Harvey M. Wiener, DO, FSIR, FCIRSE, FAHA Peripheral Arterial Disease Guidelines: Management of Patients with Lower Extremity PAD Harvey M. Wiener, DO, FSIR, FCIRSE, FAHA Phoenix, Arizona

Why A PAD Guideline? To enhance the quality of patient care Increasing recognition of the importance of atherosclerotic lower extremity PAD: High prevalence High cardiovascular risk Poor quality of life Improved ability to detect and treat renal artery disease Improved ability to detect and treat AAA The evidence base has become increasingly robust - a data-driven care guideline is now possible

Peripheral Arterial Disease Guideline: The Target Audiences Are Diverse Primary care clinicians Family practice Internal medicine PA, NP, nurse clinicians Cardiovascular/vascular medicine, vascular surgical, & interventional radiology trainees and vascular specialists This is not intended to be a procedural guideline; it is intended to provide a guide to optimal lifelong PAD care.

Defining a Population “At Risk” for Lower Extremity PAD Age less than 50 years with diabetes, and one additional risk factor (e.g., smoking, dyslipidemia, hypertension, or hyperhomocysteinemia) Age 50 to 69 years and history of smoking or diabetes Age 70 years and older Leg symptoms with exertion (suggestive of claudication) or ischemic rest pain Abnormal lower extremity pulse examination Known atherosclerotic coronary, carotid, or renal artery disease

The First Tool to Establish the PAD Diagnosis: The HPI, ROS, and Physical Examination Individuals with asymptomatic PAD should be identified in order to offer therapeutic interventions known to diminish their increased risk of myocardial infarction, stroke, and death. A history of walking impairment, claudication, and ischemic rest pain is recommended as a required component of a standard review of systems for adults >50 years who have atherosclerosis risk factors, or for adults >70 years.

The First Tool to Establish the PAD Diagnosis: The HPI, ROS, and Physical Examination Pulse intensity should be assessed and should be recorded numerically as follows: 0, absent 1, diminished 2, normal 3, bounding Use of a standard examination should facilitate clinical communication

This guideline recognizes that: Individuals with PAD Present in Clinical Practice with Distinct Syndromes Asymptomatic: Without obvious symptomatic complaint (but usually with a functional impairment). Classic Claudication: Lower extremity symptoms confined to the muscles with a consistent (reproducible) onset with exercise and relief with rest. “Atypical” leg pain: Lower extremity discomfort that is exertional, but that does not consistently resolve with rest, consistently limit exercise at a reproducible distance, or meet all “Rose questionnaire” criteria.

This guideline recognizes that: Individuals with PAD Present in Clinical Practice with Distinct Syndromes Critical Limb Ischemia: Ischemic rest pain, non-healing wound, or gangrene Acute limb ischemia: The five “P’s, defined by the clinical symptoms and signs that suggest potential limb jeopardy: Pain Pulselessness Pallor Paresthesias Paralysis (& polar, as a sixth “p”).

Hemodynamic Noninvasive Tests Resting Ankle-Brachial Index (ABI) Exercise ABI Segmental pressure examination Pulse volume recordings These traditional tests continue to provide a simple, risk-free, and cost-effective approach to establishing the PAD diagnosis as well as to follow PAD status after procedures.

The Ankle-Brachial Index Lower extremity systolic pressure Brachial artery systolic pressure ABI = The ankle-brachial index is 95% sensitive and 99% specific for PAD Establishes the PAD diagnosis Identifies a population at high risk of CV ischemic events “Population at risk” can be clinically & epidemiologically defined: Exertional leg symptoms, non-healing wounds, age > 70, age > 50 years with a history of smoking or diabetes. Toe-brachial index (TBI) useful in individuals with non-compressible pedal pulses Lijmer JG. Ultrasound Med Biol 1996;22:391-8; Feigelson HS. Am J Epidemiol 1994;140:526-34; Baker JD. Surgery 1981;89:134-7; Ouriel K. Arch Surg 1982;117:1297-13; Carter SA. J Vasc Surg 2001;33:708-14

Exercise ABI Confirms the PAD diagnosis Assesses the functional severity of claudication May “unmask” PAD when resting the ABI is normal

Arterial Duplex Ultrasound Testing Duplex ultrasound of the extremities is useful to diagnose anatomic location and degree of stenosis of peripheral arterial disease. Duplex ultrasound is useful to provide surveillance following femoral-popliteal bypass using venous conduit (but not prosthetic grafts). Duplex ultrasound of the extremities can be used to select candidates for: endovascular intervention; surgical bypass, and to select the sites of surgical anastomosis. However, the data that might support use of duplex ultrasound to assess long-term patency of PTA is not robust.

Noninvasive Imaging Tests Duplex Ultrasound Duplex ultrasound of the extremities is useful to diagnose the anatomic location and degree of stenosis of PAD. Duplex 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.

Noninvasive Imaging Tests Magnetic Resonance Angiography (MRA) MRA of the extremities is useful to diagnose anatomic location and degree of stenosis of PAD. MRA of the extremities should be performed with a gadolinium enhancement. MRA of the extremities is useful in selecting patients with lower extremity PAD as candidates for endovascular intervention. I IIa IIb III B

Noninvasive Imaging Tests Computed Tomographic Angiography (CTA) CTA of the extremities may be considered to diagnose anatomic location and presence of significant stenosis in patients with lower extremity PAD. as a substitute for MRA for those patients with contraindications to MRA.

Natural History of PAD Age > 50 years Cardiovascular Morbidity / Mortality Limb Morbidity Stable Claudication 70-80% Worsening Claudication 10-20% Critical Limb Ischemia 1-2% Nonfatal CV Events 20% Mortality 15-30% CV Causes 75% Non CV Causes 25%

Lipid Lowering and Antihypertensive Therapy IIa IIb III B Treatment with an HMG coenzyme-A reductase inhibitor (statin) medication is indicated for all patients with peripheral arterial disease to achieve a target LDL cholesterol of less than 100 mg/dl. Antihypertensive therapy should be administered to hypertensive patients with lower extremity PAD to a goal of less than 140/90 mmHg (non-diabetics) or less than 130/80 mm/Hg (diabetics and individuals with chronic renal disease) to reduce the risk of myocardial infarction, stroke, congestive heart failure, and cardiovascular death.

Antiplatelet Therapy B Antiplatelet therapy is indicated to reduce the risk of myocardial infarction, stroke, or vascular death in individuals with atherosclerotic lower extremity PAD. Aspirin, in daily doses of 75 to 325 mg, is recommended as safe and effective antiplatelet therapy to reduce the risk of myocardial infarction, stroke, or vascular death in individuals with atherosclerotic lower extremity PAD. I IIa IIb III B Clopidogrel (75 mg per day) is recommended as an effective alternative antiplatelet therapy to aspirin to reduce the risk of myocardial infarction, stroke, or vascular death in individuals with atherosclerotic lower extremity PAD.

Supervised Exercise Rehabilitation A program of supervised exercise training is recommended as an initial treatment modality for patients with intermittent claudication. Supervised exercise training should be performed for a minimum of 30 to 45 minutes, in sessions performed at least three times per week for a minimum of 12 weeks.

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

Endovascular Treatment for Claudication Endovascular procedures are indicated for individuals with a vocational or lifestyle-limiting disability due to intermittent claudication when clinical features suggest a reasonable likelihood of symptomatic improvement with endovascular intervention and… Response to exercise or pharmacologic therapy is inadequate, and/or b. there is a very favorable risk-benefit ratio (e.g. focal aortoiliac occlusive disease) I IIa IIb III

Endovascular Treatment for Claudication IIa IIb III Endovascular intervention is recommended as the preferred revascularization technique for TASC type A iliac and femoropopliteal lesions. Iliac Femoropopliteal TASC A: (PTA recommended) TASC B: (insufficient data to recommend)

Endovascular Treatment for Claudication: Iliac Arteries I IIa IIb III B Provisional stent placement is indicated for use in iliac arteries as salvage therapy for suboptimal or failed result from balloon dilation (e.g. persistent gradient, residual diameter stenosis >50%, or flow-limiting dissection). Stenting is effective as primary therapy for common iliac artery stenosis and occlusions. Stenting is effective as primary therapy in external iliac artery stenosis and occlusions. I IIa IIb III B I IIa IIb III c

Endovascular Treatment for Claudication Endovascular intervention is not indicated if there is no significant pressure gradient across a stenosis despite flow augmentation with vasodilators. Primary stent placement is not recommended in the femoral, popliteal, or tibial arteries. Endovascular intervention is not indicated as prophylactic therapy in an asymptomatic patient with lower extremity PAD. I IIa IIb III c I IIa IIb III c I IIa IIb III c

Surgery for Critical Limb Ischemia Surgery is not indicated in patients with severe decrements in limb perfusion in the absence of clinical symptoms of critical limb ischemia. I IIa IIb III Patients who have significant necrosis of the weight-bearing portions of the foot, an uncorrectable flexion contracture, paresis of the extremity, refractory ischemic rest pain, sepsis, or a very limited life expectancy due to co-morbid conditions should be evaluated for primary amputation.

Surgery for Critical Limb Ischemia IIa IIb III B For individuals with combined inflow and outflow disease with critical limb ischemia, inflow lesions should be addressed first. When surgery is to be undertaken, an aorto-bifemoral bypass is recommended for patients with symptomatic, hemodynamically significant, aorto-bi-iliac disease requiring intervention.

Surgery for Critical Limb Ischemia Bypasses to the above-knee popliteal artery should be constructed with autogenous saphenous vein when possible. Bypasses to the below-knee popliteal artery should be constructed with autogenous vein when possible. Prosthetic material can be used effectively for bypasses to the below knee popliteal artery when no autogenous vein from ipsilateral or contralateral leg or arm is available. I IIa IIb III B

Surgery for Critical Limb Ischemia IIa IIb III B Femoral-tibial artery bypasses should be constructed with autogenous vein, including ipsilateral greater saphenous vein, or if unavailable, other sources of vein from the leg or arm. Composite sequential femoropopliteal-tibial bypass, or bypass to an isolated popliteal arterial segment that has collateral outflow to the foot, are acceptable methods of revascularization and should be considered when no other form of bypass with adequate autogenous conduit is possible. I IIa IIb III B

Acute Limb Ischemia (ALI) IIa IIb III B Patients with ALI and a salvageable extremity should undergo an emergent evaluation that defines the anatomic level of occlusion, and that leads to prompt endovascular or surgical intervention. Patients with ALI and a non-viable extremity should not undergo an evaluation to define vascular anatomy or efforts to attempt revascularization.

ACC/AHA Guidelines for the Management of PAD: Major Contributions to Improved Care Standards Population at risk is now defined by epidemiologic criteria applied to practice. Presentation-specific algorithms will expedite care (e.g., asx, atypical leg pain, classic claudication, critical limb ischemia, & acute arterial occlusion). Use of exercise, pharmacologic, endovascular, and surgical interventions are emplaced in care as defined by evidence.

PAD public & physician education. The PAD Guidelines & the “PAD Coalition”: An Ideal Health Partnership To Foster Clinician and Public PAD Education The PAD Coalition A public, interdisciplinary Coalition devoted to creating a national PAD public awareness campaign and to coordinating PAD public & physician education. www.padcoalition.org