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## Complete Summary

#### GUIDELINE TITLE

Recurrent symptoms following lower extremity angioplasty.

#### BIBLIOGRAPHIC SOURCE(S)

Grollman JH, Bettmann MA, Boxt LM, Casciani T, Gomes AS, Holtzman SR,
Polak JF, Sacks D, Stanford W, Jaff M, Moneta GL, Expert Panel on
Cardiovascular Imaging. Recurrent symptoms following lower extremity
angioplasty. \[online publication\]. Reston (VA): American College of
Radiology (ACR); 2005. 6 p. \[34 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: American College of Radiology
(ACR), Expert Panel on Cardiovascular Imaging. Recurrent symptoms
following lower extremity angioplasty: claudication and threatened limb.
Reston (VA): American College of Radiology (ACR); 2002. 5 p. (ACR
appropriateness criteria).

The appropriateness criteria are reviewed annually and updated by the
panels as needed, depending on introduction of new and highly
significant scientific evidence.

### \*\* REGULATORY ALERT \*\*

#### FDA WARNING/REGULATORY ALERT

**Note from the National Guideline Clearinghouse**: This guideline
references a drug(s) for which important revised regulatory and/or
warning information has been released.

-   [May 23, 2007, Gadolinium-based Contrast
    Agents](http://www.fda.gov/medwatch/safety/2007/safety07.htm#Gadolinium):
    The addition of a boxed warning and new warnings about the risk of
    nephrogenic systemic fibrosis (NSF) to the full prescribing
    information for all gadolinium-based contrast agents (GBCAs).

### COMPLETE SUMMARY CONTENT

 \*\* REGULATORY ALERT \*\*\
 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Recurrent symptoms following lower extremity angioplasty: claudication
and threatened limb

#### GUIDELINE CATEGORY

Diagnosis

#### CLINICAL SPECIALTY

Radiology\
Surgery

#### INTENDED USERS

Health Plans\
Hospitals\
Managed Care Organizations\
Physicians\
Utilization Management

#### GUIDELINE OBJECTIVE(S)

To evaluate the appropriateness of initial radiologic examinations for
recurrent symptoms following lower extremity angioplasty: claudication
and threatened limb

#### TARGET POPULATION

Patients with recurrent symptoms following lower extremity angioplasty:
claudication and threatened limb

#### INTERVENTIONS AND PRACTICES CONSIDERED

1.  Ankle-brachial indices (ABI)

2.  Invasive (INV), peripheral arteriography

3.  Other physiologic noninvasive tests

4.  Ultrasound (US)

    -   Duplex Doppler with color

    -   Lower extremity, intravascular (in conjunction with angiography)

    -   Lower extremity, venous

5.  Magnetic resonance angiography (MRA)

6.  Computed tomography angiography (CTA), multi-detector

#### MAJOR OUTCOMES CONSIDERED

Utility of radiologic examinations in differential diagnosis

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

The guideline developer performed literature searches of peer-reviewed
medical journals, and the major applicable articles were identified and
collected.

#### NUMBER OF SOURCE DOCUMENTS

The total number of source documents identified as the result of the
literature search is not known.

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Not Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not stated

#### METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

One or two topic leaders within a panel assume the responsibility of
developing an evidence table for each clinical condition, based on
analysis of the current literature. These tables serve as a basis for
developing a narrative specific to each clinical condition.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus (Delphi)

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

Since data available from existing scientific studies are usually
insufficient for meta-analysis, broad-based consensus techniques are
needed to reach agreement in the formulation of the appropriateness
criteria. The American College of Radiology (ACR) Appropriateness
Criteria panels use a modified Delphi technique to arrive at consensus.
Serial surveys are conducted by distributing questionnaires to
consolidate expert opinions within each panel. These questionnaires are
distributed to the participants along with the evidence table and
narrative as developed by the topic leader(s). Questionnaires are
completed by the participants in their own professional setting without
influence of the other members. Voting is conducted using a scoring
system from 1-9, indicating the least to the most appropriate imaging
examination or therapeutic procedure. The survey results are collected,
tabulated in anonymous fashion, and redistributed after each round. A
maximum of three rounds is conducted and opinions are unified to the
highest degree possible. Eighty percent agreement is considered a
consensus. This modified Delphi technique enables individual, unbiased
expression, is economical, easy to understand, and relatively simple to
conduct.

If consensus cannot be reached by the Delphi technique, the panel is
convened and group consensus techniques are utilized. The strengths and
weaknesses of each test or procedure are discussed and consensus reached
whenever possible. If \"No consensus\" appears in the rating column,
reasons for this decision are added to the comment sections.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Criteria developed by the Expert Panels are reviewed by the American
College of Radiology (ACR) Committee on Appropriateness Criteria.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

**ACR Appropriateness Criteria®**

**Clinical Condition: Recurrent Symptoms Following Lower Extremity
Angioplasty**

**Variant 1: Claudication**

  ---------------------------------------------------------------------------
  **Radiologic Exam    **Appropriateness   **Comments**
  Procedure**          Rating**            
  -------------------- ------------------- ----------------------------------
  Ankle-brachial       9                   Usual first test.
  indices (ABI)                            

  INV, peripheral      8                   Use when it is thought there is
  arteriography                            likely a lesion amenable to
                                           percutaneous intervention (e.g.,
                                           restenosis).

  Other physiologic    8                   Used to clarify ABI.
  noninvasive tests                        

  US, Duplex Doppler   8                   Useful screen to define location
  with color                               and extent of lesions.

  MRA                  8                   May substitute for other
                                           non-invasive studies.

  CTA, multi-detector  6                   Although extensive data are not
                                           yet available, experience suggests
                                           that this may be or become
                                           equivalent to MRA.

  US, lower extremity, 2                   May be useful in conjunction with
  intravascular                            angiography to determine the
                                           significance of a lesion, but is
                                           not indicated alone.

  US, lower extremity, 2                    
  venous                                   

  ***Appropriateness                       
  Criteria Scale*\                         
  1 2 3 4 5 6 7 8 9\                       
  1 = Least                                
  appropriate 9 = Most                     
  appropriate**                            
  ---------------------------------------------------------------------------

Note: Abbreviations used in the tables are listed at the end of the
\"Major Recommendations\" field.

**Variant 2: Threatened limb**

  ---------------------------------------------------------------------------
  **Radiologic Exam    **Appropriateness   **Comments**
  Procedure**          Rating**            
  -------------------- ------------------- ----------------------------------
  INV, peripheral      9                   Allows diagnosis and treatment.
  arteriography                            

  Ankle-brachial       8                   Always useful as a baseline.
  indices (ABI)                            

  MRA                  6                   An adjunct usually useful only if
                                           angiography is not to be done
                                           (i.e., surgical treatment is
                                           necessary).

  CTA, multi-detector  6                   Although extensive data are not
                                           yet available, experience suggests
                                           that this may be or become
                                           equivalent to MRA.

  Other physiologic    4                    
  noninvasive tests                        

  US, Duplex Doppler   4                    
  with color                               

  US, lower extremity, 2                   May be useful in conjunction with
  intravascular                            angiography to determine the
                                           significance of a lesion, but is
                                           not indicated alone.

  US, lower extremity, 2                    
  venous                                   

  ***Appropriateness                       
  Criteria Scale*\                         
  1 2 3 4 5 6 7 8 9\                       
  1 = Least                                
  appropriate 9 = Most                     
  appropriate**                            
  ---------------------------------------------------------------------------

Note: Abbreviations used in the tables are listed at the end of the
\"Major Recommendations\" field.

Endovascular interventions for lower extremity arterial obstructive
disease, both for lifestyle-limiting claudication and for critical
ischemia with threatened limb, have become accepted treatment
modalities. The availability of these techniques has reduced the numbers
of surgical reconstructive procedures. But in spite of their very high
initial technical success rates, restenosis after angioplasty with
recurrent symptoms is frequent, especially with infrainguinal lesions.
The use of nitinol stents appears to decrease restenosis in the
peripheral arteries. The status of drug-eluting stents in decreasing
restenosis is not clear and is still under investigation. The literature
has not clarified the importance of the follow-up of patients who have
had such interventions. Recurrent symptoms usually precede the onset of
limb- or life-threatening events, in contrast to what may occur with
coronary artery disease. Close surveillance of these patients,
therefore, is often not routine; follow-up has often been driven by
recurrence of symptoms. The imaging approach to patients with
claudication or with acute limb ischemia after angioplasty is the same.

Clinical examination with evaluation of the peripheral pulses and
determination of the ABI is the obvious and accepted first step in
evaluating these patients. However, restenosis is not always clinically
discernible, since the natural progression of the patient\'s disease
process is often characterized by development of new lesions at
different sites. Thus definitive diagnosis is important for therapeutic
planning, whether for repeat endovascular intervention, for
reconstructive vascular surgery, or for medical management.

**Noninvasive Hemodynamic Studies**

The ABI is the accepted, most commonly performed noninvasive technique
for evaluating peripheral vascular disease. Deterioration from previous
levels by 0.15 or more has been accepted as indicative of restenosis.
However, this measurement is not specific as to site and is of little
value in patients with noncompressible arteries, as often occurs in
diabetics and patients with renal insufficiency. Similarly, segmental
pulse volume recordings, although more site-specific, are not accurate
nor do they provide specific enough information for treatment
decision-making in patients with symptomatic recurrent peripheral
vascular disease.

**Ultrasound Imaging**

Duplex Doppler color flow vascular US imaging has achieved widespread
usage and acceptance in the evaluation of patients with peripheral
vascular obstructive disease. It has the ability to localize the site(s)
of involvement and assess the hemodynamic significance of the lesions. A
major limitation, however, is that it is operator-dependent, requiring a
meticulous and compulsive ultrasonographer (either technologist or
physician) for accurate results. In good hands, there is a high,
although not perfect, correlation with conventional catheter
angiography. US is especially appropriate for infrainguinal arterial
disease but can also be helpful in evaluating aortoiliac disease in
suitable patients (obesity and bowel gas can significantly degrade the
quality of the study). Some authorities recommend duplex Doppler
scanning as the best screening imaging tool in the initial evaluation of
symptomatic peripheral vascular disease. It is also recommended by most
of them for routine surveillance, evaluation, or recurrent symptoms
following surgical or percutaneous intervention.

**Catheter Angiography**

Although MRA, CTA, and US have now generally supplanted catheter
angiography (CA), CA is still the \"gold standard\" for peripheral
arterial imaging. Its ability to localize and quantify obstructive
lesions accurately is exceeded only by intravascular US imaging. It also
may allow physiological evaluation by determining pressure gradients.
However, it is an invasive technique that has a small but definite risk
in every patient and a variable higher risk in patients with severe
widespread vascular disease, diabetes, renal insufficiency, or other
contraindications to the use of contrast media. CO~2~-negative contrast
angiography may be of value in certain patients at high risk for
receiving iodinated contrast medium. Gadolinium contrast agents are
thought to be less nephrotoxic and may be used for CA, but their use is
limited by the relatively large volumes needed to complete the study and
the high cost of the various available agents. Only qualified
angiographers should perform CA.

**Computed Tomography Angiography**

Multidetector CTA (MDCTA) is rapidly evolving in its ability to image
peripheral vascular obstructive disease. It has the advantage of
allowing very rapid evaluation of a large portion of the arterial tree
(for example, from the level of the diaphragm to the foot vessels),
noninvasively and in a matter of minutes. Although it is particularly
useful for evaluating a defined vascular segment, it is still somewhat
limited in the ability to grade the severity of stenotic lesions
accurately. Its resolution, however, is improving dramatically with a
significant reduction in examination time. It can be used to study
segmented arterial components and is particularly good for evaluating
aortoiliac disease, especially with its ability to view the image in
coronal and sagittal views in addition to the conventional axial
projection. Large calcified plaques currently remain a significant
problem in quantifying the degree of stenosis. Although it is relatively
noninvasive as compared with CA, it has a similar disadvantage in
requiring iodinated contrast medium.

**Magnetic Resonance Angiography**

MRA has become an accepted method of imaging arterial obstructive
disease, particularly with gadolinium-enhanced MRA. This modality has
the benefit of being totally noninvasive and without any significant
risk. It can image the entire vascular system, including
difficult-to-visualize tibial and pedal arteries. With specialized
techniques it also may be able to assess hemodynamic significance. MRA
is challenging conventional CA, although there is a tendency to
overestimate stenoses. On the other hand, when there are total
occlusions, MRA more reliably defines reconstituted vessels. Metallic
stents, especially stainless steel, cause signal intensity dropout,
which can be indistinguishable from an occlusion. This is less of a
problem with nitinol stents. MRA is now widely available, and its use,
especially in conjunction with duplex vascular US, allows reliable
determination of appropriate intervention when symptoms occur after
angioplasty. It takes longer to acquire images with MRA than with CTA,
and reconstruction and interpretation may be more complex. It is,
however, similarly noninvasive and has the advantages of not requiring
iodinated contrast agents and not using ionizing radiation.

**Radionuclide Imaging**

Isotopic arterial blood flow measurement has been described as a
technique for evaluating the hemodynamic significance of peripheral
vascular disease and for evaluating patients who have had endovascular
interventions. However, this method is not widely available and does not
have anatomic imaging capabilities.

**Summary**

A complete vascular physical examination, including measurement of the
ABI, is obviously the first step in assessing a patient with recurrent
symptoms after an initially successful endovascular intervention. With
this knowledge the clinician/angiographer can decide on appropriate
imaging studies. Duplex Doppler US is generally the first imaging study,
and it is followed by one of the angiographic contrast modalities. If it
is clear that reintervention (whether endovascular or surgical) is
necessary, and the site of the problem is certain, then proceeding
directly to catheter angiography (CA) may be appropriate. Preliminary
Duplex Doppler US imaging is usually an appropriate starting point as it
may more clearly define the problem, confirming a recurrence at the
previously treated site or suggesting progression elsewhere. Duplex
Doppler scanning is also currently considerably cheaper than CA, MRA,
and CTA.

MRA and MDCTA are increasingly promising and available imaging
techniques but have several limitations: 1) lack of available room time
because of high demand for other examinations; 2) poor ability to
distinguish mild and moderate degrees of restenosis; 3) limitation of
field of view, a problem only with older CT and MR equipment, that may
prevent visualization of the entire vascular tree from the abdominal
aorta to the pedal arches; 4) artifacts caused by calcification and
metallic devices such as stents and surgical clips; and 5) poor ability
to evaluate the condition of the more \"normal\" adjacent vessel
segments. On the other hand, when equipment and expertise are available,
with improved accuracy, comprehensiveness, and reproducibility, it may
be appropriate to proceed from the clinical examination directly to MRA
or MDCTA. MRA has been shown to be able to image potentially by-passable
infrapopliteal and pedal vessels that may not be visualized by CA. MRA
and MDCTA may more easily visualize lesions obscured by overlying bone
cortex in the calf. In patients who are at risk for renal function
deterioration and significant reactions to iodinated contrast medium,
MRA may be the procedure of choice and even warrant sending a patient to
another institution with MRA capability.

**Anticipated Exceptions**

Patients presenting with critical recurrent ischemia with motor and
sensory deficit occurring shortly after a percutaneous intervention
(\<7-10 days), and in whom the anatomy is well understood, may proceed
directly to surgical revascularization by bypass or thrombectomy.

**Abbreviations**

-   ABI, ankle-brachial indices

-   CTA, computed tomography angiography

-   INV, invasive

-   MRA, magnetic resonance angiography

-   US, ultrasound

#### CLINICAL ALGORITHM(S)

Algorithms were not developed from criteria guidelines.

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The recommendations are based on analysis of the current literature and
expert panel consensus.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Selection of appropriate radiologic imaging procedures for evaluation of
patients with recurrent symptoms following lower extremity angioplasty:
claudication and threatened limb sagittal views

#### POTENTIAL HARMS

Catheter angiography (CA) is an invasive technique that has a small but
definite risk in any patient.

**Subgroups Most Likely to be Harmed**

Catheter angiography (CA) has a variable higher risk in patients with
severe widespread vascular disease, diabetes, renal insufficiency, and
other contraindications to the use of contrast media.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

An American College of Radiology (ACR) Committee on Appropriateness
Criteria and its expert panels have developed criteria for determining
appropriate imaging examinations for diagnosis and treatment of
specified medical condition(s). These criteria are intended to guide
radiologists, radiation oncologists, and referring physicians in making
decisions regarding radiologic imaging and treatment. Generally, the
complexity and severity of a patient\'s clinical condition should
dictate the selection of appropriate imaging procedures or treatments.
Only those exams generally used for evaluation of the patient\'s
condition are ranked. Other imaging studies necessary to evaluate other
co-existent diseases or other medical consequences of this condition are
not considered in this document. The availability of equipment or
personnel may influence the selection of appropriate imaging procedures
or treatments. Imaging techniques classified as investigational by the
U.S. Food and Drug Administration (FDA) have not been considered in
developing these criteria; however, study of new equipment and
applications should be encouraged. The ultimate decision regarding the
appropriateness of any specific radiologic examination or treatment must
be made by the referring physician and radiologist in light of all the
circumstances presented in an individual examination.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

#### IMPLEMENTATION TOOLS

Personal Digital Assistant (PDA) Downloads

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Living with Illness

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Grollman JH, Bettmann MA, Boxt LM, Casciani T, Gomes AS, Holtzman SR,
Polak JF, Sacks D, Stanford W, Jaff M, Moneta GL, Expert Panel on
Cardiovascular Imaging. Recurrent symptoms following lower extremity
angioplasty. \[online publication\]. Reston (VA): American College of
Radiology (ACR); 2005. 6 p. \[34 references\]

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

1998 (revised 2005)

#### GUIDELINE DEVELOPER(S)

American College of Radiology - Medical Specialty Society

#### SOURCE(S) OF FUNDING

The American College of Radiology (ACR) provided the funding and the
resources for these ACR Appropriateness Criteria®.

#### GUIDELINE COMMITTEE

Committee on Appropriateness Criteria, Expert Panel on Cardiovascular
Imaging

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Panel Members*: Julius H. Grollman, MD (*Principal Author*); Michael A.
Bettmann, MD (*Panel Chair*); Lawrence M. Boxt, MD; Thomas Casciani, MD;
Antoinette S. Gomes, MD; Stephen R. Holtzman, MD; Joseph F. Polak, MD,
PH; David Sacks, MD; William Stanford, MD; Michael Jaff, MD; Gregory L.
Moneta, MD

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: American College of Radiology
(ACR), Expert Panel on Cardiovascular Imaging. Recurrent symptoms
following lower extremity angioplasty: claudication and threatened limb.
Reston (VA): American College of Radiology (ACR); 2002. 5 p. (ACR
appropriateness criteria).

The appropriateness criteria are reviewed annually and updated by the
panels as needed, depending on introduction of new and highly
significant scientific evidence.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the
[American College of Radiology (ACR) Web
site](http://www.acr.org/SecondaryMainMenuCategories/quality_safety/app_criteria/pdf/Vascular/RecurrentSymptomsFollowingLowerExtremityAngioplastyDoc14.aspx).

ACR Appropriateness Criteria® *Anytime*, *Anywhere*™ (PDA application).
Available from the [ACR Web
site](http://www.acr.org/SecondaryMainMenuCategories/ACRStore/FeaturedCategories/QualityandSafety/ac_pda.aspx).

Print copies: Available from the American College of Radiology, 1891
Preston White Drive, Reston, VA 20191. Telephone: (703) 648-8900.

#### AVAILABILITY OF COMPANION DOCUMENTS

The following is available:

-   ACR Appropriateness Criteria®. Background and development. Reston
    (VA): American College of Radiology; 2 p. Electronic copies:
    Available in Portable Document Format (PDF) from the [American
    College of Radiology (ACR) Web
    site](http://www.acr.org/SecondaryMainMenuCategories/quality_safety/app_criteria/pdf/background_dev.aspx).

#### PATIENT RESOURCES

None available

#### NGC STATUS

This summary was completed by ECRI on February 20, 2001. The information
was verified by the guideline developer on March 14, 2001. This summary
was updated by ECRI on March 31, 2003. The updated information was
verified by the guideline developer on April 21, 2003. This summary was
updated by ECRI on March 20, 2006. This summary was updated by ECRI
Institute on May 17, 2007 following the U.S. Food and Drug
Administration (FDA) advisory on Gadolinium-based contrast agents. This
summary was updated by ECRI Institute on June 20, 2007 following the
U.S. Food and Drug Administration (FDA) advisory on gadolinium-based
contrast agents.

#### COPYRIGHT STATEMENT

Instructions for downloading, use, and reproduction of the American
College of Radiology (ACR) Appropriateness Criteria® may be found on the
[ACR Web
site.](http://www.acr.org/SecondaryMainMenuCategories/quality_safety/app_criteria/ACRAppropriatenessCriteriaTermsandConditionsDoc1.aspx)

### DISCLAIMER

#### NGC DISCLAIMER

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/10/2008