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2016 AHA/ACC Guideline

on the Management of Patients


With Lower Extremity
Peripheral Artery Disease
Developed in Collaboration with the American Association of Cardiovascular and Pulmonary
Rehabilitation, Inter-Society Consensus for the Management of Peripheral Arterial Disease, Society
for Cardiovascular Angiography and Interventions, Society for Clinical Vascular Surgery, Society of
Interventional Radiology, Society for Vascular Medicine, Society for Vascular Nursing, Society for
Vascular Surgery, and Vascular and Endovascular Surgery Society

American Heart Association and American College of Cardiology Foundation


Citation

This slide set is adapted from the 2016 AHA/ACC Guideline on the
Management of Patients With Lower Extremity Peripheral Artery
Disease. Published on November 13th, 2016, available at: Journal of
the American College of Cardiology
[http://content.onlinejacc.org/article.aspx?doi=10.1016/j.jacc.2016.11.
007] and Circulation
[http://circ.ahajournals.org/lookup/doi/10.1161/CIR.00000000000004
71]

The full-text guidelines are also available on the following Web sites:
ACC (www.acc.org) and AHA (professional.heart.org).
2016 AHA/ACC Lower Extremity PAD Guideline
Writing Committee
Marie D. Gerhard-Herman, MD, FACC, FAHA, Chair
Heather L. Gornik, MD, FACC, FAHA, FSVM, Vice Chair*
Coletta Barrett, RN Leila Mureebe, MD, MPH, RPVI
Neal R. Barshes, MD, MPH Jeffrey W. Olin, DO, FACC, FAHA*
Matthew A. Corriere, MD, MS, FAHA Rajan Patel, MD, FACC, FAHA, FSCAI#
Douglas E. Drachman, MD, FACC, FSCAI * Judith G. Regensteiner, PhD, FAHA
Lee A. Fleisher, MD, FACC, FAHA Andres Schanzer, MD*
Francis Gerry R. Fowkes, MD, FAHA*# Mehdi H. Shishehbor, DO, MPH, PhD, FACC, FAHA, FSCAI*
Naomi M. Hamburg, MD, FACC, FAHA Kerry J. Stewart, EdD, FAHA, MAACVPR
Scott Kinlay, MBBS, PhD, FACC, FAHA, FSVM, FSCAI* ** Diane Treat-Jacobson, PhD, RN, FAHA
Robert Lookstein, MD, FAHA, FSIR* M. Eileen Walsh, PhD, APN, RN-BC, FAHA
Sanjay Misra, MD, FAHA, FSIR*

*Writing committee members are required to recuse themselves from voting on sections to which their specific relationships with
industry and other entities may apply; see Appendix 1 for recusal information. Functioning as the lay volunteer/patient
representative. ACC/AHA Representative. Vascular and Endovascular Surgery Society Representative. Society for
Cardiovascular Angiography and Interventions Representative. ACC/AHA Task Force on Clinical Practice Guidelines Liaison.
#Inter-Society Consensus for the Management of Peripheral Arterial Disease Representative. **Society for Vascular Medicine
Representative. Society of Interventional Radiology Representative. Society for Clinical Vascular Surgery Representative.
Society for Vascular Surgery Representative. American Association of Cardiovascular and Pulmonary Rehabilitation
Representative. Society for Vascular Nursing Representative.
Table 1. Applying Class
of Recommendation and
Level of Evidence to
Clinical Strategies,
Interventions,
Treatments, or
Diagnostic Testing
in Patient Care*
(Updated August 2015)
Scope of the Guideline

This guideline supersedes recommendations related to lower extremity PAD in


the ACC/AHA 2005 Guidelines for the Management of Patients With Peripheral
Arterial Disease (1) and the 2011 ACCF/AHA Focused Update of the Guideline
for the Management of Patients With Peripheral Artery Disease (2).
This guideline provides a contemporary guideline for diagnosis and management
of patients with lower extremity PAD.
This guideline is limited to atherosclerotic disease of the lower extremity arteries
(PAD) and includes disease of the aortoiliac, femoropopliteal, and infrapopliteal
arterial segments.
This guideline does not address nonatherosclerotic causes of lower extremity
arterial disease.
Future guidelines will address aneurysmal disease of the abdominal aorta and
lower extremity arteries and diseases of the renal and mesenteric arteries.

1. Hirsch AT, Haskal ZJ, Hertzer NR, et al. J Am Coll Cardiol. 2006;47:1239-312. (Also, this is the Exec sum, I would use the FT version)
2. Rooke TW, Hirsch AT, Misra S, et al. J Am Coll Cardiol. 2011;58:2020-45.
Scope of the Guideline (contd)
Clinical Assessment for PAD
Diagnostic Testing for the Patient With Suspected Lower Extremity PAD
(Claudication or CLI)
Screening for Atherosclerotic Disease in Other Vascular Beds for the Patient With PAD
Medical Therapy for the Patient With PAD
Structured Exercise Therapy
Minimizing Tissue Loss in Patients With PAD
Revascularization for Claudication
Management of CLI
Management of Acute Limb Ischemia
Longitudinal Follow-Up
Evidence Gaps and Future Research Directions
Advocacy Priorities
2016 AHA/ACC Lower Extremity PAD Guideline

Clinical Assessment for PAD


Clinical Assessment for PAD

History and Physical Examination


History and Physical Examination

COR LOE Recommendations


Patients at increased risk of PAD (Table 3) should
undergo a comprehensive medical history and a
review of symptoms to assess for exertional leg
I B-NR
symptoms, including claudication or other walking
impairment, ischemic rest pain, and nonhealing
wounds.
Patients at increased risk of PAD (Table 3) should
undergo vascular examination, including palpation of
I B-NR lower extremity pulses (i.e., femoral, popliteal, dorsalis
pedis, and posterior tibial), auscultation for femoral
bruits, and inspection of the legs and feet.
Patients with PAD should undergo noninvasive blood
I B-NR pressure measurement in both arms at least once
during the initial assessment.
Patients at Increased Risk of PAD (Table 3)

Age 65 y
Age 5064 y, with risk factors for atherosclerosis (e.g., diabetes
mellitus, history of smoking, hyperlipidemia, hypertension) or family
history of PAD
Age <50 y, with diabetes mellitus and 1 additional risk factor for
atherosclerosis
Individuals with known atherosclerotic disease in another vascular
bed (e.g., coronary, carotid, subclavian, renal, mesenteric artery
stenosis, or AAA)
History and/or Physical Examination Findings
Suggestive of PAD (Table 4)

History
Claudication
Other nonjoint-related exertional lower extremity symptoms (not
typical of claudication)
Impaired walking function
Ischemic rest pain
Physical Examination
Abnormal lower extremity pulse examination
Vascular bruit
Nonhealing lower extremity wound
Lower extremity gangrene
Other suggestive lower extremity physical findings (e.g., elevation
pallor/dependent rubor)
2016 AHA/ACC Lower Extremity PAD Guideline

Diagnostic Testing for the Patient With


Suspected Lower Extremity PAD
(Claudication or CLI)
Diagnostic Testing for the Patient With Suspected
Lower Extremity PAD (Claudication or CLI)

Resting ABI for Diagnosing PAD


Resting ABI for Diagnosing PAD

COR LOE Recommendations


In patients with history or physical examination findings
suggestive of PAD (Table 4), the resting ABI, with or
I B-NR
without segmental pressures and waveforms, is
recommended to establish the diagnosis.
Resting ABI results should be reported as abnormal
I C-LD (ABI 0.90), borderline (ABI 0.910.99), normal (1.00
1.40), or noncompressible (ABI >1.40).
In patients at increased risk of PAD (Table 3) but
without history or physical examination findings
IIa B-NR
suggestive of PAD (Table 4), measurement of the
resting ABI is reasonable.
In patients not at increased risk of PAD (Table 3) and
III: No without history or physical examination findings
B-NR
Benefit suggestive of PAD (Table 4), the ABI is not
recommended.
Diagnostic Testing for the Patient With Suspected
Lower Extremity PAD (Claudication or CLI)

Physiological Testing
Physiological Testing

COR LOE Recommendations


TBI should be measured to diagnose patients with
I B-NR suspected PAD when the ABI is greater than 1.40.

Patients with exertional nonjoint-related leg


symptoms and normal or borderline resting ABI
I B-NR (>0.90 and 1.40) should undergo exercise treadmill
ABI testing to evaluate for PAD.
In patients with PAD and an abnormal resting ABI
IIa B-NR (0.90), exercise treadmill ABI testing can be useful
to objectively assess functional status.
Physiological Testing (contd)

COR LOE Recommendations


In patients with normal (1.001.40) or borderline
(0.910.99) ABI in the setting of nonhealing wounds
IIa B-NR or gangrene, it is reasonable to diagnose CLI by
using TBI with waveforms, TcPO2, or SPP.
In patients with PAD with an abnormal ABI (0.90) or
with noncompressible arteries (ABI >1.40 and TBI
IIa B-NR 0.70) in the setting of nonhealing wounds or
gangrene, TBI with waveforms, TcPO2, or SPP can
be useful to evaluate local perfusion.
Diagnostic Testing for Suspected PAD
Diagnostic Testing for
Suspected PAD

History and physical examination


suggestive of PAD without rest pain, Suspect CLI
nonhealing wound, or gangrene (Figure 2)
Colors correspond to Class of
(Table 4)
Recommendation in Table 1.

ABI with or without ABI indicates ankle-brachial index; CLI,


segmental limb pressures critical limb ischemia; CTA, computed
and waveforms tomography angiography; GDMT, guideline-
(Class I)
directed management and therapy; MRA,
magnetic resonance angiography; PAD,
Noncompressible
Noncompressible arteries
arteries Normal
Normal ABI:
ABI: 1.001.40
1.001.40 Abnormal
Abnormal ABI:
ABI: peripheral artery disease; and TBI, toe-
ABI:
ABI: >1.40
>1.40 Borderline
Borderline ABI:
ABI: 0.910.99
0.910.99 0.90
0.90 brachial index.

TBI Exertional
Exertional nonjoint
nonjoint
(Class I) related
related leg
leg symptoms
symptoms
Exercise ABI
Normal Abnormal (Class IIa)
Yes No
(>0.70) (0.70)
Exercise ABI
(Class I) Search for
alternative
Abnormal Normal
diagnosis
Search for (Table 5)
Lifestyle-limiting claudication
alternative
despite GDMT,
diagnosis
revascularization considered
(Table 5)

Continue GDMT Do not perform invasive


Yes No
(Class I) or noninvasive anatomic
Options assessments for
asymptomatic patients
Anatomic assessment: (Class III: Harm)
Anatomic assessment:
Duplex ultrasound
Invasive angiography
CTA or MRA
(Class IIa)
(Class I)
Diagnostic Testing for Suspected CLI
Diagnostic Testing for
Suspected CLI

History and physical examination Colors correspond to Class of


suggestive of PAD with rest pain, Recommendation in Table 1.
nonhealing wound, or gangrene
(Table 4) *Order based on expert consensus.
TBI with waveforms, if not already
Search for alternative diagnosis performed.
Yes No
(Tables 5 and 6)

ABI ABI indicates ankle-brachial index; CLI,


(Class I) critical limb ischemia; CTA, computed
tomography angiography; MRA, magnetic
resonance angiography; TcPO2,
transcutaneous oxygen pressure; and TBI,
Non-compressible
Non-compressible arteries
arteries Normal
Normal ABI:
ABI: 1.001.40
1.001.40
ABI:
Abnormal ABI: 0.90
Abnormal ABI: 0.90 toe-brachial index.
ABI: >1.40
>1.40 Borderline
Borderline ABI:
ABI: 0.910.99
0.910.99

TBI Nonhealing
Nonhealing wound
wound Additional perfusion
(Class I) or
or gangrene
gangrene assessment, particularly
if ABI >0.70:
Normal Abnormal
Yes No TBI with waveforms
(>0.70) (0.70)
TcPO2*
Skin perfusion pressure*
Perfusion assessment: (Class IIa)
Search for
TBI with waveforms
alternative
TcPO2* Normal Abnormal
diagnosis
Skin perfusion pressure*
(Table 5)
(Class IIa)
Anatomic assessment:
Search for Duplex ultrasound
alternative Normal Abnormal CTA or MRA
diagnosis (Table 6) Invasive angiography
(Class I)
Diagnostic Testing for the Patient With Suspected
Lower Extremity PAD (Claudication or CLI)

Imaging for Anatomic Assessment


Imaging for Anatomic Assessment

COR LOE Recommendations


Duplex ultrasound, CTA, or MRA of the lower extremities
is useful to diagnose anatomic location and severity of
I B-NR
stenosis for patients with symptomatic PAD in whom
revascularization is considered.
Invasive angiography is useful for patients with CLI in
I C-EO
whom revascularization is considered.
Invasive angiography is reasonable for patients with
IIa C-EO lifestyle-limiting claudication with an inadequate response
to GDMT for whom revascularization is considered.
Invasive and noninvasive angiography (i.e., CTA, MRA)
III:
B-R should not be performed for the anatomic assessment of
Harm
patients with asymptomatic PAD.
2016 AHA/ACC Lower Extremity PAD Guideline

Screening for Atherosclerotic Disease in Other


Vascular Beds for the Patient With PAD
Screening for Atherosclerotic Disease in Other Vascular Beds
for the Patient With PAD

Abdominal Aortic Aneurysm

COR LOE Recommendation


A screening duplex ultrasound for AAA is reasonable in
IIa B-NR patients with symptomatic PAD.
Screening for Atherosclerotic Disease in Other Vascular Beds
for the Patient With PAD

Screening for Asymptomatic Atherosclerosis in


Other Arterial Beds
(Coronary, Carotid, and Renal Arteries)
Screening for Asymptomatic Atherosclerosis in Other
Arterial Beds (Coronary, Carotid, and Renal Arteries)
Prevalence of atherosclerosis in the coronary, carotid, and renal
arteries higher in patients with PAD than in those without PAD.
However, intensive atherosclerosis risk factor modification in patients
with PAD justified regardless of the presence of disease in other arterial
beds.
Only justification for screening for disease in other arterial beds is if
revascularization results in a reduced risk of MI, stroke, or death, and
this has never been shown.
Thus, no evidence to demonstrate that screening all patients with PAD
for asymptomatic atherosclerosis in other arterial beds improves clinical
outcome.
Intensive treatment of risk factors through GDMT is the principle
method for preventing adverse cardiovascular ischemic events from
asymptomatic disease in other arterial beds.
2016 AHA/ACC Lower Extremity PAD Guideline

Medical Therapy for the Patient With PAD


Medical Therapy for the Patient With PAD

Antiplatelet, Statin, Antihypertensive Agents,


and Oral Anticoagulation
Antiplatelet Agents

COR LOE Recommendations


Antiplatelet therapy with aspirin alone (range 75325
mg per day) or clopidogrel alone (75 mg per day) is
I A
recommended to reduce MI, stroke, and vascular death
in patients with symptomatic PAD.
In asymptomatic patients with PAD (ABI 0.90),
IIa C-EO antiplatelet therapy is reasonable to reduce the risk of
MI, stroke, or vascular death.
In asymptomatic patients with borderline ABI (0.91
IIb B-R 0.99), the usefulness of antiplatelet therapy to reduce
the risk of MI, stroke, or vascular death is uncertain.
Antiplatelet Agents (contd)

COR LOE Recommendations


The effectiveness of dual-antiplatelet therapy (aspirin
and clopidogrel) to reduce the risk of cardiovascular
IIb B-R
ischemic events in patients with symptomatic PAD is not
well established.
Dual-antiplatelet therapy (aspirin and clopidogrel) may
be reasonable to reduce the risk of limb-related events
IIb C-LD
in patients with symptomatic PAD after lower extremity
revascularization.
The overall clinical benefit of vorapaxar added to
IIb B-R existing antiplatelet therapy in patients with
symptomatic PAD is uncertain.
Statin Agents

COR LOE Recommendations


Treatment with a statin medication is indicated for all
I A
patients with PAD.
Antihypertensive Agents

COR LOE Recommendations


Antihypertensive therapy should be administered to
I A patients with hypertension and PAD to reduce the risk of
MI, stroke, heart failure, and cardiovascular death.
The use of angiotensin-converting enzyme inhibitors or
angiotensin-receptor blockers can be effective to reduce
IIa A
the risk of cardiovascular ischemic events in patients
with PAD.
Oral Anticoagulation

COR LOE Recommendations


The usefulness of anticoagulation to improve patency
IIb B-R after lower extremity autogenous vein or prosthetic
bypass is uncertain.
III: Anticoagulation should not be used to reduce the risk of
A
Harm cardiovascular ischemic events in patients with PAD.
Medical Therapy for the Patient With PAD

Smoking Cessation
Smoking Cessation

COR LOE Recommendations


Patients with PAD who smoke cigarettes or use other
I A
forms of tobacco should be advised at every visit to quit.
Patients with PAD who smoke cigarettes should be
assisted in developing a plan for quitting that includes
I A pharmacotherapy (i.e., varenicline, buproprion, and/or
nicotine replacement therapy) and/or referral to a
smoking cessation program.
Patients with PAD should avoid exposure to
I B-NR environmental tobacco smoke at work, at home, and in
public places.
Medical Therapy for the Patient With PAD

Glycemic Control

COR LOE Recommendations


Management of diabetes mellitus in the patient with
I C-EO PAD should be coordinated between members of the
healthcare team.
Glycemic control can be beneficial for patients with CLI
IIa B-NR
to reduce limb-related outcomes.
Medical Therapy for the Patient With PAD

Cilostazol, Pentoxifylline, and Chelation Therapy


Cilostazol, Pentoxifylline, and Chelation Therapy

COR LOE Recommendations


Cilostazol
Cilostazol is an effective therapy to improve
I A symptoms and increase walking distance in
patients with claudication.
Pentoxifylline
III: No Pentoxifylline is not effective for treatment of
B-R
Benefit claudication.
Chelation Therapy
III: No Chelation therapy (e.g., ethylenediaminetetraacetic
B-R
Benefit acid) is not beneficial for treatment of claudication.
Medical Therapy for the Patient With PAD

Homocysteine Lowering

COR LOE Recommendation


B-complex vitamin supplementation to lower
III: No homocysteine levels for prevention of
B-R
Benefit cardiovascular events in patients with PAD is not
recommended.
Medical Therapy for the Patient With PAD

Influenza Vaccination

COR LOE Recommendation


Patients with PAD should have an annual influenza
I C-EO
vaccination.
2016 AHA/ACC Lower Extremity PAD Guideline

Structured Exercise Therapy


Structured Exercise Therapy

COR LOE Recommendations


In patients with claudication, a supervised exercise
I A program is recommended to improve functional status and
QoL and to reduce leg symptoms.
A supervised exercise program should be discussed as a
I B-R treatment option for claudication before possible
revascularization.
In patients with PAD, a structured community- or home-
based exercise program with behavioral change
IIa A
techniques, can be beneficial to improve walking ability
and functional status.
In patients with claudication, alternative strategies of
exercise therapy, including upper-body ergometry, cycling,
IIa A and pain-free or low-intensity walking that avoids
moderate-to-maximum claudication while walking, can be
beneficial to improve walking ability and functional status.
Structured Exercise Programs for PAD: Definitions
(Table 7)
Supervised exercise program (COR I, LOE A)
Program takes place in a hospital or outpatient facility.
Program uses intermittent walking exercise as the treatment modality.
Program can be standalone or within a cardiac rehabilitation program.
Program is directly supervised by qualified healthcare provider(s).
Training is performed for a minimum of 3045 min/session; sessions are performed at
least 3 times/wk for a minimum of 12 wk.
Training involves intermittent bouts of walking to moderate-to-maximum claudication,
alternating with periods of rest.
Warm-up and cool-down periods precede and follow each session of walking.

Structured community- or home-based exercise program (COR IIa, LOE A)


Program takes place in the personal setting of the patient rather than in a clinical
setting.
Program is self-directed with guidance of healthcare providers.
Healthcare providers prescribe an exercise regimen similar to that of a supervised
program.
Patient counseling ensures understanding of how to begin and maintain the program
and how to progress the difficulty of the walking (by increasing distance or speed).
Program may incorporate behavioral change techniques, such as health coaching or
use of activity monitors.
2016 AHA/ACC Lower Extremity PAD Guideline

Minimizing Tissue Loss in Patients With PAD


Minimizing Tissue Loss in Patients With PAD

COR LOE Recommendations


Patients with PAD and diabetes mellitus should be
I C-LD counseled about selffoot examination and healthy foot
behaviors.
In patients with PAD, prompt diagnosis and treatment
I C-LD
of foot infection are recommended to avoid amputation.
In patients with PAD and signs of foot infection, prompt
IIa C-LD referral to an interdisciplinary care team (Table 8) can
be beneficial.
It is reasonable to counsel patients with PAD without
IIa C-EO diabetes mellitus about self-foot examination and
healthy foot behaviors.
Biannual foot examination by a clinician is reasonable
IIa C-EO
for patients with PAD and diabetes mellitus.
Interdisciplinary Care Team for PAD (Table 8)
A team of professionals representing different disciplines to assist in the evaluation and
management of the patient with PAD. For the care of patients with CLI, the
interdisciplinary care team should include individuals who are skilled in endovascular
revascularization, surgical revascularization, wound healing therapies and foot surgery,
and medical evaluation and care.
Interdisciplinary care team members may include:
Vascular medical and surgical specialists (i.e., vascular medicine, vascular surgery,
interventional radiology, interventional cardiology)
Nurses
Orthopedic surgeons and podiatrists
Endocrinologists
Internal medicine specialists
Infectious disease specialists
Radiology and vascular imaging specialists
Physical medicine and rehabilitation clinicians
Orthotics and prosthetics specialists
Social workers
Exercise physiologists
Physical and occupational therapists
Nutritionists/dieticians
2016 AHA/ACC Lower Extremity PAD Guideline

Revascularization for Claudication

COR LOE Recommendation


Revascularization is a reasonable treatment option for
IIa A the patient with lifestyle-limiting claudication with an
inadequate response to GDMT.
Revascularization for Claudication

Endovascular Revascularization for


Claudication
Endovascular Revascularization for Claudication

COR LOE Recommendations


Endovascular procedures are effective as a
revascularization option for patients with lifestyle-
I A
limiting claudication and hemodynamically significant
aortoiliac occlusive disease.
Endovascular procedures are reasonable as a
revascularization option for patients with lifestyle-
IIa B-R
limiting claudication and hemodynamically significant
femoropopliteal disease.
The usefulness of endovascular procedures as a
revascularization option for patients with claudication
IIb C-LD
due to isolated infrapopliteal artery disease is
unknown.
III: Endovascular procedures should not be performed in
B-NR
Harm patients with PAD solely to prevent progression to CLI.
Revascularization for Claudication

Surgical Revascularization for Claudication


Surgical Revascularization for Claudication

COR LOE Recommendations


When surgical revascularization is performed, bypass to
I A the popliteal artery with autogenous vein is
recommended in preference to prosthetic graft material.
Surgical procedures are reasonable as a
revascularization option for patients with lifestyle-limiting
IIa B-NR claudication with inadequate response to GDMT,
acceptable perioperative risk, and technical factors
suggesting advantages over endovascular procedures.
Femoral-tibial artery bypasses with prosthetic graft
III:
B-R material should not be used for the treatment of
Harm
claudication.
III: Surgical procedures should not be performed in patients
B-NR
Harm with PAD solely to prevent progression to CLI.
2016 AHA/ACC Lower Extremity PAD Guideline

Management of CLI

CLI Definition:
A condition characterized by chronic (2 wk) ischemic rest pain,
nonhealing wound/ulcers, or gangrene in 1 or both legs attributable to
objectively proven arterial occlusive disease.
The diagnosis of CLI is a constellation of both symptoms and signs.
Arterial disease can be proved objectively with ABI, TBI, TcPO2, or skin
perfusion pressure. Supplementary parameters, such as absolute ankle
and toe pressures and pulse volume recordings, may also be used to
assess for significant arterial occlusive disease. However, a very low
ABI or TBI does not necessarily mean the patient has CLI. The term
CLI implies chronicity and is to be distinguished from ALI.
Management of CLI

Revascularization for CLI

COR LOE Recommendation


In patients with CLI, revascularization should be
I B-NR performed when possible to minimize tissue loss.
An evaluation for revascularization options should
I C-EO be performed by an interdisciplinary care team
(Table 8) before amputation in the patient with CLI.
Management of CLI

Revascularization for CLI Endovascular


Revascularization for CLI
Endovascular Revascularization for CLI

COR LOE Recommendations


Endovascular procedures are recommended to
I B-R establish in-line blood flow to the foot in patients with
nonhealing wounds or gangrene.
A staged approach to endovascular procedures is
IIa C-LD
reasonable in patients with ischemic rest pain.
Evaluation of lesion characteristics can be useful in
IIa B-R
selecting the endovascular approach for CLI.
Use of angiosome-directed endovascular therapy may
IIb B-NR be reasonable for patients with CLI and nonhealing
wounds or gangrene.
Management of CLI

Revascularization for CLI Surgical


Revascularization for CLI
Surgical Revascularization for CLI

COR LOE Recommendations


When surgery is performed for CLI, bypass to the
I A popliteal or infrapopliteal arteries (i.e., tibial, pedal)
should be constructed with suitable autogenous vein.
Surgical procedures are recommended to establish in-
I C-LD line blood flow to the foot in patients with nonhealing
wounds or gangrene.
In patients with CLI for whom endovascular
revascularization has failed and a suitable autogenous
IIa B-NR vein is not available, prosthetic material can be effective
for bypass to the below-knee popliteal and tibial
arteries.
A staged approach to surgical procedures is reasonable
IIa C-LD
in patients with ischemic rest pain.
Management of CLI

Wound Healing Therapies for CLI


Wound Healing Therapies for CLI
COR LOE Recommendations
An interdisciplinary care team should evaluate and
provide comprehensive care for patients with CLI and
I B-NR
tissue loss to achieve complete wound healing and a
functional foot.
In patients with CLI, wound care after
I C-LD revascularization should be performed with the goal of
complete wound healing.
In patients with CLI, intermittent pneumatic
compression (arterial pump) devices may be
IIb B-NR
considered to augment wound healing and/or
ameliorate severe ischemic rest pain.
In patients with CLI, the effectiveness of hyperbaric
IIb C-LD
oxygen therapy for wound healing is unknown.
III: No Prostanoids are not indicated in patients with CLI.
B-R
Benefit
2016 AHA/ACC Lower Extremity PAD Guideline

Management of Acute Limb Ischemia

ALI Definition:
Acute (<2 wk), severe hypoperfusion of the limb characterized by these features:
pain, pallor, pulselessness, poikilothermia (cold), paresthesias, and paralysis.
One of these categories of ALI is assigned (Figure for Diagnosis and Management of
ALI):
I. ViableLimb is not immediately threatened; no sensory loss; no muscle
weakness; audible arterial and venous Doppler.
II. ThreatenedMild-to-moderate sensory or motor loss; inaudible arterial Doppler;
audible venous Doppler; may be further divided into IIa (marginally threatened) or
IIb (immediately threatened).
III. IrreversibleMajor tissue loss or permanent nerve damage inevitable; profound
sensory loss, anesthetic; profound muscle weakness or paralysis (rigor);
inaudible arterial and venous Doppler.
Management of Acute Limb Ischemia

Clinical Presentation of ALI


Clinical Presentation of ALI

COR LOE Recommendations


Patients with ALI should be emergently evaluated by
I C-EO a clinician with sufficient experience to assess limb
viability and implement appropriate therapy.
In patients with suspected ALI, initial clinical
I C-LD evaluation should rapidly assess limb viability and
potential for salvage and does not require imaging.
Diagnosis and Management of ALI
Diagnosis and Management
of ALI

Acutely cold, painful leg Colors correspond to Class of


Recommendation in Table 1.
Suspected ALI
ALI indicates acute limb ischemia.

Clinical evaluation, including: symptoms,


motor and sensory assessment, arterial
and venous Doppler signals
(Class I)

Audible arterial Inaudible arterial Inaudible arterial


Audible venous Audible venous Inaudible venous

Revascularization (urgent) Category I: Category III:


AND Viable limb Motor function Irreversible Primary
anticoagulation, Normal motor function assessment Complete loss of motor function amputation
unless contraindicated No sensory loss Complete sensory loss (Class I)
(Class I) Intact capillary refill Absent capillary refill

Intact Impaired

Category IIa: Category IIb:


Marginally threatened Immediately threatened
Slow-to-intact capillary refill Slow-to-absent capillary refill
Sensory loss limited to toes if present Sensory loss more than toes and with rest pain
No muscle weakness Mild or moderate muscle weakness

Salvageable if Salvageable if
treated promptly treated emergently

Revascularization (emergency) Revascularization (emergency)


AND AND
Anticoagulation, unless contraindicated Anticoagulation, unless contraindicated
(Class I) (Class I)
Management of Acute Limb Ischemia

Medical Therapy for ALI

COR LOE Recommendation


In patients with ALI, systemic anticoagulation with
I C-EO heparin should be administered unless
contraindicated.
Management of Acute Limb Ischemia

Revascularization for ALI


Revascularization for ALI
COR LOE Recommendations
In patients with ALI, the revascularization strategy
I C-LD should be determined by local resources and patient
factors (e.g., etiology and degree of ischemia).
Catheter-based thrombolysis is effective for patients
I A
with ALI and a salvageable limb.
Amputation should be performed as the first procedure
I C-LD
in patients with a nonsalvageable limb.
Patients with ALI should be monitored and treated (e.g.,
I C-LD fasciotomy) for compartment syndrome after
revascularization.
Revascularization for ALI (contd)

COR LOE Recommendations


In patients with ALI with a salvageable limb,
IIa B-NR percutaneous mechanical thrombectomy can be useful
as adjunctive therapy to thrombolysis.
In patients with ALI due to embolism and with a
IIa C-LD salvageable limb, surgical thromboembolectomy can be
effective.
The usefulness of ultrasound-accelerated catheter-
IIb C-LD based thrombolysis for patients with ALI with a
salvageable limb is unknown.
Management of Acute Limb Ischemia

Diagnostic Evaluation of the Cause of ALI

COR LOE Recommendations


In the patient with ALI, a comprehensive history should
I C-EO be obtained to determine the cause of thrombosis and/or
embolization.
In the patient with a history of ALI, testing for a
IIa C-EO
cardiovascular cause of thromboembolism can be useful.
2016 AHA/ACC Lower Extremity PAD Guideline

Longitudinal Follow-Up
Longitudinal Follow-Up
COR LOE Recommendations
Patients with PAD should be followed up with periodic
clinical evaluation, including assessment of
I C-EO
cardiovascular risk factors, limb symptoms, and
functional status.
Patients with PAD who have undergone lower extremity
revascularization (surgical and/or endovascular) should
I C-EO
be followed up with periodic clinical evaluation and ABI
measurement.
Duplex ultrasound can be beneficial for routine
IIa B-R surveillance of infrainguinal, autogenous vein bypass
grafts in patients with PAD.
Duplex ultrasound is reasonable for routine surveillance
IIa C-LD
after endovascular procedures in patients with PAD.
The effectiveness of duplex ultrasound for routine
IIb B-R surveillance of infrainguinal prosthetic bypass grafts in
patients with PAD is uncertain.
2016 AHA/ACC Lower Extremity PAD Guideline

Evidence Gaps and Future Research Directions


Evidence Gaps and Future Research Directions
Basic science and translational studies to better understand the
vascular biology of endovascular therapies and bypass grafting and to
develop new methods for preventing restenosis after revascularization.
Determination of risk factors for progression from asymptomatic PAD to
symptomatic disease, including CLI.
RCTs to determine the value of using the ABI to identify asymptomatic
patients with PAD for therapies to reduce cardiovascular risk (e.g.,
antiplatelet agents, statins, and other therapies).
Advancement in PAD diagnostics.
Comparative-effectiveness studies to determine the optimal antiplatelet
therapy for prevention of cardiovascular and limb-related events in
patients with PAD.
Development of additional medical therapies for claudicationan area
of unmet medical need with a currently limited research pipeline.
Evidence Gaps and Future Research Directions
Studies to investigate the role of dietary intervention, in addition to statin therapy,
to improve outcome and modify the natural history of PAD.
Additional research to identify the best community- or home-based exercise
programs for patients with PAD to maximize functional status and improve QoL,
as well as the role of such exercise programs before or in addition to
revascularization.
Development and validation of improved clinical classification systems for PAD
that incorporate symptoms, anatomic factors, and patient-specific risk factors and
can be used to predict clinical outcome and optimize treatment approach. An
example of a recently developed classification system is the Society for Vascular
Surgery limb classification system, based on wound, ischemia, and foot infection
(WIfI), which has been validated in different populations and may permit more
meaningful prognosis in patients with CLI.
Comparative- and cost-effectiveness studies of the different endovascular
technologies for treatment of claudication and CLI.
Additional studies to demonstrate the impact of multisocietal registries on clinical
outcomes and appropriate use.
2016 AHA/ACC Lower Extremity PAD Guideline

Advocacy Priorities
Advocacy Priorities
Availability of the ABI as the initial diagnostic test to establish the diagnosis of
PAD in patients with history or physical examination findings suggestive of PAD
Although the ABI test is generally reimbursed by third-party payers for patients
with classical claudication or lower extremity wounds, payers may not provide
reimbursement for the ABI with other findings suggestive of PAD, such as lower
extremity pulse abnormalities or femoral bruits
Insuring access to supervised exercise programs for patients with PAD
Although extensive high-quality evidence supports supervised exercise programs
to improve functional status and QoL, only a minority of patients with PAD
participate in such programs because of lack of reimbursement by third-party
payers.
Incorporation of patient-centered outcomes into the process of regulatory
approval of new medical therapies and revascularization technologies.
For revascularization technologies, regulatory approval is driven primarily by data
on angiographic efficacy (i.e., target-lesion patency) and safety endpoints. The
nature of the functional limitation associated with PAD warrants the incorporation
of patient-centered outcomes, such as functional parameters and QoL, into the
efficacy outcomes for the approval process.

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