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Peripheral Arterial Disease-Standard Treatment Guidelines

Peripheral Arterial Disease-Standard Treatment Guidelines

Peripheral Arterial Disease should be suspected for adults 50 years and older who have atherosclerosis risk factors. Likewise for adults 70 years and older with complaints of fatigue, aching, numbness or pain in the lower extremity or any history of walking impairment (suggesting exertional limitation of the lower extremity muscles), pain at rest localized to the lower leg or foot and its association with the upright or recumbent positions and poorly healing or non-healing wounds of the legs or feet(1).

Introduction

The term “Peripheral Arterial Disease (PAD)” broadly encompasses the vascular diseases caused primarily by atherosclerosis and thromboembolic pathophysiological processes that alter the normal structure and function of the aorta, iliac and the arteries of the lower extremity. Patients with PAD have an increased risk of mortality, myocardial infarction, and cerebrovascular disease. They also suffer from significant functional limitations in their daily activities, and the most severely affected are at risk of limb loss.

Ministry of Health and Family Welfare, Government of India has issued the Standard Treatment Guidelines for Peripheral Arterial Disease.
Following are the major recommendations :

Case definition

Peripheral arterial disease (PAD) is the preferred clinical term that should be used to denote stenotic and occlusive diseases of the aorta and its branch arteries, exclusive of the coronary arteries.

Incidence of the condition in our country

It is underdiagnosed, undertreated, and much more common than previously thought. Incidence of the condition in our country is not exactly known due to lack of organized data. A strong association exists between advancing age and the prevalence. Almost 20% of adults older than 70 years have PAD. An American survey of 2174 patients older than 40 years of age used the Ankle-Brachial Index (ABI) as a screening tool, and showed a PAD prevalence of 0.9% between the ages of 40 and 49 years, 2.5% between the ages of 50 and 59 years, 4.7% between the ages of 60 and 69 years, and 14.5% for the ages of 70 years and older(2).

 

Differential Diagnosis of Intermittent Claudication

Condition Location of Pain or Discomfort Characteristic Discomfort Onset Relative to Exercise Effect of Rest Effect of Body Position Other Characteris tics
Intermittent claudication Buttock, thigh, or calf muscles and rarely the foot Cramping, aching, fatigue, weakness, or frank pain After same degree of exercise Quickly relieved None Reproducible
Nerve root compression (e.g., herniated disc) Radiates down leg, usually posteriorly Sharp lancinating pain Soon, if not immediately after onset Not quickly relieved (also often present at res Relief may be aided by adjusting back position History of back problems
Spinal stenosis Hip, thigh, buttocks (follows dermatome) Motor weakness more prominent than pain After walking or standing for variable lengths of time Relieved by stopping only if position changed Relief by lumbar spine flexion (sitting or stooping forward) Frequent history of back problems, provoked by intraabdominal pressure
Arthritic, inflammatory processes Foot, arch Aching pain After variable degree of exercise Not quickly relieved (and may be present at rest) May be relieved by not bearing weight Variable, may relate to activity level
Hip arthritis Hip, thigh, buttocks Aching discomfort, usually localized to hip and gluteal region After variable degree of exercise Not quickly relieved (and may be present at rest) More comfortable sitting, weight taken off legs Variable, may relate to activity level, weather changes
Symptomatic Baker’s cyst Behind knee, down calf Swelling, soreness, tenderness With exercise Present at rest None Not intermittent
Venous claudication Entire leg, but usually worse in thigh and groin Tight, bursting pain After walking Subsides slowly Relief speeded by elevation History of iliofemoral deep vein thrombosis, signs of venous congestion, edema
Chronic compartment syndrome Calf muscles Tight, bursting pain After much exercise (e.g., jogging) Subsides very slowly  

Relief speeded by elevation

Typically occurs in heavy muscled athletes

Prevention and Counselling

Individuals at risk for lower extremity disease should undergo a vascular review of symptoms to assess walking impairment, claudication, ischemic rest pain and/or the presence of non – healing wounds.

Aggressive lifestyle modification to reduce underlying risk factors (e.g. atherogenic diet, overweight or obesity, physical inactivity), to control risk factors such as diabetes, hypertension and hyperlipidemia are recommended for individuals with asymptomatic lower extremity PAD.

Optimal Diagnostic Criteria, Investigations, Treatment & Referral Criteria –

Diagnostic Criteria

PAD is considered in the following clinical setting –

  1. Adults 50 years and older who have atherosclerosis risk factors and
  2. Adults 70 years and older with the following symptoms –
  •  Fatigue, aching, numbness or pain in the lower extremity or any history of walking
    impairment (suggesting exertional limitation of the lower extremity muscles).
  • Pain at rest localized to the lower leg or foot and its association with the upright or recumbent positions.
  • Poorly healing or non-healing wounds of the legs or feet.

Acute limb ischemia (ALI) – refers to a rapid decrease of perfusion in the affected extremity that requires urgent revascularization to preserve tissue viability. Complications include rhabdomyolysis and renal failure.

Chronic Limb Ischemia (CLI) – refers to a chronic, severely compromised arterial blood supply in the affected extremity that manifests as ischemic pain at rest, ulcers or gangrene in various combinations.

Investigations

1. Measurement of Ankle-Brachial Index (ABI)

2. Color Doppler evaluation –
Color flow and pulsed wave Doppler allows an estimation of the stenosis severity on the basis of Doppler-derived velocity criteria. It is an accurate method for determining the degree of stenosis or length of occlusion of the arteries supplying the lower extremity. It is also useful in the follow-up of patients who have undergone endovascular (percutaneous transluminal angioplasty/stent) or surgical revascularization.

3. Magnetic Resonance Angiography (MRA) –

Magnetic resonance angiography (MRA) of the aorta and peripheral vasculature can be performed rapidly with excellent image quality. Being noninvasive, it is virtually replacing invasive diagnostic angiography as the primary modality for vascular imaging. Determining the type of intervention is feasible on a technically adequate MRA study. However, availability of the scanners with capability for peripheral vascular imaging and patients with relative contraindications to MR evaluation limits the utilization.

4. Computed Tomographic Angiography (CTA) –

Higher spatial resolution, absence of flow-related phenomena that may distort MRA images and the capacity to visualize calcification and metallic implants such as endovascular stents or stent grafts is an advantage with CTA when compared with MRA. Its advantages over invasive angiography include volumetric acquisition, improved visualization of soft tissues and other adjacent anatomic structures, less invasiveness and thus fewer potential complications. Exposure to ionizing radiation and the need for iodinated contrast medium limits its utilization as also availability of scanners with capability for peripheral vascular imaging.

5. Digital Subtraction Angiography (DSA) –

Vascular imaging with ultrasonography, CTA, and MRA has replaced catheter-based techniques in the initial diagnostic evaluation in most circumstances. The major advantage of DSA is the ability to selectively evaluate individual vessels, obtain physiologic information such as pressure gradients and as a platform for percutaneous intervention. Exposure to ionizing radiation, use of iodinated contrast agents, and risks related to vascular access and catheterization are limitations of this technique.

Treatment
Two major strategies for treatment are:

  • To improve symptoms and quality of life with medical therapy alone or with percutaneous / surgical revascularization and
  • To prevent cardiovascular events with a comprehensive program that includes smoking cessation, an exercise program, control of blood pressure, achievement of goal LDL-C, antiplatelet therapy, and control of diabetes.

Asymptomatic Lower Extremity PAD –

1. Smoking cessation, lipid lowering, diabetes and hypertension treatment.
2. Antiplatelet therapy – to reduce the risk of adverse cardiovascular ischemic events.
3. Angiotensin-converting enzyme (ACE) inhibition.

Symptomatic Lower extremity PAD-

Medical Management-

Best medical treatment is considered the main therapeutic pillar in patients with PAD. These patients are at increased risk for major adverse cardiovascular events (MACE) and cardiovascular death. Antithrombotic, antihypertensive and lipid lowering therapy has been shown to reduce the relative risk by 25% each. Medication should only be used in combination with aggressive lifestyle modification to reduce underlying lifestyle risk factors as mentioned above.

Revascularization

Before offering revascularization, a predicted or observed lack of adequate response to exercise therapy and claudication pharmacotherapies must be considered. Three clear indications for revascularization in patients with PAD are ischemic rest pain, ischemic ulcers or gangrene, and claudication that interfere with the patient’s lifestyle.

Revascularization by endovascular or surgical means, will be guided by the lesion morphology based on TASC II (Trans Atlantic Society Consensus) document criteria, where TASC A & B lesions are treated by endovascular approach and type D lesion are treated surgically. TASC C lesions can be attempted by endovascular approach and if the same fails, surgery is resorted to.

Endovascular procedures for revascularization depend upon whether the clinical presentation is acute or chronic and whether it is because of thrombotic occlusion or steno-occlusive lesion. Acute thrombotic occlusions are treated by Catheter directed thrombolysis, whereas chronic occlusions may require mechanical thrombectomy. Stenosis and short length occlusions (TASC A & B) are treated by Angioplasty & Stenting. Diffuse atheromatous plaques causing stenosis require Plaque Excisional Atherectomy. Long length occlusions in Iliac and SFA may yield to subintimal angioplasty followed by stent insertion if needed.

Referral Criteria

Situation 1: At Secondary Hospital/ Non-Metro situation: Optimal Standards of Treatment in Situations where technology and resources are limited:

Clinical Diagnosis: Same diagnostic criteria as above.

Investigations: Following thorough clinical evaluation, following investigations are required –

  • Measurement of Ankle-Brachial Index (ABI) & hand held vascular doppler.
  • Color Doppler Sonography.
  • Magnetic Resonance Angiography (MRA) or Computed Tomographic Angiography (CTA).

Treatment:

Asymptomatic Lower Extremity PAD – Smoking cessation, lipid lowering, diabetes and hypertension treatment. Antiplatelet therapy – to reduce the risk of adverse cardiovascular ischemic events (10, 11).

Symptomatic Lower extremity PAD – Best medical treatment is considered the main therapeutic pillar in patients with PAD. These patients are at increased risk for major adverse cardiovascular events (MACE).

Symptomatic Lower extremity PAD:

  • Modification of lifestyle to improve diet and physical activity and to control obesity,
    diabetes, hypertension and hyperlipidemia.
  • Medical treatment with antithrombotic, antihypertensive and lipid lowering drugs.
  • Revascularization, either endovascular or surgical (12).

Standard Operating Procedure

Out Patient / Day Care – Asymptomatic and symptomatic patients with less severe symptoms are treated on an Outpatient or Day Care basis.

Referral criteria:Patients may be referred to higher medical facility based upon –

  •  Worsening of symptoms despite adequate medical management including aggressive lifestyle modification.
  • Patient presents with acute limb ischemia (ALI) where immediate limb salvage is required.

Situation 2: At Super Specialty Facility in Metro location where higher-end technology is available

Clinical Diagnosis: Same diagnostic criteria as above.

Investigations:

1. Measurement of Ankle-Brachial Index (ABI) & hand held vascular doppler
2. Color Doppler Sonography
3. Magnetic Resonance Angiography (MRA) or
4. Computed Tomographic Angiography (CTA)
5. Digital Subtraction Angiography (DSA)

Treatment:

Asymptomatic Lower Extremity PAD-

1. Smoking cessation, lipid lowering, diabetes and hypertension treatment.
2. Antiplatelet therapy – to reduce the risk of adverse cardiovascular ischemic events.

Symptomatic Lower extremity PAD-

1. Aggressive lifestyle modification to reduce underlying lifestyle risk factors (e.g. atherogenic diet, overweight/obesity, physical inactivity) to control risk factors such as diabetes, hypertension and hyperlipidemia.

2. Medical treatment with antithrombotic, antihypertensive and lipid lowering therapy is given to reduce the relative risk of adverse events.

3. Revascularization – endovascular or surgical.

Standard Operating procedure

a) Out Patient – Asymptomatic and symptomatic patients with less severe symptoms are treated on an Outpatient or Day Care basis.

b) In Patient – Symptomatic patients requiring revascularization will need hospitalization for minimum duration depending upon endovascular or surgical approach, where the former approach requires shorter hospital stay. Similarly patients with major adverse cardiovascular events will need hospitalization to treat the adverse events.

Referral Criteria:

Worsening of symptoms despite adequate medical management including aggressive lifestyle modification or patient presents with acute limb ischemia where immediate limb salvage is required.

Designation Clinical Role Timeline
Physician (Internist) Clinical Evaluation Screening on presentation to OP
Vascular Surgeon (VS) Clinical Evaluation & supervising vascular evaluation Specialist Consultant who becomes the primary care Physician once diagnosis is established
Performs Vascular Surgery When indicated or when IR procedures fail.
Biochemist Biochemical evaluation After evaluation by and on the request of VS
Diagnostic Radiologist Perform Duplex Doppler Sonography, Evaluate CTA or MRA After evaluation by and on the request of VS
Cardiologist Cardiac evaluation After consultation by and on the request of VS
Management of MACE If necessary, following VS consult and on the request of VS

 

Interventional Radiologist IR Procedures – PTRA & Stenting, Thrombolysis, Mechanical thrombectomy, Subintimal Angioplasty etc. Referring Specialist for IR procedures on the request of VS
 

Nursing Staff

 

Assist in managing the patient

In-patient or Day Care in Vascular Surgery facility, Dialysis facility and Interventional Radiology facility

 

Technician Assist in Imaging the patient

 

In CT,MR and Interventional Radiology facility after Radiology & IR consultation

RESOURCES REQUIRED FOR ONE PATIENT / PROCEDURE (PATIENT WEIGHT 60 KGS)

(Units to be specified for human resources, investigations, drugs & consumables and equipment. Quantity to also be specified)

SITUATION HUMAN RESOURCES INVESTIGATIONS DRUGS & CONSUMABLES EQUIPMENT
1. Doctors –

(Internist – 1,

Vascular Surgeon – 1,

Diagnostic Radiologist

-1,

Technician(s) – 3,

Nursing – 2

Hemoglobin,

Random Blood

Sugar, PT, APTT

or INR, Platelet

Count, Se.

Creatinine,

HBsAg, HIV

1. Drugs:

Aspirin, Clopidogrel,

Nitroglycerine,

Nimodipine, Heparin

Vascular

Doppler(1)

Color Doppler

Ultrasound (1)

MDCT or MRI

with facility for

Vascular Imaging

(1)

2. Doctors –

(Internist – 1,

Vascular Surgeon with

– 1, Diagnostic

Radiologist -1,

Interventional

Radiologist – 1,

Anaesthetist -1)

Technician(s) – 3 to 4

Nurses – 3 to 4 for all

the units

Hemoglobin,

Random Blood

Sugar, PT, APTT

or INR, Platelet

Count, Se.

Creatinine,

HBsAg, HIV

1. Drugs:

Aspirin, Clopidogrel,

Nitroglycerine,

Nimodipine, Heparin,

Non Ionic

radiographic contrast

media

2. Consumables:

Arterial access

device, Diagnostic

Catheter, Guiding

catheter, Self

expanding or balloon

expanding Stent, Pre

and post dilatation

angioplasty

balloon(s),

Compatible

guidewire (s)

Vascular

Doppler(1)

Operation

Theatre (1)

Color Doppler

Ultrasound (1)

MDCT or MRI

with Vascular

Imaging (1)

Digital

Subtraction

Angiography

System (1)

Sterile Suite

Multichannel

invasive monitor(1)

Resuscitation

equipment (1)

Crash Trolley (1)

Guidelines by The Ministry of Health and Family Welfare :

Dr. Chander Mohan
Dr. B.L. Kapur Hospital
New Delhi

Source: self
1 comment(s) on Peripheral Arterial Disease-Standard Treatment Guidelines

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  1. Number of vascular surgeon in india is still less.but now with upcoming more institutes numbers in future will be their.now yearly 15-20 vascular specilist are trained and starting their practice from well trained institution across country.
    One more thing like to add is awarness of PAD and CLI in public and doctors also.as per my experience in previous three yrs as vascular specilist.