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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!
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