the
Management of Peripheral Arterial Disease (TASC II)
Severity femoral-popliteal lesion classification
Stenosis Stenosis Plaques Femoral-popliteal lesion
Occlusion >50% 25%-49% <25% Extent of disease
Lesion type Description
4 2 1 Single lesion
13 5 3 2 Multiple lesions Type A Single stenosis #10 cm in length
affecting less than Single occlusion #5 cm in length
half the segment Type B Multiple lesions (stenoses or occlusions), each #5 cm
15 6 4 3 Multiple lesions Single stenosis or occlusion #15 cm not involving
affecting more than the intrageniculate popliteal artery
half the segment
Single or multiple lesions in the absence of
a
The vertical columns represent the different severities of atherosclerotic continuous tibial vessels to improve inflow for a
lesions observed. The rows represent the extent of the disease observed in distal bypass
each segment. The additive score for each segment is obtained by adding Heavily calcified occlusion #5 cm in length
the scores for the four different categories of severity. Single popliteal stenosis
Type C Multiple stenoses or occlusions totaling >15 cm,
with or without heavy calcifications
Table V. TransAtlantic Inter-Society Consensus for the Recurrent stenoses or occlusions that need
Management of Peripheral Arterial Disease (TASC II) treatment after two endovascular interventions
Type D Chronic total occlusion of the CFA or SFA
aortoiliac lesion classification
(#20 cm, involving the popliteal artery)
Aortoiliac lesions CFA, Common femoral artery; SFA, superficial femoral artery.

Lesion type Description

Type A Unilateral or bilateral stenosis of CIA
Unilateral or bilateral single short (#3 cm)
stenosis of EIA
Type B Short (#3 cm) stenosis of infrarenal aorta
Unilateral CIA occlusion
Single or multiple stenosis totaling 3-10 cm
Involving the EIA not extending into the CFA
Unilateral EIA occlusion not involving the origins
of internal iliac or CFA
Type C Bilateral CIA occlusions
Bilateral EIA stenoses 3-10 cm long not extending
into the CFA
Unilateral EIA stenosis extending into the CFA
Unilateral EIA occlusion that involves the origins
of internal iliac and/or CFA
Heavily calcified unilateral EIA occlusion, with or
without involvement of origins of internal iliac
and/or CFA
Type D Infrarenal aortoiliac occlusion
Diffuse disease involving the aorta and both iliac
arteries requiring treatment
Diffuse multiple stenosis involving the unilateral
CIA, EIA, and CFA
Unilateral occlusions of both CIA and EIA
Bilateral occlusions of EIA
Iliac stenosis in patients with AAA requiring
treatment and not amenable to endograft
Placement or other lesions requiring open aortic
or iliac surgery
AAA, Abdominal aortic aneurysm; CFA, common femoral artery; CIA,
common iliac artery; EIA, external iliac artery.
Calcium score. Lesion calcification has been recog-
nized to have a potential effect on procedural technical suc-
cess as well as midterm and long-term outcomes. It has
been implicated in procedural embolic complications, stent
fracture, and restenosis.51,52 Noting the degree of calcifi-
cation and its distribution is recommended. Calcium
scoring requires CTA or multiplanar DSA imaging of the
vessel segment to accurately determine the extent of
calcification. Although calcium scoring has not been vali-
dated for outcome after intervention, its effect on patency
and procedural success has been recognized.53,54 If calci-
fications are present, they should be noted, the location
should be specified, and the severity classified. Calcification
severity can be categorized as none, mild (<25% circum-
ference), moderate (25%-50%), or severe (>50%). CTA-
based coronary calcium score algorithms have not been
studied or validated in PAD outcomes and represent an
area for future study.
Lesion length. Restenosis is the main drawback of
endovascular peripheral interventions, particularly for long
SFA lesions.53 This is also reflected in the TASC II guide-
lines preferentially recommending the use of percutaneous
transluminal angioplasty for short lesions.17 Long calcified
lesions have also been demonstrated to affect therapeutic
options, because this has resulted in a rather high rate of
secondary stenting owing to suboptimal results of balloon
angioplasty alone.54 Lesions length should be categorized as
short #6 cm, intermediate 7 to 10 cm, or long >10 cm.54-57
Validation of lesion length as a determinate for infragenicu-
late interventions success has not been widely addressed in
the literature, although it is an accepted factor. A summary of
the anatomic grading systems is provided in Table VII.
Required reporting standardsdanatomic
d Anatomic characterization technique reported in methods
d TASC II grade appropriate for aortoiliac and femoro-
popliteal segments
d Bollinger score or SVS runoff score for infrageniculate
segments
 JOURNAL OF VASCULAR SURGERY
e10 Stoner et al July 2016

Table VII. Summary of anatomic grading systems

Grading system Classification Clinical utility Limitations

Bollinger score
TASC II
Runoff score
(range 1-19 score for
popliteal artery
multiplied by 3 (þ1)
before adding all four
vessel scores together)
Calcium score
Lesion length category
Numerical range Granularity for infrageniculate May not discriminate inflow
disease and femoropopliteal
disease as well
A, B, C, D Gauge aortoiliac and No tibial classification
femoropopliteal lesions
severity
Guide choice of revascularization
based on type
0 ¼ <20% stenosis, 1 ¼ 21%-49% Gauge severity of popliteal and Pedal runoff not well
stenosis, 2 ¼ 50%-99% stenosis, tibial disease captured
2.5 ¼ occlusion <half vessel length,
3 ¼ occlusion >half vessel length
0 ¼ none, 1 ¼ Mild <25%-50% Technical success, patency, Not well characterized in
circumference, 2 ¼ moderate 25%-50% short- and long-term peripheral interventions
circumference, 3 ¼ severe >50% outcomes
circumference
Short #6 cm, intermediate 7-10 cm, long Patency, need for stenting Not routinely used outside
>10 cm clinical trials

TASC II, TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease.

d Target lesion length and calcium score for comparative
device trials
INTERVENTION
Although a wide variety of balloons, stents, atherectomy,
crossing, and other devices are available, there are no clear
guidelines for reporting these interventions. In addition to
intervention specifics, the type and anatomic location of
the treated lesion should be precisely reported within the
context of vessel-specific reporting, as discussed in the next sec-
tion. This protocol will allow for more accurate comparisons
of endovascular interventions in the future.
Balloon angioplasty. Balloon angioplasty is the most
common endovascular arterial intervention performed in
the peripheral circulation. Balloon-specific trials should
note the compliance characteristics of the device. Addi-
tional characteristics of a study balloon should be noted,
including geometry, cutting ability, materials, and specifics
related to clinical effectiveness.
Drug-eluting balloons. Poor long-term patency has
been a significant factor leading to the development of drug-
eluting balloons. Paclitaxel, a cytoxic agent, has emerged as
the drug of choice because of its rapid transfer from the balloon
surface to the arterial wall and also because it has a prolonged
effect lasting up to 14 days on smooth muscle cells. The drug
diminishes or eliminates smooth cell proliferation, significantly
reducing the incidence of recurrent stenosis.58 Very recently,
the United States Food and Drug Administration approved
the first drug-eluting balloon in the United States.
Required reporting standardsdballoon trials.
d Location of intervention (vessel specific reporting)
d Primary vs repeat intervention
d Intraluminal or subintimal
d Length and diameter of the definitive balloon (largest
diameter balloon used) and type of balloon (compliant,
semicompliant, or noncompliant; cutting, cryo, or drug
eluting)
d Inflation pressure and time
Stents. Stents are generally classified into two main
categories, balloon-expandable and self- expandable.
Within each of these categories are subcategories, including
covered stents, heparin-bonded stents, and drug-eluting
stents (DES).
Restenosis remains the chief liability of LE-EV revascu-
larization. DES were developed to prevent or minimize the
inflammatory response of injured endothelial cells and sub-
sequent neointimal hyperplasia. Until recently, however,
the benefits of larger DES stents in the peripheral circula-
tion has not been as forthcoming.59,60 Contemporary
data regarding DES are mixed, and no clear appropriate-
ness guidelines exist for their use.61,62 That future compar-
ative trials will be required is anticipated.
Intention-to-treat design is a key reporting component
for all stent trials. In clinical practice, many operators use a
strategy of provisional angioplasty, reserving stenting for
unfavorable outcomes after balloon-based treatment. Clear
presentation of study design is required so that data can be
evaluated within a clinical practice context.
Required reporting standardsdstent trials.
d Predilation with balloon
d Intention-to-treat study design clearly documented
d Length and diameter of stent
d Balloon expandable or self-expanding stent
d Covered stent, heparin-bonded stent, DESdspecific
agent, including dose and drug delivery kinetics
d Final treatment diameter (poststent dilation)
JOURNAL OF VASCULAR SURGERY
Volume 64, Number 1
Atherectomy devices. Several atherectomy devices are
in current use for the treatment of PAD. These can be clas-
sified as excisional atherectomy (removal of plaque) or
ablative atherectomy (disintegration or vaporization of pla-
que without removal) devices. Aside from standard primary
treatment of tibial occlusive disease, atherectomy is most
commonly performed as an adjunctive procedure to
balloon angioplasty with the goal of achieving equal or
superior patency without the need to deploy a stent. De-
vices can also be used as adjuncts to wire placement, but
not as an absolute therapy. Contemporary data are mixed
regarding the benefit of atherectomy as an adjunct to
LE-EV revascularization.63 Embolization of plaque debris
is one of the most common complications. For this reason,
distal protection devices are frequently used during these
procedures. Reporting of atherectomy procedures should
include all device-specific variables to ensure reproducibility
and follow the same standards outlined above for balloon
and stent trials.
Required reporting standardsdatherectomy.
d Device-specific use data (including treatment time,
amount of plaque treated)
d Use of balloon or stent therapy in addition to
atherectomy
d Use of embolic protection device
d Atherectomy device as primary therapy or adjunct for
wire placement
Other adjuncts. Chronic total occlusions (CTO) are
common, comprising more than one-third of diseased,
symptomatic SFA occlusive cases. A variety of CTO devices
are available and are used as an alternative to catheter and
wire-based luminal or subintimal crossing. Overall success
rate with wire and catheter-based systems approaches 85%,
with higher rates often noted for dedicated CTO systems.
The quality of current data regarding these devices remains
limited.64-66 However, if such a device is used during a
percutaneous transluminal angioplasty (PTA), atherec-
tomy, or stent, the device should be recorded.
Embolic protection and thrombectomy devices.
Distal embolization is a recognized complication of all pe-
ripheral interventions. In the case of extensive femoropo-
pliteal disease and limited runoff, the potential benefit of
a distal protection device is more likely to be realized.67
Further studies are needed before their general use in
selected peripheral vascular procedures can be recom-
mended. However, if a distal protection device is used, the
type of device should be recorded as well as whether
embolic material was retrieved or prevented.
There are a variety of percutaneous thrombectomy de-
vices, which can be classified according to their mode of ac-
tion: mechanical, hydrodynamic, rheolytic, ultrasonic, and
mixed. These devices have been used in acute and chronic
limb ischemia. The primary complication associated with
the use of these devices is microembolization, which has
led to distal protection device use with these therapies.
Embolization events should always be reported, as dis-
cussed in the “Complications” section below.
Stoner et al e11
Radiation reporting. The increasing numbers of
endovascular procedures performed and their increasing
complexity and duration has resulted in an increase in
ionizing radiation exposure to patients, staff, and operators.
Radiation exposure is a significant patient safety issue and
thus is a requisite procedural variable.
To properly manage radiation risk, proper recording of
the radiation dose during endovascular procedures is essen-
tial. Air kerma is measured in units of Gy at the interven-
tional reference point, which is located along the central
ray of the X-ray beam at a distance of 15 cm from the iso-
center in the direction of the focal spot. This is an esti-
mated rather than actual patient radiation exposure. The
dose area product is an index of the total X-ray energy
delivered to a patient during a procedure and is expressed
as Gy-cm.2 The dose area product is well correlated with
the total energy imparted to the patient and to the stochas-
tic risk to the patient, operator, and staff. The most accu-
rate measurement of radiation exposure to the patient is
that obtained from a microdosimeter placed on the patient
where it is presumed most of the fluoroscopy will take
place.
Contrast. With respect to reporting standards, full de-
tails of the contrast agents used, medical procedural phar-
macology, and postoperative management must be
included in the Methods section of any publication.
Pharmacology. Bivalirudin, a direct thrombin inhibi-
tor, is a commonly used anticoagulant during percutaneous
coronary interventions because of its immediate effect,
short half-life (25 minutes in patients with normal renal
function), and low rates of bleeding complications.68
Experience with this medication in peripheral in-
terventions, however, is limited.
Unfractionated heparin (UFH) is the most commonly
used anticoagulant, with a usual dose of 100 to 150 U/kg
to achieve adequate anticoagulation. UFH has a half-life of
90 minutes and can be monitored intraprocedurally by
measuring the activated clotting time. We recommend
routine monitoring of activated clotting times and not
solely relying on weight-based dosing of heparin for endo-
vascular procedures. UFH dosing is independent of renal
function and easily reversed with protamine sulfate.
Mandatory use of oral antiplatelet therapy should be
reported. Aspirin and clopidogrel remain the most
commonly used agents, and their use has been largely
extrapolated from the coronary literature.69 Newer thieno-
pyridines may prove to be even more beneficial but have
not yet been fully studied. Full details of the medical
procedural pharmacology and postoperative management
must be included in the Methods section of any publication.
Outcome measuresdprocedural. Success after an
endovascular intervention is related to the indication for
the procedure and each patient’s individual goals. At min-
imum, early results are characterized by procedural out-
comes that include technical success and periprocedural
complications. Late results are defined by a combination
of sustained hemodynamic improvement and patency of
the treated segment, function, limb salvage, morbidity

e12 Stoner et al
and mortality of the procedure, and freedom from repeat
interventions.
Definition of technical and procedural success.
Technical success for LE-EV interventions is defined as
successful use of a device or technique to re-establish vessel
patency with a residual stenosis of <30%. Primary technical
success should be defined per vessel treated on an intent-
to-treat basis. Technical success is generally determined
by visual analysis of angiographic images but may also be
measured by other objective imaging such as intravascular
ultrasound. For revascularization of the aortic and iliac
arteries, technical success may also be documented by a
reduction of the pressure gradient across the lesion
to <10 mm Hg.
Procedural success is defined as technical success and
completion of the procedure without complications. For
LE-EV interventions, this represents successful treatment
of the vessels (technical success) in the absence of vessel
rupture, distal embolization, thrombosis, access complica-
tions, and major adverse cardiovascular events. These
events should be listed as occurring #24 hours and
#1 month of the procedure, similar to surgical procedures.
Reporting of patency is discussed later. It is important to
emphasize that although complications should be reported,
technical success and overall procedural success should be
reported separately.
If unplanned endovascular or surgical procedures are
needed to maintain or restore patency, then the procedure
is not primarily successful, and the terms assisted primary or
secondary technical success, respectively, should be used.
For example, if balloon angioplasty of a peripheral artery
results in persistent significant stenosis or dissection and
requires insertion of a stent, then the balloon angioplasty
should not be considered primarily successful although
the stent insertion would be. As another example, if stent
insertion results in persistent arterial stenosis or bleeding
and needs to be treated by insertion of a stent graft,
then the original stenting procedure was not primarily
successful.
Hemodynamic success. Hemodynamic success can
refer both to improvement of hemodynamic parameters
during the procedure at the treated arterial lesion and after
the procedure in the distal limb. A peak systolic pressure
drop across an arterial segment >10 mm Hg at rest or
15 mm Hg after hyperemia induced by exercise, ischemia,
or the administration of vasodilators indicates increased
resistance in this segment sufficient to reduce flow by a
clinically meaningful amount. After endovascular treatment
of the lesion, a pressure gradient of <10 mm Hg across the
lesion is considered a hemodynamically successful result.
Interventionists are not required to determine whether a
pressure gradient exists for arterial lesions that are clearly
>50% diameter reducing. Measurement of a pressure
gradient may need to be performed for aortic or iliac le-
sions with questionable degrees of hemodynamically signif-
icant stenosis based on arteriography images.
After the procedure, noninvasive testing can help
determine successful treatment and predict clinical
JOURNAL OF VASCULAR SURGERY
July 2016
improvement. An increase in the ABI of at least 0.10 has
been recommended as a guideline to provide objective
evidence of increased arterial perfusion to the segment of
the limb distal to the treated site.6 Many contemporary
studies require an ABI increase of at least 0.15, or toe-
brachial index increase of 0.10.70 However, this guideline
may not be a particularly helpful standard of hemodynamic
improvement in all patients who have undergone LE-EV
intervention because of the frequent calcified nature of
the arteries in many patients, particularly those with
diabetes. Conversely, an intervention may be considered
a hemodynamic failure if there is a lack of significant
hemodynamic improvement (no increase in ABI) despite
a patent revascularization. The common setting for this
finding is a limb with multilevel disease where a proximal
reconstruction is performed in the face of residual distal
disease. In any event, improvement in PVR waveforms
can be reliable indicator of improved perfusion to the distal
limb. An increase in PVR amplitude >50% compared to
the preprocedure level may be considered a hemodynamic
improvement.6 Failure to maintain hemodynamic success
measures (including DUS evidence of restenosis, discussed
below) is considered hemodynamic failure.
Patency. In clinical practice, an LE-EV intervention is
often considered patent if one or more of the following
criteria are present:
1. Demonstrably patent by an accepted imaging tech-
nique of the specific arterial site treated, such as
with DUS, CTA, MRA, or arteriography (best and
most appropriate criteria), that clearly shows flow
through the lesion
2. Palpable pedal pulse postprocedure compared with
lack of palpable pulses preprocedure (subjective and
weak)
3. Improvement of ABI >0.15 or increase in PVR
amplitude >50% compared with preprocedure values
(weak, for the reasons discussed above)
However, the second and third criteria should not be
accepted as proof of patency of a LE-EV intervention for
reports in scientific journals.6 Although an argument can
be made that a patient with a preprocedure ABI of 0.40
who has an ABI of 1.0 after the LE-EV procedure likely
has a patent intervention, establishment of a minimum
improvement in ABI to suggest patency of the intervention
is tenuous. ABI reflects overall perfusion to the distal limb
but does not necessarily reflect patency of a specific treated
segment. If a patient undergoes endovascular intervention
of more than one arterial segment, the postintervention
ABI may be increased even though one of the treated seg-
ments may have occluded. Reliable objective methods
must be used to assess patency of a LE-EV intervention.
DUS of the specific arterial site treated should be consid-
ered the gold standard when performed by an accredited
laboratory.
Patency alone is not sufficient to define success of an
intervention, because any flow through a treated segment
JOURNAL OF VASCULAR SURGERY
Volume 64, Number 1
could be considered a success, even in the setting of high-
grade stenosis. Sustained hemodynamic success (ABI gain
of 0.1 or PVR gain of 50%, or both), as discussed above,
must be coupled with patency when evaluating procedural
outcome over time.
Other imaging techniques, such as CTA, MRA, and
invasive arteriography, may also be used to accurately assess
patency but are associated with additional costs and radia-
tion exposure so they cannot be recommended for routine
periodic surveillance.
Primary, primary assisted, secondary patency. For
LE-EV interventions, primary patency refers to patency
that is obtained without the need for additional or sec-
ondary surgical or endovascular procedures, or the interval
from the time of the original intervention until any inter-
vention designed to maintain or re-establish patency is
performed. Assisted primary patency is patency of the
endovascular intervention achieved with the use of an
additional or secondary surgical or endovascular pro-
cedures, as long as occlusion of the primary treated site has
not occurred.71 Secondary patency is patency obtained with
the use of an additional or secondary surgical or endovas-
cular procedure after occlusion occurs.
Statistical analysis of outcome measures also needs to
be standardized. Besides patency rates and sustained hemo-
dynamic success, long-term outcome of LE-EV interven-
tions should include analysis of patient survival, freedom
from ipsilateral symptoms, such as claudication, rest pain,
or ischemic tissue loss, and freedom from amputation.
Life tables72,73 or Kaplan-Meier curves74 should be calcu-
lated for presentation of patient survival and freedom
from restenosis, amputation, and recurrence of symptoms.
LE-EV interventions should be reported in life-table or
Kaplan-Meier format as primary, assisted primary, or sec-
ondary, depending on the use of additional endovascular
or surgical procedures, as previously mentioned. The
numbers of patients at risk at the start of each interval (peri-
odically for the Kaplan-Meier curve) must be included in
the graphic images, and the standard error for each esti-
mate of patency must be displayed. When the standard er-
ror of the patency rate estimate is >10%, the curve should
not be drawn or else should be represented with a dotted
line as a means of indicating lack of reliability of the
estimate.6
Endovascular interventions to maintain or restore patency
of an LE-EV intervention include balloon angioplasty,
stenting, stent grafting, atherectomy, and catheter-directed
mechanical thrombectomy or thrombolysis. Surgical proce-
dures include surgical removal of thrombus, primary surgical
repair, or endarterectomy, with or without patching, and
performance of a surgical bypass.
A principal procedure is a LE-EV procedure that con-
tributes most to the treatment of the lesion. An adjunctive
procedure is any other procedure that is designed to
augment the effects of the principal procedure, such as a
proximal or distal LE-EV intervention, relative to the pri-
mary target lesion. The procedure may occur in the peri-
procedural or postprocedural periods and should be
Stoner et al e13
designated in a like manner. An ancillary procedure is
one that does not contribute to the overall treatment of
the target lesion, such as a contralateral lesion.35
Primary procedures refer to all interventions performed
at the time of initial LE-EV interventions. Secondary
procedures include all open or endovascular interventions
performed at a later date. It is recommended that peripro-
cedural adjunctive interventions be classified as planned
procedures or unplanned procedures. Planned procedures
comprise techniques that are part of a preformulated proce-
dural strategy, and unplanned procedures are necessary for
management of unintended complications or unsatisfactory
outcome. These adjunctive procedures are most often
related to treatment of a concomitant arterial occlusive
lesion to facilitate access, such as gaining access via a com-
mon femoral artery and performing endovascular interven-
tion of an iliac stenosis to then cross over to the
contralateral iliac artery to treat the target lesion.
Interventions after LE-EV revascularization should also
be categorized with respect to conversion to open surgery.
Conversion may be required at the original intervention or
#30 days (primary conversion) or on a later occasion (sec-
ondary conversion).35 Secondary conversion should also be
classified as urgent or elective. Therefore, intent-to-treat
should be considered initiated by any maneuver directed
at treating the lesion with a surgical or endovascular
approach that follows the completion of the definitive im-
aging study, such as DUS, CTA, MRA, or DSA. In addi-
tion, categorization of major vs minor reinterventions
should be classified as major adverse limb events
(MALE), which are defined as above-ankle amputation of
the index limb or major reintervention.70
Vessel-specific reporting. The optimal method of
reporting outcome measures should be as an intervention
relates to a specific site in a specific artery. The implications
of this approach are obvious. If a patient undergoes inser-
tion of a stent graft in the SFA and balloon angioplasty
of a posterior tibial artery, the technical success rate,
patency rate, and other outcome measures need to specif-
ically address each of these arteries and not be considered
as a global outcome, other than clinical success.
DUS, CTA, other imaging. Any narrowing of the
treated segment occurring >30 days after the LE-EV
intervention should be reported as restenosis. Patency
and degree of restenosis at the treated site during follow-up
should be assessed and reported.
DUS imaging is an efficacious and cost-effective sur-
veillance tool for restenosis for lower extremity by-
passes.75,76 DUS criteria for technical success after
balloon angioplasty (<50% diameter reduction stenosis in
this series) have been reported to be a PSV of <180 cm/
s within the treated site and PSV ratio of <2.5 across the
lesion. To determine a >70% arteriographic restenosis in
femoropopliteal arterial segments, a PSV >223 cm/s
had a sensitivity of 94% and specificity of 95%, whereas a
PSV ratio >2.5 identified 92% (69 of 75) of lesions.77
Others have documented different criteria for >70%
diameter reduction arteriographic restenosis, namely PSV

e14 Stoner et al
>300 cm/s and PSV ratio >3.0, which is generally
accepted and recommended.70
Within the context of a clinical trial, we recommend
that DUS imaging should be considered the standard
for LE-EV intervention surveillance in an accredited
noninvasive vascular laboratory at a well-defined interval.
An accepted approach would be to obtain the study
#1 week of the endovascular intervention, every 3 months
during the first year, and every 6 months or annually there-
after. Repeat noninvasive tests should also be performed for
deteriorating symptoms or other clinical evidence of steno-
sis. If surveillance warrants intervention, then angiographic
confirmation of the degree of restenosis should be obtained
and documented.
Target lesion revascularization. Target lesion revas-
cularization (TLR) has been considered a clinical marker
for angiographic restenosis after percutaneous coronary in-
terventions. However, TLR should not be considered as an
accurate primary outcome measure of efficacy after LV-EV
interventions. TLR does not always contribute to the
assessment of clinical treatment failures because it is not
always driven by clinical evidence of symptoms but rather
by a decision to perform secondary revascularization. If
TLR is reported as a secondary outcome measure, any
surgical or percutaneous revascularization procedure
involving the original target lesions should be reported as
TLR. Repeat balloon angioplasty, stenting, or open
vascular reconstructions of the treated lesions should be
considered failure of TLR. Conversely, TLR should not
include staged procedures involving other lesions in the
same vascular territory that do not involve the specific
initial lesion. Most regard TLR as a less accurate reporting
method than the patency measures described earlier.
Required reporting standardsdtechnical outcome
measures.
d Patency measures should be coupled with freedom
from hemodynamic failure and reported in a life table
or Kaplan-Meier format
d Anatomic imaging assessing patency is required
d Patency should be reported in a vessel-specific manner
d TLR is not an acceptable proxy for patency
d When an additional intervention is performed in the
target limb, a complete description of location and
indication is important
Outcome measuresddisease specific. In addition to
technical success, endovascular interventions for PAD
should be compared using clinically relevant and functional
descriptors. Given that PAD may be classified into claudica-
tion and CLI, each of which encompasses vastly different
natural histories and clinical implications, outcome mea-
sures should be disease specific.
For patients with claudication, the correlation between
quantitative and qualitative measures of disease severity re-
mains difficult to reconcile, especially because claudicant
patients often have other comorbidities that may confound
the ability to assess walking limitation.78 Nevertheless, the
WIQ has demonstrated sensitivity with regard to assessing
JOURNAL OF VASCULAR SURGERY
July 2016
functional status in claudicant patients. The specificity of
the WIQ may promote standardization when patients
with PAD are evaluated, particularly with regard to mea-
sures of quality of life. Quantitative measures of walking
ability in patients with claudication have included treadmill
testing and the 6MWT. The 6MWT test has been validated
as an objective measure of evaluating physical function in
claudicant patients; in fact, it has been touted to be more
accurate in depicting physical activity during daily life
than treadmill walking.10
The SVS has developed a series of objective performance
goals (OPGs) to assess outcomes of invasive management of
CLI (Table VIII).70 These benchmarks describe the efficacy
and safety of lower extremity revascularization and are
derived from findings of multiple randomized controlled
trials of various therapies for CLI. The effectiveness of
traditional lower extremity bypass is used as the standard to
which innovative endovascular therapies are compared.
OPGs include major adverse cardiac events, including
myocardial infarction, stroke, or death, as well as MALE,
including amputation or major reintervention such as throm-
bectomy/thrombolysis, bypass revision, or redo bypass
grafting (Table VIII). Other OPGs include above-ankle
amputation; freedom from MALE or postoperative death;
limb salvage; survival; amputation-free survival; freedom
from reintervention, amputation, or stenosis; and freedom
from reintervention or amputation. Efficacy of these OPGs
is measured at 30 days and 1 year after the intervention. Out-
comes can and should be stratified by clinically and anatom-
ically defined subgroups.70,79 OPGs were crafted to create a
standardized way of reporting outcomes of various types of
lower extremity revascularization so that valid comparisons
of newer endovascular methods could be made. Use of these
goals, however, has been demonstrated to be possible under
real-world conditions.80
Quality of life outcomes in patients with CLI have been
studied to a limited extent. The goal of lower extremity revas-
cularization in the setting of CLI is a single procedure that re-
sults in an excellent technical result without associated
complications or need for further intervention. To this end,
functional outcomes should describe relief of symptoms,
such as pain, wound healing, and maintenance/improvement
of preoperative living status without subsequent hospitaliza-
tion, frequent clinic follow-up, or prolonged wound care.
The SF-36 questionnaires may be used to assess global health
status and have been incorporated into PAD-focused studies,
such as the BASIL trial. More PAD-specific questionnaires,
such as the WIQ, have been validated for claudicant patients,
whereas the VascuQOL is seen by some as more applicable
to patients with CLI. The VascuQOL was used in the Edifoli-
gide for the Prevention of Infrainguinal Vein Graft Failure
(PREVENT III) trial, where it was able to identify patients
with significant improvement in quality of life after revascular-
ization. Several small series have described improvement of
quality of life, particularly with regard to pain in patients with
CLI, after endovascular interventions.81
With the growing number of endovascular peripheral
interventions performed annually as well as the continued
JOURNAL OF VASCULAR SURGERY
Volume 64, Number 1 Stoner et al e15

Table VIII. Society for Vascular Surgery (SVS) objective Table IX. Grading system for device-related
performance goals (OPGs) for critical limb ischemia (CLI) complications

Outcomes Definition Access-site or

intervention specific
MALE Major adverse limb event (ie, major complications Grading
amputation or revascularization)
MALE þ POD Perioperative death (30 days) or any MALE Thrombosis 1: Not requiring treatment
MACE Major adverse cardiovascular event (ie, MI, 2: Resolved with endovascular repair
CVA, death) (thrombolysis, angioplasty, stent, or
Amputation Above-ankle amputation of affected limb stent graft)
AFS Amputation-free survival 3: Resolved with surgical thrombectomy
RAO Reintervention or above-ankle amputation and repair
RAS Any intervention, above-ankle amputation, or Dissection 1: Not requiring treatment
stenosis 2: Resolved with endovascular repair
Death Death by any cause (thrombolysis, angioplasty, stent, or
stent graft)
CVA, Cerebrovascular accident; MI, myocardial infarction. Macroembolization 1: Not requiring treatment
2: Resolved with endovascular repair
(thrombolysis, angioplasty, stent, or
evolution of the field, the cost-effectiveness of PAD thera- stent graft)
pies has been incorporated into recent outcome measure 3: Resolved with surgical repair
analyses. Therefore, total medical costs per patient should Microembolization 1: Not requiring treatment
2: Resolved with endovascular repair
be risk adjusted when various endovascular and open ther- (thrombolysis, angioplasty, stent, or
apies are compared. The combination of several endovascu- stent graft)
lar techniques should also be reported because each 3: Resolved with surgical repair
therapy adds to the total cost of the peripheral intervention Rupture 1: Not requiring treatment
2: Resolved with endovascular repair
during a given session. For example, Jaff et al82 found that
(thrombolysis, angioplasty, stent, or
the lowest risk-adjusted PAD-related cost among Medicare stent graft)
beneficiaries was in patients who underwent PTA alone. 3: Resolved with surgical repair
However, as many as 30% of patients who undergo PTA Device malfunction 1: Not requiring treatment
require a reintervention. As a result, the actual cost per pa- 2: Resolved with endovascular repair
(thrombolysis, angioplasty, stent, or
tient may be higher than that reported in the current liter- stent graft retrieval)
ature and should use a method to account for multiple 3: Resolved with surgical repair
procedures on the same patient.83-85 Finally, analyses of Hematoma 1: Resolved without intervention
cost and utilization are generally limited by differences in 2: Resolved with surgical evacuation
3: Resolved with surgical evacuation and
coding because data may be incomplete or biased by those
arterial repair
annotating the data. With the continued revision and adop- Pseudoaneurysm 1: Resolved without intervention
tion of such systems as the 10th Revision of the Interna- 2: Resolved with compression or direct
tional Statistical Classification of Disease and Related thrombin injection
Health Problems, reporting standardization will help to 3: Resolved with endovascular or surgical
repair
overcome such limitations. Arteriovenous fistula 1: Not requiring treatment
Assessment of the efficacy of interventions for claudica- 2: Resolved with endovascular repair
tion has been reported from 4 weeks to 2 years after the (embolization or stent graft)
inception of various therapies. Similarly, SVS OPG report- 3: Resolved with surgical repair
Infection 1: Resolved with oral antibiotics
ing standards for patients with CLI are generally deter-
2: Resolved with intravenous antibiotics
mined at 30 days and 1 year after surgical intervention. As 3: Treated with operative drainage or
a result, reporting frequency of results for LE-EV for débridement
PAD, whether for claudication or CLI, should be at least
at 30 days and 1 year of follow-up. However, the preference
is for long-term (5-year) life table or Kaplan-Meier curves. promoting standardization, and hence, more clinically
meaningful comparisons of peripheral vascular inter-
Required reporting standardsddisease-specific ventions. Five-year follow-up is preferable.
outcome measures.
d Disease-specific quality of life measure, functional COMPLICATIONS
assessment for claudication studies Standardized reporting of endovascular complications is
d Use of CLI OPGs for patients with CLI critically important because it allows for an accurate, repro-
d The cost-effectiveness of endovascular therapies should ducible manner of describing such events and also facilitates
be risk-stratified and account for durability comparison with complications encountered as a result of
d LE-EV interventions for PAD should be reported at open surgical revascularization. Complications related to
minimum for 30-day, 1-year, and 2-year follow-up, LE-EV interventions can be classified according to whether

e16 Stoner et al
Table X. Grading system for procedure-related
complications
Systemic
complications Grading
Cardiac 1: Associated with little or no hemodynamic
consequence
2: Associated with symptoms necessitating
intravenous medication, percutaneous
transluminal coronary angiography/stent
therapy, or coronary bypass
3: Associated with hemodynamic dysfunction
necessitating cardiopulmonary resuscitation,
cardiac arrest, or fatal outcome
Respiratory 1: Associated with a prompt recovery with
medical treatment
2: Associated with a prolonged hospitalization
or intravenous antibiotics
3: Associated with a prolonged intubation,
tracheostomy, deterioration in pulmonary
status, oxygen dependence, or fatal outcome
Renal 1: Dysfunction not requiring dialysis
2: Dysfunction requiring temporary dialysis,
prolonged hospitalization, or resulting in
permanently reduced renal function
3: Dysfunction requiring permanent dialysis,
renal transplant, or ending in death
Neurologic 1: Associated with a transient neurologic deficit
2: Associated with a permanent neurologic
deficit
Deep venous 1: Requiring anticoagulation and/or IVC filter
thrombosis 2: Requiring thrombolysis or surgical
thrombectomy
3: Associated with persistent neurologic
impairment or ipsilateral leg tissue loss
Pulmonary 1: No hemodynamic instability
embolism 2: Hemodynamic instability
3: Hemodynamic instability, requiring
endovascular or surgical pulmonary
embolectomy, or resulting in fatal outcome
Allergic 1: Requiring unplanned medical treatment
reaction 2: Requiring ventilator support or resulting in
fatal outcome
Neuropathy 1: Not requiring treatment
2: Requiring treatment with medications
3: Requiring treatment with regional blocks or
surgical intervention
IVC, Inferior vena cava.
they are related to the device or to the procedure.86,87 Inter-
vention is defined as the introduction of wires, catheters, or
other endovascular devices to a site beyond the access artery,
with or without an associated endovascular procedure, such
as vessel recanalization, angioplasty, atherectomy, or deploy-
ment of a stent or stent graft.
Complications should be recorded as being acute
(#30 days), subacute (between 30 days and 12 months)
and late (>12 months). A minimum of 30 days of complica-
tion reporting is required. Complications should be reported
according to the intent-to-treat basis and classified as above.
Complications should be generally described as mild,
moderate, or severe. A mild complication is one that resolved
spontaneously or with nominal intervention, did not prolong
hospital stay, and did not cause permanent disability. A
JOURNAL OF VASCULAR SURGERY
July 2016
moderate complication includes the need for significant
intervention, prolongation of hospitalization for
>24 hours, a minor amputation, or association with minor
disability that does not interfere with normal daily activity.
A severe complication necessitates a major surgical, medical,
or endovascular intervention and includes prolonged conva-
lescence, major amputation, permanent disability, or death.
Access site-specific complications relate to the access ar-
tery or vein and its directly surrounding tissue. They include
hematoma, pseudoaneurysm, arteriovenous fistula, throm-
bosis, dissection, neuropathy, and infection. Details
regarding access-specific complications should include ac-
cess site and required treatment (medical, interventional,
and surgical modalities).
Intervention-specific complications include dissection,
pseudoaneurysm, thrombosis, macroembolization, micro-
embolization, arteriovenous fistula, rupture, central neuro-
logic complications (embolic), and device malfunction.
Systemic complications include cardiac complications,
respiratory complications, renal complications, neurologic
complications, deep venous thrombosis, pulmonary embo-
lism, coagulopathy, allergic reaction, and radiation-induced
injury.
Hematoma is defined as collection of blood around the ac-
cess or distant site as noted by physical examination or imaging
study. Pseudoaneurysm is defined as a false aneurysm involving
the access or distant site as diagnosed by DUS imaging, CT, or
conventional angiography. Arteriovenous fistula is defined as a
connection between an artery and vein at the access or distant
site as diagnosed by DUS imaging, CT, or conventional angi-
ography. Thrombosis is defined as an occlusion of the access or
distant vessel as diagnosed by DUS imaging, CT, or conven-
tional angiography. Dissection is defined as an intimal flap in
the access or distant artery as diagnosed by DUS imaging,
CT, or conventional angiography.
Neuropathy is defined as a sensory or motor neurologic
deficit attributed to a nerve in direct juxtaposition to the
access or treated distant vessel. Infection is defined as
clinical evidence of an infectious process in the direct
vicinity of the access site or distal to the treated vascular
site. Macroembolization relates to the embolization of
thrombus or plaque that leads to an occlusion of a named ar-
tery or vein. Microembolization relates to embolization of
thrombus or plaque that leads to occlusion of small,
unnamed vessels. Rupture is defined as a disruption of the
integrity of a vessel with associated bleeding. Device malfunc-
tion is an unanticipated event related to the use of an
implanted vascular device, including maldeployment, migra-
tion, infection, and fracture. Each individual complication is
defined and graded using a specific scheme (Tables IX and X).
Reporting standardsdcomplications.
d All procedurally related adverse events should be
reported and categorized as procedure-related or
device-related
d A minimum of 30 days of complication reporting is
required, subacute and late complication reporting is
suggested
JOURNAL OF VASCULAR SURGERY
Volume 64, Number 1
AUTHOR CONTRIBUTIONS
Conception and design: MS, KC, RC, AD, AF, RG, AH,
GL, DY
Analysis and interpretation: MS, KC, RC, AD, AF, RG,
AH, GL, DY
Data collection: MS, KC, RC, AD, AF, RG, AH, GL, DY.
Writing the article: MS, KC, RC, AD, AF, RG, AH, GL,
DY
Critical revision of the article: MS, KC, RC, AD, AF, RG,
AH, GL, DY
Final approval of the article: MS, KC, RC, AD, AF, RG,
AH, GL, DY
Statistical analysis: Not applicable
Obtained funding: Not applicable
Overall responsibility: MS, KC
REFERENCES
1. Criqui MH, Denenberg JO, Bird CE, Fronek A, Klauber MR,
Langer RD. The correlation between symptoms and non-invasive test
results in patients referred for peripheral arterial disease testing. Vasc
Med 1996;1:65-71.
2. Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG,
Creager MA, Olin JW, et al. Peripheral arterial disease detection,
awareness, and treatment in primary care. JAMA 2001;286:1317-24.
3. Resnick HE, Lindsay RS, McDermott MM, Devereux RB, Jones KL,
Fabsitz RR, et al. Relationship of high and low ankle brachial index to
all-cause and cardiovascular disease mortality: the Strong Heart Study.
Circulation 2004;109:733-9.
4. Aboyans V, Criqui MH, Abraham P, Allison MA, Creager MA,
Diehm C, et al. Measurement and interpretation of the ankle-brachial
index: a scientific statement from the American Heart Association.
Circulation 2012;126:2890-909.
5. Society for Vascular Surgery Lower Extremity Guidelines Writing
Group, Conte MS, Pomposelli FB, Clair DG, Geraghty PJ,
McKinsey JF, et al. Society for Vascular Surgery practice guidelines for
atherosclerotic occlusive disease of the lower extremities: management
of asymptomatic disease and claudication. J Vasc Surg 2015;61(3
Suppl):2S-41S.
6. Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S,
et al. Recommended standards for reports dealing with lower extremity
ischemia: revised version. J Vasc Surg 1997;26:517-38.
7. Hiatt WR, Nawaz D, Regensteiner JG, Hossack KF. The evaluation of
exercise performance in patients with peripheral vascular disease.
J Cardiopulm Rehabil Prev 1988;8. Available at: http://journals.lww.
com/jcrjournal/Fulltext/1988/12200/The_Evaluation_of_Exercise_
Performance_in_Patients.5.aspx. Accessed May 23, 2016.
8. Gardner AW, Skinner JS, Cantwell BW, Smith LK. Progressive vs
single-stage treadmill tests for evaluation of claudication. Med Sci
Sports Exerc 1991;23:402-8.
9. Hiatt WR, Hirsch AT, Regensteiner JG, Brass EP. Clinical trials for clau-
dication. Assessment of exercise performance, functional status, and clinical
end points. Vascular Clinical Trialists. Circulation 1995;92:614-21.
10. McDermott MM, Ades PA, Dyer A, Guralnik JM, Kibbe M, Criqui MH.
Corridor-based functional performance measures correlate better with
physical activity during daily life than treadmill measures in persons with
peripheral arterial disease. J Vasc Surg 2008;48:1231-7.e1.
11. Montgomery PS, Gardner AW. The clinical utility of a six-minute walk
test in peripheral arterial occlusive disease patients. J Am Geriatr Soc
1998;46:706-11.
12. Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB.
Lower-extremity function in persons over the age of 70 years as a
predictor of subsequent disability. N Engl J Med 1995;332:556-61.
Stoner et al e17
13. Liu K, O’Brien E, Guralnik JM, Criqui MH, Martin GJ, Greenland P,
et al. Measuring physical activity in peripheral arterial disease: a com-
parison of two physical activity questionnaires with an accelerometer.
Angiology 2000;51:91-100.
14. Mays RJ, Casserly IP, Kohrt WM, Ho PM, Hiatt WR, Nehler MR,
et al. Assessment of functional status and quality of life in claudication.
J Vasc Surg 2011;53:1410-21.
15. Regensteiner JG, Steiner JF, Panzer RJ, Hiatt WR. Evaluation of
walking impairment by questionnaire in patients with peripheral arterial
disease. J Vasc Med Biol 1990;2:142-52.
16. Dormandy JA, Rutherford RB. Management of peripheral arterial
disease (PAD). TASC Working Group. TransAtlantic Inter-Society
Consensus (TASC). J Vasc Surg 2000;31:S1-296.
17. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA,
Fowkes FG, et al. Inter-Society Consensus for the Management of
Peripheral Arterial Disease (TASC II). J Vasc Surg 2007;45(Suppl S):
S5-67.
18. Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A,
Sidawy AN, et al. The Society for Vascular Surgery Lower Extremity
Threatened Limb Classification System: risk stratification based on
wound, ischemia, and foot infection (WIfI). J Vasc Surg 2014;59:
220-34.e1-2.
19. Zhan LX, Branco BC, Armstrong DG, Mills JL. The Society for
Vascular Surgery lower extremity threatened limb classification system
based on Wound, Ischemia, and foot Infection (WIfI) correlates with
risk of major amputation and time to wound healing. J Vasc Surg
2015;61:939-44.
20. Mills JL. Update and validation of the Society for Vascular Surgery
wound, ischemia, and foot infection threatened limb classification
system. Semin Vasc Surg 2014;27:16-22.
21. Karthikesalingam A, Holt PJ, Moxey P, Jones KG, Thompson MM,
Hinchliffe RJ. A systematic review of scoring systems for diabetic foot
ulcers. Diabet Med 2010;27:544-9.
22. Bakken AM, Palchik E, Hart JP, Rhodes JM, Saad WE, Davies MG.
Impact of diabetes mellitus on outcomes of superficial femoral artery
endoluminal interventions. J Vasc Surg 2007;46:946-58; discussion:
958.
23. Saqib NU, Domenick N, Cho JS, Marone L, Leers S, Makaroun MS,
et al. Predictors and outcomes of restenosis following tibial artery
endovascular interventions for critical limb ischemia. J Vasc Surg
2013;57:692-9.
24. Paraskevas KI, Baker DM, Pompella A, Mikhailidis DP. Does diabetes
mellitus play a role in restenosis and patency rates following lower
extremity peripheral arterial revascularization? A critical overview. Ann
Vasc Surg 2008;22:481-91.
25. Alvarez LR, Balibrea JM, Suriñach JM, Coll R, Pascual MT, Toril J,
et al. Smoking cessation and outcome in stable outpatients with cor-
onary, cerebrovascular, or peripheral artery disease. Eur J Cardiovasc
Prev Rehabil 2013;20:486-95.
26. K/DOQI clinical practice guidelines for chronic kidney disease: eval-
uation, classification, and stratification. Am J Kidney Dis 2002;39(2
Suppl 1):S1-266.
27. MRC/BHF Heart Protection Study of cholesterol lowering with
simvastatin in 20,536 high-risk individuals: a randomised placebo-
controlled trial. Lancet 2002;360:7-22.
28. Bauer SM, Cayne NS, Veith FJ. New developments in the preoperative
evaluation and perioperative management of coronary artery disease in
patients undergoing vascular surgery. J Vasc Surg 2010;51:242-51.
29. Lee TH, Marcantonio ER, Mangione CM, Thomas EJ, Polanczyk CA,
Cook EF, et al. Derivation and prospective validation of a simple index
for prediction of cardiac risk of major noncardiac surgery. Circulation
1999;100:1043-9.
30. New York Heart Association, Harvey RM, Doyle EF, Bigger JT.
Nomenclature and criteria for diagnosis of diseases of the heart and
great vessels. Boston: Little Brown; 1973.
31. Taylor SM, Kalbaugh CA, Blackhurst DW, Langan EM 3rd, Cull DL,
Snyder BA, et al. Postoperative outcomes according to preoperative
medical and functional status after infrainguinal revascularization for

e18 Stoner et al
critical limb ischemia in patients 80 years and older. Am Surg 2005;71:
640-5; discussion: 645-6.
32. Durham CA, Mohr MC, Parker FM, Bogey WM, Powell CS,
Stoner MC. The impact of socioeconomic factors on outcome and
hospital costs associated with femoropopliteal revascularization. J Vasc
Surg 2010;52:600-6; discussion: 606-7.
33. Nguyen LL, Henry AJ. Disparities in vascular surgery: is it biology or
environment? J Vasc Surg 2010;51(4 Suppl):36S-41S.
34. Holman KH, Henke PK, Dimick JB, Birkmeyer JD. Racial disparities
in the use of revascularization before leg amputation in Medicare pa-
tients. J Vasc Surg 2011;54:420-6. 426.e1.
35. Timaran CH, McKinsey JF, Schneider PA, Littooy F. Reporting
standards for carotid interventions from the Society for Vascular Sur-
gery. J Vasc Surg 2011;53:1679-95.
36. Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G. Effects of
an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovas-
cular events in high-risk patients. The Heart Outcomes Prevention
Evaluation Study Investigators. N Engl J Med 2000;342:145-53.
37. Ahimastos AA, Walker PJ, Askew C, Leicht A, Pappas E, Blombery P,
et al. Effect of ramipril on walking times and quality of life among
patients with peripheral artery disease and intermittent claudication: a
randomized controlled trial. JAMA 2013;309:453-60.
38. Faulkner KW, House AK, Castleden WM. The effect of cessation of
smoking on the accumulative survival rates of patients with symptom-
atic peripheral vascular disease. Med J Aust 1983;1:217-9.
39. Jonason T, Bergström R. Cessation of smoking in patients with
intermittent claudication. Effects on the risk of peripheral vascular
complications, myocardial infarction and mortality. Acta Med Scand
1987;221:253-60.
40. Lassila R, Lepäntalo M. Cigarette smoking and the outcome after lower
limb arterial surgery. Acta Chir Scand 1988;154:635-40.
41. Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA,
Halperin JL, et al. ACC/AHA 2005 Practice Guidelines for the
management of patients with peripheral arterial disease (lower
extremity, renal, mesenteric, and abdominal aortic): a collaborative
report from the American Association for Vascular Surgery/Society
for Vascular Surgery, Society for Cardiovascular Angiography and
Interventions, Society for Vascular Medicine and Biology, Society of
Interventional Radiology, and the ACC/AHA Task Force on
Practice Guidelines (Writing Committee to Develop Guidelines for
the Management of Patients With Peripheral Arterial Disease):
endorsed by the American Association of Cardiovascular and
Pulmonary Rehabilitation; National Heart, Lung, and Blood
Institute; Society for Vascular Nursing; TransAtlantic Inter-
Society Consensus; and Vascular Disease Foundation. Circulation
2006;113:e463-654.
42. Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA,
Halperin JL, et al. ACC/AHA 2005 guidelines for the management of
patients with peripheral arterial disease (lower extremity, renal,
mesenteric, and abdominal aortic): executive summary a collaborative
report from the American Association for Vascular Surgery/Society for
Vascular Surgery, Society for Cardiovascular Angiography and In-
terventions, Society for Vascular Medicine and Biology, Society of
Interventional Radiology, and the ACC/AHA Task Force on Practice
Guidelines (Writing Committee to Develop Guidelines for the Man-
agement of Patients With Peripheral Arterial Disease) endorsed by the
American Association of Cardiovascular and Pulmonary Rehabilitation;
National Heart, Lung, and Blood Institute; Society for Vascular
Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease
Foundation. J Am Coll Cardiol 2006;47:1239-312.
43. American College of Cardiology Foundation, American Heart Associ-
ation Task Force, Society for Cardiovascular Angiography and In-
terventions, Society of Interventional Radiology, Society for Vascular
Medicine, Society for Vascular Surgery, et al. 2011 ACCF/AHA
focused update of the guideline for the management of patients with
peripheral artery disease (updating the 2005 guideline). Vasc Med
2011;16:452-76.
44. European Stroke Organisation, Tendera M, Aboyans V, Bartelink ML,
Baumgartner I, Clément D, et al. ESC guidelines on the diagnosis and
treatment of peripheral artery diseases: document covering
JOURNAL OF VASCULAR SURGERY
July 2016
atherosclerotic disease of extracranial carotid and vertebral, mesenteric,
renal, upper and lower extremity arteries: the Task Force on the
Diagnosis and Treatment of Peripheral Artery Diseases of the European
Society of Cardiology (ESC). Eur Heart J 2011;32:2851-906.
45. Intrasocietal Accreditation Commission. Standards and guidelines for
vascular testing accreditation. Available at: http://intersocietal.org/
vascular/standards/IACVascularTestingStandards2013.pdf. Accessed
May 23, 2016.
46. Koelemay MJ, Lijmer JG, Stoker J, Legemate DA, Bossuyt PM.
Magnetic resonance angiography for the evaluation of lower extremity
arterial disease: a meta-analysis. JAMA 2001;285:1338-45.
47. Barnes RW. Noninvasive diagnostic assessment of peripheral vascular
disease. Circulation 1991;83(2 Suppl):I20-7.
48. Bollinger A, Breddin K, Hess H, Heystraten FM, Kollath J, Konttila A,
et al. Semiquantitative assessment of lower limb atherosclerosis from
routine angiographic images. Atherosclerosis 1981;38:339-46.
49. Bradbury AW, Adam DJ, Bell J, Forbes JF, Fowkes FG, Gillespie I,
et al. Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)
trial: a description of the severity and extent of disease using the Bol-
linger angiogram scoring method and the TransAtlantic Inter-Society
Consensus II classification. J Vasc Surg 2010;51(5 Suppl):32S-42S.
50. Davies MG, Saad WE, Peden EK, Mohiuddin IT, Naoum JJ,
Lumsden AB. Impact of runoff on superficial femoral artery endolu-
minal interventions for rest pain and tissue loss. J Vasc Surg 2008;48:
619-25; discussion: 625-6.
51. Agatston AS, Janowitz WR, Hildner FJ, Zusmer NR, Viamonte M Jr,
Detrano R. Quantification of coronary artery calcium using ultrafast
computed tomography. J Am Coll Cardiol 1990;15:827-32.
52. Singh DK, Winocour P, Summerhayes B, Kaniyur S, Viljoen A,
Sivakumar G, et al. Prevalence and progression of peripheral vascular
calcification in type 2 diabetes subjects with preserved kidney function.
Diabetes Res Clin Pract 2012;97:158-65.
53. Johnston KW. Femoral and popliteal arteries: reanalysis of results of
balloon angioplasty. Radiology 1992;183:767-71.
54. Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, et al.
Balloon angioplasty versus implantation of nitinol stents in the super-
ficial femoral artery. N Engl J Med 2006;354:1879-88.
55. Acin F, de Haro J, Bleda S, Varela C, Esparza L. Primary nitinol
stenting in femoropopliteal occlusive disease: a meta-analysis of ran-
domized controlled trials. J Endovasc Ther 2012;19:585-95.
56. Schillinger M, Sabeti S, Dick P, Amighi J, Mlekusch W, Schlager O,
et al. Sustained benefit at 2 years of primary femoropopliteal stenting
compared with balloon angioplasty with optional stenting. Circulation
2007;115:2745-9.
57. Krankenberg H, Schlüter M, Steinkamp HJ, Bürgelin K, Scheinert D,
Schulte KL, et al. Nitinol stent implantation versus percutaneous
transluminal angioplasty in superficial femoral artery lesions up to 10
cm in length: the femoral artery stenting trial (FAST). Circulation
2007;116:285-92.
58. Ferraresi R, Centola M, Biondi-Zoccai G. Advances in below-the-knee
drug-eluting balloons. J Cardiovasc Surg (Torino) 2012;53:205-13.
59. Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Tielbeek A,
et al. Sirolimus-eluting versus bare nitinol stent for obstructive super-
ficial femoral artery disease: the SIROCCO II trial. J Vasc Interv Radiol
2005;16:331-8.
60. Duda SH, Pusich B, Richter G, Landwehr P, Oliva VL, Tielbeek A,
et al. Sirolimus-eluting stents for the treatment of obstructive superficial
femoral artery disease: six-month results. J Invasive Cardiol
2004;16(Suppl A):15A-9A.
61. Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB,
et al. Sustained safety and effectiveness of paclitaxel-eluting stents for
femoropopliteal lesions: 2-year follow-up from the Zilver PTX ran-
domized and single-arm clinical studies. J Am Coll Cardiol 2013;61:
2417-27.
62. Biondi-Zoccai GG, Sangiorgi G, Lotrionte M, Feiring A, Commeau P,
Fusaro M, et al. Infragenicular stent implantation for below-the-knee
atherosclerotic disease: clinical evidence from an international collabo-
rative meta-analysis on 640 patients. J Endovasc Ther 2009;16:251-60.
63. Reynolds S, Galiñanes EL, Dombrovskiy VY, Vogel TR. Longitudinal
outcomes after tibioperoneal angioplasty alone compared to tibial
JOURNAL OF VASCULAR SURGERY
Volume 64, Number 1
stenting and atherectomy for critical limb ischemia. Vasc Endovascular
Surg 2013;47:507-12.
64. Setacci C, Chisci E, de Donato G, Setacci F, Iacoponi F,
Galzerano G. Subintimal angioplasty with the aid of a re-entry device
for TASC C and D lesions of the SFA. Eur J Vasc Endovasc Surg
2009;38:76-87.
65. El-Sayed HF. Retrograde pedal/tibial artery access for treatment of
infragenicular arterial occlusive disease. Methodist Debakey Cardiovasc
J 2013;9:73-8.
66. Marmagkiolis K, Lendel V, Cawich I, Cilingiroglu M. Ocelot catheter
for the recanalization of lower extremity arterial chronic total occlusion.
Cardiovasc Revasc Med 2014;15:46-9.
67. Uher P, Nyman U, Lindh M, Lindblad B, Ivancev K. Long-term re-
sults of stenting for chronic iliac artery occlusion. J Endovasc Ther
2002;9:67-75.
68. Whayne TF. A review of the role of anticoagulation in the treatment of
peripheral arterial disease. Int J Angiol 2012;21:187-94.
69. Sobel M, Verhaeghe R, American College of Chest Physicians,
American College of Chest Physicians. Antithrombotic therapy for
peripheral artery occlusive disease: American College of Chest Physi-
cians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest
2008;133(6 Suppl):815S-43S.
70. Conte MS, Geraghty PJ, Bradbury AW, Hevelone ND, Lipsitz SR,
Moneta GL, et al. Suggested objective performance goals and clinical
trial design for evaluating catheter-based treatment of critical limb
ischemia. J Vasc Surg 2009;50:1462-73.e1-3.
71. Rutherford RB. Reply to “Suggested standards for reports dealing with
lower extremity ischemia.” J Vasc Surg 1988;7:717-8.
72. Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV,
et al. Design and analysis of randomized clinical trials requiring pro-
longed observation of each patient. II. Analysis and examples. Br J
Cancer 1977;35:1-39.
73. Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV,
et al. Design and analysis of randomized clinical trials requiring pro-
longed observation of each patient. I. Introduction and design. Br J
Cancer 1976;34:585-612.
74. Kaplan EL, Meier P. Nonparametric estimation from incomplete ob-
servations. J Am Stat Assoc 1958;53:457.
75. Idu MM, Blankenstein JD, de Gier P, Truyen E, Buth J. Impact of a
color-flow duplex surveillance program on infrainguinal vein graft
patency: a five-year experience. J Vasc Surg 1993;17:42-52; discussion:
52-3.
Stoner et al e19
76. Calligaro KD, Doerr K, McAffee-Bennett S, Krug R, Raviola CA,
Dougherty MJ. Should duplex ultrasonography be performed for sur-
veillance of femoropopliteal and femorotibial arterial prosthetic by-
passes? Ann Vasc Surg 2001;15:520-4.
77. Shrikhande GV, Graham AR, Aparajita R, Gallagher KA, Morrissey NJ,
McKinsey JF, et al. Determining criteria for predicting stenosis with
ultrasound duplex after endovascular intervention in infrainguinal le-
sions. Ann Vasc Surg 2011;25:454-60.
78. Myers SA, Johanning JM, Stergiou N, Lynch TG, Longo GM,
Pipinos II. Claudication distances and the Walking Impairment
Questionnaire best describe the ambulatory limitations in patients with
symptomatic peripheral arterial disease. J Vasc Surg 2008;47:550-5.
79. Conte MS. Understanding objective performance goals for critical limb
ischemia trials. Semin Vasc Surg 2010;23:129-37.
80. Goodney PP, Schanzer A, Demartino RR, Nolan BW, Hevelone ND,
Conte MS, et al. Validation of the Society for Vascular Surgery’s
objective performance goals for critical limb ischemia in everyday
vascular surgery practice. J Vasc Surg 2011;54:100-8.e4.
81. Landry GJ. Functional outcome of critical limb ischemia. J Vasc Surg
2007;45(Suppl A):A141-8.
82. Jaff MR, Cahill KE, Yu AP, Birnbaum HG, Engelhart LM. Clinical
outcomes and medical care costs among medicare beneficiaries receiving
therapy for peripheral arterial disease. Ann Vasc Surg 2010;24:577-87.
83. Sachs T, Pomposelli F, Hamdan A, Wyers M, Schermerhorn M. Trends
in the national outcomes and costs for claudication and limb threatening
ischemia: angioplasty vs bypass graft. J Vasc Surg 2011;54:1021-31.e1.
84. Stoner MC, Defreitas DJ, Manwaring MM, Carter JJ, Parker FM,
Powell CS. Cost per day of patency: understanding the impact of
patency and reintervention in a sustainable model of healthcare. J Vasc
Surg 2008;48:1489-96.
85. Moriarty JP, Murad MH, Shah ND, Prasad C, Montori VM, Erwin PJ,
et al. A systematic review of lower extremity arterial revascularization
economic analyses. J Vasc Surg 2011;54:1131-44.e1.
86. Ouriel K, Fowl RJ, Davies MG, Forbes TL, Gambhir RP, Morales JP,
et al. Reporting standards for adverse events after medical device use in
the peripheral vascular system. J Vasc Surg 2013;58:776-86.
87. Ouriel K, Fowl RJ, Davies MG, Forbes TL, Gambhir RS, Ricci MA,
et al. Disease-specific guidelines for reporting adverse events for pe-
ripheral vascular medical devices. J Vasc Surg 2014;60:212-25.
Submitted Nov 13, 2015; accepted Mar 12, 2016.
 JOURNAL OF VASCULAR SURGERY
e20 Stoner et al July 2016

APPENDIX I. Commonly used abbreviations APPENDIX II

6MWT 6-minute walk test SOCIETY FOR VASCULAR SURGERY (SVS)
ABI Ankle-brachial index LOWER EXTREMITY WOUND, ISCHEMIA, AND
CLI Critical limb ischemia FOOT INFECTION (WIFI) CLASSIFICATION
CTA Computed tomography angiography
SYSTEM FOR THREATENED LIMB
CTO Chronic total occlusion
DM Diabetes mellitus W: Wound/clinical category.
DP Dorsalis pedis artery SVS grades for rest pain and wounds/tissue loss (ulcers
DSA Digital subtraction angiography
DUS Duplex ultrasound and gangrene): 0 (ischemic rest pain, ischemia grade 3; no
ESRD End-stage renal disease ulcer) 1 (mild) 2 (moderate) 3 (severe)
GFR Glomerular filtration rate I: Ischemia.
IAV Intersocietal Accreditation Commission Hemodynamics/perfusion: Measure toe pressure (TP) or
LE-EV Lower extremity endovascular
transcutaneous pressure of oxygen (TcPO2) if ankle-brachial
MACE Major adverse cardiovascular events
MALE Major adverse limb event index (ABI) incompressible (>1.3).
MRA Magnetic resonance angiography SVS grades: 0 (none), 1 (mild), 2 (moderate), and 3
OPG Objective performance goals (severe).
PAD Peripheral arterial disease fI: foot Infection:
PSV Peak systolic velocity
PT Posterior tibial artery SVS grades: 0 (none), 1 (mild), 2 (moderate), and 3
PTA Percutaneous transluminal angioplasty (severe: limb and/or life-threatening). SVS adaptation of
QOL Quality of life Infectious Diseases Society of America (IDSA) and Inter-
RCT Randomized controlled trial national Working Group on the Diabetic Foot (IWGDF)
SFA Superficial femoral artery
perfusion, extent/size, depth/tissue loss, infection, sensa-
SVS Society for Vascular Surgery
TASC TransAtlantic Inter-Society Consensus tion (PEDIS) classifications of diabetic foot infection.
TBI Toe-brachial index
TLR Target lesion revascularization
WIfI Wound, Ischemia, and foot Infection
WIQ Walking impairment questionnaire
JOURNAL OF VASCULAR SURGERY
Volume 64, Number 1 Stoner et al e21

Grade Ulcer Gangrene IDSA/PEDIS

Clinical manifestation of infection SVS infection severity
0 No ulcer No gangrene
Clinical description: ischemic rest pain (requires typical No symptoms or signs of infection 0 Uninfected
symptoms þ ischemia grade 3); no wound. Infection present, as defined by the 1 Mild
presence of at least 2 of the
1 Small, shallow ulcer(s) on distal No gangrene following:
leg or foot; no exposed bone, d Local swelling or induration
unless limited to distal phalanx d Erythema >0.5 to #2 cm around the

Clinical description: minor tissue loss. Salvageable with simple ulcer

d Local tenderness or pain
digital amputation (1 or 2 digits) or skin coverage.
d Local warmth
2 Deeper ulcer with exposed bone, Gangrenous changes d Purulent discharge (thick, opaque to
joint or tendon; generally not limited to digits white, or sanguineous secretion)
involving the heel; shallow Local infection (as described above) 2 Moderate
heel ulcer, without calcaneal with erythema >2 cm, or involving
involvement structures deeper than skin and
Clinical description: major tissue loss salvageable with multiple subcutaneous tissues (eg, abscess,
($3) digital amputations or standard TMA 6 skin coverage. osteomyelitis, septic arthritis,
fasciitis), and
3 Extensive, deep ulcer involving Extensive gangrene No SIRS signs (as described below)
forefoot and/or midfoot; involving forefoot Local infection (as described above) 3 Severe
deep, full thickness heel and/or midfoot; full with the signs of SIRS, as manifested
ulcer 6 calcaneal involvement thickness heel by $2 of the following:
necrosis 6 calcaneal d Temperature >38 or <36 C
involvement d Heart rate >90 beats/min

Clinical description: extensive tissue loss salvageable only with a d Respiratory rate >20 breaths/min or

complex foot reconstruction or nontraditional TMA (Chopart PaCO2 <32 mm Hg

or Lisfranc); flap coverage or complex wound management d White blood cell count >2000

needed for large soft tissue defect or <4000 mm3 or 10% immature
(band) forms
TMA, Transmetatarsal amputation.
PaCO2, partial pressure of arterial carbon dioxide; SIRS systemic inflamma-
tory response syndrome.

Ankle systolic TP, TcPO2,

Grade ABI pressure, mm Hg mm Hg

0 $0.80 >100 $60

1 0.6-0.79 70-100 40-59
2 0.4-0.59 50-70 30-39
3 #0.39 <50 <30

Patients with diabetes should have TP measurements. If arterial calcification

precludes reliable ABI or TP measurements, ischemia should be docu-
mented by TcPO2, skin perfusion pressure, or pulse volume recording
(PVR). If TP and ABI measurements result in different grades, TP will be
the primary determinant of ischemia grade.
Flat or minimally pulsatile forefoot PVR ¼ grade 3.