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Peripheral Arterial Disease

Jeff Horn, MD FACS RPVI

University Surgical Associates

June 14, 2018

Disclosures

• I have no financial relationships to disclose

Who We Are

• University Surgical Associates • 8 Vascular Surgeons • Treat all vascular conditions (carotid, aorta, mesenteric, peripheral,

dialysis, venous) • Facility for clinic, procedures, diagnostic imaging, prosthetics

Overview

• Background

• Signs & Symptoms

• Diagnosis

• Natural History

• Treatment

• Case Examples

Background

• 8-12 Million in US alone • >200 Million worldwide • Increased prevalence

– Age – Smoking – Diabetes – Hypertension – Hypercholesterolemia – Non-hispanic black race – Chronic renal insufficiency – Hyperhomocysteinemia

• 2008 PAD costs exceed $200B

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Background

• Associated with severe morbidity and mortality

• Interruption of occupation

• Impaired activities of daily living

• Impacts quality of life

• Can affect independence

• Significant cost of care

Background

• PAD can be asymptomatic or symptomatic

• Can present as acute or chronic condition

• Symptomatic patients have Intermittent Claudication (IC), Atypical leg pain, Rest Pain or Tissue Loss

• Rest Pain and Tissue Loss = Critical Limb Ischemia (CLI)

Associated Mortality Signs of PAD

• Hair loss

• Slow hair growth

• Change in color

• Atrophy of limb

• Changes in toenails

Symptoms

• IC is reproducible discomfort in certain muscle groups during activity that is relieved by rest

• Comes from latin “to limp” • Calf muscles most common, but can be thighs,

buttocks or hips • Usually muscle group below stenosis/occlusion

– Commonly see calf pain, nonpalpable popliteal pulse

• Patients with PAD risk factors commonly have other inhibitors of proper leg function – Myopathy, arthritis, spine disease, neuropathy

• Symptomatic to Asymptomatic is around 1:3

Symptoms

• 30-60% of PAD asymptomatic

• 30-50% have symptoms other than classic IC

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Atypical Symptoms Atypical Symptoms

• Those with atypical scenarios (exertional pain at exertion and rest) had worse functional outcomes

• Disease of nerves, muscles, balance, arthritis – More muscle fat, decrease fat density – More neuropathy and spinal disease – Poor muscle fuel oxidation / mitochondria function

• Carry on group does the best, less depression, more motivation

• Faster decline in those without classic IC • Be wary of those with low ABI and no symptoms – they

may just not be very active • Some adjust activity level to avoid ambulatory pain

Diagnosis

• Ankle Brachial Index (ABI) is most common

• ABI < 0.9 or >1.4 highly suggestive of poor cv outcomes

• ABI < 0.9 high sensitivity and specificity for PAD (79-95% sensitivity, >95% specificity)

• Can be done in any clinical setting using handheld continuous doppler

• With compelling history be wary of normal ABI (send for exercise ABI)

Diagnosis

Diagnosis

• ABI results:

– >1.4 Calcific noncompressable arteries (need TBI)

– 1.0-1.39 Normal

– 0.9 – 0.99 Borderline

– 0.5-0.89 Moderate PAD

– 0.0 – 0.49 Severe PAD

Diagnosis

• History

– Duration, character, timing, relief, exacerbation

– Gradual or abrupt?

• Physical Exam

– Detailed pulse evaluation

– Skin integrity

– Physical maneuvers to simulate symptoms (leg elevation for nerve related pain)

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Diagnosis

• Pulse Exam

– Aorta, femoral, popliteal, dp, pt

– Quality of pulse?

– Greater than expected?

– Absent?

– Aneurysm?

Diagnosis

• Pulse Volume Recordings (PVR)

• Segmental Pressures

• Duplex Ultrasound

• CTA

• MRA

• Angiography

• Be careful with radiology reports – always recommended to get more advanced and $$ tests

Diagnosis Duplex

• Not indicated as first test (ABI)

• Noninvasive • Relatively fast (30-60

minutes) • Identify degree of plaque

AND flow characteristics • Inexpensive compare to

others • Accurate in the right hands

CTA

• A noninvasive arteriogram • Definition in multiple planes • Relatively quick acquisition • Expensive • Contrast load (nephrotoxic,

allergies) • Poor delineation in heavily

calcified arteries • Non-physiologic, detail depends on

contrast timing

MRA

• Very expensive

• Multiple modalities used (T1, T2, TOF)

• Contrast load

• Length of exam, patient comfort, anxiety

• Pacemakers, other hardware

• Worse resolution than others

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Angiography

• Gold standard in vascular diagnosis • Invasive • Expensive • Time-consuming • Contrast load issues (less than bolus dose with

CT) • Ability to treat at the same time as diagnosis • Ability to get hemodynamic data • Complication rates low but not zero (access site,

dissections, perforations, emboli)

Diagnosis

• Rutherford scale for chronic vascular insufficiency

Diagnosis

• Natural history of PAD

• Claudicants divided into 1/3’s

– 1/3 improve, 1/3 same, 1/3 decline

– Risk of amputation <1% / year

• CLI patients fare MUCH worse

– Risk of amputation ~50%

– Risk of death all causes at 5 years ~ 50%

Asymptomatic Management

• No clear benefit derived from screening for PAD in asymptomatic patient

• Accepted risk factor modification for atherosclerosis in general

• Smoking cessation, antiplatelet therapy, statin therapy, exercise therapy, surveillance

• In general invasive therapy only indicated for those with symptoms

IC Management

• Significant systemic burden of atherosclerosis

• Risk factor modification can

– Reduce cardiac complications and death

– Improve interventional complication rates

– Improve durability / patency of procedure

Smoking

• Endothelial damage • Platelet and leukocyte adhesion • Endothelial permeability • Impaired vascular tone • Vasoconstrictor effects of endothelin-1 • Abnormalities of platelet function, coagulation

and fibrinolysis • Increased blood viscosity • IC develops in smokers 2x rate of nonsmokers,

also dose dependent

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Smoking Cessation

• Quiters show increase ABI and increased walking distance on treadmill test

• Smokers have 2-3x risk of lower extremity bypass graft failure

• Those who quit have 2x survival benefit compared to those who don’t

Diabetes

• Prevalance of PAD in diabetics is ~30%

• Amputation rates 5-10x higher in diabetics

• Sensory disturbances of the extremity

• Increased risk of peripheral infections

Hypertension

• Typically associated with CV disease in this population

• Treatment to reduce risk of all cause cardiovascular mortality

Antiplatelets/Antithrombotics

• No evidence that dual therapy better than single agent for PAD

Agents to Improve Function

• Trental (Pentoxyfylline) – Reduces blood viscosity – Retard platelet aggregation – 400mg 3x/day up to 1800mg/day – Can exacerbate HTN

• Pletal (Cilostazol) – Suppresses platelet aggregation – Direct vasodilator – Improvement in pain-free walking distance in 3-4wks – Contraindicated in heart failure – 100mg TID

Exercise Therapy

• Metanalysis of 1200 pts shows improvement in walking ability of 50-200% up to 2yrs

• Enlargement of existing collaterals, induced angiogenesis, vasodilation of microcirculation

• Medical comorbidities may preclude participation • Walking, running, cycling either self directed or supervised • Walking is best, no benefit to intensity level • >30 minutes per session • >3 sessions / week • >26 weeks in duration • Structured / supervised plans have better outcomes

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Revascularization

• Benign natural history of IC vs loss of ambulatory function on ADL, occupation and QoL

• Majority who adhere to program will decline slow or not at all

• BUT 1/3 will progress to significant disability • Those that seek treatment out of fear of amputation need

be reassured • Moderate claudication in vigorous patient can be

debilitating • Severe claudication may be well tolerated in the sedentary • In most claudicants a 3-6 month trial of lifestyle

modification and medical therapy is warranted

Revascularization

• Options include Endovascular Therapy or Open Surgical

• EVT includes angioplasty, stenting, atherectomy, antiproliferative pharmacotherapy

• Open surgical can be In-line or extra anatomic

• Procedures called “inflow” and “runoff”

• Other terms include infrainguinal (below groin) and infrageniculate (below knee)

Aortoiliac

• “Inflow” disease

• Can cause hip, buttock pain and ED

– Leriche Syndrome

• Can also manifest as calf pain

• Check femoral pulses

• One instance where CTA can be helpful prior to intervention

Aortoiliac

Aortoiliac EVT

• Techniques include antegrade, retrograde, brachial, contralateral

• Balloon expandable, self expandable and covered stent options

• Hybrid options if disease in the common femoral artery

• Initial technical success 90-100%

• 1 yr primary / secondary patency 70-100% / 90-100%

• 5 yr primary / secondary patency 60-85% / 80-95%

Aortoiliac Open

• Direct “in-line” and extra anatomic bypass

• Aortofemoral bypass (Y graft) gold standard

• 10yr patency >80%

• Commonly with Dacron or ePTFE graft but can be cryopreserved aorta, or vein

• Perioperative mortality <3%

• Morbidity 10-15%

• Extra-anatomic options include Ax-fem, fem-fem

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Aortoiliac Open Infrainguinal

• SFA is the most common site of obstruction leading to IC

• Severity of symptoms related to degree of collateral network, status of profunda

• EVT considered when risk modification and exercise fail to improve functional status

• Predictors of success include lesion length, degree of stenosis, size of artery and calcium

Infrainguinal Infrainguinal

• Strategies – PTA alone

– PTA with bailout stenting

– Primary stenting (self expanding, covered)

– Atherectomy alone

– Atherectomy with PTA +/- BOS

– Drug coated balloon DCB

– Drug eluting stent DES

– Atherectomy with DCB

Infrainguinal Infrainguinal

• Primary or bailout stenting can confer a patency advantage over PTA alone

• Useful when PTA introduces dissection / injury

• Useful when immediate arterial recoil / ineffective PTA

• Nitinol material, flexible

• Not recommended behind the knee

• Inherit fracture risk, improved with newer iterations

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Infrainguinal

• Covered stents (Viabahn, iCast, Fluency)

– Useful in longer lesions (endopass)

– Useful in lesions with thrombus

– Now heparin bonded

Infrainguinal

• Atherectomy devices remove plaque

– Different techniques

– Lesion and location dependent

– Expensive

– Long term data has not born out effectiveness

– Used more for vessel prep than standalone therapy (subsequent PTA or DCB)

Atherectomy Devices

Directional Atherectomy - Hawk portfolio: Silver Hawk,

TurboHawk, & HawkOne (Medtronic) - Pantheris (Avinger)

Orbital Atherectomy - Diamondback 360 (CSI)

Rotational Atherectomy - JetStream (Boston Scientific) - Phoenix (Volcano)

Photoablation Atherectomy - Turbo-Elite & Turbo-Tandem

(Spectranetics)

Infrainguinal

DA RA OA Laser Composition

X X Ca2+

X X X X Soft

X X Thrombus

Morphology DA RA OA Laser

Focal X X

CTO X X X

Eccentric X X

Concentric X X X X

DA RA OA Laser Location

X X X X Above-knee

X X X Below-knee

ISR DA RA OA Laser

Indication X

Anatomical Location

Plaque Composition

Lesion Morphology

In-Stent Restenosis

Individual operator experience and preference are likely the primary influencers in device selection.

Infrainguinal

• Antiproliferative treatments (Paclitaxel)

– Delivers drug to arterial wall during deployment

– Drug concentration, delivery complex

– Vessel prep prior to delivery to ensure it goes to smooth muscle

– Difficult to deliver appropriate drug if circumferential calcium

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Drug Coated Balloon

55

1. Freedom from core laboratory-assessed restenosis (duplex ultrasound PSVR ≤2.4) or clinically-driven target lesion revascularization through 36

months (adjudicated by a Clinical Events Committee blinded to the assigned treatment).

2. Number at risk represents the number of evaluable subjects at the beginning of each 30-day window.

Δ +24.4%

Drug Eluting Stent

Infrainguinal

• Complications related to EVT:

– Access site (PSA, bleeding, infection)

– Contrast delivery

– Arterial injury (dissection, embolism, rupture)

– Burning bridges (comprimising future bypass options, change of outflow level)

– Covered stents go down hard (covered collaterals)

Infrainguinal Open

• Bypass is mainstay of treatment for IC for 5 decades

• Durable treatment with improvements in walking distance, ABI and pain-free walking time

• Important factors include conduit used, quality of inflow, number and quality of outflow vessels, target location

• In IC vein is recommended above and below the knee as first line conduit

• Certain vessels better with plaque removal (common femoral, profunda)

Infrainguinal Infrainguinal

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Infrainguinal Infrainguinal

Infrainguinal

• Lower extremity bypass complications

– Intraoperative mortality low

– SSI 2-10%

– Vein harvest dehiscence

– Graft failure

– Graft infection

– Bleeding

Critical Limb Ischemia

• “End stage” vascular disease • Huge burden of therapy and cost

– Wound care, rehabilitation, multiple interventions, medical comorbidities

– $43,000/pt-year (1990 data)

• Require multidisciplinary approach – Primary care, VS, podiatry, infectious disease, critical care

• Risk of amputation at this level approaches 40-50% at one year • Risk of overall mortality approaches 50% at 5 years • Some (~40-50%) may not proceed from asymptomatic to IC to CLI • May not be referred early in disease course • Tend to have multilevel disease (inflow and runoff vessels)

Critical Limb Ischemia

• Rest pain

– Pain in muscles whether ambulatory or not

– Frequently exacerbated in elevated position

• Tissue loss

– Slow healing wounds

– Ulcerations

– Gangrene (wet / dry)

Critical Limb Ischemia

• Goals of therapy – Relieve ischemic pain – Heal wounds – Prevent limb loss – Improve function and QoL – Prolong survival

• Nonoperative therapy in those unfit for intervention (advanced wound care) – 38% amputation rate, wounds healed in only 50% at

one year

• ABI < 0.5 predictor of limb loss

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Critical Limb Ischemia

• EVT good first line intervention – Ability to diagnose mulitlevel obstruction – Simultaneous treatment – Reperfuse angiosome target if possible

• Bypass first option for extensive disease – Survival and amputation-free survival similar on

outcomes at 2 years – Beyond 2 years, bypass patients fared much better

(especially vein bypass)

Critical Limb Ischemia

Critical Limb Ischemia

• WIfI System of CLI classification

Critical Limb Ischemia

Acute Limb Ischemia (ALI)

• If new onset within last two weeks

• Acute interruption of blood supply

• May be first manifestation of PAD

• 1.5 cases per 10,000

• New or worsening claudication, rest pain, absent distal pulses, mottling of skin, petechia, motor loss, sensosory loss, cold skin

• 30 day amputation rate as high as 30%

ALI

• Emboli of cardiac origin in 75% of cases • Dissection, embolism, entrapment, trauma, cyst,

hypercoagulable state, graft/stent failure • 6 P’s

– Pain – Pallor – Paresthesia – Paralysis – Poikilothermia – Pulselessness

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ALI

• History and physical very important

• Exact moment of change

• History of arrhythmia

• Normal pulses in opposite limb

• Motor and sensory exams

• Pain in muscle compartments

ALI

ALI

• Strategies are all operative • Immediate heparinization • Endovascular

– Aspiration thrombectomy – Pharmacomechanical

thrombectomy

• Open – Arteriotomy and fogarty

thrombectomy

• Amputation • Fasciotomy

Cases

• 1. CB 45 yo WF

– 1 year of progressive ambulatory discomfort

– Now with rest pain in the calves

– HTN, smoker, obesity, hypercholesterolemia

– Absent femoral pulses

– Monophasic distal pulses

– ABI 0.5 / 0.5

• 2. DB 68 yo AAF

– HTN, former smoker, DM, ESRD

– New onset left first toe gangrene

– Palpable femoral pulse

– Weak monophasic PT pulse

– Delayed capillary refill

– ABI 0.35

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Cases

• 81 yo WF

– HTN, former smoker

– Very active

– Followed in clinic for 18 months

– Prior visits show SFA stenosis, ABI 0.78, no lifestyle limitation

– This year ABI drop to 0.6, difficult ambulation

Cases

• 52 yo Construction Worker

– Former smoker, severe CAD, HLD, HTN

– Can’t walk 100 yds without stopping

– ABI 0.7, SFA occlusion

– Getting progressively worse

– Interferes with occupation

Thank You!

Questions??