The Hope Dealers: How Clinicians and New Tech Could End Unnecessary PAD Amputations

From the heart of the Mississippi Delta, where rates of diabetes and major amputations are among the highest in the nation, to laboratories where researchers ply cutting-edge technologies aimed at minimizing and repairing tissue loss, an unexpected tone has entered the conversation around limb disease: hope.

“They call me a hope dealer,” said Foluso A. Fakorede, MD (Cardiovascular Solutions of Central Mississippi, Cleveland). Born in Nigeria and educated in New Jersey, he felt drawn to work in the Delta by the disproportionately high rates of unnecessary amputations among the community of largely poor people of color. As a Black cardiologist, he also felt an urgency to step up and use his knowledge and connections within the medical community to be perhaps the only health advocate some of his patients had ever encountered.

The numbers are troubling. Black Americans are three to four times more likely to experience a major amputation as a result of advanced PAD. The situation is similarly depressing for Latinx patients, who are up to 75% more likely to experience an amputation than whites, as well as Native Americans, who are twice as likely, Fakorede said.

“As an African-American endovascular and interventional cardiologist, who represents less than 1% of my field of medicine, I cannot sit back and stay silent,” he explained. “What I decided to do was take the messaging to the people.”

We've decreased amputation rates by 80% here. That was the first sign of hope. Foluso Fakorede

By showing up at churches, health fairs, and local TV and radio shows, and building ties with community organizers, Fakorede meets his patients halfway, speaking with them like he would to a family member about their diet, exercise, and smoking habits. He believes that 90% of the amputations he’s seen among the residents of his community were likely preventable. Furthermore, how medicine is taught and the payment policies that shape healthcare, he noted, have created persistent racial and ethnic disparities that are long overdue to be addressed.

“Martin Luther King said it best in 1966. ‘Of all forms of inequality, injustice in healthcare is the most shocking and inhumane,’” Fakorede commented. “It still holds true.”

Over the last few years, his mission to educate patients that they have treatment options beyond losing their limbs has worked even better than he expected. “We've decreased amputation rates by 80% here. That was the first sign of hope,” he told TCTMD.

Messaging and Collaboration

Putting himself front and center on this issue, Fakorede has used his platform to raise awareness far and wide. He co-chairs the Association of Black Cardiologist’s PAD Initiative and writes frequent op-eds on the problem of avoidable amputations. The result of those efforts, he said, is that patients and their families who’ve seen or read about him are reaching out to his office and asking for help. He assists in referrals and welcomes the growing number of peers rallying around him to do their part to give voices to the voiceless. As bad as 2020 has been, he says, dedication to the mission by himself and others never wavered.

The type of grassroots medicine that Fakorede practices has solid data to back it, including the successful barbershop hypertension studies, where medical and behavioral protocols were taken directly to the people who needed them in their own neighborhoods, noted Eric Secemsky, MD (Beth Israel Deaconess Medical Center, Boston, MA). He agreed that successful engagement with patients is important to improving their understanding of peripheral vascular disease and its management as well as to filling in some of the toughest gaps that still exist in care.

“We've really lagged on this idea that we should approach [critical limb ischemia (CLI)] in a more comprehensive way. The focus has too often been: identify wounds, send for procedure, procedure didn't work, so amputate,” Secemsky said. “Wound care is an iterative process that requires incredibly close follow-up and management, and it does require partnership with wound-care centers and podiatrists, and it also requires buy-in from the patient.”

Another reason to be optimistic is the growing recognition about the importance of multidisciplinary CLI teams for patients with peripheral vascular disease, Secemsky added. Admittedly, the practical aspects of coordinating people who do different things at different times in the care pathway is a struggle. But he noted that an upcoming Society for Cardiovascular Angiography and Interventions document will address this issue, with an emphasis on a collaborative way of streamlining care.

“We’re going to have to build from the bottom up and we need a little bit more investigation as to how outcomes can change with CLI teams,” he said. “But being vocal and emphasizing the importance of it is a great start.”

Legislative Efforts and Changing Mindsets

Another way forward to reduce amputation rates is likely to be via legislation. In October 2020, US Representatives Donald Payne Jr (D-NJ), Bobby Rush (D-IL), and Ruben Gallego (D-AZ) introduced the Amputation Reduction and Compassion (ARC) Act. Getting to that point took significant work and educational outreach.

“We formed the CardioVascular Coalition in 2013 when we became very aware that congressional leaders and healthcare policy makers really had no idea what PAD is or the consequences of it, the worst being amputation,” said Jeffrey Carr, MD (Tyler Cardiac and Endovascular Center, TX). Through the group and its outreach to political leaders in the bipartisan Congressional PAD Caucus, the coalition helped create the legislation, which is aimed at expanding Medicare and Medicaid coverage for PAD screening and disallowing payments to physicians for nontraumatic, nonemergent amputations unless anatomical testing has been done in the prior three months.

There are still pathways in this country where patients are going straight to amputations without having any vascular evaluation being done. Jeffrey Carr

Carr said a concerted effort on a national level was clearly needed to put a pause button on the estimated 180,000-plus major amputations being done in the US each year. He also believes in the concept of the hope dealers, adding that introducing the legislation was the embodiment of work that has been ongoing for years and that will only be buoyed by adding more stakeholders.

“There are still pathways in this country where patients are going straight to amputations without having any vascular evaluation being done,” he noted. “The most common analogy we use to help frame this is of a woman who has a lump in her breast and goes to see a single doctor and they say, ‘I'm sorry, there's a lump in your breast, we're going to have to do a radical mastectomy.’ That's what's happening with limbs without first saying what are some other alternative options to save it and [trying] to provide the greatest benefit to the patient.”

The issue also is an important one to keep in front of payers to remind them that unnecessary amputations truly benefit no one, Carr added. “The healthcare costs become astronomical, and [patients’] lifestyles and even longevity goes way down. They have a 50% chance of dying within 2 years after above-the-knee amputation.” Sadly, amputations have become almost a generational rite of passage for some, with younger people seeing their parents and grandparents losing limbs and feeling it’s inevitable for them, too, because no one has told them otherwise, he noted.

“I run into that in my practice all the time,” Carr added. “Patients have been suffering for months, sometimes years, with critical limb ischemia and really had no idea that they didn't have to live like that and that there are options like revascularization that could change their trajectory and help them become pain free and/or save their limb.”

Fakorede said that while the intergenerational impact that amputation can have is “mind-blowing,” it is also understandable when viewed from the lens of a long and sordid history of mistrust that has been sewn within the Black community, one that greatly impacts their beliefs regarding what healthcare providers are telling them and about their chances of being fairly and appropriately treated as people of color in America.

“I'm very methodical in how I explain things to them, because the majority of my patients have a fourth-grade education, at best,” he said. “One of the things I tell them is, ‘Do not let doctors dictate your outcome; you are the driver of your own healthcare.’ So many of them will say that no one ever explained it to them like that. They’ll say, ‘Well, Grandma sat home with a black foot, so did mom, because they were afraid of hospitals.’ We are actively working to change that mindset.”

Both Fakorede and Carr also believe that amputation prevention needs the kind of support and well-crafted promotional campaigns that have been built around breast cancer, stroke, smoking cessation, and other public health efforts.

“It's a problem that gets neglected far too often,” Carr said. “Just taking off socks and shoes and doing an exam, that’s something everyone should and can be doing. We need to promote early recognition and screening and evidence-based care as much as possible.”

New Approaches to Treatment on the Horizon

Ehrin Armstrong, MD (Rocky Mountain Regional VA Medical Center, Denver, CO), said he sees many positive signs of change in the cutting-edge treatments being developed for PAD. The field of endovascular intervention, he added, has continued to innovate significantly, probably more so in the last 5 years than in the 10 years prior.

“There's a company called PQ Bypass that has developed a novel method for a minimally invasive bypass procedure around the superficial femoral leg artery that really expands the treatment options for people with advanced disease who are either too complex for a usual endovascular intervention or may not be candidates for surgery,” said Armstrong.

For below-the-knee (BTK) lesions, he noted that percutaneous deep-vein arterialization is an important breakthrough that is being studied in patients with severe wounds who might otherwise need major amputation. Additionally, earlier this year, the US Food and Drug Administration approved the Tack endovascular system (Intact Vascular/Philips), the first peripheral vascular implant approved in the United States for BTK interventions. The device was developed to treat dissections after balloon angioplasty, which are one of the major limitations of keeping the vessel open. Also in the pipeline is the ongoing phase III SAVAL trial, which is investigating the efficacy and safety of a new DES for BTK CLI. Armstrong indicated that he is also hopeful about ongoing investigations into several bioresorbable vascular scaffolds with unique design concepts.

“Most clinical trials in the past have focused primarily on patients with claudication and have avoided patients with critical limb ischemia because of all their other major medical problems and poor health,” Armstrong said. “For the first time, we now have some dedicated devices meant for below-the-knee use.”

Sparking some of that change in attitude toward inclusion in trials, he added, has been the realization that CLI patients are among those with the greatest need for new technologies and therapies.

“And we've learned how to study the endpoints of the vessel patency and identify ways of measuring success,” Armstrong continued. “There are also new technologies being developed to measure foot perfusion. These include sensors that are used during the procedure, as well as potentially long-term monitoring sensors to identify decreased perfusion to the foot and be a trigger for repeat interventions sooner before it gets worse.” One such cutting-edge device, the Lumee oxygen platform (Profusa) uses novel oxygen-sensor technology and artificial intelligence to measure tissue oxygen levels in real time via a wearable biosensor that gives continuous feedback.

“Another huge advance in the medical therapy arena has been the systematic study of rivaroxaban in patients with PAD,” Armstrong added. “In the VOYAGER-PAD study, rivaroxaban did show a benefit in reduction of major adverse limb events and need for repeat revascularization in patients with PAD undergoing revascularization. So, I think our medical regimen is going to shift significantly in the next few years. Instead of using aspirin and clopidogrel postprocedure, we're going to be moving more towards using aspirin and low-dose rivaroxaban long-term.”

Secemsky cautioned that the type of change needed to lessen the tide of amputations is rarely dramatic, but said the fact that greater investment than ever before is being made in these patients and their outcomes gives hope that something is on the way.

“I do think we're going to make headway, hopefully over my career and over the next decade of healthcare for these patients, because we absolutely can't go backwards,” he observed.

COVID-19 and Beyond

Not surprisingly, the COVID-19 pandemic has created new obstacles for patients with PAD that make it even more important for physicians to be proactive to avoid amputations.

“I think it's emphasized even further the need for getting the best possible [revascularization] result and monitoring these patients with telemonitoring methods as much as possible,” said Armstrong. While telehealth exams of patients with tissue loss in their legs and feet can be challenging for both provider and patient, he said, the pandemic may help to push forward developments in that area that hopefully result in a better, safer means of following up patients for whom those frequent visits are critical.

“We need new platforms to help with this, because I don’t think anyone has a great system for doing it right now,” Armstrong observed.

Secemsky agreed, adding that digital health and more-frequent contact with patients are increasingly being recognized as key to optimal CLI care.

“We need to be able to either identify wounds that could potentially be arterial insufficiency and refer to the lab quicker, or identify wounds that are not healing as would be expected postintervention and should be considered for another intervention,” he noted. The more-frequent contact also can give physicians added opportunity to focus on other moving parts of the PAD equation, including the need to avoid becoming malnourished. In one recent study that Secemsky was involved in, malnutrition ranged from 11% to 24% in CLI patients and was associated with increased risk of both in-hospital mortality and major amputation.

“We should be focusing on all properties of wound healing that not only to take into account restorative blood flow, but also the local wound properties and the global healing properties of the patient,” he explained. “We can engage with our patients much more frequently and we probably should.”

But while telehealth is a great option, as Fakorede pointed out, it can be more challenging for him and his patients than seeing them in person.

“Only about 60% of my patients have any form of internet service,” he said. As a work-around, he and his staff make calls asking patients to come in, with reminders about masking, not bringing a friend or relative into the clinic, and that their temperature will be taken. He’s become even more proactive in recent months, he said, to avoid what happened too often earlier in the pandemic, when people simply didn’t come in and died at home.

“As time went on, we became more aggressive in pushing them to come in,” Fakorede said. “The COVID crisis has widened the fractures that already existed in these communities.” But pivoting in response to needs in real time is something he said he’s happy to do.  

“I'm glad and I'm honored to treat them,” Fakorede said. “Coming here and seeing what these folks have been through, you understand that their hourglass has been turned, and it's turned the day they're born.”