Going out on a Limb: Peripheral Arterial Disease in Primary Care No Financial Disclosures Adam M. Levine, D.O. FACC Lourdes Cardiology Services South Jersey Heart Group September 13, 2014

Goals Who is at risk for development of PAD When and How to screen How to treat

Peripheral Artery Disease (PAD) PAD affects 12-20% of Americans age 65 and older.1 12 million with PAD in the U.S. alone2 3x greater risk in those with diabetes over the age of 50.3 4x greater risk in current or past smokers. 1 1. Becker, GJ, et al. The Importance of Increasing Public and Physician Awareness of Peripheral Arterial Disease. J Vasc interv Radiol 2002; 13[1];7-11. 2. “Peripheral Arterial Disease in People with Diabetes”, American Diabetes Association Consensus Statement, Diabetes Care, Volume 26, Number 12, December 2003, 3333-3341. 3. “Diagnosis of PAD is Important for People with Diabetes”, American Diabetes Association Consensus Statement, Diabetes Care, November 21, 2003, www.diabetes.org.

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

Presentations in Clinical Practice Asymptomatic, may have functional impairment Reproducible (typical) claudication Atypical Leg Pain Critical Limb Ischemia Rest pain, tissue loss, threatened limb loss Acute Limb Ischemia Pain, Pulseless, Pallor, Parasthesias, Paralysis

CLI Impact and Mortality 1.5-2 million people in the US and Europe suffer from CLI1 Mortality rates for CLI patients2 at one year : 25% two years : 31.6% three years : 60% 40-50 % amputation rate within 1st year of Dx. 3 1-2. “Conquering Critical Limb Ischemia”, Michael R. Jaff, DO and Giancarlo Biamino, MD, Endovascular Today, February 2004, Volume 3, No. 2 3. Dormandy J.A., Heeck L., Vig S.: The fate of subjects with critical leg ischemia. Semin Vasc Surg 12. 142-147.1999;

Symptomatic and Asymptomatic PAD Prior Diagnosis of PAD (n=366) Newly Diagnosed PAD (n=457) PARTNERS Study Hirsch AT et al. JAMA. 2001;286:1317-1324.

Prognosis in Patients with Intermittent Claudication Peripheral Vascular Outcomes Other Cardiovascular Morbidity/Total Mortality Lower Extremity Bypass Surgery 7% Major Amputation 4% Worsening Claudication 16% Population >55 yr Intermittent Claudication Nonfatal Cardiovascular Event (MI/Stroke, 5-year Rate) 20% 5-yr Mortality 30% Cardiovascular Cause 75% Adapted from Weitz JI et al. Circulation. 1996;94:3026-3049.

Does “Asymptomatic” PAD Really Matter? Coronary Artery Surgery Study (CASS) in patients with known CAD the presence of PAD increased Cardiovascular mortality by 25% during a 10 yr follow-up (J AM Coll Cardiol 1994:23:1091-5) PAD, symptomatic or asymptomatic, is a powerful independent predictor of CAD and CVD (Vasc.Med.3,241,1998.)

Symptoms of PAD Claudication: Dull cramping or pain in muscles of hips, thighs or calf muscles when walking, climbing stairs, or exercise which is relieved with cessation of activity Fatigue in legs which may require patient to stop and rest while walking Slow or shuffled gait & having difficulty keeping up with others

Symptoms of PAD Neuropathy or pain in feet with exercise Rest pain or night pain that occurs when legs elevated in bed, relieved when placed in dependent position. Typically in the distal foot, possibly in vicinity of an ulcer Impotence may be a sign of iliac disease and may see some relief with sildenafil citrate.

Differential Diagnosis of Exertional Leg Pain Vascular Causes Atherosclerosis Thrombosis Embolism Vasculitis Thromboangiitis obliterans Takayasu arteritis Giant cell arteritis Aortic coarctation Fibromuscular dysplasia Irradiation Endofibrosis of the external iliac artery Extravascular compression Arterial entrapment (e.g., popliteal artery entrapment, thoracic outlet syndrome) Adventitial cysts

Visual Cues to PAD and Arterial Insufficiency Cool, dry, atrophic skin on legs May have signs of cellulitis Thickened or deformed nails-dystrophic Hair loss or uneven distribution on legs Muscle weakness or atrophy Bruits on auscultation Ulcers or wounds on lower extremities Gangrene

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

PAD Diagnostic Tests Non-invasive tests1 Invasive tests1 ABI (Ankle/Brachial Index) Exercise Test Segmental Pressures Segmental Volume Plethysmography Duplex Ultrasonography MRA (Magnetic Resonance Arteriography),or CTA Invasive tests1 Peripheral Angiography 1. Krajewski and Olin Chapter 11 Peripheral Vascular Disease. 2nd ed. 1996

Recommendations for ABI, Toe-Brachial Index, and Segmental Pressure Examination IIa IIb III B 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 years, or ≥50 years with a history of smoking or diabetes. MODIFIED 2011 ACC/AHA Guideline for Management of PAD

The Ankle-Brachial Index ABI = Lower extremity systolic pressure Brachial artery systolic pressure Normal 0.95-1.2 PAD <0.90 Rest pain/ulceration <0.40 The Ankle-Brachial Index is 95% sensitive and 99% specific for PAD Both ankle and brachial systolic pressures are obtained using a hand-held Doppler instrument Source: Peripheral Arterial Disease in People with Diabetes, ADA, Consensus Statement, Diabetes Care, Volume 26, Number 12, December 2003.

The Ankle-Brachial Index Performing a resting ankle-brachial index measurement ABI >1.30 (abnormal) ABI 0.91 to1.30 (borderline &normal ABI <= to 0.90 Confirmation of PAD diagnosis Measure ABI After exercise test PVR, Toe-brachial index Duplex ultrasonography Decreased post-exercise ABI MRA,or CTA Peripheral Angiography MRA, or CTA

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

Arterial Duplex Ultrasound Recommendations IIa IIb III A 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). 2011 ACC/AHA Guideline for Management of PAD

Arterial Duplex Ultrasound Testing 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.

Surveillance post Bypass or Endovascular Procedure Duplex Ultrasound 3, 6, 12 months post and at yearly intervals Early Failure Rates 9-47% after PTA If recognized secondary patency rates > 90% Indications for restudy Worsening ABI ( 0.15) is an indication for restudy Decreased flow less then 40 cm/sec PSV >180 cm/sec, Vr > 2

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

Computed Tomographic Angiography Computed tomographic angiography (CTA) of the extremities may be considered to diagnose anatomic location and presence of significant stenosis in patients with lower extremity PAD. CTA of the extremities may be considered as a substitute for magnetic resonance angiography (MRA) for those patients with contraindications to MRA. I IIa IIb III B

Lower Extremity Angiography Contrast angiography provides detailed information about arterial anatomy and is recommended for evaluation of patients with lower extremity PAD when revascularization is contemplated. (Class I, LOE B)

Summary of Diagnostic tests Suspected PAD exertional leg symptoms or non-healing wounds Age ≥65 years Age ≥50 years with a history of smoking or diabetes. ABI/PVR If normal and symptomatic then Exercise ABI Duplex ultrasound MRA CTA Angiogram

Treatment Risk Factor Modification Hypertension - BP < 140/90 Diabetes – HgA1c ≤ 7% Hyperlipidemia – LDL ≤ 100 Smoking Cessation Supervised Exercise Program (30-45 min/day, 3 days/week) Class I, LOE A

Pharmacotherapy Antiplatlet to reduce risk of MI, stroke, vascular death in PAD Symptomatic Aspirin (Class I, LOE B) Clopidogrel (Class I, LOE B) Asymptomatic If ABI ≤ 0.90 (Class IIa, LOE C) Cilostazol (Class I, LOE A) Indicated to improved symptoms and increase walking distance in PAD Contraindicated in CHF 100mg BID

Revascularization Options Endovascular Advantage Local anesthesia No vein grafts needed Fast recovery Potential for Hybrid approach Disadvantage Lower Patency rates Need for repeat procedures Surgical Advantage Less interventions Better patency Disadvantage General anesthesia Need vein grafts Longer recovery Higher systemic complications

Comparative Intervention Treatment Options 1 year primary patency 2 year primary patency Percutaneous Transluminal Angioplasty (PTA) 58% 51% Stents 65-85% 55-68% Bypass 77-81% 66-77% SilverHawk has a one-year patency of 79-88%. Angioplasty is not close to that level. Stents are not recommended for the legs by the ACC/AHA Guidelines. Bypass is not a good option for some patients. Source: J Endovas There 2004;11(suppl II):II-107-II-127 “Lower Extremity Endovascular Interventions” Bates and AbuRahma

Summary Who is at risk for development of PAD When and How to screen Diabetes, known vascular disease, Smokers, Older age When and How to screen Exertional leg symptoms or nonhealing wounds Anyone age ≥65 years or ≥50 years with a history of smoking or diabetes. ABI and doppler ultrasound is first line How to treat Aspirin, exercise, risk factor modification, cilostazol, revascularization

Conclusion Prevention is KEY!!!!! When in doubt, refer to your local vascular specialist.