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Embassy Suites Raleigh-Durham/Research Triangle Cary, North Carolina June 21, 2008

Embassy Suites Raleigh-Durham/Research Triangle Cary, North Carolina June 21, 2008. 2008. Symposia Series 2. 1. Peripheral Arterial Disease: Keeping Pace With Current Diagnostic and Treatment Options. Joshua A. Beckman, MD Assistant Professor of Medicine Harvard Medical School

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Embassy Suites Raleigh-Durham/Research Triangle Cary, North Carolina June 21, 2008

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  1. Embassy Suites Raleigh-Durham/Research Triangle Cary, North Carolina June 21, 2008 2008 Symposia Series 2 1

  2. Peripheral Arterial Disease: Keeping Pace With Current Diagnostic and Treatment Options Joshua A. Beckman, MD Assistant Professor of Medicine Harvard Medical School Brigham and Women’s Hospital Boston, Massachusetts 2 2

  3. Faculty Disclosure Dr Beckman: honorarium: Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership 3 3

  4. ? 7 KEY QUESTION How many of your patients with CV risk do you test for PAD? • 0%-24% • 25%-50% • 51%-75% • 76%-100% Use your keypad to vote now! 4

  5. Learning Objectives • State the clinical manifestations of PAD • Perform ankle-brachial index measurements in patients at risk for PAD • Describe medical treatments for improving leg symptoms in patients with PAD PAD = peripheral arterial disease.

  6. PAD: Prevalence in the Primary Care Office Setting NHANES1 Age >40 4.3% The prevalence of PAD in primarycare clinics was almostin high-risk patients San Diego2 Mean age = 66 11.7% 30% NHANES1 Age ≥70 14.5% Rotterdam3 Age >55 19.1% Diehm4 Age ≥65 19.8% PARTNERS5 Age >70, or between 50-69 with history of diabetes or smoking 29% 0% 5% 10% 15% 20% 25% 30% 35% NHANES = National Health and Nutrition Examination Survey; PARTNERS = PAD Awareness, Risk, and Treatment New Resources for Survival Program. 1. Selvin E, et al. Circulation. 2004;110:738-743; 2. Criqui MH, et al. Circulation.1985;71:510-515; 3. Meijer WT, et al. Arterioscler Thromb Vasc Biol. 1998;18:185-192; 4. Diehm C, et al. Atherosclerosis. 2004;172:95-105; 5. Hirsch AT, et al. JAMA. 2001;286:1317-1324. 6

  7. What Is PAD? Atherosclerotic occlusion of the arteries to the legs PAD may be asymptomatic or present with atypical symptoms Common, but often overlooked Associated with significant morbidity and mortality www.nhlbi.nih.gov/health/dci/Diseases/pad.

  8. VIDEO CLIP: Predilation Arteriogram—Bilateral Iliac Artery Stenosis Severe Aortic Atherosclerosis Courtesy: Michael R. Jaff, DO Director, Vascular Center Massachusetts General Hospital Boston, Massachusetts

  9. Predilation Arteriogram—Bilateral Iliac Artery Stenosis Severe Aortic Atherosclerosis-VIDEO 9

  10. 16 PAD affects 8-12 million Americans, second only to CHD* Proportionately, for every 4 patients seen with CHD,* clinicians might expect to see approximately 3 patients with PAD 14 13 12 8-12 10 Prevalence (millions) 8 6 4 5.4 2 0 Stroke PAD CHD* PAD: Scope of the Problem • Exact prevalence is unknown *Includes MI and angina pectoris. CHD = coronary heart disease; MI = myocardial infarction. AHA. Heart Disease and Stroke Statistics—2008 Update. www.americanheart.org; Hiatt WR. N Engl J Med. 2001;344:1608-1621. .

  11. ? 7 KEY QUESTION PAD increases the risk of CHD death by approximately: • 1×-2× • 3×-4× • 5×-6× • 6×-7× • 7×-8× Use your keypad to vote now! 11

  12. PAD: Increased Risk of Mortality Patients with large-vessel PAD* are at ~6×the risk of dying from CHD compared with patients without PAD 10.0 8.0 6.6 (2.9-14.9) 6.0 Relative Risk of Death (95% CI) 4.0 3.1 (1.9-4.9) 2.0 0.0 Death From CHD All-Cause Mortality Cause of Death *ABI ≤0.8. ABI = ankle-brachial index. Adapted from Criqui MH, et al. N Engl J Med. 1992;326:381-386.

  13. Case Study

  14. Patient Profile 58-year-old Latino male Presents to the clinic after referral from emergency department where he was evaluated and discharged after an episode of chest pain Coronary event ruled out by lab and diagnostic studies Construction worker with no health benefits Scenario #1

  15. Current History Complains of fatigue and inability to maintain current productivity at the work site Mild leg pain Remembers being told his “sugar was a little high” Reports he is not on any medications Reports he does not drink alcohol Smokes 1 pack/d x 30 years

  16. Physical Examination Results Height: 5 ft 9 in Weight: 190 lb BMI: 28.1 kg/m2 Waist circumference: 40 in Blood pressure: 130/85 mm Hg Pulse: 72 bpm BMI = body mass index.

  17. ? 7 DECISION POINT Which element of the patient’s history creates the highest index of suspicionfor PAD? • Age • Diabetes • Ethnicity • Hypertension • Smoking Use your keypad to vote now! 17

  18. PAD: Common Risk Factors* ◄Lesser risk Greater risk ► Diabetes 4.05 Smoking 2.55 Patients with diabetes are at a 4x higher risk of developing symptomatic PAD versus the general population Hypertension 1.51 Total cholesterol (10 mg/dL) 1.10 0 1 2 3 4 5 6 Age >40 years *PAD diagnosis based on ABI <0.90. Newman AB, et al. Circulation. 1993;88:837-845.

  19. PAD: Prevalence Increases With Age Rotterdam Study (ABI <.9) San Diego Study (PAD by noninvasive tests) 60 50 40 Patients With PAD (%) 30 20 10 0 55-59 60-64 65-69 70-74 75-79 80-84 85-89 Age Group (y) Creager M, ed. Management of Peripheral Arterial Disease. Medical, Surgical and Interventional Aspects. 2000.

  20. San Diego Population StudyPAD and Ethnicity Criqui MH, et al. Circulation. 2005;112:2703-2707.

  21. REACHScope of the Problem: Cerebro- and Cardiovascular Disease 63% of PAD patients had polyvascular* disease N = 7013 Cerebro-vascular Coronary artery 14.2% 9.5% 39.4% Peripheral artery Polyvascular disease *PAD patients with polyvascular disease had concomitant symptomatic cerebrovascular disease and/or CVD. REACH = REduction of Atherothrombosis for Continued Health. CVD = cardiovascular disease. Bhatt DL, et al. Presented at: ACC Scientific Session; March 6-9, 2005; Orlando, Fla.

  22. ? 7 DECISION POINT What is the next step in assessing the patient for possible PAD? • ABI testing • Differential diagnosis for leg pain • Lipid/endocrine panel • Vascular laboratory tests Use your keypad to vote now! 22

  23. PAD: Intermittent Claudication Not Always Present Patients With PAD PARTNERS: up to 90%* of patients with PAD would be missed if healthcare providers relied solely on classic symptoms of intermittent claudication Healthcare providers should routinely ask about atypical symptoms *In patients with ABI ≤0.9. Asymptomatic PAD ~40% Symptomatic PAD ~60% Typical Symptoms(Intermittent Claudication) ~10% Exercise calf pain Not present at rest Relieved within 10 minutes by rest Atypical Symptoms~50% Occlusion may develop slowly, allowing collateral circulation to develop AHA. Heart Disease and Stroke Statistics—2008 Update. www.americanheart.org; Criqui MH, et al. Vasc Med. 1996;1:65-71; Hirsch AT, et al. JAMA. 2001;286:1317-1324.

  24. PAD: Diagnostic Critical Pathway ABI Available ABI Not Available Clinical Evaluation: History and Physical Referral to Vascular Lab • Assessment of location/ severity is desired • Patients with poorly compressible vessels • Normal ABI where PAD suspicion is high Vascular Lab Evaluation • Segmental pressures • Pulse volume recordings • Treadmill PAD Diagnosis PAD Diagnosis Adapted from American Diabetes Association. Diabetes Care. 2003;26:3333-3341.

  25. Simple Questions to Ask Your Patient Who Has Symptoms of PAD Do you walk? If you do not walk, why not? Do you have pain in either leg when you walk? How far can you walk? How far do you walk without stopping? What stops you when you are walking? Have you had any poor or non-healing leg or foot wounds? Olson KWP, et al. J Vasc Nurs. 2004;22:72-77.

  26. PAD: Physical Evaluation—Differential Diagnosis in Patients With Intermittent Claudication • Calf • Venous occlusion • Chronic compartment syndrome • Nerve root compression • Baker’s cyst • Hip/thigh/buttock • Hip arthritis • Spinal cord compression • Foot • Arthritis • Buerger disease Adapted from Schmieder FA, et al. Am J Cardiol. 2001;87:3D-13D.

  27. PAD: Physical Examination Additional examination by palpation and auscultation to detect abnormal aortic aneurysm or bruit Gey DC, et al. Am Fam Physician. 2004;69:525-532.

  28. Physical Examination Results CV: RRR S1 and S2 with no murmurs or gallops Chest: clear to A/P Abdomen: rotund, but no pulsatile masses or distention Vascular: no bruits; upper extremity pulses—normal limits Lower extremity pulses reveal normal femoral bilaterally Right popliteal, DP, and PT palpable Left shows decreased popliteal, DP, and PT Musculoskeletal: no evidence of foot ulceration or dependent rubor Neurologic: sensory function intact in upper and lower extremities DP = dorsalis pedis; PT = posterior tibial.

  29. ? 7 KEY QUESTION How often do you perform ABIs for patients who have a similar clinical profile? • 0%-25% • 26%-50% • 51%-75% • 76%-100% Use your keypad to vote now! 29

  30. PAD: Diagnostic Critical Pathway ABI Available ABI Not Available Clinical Evaluation: History and Physical Referral to Vascular Lab • Assessment of location/ severity is desired • Patients with poorly compressible vessels • Normal ABI where PAD suspicion is high Vascular Lab Evaluation • Segmental pressures • Pulse volume recordings • Treadmill PAD Diagnosis PAD Diagnosis Adapted from American Diabetes Association. Diabetes Care. 2003;26:3333-3341. 30

  31. PARTNERSIncorporating ABI Into Primary Care 358% 300% Weekly Increase in ABI Use in Office Monthly Increase in ABI Use in Office After Clinicians Participated in PARTNERS: 88% Clinicians thought it feasible to incorporate ABI into daily practice Mohler ER, et al. Vasc Med. 2004;9:253-260.

  32. ABI: Indications American Diabetes Association. Diabetes Care. 2004;22:181-189.

  33. Concept of ABI Systolic blood pressure in the leg should be approximately the same as that in the arm Leg Pressure Therefore, the ratio of systolic blood pressure in the leg versus the arm should be approximately 1 or slightly higher ÷≈ 1 Arm Pressure ABI is 95% sensitive and 99% specific for angiographically diagnosed PAD Adapted from Weitz JI, et al. Circulation. 1996;94:3026-3049.

  34. ABI Video Vascular Disease Foundation

  35. ABI Video 35

  36. ABI Workshops CME/CE–accredited demonstrations available throughout the day

  37. ABI Reimbursement: Medicare Noninvasive PAD testing does not have “national coverage“ Each individual Medicare provider determines local coverage requirements CPT 93922 Coverage Most Medicare providers consider ABI exam without blood flow waveforms part of general physical examination Hence, ABIs are not reimbursable unless waveform analysis is included CPT 93922 provides coverage for a single-level lower extremity physiologic study © 2008 Vascular Disease Foundation. www.vdf.org. Used with permission. 37

  38. Usually Meet Requirements Claudication of <1 block; severity interferes significantly with occupation or lifestyle Rest pain (typically including forefoot), usually associated with absent pulses, that becomes increasingly severe with elevation and diminishes with leg in dependent position Tissue loss (gangrene or pregangrenous changes); ischemic ulceration in absence of pulses Aneurysmal disease Evidence of thromboembolic events; and/or Blunt/penetrating trauma (including complications of diagnostic and/or therapeutic procedures) May Not Meet Requirements Continuous burning of feet (considered neurologic symptom) “Leg pain, nonspecific” and “pain in limb” as single diagnoses are too general to warrant further investigation (must be related to other signs/symptoms) Edema, unless immediately postop, in association with another inflammatory process or rest pain; and/or Absence of pulses in minor arteries in the absence of symptoms Absence of pulses not indication to proceed beyond physical exam unless related to other signs/ symptoms Medical Necessity: Documentation Needed © 2008 Vascular Disease Foundation. www.vdf.org. Used with permission . 38

  39. ABI Reimbursement: Commercial Insurance • Reimbursement rates for the single level lower extremity physiologic study are set by the individual insurance companies • Medical billing consultants are available who can prepare reports that detail allowable rates for a specific practice and locality © 2008 Vascular Disease Foundation. www.vdf.org. Used with permission . 39

  40. ABI Results • Diagnostic intervention • Evaluate vascular status ABI results • Right = 1.00 • Left = 0.56

  41. Treatment Rationale The lower the ABI, the greater the risk of cardiovascular events Patients with critical leg ischemia—the most severe clinical manifestation of PAD—who have the lowest ABI values have an annual mortality of 25% Hiatt WR. N Engl J Med. 2001;344:1608-1621.

  42. Patient Consultation You tell your patient he has: PAD A serious disease The cause of his walking problem A marker for the systemic disease atherosclerosis—and he is at risk for heart attack or stroke

  43. ? 7 DECISION POINT Appropriate management of this patient should be to: • Treat symptoms • Reduce CV risk • Treat symptoms then address CV risk reduction • Simultaneously treat symptoms and reduce CV risk Use your keypad to vote now! 43

  44. PAD: 2-Pronged Management Strategy Patient Management Requires BOTH Approaches Simultaneously Risk Reduction of Ischemic Events • Objective • Reduce risk of events causing morbidity and mortality • Control risk factors • Antiplatelet therapy (clopidogrel) Treatment of Symptoms • Objective • Reduce symptoms to increase mobility, exercise tolerance, functional capacity • Exercise • Pharmacology therapy (cilostazol) • Selective use of interventional therapy Kempczinski RF, et al. In: Rutherford RB, ed. Vascular Surgery. 1989; Clagett GP, et al. Chest. 1995;108:431S-443S; McDermott MM, et al. Surg Clin North Am. 1995;75:581-591.

  45. Despite its prevalence and cardiovascular risk implications, only 25% of patients with PAD are undergoing treatment! PAD: Undertreated • In a recent study of 1733 patients with known PAD: • 33% were taking a beta blocker • 29% were taking an ACE inhibitor • 31% were taking a statin • Of those with diabetes, only 46% had an A1C of <7% ACE = angiotensin-converting enzyme. AHA. Heart Disease and Stroke Statistics—2008 Update. www.americanheart.org; Rehring TF, et al. J Vasc Surg. 2005;41:816-822.

  46. Management Plan—Risk Reduction Appropriate management includes: Smoking cessation Blood pressure control Antiplatelet therapy Exercise program Order lipid/metabolic profiles Follow-up in 1 month

  47. PAD: Aggressive Risk Factor Modification—Smoking Cessation 50 Varenicline (n = 344) Bupropion SR (n = 342) Placebo (n = 341) 45 40 35 Continuous Abstinence (%) 30 25 20 15 10 5 0 Week 9-24† Week 9-12* Week 9-52† *Carbon monoxide level confirmed at clinic visits. †Clinic and telephone visits. Jorenby DE, et al. N Engl J Med. 2006;296:56-63. 47

  48. Meta-AnalysisPAD: Aggressive Risk Factor Modification—Supervised Exercise 179% 122% Percentage Increase Distance to Maximal Claudication Pain Distance to Onset of Claudication Pain At 6 Months AMA has published a CPT code for supervised PAD rehabilitation (93668)2 Greatest improvement: • Sessions lasted >30 min • 3 sessions/week • Walk to near-maximal pain • >6-month program CPT = current procedural terminology. 1. Gardner AW, et al. JAMA. 1995;274:975-980; 2. Kanjwal MK, et al. JK Practitioner. 2004;11:225-232.

  49. HOPEPAD: Aggressive Risk Factor Modification—Antihypertensive Therapy 0.6 0.8 1.0 1.2 • Benefit seen independent of antihypertensive effect Relative Risk in Ramipril Group HOPE Study Investigators. N Engl J Med. 2000;342:145-153.

  50. ? 7 DECISION POINT Which of the following would you recommend for the pharmacologic management of his PAD? • Aspirin • Cilostazol • Clopidogrel • Pentoxifylline Use your keypad to vote now! 50

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