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Reducing Amputation Rates in Critical Limb Ischemia Patients Via a Limb Salvage Program: A Retrospective AnalysisJulio Sanguily III, MD1; Brad J. Martinsen, PhD2; Zsuzsanna Igyarto, PhD2; MaiKhoi T. Pham, DPM1
From 1Martin Health Systems, Stuart, Florida, and 2Cardiovascular Systems Inc., St. Paul, Minnesota.
ABSTRACT: Objectives: Peripheral artery disease (PAD) is a prevalent disorder that affects approximately
18 million Americans. Left untreated, PAD can lead to critical limb ischemia (CLI), which in turn leads
to amputation. The number of amputations performed annually in the United States is estimated to be
160,000 to 180,000, and more than 50% of these patients had no diagnostic/therapeutic endovascular
intervention performed in the year before an amputation. The objective of this retrospective analysis is to
describe and evaluate the recently implemented limb salvage program (LSP) at Martin Health Systems
(MHS) in Stuart, Florida. Methods: This retrospective, observational, single-center study of high-risk
patients with CLI, treated between 2010 and 2014, was completed to determine the impact of a LSP
on angiography usage and the incidence of major amputations. Results: The implementation of a LSP
at MHS led to a multidisciplinary algorithm of patient screening, diagnosis, treatment, and subsequent
intensive wound care follow-up. As a result, from 2010 to 2014, the number of CLI patients at MHS
who received an angiographic assessment increased from 84 to 500, while the number of number of
major amputations decreased from 24 to 5. Thus, during a 5-year period, the MHS multidisciplinary LSP
lowered the amputation rate from 29% to 1%. Conclusions: This retrospective analysis demonstrates
that the implementation of a comprehensive LSP can lead to increased angiographic assessment and
endovascular treatment of high-risk CLI patients, preventing unnecessary major amputations within a
community hospital.
VASCULAR DISEASE MANAGEMENT 2016;13(5):E112-E119 Key words: peripheral vascular disease, critical limb ischemia, amputation, angiography,
limb salvage program
Approximately 18 million US citizens have peripheral artery disease (PAD), and of these patients 2 mil-
lion suffer from critical limb ischemia (CLI), the most severe and deadly form of the disease.1 Critical
limb ischemia increases the risks of limb loss and mortality. Patients with CLI have a major amputation
rate as high as 40% at 6 months and a mortality rate of 20% to 25% in the first year after presentation.2,3 At 5
years, the all-cause mortality rate of 70% exceeds that of colorectal cancer, breast cancer, stroke, and coronary ar-
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tery disease.1,4-6 Patients with CLI are typically elderly
and have a high prevalence of multiple severe comor-
bidities including diabetes, cardiovascular or cerebro-
vascular disease, histories of hypertension, renal insuf-
ficiency, and transient ischemic attack.7
Over the last 15 years, the interventional treatment
of PAD and CLI has changed significantly with en-
dovascular revascularization replacing surgical bypass
as the dominant therapy. Major amputations have also
declined.8-11 However, major amputation continues to
be the first therapy in 60%-70% of CLI patients and
about half of major amputations occur without any prior
diagnostic evaluation.9,10,12,13 Major amputation is associ-
ated with high perioperative mortality and morbidity
as well as high revision rates.14 These complications in-
crease length of stay and add to the costs of the overall
treatment. Five percent to 10% of below-knee amputees
and 15% to 20% of above-knee amputees die in the
hospital.15-18 In comparison, perioperative mortality for
infrainguinal bypass and endovascular revascularization
is 2% to 8% and 1% to 3%, respectively.19-22 Review of
the literature demonstrates that primary amputation is
considered the appropriate procedure in only 15% of CLI
cases whereas revascularization is considered appropri-
ate in 70%,13,23-25 with the other 15% recommended to
undergo palliative care/wound care.26
The 20% to 37% major complication rate associated
with amputation is considerably higher than the 16%
to 17% average for vascular surgery and the 5% to 9%
for endovascular revascularization.2,14,21,22,27 Wound
infection, the most frequent complication, occurs at
a rate of 10% to 30%, and if not resolved it can lead
to reamputation at a higher level.15,16,28,29 Other se-
rious complications include high rates of deep vein
thrombosis (13%-26%), cardiac complications (9%-
10%), sepsis (9%), bleeding (8%), and renal failure
(2%-3%).9,10,16,17,30,31
In a recent study, the rates of preamputation arterial
testing, including ABI measurement, duplex ultra-
sound, invasive angiography, computed tomographic
angiography, and magnetic resonance angiography
were reported in Medicare beneficiaries undergoing
lower extremity amputation from 2000 to 2010.32
Strikingly, of the 17,463 patients, 31.6% did not un-
dergo arterial testing in the 12 months preceding
amputation. Another recent study found similar low
utilization with only 27% of Medicare CLI patients
undergoing an angiogram prior to amputation.33
Arterial testing should be offered to patients referred
for major amputation, given the benefit of revascu-
larization in improving amputation-free survival and
quality of life (QOL).32 In addition, CLI patients un-
dergoing diagnostic angiography have a 90% lower
odds of having an amputation.33
Previous research also supports the necessity of mul-
tidisciplinary approaches to limb salvage. The evalua-
tion, diagnosis, and management of lower-extremity
wounds by general physicians, vascular surgeons, in-
terventionalists, podiatrists, and wound care specialists
is critical. The multidisciplinary approach provides a
comprehensive treatment protocol and significantly
increases the chances of successfully healing an ulcer,
subsequently preventing wound recurrence or amputa-
tion.34 For example, the implementation of a limb pres-
ervation service at a military medical center resulted
in an 82% decrease in lower-extremity amputations
over a 5-year period.35 In addition, a prospective study
in the United Kingdom reported a 62% reduction in
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major amputations over an 11-year period following
the implementation of multidisciplinary foot care ser-
vice consisting of improved vascular, radiologic, and
microbiologic services.36 Unfortunately, similar mul-
tidisciplinary programs have not been widely adopted
at a national level.
The purpose of this study is to provide evidence that a
community hospital can reduce major amputation rates
by following a dedicated focus on (1) PAD awareness
programs, (2) the implementation of advanced endo-
vascular therapies, and (3) multidisciplinary wound
care protocols. This article describes and evaluates the
Martin Health Systems (MHS) limb salvage program
(LSP) for reduction of incidence of major amputations
between 2010 and 2014.
METHODSKey Components of a Limb Salvage Program
In 2010, MHS instituted an evidence-based amputa-
tion prevention approach that has evolved into a mul-
tidisciplinary LSP. One of the main initiatives of the
program was to identify the need for PAD and CLI
patient care within the surrounding communities and
reduce the rate of major amputation. Martin Health
Systems accomplished this by establishing four focus
areas: (1) physician, staff, and patient education; (2)
community PAD and CLI awareness programs; (3) a
multidisciplinary approach to amputation prevention;
and (4) hyper-focused wound care of intractable ulcers
via hyperbaric oxygen therapy.
RESULTSEducation of Professionals and Patients
Educating physicians who treat patients who are el-
derly, are diabetic, and/or have renal insufficiency was
one of the key focus areas because these comorbidities
are common in CLI. In addition, physician awareness
of PAD, CLI, and minimally invasive endovascular
treatment options would likely result in earlier diag-
nosis, referral, and treatment of CLI, which is essential
for limb preservation. Rogers and Chopra previously
had found that only 42% of the primary care phy-
sicians and nephrologists were aware of certain risk
factors of PAD, 60% did not refer patients with lower
extremity wounds to PAD specialists, and 72% did not
refer patients with diabetes to specialists for vascular
assessment.37
Therefore, the lead interventionalist at MHS attended
training programs and CLI courses to learn the most
advanced techniques in the rapidly evolving field of
peripheral intervention from the best CLI experts in
the United States. These programs focused on the
latest advances in atherectomy treatment of calcified
plaque, angiosome-guided therapy, chronic total oc-
Figure 1. Multidisciplinary team approach for limb salvage.
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clusion crossing techniques, and tibiopedal access. That
information was then used to educate MHS diagnos-
ing physicians, nurses, physician assistants, and nurse
practitioners on what to look for and how they can
work together to save patients from amputation. Rais-
ing staff awareness of high-risk patients and educating
them on mission, program goals, recognition of CLI,
and the latest advances in peripheral CLI intervention
techniques played an important role in implementing
the LSP.
Patient education on PAD risk factors was also a
high priority, because the benefit of patient education
in reducing diabetic foot ulcers and lower-extremity
amputations is well documented.38,39 However, it has
been shown that most PAD and CLI patients do not
ask for proper treatment and often seek medical care
after it is too late to salvage the limb.40 Therefore, at
Figure 2. Key components of a limb salvage program. CLI, critical limb ischemia; ER, emergency room; PAD, peripheral arterial disease; WCC, wound care clinic.
Figure 3.Treatment algorithm for lower-extremity wound.
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MHS, clinicians educated patients on PAD risk factors
and the importance of proper diabetes management
during patient examinations. In addition, patients were
also advised to avoid foot trauma by following proper
foot hygiene, proper shoe selection, and completion
of daily foot inspections.
Multidisciplinary Team Approach
The LSP consisted of a multidisciplinary team
(Figures 1 and 2) that included a lead CLI in-
terventionalist, a noninvasive imaging specialist,
a podiatrist, an infectious disease and wound care
specialist, and a nurse practitioner. In addition,
hospitalists and emergency department profession-
als were essential to the multidisciplinary approach.
The MHS lead CLI interventionalist worked with
the David L. Smythe Wound Care Center to develop
protocols (Figure 3) and treatments to improve
wound healing, subsequently preventing amputa-
tions. The implementation of a multidisciplinary
team-based approach led to a systematic process for
patient screening, evaluation, treatment, and follow-
up, with the collective goal of achieving the best
patient outcomes (Figure 4).
Each year, significantly more MHS patients were
evaluated for PAD/CLI, while at the same time the
number of amputations decreased (Figure 5) as a
result of implementing the LSP. In 2010, 24 of the 84
patients (29%) who were evaluated had amputations;
in 2011, 18 of 146 patients (12%) who were evaluated
Figure 4. Patient assessment, treatment, and follow-up protocol.
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had amputations; in 2012, 10 of 228 patients who
were evaluated had amputations (4%); and in 2013,
6 of 249 patients (2%) had amputations. Finally in
2014, 500 patients were evaluated, and five (1%) had
amputations. As a result, the rate of major amputations
fell from 29% in 2010 to only 1% in 2014, while the
use of angiography increased. In comparison, 25%
to 33% of Medicare CLI patients undergo primary
amputation.33,41
DISCUSSIONThe rate of amputations at MHS decreased from
29% to only 1% over a 5-year period after the cen-
ter implemented the LSP that ensured each PAD/
CLI patient received an angiographic assessment. In
addition, significantly more patients were evaluated
because of a program to increase awareness regarding
PAD and potential treatment options among patients
and physicians.
It is also important to note that PAD is not cur-
able; symptoms are treated so patients can improve
their quality of life and avoid amputations. Once a
patient is diagnosed with PAD it is critical to moni-
tor them for the rest of their lives with an aggres-
sive surveillance program (Figure 4). This is the
best way to address problems before they become
more complex. Therefore, it is recommended that
patients are evaluated at 3, 6, 9, and 12 months post
intervention via duplex ultrasound and then once a
year thereafter.
Figure 5. Increased use of angiography leads to reduced incidence of major amputations.
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CONCLUSIONSDuring a 5-year period, after the implementation of
a LSP, MHS lowered its amputation rate from 29% to
1%. These results demonstrate the benefits of a multi-
disciplinary approach to treat CLI that includes PAD
awareness programs, CLI interventionalists, vascular
surgeons, podiatrists, infectious disease specialists, and
wound care specialists. At MHS, the successful LSP has
resulted in the treatment of significantly more patients
each year with significantly fewer major amputations. n
Editor’s note: The authors have completed and returned
the ICMJE Form for Disclosure of Potential Conflicts of
Interest. Drs. Sanguily and Pham report employment with
Martin Health System. Dr. Sanguily reports consultancy to
and honoraria and travel reimbursements from Cardiovascu-
lar Systems, Inc. Drs. Martinsen and Igyarto report employ-
ment and stock options with Cardiovascular Systems, Inc.
Manuscript received November 30, 2015; provisional ac-
ceptance given December 16, 2015; manuscript accepted
February 9, 2016.
Address for correspondence: Julio Sanguily, III, MD,
Martin Health Systems, 509 SE Riverside Drive, Stuart,
FL 34994, United States. Email: [email protected]
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