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Limb Salvage Versus Amputation: A Closer Look At The Evidence, Costs And Long-Term Outcomes

Given that diabetes remains the most common cause of non-traumatic amputation in the United States, these authors strongly emphasize a multidisciplinary approach and provide a compelling review of the literature to assess key factors, costs and outcomes in choosing between limb salvage and amputation in this patient population.

The definition of limb salvage is saving a lower extremity that would have otherwise been amputated. In addition to avoiding primary amputation, the goal of a limb preservation initiative is to achieve a plantigrade foot that provides the highest level of function with the shortest recovery period, even if that means a minor amputation and/or reconstructive foot surgery.

Multiple articles support the value of multidisciplinary limb preservation centers.1-10 The key components of a limb preservation initiative are advanced podiatric care, revascularization teams, wound care teams, rehabilitation specialists and quality prosthetists and orthotists.1,4,11,12 There is excellent evidence that utilization of multidisciplinary teams results in lower amputation rates. Despite this supporting literature, the concept has been slow in universal acceptance and a large number of unnecessary primary amputations are still occurring today, resulting in significant morbidity, loss of function and independence, a reduced quality of life, high mortality rates and increased healthcare costs.1,13,14

Centers for Disease Control and Prevention (CDC) statistics from 2010 documented 73,000 non-traumatic amputations in adults 20 years or older.15 Sixty percent of these amputations occurred in patients with diabetes, making diabetes the most common cause of non-traumatic amputation in the United States. One diabetes-related primary lower extremity amputation occurs every 30 seconds worldwide, resulting in over 2,500 limbs lost per day.16-18

In 2012, the total healthcare costs related to diabetes were $245 billion, accounting for 25 percent of all Medicare expenditures.15 The direct medical costs related to diabetes, $176 billion, were more than twice the direct medical costs of treating people without diabetes. The remaining $69 billion are the indirect costs of diabetes due to disability, lost time at work and premature death.

With the future incidence of diabetes projected to rise to 550 million people worldwide by the year 2030, the concept of limb salvage has become an international and national trend.16-18 However, some argue that the medical costs related to limb salvage exceed those of primary amputation. With the paucity of reported and comparable literature, it is difficult to determine the optimal evidence–based and cost-effective pathway: limb salvage or primary amputation.

Healthcare Costs And Diabetic Foot Ulcerations: What You Should Know
The common argument supporting primary amputation is that a prolonged course of non-integrated medical management and wound care eventually results in primary amputation, equating to increased healthcare costs with the same end result. However, healthcare costs related to diabetic lower extremity ulcerations flow from the requirement for hospital admission and inpatient costs that increase further when one must address poor vascular status via endovascular or open surgical procedures. Whether payment occurs via Medicare or private payer insurance, inpatient expenditures account for 73 to 80 percent of the total healthcare costs of treatment.19,20 Contrast this with routine outpatient wound care, which accounts for less than 25 percent of healthcare costs related to wound care.

As hospitalization and revascularization drive the cost of treatment, it is understandable that healthcare cost rises with the increasing severity of ulceration classification (i.e., increasing severity of infection and ischemia). While the initial costs of revascularization are higher, the subsequent cost related to surveillance and follow-up is lower in contrast to what occurs with primary amputation. With primary amputation, the initial cost is lower while the follow-up care increases due to costs related to rehabilitation and prosthesis production and maintenance. The mean reimbursement for all Medicare services for those with a diabetic foot ulceration rose from $15,200 in 2006 to $16,700 in 2008.21 However, this remained less than half of the mean reimbursement for all Medicare services for those with a major lower extremity amputation at $33,700 in 2006 and $36,500 in 2008.

What Is The True Cost Of Primary Amputation?
The true cost of amputation must also take into account the loss of function and independence, reduced quality of life and the increased mortality rate. While some researchers claim that primary amputation will lead to a shorter recovery time and ambulation with a prosthesis, only 47 to 67 percent of patients with ischemia and/or ulceration who undergo primary amputation successfully rehabilitate to this level.20,22 The costs of wheelchair accommodation and long-term assisted care due to primary amputation have not yet been reported in the literature.

Patients with a primary amputation related to diabetes also reportedly have a 30 percent increased incidence of depression.23 Patients with Charcot neuroarthropathy of the foot and ankle, diabetic foot ulceration and diabetic foot infections self reported diminished physical and mental scores on various health questionnaires.24-28 Approximately 85 percent of patients with a diabetic foot ulceration reported being unable to ambulate independently, which significantly limited their physical activities and negatively impacted their quality of life.25 Patients who eventually required a below-knee amputation due to non-reconstructible Charcot neuroarthropathy of the foot and chronic osteomyelitis had significant self-reported improvement in the physical aspects of their lives without any positive change to the mental component on these questionnaires.29

Mortality rates following primary amputation reach up to 40 percent at one year postoperative and 80 percent at five years.30-35 Mortality rates secondary to diabetic foot ulceration and diabetic foot ulceration-related primary amputation exceed the combined mortality rate of prostate cancer, breast cancer and Hodgkin’s lymphoma. A retrospective review of all non-traumatic amputations performed in a Denmark hospital in 2009 for treatment of gangrene or a non-healing wound/infection found above-knee and below-knee amputation to be the most common amputation levels performed followed by toe and partial foot amputation.35 Mortality rates while patients were admitted and within 30 days postoperative were 27 and 30 percent respectively. The mortality rate at 90 days was 44 percent and increased to 54 percent at one year postoperative.

Currently, the majority of non-traumatic primary amputations related to diabetes occur in an emergent fashion or after a prolonged course of non-integrated medical management and wound care. Once primary amputation occurs, patients often experience reduced or lost function and independence, depression presents or worsens, mortality rates are significant and healthcare costs continue to rise.

Pertinent Insights On The Toll Of Critical Limb Ischemia
Critical limb ischemia (CLI) is the final stage of peripheral arterial disease (PAD).  An estimated 1 percent of patients under age 50 will develop CLI.31-33 Critical limb ischemia causes approximately 65,000 to 75,000 major amputations, costs $25 billion in healthcare expenditures annually and has a five-year mortality rate that exceeds the mortality rates of coronary artery disease, breast cancer and colarectal cancer.31-33 The coexistence of CLI in the setting of diabetes, peripheral neuropathy, rigid foot deformity, inadequate protection and routine foot care leads to non-healing wounds that have a high potential to result in primary amputation. Therefore, the identification and management of PAD are critical components of a limb preservation initiative.

The ability to restore adequate perfusion to the diabetic foot has improved with technology, training and skill advancements by various types of vascular interventionalists, namely in the endovascular arena. As Mustapha recently emphasized, the treatment of CLI needs to move toward meaningful endpoints, quality benchmarks, enhanced training and centers of excellence.36 Even with advancement in endovascular intervention, traditional bypass procedures still play an important role in the revascularization pathway as techniques continue to improve, allowing for distal bypass to the pedal vasculature.

Hybrid procedures combining both endovascular and open surgical techniques are also becoming very important. Vascular surgeons are incorporating open superficial femoral endarterectomies (often in combination with an iliac stent or distal endovascular procedure) into their armamentarium in the battle for limb salvage. Hybrid techniques reportedly achieve a limb salvage success rate of 86 percent in the first 30 postoperative days.37 Lantis and colleagues combined endovascular intervention of the superficial femoral artery with popliteal to distal bypass for patients with CLI and tissue loss, reporting primary and secondary patency rates of 95 and 100 percent respectively.38

After many decades of experience and improvements in open surgical techniques and recent advances in endovascular techniques, the question of optimal treatment for CLI has been a topic of debate. The BEST-CLI (Best Endovascular Versus Best Surgical Therapy in Patients with CLI) trial is a prospective, randomized, multicenter, superiority trial comparing the best endovascular intervention with the best open surgical intervention in patients with CLI.39 This ongoing study aims to answer this current topic of contention.

Regardless of the techniques involved, all patients with diabetes having an elective amputation should receive a referral for vascular evaluation and consideration of revascularization either to prevent or lower the level of amputation. There are still a large number of amputations performed in patients with diabetes without vascular evaluation, arteriogram or attempted revascularization with surgeons utilizing the excuse that patients with diabetes have small vessel disease and thus are not candidates for revascularization.22 With the currently available endovascular and open techniques, one can accomplish revascularization in the majority of patients with diabetes.

Understanding The Impact Of Ulceration And Infection In Patients With Diabetes
The annual incidence of foot ulceration in patients with diabetes is approximately 2 percent.40 It has been well established that peripheral neuropathy is intimately involved with the development of rigid deformity of the foot and ulceration, which can ultimately lead to infection and the need for amputation. The neuropathy itself does not cause ulceration but is part of a cascade of events that lead to ulcer formation. Authors postulate that muscle imbalance occurs due to neuropathy with subsequent deformity development.40 A subsequent increase in skin pressures or external trauma then results in ulcer development. Ulcers may then become infected and lead to amputation.

Hospital discharge data shows that among peripheral arterial disease, neuropathy and ulceration, ulceration resulted in the highest number of hospital discharges at 113,000 in 2007.41 A recent retrospective review of all patients with diabetes presenting for care to an emergency department from 2006 to 2010 showed a 28 percent increase in lower extremity diabetic complications with 52 percent of complications requiring hospital admission for treatment.42 Those patients presenting with sepsis, approximately 10 percent, had the highest mortality rates (39 percent) and incidence of primary amputation (31 percent). The total cost for all treatment was approximately $9 billion per year with $2 billion attributed to the emergency department alone.

Costs increased significantly with primary amputation ($116,000) as opposed to the average cost for evaluation, preliminary treatment and discharge from the emergency department ($2,300).42 This data illustrates the common, complex and costly nature of lower extremity diabetic complications.

Infection is a frequent costly complication of these ulcers, occurring in 40 to 80 percent of all patients with diabetic foot ulcerations.19 Authors have also postulated that infection is the most common cause of diabetes-related hospital admission and one of the major causative factors of primary amputation.43-48 Clinicians have aimed treatment efforts at different steps along the devastating cascade of events to reduce amputation rates.43-48 Skrepnek, Mills and Armstrong stated that “development of better systems of comprehensive outpatient diabetic foot services to provide earlier coordinated care should be a major point of healthcare emphasis as it has the potential to reduce costs of emergency (care) and subsequently inpatient care and improve outcomes.”42

The Value Of An Integrated Multidisciplinary Limb Salvage Team
The creation of an integrated system of care for patients with diabetes in the form of a dedicated multidisciplinary limb salvage team theoretically results in reduced amputation rates due to the implementation of standardized evidence-based prevention and treatment protocols. The recent international and national trend toward these programs has borne this out.

A multidisciplinary limb salvage team is an integrated team that manages various aspects of the patient with diabetes. Each participant plays a vitally important role in the care of these patients through medical and surgical prevention and treatment. These teams allow for greater provider and patient education and integrated, appropriate and timely consultation, resulting in earlier and more aggressive intervention when warranted. This can reduce healthcare costs associated with emergency department visits, hospitalizations for intensive medical and surgical care and primary amputation.  

A retrospective review of a limb salvage program in Sweden reported a 78 percent reduction in major amputation rates.7 Prospective studies in the United States (over five years) and United Kingdom (over 11 years) have shown an 83 percent reduction and 62 percent reduction respectively when utilizing a team approach to limb salvage.19

In a one-year (2012–2013) retrospective review of all neuroischemic wounds treated by a multidisciplinary amputation prevention team, the authors looked at the specific clinical endpoints of wound healing, reulceration rate and ambulatory status.48 They found that 59 percent of 89 patients healed their wounds by 12 weeks. There were only three primary amputations with a major to minor amputation ratio of 0.06. Seventy-four percent of patients were able to maintain or improve their ambulatory status, and there was an 11 percent reduction in readmission rates in comparison to admissions for an all-inclusive population that underwent lower extremity revascularization at their institution.

In a retrospective review over a 10-year period, researchers assessed 40 patients with Fontaine Class IV CLI who underwent distal bypass and minor amputation for limb salvage.49 They found that salvage of the heel was sufficient in keeping patients ambulatory and independent, maintaining a better quality of life.

Early recognition begins with patient and provider-given foot exams. Despite the global agreement that early intervention is beneficial, both self-foot examination and provider-directed foot examination happen less than 60 to 70 percent of the time.50,51 If patient and provider foot examinations occur more often, earlier detection of pathology and appropriate referral may lead to a decrease in lower extremity complications and the potential for primary amputation, resulting in reduced healthcare costs.  

Multidisciplinary limb salvage teams are also more likely to develop treatment strategies involving standardized protocols and guidelines for care leading to more appropriate and cost-effective care. In 2004, the authors of a Netherlands study found that guideline-based care was more cost-effective, reduced the incidence of foot complications and increased quality-adjusted life-years in patients with diabetes in comparison to standard care.52 More recently, Driver and colleagues reported a cost savings of $2,900 to $4,442 per patient with one-year cost savings ranging from $750,000 to $1.1 million.19

Initiation of a protocol for patients at risk for amputation due to CLI, foot ulcer and gangrene that included early and aggressive surgical debridement, immediate broad-spectrum antibiotic therapy and peripheral transluminal angioplasty as first choice for revascularization also reportedly has long-term benefits.53 In regard to the initial results of 456 patients treated with this protocol (mean follow-up of 20 ± 13 months), 62 percent healed, 15 percent required major amputation, 15 percent of the patients died and 8 percent remained unhealed at 12 months. The surviving 396 patients had follow-up for an additional 83 ± 27 months and the study authors made the following observations.

1.    Limb salvage can provide long-term benefits as wound healing persists over time.
2.    Few patients required an amputation.
3.    The mortality rate was similar to that of the general diabetic population.
4.    Patients who underwent primary amputation had a shorter life span.
5.    Patients receiving clinical follow-up in addition to telephone follow-up had better outcomes.

In Conclusion
The decision to attempt limb salvage as opposed to performing primary amputation is often difficult, unless the patient is presenting with ischemia or sepsis, warranting a primary extremity amputation. We should employ the motto of “toe before foot, foot before leg and leg before life” in every instance of patients presenting with diabetic lower extremity amputation.

Outside of these conditions, the decision to amputate or save a limb becomes more tenuous. Each patient presents with a myriad of comorbidities and psychosocial attributes affecting treatment. Ideally, the treatment should be evidence-based, cost-effective, low in morbidity and mortality, and improve or maintain a patient’s quality of life.

Primary amputation usually does not meet these parameters and results in increased healthcare costs and mortality rates while adversely affecting a patient’s mobility, independence and quality of life. Eighty-five percent of amputees who took a survey following multiple revascularization procedures prior to their amputation reported that if they faced a similar scenario again, they would do everything to save their limb regardless of the number of procedures they would need.54

The creation of limb preservation teams using a multidisciplinary approach of integrated patient care and standardized protocols results in early and effective treatment. This results in a reduced need for hospitalization and intensive medical and surgical care. Utilization of the multidisciplinary, integrated limb salvage team results in an overall reduction in long-term healthcare costs, morbidity and mortality, and can maintain or improve a patient’s function and independence, which correlates with a better quality of life.

Dr. Ponticello is the Chief of the Limb Preservation Service and Director of the Complex Lower Extremity Surgery and Research Fellowship at Madigan Army Medical Center in Tacoma, Wash. He is a Fellow of the American College of Foot and Ankle Surgeons, and the American Professional Wound Care Association.

Dr. Andersen is the Chief of the Vascular/Endovascular Surgery Service and the Medical Director of the Madigan Army Medical Center Outpatient Wound Care Clinic in Tacoma, Wash. He is a Fellow of the American College of Surgeons and the American Professional Wound Care Association.

Dr. Marmolejo (Schade) is a Fellow of the American College of Foot and Ankle Surgeons, and the American College of Foot and Ankle Orthopedics and Medicine. She is the Clinical Marketing Specialist and Research Liaison in Wound Care for Novadaq Technologies, Inc.

References

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For further reading, see “How Fluorescence Angiography Illuminates The Potential For Limb Salvage” and “Current Concepts In Revascularization For Limb Salvage” in the September 2015 issue of Podiatry Today or “When Patients With Diabetes May Benefit From Below-Knee Amputation” in the October 2014 issue.

For an enhanced reading experience, check out Podiatry Today on your iPad or Android tablet.

Features
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Mario Ponticello, DPM, FACFAS, FAPWCA, Charles A. Andersen, MD, FACS, FAPWCA, and Valerie L. Marmolejo (Schade), DPM, FACFAS, FACFAOM

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