Peripheral Matters | Disparities in the Care of Patients with Peripheral Artery Disease and Critical Limb Ischemia

Despite improvements in technology, interventional therapies, medications and awareness, disparities remain in the care of patients with peripheral artery disease (PAD). The elimination of these health care disparities is a goal of paramount importance of the U.S. Department of Health and Human Services.

In a presentation titled Underdiagnosis and Undertreatment of PAD at the 2015 Medicare Evidence Development and Coverage Advisory Committee (MEDCAC), Joshua A. Beckman, MD, MS, FACC, proclaimed, “PAD is the disparity.” Evidence for under-diagnosis and under-treatment of PAD continues to grow. The incidence of PAD and critical limb ischemia (CLI) is increasing. This can be attributed, at least in part, to the escalating percentage of our population over 65 years and the increasing prevalence of diabetes and obesity. Major lower extremity amputation rates declined over the past decade, while rates of revascularization procedures (particularly endovascular) skyrocketed. Yet, guidelines regarding medical therapy are very similar with those created over a decade ago. Adherence rates to optimal medical therapy remain very low.

Disparities Associated With Sex

Sex-related differences in treatment strategies and outcomes have been observed in many different cardiovascular disease processes. Despite tremendous progress in care of patients with STEMI, women have a significantly higher unadjusted and adjusted risk of in-hospital mortality after STEMI. In vascular disease, women have a higher rate of rupture with abdominal aortic aneurysms (AAA) at equivalent diameters to men and higher perioperative mortality after open AAA repair. In a landmark study of symptomatic carotid artery disease, female sex was associated with a reduced benefit vs. male counterparts after carotid endarterectomy. The etiology of these differences are debatable and most likely multifactorial, encompassing age at presentation, hormonal and anatomical differences and social factors.

The disparities based on sex for CLI remain a focus for cardiologists, vascular medicine clinicians and surgeons. A recent meta-analysis exploring the effect of sex on outcomes following lower extremity revascularization demonstrated that women had a significantly higher risk of 30-day mortality and major amputation following both endovascular and/or open surgical revascularization. Women had worse outcomes for early graft thrombosis, vascular access complications, cardiac and pulmonary events, and stroke. These differences in perioperative mortality and outcomes were maintained when stratified by endovascular and open surgery. However, for long-term outcomes in this meta-analysis, sex differences did not persist.

In the largest longitudinal study of CLI disparities from the Healthcare Utilization Project Nationwide Inpatient Sample (NIS) from 2002 to 2011, women maintained a higher ratio of above-knee amputations to below-knee amputations vs. men. This difference in amputation level often leads to reduced mobility, poorer functional status, and ultimately higher morbidity and mortality. These findings were corroborated in a separate study of NIS data from 1998 to 2002 showing women with limb ischemia were more likely to undergo a major amputation. While other studies have refuted these data, higher quality, prospective studies are needed to understand which factors are important regarding sex-related disparities.

Disparities Associated With Race

PAD is significantly more prevalent in the African-American population compared with the Hispanic and non-Hispanic white population across all age groups. This mirrors disproportionate rates of cardiovascular disease and cardiovascular events (myocardial infarction, stroke and heart failure) seen in African-American patients. While African-Americans are more likely to have CLI on initial presentation, significantly higher rates of major amputation in this population is cause for alarm. Their rates of limb-salvage open revascularization and endovascular revascularization procedures are disproportionately low. These patterns of African-American patients being significantly less likely to receive aggressive limb-salvage procedures and significantly higher amputations is not a recent phenomenon and has not changed dramatically over the last two decades.

Regrettably, even outcomes following surgical or endovascular revascularization are worse for African-Americans. Following endovascular interventions for PAD, African-Americans and Hispanics had an increased risk of major amputation within 30 days of intervention and a lower amputation-free survival at one year vs. non-Hispanic whites. A recent analysis of >16,000 patients who underwent open infra-inguinal bypass found a higher rate of early graft failure in African-Americans despite no difference in use of an autogenous conduit.

Some suggest these racial disparities in revascularization are due to lack of access. However, more recent studies identified these same broad disparities at centers with robust revascularization capabilities, demonstrating access is not the only contributing factor. Biologic differences among patients of different races and ethnicities have been proposed as a potential etiology, given the higher prevalence of diabetes and metabolic syndrome within African-Americans. However, non-diabetic African-Americans had a higher likelihood of undergoing major amputation vs. non-diabetic whites. Further, previous studies controlled for diabetes still found blacks were less likely to receive limb-salvage revascularization.

Approach to Mitigating Disparities

There’s no question the PAD community needs to perform high-quality, real-world studies of patients with CLI. These studies, along with recognition of disparities of care, could improve the overall care of patients with advanced forms of vascular disease.

Within the Duke University Health System, we’ve adopted a widely-described approach to the treatment of patients with PAD/CLI that involves multifaceted, collaborative, multidisciplinary care teams that rely on three basic concepts.

One, we believe that improving disease awareness in the local/regional community and facilitating access across the full patient spectrum will reduce potential barriers to seeking care at a medical facility with vascular specialists with expertise in limb salvage.

Two, skilled and timely interventions with a keen eye and ear open to patient preferences and addressing critical questions about risk/benefit/alternatives are essential. Intervention on patients with ischemic rest pain/ulceration (i.e., mild to moderate disease) followed by preventive measures (medical therapy, behavior/diet modification, risk profile enhancement, smoking cessation, etc.) can mitigate disease progression and ultimately improve clinical outcomes.

Three, interdisciplinary collaboration and continuity of care are indispensable. The popularized “toe and flow” model demonstrates the benefits of a collaborative team approach in dealing with arterial insufficiency in the setting of lower extremity tissue loss. The use of a multi-specialty team ensures all intervention options are identified and available. Further, the diversity of medical expertise provides a comprehensive knowledge base and ability to deliver creative and effective cutting-edge treatment.

This collaborative approach also allows for continuous care that is delivered in hospitalized patients, patients undergoing revascularization in outpatient or office-based clinics and patients seeking preventive and/or follow-up care in the clinic setting.

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Clinical Topics: Diabetes and Cardiometabolic Disease, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Prevention, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Acute Heart Failure, Interventions and Vascular Medicine, Diet

Keywords: ACC Publications, Cardiology Interventions, Peripheral Arterial Disease, Prevalence, African Americans, Metabolic Syndrome X, Limb Salvage, Incidence, Healthcare Disparities, Endarterectomy, Carotid, Hospital Mortality, Aortic Aneurysm, Abdominal, Aftercare, Inpatients, Prospective Studies, Longitudinal Studies, Patient Preference, Outpatients, Outpatients, Advisory Committees, Sex Characteristics, Myocardial Infarction, Biological Factors, Smoking Cessation, Hispanic Americans, European Continental Ancestry Group, Amputation, Diabetes Mellitus, Lower Extremity, Stroke, Carotid Artery Diseases, Obesity, Heart Failure, Thrombosis, Surgeons, Disease Progression, Knowledge Bases, Pain, Biological Products, Diet

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