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APPROPRIATE USE CRITERIA

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ACC/AHA/SCAI/SIR/SVM2018 Appropriate Use Criteria forPeripheral Artery InterventionA Report of the American College of Cardiology Appropriate Use Criteria Task Force,American Heart Association, Society for Cardiovascular Angiography and Interventions,Society of Interventional Radiology, and Society for Vascular Medicine

Peripheral Steven R. Bailey, MD, FACC, MSCAI, FAHA, Ch
ArteryInterventionWriting Group
air*

Joshua A. Beckman, MD, FACC, MSVM*Timothy D. Dao, MD, FACC*

0

This document was approved by the American College of Cardiology Clini

The American College of Cardiology requests that this document be cite

White CJ. ACC/AHA/SCAI/SIR/SVM 2018 Appropriate Use Criteria for periph

Appropriate Use Criteria Task Force, American Heart Association, Society fo

Radiology, and Society for Vascular Medicine. J Am Coll Cardiol 2019;73:214

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Sanjay Misra, MD, FSIR, FAHAyPiotr S. Sobieszczyk, MD, RVT, FSVMzChristopher J. White, MD, FACC, MSCAIx

PeripheralArteryInterventionRating Panel

L. Samuel Wann, MD, MACC, Moderator*Steven R. Bailey, MD, FACC, MSCAI, FAHA,Writing Group Chair*Timothy Dao, MD, FACC, Writing Group Representative*

Herbert D. Aronow, MD, MPH, FACC, FSCAI, FSVMzReza Fazel, MD, FACC, FSCAI, FAHA*Heather L. Gornik, MD, FACC, FAHA, FSVM*Bruce H. Gray, DO, MSVM, FSCAIzJonathan L. Halperin, MD, FACC, FAHA, MSVM*Alan T. Hirsch, MD, FACC*Michael R. Jaff, DO, FACC, FSCAI, FAHA, MSVMxVenkataramu Krishnamurthy, MBBSy

Sahil A. Parikh, MD, FACC, FSCAI*Amy B. Reed, MD, FACS, RPVIkFadi Shamoun, MD, FACC, FSVM*Rita E. Shugart, RN, RVT, FSVU{E. Kent Yucel, MD, FACR, FAHA#

*American College of Cardiology Representative. ySociety of

Interventional Radiology Representative. zSociety for Vascular Medicine

Representative. xSociety for Cardiovascular Angiography and

Interventions Representative. kSociety for Vascular Surgery

Representative. {Society for Vascular Ultrasound Representative.

#American College of Radiology Representative.

https://doi.org/10.1016/j.jacc.2018.10.002

cal Policy Approval Committee in September 2018.

d as follows: Bailey SR, Beckman JA, Dao TD, Misra S, Sobieszczyk PS,

eral artery intervention: a report of the American College of Cardiology

r Cardiovascular Angiography and Interventions, Society of Interventional

–37.

nterventions.

erican College of Cardiology (www.acc.org). For copies of this document,

mail ([email protected]).

/or distribution of this document are not permitted without the express

[email protected].

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J A C C V O L . 7 3 , N O . 2 , 2 0 1 9 Bailey et al.J A N U A R Y 2 2 , 2 0 1 9 : 2 1 4 – 3 7 2018 AUC for Peripheral Artery Intervention

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AppropriateUse CriteriaTask Force

Co-Chair**John U. Doherty, MD, FACC, Co-Chair**

Gregory J. Dehmer, MD, MACC, MSCAI, FAHA,

Steven R. Bailey, MD, FACC, MSCAI, FAHAyyNicole M. Bhave, MD, FACC**Alan S. Brown, MD, FACC, FSCAI, FAHAyyStacie L. Daugherty, MD, FACC**Larry S. Dean, MD, FACC, MSCAI, FAHA**Milind Y. Desai, MD, FACC, FAHA**Claire S. Duvernoy, MD, FACCyyLinda D. Gillam, MD, MPH, FACC, FAHA**Robert C. Hendel, MD, FACC, FAHAyyChristopher M. Kramer, MD, FACC, FAHAzz

Bruce D. Lindsay, MD, FACCyyWarren J. Manning, MD, FACCyyPraveen Mehrotra, MD, FACC**Manesh R. Patel, MD, FACC, FSCAI, FAHAxxRitu Sachdeva, MBBS, FACC**L. Samuel Wann, MD, MACCyyDavid E. Winchester, MD, FACC**

**Current Task Force member; member during the writing effort.

yyFormer Task Force member; member during the writing effort.

zzFormer Task Force Co-Chair during the writing effort.

xxFormer Task Force Chair during the writing effort.

TABLE OF CONTENTS

ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216

PREFACE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216

1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217

2. METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217

3. GENERAL ASSUMPTIONS . . . . . . . . . . . . . . . . . . . . . . 219

Section 1 Assumptions: RAS . . . . . . . . . . . . . . . . . . . . . 220

Section 2 Assumptions: Lower Extremity Disease . . . . 220

Section 3 Assumptions: Critical Limb Ischemia . . . . . . 220

Section 4 Assumptions: Asymptomatic Artery Disease . 221

Section 5 Assumptions: Options for EndovascularTreatment When Deemed Appropriate orMay Be Appropriate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221

Section 6 Assumptions: Secondary Treatment Optionsfor Lower Extremity Disease . . . . . . . . . . . . . . . . . . . . . 221

4. DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221

Table 1: Classification Comparison forChronic Limb Ischemia . . . . . . . . . . . . . . . . . . . . . . . . . 223

5. ABBREVIATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223

6. PERIPHERAL ARTERY INTERVENTION

APPROPRIATE USE CRITERIA (BY INDICATION) . 223

Section 1 Renal Artery Stenosis . . . . . . . . . . . . . . . . . . . 223

Table 1.1 Chronic Kidney Disease . . . . . . . . . . . . . . . 223

Table 1.2 Hypertension . . . . . . . . . . . . . . . . . . . . . . . 223

Table 1.3 Cardiac Destabilization . . . . . . . . . . . . . . . . 224

Table 1.4 Incidentally Discovered RAS . . . . . . . . . . . 224

Table 1.5 Borderline (50% to 69%) RAS WithoutHemodynamic Confirmation of Severity . . . . . . . . . 224Section 1 Results and Discussion . . . . . . . . . . . . . . . . . 224

Section 2 Lower Extremity Disease . . . . . . . . . . . . . . . . 225

Table 2.1 Intermittent Claudication;No Prior Guideline-Directed Medical Therapy . . . . . 225

Table 2.2 Intermittent Claudication DespiteGuideline-Directed Medical Therapy—Stenotic Lesions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225

Table 2.3 Intermittent Claudication DespiteGuideline-Directed Medical Therapy—Chronic Total Occlusion . . . . . . . . . . . . . . . . . . . . . . . 225Section 2 Results and Discussion . . . . . . . . . . . . . . . . . 225

Section 3 Critical Limb Ischemia . . . . . . . . . . . . . . . . . . 226

Table 3.1 Critical Limb Ischemia . . . . . . . . . . . . . . . . 226Section 3 Results and Discussion . . . . . . . . . . . . . . . . . 226

Section 4 Asymptomatic Artery Disease . . . . . . . . . . . . 226

Table 4.1 Access in Support of OtherLife-Saving Interventions . . . . . . . . . . . . . . . . . . . . . 226Section 4 Results and Discussion . . . . . . . . . . . . . . . . . 226

Section 5 Options for Endovascular Treatment WhenDeemed Appropriate or May Be Appropriate . . . . . . . . 226

Table 5.1 Isolated Common Iliac Artery . . . . . . . . . . 226

Table 5.2 Isolated External Iliac Artery . . . . . . . . . . . 226

Table 5.3 Diffuse Common Iliac Artery andExternal Iliac Artery . . . . . . . . . . . . . . . . . . . . . . . . . . 226

Table 5.4 SFA and Popliteal Artery . . . . . . . . . . . . . . 227

Table 5.5 Below the Knee . . . . . . . . . . . . . . . . . . . . . 227Section 5 Results and Discussion . . . . . . . . . . . . . . . . . 227

Section 6 Secondary Treatment Options forLower-Extremity Disease . . . . . . . . . . . . . . . . . . . . . . . . 227

Table 6.1 In-Stent Restenosis . . . . . . . . . . . . . . . . . . 227

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2018 AUC for Peripheral Artery Intervention J A N U A R Y 2 2 , 2 0 1 9 : 2 1 4 – 3 7

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Table 6.2 Venous Bypass Graft Failure . . . . . . . . . . . 227

Table 6.3 Prosthetic Bypass Graft Failure . . . . . . . . . 228Section 6 Results and Discussion . . . . . . . . . . . . . . . . . 228

7. SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228

7.1 Trends and Themes in Scoring . . . . . . . . . . . . . . . . 228

7.2 Use of AUC to Improve Care . . . . . . . . . . . . . . . . . . 230

8. CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 230

ACC PRESIDENT AND STAFF . . . . . . . . . . . . . . . . . . . . . 230

REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231

KEY WORDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231

APPENDIX A

Relationships With Industry (RWI) andOther Entities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232

ABSTRACT

The American College of Cardiology (ACC) collaboratedwith the American Heart Association, Society for Cardio-vascular Angiography and Interventions, Society ofInterventional Radiology, and Society for Vascular Medi-cine, along with several ACC Councils, to establish andevaluate Appropriate Use Criteria (AUC) for peripheralartery intervention (PAI). Although PAI has been thesubject of prior single-society papers, this is the firstmultisocietal effort on the topic.

To initiate the AUC process, patient scenarios that arecommon in clinical practice were drafted, along with as-sumptions and definitions for those scenarios. The sce-narios were created using published guidelines, trial data,and expert opinions from within the field of peripheralartery disease. The writing group developed 45 clinicalscenarios with up to 6 intervention options per scenarioand categorized them into 6 general sections. A separate,independent rating panel evaluated each indication usinga scoring scale from 1 to 9, thereby designating eachindication as “Appropriate” (score of 7 to 9), “May BeAppropriate” (score of 4 to 6), or “Rarely Appropriate”(score of 1 to 3).

Throughout the scenarios, emphasis was placed onadhering to and exhausting medical therapy to achievemaximal benefit in those situations in which symptommanagement was desired or incidental disease wasdiscovered. However, situations arise in which medicaltherapy is insufficient, and identifying a suitable revas-cularization strategy is necessary. After considering fac-tors such as symptom burden, anatomic distribution, and

ischemic burden, the rating panel determined that bothendovascular and surgical approaches are Appropriate inclinical scenarios involving concomitant tissue loss or endorgan compromise. There was a tendency to selectendovascular approaches in these scenarios, particularlyin anatomic distributions below the knee and where priorendovascular or surgical revascularization has been per-formed. Given the dynamic landscape of cardiovascularmedicine, the writing group felt it was necessary toaddress situations in which adjunct arterial revasculari-zation may be necessary to facilitate other proceduressuch as percutaneous valve replacement or hemodynamicsupport. The clinical situations where this occurs oftenmake endovascular interventions more attractive andthat was reflected in the ratings.

The purpose of this particular AUC is to provide guid-ance to clinicians who may refer patients for revascular-ization treatments and to interventionalists and surgeonsthemselves. With the field of peripheral artery diseaseconstantly evolving, it is imperative to offer tools andresources that physicians can utilize to provide the bestcare for their patients.

PREFACE

Stimulated by the potential overuse of cardiovascularimaging, the first Appropriate Use Criteria (AUC) weredeveloped in 2005. Since then, many other topics havebeen explored and translated into appropriate use ratings.In an effort to address the rational use of tests andprocedures in the delivery of high-quality cardiovascularcare, the American College of Cardiology (ACC) andnumerous partnering societies have undertaken a processto determine the appropriate use of treatment options forpatients with peripheral artery disease.

AUC publications reflect an ongoing effort by the ACCand its partners to critically and systematically evaluateclinical situations in which treatments and procedures areutilized by physicians caring for patients with known orsuspected cardiovascular disease. The process is basedon our current understanding of the technical capabilitiesof the modalities and procedures examined. Although notintended to be comprehensive owing to the diversityof clinical disease, the patient indications included inthis document are meant to identify common scenariosencountered by clinicians in contemporary practice.The AUC indications are often chosen on the basis of gapsand gray areas in Clinical Practice Guidelines and a lack ofevidence-based data, thereby relying on clinical practiceexperience and physician judgment to determine the finalAUC ratings.

The ultimate objective of AUC is to improve patientcare and health outcomes in a cost-effective manner.


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They are not intended to ignore the ambiguity andnuance intrinsic to clinical decision making. Localparameters, such as the availability or quality of equip-ment and personnel, may influence the selection ofcertain treatments or procedures. Thus, AUC should notbe considered as substitutes for clinician judgment andpractice experience.

I would like to thank the writing group for theirdedication to the drafting and editing of numerousversions of this manuscript, which resulted in an essentiallist of clinical scenarios, and to the rating panel forscoring the scenarios numerous times and offering sageinput in this process. A special tribute is extended torating panelist Dr. Alan Hirsch, whose untimely passingcreated a void in the peripheral vascular community. I amalso grateful to the parent AUC Task Force, whichprovided significant guidance and insights, and the ACCstaff—Joe Allen, and especially Lara Gold—for their vitalcontributions and assistance in the development of thisdocument.

Steven R. Bailey, MD, FACC, MSCAIChair, Peripheral Artery Intervention Writing Group

1. INTRODUCTION

Improvements in the diagnosis of peripheral arterydisease (PAD) have led to an increasing number oftreatment and revascularization methods, especiallyendovascular interventions. As new and increasingly so-phisticated devices are developed, the medical commu-nity needs to understand how best to incorporate thesetechnologies into daily clinical decision making and care,and how to choose between new and more establishedmethods. This AUC project was initiated to respond tothis need and to ensure the effective use of peripheralartery revascularization.

The purpose of this guidance document is neither todetail every clinical situation nor to describe the use ofevery device used in the treatment of PAD. Rather, thegoal is to provide generalized guidance into the use ofthese devices and techniques, while understanding thateach clinical situation is unique, with physicians usingtheir best judgment and the available evidence base tocraft the most beneficial approach for the patient. In allcases, it is assumed that guideline-directed medicaltherapy should be applied first. Moreover, in determiningthe appropriate use of the described treatments, the rat-ing panel was instructed to not compare the treatmentoptions with each other. Although it is difficult to avoidcomparing “scores” for each treatment in the patientscenarios, each treatment option should be considered onits own merits and not ranked against the other options.This is necessary owing to the diffusion of expertise

and availability of techniques and tools, which variesacross the range of situations and settings in which care isprovided to patients with PAD.

2. METHODS

To begin the AUC process, a multidisciplinary writinggroup consisting of representatives from several cardio-vascular subspecialty societies and ACC Councils wasformed. The goal of the writing group was to developcommon patient scenarios experienced in clinical prac-tice, and to categorize these scenarios on the basis offactors such as patient symptoms, anatomy, and diseasestate. The writing group focused on identifying typicalsituations encountered in daily practice, because it wouldbe impossible to cover every conceivable patient presen-tation without making the number of scenarios excessive.Whenever possible during the writing process, the writinggroup mapped the indications to relevant guidelines,clinical trials, and other key references (see GuidelineMapping and References). Once the indications wereformed, they were reviewed and critiqued by theparent AUC Task Force and numerous external reviewersrepresenting a variety of cardiovascular subspecialtysocieties and ACC Councils. After the writing groupincorporated this feedback, the indications were sent toan independent rating panel comprised of additionalexperts specializing in PAD. Panelists were also sent aguideline and clinical trial mapping document for theirreference (see Guideline Mapping and References).

The rating panelists were then tasked with scoring theclinical scenarios from 1 through 9, with 1 to 3 classified as“Rarely Appropriate care,” 4 to 6 as “May Be Appropriatecare,” and 7 to 9 as “Appropriate care.” Panelists con-ducted this scoring via an electronic survey platform, andthe median score from the 13 panelists was calculated foreach scenario. Next, the panelists, several writing grouprepresentatives, and a moderator came together for an in-person rating panel meeting, where robust discussion ofeach indication ensued, and feedback was given to thewriting group representatives. The writing group thentook this input and completed further vetting of theclinical scenarios before sending the document back tothe rating panel for an additional round of electronicscoring. After the second round of ratings, a few of thescenarios had scores that were misaligned with guidelinerecommendations and other evidence. The writing groupfelt this misalignment came from 2 sources. First, wordingof the affected scenarios was ambiguous to some mem-bers of the rating panel. Second, as a rapidly evolvingfield, new evidence emerged during the rating processthat confounded the scoring for some rating panel mem-bers. Therefore, the writing group edited the language

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used for these scenarios to make them clearer and tomake sure results from the new studies were consideredin the ratings by all members of the rating panel. Afteradditional rating of these scenarios was completed, thefinal round of scoring was achieved (see FinalDeidentified AUC Scores). These additional rounds of re-view and subsequent revision ensured that multipleviewpoints were considered throughout the AUC process.

A detailed description of the methods used for ratingthe clinical scenarios can be found in previous AUCmethodology publications, including the ACC AppropriateUse Criteria Methodology: 2018 Update (1–3). Briefly, thisprocess combines evidence-based medicine and practiceexperience and engages a rating panel in a modifiedDelphi exercise. The composition of the rating panelis key; to prevent bias in the scoring, the majority of rat-ing panelists chosen were generalists/nonproceduralists.Proceduralists such as surgeons and interventionalists,while offering important clinical and technical insights,might have a natural tendency to rate the indicationswithin their specialty at a higher degree of appropriate-ness than nonprocedural raters. For the scoring, care wastaken to provide the rating panel with objective, unbiasedinformation, including guidelines and key references inthe field (see Guideline Mapping and References).

In scoring the clinical scenarios, the rating panel wasasked to assess whether the use of a specific interventionfor each clinical indication should be categorized asAppropriate, May Be Appropriate, or Rarely Appropriate. Itwas emphasized that the treatment options should not beranked in comparison with each other or based on physi-cian preference, but should instead be considered on theirown merits and reasonableness for the given clinical sce-nario. When scoring the indications, the rating panel wasgiven the following definition of appropriate use:

An Appropriate treatment is one in which the potentialbenefits, in terms of survival or health outcomes (symptoms,functional status, and/or quality of life), exceed thepotential negative consequences of the treatment strategy.

The rating panel scored each indication using thefollowing definitions and their associated numeric ranges:

Median Score 7 to 9: Appropriate care for specificindication (treatment is generally acceptable and is areasonable approach for the indication).

An appropriate option for management of patients in thispopulation due to benefits generally outweighing risks;effective option for individual care plans although notalways necessary depending on physician judgment andpatient-specific preferences (i.e., treatment is generallyacceptable and is generally reasonable for the indication).

Median Score 4 to 6: May Be Appropriate care

for specific indication (treatment may be generallyacceptable and may be a reasonable approach for the

indication). May Be Appropriate also implies that moreresearch and/or patient information is needed to classifythe indication definitively.

At times an appropriate option for management of pa-tients in this population due to variable evidence or lack ofagreement regarding the benefits/risks ratio, potentialbenefit based on practice experience in the absence of evi-dence, and/or variability in the population; effectivenessfor individual care must be determined by a patient’sphysician in consultation with the patient based on addi-tional clinical variables and judgment along with patientpreferences (i.e., treatment may be acceptable and may bereasonable for the indication).

Median Score 1 to 3: Rarely Appropriate care

for specific indication (treatment is not generallyacceptable and is not a reasonable approach for theindication).

Rarely an appropriate option for management of pa-tients in this population due to the lack of a clear benefit/risk advantage; rarely an effective option for individualcare plans; exceptions should have documentation of theclinical reasons for proceeding with this care option (i.e.,treatment is not generally acceptable and is not generallyreasonable for the indication).

The division of the numerical scores into 3 levels ofappropriateness is somewhat arbitrary, and the numericdesignations should be viewed as a continuum. It isimportant to note that there may be diversity in clinicalopinion for particular scenarios such that scores in theintermediate level of appropriate use should be labeledMay Be Appropriate as critical patient or research datamay be lacking or discordant. This designation shouldserve as a prompt to carry out definitive research in thisfield whenever possible. It is anticipated that AUC reportswill continue to be revised as further data are generatedand information from implementation of the criteria isaccumulated.

The scenarios included in this document are basedon our current understanding of the potential patientbenefits compared with the risks of the treatmentstrategies involved. Each patient should be treatedindividually based on his or her own particular needs,so it is expected that all clinicians will occasionallycare for patients with unique conditions that couldresult in the choice of a therapy rated as Rarely Appro-priate. When this occurs, clinicians should documentthe specific situation and patient characteristics thatsupport performing that procedure; the Rarely Appro-priate rating should not be used as a deterrent fortreating the patient or grounds for denial of reimburse-ment. While a Rarely Appropriate designation shouldnot prevent a procedure from being performed, anAppropriate designation is also not a requirement or

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“must do” for a given procedure. The AUC are offeredto help guide patient care but should not be considereda substitute for clinical judgment and practiceexperience.

3. GENERAL ASSUMPTIONS

1. This document will address the use of peripheralartery revascularization using endovascular andsurgical approaches. This broadly inclusive term isused so that this document may be expanded in thefuture as new data become available.

2. Diagnostic tests and revascularizations are performedand interpreted by qualified individual(s) in a facilitythat is compliant with national standards for per-forming peripheral artery revascularization (endo-vascular and surgical procedures).

3. A qualified clinician has obtained a complete clinicalhistory and performed the physical examination suchthat the clinical status of the patient can be assumedto be valid as stated in the indication (e.g., anasymptomatic patient is truly asymptomatic for thecondition under consideration and the patient hasbeen questioned sufficiently).

4. In this document, the term “family history” refers tofirst-degree relatives only.

5. The indications are at times purposefully broad tocover an array of cardiovascular signs and symptomsand to account for the ordering physician’s bestjudgment as to the presence of cardiovascular abnor-malities. Clear documentation of the indicationfor revascularization should be included in the med-ical record. Additionally, certain clinical scenarios,such as acute limb ischemia, are not covered in thisdocument because revascularization is indicatedif feasible.

6. For patients having revascularization for more than 1indication—e.g., chronic kidney disease, worseninghypertension, the treatment of renal artery stenosis(RAS)—the most clinically significant of the in-dications should be noted as that indication has beenused to construct the following tables.

7. Revascularization options are rated for their level ofappropriateness specific to clinical scenarios, ratherthan being compared in rank order against otherrevascularization options. The goal of this documentis to identify all revascularization options that areconsidered reasonable for a given clinical indication,rather than determining a single best procedure foreach scenario. As such, >1 intervention type or evenall procedures may be considered Appropriate, MayBe Appropriate, or Rarely Appropriate for any givenclinical indication.

8. Cost is considered implicitly in the appropriate usedetermination. Clinical benefits should always beconsidered first, and costs should be considered inrelationship to these benefits to better convey netvalue. For example, a procedure with moderate clin-ical efficacy for a given AUC indication should not bescored as more appropriate than a procedure withhigh clinical efficacy solely because of its lower cost.When scientific evidence exists to support clinicalbenefit, cost efficiency and cost effectiveness shouldbe considered for any indication.

9. The level of appropriateness does not consider issuesof local availability or skill.

10. The category of “May Be Appropriate” (M) is usedwhen insufficient data are available for a definitivecategorization or there is substantial disagreementregarding the appropriateness of that indication. Thedesignation of “May Be Appropriate” should not beused as grounds for denial of reimbursement.

11. Indication ratings contained herein supersede theratings of similar indications contained in previousAUC documents.

12. Patients deemed suitable for a procedure should havea lesion suitable for a revascularization procedure andhave a reasonable procedure-related risk.

13. A stenosis is considered hemodynamically significantif it has a $70% diameter narrowing or has a hemo-dynamically significant gradient at rest or after avasodilator challenge. Pressure gradient should bemeasured with a pressure wire or catheter #5-Fr.

14. All lesions represent de novo disease and not in-stentrestenosis, unless otherwise stated.

15. Patients have received or are undergoing risk factorreduction and medical therapy, including exercisetherapy (preferably supervised), as recommended bythe 2016 AHA/ACC Guideline on the Management ofPatients With Lower Extremity Peripheral Artery Dis-ease (4), unless otherwise noted. Risk factor reductionbegins with improvement in lifestyle, includingattainment of a healthy weight, tobacco cessation,and routine exercise. For patients with PAD, medicaltherapy should include antiplatelet therapy withaspirin or clopidogrel, moderate- or high-dose statintherapy, and angiotensin-converting enzyme inhibi-tor use. Blood pressure should be controlled as perthe 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention,Detection, Evaluation, and Management of HighBlood Pressure in Adults (5). This guideline states thatthere is no major difference in the relative riskreduction in cardiovascular disease from bloodpressure–lowering therapy between patients withcomorbid hypertension and PAD and patients withhypertension but without PAD.



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Section 1 Assumptions: RAS

16. Patients should be taking 3 appropriate blood pres-sure medications, which should include a diuretic.

17. Patients with newly discovered atherosclerotic RAS willbe managed according to the data published in the ran-domized CORAL trial (Stenting and Medical Therapy forAtherosclerotic Renal-Artery Stenosis) (6), which endorsethe use of the best medical therapy. However, patientswith poorly controlled hypertension (on 3 blood pressuremedicines at maximally tolerated doses, 1 of which is adiuretic) would be candidates for renal intervention asoutlined in the ACC/AHA 2005 Guidelines for the Man-agement of Patients with Peripheral Arterial Disease(Lower Extremity, Renal, Mesenteric, and AbdominalAortic) document (7).

18. Full-dose medication, as defined by relevant guide-lines, may not be achievable in some patients due tomedication intolerance. Therefore, renal stenting maybe considered for patients with uncontrolled hyper-tension who are intolerant of 3 antihypertensivemedications given at maximal doses.

19. Intravascular ultrasound will be used as needed tooptimize stent deployment and conserve contrast forRAS procedures.

20. Post-procedure renal duplex (#30 days, 6 � 1 months,and #12 � 1 months and annually) is recommended.

21. Primary renal stent placement is indicated foratherosclerotic RAS lesions.

22. Both clinical and anatomic lesion criteria must be metfor renal revascularization indications to be consis-tent with those in the AHA/ACC PAD Guideline (7):a. Clinical criteria:

i. Accelerated hypertension, resistant hypertension,
malignant hypertension, hypertension with anunexplained unilateral small kidney, and hy-pertension with intolerance to medication; or
ii. Progressive chronic kidney disease with bilateral
RAS, RAS to a solitary functioning kidney, orunilateral RAS; or
iii. Recurrent, unexplained congestive heart failure
or sudden, unexplained pulmonary edema orrecurrent unstable angina.
b. Lesion criteria (8–10):i. 50% to 69% diameter stenosis by visual esti-

mation with hemodynamic confirmation ofthe severity of the stenosis (i.e., a resting sys-tolic translesional gradient [measured witha #5-Fr catheter or pressure wire] $20 mm Hgor a resting mean gradient $10 mm Hg, ahyperemic systolic gradient $20 mm Hg or ahyperemic mean gradient $10 mm Hg, or afractional flow reserve performed with dopa-mine [50 mg/kg] or papaverine [32mg] of<0.8);

ii. Any stenosis $70% diameter; oriii. Any stenosis $70% diameter by intravascular

ultrasound measurement.

Section 2 Assumptions: Lower Extremity Disease

23. Patients with intermittent claudication have lifestyle-or vocation-limiting symptoms and have undergonea trial of medical therapy and exercise therapy(supervised). For medical therapy, cilostazol shouldbe employed for $3 months to improve absoluteclaudication distance. Per the 2016 AHA/ACC Guide-line on the Management of Patients With LowerExtremity Peripheral Artery Disease (4), to be effec-tive, exercise therapy should constitute a supervised,structured program of exercise lasting for 30 to45 min, 3 times/week, for a minimum of 12 weeks.

24. Popliteal artery aneurysmal disease is not included.25. Common femoral artery disease is not included.26. The superficial femoral artery (SFA) extends from its

ostium after bifurcation of the common femoral arteryto the adductor canal.

27. The below-the-knee segment extends from the originof the anterior tibial artery to the pedal arch.

28. The trifurcation refers to the division of the poplitealartery into the anterior tibial artery and the tibioper-oneal trunk, which subsequently divides into theposterior tibial and peroneal arteries.

29. Two-year survival is an estimate based upon patientcharacteristics and comorbidities: age $80 years,body mass index <18.0 kg/m2, nonambulatory status,hemodialysis, cerebrovascular disease, left ventricu-lar ejection fraction <40%, Rutherford class 5 or 6.

Section 3 Assumptions: Critical Limb Ischemia

30. Patients with critical limb ischemia (CLI) haveischemic limb pain at rest, nonhealing ulcerations, organgrene.

31. Popliteal artery aneurysmal disease is not included.32. Common femoral artery disease is not included.33. The SFA extends from its ostium after bifurcation of

the common femoral artery to the adductor canal.34. The below-the-knee segment extends from the origin

of the anterior tibial artery to the pedal arch.35. The trifurcation refers to the division of the popliteal

artery into the anterior tibial artery and the tibioper-oneal trunk, which subsequently divides into theposterior tibial and peroneal arteries.

36. Two-year survival is an estimate based upon patientcharacteristics and comorbidities: age$80 years, bodymass index <18.0 kg/m2, non-ambulatory status,hemodialysis, cerebrovascular disease, left ventricularejection fraction <40%, Rutherford class 5 or 6.


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Section 4 Assumptions: Asymptomatic Artery Disease

37. This section addresses when peripheral artery pro-cedures may be needed to facilitate arterial access toperform other cardiovascular procedures that aredeemed life-saving.

38. Some patients who require large-diameter catheteraccess for therapy may have obstructive disease thatis not causing symptoms and would not have beenincluded in other treatment tables.

39. Alternate vascular access should be considered beforeperipheral artery access is deemed the best option.

40. The revascularizations in this section should not beundertaken for the management of PAD, per se, but tofacilitate care that is deemed necessary and reliesupon suitable arterial access. One common examplewould be the need for placement of a large-diameterdevice for hemodynamic support in the setting ofcardiogenic shock or before a high-risk coronaryintervention.

Section 5 Assumptions: Options for Endovascular TreatmentWhen Deemed Appropriate or May Be Appropriate

41. Popliteal artery aneurysmal disease is not included.42. Common femoral artery disease is not included.43. The SFA extends from its ostium after bifurcation of

the common femoral artery to the adductor canal.44. The lesion length cutoff of 100 mm is based on the

2007 Inter-Society Consensus for the Management ofPeripheral Arterial Disease (TASC II) document (11);and extrapolation of the FAST randomized trial(Nitinol Stent Implantation Versus PercutaneousTransluminal Angioplasty in Superficial FemoralArtery Lesions Up to 10 cm in Length: The FemoralArtery Stenting Trial) (12) and ABSOLUTE randomizedtrial (Balloon Angioplasty Versus Implantation ofNitinol Stents in the Superficial Femoral Artery) (13),which compared durability of balloon angioplasty andstenting in patients with femoropopliteal diseaseand claudication. These trials suggest that lesions<100 mm may be treated with balloon angioplasty,whereas stenting is a more durable option for longerlesions.

Section 6 Assumptions: Secondary Treatment Options forLower Extremity Disease

45. The SFA extends from its ostium after bifurcation ofthe common femoral artery to the adductor canal.

46. Restenosis is defined as luminal narrowing $50%identified on angiography or artery ultrasound. Theultrasonographic criterion for restenosis is definedas a 2.5-fold increase in the peak systolic velocity in

the narrowed segment compared with the adjacentproximal segment. In clinical practice, the recurrenceof symptoms, a 20% decline in ankle-brachial index,and a >3-fold increase in peak systolic velocity ratioare combined to guide the decision regardingreintervention.

47. Treatment of asymptomatic restenosis may beconsidered given that restoring patency of anoccluded, previously treated segment is more difficultthan restoring that of a restenosed segment. Norandomized studies have been conducted to deter-mine whether this approach is clinically effective,which reintervention strategy is optimal, and whatthreshold should be used for consideration ofreintervention.

48. For the purposes of this document, focal restenosis isdefined as a lesion length #50 mm, whereas diffuserestenosis is defined as >50 mm (14). No consistentdefinition is currently found in the literature.

49. The mechanism of graft failure from implantationuntil 30 days is assumed to be technical in nature.This includes, but is not limited to, intrinsic veindisease, tunneling errors, hypercoagulable states,inadequate runoff, and errors in creating theanastomosis.

50. Graft failure beyond the 30-day postoperative periodis most often caused by neointimal hyperplasia and/or progression of native artery disease.

4. DEFINITIONS

Angioplasty: Endovascular repair or recanalization of ablood vessel, especially by balloon dilation.Atherectomy: Removal of atheromatous plaque fromwithin a blood vessel by utilizing a catheter usually fittedwith a cutting blade, laser, or grinding burr.Aortoiliac: Relating to or joining the abdominal aorta andthe iliac arteries.Claudication: Cramping, discomfort, and/or weakness inthe legs and especially the calves when walking that re-solves after short rest and is associated with inadequateblood supply to the muscles.Common femoral artery: Continuation of the externaliliac artery from the origin of the inferior epigastric arteryto the bifurcation of the superficial femoral and profundafemoris arteries.Common iliac artery: Artery that arises from the aorticbifurcation and ends when it divides into the external andinternal iliac arteries.Critical limb ischemia (CLI): Arterial insufficiency withgangrene, a nonhealing ischemic ulcer, or rest pain.



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Endovascular treatment: A minimally invasive percuta-neous procedure in which treatment for artery diseaseis delivered via catheter-based devices. Treatmentsinclude but are not limited to balloon angioplasty andstenting.External iliac artery: Terminal branch of the commoniliac artery extending from the origin of the internal iliacartery to the inferior epigastric artery.Fontaine Classification of Limb Ischemia: Clinical stagingsystem for describing PAD. It includes 5 stages: Stage I:Asymptomatic; Stage IIa: Mild claudication (able towalk more than 200 meters); Stage IIb: Moderate-severeclaudication (walking limited to less than 200 meters);Stage III: Ischemic rest pain; Stage IV: Ulceration organgrene.Hemodynamically significant RAS:

a. Any narrowing $70% diameter stenosis by visualestimation; or

b. A stenosis in the range of 50% to 69% by visualestimation is considered significant if there isa resting or hyperemic systolic translesional gradient$20 mm Hg or a mean gradient $10 mm Hg(measured with a #5-Fr catheter or pressure wire),hyperemic gradients of the same magnitude, or afractional flow reserve of <0.8.

Hyperemia for measurement of renal fractional flowreserve is induced with a 32-mg intrarenal bolus ofpapaverine or 50 mg/kg intrarenal bolus of dopamine.Pressure gradient measured with a nonobstructivecatheter (#5-Fr) or a 0.014-in pressure wire (8–10).Hypertension: Abnormally high artery blood pressurethat is usually indicated by a systolic blood pressure $140mm Hg and/or a diastolic blood pressure $90 mm Hg (15).As noted previously, the 2017 Guideline for the Preven-tion, Detection, Evaluation, and Management of HighBlood Pressure in Adults was published after this AUC wasdeveloped; therefore, clinicians will need to consider therole of new guideline goals in the treatment of individualpatients. The cause of hypertension in most cases is un-known or is multifactorial (primary or essential hyper-tension). It may be attributable to a pre-existing condition(such as a renal or endocrine disorder) that typicallyresults in a thickening and inelasticity of arterial wallsand hypertrophy of the left heart ventricle, and that is arisk factor for various pathological conditions or events(such as heart attack, heart failure, stroke, chronic kidneydisease, or retinal hemorrhage).In-stent restenosis: A process of neointimal hyperplasiathat occurs in up to 20% of stents within a year ofimplantation. Restenosis is defined as a 50% luminalnarrowing identified on angiography or artery ultrasound.The ultrasonographic criterion is defined as a 2.5-fold

increase in the peak systolic velocity in the narrowedsegment compared with the adjacent proximal segment(16,17). In clinical practice, the recurrence of symptoms,a 20% decline in ankle-brachial index, and a >3-foldincrease in peak systolic velocity ratio are combinedto guide the decision regarding reintervention (17).The primary impetus behind surveillance of in-stentrestenosis is that an occluded stent is more difficultto restore. However, no randomized studies have beenconducted to determine whether this approach is clini-cally effective, which reintervention strategy is optimal,and what threshold should be used for consideration ofreintervention.Interposition graft: A piece of newly harvested vein thatis sewn into the vein graft following the removal ofa stenotic segment of the vein graft.Maximal medical therapy: Guideline-directed pharma-cological and lifestyle modification that includes exercise(preferably supervised) therapy given with sufficient timefor titration and stabilization to occur to determine theimpact of medication changes.Pharmacomechanical thrombectomy: Thrombus dissolu-tion and removal using percutaneous techniques involvingcatheter-directed thrombolytic agents combined with me-chanical devices.Popliteal artery: Arterial segment extending from theadductor canal to its bifurcation into the anterior tibialartery and tibioperoneal trunk.Rutherford Classification of Chronic Limb Ischemia:

Clinical staging system for describing PAD. It includes7 categories: 0—Asymptomatic; 1—Mild claudication; 2—Moderate claudication (The distances that delineate mild,moderate, and severe claudication are not specified inthe Rutherford classification but are mentioned in theFontaine classification as 200 meters.); 3—Severe claudi-cation; 4—Rest pain; 5—Ischemic ulceration not exceedingulcer of the digits of the foot; and 6—Severe ischemiculcers or frank gangrene. The Fontaine and Rutherfordtaxonomies are the 2 most commonly used systems forclassifying chronic limb ischemia (Table 1).Stent: A small, narrow metal or plastic tube often in theform of a mesh that is inserted into the lumen of an artery,especially to keep a previously blocked passageway open.Stents used in the peripheral vascular system includebut are not limited to nitinol self-expanding stents, drug-eluting stents, and covered self-expanding stents.Superficial femoral artery: Terminal branch of the com-mon femoral artery extending from the origin ofthe profunda femoris branch to the adductor canal in thedistal thigh.Surgical treatment: Artery revascularization procedurethat requires skin incision and manipulation of thetarget artery under direct visualization. Such surgery

TABLE 1Classification Comparison for Chronic LimbIschemia

FONTAINE RUTHERFORD

Stage Clinical Grade Category Clinical

I Asymptomatic 0 0 Asymptomatic

IIa Mild claudication I 1 Mild claudication

IIb Moderate-severe claudication I 2 Moderate claudicationI 3 Severe claudication

III Ischemic rest pain II 4 Ischemic rest pain

IV Ulceration or gangrene III 5 Minor tissue loss

IV 6 Ulceration or gangrene

Adapted from Norgren et al. (11) and Hardman et al. (18).

TABLE 1.1 Chronic Kidney Disease

Indications

AUC Score

Continue orIntensifyMedicalTherapy

Renal Stent Placement(Primary Stenting)—

Atherosclerotic Lesions

Hemodynamically Significant RAS (With a Severe [70%–99%] RAS or50%–69% RAS With Hemodynamic Significance)

1. n Unilateral smallerkidney (<7cm poleto pole)

A (9) R (2)

2. n Acceleratingdecline in renalfunction

n Unilateral RAS

A (9) M (4)

3. n Acceleratingdecline in renalfunction

n Bilateral RAS ora solitary viable*kidney with RAS

A (7)

*Viable is pole to pole kidney length $7 cm.

A ¼ Appropriate; AUC ¼ Appropriate Use Criteria; M ¼ May Be Appropriate;R ¼ Rarely Appropriate; RAS ¼ Renal Artery Stenosis.

TABLE 1.2 Hypertension

Indications

AUC Score

Continueor Intensify

MedicalTherapy

Renal Stent Placement(Primary Stenting) —

AtheroscleroticLesions


4. n New onsetn No medical management

A (9) R (1)

5. n Well-controlled bloodpressure on $2 anti-hypertensive medications

A (9) R (1)

6. n Uncontrolled on <3antihypertensivemedications

A (9) R (3)

7. n Failure to controlblood pressure on 3maximally toleratedmedications, 1 of whichis a diuretic

M (6)

A ¼ Appropriate; AUC ¼ Appropriate Use Criteria; M ¼ May Be Appropriate; R ¼ RarelyAppropriate; RAS ¼ renal artery stenosis.


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may involve endarterectomy of the artery, or bypassof the artery with a prosthetic or autologous vein conduit.Vein patch angioplasty: A vein that is opened in thelongitudinal direction and used as a patch sewn over astenotic lesion in the vein graft to increase the vein graft’slumen area.Viable kidney: According to the ACC/AHA 2005 Guide-lines for the Management of Patients with PeripheralArterial Disease (Lower Extremity, Renal, Mesenteric, andAbdominal Aortic) (7), a viable kidney is defined as havinga pole-to-pole linear length >7 cm.

5. ABBREVIATIONS

AUC ¼ Appropriate Use Criteria

CLI ¼ critical limb ischemia

PAD ¼ peripheral artery disease

PAI ¼ peripheral artery intervention

RAS ¼ renal artery stenosis

SFA ¼ superficial femoral artery

6. PERIPHERAL ARTERY INTERVENTION

APPROPRIATE USE CRITERIA (BY INDICATION)

The final ratings for PAI are listed by indication inTables 1.1 to 6.3. The final score for each indication re-flects the median score of the 13 rating panel membersand has been categorized as Appropriate/A (median score7 to 9), May Be Appropriate/M (median score 4 to 6), andRarely Appropriate/R (median score 1 to 3). In the tables,the final numerical score for each indication is shown inparentheses next to the AUC rating of A, M, or R.

Section 1 Renal Artery Stenosis

TABLE 1 .3 Cardiac Destabilization

Indications

AUC Score


MedicalTherapy

Renal Stent Placement(Primary Stenting) —


Hemodynamically Significant RAS (With a Severe [70%–99%]RAS or 50%–69% RAS With Hemodynamic Significance)

8. n Recurrent heart failuren Uncontrolled on

maximal medicaltherapy

M (6)

9. n Sudden-onset flashpulmonary edema

A (7)

10. n Uncontrolled unstableangina despitemaximal medical therapy

M (6)

A ¼ Appropriate; AUC ¼ Appropriate Use Criteria; M ¼May Be Appropriate; RAS ¼ renalartery stenosis.

TABLE 1.4 Incidentally Discovered RAS

Indications

AUC Score

Continue orIntensify Medical

Therapy

Renal StentPlacement (Primary

Stenting) –



11. n Unilateral RAS A (9) R (2)

12. n Bilateral RAS ora solitary viable*kidney with RAS

A (9) R (2)

*Viable is pole-to-pole kidney length $7 cm.

A ¼ Appropriate; AUC¼ Appropriate Use Criteria; R¼ Rarely Appropriate; RAS¼ renalartery stenosis.

TABLE 1.5Borderline (50%–69%) RAS WithoutHemodynamic Confirmation of Severity

Indications

AUC Score

Continue orIntensify

Medical Therapy

Renal Stent Placement(Primary Stenting) –

Atherosclerotic Lesions

13. n Unilateral RAS,bilateral RAS,or a solitaryviable* kidneywith RAS

A (9) R (2)

*Viable is pole to pole kidney length of $ 7 cm.

A ¼ Appropriate; AUC¼ Appropriate Use Criteria; R¼ Rarely Appropriate; RAS¼ renalartery stenosis.



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Section 1 Results and Discussion

The appropriate use recommendations for RAS inter-vention are based on expert consensus and evidence,including the randomized CORAL trial (Stenting andMedical Therapy for Atherosclerotic Renal-Artery Steno-sis) (6), which recommends best medical therapy as theinitial treatment for a newly diagnosed patient. Therecommendations for renal intervention outlined in theACC/AHA 2005 Guidelines for the Management of Patientswith Peripheral Arterial Disease (Lower Extremity, Renal,Mesenteric, and Abdominal Aortic) (7) and its update, the2016 AHA/ACC Guideline on the Management of Patientswith Lower Extremity Peripheral Artery Disease (4),define both clinical and anatomic lesion criteria andadditionally define optimal medical therapy as 3 antihy-pertensive medications, 1 of which should be a diuretic.In patients intolerant of the 3-antihypertensive medica-tion regimen who have hemodynamically significant RAS,renal artery stenting may be considered. Primary stentinghas become accepted practice, and intravascular ultra-sound is a valuable tool for optimally sizing renal stents,given that undersizing may be safe but leads to a higherrestenosis rate, whereas oversizing risks vessel ruptureand dissection. Given that invasive angiography is unableto distinguish hemodynamic significance among moder-ate renal artery stenoses (50% to 69% diameter stenoses),it is necessary to confirm the severity of moderate RASlesions by measuring translesional pressure gradientswith nonobstructive catheters.

In patients with an accelerating decline in renal func-tion and bilateral or solitary significant RAS (e.g., severeRAS [$70% diameter stenosis]) or moderate RAS (50% to69% diameter stenosis)] with translesional gradients thatexceed threshold measurements, the rating panel findsrenal stenting to be Appropriate. In patients with stablerenal function and unilateral significant RAS, optimizingand intensifying medical therapy is deemed Appropriate,whereas renal stenting is deemed May Be Appropriate insome patients. In patients with small (<7 cm pole to pole)nonviable kidneys, revascularization is found to be RarelyAppropriate.

For patients with hypertension and significant RAS,the threshold for renal artery stenting is failure of $3maximally tolerated antihypertensive medications, 1 ofwhich is a diuretic, to control hypertension. The ratingpanel feels that newly diagnosed RAS patients shouldinitially be treated with optimal medical therapy, notrenal stenting. They also determined that patients withwell-controlled hypertension and RAS, and patientswith poorly controlled hypertension on <3 antihyperten-sive medications, are rarely candidates for renal stenting.The rating panel deems selected patients with cardiacdestabilization syndromes manifested as recurrent heartfailure or uncontrolled unstable angina despite maximal


225

medical therapy and severe RAS as May Be Appropriatefor renal stenting, whereas those with sudden onset or“flash” pulmonary edema and severe RAS are Appropriatefor renal stenting. Patients with incidentally discoveredRAS should initially be treated with optimal medicaltherapy, as renal stenting in this group is consideredRarely Appropriate. Finally, patients with moderate RAS(50% to 69% diameter stenosis) with translesional gradi-ents that fail to achieve the threshold are consideredRarely Appropriate for renal stenting (19).

Section 2 Lower Extremity Disease

TABLE 2.1Intermittent Claudication; No Prior Guideline-Directed Medical Therapy

Indications

AUC Score

Initiate MedicalTherapy

EndovascularTreatment

SurgicalTreatment

14. n Any lowerextremity disease

A (9) R (2) R (1)

A ¼ Appropriate; AUC ¼ Appropriate Use Criteria; R ¼ Rarely Appropriate.

TABLE 2.2Intermittent Claudication Despite Guideline-Directed Medical Therapy—Stenotic Lesions

Indications

AUC Score

Continue or IntensifyMedical Therapy


SurgicalTreatment

15. n Aortoiliac A (9) A (8) M (4)

16. n SFA andpopliteal artery

A (9) A (7) M (6)

17. n Below the knee A (9) M (5) R (3)

A ¼ Appropriate; AUC ¼ Appropriate Use Criteria; M ¼ May Be Appropriate; R ¼ RarelyAppropriate; SFA ¼ superficial femoral artery.

TABLE 2.3Intermittent Claudication DespiteGuideline-Directed Medical Therapy—Chronic Total Occlusion

Indications

AUC Score

Continue or IntensifyMedical Therapy


SurgicalTreatment

18. n Aortoiliac A (9) A (7) M (6)


A (9) M (6) M (6)

20. n Below the knee A (9) M (4) R (3)

A ¼ Appropriate; AUC ¼ Appropriate Use Criteria; M ¼ May Be Appropriate; R ¼ RarelyAppropriate; SFA ¼ superficial femoral artery.


The AUC recommendations for lower extremity revas-cularization in patients with claudication are based onexpert consensus statements most recently summarizedin the 2016 AHA/ACC Guideline on the Management ofPatients with Lower Extremity Peripheral Artery Disease(4). The tables in this section define the appropriate use ofrevascularization therapies for patients with stablesymptoms without acute limb ischemia or CLI. Revascu-larization therapies constitute 1 of several components ofPAD management and complement the comprehensivemedical therapy defined in the societal guidelines. Pa-tients experiencing intermittent claudication should beconsidered for revascularization only after other,nonvascular causes of limb symptoms have beenexcluded. The symptoms should be lifestyle limitingdespite appropriate pharmacological and exercise thera-pies. Angiographic presence of an intermediate-severitystenosis may not indicate a hemodynamically signifi-cant, symptom-inducing lesion. Therefore, physiologicalassessments demonstrating a significant flow limitationwith segmental Doppler pressures, exercise ankle-brachial index testing, and/or measurement of transle-sional gradients are essential in selecting patients whowill benefit from revascularization.

Patients with PAD and intermittent claudicationshould first be treated with guideline-directed medicaltherapy and structured exercise (19). This strategy is oftensuccessful and has been evaluated in randomizedcontrolled trials (20,21). Revascularization of arteriesshould be considered only in patients who continue tohave lifestyle-limiting claudication despite these nonin-vasive approaches. Intermittent claudication is mostcommonly caused by hemodynamically significant lesionsin the aortoiliac and femoropopliteal artery segments.Infrapopliteal (below the knee) disease is a less commoncause of claudication, so revascularizations in thissegment are reserved for special circumstances. The se-lection of surgical or endovascular revascularization de-pends on the risk-benefit ratio unique to each patient andthe perceived likelihood of a durable clinical benefit.Lesion characteristics, such as the anatomical location ofthe lesion, presence of stenosis or occlusion, and length ofthe lesion, will influence that choice. For example,endovascular therapy of a long-segment occlusion of theSFA is likely to result in a less durable clinical result thantreatment of a short-segment stenosis in the same vessel(22,23). Iliac artery stenting, on the other hand, providessimilar durability to surgical revascularization but hasmuch lower periprocedural risk (24). The TASC II docu-ment reflects the improvement in endovascular tech-niques and serves as a basis for guiding the AUCrecommendations (11).



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Section 3 Critical Limb Ischemia

TABLE 3.1 Critical Limb Ischemia

Indications

AUC Score


Medical TherapyEndovascularTreatment

SurgicalTreatment

21. n Aortoiliac A (8.5) A (8)


A (8) A (8)

23. n Below the knee A (8) A (8)

A ¼ Appropriate; AUC ¼ Appropriate Use Criteria; SFA ¼ superficial femoral artery.

TABLE 5.1 Isolated Common Iliac Artery

Indications

AUC Score

AtherectomyBalloon

Angioplasty Stent

27. n Discrete stenosis R (2) A (7) A (8)

28. n Diffuse disease or multiplestenoses of the CIA

R (2) M (6) A (8)

A ¼ Appropriate; AUC ¼ Appropriate Use Criteria; CIA ¼ common iliac artery; M ¼ MayBe Appropriate; R ¼ Rarely Appropriate.

TABLE 5.2 Isolated External Iliac Artery

Indications

AUC Score

AtherectomyBalloon

Angioplasty Stent


This table was designed to determine the appropriate-ness of revascularization modalities for the presentationof CLI. For these patients, the decision to continue orintensify medical therapy without any other revasculari-zation is grayed out because it is not considered areasonable treatment. The intervention options in thistable have been divided into either endovascular or sur-gical treatment.

Revascularization, whether endovascular or surgical, iscritical for the reduction of high morbidity and mortalityrates associated with limb loss. Mortality rates have beenreported to be as high as 20% within 6 months of diag-nosis, and exceeding 50% after 5 years in patients leftuntreated (25). Furthermore, this degree of PAD iscommonly associated with excessive cardiovascularevents, often surpassing mortality rates associated witheven symptomatic coronary artery disease. In allanatomic subsets, both endovascular treatment and sur-gical treatment were considered Appropriate by the ratingpanel and received a median score of 8. For endovasculartreatment in the aortoiliac segment, the score of 8.5 wasdetermined after calculating the median score from 12panelists rather than the original 13 (1 panelist passedaway during the rerating process).

Section 4 Asymptomatic Artery Disease

TABLE 4.1Access in Support of Other Life-SavingInterventions

Indications

AUC Score

EndovascularTreatment Surgical Access

24. n Access for coronary intervention A (7) A (8)

25. n Access for hemodynamic support A (7) M (4)

26. n Access for large vascular orvalvular intervention

A (7) M (5)

A ¼ Appropriate; AUC ¼ Appropriate Use Criteria; M ¼ May Be Appropriate.

29. n Discrete stenosis R (2) A (7) A (8)

A ¼ Appropriate; AUC ¼ Appropriate Use Criteria; R ¼ Rarely Appropriate.

TABLE 5.3Diffuse Common Iliac Artery and ExternalIliac Artery

Indications

AUC Score

AtherectomyBalloon

Angioplasty Stent

30. n Unilateral EIA stenosiswith multiple CIA stenoses

R (2) M (5) A (8)

31. n Chronic total occlusion R (2) M (4) A (8)

A ¼ Appropriate; AUC ¼ Appropriate Use Criteria; CIA ¼ common iliac artery;EIA ¼ external iliac artery; M ¼ May Be Appropriate; R ¼ Rarely Appropriate.


The appropriate use recommendations for asymptom-atic artery disease are specific for clinical situations in

which peripheral artery procedures may be needed tofacilitate arterial access before other necessary cardio-vascular procedures, some of which may be life-saving. Asthere is no published research in this area, the scoresrepresent a consensus of experts. This section assumesthat some patients who require large-diameter catheteraccess for therapy may have asymptomatic obstructivedisease and are not included in other treatment tables. Thewriting group assumed that alternate vascular access hadbeen considered and that peripheral artery access hadbeen deemed the best option. It is emphasized that theserevascularizations are not undertaken for the manage-ment of PAD, per se, but to facilitate care that is deemednecessary and is dependent upon suitable vascular access.

For example, femoral artery access is an importantconduit for transcatheter aortic valve replacement andhas had better outcomes than transapical access in apropensity-matched comparison study (26). Other exam-ples include the placement of hemodynamic support de-vices such as an intra-aortic balloon pump or the presenceof dialysis shunts in the upper extremities.

Section 5 Options for Endovascular Treatment When DeemedAppropriate or May Be Appropriate

TABLE 5.4 SFA and Popliteal Artery

Indications

AUC Score

Atherectomy Balloon Angioplasty Drug-Coated Balloon Bare Metal Stent Drug-Eluting Stent Covered Stent

32. n Length <100 mm M (6) A (7) A (7) A (7) A (7) M (6)

33. n Length $100 mm M (5) M (5) A (7) A (7) A (7) M (6)

A ¼ Appropriate; AUC ¼ Appropriate Use Criteria; M ¼ May Be Appropriate; SFA ¼ superficial femoral artery.

TABLE 5.5 Below the Knee

Indications

AUC Score

Atherectomy Balloon Angioplasty Drug-Coated Balloon Bare Metal Stent Drug-Eluting Stent Covered Stent

34. n Length <100 mm M (4) A (7) M (4) M (5) A (7) R (3)

35. n Length $100 mm M (4) A (7) M (4) M (5) M (6) R (3)

A ¼ Appropriate; AUC ¼ Appropriate Use Criteria; M ¼ May Be Appropriate; R ¼ Rarely Appropriate.

TABLE 6.1 In-Stent Restenosis

Indications

AUC Score


Medical TherapyEndovascularTreatment

SurgicalTreatment

Recurrent Symptoms

36. n Focal stenosis A (9) A (7) M (5)

37. n Diffuse stenosis A (9) A (7) M (6)

Asymptomatic

38. n Focal stenosis A (9) M (5) R (2)

39. n Diffuse stenosis A (9) M (4) R (3)

A ¼ Appropriate; AUC ¼ Appropriate Use Criteria; M ¼ May Be Appropriate; R ¼ RarelyAppropriate.

TABLE 6.2 Venous Bypass Graft Failure

Indications

AUC Score

Endovascular TreatmentBalloon Angioplasty,

Stenting, and/or Catheter-Directed Thrombolysis

Surgical TreatmentVein Patch

Angioplasty orInterposition Graft

Stenotic Lesions Developing After 30 days

40. n Focal stenosis A (7) M (5)

41. n Diffusestenosis

M (6) M (6)

42. n Thrombosedgraft

M (6) M (6)



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The clinical scenarios in Section 5 specifically address 3broad treatment options for the disease states listed.Given the variability in the lesion lengths that span mul-tiple vascular territories, the authors organized treat-ments above and below the inguinal ligament and belowthe knee. The literature review demonstrated severaldefinitions of discrete and diffuse stenosis, with noconsensus for a standardized measurement. After exten-sive discussions among members of the writing group, alength of 100 mm was used as the cutoff point betweendiscrete and diffuse lesions. The table categorizes themost commonly used endovascular treatment modalities,encompassing a wide range of scenarios that operatorsmay face when revascularizing peripheral artery lesions.

Endovascular therapies are common and increasinglyused for patients with symptomatic PAD. There has beensignificant development in the technology available forintervention in these vascular beds. Moreover, recentdata suggest that the choice of technology may varydepending on preference as much as on scientific dataand clinical experience (27,28). Of note, the use of athe-rectomy in the iliac artery has been rated Rarely Appro-priate in all clinical scenarios. This rating derives from anabsence of data supporting the use of this technologycompared with balloon angioplasty and stenting (29).Similarly, the use of atherectomy in the superficialfemoral and popliteal arteries and below-the-knee vesselsalso received a lower score, again because of the lack ofcomparative data relative to technologies with prospec-tively collected data. The evidence base to judge inter-vention below the knees is not as developed as otherlower-extremity locations, which results in morefrequent use of the May Be Appropriate category. Therating panel felt that below-the-knee atherectomy onceagain lacked comparative evidence to support generaluse. Exceptions favoring atherectomy include severe

calcification and undilatable lesions; however, othertechnologies had a better evidence base for routinerevascularization in most settings (30). Given the expenseand paucity of data regarding atherectomy, furthercomparative investigation is recommended into the risksand benefits of atherectomy in femoral popliteal lesions.

Section 6 Secondary Treatment Options forLower-Extremity Disease

TABLE 6.3 Prosthetic Bypass Graft Failure

Indications

AUC Score

Endovascular TreatmentBalloon Angioplasty,

Stenting, and/or Catheter-Directed Thrombolysis

SurgicalTreatmentVein Patch

Angioplasty orInterposition Graft

Stenotic Lesions Developing After 30 Days

43. n Focal stenosis A (7) M (5)

44. n Diffusestenosis

M (6) M (6)

45. n Thrombosedgraft

M (5) M (6)




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The indications in Section 6 specifically addresspreviously treated segments that have restenosed oroccluded. The clinical scenarios relate to lesions previ-ously treated with stents, surgically bypassed using avenous conduit, or revascularized using a prostheticconduit. The table broadly specifies the therapy by cate-gory but does not specify the device or surgical approach,as these may vary widely among physicians and facilities.It is recognized that the need for revascularization of afailing conduit, graft, or stent is a marker of adverseoutcomes for all of the reparative modalities employed(31). Literature comparing treatment modalities for in-stent stenosis, venous graft failures, and arterial graftfailures is very limited. Therefore, the recommendationsprimarily reflect consensus based upon current clinicalpractice.

The role of endovascular therapies and surgical revas-cularization for stenosis or occlusion after prior periph-eral vascular procedures remains an important clinicalquestion. The choice of therapy may vary depending onpreference and clinical experience. One benefit of abroadly representative review and rating panel is theinclusion of a range of opinions, which was well-capturedin the ratings of this section. The rating panel felt the useof surgical revascularization was Rarely Appropriate inthe setting of in-stent stenosis, particularly in theasymptomatic patient. The rating panel also felt it wasAppropriate to address focal stenoses with endovasculartherapy in patients with prior surgical grafts and bio-prosthetic material, whereas in patients with diffusestenosis or thrombosed grafts, endovascular and surgicaltreatment were rated as May Be Appropriate. The specifictype of therapy (device or surgical procedure) is at thediscretion of the clinician dictated by the clinical scenarioplus physician and facility experience. The generallylower ratings in this section represent the evidence baseupon which determinations could be made.

7. SUMMARY

This is the first effort by the ACC and collaborating orga-nizations to address appropriate use in the field of PAI.This was more challenging than the development of AUCson other topics mainly because supporting literature isnot as developed or robust as for other topics covered.The clinical scenarios were developed by experts in thefield representing multiple subspecialty societies and ACCCouncils, evaluated by numerous external reviewers andstakeholders, and scored by an independent group ofexperts to arrive at the final AUC ratings. This multi-societal AUC effort contributes important guidance to thefield of peripheral vascular disease, which is constantlychanging due to the development of new devices, tech-nologies, and intervention methods.

Although the development of these AUC incorporatedevidence where available, it is important to note the dif-ferences between clinical practice guidelines and AUC.The ACC/AHA guidelines are developed using evidence-based documents and expert opinion and are generallyquite broad. Even though AUC are evidence-based, theyare structured around typical patient scenarios encoun-tered in everyday practice. Although the AUC ratings inthis report provide guidance for specific treatment op-tions in patient populations, the scores are not areplacement for clinical judgement and practice experi-ence in determining the best options for individual pa-tients. Each patient is unique, and the possible use ofdifferent treatment options deserves to be considered infull clinical context.

7.1. Trends and Themes in Scoring

In general, the indications rated as Appropriate includeprocedures in which the benefits generally outweigh therisks, the procedure is an effective option for individualcare, and the procedure is generally acceptable andreasonable for the indication. The clinical scenariosscored as May Be Appropriate often involve uncertainty orrequire additional clinical evidence to better define theappropriateness of the treatment. There may be utility forcertain treatment strategies in selected cases based uponclinical experience in the absence of comparative evi-dence. The appropriateness of a specific procedure in anyindividual must be determined by that patient’s physicianin consultation with the patient considering the risk tobenefit ratio. The indications rated as Rarely Appropriatecluster around options for the management of a patientwith either an adverse or an uncertain risk to benefit ratiothat are not generally considered to be effective therapy.The procedure may be recognized to be effective in iso-lated situations but is not generally used for these


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indications. Procedures in this category require docu-mentation of the rationale for choosing this treatmentincluding the individual patient circumstances.

The scenarios in this document are arranged accordingto the clinical decision points confronting vascular prac-titioners in everyday clinical practice. These include thepresence or absence of symptoms, presence or absenceof limb-threatening disease, severity and anatomicallocation of the culprit lesion, recurrent or de novo disease,the advantage of endovascular or surgical revasculariza-tion, and the expected durability of clinical benefit afteran intervention. The general principles used to identifyand define these clinical scenarios follow the 2015 ACC/AHA PAD Guideline, the TASC II document, and data fromrandomized controlled trials. The section on GeneralAssumptions further details these principles. It is impor-tant to note that the spectrum of vascular interventionscontinues to evolve rapidly, driven by technologicaladvances. The final scores, therefore, reflect the bodyof evidence and interventional treatment strategiesavailable at the time of rating.

Several common themes were identified among theratings of these clinical scenarios. Guideline-directedmedical therapy plus lifestyle and risk factor modificationare cornerstones of therapy in patients with peripheralartery disease irrespective of whether revascularizationis contemplated. There was consensus that patientswith incidentally discovered and clinically silent renovas-cular or peripheral artery disease rarely require revascu-larization. The therapeutic approach to these patientsshould focus on prevention of disease progression andreduction of cardiovascular morbidity and mortality.There was clear agreement that revascularization inpatients who experience intermittent claudicationshould only be considered if the symptoms are lifestylelimiting and do not improve with medical and exercisetherapy. The current best practice is to demonstratethe hemodynamic significance of intermediate-severityrenal artery stenosis before revascularization.

Renal artery revascularization to facilitate bloodpressure control is considered Rarely Appropriate inpatients in whom pharmacological options have notbeen exhausted or lesions of intermediate severity if thehemodynamic significance of the lesion has not beenconfirmed. Similarly, improving perfusion of an atrophic(<7 cm) kidney is unlikely to improve renal function. Incontrast, renal artery stenting is Appropriate when globalrenal hypoperfusion from a severely stenotic renal arteryresults in a decline of renal function or the developmentof “flash” pulmonary edema. Interventions May BeAppropriate and are guideline supported in patients witha severely stenotic renal artery and hypertension thatis refractory to maximal medical therapy (defined asmaximal tolerated doses of 3 medications, 1 of which is

a diuretic). Such interventions have been supported bysocietal guideline documents, but recent randomizedcontrolled studies have not adequately addressed thispatient population. Recurrent heart failure and uncon-trolled angina associated with severe RAS are complexsituations; therefore, renal artery revascularization wasrated as May Be Appropriate.

Sections 2 and 3 describe clinical scenarios encoun-tered in patients with lower-extremity PAD. With theexception of claudication that imposes lifestyle- orvocation-limiting symptoms, revascularization for inter-mittent claudication, predominantly caused by aortoiliacand femoropopliteal disease, is only Appropriate after atrial of guideline-directed medical therapy and exercise.The ratings reflect the improved durability and reducedmorbidity of endovascular therapy, particularly in pa-tients with native artery stenoses. Surgical revasculari-zation remains a reasonable option for patients inwhom anatomical or clinical features make endovasculartherapy less effective. For patients with CLI, the impor-tance of early revascularization is critical to limb salvage.The choice of a surgical or endovascular strategy dependson anatomical severity and location of the disease and thepatient’s clinical characteristics. Although asymptomaticPAD rarely warrants revascularization, the advent ofpercutaneous cardiac support devices and valve replace-ment therapies described in Section 4 may require arterialinterventions to facilitate vascular access.

Section 5 rates the currently available endovasculardevices in specific anatomical locations and diseaseburden defined by lesion length. These ratings tend toreflect the favorable data regarding the durable patencyof drug-coated balloons and drug-eluting stents in thefemoral arteries over conventional angioplasty, particu-larly in longer lesions. Drug-coated balloons have notbeen rigorously evaluated in the iliac arteries andhave not been included as a treatment option in thisanatomic region. Atherectomy is not well-suited for iliacarteries and is Rarely Appropriate in these vessels.Covered stents are Rarely Appropriate in the infrapopli-teal vessels because of the small vessel size and risk ofthrombosis.

Section 6 addresses an area of controversy driven by apaucity of well-designed studies comparing various formsof revascularization and medical therapy. The optimaltherapy for symptomatic femoral artery in-stent reste-nosis is unclear, although an endovascular treatmentis usually preferred as the first strategy. In general,revascularization is Rarely Appropriate in patientswithout symptoms. Surgical graft failure, involving a veinor prosthetic graft, is commonly addressed with endo-vascular intervention if the culprit lesion is a focalstenosis. The ratings reflect this common clinical practice.The decision whether to intervene at all and the choice



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of endovascular or surgical intervention in more complexgraft lesions depend on clinical symptoms, anatomicalfeatures, and patient characteristics.

The final trend noted in these AUC scenarios andtheir ratings reflects the anatomical complexity of arterydisease and the presence of coexisting medical comor-bidities influencing treatment decisions. Thus, a similaranatomical lesion and set of symptoms with varyingcoexisting medical comorbidities may warrant a differentrating for medical, endovascular, or surgical treatment.

7.2. Use of AUC to Improve Care

The writing group foresees several important applicationsof these AUC for both clinicians and patients. The mostobvious use of this document will be to support theclinical decision making of a physician as to the appro-priateness of care that they deliver to an individualpatient. It is important to acknowledge that an Appro-priate rating in this document should not be misconstruedas a mandate to perform a specific intervention in everypatient that meets the indications described herein.Rather, it should be interpreted as something that wouldbe reasonable to do if the intervention performed couldbenefit the patient.

It is also important to note that a Rarely Appropriaterating should not be misinterpreted as denoting anindication in which an intervention should never beperformed. This category was entitled “Inappropriate”in prior AUC documents, but due to substantialmisunderstandings, the AUC Task Force changed theterminology to Rarely Appropriate in 2013. This changeemphasized the role of clinical judgment and the exis-tence of individual patient circumstances that couldmake it reasonable to perform an intervention. Insteadof functioning as the arbitrator for individual cases,the purpose of the AUC lies more in identifying practicepatterns that deviate from the expected distribution.Indications rated as May Be Appropriate should beconsidered reasonable for an intervention, particularly ifthe physician determines that it could help the patient.These 2 categories should not be considered as the basisfor denying insurance coverage or reimbursement for theprocedure, as individual decision making is required todetermine what is best for each patient. Nevertheless, it isimportant for the clinicians performing these procedures

to recognize that healthcare facilities, accreditationbodies, and payers may use this document to ensurequality patient care and proper management of financialresources.

Ideally, this document will serve as an educational andquality improvement tool for addressing Rarely Appro-priate revascularizations either performed or referredby individual clinicians. Experience with prior AUCtopics has shown that physician engagement in qualityimprovement programs, plus tracking and benchmarkingof ordering behavior, has reduced the percentage ofRarely Appropriate interventions. Finally, the AUCprovide physician-driven and peer-reviewed recommen-dations that may reduce administrative controls or gov-ernment regulation if proven to be effective in reducingRarely Appropriate revascularizations.

8. CONCLUSION

This AUC report provides a guide for clinicians in deter-mining the role of different revascularization options inthe care of patients with PAD. Future studies to evaluateimplementation of these AUC in clinical settings will beuseful not only in identifying any deficiencies in thecurrent document, but also in defining patterns of carefor individual practitioners and understanding variationsin the delivery of care. The study of PAD is continuouslychanging as new devices, techniques, and approachesare developed, and a regular review of these clinicalscenarios will be imperative in moving the field forward.

ACC PRESIDENT AND STAFF

C. Michael Valentine, MD, FACC, PresidentTimothy W. Attebery, DSc, MBA, FACHE, Chief Executive

OfficerWilliam J. Oetgen, MD, FACC, Executive Vice President,

Science, Education, Quality, and PublishingJoseph M. Allen, MA, Senior Director, Clinical Policy and

PathwaysLara M. Gold, MA, Senior Research Specialist, Appropriate

Use CriteriaAmelia Scholtz, PhD, Publications Manager, Clinical

Policy and Pathways


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2. Carr JJ, Hendel RC, White RD, et al. 2013 appropriateutilization of cardiovascular imaging: a methodologyfor the development of joint criteria for the appro-priate utilization of cardiovascular imaging by theAmerican College of Cardiology Foundation andAmerican College of Radiology. J Am Coll Cardiol.2013;61:2199–206.

3. Patel MR, Spertus JA, Brindis RG, et al. ACCF pro-posed method for evaluating the appropriateness ofcardiovascular imaging. J Am Coll Cardiol. 2005;46:1606–13.

4. Gerhard-Herman MD, Gornik HL, Barrett C, et al.2016 AHA/ACC guideline on the management of pa-tients with lower extremity peripheral artery disease:executive summary: a report of the American Collegeof Cardiology/American Heart Association Task Forceon Clinical Practice Guidelines. J Am Coll Cardiol. 2017;69:1465–508.

5. Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNAguideline for the prevention, detection, evaluation,and management of high blood pressure in adults: areport of the American College of Cardiology/AmericanHeart Association Task Force on Clinical PracticeGuidelines. J Am Coll Cardiol. 2018;71:e127–248.

6. Cooper CJ, Murphy TP, Cutlip DE, et al. Stenting andmedical therapy for atherosclerotic renal-artery ste-nosis. N Engl J Med. 2014;370:13–22.

7. Hirsch AT, Haskal ZJ, Hertzer NR, et al. ACC/AHA2005 guidelines for the management of patients withperipheral arterial disease (lower extremity, renal,mesenteric, and abdominal aortic): executive summary:a collaborative report from the American Associationfor Vascular Surgery/Society for Vascular Surgery, So-ciety for Cardiovascular Angiography and In-terventions, Society for Vascular Medicine and Biology,Society of Interventional Radiology, and the ACC/AHATask Force on Practice Guidelines (Writing Committeeto Develop Guidelines for the Management of PatientsWith Peripheral Arterial Disease). J Am Coll Cardiol.2006;47:1239–312.

8. Mitchell JA, Subramanian R, White CJ, et al. Pre-dicting blood pressure improvement in hypertensivepatients after renal artery stent placement: renalfractional flow reserve. Catheter Cardiovasc Interv.2007;69:685–9.

9. Subramanian R, White CJ, Rosenfield K, et al. Renalfractional flow reserve: a hemodynamic evaluation of

moderate renal artery stenoses. Catheter CardiovascInterv. 2005;64:480–6.

10. Manoharan G, Pijls NH, Lameire N, et al. Assess-ment of renal flow and flow reserve in humans. J AmColl Cardiol. 2006;47:620–5.

11. Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society consensus for the management of peripheralarterial disease (TASC II). Eur J Vasc Endovasc Surg.2007;33 Suppl 1:S1–75.

12. Krankenberg H, Schluter M, Steinkamp HJ, et al.Nitinol stent implantation versus percutaneous trans-luminal angioplasty in superficial femoral artery lesionsup to 10 cm in length: the femoral artery stenting trial(FAST). Circulation. 2007;116:285–92.

13. Schillinger M, Sabeti S, Loewe C, et al. Balloonangioplasty versus implantation of nitinol stents in thesuperficial femoral artery. N Engl J Med. 2006;354:1879–88.

14. Tosaka A, Soga Y, Iida O, et al. Classification andclinical impact of restenosis after femoropoplitealstenting. J Am Coll Cardiol. 2012;59:16–23.

15. James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high bloodpressure in adults: report from the panel membersappointed to the Eighth Joint National Committee (JNC8). JAMA. 2014;311:507–20.

16. Pollak AW, Norton PT, Kramer CM. Multimodalityimaging of lower extremity peripheral arterial disease:current role and future directions. Circ Cardiovasc Im-aging. 2012;5:797–807.

17. Sobieszczyk P, Eisenhauer A. Management of pa-tients after endovascular interventions for peripheralartery disease. Circulation. 2013;128:749–57.

18. Hardman RL, Jazaeri O, Yi J, et al. Overview ofclassification systems in peripheral artery disease.Semin Intervent Radiol. 2014;31:378–88.

19. Murphy TP, Cutlip DE, Regensteiner JG, et al. Su-pervised exercise versus primary stenting for claudi-cation resulting from aortoiliac peripheral arterydisease: six-month outcomes from the claudication:exercise versus endoluminal revascularization(CLEVER) study. Circulation. 2012;125:130–9.

20. Murphy TP, Cutlip DE, Regensteiner JG, et al. Su-pervised exercise, stent revascularization, or medicaltherapy for claudication due to aortoiliac peripheralartery disease: the CLEVER study. J Am Coll Cardiol.2015;65:999–1009.

21. Fakhry F, Spronk S, van der Laan L, et al. Endo-vascular revascularization and supervised exercise for

peripheral artery disease and intermittent claudication:a randomized clinical trial. JAMA. 2015;314:1936–44.

22. Bodewes TCF, Darling JD, Deery SE, et al. Patientselection and perioperative outcomes of bypass andendovascular intervention as first revascularizationstrategy for infrainguinal arterial disease. J Vasc Surg.2018;67:206–16.e2.

23. Fakhry F, Fokkenrood HJ, Spronk S, et al. Endo-vascular revascularisation versus conservative man-agement for intermittent claudication. CochraneDatabase Syst Rev. 2018;3:CD010512.

24. Malgor RD, Alahdab F, Elraiyah TA, et al.A systematic review of treatment of intermittentclaudication in the lower extremities. J Vasc Surg.2015;61:54S–73S.

25. Soga Y, Iida O, Takahara M, et al. Two-year lifeexpectancy in patients with critical limb ischemia. J AmColl Cardiol Intv. 2014;7:1444–9.

26. Blackstone EH, Suri RM, Rajeswaran J, et al. Pro-pensity-matched comparisons of clinical outcomes af-ter transapical or transfemoral transcatheter aorticvalve replacement: a placement of aortic transcathetervalves (PARTNER)-I trial substudy. Circulation. 2015;131:1989–2000.

27. Turley RS, Mi X, Qualls LG, et al. The effect ofclinical care location on clinical outcomes after pe-ripheral vascular intervention in Medicare beneficiaries.J Am Coll Cardiol Intv. 2017;10:1161–71.

28. Dave RM, Patlola R, Kollmeyer K, et al. Excimerlaser recanalization of femoropopliteal lesions and 1-year patency: results of the CELLO registry. J EndovascTher. 2009;16:665–75.

29. Rosenfield K, Jaff MR, White CJ, et al. Trial of apaclitaxel-coated balloon for femoropopliteal arterydisease. N Engl J Med. 2015;373:145–53.

30. Dippel EJ, Makam P, Kovach R, et al. Randomizedcontrolled study of excimer laser atherectomy fortreatment of femoropopliteal in-stent restenosis:initial results from the EXCITE ISR trial (EXCImer LaserRandomized Controlled Study for Treatment of Fem-oropopliTEal In-Stent Restenosis). J Am Coll CardiolIntv. 2015;8:92–101.

31. Jones DW, Schanzer A, Zhao Y, et al. Growingimpact of restenosis on the surgical treatment of pe-ripheral arterial disease. J Am Heart Assoc. 2013;2:e000345.

KEY WORDS ACC Appropriate Use Criteria,peripheral artery disease, peripheral arteryintervention

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APPENDIX A. RELATIONSHIPS WITH INDUSTRY AND OTHER ENTITIES

Appropriate Use Criteria for Peripheral Artery Intervention:Members of the Writing Group, Rating Panel, ExternalReviewers, and AUC Task Force—Relationships With Industryand Other Entities (Relevant)

The ACC and the AUC Task Force continue to focusconsiderable attention on avoiding real or perceived re-lationships with industry (RWI) and other entities thatmight affect the rating of a test/procedure. The ACCmaintains a database that tracks all relevant relationshipsfor all ACC members and persons who participate in ACCactivities, including the development of AUC. A table ofrelevant disclosures by the writing group, rating panel,external reviewers, and AUC Task Force can be foundbelow. In addition, to ensure complete transparency, afull list of disclosure information—including relationshipsnot pertinent to this document—is available as an OnlineAppendix.

A more specific RWI policy applies to the Writing Groupand Rating Panel of AUC documents:n Writing Group: AUC Writing Groups must be chaired bya person with no relevant RWI. Although Writing Groupmembers play an important role in the development ofthe final published document for a given set of AUC,they do not have any role in the AUC rating process and

therefore have limited impact on how the documentswill guide clinical care. Accordingly, RWI restrictionsare not applied to Writing Group members, other thanthe Chair.

n Rating Panel: To avoid the potential for bias in theactual indication rating, fewer than 50% of RatingPanel members may have relevant RWI. AUC docu-ments utilize a modified Delphi consensus method asoutlined in the RAND Appropriateness Criteria Methodpaper and the ACC AUC Methodology paper. Thismethod utilizes a 2-step process: Delphi Method Step1) writing committee members develop a list of typicalclinical scenarios/indications; Delphi Method Step2) technical panel members review and rate the indi-vidual clinical scenarios. The RAND Delphi methodallows for the contribution of a wide range of view-points while minimizing and controlling bias throughan independent rating panel, a review of score disper-sion, use of the median rating to determine finalrecommendations, and a highly structured process fordetermining recommendations. As such, all ratingpanel members, even those with RWI, are allowed torate as part of the technical panel modified Delphiprocess.

http://jaccjacc.acc.org/Clinical_Document/PAI_AUC_Comprehensive_RWI_Table(10-30-18).pdf

http://jaccjacc.acc.org/Clinical_Document/PAI_AUC_Comprehensive_RWI_Table(10-30-18).pdf

Participant Employment Representing Consultant Speakers Bureau

Ownership/Partnership/Principal Person

Institutional, Organizational,or Other Financial Benefit Expert Witness

Writing Group

Steven R. Bailey, MD,Chair

University of Texas Health ScienceCenter at San Antonio—Program

Director, InterventionalCardiology; Professor of Medicine

and Radiology

ACC None None None n Bosto(DSM

Joshua A.Beckman, MD

Vanderbilt University MedicalCenter, Cardiovascular Fellowship

Program—Director

ACC None None None

Timothy D. Dao, MD Heart Place Plano—StaffCardiologist

ACC None None None

Sanjay Misra, MD Mayo Clinic, Division of Vascularand Interventional Radiology—

Professor of Radiology

SIR None None None n Flext

Piotr S.Sobieszczyk, MD

Brigham and Women’s Hospitaland Harvard Medical School,

Vascular Medicine Section, CardiacCatheterization Lab—Associate

Director

SVM None None None

Christopher J. White,MD

Ochsner Medical Center—Chief ofMedical Services; The OchsnerClinical School, University ofQueensland—Professor and

Chairman of Medicine

SCAI None None None

Rating Panel

Herbert D.Aronow, MD

Lifespan Cardiovascular Institute,Interventional Cardiology—

Director; Rhode Island and TheMiriam Hospitals, Cardiac

Catheterization Laboratories—Director; Warren Alpert MedicalSchool of Brown University—

Assistant Professor of Medicine

SVM None None None n PORT

Reza Fazel, MD Brigham and Women’s Hospital,Division of Cardiology—Associate

Physician

ACC None None None

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n ScientificB)

None None

None None None

None None None

end (DSMB) None None

None None None

None n Surmodics (ScientificAdvisory Board)

None

RAIT (Co-PI)* n Abbott Vascular†n Bard†n Gardia Medical†n Gore†

n Plaintiff, peripheralcoronary andvascular interven-tion appropriate-ness, 2014‡

None None None

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Ownership/Partnership/Principal Personal Research


Heather L.Gornik, MD

Cleveland Clinic FoundationCardiovascular Medicine, VascularMedicine—Section Head; ClevelandClinic Learner College of Medicine

of Case Western ReserveUniversity—Associate Professor of

Medicine

ACC None None n SummitDopplerSystems*

n AstraZeneca –

Euclid Trial (PI)‡None None

Bruce H. Gray, D.O. Greenville Health System,Endovascular Service—Director;University of South Carolina

School of Medicine—Professor ofSurgery/Vascular Medicine

SVM None None None n Abbott* n Cordis†n Gore†

None

Jonathan L. Halperin,MD

Mount Sinai Medical Center—Professor of Medicine

ACC None None None None None None

Alan T. Hirsch, MD University of Minnesota MedicalSchool—Professor of Medicine,Epidemiology, and Community

Health; Vascular MedicineProgram—Director

ACC None None None None None

Michael R. Jaff, DO Newton-Wellesley Hospital—President; Harvard Medical

School—Professor of Medicine

SCAI n VascularTherapies

n Volcano/Philips

None n Embolitech‡n Geminin Northwindn PQ Bypassn Sano Vn Valiant

Medicaln Venarum

None n Abbott Vascular (Advisor)*n Boston Scientific (Advisor)*n Cordis (Advisor)*n Medtronic Vascular

(Advisor)*

None

VenkataramuKrishnamurthy,MBBS

VA Ann Arbor Health System—

Chief of Radiology Services;University of Michigan Hospitals—Clinical Professor of Radiology and

Vascular Surgery

SIR None None None None None None

Sahil A. Parikh, MD Columbia University Irving MedicalCenter/ NY Presbyterian Hospital,Center for Interventional VascularTherapy, Endovascular Services—Director; Columbia University

Vagelos College of Physicians andSurgeons—Associate Professor of

Medicine

ACC n AbbottVascular‡

n Asahin Boston

Scientific‡n Medtronic‡n Spectraneticsn St. Jude Medicaln Terumo

n Lutonix/CRBard

n Spectraneticsn St. Jude

Medicaln Terumo‡

None n AstraZenecaPharmaceutical*

n Lutonix/CR Bardn Medtronicn Shockwave

Medical*n TriReme Medical*

n Abbott (Advisory Board)*n Boston Scientific (Advisory

Board)*n Medtronic (Advisory Board)*n Spectranetics (Advisory

Board)*n TriReme Medical†

None

Amy B. Reed, MD Fairview Vascular Services—Director; University of Minnesota,

Vascular and EndovascularSurgery—Professor and Chief

SVS None None None None None None


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Fadi Shamoun, MD Mayo Clinic, AnticoagulationClinic—Medical Director; Division

of Cardiovascular Diseases,Vascular Medicine—Assistant

Professor of Medicine


Rita E. Shugart, RN,RVT

Shugart Consulting—VascularUltrasound

SVU None None None None None None

E. Kent Yucel, MD Tufts Medical Center—Chair andProfessor of Radiology

ACR None None None None None None

External Reviewers

Christopher J.Abularrage, MD

The Johns Hopkins Hospital,Diabetic Foot and Wound Clinic—Director and Associate Professor

of Surgery

SVS n Medtronic None None None None None

H. Vernon Anderson,MD

Memorial Hermann Heart andVascular Institute, McGovern

Medical School, and University ofTexas Health Science Center—Professor of Medicine and

Cardiology


Ehrin J. Armstrong,MD, MSc

VA Eastern Colorado HealthcareSystem, Interventional

Cardiology—Cardiology Director;and Vascular Laboratory—Co-

Director; University of Colorado—Associate Professor of Medicine

AHA n Abbott Vascularn Abiomedn Boston

Scientificn Cardiovascular

Systemsn Medtronicn Spectranetics

None None None None None

Mark OttoBaerlocher, MD

Royal Victoria Hospital,Interventional Radiology—Chief

SIR n BostonScientific

None None None None None

Michael Conte, MD University of California SanFrancisco, Division of Vascular andEndovascular Surgery—Professor

and Chief; UCSF Heart andVascular Center—Co-Director;

UCSF Center for LimbPreservation—Co-Director

AHA n Cook Medicaln Medtronic

None None n Bard (DSMB) None None

Sean R. Dariushnia,MD

Emory University School ofMedicine, Department of

Radiology and Imaging Sciences,Division of Interventional

Radiology and Image-GuidedMedicine—Assistant Professor




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Alain T. Drooz, MD INOVA Fairfax Hospital—StaffPhysician

SVM n Philips/PercuNav*

n Possis Medical/BostonScientific*

None None n Bard (DSMB)n Cordis

None None

Joseph P. Hughes,RVT, RVS

NAVIX Diagnostix—Director ofBusiness Development; Society forVascular Ultrasound—President


J. Kevin McGraw, MD Riverside Methodist Hospital,Interventional Radiology—SectionHead; Riverside Radiology and

Interventional Associates


George H. Meier, MD,RVT

University of Cincinnati College ofMedicine, Vascular Surgery—Professor, Chief, and Program

Director


Jeffrey W. Olin,DO

Icahn School of Medicine at MountSinai, Cardiovascular Institute andCenter for Cardiovascular Health,Vascular Medicine and VascularDiagnostic Laboratory—Director

and Professor of Medicine(Cardiology)

ACC None None n Northwind‡ None None None

Gregory Piazza,MD

Brigham and Women’s Hospital,and Harvard Medical School—Assistant Professor of Medicine

ACC n BIO2 None None n Bristol-MyersSquibb‡

n Daiichin EKOS‡

None None

Eva M. Rzucidlo, MD McLeod Vascular Associates ofSouth Carolina—Vascular Surgeon;

Dartmouth Medical School—Associate Professor of Surgery

SVS None None None None None None

Drew C. Schemmer,MD

Royal Victoria Regional HealthCenter, Diagnostic Imaging,Vascular and Interventional

Radiology Department—VascularRadiologist


Marc Schermerhorn,MD

Beth Israel Deaconess MedicalCenter, Vascular and Endovascular

Surgery Department—Chief;Harvard Medical School—Professor

of Surgery

SVS n AbbottLaboratories‡

n Cookn Philips

None None n Medtronic Vascular– ENGAGE PAS (PI)*

n Boston Scientific Inc†n Medtronic Vascular†n W.L. Gore & Associates†

None


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Mehdi Shishehbor,MD

Cleveland Clinic, EndovascularServices—Director

ACC n Abbott*n BioClinica*n Boston

Scientific*n Medtronic*n Philips*n Shockwave

Medical*n Spectranetics*n Terumo*n Volcano*

None None None n Volcano/ Philips† None

David P. Slovut, MD,PhD, MHA

Network Performance Group—Director of Cardiovascular Quality;

Montefiore Medical Center,Cardiology, Patient Safety andQuality—Vice Chief; TAVR—Co-Director; Medicine andCardiovascular and Thoracic

Surgery—Professor

SVM None None None None None None

Eric H. Yang, MD Mayo Clinic of Arizona, CardiacCatheterization Laboratory—

Director

AHA None None None None None None

This table represents relevant relationships of participants with industry and other entities that were reported at the time this document was under development. The table does not necessarily reflect relationships with industry at the time of publication.A person has a relevant relationship IF: the relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; the company/entity (with whom the relationship exists) makes adrug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or the person or a member of the person’s household, has a reasonable potential for financial, professional, or other personal gain orloss as a result of the issues/content addressed in the document.A person is deemed to have a significant interest in a business if the interest represents ownership of $5% of the voting stock or share of the business entity, or ownership of $$5,000 of the fair market value of the business entity; or if funds received bythe person from the business entity exceed 5% of the person’s gross income for the previous year. Relationships in this table with no symbol are considered modest (less than significant under the preceding definition). Relationships that exist with nofinancial benefit are also included for the purpose of transparency. Please refer to http://www.acc.org/guidelines/about-guidelines-and-clinical-documents/relationships-with-industry-policy for definitions of disclosure categories or additional infor-mation about the ACC Disclosure Policy for Writing Committees. RWI and disclosure statements for members of the ACC Task Force on Appropriate Use Criteria can be found here: http://www.acc.org/guidelines/about-guidelines-and-clinical-documents/guidelines-and-documents-task-forces.*No financial benefit.†Clinical Trial Enroller.‡Significant relationship.

ACC ¼ American College of Cardiology; ACR ¼ American College of Radiology; AHA ¼ American Heart Association; AUC ¼ Appropriate Use Criteria; Co-PI ¼ Co-Principal Investigator; DSMB ¼ Data Safety Monitoring Board; PI ¼ Principal Investigator;SCAI ¼ Society for Cardiovascular Angiography and Interventions; SCVS ¼ Society for Clinical Vascular Surgery; SIR ¼ Society of Interventional Radiology; SVM ¼ Society for Vascular Medicine; SVS ¼ Society for Vascular Surgery; SVU ¼ Society forVascular Ultrasound; TAVR ¼ transcatheter aortic valve replacement.


VOL.73,NO.2,2019

Bailey

etal.

JANUARY

22,2019

:214–37

2018

AUCfor

PeripheralArtery

Intervention

237

http://www.acc.org/guidelines/about-guidelines-and-clinical-documents/relationships-with-industry-policy

http://www.acc.org/guidelines/about-guidelines-and-clinical-documents/guidelines-and-documents-task-forces

http://www.acc.org/guidelines/about-guidelines-and-clinical-documents/guidelines-and-documents-task-forces

appropriate use criteria acc/aha/scai/sir/svm 2018 ... · white cj. acc/aha/scai/sir/svm 2018...

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