Q&A: Much work needed to overcome disparities in CLI diagnosis, care
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Peripheral artery disease and its most advanced form, critical limb ischemia, are major sources of morbidity and mortality, yet many patients are not diagnosed in time to prevent amputation.
For example, as Healio previously reported, among Medicare fee-for-service beneficiaries with CLI who had a major amputation in 2017, 63% had neither revascularization nor angiography in the year before amputation.
M. Laiq Raja, MD, FACC, FSCAI, is one clinician who has been working to reduce amputations in patients with CLI and to find solutions to the barriers to access to care for certain patient groups. Raja, an interventional cardiologist at El Paso Cardiology Associates, working with The Hospitals of Providence – Memorial Campus in El Paso, Texas, founded PULSE Amputation Prevention Centers to address the epidemic of CLI among the Hispanic and Latin American populations in the El Paso area.
Healio spoke with Raja and his team about the problem of late diagnoses of PAD and CLI; the disparities in who gets CLI and the quality of care they receive; the barriers to access to care and high-quality care for the CLI population; the use of a multidisciplinary approach to improve outcomes and reduce disparities in diagnosis, treatment and access to care; and the role of office-based labs in changing the way patients with CLI are managed.
Healio: What are the consequences of PAD and CLI not being treated in time or at all?
Raja: PAD and CLI are devastating diseases stemming from many comorbid conditions. When patients are not treated effectively by a CLI specialist, patients who have wounds often lose their limbs to a major amputation. The 1-year mortality rate for patients with CLI is 25%, with a 60% mortality within 3 years. Even with new treatments available, there are still more than 150,000 amputations performed each year in the United States, and 50% of those are primary treatment with no attempt at limb salvage. It is estimated that 51% to 73% of amputations performed are done without angiographic evaluation and 70% to 71% of patients have amputation and never have any revascularization. Lastly, patients who receive a CLI diagnosis and subsequent amputation have an estimated 1-year mortality rate of 40%.
Healio: Are there disparities in who gets CLI? What are the factors behind them?
Raja: There are many disparities in patients who have a propensity for having CLI. Our population here in El Paso is predominantly Hispanic patients who present with CLI and diabetic foot ulcers. Our literature review revealed that patients from historically underrepresented backgrounds had both a higher incidence and proportion of diabetes-related lower-extremity amputation compared with non-Hispanic white patients. Mexican American patients had more diabetes-related amputation (85.95%) than Black or non-Hispanic white patients (74.7% and 56.3%, respectively). In addition, the data reveal that patients with diabetes who live in a lower-income neighborhood have higher rates of lower-extremity amputations than those who reside in more affluent areas.
There are many factors contributing to these disparities such as access to care, education deficits and poverty. The low average income and education attainment in Hispanic individuals are obstacles in achieving timely and appropriate health care. Too many Hispanic patients also have many economic and geographic challenges. Many are undocumented and unfunded with no insurance coverage. The financial burden on patients with CLI can be devastating, as they must undergo months of wound treatment and multiple procedures to heal their wounds, leaving them with thousands of dollars in copays that must be covered. Many patients do not have transportation, limiting their access to adequate and timely health care, and access to a specialist is even less likely.
The bureaucracy of the health care system adds to the system barriers to care for many of these patients. They seem to get lost in the “red tape” of health care and have no advocates to help them as they navigate this very complex disease. Many patients just do not seek care due to lack of time and compliance, as many may work multiple jobs and lack understanding of the severity of their disease, leading to poor compliance and poor follow-up.
Healio: Are there disparities in who gets proper care for CLI? What are the factors behind them?
Raja: This population has many comorbidities, and this leads to an extraordinarily complex disease process with many obstacles to healing. As previously mentioned, the majority of patients have many environmental factors limiting good care, and they lack the understanding of the severity of the situation or how to deal with all the many needs they will have to manage the disease and its sequalae. Many times, they are suddenly in the middle of a crisis as a wound worsens and they are referred for too many studies and specialists all at once. This can be an overwhelming experience for patients, and they tend to get lost in the bureaucracy of navigating all the aspects of care. The loss to follow-up is a result of this overwhelming situation and a common obstacle in treating CLI in this population, leading to disparities in care and outcomes.
Delayed treatment is a major disparity affecting the treatment of this patient population. The treatment of CLI has advanced so rapidly that the medical community has not been updated on best practices. Primary care doctors are overwhelmed and too busy, leading to delays in the referral process, as well as lack of knowledge on the best path of treatment. The first path is usually to send a patient for routine studies and to a wound care specialist, often overlooking the need for a vascular workup. There are very few CLI specialists in this country, and this leads to a delay in vascular evaluation and treatment in many areas due to inability to obtain urgent appointments. These delays lead to worsening wounds that often end in an ED visit and a referral for major amputation.
In the areas where patients are actually getting to the wound care specialist efficiently and getting referred for vascular evaluation, there are still challenges, as many vascular specialists lack the training or experience to treat the most severe CLI lesions, leading to failed attempts and, ultimately, still resulting in a major amputation. Finally, in areas where the community is lucky enough to have a true CLI expert available to treat CLI patients, there often is a lack of an organized system to navigate the patient through all the aspects of care. There is poor communication among the various specialists, leading to poor follow-up and readmissions. Patients still tend to get lost among all the different physicians and poor compliance still results in poor outcomes. Major amputations can still happen despite our best efforts.
Healio: How can improved access to health care improve CLI care and reduce disparities? What can be done to improve access to health care for people with or at risk for CLI?
Raja: Access to care is a major disparity in this population, in general. However, the greater disparity is having access to a trained and experienced CLI specialist and a good CLI team to help a patient navigate the process.
The key to effectively treating patients with CLI and preventing amputations is the use of a multidisciplinary approach to amputation prevention, where the patient is at the center of the care with a team of specialists working in unison. It is essential to have a vascular specialist, podiatrist and infectious disease specialist all on the team immediately to manage all the aspects of care for the patient. There are many other essential parts of the team such as nephrologist, nutritionist, mental health specialist, rehab/therapy and, of course, primary care; however, a very important component is having a nurse navigator to help coordinate all the care between all the specialists in order to have efficient, effective care without losing the patient to follow-up. Discharge planning and coordination of care for these patients is a very important aspect of the process leading to good follow-up and good outcomes.
Outreach programs and satellite clinics with screening programs for prevention and early detection of PAD and CLI are also essential to reaching the patients who have poor access in outlying areas.
In our system, we have developed a very successful transfer program that helps to bring patients to our hospital emergently when a patient with CLI presents to one of the outlying facilities. We have developed a very successful regional program where patients are referred to us for CLI treatment. Depending on the patient’s health status, either interventions are performed at the office-based lab on an outpatient basis, or the patient is directly admitted to the hospital with a very specific care and intervention plan executed. This has afforded us a great opportunity to help our regional community in the fight against amputation. In fact, the office-based lab industry has grown significantly over the last several months, as the desire to keep patients out of the hospital and safe from infection increased during the COVID-19 pandemic. Some companies, such as Philips, have been embracing the office-based lab movement to help overcome racial disparities in access to care by providing a full range of solutions for office-based labs to treat patients with peripheral vascular disease during the pandemic and beyond.
Our approach also has the added benefit of teaching and training other physicians who are interested in learning more about CLI and improving their interventional skills. Industry partners such as Philips can also be helpful in providing resources to health systems and organizations to help address racial health disparities in CLI and offer trainings for physicians. I have trained many physicians around the country in advanced CLI treatment both through industry programs and national conferences. It is important to continue to train new physicians in these advanced techniques as well as teaching them the necessary aspects of the CLI multidisciplinary team approach. We continue to provide outreach and education to primary care physicians and podiatrists in our area sharing new developments in the treatment of CLI, encourage early and urgent referrals for vascular evaluation and treatment and take urgent referrals, sometimes even on the same day. In treating CLI, it is essential to remember that time is tissue and saving limbs saves lives.
Healio: Is there anything else you would like to mention?
Raja: The key is to continue the efforts regarding awareness of PAD among physicians and patients. Teach patients and the community about the signs and symptoms of PAD and CLI and how to find the right physicians in their community. Encourage the need for second opinions and that amputation should not be accepted without a second opinion. No one should accept amputation without adequate revascularization. Most importantly, develop a good multidisciplinary team to manage patients and work in close communication.
References:
- Escarce JJ, et al. Access to and Quality of Health Care. In: National Research Council (US) Panel on Hispanic in the United States; Tienda M, Mitchell F, editors. Hispanics and the Future of America. Washington, DC: National Academies Press (US); 2006.
- Lavery LA, et al. South Med J. 1999;doi:10.1097/00007611-199906000-00008.
- Sukumaran P. Latinos diabetes patients much more likely to undergo amputations. Salud America. Published May 10, 2019. Accessed Oct. 13, 2021.
- Tan TW, et al. PLoS One. 2019;doi:10.1371/journal.pone.0211481.
For more information:
M. Laiq Raja, MD, FACC, FSCAI, can be reached at PULSE Amputation Prevention Centers, 2311 N. Oregon St., 5th Floor, El Paso, TX 79902.
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