The main diagnosis criteria of surgical, vascular diseases in General Practitioner’s Practice of Family Medicine. Management (treatment), prevention, rehabilitation in the Outpatient Department of Family Doctor. Medical and Labour Expert Examination.

 

PERIPHERAL VASCULAR DISEASE: DIAGNOSIS AND TREATMENT

 

 

 

 

How is PAD diagnosed?

Diagnosing PAD begins with a medical history and physical exam. In the exam, your doctor can do a simple test called the ABI (ankle brachial index). After that, other tests may be done. They include:

   Doppler and duplex ultrasound imaging

   magnetic resonance angiogram (MRA)

   CT angiogram

   regular (catheter-based) angiogram

Peripheral vascular disease (PVD) refers to diseases of blood vessels outside the heart and brain. It’s often a narrowing of vessels that carry blood to the legs, arms, stomach or kidneys.

There are two types of PVD:

   Functional PVDs don’t involve defects in blood vessels’ structure. (The blood vessels aren’t

physically damaged.) These diseases often have symptoms related to “spasm” that may come and go.

   Organic PVDs are caused by structural changes in the blood vessels. Examples could include inflammation and tissue damage.

The most common sites for PAD are the iliac artery (in the lower torso), the femoral artery (in the groin), the popliteal artery (at the knee), and the tibial arteries (at the shin and calf).

ETIOLOGY

Peripheral Vascular Disease (PVD), also known as peripheral arterial occlusive disease (PAOD) or arteriosclerosis obliterans, refers to occlusion or stenosis of arteries, usually in the lower extremities.  The disease has become nearly pandemic, with the potential to cause loss of limb or even life.  As with most vascular diseases, the problem is primarily the result of atherosclerosis. 

 

In atherosclerotic arteries, the atheroma (consisting of a cholesterol/protein core) gradually enlarges, stenosing or even occluding medium and large vessels (see picture).  The result is impaired hemodynamics leading to alterations in the distal pressures afforded to affected muscle groups.  This loss of pressure can be described according to Poiseuille's Law which states that the loss of pressure is inversely proportional to the arterial radius to the 4th power.  Thus, when the reduction in diameter of the artery is approximately 50% (i.e. a 75% reduction in cross-sectional area), the loss of pressure increases exponentially!  The impact is even more pronounced (additive) when two or more occlusive lesions are located sequentially in the same artery.

 

The symptoms (see below) of PVD typically do not manifest themselves under resting conditions.  The reason is that patients with PVD typically have resting blood flows (300-400mm/min) similar to a healthy person.  It is not until the patient begins to exercise, where blood flow would normally increase to 10 times that amount owing to the increased cardiac output and compensatory vasodilation, that problems arise.  Because of the proximal stenosis caused by atherosclerosis, patients with disease cannot maximally increase blood flow distal to the obstruction during exercise.  When the metabolic demands of the distal muscles exceed supply, tissue ischemia results leading to symptoms.  When exercise ceases, blood flow and metabolic demand return to normal, and symptoms resolve within a few minutes.

 

 

CLINICAL PRESENTATION

 

When blood flow past a stenotic lesion cannot meet the demands of distal tissues, ischemia develops.  Ischemia can cause intermittent claudication, rest pain, skin ulceration, and/or gangrene.  Claudication is defined as reproducible, ischemic muscle pain and is the most commonly described symptoms (and may be the sole manifestation of early disease).  Claudication typically develops during exercise and is relieved after rest.  The pain is due to inadequate blood flow and the local metabolic acidosis which occurs due to a switch to anaerobic metabolism in the tissues.  Hence, the muscles affected are always distal to the arterial obstruction.  In addition to, and sometimes unassociated with pain, some patients have reported a sense of their hip or leg "giving out" after a certain degree of exertion.

Symptoms of PAD are related to the organ or part of the body deprived of blood. This includes:

·             Pain, fatigue, aching, tightness, weakness, cramping or tingling in the leg(s) brought on by exercise that goes away when resting

·             Numbness and pain of the legs or feet at rest

·             Cold hands, legs, or feet

·             Loss of hair on the legs and/or feet

·             Paleness or blueness of the legs

·             Weak or absent pulse in the leg

·             Sores, ulcer, or infection of the feet and legs that heal slowly

·             Erectile dysfunction

·             Swelling in lower extremities

·             Muscle atrophy

Rest pain is more worrisome and indicates more insidious, advanced disease.  Commonly, patients have pain in their very distal extremities (toes and metatarsal heads) while lying in bed.  The pain results from both PVD as well as inadequate perfusion (even at rest), often exacerbated by poor cardiac output (i.e. CHF).  Nerve ischemia appears to be the root cause of the pain, as these tissues are more sensitive to hypoxia.  The pain is typically relieved by placing the extremity in a dependant position (over the bedside) or by standing, thus allowing gravity to enhance perfusion.

 

A particular syndrome known as Leriche Syndrome has been named which describes the triad of intermittent claudication, impotence, and significantly decreased or absent femoral pulses.  Leriche Syndrome signifies chronic peripheral arterial insufficiency owing to narrowing of the distal aorta.

 

Like venous disease, arterial insufficiency can cause ulceration and gangrene.  The skin of the feet are at risk of ulceration due to poor blood supply and even minor trauma can lead to progressive ulceration as there is insufficient perfusion to allow for healing.  Arterial ulcers are often painful (except in diabetics with peripheral neuropathy) and a severely ischemic foot is at risk of developing uncontrolled infection, which can lead to gangrene.

 

In addition to the above, a thorough history often reveals typical risk factors for atherosclerosis (namely smoking, hypertension, and hyperlipidemia).  A systematic evaluation of the peripheral vasculature often reveals the classic "5 P's" of PVD:  Pulselessness, Pallor, Pain, Paresthesias, and Paralysis.  The last two suggest limb-threatening ischemia and prompt mandatory evaluation and consultation.

A useful tool in assessing the peripheral vasculature is the ankle-brachial index (ABI).  The ABI can be done in the office or at the bedside and involves the use of a blood pressure cuff and Doppler ultrasound.  In the supine position, the cuff is inflated on the calf and slowly deflated while the Doppler signal is monitored.  The pressure at which the Doppler signal reappears is the systolic pressure within the artery.  By dividing this pressure by the systolic blood pressure in the arm, the ABI is normalized.  Normally the ratio is greater than 1 and an ABI between 0.9 and 1.1 is considered normal.  The lower the ABI, the worse the disease.  A patient with an ABI less than 0.9 has (by definition) some degree of PVD, and claudication typically occurs at an ABI of about 0.8.  Rest pain and tissue loss occur at an ABI of less than 0.4.

 

Another test that the physician can use is segmental plethysmography.  Here, a blood pressure cuff is inflated at various points along the arms or legs to measure systolic blood pressures.  The cuffs are attached to a pulse volume recorder (plethysmograph) and the pressures between the upper and lower extremities are compared.  In this way, the examiner can determine the severity of disease in the arteries of the extremities.

 

The gold standard for diagnosis is arteriography.  Through a percutaneous femoral artery puncture, radiopaque dye is injected into the abdominal aorta in order to visualize the distal arterial tree.

 

 

 

TREATMENT

 

The treatment of claudication is mainly medical, with surgery reserved for the most severe of cases (rest pain, gangrene).  The goal of management is to stop the progression of disease and begins with smoking cessation and a regimented exercise program.  In fact, upwards of 50% of patients with claudication will obtain significant relief from smoking cessation and exercise alone.  A regular walking program of 45-60 minutes daily is recommended.  Additionally, other factors contributing to atherosclerotic disease should be controlled, including hypertension, diabetes, and the patient's lipid profile.

 

When limp-threatening ischemia or lifestyle-limiting claudication presents itself, then referral to a vascular surgeon is necessary.  The three surgical procedures which are currently used are endarterectomy, bypass, and amputation.  

 

Early treatment can slow or stop the disease. Talk with your doctor about the best treatment plan for you. Treatment options include the following:

 

Lifestyle Changes  

•Smoking cessation

•Diabetes control

•Blood pressure control

•Increased physical activity —such as a walking program

•Weight loss , if overweight

•Low-saturated fat, low-cholesterol diet

•Foot care —very important for people with diabetes:

•Shoes that fit properly

•Proper treatment of all foot injuries—healing is slowed when circulation is poor, so the risk of infection is higher

Medication  

•Blood thinners

•Pain medication

•Cholesterol-lowering agents called statins

•Medicines to enlarge or dilate the affected arteries

Invasive Procedures  

Procedures may include:

 

•Balloon angioplasty —a balloon is inflated in the artery to stretch it

•Stent implant—a wire mesh tube is placed in the artery; the stent expands and stays in place, keeping the artery open

•Laser treatment

•Atherectomy —a tube called a catheter is used to remove plaque inside a blood vessel

Surgery  

Surgery to open up narrowed arteries is performed in severe cases.

 

•Endarterectomy —the lining of the artery is removed, along with plaque build up

•Bypass surgery—a vein from another part of the body or a synthetic graft replaces the vessel

 

Endarterectomy has limited use in disease of the lower extremities as atherosclerosis is often extensive.  It involves removing the lining of the artery by excising the arterial wall, including the endothelium, the occluding plaque, and part of the media.  Its usefulness is more often demonstrated in the treatment of carotid disease.

Arterial bypass has become the primary operative treatment for PVD.  The choice of bypass is tailored to the type of disease present and differs depending on the anatomic location of occlusion.  For example, in aortoiliac disease, aorto-femoral or axillary-femoral bypasses could be used, depending on the state of the patients health, and feasibility of abdominal surgery.  Thus, for some patients who are not candidates for abdominal surgery (i.e. hostile abdomen), a subcutaneous graft could be placed from the axillary artery to the femoral (axillary-femoral bypass).

Femoropopliteal disease is best treated with a bypass (usually with the patients' autologous vein, i.e. saphenous) of the occluded segment.  As in the picture, the saphenous vein is connected to the femoral artery above the occlusion to the popliteal artery below.  The diseased segment in between is usually ligated to ensure that atheroma or thrombus does not embolize distally at a later time.

 

The complications of surgery include bleeding at the anastomosis, graft thrombosis, and hematoma at the incision site,  However, the success rate (5-year patency rate) of grafting is high (>90%). 

 

For some patients whom surgical revascularization is not possible, or who do not have a suitable target vessel for bypass, amputation may be the only option.  Selecting the appropriate amputation site is important as the more distal the amputation, the better the potential for rehabilitation and adequate wound healing.  Taking into account the perfusion pressures at different levels of the lower extremity helps the surgeon to decide whether an above-the-knee amputation (AKA) or below-the-knee amputation (BKA) is required and which will have the best success of healing post-operatively.

1  Vascular History and Physical Examination: Recommendations

Class I

· 1Individuals at risk for lower extremity peripheral artery disease (PAD) should undergo a vascular review of symptoms to assess walking impairment, claudication, ischemic rest pain, and/or the presence of nonhealing wounds. (Level of Evidence: C)

· 2Individuals at risk for lower extremity PAD should undergo comprehensive pulse examination and inspection of the feet. (Level of Evidence: C)

· 3Individuals over 50 years of age should be asked if they have a family history of a first-order relative with an abdominal aortic aneurysm (AAA). (Level of Evidence: C)

2  Lower Extremity PAD: Recommendations

2.1  Clinical Presentation
2.1.1  Asymptomatic

Class I

· 1A history of walking impairment, claudication, ischemic rest pain, and/or nonhealing wounds is recommended as a required component of a standard review of symptoms for adults 50 years and older who have atherosclerosis risk factors and for adults 70 years and older. (Level of Evidence: C)

· 2Individuals with asymptomatic lower extremity PAD should be identified by examination and/or measurement of the ankle-brachial index (ABI) so that therapeutic interventions known to diminish their increased risk of myocardial infarction (MI), stroke, and death may be offered. (Level of Evidence: B)

· 3Smoking cessation, lipid lowering, and diabetes and hypertension treatment according to current national treatment guidelines are recommended for individuals with asymptomatic lower extremity PAD. (Level of Evidence: B)

· 4Antiplatelet therapy is indicated for individuals with asymptomatic lower extremity PAD to reduce the risk of adverse cardiovascular ischemic events. (Level of Evidence: C)

Class IIa

· 1An exercise ABI measurement can be useful to diagnose lower extremity PAD in individuals who are at risk for lower extremity PAD who have a normal ABI (0.91 to 1.30), are without classic claudication symptoms, and have no other clinical evidence of atherosclerosis. (Level of Evidence: C)

· 2A toe-brachial index or pulse volume recording measurement can be useful to diagnose lower extremity PAD in individuals who are at risk for lower extremity PAD who have an ABI greater than 1.30 and no other clinical evidence of atherosclerosis. (Level of Evidence: C)

Class IIb

· 1Angiotensin-converting enzyme (ACE) inhibition may be considered for individuals with asymptomatic lower extremity PAD for cardiovascular risk reduction. (Level of Evidence: C)

2.1.2  Claudication

Class I

· 1Patients with symptoms of intermittent claudication should undergo a vascular physical examination, including measurement of the ABI. (Level of Evidence: B)

· 2In patients with symptoms of intermittent claudication, the ABI should be measured after exercise if the resting index is normal. (Level of Evidence: B)

· 3Patients 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. (Level of Evidence: C)

· 4Individuals with intermittent claudication who are offered the option of endovascular or surgical therapies should: (a) be provided information regarding supervised claudication exercise therapy and pharmacotherapy; (b) receive comprehensive risk factor modification and antiplatelet therapy; (c) have a significant disability, either being unable to perform normal work or having serious impairment of other activities important to the patient; and (d) 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. (Level of Evidence: C)

Class III

· 1Arterial imaging is not indicated for patients with a normal postexercise ABI. This does not apply if other atherosclerotic causes (e.g., entrapment syndromes or isolated internal iliac artery occlusive disease) are suspected. (Level of Evidence: C)

2.1.3  Critical Limb Ischemia

Class I

· 1Patients with critical limb ischemia (CLI) should undergo expedited evaluation and treatment of factors that are known to increase the risk of amputation. (Level of Evidence: C)

· 2Patients with CLI in whom open surgical repair is anticipated should undergo assessment of cardiovascular risk. (Level of Evidence: B)

· 3Patients with a prior history of CLI or who have undergone successful treatment for CLI should be evaluated at least twice annually by a vascular specialist owing to the relatively high incidence of recurrence. (Level of Evidence: C)

· 4Patients at risk of CLI (ABI <0.4 in an individual with diabetes, or any individual with diabetes and known lower extremity PAD) should undergo regular inspection of the feet to detect objective signs of CLI. (Level of Evidence: B)

· 5The feet should be examined directly, with shoes and socks removed, at regular intervals after successful treatment of CLI. (Level of Evidence: C)

· 6Patients with CLI and features to suggest atheroembolization should be evaluated for aneurysmal disease (e.g., abdominal aortic, popliteal, or common femoral aneurysms). (Level of Evidence: B)

· 7Systemic antibiotics should be initiated promptly in patients with CLI, skin ulcerations, and evidence of limb infection. (Level of Evidence: B)

· 8Patients with CLI and skin breakdown should be referred to healthcare providers with specialized expertise in wound care. (Level of Evidence: B)

· 9Patients 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. (Level of Evidence: C)

· 10Patients at risk for or who have been treated for CLI should receive verbal and written instructions regarding self-surveillance for potential recurrence. (Level of Evidence: C)

2.1.4  Acute Limb Ischemia

Class I

· 1Patients with acute limb ischemia and a salvageable extremity should undergo an emergent evaluation that defines the anatomic level of occlusion and that leads to prompt endovascular or surgical revascularization. (Level of Evidence: B)

Class III

· 1Patients with acute limb ischemia and a nonviable extremity should not undergo an evaluation to define vascular anatomy or efforts to attempt revascularization. (Level of Evidence: B)

2.1.5  Prior Limb Arterial Revascularization

Class I

· 1Long-term patency of infrainguinal bypass grafts should be evaluated in a surveillance program, which should include an interval vascular history, resting ABIs, physical examination, and a duplex ultrasound at regular intervals if a venous conduit has been used. (Level of Evidence: B)

Class IIa

· 1Long-term patency of infrainguinal bypass grafts may be considered for evaluation in a surveillance program, which may include conducting exercise ABIs and other arterial imaging studies at regular intervals. (Level of Evidence: B)

· 2Long-term patency of endovascular sites may be evaluated in a surveillance program, which may include conducting exercise ABIs and other arterial imaging studies at regular intervals. (Level of Evidence: B)

2.2  Diagnostic Methods
2.2.1  Ankle- and Toe-Brachial Indices, Segmental Pressure Examination

Class I

· 12011 Updated Recommendation: The resting ABI should be used to establish the lower extremity PAD diagnosis in patients with suspected lower extremity PAD, defined as individuals with 1 or more of the following: exertional leg symptoms, nonhealing wounds, age 65 and older, or 50 years and older with a history of smoking or diabetes. (Level of Evidence: B)

· 2The ABI should be measured in both legs in all new patients with PAD of any severity to confirm the diagnosis of lower extremity PAD and establish a baseline. (Level of Evidence: B)

· 3The toe-brachial index should be used to establish the lower extremity PAD diagnosis in patients in whom lower extremity PAD is clinically suspected but in whom the ABI test is not reliable due to noncompressible vessels (usually patients with long-standing diabetes or advanced age). (Level of Evidence: B)

· 4Leg segmental pressure measurements are useful to establish the lower extremity PAD diagnosis when anatomic localization of lower extremity PAD is required to create a therapeutic plan. (Level of Evidence: B)

· 52011 New Recommendation: ABI results should be uniformly reported with noncompressible values defined as greater than 1.40, normal values 1.00 to 1.40, borderline 0.91 to 0.99, and abnormal 0.90 or less. (Level of Evidence: B)

2.2.2  Pulse Volume Recording

Class IIa

· 1Pulse volume recordings are reasonable to establish the initial lower extremity PAD diagnosis, assess localization and severity, and follow the status of lower extremity revascularization procedures. (Level of Evidence: B)

2.2.3  Continuous-Wave Doppler Ultrasound

Class I

· 1Continuous-wave Doppler ultrasound blood flow measurements are useful to provide an accurate assessment of lower extremity PAD location and severity, to follow lower extremity PAD progression, and to provide quantitative follow-up after revascularization procedures. (Level of Evidence: B)

2.2.4  Treadmill Exercise Testing With and Without ABI Assessments and 6-Minute Walk Test

Class I

· 1Exercise treadmill tests are recommended to provide the most objective evidence of the magnitude of the functional limitation of claudication and to measure the response to therapy. (Level of Evidence: B)

· 2A standardized exercise protocol (either fixed or graded) with a motorized treadmill should be used to ensure reproducibility of measurements of pain-free walking distance and maximal walking distance. (Level of Evidence: B)

· 3Exercise treadmill tests with measurement of pre-exercise and postexercise ABI values are recommended to provide diagnostic data useful in differentiating arterial claudication from nonarterial claudication (“pseudoclaudication”). (Level of Evidence: B)

· 4Exercise treadmill tests should be performed in individuals with claudication who are to undergo exercise training (lower extremity PAD rehabilitation) so as to determine functional capacity, assess nonvascular exercise limitations, and demonstrate the safety of exercise. (Level of Evidence: B)

Class IIb

· 1A 6-minute walk test may be reasonable to provide an objective assessment of the functional limitation of claudication and response to therapy in elderly individuals or others not amenable to treadmill testing. (Level of Evidence: B)

2.2.5  Duplex Ultrasound

Class I

· 1Duplex ultrasound of the extremities is useful to diagnose anatomic location and degree of stenosis of PAD. (Level of Evidence: A)

· 2Duplex ultrasound is recommended for routine surveillance after femoral-popliteal or femoral-tibial-pedal bypass with a venous conduit. Minimum surveillance intervals are approximately 3, 6, and 12 months, and then yearly after graft placement. (Level of Evidence: A)

Class IIa

· 1Duplex ultrasound of the extremities can be useful to select patients as candidates for endovascular intervention. (Level of Evidence: B)

· 2Duplex ultrasound can be useful to select patients as candidates for surgical bypass and to select the sites of surgical anastomosis. (Level of Evidence: B)

Class IIb

· 1The use of duplex ultrasound is not well established to assess long-term patency of percutaneous transluminal angioplasty. (Level of Evidence: B)

· 2Duplex ultrasound may be considered for routine surveillance after femoral-popliteal bypass with a synthetic conduit. (Level of Evidence: B)

2.2.6  Computed Tomographic Angiography

Class IIb

· 1Computed tomographic angiography (CTA) of the extremities may be considered to diagnose anatomic location and presence of significant stenosis in patients with lower extremity PAD. (Level of Evidence: B)

· 2CTA of the extremities may be considered as a substitute for magnetic resonance angiography (MRA) for those patients with contraindications to MRA. (Level of Evidence: B)

2.2.7  Magnetic Resonance Angiography

Class I

· 1MRA of the extremities is useful to diagnose anatomic location and degree of stenosis of PAD. (Level of Evidence: A)

· 2MRA of the extremities should be performed with gadolinium enhancement. (Level of Evidence: B)

· 3MRA of the extremities is useful in selecting patients with lower extremity PAD as candidates for endovascular intervention. (Level of Evidence: A)

Class IIb

· 1MRA of the extremities may be considered to select patients with lower extremity PAD as candidates for surgical bypass and to select the sites of surgical anastomosis. (Level of Evidence: B)

· 2MRA of the extremities may be considered for postrevascularization (endovascular and surgical bypass) surveillance in patients with lower extremity PAD. (Level of Evidence: B)

2.2.8  Contrast Angiography

Class I

· 1Contrast angiography provides detailed information about arterial anatomy and is recommended for evaluation of patients with lower extremity PAD when revascularization is contemplated. (Level of Evidence: B)

· 2A history of contrast reaction should be documented before the performance of contrast angiography and appropriate pretreatment administered before contrast is given. (Level of Evidence: B)

· 3Decisions regarding the potential utility of invasive therapeutic interventions (percutaneous or surgical) in patients with lower extremity PAD should be made with a complete anatomic assessment of the affected arterial territory, including imaging of the occlusive lesion, as well as arterial inflow and outflow with angiography or a combination of angiography and noninvasive vascular techniques. (Level of Evidence: B)

· 4Digital subtraction angiography is recommended for contrast angiographic studies because this technique allows for enhanced imaging capabilities compared with conventional unsubtracted contrast angiography. (Level of Evidence: A)

· 5Before performance of contrast angiography, a full history and complete vascular examination should be performed to optimize decisions regarding the access site, as well as to minimize contrast dose and catheter manipulation. (Level of Evidence: C)

· 6Selective or super selective catheter placement during lower extremity angiography is indicated because this can enhance imaging, reduce contrast dose, and improve sensitivity and specificity of the procedure. (Level of Evidence: C)

· 7The diagnostic lower extremity arteriogram should image the iliac, femoral, and tibial bifurcations in profile without vessel overlap. (Level of Evidence: B)

· 8When conducting a diagnostic lower extremity arteriogram in which the significance of an obstructive lesion is ambiguous, transstenotic pressure gradients and supplementary angulated views should be obtained. (Level of Evidence: B)

· 9Patients with baseline renal insufficiency should receive hydration before undergoing contrast angiography. (Level of Evidence: B)

· 10Follow-up clinical evaluation, including a physical examination and measurement of renal function, is recommended within 2 weeks after contrast angiography to detect the presence of delayed adverse effects, such as atheroembolism, deterioration in renal function, or access site injury (e.g., pseudoaneurysm or arteriovenous fistula). (Level of Evidence: C)

Class IIa

· 1Noninvasive imaging modalities, including MRA, CTA, and color flow duplex imaging, may be used in advance of invasive imaging to develop an individualized diagnostic strategic plan, including assistance in selection of access sites, identification of significant lesions, and determination of the need for invasive evaluation. (Level of Evidence: B)

· 2Treatment with n-acetylcysteine in advance of contrast angiography is suggested for patients with baseline renal insufficiency (creatinine >2.0 mg per dL). (Level of Evidence: B)

2.3  Treatment
2.3.1  Cardiovascular Risk Reduction
2.3.1.1  Lipid-Lowering Drugs

Class I

· 1Treatment with a hydroxymethyl glutaryl coenzyme-A reductase inhibitor (statin) medication is indicated for all patients with PAD to achieve a target low-density lipoprotein cholesterol level of less than 100 mg per dL. (Level of Evidence: B)

Class IIa

· 1Treatment with a hydroxymethyl glutaryl coenzyme-A reductase inhibitor (statin) medication to achieve a target low-density lipoprotein cholesterol level of less than 70 mg per dL is reasonable for patients with lower extremity PAD at very high risk of ischemic events. (Level of Evidence: B)

· 2Treatment with a fibric acid derivative can be useful for patients with PAD and low high-density lipoprotein cholesterol, normal low-density lipoprotein cholesterol, and elevated triglycerides. (Level of Evidence: C)

2.3.1.2  Antihypertensive Drugs

Class I

· 1Antihypertensive therapy should be administered to hypertensive patients with lower extremity PAD to achieve a goal of less than 140 mm Hg systolic over 90 mm Hg diastolic (individuals without diabetes) or less than 130 mm Hg systolic over 80 mm Hg diastolic (individuals with diabetes and individuals with chronic renal disease) to reduce the risk of MI, stroke, congestive heart failure, and cardiovascular death. (Level of Evidence: A)

· 2Beta-adrenergic blocking drugs are effective antihypertensive agents and are not contraindicated in patients with PAD. (Level of Evidence: A)

Class IIa

· 1The use of ACE inhibitors is reasonable for symptomatic patients with lower extremity PAD to reduce the risk of adverse cardiovascular events. (Level of Evidence: B)

Class IIb

· 1ACE inhibitors may be considered for patients with asymptomatic lower extremity PAD to reduce the risk of adverse cardiovascular events. (Level of Evidence: C)

2.3.1.3  Diabetes Therapies

Class I

· 1Proper 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 patients with diabetes and lower extremity PAD. (Level of Evidence: B)

Class IIa

· 1Treatment of diabetes in individuals with lower extremity PAD by administration of glucose control therapies to reduce the hemoglobin A1C to less than 7% can be effective to reduce microvascular complications and potentially improve cardiovascular outcomes. (Level of Evidence: C)

2.3.1.4  Smoking Cessation

Class I

· 12011 New Recommendation: Patients who are smokers or former smokers should be asked about status of tobacco use at every visit. (Level of Evidence: A)

· 22011 New Recommendation: Patients should be assisted with counseling and developing a plan for quitting that may include pharmacotherapy and/or referral to a smoking cessation program. (Level of Evidence: A)

· 32011 Updated Recommendation: Individuals with lower extremity PAD who smoke cigarettes or use other forms of tobacco should be advised by each of their clinicians to stop smoking and offered behavioral and pharmacological treatment. (Level of Evidence: C)

· 42011 New Recommendation: In the absence of contraindication or other compelling clinical indication, 1 or more of the following pharmacological therapies should be offered: varenicline, bupropion, and nicotine replacement therapy. (Level of Evidence: A)

2.3.1.5  Homocysteine-Lowering Drugs

Class IIb

· 1The effectiveness of the therapeutic use of folic acid and B12 vitamin supplements in individuals with lower extremity PAD and homocysteine levels greater than 14 micromoles per liter is not well established. (Level of Evidence: C)

2.3.1.6  Antiplatelet and Antithrombotic Drugs

Class I

· 12011 Updated Recommendation: Antiplatelet therapy is indicated to reduce the risk of MI, stroke, and vascular death in individuals with symptomatic atherosclerotic lower extremity PAD, including those with intermittent claudication or CLI prior lower extremity revascularization (endovascular or surgical), or prior amputation for lower extremity ischemia. (Level of Evidence: A)

· 22011 Updated Recommendation: Aspirin, typically in daily doses of 75 to 325 mg, is recommended as safe and effective antiplatelet therapy to reduce the risk of MI, stroke, or vascular death in individuals with symptomatic atherosclerotic lower extremity PAD, including those with intermittent claudication or CLI, prior lower extremity revascularization (endovascular or surgical), or prior amputation for lower extremity ischemia. (Level of Evidence: B)

· 32011 Updated Recommendation: Clopidogrel (75 mg per day) is recommended as a safe and effective alternative antiplatelet therapy to aspirin to reduce the risk of MI, ischemic stroke, or vascular death in individuals with symptomatic atherosclerotic lower extremity PAD, including those with intermittent claudication or CLI, prior lower extremity revascularization (endovascular or surgical), or prior amputation for lower extremity ischemia. (Level of Evidence: B)

Class IIa

· 12011 New Recommendation: Antiplatelet therapy can be useful to reduce the risk of MI, stroke, or vascular death in asymptomatic individuals with an ABI less than or equal to 0.90. (Level of Evidence: C)

Class IIb

· 12011 New Recommendation: The usefulness of antiplatelet therapy to reduce the risk of MI, stroke, or vascular death in asymptomatic individuals with borderline abnormal ABI, defined as 0.91 to 0.99, is not well established. (Level of Evidence: A)

· 22011 New Recommendation: The combination of aspirin and clopidogrel may be considered to reduce the risk of cardiovascular events in patients with symptomatic atherosclerotic lower extremity PAD, including those with intermittent claudication or CLI, prior lower extremity revascularization (endovascular or surgical), or prior amputation for lower extremity ischemia and who are not at increased risk of bleeding and who are high perceived cardiovascular risk. (Level of Evidence: B)

Class III: No Benefit

· 12011 Updated Recommendation: In the absence of any other proven indication for warfarin, its addition to antiplatelet therapy to reduce the risk of adverse cardiovascular ischemic events in individuals with atherosclerotic lower extremity PAD is of no benefit and is potentially harmful due to increased risk of major bleeding. (Level of Evidence: B)

2.3.2  Claudication
2.3.2.1  Exercise and Lower Extremity PAD Rehabilitation

Class I

· 1A program of supervised exercise training is recommended as an initial treatment modality for patients with intermittent claudication. (Level of Evidence: A)

· 2Supervised exercise training should be performed for a minimum of 30 to 45 minutes, in sessions performed at least 3 times per week for a minimum of 12 weeks. (Level of Evidence: A)

Class IIb

· 1The usefulness of unsupervised exercise programs is not well established as an effective initial treatment modality for patients with intermittent claudication. (Level of Evidence: B)

2.3.2.2  Medical and Pharmacological Treatment for Claudication
2.3.2.2.1  Cilostazol

Class I

· 1Cilostazol (100 mg orally 2 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). (Level of Evidence: A)

· 2A therapeutic trial of cilostazol should be considered in all patients with lifestyle-limiting claudication (in the absence of heart failure). (Level of Evidence: A)

2.3.2.2.2  Pentoxifylline

Class IIb

· 1Pentoxifylline (400 mg 3 times per day) may be considered as second-line alternative therapy to cilostazol to improve walking distance in patients with intermittent claudication. (Level of Evidence: A)

· 2The clinical effectiveness of pentoxifylline as therapy for claudication is marginal and not well established. (Level of Evidence: C)

2.3.2.2.3  Other Proposed Medical Therapies

Class IIb

· 1The effectiveness of L-arginine for patients with intermittent claudication is not well established. (Level of Evidence: B)

· 2The effectiveness of propionyl-L-carnitine as a therapy to improve walking distance in patients with intermittent claudication is not well established. (Level of Evidence: B)

· 3The effectiveness of ginkgo biloba to improve walking distance for patients with intermittent claudication is marginal and not well established. (Level of Evidence: B)

Class III

· 1Oral vasodilator prostaglandins such as beraprost and iloprost are not effective medications to improve walking distance in patients with intermittent claudication. (Level of Evidence: A)

· 2Vitamin E is not recommended as a treatment for patients with intermittent claudication. (Level of Evidence: C)

· 3Chelation (e.g., ethylenediaminetetraacetic acid) is not indicated for treatment of intermittent claudication and may have harmful adverse effects. (Level of Evidence: A)

2.3.2.3  Endovascular Treatment for Claudication

Class I

· 1Endovascular 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) there has been an inadequate response to exercise or pharmacological therapy and/or (b) there is a very favorable risk-benefit ratio (e.g., focal aortoiliac occlusive disease). (Level of Evidence: A)

· 2Endovascular intervention is recommended as the preferred revascularization technique for TASC type A iliac and femoropopliteal arterial lesions. (Level of Evidence: B)

· 3Translesional pressure gradients (with and without vasodilation) should be obtained to evaluate the significance of angiographic iliac arterial stenoses of 50% to 75% diameter before intervention. (Level of Evidence: C)

· 4Provisional stent placement is indicated for use in the iliac arteries as salvage therapy for a suboptimal or failed result from balloon dilation (e.g., persistent translesional gradient, residual diameter stenosis >50%, or flow-limiting dissection). (Level of Evidence: B)

· 5Stenting is effective as primary therapy for common iliac artery stenosis and occlusions. (Level of Evidence: B)

· 6Stenting is effective as primary therapy in external iliac artery stenoses and occlusions. (Level of Evidence: C)

Class IIa

· 1Stents (and other adjunctive techniques such as lasers, cutting balloons, atherectomy devices, and thermal devices) can be useful in the femoral, popliteal, and tibial arteries as salvage therapy for a suboptimal or failed result from balloon dilation (e.g., persistent translesional gradient, residual diameter stenosis >50%, or flow-limiting dissection). (Level of Evidence: C)

Class IIb

· 1The effectiveness of stents, atherectomy, cutting balloons, thermal devices, and lasers for the treatment of femoral-popliteal arterial lesions (except to salvage a suboptimal result from balloon dilation) is not well-established. (Level of Evidence: A)

· 2The effectiveness of uncoated/uncovered stents, atherectomy, cutting balloons, thermal devices, and lasers for the treatment of infrapopliteal lesions (except to salvage a suboptimal result from balloon dilation) is not well established. (Level of Evidence: C)

Class III

· 1Endovascular intervention is not indicated if there is no significant pressure gradient across a stenosis despite flow augmentation with vasodilators. (Level of Evidence: C)

· 2Primary stent placement is not recommended in the femoral, popliteal, or tibial arteries. (Level of Evidence: C)

· 3Endovascular intervention is not indicated as prophylactic therapy in an asymptomatic patient with lower extremity PAD. (Level of Evidence: C)

2.3.2.4  Surgery for Claudication
2.3.2.4.1  Indications

Class I

· 1Surgical interventions are indicated for individuals with claudication symptoms who have a significant functional disability that is vocational or lifestyle limiting, who are unresponsive to exercise or pharmacotherapy, and who have a reasonable likelihood of symptomatic improvement. (Level of Evidence: B)

Class IIb

· 1Because the presence of more aggressive atherosclerotic occlusive disease is associated with less durable results in patients younger than 50 years of age, the effectiveness of surgical intervention in this population for intermittent claudication is unclear. (Level of Evidence: B)

Class III

· 1Surgical intervention is not indicated to prevent progression to limb-threatening ischemia in patients with intermittent claudication. (Level of Evidence: B)

2.3.2.4.2  Preoperative Evaluation

Class I

· 1A preoperative cardiovascular risk evaluation should be undertaken in those patients with lower extremity PAD in whom a major vascular surgical intervention is planned. (Level of Evidence: B)

2.3.2.4.3  Inflow Procedures: Aortoiliac Occlusive Disease

Class I

· 1Aortobifemoral bypass is beneficial for patients with vocational- or lifestyle-disabling symptoms and hemodynamically significant aortoiliac disease who are acceptable surgical candidates and who are unresponsive to or unsuitable for exercise, pharmacotherapy, or endovascular repair. (Level of Evidence: B)

· 2Iliac endarterectomy and aortoiliac or iliofemoral bypass in the setting of acceptable aortic inflow should be used for the surgical treatment of unilateral disease or in conjunction with femoral-femoral bypass for the treatment of a patient with bilateral iliac artery occlusive disease if the patient is not a suitable candidate for aortobifemoral bypass grafting. (Level of Evidence: B)

Class IIb

· 1Axillofemoral-femoral bypass may be considered for the surgical treatment of patients with intermittent claudication in very limited settings, such as chronic infrarenal aortic occlusion associated with symptoms of severe claudication in patients who are not candidates for aortobifemoral bypass. (Level of Evidence: B)

Class III

· 1Axillofemoral-femoral bypass should not be used for the surgical treatment of patients with intermittent claudication except in very limited settings. (Level of Evidence: B)

2.3.2.4.4  Outflow Procedures: Infrainguinal Disease

Class I

· 1Bypasses to the popliteal artery above the knee should be constructed with autogenous vein when possible. (Level of Evidence: A)

· 2Bypasses to the popliteal artery below the knee should be constructed with autogenous vein when possible. (Level of Evidence: B)

Class IIa

· 1The use of synthetic grafts to the popliteal artery below the knee is reasonable only when no autogenous vein from ipsilateral or contralateral leg or arms is available. (Level of Evidence: A)

Class IIb

· 1Femoral-tibial artery bypasses constructed with autogenous vein may be considered for the treatment of claudication in rare instances for certain patients. (Level of Evidence: B)

· 2Because their use is associated with reduced patency rates, the effectiveness of the use of synthetic grafts to the popliteal artery above the knee is not well established. (Level of Evidence: B)

Class III

· 1Femoral-tibial artery bypasses with synthetic graft material should not be used for the treatment of claudication. (Level of Evidence: C)

2.3.2.4.5  Follow-Up After Vascular Surgical Procedures

Class I

· 1Patients who have undergone placement of aortobifemoral bypass grafts should be followed up with periodic evaluations that record any return or progression of claudication symptoms, the presence of femoral pulses, and ABIs at rest and after exercise. (Level of Evidence: C)

· 2Patients who have undergone placement of a lower extremity bypass with autogenous vein should undergo periodic evaluations for at least 2 years that record any claudication symptoms; a physical examination and pulse examination of the proximal, graft, and outflow vessels; and duplex imaging of the entire length of the graft, with measurement of peak systolic velocities and calculation of velocity ratios across all lesions. (Level of Evidence: C)

· 3Patients who have undergone placement of a synthetic lower extremity bypass graft should, for at least 2 years after implantation, undergo periodic evaluations that record any return or progression of claudication symptoms; a pulse examination of the proximal, graft, and outflow vessels; and assessment of ABIs at rest and after exercise. (Level of Evidence: C)

2.3.3  CLI and Treatment for Limb Salvage
2.3.3.1  Medical and Pharmacological Treatment for CLI

Class III

· 1Parenteral administration of pentoxifylline is not useful for the treatment of CLI. (Level of Evidence: B)

2.3.3.1.1  Prostaglandins

Class IIb

· 1Parenteral administration of PGE-1 or iloprost for 7 to 28 days may be considered to reduce ischemic pain and facilitate ulcer healing in patients with CLI, but its efficacy is likely to be limited to a small percentage of patients. (Level of Evidence: A)

Class III

· 1Oral iloprost is not an effective therapy to reduce the risk of amputation or death in patients with CLI. (Level of Evidence: B)

2.3.3.1.2  Angiogenic Growth Factors

Class IIb

· 1The efficacy of angiogenic growth factor therapy for treatment of CLI is not well established and is best investigated in the context of a placebo-controlled trial. (Level of Evidence: C)

2.3.3.2  Endovascular Treatments for CLI

Class I

· 1For individuals with combined inflow and outflow disease with CLI, inflow lesions should be addressed first. (Level of Evidence: C)

· 2For 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. (Level of Evidence: B)

· 3If it is unclear whether hemodynamically significant inflow disease exists, intra-arterial pressure measurements across suprainguinal lesions should be measured before and after the administration of a vasodilator. (Level of Evidence: C)

Class IIa

· 12011 New Recommendation: For patients with limb-threatening lower extremity ischemia and an estimated life expectancy of 2 years or less in patients in whom an autogenous vein conduit is not available, balloon angioplasty is reasonable to perform when possible as the initial procedure to improve distal blood flow. (Level of Evidence: B)

· 22011 New Recommendation: For patients with limb-threatening ischemia and an estimated life expectancy of more than 2 years, bypass surgery, when possible and when an autogenous vein conduit is available, is reasonable to perform as the initial treatment to improve distal blood flow. (Level of Evidence: B)

2.3.3.3  Thrombolysis for Acute and CLI

Class I

· 1Catheter-based thrombolysis is an effective and beneficial therapy and is indicated for patients with acute limb ischemia (Rutherford categories I and IIa) of less than 14 days' duration. (Level of Evidence: A)

Class IIa

· 1Mechanical thrombectomy devices can be used as adjunctive therapy for acute limb ischemia due to peripheral arterial occlusion. (Level of Evidence: B)

Class IIb

· 1Catheter-based thrombolysis orthrombectomy may be considered for patients with acute limb ischemia (Rutherford category IIb) of more than 14 days' duration. (Level of Evidence: B)

2.3.3.4  Surgery for CLI

Class I

· 1For individuals with combined inflow and outflow disease with CLI, inflow lesions should be addressed first. (Level of Evidence: B)

· 2For 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. (Level of Evidence: B)

· 3Patients who have significant necrosis of the weight-bearing portions of the foot (in ambulatory patients), an uncorrectable flexion contracture, paresis of the extremity, refractory ischemic rest pain, sepsis, or a very limited life expectancy due to comorbid conditions should be evaluated for primary amputation of the leg. (Level of Evidence: C)

Class III

· 1Surgical and endovascular intervention is not indicated in patients with severe decrements in limb perfusion (e.g., ABI <0.4) in the absence of clinical symptoms of CLI. (Level of Evidence: C)

2.3.3.4.1  Inflow Procedures: Aortoiliac Occlusive Disease

Class I

· 1When surgery is to be undertaken, aortobifemoral bypass is recommended for patients with symptomatic, hemodynamically significant, aortobiiliac disease requiring intervention. (Level of Evidence: A)

· 2Iliac endarterectomy, patch angioplasty, or aortoiliac or iliofemoral bypass in the setting of acceptable aortic inflow should be used for the treatment of unilateral disease or in conjunction with femoral-femoral bypass for the treatment of a patient with bilateral iliac artery occlusive disease if the patient is not a suitable candidate for aortobifemoral bypass grafting. (Level of Evidence: B)

· 3Axillofemoral-femoral bypass is indicated for the treatment of patients with CLI who have extensive aortoiliac disease and are not candidates for other types of intervention. (Level of Evidence: B)

2.3.3.4.2  Outflow Procedures: Infrainguinal Disease

Class I

· 1Bypasses to the above-knee popliteal artery should be constructed with autogenous saphenous vein when possible. (Level of Evidence: A)

· 2Bypasses to the below-knee popliteal artery should be constructed with autogenous vein when possible. (Level of Evidence: A)

· 3The most distal artery with continuous flow from above and without a stenosis greater than 20% should be used as the point of origin for a distal bypass. (Level of Evidence: B)

· 4The tibial or pedal artery that is capable of providing continuous and uncompromised outflow to the foot should be used as the site of distal anastomosis. (Level of Evidence: B)

· 5Femoral-tibial artery bypasses should be constructed with autogenous vein, including the ipsilateral greater saphenous vein, or if unavailable, other sources of vein from the leg or arm. (Level of Evidence: B)

· 6Composite sequential femoropopliteal-tibial bypass and bypass to an isolated popliteal arterial segment that has collateral outflow to the foot are both acceptable methods of revascularization and should be considered when no other form of bypass with adequate autogenous conduit is possible. (Level of Evidence: B)

· 7If no autogenous vein is available, a prosthetic femoral-tibial bypass, and possibly an adjunctive procedure, such as arteriovenous fistula or vein interposition or cuff, should be used when amputation is imminent. (Level of Evidence: B)

Class IIa

· 1Prosthetic material can be used effectively for bypasses to the below-knee popliteal artery when no autogenous vein from ipsilateral or contralateral leg or arms is available. (Level of Evidence: B)

2.3.3.4.3  Postsurgical Care

Class I

· 1Unless contraindicated, all patients undergoing revascularization for CLI should be placed on antiplatelet therapy, and this treatment should be continued indefinitely. (Level of Evidence: A)

· 2Patients who have undergone placement of aortobifemoral bypass grafts should be followed up with periodic evaluations that record any return or progression of ischemic symptoms, the presence of femoral pulses, and ABIs. (Level of Evidence: B)

· 3If infection, ischemic ulcers, or gangrenous lesions persist and the ABI is less than 0.8 after correction of inflow, an outflow procedure should be performed that bypasses all major distal stenoses and occlusions. (Level of Evidence: A)

· 4Patients who have undergone placement of a lower extremity bypass with autogenous vein should undergo for at least 2 years periodic examinations that record any return or progression of ischemic symptoms; a physical examination, with concentration on pulse examination of the proximal, graft, and outflow vessels; and duplex imaging of the entire length of the graft, with measurement of peak systolic velocities and calculation of velocity ratios across all lesions. (Level of Evidence: A)

· 5Patients who have undergone placement of a synthetic lower extremity bypass graft should undergo periodic examinations that record any return of ischemic symptoms; a pulse examination of the proximal, graft, and outflow vessels; and assessment of ABIs at rest and after exercise for at least 2 years after implantation. (Level of Evidence: A)

3  Renal Arterial Disease: Recommendations

3.1  Clinical Clues to the Diagnosis of Renal Artery Stenosis

Class I

· 1The performance of diagnostic studies to identify clinically significant renal artery stenosis (RAS) is indicated in patients with the onset of hypertension before the age of 30 years. (Level of Evidence: B)

· 2The performance of diagnostic studies to identify clinically significant RAS is indicated in patients with the onset of severe hypertension [as defined in The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC-7 report] after the age of 55 years. (Level of Evidence: B)

· 3The performance of diagnostic studies to identify clinically significant RAS is indicated in patients with the following characteristics: (a) accelerated hypertension (sudden and persistent worsening of previously controlled hypertension); (b) resistant hypertension (defined as the failure to achieve goal blood pressure in patients who are adhering to full doses of an appropriate 3-drug regimen that includes a diuretic); or (c) malignant hypertension (hypertension with coexistent evidence of acute end-organ damage, i.e., acute renal failure, acutely decompensated congestive heart failure, new visual or neurological disturbance, and/or advanced [grade III to IV] retinopathy). (Level of Evidence: C)

· 4The performance of diagnostic studies to identify clinically significant RAS is indicated in patients with new azotemia or worsening renal function after the administration of an ACE inhibitor or an angiotensin receptor blocking agent. (Level of Evidence: B)

· 5The performance of diagnostic studies to identify clinically significant RAS is indicated in patients with an unexplained atrophic kidney or a discrepancy in size between the 2 kidneys of greater than 1.5 cm. (Level of Evidence: B)

· 6The performance of diagnostic studies to identify clinically significant RAS is indicated in patients with sudden, unexplained pulmonary edema (especially in azotemic patients). (Level of Evidence: B)

Class IIa

· 1The performance of diagnostic studies to identify clinically significant RAS is reasonable in patients with unexplained renal failure, including individuals starting renal replacement therapy (dialysis or renal transplantation). (Level of Evidence: B)

Class IIb

· 1The performance of arteriography to identify significant RAS may be reasonable in patients with multivessel coronary artery disease and none of the clinical clues or PAD at the time of arteriography. (Level of Evidence: B)

· 2The performance of diagnostic studies to identify clinically significant RAS may be reasonable in patients with unexplained congestive heart failure or refractory angina. (Level of Evidence: C)

3.2  Diagnostic Methods

Class I

· 1Duplex ultrasonography is recommended as a screening test to establish the diagnosis of RAS. (Level of Evidence: B)

· 2CTA (in individuals with normal renal function) is recommended as a screening test to establish the diagnosis of RAS. (Level of Evidence: B)

· 3MRA is recommended as a screening test to establish the diagnosis of RAS. (Level of Evidence: B)

· 4When the clinical index of suspicion is high and the results of noninvasive tests are inconclusive, catheter angiography is recommended as a diagnostic test to establish the diagnosis of RAS. (Level of Evidence: B)

Class III

· 1Captopril renal scintigraphy is not recommended as a screening test to establish the diagnosis of RAS. (Level of Evidence: C)

· 2Selective renal vein renin measurements are not recommended as a useful screening test to establish the diagnosis of RAS. (Level of Evidence: B)

· 3Plasma renin activity is not recommended as a useful screening test to establish the diagnosis of RAS. (Level of Evidence: B)

· 4The captopril test (measurement of plasma renin activity after captopril administration) is not recommended as a useful screening test to establish the diagnosis of RAS. (Level of Evidence: B)

3.3  Treatment of Renovascular Disease: RAS
3.3.1  Medical Treatment

Class I

· 1ACE inhibitors are effective medications for treatment of hypertension associated with unilateral RAS. (Level of Evidence: A)

· 2Angiotensin receptor blockers are effective medications for treatment of hypertension associated with unilateral RAS. (Level of Evidence: B)

· 3Calcium-channel blockers are effective medications for treatment of hypertension associated with unilateral RAS. (Level of Evidence: A)

· 4Beta blockers are effective medications for treatment of hypertension associated with RAS. (Level of Evidence: A)

3.3.2  Indications for Revascularization
3.3.2.1  Asymptomatic Stenosis

Class IIb

· 1Percutaneous revascularization may be considered for treatment of an asymptomatic bilateral or solitary viable kidney with a hemodynamically significant RAS. (Level of Evidence: C)

· 2The usefulness of percutaneous revascularization of an asymptomatic unilateral hemodynamically significant RAS in a viable kidney is not well established and is presently clinically unproven. (Level of Evidence: C)

3.3.2.2  Hypertension

Class IIa

· 1Percutaneous revascularization is reasonable for patients with hemodynamically significant RAS and accelerated hypertension, resistant hypertension, malignant hypertension, hypertension with an unexplained unilateral small kidney, and hypertension with intolerance to medication. (Level of Evidence: B)

3.3.2.3  Preservation of Renal Function

Class IIa

· 1Percutaneous revascularization is reasonable for patients with RAS and progressive chronic kidney disease with bilateral RAS or a RAS to a solitary functioning kidney. (Level of Evidence: B)

Class IIb

· 1Percutaneous revascularization may be considered for patients with RAS and chronic renal insufficiency with unilateral RAS. (Level of Evidence: C)

3.3.2.4  Impact of RAS on Congestive Heart Failure and Unstable Angina

Class I

· 1Percutaneous revascularization is indicated for patients with hemodynamically significant RAS and recurrent, unexplained congestive heart failure or sudden, unexplained pulmonary edema. (Level of Evidence: B)

Class IIa

· 1Percutaneous revascularization is reasonable for patients with hemodynamically significant RAS and unstable angina. (Level of Evidence: B)

3.3.3  Endovascular Treatment for RAS

Class I

· 1Renal stent placement is indicated for ostial atherosclerotic RAS lesions that meet the clinical criteria for intervention. (Level of Evidence: B)

· 2Balloon angioplasty with bailout stent placement if necessary is recommended for fibromuscular dysplasia lesions. (Level of Evidence: B)

3.3.4  Surgery for RAS

Class I

· 1Vascular surgical reconstruction is indicated for patients with fibromuscular dysplastic RAS with clinical indications for interventions (same as for percutaneous transluminal angioplasty), especially those exhibiting complex disease that extends into the segmental arteries and those having macroaneurysms. (Level of Evidence: B)

· 2Vascular surgical reconstruction is indicated for patients with atherosclerotic RAS and clinical indications for intervention, especially those with multiple small renal arteries or early primary branching of the main renal artery. (Level of Evidence: B)

· 3Vascular surgical reconstruction is indicated for patients with atherosclerotic RAS in combination with pararenal aortic reconstructions (in treatment of aortic aneurysms or severe aortoiliac occlusive disease). (Level of Evidence: C)

 Mesenteric Arterial Disease: Recommendations

.1  Acute Intestinal Ischemia
4.1.1  Acute Intestinal Ischemia Caused by Arterial Obstruction
4.1.1.1  Diagnosis

Class I

· 1Patients with acute abdominal pain out of proportion to physical findings and who have a history of cardiovascular disease should be suspected of having acute intestinal ischemia. (Level of Evidence: B)

· 2Patients who develop acute abdominal pain after arterial interventions in which catheters traverse the visceral aorta or any proximal arteries or who have arrhythmias (such as atrial fibrillation) or recent MI should be suspected of having acute intestinal ischemia. (Level of Evidence: C)

Class III

· 1In contrast to chronic intestinal ischemia, duplex sonography of the abdomen is not an appropriate diagnostic tool for suspected acute intestinal ischemia. (Level of Evidence: C)

4.1.1.2  Surgical Treatment

Class I

· 1Surgical treatment of acute obstructive intestinal ischemia includes revascularization, resection of necrotic bowel, and, when appropriate, a “second look” operation 24 to 48 hours after the revascularization. (Level of Evidence: B)

4.1.1.3  Endovascular Treatment

Class IIb

· 1Percutaneous interventions (including transcatheter lytic therapy, balloon angioplasty, and stenting) are appropriate in selected patients with acute intestinal ischemia caused by arterial obstructions. Patients so treated may still require laparotomy. (Level of Evidence: C)

4.1.2  Acute Nonocclusive Intestinal Ischemia
4.1.2.1  Etiology

Class I

· 1Nonocclusive intestinal ischemia should be suspected in patients with low flow states or shock, especially cardiogenic shock, who develop abdominal pain. (Level of Evidence: B)

· 2Nonocclusive intestinal ischemia should be suspected in patients receiving vasoconstrictor substances and medications (e.g., cocaine, ergots, vasopressin, or norepinephrine) who develop abdominal pain. (Level of Evidence: B)

· 3Nonocclusive intestinal ischemia should be suspected in patients who develop abdominal pain after coarctation repair or after surgical revascularization for intestinal ischemia caused by arterial obstruction. (Level of Evidence: B)

4.1.2.2  Diagnosis

Class I

· 1Arteriography is indicated in patients suspected of having nonocclusive intestinal ischemia whose condition does not improve rapidly with treatment of their underlying disease. (Level of Evidence: B)

4.1.2.3  Treatment

Class I

· 1Treatment of the underlying shock state is the most important initial step in treatment of nonocclusive intestinal ischemia. (Level of Evidence: C)

· 2Laparotomy and resection of nonviable bowel is indicated in patients with nonocclusive intestinal ischemia who have persistent symptoms despite treatment. (Level of Evidence: B)

Class IIa

· 1Transcatheter administration of vasodilator medications into the area of vasospasm is indicated in patients with nonocclusive intestinal ischemia who do not respond to systemic supportive treatment and in patients with intestinal ischemia due to cocaine or ergot poisoning. (Level of Evidence: B)

4.2  Chronic Intestinal Ischemia
4.2.1  Diagnosis

Class I

· 1Chronic intestinal ischemia should be suspected in patients with abdominal pain and weight loss without other explanation, especially those with cardiovascular disease. (Level of Evidence: B)

· 2Duplex ultrasound, CTA, and gadolinium-enhanced MRA are useful initial tests for supporting the clinical diagnosis of chronic intestinal ischemia. (Level of Evidence: B)

· 3Diagnostic angiography, including lateral aortography, should be obtained in patients suspected of having chronic intestinal ischemia for whom noninvasive imaging is unavailable or indeterminate. (Level of Evidence: B)

4.2.2  Endovascular Treatment for Chronic Intestinal Ischemia

Class I

· 1Percutaneous endovascular treatment of intestinal arterial stenosis is indicated in patients with chronic intestinal ischemia. (Level of Evidence: B)

4.2.3  Surgical Treatment

Class I

· 1Surgical treatment of chronic intestinal ischemia is indicated in patients with chronic intestinal ischemia. (Level of Evidence: B)

Class IIb

· 1Revascularization of asymptomatic intestinal arterial obstructions may be considered for patients undergoing aortic/renal artery surgery for other indications. (Level of Evidence: B)

Class III

· 1Surgical revascularization is not indicated for patients with asymptomatic intestinal arterial obstructions, except in patients undergoing aortic/renal artery surgery for other indications. (Level of Evidence: B)

5  Aneurysms of the Abdominal Aorta, Its Branch Vessels, and the Lower Extremities: Recommendations

5.1  Abdominal Aortic and Iliac Aneurysms
5.1.1  Etiology
5.1.1.1  Atherosclerotic Risk Factors

Class I

· 1In patients with AAAs, blood pressure and fasting serum lipid values should be monitored and controlled as recommended for patients with atherosclerotic disease. (Level of Evidence: C)

· 2Patients with aneurysms or a family history of aneurysms should be advised to stop smoking and be offered smoking cessation interventions, including behavior modification, nicotine replacement, or bupropion. (Level of Evidence: B)

5.1.2  Natural History
5.1.2.1  Aortic Aneurysm Rupture

Class I

· 1Patients with infrarenal or juxtarenal AAAs measuring 5.5 cm or larger should undergo repair to eliminate the risk of rupture. (Level of Evidence: B)

· 2Patients with infrarenal or juxtarenal AAAs measuring 4.0 to 5.4 cm in diameter should be monitored by ultrasound or computed tomographic scans every 6 to 12 months to detect expansion. (Level of Evidence: A)

Class IIa

· 1Repair can be beneficial in patients with infrarenal or juxtarenal AAAs 5.0 to 5.4 cm in diameter. (Level of Evidence: B)

· 2Repair is probably indicated in patients with suprarenal or type IV thoracoabdominal aortic aneurysms larger than 5.5 to 6.0 cm. (Level of Evidence: B)

· 3In patients with AAAs smaller than 4.0 cm in diameter, monitoring by ultrasound examination every 2 to 3 years is reasonable. (Level of Evidence: B)

Class III

· 1Intervention is not recommended for asymptomatic infrarenal or juxtarenal AAAs if they measure less than 5.0 cm in diameter in men or less than 4.5 cm in diameter in women. (Level of Evidence: A)

5.1.3  Diagnosis
5.1.3.1  Symptomatic Aortic or Iliac Aneurysms

Class I

· 1In patients with the clinical triad of abdominal and/or back pain, a pulsatile abdominal mass, and hypotension, immediate surgical evaluation is indicated. (Level of Evidence: B)

· 2In patients with symptomatic aortic aneurysms, repair is indicated regardless of diameter. (Level of Evidence: C)

5.1.3.2  Screening High-Risk Populations

Class I

· 1Men 60 years of age or older who are either the siblings or offspring of patients with AAAs should undergo physical examination and ultrasound screening for detection of aortic aneurysms. (Level of Evidence: B)

Class IIa

· 1Men who are 65 to 75 years of age who have ever smoked should undergo a physical examination and 1-time ultrasound screening for detection of AAAs. (Level of Evidence: B)

5.1.4  Observational Management
5.1.4.1  Blood Pressure Control and Beta-Blockade

Class I

· 1Perioperative administration of beta-adrenergic blocking agents, in the absence of contraindications, is indicated to reduce the risk of adverse cardiac events and mortality in patients with coronary artery disease undergoing surgical repair of atherosclerotic aortic aneurysms. (Level of Evidence: A)

Class IIb

· 1Beta-adrenergic blocking agents may be considered to reduce the rate of aneurysm expansion in patients with aortic aneurysms. (Level of Evidence: B)

5.1.5  Prevention of Aortic Aneurysm Rupture
5.1.5.1  Management Overview

Class I

· 12011 Updated Recommendation: Open or endovascular repair of infrarenal AAAs and/or common iliac aneurysms is indicated in patients who are good surgical candidates. (Level of Evidence: A)

· 22011 Updated Recommendation: Periodic long-term surveillance imaging should be performed to monitor for an endoleak, to document shrinkage or stability of the excluded aneurysm sac, and to determine the need for further intervention in patients who have undergone endovascular repair of infrarenal aortic and/or iliac aneurysms. (Level of Evidence: A)

Class IIa

· 12011 New Recommendation: Open aneurysm repair is reasonable to perform in patients who are good surgical candidates but who cannot comply with the periodic long-term surveillance required after endovascular repair. (Level of Evidence: C)

Class IIb

· 12011 New Recommendation: Endovascular repair of infrarenal aortic aneurysms in patients who are at high surgical or anesthetic risk as determined by the presence of coexisting severe cardiac, pulmonary, and/or renal disease is of uncertain effectiveness. (Level of Evidence: B)

5.2  Visceral Artery Aneurysms

Class I

· 1Open repair or catheter-based intervention is indicated for visceral aneurysms measuring 2.0 cm in diameter or larger in women of childbearing age who are not pregnant and in patients of either gender undergoing liver transplantation. (Level of Evidence: B)

Class IIa

· 1Open repair or catheter-based intervention is probably indicated for visceral aneurysms 2.0 cm in diameter or larger in women beyond childbearing age and in men. (Level of Evidence: B)

5.3  Lower Extremity Aneurysms
5.3.1  Natural History

Class I

· 1In patients with femoral or popliteal aneurysms, ultrasound (or computed tomography or magnetic resonance) imaging is recommended to exclude contralateral femoral or popliteal aneurysms and AAA. (Level of Evidence: B)

5.3.2  Management

Class I

· 1Patients with a palpable popliteal mass should undergo an ultrasound examination to exclude popliteal aneurysm. (Level of Evidence: B)

· 2Patients with popliteal aneurysms 2.0 cm in diameter or larger should undergo repair to reduce the risk of thromboembolic complications and limb loss. (Level of Evidence: B)

· 3Patients with anastomotic pseudoaneurysms or symptomatic femoral artery aneurysms should undergo repair. (Level of Evidence: A)

Class IIa

· 1Surveillance by annual ultrasound imaging is suggested for patients with asymptomatic femoral artery true aneurysms smaller than 3.0 cm in diameter. (Level of Evidence: C)

· 2In patients with acute ischemia and popliteal artery aneurysms and absent runoff, catheter-directed thrombolysis or mechanical thrombectomy (or both) is suggested to restore distal runoff and resolve emboli. (Level of Evidence: B)

· 3In patients with asymptomatic enlargement of the popliteal arteries twice the normal diameter for age and gender, annual ultrasound monitoring is reasonable. (Level of Evidence: C)

· 4In patients with femoral or popliteal artery aneurysms, administration of antiplatelet medication may be beneficial. (Level of Evidence: C)

5.3.2.1  Catheter-Related Femoral Artery Pseudoaneurysms

Class I

· 1Patients with suspected femoral pseudoaneurysms should be evaluated by duplex ultrasonography. (Level of Evidence: B)

· 2Initial treatment with ultrasound-guided compression or thrombin injection is recommended in patients with large and/or symptomatic femoral artery pseudoaneurysms. (Level of Evidence: B)

Class IIa

· 1Surgical repair is reasonable in patients with femoral artery pseudoaneurysms 2.0 cm in diameter or larger that persist or recur after ultrasound-guided compression or thrombin injection. (Level of Evidence: B)

· 2Reevaluation by ultrasound 1 month after the original injury can be useful in patients with asymptomatic femoral artery pseudoaneurysms smaller than 2.0 cm in diameter. (Level of Evidence: B)

VARICOSE VEINS OF THE LOWER EXTREMITIES

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Varicose veins of the lower extremities are found in the superficial venous system which includes the great saphenous vein (GSV) and the small saphenous vein (SSV), and their  tributaries. One-way valves are present in the superficial venous system. These valves prevent backward flow of blood within the vein (reflux) and keep the blood moving toward the heart.  The condition of improperly functioning valves and the resultant  valve reflux (incompetence) in the superficial venous system is known as chronic venous insufficiency. Varicose veins are the most frequent manifestation of chronic venous insufficiency. (Tassiopoulos et al., 2000; Nicolaides AN, 2000)   Approximately 25% of the population has lower extremity varicose veins, and age is the only consistently identified risk factor. The incidence of varicose veins increases linearly with age. Varicose veins have long been considered a cosmetic problem however varicose veins are frequently the cause of disability, loss of limb and loss of life. 

 

An advanced case of varicose veins

varicose veins-advancedvaricose veins-advanced

There are two types of superficial venous reflux i.e., primary & secondary. Primary reflux pertains to reflux in the sapheno-femoral junction or sapheno-popliteal junction in case of the lesser saphenous vein and secondary reflux is due to perforator incompetence

 Classification of varicose veins

Heyerdale and Stalker proposed the first anatomic classification of varicose veins in  

1941, and over the years various ways of classifying varicose veins have been used.

None of these classifications achieved universal acceptance and widespread use. Because of this, there was no possibility for meaningful communication about chronic venous disease, and a basis for a more scientific analysis of management alternatives                          

Over many years, lower limb venous anatomical terminology has been the subject of much controversy. An International Interdisciplinary Consensus Committee on Venous Anatomical Terminology met in Rome in 2001 to develop a universally accepted common anatomical terminology (Caggiati et al. 2002). The great saphenous vein is also known as the long saphenous vein, and the small saphenous vein is also known as the lesser or short saphenous vein. This has led to confusion because the acronym “LSV” can represent either the long saphenous vein or the lesser saphenous vein. This policy uses the nomenclature great saphenous vein and small saphenous vein, however it should be noted that current CPT nomenclature uses long and short saphenous vein.  The superficial venous system connects to the deep venous system at the following locations:

  Saphenofemoral junction (SFJ): located proximally at the groin where the GSV meets the femoral vein.

  Saphenopopliteal junction (SPJ): located behind the knee where the SSV meets the

popliteal vein.

  Perforator veins: these veins traverse the muscular fascia of the lower extremity to connect superficial veins with deep veins. A number of perforators are found in the leg.

 Valvular reflux is defined as abnormal—and the valve incompetent—when retrograde flow through the valve lasts longer than 0.5 seconds by duplex criteria.  The GSV is the source of venous reflux in 60% of patients, the SSV is the source of reflux in 20% of patients, and the remaining 20% of patients have reflux in both the GSV and SSV (Labropoulos et al., 1997; Engelhorn et al., 2005) was missing. An international committee produced a consensus document for the classification and grading of chronic venous disease known as the CEAP classification in 1995. The most recent revision of the CEAP classification was published in 2004 (Eklof et al., 2004) Currently, venous disease of the legs is classified according to the severity, cause, site and specific abnormality using the CEAP classification. Use of such a classification improves the accuracy of the diagnosis and improves communication between specialists. The elements of the CEAP classification are: 

     Clinical severity – see table below

    Etiology -  Ec: congenital

-  Ep: primary

-  Es: secondary (postthrombotic)

-  En: no venous cause identified

    Anatomy  -  As: superficial veins

-  Ap: perforator veins

-  Ad: deep veins

-  An: no venous location identified

    Pathophysiology -  Pr: reflux

-  Po: obstruction

-  Pr,o: reflux and obstruction

-  Pn: no venous pathophysiology identifiable

 CEAP is not a static classification; disease can be reclassified at any time. Classification starts with the patient’s initial visit, but can be better defined after further investigations. A final classification may not be complete until after surgery and histopathologic assessment. Eklof et al. therefore recommend that any CEAP classification be followed by the date, for example, C4bS, Ep, As, Pr (2003-08-21). The grades of increasing clinical severity are:

Grade     Description

C 0         No evidence of venous disease.

C 1         Telangiectasis or reticular veins less than 3 mm 

C 2         Simple varicose veins (3 mm or larger)

C 3  Ankle edema of venous origin (not foot edema)

C 4a  Skin pigmentation or eczema

C 4b  Lipodermatosclerosis or atrophie blanche

C 5  Healed venous ulcer

C 6  Open venous ulcer

S      Symptomatic, including ache, pain, tightness, skin irritation, heaviness, and  muscle cramps, and other complaints attributable to venous dysfunction   

A     Asymptomatic

 Conservative treatment

Asymptomatic varicose veins that cause no symptoms require no treatment unless  there is a desire to improve the aesthetic (cosmetic) appearance of the leg. Varicose  veins that cause symptoms, which may include tingling, aching, burning, pain, muscle  cramps, swelling, sensations of throbbing or heaviness, itching skin, restless legs, leg tiredness and fatigue, require treatment. The first-line treatment for symptomatic  varicose veins is conservative treatment including leg elevation, daily exercise, weight reduction where appropriate, and compression therapy. The different forms of compression therapy include gradient compression stockings, paste gauze boots (UNNA boot), multilayer elastic wraps/bandages, and pneumatic compression devices. The rationale of compression therapy is to compensate for the increased venous hypertension. 

Wearing compression improved symptom management in cases of uncomplicated varicose veins, however the studies did not provide evidence that wearing compression stockings slowed disease progression or prevented recurrence of varicose veins after treatment. The authors speculate that the results could have been confounded by the high number of noncompliant patients in these studies. (Palfreyman and Michaels, 2009). In a 2011 systematic review of compression stockings for the initial treatment of varicose veins, Shingler et al. found insufficient high quality evidence to determine whether or not compression stockings can effectively manage and treat varicose veins in the early stages. (Shingler et al., 2011). The evidence for the benefit of compression therapy is equivocal. Well designed randomized controlled trials are needed to assess the efficacy of this intervention.  The efficacy of conservative treatment versus surgical treatment for simple varicose veins (CEAP Clinical Classification C2) was evaluated by Michaels et al. (2006). The REACTIV Trial randomized 246 patients to conservative treatment or surgery. Conservative treatment included exercise, leg elevation, weight management, and compression stockings. Patients in the surgical arm also received the same lifestyle advice but underwent high ligation, stripping and phlebectomy. In the first 2 years after treatment, there was a significant quality of life benefit for surgery, and in a cost-effectiveness analysis, surgery produced an estimated discounted benefit of 0.054 quality-adjusted life years (QALYs). Economic modeling suggested that surgery produced a still greater benefit when considered with a 10-year time horizon. The Clinical Practice Guidelines for the Society for Vascular Surgery (SVS) and the American Venous Forum (AVF) recommend gradient compression stockings with an ankle                                              

Simple elevation of the legs above heart level for 30 minutes three or four times per day can reduce swelling and improve circulation and may be the only treatment needed for people with mild venous insufficiency. (Abu-Own et al., 1994)

Gradient compression stockings are classified into four grades on the basis of pressure exerted at the ankle. Stockings are graded as 20-30 mm Hg, 30-40 mm Hg, 40-50 mm Hg, or greater than 50 mm Hg. (Weingarten MS, 2001)  pressure of 20 to 30 mm HG for patients with symptomatic varicose veins (CEAP Clinical Classification C2) who are not candidates for surgery. (Gloviczki et al., 2011) 

 Approximately 1% to 1.5% of people with varicose veins will develop secondary complications such as superficial venous thrombophlebitis (SVT) and venous stasis ulcers. (Nicolaides AN, 2000) 

  SVT is the combination of thrombosis and inflammation in a superficial vein, and involves the GSV in 60% to 80% of cases.  SVT should not to be confused with a deep vein thrombophlebitis (DVT), which is a blood clot in a deep vein, however SVT may be associated with acute DVT in 6% to 40% of cases (and with symptomatic pulmonary embolism in 2% to 13% of cases). Given the potential morbidity of untreated SVT, prompt recognition and understanding of the pathophysiology and sequelae are paramount for physicians treating this disease (Litzendorf and Satiani, 2011) 

  Venous stasis ulcers are ulcers arising from chronic venous insufficiency. Venous stasis ulcers may persist for weeks to many years, and tend to recur. Larger ulcer size and longer duration of the ulcer usually signify a worse prognosis. Severe complications of venous ulcers include cellulitis, osteomyelitis, and malignant changes.  Compression therapy remains the standard of care for patients with advanced varicose veins and venous ulcers (CEAP Clinical Classification C3 through C6). In patients with venous stasis ulcers, gradient compression is effective as the primary treatment to aid healing of venous ulceration and as adjuvant therapy to prevent recurrences of venous ulcers. (Howard et al., 2008; O’Meara et al., 2009; Beavis and Earnshaw, 2011) The Effect of Surgery and Compression on Healing and Recurrence (ESCHAR) study randomized 500 patients with leg ulcers to compression treatment alone or compression combined with superficial vein ablation. Compression consisted of multilayer compression bandaging, followed by Class 2 (18-24 mm Hg,) below-knee stockings. Superficial venous surgery included saphenous vein ablation with high ligation and stripping (HL/S) as well as avulsion of varicose veins of the calf. General anesthesia could not be used in 25% of the patients, and in these, high saphenous vein ligation alone was performed. Compression treatment alone was as effective as compression with surgery to heal venous ulcers (65% versus 65%), but 12-month ulcer recurrence rates were reduced in the compression with surgery group versus those with compression alone (12% versus 28%). The difference in ulcer recurrence rates persisted between the two groups at 4 years. (Barwell et al., 2004; Gohel et al., 2007)

The Clinical Practice Guidelines for the Society for Vascular Surgery (SVS) and the

American Venous Forum (AVF) recommends compression therapy as the primary therapy to aid in healing of venous stasis ulcers and the adjuvant therapy to superficial vein ablation to prevent ulcer recurrence. (Gloviczki et al., 2011)

Ligation and stripping

Surgical treatment with high ligation and stripping is the gold standard against which  new endovenous and surgical methods should be compared. High ligation and stripping is defined as ligation of the GSV at its confluence with the common femoral

vein (SFJ), including ligation and division of all upper GSV tributaries. The primary goal is removal of refluxing vein(s) and improvement of symptoms. 

Ligation and stripping is typically a three-step process:

1.  Control of the most proximal point of reflux, most commonly at the SFJ, as identified by Doppler or duplex ultrasound. Ligation is the most common treatment for controlling reflux. Ligation refers to the surgical tying off of an incompetent (i.e., varicose) vein in the leg. The GSV is typically treated by high ligation at the SFJ followed by stripping to the knee. Most commonly the SSV is ligated at the saphenopopliteal junction (SPJ) only.

2.  Removal of the incompetent vein from circulation.  The most common strategy for this is vein stripping (more appropriately called saphenectomy). Stripping refers to the removal of the incompetent vein through incisions in the groin area and behind the knee (stripping is limited to between the groin and knee). An alternative to stripping is stab phlebectomy also known as stab avulsion or ambulatory stab phlebectomy. 

3.  Removal of varicose tributaries. Strategies for removal may include stab phlebectomy or sclerotherapy, either at the time of ligation or subsequent to.  Much has been written on the topic of recurrent of varicose veins following ligation and stripping (REVAS). Over the past several years, the concept of ‘‘neovascularization’’ has gained increasing popularity and attention. Neovascularization is defined as growth and development of new venous tributaries (angiogenesis) at the site of previously ligated or stripped varicosities. Neovascularization is particularly prevalent at the SFJ  but may occur at any point of previous vascular surgery. Its exact prevalence and time of occurrence are difficult to establish because most patients are lost to follow-up. It can manifest itself as long as 10 years after the initial surgery and often leads to recurrence of symptoms and unsightly visible varicosities. Endovenous radiofrequency therapy and endovenous laser therapy Minimally invasive alternatives to surgical ligation and stripping have been developed in recent years for the treatment of chronic venous insufficiency of the GSV, notably, endovenous radiofrequency therapy (EVRT) and endovenous laser therapy (EVLT). Both of these procedures can be performed in an office or outpatient setting with local anesthesia and typically requiring no sedation. EVRT and EVLT are similarly designed to damage the endothelium of the vein resulting in fibrosis and ultimately occlusion of a segment of the vein, thus eliminating reflux or the backflow of blood. The vein therefore need not be ligated surgically and stripped out. Several endovenous ablation devices have received FDA approval.  

It is now recognized that stripping of the GSV to the level of the knee is sufficient to obtain optimal results and avoids the troublesome complications of saphenous nerve injury associated with stripping to the calf.  Ligation of the GSV at the SFJ as a stand-alone procedure is unproven as a treatment for chronic venous insufficiency. Ligation of the GSV as a stand-alone procedure is associated with higher rates of neovascularization and recurrence of varicose veins compared to ligation and stripping. (Racek C, 2004; Winterborn et al., 2004; Dwerryhouse et al., 1999; Jones et al., 1996; Rutgers et al., 1994; Sarin et al., 1994)  EVRT and EVLT are unproven as a treatment of chronic venous insufficiency of the SSV. Randomized controlled trials are needed.   that “evidence from a number of randomized comparative trials and prospective studies suggests that endovenous laser therapy (EVLT) effectively provides venous occlusion to treat symptomatic varicose veins due to great saphenous vein (GSV) reflux in adult patients. Several studies of moderate to good quality that evaluated the relative efficacy of EVLT compared with conventional surgical techniques reported comparable or superior clinical results of EVLT, with rates of recurrence generally less than 5%.” (Endovenous Laser Therapy for Varicose Veins Due to Great Saphenous Vein Reflux. © 2009 Winifred S. Hayes, Inc.)  Rass et al. (2011) recently published a study with 2 year follow-up, comparing EVLT to ligation and stripping in 400 randomly assigned patients. Clinically recurrent varicose veins after surgery were similarly observed in both groups: 16.2% (EVLT) versus 23.1% (ligation and stripping). However, duplex-detected saphenofemoral reflux occurred significantly more frequently after EVLT as compared to ligation and stripping (17.8% versus 1.3%). Rass et al. concluded that the matter of duplex-detected saphenofemoral reflux should be investigated further. (Rass et al., 2011)  Results of several randomized controlled studies question the continuing role of open surgery with high ligation and stripping as the gold standard treatment for varicose veins. The Society for Vascular Surgery (SVS) and the American Venous Forum (AVF) published clinical practice guidelines for the care of patients with varicose veins of the lower extremities. For the treatment of the incompetent GSV, the SVS/AVF Clinical Practice Guidelines now recommend endovenous thermal ablation (EVLT or EVRT) over high ligation and stripping because of reduced convalescence and decreased pain and morbidity. (Gloviczki et al., 2011)

It is important to note that patient selection for endovenous ablation is critical to the success of the procedure. Endovenous ablation is only a treatment option for sufficiently straight superficial vein segments that will allow passage of the device. (Khilnani et al., (2010) Ligation and stripping is indicated for patients with overly large or dilated and tortuous saphenous veins located immediately under the skin, those with a history of superficial thrombophlebitis resulting in a partially obstructed saphenous vein (because of previous thrombophlebitis of the GSV or SSV, percutaneous placement of the laser fiber or radiofrequency catheter may not be possible, and open techniques have to be used for removal of the vein), and those with varicose anterolateral thigh veins (if these originate at the SFJ, EVLT or EVRT will not be effective).  Subfascial endoscopic perforator surgery Over the years, the role of incompetent perforator veins has been investigated in patients with advanced clinical sequelae of chronic venous insufficiency (i.e., venous ulcers). Perforator veins allow blood to pass from the superficial venous system to the deep venous system. An open surgical procedure known as the Linton procedure was developed in 1938 to treat incompetent perforator veins. The Linton procedure requires a long incision through compromised skin, frequently results in non-healing surgical incisions, infection, and recurrence of ulcers, and has largely been abandoned.

In 1985 an endoscopic approach to the treatment of incompetent perforator veins known as subfascial endoscopic perforator surgery (SEPS) was introduced. A number of studies have shown that SEPS appears to be a safe procedure compared to the Linton  procedure. However the controversy relates to questions regarding the role of perforator incompetence in the treatment of chronic venous insufficiency. In general there is an incomplete understanding of how the hemodynamics of one venous system may affect the hemodynamics of the other. A variety of factors limit an evidence-based approach to assessment of SEPS: 

1.  There is inadequate evidence with which to make a determination of efficacy of SEPS compared to medical management, either in terms of healing of venous ulcers, or in preventing recurrent venous ulcers. 

2.  In many of the reported case studies and randomized controlled trials, patients have undergone both SEPS and other treatments of the superficial venous system making it difficult to assess the independent contribution of either component alone. 

3.  Patients with venous leg ulcers represent a heterogeneous group. Venous insufficiency may be either superficial, perforator or deep venous, or a combination. Results may be different in patients with primary venous insufficiency compared to those with post-thrombotic superficial venous insufficiency. In addition, the severity is variable in reported case series, ranging from those with active ulcers, healed ulcers, skin changes or simply the presence of varicose veins.  

 “The role of incompetent perforator vein ablation alone or with concomitant with GSV treatment awaits the results of properly conducted randomized controlled clinical trials. “ (O’Donnell, 2008) The Clinical Practice Guidelines for the Society for Vascular Surgery (SVS) and the American Venous Forum (AVF) has determined that current studies do not support treatment of perforator veins in patients with CEAP Class C2 disease. Patients with advanced chronic venous insufficiency (large >/= 3.5 mm, incompetent pathologic perforators with reflux >/= 500 ms located in the affected area of the limb with outward flow on duplex scan), CEAP Class C5 or C6, may benefit from the SEPS procedure. (Gloviczki et al., 2011). With respect to the use of endovenous ablation for the treatment of incompetent perforator veins, at this time, “the scope and quality of the clinical studies are insufficient to conduct an evidence-based assessment of the safety and efficacy of EVLT for incompetent perforator veins. Hence, no recommendation regarding the adoption or use of this technology can be offered at this time.” (Winifred S. Hayes, Inc., Endovenous Laser Therapy for Incompetent Perforator Veins) The recommended treatment for varicose veins and venous stasis ulcers is saphenous vein ablation. 

SCLEROTHERAPY

Sclerotherapy is the injection of a chemical (sclerosing agent) into a visible vein to achieve endoluminal fibrosis and obstruction of the vein. Sclerosing agents are regulated by the FDA. Current FDA-approved sclerosing agents include osmotic agents, detergents, and alcohol agents. Liquid sclerotherapy is used primarily for obliteration of spider veins, reticular veins or telangiectasia (veins < 3 mm in diameter, CEAP Class C1). Liquid sclerotherapy is performed using small gauge needles. The  procedure is started at the proximal end of the vein. Gauze pads are placed on the injection sites and the patients is instructed to wear gradient compression stockings for several days after treatment.  There is little evidence for the use of liquid sclerotherapy as the primary treatment of symptomatic varicose veins. Most clinicians consider liquid sclerotherapy an adjunctive treatment to other procedures, i.e., ligation and stripping, EVLT or EVRT of the GSV. Liquid sclerotherapy as the sole treatment of symptomatic varicose tributaries of the GSV is not indicated in the presence of SFJ or SPJ reflux. Published studies indicate that such treatment, without definitive treatment of valvular incompetence of the saphenous veins without stripping and ligation or other surgical treatments provides

little long-term benefit and leads to high recurrence rates. (Tisi et al., 2006)  The overwhelming majority of symptomatic varicose tributaries are related to valvular incompetence of the GSV or LSV. However, a small subset of patients may have symptomatic varicose veins in the absence of underlying junctional incompetence. Sclerotherapy as a sole therapy has been proposed for these patients. A literature search identified one controlled study of this group. In this placebo-controlled randomized study of 25 patients, those receiving sclerosant reported a high obliteration rate compared to those receiving normal saline at 12 weeks follow-up. Although this study valuated sclerotherapy efficacy in obliterating varicosities, it did not address its effectiveness at relieving pain. (Kahle and Leng, 2004) Ultrasound-guided foam sclerotherapy is a modification of liquid sclerotherapy but instead of injecting liquid, the liquid is transformed into foam by forcibly mixing it with air or other type of gas such as oxygen or carbon dioxide.

Ultrasound-guided foam sclerotherapy is increasingly used in clinical practice and it has become clear that foam sclerotherapy is more effective than liquid sclerotherapy. (Ouvry et al., 2008, Rabe et al., 2008; Yamaki et al., 2008)  Only a few high-quality randomized controlled studies have been published on the results of ultrasound-guided foam sclerotherapy for the treatment of varicose GSV, although the results are encouraging. (Wright et al., 2006; Figueiredo et al., 2009; Rasmussen et al., 2011; Liu et al., 2011) On the basis of the available data, the Clinical Practice Guidelines for the SVS/AVF recognizes that results of foam sclerotherapy have improved but concludes that they are not yet equivalent to those obtained for ligation or endovenous thermal ablation for the treatment of varicose GSV. The Committee recommended that there is an urgent need for well-designed, large randomized          

Sclerotherapy directed at the underlying reflux saphenous veins (as opposed to the visible varicosities of the tributary veins) requires ultrasound guidance. This procedure is referred to as ultrasound-guided foam sclerotherapy or echosclerotherapy. One protocol for sclerotherapy of valvular incompetence of the greater or lesser saphenous vein is the COMPASS procedure. COMPASS is an acronym for comprehensive objective mapping, precise image-guided injection, antireflux positioning, and sequential sclerotherapy. Comprehensive objective  mapping describes the preoperative use of Duplex ultrasound to identify the point of origin of reflux and other contributing refluxing sources. Precise image-guided injection refers to the use of intraoperative Duplex ultrasound to guide the injection of the sclerosant into the greater saphenous vein. Antireflux positioning refers to the positioning of the patient with legs elevated to eliminate reflux and venous hypertension. Finally, sequential sclerotherapy refers to the use of 2 or 3 sessions of sclerotherapy until the varicosities resolve, with ongoing monitoring and repeat treatment, if needed, for up to 12 months.   controlled studies comparing the results of ligation, EVLT and foam sclerotherapy(Gloviczki et al., 2011) The current evidence supports the current place of sclerotherapy (liquid or foam) in modern clinical practice, which is limited to the treatment of residual or recurrent varicose tributary veins following control of reflux in the GSV either by ligation or endovenous thermal ablation.

Definitions

VaricoseVeins

Chronic venous disorder - The term chronic venous disorder includes the full spectrum of morphologic and functional abnormalities of the venous system, from telangiectasias to venous ulcers. Some of these, such as telangiectasias, are highly prevalent in the healthy adult population, and in many cases use of the term “disease” is not appropriate. The term chronic venous insufficiency implies a functional abnormality of the venous system, and is usually reserved for more advanced disease, including edema (C3), skin changes (C4), or venous ulcers (C5-6). Duplex ultrasound - a type of vascular ultrasound procedure done to assess blood flow (reflux and patency) and the structure of the leg veins. The term "duplex" refers to the fact that two modes of ultrasound are used - Doppler and B-mode. The Doppler probe within the transducer evaluates the velocity and direction of blood flow in the vessel. The B-mode transducer (like a microphone) obtains an image of the vessel being studied. Lipodermatosclerosis − is caused by an excessively high venous pressure in the subcutaneous veins in the lower leg in patients with long-standing venous insufficiency. Lipodermatosclerosis is a slow process that occurs over a number of years, and two-thirds of affected patients are obese. Lipodermatosclerosis affects the skin just above the ankle, usually on the inside surface. Over time the skin becomes brown, smooth, tight and often painful.  The precise mechanism of lipodermatosclerosis is not fully understood. The most important part of management is compression therapy to correct venous stasis. Unless the underlying cause is treated, the patient is at high risk of developing venous leg ulcers. Once lipodermatosclerosis is established, the skin has been permanently and irreversibly damaged and treatment at that stage can only hope to prevent progression to an open leg ulcer. 

Saphenous veins − The superficial veins of the foot and leg interconnect to form a complex network below the skin. These vessels drain into two major trunks: the small and great saphenous veins. The "small saphenous vein (SSV)" begins on the lateral portion of the foot and passes upward, rising along the back of the calf, enters the popliteal fossa (a depression in the bone behind the knee) to join the popliteal vein. The "great saphenous vein (GSV)," which is the longest vein in the body, begins on the medial side of the foot. It rises to extend up along the inner side of the leg and penetrates deep into the thigh just below the inguinal ligament in the lower abdomen, where it joins the femoral vein. Near its distant end, it receives vessels that drain the upper thigh, groin, and lower abdominal wall. The femoral and the great saphenous veins merge into the external iliac vein.                                           

Sclerotherapy is used for the treatment of reticular varicosities and telangiectasia (CEAP Class C1). Any treatment, including but not limited to sclerotherapy for reticular varicosities and telangiectasia is considered cosmetic and not medically necessary.  

Stab phlebectomy −  also known as ambulatory phlebectomy, a surgical treatment for varicose veins. This procedure involves the removal of varicose veins through small “stab” 1-2 mm incisions in the skin overlying the vein. The varicose vein is hooked and brought to the surface at each incision site to release it from the surrounding tissues and to sever any connections to other veins. This procedure is most effective when performed adjunct to surgical ligation of the incompetent vein (GSV).

Stripping − a surgical treatment for varicose veins. In this procedure, an incision is  made in the groin, and the GSV is ligated. Then, a wire ‘stripper’ is threaded into the varicosed vein and the stripper and vein are then pulled (stripped) distally. Stasis dermatitis − Stasis dermatitis is an inflammatory skin disease that occurs on the lower extremities in patients with chronic venous insufficiency with venous hypertension. The condition rarely occurs before the fifth decade of life, except in patients with acquired venous insufficiency due to surgery, trauma, or thrombosis. Stasis dermatitis is usually the earliest sequela of venous insufficiency, and it may be a precursor to more problematic conditions, such as lipodermatosclerosis and venous leg ulceration.

venous_stasis_ulcer

Thrombophlebitis  − inflammation in a vein in an area where a blood clot has formed. (Often the term thrombophlebitis is shortened to "phlebitis.")

There are two types of thrombophlebitis:

1.  Superficial venous thrombophlebitis (SVT) occurs when a blood clot and inflammation develop in a small vein near the surface of the skin. SVT is usually self-limiting. 

2.  Deep vein thrombophlebitis (DVT) occurs when a blood clot and inflammation are deep inside a vein in a leg, the lower abdomen (pelvis), or, rarely, the arm. In deep vein phlebitis, a blood clot may break away and travel to the lungs, where it may block a blood vessel (a condition known as pulmonary embolus).  Transilluminated powered phlebectomy (TIPP) − In October 2003 the FDA approved the Trivex™ System (Smith & Nephew, Inc., Andover, MA) for the resection and ablation of varicose veins. This procedure involves the use of two devices: an illuminator and a resector. The illuminator is introduced via a groin incision underneath the varicose vein so that the vein becomes visible. The resector is then inserted beneath the illuminated vein. The tip of the resector is advanced slowly, ablating the varicose vein and aspirating the fragments. TIPP has been proposed as an alternative to stab phlebectomy. The scope and quality of the clinical studies of this treatment for varicose veins are insufficient to conduct an evidence-based assessment of safety and efficacy, therefore TIPP is considered experimental/investigational.

Varicose veins − Varicose veins of the lower limbs are dilated subcutaneous veins that are >/=3 mm in diameter measured in the upright position. Varicose veins, also called varicosities, are most common in the legs, although they can be found in other parts of the body. The term “varicose vein” does not apply to spider veins (telangiectasias) or reticular veins that are less than 3 mm in diameter (CEAP Class C1).                                 

The international CEAP consensus document (Eklof et al., 2004) for the classification and grading of chronic venous disease provides the following definitions of reticular veins and telangiectasias: 

  Reticular veins are visible, dilated, bluish, subdermal, nonpalpable veins 1 to 3 mm in diameter. Reticular veins are often called “feeder veins” because they give rise to telangiectasias. Venous incompetence (reflux) − backward blood flow in a superficial vein due to a defective or damaged valve which results in high venous pressure. When there is sustained superficial venous hypertension, the vein eventually becomes varicose or distorted, distended and tortuous.  Policy Prior authorization by FCHP is required for the treatment of varicose veins of the lower extremities.

Photographs of the affected limb(s) may be required at FCHP’s discretion. FCHP covers ligation and stripping, endovenous radiofrequency therapy (EVRT) or endovenous laser therapy (EVLT) of the great saphenous vein (GSV) or short saphenous vein (SSV) when documentation of all the following medical necessity criteria is submitted:

1.  History and physical exam findings consistent with varicose veins caused by incompetence/reflux of the superficial venous system. 

2.  Reflux in the GSV/SSV has been demonstrated by duplex scan (performed no

more than 12 months prior to the date of the requested procedure)

3.  The vein to be treated is ≥ 3 millimeters in diameter (CEAP Class C2 through CEAP Class C6). 

4.  A trial of conservative therapy, which has included the use of properly fitted gradient compression (minimum 20 mmHg) stockings (unless medically contraindicated ) has failed to relieve symptoms or complications directly attributable to varicose veins of the lower extremities (see number 5 below).                                                                                                                                                

  Telangiectasias are very small (<1 mm) dilated blood vessels usually found in clusters near the surface of the skin. Telangiectasias are commonly called spider veins or thread veins. Reticular veins and spider veins (CEAP Class C1) are not associated with symptoms that significantly impair mobility or interfere with activities of daily living and their treatment is considered cosmetic. Duplex scan is recommended as the first diagnostic test for all patients with suspected chronic venous insufficiency. Duplex scan is safe, noninvasive, cost-effective and reliable. It has much better diagnostic accuracy in the assessment of venous insufficiency that Doppler ultrasonography. Duplex scan should be performed with the patient upright. The supine position gives both false-positive and false-negative results of reflux. (Gloviczki et al., 2011) Medical contraindications for the use of gradient compression stockings include severe peripheral arterial disease of the lower extremities (ABPI < 0.8), absence of palpable pedal pulses, or arterial compromise due to massive venous obstruction, or the physical inability to apply stockings daily,  e.g. severe arthritis, arm paralysis, and unavailability of a caregiver to apply stockings daily. (Kahn et al. 2007) 

 Symptoms directly attributable to varicose veins include aching, throbbing, feeling of a heavy leg, fatigue, cramps, pruritus, restless leg, ankle swelling, and tenderness or pain along bulging varicose veins which significantly impairs mobility or interferes with activities of daily living, or one of the following complications of varicose veins exists:

a.  Recurrent (more than 2) episodes of superficial venous thrombophlebitis where an incompetent superficial vein is a significant contributing factor.

b.  Venous stasis ulceration where an incompetent superficial vein is a significant contributing factor.

c.  Severe stasis dermatitis or lipodermatosclerosis where an incompetent superficial vein is a significant contributing factor.

d.  Rupture and external hemorrhage of a varicose vein. 

a.  For CEAP Class C2 a minimum three (3) month trial of conservative therapy is required.

b.  For CEAP Class C3 through CEAP Class C6 - a minimum two (2) week trial of conservative therapy is required. 

FCHP covers ligation and stripping or sclerotherapy of accessory saphenous veins, i.e., veins that ascend in parallel to the GSV, e.g., the anterior accessory saphenous vein (AASV), posterior accessory saphenous vein (PASV) and superficial accessory saphenous vein (SASV), when the GSV has been previously eliminated or is being eliminated during the same operative session, when documentation of all the following medical necessity criteria is submitted:

1.  Reflux in the accessory saphenous vein has been demonstrated by duplex scan (performed no more than 12 months prior to the date of the requested procedure)

2.  The vein to be treated is ≥ 3 millimeters in diameter (CEAP Class C2  through CEAP Class C6). 

 A maximum of 3 sessions of sclerotherapy (per leg) will be authorized (CPT codes 36470 or 36471) over a period of not more than 12 months following the primary procedure (i.e., GSV ligation and stripping, EVRT or EVLT). FCHP covers ligation and stripping (sclerotherapy is only covered as an adjunct procedure) of accessory saphenous veins with preservation of a competent GSV when documentation of all the following medical necessity criteria is submitted:

1.  History and physical exam findings consistent with varicose veins caused by incompetence/reflux of the superficial venous system. 

2.  Reflux in the accessory saphenous vein has been demonstrated by duplex scan(performed no more than 12 months prior to the date of the requested procedure) 3.  The vein to be treated is ≥ 3 millimeters in diameter (CEAP Class C2  through CEAP Class C6).

4.  A trial of conservative therapy, which has included the use of properly fitted gradient compression (minimum 20 mmHg) stockings (unless medically contraindicated) has failed to relieve symptoms or complications directly attributable to varicose veins of the lower extremities (see number 5 below).                                                   

Most patients (85%) have only GSV reflux and GSV stripping has been shown to restore SFJ competency at the 1 year follow-up. When SFJ incompetence is associated with reflux in more than one vein, all incompetent veins require stripping to restore SFJ competency. (The existing literature does not support EVLT or EVRT for veins other than the GSV.) Isolated AASV/SFJ reflux occurs in approximately 10% of patients. During surgery many surgeons strip the AASV and the competent GSV because of the possibility that stripping of the incompetent AASV may subsequently promote GSV reflux and recurrence of varicose veins. Although stripping of incompetent axial/truncal veins is required to avoid recurrence, there is not evidence to support this for competent veins. (Theivacumar et al., 2009)   Duplex scan is recommended as the first diagnostic test for all patients with suspected chronic venous insufficiency. Duplex scan is safe, noninvasive, cost-effective and reliable. It has much better diagnostic accuracy in the assessment of venous insufficiency that Doppler ultrasonography. Duplex scan should be performed with the patient upright. The supine position gives both false-positive and false-negative results of reflux. (Gloviczki et al., 2011)  Medical contraindications for the use of gradient compression stockings include severe peripheral arterial disease of the lower extremities (ABPI < 0.8), absence of palpable pedal 

a.  For CEAP Class C2 a minimum three (3) month trial of conservative therapy is required.

b.  For CEAP Class C3 through CEAP Class C6 - a minimum two (2) week trial of conservative therapy is required. 

FCHP covers sclerotherapy (using foam or liquid sclerosant) or stab phlebectomy for symptomatic varicose tributaries of the GSV as an adjunct to ligation and stripping, EVRT or EVLT of the GSV by when documentation of all of the following medical necessity criteria is submitted:

1.  Reflux in the tributary has been demonstrated by duplex scan (performed no more than 12 months prior to the date of the requested procedure). 

2.  The vein to be treated is ≥ 3 millimeters in diameter (CEAP Class C2  through CEAP Class C6). 

A maximum of 3 sessions of sclerotherapy (per leg) will be authorized (CPT codes 36470 or 36471) over a period of not more than 12 months following the primary procedure (i.e., GSV ligation and stripping, EVRT or EVLT). One session of stab phlebectomy (per leg) will be authorized (CPT codes 37765 or 37766), not more than 12 months following the primary procedure. FCHP covers ligation (SEPS procedure) for the treatment of large (>/= 3.5 mm), incompetent pathologic perforators (CEAP Class C5 or C6) by when documentation of all of the following medical necessary criteria is submitted:

1.  Duplex ultrasound has demonstrated perforator vein incompetence/reflux (reflux >/= 500 ms located in the affected area of the limb with outward flow). 

2.  Venous ulceration persists despite previous treatment for incompetence of the GSV and/or SSV and gradient compression therapy. 

 Exclusions

1.  Surgical treatment of varicose veins is contraindicated in patients who cannot remain active enough to reduce the risk of post-operative deep vein thrombosis.

2.  Surgical treatment of varicose veins is contraindicated during pregnancy because many varicose veins spontaneously regress after pregnancy.                                                                                                                                         

pulses, or arterial compromise due to massive venous obstruction, or the physical inability to apply stockings daily,  e.g. severe arthritis, arm paralysis, and unavailability of a caregiver to apply stockings daily. (Kahn et al. 2007)   Symptoms directly attributable to varicose veins include aching, throbbing, feeling of a heavy leg, fatigue, cramps, pruritus, restless leg, ankle swelling, and tenderness or pain along bulging varicose veins which significantly impairs mobility or interferes with activities of daily living, or one of the following complications of varicose veins exists:

e.  Recurrent (more than 2) episodes of superficial venous thrombophlebitis where an incompetent superficial vein is a significant contributing factor.

f.  Venous stasis ulceration where an incompetent superficial vein is a significant contributing factor.

g.  Severe stasis dermatitis or lipodermatosclerosis where an incompetent superficial vein is a significant contributing factor.

h.  Rupture and external hemorrhage of a varicose vein.  

3.  Sclerotherapy for the treatment of valvular incompetence/reflux of the saphenofemoral junction or saphenopopliteal junction or for the treatment of varicose saphenous veins is considered experimental/investigational. Compressive sclerotherapy for the treatment of incompetent perforator veins is considered experimental/investigational. Compressive sclerotherapy of varicose saphenous tributaries without concomitant or prior ligation of the greater or lesser saphenous veins is considered experimental/investigational. 

4.  Stab phlebectomy for the treatment of valvular incompetence/reflux of the saphenofemoral junction or saphenopopliteal junction or for the treatment of varicose saphenous veins is considered experimental/investigational. Stab phlebectomy for the treatment of incompetent perforator veins is considered experimental/investigational. Stab phlebectomy of varicose saphenous tributaries or perforators without concomitant or prior ligation of the greater or lesser saphenous veins is considered experimental/investigational. 

5.  Transilluminated powered phlebectomy (Trivex™ System, Smith & Nephew, Inc., Andover, MA) is considered experimental/investigational. The scope and quality of the clinical studies of this treatment for varicose veins are insufficient to conduct an evidence-based assessment of safety and efficacy. There is no specific CPT/HCPCS code for this procedure. The correct CPT code to report this procedure is unlisted procedure code 37799.

6.  Open ligation of perforator veins (e.g.., Linton procedure), CPT codes 37760, 37761, for any indication including chronic venous ulcers, is considered experimental/investigational.

7.  Treatment for telangiectasias (spider veins) or reticular veins (CPT codes 36468 and 36469) is not covered.

Codes

Ultrasound guidance for endovenous ablation is considered incidental to the procedure. Ultrasound guidance for needle placement (CPT 76942) is considered incidental to the injection procedure. 

varicose+veins-2a

 

Codes  Number  Description

CPT  36470  Injection of sclerosing solution; single vein   36471  Multiple veins, same leg   36475  Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, radiofrequency; first vein treated   36476  Second and subsequent veins treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure) (Use 36476 in conjunction with 36475)   36478  Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, laser; first vein treated   36479  Second and subsequent veins treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure) (Use 36479 in conjunction with 36478)

 Codes  Number  Description

  37500*  Vascular endoscopy, surgical, with ligation of perforator veins, subfascial (SEPS)

  37700  Ligation and division of long saphenous vein at saphenofemoral junction, or distal interruptions

  37718  Ligation, division, and stripping, short saphenous vein

  37722  Ligation, division, and stripping, long (greater) saphenous veins from saphenofemoral junction to knee or below

  37735  Ligation and division and complete stripping of long or short saphenous veins with radical excision of ulcer and skin graft and/or interruption of communicating veins of lower leg, with excision of deep fascia

  37760  Ligation of perforator veins, subfascial, radical (Linton type), including skin graft, when performed, open, 1 leg

  37761  Ligation of perforator vein(s), subfascial, open, including ultrasound guidance, when performed, 1 leg

  37765  Stab phlebectomy of varicose veins, one extremity; 10-20 stab incisions

  37766  More than 20 incisions

  37780  Ligation and division of short saphenous vein at saphenopopliteal junction (separate procedure)

  37785  Ligation, division, and or excision of varicose vein cluster(s), one leg.