Peripheral arterial disease

Dr Virbhan Balai

Peripheral Arterial Disease

Atherosclerosis affects up to 10% of the Western population older than 65 years.

It is estimated that 2% of the population aged 40-60 years and 6% of the population older than 70 years are affected with PAD (claudication).

Most commonly manifests in men older than 50 years. PAD has no racial predilection.

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, or meet all “Rose questionnaire” criteria.

Individuals With PAD Present in Clinical Practice With Distinct Syndromes

Rose questionnaire

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

Individuals With PAD Present in Clinical Practice With Distinct Syndromes

Intermittent claudication typically causes pain that occurs with physical activity.

Determining how much physical activity is needed before the onset of pain is crucial.

Walking distance helps quantify patients’ condition before and after therapy.

History

Pain is reproducible within the same muscle groups.It ceases with a resting period of 2-5 minutes.PAD is most common in the distal superficial femoral

artery.This corresponds to claudication in the calf muscle area. When atherosclerosis is distributed throughout the aorto

iliac area, thigh and buttock muscle claudication predominates.

Clinical Presentations of PAD~15%

Classic (Typical) Claudication

~33%Atypical Leg Pain(functionally limited)

50%Asymptomatic

1%-2%Critical Limb Ischemia

Claudication vs. Pseudoclaudication

Claudication PseudoclaudicationCharacteristic of discomfort

Cramping, tightness, aching, fatigue

Same as claudication plus tingling, burning,

numbness

Location of discomfort

Buttock, hip, thigh, calf, foot

Same as claudication

Exercise-induced Yes Variable

Distance Consistent Variable

Occurs with standing No Yes

Action for relief Stand Sit, change position

Time to relief <5 minutes 30 minutes

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

Factors that reduce blood flow to the microvascular bed- Diabetes- Severe renal failure- Severely decreased cardiac output (severe heart failure or

shock)- Vasospastic diseases or concomitant conditions (e.g.,

Raynaud’s phenomenon, prolonged cold exposure)- Smoking and tobacco use

Factors that increase demand for blood flow to the microvascular bed- Infection (e.g., cellulitis, osteomyelitis)- Skin breakdown or traumatic injury

Factors That Increase Risk of Limb Loss in Patients With Critical Limb Ischemia


50-90% of patients with definite intermittent claudication do not report their symptom to clinician.

Most patients appear to accept a decrease in walking distance as a part of aging.

The risk factors for PAD are the same as those for CAD or cerebro vascular disease and include the following:

DiabetesHypertensionHyperlipidemiaFamily historySedentary lifestyleTobacco use

Smoking is the greatest of all the cardiovascular risk factors.

The mechanism is unknown. Degree of damage is directly related to the amount of

tobacco used.

Complete lower-extremity evaluation and pulse examination.

Pulses should be examined from the abdominal aorta to the foot.

The absence of a pulse signifies arterial obstruction proximal to the area.

Physical Examination

The First Tool to Establish the PAD Diagnosis:A Standardized Physical ExaminationPulse intensity should be assessed and should be

recorded numerically as follows:

0, absent 1, diminished 2, normal

3, bounding

Use of a standardexamination shouldfacilitate clinicalcommunication

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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.

Evaluation of the Patient With Critical Limb Ischemia



Auscultation for bruits in the abdominal and pelvic regions.

Atrophy of calf muscles, Loss of extremity hair, and Thickened toe nails are clues to underlying PAD.

When palpable pulses are not present, further assessment with handheld Doppler device.

An audible Doppler signal assures the clinician that some blood flow is perfusing the extremity.

If no Doppler signals can be heard, a vascular surgeon should be consulted immediately.

Lower extremity systolic pressureBrachial artery systolic pressure ABI

=• The ankle-brachial index is 95% sensitive and 99%

specific for PAD• Establishes the PAD diagnosis• Identifies a population at high risk of CV ischemic events• “Population at risk” can be clinically & epidemiologically

defined:

The Ankle-Brachial Index

Exertional leg symptoms, non-healing wounds, age > 70, age > 50 years with a history of smoking or diabetes.

An accurate pressure reading is obtained as follows: Place the pneumatic cuff around the ankle Position the Doppler probe over the dorsalis pedis or the

posterior tibial artery Inflate the cuff to a reading above the systolic pressure and

deflate; the systolic tone at the ankle vessel is the pressure recorded

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

ABI Procedure

A healthy person the pressure at the ankle may be 10-20 mm Hg higher.

In a patient with claudication, the measured pressure at the ankle will be diminished, depending on the severity of PAD.

A useful tool in assessing a patient with claudication is the ankle-brachial index .

Ratio of systolic blood pressure at the ankle to systolic blood pressure in the arm.

A normal ABI is 0.9-1.1. ABI < 0.9 =PAD. As PAD worsens, the ABI decreases further.

Interpreting the Ankle-Brachial Index

Adapted from Hirsch AT, et al. J Am Coll Cardiol. 2006;47:e1-e192. Figure 6.

ABI Interpretation1.00–1.29

Normal

0.91–0.99

Borderline

0.41–0.90

Mild-to-moderate disease

≤0.40 Severe disease≥1.30 Noncompressible

Exercise ABI Testing: Treadmill

Indicated when the ABI is normal or borderline but symptoms are consistent with claudication;

An ABI fall post-exercise supports a PAD diagnosis;

Assesses functional capacity (patient symptoms may be discordant with objective exercise capacity).

.

The ABI may be a less accurate assessment tool in patients with diabetes.

Peripheral vessels in patients with diabetes may have extensive medial-layer calcinosis, which renders the vessel resistant to compression by the pneumatic cuff.

ABI LimitationsIncompressible 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”

Toe-Brachial Index MeasurementThe 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.

1. Chronic Venous Insufficiency2. Compartment Syndrome, Lower Extremity3. Degenerative Disk Disease4. Osteoarthritis5. Spinal Stenosis6. Thromboangiitis Obliterans7. Varicose Veins

Differential Diagnoses

Differential Diagnosis of Common Foot Ulcers

Neuropathic Ulcer Neuroischemic UlcerPainless Painful

Normal pulses Absent pulses

Typically punches-out appearance Irregular margins

Often located on sole or edge of foot or metatarsal head

Commonly located on toes

Presence of calluses Calluses absent or infrequent

Loss of sensation, reflexes, and vibration sense

Variable sensory findings

Increase in blood flow (arteriovenous shunting)

Decrease in blood flow

Dilated veins Collapsed veins

Dry, warm foot Cold foot

Bone deformities No bony deformities

Red appearance Pale, cyanoticReprinted with permission from Dormandy JA, Rutherford RB. J Vasc Surg. 2000;31:S1-

S296.

Laboratory studies Renal functionElevated lipid profiles.

AngiographyComputed tomography angiography (CTA) Magnetic resonance angiography (MRA)Duplex ultrasonography.

Approach Considerations

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 claudication

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

Angiography is the criterion standard arterial imaging study for the diagnosis of PAD.

Usually reserved for when an intervention is planned.

Standard Angiography

1. MRA is useful for imaging large and small vessels. MRA also to help plan the type of intervention.

2. CTA is another modality used to image arterial disease. Requires a large amount of contrast media.

3. Duplex ultrasonography is performed to evaluate the status of a patient’s vascular disease.

NoninvasiveRequiring no contrast media. Unfortunately, it is highly technician-dependent.

Other Studies

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.



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MRA of the extremities is useful to diagnose

anatomic location and degree of stenosis of

PAD.

MRA of the extremities should be performed

with a gadolinium enhancement.

MRA of the extremities is useful in selecting

patients with lower extremity PAD as candidates

for endovascular intervention.

Magnetic Resonance Angiography (MRA)

Noninvasive Imaging Tests

Noninvasive Imaging Tests



CTA of the extremities may be considered

to diagnose anatomic location and presence of significant stenosis in patients with lower extremity PAD.

CTA of the extremities may be considered

as a substitute for MRA for those patients

with contraindications to MRA.

Computed Tomographic Angiography (CTA)

Treatment of claudication is medical, except in severe cases.

Goal - is to impede the progression of the disease. 1. Pharmacologic2. Nonpharmacologic measures.

Management

The most expedient way of impeding the progression of PAD is to stop tobacco use.

Smoking Cessation

Aspirin is recommended for overall cardiovascular care. Standard dosages range from 81 to 325 mg/day, but no

consensus has been reached on the most effective dose.Pentoxifylline shows promise.

Numerous RCT have documented modest improvements in walking distance in pentoxifylline treatment groups as compared with placebo treatment groups.

Treatment may take as long as 2-3 months to produce noticeable results.

Pharmacologic Therapy

Clopidogrel bisulfate Enoxaparin sodiumCilostazol

↑walking distance Lipid profiles- also improved

Statins - seemed to be the best at improving maximal walking distance.

Antiplatelet Therapy

Antiplatelet therapy is indicated to reduce the risk of myocardial infarction, stroke, or vascular death in individuals with atherosclerotic lower extremity PAD. Aspirin, in daily doses of 75 to 325 mg, is recommended as safe and effective antiplatelet therapy to reduce the risk of myocardial infarction, stroke, or vascular death in individuals with atherosclerotic lower extremity PAD.



Clopidogrel (75 mg per day) is recommended as an effective alternative antiplatelet therapy to aspirin to reduce the risk of myocardial infarction, stroke, or vascular death in individuals with atherosclerotic lower extremity PAD.


Pharmacotherapy of Claudication

Cilostazol (100 mg orally two times per day) is indicated as an effective therapy to improve symptoms and increase walking distance in patients with lower extremity PAD and intermittent claudication (in the absence of heart failure).


In July 2014, the SCAI issued a consensus statement on the treatment of infrapopliteal arterial disease.

1. Endovascular intervention is not appropriate for most single-vessel, mildly symptomatic, or asymptomatic blockages of infrapopliteal vessels.

2. It is not appropriate to treat most cases of moderate-to-severe claudication or major tissue loss in one-vessel disease and mild claudication in one-, two-, or three-vessel disease.

3. Primary amputation should be the preferred intervention in non ambulatory patients with a limited life expectancy and extensive necrosis or gangrene.

4. Consider surgical bypass and evaluate its associated risks for ambulatory patients with a patent infrapopliteal artery that has direct flow to the foot and an adequate autologous venous conduit.

5. Use balloon angioplasty for clinically significant infra popliteal arterial disease; consider bailout bare-metal and drug-eluting stents for tibial arterial disease that is refractory to treatment with balloon angioplasty.

The SCAI indicated that intervention for infrapopliteal disease is appropriate in

1. Patients with two- or three-vessel disease and moderate-to-severe claudication with a focal arterial lesion.

2. ischemic foot pain during rest (Rutherford classification 4)

3. Minor and major (skin necrosis, gangrene) tissue loss.

Diabetes- Control BARI 2D trial- those treated with insulin-sensitizing

therapy (16.9%) (ie, metformin or a glitazone) were less likely to develop any type of new PAD during 4.6 years of follow-up than were patients treated with insulin-providing therapy (24.1%).

Additional medical treatment

Surgical treatment options1. Patients with more severe disease or 2. Nonsurgical management fails

A. Open bypass surgeryB. Endovascular therapy (eg, stents, balloons, or

atherectomy devices).

Surgical Intervention

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.

Endovascular Treatment for Claudication




Surgery for Critical Limb Ischemia

Patients who have significant necrosis of the weight-bearing portions of the foot, an uncorrectable flexion contracture, paresis of the extremity, refractory ischemic rest pain, sepsis, or a very limited life expectancy due to co-morbid conditions should be evaluated for primary amputation.

Surgery is not indicated in patients with severe decrements in limb perfusion in the absence of clinical symptoms of critical limb ischemia.


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For individuals with combined inflow and

outflow disease with critical limb ischemia,

inflow lesions should be addressed first.

When surgery is to be undertaken, an aorto-

bifemoral bypass is recommended for patients

with symptomatic, hemodynamically significant, aorto-bi-iliac disease

requiringintervention.




Bypasses to the above-knee popliteal artery should be constructed with

autogenoussaphenous vein when possible.

Bypasses to the below-knee popliteal artery

should be constructed with autogenous vein

when possible.

Prosthetic material can be used effectively

for bypasses to the below knee popliteal artery when no autogenous vein from

ipsilateral or contralateral leg or arm is available.





Femoral-tibial artery bypasses should beconstructed with autogenous vein, including ipsilateral greater saphenous vein, or if unavailable, other sources of vein from the leg or arm.

Composite sequential femoropopliteal-tibial bypass, or bypass to an isolated popliteal arterial segment that has collateral outflow to the foot, are acceptable methods of revascularization and should be considered when no other form of bypass with adequate autogenous conduit is possible.



Acute Limb Ischemia (ALI)

Patients with ALI and a salvageable extremity should undergo an

emergent evaluation that defines the anatomic

level ofocclusion, and that leads to prompt endovascular or surgical

intervention.

Patients with ALI and a non-viable extremity

should not undergo an evaluation to define

vascular anatomy or efforts to attempt

revascularization.



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 claudication

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 Asymptomatic PAD and Atypical Leg Pain

Individuals“at risk”for PAD

Age 50 to 69 years and history of smoking or diabetesAge ≥ 70 yearsAbnormal lower extremity pulse examinationKnown atherosclerotic coronary, carotid, or renal arterial disease

Acute limb ischemia(ALI)



Individual at PAD risk: No leg symptoms or atypical leg symptomsConsider use of the San Diego Walking Impairment Questionnaire


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

ACC/AHA Guideline for the Management of PAD:Diagnosis and Treatment of Asymptomatic PAD


ACC/AHA Guideline for the Management of PAD:Diagnosis and Treatment of Asymptomatic PAD

Risk factor normalization:Immediate smoking cessationTreat hypertension: JNC-7 guidelinesTreat lipids: NCEP ATP III guidelinesTreat diabetes mellitus: HbA1c less than 7%

Pharmacological Risk Reduction:Antiplatelet therapy (ACE inhibition; Class IIb, LOE C)

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.

ACC/AHA Guideline for the Management of PAD:Diagnosis of Claudication and Systemic Risk Treatment 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

Abnormalresults

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

ACC/AHA Guideline for the Management of PAD: Diagnosis of Claudication and Systemic Risk Treatment

Risk factor normalization:Immediate smoking cessationTreat hypertension: JNC-7 guidelinesTreat lipids: NCEP ATP III guidelinesTreat diabetes mellitus: HbA1c less than 7%

Pharmacological risk reduction:Antiplatelet therapy(ACE inhibition; Class IIa)

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.

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.

ACC/AHA Guideline for the Management of PAD:Treatment of Claudication


ACC/AHA Guideline for the Management of PAD:Diagnosis and Treatment of Critical Limb Ischemia

Chronic CLI symptoms: Ischemic rest pain, gangrene, nonhealing woundIschemic etiology must be established promptly by examination and objective vascular studiesImplication: 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.

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.

ACC/AHA Guideline for the Management of PAD:Diagnosis and Treatment of Critical Limb Ischemia (1)

Cont’d

Patient is a candidate for revascularization

• 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

ACC/AHA Guideline for the Management of PAD:Diagnosis and Treatment of Critical Limb Ischemia (2)

Imaging of relevant arterial circulation (noninvasive and angiographic)


Regular walking programs result in substantial improvement (80-234% in controlled studies).

A daily walking program of 45-60 minutes is recommended.

The patient walks until claudication pain occurs, rests until the pain subsides, and then repeats the cycle. Exact mechanism -unknown, Condition muscles, work more efficiently (ie, extract more

blood)Increase collateral vessel formation.

Physical Activity

Supervised Exercise Rehabilitation

A program of supervised exercise training is recommended as an initial treatment modality for patients with intermittent claudication.

Supervised exercise training should be performed for a minimum of 30 to 45 minutes, in sessions performed at least three times per week for a minimum of 12 weeks.



Every 4-6 months to assess the effects of therapy. Hypertension and diabetes should be controlled.A repeat pulse examination should be performed and the

ABI measured. If the patient’s symptoms are worsening, intervention and

referral to a vascular surgeon.

Long-Term Monitoring

Limb-threatening ischemia leading to amputation.In the Framingham study, only 1.6% of patients with

claudication reached the amputation stage after 8.3 years of follow-up.

Complications

Predicted mortality for patients with claudication is approximately 30% at 5 years of follow-up. 50% at 10 years. 70% at 15 years.

Prognosis

The US FDA has approved the first drug-coated balloon (DCB) for the treatment of peripheral arterial vascular disease, the Lutonix 035 Drug Coated Balloon.

Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB).

The device is coated with paclitaxel and intended for use to treat stenotic or obstructive lesions in the femoro popliteal arteries to improve limb perfusion.

Essential update

THANKYOU

Peripheral arterial disease

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