Disclosure Information

1. Disclosure Information Dan Varga, MD discloses that he has nothing to disclose.

2. The ABCs of Vascular Disease What is it?

3. Agenda • Peripheral Vascular Disease (PVD) defined • What is PAD (Peripheral Artery Disease)? • PAD Risk Factors • Signs + Symptoms of Advanced PAD • PVD Conditions • Symptomatic + Asymptomatic PAD • CLI (Critical Limb Ischemia) • Amputation Impact • Vascular Screening Recommendations • Vascular Tests – Diagnosis of PAD • Non-invasive • Invasive • The MultidisciplinaryTeam • PAD Treatment Options • Vascular Center Organization Chart • Conclusion

4. What is Peripheral Vascular Disease?* 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 these circulation disorders: • Functional peripheral vascular diseases don't have an organic cause. They don't involve defects in blood vessels' structure. They're usually short-term effects related to "spasm" that may come and go. Raynaud's disease is an example. It can be triggered by cold temperatures, emotional stress, working with vibrating machinery or smoking. • Organic peripheral vascular diseases are caused by structural changes in the blood vessels, such as inflammation and tissue damage. Peripheral artery disease is an example. It's caused by fatty buildups in arteries that block normal blood flow. * PVD definition is from the American Heart Association

5. Peripheral Artery Disease (PAD) • PAD is most commonly caused by atherosclerotic plaque build up in the arteries. The plaque causes obstruction to blood flow in the extremities of the body, such as the legs. • PAD affects 12-20% of Americans age 65 and older. • Only 25% of PVD patients are in treatment. • 14-18 million have PAD (in the US) • 3x greater risk for diabetics over the age of 50 • 4x-5x higher risk of dying from a cardiovascular event Period Change: 28% Source: Meditech Insights “U.S. Markets for Interventional Peripheral Vascular Products”

6. PAD Risk Factors NON-MODIFIABLE RISKS: • Age. The risk of limb loss due to PAD increases with age. People 65 or older are two to three times more likely to have an amputation. • Gender.Men with PAD are twice as likely to undergo an amputation as women. • Race/ethnicity. Some racial and ethnic groups have a higher risk of amputation (i.e., African Americans, Latino Americans, and Native Americans). This is because they are at increased risk for diabetes and cardiovascular disease. • Family history of heart disease. A family history of cardiovascular disease is an indicator for risk at developing PAD. MODIFIABLE RISKS: • Cigarette smoking.  Smoking is a major risk factor for PAD. Smokers may have four times the risk of PAD than nonsmokers.  • Obesity.People with a Body Mass Index (BMI) of 25 or higher are more likely to develop heart disease and stroke even if they have no other risk factors.  • Diabetes mellitus.  Having diabetes puts individuals at greater risk of developing PAD as well as other cardiovascular diseases.  • Physical inactivity. Physical activity increases the distance that people with PAD can walk without pain and also helps decrease the risk of heart attack or stroke. Supervised exercise programs are one of the treatments for PAD patients.  • High blood cholesterol. High cholesterol contributes to the build-up of plaque in the arteries, which can significantly reduce the blood's flow. This condition is known as atherosclerosis. Managing cholesterol levels is essential to prevent or treat PAD. • High blood pressure.When blood pressure remains high, the lining of the artery walls becomes damaged. Many PAD patients also have high blood pressure. • High levels of Homocysteine.This is an amino acid found in plasma (blood). Some recent studies show higher levels are associated with PAD.

7. Signs + Symptoms of Advanced PAD • Pain in the toes or feet. This is called rest pain and occurs because the body is unable to deliver enough blood to the feet at rest. Rest pain usually worsens when the legs are elevated, and may be relieved by lowering the legs. When the legs are unable to get the nutrition needed for growth and repair, gangrene or death of the tissue can occur. • Decreased hair growth on the legs • Paleness of the leg or foot when elevated • Blue/red discoloration of the foot when hanging down • Absence of pulses in the foot • Numbness, tingling, or pain in the foot, toes or leg • Decreased ability to spread the toes and move the foot • Cool temperature of the foot and leg • A sore on the foot that does not heal • Fatigue in legs which may require may require patient to stop and rest while walking. • Slow or shuffled gait + having difficulty keeping up with others. • Impotence may be a sign of iliac disease and may see some relief with sildenafil citrate.

8. Vascular Conditions • Abdominal Aneurysm  • Aortoiliac Disease  • Upper Extremity Disease  • Carotid Artery Disease  • Claudication • Deep Vein Thrombosis  • Diabetic Problems  • Hyperlipidemia • Lymphedema  • Mesenteric Ischemia • Peripheral Aneurysm  • Peripheral Arterial Disease  • Pulmonary Embolism  • Renovascular Conditions  • Thoracic Aneurysm  • Thoracic Outlet Syndrome  • Varicose Veins  • Venous Insufficiency 

9. Symptomatic + Asymptomatic PAD Hirsh AT et al. JAMA. 2001; 289: 1317-1324

10. 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-year 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)

11. Critical Limb Ischemia (CLI) • CLI affects 2 million Americans who are at risk for amputation of the toes, feet + legs • 40% of amputees die within 2 years • CLI causes persistently recurring rest pain requiring regular analgesia • CLI is a non-healing ulceration or gangrene of the foot or toes. Threatened limb loss or tissue loss • Rutherford Becker Categories 4 – 6 • 4: Ischemic rest pain • 5: minor tissue loss, e.g. non-healing ulcer, focal gangrene • 6: major tissue loss, i.e. above transmet level

12. CLI: Vascular Compromise (Impact + Mortality) • Often due to diffuse, multi-level arterial involvement • Frequently involves infra-popliteal arteries with sever diffuse disease and/or total occlusion • Diabetics often have entirely infra-popliteal disease

13. Amputation Impact • International Diabetes Federation estimates that somewhere in the world, a leg is lost to diabetes every 30 seconds • The risk of leg amputation is 15-40 times greater for a person with diabetes • Each year there are 150,000 lower extremity amputations with a $270 million price Source: American Cancer Society, American Heart Association, Alzheimer's Disease Education / Referral Center, American Diabetes Association, SAGE Group.

14. Does “Asymptomatic” PAD Really Matter?

15. ADA Consensus Panel recommends ABI Screening for: Patients over the age of 50 years who have diabetes Patients with diabetes younger than 50 years of age who have other PAD risk factors (i.e. smoking, hypertension, hyperlipidemia, diabetes more than 10 years) ABI should be repeated in 5 years if normal If ABI is abnormal, then patient should be referred TASC II recommends ABI Screening for: All patients who have exertional leg symptoms All patients between the age of 50-69 and who have a cardiovascular risk factor All patients age greater than 70 years regardless of risk factor status All patients with a Framingham risk score of 10%-20% Vascular Screening Recommendations

16. Vascular Tests – Diagnosis of PAD • Non-invasive techniques • ABI (Ankle/Brachial Index) • Exercise Test • Segmental Pressures • Segmental Volume Plethysmography • Duplex Ultrasonography • CT Angiogram • MRA (Magnetic Resonance Arteriography) • Carotid Doppler identifies patients who are at risk for stroke • Vascular ultrasound • Invasive techniques • Peripheral Angiograms • CT Angiograms • MR Angiograms

17. PAD Diagnosic Test:ABI (Ankle-Brachial Index) Medicare Reimbursement of CPT Code 93922 = $97 - $165 (depending on location) • Simple, reliable means for diagnosing PAD.  Blood pressure measurements are taken at the arms and ankles using a Doppler. • The ABI test is simple enough to be performed in any doctor's office. • Inexpensive equipment and reimbursable tests. • Please note: Blood-flow waveform analysis must be included for Medicare reimbursement. CPT 93922 provides coverage for a single-level lower extremity physiologic study. Test must be diagnosed as medically necessary (e.g. leg pain when walking). • Sample vendors that meet reimbursement criteria: • LifeDop ABI ($2,000) • PADnet ($22,000 – auto transmission)

18. Normal ABI Exceptions • Normal resting ABI does not exclude PAD in patients with symptoms of PAD • Exercise induced claudication • Patients with diabetes with arterial claudication • Toe pressures

19. PAD Diagnostic Test: Segmental Pressures • Similar to the ABI plus 2 or 3 additional blood pressure cuffs. These additional cuffs are placed just below the knee and one large cuff or two narrow cuffs are placed above the knee and at the upper thigh. These cuffs are then inflated above your normal systolic blood pressure, and then slowly deflated. • Using the Doppler instrument, a significant drop in pressure between two adjacent cuffs indicates a narrowing of the artery or blockage along the arteries in this portion of your leg. This allows the physician to identify more precisely the location of such blockages in the arteries of your leg.

20. PAD Diagnostic Test:Duplex Scanning • Duplex Scanning = a combination of real-time and Doppler ultrasonography • Purpose: to evaluate arterial and venous disorders noninvasively. • The most common application for the examination is to determine the presence of deep vein thrombosis (DVT) in the extremity, usually because of leg swelling. • The deep veins are examined every 1-2 cm and gentle pressure is applied with the scan head to demonstrate that the walls of the vein can be easily collapsed. When thrombus is present there is little if any compressibility. The flow patterns are also assessed with Doppler recording. The presence or absence of venous valve insufficiency is assessed with compression maneuvers of the extremity. • TYPES OF DUPLEX SCANS: • Extracranial Cerebrovascular • Abdominal • Renal • Aortoiliac • Mesenteric Arterial • Venous Duplex Scan Upper and Lower Extremities

21. The Team

22. The Team • Podiatry • Care directly for patients with CLI • Wound Care: Medication, Debridement, HBO, Skin Grafting, Limited Amputation • Identify Patients who may benefit from revascularization…for claudication as well as for CLI • Serve as “Gate Keeper/PCP” as 70% of patients with PAD also have CAD , Carotid Disease, other vascular disease (AAA, RAS)

23. The Multidisciplinary Team • Interventional Cardiology Committed to Endovascular Revascularization • Management of Dyslipidemia • Screening for CAD: nuclear stress testing • Evaluation of carotid disease: stenting vs. CEA • Interventional Radiology • Committed to Endovascular Revascularization • Experts in Vascular Imaging • Screening for Vascular Disease in other areas • Experts in Endovascular Therapy for other Vascular areas • Surgery • Committed to Endovascular Revascularization • Experts in Vascular Disease • Screening for Vascular Disease in other areas • Can offer both Open and Endovascular Revascularization • Experts in Vascular Imaging MOST PATIENTS WITH PAD DIE FROM MI OR STROKE

24. PAD Treatment Options • Medical • Risk Factor Modification • Exercise Therapy • Drug Therapy • Endovascular Therapy • Peripheral Transluminal Therapy • Peripheral Stenting • Angioplasty • Laser • Cryoplasty • Atherectomy • Thrombolic Therapy (adjunctive) • Surgery • Bypass Grafts • Amputation • Endarterectomy

25. AAA Screening • Medicare now pays for this! • Class 1 Indication: Current or prior • Smoking history, male, age 65-75 • Ultrasound, CT or MRA all acceptable, but cost argues for ultra sound

26. Medical Care of the PAD Patient • Remember: You are treating a systemic disease

27. Medical Care of the PAD Patient • Most PAD patients will die of cardiovascular disease distant from the affected limb. • Five year MI risk of mild claudicants exceeds that of a MI survivor! • CLI patients have an exceptionally poor prognosis—average survival less than one year in some series.

28. Medical Care of the PAD Patient • Antiplatelet agents --ASA or Clopidogrel; both in high risk patients only • Lipid lowering agents --PAD is a CAD risk equivalent; LDL target is ,100 --Statins are the preferred agent • Blood Pressure targets are also secondary prevention targets

29. Vascular Center Organizational Chart

30. Thank you.