AMPUTATION AS A LAST RESORT– A Multidisciplinary Approach to Limb Salvage

George L. Adams, MD, MHS, FACC, FSCAI

Clinical Associate Professor of Medicine, University of

North Carolina Health System, Director of Cardiovascular

and Peripheral Vascular Research, Rex Healthcare,

Raleigh, North Carolina

Conflicts/Disclosures

Consultant/Advisory Board/Research Support/ Educational Services

Daiichi SankyoCook Medical

Cardiovascular Systems Inc.Cardiovascular Systems Inc.Lake Region Medical

SpectraneticsAbbott Vascular

TerumoClosys

Background

• Approximately 8 million Americans over the age of 40have PAD.

• PAD causes morbidity in the form of claudication (a• PAD causes morbidity in the form of claudication (apainful cramp in the muscles of the leg with exercise)

• At its worst, PAD results in failing to heal wounds andultimately amputation.

Am J of Prev Med. 2007;32:328-334.J Vasc Interv Radiol. 2002;13:7-11.

Clinical Presentations of PAD

~15%

Classic (Typical)Claudication

50%Asymptomatic

~33%

AtypicalLeg Pain

(functionally limited)

1%-2%Critical

Limb Ischemia

Fisher, Critical Limb Ischemia. Futura Publishing Company. Armonk, NY: 1999; 19-25Jaff, M. EVT. 2004;3:2

Complications of Amputation

Phantom Pain

5-80%

Stump Infection

Phantom Pain

DVT & PE

Up to 40% Stump Infection

10-30%

Non-healing

10-30%

Poor circulation

Up to 40%

Increases withhigher levels

Pneumonia

Flexion contracture

Renal insufficiency

Complications of Amputation

DeathMortality increases with the level of amputation

BKA: 3-10%AKA: 20%AKA: 20%

Dramatic increase above 70 years of age

2/3rds of deaths are cardiovascular complications Stroke and heart attack

Cardiovascular Risk Increases WithDecreases in Ankle-Brachial Index

CH

DE

ve

nt

Ou

tco

me

sp

er

Ye

ar

(%)

3

4

5-year risk:

5-year risk:19%

Framingham “High Risk” = 20% at 10 yearsEvery patient with PAD is at “very high risk”

3.8%

>1.1 1.1–1.01 1.0–0.91 0.9–0.71 <0.7

ABI

CH

DE

ve

nt

Ou

tco

me

sp

er

Ye

ar

(%)

0

1

2

35-year risk:

10%

PAD

2%

3.8%

1.4%

Leng GC, et al. Brit Med J. 1996;313:1440-44.

Peripheral Arterial Disease:All-Cause Mortality*

Asymptomatic PAD

100100

7575

5050

Pa

tie

nt

Su

rviv

al

(%)

Pa

tie

nt

Su

rviv

al

(%) ~40% 10-yr

mortalityNormal Subjects

Criqui MH et al.Criqui MH et al. N Engl J MedN Engl J Med. 1992;326:381. 1992;326:381

Asymptomatic PAD

Symptomatic PAD

Severe Symptomatic PAD

5050

2525

0000 22 44 66 88 1010 1212

Pa

tie

nt

Su

rviv

al

(%)

Pa

tie

nt

Su

rviv

al

(%)

Time (yr)Time (yr)*Majority of deaths dueto cardiovascular causes

~75% 10-yrmortality

Geographic Variation inLower-Extremity Amputation

Compared with National AverageJACC Vol.60, No 21, 2012

So how do we addressthese staggering statistics?

by…. WORKING TOGETHER

VascularSpecialist

Primary CareEndocrinology

Nephrology

Wound CareSpecialist

1990 2016

Specialist

The Importance of the Front Line

Patient and Physician Identification

• Many people mistake the symptoms of PAD forsomething else.

• PAD often goes undiagnosed by healthcare• PAD often goes undiagnosed by healthcareprofessionals.

Am J of Prev Med. 2007;32:328-334.

J Vasc Interv Radiol. 2002;13:7-11.

Diagnosis of Peripheral Arterial Disease

in High-Risk Patients• PARTNERS evaluated 6979 patients in physicians’ offices

• Possibility of PAD evaluated in– All patients >70 yr; mean (±SD) age: 70 (±10 yr)– Patients 50 -69 yr with history of diabetes and/or smoking

(at least 10 pack/yr)Only 49% of PAD patients physicians knew they

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

Patients diagnosed with PADPAD onlyPAD and cardiovascular disease

29%29%44%44%

56%56%

Only 49% of PAD patients physicians knew theyhad PAD

Advance AgeAdvance Age

• 40.3 MillionAmericans (13%)are age 65 andabove. This numberwill be more thandouble by 2050

Type I &Type IIType I &Type IIDiabetesDiabetes

• 10.9 MillionAmericans over theage of 65 (26.9%)have diabetes

• Diabetes is

Kidney DiseaseKidney Disease

• 26 MillionAmericans haveKidney Disease

• Diabetes is theleading cause ofdouble by 2050 • Diabetes is

America’s fastestgrowing healthproblem

leading cause ofKidney Disease

12-14% of Americans w/PADU.S. Census Bureau, 20102011 National Diabetes Fact Sheet Found onAmerican Diabetes Association Website Searched on 27 Sept, 2012Diabetes Fact Sheet from American Diabetes AssociationAmerican Kidney Fund Website: News Release 27 Sept, 2012

Elderly

Rotterdam Study (ABI <0.9)1 San Diego Study (PAD by noninvasive tests)2

40

50

60

Pa

tie

nts

With

PA

D(%

)

Prevalence of PAD Increases With Age

Meijer WT, et al. Arterioscler Thromb Vasc Biol. 1998;18:185-192.Criqui MH, et al. Circulation. 1985;71:510-515.

0

10

20

30

Pa

tie

nts

With

PA

D(%

)

55-59 60-64 65-69 70-74 75-79 80-84 85-89

Age (years)ABI=ankle-brachial index

Endovascular Complications Related to Age

Dick et al. J Endovasc Ther 2008;15:383-89.

Treatment Hampered in the ElderlyFocus:

Reducing symptoms and preventing furtherprogression

of disease.

Regular physical activity:

Start slow – simple walking regimens, legexercises and treadmill exercise programs threetimes a week.

Diet:

Low in saturated fat, trans fat and cholesterol.

Diabetes

Diabetes Increases the Risk of PAD

22.4*19.9*

12.515

20

25

Pre

vale

nce

of

PA

D(%

)

0

5

10

Normal GlucoseTolerance

Impaired GlucoseTolerance

Diabetes

Pre

vale

nce

of

PA

D(%

)

Lee AJ, et al. Br J Haematol 1999;105:648-654.

Impaired glucose tolerance was defined as oral glucose tolerance test value ≥140 mg/dL but <200 mg/dL.*P.05 vs. normal glucose tolerance.

Diagnosed Diabetes in the US: 2008CDC BRFSS: Self-Reported Diabetes: 8.2% Nationwide

http://apps.nccd.cdc.gov/brfss/list.asp?cat=DB&yr=2008&qkey=1363&state=Allhttp://apps.nccd.cdc.gov/brfss/list.asp?cat=DB&yr=2008&qkey=1363&state=All

4 – 6% 6 – 8% 8 – 10% 10 – 12%

25.039.759%

38.244.216%

13.6

81.8156.191%

18.2

Global Projections For The Diabetes Epidemic: 2003-

2025 (millions)

10.419.788%

1.11.7

59%

13.626.998%

WorldWorld2003 = 189 million2003 = 189 million2025 = 324 million2025 = 324 million

Increase 72%Increase 72%

91%18.235.997%

Diagnosed Cardiovascular Disease (CVD) and Total Mortality:U.S. Men and Women Ages 30-74

***

***

***

(Risk-factor adjusted Cox regression) NHANES II Follow-Up (n=6255)

* p<.05, ** p<.01, **** p<.0001 compared to none

*

***

**

***

***

***

***

***

Malik and Wong, et al., Circulation 2004; 110: 1245-1250.

***

Kidney Disease

Biancari F, et al. Scandanavian J of Surg 2012; 101:138-43

Overall Survival in Patients with Renal Diseases/p Infrainguinal Endovascular Intervention

Biancari F, et al. Scandanavian J of Surg 2012; 101:138-43

Who are the Vascular Specialists and

Why are They Important?Why are They Important?

VascularSurgery

Radiology

Cardiology

1990 2016

Surgery

For Healing to Happen,the Pipes Must be Open!

Angiosomes of the Body

Angiosome Concept: Introduced byTaylor and Palmer in 1987 which divides

Taylor I, PRS 89:181, 1991

Taylor and Palmer in 1987 which dividesthe body into 3-dimensional vascularterritories supplied by specific sourcearteries and drained by specific veins.

Angiosomes of Source Arteries (Lower leg)

Anterior Tibial Artery (anterior/lateral)

Taylor I, PRS 89(2):181-215,1992

Anterior Tibial Artery (anterior/lateral) Posterior Tibial Artery (medial) Peroneal Artery (posterior)

Angiosomes of Source Arteries (Foot)

Iida O, et al. EVT. Sept 2010; 96-100.

Outflow Impacts Patency and Limb SalvageLimb Salvage is Better with Good Outflow

5 Years Post-Endovascular Intervention(N=361 limbs)

(SVS Modification Runoff Score)Gallino, Circulation, 70; 619-624, 1984

Davies, JVS, 48:3; 619-626, 2008

Angiographic Considerations

Vessel Size and disease length

Calcification and location in respect to ostium

Ability to tolerate antiplatelet therapy

Important Collaterals Important Collaterals

Renal function

Runoff status

Access sites possible

Patency duration requirement

Arterial Vasculature of the Lower Leg“Think Outside the Box”

Options in Limb Revascularization

Endovascular reconstruction options Percutaneous transluminal angioplasty (PTA) Atherectomy Stents Stents

Surgical reconstruction options Aortoiliac/aortofemoral reconstruction Femoropopliteal bypass (above knee and below knee) Femorotibial bypass Endarterectomy

Endovascular Treatment

Balloon

Laser

Stent

Silverhawk

Diamondback 360

Two Major Goals in TreatingPatients with PAD

Limb outcomes

– Improved ability to walk

Cardiovascular Morbidityand Mortality Outcomes

– Prevention of progressionto CLI and amputation

• -Increase in peak walking distance

• -Improvement in quality of life

Decrease in morbidity fromnon-fatal MI and stroke

Decrease in cardiovascularmortality from fatal MI andstroke

PAD Treatment

• Focus: Reducing symptoms andpreventing further progression of disease.• Regular physical activity: Start slow – simple walking regimens,• Regular physical activity: Start slow – simple walking regimens,

leg exercises and treadmill exercise programs three times aweek.

• Diet: Low in saturated fat, trans fat and cholesterol.• Smoking Cessation: 4x risk of PAD than nonsmokers.

Medical Treatment

• Medications:• High blood pressure medications (ACE-Inhibitors)

• High cholesterol medications (statins)

• Cilostazol and pentoxifylline

• Antiplatelet medications (aspirin & clopidogrel)

Pharmacotherapy for Critical Limb Ischemia

There are currently no Class I or IIarecommended medical treatments for CLI torecommended medical treatments for CLI toimprove limb outcomes (e.g., improvewound healing or amputation prevention)

Trends in Endovascular and Bypass Surgery

Goodney et al; J Vasc Surg 2009: 50;54-60.

What is the Role of the Wound Care Clinic?

To Help Heal the Wound

How Diabetes Affects Wound Healing

• Blood Circulation• Microvascular disease: decreased blood flow and oxygen to the wound

• Neuropathy• Loss of sensation: inability to feel a blister, infection or surgical wound

problem

• Immune System Deficiency• Ineffective immune cells

• Higher Risk of Infection

Debride = Getting to the ‘Good Stuff’

Cut Here!

Debride = (Fr).’To release or set free’HyperkeratoticTissue

Debride = (Fr).’To release or set free’

Tomic-Canic, Ayello, Stojadinovic et al (2008)ASWC 2008

Dressings: What Do We Know?

One Size DOESN’T Fit All…

• Selection is based on-

– Wound requirements (i.e. moisture content)– Wound requirements (i.e. moisture content)

– Patient requirements (usage frequency/ cost)

• Think Property-- not Product(or Brand Name!)

Question:What is Our Goal?

Answer: A Clean, Moist Wound Bed

Foot Infection

• What do we KNOW?

– Recognition is Critical, but challenging…

CriticalCriticalColonization?

Pain

Pus

Erythema

Systemic Illness

Diabetic Foot Infections

What We Don’t Know

• Diagnosis: NO definitive consensus– Only 3 studies suitable for review

– Deep tissue cultures most likely of benefit– Deep tissue cultures most likely of benefit

• Antibiotic selection: NO definitive consensus– Only 23 studies identified (5 with oral agents)

– Evidence too weak for specific drug recommendations or durationof therapy

O’Meara et al. Diabetic Med 2006;23:341Nelson et al. Diabetic Med 2006;23:348

Hyperbaric Oxygen Therapy (HBO)

HBO

• Accelerate the rate of healing

• Reduce amputation rates

• Increase the number of wounds that are completelyhealed at long term follow-up

• HBO therapy is an adjuvant treatment and can beused at any stage of the wound care process.

Faglia E, et al. Diabetes Care. 1996;19:1338-43.

Critical Limb Ischemia - Decision Tree

Wound CareVascular

Medical Therapy

Angiosome

Gardner S, et al. EVT 2011

Angiography

EndovascularTherapy

SurgicalTherapy

HBO Therapy

Amputation

Thank You!