Advances in Diagnosis and Management Of

OSU Vascular Medicine Clinics and Diagnostic Vascular Laboratory (outpatient clinic/diagnostic testing) 3900 Stoneridge Lane Dublin, Ohio 43017 Advances in Diagnosis Appointment scheduling: 614-889-5001, option 2 and Management of PAD OR tollfree at 888-293-7677 Vascular CT and MR Imaging Richard M. Ross Heart Hospital 452 W. 10th Avenue Sanjay Rajagopalan Columbus, Ohio 43210 Wolfe Professor of Medicine and Radiology Appointment scheduling: 888-293-7677 Director, Vascular Medicine The Ohio State University School of Medicine Vascular Medicine Research and Administrative Offices OSU Biomedical Research Tower 460 W. 12th Avenue Columbus, Ohio 43210 614-247-7760

Vascular Medicine Atherothrombosis in Contemporary Program Staff Practice: The REACH REGISTRY

Quinn Capers IV, MD, FACC Mean age 69 yrs; >75% on statin, ACE/ARB and anti- Vascular Medicine, Cardiology and platelet agents Endovascular Intervention Steven M Dean, DO, FBVM, FACP MACE Vascular Medicine and Imaging 2525 All Cause Mortality Sanjay Rajagopalan, MD, FACC FBVM 21.121.1 2020 Vascular Medicine, Cardiology and Imaging 15.2 14.414.4 15.2 14.514.5 Ernie Mazzaferri, MD FACC 1515 12.8112.81 Vascular Medicine, Cardiology and Endovascular Intervention year) 1010 5.35.3 Kirsten Houck, BS 3.83.8 55 2.82.8 2.92.9 3.13.1 2.62.6 Vascular Medicine Program Coordinator Mortality/MACE (% 1.51.5 Carrie Morton, RN 00 Vascular Medicine Nurse Any CAD CVD PAD RF All Revasc 5% 12.38% Steg et al. JAMA March 21, 2007; 927;1997-06.

1 Systemic Manifestations of Atherosclerosis Case Presentation • FG is a 65-year-old man with the complaint of lower • TIA extremity pain with exertion. He visits his primary • Ischemic stroke clinician who recommends an ABI. The ABI results • Q-wave MI are abnormal. • Non-Q-wave MI • The most likely event that FG will experience in the • Unstable angina pectoris next 10 yr is • Renovascular hypertension 1. Worsening leg pain • Intestinal ischemia • Erectile dysfunction 2. Gangrene and/or amputation • Claudication 3. Death • Critical limb ischemia, rest pain, gangrene, 4. Myocardial infarction and stroke amputation

Arterial Disease Syndromes in the Limb and Cardiovascular USA Outcomes in PAD Annual Population >55 yr Incidence Prevalence (Millions) (Millions) Intermittent 1 2 Claudication Stroke 0.73 4.6 5% 3 4 TIA 0.50 4.9 Peripheral Vascular Other Cardiovascular 5 2† ACS 1.93 * 12.6 Outcomes Morbidity/Total Mortality 6 PAD --- 8–12 Worsening Lower Major Nonfatal 5-yr Claudication Extremity Amputation Cardiovascular Mortality TIA = transient ischemic attack. ACS = acute coronary syndrome. PAD = peripheral arterial disease. 30% *Includes coronary insufficiency, nocturnal and variant angina, atrial/papillary and undetermined MI 16% Bypass 4% Event †Includes history of MI or stable/unstable angina pectoris or both. Surgery (MI/Stroke, 7% 5-yr Rate) Cardiovascular 1. Broderick J et al. Stroke. 1998;29:415-421. 4. NSA Press Release. April 25, 2000. Cause 2. American Heart Association. 2002 Heart and 5. National Hospital Discharge Survey 1999. National Center for 20% Stroke Statistical Update. Health Statistics/Centers for Disease Control and Prevention. 75% 3. Brown et al. Amer. Stroke Assoc. 25th Int. Stroke Series 13, No.151. September 2001. Adapted from Weitz JI et al. Circulation. 1996;94:3026-3049. ACC/AHA PAD Conference. 2000. 6. Hirsch AT et al. JAMA. 2001;286:11:1317-1324. Guidelines 2006

2 Quality of Life in PAD Is Comparable to Chronic Illnesses Assessment of Disease

Critical Intermittent Limb Claudication Ischemia

Congestive Chronic Average • Vascular history Average Heart Lung Well Adult Failure Disease Adult • Physical examination

# of People # of • Noninvasive vascular laboratory tests

30 3436 38 40 50 55 Physical Component Summary (PCS)

Adapted from Ware JE. Ann Rev Pub Health. 1995;16:327-354

Risk Factors for Developing PAD Anatomy: Sites PAD/Intermittent Claudication of Claudication Protective Harmful Regardless of the location of PAD within the lower extremity -2-101234-2-101234 vasculature, claudication is most frequently localized to the muscles of the calf Male gender (vs Despite the relative female) Obstruction in Symptoms risk associated with Age (per 10 yr) Aorta or Buttock, hip, male gender (which is iliac artery thigh Diabetes age-dependent), the prevalence of PAD is Femoral artery Smoking Thigh, calf gender-equal in the or branches Hypertension post-menopausal years. Hypercholesterolemia Popliteal Calf, ankle, foot CRP (>2) Tibio-peroneal Tibio-peroneal Calf, ankle, foot (diabetic)

Adapted from TASC Working Group. J Vasc Surg. 2000;31(1 suppl):S1-S296 Ridker PM et al. Circulation 1998;97:425-428

3 PAD: Classic Symptoms Are Rare, Contributing to Underdiagnosis Understanding the ABI

Data from PARTNERS ABI Interpretation study of primary care practices Newly Diagnosed Prior Diagnosis 0.90–1.30 Normal PAD (%) of PAD (%) 0.70–0.89 Mild n=457 n=366 0.40–0.69 Moderate No pain 48.3 25.8 ≤0.40 Severe Atypical leg 46.3 61.7 >1.30 Noncompressible symptoms vessels Classic Rose 5.5 12.6 • The ABI does not correlate closely with limb claudication symptoms or severity of claudication • Request a Toe Brachial Index if vessels noncompressible

Hirsch AT et al. JAMA. 2001;286:1317-1324 TASC Working Group. J Vasc Surg. 2000;31(1 suppl):S66-S67

Determination of Ankle- Other Noninvasive Brachial Index (ABI) Diagnostic Tests Ankle systolic pressure • Segmental blood pressure recording ABI = Brachial systolic pressure • Segmental pulse volume recording • Measure ankle and brachial systolic pressures • Exercise Doppler (ABI) stress testing with handheld Doppler device • Duplex ultrasound • Use highest arm and each ankle pressure • Magnetic resonance angiography (MRA) • ABI is 95% sensitive, 99% specific for PAD • CT angiography • Lower ABI values are inversely related to The tools of the noninvasive vascular laboratory provide additional details related to PAD diagnosis, including anatomic localization (to aid increased mortality and risk of limb loss choice of revascularization options) and objective physiologic assessment of PAD severity Adapted from Manual of Vascular Diseases. Eds Rajagopalan, Mohler and Mukherjee 1rst Ed Lippincott TASC Working Group. J Vasc Surg. 2000;31(1 suppl):S66-S67 Williams and Wilkins, Philadelphia.

4 Slide 13

ATH14 Title changed Alan T. Hirsch, M.D., 9/20/2003 H&P AND ABI

MILD MODERATE SEVERE

SEGMENTAL PRESSURE AND WAVEFORMS Reduction in AORTO-ILIAC FEMORAL/INFRAPOP INCONSISTENT Mortality and Morbidity CE MRA/CTA Is the Primary Goal! EXERCISE ABI INTERVENTION

NO FURTHER W/U Duplex MR/CT

ROUTINE SURVEILLANCE RE-INTERVENTION

Dellegrottaglie, Rajagopalan S. Nature Cardiovascular Reviews 2007.

Essentials of PAD Disease Management Therapies to lower risk of MI, stroke, and death Peripheral Arterial Risk factor normalization Antiplatelet therapies • Smoking cessation Clopidogrel, aspirin Disease: – Goal: complete cessation • Lipid management Symptom-directed therapies – Goal LDL <70* mg/dL Supervised exercise rehab • Blood pressure control Cilostazol Management – Goal <135/85 mm Hg Selective use of • Blood sugar control (diabetic revascularization (PTA, patients) bypass) – Goal: A1C <7%

5 Medications Proven to Improve If Your Patient Did This…. Outcomes in Individuals with PAD Drug Outcome Aspirin 18% reduction MI/CVA/death 43% reduction in graft occlusion Clopidogrel 24% reduction MI/CVA/death vs aspirin

Ramipril 22% reduction MI/CVA/death Simvastatin 24% reduction MI/CVA/death Cilostazol Improvement in claudication symptoms and quality of life

CVA = cerebrovascular accident

Indications for But they don’t! Revascularization for Intermittent Claudication

• Lifestyle-limiting symptoms • Continued disability despite appropriate nonsurgical management • Technically feasible revascularization options exist • Expectation of favorable risk/benefit ratio

6 Surgical Intervention Results Systemic Atherosclerosis: An Interventionalist’s GRAFT 5-yr Bypass Type 5 year Perspective (%) Aorto-Bifemoral 90% Aortic 92% Fem-Pop AK Vein 66 Endarterectomy Fem-Pop BK Vein 56-65 Fem-Pop AK Prosth 47 Fem-Pop BK Prosth 33 Fem-Distal Vein 50-75 Quinn Capers, IV, MD, FACC, FSCAI Fem-Distal Prosth 25 Asst. Professor of Medicine Division of Cardiovascular Medicine Outcome depends on a number of factors including context Director, Peripheral Vascular Interventions, Ross Heart Hospital Diabetic status, state of the outflow vessels etc.. Director, Cardiovascular Cath Lab, University Hospital East

ACC/AHA Guidelines on Peripheral Arterial Disease. Circulation 2005. The Ohio State University Medical Center

Aorto-Iliac Disease Surgical Systemic Atherosclerosis Results Morbidity/Mortality Current Treatments COMPLICATION %

Wound infection 10-30 2 therapeutic goals Mortality 1.3-6

Myocardial 1.9-3.4 infarction Symptom Relief CV Event Reduction Early Graft 0-24 Mechanical Revascularization Mechanical revascularization Failure Therapeutic walking program ACE inhibitors Surgical >20 Anti-claudication drugs Statins Aspirin/ Revision Plavix TASC J Vasc Surg 2000

7 Systemic Atherosclerosis Trans-Atlantic Inter-Society Current Treatment Consensus Document (TASC) • Symptom Relief 9 Mechanical Revascularization • Surgical • “A”: Endovascular approach recommended –Endarterectomy –Bypass • “B”: Endovascular likely better than surgery –Thrombectomy • “C”: Surgery likely better than endovascular • Percutaneous –PTA • “D”: Surgical approach recommended –Stent –Laser –Atherectomy –Thrombectomy

Trans-Atlantic Inter-Society Consensus Trans-Atlantic Inter-Society Document (TASC): Progress in Consensus Document (TASC) Endovascular Approaches • What happened from 2000 to 2007? • Document published in 2000 (updated 2007) 9 More aggressive approaches to endovascular mgmt 9 (radiology, surgical, cardiology, medical 9 New technology societies collaborated) • Atherectomy 9 Evidence and experience-based guidelines • Self-expanding stents for revascularization of LE atherosclerotic • Cryoplasty disease • Laser • ? Medical approaches to retard progression of atherosclerosis (statins, ACE inh)

8 Trans-Atlantic Inter-Society Consensus Document (TASC): Progress in Stent vs PTA in SFA Endovascular Approaches Disease • TASC (2000) • TASC II (2007) • “A”: SFA stenosis <3 cm • “A”: SFA stenosis up to 10 cm/SFA occlusion up to 5 cm

• “B”: SFA stenosis or • “B”: SFA stenosis up to occlusion up to 15 cm 10 cm

• “B”: popliteal stenosis CT and DSA Patency Duplex US Derived Patency

N Engl J Med 2006;354:1879-88

Stent vs PTA in SFA Case 1: Severe LLE Claudication Disease

• 104 patients with Rutherford 3-5 PAD • SFA stenosis/occlusion >3 cm • Primary Endpoint 9 Restenosis >50% at 6-months as determined by CTA or DSA • Secondary Endpoints 9 DUS restenosis >50% at 3, 6, 12 months or finding of stent fracture 9 Clinical and Resting ABI

N Engl J Med 2006;354:1879-88

9 Case 1: Severe LLE Claudication Case 2

De novo atherosclerotic lesion

In-stent restenotic lesions In SFA/popliteal

Case 1: Atherectomy of occluded L SFA Case 2 POST •Multifocal lesions in diffusely diseased SFA/popliteal PRE •Post atherectomy/balloon angioplasty •ABI=0.85 Widely Total Occlusion Patent PRE POST

figure

Excised plaque

10 Case 2 Case 3 • Multifocal lesions in diffusely diseased SFA/popliteal • Severe bilateral LE claudication • Post laser atherectomy/balloon angioplasty • ABI=0.85 PRE POST Debris captured from distal protection device Balloon angioplasty of In-stent lesion in aorta

Case 3 Case 4 • Severe bilateral LE claudication

Angioseal collagen Focal in-stent restenosis plug device in CFA Infrarenal aorta

11 Case 4 Case 4 • New, severe RLE ischemia, ABI 0.5 • 2 days after cardiac cath • New, severe RLE ischemia, ABI 0.5 • 2 days after cardiac cath Step 1: Advance distal protection device Step 4: Prolonged balloon Step 2: Angioplasty (4 min) required “Vaporize” with laser

Step 3: Debulk with atherectomy catheter

Case 4 Case 4 • New, severe RLE ischemia, ABI 0.5 • New, severe RLE ischemia, ABI 0.5 • 2 days after cardiac cath • 2 days after cardiac cath

Fragments of collagen plug captured in distal protection Preliminary results: device Filling defect still visible.

12 Case 4 . . . think of this! • New, severe RLE ischemia, ABI 0.5 • 2 days after cardiac cath

Final result: ABI=0.9

Severe LMCA lesion

Remember: When you see this . . . Go Bucks!!!

Iliac artery aneurysms Small AAA

OSU Ross Heart Hospital