Surgical Management of Lower Limb Occlusive Arterial Disease

SURGICAL MANAGEMENT OF LOWER LIMB
OCCLUSIVE ARTERIAL DISEASE
Dr. Rajendra M
Dept. Of Surgical Disciplines

Definition
• Peripheral Artery Disease(PAD) is defined as chronic, atherosclerotic, occlusive
disease of the lower extremities.
• Peripheral – disease in the vascular beds other than the coronaries – upper limb,
lower limb, mesenteric, renal
• Arterial narrowing/occlusion impairing blood/oxygen/nutrient supply to the
target
• Acute/Chronic
• Acute – thrombotic/embolic
• Chronic – atherosclerotic syndrome
Rutherford's Vascular Surgery and Endovascular Therapy, 9th Edition, p1368

Epidemiology
• Recent epidemiologic projections – Prevalence of PAD – 11 to 16%
• 27 million affected in Europe and North America alone
• The reported prevalence depends on the selected population and methods of
testing (ABPI < 0.90).
• NHANES – 14.5% in >70yr, 4.3% in ~40yr
• Symptomatic : Asymptomatic = 1:3 to 1:4
• Male>Female in younger age groups, Male=Female in older age groups.
• Phys Med Rehabil Clin N Am 20 (2009) 627–656
• Circulation 2004;110:738–43.
• Hirsch A, Criqui M, Treat-Jacobson D, Regensteiner J, Creager M, Olin J, et al. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA
2001;286(11):1317-1324.

Epidemiology in India
• Prevalence rates of 2.7%, 2.9% and 6.3% in NGT, IGT and diabetics. Overall
prevalence of 3.2%
• In Type 2 DM – 4.8% vs 1.9% in non-diabetics
• Indian Asian men have less peripheral arterial disease than European men for
equivalent levels of coronary disease.
• Thromboangitis obliterans – among all patients of PAD – 45 to 63%
• Diabetes Care 23:1295–1300, 2000. Prevalence and Risk Factors of Peripheral Vascular Disease in a Selected South Indian Population
• The Chennai Urban Population Study -J Assoc Physicians of India. 2010 Jul;58:430-3
• Atherosclerosis. 2007 Jul;193(1):204-12.
• Epub 2006 Jul 24.
• Orphanet J Rare Dis. 2006 Apr 27;1:14

Risk Factors For PAD
• Most factors evidence is only for
an association
• Smoking, dyslipidemia – “true” risk
factors
• Risk may be conferred by metabolic
and circulatory abnormalities in
Diabetes
TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. J Am Coll Cardiol 2006;47(6):1239-312.
Risk Factors for PAD
Race
Gender
Age
Smoking
Diabetes Mellitus
Hypertension
Dyslipidemia
Inflammatory Markers
Hyper-viscosity and hypercoagulable states
Hyperhomocysteinemia
Chronic renal insufficiency

Race
• NHANES - non Hispanic Blacks (7.8% prevalence) > Whites (4.4%)
• MESA (Multi Ethnic Study of Atherosclerosis) : Blacks > Whites and Hispanics
• GENOA (Genetic Epidemiology Network of Arteriopathy) study- difference was
not explained by a difference in classical risk factors for atherosclerosis.
• Circulation 2004;110:738–43.
• Genetic Epidemiology Network of Arteriopathy (GENOA) study. Vasc Med 2003;8(4):237-242.

Gender & Age
• Prevalence of both asymptomatic and symptomatic PAD is higher in males
• Intermittent claudication (IC)– Males : Female = 1:1 to 2:1
• Critical limb ischemia – 3:1
• With advancing age, more equal distribution
• Age : increasing prevalence with increasing age.
• Incidence of major amputation increases with age.

Smoking
• Strongest risk factor for the development and progression of PAOD
• Association with PAOD is even stronger than Coronary artery disease
• Diagnosis of PAD is made a decade earlier in smokers
• Severity of PAD increases with number of cigarettes
• Smoking onset age <=16yrs – independent association with symptomatic PAOD
(OR : 2.19)
• Heavy smokers – fourfold increase in intermittent claudication
• J Vasc Surg 2002;35:506-9
• Surg Clin North Am 1998;78:409-29.

John A. Ambrose, and Rajat S. Barua J. Am. Coll. Cardiol. 2004;43;1731-1737

Diabetes Mellitus
• Intermittent claudication – twice more commoner among diabetics
• Every 1% increase in HbA1c – 26% increased risk of PAOD
• Insulin resistance – clustering of cardiometabolic risk factors
• Early large vessel involvement with symmetric neuropathy
• ADA recommends PAD screening with ABI every 5 years once in diabetics
-Meta-analysis: glycosylated hemoglobin and cardiovascular disease in diabetes mellitus. Ann Intern Med 2004;141(6):421-431.
-Relationship between HbA1c level and peripheral arterial disease. Diabetes Care 2005;28(8):1981-1987.

Hypertension & Dyslipidemia
• Hypertension: associated with all forms of cardiovascular diseases including PAOD
• Dyslipidemia: Framingham study – Fasting cholesterol >270mg%, doubling of IC.
• Total cholesterol/HDL – better predictor
• Hypertriglyceridemia – progression and systemic complications of PAOD
• Treatment of dyslipidemia reduces both progression and incidence of PAD
• Lipoprotein(a) – significant independent risk factor
JAMA 2001;285(19):2481-2485.

Other Risk Factors
• Inflammatory markers – CRP (strongest non lipid marker for risk: RR 2.8),
prostaglandin (F2 alpha)
• Hyperviscosity and hypercoagulability – Raised hematocrit, Fibrinogen levels
• Hyperhomocysteinemia -30% with PAOD (cf: 1% in general population). Stronger
risk factor than for CAD
• Chronic renal insufficiency
-Ridker PM, Stampfer MJ, Rifai N. Novel risk factors for systemic atherosclerosis: a comparison of C-reactive protein, fibrinogen, homocysteine,lipoprotein(a), and
standard cholesterol screening as predictors of peripheral arterial disease. JAMA 2001;285(19):2481-2485.
-J Am Soc Nephrol 2004;15(4):1046-101.

Fig. A2
Journal of Vascular Surgery 2007 45, S5-S67.
Risk Factors

Types of
Classifications
• Anatomic lesion
classification:
• GLASS classification
• TASC classification
• Bollinger score method
• Graziani morphologic
classification
• Symptom classification:
• Rutherford
• Fontaine
• WIfI

Fig 5.2
Journal of Vascular Surgery 2019 69, 3S-125S.e40DOI: (10.1016/j.jvs.2019.02.016)
Copyright © 2019 Society for Vascular Surgery and European Society for Vascular Surgery
Global Limb Anatomic Staging System (GLASS)
Femoro popliteal disease

Fig 5.2
Global Limb Anatomic
Staging System (GLASS)
Infra popliteal disease

Fig 5.3
Infra popliteal disease

Copyright © 2019 Society for Vascular Surgery and European Society for Vascular
Infra malleolar

Bollinger Scoring System
Location Occlusive pattern
Plaque < 25% Stenosis ≤ 50% Stenosis > 50%
Single 1 2 4
Multiple ≤ 50% segment 2 3 5
Multiple > 50% segment 3 4 6
Occlusions < 50% = 13
≥ 50% = 15
Follow-up: 2+ cm decrease = − 1; 2+ cm increase = +1
Note: Evaluate each Bollinger segment and score based on occlusions and stenoses. In the presence of
occlusions, plaques and stenoses are not considered. On follow-up examinations, if occlusion segment length
increases over 2 cm, it adds a point (e.g., occlusion initially receiving score of 13 would be graded as 14).
Occlusion segment decrease of 2 cm would subtract one point.
Hardman RL, Jazaeri O, Yi J, Smith M, Gupta R. Overview of classification systems in peripheral artery disease. Semin Intervent Radiol. 2014;31(4):378-388.
doi:10.1055/s-0034-1393976

Graziani Morphologic Classification
Class Angiographic finding
1 Isolated, one vessel tibial or peroneal artery obstruction
2a Isolated femoral/popliteal artery or two below knee arteries obstructed but with patency of one of
the two tibial arteries
2b Isolated femoral/popliteal artery or two below knee tibial arteries obstructed but with patency of the
peroneal artery
3 Isolated, one artery occluded and multiple stenosis of tibial/peroneal and/or femoral/popliteal
arteries
4 Two arteries occluded and multiple stenoses of tibial/peroneal and/or femoral/popliteal vessels
5 Occlusion of all tibial and peroneal arteries (below knee cross-sectional occlusion)
6 Three arteries occluded and multiple stenosis of tibial/peroneal and/or femoral/popliteal arteries
7 Multiple femoropopliteal obstructions with no visible below the knee arterial segments
doi:10.1055/s-0034-1393976
Notes: Anatomic classification of patients with diabetes with foot ulcers or gangrene. Increasing class is
associated with increasing disease severity.

Society for Vascular Surgery WIfI (wound,
ischemia, foot infection) classification
Wound
Grade Ulcer Gangrene
0 No ulcer No gangrene
1 Small, shallow ulcer on distal leg or foot; no exposed bone,
unless limited to distal phalanx
No gangrene
2 Deeper ulcer with exposed bone, joint, or tendon; generally
not involving the heel; shallow heel ulcer, without calcaneal
involvement
Gangrenous changes limited to digits
3 Extensive, deep ulcer involving forefoot and/or midfoot;
deep, full-thickness heel ulcer ± calcaneal involvement
Extensive gangrene involving the
forefoot/midfoot; full-thickness heel
necrosis ± calcaneal involvement
Abbreviations: ABI, ankle brachial index; PaCO2, partial pressure of carbon dioxide; SIRS, systemic inflammatory response syndrome; TcPO2,
transcutaneous oximetry; TP, toe pressure.
Notes: Patient's symptoms are graded by three categories: foot wound severity, tissue perfusion by ABI or transcutaneous oximetry, and the
presence of infection.
doi:10.1055/s-0034-1393976

Ischemia
Grade ABI Ankle systolic pressure TP, TcPO2
0 ≥ 0.80 > 100 mm Hg ≥ 60 mm Hg
1 0.6–0.79 70–100 mm Hg 40–59 mm Hg
2 0.4–0.59 50–70 mm Hg 30–39 mm Hg
3 ≤ 0.39 < 50 mm Hg < 30 mm Hg
Abbreviations: ABI, ankle brachial index; PaCO2, partial pressure of carbon dioxide; SIRS, systemic inflammatory response syndrome; TcPO2,
transcutaneous oximetry; TP, toe pressure.
Notes: Patient's symptoms are graded by three categories: foot wound severity, tissue perfusion by ABI or transcutaneous oximetry, and the
presence of infection.
doi:10.1055/s-0034-1393976

Infection
Grade Clinical manifestation of infection
0 No symptoms or signs of infection
Infection present, as defined by the presence of at least two of the following items:
• Local swelling or induration
• Erythema 0.5–2 cm around the ulcer
• Local tenderness or pain
• Local warmth
• Purulent discharge (thick, opaque to white, or sanguineous secretion)
1 Local infection involving only the skin and the subcutaneous tissue
Exclude other causes of an inflammatory response of the skin (trauma, gout, acute Charcot, fracture, thrombosis, venous stasis)
2 Local infection with erythema >2 cm, or involving structures deeper than skin and subcutaneous tissues, and no systemic
inflammatory response signs
3 No systemic inflammatory response signs
Local infection with the signs of SIRS, as manifested by two or more of the following:
• Temperature > 38 or < 36°C
• Heart rate > 90 beats/min
• Respiratory rate > 20 breaths/min or PaCO2 < 32 mm Hg
• White blood cell count > 12,000 or < 4,000 cu/mm or 10% immature bands
Abbreviations: ABI, ankle brachial index; PaCO2, partial pressure of carbon dioxide; SIRS, systemic inflammatory response syndrome; TcPO2, transcutaneous
oximetry; TP, toe pressure.
Notes: Patient's symptoms are graded by three categories: foot wound severity, tissue perfusion by ABI or transcutaneous oximetry, and the presence of
infection.
Hardman RL, Jazaeri O, Yi J, Smith M, Gupta R. Overview of classification systems in peripheral artery disease. Semin Intervent Radiol. 2014;31(4):378-388. doi:10.1055/s-0034-1393976

Clinical stages of major limb amputation risk
based on (WIfI) classification
Risk Of Amputation Proposed Clinical Stages WIfI Spectrum Score
Very low Stage 1 W0 I0 fI0,1, W0 I1 fI0, W1 I0 fI0,1, W1 I1 fI 0
Low Stage 2
W0 I0 fI2, W0 I1 fI1, W0 I2 fI0, Wo I3 fI0, W1 I0 fI2, W1
I1 fI1, W1 I2 fi0, W2 I0 fI0/1
Moderate Stage 3
W0 I0 fI3, W0 I2 fI1,2, W0 I3 fI1,2, W1 I0 fI3
W1 I1 fI2, W1 I2 fI1, W1 I3 fI0,1, W2 I0 fI2
W2 I 1 fI0,1, W2 I2 fi0, W3 I0 fi0,1
High Stage 4
W0 I1,2,3 fI3, W1 I1 fI3, W1 I2,3 fI2,3, W2 I0 fi3
W2 I1 fI2,3, W2 I2 fi1,2,3, W2 I3 fI0,1,2,3, W3 I0 fI2,3
W3 I1,2,3 fI0,1,2,3
J Vasc Surg. 2019 Jun;69(6S):3S-125S.e40. Global vascular guidelines on the management of chronic limb-threatening ischemia.

Classification of PAD
Fontaine’s
Stage Clinical
I Asymptomatic
IIa Mild claudication
IIb
Moderate-severe
claudication
III Ischemic rest pain
IV Ulceration/gangrene
Rutherford’s
Grade Category Clinical
0 0 Asymptomatic
I 1 Mild Claudication
I 2
Moderate
Claudication
I 3 Severe Claudication
II 4 Ischemic rest pain
III 5 Minor tissue loss
IV 6 Ulceration/gangrene
J Vasc Surg, 31, Dormandy JA, Rutherford RB, for the TransAtlantic Inter-Society Consensus (TASC) Working Group, Management of peripheral arterial disease (PAD),
S1–S296

History
• To elicit risk factors
• Characterisation of pain/tissue loss
• To identify significant comorbidities
• To incorporate these along with socioeconomic factors that will impact diagnostic and
therepeutic plan that will eventually affect QOL of the patient
Rutherford: Vascular Surgery, 6th ed

Vision : DM , intrinsic renal disease
Carotids
BP, PR – both arms
Lung, CVS
P/A: abdominal aortic aneurysm,
mass, pulsations
Anemia
Neurologic assessment
Skin, hair, nail changes
Ulcers
Calf/ankle edema

Physical Examination
• Palpation of peripheral pulses
• Palpated for sufficient length of time to know presence, strength and
character(upstroke, downstroke and thrills)
• Graded for simplicity – Grade 2 : normal , Grade 1 : diminished, Grade 0 : absent
• Auscultation – for bruits
• Patient with history/ examination s/o PAOD should undergo objective testing

Snippet
• Prevalence – 73% vs25% (diagonal
crease) , 80% vs 43% (anterior crease)
• Association as risk factor for
atherosclerosis – OR – 8.1(diagonal
crease) and 4.1(anterior crease)
Ramos PM, Gumieiro JH, Miot HA. Association between ear creases and peripheral arterial disease. Clinics.2010;65(12):1325-1327.

Initial hematologic evaluation of the
claudicant
CBC, including WBC’s and platelets
Fasting blood glucose
Serum creatinine
Fasting lipid profile
Fibrinogen level
Homocysteine levels
Urinalysis, ECG
Secondary evaluation based on clinical
suspicion
Thrombin/ Prothrombin time
aPTT
Protein S/C assays
Factor V Leiden assays
Lupus anticoagulant assays
Heparin induced platelet antibodies
Platelet adhesiveness/aggregability
Fibrinogen/plasminogen levels
Antithrombin activity
Anticardiolipin antibody assay
Modified from TASC Working Group: Management of peripheral arterial disease. J Vasc Surg 31(Pt 2):S59, 2000.

Biomarkers associated with PAD
Inflammatory cyokines : CRP, IL-6
Markers of endothelial dysfunction – ADMA, soluble cell adhesion molecules, vWF
Modulators of angiogenesis : soluble Tie2, VEGF, hepatocyte growth factor
Lipoproteins : oxidised LDL, lipoprotein (a)
Indicators of oxidative stress: homocysteine, 8-hydroxy-2-deoxy-2-deoxyguanosine,
isoprostanes
Coagulation factors: thrombomodulin , D-dimer, TPA, PAI-1,
fibrinogen
J Am Coll Cardiol 2010;55:2017–23)

Diagnostic evaluation of PAOD
• Ankle Brachial Pressure Index (ABPI), Toe pressure
• Non invasive physiological testing – segmental pressures, Pulse wave recordings
(PVR), TcPO2
• Duplex Ultrasound
• Computed Tomography Angiography(CTA)
• Magnetic Resonance Angiography (MRA)
• Contrast Arteriography

Ankle Brachial Pressure Index
• Most effective PAD screening tool.
• Patient supine for 5-10 minutes.
• Appropriate size cuff (10-12cm)
• Hand held Doppler (5 – 10 MHz) with acoustic gel/ automated.

Index leg – the one with the lower ABI

Modified ABI
• Low ankle pressure(LAP) instead of High ankle pressure (HAP) in the numerator
• N= 216, LAP had sensitivity of 0.89 and specificity of 0.93 (cf :0.68 and 0.99 for HAP)
• LAP is superior method – especially in epidemiological studies
J Vasc Surg 2006;44:531-6.

ABI benefits
Confirms diagnosis of PAD
Detects PAD in asymptomatic patients/
Screening tool
To differentiate leg symptoms due to other
etiology
Long term prognosis and risk stratification
ABI limitations
Non compressible vessels – falsely elevated
ABI – Diabetes, CKD, Medial calcification
Aortoiliac disease with collaterals – apparently
normal ABI
(ABI at rest followed by ABI after exercise –
treadmill at 3.2kmph at grade 10-12% until
claudication develops/5 minutes) – a decrease
of 15-20% is considered diagnostic or 6-minute
walk test in elderly.
TASC-IIWorking Group. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC-II). J Vasc Surg 2007;45(Suppl S):S5–67.

Resnick HE, et al. Circulation 2004;109(6):733-739.

• In the setting of non compressible ankle measurements (ankle
pressure >=250mmHg/ ABI > 1.40)
• Distal small vessels usually do not become non compressible
• Special small cuff with flow sensor
• Toe pressure is ~30mmHg lesser than ankle pressure and abnormal TBI is <0.70
• Limitation : preexisting ulcer/inflammation/tissue loss
Toe pressures and Toe brachial index

Non Invasive Physiologic Testing
• Segmental Limb Pressures(SLP) and Pulse Volume Recordings (PVR)
• SLP – segmental limb systolic pressures at thigh, calf and ankle;
location and severity of occlusive lesion is evident from pressure
gradients.
• PVR’s – using plethysmography (cuff inflated to ~65mmHg) – transient
volume change
• SLP and PVR used together – accuracy 95%
• Continuous wave Doppler tracings – alternate to PVR’s
Rutherford RB, Lowenstein DH, Klein MF. Combining segmental systolic pressures and plethysmography to diagnose arterial occlusive disease of the legs.Am J Surg
1979;138(2):211-218.

Colour assisted Duplex Ultrasonography
• Essential anatomic information and severity plus some functional
information (velocity gradients across stenosis)
• Useful tool for graft surveillance after
femoropopliteal/femorotibial bypass (venous graft)
• Limitations :
• Long time, operator dependent
• Proximal lesions (aortoiliac – limited accuracy)
• Diminished predictive value in surveillance of prosthetic grafts

Duplex Ultrasound
Velocity at level of stenosis / Velocity at normal proximal segment >= 2 is suggestive of stenosis >50%
Current Medicine, Inc.;2003. p. 47–79.

MRA
• Useful to asses anatomy and severity of PAD
• Also to select candidates for endovascular/surgical intervention (3D, helpful)
• Superior in visualisation of distant patent vessels
• CEMRA –sensitivity and specificity of >93%
• Parallel imaging methods, newer coils, higher spatial resolution –
improved abilty to image distal vessels
Koelemay MJ, Lijmer JG, Stoker J, et al: Magnetic resonance angiography for the evaluation of lower extremity arterial disease: A meta-analysis. JAMA 285:1338–1345,
2001

MRA - Limitations
• Tends to overestimate the degree of stenosis
• May be inaccurate in arteries treated with metal stents
• Cannot be used in patients with pacemakers, defibrillators,
intracranial metallic stents, clips, coils, and other devices and in
claustrophobia.

CT Angiography
• Being increasingly used to evaluate PAOD
• Multidetector Computed Tomography Angiography (MDCTA) –
widely adoped for initial diagnostic evaluation and treatment planning
• Enables fast imaging
• Sensitivity, specificity and accuracy – close to DSA
Jakobs TF, Wintersperger BJ, Becker CR. MDCT-imaging of peripheral arterial disease. Semin Ultrasound CT MR 2004;25(2):145-155.

J Vasc Interv Radiol 2006; 17:1915–1921

Eur Radiol. 2007 December; 17(12): 3208–3222.

DSA
• Arteriography – considered “gold standard”
• Definitive method for anatomic evaluation of PAD when revascularization is
planned.
• Diagnostic and therapeutic
• Invasive, 0.1% - reaction to contrast, 0.16% - mortality, 0.7% - serious
complication
• Distal vessels – difficult to visualize
• Multiple projections to visualize eccentric lesions
Bettmann MA, Heeren T, Greenfield A, et al: SCVIR contrast agent registry report. Radiology 203:611–620, 1997.

Typical Noninvasive Vascular Laboratory Tests
for Lower Extremity PAD Patients by Clinical
Presentation
Clinical Presentation Noninvasive Vascular Test
Asymptomatic lower extremity PAD ABI
Claudication
ABI, PVR, or segmental pressures
Duplex ultrasound
Exercise test with ABI to assess functional status
Possible pseudoclaudication Exercise test with ABI to assess functional status
Postoperative vein graft follow-up Duplex ultrasound
Femoral pseudoaneurysm; iliac or popliteal aneurysm Duplex ultrasound
Suspected aortic aneurysm; serial AAA follow-up Abdominal ultrasound, CTA or MRA
Candidate for revascularization Duplex ultrasound, MRA or CTA
Primary Cardiology, 2nd ed., Braunwald E, Goldman L, eds., “Recognition and management of peripheral arterial disease,” Hirsch AT, 659–71

Treatment of PAOD
General Principles:
• Identification and treatment of
underlying systemic atherosclerosis
• Improvement of the functional status
• Preservation of the limb
Steps:
1. Risk Factor Modification
2. Exercise rehabilitation
3. Pharmacotherapy
4. Endovascular Revascularization
5. Surgical

Cardiovascular Risk Reduction
• Lipid lowering drugs:
• Dietary modification + Statins
• LDL target <100mg/dl
• LDL < 70mg/dl (in high risk – multiple risk factors, poorly controlled risk
factors, metabolic syndrome, acute coronary syndromes)
• Fibric acid derivatives
-Lancet 2002;360:7–22
-Arterioscler Thromb Vasc Biol2004;24:e149–61

Hypertension
• Target BP:
• < 140/90 mmHg
• < 130/80 mmHg (diabetics and chronic renal disease)
• Beta adrenergic blockers are not contraindicated – do not adversely affect walking
capacity
• ACE inhibitors – in symptomatic PAD - reduce risk of cardiovascular events (HOPE
study)
- JACC Vol. 47, No. 6, 2006 Hirsch et al. 1303 March 21, 2006:1239–312
-Heart Outcomes Prevention Evaluation Study Investigators. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk
patients. N Engl J Med 2000;342:145–53.

Diabetes
• Aggressive treatment to prevent and reduce microvascular events
• HbA1c < 7%
• Proper foot care – footwear, foot inspection, skin cleansing, topical moisturizers
• Urgent treatment of skin lesions/ulcers
Standards of medical care for patients with diabetes mellitus. Diabetes Care 2003;26 Suppl 1:S33–50.

Smoking Cessation
• Cornerstone in the management of PAD
• Cigarettes/other forms of tobacco – to be stopped – to be impressed by EACH of
the treating clinician
• Comprehensive smoking cessation – behavior therapy, Nicotine replacement
therapy, Bupropion
• Physician advise + formal cessation program + Replacement therapy – 22%
cessation at 5 years (cf: 5% in the usual core group)
• Nicotine + bupropion - better
-JAMA 2003;290(1):86-97
-Ann Intern Med 2005;142(4):233-239.

Percent Abstinence For Bupropion SR,
Nicotine Replacement Or Both Vs Placebo
Jorenby DE, et al. N Engl J Med 1999;340(9):685-691.

Antiplatelet Drug Therapy
• To reduce risk of recurrent vascular events(viz. MI, stroke and vascular death)
• No improvement in claudication symptoms
• Antiplatelet Trialists’ Collaboration, a meta-analysis of 287 studies -23%
odds reduction
• Low dose Aspirin – 75mg to 325mg/day
• Clopidogrel – “effective alternative” – CAPRIE
• ASA + Clopidogrel – no evidence
• Other drugs – Picotamide, Ticlodipine
-BMJ 2002;324:71–86.
-J Am Coll Cardiol 2006;47:1239–312.

Exercise Therapy In IC
• Primary treatment: improves QOL and functional capacity
• Supervised exercise training: 30-45mins, 3 times a week, for 12 weeks
• Muscle metabolism, attenuates inflammation and favorably affects CV risk factors
• Role in asymptomatic PAD also.
• CLEVER and another Dutch study: Treatment groups equivalent in terms of QOL
and functional capacity at 12 months
-J Am Coll Cardiol 2006;47:1239–312.
– ACC/AHA guidelines.
- The Claudication: Exercise Vs. EndoluminalRevascularization (CLEVER) study: rationale and methods. J Vasc Surg2008;47(6):1356–63.

Pharmacotherapy for IC
1. Drugs with evidence of clinical utility in IC: Cilostazol, Naftidrofuryl
2. Drugs with supporting evidence: Carnitine and Propionyl-L-Carnitine, Statins
3. Drugs with insufficient evidence: Pentoxifylline, ASA, Clopidogrel, Vasodilators, L-
Arginine, 5HT antagonists, PG’s, Buflomedil, Defibrotide
4. Other agents: Vitamin e, chelation therapy, Omega-3 fatty acids, ginko-biloba

Cilostazol
• FDA approved in 1999 for PAD
• Exact mechanism in PAD not known
Cilostazol
PDE 3 inhibitor, AMPK activation
(cAMP ↑)
Peripheral vasodilation Decreased platelet aggregation Increased HDL, Decreased TG’s NF-kB: reduces inflammation

Cilostazol
• Cilostazol increases pain-free and maximal walking distance(WD) in PAD patients
by 40% to 60% in comparison to placebo.
• In addition – improves health related QOL
• 100mg BD > 50mg BD
• Side effects – headache, diarrhea, dizziness, palpitations. (metabolised by CYP3A4
and to a lesser extent, CYP2C19), Bleeding time – only marginally elevated.
• Contraindicated in heart failure.
• Also role in prevention of restenosis in endovascular stents
• Vasc Endovascular Surg 2002;36:83–91.
• Arch Intern Med 1999;159:2041–50.

Naftidrofuryl
• European countries
• 5HT 2 antagonist - muscle metabolism, RBC and platelet aggregation
• In meta analysis of five studies – 26% improvement in pain free WD
• 600mg/day
• Side effects minor : mostly gastrointestinal
• TASC-II). J Vasc Surg 2007;45(Suppl S):S5–67.
• J.Cardiovasc Pharmacol 1994;23 Suppl3:S48-S52.

Carnitine and Propionyl-L-Carnitine
• PAD -metabolic abnormalities –skeletal muscle
• These drugs - skeletal muscle oxidative metabolism
• In two multicenter trials (N=730 patients), initial and maximal treadmill walking
distance improved more with propionyl-L-carnitine than placebo
• Improved QOL, minimal side effects
• J Am Coll Cardiol 1999;34:1618-1624
• Am J Med 2001;110(8):616-622.

Lipid Lowering Drugs
• PAD - endothelial and metabolic abnormalities secondary to their atherosclerosis
• Statin drugs improve exercise performance
• Further studies – clinical benefit in disease progression and symptom relief
Am J Med 2003;114(5):359-364. 103. Girolami B, et al

Pentoxifylline
• Lowers fibrinogen levels, improves RBC and WBC deformability, lowers
blood viscosity
• Early trials were positive but later studies demonstrated that pentoxifylline was
no more effective than placebo (both WD and functional status)
• Several meta-analyses - modest increases in treadmill walking distance over
placebo, but the overall clinical benefits were questionable
• Does not have an extensive safety database.

Rivaroxaban
• Noval oral anticoagulant
• Oral factor Xa inhibitor
• VOYAGER PAD trial:
• In patients with PAD who had undergone lower extremity revascularization.
• Rivaroxaban @ 2.5 mg TD plus aspirin was associated with a significantly
lower incidence of the composite outcome of acute limb ischemia, major amputation
for vascular causes, myocardial infarction, ischemic stroke, or death from
cardiovascular causes than aspirin alone.
• Risk of major bleeding (5.94% and 4.06%; hazard ratio: 1.42; 95% CI, 1.10 to
1.84; P=0.007).

Vasodilators
• Arteriolar vasodilators were the first class of agents used to treat claudication.
• Alpha blockers, Papaverine, Beta2- agonists, CCB’s (nifedipine) and ACE inhibitors.
• No clinical efficacy in RCT’s
• “Steal phenomenon”
Vasc Med 2000;5(1):11-19.

Other Drugs
• L-Arginine : improve endothelial function, nutritional supplementation (pain free
WD)
• 5-Hydroxytryptamine antagonists : Ketanserin, AT-1015, Sarpogrelate: blood
viscosity, vasodilator and antiplatelet properties
• Prostaglandins: PGE1 (iv), oral beraprost
• Vasc Med 2006;11:75-83.
• Circulation 2000;102(4):426-431.
• J Am Coll Cardiol2003;41(10):1679-1686.

Stem Cell Therapy
• Newer techniques of re-
vascularization – to reduce
amputation and improve ulcer/rest
pain
Therapeutic Angiogenesis
Angiogenetic Cytokines
(vEGF, bFGF)
Protein (I.m./i.v.)
Bone Marrow Progenitor
Cells
Peripheral Mononuclear
Stem Cells
Gene Transfer
Virus Plasmid Vectors
Circulation. 2003;108:1933-1938.

• Encouraging results of preclinical studies have rapidly led to several trials
• Clinical benefits - improvement of ABI, TcPO2 pain, and decreased need for
amputation
• Nonetheless, large randomised, placebo-controlled, double-blind studies are
necessary and currently ongoing (BONMOT-CLI, JUVENTUS and NCT00498069)
• Further research -optimal cell type and dosage, the isolation method, the role of
colony-stimulating factors, administration route, and the supportive stimulation
of cells with reduced functioning due to advanced PAD
Stem Cell Therapy (Contd.)
Thromb Haemost. 2010 Apr;103(4):696-709. Epub 2010 Feb 19.

• Endovascular procedures
• Surgical
Revascularization

Revascularization
Indications:
1. Response to at least 3 months of exercise or pharmacologic therapies for
claudication has been inadequate
2. Lifestyle-limiting disability: vocational and activities of daily living
3. Vascular anatomy - suitability for intervention-a favorable risk to benefit ratio
4. Patient preference also plays a significant role
ACC/AHA guidelines J Am Coll Cardiol 2006;47:1239–312.

Risk of specific
intervention
Degree and durability
of improvement

Revascularization – General Principles
• Adequate inflow and appropriate outflow
• Location and morphology determine choice of procedure
• General outcome : Subjacent arterial tree, systemic disease and type of
procedure

Endovascular v/s Surgery – TASC classification
• Type A : Excellent results from endovascular
• Type B: Sufficiently good results from endovascular (unless open for other lesions
same area)
• Type C: Superior enough long term –open (endovascular only in high risk for
surgery)
• Type D: Surgery primary treatment
TASC-II). J Vasc Surg 2007;45(Suppl S):S5–67

TASC Classification
• In Type B and Type C lesions – Patient comorbidities, fully informed patient
preference and the surgeon/interventionalist’s long term success
• PAD – more than one lesion at more than one level

Type A:
• Unilateral or bilateral stenoses
of CIA
• Unilateral or bilateral single
short (<=3 cm) stenosis of EIA
TASC Classification For Aortoiliac Disease (Inflow)
Type B:
• Short (<= 3cm) stenosis of
infrarenal aorta
• Unilateral CIA occlusion
• Single or multiple stenosis totaling
3–10 cm involving the EIA not
extending into the CFA
• Unilateral EIA occlusion not
involving the origins of internal iliac
or CFA

TASC Classification For Aortoiliac Disease (Inflow)...
Type C:
• Bilateral CIA occlusions
• Bilateral EIA stenoses 3–10 cm long not extending into the CFA
• Unilateral EIA stenosis extending into the CFA
• Unilateral EIA occlusion that involves the origins of internal iliac and/or CFA
• Heavily calcified unilateral EIA occlusion with or without involvement of origins of internal
iliac and/or CFA

TASC Classification For Aortoiliac Disease (Inflow)...
Type D:
• Infra-renal aortoiliac occlusion
• Diffuse disease involving the aorta and both iliac arteries requiring treatment
• Diffuse multiple stenoses involving the unilateral CIA,EIA and CFA
• Unilateral occlusions of both CIA and EIA
• Bilateral occlusions of EIA
• Iliac stenoses in patients with AAA requiring treatment and not amenable to endograft
placement or other lesions requiring open aortic or iliac surgery

TASC Classification For Femoropopliteal
Disease (Outflow)
• Type A:
• Single stenosis <=10 cm in length
• Single occlusion <=5 cm in length
• Type B:
• Multiple lesions (stenoses or occlusions),
each <=5cm
• Single stenosis or occlusion <=15 cm not
involving the infra geniculate popliteal
artery
• Single or multiple lesions in the absence
of continuous tibial vessels to improve
inflow for a distal bypass
• Heavily calcified occlusion <=5 cm
in length
• Single popliteal stenosis

TASC Classification For
Femoropopliteal Disease (outflow)...
Type C:
• Multiple stenoses or occlusions totaling >15
cm with or without heavy calcification
• Recurrent stenoses or occlusions that need
treatment after two endovascular
interventions
Type D:
• Chronic total occlusions of CFA
or SFA (>20 cm,involving the popliteal artery)
• Chronic total occlusion of popliteal artery and
proximal trifurcation vessels

Endovascular Revascularization
• Percutaneous transluminal balloon angioplasty (PTA) with or without
stent placement
• PTA provides in-line, autologous reconstruction at relatively low morbidity
in many clinical settings.
• Stents function by holding open an obstructed arterial segment and may be used
to supplement balloon angioplasty when necessary.

Factors Affecting Outcome of Endovascular Interventions for Chronic Lower Extremity Ischemia
1)Lesion Characteristics
Location of lesion
Stenosis versus occlusion
Lesion length
Multiple stenoses in same segment
2)Pattern of Vascular Disease
Multilevel occlusive disease
Runoff status
3)Patient Demographics
Gender
Diabetes
4)Clinical Situation
Indication for intervention
Recurrent stenosis
5)Intraprocedural Factors
Dissection or residual stenosis after percutaneous balloon angioplasty
Initial hemodynamic response

Standards for Description of the Lesion to Be Treated with Endovascular
Techniques
Location Aorta, common iliac, external iliac, superficial femoral, popliteal, tibioperoneal trunk, tibial
Type
Occlusion versus stenosis, diffuse versus focal, eccentric versus concentric, ulcerated versus
smooth, calcified versus noncalcified
Length <2 cm, 2–5 cm, >5–10 cm, >10 cm
Runoff
Aortoiliac procedures: good = SFA <50% stenosis, poor = SFA >50% stenosis or occluded
Infrainguinal procedures: good = 2–3 patent tibial arteries, poor = 0–1 patent tibial arteries
From Ahn SS, Rutherford RB, Becker GJ, et al: Reporting standards for lower extremity arterial endovascular procedures. J Vasc Surg 17:1103–1107, 1999.

Clinical Improvement After Percutaneous Interventions for Lower Extremity Ischemia
+3
Markedly
improved
No ischemic symptoms, and any foot lesions completely healed; ABI essentially “normalized” (increased to
>0.90)
+2
Moderately
improved
No open foot lesions; still symptomatic but only with exercise and improved by at least one category ;
ABI not normalized but increased by >0.10
+1
Minimally
improved
>0.10 increase in ABI, † but no categorical improvement, or vice versa (i.e., upward categorical shift without
an increase in ABI of >0.10)
0 No change No categorical shift and <0.10 change in ABI
−1 Mildly worse No categorical shift, but ABI decreased >0.10, or downward categorical shift with ABI decrease <0.10
−2
Moderately
worse
One category worse or unexpected minor amputation
−3
Markedly
worse
More than one category worse or unexpected major amputation
From Rutherford RB, Baker JD, Ernst C, et al: Recommended standards for reports dealing with lower extremity ischemia: Revised version. J Vasc Surg 26:517–538, 1997.

Results Of Endovascular Intervention
• The technical and initial clinical success of PTA of iliac stenoses exceeds 90%
• ~ 100% for focal iliac lesions.
• Recanalization of long segment iliac occlusions is 80 to 85% with or without
additional fibrinolysis (Hydrophilic guidewires, Subintimal angioplasty)
J Endovasc Ther 2004;11(3):274-280.

Estimated Success Rate Of Iliac Artery
Angioplasty From Weighted Averages
(Ranges) From Reports Of 2222 Limbs

Iliac PTA Versus Iliac Stent Placement: Results
Of A Meta-analysis
Radiology 204:87–96, 2004

Pooled Results of Femoral Popliteal
Dilatations

Right Iliac Artery Stenosis After PTA & Stenting

Dilatation Of The Atherosclerotic “Waist”
Schneider PA: Endovascular Skills. New York, Marcel Dekker, 2003, pp 201–216

Superficial Femoral Artery Balloon Angioplasty For Limb Salvage

Stents In Endovascular Intervention
• Treatment for acute postangioplasty dissection and residual stenosis, decreasing
the rate of initial failure.
• Expanded the variety of lesions that may be treated
• Long-term patency of iliac PTA for all types of lesions.
• The promise of further technologic development of stents (i.e., drug-eluting
stents, covered stents, various configurations and compositions) supports the
hope that contemporary results can be improved.

Hybrid procedure:
Endovascular
Intervention +
Surgery

Complications Of Endovascular Procedure
• Puncture site – Bleeding, False aneurysm, AVF – 4%
• Angioplasty site – thrombosis, rupture – 3.5%
• Distal vessel – dissection, embolization – 2.7%
• Systemic – renal failure, MI – 0.4%
• Consequence – Surgery (2%), limb loss (0.2%), mortality (0.2%)
Circulation 89:511–531, 2003

Endovascular Failure
• Acute failure: <30days of procedure
• Later failure: >30 days of procedure (usually due to recurrent stenosis)

Adjunct Devices
• Drug eluting stents – sirolimus, nitinol
• Stent grafts and covered stents
• Laser and atherectomy devices
• Endovascular brachytherapy (BT)with gamma emitting sources such as 192Ir
• Cardiovasc Interv. 2010;3:327-334.
• Circulation 2000;102(22):2694-2699.

Surgical Treatment Of Aorto Iliac Disease
• Aortobifemoral -“gold standard” for the treatment of aortoiliac occlusive disease
• Transperitoneal/ Retroperitoneal approach.
• Interest is increasing in laparoscopic approach.
• Configuration of the proximal anastomosis – not shown influence patency.
• PTFE vs Dacron – surgeon preference
• Younger patients (<50 years of age): lower primary and secondary patency -
greater need for secondary bypass
J Vasc Surg 2003;37:1219-1225.

Proximal – End To Side Preferred
Patent and
enlarged inferior
mesenteric artery
Low-lying
accessory renal
artery
Occlusive lesions
confined largely to
the external iliac
arteries
Reconstitution of
pelvic circulation
by collateral sources

General Principles
• Proximal – as high up in the infrarenal aorta
• Distal – at femoral level
• Establishment of good distal outflow (profundoplasty, formal endarterectomy)
• Assess intraoperative revascularisation

Patency Rates After Aorto Bifemoral Bypass
J Vasc Surg 2005;26(4):558-569

Extra-anatomic Bypass
• ‘Hostile abdomen’ or cardiac and/or pulmonary risks
• Axillo-uni-femoral/ Axillo-bi-femoral bypass
• Femorofemoral bypass
• Thoracic aorta – may also be the inflow vessel
• Patency of unilateral bypass can be supplemented by endovascular means.

Extra Anatomic Bypass
Cross over Femoro-
femoral bypass: Inverted
C configuration
Axillo-Bi-femoral
bypass

Patency Rates of Extra Anatomic Bypass
Grafts
TASC-II J Vasc Surg 2007;45(Suppl S):S5–67

Surgical Treatment Of Infrainguinal Occlusive
Disease
• Patent and uncompromised inflow artery (CFA/SFA/poplitealartery does not
correlate with patency)
• The quality of the outflow artery is a more important determinant of patency
than the actual level where the distal anastomosis is performed.
J Vasc Surg 2004;39:336-342

Patency Rates of Femoropopliteal Bypass
Grafts
TASC-II J Vasc Surg 2007;45(Suppl S):S5–67

Conduit In Infrainguinal Disease
• Vein has better long-term patency than prosthetic in the infra inguinal region
• Long saphenous vein - reversed /in situ configuration - best match of size and
quality.
• Contralateral long saphenous vein, short saphenous vein, femoral vein and arm
veins
J Vasc Surg 2003;37:1263-1269.

Vein Cuff Techniques
Rutherford's Vascular Surgery and Endovascular Therapy, 9th Edition, p1447

Types Of Conduit - Infrainguinal
Ann Vasc Surg 2003;17(5):486-491.

Cumulative Observed Morbidity Outcomes
For Bypass In Critical Limb Ischemia
Parameter Short term (1st year) Long term (3-5yr)
Mean time to pedal wound healing 15-20 weeks -
Incisional wound complications 15%-25% -
Persistent severe ipsilateral lymphedema 10%-20% Unknown
Graft stenosis 20% 20%-30%
Graft occlusion 10%-20% 20%-40%
Graft surveillance studies 100% 100%
Major amputation 5%-10% 10%-20%
Ischemic neuropathy Unknown Unknown
Graft infection 1%-3% -
Perioperative death (primarily cardiovascular) 1%-2% -
All death (primarily cardiovascular) 10% 30%-50%
J Vasc Surg 2005;37:1263-7

Antiplatelet & Anticoagulant Therapy
• Antiplatelet therapy – preoperatively & continue as adjunct. (prosthetic >
autogenous)
• Unless subsequently contraindicated, this should be continued indefinitely
• Warfarin may be added for autogenous grafts (monitored)
Eur J Vasc Endovasc Surg 2000;19:370-380.

Clinical Surveillance Program For Bypass
Grafts
• Interval history , Vascular examination, ABI
• Duplex scanning – vein grafts (if suspicion)
• Immediate postoperative period and at regular intervals (usually
every 6 months) for at least 2 years
Circulation 2005;112(13):1985-1991

Pain Management
• To improve function and QOL
• Regularly, than in demand
• Frequently require opioids
• Improved response by addition of antidepressants
• Lumbar sympathectomy

Lumbar Sympathectomy
Indications:
• Unreconstructable distal disease
• Cold feet and pain
• Non-healing ulcer
• Critical limb ischemia
• Avoid major amputation
• Vasospastic conditions
RCTs failed to identify objective benefits:
• Rest pain relieved in up to 60 – 75%
short term and 50% on the long term
• More response if :
• Distal vessel disease
• SBP not below 60mm
• ABPI > 0.3
• Patent femoral artery present
• Ann Surg. 1953 Nov;138(5):759-64. Lumbar sympathectomy for arteriosclerotic peripheral vascular disease. FRYMARK WB, SULLIVAN JM.
• Int J Surg. 2009 Apr;7(2):145-9. doi: 10.1016/j.ijsu.2009.01.004. Epub 2009 Jan 27. Lumbar chemical sympathectomy in peripheral vascular disease: does it still have a role?
Nesargikar PN1, Ajit MK, Eyers PS, Nichols BJ, Chester JF.
• Cochrane Database Syst Rev. 2016 Dec 13;12:CD011519. doi: 10.1002/14651858.CD011519.pub2. Lumbar sympathectomy techniques for critical lower limb ischaemia due to
non-reconstructable peripheral arterial disease. Karanth VK1, Karanth TK2, Karanth L3

Spinal Cord Protection
• Most feared complication following aortic surgeries.
• Persistent neurological deficits following spinal cord ischemia.
• The objective is to
• Rapidly identify the ischemic condition
• Restore spinal cord perfusion
• Attempt to minimize the duration of spinal cord ischemia

Pathophysiology
• The temporary interruption of distal aortic perfusion
• Sacrifice of segmental arteries during repair – central events in the pathogenesis

Pathogenesis Paraplegia /
Paraparesis
Immediate
Hypoperfusion Hypoxia
Delayed
1 to 21 days
after surgery
Reperfusion
surgery
• Duration & Degree of ischemia
• Failure to reestablish blood flow to the spinal cord after repair
• Biochemically mediated reperfusion injury

Prevention
• Minimise spinal cord ischemia
• Depends on duration of cross
clamping
• <15 min: 0 to 25% risk of
ischemia
• >60 min: 100% risk of ischemia
• Increase tolerance to ischemia
• Induce mild hypothermia
• Augmentation of perfusion
• Maintain SCPP: 70 to 80 mmHg
• Early detection of ischemia
• Neuro physiological monitoring of
spinal cord
• Primary injury during surgery &
aortic cross clamp: Hypoxic
damage of neurons
• Conduction of nerve impulses:
Highly sensitive
Guerit, Jean-Michel, Robert Verhelst, Jean Rubay, G. Khoury, A. Matta, and R. Dion. "Multilevel somatosensory evoked potentials (SEPs) for spinal cord monitoring in
descending thoracic and thoraco-abdominal aortic surgery." European journal of cardio-thoracic surgery 10, no. 2 (1996): 93-104.

Angiosomes
• Proposed by Taylor in 1987.
• Angiosome is a 3D block of tissue that supplies blood by an underlying source
artery.
• Concept is used in:
• In Tx of CLI, angiosome based revascularization to restore the blood supply to
an ischemic lesion.
• For wound healing in CLI, to make use of the blood supply as much as possible,
esp. in a surgical procedure such as debridement, amputation or
reconstruction.
Fujii M, Terashi H. Angiosome and Tissue Healing. Ann Vasc Dis. 2019;12(2):147-150. doi:10.3400/avd.ra.19-00036

Okazaki, Jin & Ishida, Masaru & Kuma, Sosei & Morisaki, Koichi. (2015). Infrapopliteal Bifurcated Dual Run-off Bypass in Critical Limb Ischemia: A Report of 2 Cases. Annals of Vascular
Surgery. 29. 10.1016/j.avsg.2015.01.024.

Respect the tissue planes
Preserve the blood supply
Mehdi H. Shishehbor. Circulation: Cardiovascular Interventions. Personalized Approach to Revascularization of Critical Limb Ischemia, Volume: 7, Issue: 5, Pages: 642-644, Improving the
assessment and outcome of free tissue transfer breast reconstruction. Gilmour, Adam (2016) Improving the assessment and outcome of free tissue transfer breast reconstruction. MD
thesis, University of Glasgow.

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