2016 AHA/ACC Guideline on the Management of Patients

44 Pages·2017·3.73 MB·English

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY VOL. 69, NO. 11, 2017
ª2017 BY THE AMERICAN HEART ASSOCIATION, INC. AND ISSN 0735-1097/$36.00
AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION http://dx.doi.org/10.1016/j.jacc.2016.11.008
PUBLISHED BY ELSEVIER
CLINICAL PRACTICE GUIDELINE: EXECUTIVE SUMMARY
2016 AHA/ACC Guideline on the
Management of Patients With Lower
Extremity Peripheral Artery Disease:
Executive Summary
AReportoftheAmericanCollegeofCardiology/AmericanHeartAssociation
TaskForceonClinicalPracticeGuidelines
DevelopedinCollaborationWiththeAmericanAssociationofCardiovascularandPulmonaryRehabilitation,
Inter-SocietyConsensusfortheManagementofPeripheralArterialDisease,
SocietyforCardiovascularAngiographyandInterventions,SocietyforClinicalVascularSurgery,
SocietyofInterventionalRadiology,SocietyforVascularMedicine,SocietyforVascularNursing,
SocietyforVascularSurgery,andVascularandEndovascularSurgerySociety
Writing MarieD.Gerhard-Herman,MD,FACC,FAHA,Chair MehdiH.Shishehbor,DO,MPH,PHD,FACC,FAHA,
Committee HeatherL.Gornik,MD,FACC,FAHA,FSVM,ViceChair* FSCAI*z
Members* KerryJ.Stewart,EDD,FAHA,MAACVPRzkk
ColettaBarrett,RNy DianeTreat-Jacobson,PHD,RN,FAHAz
NealR.Barshes,MD,MPHz M.EileenWalsh,PHD,APN,RN-BC,FAHA{{
MatthewA.Corriere,MD,MS,FAHAx
DouglasE.Drachman,MD,FACC,FSCAI*k
LeeA.Fleisher,MD,FACC,FAHA{ *Writingcommitteemembersarerequiredtorecusethemselvesfrom
votingonsectionstowhichtheirspecificrelationshipswithindustryand
FrancisGerryR.Fowkes,MD,FAHA*#
otherentitiesmayapply;seeAppendix1forrecusalinformation.
NaomiM.Hamburg,MD,FACC,FAHAz yFunctioningasthelayvolunteer/patientrepresentative.zACC/AHA
ScottKinlay,MBBS,PHD,FACC,FAHA,FSVM,FSCAI*** Representative.xVascularandEndovascularSurgerySociety
RobertLookstein,MD,FAHA,FSIR*z Representative.kSocietyforCardiovascularAngiographyand
InterventionsRepresentative.{ACC/AHATaskForceonClinicalPractice
SanjayMisra,MD,FAHA,FSIR*yy
GuidelinesLiaison.#Inter-SocietyConsensusfortheManagementof
LeilaMureebe,MD,MPH,RPVIzz PeripheralArterialDiseaseRepresentative.**SocietyforVascular
JeffreyW.Olin,DO,FACC,FAHA*z MedicineRepresentative.yySocietyofInterventionalRadiology
RajanA.G.Patel,MD,FACC,FAHA,FSCAI# Representative.zzSocietyforClinicalVascularSurgeryRepresentative.
xxSocietyforVascularSurgeryRepresentative.kkAmericanAssociationof
JudithG.Regensteiner,PHD,FAHAz CardiovascularandPulmonaryRehabilitationRepresentative.{{Society
AndresSchanzer,MD*xx forVascularNursingRepresentative.
ThisdocumentwasapprovedbytheAmericanCollegeofCardiologyBoardofTrusteesinOctober2016,theAmericanHeartAssociationScience
AdvisoryandCoordinatingCommitteeinSeptember2016,andtheAmericanHeartAssociationExecutiveCommitteeinOctober2016.
TheAmericanCollegeofCardiologyrequeststhatthisdocumentbecitedasfollows:Gerhard-HermanMD,GornikHL,BarrettC,BarshesNR,CorriereMA,
DrachmanDE,FleisherLA,FowkesFGR,HamburgNM,KinlayS,LooksteinR,MisraS,MureebeL,OlinJW,PatelRAG,RegensteinerJG,SchanzerA,
ShishehborMH,StewartKJ,Treat-JacobsonD,WalshME.2016AHA/ACCguidelineonthemanagementofpatientswithlowerextremityperipheralartery
disease:executivesummary:areportoftheAmericanCollegeofCardiology/AmericanHeartAssociationTaskForceonClinicalPracticeGuidelines.JAm
CollCardiol2017;69:1465–508.
ThisarticlehasbeencopublishedinCirculationandreprintedinVascularMedicine.
Copies:ThisdocumentisavailableontheWorldWideWebsitesoftheAmericanCollegeofCardiology(www.acc.org)andtheAmericanHeartAssociation
(professional.heart.org).Forcopiesofthisdocument,pleasecontactElsevierReprintDepartmentviafax(212-633-3820)ore-mail([email protected]).
Permissions:Multiplecopies,modification,alteration,enhancement,and/ordistributionofthisdocumentarenotpermittedwithouttheexpress
permissionoftheAmericanCollegeofCardiology.RequestsmaybecompletedonlineviatheElseviersite(http://www.elsevier.com/about/policies/
author-agreement/obtaining-permission).
1466 Gerhard-Hermanetal. JACC VOL. 69, NO. 11, 2017
2016AHA/ACCLowerExtremityPADGuideline:ExecutiveSummary MARCH 21, 2017:1465–508
ACC/AHATask JonathanL.Halperin,MD,FACC,FAHA,Chair LeeA.Fleisher,MD,FACC,FAHA
ForceMembers GlennN.Levine,MD,FACC,FAHA,Chair-Elect FedericoGentile,MD,FACC
SamuelGidding,MD,FAHA
SanaM.Al-Khatib,MD,MHS,FACC,FAHA MarkA.Hlatky,MD,FACC
KimK.Birtcher,PHARMD,MS,AACC JohnIkonomidis,MD,PHD,FAHA
BiykemBozkurt,MD,PHD,FACC,FAHA JoséJoglar,MD,FACC,FAHA
RalphG.Brindis,MD,MPH,MACC SusanJ.Pressler,PHD,RN,FAHA
JoaquinE.Cigarroa,MD,FACC DumindaN.Wijeysundera,MD,PHD
LesleyH.Curtis,PHD,FAHA
TABLE OF CONTENTS
PREAMBLE.................................... 1467 5.5. HomocysteineLowering ................... 1481
5.6. InfluenzaVaccination...................... 1481
1.INTRODUCTION ............................. 1469
6.STRUCTUREDEXERCISETHERAPY:
1.1. MethodologyandEvidenceReview .......... 1469
RECOMMENDATIONS ....................... 1481
1.2. OrganizationoftheWritingCommittee ....... 1470
7.MINIMIZINGTISSUELOSSINPATIENTSWITH
1.3. DocumentReviewandApproval............. 1470
PAD:RECOMMENDATIONS .................. 1482
1.4. ScopeofGuideline ........................ 1470
8.REVASCULARIZATIONFORCLAUDICATION:
2.CLINICALASSESSMENTFORPAD ............. 1470 RECOMMENDATIONS ....................... 1483
2.1. HistoryandPhysicalExamination: 8.1. RevascularizationforClaudication .......... 1483
Recommendations......................... 1472
8.1.1.EndovascularRevascularizationfor
Claudication ....................... 1484
3.DIAGNOSTICTESTINGFORTHEPATIENTWITH
8.1.2.SurgicalRevascularizationfor
SUSPECTEDLOWEREXTREMITYPAD Claudication ....................... 1484
(CLAUDICATIONORCLI):RECOMMENDATIONS . 1473
9.MANAGEMENTOFCLI:RECOMMENDATIONS .. 1485
3.1. RestingABIforDiagnosingPAD ............. 1473
9.1. RevascularizationforCLI.................. 1485
3.2. PhysiologicalTesting ...................... 1474
9.1.1.EndovascularRevascularizationforCLI... 1486
3.3. ImagingforAnatomicAssessment ........... 1478
9.1.2.SurgicalRevascularizationforCLI...... 1487
9.2. WoundHealingTherapiesforCLI........... 1487
4.SCREENINGFORATHEROSCLEROTICDISEASEIN
OTHERVASCULARBEDSFORTHEPATIENTWITH 10.MANAGEMENTOFACUTELIMBISCHEMIA:
PAD:RECOMMENDATIONS ................... 1478 RECOMMENDATIONS ....................... 1487
4.1. AbdominalAorticAneurysm ................ 1478 10.1. ClinicalPresentationofALI ............... 1489
4.2. ScreeningforAsymptomaticAtherosclerosisin 10.2. MedicalTherapyforALI ................. 1489
OtherArterialBeds(Coronary,Carotid,and
RenalArteries) ........................... 1478 10.3. RevascularizationforALI................. 1489
10.4. DiagnosticEvaluationoftheCauseofALI ...1490
5.MEDICALTHERAPYFORTHEPATIENTWITHPAD:
RECOMMENDATIONS ........................ 1478 11.LONGITUDINALFOLLOW-UP:
RECOMMENDATIONS ....................... 1490
5.1. Antiplatelet,Statin,AntihypertensiveAgents,
andOralAnticoagulation................... 1479
12.EVIDENCEGAPSANDFUTURERESEARCH
5.2. SmokingCessation ........................1480 DIRECTIONS ............................... 1491
5.3. GlycemicControl .........................1480
13.ADVOCACYPRIORITIES ..................... 1491
5.4. Cilostazol,Pentoxifylline,andChelation
Therapy.................................1480 REFERENCES ................................. 1492
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APPENDIX1 Modernization
AuthorRelationshipsWithIndustryand Processes have evolved to support the evolution of
OtherEntities(Relevant)...................... 1500 guidelinesas“livingdocuments”thatcanbedynamically
updated. This process delineates a recommendation to
address a specific clinical question, followed by concise
APPENDIX2
text (ideally <250 words) and hyperlinked to supportive
ReviewerRelationshipsWithIndustryand evidence. This approach accommodates time constraints
OtherEntities(Comprehensive) ................ 1502
on busy clinicians and facilitates easier access to recom-
mendations via electronic search engines and other
APPENDIX3 evolvingtechnology.
Abbreviations ............................... 1508
EvidenceReview
Writingcommitteemembersreviewtheliterature;weigh
the quality of evidence for or against particular tests,
PREAMBLE treatments,or procedures;andestimateexpectedhealth
outcomes. In developing recommendations, the writing
Since1980,theAmericanCollegeofCardiology(ACC)and committee uses evidence-based methodologies that are
AmericanHeartAssociation(AHA)havetranslatedscien- basedonallavailabledata(3–7).Literaturesearchesfocus
tific evidence into clinical practice guidelines with rec- on randomized controlled trials (RCTs) but also include
ommendations to improve cardiovascular health. These registries, nonrandomized comparative and descriptive
guidelines,basedonsystematicmethodstoevaluateand studies, case series, cohort studies, systematic reviews,
classify evidence, provide a cornerstone of quality car- andexpertopinion.Onlyselectedreferencesarecited.
diovascularcare. The Task Force recognizes the need for objective,
In response to reports from the Institute of Medicine independent Evidence Review Committees (ERCs) that
(1,2) and a mandate to evaluate new knowledge and include methodologists, epidemiologists, clinicians, and
maintain relevance at the point of care, the ACC/ biostatisticians who systematically survey, abstract, and
AHA Task Force on Clinical Practice Guidelines (Task assess the evidence to address systematic review ques-
Force) modified its methodology (3–5). The relationships tions posed in the PICOTS format (P¼population,
among guidelines, data standards, appropriate use I¼intervention, C¼comparator, O¼outcome, T¼timing,
criteria, and performance measures are addressed else- S¼setting) (2,4–6). Practical considerations, including
where(5). time and resource constraints, limit the ERCs to evi-
dence that is relevant to key clinical questions and
IntendedUse lends itself to systematic review and analysis that could
Practice guidelines provide recommendations applicable affect the strength of corresponding recommendations.
to patients with or at risk of developing cardiovascular
Guideline-DirectedManagementandTreatment
disease. The focus is on medical practice in the United
States, but guidelines developed in collaboration with The term “guideline-directed management and therapy”
other organizations may have a broader target. (GDMT) refers to care defined mainly by ACC/AHA
Although guidelines may be used to inform regulatory Class I recommendations. For these and all recom-
or payer decisions, the intent is to improve quality of mended drug treatment regimens, the reader should
care and align with patients’ interests. Guidelines are confirm dosage with product insert material and care-
intended to define practices meeting the needs of pa- fully evaluate for contraindications and interactions.
tients in most, but not all, circumstances, and should Recommendations are limited to treatments, drugs,
not replace clinical judgment. Guidelines are reviewed and devices approved for clinical use in the United
annually by the Task Force and are official policy of States.
the ACC and AHA. Each guideline is considered current
until it is updated, revised, or superseded by published ClassofRecommendationandLevelofEvidence
addenda, statements of clarification, focused updates, The ClassofRecommendation(COR; i.e.,the strengthof
or revised full-text guidelines. To ensure that guide- the recommendation) encompasses the anticipated
lines remain current, new data are reviewed biannually magnitude and certainty of benefit in proportion to risk.
to determine whether recommendations should be The Level of Evidence (LOE) rates evidence supporting
modified. In general, full revisions are posted in 5-year the effect of the intervention on the basis of the type,
cycles (3–6). quality, quantity, and consistency of data from clinical
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ApplyingClassofRecommendationandLevelofEvidencetoClinicalStrategies,Interventions,Treatments,or
TABLE 1
DiagnosticTestinginPatientCare*(UpdatedAugust2015)
trials and other reports (Table 1) (3–5). Unless otherwise RelationshipsWithIndustryandOtherEntities
stated, recommendations are sequenced by COR and The ACC and AHA sponsor the guidelines without com-
then by LOE. Where comparative data exist, preferred mercial support, and members volunteer their time. The
strategies take precedence. When >1 drug, strategy, or Task Force zealously avoids actual, potential, or
therapy exists within the same COR and LOE and no perceived conflicts of interest that might arise through
comparative data are available, options are listed relationships with industry or other entities (RWI). All
alphabetically. writingcommitteemembersandreviewersarerequiredto
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MARCH 21, 2017:1465–508 2016AHA/ACCLowerExtremityPADGuideline:ExecutiveSummary
disclose current industry relationships or personal and indexed in MEDLINE (through PubMed), EMBASE,
interests,from12monthsbeforeinitiationofthewriting theCochraneLibrary,theAgencyforHealthcareResearch
effort.ManagementofRWIinvolvesselectingabalanced and Quality, and other selected databases relevant to
writingcommittee andassuringthatthechair andama- this guideline, was conducted from January through
jority of committee members have no relevant RWI September 2015. Key search words included but were
(Appendix 1). Members are restricted with regard to not limited to the following: acute limb ischemia, angio-
writing or voting on sections to which their RWI apply. plasty, ankle-brachial index, anticoagulation, antiplatelet
For transparency, members’ comprehensive disclosure therapy, atypical leg symptoms, blood pressure lowering/
information is available online. Comprehensive disclo- hypertension,bypassgraft/bypassgrafting/surgicalbypass,
sure information for the Task Force is also available cilostazol, claudication/intermittent claudication, critical
online. limb ischemia/severe limb ischemia, diabetes, diagnostic
The Task Force strives to avoid bias by selecting ex- testing, endovascular therapy, exercise rehabilitation/
perts from a broad array of backgrounds representing exercise therapy/exercise training/supervised exercise,
different geographic regions, sexes, ethnicities, intellec- lower extremity/foot wound/ulcer, peripheral artery dis-
tual perspectives/biases, and scopes of clinical practice, ease/peripheral arterial disease/peripheral vascular dis-
and by inviting organizations and professional societies ease/lower extremity arterial disease, smoking/smoking
with related interests and expertise to participate as cessation,statin,stenting,andvascularsurgery.Additional
partnersorcollaborators. relevant studies published through September 2016,
during the guideline writing process, were also consid-
IndividualizingCareinPatientsWithAssociatedConditions eredbythewritingcommittee,andaddedtotheevidence
andComorbidities tables when appropriate. The final evidence tables
included in the Online Data Supplement summarize the
Managing patients with multiple conditions can be com-
evidence utilized by the writing committee to formulate
plex, especially when recommendations applicable to
recommendations. Additionally, the writing committee
coexistingillnessesarediscordantorinteracting(8).The
guidelines are intended to define practices meeting reviewed documents related to lower extremity PAD
previously published by the ACC and AHA (10,11). Refer-
theneedsofpatientsinmost,butnotall,circumstances.
The recommendations should not replace clinical ences selected and published in this document are
judgment. representativeandnotall-inclusive.
As stated in the Preamble, the ACC/AHA guideline
methodologyprovidesforcommissioninganindependent
ClinicalImplementation
ERC to address systematic review questions (PICOTS
Management inaccordancewithguideline recommenda-
format) to inform recommendations developed by the
tions is effective only when followed. Adherence to rec-
writingcommittee.Allotherguidelinerecommendations
ommendations can be enhanced by shared decision
(notbasedonthesystematicreviewquestions)werealso
making between clinicians and patients, with patient
subjected to an extensive evidence review process. For
engagement in selecting interventions on the basis of
thisguideline,thewritingcommitteeinconjunctionwith
individualvalues,preferences,andassociatedconditions
the Task Force and ERC Chair identified the following
and comorbidities. Consequently, circumstances may
systematic review questions: 1) Is antiplatelet therapy
arise in which deviations from these guidelines are
beneficial for prevention of cardiovascular events in the
appropriate.
patient with symptomatic or asymptomatic lower ex-
Thereaderisencouragedtoconsultthefull-textguide-
tremity PAD? 2) What is the effect of revascularization,
line(9)foradditionalguidanceanddetailswithregardto
compared with optimal medical therapy and exercise
lower extremity peripheral artery disease (PAD) because
training, on functional outcome andquality of life (QoL)
theexecutivesummarycontainslimitedinformation.
among patients with claudication? Each question has
JonathanL.Halperin,MD,FACC,FAHA
been the subject of recently published, systematic evi-
Chair,ACC/AHATaskForceonClinicalPracticeGuidelines
dence reviews (12–14). The quality of these evidence re-
viewswasappraisedbytheACC/AHAmethodologistand
1. INTRODUCTION
a vendor contracted to support this process (Doctor Evi-
dence [Santa Monica, CA]). Few substantive randomized
1.1. MethodologyandEvidenceReview or nonrandomized studies had been published after the
Therecommendationslistedinthisguidelineare,when- end date of the literature searches used for the existing
ever possible, evidence based. An initial extensive evi- evidence reviews, so the ERC concluded that no addi-
dence review, which included literature derived from tionalsystematic review was necessary toaddresseither
researchinvolvinghumansubjects,publishedinEnglish, ofthesecriticalquestions.
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2016AHA/ACCLowerExtremityPADGuideline:ExecutiveSummary MARCH 21, 2017:1465–508
Athirdsystematicreviewquestionwasthenidentified: Vascular andEndovascular SurgerySociety;and16addi-
3)Isonerevascularizationstrategy(endovascularorsur- tional individual content reviewers. Reviewers’ RWI in-
gical)associatedwithimprovedcardiovascularandlimb- formationwasdistributedtothewritingcommitteeandis
related outcomes in patients with critical limb ischemia publishedinthisdocument(Appendix2).
(CLI)? This question had also been the subject of a high- This document was approved for publication by
quality systematic review that synthesized evidence thegoverningbodiesoftheACCandtheAHAandendorsed
fromobservationaldataandanRCT(15);additionalRCTs by the American Association of Cardiovascular and Pul-
addressingthisquestionareongoing(16–18).Thewriting monary Rehabilitation, Inter-Society Consensus for the
committee and the Task Force decided to expand the Management of Peripheral Arterial Disease, Society for
survey to include more relevant randomized and obser- Cardiovascular Angiography and Interventions, Society
vational studies. Based on evaluation of this additional for Clinical Vascular Surgery, Society of Interventional
evidencetheERCdecidedthatfurthersystematicreview Radiology, Society for Vascular Medicine, Society for
was not needed to inform the writing committee on this Vascular Nursing, Society for Vascular Surgery, and
question. Hence, the ERC and writing committee VascularandEndovascularSurgerySociety.
concluded that available systematic reviews could be
used to inform the development of recommendations 1.4. ScopeofGuideline
addressing each of the 3 systematic review questions LowerextremityPADisacommoncardiovasculardisease
specified above. The members of the Task Force and that is estimated to affect approximately 8.5 million
writing committee thank the members of the ERC that Americans above the age of 40 years and is associated
beganthisprocessandtheirwillingnesstoparticipatein with significant morbidity, mortality, and QoL impair-
this volunteer effort. They include Aruna Pradhan, MD, ment (19). It has been estimated that 202 million people
MPH (ERC Chair); Natalie Evans, MD; Peter Henke, MD; worldwidehavePAD(20).Thepurposeofthisdocument
Dharam J. Kumbhani, MD, SM, FACC; and Tamar istoprovideacontemporaryguidelinefordiagnosisand
Polonsky,MD. management of patients with lower extremity PAD. This
documentsupersedesrecommendationsrelatedtolower
1.2. OrganizationoftheWritingCommittee extremity PAD in the “ACC/AHA 2005 Guidelines for the
The writing committee consisted of clinicians, including ManagementofPatientsWithPeripheralArterialDisease”
noninvasive and interventional cardiologists, exercise (10) and the “2011 ACCF/AHA Focused Update of the
physiologists, internists, interventional radiologists, GuidelinefortheManagementofPatientsWithPeripheral
vascular nurses, vascular medicine specialists, and ArteryDisease”(11).Thescopeofthisguidelineislimited
vascular surgeons, as well as clinical researchers in the to atherosclerotic disease of the lower extremity arteries
field of vascular disease, a nurse (in the role of patient (PAD) and includes disease of the aortoiliac, femo-
representative), and members with experience in epide- ropopliteal, and infrapopliteal arterial segments. It does
miology and/or health services research. The writing notaddressnonatheroscleroticcausesoflowerextremity
committee included representatives from the ACC and arterial disease, such as vasculitis, fibromuscular
AHA, American Association of Cardiovascular and Pul- dysplasia, physiological entrapment syndromes, cystic
monary Rehabilitation, Inter-Society Consensus for the adventitialdisease,andother entities.Futureguidelines
Management of Peripheral Arterial Disease, Society for will address aneurysmal disease of the abdominal aorta
Cardiovascular Angiography and Interventions, Society andlowerextremityarteriesanddiseasesoftherenaland
for Clinical Vascular Surgery, Society of Interventional mesentericarteries.
Radiology, Society for Vascular Medicine, Society for Forthepurposesofthisguideline,keytermsassociated
Vascular Nursing, Society for Vascular Surgery, and withPADaredefinedinTable2.
VascularandEndovascularSurgerySociety.
2. CLINICAL ASSESSMENT FOR PAD
1.3. DocumentReviewandApproval
This document was reviewed by 2 official reviewers Evaluating the patient at increased risk of PAD (Table 3)
nominated by the ACC and AHA; 1 to 2 reviewers each beginswiththeclinicalhistory,reviewofsymptoms,and
from the American Association of Cardiovascular and physical examination. The symptoms and signs of PAD
PulmonaryRehabilitation,Inter-SocietyConsensusforthe are variable. Patients with PAD may experience the
Management of Peripheral Arterial Disease, Society for classic symptom of claudication or may present with
Cardiovascular Angiography and Interventions, Society advanced disease, including CLI. Studies have demon-
for Clinical Vascular Surgery, Society of Interventional stratedthatthemajority ofpatientswithconfirmedPAD
Radiology, Society for Vascular Medicine, Society for do not have typical claudication but have other non–
Vascular Nursing, Society for Vascular Surgery, and joint-related limb symptoms (atypical leg symptoms) or
JACC VOL. 69, NO. 11, 2017 Gerhard-Hermanetal. 1471
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TABLE 2 DefinitionofPADKeyTerms
Term Definition
Claudication Fatigue,discomfort,cramping,orpainofvascularorigininthemusclesofthelowerextremitiesthatisconsistentlyinducedby
exerciseandconsistentlyrelievedbyrest(within10min).
Acutelimbischemia(ALI) Acute(<2wk),severehypoperfusionofthelimbcharacterizedbythesefeatures:pain,pallor,pulselessness,poikilothermia(cold),
paresthesias,andparalysis.
n OneofthesecategoriesofALIisassigned(Section10):
I. Viable—Limbisnotimmediatelythreatened;nosensoryloss;nomuscleweakness;audiblearterialandvenousDoppler.
II. Threatened—Mild-to-moderatesensoryormotorloss;inaudiblearterialDoppler;audiblevenousDoppler;maybe
furtherdividedintoIIa(marginallythreatened)orIIb(immediatelythreatened).
III. Irreversible—Majortissuelossorpermanentnervedamageinevitable;profoundsensoryloss,anesthetic;profound
muscleweaknessorparalysis(rigor);inaudiblearterialandvenousDoppler(21,22).
Tissueloss Typeoftissueloss:
n Minor—nonhealingulcer,focalgangrenewithdiffusepedalischemia.
n Major—extendingabovetransmetatarsallevel;functionalfootnolongersalvageable(21).
Criticallimbischemia(CLI) Aconditioncharacterizedbychronic($2wk)ischemicrestpain,nonhealingwound/ulcers,organgrenein1orbothlegsattributable
toobjectivelyprovenarterialocclusivedisease.
n ThediagnosisofCLIisaconstellationofbothsymptomsandsigns.ArterialdiseasecanbeprovedobjectivelywithABI,TBI,
TcPO2,orskinperfusionpressure.Supplementaryparameters,suchasabsoluteankleandtoepressuresandpulsevolume
recordings,mayalsobeusedtoassessforsignificantarterialocclusivedisease.However,averylowABIorTBIdoesnot
necessarilymeanthepatienthasCLI.ThetermCLIimplieschronicityandistobedistinguishedfromALI(23).
In-linebloodflow Directarterialflowtothefoot,excludingcollaterals.
Functionalstatus Patient’sabilitytoperformnormaldailyactivitiesrequiredtomeetbasicneeds,fulfillusualroles,andmaintainhealthandwell-
being.Walkingabilityisacomponentoffunctionalstatus.
Nonviablelimb Conditionofextremity(orportionofextremity)inwhichlossofmotorfunction,neurologicalfunction,andtissueintegritycannotbe
restoredwithtreatment.
Salvageablelimb Conditionofextremitywithpotentialtosecureviabilityandpreservemotorfunctiontotheweight-bearingportionofthefootif
treated.
Structuredexerciseprogram Plannedprogramthatprovidesindividualizedrecommendationsfortype,frequency,intensity,anddurationofexercise.
n Programprovidesrecommendationsforexerciseprogressiontoassurethatthebodyisconsistentlychallengedtoincrease
exerciseintensityandlevelsasfunctionalstatusimprovesovertime.
n Thereare2typesofstructuredexerciseprogramforpatientswithPAD:
1. Supervisedexerciseprogram
2. Structuredcommunity-orhome-basedexerciseprogram
Supervisedexerciseprogram Structuredexerciseprogramthattakesplaceinahospitaloroutpatientfacilityinwhichintermittentwalkingexerciseisusedasthe
treatmentmodality.
n Programcanbestandaloneorcanbemadeavailablewithinacardiacrehabilitationprogram.
n Programisdirectlysupervisedbyqualifiedhealthcareprovider(s).
n Trainingisperformedforaminimumof30to45minpersession,insessionsperformedatleast3times/wkforaminimum
of12wk(24–34).Patientsmaynotinitiallyachievethesetargets,andatreatmentgoalistoprogresstotheselevelsover
time.
n Traininginvolvesintermittentboutsofwalkingtomoderate-to-maximumclaudication,alternatingwithperiodsofrest.
n Warm-upandcool-downperiodsprecedeandfolloweachsessionofwalking.
Structuredcommunity-or Structuredexerciseprogramthattakesplaceinthepersonalsettingofthepatientratherthaninaclinicalsetting(29,35–39).
home-based n Programisself-directedwiththeguidanceofhealthcareproviderswhoprescribeanexerciseregimensimilartothatofa
exerciseprogram supervisedprogram.
n Patientcounselingensuresthatpatientsunderstandhowtobegintheprogram,howtomaintaintheprogram,andhowto
progressthedifficultyofthewalking(byincreasingdistanceorspeed).
n Programmayincorporatebehavioralchangetechniques,suchashealthcoachingand/oruseofactivitymonitors.
Emergencyversusurgent n Anemergencyprocedureisoneinwhichlifeorlimbisthreatenedifthepatientisnotintheoperatingroomorinter-
ventionalsuiteand/orwherethereistimefornoorverylimitedclinicalevaluation,typicallywithin<6h.
n Anurgentprocedureisoneinwhichtheremaybetimeforalimitedclinicalevaluation,usuallywhenlifeorlimbis
threatenedifthepatientisnotintheoperatingroomorinterventionalsuite,typicallybetween6and24h.
Continuedonthenextpage
are asymptomatic (40,41). Patients with PAD who have confirm the diagnosis of PAD, abnormal physical exami-
atypical leg symptoms or no symptoms may have func- nationfindingsmustbeconfirmedwithdiagnostictesting
tional impairment comparable to patients with claudica- (Section3),generallywiththeankle-brachialindex(ABI)
tion (42). The vascular examination for PAD includes astheinitialtest.
pulse palpation, auscultation for femoral bruits, and in- Patients with confirmed diagnosis of PAD are at
spectionofthelegsandfeet.Lowerextremitypulsesare increased risk for subclavian artery stenosis (43–45). An
assessedandratedasfollows:0,absent;1,diminished;2, inter-armbloodpressuredifferenceof>15to20mmHgis
normal; or 3, bounding. See Table 4 for history and abnormal and suggestive of subclavian (or innominate)
physical examination findings suggestive of PAD. To artery stenosis. Measuring blood pressure in both arms
1472 Gerhard-Hermanetal. JACC VOL. 69, NO. 11, 2017
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TABLE 2 Continued
Term Definition
Interdisciplinarycareteam AteamofprofessionalsrepresentingdifferentdisciplinestoassistintheevaluationandmanagementofthepatientwithPAD.
n ForthecareofpatientswithCLI,theinterdisciplinarycareteamshouldincludeindividualswhoareskilledinendovascular
revascularization,surgicalrevascularization,woundhealingtherapiesandfootsurgery,andmedicalevaluationandcare.
n Interdisciplinarycareteammembersmayinclude:
n Vascularmedicalandsurgicalspecialists(i.e.,vascularmedicine,vascularsurgery,interventionalradiology,
interventionalcardiology)
n Nurses
n Orthopedicsurgeonsandpodiatrists
n Endocrinologists
n Internalmedicinespecialists
n Infectiousdiseasespecialists
n Radiologyandvascularimagingspecialists
n Physicalmedicineandrehabilitationclinicians
n Orthoticsandprostheticsspecialists
n Socialworkers
n Exercisephysiologists
n Physicalandoccupationaltherapists
n Nutritionists/dieticians
Cardiovascularischemicevents Acutecoronarysyndrome(acuteMI,unstableangina),stroke,orcardiovasculardeath.
Limb-relatedevents Worseningclaudication,newCLI,newlowerextremityrevascularization,ornewischemicamputation.
ABIindicatesankle-brachialindex;ALI,acutelimbischemia;CLI,criticallimbischemia;MI,myocardialinfarction;PAD,peripheralarterydisease;TBI,toe-brachialindex;andTcPO2,
transcutaneousoxygenpressure.
TABLE 3 PatientsatIncreasedRiskofPAD
n Age$65y
n Age 50–64 y, with risk factors for atherosclerosis (e.g., diabetes mellitus, history of smoking, hyperlipidemia,
hypertension) or family history of PAD (52)
n Age<50y,withdiabetesmellitusand1additionalriskfactorforatherosclerosis
n Individualswithknownatheroscleroticdiseaseinanothervascularbed(e.g.,coronary,carotid,subclavian,renal,mesenteric
arterystenosis,orAAA)
AAAindicatesabdominalaorticaneurysm;PAD,peripheralarterydisease.
identifies the arm with the highest systolic pressure, a in the treatment of hypertension (i.e., blood pressure is
requirement for accurate measurement of the ABI (46). takenatthearmwithhighermeasurements).
Identificationofunequalbloodpressuresinthearmsalso See Online Data Supplements 1 and 2 for data sup-
allowsformoreaccuratemeasurementofbloodpressure portingSection2.
2.1. HistoryandPhysicalExamination:Recommendations
RecommendationsforHistoryandPhysicalExamination
COR LOE RECOMMENDATIONS
PatientsatincreasedriskofPAD(Table3)shouldundergoacomprehensivemedicalhistoryandareviewof
I B-NR symptomstoassessforexertionallegsymptoms,includingclaudicationorotherwalkingimpairment,ischemicrest
pain,andnonhealingwounds(40–42,47–49).
PatientsatincreasedriskofPAD(Table3)shouldundergovascularexamination,includingpalpationoflower
I B-NR extremitypulses(i.e.,femoral,popliteal,dorsalispedis,andposteriortibial),auscultationforfemoralbruits,and
inspectionofthelegsandfeet(48,50,51).
PatientswithPADshouldundergononinvasivebloodpressuremeasurementinbotharmsatleastonceduringthe
I B-NR initialassessment(43–45).
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waveforms (pulse volume recordings) are often per-
Historyand/orPhysicalExaminationFindings
TABLE 4
SuggestiveofPAD formed along with the ABI and can be used to localize
anatomic segments of disease (e.g., aortoiliac, femo-
History
n Claudication ropopliteal,infrapopliteal)(22,53,54).
n Othernon–joint-relatedexertionallowerextremity Dependingon the clinicalpresentation(e.g.,claudica-
symptoms(nottypicalofclaudication)
tionorCLI)andtherestingABIvalues,additionalphysi-
n Impairedwalkingfunction
n Ischemicrestpain ological testing studies may be indicated, including
exercise treadmill ABI testing, measurement of the toe-
PhysicalExamination
n Abnormallowerextremitypulseexamination brachial index (TBI), and additional perfusion assess-
n Vascularbruit
ment measures (e.g., transcutaneous oxygen pressure
n Nonhealinglowerextremitywound
n Lowerextremitygangrene [TcPO ], or skin perfusion pressure [SPP]). Exercise
n Othersuggestivelowerextremityphysicalfindings 2
treadmillABItestingisimportanttoobjectivelymeasure
(e.g.,elevationpallor/dependentrubor)
functionallimitationsattributabletolegsymptomsandis
PADindicatesperipheralarterydisease. useful in establishing the diagnosis of lower extremity
PAD in the symptomatic patient when resting ABIs are
3. DIAGNOSTIC TESTING FOR THE PATIENT normalorborderline(54–59).TheTBIisusedtoestablish
WITH SUSPECTED LOWER EXTREMITY PAD the diagnosis of PAD in the setting of noncompressible
(CLAUDICATION OR CLI): RECOMMENDATIONS arteries (ABI >1.40) and may also be used to assess
perfusion in patients with suspected CLI. Studies for
History or physical examination findings suggestive of anatomic imaging assessment (duplex ultrasound,
PAD need to be confirmed with diagnostic testing. The computed tomography angiography [CTA], or magnetic
restingABIistheinitialdiagnostictestforPADandmay resonanceangiography[MRA],invasiveangiography)are
be the only test required to establish the diagnosis and generally reserved for highly symptomatic patients in
instituteGDMT.TherestingABIisasimple,noninvasive whom revascularization is being considered. Depending
test that is obtained by measuring systolic blood pres- onthemodality,thesestudiesmayconferproceduralrisk.
sures at the arms (brachial arteries) and ankles (dorsalis SeeTable5foralternativecausesoflegpaininthepa-
pedis andposterior tibial arteries) in the supine position tientwithnormalABIandphysiologicaltesting;Figure1for
by using a Doppler device. The ABI of each leg is calcu- thealgorithmondiagnostictestingforsuspectedPADand
latedbydividingthehigherofthedorsalispedispressure claudication;Table6foralternativecausesofnonhealing
or posterior tibial pressure by the higher of the right or woundsinpatientswithoutPAD;Figure2forthealgorithm
left arm blood pressure (46). Segmental lower extremity on diagnostic testing for suspected CLI; and Online Data
blood pressures and Doppler or plethysmographic Supplements3to7fordatasupportingSection3.
3.1. RestingABIforDiagnosingPAD
RecommendationsforRestingABIforDiagnosingPAD
COR LOE RECOMMENDATIONS
InpatientswithhistoryorphysicalexaminationfindingssuggestiveofPAD(Table4),therestingABI,withor
I B-NR withoutsegmentalpressuresandwaveforms,isrecommendedtoestablishthediagnosis(60–65).
RestingABIresultsshouldbereportedasabnormal(ABI£0.90),borderline(ABI0.91–0.99),normal(1.00–1.40),or
I C-LD noncompressible(ABI>1.40)(46,63–66).
InpatientsatincreasedriskofPAD(Table3)butwithouthistoryorphysicalexaminationfindingssuggestiveofPAD
IIa B-NR (Table4),measurementoftherestingABIisreasonable(41,42,67–89).
InpatientsnotatincreasedriskofPAD(Table3)andwithouthistoryorphysicalexaminationfindingssuggestiveof
III:NoBenefit B-NR PAD(Table4),theABIisnotrecommended(87,90).
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3.2. PhysiologicalTesting
RecommendationsforPhysiologicalTesting
COR LOE RECOMMENDATIONS
Toe-brachialindex(TBI)shouldbemeasuredtodiagnosepatientswithsuspectedPADwhentheABIisgreaterthan
I B-NR 1.40(66,91–94).
Patientswithexertionalnon–joint-relatedlegsymptomsandnormalorborderlinerestingABI(>0.90and£1.40)
I B-NR shouldundergoexercisetreadmillABItestingtoevaluateforPAD(54–59).
InpatientswithPADandanabnormalrestingABI(£0.90),exercisetreadmillABItestingcanbeusefultoobjectively
IIa B-NR assessfunctionalstatus(54–59).
Inpatientswithnormal(1.00–1.40)orborderline(0.91–0.99)ABIinthesettingofnonhealingwoundsorgangrene,
IIa B-NR itisreasonabletodiagnoseCLIbyusingTBIwithwaveforms,TcPO ,orSPP(95–99).
2
InpatientswithPADwithanabnormalABI(£0.90)orwithnoncompressiblearteries(ABI>1.40andTBI£0.70)in
IIa B-NR thesettingofnonhealingwoundsorgangrene,TBIwithwaveforms,TcPO ,orSPPcanbeusefultoevaluatelocal
2
perfusion(95–99).
TABLE 5 AlternativeDiagnosesforLegPainorClaudicationWithNormalPhysiologicalTesting(NotPAD-Related)
Condition Location Characteristic EffectofExercise EffectofRest EffectofPosition OtherCharacteristics
Symptomatic Behindknee,down Swelling, Withexercise Alsopresentatrest None Notintermittent
Baker’scyst calf tenderness
Venousclaudication Entireleg,worsein Tight,burstingpain Afterwalking Subsidesslowly Reliefspeededby Historyofiliofemoraldeep
calf elevation veinthrombosis;edema;
signsofvenousstasis
Chronic Calfmuscles Tight,burstingpain Aftermuch Subsidesvery Reliefwithrest Typicallyheavymuscled
compartment exercise slowly athletes
syndrome (jogging)
Spinalstenosis Oftenbilateral Painandweakness Maymimic Variablereliefbut Reliefbylumbar Worsewithstandingand
buttocks, claudication cantakealong spineflexion extendingspine
posteriorleg timetorecover
Nerveroot Radiatesdownleg Sharplancinating Inducedbysitting, Oftenpresentat Improvedby Historyofbackproblems;
compression pain standing,or rest changein worsewithsitting;relief
walking position whensupineorsitting
Hiparthritis Lateralhip,thigh Achingdiscomfort Aftervariable Notquickly Improvedwhennot Symptomsvariable;history
degreeof relieved weightbearing ofdegenerativearthritis
exercise
Foot/anklearthritis Ankle,foot,arch Achingpain Aftervariable Notquickly Mayberelievedby Symptomsvariable;maybe
degreeof relieved notbearing relatedtoactivitylevel
exercise weight orpresentatrest
ModifiedfromNorgrenL,etal.(23).
PADindicatesperipheralarterydisease.