Preventing Critical Limb Ischemia

Transcription

Preventing Critical Limb Ischemia
Supplement to Podiatry Today®
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Preventing
Critical Limb
Ischemia
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Experts Discuss Podiatric and Cardiovascular
Interdisciplinary Care
Supported by
Supplement to Podiatry Today® and Vascular Disease Management®
Preventing Critical Limb Ischemia
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Table of Contents
Introduction: A Primer on Critical Limb Ischemia
Joseph Caporusso, DPM...................................................................................................................... pg. 3
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New Treatment Paradigm: The Angiosome Concept
Kanwar P. Singh, MD, FACC............................................................................................................... pg. 4
Holistic Patient Management: Working With an Interventionalist
Peter A. Soukas, MD, FACC, FSVM, FSCAI, RPVI, and Harold B. Glickman, DPM....................................... pg. 8
Amputation Prevention: A Multidisciplinary Approach
J. A. Mustapha, MD, FACC, FSCAI; Desmond Bell, DPM, CWS;Yazan Khatib, MD, FACC, FSCAI, FSVMB,
FABVM; Fadi Saab, MD; Carmen M. Heaney, BSN, RN, CCRC, CIP......................................................... pg. 12
Diagnosing CLI: The Role of the Podiatrist
Joseph Caporusso, DPM...................................................................................................................... pg.18
Comprehensive Wound Care Management
Rasesh M. Shah, MD, FACS, and John Steinberg, DPM, FACFAS................................................................ pg. 21
Authors
Desmond Bell, DPM, CWS
Executive Director, Save A Leg,
Save A Life Foundation
CEO, Limb Salvage Institute
Jacksonville, FL
Joseph Caporusso, DPM
Chairman
PAD Coalition
McAllen, TX
Harold B. Glickman, DPM
Past President, American Podiatric Medical
Association
Chairman Dept. Podiatric Surgery
Sibley Memorial Hospital
Washington, DC
Carmen M. Heaney, BSN, RN, CCRC, CIP
Director of Clinical Research
Metro Health Hospital
Wyoming, MI
Yazan Khatib, MD, FACC, FSCAI,
FSVMB, FABVM
Co-Founder, First Coast Cardiovascular Institute
Co-Founder, Save A Leg, Save A Life Foundation
Jacksonville, FL
Kanwar P. Singh, MD, FACC
Assistant Professor of Medicine
Director,Vascular Medicine and Intervention
Co-Director, Interventional Cardiology
University of Connecticut Health Center
Farmington, CT
J. A. Mustapha, MD, FACC, FSCAI
Director of Endovascular Interventions
Director of Cardiovascular Research
Metro Health Hospital
Wyoming, MI
Peter A. Soukas, MD, FACC, FSVM,
FSCAI, RPVI
Director,Vascular Medicine and
Interventional Peripheral Vascular Lab
Director, Brown Vascular &
Endovascular Medicine
Fellowship Program
Assistant Professor of Medicine
Warren Alpert School of Medicine of
Brown University
The Miriam and Rhode Island Hospitals
Providence, RI
Fadi Saab, MD
Metro Heart & Vascular
Wyoming, MI
Rasesh M. Shah, MD, FACS
Sentara Vascular Specialists
Virginia Beach,VA
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John Steinberg, DPM, FACFAS
Associate Professor/Department of
Plastic Surgery
Co-Director, Center for Wound Healing
Georgetown University School of Medicine
Georgetown University Hospital
Washington, DC
Disclaimer: The authors of the articles contained in this Supplement to Podiatry Today® and Vascular Disease Management® are paid consultants for Cordis
Corporation. These articles contain the techniques, approaches and opinions of the individual authors. It does not constitute recommendations or medical
advice of Cordis Corporation. Cordis does not provide medical advice. Cordis has no independent knowledge concerning the information contained in any
of the articles, and the studies, findings and conclusions expressed are those reached by the authors. This Cordis-sponsored publication is not intended to be
used as a training guide. Before using any medical device, please review all relevant package inserts with particular attention to the indications, contraindications, warnings and precautions, and steps for use of the device(s).
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Preventing Critical Limb Ischemia
Supplement to Podiatry Today® and Vascular Disease Management®
Introduction:
A Primer on Critical Limb Ischemia
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Joseph Caporusso, DPM
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References
1. Selvin E, Erlinger TP. Prevalence of and risk factors for peripheral arterial
disease in the United States: results from the National Health and Nutrition
Examination Survey, 1999-2000. Circulation. 2004;110(6):738–743.
2. Criqui MH, Fronek A, Barrett-Connor E, et al. The prevalence of peripheral arterial disease in a defined population. Circulation. 1985;71(3):510–515.
3. Diehm C, Schuster A, Allenberg JR, et al. High prevalence of peripheral arterial disease and comorbidity in 6880 primary care patients: cross-sectional
study. Atherosclerosis. 2004;172(1):95–105.
4. Meijer WT, Hoes AW, Rutgers D, et al. Peripheral arterial disease in the elderly:The Rotterdam Study. Arterioscler Thromb Vasc Biol. 1998;18(2):185–192.
5. Hirsch AT, Criqui MH, Treat-Jacobson D, et al. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA.
2001;286(11):1317–1324.
6. Dormandy JA, Rutherford RB. Management of peripheral arterial disease (PAD). TASC Working Group. TransAtlantic Inter-Society Consensus
(TASC). J Vasc Surg. 2000;31(1 Pt 2):S1–S296.
7. Hirsch AT, Haskal ZJ, Hertzer NR, et al; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional
Radiology;ACC/AHA Task Force on Practice Guidelines;American Association of
Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing;TransAtlantic Inter-Society Consensus;Vascular
Disease Foundation. ACC/AHA 2005 guidelines for the management of patients
with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal
aortic): executive summary a collaborative report from the American Association
for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of
Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines
(Writing Committee to Develop Guidelines for the Management of Patients With
Peripheral Arterial Disease) endorsed by the American Association of Cardiovascular
and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society
for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease
Foundation. J Am Coll Cardiol. 2006;47(6):1239–1312.
8. Izumi Y, Satterfield K, Lee S, Harkless LB. Risk of reamputation in diabetic
patients stratified by limb and level of amputation: a 10-year observation.
Diabetes Care. 2006;29(3):566–570.
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Supplement to Podiatry Today® and Vascular Disease Management®
cess. Amputation before or after revascularization is most likely
needed. The literature has highlighted the downward spiral that
occurs after that first pedal amputation.8 The stresses and increased
pressures applied to the contralateral limb after amputation puts
the remaining extremity at an increased risk for amputation. For
these reasons, it’s extremely important that the length of the amputated limb be preserved as distally as possible. The energy the
patient needs to ambulate greatly increases as the amputation level
becomes more proximal. Patients are increasingly aware of the
sequelae and are demanding limb salvage at all costs.
The devastating effects of CLI warrant a team approach to its
evaluation and treatment. The podiatrist working with the vascular specialist can increase the chance of limb salvage and lessen
the horrific consequences of CLI. Appropriate revascularization
of the affected limb — along with appropriate wound care, debridement and/or lesser amputation — can let the patient function very close to his/her normal level. n
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ower-extremity peripheral artery disease (PAD) is a
major health concern worldwide. PAD prevalence has
been estimated to be between 4.3% and 29%.1–5 Older
populations have higher rates of PAD and, in most age
groups, males have higher PAD rates than females.3
PAD natural history includes asymptomatic PAD, atypical leg
pain, claudication and critical limb ischemia (CLI). CLI presents in
1–2% of the PAD population and is defined as ischemic rest pain,
nonhealing wounds or gangrene.6,7 The degree and developmental chronicity of CLI determine patients’ clinical manifestations.
The Rutherford and Fontaine clinical classification systems offer
insight into ischemic classification and limb salvageability. CLI
presents with multifocal areas of occlusion in a lower extremity’s
arterial tree; the disease process is usually symmetrical.
CLI is most commonly caused by obstructive atherosclerotic arterial disease. Other causes include atheroembolic
or thromboembolic disease, trauma, and vasculitis. Disease
chronicity plays a role in CLI’s formation instead of acute
limb ischemia’s. Conditions such as diabetes and severe lowcardiac output reduce blood flow to the microvascular beds
and can exacerbate or contribute to CLI development.
CLI is associated with very high intermediate-term morbidity and mortality. Patients with PAD are at 3 to 5 times
greater risk of cardiovascular mortality than those without
PAD.7 Advanced PAD and CLI greatly increase the risk of
cardiovascular ischemic events. Given that this devastating
disease can ­­— and, in many cases, will — end in primary
amputation, early detection and intervention are crucial.
The ischemic rest pain associated with CLI typically occurs at
night and continuously in more severe cases. Patients will often
present with a history of pain while asleep and waking to massage
the foot and/or walk around the room to try to achieve relief.
In some cases, partial relief occurs with dependency of the limb.
When patients with pain have reached a point where the pain
does not permit sleep in a supine position, their general physical
and psychological conditions further decline.
Ischemic ulceration is an ominous sign in CLI. Ischemic ulcerations have vastly different presentations than neuropathic ulcerations. Instead of the healthy, granular base seen with neuropathic
ulceration, ischemic ulceration presents with a necrotic/fibrotic
base. The hyperkeratotic covering or rim is also absent and has a
more “punched out” appearance.
Gangrene is the end-stage of tissue loss.This is the most feared
complication of CLI due to the treatment indicated for this pro-
Preventing Critical Limb Ischemia
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New Treatment Paradigm:
The Angiosome Concept
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Kanwar P. Singh, MD, FACC
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s discussed throughout this supplement, critical
limb ischemia (CLI) is the most severe form of
peripheral arterial disease (PAD). It occurs when
the resting metabolic need of tissue is not met by
the arterial supply. The anatomic substrate of CLI typically
consists of severe, multi-level occlusive or stenotic atherosclerotic disease, including combinations of aorto-iliac, femoral, popliteal and tibial vessels. The conditions of patients
with CLI are typically complicated by medically significant
comorbidities including advanced age, diabetes, renal insufficiency, coronary artery disease, and cerebrovascular disease,
among others. Such patients are at increased risk of surgical revascularization complications, rendering percutaneous
options more attractive. However, these same medical issues
may complicate percutaneous revascularization.
Taylor and Palmer published the angiosome concept in
1987,1 describing a three-dimensional model of human
anatomy segregated into 40 blocks of tissue fed by source arteries. Its initial clinical application was centered on healing
surgical graft sites for operative wounds and plastic surgery
reconstructions. More recently, the angiosome concept has
been shown to help successfully guide tibial vessel selection
in optimizing revascularization strategies for surgical and endovascular CLI therapies.
The angiosome concept is part of a new paradigm in
the treatment of CLI that aims to simplify these complex cases and gives the vascular specialist a framework to
guide therapies.
Class I status despite having the lowest caliber of evidence
(Level C, expert opinion).2
However, staged vascular procedures carry additional
risks: vascular access, sedation, contrast, radiation, healthcare
costs, and disruption of patient’s lives. Additionally, patients
are (appropriately) often reluctant to accept a wait-and-see
approach and wish for definitive procedures. So in many
cases, I choose to optimize the endovascular treatment with
a single procedure to re-establish inflow and the key tibial
vessel.The angiosome model drives the choice of tibial runoff target.
The Angiosome Model
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Traditional Approach to CLI
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The first issue in treating CLI is determining the acuity of
the clinical scenario. In truly acute presentations, it’s urgent
that patency of the affected vessels be restored.With subacute
or more chronic presentations, the traditional approach has
been to consider staged or sequential revascularizations, focusing first on inflow and subsequently on infrainguinal and
infrapopliteal lesions.
Indeed, the 2011 American College of Cardiology/American Heart Association update to the guidelines for managing patients with PAD suggests that patients with CLI should
undergo outflow interventions only after an incomplete response to inflow therapy, a recommendation carried over
from the 2005 document. This recommendation is afforded
The human body has been divided into 40 discrete angiosomes. With regard to foot ulcerations, six territories are described according to the anterior tibial (ATA), posterior tibial
(PTA) and peroneal (PA) arteries (see Figure 1 on page 5).
The ATA arises from the popliteal artery and courses anterolaterally in the anterior compartment, then crosses the
dorsal aspect of the shin and over the ankle joint, where it
becomes the familiar dorsalis pedis (DP) pulse. With this
anatomic path in mind, it becomes easy to identify the anterior tibial angiosome.
The popliteal artery continues after the ATA separates
and becomes the tibioperoneal trunk (TPT). From here,
the TPT divides into the PTA and PA. The PTA travels in
the deep posterior compartment and follows the medial
aspect of the tibia. It tucks behind the medial malleolus,
where it’s typically identified on exam, and wraps along
the plantar surface of the heel. Under the heel, it gives off
medial calcaneal branches, and then divides into a medial
plantar and lateral plantar arteries. These two arteries feed
the plantar aspect of the foot (Figure 1).
The PA is the other branch of the TPT, running along
the posterior side of the fibula in the superficial posterior
compartment. As it terminates at the ankle, it gives off lateral calcaneal branches for its own angiosome distribution,
as well as named collaterals that perfuse the AT and PTA.
One of the PA’s key aspects is that it’s the most in-line continuation of the popliteal artery. When the popliteal artery
is occluded and there are no visible tibial targets, crossing
catheters and wires will most commonly enter the PA, allowing revascularization. PA collaterals can at times be used
to perform retrograde revascularization of occluded tibials
via antegrade femoral or retrograde pedal access.
Selected Data Supporting
Angiosome-based Revascularization
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Surgical bypass and endovascular revascularizations are
accepted options for treating patients with CLI and promoting healing. Retrospective analyses of both approaches show
that direct revascularization (DR) — in which the target
artery for reperfusion is the one associated with the ischemic angiosome — is associated with higher limb-salvage
rates than indirect revascularization (IR), in which a nonangiosome-based vessel is targeted.
Neville et al reported on 48 consecutive patients with 52
non-healing ulcerations who underwent tibial bypass over a
2-year period. In a retrospective analysis, DR was associated
with a fourfold lower rate of amputation rate when compared with IR (9.1% vs. 38%, P = 0.03) (Figure 2).3 Similarly, Iida et al reported on 329 consecutive patients with
369 ischemic limbs managed with endovascular therapy, and
found freedom from major amputations at 4 years, and overall amputation-free survival was significantly higher among
patients treated with DR versus IR (Figure 3).4
These analyses are limited by their retrospective nature
and, therefore, cannot control for decisions made by individual treating physicians in choosing the revascularization
targets. Not all DR targets will be suitable for grafting, nor
will all DR targets be crossable or revascularizable from the
endovascular perspective. Nonetheless, these and other data
suggest that, whenever possible, an angiosome-based direct
approach may be preferable to an indirect one. Ideally, a randomized, blinded clinical trial would be performed to determine if DR is superior to IR, but this type of trial would
be challenging to populate, as providers familiar with the
angiosome concept are unlikely to feel satisfactory clinical
equipoise for such an investigation.
The Angiosome in Context
of the BASIL Trial
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Perhaps the most significant change regarding CLI in
the updated guidelines statement was the statement that a
patient’s overall prognosis should be considered when determining whether to use surgical or endovascular revascularization. The new statement indicates that, in patients
likely to survive longer than 2 years, a surgical approach
is preferable to an endovascular one. This is based on two
key observations of the large Bypass Versus Angioplasty
in Severe Ischemia of the Leg (BASIL) Trial. Patients first
treated with bypass enjoyed improved overall survival and
amputation-free survival. Furthermore, among patients who
first underwent endovascular therapy and failed, outcomes
were significantly worse than for patients who underwent
primary bypass.5
Figure 1. The angiosome model describes six
territories according to the anterior tibial, posterior tibial and peroneal arteries.
Images courtesy of Cordis Corporation
Preventing Critical Limb Ischemia
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100
Direct Revascularization
Indirect Revascularization
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91%
tion, and no data describe the thoroughness of endovascular
reconstruction.Therefore, it’s unclear if an optimal strategy was
pursued, although the suggestion is that it wasn’t.
Second, only 10% of patients with CLI at the participating
centers were enrolled in the study. This leaves the remaining
90% of patients (the “real world” patients) out of the analysis.
Third, there is no subgroup analysis that guides us regarding
the anatomic patterns that may be better suited to bypass than
the endovascular approach — a key factor in clinical practice.
Fourth, a practitioner’s ability to reliably discern patients
most likely to survive to 2 years (and hence be most likely
to derive benefit from surgical revascularization) is suspect at
best. A subsequent analysis attempted to develop a predictive
model of survival, but the model requires prospective validation and cannot predict outcomes for individual patients.6
Additional limitations of the BASIL Trial have been expertly described by Conte.7 As a result, while the study’s
findings are thought-provoking, they require additional
validation and support before the conclusions can carry the
weight of evidence beyond opinion. Regardless, angiosomebased revascularization is associated with improved limb-salvage rates using endovascular and surgical approaches, so the
type of revascularization is less important than re-establishing
flow to the correct territory to promote wound healing.
80
62%
60
40
38%
20
9%
0
Direct (n=22)
Complete healing
InDirect (n=21)
Failed to heal
Conclusion
Rates of complete healing were superior among
patients who underwent direct revascularization
compared with indirect revascularization (P = 0.03,
Fisher’s exact test).3 Reprinted with permission.
Figure 2. Surgical outcomes comparing direct
and indirect revascularization
Preventing Critical Limb Ischemia
1. Taylor GI, Palmer JH.The vascular territories (angiosomes)
of the body: experimental study and clinical applications.
Br J Plast Surg. 1987;40(2):113–141.
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References
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On the surface, these findings might suggest endovascular
therapy’s role in CLI should be limited. However, it’s worth
noting many limitations on the general applicability of these
findings relative to real-world practice.
First, the trial suffers immediate obsolescence when published relative to modern endovascular care. Indeed, patients
currently treated endovascularly for CLI have the options of
treatment with many devices that might increase salvage and
patency rates, including atherectomy and covered, self-expanding stents (including the use of coronary drug-eluting stents for
tibial vessels, albeit off-label). Patients in the BASIL Trial were
treated with balloon angioplasty; a minority underwent endovascular stenting. Anatomic analysis of the angioplasty treatments suggested that few patients underwent tibial reconstruc-
CLI is the most severe form of PAD and carries a significant risk of amputation, morbidity and mortality. Revascularization in this setting is complex, as CLI is typically a function of multi-segmental disease, and patients generally have
significant comorbid conditions. The optimal strategy for revascularization — endovascular or via surgical bypass — remains an area of active research and debate, but ultimately is
a combination of lesion, patient, operator and local resource
characteristics. However, the angiosome concept provides an
important framework that guides the vascular caregiver to
choose the optimal target for re-establishing inline flow to
the ischemic distribution. A definitive randomized clinical
trial would provide an interesting challenge to this hypothesis but is unlikely to be performed. n
2. Rooke TW, Hirsch AT, Misra S, et al. 2011 ACCF/AHA
focused update of the guideline for the management of
patients with peripheral artery disease (updating the 2005
guideline): a report of the American College of Cardiology
Foundation/American Heart Association Task Force on
Practice Guidelines. J Am Coll Cardiol. 2011;58:2020–2045.
Supplement to Podiatry Today® and Vascular Disease Management®
Freedom from major amputation (%)
P=0.002
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100
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Amputation-free survival (%)
100
60
40
Direct
20
Indirect
0
0
12
24
36
48
60
40
P=0.02
Direct
20
Indirect
0
0
12
24
Months
36
48
Months
Number at risk
Number at risk
Direct group
118
61
27
15
8
Direct group
118
61
27
15
8
Indirect group
118
44
18
12
6
Indirect group
118
44
18
12
6
Reprinted with permission.4
Figure 3. Long-term outcomes in patients with CLI treated with direct versus indirect revascularization.
3. Neville RF, Attinger CE, Bulan EJ, et al. Revascularization
of a specific angiosome for limb salvage: does the target
artery matter? Ann Vasc Surg. 2009;23(3):367–373.
4. Iida O, Soga Y, Hirano K, et al. Long-term results of direct
and indirect endovascular revascularization based on the
angiosome concept in patients with critical limb ischemia
presenting with isolated below-the-knee lesions. J Vasc
Surg. 2011 Nov 1. [Epub ahead of print]
5. Bradbury AW, Adam DJ, Bell J, et al. Byass versus Angioplasty
in Severe Ischemia of the Leg (BASIL) trial: Analysis of
amputation free and overall survival by treatment received.
J Vasc Surg. 2010;51(Suppl 10):18S–31S.
6. Bradbury AW, Adam DJ, Bell J, et al. Bypass versus
Angioplasty in Severe Limb Ischemia of the Leg (BASIL)
trial: a survival prediction model to facilitate clinical
decision making. J Vasc Surg. 2010;51(Suppl 10):43S–51S.
7. Conte M. Bypass versus Angioplasty in Severe Limb
Ischemia of the Leg (BASIL) and the (hoped for) dawn
of evidence –based treatment for advanced limb ischemia.
J Vasc Surg. 2010;51(Suppl 10):69S–75S.
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Preventing Critical Limb Ischemia
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Holistic Patient Management:
Working With an Interventionalist
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Peter A. Soukas, MD, FACC, FSVM, FSCAI, RPVI, and Harold B. Glickman, DPM
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ritical limb ischemia (CLI) results from severe compromise of blood flow to the affected extremity
and manifests as rest pain, ulceration or gangrene.
It’s usually caused by multi-segmental obstructive
atherosclerosis, but may be caused by atheroembolic, thromboembolic or vasculitic disease (Table 1). With the staggering increase in the number of CLI cases, primarily due to
smoking and the diabetes pandemic, it’s vital that a dedicated
multidisciplinary team treat patients to save limbs and lives. A
successful team should feature a strong partnership between
the podiatrist and the interventionalist.
Persistent recurring
ischemic rest pain
Requiring opiate analgesics
for at least 14 days
Ulceration or gangrene of
the foot or toes
ABI < 0.40
Toe pressure < 30 mmHg
Systolic ankle
pressure < 50 mmHg
Flat pulse volume
waveform
Absent pedal pulses
Adapted from Norgren L, Hiatt WR, Dormandy JA, et al.
Inter-society consensus for the management of peripheral arterial disease
(TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1–75.
In 2003, more than 2.5 million Americans had CLI, and
there were more than 240,000 amputations in the United
States and Europe.1 Primary amputation was the initial treatment in 67% of these patients and, surprisingly, 50% were
performed without angiography or even an ABI.1
Risk factors for developing CLI include age (older than
65), hypertension, hyperlipidemia and abnormal ABI. The
most lethal risk factors for CLI are smoking and diabetes.
The number of cases of diabetes mellitus (DM) has swelled
from 30 million to 230 million in the last 20 years. Diabetes
increases CLI risk fourfold; smoking triples the risk.2 Diabetic patients with CLI are 10 times more likely to require
amputation than non-diabetics.3 Worldwide, a limb is lost
every 30 seconds to diabetes.4
Survival (%)
Scope of the Problem
Table 1. Critical Limb Ischemia Definition
Fate of the CLI Patient
Figure 1. Survival of patients with peripheral arterial
disease. Adapted from Norgren L, Hiatt WR, Dormandy JA, et
The CLI patient faces a poor prognosis, principally due
to death from cardiovascular and cerebrovascular disease. As
depicted in Figure 1, 25% will die within 1 year, and 50%
will die within 5 years. A year after initial presentation, 30%
are alive with amputation and, after 2 years, 15% will require
above-knee amputation, and 15% will undergo contralateral
amputation (Figures 2 and 3).5
100
80
Controls
60
40
IC
20
CLI
0
0
10
5
15
Follow up (years)
al. Inter-society consensus for the management of peripheral
arterial disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl
1:S1–75.
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Preventing Critical Limb Ischemia
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How Podiatrists and Interventionalists
Can Improve CLI Outcomes
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Primary care providers often don’t ask patients at risk for
CLI to remove their shoes and socks, nor do they perform
thorough pulse examinations or detailed vascular histories.
As such, podiatrists are frequently the first healthcare professionals to actually see CLI manifest.
Patients should be asked about their atherosclerosis risk factors and symptoms of claudication, and should fill out a walking impairment questionnaire, (e.g., the WHO/Rose or Edinburgh Claudication Questionnaire).6,7 In the physical exam,
document blood pressure in both arms, assess cardiac murmurs,
palpate for abdominal aortic and popliteal aneurysms, perform
a thorough pulse exam, and listen for bruits. CLI patients often
present with ischemic ulcers or gangrene. Ulcers above the ankle are frequently venous; foot ulcers may be neurotrophic due
to DM or underlying ischemia. Document ulcer size, location
and type. Promptly refer CLI patients to the interventionalist
for diagnostic evaluation and candidacy for revascularization.
Primary treatment
A year later
Medical
treatment only
25%
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CLI
resolved
25%
Primary
amputation
25%
Revascularization
50%
Continuing
CLI
20%
Dead
25%
Alive with
amputation
30%
Figure 2. Fate of patients presenting with CLI. Adapted from Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society consensus
for the management of peripheral arterial disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1–75.
Early
After 2 years
Contralateral
amputation
15%
2o healing
15%
Above-knee
amputation
15%
1o healing
60%
Perio
pera
t
deat ive
h
10%
Full mobility
40%
nee
Above-k on
ti
ta
u
p
m
a
15%
Dead
30%
Figure 3. Fate of patients with below-knee amputation. Adapted from Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society
consensus for the management of peripheral arterial disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1–75.
Diagnostic Evaluation
The primary goals of CLI treatment are to relieve ischemic
pain, heal ulcers, prevent limb loss, and improve function and
Supplement to Podiatry Today® and Vascular Disease Management®
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Treatment of CLI
quality of life for the patient. CLI patients who develop cellulitis or spreading infection require systemic antibiotic therapy.
Figure 4 presents a general treatment algorithm for the CLI
patient. Podiatrists are vital to implementing limb-loss prevention strategies including: education about self-care of the feet;
provision of conforming orthotics and shoes; and aggressive
wound care, such as debridement, dressings and skin grafting.
Before revascularization, all patients should undergo riskfactor modification, such as smoking cessation, statin therapy
to reduce LDL cholesterol to < 100 mg/dl, glucose control to
achieve HgA1c < 7.0%, BP <140/90 mmHg, BP < 130/80 if
diabetic or renal disease, and antiplatelet therapy with aspirin
or clopidogrel. Given the high prevalence of coronary artery
disease (CAD) in patients with CLI, evaluate for evidence of
CAD. Manage patients with clinical evidence of heart disease — as manifested by angina, congestive heart failure or
symptomatic arrhythmias — according to current guidelines.9
io
Diagnostic evaluation usually begins with an ankle-brachial
index (ABI). Evaluate toe pressure or transcutaneous oxygen
tension in patients for whom ABI may be unreliable (e.g., those
with medial calcinosis, DM or renal failure). Reduced ABI has
been shown to be a powerful predictor of future cardiovascular
events; the lower the ABI, the higher the risk.8 Duplex ultrasound and pulse volume recordings are useful for defining the
severity and level of disease, and to plan intervention. CT and
magnetic resonance angiographies can better evaluate aortoiliac and distal infrapopliteal diseases, respectively. If the patient
is deemed a candidate for revascularization, angiography can
be used to confirm the diagnosis and define treatment options.
Preventing Critical Limb Ischemia
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CLI confirmed
Not a candidate for
revascularization
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Candidate for
revascularization
Imaging (Duplex,
angiography, MRA,CTA)
Stable pain and lesion
Not-tolerable pain,
spreading infection
Revascularization
as appropriate
Medical treatment
(non-operative)
Amputation
Figure 4.
Adapted from Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society consensus for the management of peripheral arterial disease
(TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1–75.
Routine coronary revascularization in preparation for vascular
surgery or endovascular intervention isn’t recommended, except for individuals found to be at very high risk.10
10
Supplement to Podiatry Today® and Vascular Disease Management®
Revascularization Strategies
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Preventing Critical Limb Ischemia
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Multi-level disease is common in CLI.As such, general principles subscribe to first correcting inflow, and then outflow
with the goal of establishing in-line flow to the foot. More
recent guidelines call for providing direct flow to the ischemic
angiosome, the composite anatomic vascular territories of skin
and underlying muscles, tendons, nerves and bones, based on
segmental or distributing arteries.11 Successful wound healing,
whether accomplished by open bypass or endovascular therapy, is accomplished in 91% and 87% of patients, respectively, if
the proper angiosome is revascularized.12,13
The risk of the intervention and expected degree and durability of improvement determine the revascularization method.
CLI patients are often elderly with multiple comorbidities, and
the goal is not primary patency of the intervention, but limb
salvage. Endovascular techniques are therefore preferred for
most patients. Surgery is reserved for patients with failed endovascular procedures, long occlusive disease or recurrent restenosis, who are healthy enough to undergo open repair or bypass.
Primary amputation may be appropriate in cases of unreconstructable arterial disease, persistent infection, sepsis or in the
presence of paresis with an uncorrectable flexion contracture.
Specific endovascular techniques and devices are beyond
the scope of this paper. Generally, aortoiliac inflow disease
is treated with stenting because stents are more durable over
balloon angioplasty/percutaneous transluminal angioplasty
(PTA). Common femoral and ostial profunda femoris lesions
are best treated with local endarterectomy and patch angioplasty in patients who are good surgical candidates.
Infrainguinal lesions may require plaque-debulking technologies. For heavily calcified lesions, orbital atherectomy and
rotational atherectomy may be used alone or with PTA and
stenting. A plaque-excision atherectomy device may be used
to remove obstructive atheroma, particularly in arterial segments where stents are to be avoided, such as the common
femoral, profunda femoris, behind-the-knee popliteal and
tibial vessels. Laser atherectomy may be used to photoablate
plaque and is preferred for treating in-stent restenosis.
Infrainguinal vessels are often occluded in patients with
CLI. The development of dedicated chronic total occlusion
(CTO) devices has significantly increased the success rates
of CTO traversal, up to 90%, in our practice. They include
controlled-microdissection, ultrasound-energy-emitting and
spiral-wedge-turning devices. When these devices result in
subintimal passage, specialty-needle lumen-re-entry devices
allow wire access to the reconstituted true lumen.
PTA is reserved for short, focal lesions due to vessel recoil,
a high risk of restenosis and the risk of arterial dissections in
long, calcified lesions. Self-expanding nitinol stents provide
intravascular scaffolding and seal dissections after PTA, and
have proven to provide good short- and mid-term patency
in lesions up to 10 cm long. Covered stents efficaciously seal
perforations and treat longer segment lesions.This nitinol stent
is covered with a PTFE and has heparin covalently bonded to
the endoluminal surface.
Anatomic factors that limit patency include severity of disease in the run-off vessels, length of the stenosis/occlusion,
small vessel diameters and number of lesions treated. Adverse
clinical variables include DM, renal failure and ischemia severity. All patients undergoing endovascular treatment require
anti-platelet therapy with aspirin; clopidogrel is additionally
used in patients undergoing stent implantation.
Post-Revascularization Management
In our experience, podiatric and vascular interventionalist
practices complement one another. They not only can refer
patients back and forth, but prevent lower-extremity amputations in many diabetic and non-diabetic patients.
In the large urban area where we practice, it’s very easy to
find this type of approach to CLI. It might not be that way in
smaller communities. Either the podiatrist or interventionalist must take the initiative to start such a relationship. Don’t
hesitate to pick up the phone to discuss referring patients to
one another.This team approach is critical to preventing lowerextremity amputations, and patients’ lives may depend on it. n
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After revascularization, the interventionalist must communicate with his/her podiatric colleague to review the angiographic findings and revascularization procedures. The new
medical regimen is reviewed, and the timing of any additional
procedures is discussed. Coordination of wound care and adjunctive therapies — such as hyperbaric oxygen treatment,
systemic antibiotics and possible need for amputation — are
discussed and agreed upon.
The podiatrist again assumes the primary role in successful limb salvage. Pre- and post-revascularization, the podiatrist
treats the ulcer patient with offloading, achieved by several
methods, including shoe modifications, orthotics and casting
techniques. Although discussing each ulcer product in depth is
beyond the scope of this article, the principles of wound care
should be faithfully followed. Chief among them is removing
infected/necrotic tissue from the ulcer, treating infection, and
maintaining a moist environment to promote ulcer healing.
The interventionalist must routinely follow the CLI patient with ABI and duplex ultrasound surveillance to assess
the patency of the endovascular or surgical bypass site. Return
of claudication or rest pain, drop in ABI or elevated Doppler
velocities at the treated segment likely represents restenosis,
mandating prompt angiography and repeat revascularization
to avoid vessel re-occlusion.
The podiatrist can frequently recognize impending treatment site failure by noting slowed wound healing, worsening pulse exam, elevation pallor and dependent rubor, ulcer
growth, or new areas of ischemia on the toes and foot. In
such a case, the interventionalist should be contacted to assess
vessel patency.
Both the podiatrist and interventionalist should use every
office visit to reinforce risk factor reduction strategies, medication compliance, and engage patients in playing active roles in
their care. By partnering, the interventionalist and podiatrist
can save both limbs and lives.
Partnering for Interdisciplinary Care
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When the podiatrist recognizes and diagnoses CLI and
PAD, and there’s a lesion such as a wound on one or both
feet, the podiatrist should properly treat and debride the
wound, then refer the patient to the vascular specialist for
examination and treatment of the PAD. Similarly, the vascular interventionalist should refer the patient back to the
podiatric physician for continued treatment of the lowerextremity wound. This is the ideal path for overcoming the
patient’s disease state.
To that end, it’s critical that the podiatric physician who
has diagnosed CLI and PAD maintain a working relationship
with the vascular interventionalist.This relationship should be
based on competency, knowledge, trust and friendship. Faceto-face contact between the podiatrist and interventionalist is
the easiest and best way to start a working relationship.
References
1. Allie DE, Hebert CJ, Lirtzman MD, et al. Critical limb ischemia: a global
epidemic. A critical analysis of current treatment unmasks the clinical
and economic costs of CLI. EuroIntervention. 2005;1:75–84.
2. Dormandy J, Verstraete M, Andreani D, et al. Second European consensus document on chronic critical leg ischemia. Circulation. 1991;84(Suppl
4):1–26.
3. DeBakey ME, Crawford ES, Garrett E, et al. Occlusive disease of
the lower extremities in patients 16 to 37 years of age. Ann Surg.
1964;159:873–890.
4. International Working Group on the Diabetic Foot, available at www.
iwgdf.org
5. Norgren L, Hiatt WR, Dormandy JA, et al. Inter-Society Consensus
for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc
Endovasc Surg. 2007;33 Suppl 1:S1–75.
6. Rose G, McCartney P, Reid DD. Self-administration of a questionnaire on chest pain and intermittent claudication. Br J Prev Soc Med.
1977;31(1):42–48.
7. Leng G, Fowkes F. The Edinburgh claudication questionnaire: an improved version of the WHO/Rose questionnaire for use in epidemiological surveys. J Clin Epidemiol. 1992;45(10):1101–1109.
8. Resnick HE, Lindsay RS, McDermott MM, et al. Relationship of high and
low ankle brachial index to all-cause and cardiovascular disease mortality:
the Strong Heart Study. Circulation. 2004;109(6):733–739.
9. Eagle KA, Berger PB, Calkins H, et al. ACC/AHA guideline update
for perioperative cardiovascular evaluation for non-cardiac surgeryexecutive summary: a report of the American College of Cardiology/
American Heart Association Task Force on Practice Guidelines. J Am
Coll Cardiol. 2002;39(3):542–553.
10. McFalls EO, Ward HB, Moritz TE, et al. Coronary artery revascularization before elective major vascular surgery. N Engl J Med.
2004;351(27):2795–2804.
11. Taylor GI, Palmer JH. The vascular territories (angiosomes) of the
body: experimental study and clinical applications. Br J Plast Surg.
1987;40(2):113–141.
12. Neville RF, Attinger CE, Bulan EJ, et al. Revascularization of a specific
angiosome for limb salvage: does the target artery matter? Annals of
Vasc Surg. 2009;(3):367–373.
13. Iida O, Nanto S, Uematsu M, et al. Importance of the angiosome concept for endovascular therapy in patients with critical limb ischemia.
Catheter Cardiovasc Interv. 2010;75(6):830–836.
Preventing Critical Limb Ischemia
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Amputation Prevention:
A Multidisciplinary Approach
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J. A. Mustapha, MD, FACC, FSCAI; Desmond Bell, DPM, CWS; Yazan Khatib, MD, FACC, FSCAI, FSVMB,
FABVM; Fadi Saab, MD; Carmen M. Heaney, BSN, RN, CCRC, CIP
A
mputation is no longer an acceptable first option
for patients with critical limb ischemia (CLI). This
is primarily because rapidly evolving technology, including less-invasive endovascular and hybrid (combined surgical and endovascular) procedures, and
clinical follow-up with podiatry and wound care specialists
are more likely to lead to amputation prevention. Due to
post-amputation consequences, immediate revascularization
should be the first step in treating patients with CLI to prevent the comorbidity associated with limb loss.
Unfortunately, this primary goal is achieved in only a minority of patients. In a recent series, only 40% of patients
with CLI received prompt revascularization.1 This low rate
is explained partly by late referrals and the fact there’s no
agreed upon definition of a non-salvageable limb.
With currently available, swift vascular therapeutic options,
the issue remains how to identify and refer CLI patients early
to ensure the complete benefit of early revascularization in
conjunction with podiatric, wound care and diabetic specialists. The answer lies in a multidisciplinary team approach,
which we believe has been shown to lower amputation rates.
Evolution of Centralized Care
The term “wound care center” was not part of the specialty’s vocabulary as recently as approximately 20 years ago.The
Patients
enter
the cycle
Initiate
revascularization
plan
Figure 1. In a multidisciplinary therapeutic treatment
flow, the cycle of therapy does not always start in the
office of the same specialist.
12
Preventing Critical Limb Ischemia
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Non-invasive and
physical testing
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Initiate
pharmacological
treatment plan
Evaluated by
health care
provider
concept of a central location where individuals with chronic
or non-healing wounds could receive intensive care and advanced treatment has gone from a novel medical concept to
a well-established service and has become a common term
in the process. By taking the team approach found in other
areas of medicine (stroke teams, burn teams) and applying
it to wound care, we have not only improved outcomes for
many suffering patients, but raised the bar by creating a demand for greater research, clinical practice, standardization
and improved outcomes.
The team approach to wound care has been validated
through retrospective analyses and the number of positively
affected lives. Evidence has shown that a team approach to
managing diabetes is an effective way to avoid or postpone
the onset of serious complications.2 The Nashville, TN,
Department of Veterans Affairs Medical Center used the
Preservation Amputation Care and Treatment program and
demonstrated a 40% decrease in the number of lower-extremity amputations over the past 5 years. The program has
decreased the costs of pharmaceuticals by 48%, lab studies
by 32% and inpatient bed days by 44%.3 Concomitant to the
team approach, lower-extremity preservation and the use of
limb salvage, limb preservation and amputation prevention
has increased.
The acute risk of mortality and morbidity facing patients
with CLI necessitates critical urgency for limb preservation,
particularly given the aging population and the number of patients with diabetes increasing at an alarming rate, both in the
United States and worldwide. The financial impact and the inherent issues associated with lower-extremity amputation compound the importance of lower-extremity preservation.
Patients suffering from non-healing, lower-extremity
wounds and CLI often have multiple comorbidities requiring multiple specialties. Patients with CLI are among the
most complicated to treat and, as a result, a specialized team
is best suited for managing limb-threatening complications.
Better understanding of the need for limb preservation
and development of breakthrough technologies have given
rise to a concept similar to that of wound care centers —
increasingly referred to as limb-salvage, limb-preservation or
amputation-prevention centers. This model inherently incorporates the need for a team approach. Not that the team
members need work under the same roof. Rather, the concept should be community-centered — whether hospitalSupplement to Podiatry Today® and Vascular Disease Management®
AMPUTATION
CLI Patient Entry Into
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Multidisciplinary Cycle
PREVENTION
Working together from
diagnosis through treatment
and rehabilitation, a team of
specialists, working as a multidisciplinary team, can achieve
the mutual goal of best patient
outcome.
The CLI patient can enter the
treatment cycle via any
specialty including vascular,
wound, podiatry, orthopedics,
infectious disease, and primary
care.
Team Approach to
Follow Up
• CLI Patient Presents to
any Specialist
• Physical Evaluation
• Noninvasive Evaluation
• Selective Angiography
• Medical Therapy
• Wound Therapy
• Rehabilitation
• Patient Education
• Prevention
• Surgical Approach
• Versus Endovascular
Approach
• Versus Hybrid Approach
Amputation
Prevention
Revascularization
Strategy Determined
Figure 2. Cyclical course of limb-salvage therapy
based, private-practice-based or a combination — to develop
processes for screening, evaluation, treatment and follow-up,
with the collective goal of achieving the best outcomes.
The Multidisciplinary Team
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Members of the multidisciplinary limb preservation team
include those typically found in a wound care team or center.
The members include primary care physicians, podiatrists,
nurse practitioners, physician assistants, internists, hospitalists, cardiologists (interventional and non-interventional),
vascular surgeons, radiologists (interventional and noninterventional), infectious disease specialists, DM specialists, endocrinologists, plastic surgeons, orthopedic surgeons,
nephrologists, neurologists, nurses, case managers, physical
therapists, certified pedorthitists, patient caregivers and, most
importantly, patients themselves.
The team approach can be summarized by three points: a
high level of primary medical team awareness; dedicated foot
clinics; and inclusion of multiple disciplines.4 The care provided by the disciplines should coordinate diagnosis, offloading,
preventive care and revascularization procedures; aggressively
treat infections; and manage medical comorbidities.5
An invasive vascular specialist incorporates the necessary
diagnostic modalities and endovascular/surgical therapies to
provide an inside-out approach to restoring the blood flow
to the affected wound. Angiography plays a vital role in the
decision-making process of a vascular specialist.
The role of the podiatrist is paramount to the success of
any multidisciplinary limb-preservation team. Podiatrists
serve as the front line in identifying those at increased risk
for amputation, and their surgical expertise often is the difference between the amputations of a toe and a higher-level
amputation, such as below the knee or higher.
Communication with other members of the team often
begins with the podiatrist, who must know when to make
appropriate referrals, especially when moderate to severe
Preventing Critical Limb Ischemia
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250
ULCER
200
GANGRENE
TOTAL CLI-
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150
tionalist (cardiologist, vascular surgeon or radiologist) should
be mutually beneficial and ultimately benefit patients at high
risk for amputation.
In a multidisciplinary therapeutic treatment flow, the cycle
of therapy does not always start in the office of the same specialist (Figure 1). A patient with CLI may enter the multidisciplinary cycle via a podiatry office, primary care practitioner, wound clinic or vascular specialist. Whatever the point
of entry into the cycle (Figure 2), the patient should receive
the appropriate care each specialist can offer.
AKA
100
BKA
TOTAL AMP
50
TOTAL SALVAGE
0
2004
2005
2006
2007
2008
Projection
ULCER
87
65
43
126
172
GANGRENE
36
26
29
43
32
TOTAL CLI-
123
91
72
169
204
AKA
22
19
20
28
20
BKA
28
17
18
19
24
TOTAL AMP
50
36
38
47
44
TOTAL SALVAGE
73
55
34
122
160
Approach to Patient Evaluation
The success of a patient’s experience (including evaluation,
therapy and recovery) who presents with critical limb ischemia requires a collaborative approach to all aspects of care
using the following criteria.
Based on ICD-9 codes for Ischemia 440.20 and Ischemia Gangrene 440.24
Data courtesy of the article authors
Figure 3. Outcomes based on ICD-9 codes for ischemia
440.20 and ischemia with gangrene 440.24.
Memorial Hospital of Jacksonville Amuputation
and Salvage Rate 2004-2008
90%
80%
70%
60%
50%
% Amputee
% Salvage
40%
30%
20%
10%
0%
2005
2006
2007
2008
41%
39.50%
53%
27%
21%
% Salvage
59%
60.50%
47%
73%
79%
Based on ICD-9 codes for Ischemia 440.20 and Ischemia w/Gangrene 440.24
ns
Data courtesy of the article authors
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2004
% Amputee
Thorough Physical Exam
The physical examination can significantly increase the
diagnostic accuracy in patients evaluated for suspected PAD.
A systematic approach using palpation, auscultation and inspection is quite effective. Blood pressure should be measured in both arms.The examiner should palpate the femoral,
popliteal, dorsalis pedis and posterior tibial pulses, and note
the amplitude and symmetry in each territory. Carefully inspect the extremities and note the color (e.g., cyanosis, pallor), temperature, distribution of hair growth, and presence of
trophic skin or muscle changes.
PAD and CLI remain clinical diagnoses that should be
classified for severity according to either the Rutherford
or Fontaine classification. Multiple modalities can aid CLI
diagnosis, particularly when examining peripheral pulses at
baseline. A provider who is unable to palpate pulses should
document the pulse by an arterial doppler (triphasic, biphasic, monophasic). An ankle-brachial index (ABI) is an adequate starting point to assess the significance of the disease.
An ABI test can be easily performed and interpreted by the
performing discipline. A transcutaneous partial pressure of
oxygen (TcPO2) is another measurement that can be used in
a podiatry or wound clinic setting. A TcPO2 less than 30–50
mmHg is consistent with CLI and poor healing. Currently
available technology lets skin-perfusion pressure be done
within 4 minutes and doesn’t require the recalibration needed with older-generation TcPO2 machinery. Skin-perfusion
pressure should be routinely measured in all patients with
Rutherford grades IV–VI.
peripheral arterial disease (PAD) is suspected or observed.
Developing a working relationship with a vascular interven-
Computerized Tomography and Magnetic Resonance Angiographies
Computerized tomography angiography (CTA) and magnetic resonance angiography (MRA) are two noninvasive
modalities that can, despite their limitations, better define
the vascular anatomy of patients with CLI.
Multiple studies have demonstrated that CTA of the ex-
14
Supplement to Podiatry Today® and Vascular Disease Management®
Figure 4. Outcomes based on ICD-9 codes for ischemia
440.20 and ischemia with gangrene 440.24.
Preventing Critical Limb Ischemia
Image courtesy of the article authors
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tremities accurately detects arterial occlusions and stenosis
> 50%.5 CTA usually requires an IV injection of 100–200
ml of iodinated contrast, and exposure to radiation. CTA is
limited by poor visualization of vessels with heavy calcification, artifact from stented vessels, venous opacification, and
decreased spatial resolution when compared to digital subtraction angiography.
MRA with gadolinium contrast enhancement is very effective for diagnosing the anatomic location and degree of
stenosis in PAD. A recent meta-analysis demonstrated MRA’s
superior accuracy compared to arterial duplex ultrasound in
detecting arterial stenosis > 50%.6 Limitations of MRA include mainly an overestimation of the degree of stenosis due
to turbulence, artifact due to metal clips, and association of
gadolinium toxicity in patients with renal insufficiency.
Arteriogram With Run-Off
Arteriogram (or CTA, MRA) with run-off to the digital
branches of the foot is done primarily to evaluate the aortoiliac and superficial femoral arteries. Arteriogram has shown
to less accurately visualize the tibial arteries and their collaterals, especially, the communicating collaterals. The pedal
vessels are also under-visualized in most cases. In the authors’
opinion, retrograde angiography using tibial access might
highlight different vascular conduits.
Selective Angiography
Selective angiography with and without vasodilators must
be performed. Amputation should never be recommended
without having performed combined antegrade retrograde
selective angiography.
Supplement to Podiatry Today® and Vascular Disease Management®
sue. Antegrade angiosome arterial mapping defines whether
blood perfusion is reaching the target tissue via direct or
indirect arterial flow. In our experience, a long tibio-pedal
CTO can easily be reduced to a short-segment CTO just by
adding a retrograde angiogram via tibio-pedal access.
Treatment
Interdisciplinary discussions and referrals, advances in
pharmacological therapy and wound care treatment, and
more successful foot surgery provide more options for treating complex disease. Excellent femoral, tibial and hybrid endovascular procedures provided by multiple specialties have
improved revascularization success in critically ischemic
limbs that otherwise would have been unsalvageable a few
years ago.
ns
Angiosome Mapping
Cutaneous and arterial angiosome mapping is easy to perform. Cutaneous angiosome is straightforward and should be
done on all patients with Rutherford V and VI ischemic tis-
Figure 5. An arteriogram is done primarily to evaluate
the aortoiliac and superficial femoral arteries.
io
Tibio-pedal Access and Angiography With and Without Vasodilators
This is an absolute must in all CLI cases previously deemed
not salvageable. The data collected from retrograde access almost always changes the therapy path from major amputation to either minor or no amputation. Another important
element is determining the true lesions and lesion lengths. It
lets operators accurately visualize the length of the chronic
total occlusion (CTO).
A single tibial access angiogram usually opacifies most of
the tibial arteries and their branches. The antegrade flow is
delayed to the tibio-pedal bed due to either high-grade stenosis or CTO. This causes low-pressure states in the tibiopedal vessels distal to the lesion, which can cause vasospasm
and a low-flow state, which causes it not to fill the entire
length of its patent vessel. This appears to be a long CTO
when the reality is a short CTO or subtotal occlusion.
Outcomes/Follow-Up
It’s difficult to identify objective performance goals in patients with CLI. The Society of Vascular Surgery has pro
Preventing Critical Limb Ischemia
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Image courtesy of the article authors
Image courtesy of the article authors
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Figure 6. Selective angiography with and without
vasodilators must be performed.
Figure 7. A single tibial access angiogram usually
opacifies most of the tibial arteries and their branches.
Successes of the Team Approach
System changes have had a major impact on management
of the diabetic foot during the past decades. Comprehensive multidisciplinary foot-care programs have been shown
to increase quality of care and reduce amputation rates by
36% to 86%.8
Take, for example, the work of the Save a Leg, Save a Life
Foundation. The foundation — originally a local, informal,
lunch-and-learn/journal club — was later incorporated as
a non-profit. Its primary purpose is to increase education
among healthcare providers, specifically in wound care and
PAD. Through a series of local meetings, initially focusing
on home health nurses, the message quickly spread to other
providers who were similarly interested in these topics. In
approximately 1 year, the group grew from 15 members to
more than 100.
The regular gatherings began to form relationships within
the community. In turn, these relationships positively affect-
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Preventing Critical Limb Ischemia
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posed the use of major adverse limb events (MALEs) as
a primary end-point to determine such goals.7 MALEs
include amputation or any major vascular intervention
with 30 days. With the rapidly evolving techniques and the
significant impact of revascularization on a patient’s life,
clinical trials should focus on quality of life as a primary
measure to evaluate outcomes.
Podiatrists and wound clinics should closely follow up
with CLI patients who undergo complex revascularization.
It’s important to document treatment response and the
healing process, particularly in patients with non-healing
foot ulcers. There are multiple questionnaires that can help
with this. By the same token, deterioration or therapy failure can be recognized by the patient’s wound care specialist or podiatrist, and triage to appropriate therapy can be
initiated. Reasonable follow-up modalities include postprocedure ABIs, screening arterial Doppler ultrasound and
measuring tissue oxygenation.
ed quality of care. The desire to quantify this impact was the
impetus for gathering data regarding lower-extremity amputation rates for the period from 2 years before and 2 years
after the organization’s founding.
Data were obtained from the Agency of Health Care Administration, the Duval County Department of Health (Jacksonville, FL) and local hospitals, and amputation rates for the
4-year period were analyzed (Figure 3). The most striking
data revealed some unanticipated and significant findings,
centering on Memorial Hospital of Jacksonville. Among our
conclusions were that the multidisciplinary approach, expedited by regular educational meetings, helped develop relationships — and the teams within a community had lowered
amputation rates and increased limb-salvage rates (Figure 4).
In Singapore, the LEAP (lower extremity amputation
prevention) group showed its multidisciplinary approach to
amputation prevention resulted in a lower amputation rate
(29% versus 76 %, P = 0.00001), lower related death rate (1%
versus 19 %, P = 0.00001) and fewer in-hospital days per
patient (17.8 days versus 23.16 days, P = 0.048) as compared
to the standard clinical practice group.9
The LEAP strategy also generated significant cost savings per patient during admission when compared with the
pre-LEAP approach. The LEAP strategy dominated standard
practice in the management of patients with DM and CLI.
In essence, the implementation of this multidisciplinary approach significantly improved patient outcomes and reduced
hospital stays.9
References
Conclusion
7. Conte MS. Technical factors in lower-extremity vein bypass surgery: how can we improve outcomes? Semin Vasc
Surg. 2009;22(4):227–233.
1. O’Hare AM, Bertenthal D, Sidawy AN, et al. Renal insufficiency and use of revascularization among a national
cohort of men with advanced lower extremity peripheral
arterial disease. Clin J Am Soc Nephrol. 2006;1(2):297–304.
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4. Bass A. [Prevention is the name of the game]. Harefuah.
2010;149(12):782–3, 811. Hebrew.
5. Ofer A, Nitecki SS, Linn S, et al. Multidetector CT angiography of peripheral vascular disease: a prospective
comparison with intraarterial digital subtraction angiography. Am J Roentgenol. 2003;180(3):719–724.
6. Visser K, Hunink MG. Peripheral arterial disease:
gadolinium-enhanced MR angiography versus color-guided duplex US — a meta-analysis. Radiology.
2000;216(1):67–77.
8. Sanders LJ, Robbins JM, Edmonds ME. History of the
team approach to amputation prevention: pioneers and
milestones. J Am Podiatr Med Assoc. 2010;100(5):317–334.
9. Tan
ML, Feng J, Gordois A, Wong ES. Lower extremity
amputation prevention in Singapore: Economic analysis
of results. Singapore Med J. 2011;52(9):662–668
10. Ziegler-Graham K, MacKenzie EJ, Ephraim PL, et al. Estimating the prevalence of limb loss in the United States:
2005 to 2050. Arch Phys Med Rehabil. 2008;89(3):422–429.
11. Gardner
BA, Chenchen H, Sing H, Adams G. Amputation
as a last resort. A look at critical limb ischemia and the
treatment options available before amputation is the only
remaining option. Endovasc Today. 2011;10(8):38–44.
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3. Hinkes M. Diabetes: taking steps to prevent amputation. Lower Extremity Review. August 2009. Available
from www.lowerextremityreview.com/article/diabetestaking-steps-to-prevent-amputation
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Approximately 30,000 to 40,000 Americans undergo amputation annually. In 2008, an estimated 1.6 million Americans were living with an amputation, and it is estimated that
by 2050, 3.6 million will be living with an amputation.10
With the advancements described herein, does it make sense
to perform major amputations (above- or below-knee) without fully evaluating other options? We emphatically say “No.”
In addition, we’re facing a major ethical dilemma. Many
limb-salvage specialists are successfully revascularizing patients who have been told they had no options. Unfortunately, many of these patients had received gloomy recommendations without the benefit of an adequate evaluation
(selective angiography, etc.). Today, no patient should undergo amputation without a full amputation-prevention assessment followed by attempted revascularization using the appropriate surgical, endovascular or hybrid approach. In short,
amputation should be the treatment of last resort, used only
when all other options have been exhausted, and should be
described as treatment failure.11 n
2. Agency for Healthcare Research and Quality. Improving
care for diabetes patients through intensive therapy and a
team approach. Research in Action. 2001:2:1–12. Available
from 2http://www.ahrq.gov/research/diabria/diabetes.htm
Preventing Critical Limb Ischemia
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Diagnosing CLI:
The Role of the Podiatrist
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Joseph Caporusso, DPM
D
iagnosing a patient with critical limb ischemia
(CLI) requires the podiatrist to perform a detailed
history along with physical, vascular laboratory
and possible referral angiographic examinations.
Although the evaluation is not as urgent with CLI as it is
in acute limb ischemia, thoroughly evaluating each of these
areas in a semi-urgent manner can prevent tissue loss and a
more distal amputation (should it come to that).
History and Initial Physical Evaluation
Palpation of Pulses
Figure 1. An ominous sign of peripheral aterial disease/
critical limb ischemia is when subcutaneous tissue
atrophy can be seen at the ends of the toes.
Figure 2. Atrophy and loss of subcutaneous-tissue elasticity prevent rebounding of the subcutaneous tissues
when pressure is applied to end of the toe ­­— much like
an over-baked potato that has lost its shape.
Preventing Critical Limb Ischemia
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Image courtesy of Joseph Caporusso, DPM
Palpation of the lower-extremity pulses is another aspect
of the physical exam necessary for diagnosing CLI. Although
there are several grading systems for lower-extremity pulses
— such as the four-level grading system — a simple “palpable” or “not palpable” will suffice. The literature has reported variance between clinicians when palpitating pulses.2
There may be times when one clinician believes a pedal
Image courtesy of Joseph Caporusso, DPM
The patient’s presentation history plays an important role in
the evaluation of CLI. The onset of the disease process needs
to be known to help differentiate CLI from acute limb ischemia. This distinction is quite important, because the prognosis, evaluation and treatment differ between the two scenarios.
An abrupt change in foot color — bluish discoloration, with
an acute onset of foot pain — could very well point to an
acute ischemic event of that lower limb. These events, compared to the more chronic in nature CLI changes, must be
treated as an acute emergency to avoid limb loss.
The vascular history should include evaluation for arterial
disease in other sites (e.g., carotid, coronary), global risk factors
for atherosclerosis, and history of trauma or other incident that
may have caused skin breakdown. Shoe wear can be the inciting element and should be evaluated both in the history and
the exam. Patients who have exhibited CLI symptoms previously remain at risk for recurrent symptoms or signs of CLI.
Prior bouts of CLI, along with their treatments and outcomes,
can assist the clinician with the current episode.1
The physical examination of the lower extremity with suspected CLI begins with an overall perusal of the bilateral
lower extremities. Signs of chronic ischemia include dependent rubor, lack of hair growth, pallor on elevation, atrophic
shiny skin, nail dystrophy and delayed capillary refill time.1 In
our experience, an ominous sign of peripheral aterial disease
(PAD)/CLI is when subcutaneous tissue atrophy can be seen
at the ends of the toes (Figure 1). The atrophy and the loss of
elasticity of the subcutaneous tissues prevent rebounding of
the subcutaneous tissues when pressure is applied to the end
of the toe. We liken this sign to a baked potato that has been
over-baked and lost its shape (Figure 2).
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Figure 3. Duplex ultrasound can be used to provide patency information after femoral-popliteal bypass using a
venous conduit.
Image courtesy of Joseph Caporusso, DPM
pulse can be felt, while another clinician doesn’t. This subjectivity is to be considered when palpating pedal pulses.
Note that both the posterior tibial and the dorsalis pedis
arteries have accepted rates of anatomical absences.2
Capillary refill time is another indication of PAD/
CLI. The longer it takes the capillaries to refill after the
application of pressure indicates the presence of vascular
disease. Less than three seconds indicates a normal capilliary
refill time.3
Ulceration Classification
Vascular Laboratory and Imaging
The vascular laboratory can further help the clinician
evaluate the patient with suspected CLI. Arterial duplex ultrasound of the lower extremities can diagnose the anatomic
location and degree of stenosis present in a peripheral artery.
Duplex ultrasound can be used to provide patency information after femoral-popliteal bypass using a venous conduit
(Figure 3). This examination of the extremities can also be
used to select candidates for endovascular intervention, surgical bypass and selection of surgical sites for anastomosis.
More advanced and invasive tests such as computerized tomography angiogram (CTA), magnetic resonance angiogram
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The calculation of an ankle brachial index (ABI) is the
next step in evaluating the patient with CLI. The ABI has
been reported to be 95% sensitive to and 99% specific for
PAD.4 Performing the ABI helps define the at-risk population clinically and epidemiologically. An ABI index of less
than or equal to 0.40 is consistent with CLI.1,4
Although a very useful test, the ABI does have limitations.
First, when there are incompressible arteries, the ABI can
be falsely elevated. In such cases, use the toe brachial index
to provide more information regarding the PAD/CLI spectrum. The ABI also isn’t designed to define the degree of
functional limitation. Segmental pressures and pulse-volume
recordings in conjunction with the ABI can provide the clinician with further information.
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Any ulceration that’s present should be classified as to
its etiology. Distinction should be made between ischemic
(arterial), neuropathic, mixed and venous ulcerations. Determining classification is extremely important to ensure
appropriate treatment of the ulceration. Each type of ulceration has a unique presentation, letting the clinician differentiate one from another.
Ischemic (arterial) ulcerations occur at the ends of the
digits and in the heel area.They’re usually extremely painful,
although some patients who have diabetes and peripheral
neuropathy may not experience the pain associated with
these ulcerations. The ulcer base demonstrates an unhealthy
appearance with necrosis present. A hyperkertotic rim isn’t
usually associated with an arterial ulcer. Rather, the neuropathic ulceration presents with a base that is granular and
healthy in appearance, usually with a hyperkeratotic rim or
covering that rules out a purely ischemic ulcer.
Calculating the Ankle Brachial Index
Preventing Critical Limb Ischemia
19
cular specialist is paramount to successful outcomes.The treatment of CLI and its pedal complications is yet another example of how the multidisciplinary team approach yields the
best results. The podiatrist, working in conjunction with the
vascular team, affords the patient the necessary holistic care. n
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(MRA) and traditional contrast angiography can be used to
further detail the extent of the PAD. Each exam has its pros
and cons. A complete description is beyond the scope of this
work, but a cursory view will be given of each.
The angiographic image produced by CTA is constructed
by multiple cross-sectional images, and then presented in
a projection similar to that of a standard arteriogram. This
projection can be rotated three dimensionally to view any
oblique projection, a potential diagnostic advantage when
compared to catheter angiography. A possible disadvantage
of CTA versus catheter angiography is the lower spatial resolution. CTA does offer patients with pacemakers, defibrillators, metal clips stands and prostheses an alternative to MRA.
CTA also has a higher resolution than MRA, which can provide images of calcification within the vessel wall. CTA scan
times are significantly faster than those of MRA.
MRA is based on imaging the arteries similar to standard arteriography, and has evolved and improved over
the years. MRA accuracy depends on the technique used
and the standard against which it’s compared. The MRA
literature provides somewhat mixed results compared to
catheter angiography.4
Contrast angiography has been considered the gold standard
for defining both normal and abnormal vascular anatomy. It’s
widely available and the most used technique, partly because
physicians can easily interpret the images. The addition of
digital subtraction techniques enhances image quality to allow
better detection of abnormalities. The technological advances
in angiography instrumentation have further enhanced the
patient safety profile of this technique, although potential
complications remain. These include bleeding, infection,
vessel disruption, contrast reaction and nephrotoxicity. Less
common complications could include artheroembolization,
dissection, and vessel wall disruption or perforation.4
The choice of an advanced or invasive arterial angiographic
technique may depend on availability on instrumentation/
devices, physician experience and regional practice preferences.
References
1. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, et al. Inter-society consensus for the
management of peripheral arterial disease (TASC II). J Vasc
Surg. 2007;45(Suppl S):S5–S67.
2. Kazmers A, Koski ME, Groehn H, et al. Assessment of
noninvasive lower extremity arterial testing versus pulse
exam. Am Surg. 1996;62(4):315–319.
3. Ikem R, Ikem I, Adebayo O, Soyoye D. An assessment of
peripheral vascular disease in patients with diabetic foot
ulcer. Foot (Edinb). 2010;20(4):114–117.
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Conclusion
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When it comes to the treatment of foot ulceration and/or
gangrene caused by CLI, the podiatric physician plays the role
of both diagnostician and interventionalist. Many times, the
podiatric physician is the first to discover the effects of CLI
on the feet and, in doing so, sets the necessary mechanisms in
motion to help the patient. Coordination of care with the vas-
4. Hirsch AT, Haskal ZJ, Hertzer NR, et al; American Association for Vascular Surgery; Society for Vascular Surgery;
Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society
of Interventional Radiology; ACC/AHA Task Force on
Practice Guidelines; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart,
Lung, and Blood Institute; Society for Vascular Nursing;
TransAtlantic Inter-Society Consensus; Vascular Disease
Foundation. ACC/AHA 2005 guidelines for the management of patients with peripheral arterial disease (lower
extremity, renal, mesenteric, and abdominal aortic): executive summary a collaborative report from the American
Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task
Force on Practice Guidelines (Writing Committee to
Develop Guidelines for the Management of Patients With
Peripheral Arterial Disease) endorsed by the American
Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society
for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. J Am Coll Cardiol.
2006;47(6):1239–1312.
Preventing Critical Limb Ischemia
Comprehensive Wound
Care Management
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Rasesh M. Shah, MD, FACS, and John Steinberg, DPM, FACFAS
P
eripheral arterial disease (PAD) affects nearly 9 million Americans and significantly increases the risk
of heart attack, stroke, and death in that population.
PAD can present as leg pain that’s often mistakenly
attributed to old age or arthritis. The most serious presentation of PAD is critical limb ischemia (CLI), defined as ischemic rest pain or tissue loss present for more than 2 weeks and
arterial insufficiency corroborated by objective testing (see
below). Approximately 300,000 patients a year present with
this advanced degree of ischemia in the United States. Patients
presenting with CLI face a prognosis worse than that of many
cancers (Figure 1), yet CLI is often underdiagnosed and not
aggressively treated.
Two demographic features suggest that the prevalence of
CLI will increase over the next two decades. First, the number
of persons 65 or older is expected to increase from 46 million
to 80 million.1 Aging alone may account for a nearly 50%
increase in the number of patients presenting with CLI.2 Second, as the incidence of diabetes mellitus continues to increase,
so too will the number of patients with CLI. Optimum care
of these patients needs to be multidisciplinary. These patients
must have very aggressive treatment of all atherosclerotic risk
factors, expeditious revascularization, and meticulous wound
management to achieve the ultimate goal of limb salvage.
Restoration of Inflow
The pathophysiology of CLI is quite simple. Tissue nutritive demand is greater than the supply, with arterial lesions
limiting perfusion of the affected area. This typically occurs
in patients with multi-level occlusive disease that affects the
aortoiliac, femoral-popliteal, and tibial segments. Microcirculatory defects can also affect flow-regulatory and defense
mechanisms. There’s often a combination of contributing
factors, including endothelial dysfunction, altered hemorheology and activation of white blood cell count with inflammation. CLI therapy’s goals are relieving ischemic rest pain,
healing the wound, preventing limb loss, and improving patient function/quality of life.
Adequate tissue perfusion is necessary for healing ischemic
ulcerations. Restoration of inflow must take priority over attempted wound healing or tissue debridement unless there is
concern for deep or ascending infection with systemic signs.
Objective criteria for defining ischemia include ABI < 0.50,
ankle systolic pressure < 50 mm Hg, toe systolic pressure <
30 mm Hg, and transcutaneous oxygen tension <30 mm Hg.
The presence of even one of these factors in a patient with
a non-healing, lower-extremity wound should dictate that
revascularization be achieved to ensure healing.
The natural history of ischemic wounds has been studied
Within 3 months
of presentation
Amputation
12%
2 years
21%
Mortality
9%
3 years
31.6%
5 years
50%
10 years
70%
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Myocardial
infarction
1%
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Presistent CLI
18%
Mortality
Cerebral
Vascular accident
1%
Figure 1. Prognosis for patients with critical limb ischemia. Adapted from Norgren L, Hiatt WR, Dormandy JA, Nehler
MR, Harris KA, Fowkes FG, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). J
Vasc Surg. 2007;45(Suppl S):S5–S67.
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Preventing Critical Limb Ischemia
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Figure 2. Revascularization of a patient with gangrene of the dorsum of the foot and toes.
Images courtesy of Rasesh M. Shah, MD, and John Steinberg, DPM, FACFAS
Meticulous wound care is a must. Revascularization alone
— without good wound management — has been shown to
result in a 5% to 7% major amputation rate.6,7 Accordingly, we
developed the following therapeutic algorithm:
1. Aggressive debridement of all devitalized tissues.
2. Culture based antibiotic therapy
3. Expeditious revascularization
4. Advanced wound care therapies as appropriate
5. Hyperbaric oxygen therapy as appropriate
6. Podiatric treatment with minor amputations and excision
of osteomyelitis
7. Cessation of weight-bearing on the areas being treated
Resumption of weight-bearing/ambulation only with
8. offloading and appropriate support/foot orthotics.
Fortunately, an array of advanced wound-healing technology is widely available to help turn the tables in favor of limb
salvage. These technologies include bioengineered alternative
tissues, advanced surgical procedures, negative pressure wound
therapy, hyperbaric oxygen therapy, topical growth factors, and
advanced active dressings and topical care. In addition, our
ability to offload pressure in patients with weight-bearing and
decubitus ulcerations has significantly improved.
While detractors may criticize the expense of these newer
technologies, we would encourage decision-makers to first review the costs of non-healing ulcerations and amputations to
our healthcare system. For example, we already know that an
average diabetic foot ulcer costs over $27,000.4 Foot ulcer care
costs are four times higher when PAD is associated with the
wound.4 And up to 84% of the cost of diabetic foot ulcer care
is associated with inpatient hospital stays.4 If new technologies
can heal wounds and prevent hospitalizations, they may actually present a major cost containment victory.
When confronted with a non-healing lower-extremity
wound in the lower extremity, one of the first challenges is to
convert the wound surface into a properly prepared wound
bed for the next stage of healing. Topical and systemic means,
via conservative and surgical procedures, should be used to rid
the wound of biofilm, excessive drainage and non-viable tissue. (Wound bed preparation should be performed after revascularization to prevent unnecessary tissue loss from ischemia.)
Once the wound has been prepared and the blood flow is suf-
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extensively. Although up to 50% of wounds may actually heal
with aggressive wound management, the rate of major amputation is nearly 40% at 1 year from the initiation of wound care
if there is no revascularization.3 As such, amputation prevention and limb-function preservation for ambulation rely on
timely revascularization.
Options for revascularization include both endovascular
and open surgical bypass procedures. The decision-making
depends on the anatomical distribution of arterial stenoses/
occlusions, medical comorbidities of the patient, morbidity of
the procedure (endovascular versus open), the likelihood of
limb salvage, and the durability of the revascularization. The
Transatlantic Inter-Society Guidelines provide a good framework for deciding.4 Some vascular lesions can be easily treated
percutaneously, while others may be better served with an
open surgical approach.
Remember, it might not be necessary to focus on achieving
long-term patency of the revascularization if the immediate
goal of wound healing and limb salvage are met in the short
term. For example, the ultimate goal of limb salvage is still
achieved if revascularization fails in the future, but the wound
doesn’t recur because the entire team is managing the patient,
who no longer faces the immediate danger of an open wound.
The definition of “adequate” circulation to the foot depends on the part of the foot involved. The angiosome concept divides the foot into six angiosomes based on the three
tibial vessels: anterior tibial, posterior tibial and peroneal.5 Intervention directed toward revascularization of the correct tibial artery and, therefore, the correct angiosome may improve
wound healing. In Figure 2, for example, in a patient with
gangrene of the dorsum of the foot and toes, revascularization
of the anterior tibial artery angiosome resulted in wound healing and limb salvage.
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ficient, ultimate wound closure should be achieved via grafting,
secondary intention or surgical means.“Reconstructive ladder”
is a term that refers to the stepwise decision-making process
that should be used to determine the most appropriate way to
heal a given wound.
After revascularization comes excisional debridement of the
non-healing wound. Remove all necrotic and non-viable tissue from the wound base and the wound margins so that the
exudate is reduced to moderate levels, the margins are no longer undermined, and the wound is free from excessive bacterial load. Negative pressure wound therapy (NPWT) is a key
technology used in combination with surgical debridement.
NPWT applies sub-atmospheric pressure to the wound in the
form of an active, closed-suction drain. The negative pressure
is also responsible for reduced bacterial count, stimulation of
angiogenesis, exercise of the cell membrane and re-approximation of the wound edges. Bioengineered alterative tissues
and advanced surgical reconstruction techniques can be applied when the wound is deemed properly prepared for closure.
It’s imperative to determine the wound etiology early in
the diagnostic workup. Many diabetic foot ulcers occur on
the plantar aspect of the foot, primarily due to abnormal biomechanics during the gait cycle. Given that one of the key
goals of limb salvage is that a patient be able to use a limb
after wound healing, more than skin coverage is needed at
the wound site. Unless the underlying tendon, bone or mechanical abnormality is corrected as part of the comprehensive
treatment plan, the patient is almost certainly doomed to suffer
wound recurrence after returning to a weight-bearing status.
Case Study
In Figure 3, the patient presents with a non-healing wound
after a partial third ray amputation. This wound is fibrotic
and probes deeply, but shows no evident abscess formation
or ascending infection. Given the relatively stable nature of
the wound, a timely vascular consultation is done before any
debridement or advanced wound care attempts.
The center photo shows the wound after revascularization and subsequent surgical debridement. Now the advanced
wound care technologies can be safely applied in the face of
restored tissue oxygenation. For this example, bioengineered
alternative tissues were combined with NPWT to ultimately
provide wound closure and successful amputation prevention/
limb salvage.
ego-driven decisions or isolationism. The team approach simultaneously and rapidly tackles the problem, reassures the
family and patient everything possible is being done, and helps
spread the liability associated with these challenging case types.
Individuals routinely involved in limb salvage include vascular specialists, podiatrists, plastic surgeons, orthopedists, nurse
practitioners, physical therapists, infectious disease specialists,
rheumatologists, endocrinologists, nephrologists, hospitalists
and prosthetists/orthotists. n
References
1. Population Division, Department of Economic and Social
Affairs, United Nations. World Population Ageing 19502050. 2002. Available at http://www.un.org/esa/population/publications/worldageing19502050/
2. Jensen SA,Vatten LJ, Myhre HO.The prevalence of chronic critical lower limb ischemia in a population of 20,000
subjects 40–69 years of age. Eur J Vasc Endovasc Surg.
2006;32:60–65.
3. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, et al. Inter-society consensus for the
management of peripheral arterial disease (TASC II). J Vasc
Surg. 2007;45(Suppl S):S5–S67.
4. Hunt NA, Liu GT, Lavery LA. The economics of limb
salvage in diabetes. Plast Reconstr Surg. 2011;127 Suppl
1:289S–295S.
5. Taylor GI, Palmer JH. The vascular territories (angiosomes) of the body: experimental study and clinical applications. Br J Plast Surg. 1987;40(2):113-141.
6. Samson RH, Sprayregen S, Veith FJ, et al. Management
of angioplasty complications, unsuccessful procedures and
early and late failures. Ann Surg. 1984;199(2):234–240.
7. Karacagil S,Almgren B, Bowald S, Eriksson I.Angiographic
criteria for prediction of early graft failure of secondary infrainguinal bypass surgery. J Vasc Surg. 1990;12(2):131–138.
8. Centers for Disease Control and Prevention. 2011 National Diabetes Fact Sheet. 2011. Available at www.cdc.
gov/diabetes/pubs/factsheet11.htm
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Communication and teamwork are paramount to limb salvage. This is a high-stakes pathology — major morbidity and
mortality are associated with even very distal amputation in
the extremity. Literature reviews have repeatedly shown that
comprehensive amputation prevention teams can lower the
rates of proximal leg amputation significantly.8 While someone should direct a patient’s care process, there’s no room for
Images courtesy of Rasesh M. Shah, MD, and John Steinberg,
DPM, FACFAS
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Conclusion
Figure 3. The patient presented with a non-healing
wound after a partial third ray amputation.
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