Limb Salvage in Diabetics
My Background
•Internship, Sinai Hospital
•Residency, University of Arizona
•Nephrology Fellowship, University of
Arizona
•Cardiology Fellowship, UC Davis
•Interventional Cardiology Fellowship, CIS
•Vascular Intervention Fellowship, CIS
Coronado Vein Center, Redding CA
My Background
• Director, Peripheral & Interventional Cardiology,
DMC, Modesto, CA
• Past Director and Chief of Cardiology, SRMC
• Founder and President, NHVI
• Founder and President, Coronado Vein Center
• Vice President and Co-founder of The American
Society of Cardiovascular Phlebology
Coronado Vein Center, Redding CA
Magnitude of the Problem
• Somewhere in the world, a leg is lost to diabetes
every 30 seconds
• Leading cause of new onset blindness
• 10% to 20% of people with diabetes died of renal
failure
• Diabetes of the leading cause of end-stage renal
disease requiring dialysis
• Every 10 seconds person dies from diabetesrelated causes
Coronado Vein Center, Redding CA
Therapeutic Failures in Diabetes
•When the patient reaches end-stage renal
failure
•When the patient becomes blind or severely
visually impaired
•When the patient suffers from MI or stroke
•When the patient had a leg or foot
amputated
Coronado Vein Center, Redding CA
Coronado Vein Center, Redding CA
US Prevalence of Major Diseases-2015
(in Millions)
Venous Reflux Disease
Diabetes
Peripheral Arterial Disease
Coronary Heart Disease
Cancer
Stroke
Alzheimers
0
Coronado Vein Center, Redding CA
10
20
30
40
Manifestations of Atherosclerosis
Transient ischemic attack
Ischemic stroke
Stable angina pectoris
Non-Q wave myocardial infarction
Q wave myocardial infarction
Ischemic
Sudden Death
Claudication
Critical limb ischemia, rest pain, gangrene, amputation
Coronado Vein Center, Redding CA
Diabetes and the CV System
• Accelerates Atherosclerosis 200-400%
• Results in 2-4 times the risk of coronary artery ischemic
events
• Results in 4 times the risk of stroke
• CV risk equivalent to 3 non-diabetic risk factors
• PAD 11 times more prevalent
• PAD develops a decade earlier
Coronado Vein Center, Redding CA
Risk factors for Microvascular
Complications
• Degree of glycemic control
• Duration of disease
• Hypertension
• Dyslipidemia
• Smoking
Coronado Vein Center, Redding CA
UKPDS Results of Intensive Therapy
Risk Reduction vs. Conventional Therapy
Any diabetesrelated endpoint
Micro-vascular
complications
0%
5%
10%
15%
20%
25%
30%
35%
40%
Coronado Vein Center, Redding CA
Retinopathy
progression (12y) Micro-albuminuria
MI
Diabetes-related
death
All-cause
mortality
Risk Factors for Atherosclerosis
Age
Diabetes
Dyslipidemia
Hyperhomocystinemia
Genetics
Coronado Vein Center, Redding CA
Atherosclerosis
Hypertension
Smoking
Obesity
PAD Natural History
Population >55 y
Peripheral Arterial
Outcomes
Stable
Claudication
(73%)
Worsening
Claudication
(16%)
Coronado Vein Center, Redding CA
Critical Leg
Ischemia
(10%)
Intermittent
Claudication (40%)
Asymptomatic
(50 %)
Leg Bypass
Surgery
(7%)
Cardiovascular
Morbidity/Mortality
Major
Amputation
(4%)
Nonfatal CV
Events
(MI/Stroke)
(20%)
Mortality
(20-30%)
Peripheral Arterial Disease
Relative 5-Year Mortality Rates
100
90
80
70
60
50
40
30
20
10
0
Breast Cancer
Coronado Vein Center, Redding CA
Hodgkin's Disease
PAD
Colon &Rectal Cancer
Lung Cancer
PAD Annual Economic Burden
$212-$389 BILLION
Coronado Vein Center, Redding CA
Source Mahoney 2008, Margolis J 2005 and Yost real cost.
2015 Annual Economic Burden*
(Billions $)
Cancer
CAD
Diabetes
PAD
$0
Coronado Vein Center, Redding CA
$100
$200
$300
$400
Source: Yost 2011, Mahoney 2008, Margolis 2005, ACS, ADA 2013 and THE SAGE GROUP.
PAD—Why Is Early Diagnosis
& Treatment Important?
• Costs ↑ w/ Disease Severity— IC Lowest, Amp Highest
Hospital Costs: 62%-87% of PAD Costs
• Hospitalizations ↑ w/ Disease Severity (IC 25% Amp 36%)
• 70% Have Polyvascular Disease—50% PAD + CAD
• CVD Costs Add Significantly—43% of Total Costs
• CVD Events ↑ w/ Disease Severity—AS 21% Amp 34%
Coronado Vein Center, Redding CA
Source: Yost PAD real cost 2011, Mahoney 2008, Mahoney 2010, Margolis 2005 and Gupta 1988.
Major Amputation
•25%-33% CLI patients undergo primary
amputation (PA)
•65,000-75,000 major amputations
performed annually
Coronado Vein Center, Redding CA
Source: Yost. EVT 2014, Henry 2011 and Baser.
CLI
Pathway To Amputation
•Frequently the first and only therapy for CLI
•51%-73% No Angiogram—Despite fact
•that angio the odds by 90%
•60%-71% No Revascularization
Coronado Vein Center, Redding CA
Source: Henry 2011, Allie 2005, Goodney 2012.
CLI Prevalence & Cost 2015
2-3 Million
400,000-700,000 Treated w/
Revascularization or Amputation-Major & Minor
Cost $40-$66 Billion
Coronado Vein Center, Redding CA
Source: Yost. CLI Vol I, Nehler 2014, Baser, HCUP Queries, Barshes 2012, Mahoney 2010,
Dillingham 2005 and THE SAGE GROUP estimates.
Clinical Signs of PAD
•Physical Examination
• BP Both Arms
• Pulses
• Ankle/brachial Index (ABI)
• Ulcers
Coronado Vein Center, Redding CA
Claudication:
The Functional Limitation of PAD
• Exertional aching pain, cramping, tightness, fatigue
• Occurs in muscle groups, not joints
• Reproducible from one day to the next (level of walking
ability consistent)
• Resolves completely within 2-3 minutes
• Occurs again at same distance once activity has been
resumed
Coronado Vein Center, Redding CA
UNRELIABLE Indicators of PAD
•Cold Hands and Feet
•Poor Hair Growth
•Poor Skin Condition
Coronado Vein Center, Redding CA
Ischemic Rest Pain
•Distinguish from neuropathy
•Asymmetrical symptoms
•Usually worse at night
•Relieved by dependency
•Deep tendon reflexes intact
•No sensory abnormalities
Coronado Vein Center, Redding CA
Ischemic Ulcers and Gangrene
•End Stage Peripheral Arterial Disease
•Frequently leads to amputation
•Morbidity and Mortality
•Too little, Too late
Coronado Vein Center, Redding CA
Diagnosis of PAD
• Vascular History
• Physical Examination
• Assess pulses
• Ankle-brachial Index Measurement
• Noninvasive vascular laboratory
• Arteriography
Coronado Vein Center, Redding CA
Arterial Physical Exam:
Lower Extremities
• Ascultate the abdomen for the presence of bruits
(systolic/diastolic)
• Palpate for the presence of an abdominal aortic aneurysm
• Palpate the femoral, popliteal, posterior tibial, and dorsalis
pedis pulses
• Inspect the feet for ulcers, fissures, calluses, tinea, tendonous
xanthomas, and evaluate overall skin care
Coronado Vein Center, Redding CA
Noninvasive Vascular Tests &
Subjective Questionnaires
• Pulse volume recordings
• Segmental pressure measurements
• Duplex ultrasonography
• Treadmill exercise testing
• Quality of life questionnaires (WIQ, SF36)
• Ankle-to-brachial pressure index
Coronado Vein Center, Redding CA
The Ankle-Brachial Index
ABI = Lower extremity systolic pressure
Brachial artery systolic pressure
• The Ankle-Brachial Index is 95% sensitive and 99% specific for PAD
• Both ankle and brachial systolic pressures can be taken using a hand-held
Doppler instrument
Normal
ABI
PAD
ABI
Rest pain/ulceration ABI
Coronado Vein Center, Redding CA
0.95-1.2
<0.90
<0.40
Non-Invasive Evaluation
Claudication Treadmill
• Quiescent lesions at rest with unremarkable ABI
• Performed on treadmill
• Pressures measured again, after 5 minutes at 1.5
mph
• ABI decreases if severe
Coronado Vein Center, Redding CA
Non-Invasive Evaluation
Duplex Imaging
• Can now provide direct anatomic and physiologic
information
• Determine length of occlusion
• Diagnose other abnormalities
Coronado Vein Center, Redding CA
Arteriography
• Perform only when considering a revascularization
intervention (surgery, PTA, stents, etc)
• Provides an anatomic assessment but not a
physiologic assessment
• Always assess inflow and outflow (aortogram with
runoffs)
Coronado Vein Center, Redding CA
Treatment of PAD
• Medical
• Surgical
• Interventional
Coronado Vein Center, Redding CA
Pad A Risk Factor Equivalent To CAD
• Costs ↑ w/ Disease Severity— IC Lowest, Amp Highest
Hospital Costs: 62%-87% of PAD Costs
• Hospitalizations ↑ w/ Disease Severity (IC 25% Amp 36%)
• 70% Have Polyvascular Disease—50% PAD + CAD
• CVD Costs Add Significantly—43% of Total Costs
• CVD Events ↑ w/ Disease Severity—AS 21% Amp 34%
Coronado Vein Center, Redding CA
Source: Yost PAD real cost 2011, Mahoney 2008, Mahoney 2010, Margolis 2005 and Gupta 1988.
PAD A Risk Factor Equivalent To CAD
Risk Factor Modification Therapy Underutilized
Antihypertensive
Antiplatelet
Antilipid
Coronado Vein Center, Redding CA
No Rx 12%-50%
No Rx 33%-70%
No Rx 44%-60%
Case Presentations
Case 1
• 61 y/o male with PMH CAD s/p CABG
• Hypercholesterolemia, HTN, diabetes, >50yrs of tobacco use
• Lower extremity “fatigue” and symptoms of claudication
• Previous coronary angio w/ significant iliac disease
• Angiogram revealed severe ostial common iliac disease
• ABI indicated severe arterial insufficiency
• Pt referred appropriately for PCI
Coronado Vein Center, Redding CA
Case 2
• 68 y/o caucasian female c/o inability to walk more than
half a city block
• PMH: HTN, CAD and diabetes
• PE: lack of pulses in LLE and pulses in RLE
• ABI revealed severe bilateral disease, worse on L
• Angiogram revealed mod-severe stenosis of proximal
right common iliac and severe stenosis of the distal right
common iliac. Left common iliac 100% occluded and
presumed to be chronic due to chronic stable symptoms.
Coronado Vein Center, Redding CA
Interventional Therapy
• Increased patient acceptance
• Decreased morbidity
• Decreased mortality
• Excellent long term patency rates depending on location
• Not widely available
• Now available from cardiology clinician
Coronado Vein Center, Redding CA
Coronado Vein Center, Redding CA
Chronic Venous
Insufficiency and
Varicose Veins
Coronado Vein Center, Redding CA
What we will not discuss:
•
•
•
•
•
DVT prophylaxis or its treatment
Pulmonary Embolus
Hypercoagulable states
Congenital Venous Malformations
Anticoagulation
Coronado Vein Center, Redding CA
Manifestations of Venous
Insufficiency
Varicose Veins
Swollen Legs
Photos courtesy of Rajabrata Sarkar, MD, PhD.
Coronado Vein Center, Redding CA
Skin Changes
Skin Ulcers
Coronado Vein Center, Redding CA
Pathophysiology of Venous
Insufficiency
Coronado Vein Center, Redding CA
25 Million people suffer from venous
reflux disease and varicose veins
Images courtesy of Paul McNeill, MD and Rajabrata Sarkar, MD
Risk Factors of Venous
Insufficiency
• Heredity
• Occupation
• Pregnancy
• Obesity
Coronado Vein Center, Redding CA
• Age
• Sedentary Lifestyle
• Diabetes
Symptoms and Findings of
Venous Insufficiency
• Edema
• Spider Veins
• Varicose Veins
• Skin Changes
Coronado Vein Center, Redding CA
• Ulcers
• Pain often described as
an ache, fatigue, or
heaviness
Symptoms and Findings of
Venous Insufficiency (cont’d)
•Nocturnal Cramps
•Restless Leg Sx
•Beware of the Pt w/ “Neuropathy” w/ these Sx
•No Diabetes or Other Risk Factors for
Neuropathy
Coronado Vein Center, Redding CA
Physical Exam
•Edema
•Varicose Veins
•Spider Veins
•Skin Discoloration
•Ulcers
Coronado Vein Center, Redding CA
Diagnosis
• Antegrade flow: Blood flow toward the heart
• Patency: Vessel is clear of obstruction and flow is present
• Compression: Vein wall collapses when pressure applied
over vein with transducer
• Occlusion: Complete closure of a vessel with no flow
present
• RETROGRADE FLOW: Blood flow away from the heart
Coronado Vein Center, Redding CA
Distal Augmentation
Normal valve closure
after augmentation
Coronado Vein Center, Redding CA
Abnormal valve
closure after
augmentation
Coronado Vein Center, Redding CA
• Detoxified by Liver
• Cleared or filtered by kidneys
• Oxygenated and CO2
removed by lungs
• Not cleared of dying
red/white blood cells by
spleen
Coronado Vein Center, Redding CA
Treatment Options
•Conservative/Medical Treatment
•Definitive
•Adjunctive
Coronado Vein Center, Redding CA
Surgical Intervention
•Archaic
•Barbaric
•Obsolete
Coronado Vein Center, Redding CA
Radiofrequency Ablation
Adjunctive Therapies
•Microphlebectomy
•Sclerotherapy
•Clinical and cosmetic applications
Coronado Vein Center, Redding CA
Thank you
Robert Coronado, MD, FACC
Coronado Vein Center, Redding CA