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Steve Henao MD Peripheral Peripheral Arterial Disease Arterial Disease or or P.A.D. P.A.D. GUIDELINES GUIDELINES

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An update on the state of the art in vascular health. Based on current ACC/AHA guidelines.

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Page 1: Henao

Steve Henao MD

Peripheral Peripheral Arterial DiseaseArterial Disease

ororP.A.D.P.A.D.

GUIDELINES GUIDELINES

Page 2: Henao

Steve Henao MD

• To enhance the quality of patient care• Increasing recognition of the importance of

atherosclerotic lower extremity PAD:

– High prevalence

– High cardiovascular risk

– Poor quality of life• Improved ability to detect and treat renal artery

disease• Improved ability to detect and treat abdominal aortic

aneurysm• The evidence base has become increasingly robust,

so that a data-driven care guideline is now possible

Why a PAD Guideline?

Page 3: Henao

Steve Henao MD 1. Meijer WT, et al. Arterioscler Thromb Vasc Biol. 1998;18:185-192.

2. Criqui MH, et al. Circulation. 1985;71:510-515.

Rotterdam Study San Diego Study

0

10

20

30

40

50

60

Pat

ien

ts W

ith

PA

D (

%)

55-59 60-64 65-69 70-74 75-79 80-84 85-89

Age (years)

Prevalence of PAD Increases With Age

ABI=ankle-brachial index

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Steve Henao MD

Gender Differences in the Prevalence of PAD

Adapted from Diehm C. Atherosclerosis. 2004;172:95-105 with permission from Elsevier.

Pre

vale

nce

(%

)

Women

Men

6880 Consecutive Patients (61% Female) in 344 Primary Care Offices

<700

2

4

6

8

10

12

14

16

70–74 75–79 80–84 >85

Age (years)

18

Page 5: Henao

Steve Henao MD

Ethnicity and PAD:The San Diego Population Study

NHW Black Hispanic Asian0

1

2

3

4

5

6

7

8

9

10

Fra

ctio

n of

Pop

ulat

ion

With

PA

D (

%)

NHW = Non-hispanic white. Reprinted with permission from Criqui, et al. Circulation. 2005:112:2703-07.

Page 6: Henao

Steve Henao MD

Diabetes Increases the Risk of PAD

22.4*19.9*

12.5

0

5

10

15

20

25

Normal GlucoseTolerance

Impaired Glucose Tolerance

Diabetes

Pre

vale

nce

of

PA

D (

%)

Impaired glucose tolerance was defined as oral glucose tolerance test value ≥140 mg/dL but <200 mg/dL.*P.05 vs. normal glucose tolerance. Reprinted with permission from Lee AJ, et al. Br J Haematol. 1999;105:648-654. www.blackwell-synergy.com

Page 7: Henao

Steve Henao MD Hirsch AT, et al. J Am Coll Cardiol. 2006;47:e1-e192.

Relative Risk

Smoking

Diabetes

Hypertension

Hypercholesterolemia

Hyperhomocysteinemia

C-Reactive Protein

Reduced Increased

Risk Factors for PAD

1 2 3 4 5 60

Page 8: Henao

Steve Henao MD

• Age less than 50 years with diabetes, and one additional risk factor (e.g., smoking, dyslipidemia, hypertension, or hyperhomocysteinemia)

• Age 50 to 69 years and history of smoking or diabetes

• Age 70 years and older• Leg symptoms with exertion (suggestive of

claudication) or ischemic rest pain• Abnormal lower extremity pulse examination• Known atherosclerotic coronary, carotid, or renal

artery disease

Based on the epidemiologic evidence base, an “at risk” population for PAD can be

objectively defined by:

Individuals “At Risk” for Lower Extremity PAD

Page 9: Henao

Steve Henao MD

Individuals With PAD Present in Clinical Practice With Distinct Syndromes

Asymptomatic: Without obvious symptomatic complaint (but usually with a functional impairment).

Classic claudication: Lower extremity symptoms confined to the muscles with a consistent (reproducible) onset with exercise and relief with rest.

“Atypical” leg pain: Lower extremity discomfort that is exertional but that does not consistently resolve with rest, consistently limit exercise at a reproducible distance.

Page 10: Henao

Steve Henao MD

Individuals With PAD Present in Clinical Practice With Distinct Syndromes

Critical limb lschemia: Ischemic rest pain, nonhealing wound, or gangrene/

Acute limb ischemia: The five “P”s, defined by the clinical symptoms and signs that suggest potential limb jeopardy:

Pain Pulselessness Pallor Paresthesias Paralysis (& polar, as a sixth “P”).

Page 11: Henao

Steve Henao MD

PADPrognosis

Page 12: Henao

Steve Henao MD

The Natural History of PAD

• Individuals with PAD are at increased risk for cardiovascular ischemic events due to concomitant CAD (fatal and non-fatal MI) and cerebrovascular disease (fatal and non-fatal stroke).

• Cardiovascular events are more frequent than ischemic limb events in any lower extremity PAD cohort, regardless of the clinical presentation.

Page 13: Henao

Steve Henao MD

Natural History of Atherosclerotic Lower Extremity PAD

PAD Population (50 years and older)

Initial clinical presentation

Asymptomatic PAD20%-50%

Atypical leg pain40%-50%

Claudication10%-35%

Critical limb ischemia1%-2%

Progressive functional

impairment

1-year outcomes

Alive w/ 2 limbs50%

Amputation

25%

CV mortality

25%

5-year outcomes

(to next slide)

Reprinted with permission from Hirsch AT, et al. Circulation. 2006;113:e463-654.

Page 14: Henao

Steve Henao MD

Claudication10%-35%

5-year outcomes

Limb morbidity

Stable claudication

70%-80%

Worsening claudicatio

n10%-20%

Critical limb ischemia1%-2%

Amputation(see CLI data)

CV morbidity & mortality

Nonfatal CV event(MI or stroke) 20%

Mortality15%-30%

CV causes 75%

Non-CV causes

25%

Reprinted with permission from Hirsch AT, et al. Circulation. 2006;113:e463-654.

Asymptomatic PAD20%-50%

Atypical leg pain40%-50%

For each of these PAD clinical syndromes

CLI=critical limb ischemia; CV=cardiovascular; MI=myocardial infarction

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Steve Henao MD

Long-Term Survival in Patients With PAD

Criqui MH et al. N Engl J Med. 1992;326:381-386. Copyright © 1992 Massachusetts Medical Society. All rights reserved.

Normal subjects

Asymptomatic PAD

Symptomatic PAD

Severe symptomatic PAD

100

75

50

25

0 2 4 6 8 10 12

Su

rviv

al (%

)

Year

Page 16: Henao

Steve Henao MD

Association Between ABI and All‑Cause Mortality*

0

10

20

30

40

50

60

70

80

<0.61

(n=156)

0.61-0.70

(n=141)

0.71-0.80

(n=186)

0.81-0.90

(n=310)

0.91-1.00

(n=709)

1.01-1.10

(n=1750)

1.11-1.20

(n=1578)

1.21-1.30

(n=696)

1.31-1.40

(n=156)

>1.40

(n=66)

Baseline ABI

Tota

l M

ort

alit

y (

%)

Age range=mid- to late-50s; ABI=ankle-brachial index; *Median duration of follow-up was 11.1 (0.1–12) years.

Adapted from O’Hare AM et al. Circulation. 2006;113:388-393.

N=5748Risk increases at ABI values below 1.0 and above 1.3

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Steve Henao MD

Cardiovascular Risk Increases With Decreases in ABI

>1.1 1.1–1.01 1.0–0.91 0.9–0.71 <0.7

ABI

CH

D E

ven

t O

utc

om

es

per

Year

(%)

0

1

2

3

4

5-year risk:10%

5-year risk:19%

Framingham “High Risk” = 20% at 10 yearsEvery patient with PAD is at “very high risk”

PAD*Fatal or nonfatal MI. ABI=ankle-brachial index; CHD=chronic heart failure

2%

3.8%

1.4%

Leng GC, et al. Brit Med J. 1996;313:1440-44.

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Steve Henao MD

Critical Limb Ischemia (CLI)

Fate of Patients With CLI After Initial Treatment

Summary of 6-month outcomes from 19 studies

Dormandy JA, Rutherford RB. J Vasc Surg. 2000;31:S1-S296.

Dead20%

Alive without amputation

45%

Alive with amputation

35%

Critical limb ischemia is defined as

ischemic rest pain, nonhealing

wounds, or gangrene.

Page 19: Henao

Steve Henao MD

Class I Benefit >>> Risk

Procedure/ Treatment SHOULD be performed/ administered

Class IIa Benefit >> RiskAdditional studies with focused objectives needed

IT IS REASONABLE to perform procedure/administer treatment

Class IIb Benefit ≥ RiskAdditional studies with broad objectives needed; Additional registry data would be helpful

Procedure/Treatment MAY BE CONSIDERED

Class III Risk ≥ BenefitNo additional studies needed

Procedure/Treatment should NOT be performed/administered SINCE IT IS NOT HELPFUL AND MAY BE HARMFUL

Level B Limited (2-3) population risk strata evaluated

Level A Multiple (3-5) population risk strata evaluated General consistency of direction and magnitude of effect

Level C Very limited (1-2) population risk strata evaluated

Applying Classification of Recommendations and Level of

Evidence

Page 20: Henao

Steve Henao MD

The Vascular History and Physical Examination

Individuals at risk for lower extremity PAD

should undergo a vascular review of symptoms to assess walking impairment, claudication, ischemic rest pain, and/or

the presence of nonhealing wounds.

Individuals at risk for lower extremity PAD

should undergo comprehensive pulse examination and inspection of the feet.

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

Page 21: Henao

Steve Henao MD

Identification of the Asymptomatic Patient With PAD

A history of walking impairment, claudication, and ischemic rest pain is recommended as a required component of a standard review of systems for adults >50 years who have atherosclerosis risk factors, or for adults >70

years.

Individuals with asymptomatic PAD should be identified in order to offer therapeutic interventions known to diminish their increased risk of myocardial infarction, stroke, and death.

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

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Steve Henao MD

Identification of the Symptomatic Patient With Intermittent Claudication

Patients with symptoms of intermittent claudication should undergo a vascular physical examination, including

measurement of the ABI.

In patients with symptoms of intermittent claudication, the ABI should be measured

after exercise if the resting index is normal.

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

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Steve Henao MD

Patients with intermittent claudication should have significant functional impairment with a reasonable likelihood of symptomatic improvement and absence of other disease

that would comparably limit exercise even if the claudication was improved (e.g., angina, heart failure, chronic respiratory disease, or orthopedic limitations) before undergoing an evaluation for revascularization.

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

Page 24: Henao

Steve Henao MD

Revascularization of the Patient With Intermittent Claudication

Individuals with intermittent claudication who are offered the option of endovascular or surgical therapies should:

• be provided information regarding supervised claudication exercise therapy and pharmacotherapy;

• receive comprehensive risk factor modification and antiplatelet therapy;

• have a significant disability, either being unable to perform normal work or having serious impairment of other activities important to the patient;

• have lower extremity PAD lesion anatomy such that the revascularization procedure would have low risk and a high probability of initial and long-term success.

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

Page 25: Henao

Steve Henao MD

Evaluation of the Patient With Critical Limb Ischemia

Patients with CLI should undergo expedited evaluation and treatment of factors that are known to increase the risk of amputation.

Patients with CLI in whom open surgical repair is

anticipated should undergo assessment of cardiovascular risk.

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

Page 26: Henao

Steve Henao MD

Patients at risk of CLI (ABI less than 0.4 in a nondiabetic individual, or any diabetic individual with known lower extremity PAD) should undergo regular inspection of the feet to detect objective signs of CLI.

The feet should be examined directly, with shoes and socks removed, at regular intervals after successful treatment of CLI.

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

Page 27: Henao

Steve Henao MD

Patients with CLI and skin breakdown should be referred to healthcare providers with specialized expertise in wound care.

Patients at risk for CLI (those with diabetes, neuropathy, chronic renal failure, or infection) who develop acute limb symptoms represent potential vascular emergencies and should be assessed immediately and treated by a specialist competent in treating vascular disease.

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

Page 28: Henao

Steve Henao MD

The Clinical Approach to the Patient With, or at Risk for, PAD

• A vascular review of symptoms• A vascular-focused physical examination• Use of the noninvasive vascular diagnostic

laboratory (ABI and toe-brachial index [TBI], exercise ABI, Duplex ultrasound, magnetic resonance angiography [MRA], and computed tomographic angiography [CTA])

• When required, use of diagnostic catheter-based angiography

Clinicians who care for individuals with PAD should be able to provide:

Page 29: Henao

Steve Henao MD

The Vascular Review of Symptoms: An Essential Component of the Vascular History

Key components of the vascular review of systems (not usually included in the review of systems of the extremities) and family history include the following:

• Any exertional limitation of the lower extremity muscles or any history of walking impairment. The characteristics of this limitation may be described as fatigue, aching, numbness, or pain. The primary site(s) of discomfort in the buttock, thigh, calf, or foot should be recorded, along with the relation of such discomfort to rest or exertion.

• Any poorly healing or nonhealing wounds of the legs or feet.• Any pain at rest localized to the lower leg or foot and its association

with the upright or recumbent positions.• Post-prandial abdominal pain that reproducibly is provoked by

eating and is associated with weight loss.• Family history of a first-degree relative with an abdominal aortic

aneurysm.

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Steve Henao MD

Comprehensive Vascular Examination

• Pulse Examination– Carotid – Radial/ulnar– Femoral– Popliteal– Dorsalis pedis– Posterior tibial

• Scale:– 0=Absent– 1=Diminished– 2=Normal– 3=Bounding (aneurysm)

• Bilateral arm blood pressure (BP)

• Cardiac examination• Palpation of the

abdomen for aneurysmal disease

• Auscultation for bruits

• Examination of legs and feet

Key components of the vascular physical examination include:

Page 31: Henao

Steve Henao MD

ACC/AHA Guideline for the Management of PAD:Steps Toward the Diagnosis of PAD

Perform a resting ankle-brachial index measurement

Recognizing the “at risk” groups leads to recognition of the five main PAD clinical

syndromes:

No leg pain

Classic claudicati

on

Chronic critical

limb ischemia

(CLI)

Acute limb

ischemia

(ALI)

“Atypical”

leg pain

Obtain history of walking impairment and/or limb ischemic symptoms:

Obtain a vascular review of symptoms:• Leg discomfort with exertion

• Leg pain at rest; non-healing wound; gangrene

Page 32: Henao

Steve Henao MD

• Performed with the patient resting in the supine position

• All pressures are measured with an arterial Doppler and appropriately sized blood pressure cuff (edge 1-2 inches above the pulse; cuff width should be 40% of limb circumference).

• Systolic pressures will be measured in the right and left brachial arteries followed by the right and left ankle arteries.

How to Perform an ABI Exam

Page 33: Henao

Steve Henao MD

ABI Procedure

• Step 1: Apply the appropriately sized blood pressure cuff on the arm above the elbow (either arm).

• Step 2: Apply Doppler gel to skin surface.

• Step 3: Turn on the Doppler and place the probe in the area of the pulse at a 45-60° angle to the surface of the skin, pointing to the shoulder.

• Step 4: Move the probe around until the clearest arterial signal is heard.

Page 34: Henao

Steve Henao MD http://www.nhlbi.nih.gov/health/dci/Diseases/pad/pad_diagnosis.html

ABI Procedure

Page 35: Henao

Steve Henao MD

• Step 5: Inflate the blood pressure cuff to approximately 20 mmHg above the point where systolic sounds are no longer heard.

• Step 6: Gradually deflate until the arterial signal returns. Record the pressure reading.

• Step 7: Repeat the procedure for the right and left posterior tibial and dorsalis pedis arteries. Place the probe on the pulse and angle the probe at 45o toward the knee.

• Step 8: Record the systolic blood pressure of the contralateral arm.

ABI Procedure

Page 36: Henao

Steve Henao MD

Understanding the ABI

The ratio of the higher brachial systolic pressure and the higher ankle systolic pressure for each leg:

Ankle systolic pressure

Higher brachial artery systolic pressure

ABI =

Page 37: Henao

Steve Henao MD

Using the ABI: An Example

ABI=ankle-brachial index; DP=dorsalis pedis; PT=posterior tibial; SBP=systolic blood pressure.

Right ABI80/160=0.50

Brachial SBP160 mm Hg

PT SBP 120 mm Hg

DP SBP 80 mm Hg

Brachial SBP150 mm Hg

PT SBP 40 mm HgDP SBP 80 mm Hg

Left ABI120/160=0.75

Highest brachial SBP

Highest of PT or DP SBP

ABI(Normal >0.90)

Page 38: Henao

Steve Henao MD

ABI Limitations

• Incompressible arteries (elderly patients, patients with diabetes, renal failure, etc.)

• Resting ABI may be insensitive for detecting mild aorto-iliac occlusive disease

• Not designed to define degree of functional limitation

• Normal resting values in symptomatic patients may become abnormal after exercise

• Note: “Non-compressible” pedal arteries is a physiologic term and such arteries need not be “calcified”

Page 39: Henao

Steve Henao MD

Toe-Brachial Index Measurement

• The toe-brachial index (TBI) is calculated by dividing the toe pressure by the higher of the two brachial pressures.

• TBI values remain accurate when ABI values are not possible due to non-compressible pedal pulses.

• TBI values ≤ 0.7 are usually considered diagnostic for lower extremity PAD.

Page 40: Henao

Steve Henao MD

Arterial Duplex Ultrasound Testing

• Duplex ultrasound of the extremities is useful to diagnose anatomic location and degree of stenosis of peripheral arterial disease.

• Duplex ultrasound is useful to provide surveillance following femoral-popliteal bypass using venous conduit (but not prosthetic grafts).

• Duplex ultrasound of the extremities can be used to select candidates for:(a) endovascular intervention (b) surgical bypass, and(c) to select the sites of

surgical anastomosis.

However, the data that might support use of duplex ultrasound to assess long-term patency of PTA is not robust.

PTA=percutaneous transluminal angioplasty.

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Steve Henao MD

Computed Tomographic Angiography (CTA)

• Requires iodinated contrast

• Requires ionizing radiation

• Produces an excellent arterial picture

Page 42: Henao

Steve Henao MD

Computed Tomographic Angiography (CTA)

• Requires iodinated contrast

• Requires ionizing radiation

• Produces an excellent arterial picture

Page 43: Henao

Steve Henao MD

ACC/AHA Guideline for the Management of PAD:Steps Toward the Diagnosis of PAD

Obtain history of walking impairment and/or limb ischemic symptoms: Obtain a vascular review of

symptoms:• Leg discomfort with exertion

• Leg pain at rest; nonhealing wound; gangrene

No leg pain

Classic claudicati

on

Chronic critical limb

ischemia(CLI)

“Atypical” leg pain

Diagnosis and Treatment of

Asymptomatic PAD and Atypical Leg

Pain

Diagnosis and

Treatment of

Claudication

Diagnosis and Treatment of Critical Limb

Ischemia

Diagnosis and Treatment of Acute

Limb Ischemia

Diagnosis and Treatment of Asymptomati

c PAD and Atypical Leg

Pain

Individuals“at risk”for PAD

Age 50 to 69 years and history of smoking or diabetesAge ≥ 70 years

Abnormal lower extremity pulse examinationKnown atherosclerotic coronary, carotid, or renal arterial disease

Acute limb

ischemia(ALI)

Perform a resting ankle-brachial index measurement

Hirsch AT, et al. J Am Coll Cardiol. 2006;47:e1-e192.

Page 44: Henao

Steve Henao MD

Individual at PAD risk: No leg symptoms or atypical leg symptoms

Perform a resting ankle-brachial index measurement

Confirmation of PAD

diagnosis

ABI ≥ 1.30(abnormal)

ABI ≤ 0.90(abnormal)

Pulse volume recordingToe-brachial index

(Duplex ultrasonography)

Abnormal

results

Evaluate other causes of leg

symptoms

Decreased post-exercise ABI

Normal post-exercise ABI:

No PAD

Measure ABI afterexercise test

ABI 0.91 to 1.30(borderline & normal)

Normal results:No PAD

Hirsch AT, et al. J Am Coll Cardiol. 2006;47:e1-e192.

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Steve Henao MD

Risk factor normalization:Immediate smoking cessation

Treat hypertensionTreat lipids

Treat diabetes mellitus: HbA1c less than 7%

Pharmacological Risk Reduction:Antiplatelet therapy (ACE inhibition)

Confirmation of PAD diagnosis

Hirsch AT, et al. J Am Coll Cardiol. 2006;47:e1-e192.ACE=angiotensin-converting enzyme; JNC-7=Joint National Committee on Prevention ;NCEP=National Cholesterol Education Program – Adult Treatment Panel III.

Page 46: Henao

Steve Henao MD

Antihypertensive Therapy

Antihypertensive therapy should be administered to hypertensive patients with lower extremity PAD to a goal of less than 140/90 mm Hg (non-diabetics) or less than 130/80 mm Hg (diabetics and individuals with chronic renal disease) to reduce the risk of myocardial infarction, stroke, congestive heart failure, and cardiovascular death.

Beta-adrenergic blocking drugs are effective antihypertensive agents and are not contraindicated in patients with PAD.

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

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Steve Henao MD

Lipid Lowering Therapy

Treatment with a HMG coenzyme-A reductase inhibitor (statin) medication is indicated for all patients with peripheral arterial disease to achieve a target LDL cholesterol of less than 100 mg/dL.

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

Treatment with a HMG coenzyme-A reductase inhibitor (statin) medication to achieve a target LDL cholesterol level of less than 70 mg per dl is reasonable for patients with lower extremity PAD at very high risk of ischemic events†.

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

† Factors that define “very high risk” in individuals with established PAD are: (a) multiple major risk factors (especially diabetes), (b) severe and poorly controlled risk factors (especially continued cigarette smoking), (c) multiple risk factors of the metabolic syndrome and (d) individuals with acute coronary syndromes.

HMG coenzyme=3-hydroxy-3-methylglutaryl coenzyme

Page 48: Henao

Steve Henao MD

PAD Care Standards for Patients With Diabetes

Proper foot care, including use of appropriate footwear, chiropody/podiatric medicine, daily foot inspection, skin cleansing, and use of topical moisturizing creams, should be encouraged and skin lesions and ulcerations should be addressed urgently in all diabetic patients with lower extremity PAD.

Treatment of diabetes in individuals with lower extremity PAD by administration of glucose control therapies to reduce the hemoglobin HbA1C to less than 7% can be effective to reduce microvascular complications and potentially improve cardiovascular outcomes.

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

Page 49: Henao

Steve Henao MD

Risk Reduction of Clopidogrel vs. Aspirin in Patients With Atherosclerotic Vascular Disease

Reprinted with permission from CAPRIE Steering Committee. Lancet. 1996;348:1329-1339.

Stroke

0 10 20-10-20

MI

PAD

All patients

Aspirin favored

-30 30 40

Clopidogrel favored

N=19,185

Page 50: Henao

Steve Henao MD

Classic Claudication Symptoms:Muscle fatigue, cramping, or pain that

reproducibly begins during exercise and that promptly resolves with rest

Document pulse examination

ABI Exercise ABI

(TBI, segmental pressure, or Duplex

ultrasound examination)

Chart document the history of walking impairment (pain-free and total walking

distance) and specific lifestyle limitations

Confirmed PAD diagnosis

ABI greater

than 0.90

ABI less than or equal to 0.90

No PAD or consider arterial entrapment syndromes

Normalresults

Abnormal

results

Cont’d

Hirsch AT, et al. J Am Coll Cardiol. 2006;47:e1-e192.ABI=ankle-brachial index; TBI=toe-brachial index.

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Steve Henao MD

Risk factor normalization:Immediate smoking cessation

Treat hypertensionTreat lipids

Treat diabetes mellitus: HbA1c less than 7%

Pharmacological risk reduction:Antiplatelet therapy

(ACE inhibition)

Confirmed PAD diagnosis

Treatment of Claudication

Hirsch AT, et al. J Am Coll Cardiol. 2006;47:e1-e192.ACE=angiotensin-converting enzyme; JNC-7=Joint National Committee on Prevention ;NCEP=National Cholesterol Education Program – Adult Treatment Panel III.

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Steve Henao MD

Significant disability despite medical therapy and/or inflow

endovascular therapy, with documentation of outflow PAD,

with favorable procedural anatomy and procedural risk-

benefit ratio

No significant functional disability

Lifestyle-limiting symptoms

Supervisedexercise program

Three-month trial

Preprogram and

postprogram exercise testing

for efficacy

Lifestyle-limiting symptoms with

evidence of inflow disease

Further anatomic definition by more

extensive noninvasive or angiographic

diagnostic techniques

Clinical improvement:Follow-up visits at least annually

Endovasculartherapy or

surgical bypass per anatomy

Pharmacological therapy:Cilostazol

(Pentoxifylline)

Three-month trial

Evaluation for additional endovascular or surgical revascularization

Confirmed PAD Diagnosis

• No claudication treatment required.

• Follow-up visits at least annually to monitor for development of leg, coronary, or cerebrovascular ischemic symptoms.

Hirsch AT, et al. J Am Coll Cardiol. 2006;47:e1-e192.

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Steve Henao MD

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

Endovascular Treatment for Claudication

Endovascular procedures are indicated for individuals with a vocational or lifestyle-limiting disability due to intermittent claudication when clinical features suggest a reasonable likelihood of symptomatic improvement with endovascular intervention and …

a. response to exercise or pharmacologic therapy is inadequate, and/or

b. there is a very favorable risk-benefit ratio (e.g., focal aortoiliac occlusive disease)

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Steve Henao MD

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

Endovascular Treatment for Claudication

Endovascular intervention is not indicated if there is no significant pressure gradient across a stenosis despite flow augmentation with vasodilators.

Primary stent placement is not recommended in the femoral, popliteal, or tibial arteries.

Endovascular intervention is not indicated as prophylactic therapy in an asymptomatic patient with lower extremity PAD.

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Steve Henao MD

Chronic CLI symptoms: Ischemic rest pain, gangrene, nonhealing wound

Ischemic etiology must be established promptly by examination and objective vascular studies

Implication: Impending limb loss

History and physical examination: Document lower extremity pulses;

Document presence of ulcers or infection

ABI, TBI, or Duplex US Evaluation of source

(ECG or Holter monitor; TEE; and/or

abdominal US, MRA, or CTA);

or venous Duplex

Consider atheroembolism,

thromboembolism, or phlegmasia cerulea dolens

No or minimal atherosclerotic

arterial occlusive disease

Assess factors that may contribute to limb risk:

diabetes, neuropathy, chronic renal failure, infection

Severe lower extremity PAD documented:

ABI less than 0.4; flat PVR waveform; absent pedal flow

Cont’d

Hirsch AT, et al. J Am Coll Cardiol. 2006;47:e1-e192.

ABI=ankle-brachial index; CLI=critical limb ischemia; CTA=computed tomographic angiography; ECG=electrocardiogram; MRA=magnetic resonance angiography; PVR=pulse volume recording; TEE=transesophageal echocardiogram; TBI=toe-brachial index; US= ultrasound.

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Steve Henao MD

Obtain prompt vascular specialist consultation:

• Diagnostic testing strategy• Creation of therapeutic intervention

plan

Ongoing vascular surveillance

Written instructions for self-surveillance

Patient is not a candidate for

revascularization

Medical therapyor amputation (when

necessary)

Severe lower extremity PAD documented:ABI less than 0.4; flat PVR waveform; absent pedal flow

Systemic antibiotics if skin ulceration and limb infection

are present

ABI=ankle-brachial index; PVR=pulse volume recording.

Hirsch AT, et al. J Am Coll Cardiol. 2006;47:e1-e192.

Cont’d

Patient is a candidate for

revascularization

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Steve Henao MD

• Define limb arterial anatomy• Assess clinical and objective severity

of ischemia

Revascularization possible(see treatment text, with

application of thrombolytic, endovascular,

and surgical therapies)

Revascularization not possible:medical therapy;

amputation (when necessary)

Ongoing vascular surveillance

Written instructions for self-surveillance

Patient is a candidate for

revascularization

Imaging of relevant arterial circulation (noninvasive and

angiographic)

Hirsch AT, et al. J Am Coll Cardiol. 2006;47:e1-e192.

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Steve Henao MD

For individuals with combined inflow and outflow

disease with CLI, inflow lesions should be addressed first.

For individuals with combined inflow and outflow

disease in whom symptoms of CLI or infection

persist after inflow revascularization, an outflow

revascularization procedure should be performed.

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

III IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIII IIaIIaIIa IIbIIbIIb IIIIIIIIIIIaIIaIIa IIbIIbIIb IIIIIIIII

Endovascular Treatment for Critical Limb Ischemia

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Steve Henao MD

• Achieve pulsatile flow to the foot.• Restore straight-line flow to the pedal arch in order to

achieve clinical success.

Effective endovascular treatment will usually:

• Dilation of a proximal (inflow) lesion alone in the setting of a distal arterial occlusion may not be adequate to achieve wound healing.

• Balloon angioplasty with bail-out (provisional) stent placement is the treatment of choice.

Note:

Endovascular Treatment for Critical Limb Ischemia

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Steve Henao MD

• Appropriate patient and lesion selection is critical to success.

• Focal stenoses do best. 6 cm occlusions 5 stenotic lesions

• Success is measured by:– Relief of rest pain– Healing of ulcers– Avoidance of amputation

Endovascular Treatment for Critical Limb Ischemia

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Steve Henao MD

The PAD Guideline is Intended to Guide Lifelong Primary to Specialty PAD Care

Population at risk:(Age and risk factors)

Establish the PAD diagnosis

Population with symptoms:Improve limb outcomes

Prevent CV ischemic events

MedicalTherapy

EndovascularTherapy

SurgicalTherapy

Integrated care requires a partnership of vascular specialists (vascular surgery, nursing,

podiatry, and others)

•ABI

•TBI

•Duplex US

•MRA

•CTA

•Angiography

Population remains at risk:

Primary care management of legs and life, in

collaboration withvascular specialists

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Steve Henao MD

Public Awarenessof

Peripheral ArterialDisease

Clinician Awarenessof

Peripheral ArterialDisease

The PAD Coalition & PAD Guideline

Individual “at risk” or with PADseeks care (primary care)

Individual “at risk” or with PADreceives vascular care

The Ideal Clinical Synergy:When an Informed Patient Seeks an

Informed Clinician

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Steve Henao MD

NMHI Vascular: 843-NMHI Vascular: 843-25252525