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Central Texas Veterans Health Care System
Factors Influencing the Decision for Direct/Open Surgical Revascularization for Chronic Limb Ischemia &
Anticipated Outcomes for These InterventionsClifford J. Buckley, MD, FACS
Professor of Surgery
Diabetic Foot Update 2015
San Antonio, Texas
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Disclosure
I have no relevant financial relationships with
proprietary entities producing health care goods
or services related to the content of this
presentation.
Content may not reflect position of US GovernmentWate
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Outcome Assessment
• Patency most important
• Variables
• Location of bypass
• Type of conduit
• Quality of inflow/outflow
• Patient’s other comorbidities
• Limb salvage
• Return to acceptable QOL
Surgeon Perspective
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Outcome Assessment
• Return to acceptable QOL
• Limb salvage
• Duration of incapacitation
• Patency irrelevant
Patient Perspective
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Management Paradigm for PAD
Pre 1990• Claudication
• Conservative management
• Exercise
• Limited pharmacotherapy
• Risk factor control
• PTA for treatment failures
• Bypass rarely justifiedWate
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Management Paradigm for PAD
Pre 1990• Chronic CLI
• Intervention based therapy
• Surgical bypass for limb salvage
• Pharmacotherapy limited value
• Endovascular intervention used occasionally
• Primarily PTA – often hybrid procedure componentWate
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Management Paradigm for PAD
1990 - Present• Claudication
• Endovascular intervention increasingly more
common as first line treatment
• Exercise, pharmacotherapy not considered first line
therapy in “most” vascular practices
• Better risk factor control
• Bypass still rarely justifiedWate
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Management Paradigm for PAD
1990 - Present• CLI
• Endovascular intervention primary therapy
• Bypass for limb salvage after EVI failure
• Pharmacotherapy rarely used
• Patients prospect for survival & functional status
not routinely considered in decision for therapyWate
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Direct Surgical Therapy for
Lower Extremity Revascularization
• Pros
• Durable
• Results generally predictable
• Time tested procedures with evidence based
outcomes
• Criticisms
• Significant morbidity & mortality
• Expensive - related to need for longer
hospitalization than EVI and wound issuesW
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Aorto-femoral Bypass
• Best & most durable arterial reconstruction
• 3% per year failure rate
• 75% 10-year patency
• 3-5% mortality
• 10-15% major morbidity risk
• 50% of patients deceased 5 years from other
comorbidities
• DM – mild increase in M/MWate
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Above-Knee Femoral-Popliteal Bypass
• Claudication
• Rarely justified unless symptoms truly disabling
• Status of profunda femoris perfusion – key
determinate
• Critical Limb Ischemia
• Bypass of SFA lesions usually required to heal
ischemic lesions on foot / toes
Allen BT et al, Ann Vasc Surg 1996
Pursell R et al, Brit J Surg 2005
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Above-Knee Femoral-Popliteal Bypass
• Autogenous vein – best conduit
• 5 yr patency – 60% - 76%
• Heparin bonded PTFE & Dacron
• Equivalent patency
• 5 yr patency – 40% - 45%
Klinkert, et al 2003
Johnson, et al 2000
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Femoral-popliteal BypassBelow Knee
• Used for long segment femoral-popliteal
occlusions or multiple segmental stenoses
& occlusions
• May be necessary for relief of disabling
claudication
• Necessary to heal ischemic foot/toe
lesions
• Autogenous vein, reversed or in-situ, is
best conduit
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Femoral-tibial or Popliteal-tibial Bypass
Procedures
• Autogenous vein best conduit except for femoral-anterior
tibial grafts where prosthetics may be equivalent
• Use of adjunctive outflow AV fistula maximizes flow
through grafts & can be useful when a prosthetic conduit
is all that is available
• Patency
• Autogenous vein: 70% 5-year
• Prosthetic: variable, 50-70% 2 year; should be used
for limb salvage only
• 15-20% decreased patency with DMWate
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Segmental Endarterectomy
• Reserved for very localized segmental disease
• Requires relatively large artery
• Frequently mandates use of patch closure of vessel
• Patency generally less than for vein bypass procedures but is more durable than prosthetic bypass grafting
• Rarely possible in diabetic patientsWate
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Surgeons:What We Gloss Over
• Chronic kidney disease, nutritional status
& DM predictors of poor long term
outcome for bypass
• Wound healing problems in 10 – 35% of
saphenous vein harvest sites
• CLI patients
• 25% 1 year mortality
• ~ 50% 2 year mortalityWate
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Outcomes of Lower Extremity Revascularization
Meta-Analysis
• Medline and Embase (English language)
• 1980 – June 2010
• Sub-group of patients with diabetes reported separately
(30 pubs)
• Ulceration/gangrene/tissue loss reported (80% of pubs)
• PAD: any flow limiting atherosclerotic lesion of the
arteries below the inguinal ligament
• No medical, topical or local therapies considered
• Outcomes: Ulcer healing, limb salvage, major
amputation, survivalW
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Meta-Analysis
• 8,290 patients
• 49 studies
• No randomized trials
• 3 studies with a control group
• 46 case seriesWate
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Why is PAD difficult to treat in patients with diabetes?
• Multilevel disease
• Extensive calcification
• Long occlusions
• Predilection for crural vessel disease
• Technically challenging
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Mortality
• Perioperative
• Reported in 30 studies
• 1.4% (0.8 - 3.7%) open surgery (n=20)
• 0.5% (0 - 4.3%) endovascular (n=10)
• 30-day - 0% - 9%
• 1 year - 13.5% (11.3 – 31.8%)
• 5 years - 46.5% (36-52.3%)
• Rates varied widely
• Paucity of data on endovascularWate
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Limb Salvage and Wound Healing
• Most studies reported on limb salvage
• 1-year 85% (80 – 90%) open surgery
• 1-year 76% (72 – 78.5%) endovascular
• Wound healing poorly reported
• > 60% at 1-year in all studies
Lack of clear definitions
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Amputation
• Rates of minor amputation varied
considerably (12 – 92%)
• Major amputation within 2 years
• 17.3% (12.8 – 22.8%) open surgery
• 8.9% (5.4 - 12.5%) endovascularWate
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Chronic Kidney Disease
• 6 pubs
• Definitions of chronic kidney disease varied
• Appeared to have significantly worse
outcomes
• 1-year mortality 38% (25.5 – 41.5%)
• 1-year limb salvage rates 70% (65 – 75%)Wate
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Pedal Bypass Grafts
• 10 pubs
• Severity of PAD and foot lesion poorly described
• Limb salvage
• 86% (85-98%) at 1-year
• 82.3% (81.3 – 88.5%) at 3-years
• 78% (78 – 82.3%) at 5-years
• Numbers low at 3 and 5 year follow-upWate
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Discussion
• Limb salvage rate 54% at 1-year with NO
revascularization (Lepantalo)
• 78 – 85% 1-year limb salvage with
revascularization – open or endo
Evidence of effectiveness of revascularization
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Discussion
• Increasing numbers of studies reporting patients
with PAD and diabetes / ulcer
• Study quality generally poor (selection /
publication bias)
• Insufficient evidence to recommend PTA over
bypass surgery
• Optimize medical therapy (high mortality)
• Need standard reporting / standard managementWate
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CostAngioplasty
Balloon
$500 - $1600
Balloon Expand
Stent
$1097
Self Expand
Stent
$1212
SilverHawk $2738
Laser Catheter $1643
Cryoplasty
Balloon
$1700
Cutting Balloon $800
PTFE Graft $476
Distalflo Graft $1000
Propaten Graft $2660
Cryovein $5000
Hospital DRG
Reimbursement
$6754 - $9768Wate
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Cost
P < 0.001
With
Hospitalization
Without
Hospitalization
Open $21,248.84 $1,539.54
Endo $15,454.83 $3,632.13
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Baylor Scott & White Lower Extremity
Revascularization Experience 2005 - 2012
• 400 patients
• 242 male
• 158 female
• 439 total limbs
• Type of vascular intervention
• 267 endovascular
• 172 open
• No significant difference in age & co-morbidities
• All prospectively followed – mean follow-up 5 yearsWate
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Outcomes
• Patients receiving open bypass have an increase incidence of CAD, CVD, COPD, and worse TASC score
• Amputation rate is higher in open group
• Open operations are more cost effective in the OR, but loose their benefit in cost due to length of stay W
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Improving Outcomes
• Risk factor reduction
• Statins LDL < 70
• Ace/ARB
• HgB A1C < 7.0
• Stop Smoking!
• Earlier treatment of disease?
• More aggressive treatment of disease
• Will there be a better technique?
• Increased use of hybrid operations
• Angioplasty, stenting, atherectomy, drug coatings to
balloons or stentsW
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Thank You
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