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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: jsanguily@comcast.net

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