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
·
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.
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)
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)
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)
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 <
· 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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Class I
· 1Antihypertensive therapy should be administered to hypertensive patients
with lower extremity PAD to achieve a goal of less than
· 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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Class III
· 1Parenteral administration of pentoxifylline is not useful for the
treatment of CLI. (Level of Evidence: B)
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)
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)
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)
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)
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)
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)
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)
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)
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
· 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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Class I
· 1Percutaneous endovascular treatment of intestinal arterial stenosis is
indicated in patients with chronic intestinal ischemia. (Level of Evidence:
B)
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)
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)
Class I
· 1Patients with infrarenal or juxtarenal AAAs measuring
· 2Patients with infrarenal or juxtarenal AAAs measuring 4.0 to
Class IIa
· 1Repair can be beneficial in patients with infrarenal or juxtarenal AAAs
5.0 to
· 2Repair is probably indicated in patients with suprarenal or type IV
thoracoabdominal aortic aneurysms larger than 5.5 to
· 3In patients with AAAs smaller than
Class III
· 1Intervention is not recommended for asymptomatic infrarenal or juxtarenal
AAAs if they measure less than
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)
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)
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)
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)
Class I
· 1Open repair or catheter-based intervention is indicated for visceral
aneurysms measuring
Class IIa
· 1Open repair or catheter-based intervention is probably indicated for
visceral aneurysms
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)
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
· 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
· 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)
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
·
2Reevaluation by ultrasound 1 month after the original injury can be
useful in patients with asymptomatic femoral artery pseudoaneurysms smaller
than
VARICOSE VEINS OF THE
LOWER EXTREMITIES
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.
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
C 2 Simple varicose veins (
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-
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-
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 >/=
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 <
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
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-
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.
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
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
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 ≥
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 (<
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 ≥
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 ≥
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 ≥
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 (>/=
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.
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
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.