PAD:
Peripheral Arterial Occlusive Disease
PAD in the United States

Common Manifestation of Atherosclerosis

Prevalence: 12% - 14% of the General Population
- Up to 20% of Population > 75 Years Old

Increased risk from Cerebrovascular & Coronary Disease
PAD: PREVALENCE vs AGE
Criqui MH, et al, Circulation, 1985
EPIDEMIOLOGY OF ATHEROSCLEROSIS
STROKE
MI
PAD
Incidence
Prevalence
Mortality
(millions)
(millions)
(%)
.7
4
1.1
7
-
22
31
33
4
PAD: LONG-TERM MORTALITY
Criqui MH, et al, Vasc Med, 2001
PATIENTS WITH INTERMITTENT CLAUDICATION
Cause of Death
Coronary Artery Disease
63%
Cerebrovascular Disease
9%
All Cardiovascular Diseases
80%
Smith DG, et al, Circulation, 1990
INTERMITTENT CLAUDICATION
 Exercise-Induced Limb Pain / Weakness
 Symptoms Relieved with Rest
 Marker for Underlying Systemic Atherosclerosis
 Prognosis Worse with Multiple Risk Factors
CLAUDICANTS: LONG-TERM OUTCOME
Ouriel K, Lancet, 2001
PAD: NONINVASIVE LAB EVALUATION (PVR)
PAD: ABI PREDICTS SURVIVAL
PAD: Rx of INTERMITTENT CLAUDICATION
Symptomatic Rx
Systemic Rx
Exercise
Risk Factor Control
Smoking Cessation
Pharmacologic
Endovascular /
Open Surgery
-
Smoking
Hyperlipidemia
Hypertension
Diabetes
Pharmacologic
- Antiplatelet
- Statins
- Beta Blockers
AORTO-ILIAC OCCLUSIVE DISEASE
PATIENTS




Younger than Femoral-Popliteal Disease
More Often Hyperlipidemic
Less Often Diabetic
Claudicants
AORTO-ILIAC OCCLUSIVE DISEASE
DIAGNOSIS
 HISTORY:
- Proximal Claudication +/-
 PHYSICAL EXAM:
- Femoral Pulses +/-
 NONINVASIVE LABORATORY ***
- Thigh Pressure +/- Waveform ***
AORTO-ILIAC OCCLUSIVE DISEASE
SURGICAL OPTIONS
BILATERAL DISEASE
UNILATERAL DISEASE
Aorto-Iliac Endarterectomy
Ilio-Femoral Bypass
Aorto-Bifemoral Bypass
Femoral-Femoral Bypass
Axillo-Bifemoral Bypass
Axillo-Femoral Bypass
Thoracic Aorta-Fem-Fem Bypass
(PTA & Femoral-Femoral Bypass)
AORTO-ILIAC OCCLUSIVE DISEASE
SURGICAL OPTIONS
ANATOMIC
EXTRA-ANATOMIC
Aorto-Iliac Endarterectomy
Femoral-Femoral Bypass
Aorto-Femoral Bypass
Axillo-Bifemoral Bypass
Ilio-Femoral Bypass
AORTO-ILIAC ENDARTERECTOMY
INDICATIONS:
Focal Disease
CONTRAINDICATIONS:
Aneurysm
Disease Extending to Renal Arteries
Disease Extending to
External Iliac Arteries
Largely Replaced Today with Angioplasty
AORTO-ILIAC ENDARTERECTOMY
AORTO-FEMORAL BYPASS
AORTO-FEMORAL BYPASS
OPERATIVE MORTALITY




1960s
12%
1970s
6%
1980s
< 5%
1990s
2%
AORTO-FEMORAL BYPASS
PATENCY
Source (Yr)
# Pts.
Brewster (1978)
Martinez (1980)
Crawford (1981)
Szilagyi (1986)
Rutherford (1986)
Vantinnen (1991)
Nevelsteen (1991)
464
376
949
1749
157
177
912
PATENCY (%)
5-Yr
10-Yr
15-Yr
88
88
87
85
86
91
93
75
78
84
83
74
77
AORTO-FEMORAL BYPASS
COMPLICATIONS
 Graft Limb Occlusion
 Graft Infection
 Graft-Enteric Fistula
 Anastomotic Aneurysms
 Ureteral Obstruction
 Male Sexual Dysfunction
AORTO-FEMORAL GRAFT LIMB OCCLUSION
ETIOLOGY
EARLY
Distal Intimal Flap
Kinking / Twisting
Incomplete Clot Evacuation
Unsuspected Hypercoagulability
SEVERE OUTFLOW DISEASE ***
AORTO-FEMORAL GRAFT LIMB OCCLUSION: LATE
LATE (< 2 Yr)
Anastomotic Hyperplasia
ANGIOGRAPHY:
Anastomoses
Contralateral Limb
Run-Off: LYSIS
LATE (> 2 Yr)
Progressive Atherosclerosis***
Anastomotic Pseudoaneurysm
AXILLO-FEMORAL BYPASS
CANDIDATES:

Severe Comorbidity &
Limb-threatened

Infection
AXILLO-FEMORAL BYPASS
PATENCY
1- YEAR …………………… 22% - 100%
3-YEAR …………………… 36% - 97%
5-YEAR …………………… 34% - 87%
AXILLO-FEMORAL BYPASS
(Oregon HSU)
PATENCY
%
P
A
T
E
N
C
Y
100
90
80
70
60
50
40
30
20
10
0
Ax-Fem
Aorto-Fem
1
2
3
YEARS
4
5
AXILLO-BIFEMORAL BYPASS
UNILATERAL ILIAC ARTERY OCCLUSION
FEMORAL-FEMORAL BYPASS
ILIO-FEMORAL BYPASS
- Extra-Anatomic
- Anatomic
- Superficial
- Retroperitoneal Dissection
vs
- Less Morbidity
- More Morbid
- Lower Patency
- Better Patency
FEMORAL-FEMORAL BYPASS
PATENCY
(13 Series / 919 Patients)
1- YEAR …………………… 74% - 98%
(mean, 88%)
3-YEAR …………………… 62% - 85%
(mean, 77%)
5-YEAR …………………… 45% - 80%
(mean, 67%)
BILATERAL ILIAC ARTERY DISEASE
- PTA & FEMORAL-FEMORAL BYPASS Johns Hopkins
100
% 90
80
70
P
60
A
50
T
40
E
30
N
20
C
10
Y
0
J Vasc Surg. 1996
66%
59%
PTA & FEM-FEM
FEM-FEM
1
2
3
4
YEARS
5
6
7
ILIO-FEMORAL BYPASS
PATENCY
INSTITUTION
# PTS
PATENCY
F/U (YRS)
Brigham
56
75%
4
U. Toronto
50
92%
3
U. Wisconsin
20
100%
2
Johns Hospkins
22
92%
6
THORACIC AORTA-FEMORAL BYPASS
PATENCY (U North Carolina)
J Vasc Surg, 1999
ILIAC ANGIOPLASTY:
UCLA (1993 – 2004)
J Vasc Surg, 2005
ILIAC ANGIOPLASTY:
UCLA (1993 – 2004)
J Vasc Surg, 2005
AORTOILIAC RECONSTRUCTION




SUMMARY
Increasing Endovascular Interventions
Decreasing Open Surgical Procedures
Multiple Surgical Options
- Anatomy
- Comorbidity
Patient Selection Key
INFRAINGUINAL ARTERIAL OCCLUSIVE DISEASE
EPIDEMIOLOGY




Lower Extremity Atherosclerosis: 10% > 70 yo
Limb-Threatening Ischemia: 50,000 Individuals / Year
80,000 Infrainguinal Bypass Grafts / Year
Elderly: Fastest Growing Population Segment
FEMORAL-POPLITEAL-TIBIAL BYPASS
- Indications -
****
**
LIMB THREATENING ISCHEMIA
- Rest Pain
- Nonhealing Ulcers
- Gangrene
CLAUDICATION
- 50%-67% Improve Medically
- 2% -7% Limb Loss / Year
FEMORAL-POPLITEAL-TIBIAL BYPASS
- Operative Mortality SOURCE
Cleveland Clinic
Med Coll WI
Albany Med Coll
UCLA
Brigham
Oregon U
Johns Hopkins
VA Multicenter
Brigham
(Yr)
(1987)
(1987)
(1988)
(1988)
(1988)
(1990)
(1995)
(2000)
(2000)
No. Pts.
932
192
1038
120
266
564
100
752
172
% Mortality
4.4%
3.0%
6.7%
1.2%
1.4%
1.3%
2.0%
0.8%
2.4%
FEMORAL-POPLITEAL-TIBIAL BYPASS
- Wound Morbidity -
INCIDENCE:
5% - 30%
RISK FACTORS:
-
Vein Harvesting
Ischemic Limb
Diabetes
Re-Do Procedures
Infected Lesions
FEMORAL-POPLITEAL-TIBIAL BYPASS
- Wound Morbidity –
Oregon Health Science U


PATIENTS:
112
Diabetes ……………. 53%
Renal Failure ……… 22%
Limb Salvage ……… 96%
PROCEDURES:
Fem-Pop ……………
Fem-Tib ……………
Pop-Tib ……………
Vein …………………
52%
38%
10%
91%
WOUND COMPLICATIONS: 24%
TIME TO HEALING:
0.4 – 10.1 (mean, 1.9) Months
J Vasc Surg, 1998
FEMORAL-POPLITEAL-TIBIAL BYPASS
REDUCED WOUND MORBIDITY
Duplex Vein Mapping
Endoscopic Vein Harvest
FEMORAL-POPLITEAL-TIBIAL BYPASS
Kent & Queen Anne Hosp
METHOD OF VEIN HARVEST
ENDOSCOPIC
(n=16)
CONVENTIONAL
(n=16)
Wound Complications
0%
31%
Mean LOS (days)
3.8
6.2
JACS, 1998
FEMORAL-POPLITEAL-TIBIAL BYPASS
PATENCY:
KEY VARIABLES
***
GRAFT MATERIAL
Vein vs Prosthetic
**
SITE OF DISTAL ANASTOMOSIS
Fem-Pop vs Fem-Tib
*
CLINICAL INDICATION
Claudication vs Limb salvage
FEMORAL-POPLITEAL-TIBIAL BYPASS
CLINICAL INDICATION
CLAUDICATION vs LIMB SALVAGE
100
%
Claudication
80
P
A
T
E
N
C
Y
60
Limb Salvage
40
20
2,572 PATIENTS
15 YEARS
0
1
2
3
YEARS
4
5
FEMORAL-POPLITEAL-TIBIAL BYPASS
DISTAL ANATOMOSIS
FEM-POP vs FEM-TIB (SAPH. VEIN)
100
%
Fem-Pop
80
P
A
T
E
N
C
Y
60
40
Fem-Tib
20
2,572 PATIENTS
15 YEARS
0
1
2
3
YEARS
4
5
FEMORAL-POPLITEAL-TIBIAL BYPASS
GRAFT MATERIAL
FEM-POP
%
% 100
P
A
T
E
N
C
Y
FEM-TIB
100
p < .025
80
Vein
60
PTFE
40
20
2,572 PATIENTS
15 YEARS
0
P
A
T
E
N
C
Y
P< .001
80
Vein
60
40
PTFE
20
2,572 PATIENTS
15 YEARS
0
1
2
3
YEARS
4
5
1
2
3
YEARS
4
FEMORAL-POPLITEAL BYPASS
- LONG-TERM 1 0 PATENCY -
Randomized Prospective Trial: FEM-POP
%
P
A
T
E
N
C
Y
J Vasc Surg, 1986
68%
38%
MONTHS
FEMORAL-TIBAL BYPASS
- LONG-TERM 1 0 PATENCY -
Randomized Prospective Trial: FEM-TIB
%
P
A
T
E
N
C
Y
J Vasc Surg, 1986
49%
12%
MONTHS
FEMORAL-POPLITEAL BYPASS
LONG-TERM PATENCY: GRAFT MATERIAL
SERIES:
YEARS:
PROCEDURES:
%
P
A
T
E
N
C
Y
69
15
11,600
100
72%
80
58%
45%
60
40
20
0
1
2
3
YEARS
5
VEIN
HUV
PTFE
FEMORAL-TIBIAL BYPASS
LONG-TERM PATENCY: GRAFT MATERIAL
SERIES:
YEARS:
PROCEDURES:
69
15
11,600
%
P
A
T
E
N
C
Y
100
80
56%
42%
60
33%
40
20
0
1
3
YEARS
VEIN
HUV
PTFE
FEMORAL-POP BYPASS (Above Knee)
- LONG-TERM PATENCY RANDOMIZED TRIAL: VA MULTICENTER
PATIENTS:
752
ASSISTED 10 PATENCY
%
P
A
T
E
N
C
Y
J Vasc Surg, 2000
73%
53%
MONTHS
P < .01
MONTHS
39%
FEMORAL-POPLITEAL-TIBIAL BYPASS
- SECONDARY PROCEDURES Oregon HSU
GRAFTS:
YEARS:
REVISIONS:
%
1,498
1990 – 2000
330 / 259 GRAFTS (17%)
100
90
80
70
60
50
40
30
20
10
0
Assisted
10 Patency
Limb
Salvage
1
J Vasc Surg, 2002
3
5
7
YEARS
9
10
FAILING VEIN GRAFT
- DIAGNOSIS -



SYMPTOMS
ANKLE-BRACHIAL INDEX: 15%
DUPLEX SURVEILLANCE
FAILING VEIN GRAFT
DUPLEX SURVEILLANCE



Sys Vel Ratio 2:1 ….. > 50%
Sys Vel Ratio 3:1 ….. > 75%
Sys Vel Ratio 4:1 ….. > 90%

Sys Velocity < 45 cm/sec
INFRAINGUINAL VEIN GRAFT STENOSES
PTA
vs
SURG
- Solitary Stenosis
- Multiple Stenoses
- Focal Stenosis
- Longer Stenoses
- First Presentation
- Recurrent Stenoses
- Reversed Graft
- In-Situ Graft
vs
FEMORAL–POPLITEAL–TIBIAL BYPASS
PATENCY
META-ANALYSIS (RCTs):
Antiplatelet Rx vs Placebo
J Vasc Surg, 1999
FEMORAL–POPLITEAL–TIBIAL BYPASS
PATENCY
META-ANALYSIS (RCTs):
Antithrombotic Rx vs Placebo
Am J Med, 2004
FEMORAL–POPLITEAL–TIBIAL BYPASS
STATIN Rx
Brigham & Women’s Hosp
Patients:
Limb Salvage:
Infrapopliteal:
PRIMARY PATENCY
189
92%
65%
SECONDARY PATENCY
Statins
Statins
No Statins
No Statins
p= .25
J Vasc Surg, 2004
p< .02
TREATMENT OF
CARDIOVASCULAR DISEASE
CONTEMPORARY PRACTICE :
> 70% OF OPEN OPERATIONS
WILL BE REPLACED BY
PERCUTANEOUS OR
ENDOVASCULAR
PROCEDURES
PAOD REVASCULARIZATION
Surgery vs Endovascular: 2002 - 2009
2002
42%
2009
70%
Health Care Advisory Board
Innovations Center Futures Database
SURGERY
ENDO
PAOD REVASCULARIZATION
Volume Projections: 2004 - 2009
400,000
+25%
350,000
300,000
#
+ 37%
250,000
200,000
150,000
+ 4%
100,000
50,000
0
2004
Health Care Advisory Board
Innovations Center Futures Database
2009
YEARS
SURGERY
ENDO
TOTAL
SFA OCCLUSIVE DISEASE
Advantages of Endovascular Therapy





Less Risk
Less Morbidity
Shorter LOS
Acceptable Clinical Outcomes
Cost Efficacy
INFRAINGUINAL OCCLUSIVE DISEASE
ENDOVASCULAR THERAPEUTIC OPTIONS
 PTA











Stents
Subintimal Angioplasty
Drug Eluting Stents
Covered Stents
Bioabsorbable Stents
Cutting Balloon PTA
Cryoplasty
Brachytherapy
Excimer Laser
Atherectomy
Percutaneous Bypass
x = Fem-Pop (Saph V.)
J Vasc Surg, 2005
ACUTE ARTERIAL ISCHEMIA
ACUTE LIMB ISCHEMIA
TREATMENT GOALS
PRIMARY:
Restore Perfusion
SECONDARY:
Identify & Correct
Underlying Lesions
vs
ACUTE LIMB ISCHEMIA:
SEVERITY
SVS CLINICAL CLASSIFICATION
I.
Viable
Doppler
Arterial. Venous
SENSORY
MOTOR
-
-
+
+
+/- toes
-
-
+
-
+
-
-
II. Threatened:
Marginally
Immediately > toes
III. Irreversible profound
mild - mod
paralysis
ACUTE LIMB ISCHEMIA:
ETIOLOGY
THROMBOTIC (60%)
EMBOLIC (40%)
Bypass Graft
Atherosclerotic
Aneurysm
Iatrogenic
Nonatherosclerotic
Cardiac
Atherosclerosis
Aneurysm
Paradoxical
Tumor
“Cryptogenic”
LOCATION


Lower vs Upper Extremity
Proximal vs Distal
ACUTE LIMB ISCHEMIA
BENEFITS OF THROMBOLYTIC THERAPY






Restores Perfusion
Controlled Reperfusion
Maximizes Reperfusion
Accurate Diagnosis
Endovascular Intervention
Avoids Emergency Surgery
ACUTE LIMB ISCHEMIA: THROMBOLYSIS
- RANDOMIZED CLINICAL TRIALS -
U ROCHESTER: < 7 Days Ischemia
UK
SURG
n=57
n=57
p
30-Day Amputation
30-Day Mortality
9%
12%
14%
18%
ns
ns
30-Day Cardiopulmonary Morbidity
30-Day M.I.:
16%
5%
49%
16%
.001
.02
1-Yr Mortality Rate:
1-Yr Limb Salvage:
16%
82%
42%
82%
.001
ns
THROMBOSED POPLITEAL ANEURYSMS:
- Thrombolysis vs Immediate Surgery -
30-DAY LIMB SALVAGE
Institution (Year)
U Penn (1993)
U Rochester (1998)
U Florence (2002)
U Lausanne (2002)
U Hosp Birmingham (2003)
Lysis
& Surgery
Immediate
Surgery
100%
100%
86%
83%
100%
57%
70%
77%
LIMITATIONS OF THROMBOEMBOLECTOMY
 Leaves Residual Thrombus
Mural Thrombus:
Infra-Popliteal Vessels:
(35% – 85%)
Refined Catheters
Angio-Directed Embolectomy
 Cannot Clear Branch Vessel Occlusion
THROMBOLYTIC AGENTS: EVOLUTION
AGENT
t½
FIBRIN SPECIFICITY
Streptokinase
23 min
+
Urokinase
16 min
++
Alteplase
Retaplase
Tenecteplase
4-5 min
14 min
20-24 min
+++
++
++++
Prourokinase
Staphylokinase
Desmoteplase
Plasmin
Alfimeprase
7 min
6 min
40-50 x t-PA
0.1 sec
N.A.
++
++++
++++
+++++
+++++
Percutaneous Mechanical Thrombectomy Devices
Aspiration Devices
AngioJet*
Possis Medical, Minneapolis, MN
Trellis*
Bacchus Vascular, Santa Clara, CA
Fino
Bacchus Vascular, Santa Clara, CA
Solera
Bacchus Vascular, Santa Clara, CA
Rescue
Boston Scientific, Watertown, MA
Oasis
Boston Scientific, Watertown, MA
Hydrolyser
Cordis Endovascular, Miami, FL
Gelbfish EndoVac
NeoVascular Technologies, Brooklyn, NY
Thrombex PMT System
Edwards Life Sciences, Irvine, CA
The Cleaner
Rex Medical/Boston Scientific, Watertown, MA
Xtrak Thrombectomy Device
Xtrak Medical, Salem, NH
Rotarex
Straub Medical, Wangs, Switzerland
X-Sizer
EndiCOR Medical, San Clemente, CA
Microfragmentation Devices
Arrow-Trerotola
Arrow International, Reading, PA
Amplatz Clot Buster
Microvena, White Bear Lake, MN
Cragg brush
Micro Therapeutics, Aliso Viego, CA
Castaneda brush
Micro Therapeutics, Aliso Viego, CA
Ultrasound Devices
Acolysis
Angiosonics, Morrisville, NC
Resolution 360 therapeutic wire
Omnisonics, Wilmington, MA
ACUTE LIMB ISCHEMIA: ANGIOJET
Author
Muller-Hulsbeck
#
Success
112
71%
Lyis
18%
Complications (%)
Embolism (10%)
Amputation (1.8%)
Mortality (7%)
Silva
22
95%
0%
Embolism (9%)
Amputation (5%)
Mortality (14%)
Wagner
50
52%
30%
Embolism (6%)
Amputation (8%)
Mortality (0%)
Kasirajan
86
84%
50%
Embolism (2.3%)
Amputation (11.6%)
Mortality (9.3%)
ACUTE LIMB ISCHEMIA
- Contemporary Management VIABLE /
MARG. THREATENED
IMMEDIATELY
THREATENED
IRREVERSIBLE
Arteriogram
Embolus
Thrombotic
Thrombolysis
Thrombolysis
- UE
- Distal LE
Surgery
Intra-Op Arteriogram
+/- Intervention
Surgery
Intraoperative
Thrombolysis
Amputation