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Advances in Diagnosis and Management of PAD

Sanjay RajagopalanWolfe Professor of Medicine and Radiology

Director, Vascular MedicineThe Ohio State University School of Medicine

Quinn Capers IV, MD, FACCVascular Medicine, Cardiology and Endovascular Intervention Steven M Dean, DO, FBVM, FACPVascular Medicine and ImagingSanjay Rajagopalan, MD, FACC FBVMVascular Medicine, Cardiology and ImagingErnie Mazzaferri, MD FACCVascular Medicine, Cardiology and Endovascular InterventionKirsten Houck, BSVascular Medicine Program CoordinatorCarrie Morton, RNVascular Medicine Nurse

Vascular Medicine Program Staff

OSU Vascular Medicine Clinics and Diagnostic Vascular Laboratory(outpatient clinic/diagnostic testing)

3900 Stoneridge LaneDublin, Ohio 43017

Appointment scheduling: 614-889-5001, option 2 OR tollfree at 888-293-7677

Vascular CT and MR ImagingRichard M. Ross Heart Hospital

452 W. 10th AvenueColumbus, Ohio 43210

Appointment scheduling: 888-293-7677

Vascular Medicine Research and Administrative OfficesOSU Biomedical Research Tower

460 W. 12th AvenueColumbus, Ohio 43210

614-247-7760

Atherothrombosis in Contemporary Practice: The REACH REGISTRY

Steg et al. JAMA March 21, 2007; 927;1997-06.

14.4 15.2 14.5

21.1

5.3

12.81

2.61.53.83.12.92.8

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5

10

15

20

25

14.4 15.2 14.5

21.1

5.3

12.81

2.61.53.83.12.92.8

0

5

10

15

20

25

Mor

talit

y/M

AC

E (%

ye

ar)

Mean age 69 yrs; >75% on statin, ACE/ARB and anti-platelet agents

Any CAD CVD PAD RF All

Revasc 5% 12.38%

MACEAll Cause Mortality

2

• TIA• Ischemic stroke

• Claudication• Critical limb ischemia, rest pain, gangrene,

amputation

• Renovascular hypertension• Intestinal ischemia• Erectile dysfunction

• TIA• Ischemic stroke• TIA• Ischemic stroke

• Q-wave MI• Non-Q-wave MI• Unstable angina pectoris

Systemic Manifestationsof Atherosclerosis

1. Broderick J et al. Stroke. 1998;29:415-421.2. American Heart Association. 2002 Heart and

Stroke Statistical Update.3. Brown et al. Amer. Stroke Assoc. 25th Int. Stroke

Conference. 2000.

4. NSA Press Release. April 25, 2000.5. National Hospital Discharge Survey 1999. National Center for

Health Statistics/Centers for Disease Control and Prevention. Series 13, No.151. September 2001.

6. Hirsch AT et al. JAMA. 2001;286:11:1317-1324.

TIA = transient ischemic attack. ACS = acute coronary syndrome. PAD = peripheral arterial disease.*Includes coronary insufficiency, nocturnal and variant angina, atrial/papillary and undetermined MI †Includes history of MI or stable/unstable angina pectoris or both.

PADACSTIAStroke

8–126

---

12.62†

1.935*

4.94

0.503

4.62

0.731

Prevalence(Millions)

AnnualIncidence(Millions)

Arterial Disease Syndromes in the USA

Case Presentation• FG is a 65-year-old man with the complaint of lower

extremity pain with exertion. He visits his primaryclinician who recommends an ABI. The ABI resultsare abnormal.

• The most likely event that FG will experience in thenext 10 yr is

1. Worsening leg pain2. Gangrene and/or amputation3. Death4. Myocardial infarction and stroke

Limb and Cardiovascular Outcomes in PAD

Adapted from Weitz JI et al. Circulation. 1996;94:3026-3049. ACC/AHA PAD Guidelines 2006

Population >55 yr

IntermittentClaudication

5%

Peripheral VascularOutcomes

Other CardiovascularMorbidity/Total Mortality

Lower Extremity

Bypass Surgery

7%

MajorAmputation

4%

WorseningClaudication

16%

NonfatalCardiovascular

Event(MI/Stroke, 5-yr Rate)

20%

5-yrMortality

30%

CardiovascularCause75%

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

Quality of Life in PAD Is Comparable to Chronic Illnesses

30 34 38 40 50 55

Average Adult

Average Well Adult

Physical Component Summary (PCS)

36

IntermittentClaudication

# of

Peo

ple Congestive

Heart Failure

Chronic Lung

Disease

Critical Limb

Ischemia

Risk Factors for Developing PAD/Intermittent Claudication

Adapted from TASC Working Group. J Vasc Surg. 2000;31(1 suppl):S1-S296Ridker PM et al. Circulation 1998;97:425-428

Protective Harmful

-2 -1 0 1 2 3 4-2 -1 0 1 2 3 4

Male gender (vs female)

Age (per 10 yr)

Diabetes

SmokingHypertension

Hypercholesterolemia

CRP (>2)

Despite the relative risk associated with

male gender (which is age-dependent), the prevalence of PAD is gender-equal in the post-menopausal

years.

Assessment of Disease

• Vascular history• Physical examination • Noninvasive vascular laboratory tests

SymptomsSymptomsButtock, hip,Buttock, hip,thighthigh

Thigh, calfThigh, calf

Calf, ankle, footCalf, ankle, foot

Obstruction inObstruction inAorta orAorta oriliac arteryiliac artery

Femoral arteryFemoral arteryor branchesor branches

PoplitealPopliteal

TibioTibio--peronealperoneal(diabetic) (diabetic) Calf, ankle, footCalf, ankle, foot

Regardless of the location of PAD within the lower extremity vasculature, claudication is most frequently localized to the

muscles of the calf

PAD Anatomy: Sites of Claudication

4

12.65.5Classic Rose claudication

61.746.3Atypical leg symptoms

25.848.3No pain

Prior Diagnosis of PAD (%)

n=366

Newly Diagnosed PAD (%)n=457

Hirsch AT et al. JAMA. 2001;286:1317-1324

Data from PARTNERS study of primary care

practices

PAD: Classic Symptoms Are Rare, Contributing to Underdiagnosis

Determination of Ankle-Brachial Index (ABI)

• Measure ankle and brachial systolic pressures with handheld Doppler device• Use highest arm and each ankle pressure

• ABI is 95% sensitive, 99% specific for PAD• Lower ABI values are inversely related to

increased mortality and risk of limb loss

Ankle systolic pressureBrachial systolic pressure

ABI =

TASC Working Group. J Vasc Surg. 2000;31(1 suppl):S66-S67

Understanding the ABI

• The ABI does not correlate closely with limb symptoms or severity of claudication

• Request a Toe Brachial Index if vessels noncompressible

TASC Working Group. J Vasc Surg. 2000;31(1 suppl):S66-S67

Noncompressible vessels

>1.30

InterpretationABI

Severe≤0.40Moderate0.40–0.69Mild0.70–0.89Normal0.90–1.30

Other Noninvasive Diagnostic Tests

• Segmental blood pressure recording• Segmental pulse volume recording• Exercise Doppler (ABI) stress testing• Duplex ultrasound• Magnetic resonance angiography (MRA)• CT angiography

The tools of the noninvasive vascular laboratory provide additional details related to PAD diagnosis, including anatomic localization (to aid choice of revascularization options) and objective physiologic assessment of PAD severityAdapted from Manual of Vascular Diseases. Eds Rajagopalan, Mohler and Mukherjee 1rst Ed Lippincott Williams and Wilkins, Philadelphia.

Slide 13

ATH14 Title changedAlan T. Hirsch, M.D., 9/20/2003

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EXERCISE ABI

H&P AND ABI

SEVEREMODERATE MILD

AORTO-ILIAC FEMORAL/INFRAPOP INCONSISTENT

INTERVENTION

CE MRA/CTA

SEGMENTAL PRESSURE AND WAVEFORMS

NO FURTHER W/U

ROUTINE SURVEILLANCE RE-INTERVENTION

Duplex MR/CT

Dellegrottaglie, Rajagopalan S. Nature Cardiovascular Reviews 2007.

Peripheral Arterial Disease:

Management

Reduction in Mortality and Morbidity

Is the Primary Goal!

Essentials of PAD Disease Management

Risk factor normalization• Smoking cessation

– Goal: complete cessation

• Lipid management

– Goal LDL <70* mg/dL

• Blood pressure control

– Goal <135/85 mm Hg

• Blood sugar control (diabetic patients)

– Goal: A1C <7%

Antiplatelet therapies

Clopidogrel, aspirin

Symptom-directed therapies

Supervised exercise rehab

Cilostazol

Selective use of revascularization (PTA, bypass)

Therapies to lower risk of MI, stroke, and death

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If Your Patient Did This….

But they don’t!

Medications Proven to Improve Outcomes in Individuals with PADDrug Outcome

Aspirin 18% reduction MI/CVA/death

43% reduction in graft occlusion

Clopidogrel 24% reduction MI/CVA/deathvs 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 Revascularization for

Intermittent Claudication

• Lifestyle-limiting symptoms• Continued disability despite appropriate

nonsurgical management• Technically feasible revascularization

options exist• Expectation of favorable risk/benefit ratio

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Surgical Intervention Results

25ProsthFem-Distal50-75VeinFem-Distal33ProsthFem-Pop BK

47ProsthFem-Pop AK56-65VeinFem-Pop BK

66VeinFem-Pop AK

5 year (%)

TypeBypass

ACC/AHA Guidelines on Peripheral Arterial Disease. Circulation 2005.

Outcome depends on a number of factors including contextDiabetic status, state of the outflow vessels etc..

5-yrGRAFT

92%Aortic Endarterectomy

90%Aorto-Bifemoral

Aorto-Iliac Disease Surgical Results Morbidity/Mortality

>20Surgical Revision

0-24Early Graft Failure

1.9-3.4Myocardial infarction

1.3-6Mortality

10-30Wound infection

%COMPLICATION

TASC J Vasc Surg 2000

Systemic Atherosclerosis:An Interventionalist’s

Perspective

Quinn Capers, IV, MD, FACC, FSCAIAsst. Professor of Medicine

Division of Cardiovascular MedicineDirector, Peripheral Vascular Interventions, Ross Heart Hospital

Director, Cardiovascular Cath Lab, University Hospital East

The Ohio State University Medical Center

Systemic AtherosclerosisCurrent Treatments

2 therapeutic goals

Symptom Relief CV Event ReductionMechanical RevascularizationTherapeutic walking programAnti-claudication drugs

Mechanical revascularizationACE inhibitorsStatinsAspirin/Plavix

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Systemic AtherosclerosisCurrent Treatment

• Symptom ReliefMechanical Revascularization• Surgical

–Endarterectomy–Bypass–Thrombectomy

• Percutaneous–PTA–Stent–Laser–Atherectomy–Thrombectomy

Trans-Atlantic Inter-Society Consensus Document (TASC)

• Document published in 2000 (updated 2007)

(radiology, surgical, cardiology, medical societies collaborated)

Evidence and experience-based guidelines for revascularization of LE atherosclerotic disease

Trans-Atlantic Inter-Society Consensus Document (TASC)

• “A”: Endovascular approach recommended

• “B”: Endovascular likely better than surgery

• “C”: Surgery likely better than endovascular

• “D”: Surgical approach recommended

Trans-Atlantic Inter-Society Consensus Document (TASC): Progress in

Endovascular Approaches• What happened from 2000 to 2007?

More aggressive approaches to endovascular mgmtNew technology• Atherectomy• Self-expanding stents• Cryoplasty• Laser• ? Medical approaches to retard progression

of atherosclerosis (statins, ACE inh)

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Trans-Atlantic Inter-Society Consensus Document (TASC): Progress in

Endovascular Approaches• TASC (2000)• “A”: SFA stenosis <3 cm

• “B”: SFA stenosis up to 10 cm

• TASC II (2007)• “A”: SFA stenosis up to

10 cm/SFA occlusion up to 5 cm

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

• “B”: popliteal stenosis

Stent vs PTA in SFA Disease

• 104 patients with Rutherford 3-5 PAD• SFA stenosis/occlusion >3 cm• Primary Endpoint

Restenosis >50% at 6-months as determined by CTA or DSA

• Secondary EndpointsDUS restenosis >50% at 3, 6, 12 months or finding of stent fractureClinical and Resting ABI

N Engl J Med 2006;354:1879-88

Stent vs PTA in SFA Disease

N Engl J Med 2006;354:1879-88

Duplex US Derived PatencyCT and DSA Patency

Case 1: Severe LLE Claudication

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Case 1: Severe LLE Claudication

Case 1: Atherectomy of occluded L SFA

PRE

Total Occlusion

Widely

Patent

figure

POST

Excised plaque

In-stent restenotic lesionsIn SFA/popliteal

De novo atherosclerotic lesion

Case 2

PRE POST

Case 2•Multifocal lesions in diffusely diseased SFA/popliteal•Post atherectomy/balloon angioplasty•ABI=0.85

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Case 2

PRE POSTDebris captured from distal protection device

• Multifocal lesions in diffusely diseased SFA/popliteal• Post laser atherectomy/balloon angioplasty• ABI=0.85

Focal in-stent restenosisInfrarenal aorta

Case 3• Severe bilateral LE claudication

Balloon angioplasty of In-stent lesion in aorta

Case 3• Severe bilateral LE claudication

Case 4

Angioseal collagenplug device in CFA

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Case 4Step 1: Advancedistal protectiondevice

Step 2:“Vaporize”with laser

Step 3: Debulk withatherectomy catheter

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

Case 4

Preliminary results:Filling defect still visible.

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

Step 4: Prolonged balloonAngioplasty (4 min) required

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

Case 4

Fragments of collagen plug capturedin distal protection device

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

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Final result: ABI=0.9

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

Remember:When you see this . . .

Small AAAIliac artery aneurysms

. . . think of this!

Severe LMCA lesion

Go Bucks!!!

OSU Ross Heart Hospital