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Peripheral Arterial

Disease

Mary MacDonald CD MD PhD FRCSC RPVI

Vascular Surgeon

Thunder Bay Regional Health Sciences Centre

Assistant Professor

Northern Ontario School of Medicine

Presentation

Prevention

Treatment

Cardiovascular and Stroke Summit 1 June 2018

Faculty/Presenter Disclosure

• Faculty: Dr. Mary MacDonald

• Relationships with commercial interests:

• none

Disclosure of Commercial Support

• Dr. Mary MacDonald, Vascular Surgeon, TBRHSC

• This program has received no financial or in-kind

support

• Potential for conflict(s) of interest:

• I have no conflict of interest or

affiliations that have influenced

this presentation to disclose

Objectives

1. Review presentation of peripheral

arterial disease

2. Evidence based prevention and risk

factor management

3. Treatment options: indications for

angiography and surgical bypass

Overview

Chronic Peripheral Arterial Disease

Presentation of PAD

Prevention and Management of Risk Factors

Guidelines for Treatment of Claudication

Guidelines for Treatment of Critical Limb Ischemia

Guidelines for Management of Diabetic Foot Ulcer

Treatment: Indications for intervention

What is Peripheral Arterial Disease?

Stenosis or occlusion of the aorta or limb

arteries which leads to lack of tissue

oxygenation (ischemia)

Acute PAD most often caused by

embolization

Chronic PAD most often by atherosclerosis

Either acute or chronic peripheral arterial

disease can lead to death of tissues (nerve,

muscle, bone) and loss of the limb

Peripheral Arterial Disease

The Aging Population

0

5

10

15

20

25

10 20 30 40 50 60 70 80 90

Age (years)

Pop

ula

tio

n (

mill

ion

s)

1980

1990

2000

2010

17% of the population 55-70 years of age has PAD

Fowkes FG, et al. Int J Epidemiol. 1991;20:384-392.

PAD = peripheral arterial disease

N=1592

Independent Risk Factors for PAD*

Newman AB, et al. Circulation. 1993;88:837-845

* PAD diagnosis based on ABI <0.90.

1.10 1.51

2.55

4.05

Relative Risk vs the General Population

Reduced Increased

Diabetes

Smoking

Hypertension

Total cholesterol (10 mg/dL)

Chronic Peripheral

Arterial Disease

Causes of Chronic Peripheral Arterial Ischemia

Popliteal Entrapment

Syndrome

Popliteal Adventitial

Cyst

Popliteal Aneurysm

Thromboangiitis

Obliterans (Buerger’s

disease)

Arteritis

Fibromuscular Dysplasia

Atherosclerosis

85%

5%

10%

Atherosclerosis

Atherosclerosis Risk Factors

The Ankle-Brachial Index (ABI)

Ankle systolic pressure

Brachial systolic pressure

Ankle pressure from

Posterior Tibial and

Dorsalis Pedis – use

highest

Chronic Peripheral Arterial Disease

Clinical Ankle Brachial

Index

Normal ABI is 1.0

intermittent

claudication <0.7

rest pain <0.5

tissue loss

ulcers, gangrene <0.3

Critical Limb Ischemia

Peripheral Arterial Disease w/ inadequate

tissue oxygenation even at rest

Rubor

Rest Pain

Tissue Loss

ulcers, gangrene, infection

Chronic Peripheral Arterial

Disease -- Natural History

Of patients age 50 and older with PAD,

only 1-2% will go on to develop critical

limb ischemia

but

in patients who develop critical limb

ischemia, after 1 year only 50% will be

alive with both lower limbs

Case: Belinda B

Belinda is a 70 year old who presents with

intermittent, reproducible bilateral calf pain

at 3 blocks (5-10 minutes). Symptoms have

been present for approximately 6 months.

She denies pain in her toes or feet at night

There has been no tissue loss

She has had no prior vascular interventions

Case: Belinda B

What is your next action?

A. Order a CT Angiogram

B. Refer for conventional angiogram +/-

angioplasty

C. Start ASA, statin, and a walking program

D. Do an ABI in the office

Clinical Presentation of PAD

Initial PAD Presentation

Symptomatic PAD

Atypical Leg Pain

40-50% Intermittent Claudication

10-35%

Critical Limb Ischemia

1-2%

Asymptomatic PAD

20-50%

Hirsch AT, Haskal ZJ, Hertzer NR, et al. Available at http://www.acc.org/clinical/guidelines/pad/summary.pdf. Accessed December 13, 2005.

Natural History of Claudication

Natural History of PAD: 5-year

Outcomes

Stable Claudication70-80%

Worsening Claudication10-20%

Critical Limb Ischemia 1-2 %

Non-CV Causes 25% CV Causes 75%

Mortality 15-30%

Nonfatal CV Events 15-30%

Limb Morbidity Limb Morbidity Cardiovascular Morbidity and Mortality

Fate of Patients With Critical Limb

Ischemia After Initial Treatment

Dormandy JA, et al. J Vasc Surg. 2000;31:S1-S296.

Summary of 19 studies

on 6-month outcomes

5 year outcomes show

increased mortality due to

cardiovascular causes

Dead 20%

Alive Without Amputation 45%

Alive With Amputation 35%

Chronic Peripheral Arterial

Disease Management

Medical management: Risk factor modification

Antiplatelet

Statin

Revascularization

Open surgery: Endarterectomy

Bypass – anatomic

extraanatomic

Endovascular: Angioplasty – transluminal

subintimal

Stent

Other (Atherectomy, Cryoplasty)

Therapy of Intermittent Claudication:

Magnitude of Functional Improvement

Pentoxifylline

(Trental)

Cilostazol *

Supervised Exercise

Improvement Over Baseline After 90 to 180 Days (%)

Gardner AW, Poehlman ET. JAMA. 1995;274:975-980; Girolami B, et al. Arch Intern Med. 1999;159:337-345. Hiatt WR. N Engl J Med. 2001; 344;1608-1621.

0 50 100 150 200

antiplatelet not avail in Canada

Effects of Exercise Training on

Claudication

Gardner AW, Poehlman ET. JAMA. 1995;274:975-980.

Exercise Training

Control

200

0

20

40

60

80

100

120

140

160

180

Onset of Claudication Pain

Maximal Claudication Pain

Ch

ange

in T

read

mill

Wal

kin

g D

ista

nce

(%

) Meta-analysis of 21 Studies

Intermittent Claudication:

Exercise Therapy

Frequency: 3-5 supervised

sessions/week

Duration: 35 to 50 minutes of

exercise/session

Type of exercise: treadmill or track

walking to near-maximal claudication

pain

Length: 6 months or more

Results: 100%-150% improvement in

maximal walking distance

Improvement in quality of life

Stewart KJ, et al. N Eng J Med. 2002;347:1941-1951.

Goals in Treating Patients With PAD

•Improve ability to walk

–Increase walking

distance

–Improvement in

QOL

•Prevent progression to

critical limb ischemia

and amputation

Decrease mortality from

MI, stroke, and

cardiovascular death

Decrease nonfatal MI

and stroke

Limb

Outcomes

Outcomes in

Cardiovascular

Morbidity and Mortality

2015 SVS Guidelines for the

Management of Peripheral

Arterial Disease

Diagnosis

Diagnosis of PAD: The Ankle-

Brachial Index

Use ABI first to establish lower extremity PAD diagnosis

Recommend against routine screening in the absence of symptoms or risk factors

Use toe-brachial index in patients with non-compressible vessels

Anatomic imaging if revascularization is being considered

Hirsch AT, Haskal ZJ, Hertzer NR, et al. Available at http://www.acc.org/clinical/guidelines/pad/summary.pdf. Accessed December 13, 2005.

2015 SVS Guidelines for the

Management of Peripheral

Arterial Disease

Risk Factor Management

Risk Factor Management:

Asymptomatic Patient

1A Comprehensive Smoking Cessation

intervention(s)

1C Educate re S&S of PAD progression

1C Recommend against invasive

treatment in the absence of symptoms

Hirsch AT, Haskal ZJ, Hertzer NR, et al. Available at http://www.acc.org/clinical/guidelines/pad/summary.pdf. Accessed December 13, 2005.

Risk Factor Management:

Symptomatic Patient

1A Comprehensive Smoking Cessation intervention(s)

1A Statin therapy

1A ASA 81 mg PO OD

1B optimal diabetes control

1B B-blocker use as indicated

1B Plavix if ASA not tolerated

Risk Factor Management:

Smoking Cessation

Patient should discontinue use of

cigarettes or other forms of tobacco

Offer comprehensive smoking cessation

interventions

Behavior modification therapy, nicotine

replacement therapy, and/or bupropion

Hirsch AT, Haskal ZJ, Hertzer NR, et al. Available at http://www.acc.org/clinical/guidelines/pad/summary.pdf.

2015 SVS Guidelines for the

Management of Peripheral

Arterial Disease

Treatment for Claudication

Claudication Treatment: Exercise

Supervised exercise training should be

the initial treatment

30-45 minute sessions

3 or more times per week

At least 12 weeks

Value of unsupervised exercise programs

is not well established

Hirsch AT, Haskal ZJ, Hertzer NR, et al. Available at http://www.acc.org/clinical/guidelines/pad/summary.pdf. Accessed December 13, 2005.

Claudication Treatment:

Endovascular or Surgical Therapies

Indicated only for patients with

Vocational or lifestyle-limiting disability;

Reasonable likelihood of symptomatic improvement;

Prior failure of exercise therapy or pharmacological therapy; and

Favorable risk-benefit ratio

Not indicated as a prophylactic treatment for asymptomatic patients

1A Optimal Medical Management postintervention (Smoking cessation, ASA, Statin, glycemic and HTN control)

Hirsch AT, Haskal ZJ, Hertzer NR, et al. Available at http://www.acc.org/clinical/guidelines/pad/summary.pdf. Accessed December 13, 2005.

PAD Indications for Intervention

Persistent, lifestyle limiting claudication

despite maximal medical therapy

Rest pain

Nonhealing ulcer

Gangrene

Case: Belinda B

Belinda is a 70 year old who presents with

intermittent, reproducible bilateral calf pain

at 3 blocks (5-10 minutes). Symptoms have

been present for approximately 6 months.

She denies pain in her toes or feet at night

There has been no tissue loss

She has had no prior vascular interventions

Case: Belinda B

What is your next action?

A. Order a CT Angiogram

B. Refer for conventional angiogram +/-

angioplasty

C. Start ASA, statin, and a walking program

D. Do an ABI in the office

Case: Clive C

78 year old man brought to clinic by his daughters, who describe progressive loss of mobility. At camp last summer, Clive could walk for at least 30 min, but now complains of severe pain in his left calf when walking to the mailbox (100m) and left foot pain that wakes him at night.

PMHx: CAD with stents 10 yrs ago, HTN, ex-smoker. Not taking any medication. No prior leg-related complaints.

On examination of the left leg he has dependent rubor without tissue loss in the left foot and no palpable pulses in either groin or the distal left leg.

Case 3: Clive C

Case: Clive C

Initial management options:

A. Give him a prescription for aspirin and tell

him to walk it out -- reassess in a few

months

B. Start aspirin, a statin and an ACE Inhibitor

and arrange an outpatient CT angiogram

C. Admit him to hospital and continue the

workup as an inpatient

D. Start a heparin infusion and take him to

the OR

Chronic Peripheral Arterial

Insufficiency

Clinical Ankle Brachial

Index

Normal ABI is 1.0

intermittent

claudication <0.7

rest pain <0.5

tissue loss

ulcers, gangrene <0.3

Rubor

Tissue

Loss

Major Tissue Loss

Selection of Treatment

Acute or Chronic?

Critical/Limb-threatening?

Level, extent and severity of

lesion(s)

Surgical Revascularization for

Peripheral Arterial Disease

Endarterectomy

Bypass

anatomic

extra-anatomic

autogenous (vein) or non-

autogenous graft (Dacron, PTFE)

Peripheral Arterial Disease

Endovascular Treatment

Endovascular:

Angioplasty –

transluminal

subintimal

Stent

Other

(Atherectomy, Cryoplasty)

Superficial Femoral Artery Occlusion

Superficial

Femoral

Artery

Angioplasty

Stent Deployment

://www.youtube.com/watch?v=xRwI

R7XUnvs

Surgical Bypass

Open

Anatomic

Bypass with

Saphenous

Vein Graft

Popliteal-popliteal

bypass with

saphenous vein graft

Femoral Endarterectomy

Postintervention Surveillance

2C Clinical surveillance program to

include interval history, ABI, Duplex

scanning (for vein grafts), and

1C prophylactic reintervention for graft

stenosis to promote long-term bypass

patency

Case: Clive C

78 year old man with dependent rubor, left foot

pain at night and no pulses in the groins or left

leg.

A. Give him a prescription for aspirin and tell him

to walk it out -- reassess in a few months

B. Start aspirin, a statin and an ACE Inhibitor and

arrange an outpatient CT angiogram

C. Admit him to hospital and continue the workup

D. Start a heparin infusion and take him to the OR

Management of Peripheral Arterial

Disease -- Summary

Asymptomatic: CV Risk Factor Management

Claudication:

CV RF Mgt + Walking Program

Consider Revascularization if disabling

Critical Limb Ischemia:

CV Risk Factor Management +

Revascularization

Wound Healing after

Revascularization

Ischemia and Diabetes

Risk Factor Management:

Diabetes Therapies

Encourage proper foot care

Appropriate footwear, chiropody/podiatric medicine, daily foot inspection, skin cleansing, and topical moisturizing creams

Urgently address skin lesions and ulcerations

Target HbA1C<7% to reduce microvascular complications and potentially improve cardiovascular outcomes

Hirsch AT, Haskal ZJ, Hertzer NR, et al. Available at http://www.acc.org/clinical/guidelines/pad/summary.pdf. Accessed December 13, 2005.

Diabetic Foot Ulcer/Infection

NEUROPATHY + ISCHEMIA = INFECTION

20-40% of healthcare resources spent on diabetes are related to diabetic feet

7-10% annual incidence ulcer formation if NO confounders

25-30% annual incidence if PAD, Charcot foot, prior ulcers or amputation

Diabetic Foot Ulcer/Infection

5-8% of patients with new ulcers require major amputation within a year

Ischemia should be considered as a cause of DFU unless proven absent

Neuroischemic and ischemic lesions should be considered together as both may require revascularization

Diabetic Foot Ulcer/Infection

As intermittent claudication and rest pain are reported far less commonly in diabetics with ischemia compared to non-diabetics;

early non-invasive vascular evaluation (ABI) recommended for patients with poor ulcer healing and a high risk for amputation;

IWG for the Diabetic Foot recommends vascular studies if the DFU has not healed in 6 weeks even if initial diagnostics suggest only mild disease

Diabetic Foot Ulcer/Infection

2B Surgical intervention for moderate or severe infections is likely to decrease the risk of major amputation

2B open, endovascular or hybrid methods should be chosen depending on patient comorbidities, anatomy of the arterial lesion(s) and expertise of the centre

1A Negative-pressure wound therapy appears to be as, or more, effective than other local wound treatments in patients without significant infection

Summary: Peripheral Arterial

Disease

Chronic Limb Ischemia: clinical presentation,

risk factors, medical, surgical and endovascular

management

Guidelines for care of Diabetic Foot Ulcers

Acute Limb Ischemia: clinical presentation and

treatment

Barriers to Practice Change

Discussion

What is the most prevalent barrier

to change that you see in your

practice?

What can vascular surgery do to

mitigate this barrier?

Rapid Access to Vascular Evaluation

RAVE clinic weekly at TBRHSC

we intend to expand clinic frequency,

resources

Rapid referral and assessment for patients

with tissue loss and suspected vascular

disease

No imaging required – we will arrange

Fax referrals to 1-888-504-1696 (office)

References

Cronenwett and Johnston (2012). Rutherford’s Vascular Surgery 7th ed, Elsevier, Philadelphia PA

Dormandy JA, et al. J Vasc Surg. 2000;31:S1-S296.

Fowkes FG, et al. Int J Epidemiol. 1991;20:384-392.

Hirsch AT, Haskal ZJ, Hertzer NR, et al. Available at http://www.acc.org/clinical/guidelines/pad/summary.pdf.

Newman AB, et al. Circulation. 1993;88:837-845

Norgren et al., (2007). Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC

II). JVS 45:1(S) 1A-65A.

Pomposelli et al Society for Vascular Surgery Clinical Guidelines for Management of Peripheral Arterial

Insufficiency JVS 66:3(S) Dec 2015

Schneider, PA (2009). Endovascular Skills: Guidewire and catheter skills for endovascular surgery 3rd ed

Informa, New York NY.

Zarins and Gewertz (2005). Atlas of Vascular Surgery 2nd ed, Elsevier, Philadelphia PA

Questions?

Acute limb ischemia

Case: Eric E

58 year old man presents to ED with 4

hours of right foot pain which woke him

from sleep. The foot is pale, with no

palpable pulses or Doppler signal.

He now also has motor weakness at the

ankle and toes, and numbness from the

mid-shin down to the toes.

He is a 1 PPD smoker with hypertension.

He is otherwise healthy and has had no

previous problems with either leg.

Case: Eric E

Initial management options:

A. Give the patient aspirin and get him to

walk it out -- reassess in an hour

B. Start a heparin infusion and obtain a CT

scan

C. Start a heparin infusion and obtain an

urgent conventional angiogram

(diagnostic, possibly therapeutic)

D. Start a heparin infusion and take the

patient to the Operating Room

Causes of

Acute Limb Ischemia

Acute limb ischemia is usually embolic -- a

blood clot forms elsewhere in the body

and travels to the limb

Most (85%) emboli come from the heart;

the remainder originate in proximal

arteries (especially if these arteries are

aneurysmal)

Non embolic causes: thrombosis,

dissection, trauma (including iatrogenic)

Cardiac Embolization

Acute limb ischemia – like a stroke, but for your leg

Clinical Presentation of Acute

Limb Ischemia

Acute limb ischemia:

pain, progressive loss of motor and

sensory function, diminished or absent

pulses

Clinical examination +/- imaging localize

the level of occlusion

Acute occlusion of a major artery is not

well tolerated as there is little collateral

flow, and the tissues will not typically

survive longer than 4-6 hours

Clinical Presentation of

Acute Limb Ischemia

Rutherford Classification

Sensory Motor Doppler

Arterial Venous

I Normal Normal Normal Audible

IIa Toes only/ Normal Diminished Audible

No change

IIb Pain/ Weak Poor/no Audible

sens loss

III Pain/ No/Rigor None None

insensate

Acute Limb Ischemia --

Treatment

1. Embolectomy

2. Thrombolysis

IF the limb is viable, heparin infusion and catheter-directed TPA

may be appropriate

Femoral Embolectomy for Acute

Limb Ischemia

Incision and exposure

Proximal and distal control

Transverse arteriotomy

Embolectomy with

Fogarty catheter of

1-3 vessels

On-table angio if poor result

Closure

http://youtu.be/QBSGFf4YSFk

Acute Ischemia: Embolus

Pre and Post Embolectomy

Case: Eric E

58 year old man presents acutely to ED with a pale,

pulseless right foot, with progressive sensory and

motor changes

A. Give the patient aspirin and get him to walk it out -

- reassess in an hour

B. Start a heparin infusion and obtain a CT scan

C. Start a heparin infusion and obtain an angiogram

D. Start a heparin infusion and take the patient to the

Operating Room

Classification of Recommendations

Class I: Evidence and/or general agreement that

procedure or treatment is beneficial, useful, and

effective

Class II: Conflicting evidence and/or divergence

of opinion about usefulness or efficacy of a

procedure or treatment

Class IIa: Weight of evidence or opinion favors

usefulness or efficacy

Class IIb: Usefulness or efficacy is less well

established by evidence or opinion

Class III: Evidence and/or general agreement that

procedure is not useful or effective and in some

cases may be harmful Hirsch AT, Haskal ZJ, Hertzer NR, et al. Available at http://www.acc.org/clinical/guidelines/pad/summary.pdf. Accessed December 13, 2005.

Classification of Recommendations

Class I: Evidence and/or general agreement that

procedure or treatment is beneficial, useful, and

effective

Class II: Conflicting evidence and/or divergence

of opinion about usefulness or efficacy of a

procedure or treatment

Class IIa: Weight of evidence or opinion favors

usefulness or efficacy

Class IIb: Usefulness or efficacy is less well

established by evidence or opinion

Class III: Evidence and/or general agreement that

procedure is not useful or effective and in some

cases may be harmful Hirsch AT, Haskal ZJ, Hertzer NR, et al. Available at http://www.acc.org/clinical/guidelines/pad/summary.pdf. Accessed December 13, 2005.

Peripheral Arterial Disease

Aneurysms

Rupture, thrombosis, embolization or mass

effect

Risk of rupture increases with size of

aneurysm

Treatment involves exclusion of the entire

aneurysm sac with preservation of vascular

supply to branch vessels and end organs

Aneurysm thrombus may embolize distally,

causing acute or chronic limb ischemia

Endovascular Complications Dissection: intimal tear +/- propagation, arterial occlusion

Perforation: 1-3%, tx usually conservative

Embolization: 3-5% distal embolization of which approx half is clinically significant. Anticoagulate early and minimize traversal of lesion(s)

Access Site:

Groin Hematoma

Retroperitoneal Hematoma

Pseudoaneurysm

AV Fistula

Axillary/Brachial Nerve Injury

Axillary/Brachial Thrombosis

Closure Device Complications

Ischemic

Infectious (EVAR 02-1.2% with 18-50% mortality)

Evidence Based Guidelines for

Management of PAD

ACC/AHA/TASC Guidelines for Treatment -- Class I

Evaluate and treat conditions known to increase risk for

primary amputation

Onset of acute limb symptoms in an at-risk patient should

be evaluated by a specialist in vascular disease

Specialized wound care for skin breakdown

Patients with CLI should be evaluated at least twice yearly

by a specialist in vascular disease

Evaluate patients with evidence of embolization for

aneurysmal disease

Hirsch et al 2005 Consensus Guidelines

Critical Limb Ischemia -- Evidence

Based Guidelines ACC/AHA/TASC Guidelines for Treatment -- Class I

Preop cardiac risk stratification prior to open repair

Prompt antibiotics in patients with skin ulceration or evidence of limb infection

Catheter-based thrombolysis for acute limb ischemia (class I or IIa) of less than 14 days duration

Address inflow lesion(s) first in combined disease, then revascularize outflow for persistent symptoms or infection

If there is uncertainty regarding inflow disease, measure intraarterial pressures before and after vasodilator administration

Hirsch et al 2005 Consensus Guidelines

Thrombolysis

Contraindications

Absolute – existing,very recent or high risk

hemorrhage

true allergy

ie. active internal bleeding,

recent (2 months) stroke, trauma or neurosurgery

known intracranial neoplasm

uncontrollable coagulopathy or hypertension,

known allergic reaction

Relative -- moderate risk for bleeding (recent biopsy, obstetric,

GI surgery or bleeding, trauma, endocarditis, pancreatitis);

severe renal or hepatic failure

Peripheral artery thrombolysis led to significant hemorrhage in 5.7%

(STILE) to 13% (TOPAS) of patients

Thrombolysis

Complications

Hemorrhagic -- local up to 25%, intracerebral 1-2%

Antigenic -less than 0.01% with TPA

Catheter-related -- up to 3%

Embolic -- distal limb 9 to 13%, of which most (75%+)

may be treated by advancing the catheter and

continuing the infusion

post DVT PE up to 10%, not all clinically significant

Thrombolytic Treatment of Critical

Limb Ischemia

Catheter-based thrombolysis is effective and beneficial for patients with Rutherford category I-IIa acute limb ischemia of less than 14 days’ duration

Mechanical thrombectomy can be used as an adjunctive therapy for acute limb ischemia

Catheter-based thrombolysis or thrombectomy may be considered for Rutherford category IIb acute limb ischemia of more than 14 days’ duration

Hirsch AT, Haskal ZJ, Hertzer NR, et al. Available at http://www.acc.org/clinical/guidelines/pad/summary.pdf. Accessed December 13, 2005.

Thrombolytic Treatment of Critical

Limb Ischemia

Catheter-based thrombolysis is effective and beneficial for patients with Rutherford category I-IIa acute limb ischemia of less than 14 days’ duration

Mechanical thrombectomy can be used as an adjunctive therapy for acute limb ischemia

Catheter-based thrombolysis or thrombectomy may be considered for Rutherford category IIb acute limb ischemia of more than 14 days’ duration

Hirsch AT, Haskal ZJ, Hertzer NR, et al. Available at http://www.acc.org/clinical/guidelines/pad/summary.pdf. Accessed December 13, 2005.

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