News & Press

Healthcare Disparities and CLI Treatment

The CLI Global Society Recent Webinar “Racial and Ethnic Disparities in CLI Diagnosis and Treatment: The Ugly Truth and What We Must All Do About This”

Moderator: Paul Michael, MD
Guest Speaker: Wayne Batchelor, MD
Panelists: Barry Katzen, MD; Jihad Mustapha, MD; Richard Neville, MD; Michael R. Jaff, DO; and Michael Parker, MD

BACKGROUND

Healthcare disparities are the inequalities experienced by different groups as they interact with the healthcare system. These groups can be divided by race, sex, geographic location, education level, and a variety of other factors. As early as 1840, reports have demonstrated mortality differences between social classes. In the United States, the US Department of Health and Human Services released “Health, United States, 1983,” detailing an increased “burden of death and illness experienced by blacks and other minority Americans…” It has been almost 40 years since that report was published and racial healthcare disparities remain a well documented and troubling issue.

“What we see changes what we know. What we know changes what we see.”
– Jean Piaget

Race is one of the most consistently demonstrated factors leading to healthcare disparities. Black patients are more likely to undergo amputation, less likely to have a procedure prior to amputation, more likely to have an above knee amputation, and more likely to have open vascular intervention than white patients.3,4 These trends are disturbing. The majority of the aforementioned studies attempted to find confounding reasons for these inequalities. While some portion of these disparities can be explained as race being a surrogate for socioeconomic status or access to healthcare,5 after logistic regression and independent of all other variables, being black, alone, increased the odds of receiving an amputation by 78%.6 These very real inequalities exist, and we need to do more than describe them if we hope to change practice patterns.

“While some portion of these disparities can be explained as race being a surrogate for socioeconomic status or access to healthcare,5 after logistic regression and independent of all other variables, being black, alone, increased the odds of receiving an amputation by 78%.6

In addition to racial disparities, the intensity of vascular care and the amputation rate vary significantly across different regions.7,8,9 For instance, patient in regions of high intensity care in a 2012 study were shown to be 2.4 times more likely to undergo a revascularization attempt the year prior to amputation. Other factors are intrinsic such as sex and race. Women are less likely to receive an open bypass and more likely to die from CLI or have an amputation than men.10

These trends have been clear for several decades, the real question is what do we do next?

The field of Amputation Prevention provides a unique arena to examine the thought provoking, often avoided, and uncomfortable topic of racial and ethnic disparities in healthcare due to the contribution of complex social determinants of health. Critical Limb Ischemia (CLI) represents end-stage peripheral arterial disease (PAD) and is created by a perfect storm of multiple out of control chronic disease states, primarily diabetes and foot infection which become the leading cause of preventable amputation in the United States. Worldwide, a diabetic related amputation occurs every thirty seconds. The staggering mortality numbers fueled by preventable amputations due to CLI have been well established in the medical literature. The higher mortality numbers of minorities have also been examined and documented, with African American and Hispanic patients in the US having twice the preventable amputation rates of nonminority patients. Even the mainstream media has picked up this story (CNN: Black, Latino Patients Much More Likely Than Whites to Undergo Amputations Related to Diabetes).

Despite the necessary modern awareness for this monumental medical problem, our healthcare delivery system persists in struggling to contain preventable amputations. Over one hundred years ago in Boston, a medical prophet named Elliott P. Joslin established the world’s first multidisciplinary foot clinic. Joslin had the foresight to establish a multidisciplinary infrastructure, starting with seeing patients in his own home. This concept spread out into his community and eventually the entire world. He understood the pandemic proportion of a problem he called “the menace of diabetic gangrene.” He described what it would become and fought a great fight for his fellow man by preaching awareness, prevention, discipline, and love. This same message is being disseminated by the Amputation Prevention Symposium (AMP) and embodied by the CLI Global Society which understand that the beginning of limb salvage is the fear of amputation.

Why then, with such amazing progress and light being shed on an old problem, do we persist in contributing to a state of preventable amputation marked by drastic disparities in all aspects of healthcare, spanning from awareness to access to delivery? Why does the modern medical culture and political system allow itself to fall short in serving those intended for it to protect? Perhaps the reason for this is that we have individually and systemically allowed ourselves to remain in a collective self-state of thinking even when attempting to comprehend others’ problems. This global pandemic has proven to be a great equalizer, sparing no one and affecting anyone. Equalizing times allow us to open our peripheral vision for contemplation to focus on things that matter, and people matter, minorities matter. If people matter, then racial and ethnic disparities in amputation prevention, CLI, and all healthcare matter. We must begin to invest in who we are treating instead of what we are treating.

The opportunity to have a respectful conversation about who and what matters was provided by the CLI Global Society on June, 24th, 2020 through a dynamic webinar “Racial and Ethnic Disparities in CLI Diagnosis and Treatment: The Ugly Truth and What We Must All Do About This.” The discussion was moderated by Dr. Paul Michael, Medical Director of the JFK Wound Management & Limb Preservation Center at JFK Medical Center and hosted by The CLI Global Society Board members, Drs. Katzen, Jaff, Mustapha, and Neville, with guests Dr. Wayne Batchelor and Dr. Michael Parker.

The CLI Global Society Board members are passionate physicians who have devoted their careers to the advancement of care for patients with advanced PAD and CLI. Dr. Barry Katzen, is an interventional radiologist and Chief Medical Innovation Officer for Baptist Health South Florida and Miami Innovation Institute. Dr. Michael R. Jaff, is a vascular medicine specialist and Chief Medical Officer and Vice President, Clinical Affairs, Innovation & Technology, Peripheral Interventions for Boston Scientific. Dr. Jihad Mustapha is an interventional cardiologist, practicing at Advanced Cardiac & Vascular Centers for amputation prevention. He is the founding board member of the CLI Global Society and founder & director of the Amputation Prevention Symposium. Dr. Richard Neville is a vascular surgeon who is the Associate Director of Inova Heart and Vascular Institute and Vice Chairman of the Department of Surgery at Inova Health System. The guest speaker is Dr. Wayne Batchelor who serves as the Director of Interventional Cardiology, Director of Interventional Cardiology Research, Innovation and education, and Associate Director of the Innova Heart and Vascular Institute. Dr. Batchelor has lectured and published extensively on topics related to disparities in cardiovascular medicine.

To begin the conversation, Dr. Batchelor was asked about his thoughts on the staggering morbidity and mortality numbers associated with CLI alone. His initial impression was that health care disparities in amputation prevention further exacerbate these data in CLI. When examined closely, the amount of lives that could be saved by not only raising awareness but actually paving a pathway for a solution to addressing these differences could save millions. One solution to addressing the problem would be to design better clinical trials, inclusive of minorities, women, and older adults, taking into consideration the demographic makeup of the United States. Because minorities are largely underrepresented in trials, a huge data gap persists in outcomes research. Dr. Batchelor cited the Platinum Diversity Trial, which enrolled 1501 women and minorities across 52 centers, where coronary stent outcomes were followed to in an attempt to help provide a better understanding of treatment effects in a more diverse patient population.

Although selecting minority populations improves detection, unknown biases also contribute to the disparities in minority outcomes as evidenced by a landmark 1999 New England Journal of Medicine paper. In this study, actors representing different cardiovascular disease presentations were interviewed by over 700 cardiologists. Despite the same objective test results, fewer black women were selected for cardiac catheterization. Dr. Batchelor mentioned the importance of recognizing implicit bias, the conscious and unconscious. He stated that the only way to overcome this hurdle is to recognize it and train ourselves to avoid it from the very beginning, starting in medical school. Being trustworthy, empathetic, and compassionate contributes to patient compliance, and has major implications in how we manage public health across the country.

If the data shock in regard to CLI is real, then the lack of awareness must begin somewhere. When Dr. Michael Parker, senior surgical resident, was asked “how many times did you hear the word critical limb ischemia in medical school?” The answer was “zero,” despite being a well established problem for over 100 years.

When Dr. Mustapha was asked why the CLI data are currently so poor, he stated there is a consensus for the need for meaningful data. This stems from the fact that patients facing amputation are not in trials, and this task needs to be better handled by dedicated facilities practicing CLI therapy and amputation prevention. Meaningful data feeding better therapy would reduce regional variances in care and prevent the amputation lottery which occurs on a daily basis in this country.

Recognizing our own biases in order to more effectively communicate is something physicians feel they are good at, but Dr. Michael Jaff carefully pointed out that we are not so good at recognizing what we don’t know or understand. The opportunity to prove this was offered by allowing the audience to visit https://www.implicit.harvard.edu to test themselves in regards to self-bias and prepare to potentially be enlightened by the degree of bias we actually carry before even walking into a patient’s room.

One of the issues plaguing CLI data is operator variability, Dr. Batchelor pointed out that in his data analysis the same level of respect for CAD and Structural Heart Disease operator skill is not demanded of the community when it comes to CLI. He stated it must become the responsibility of those working in the CLI space to build expert teams.

When Dr. Richard Neville was asked how we can make a dent in amputation disparities in regard to minorities, the answer was simple: fix our broken training system. He stressed that we need to increase the diversity in outreach training programs. Well established in PAD outcomes disparities, Dr. Neville stressed the importance of having the tough conversations and making a multidisciplinary plan of action to tackle these real problems, not to be afraid of them.

Dr. Katzen was asked about a unique program addressing a major need at the medical school level. He elaborated on a Florida International University Medical School’s initiative to implant medical students at the community level in patients’ homes from a healthcare delivery standpoint allowing each to follow a family throughout their training. By identifying underserved communities and placing students among those who are experiencing socioeconomic healthcare disparities, a sense of responsibility and empathy can begin.

Through numerous trials and studies, two of the most important predictors of outcomes after one year of cardiovascular therapy were found to be social determinants of health and bereavement. Losing loved ones dramatically affects overall mortality and myocardial infarction outcomes. Dr. Batchelor then highlighted what the implications of losing a limb would be and why it is crucial to collect these data to better understand the overall impact of untreated CLI.

Dr. Jaff pointed out that although we are in pandemic times fueling further disparities in access to care, by opening the discussion with a call to action, we are doing much better than we imagine. We now have a dedicated society, culture, and CLI specialists who are committed to moving beyond the status quo. Dr. Neville echoed this sentiment by stating that the time for talk is over, and the time for action and prevention is at hand. Integrating societies and using the platform of the CLI Global Society’s dedication to amputation prevention will lead to a solution and reduce the number of people at home who face mortality accelerated by limb loss.

In his closing remarks, Dr. Neville challenged the CLI Global Society to survey patients as a new starting point to really understand the roots of their psychosocial problems and avoid the ivory tower approach to data collection. The solution to a better understanding is through the providers and patients who are suffering the most. This was also the main take-away point of Dr. Jihad Mustapha, who described in detail why the current CLI data is so poor and how a CLI focused approach benefits CLI patients. Dr. Mustapha stressed the importance of having a CLI specific code diagnoses to actually identify these patients in the healthcare system and allow them to be heard and felt in the healthcare system for the disease burden they are bearing. Without the code to identify CLI patients, Dr. Katzen acknowledged that the costs associated with this critical illness are hidden within numerous avenues of healthcare, making them difficult to measure.

The panel ended by reinforcing the need to develop a new comfort level with the uncomfortable, and recognition of how during a time of social distancing we can come together to find new meaning in providing inclusive amputation prevention therapy. The conversation took on an often-avoided topic of minority morbidity and mortality associated healthcare disparities and agree that something must be done, and something will be done. Minorities matter.

REFERENCES

1. Macintyre S. The black report and beyond what are the issues? Soc Sci Med. 1997;44(6), 723-745.
2. NCHS: Health, United States, 1983; and Prevention Profile. [PHS] 84-1232. Washington, DC: US Government Printing Office; 1983.
3. Regenbogen SE, Gawande AA, Lipsitz SR, Greenberg CC, Jha AK. Do differences in hospital and surgeon quality explain racial disparities in lower-extremity vascular amputations? Ann Surg. 2009;250(3):424–431.
4. Holman KH, Henke PK, Dimick JB, Birkmeyer JD. Racial disparities in the use of revascularization before leg amputation in Medicare patients. J Vasc Surg. 2011;54(2):420–426.
5. Mustapha JA, Fisher BT Sr, Rizzo JA, et al. Explaining racial disparities in amputation rates for the treatment of peripheral artery disease (PAD) using decomposition methods [published online ahead of print, 2017 Feb 15]. J Racial Ethn Health Disparities. 2017;4(5):784–795.
6. Durazzo TS, Frencher S, Gusberg R. Influence of race on the management of lower extremity ischemia: revascularization vs amputation. JAMA Surg. 2013;148(7):617–623.
7. Goodney PP, Travis LL, Nallamothu BK, et al. Variation in the use of lower extremity vascular procedures for critical limb ischemia [published correction appears in Circ Cardiovasc Qual Outcomes. 2012 May;5(3):e27]. Circ Cardiovasc Qual Outcomes. 2012;5(1):94–102.
8. Minc SD, Hendricks B, Misra R, et al. Geographic variation in amputation rates among patients with diabetes and/or peripheral arterial disease in the rural state of West Virginia identifies areas for improved care. J Vasc Surg. 2020 May;71(5):1708–1717.
9. Goodney PP, Holman K, Henke PK, et al. Regional intensity of vascular care and lower extremity amputation rates. J Vasc Surg. 2013;57(6):1471–1480, discussion 1479‑1480.
10. Lo RC, Bensley RP, Dahlberg SE, et al. Presentation, treatment, and outcome differences between men and women undergoing revascularization or amputation for lower extremity peripheral arterial disease. J Vasc Surg. 2014;59(2):409–418.