Revolutionary Solutions: Improving Outcomes for Peripheral Artery Disease - A Deadlier Battle Than Cancer

Last night, while flipping through channels, I stumbled upon an advertisement promoting a forthcoming TV program that aims to honor the breakthroughs in cancer research and treatment.

It got me thinking about how we perceive and appreciate the collective efforts of industries, medical professionals, and patients coming together to combat an even deadlier disease than most cancers combined, known as Peripheral Artery Disease (PAD), through innovative approaches.

PAD is?a circulation issue where arteries become narrowed/blocked and restrict blood flow to the feet, which is becoming more prevalent with an aging population and diabetes epidemic.

Unfortunately, underdiagnosis and undertreatment at early stages are common as symptoms like leg pain, cramps, and neuropathy can mimic other ailments. Consequently, individuals only seek medical attention when PAD has progressed into its advanced stage known as critical limb ischemia (CLI). At this point, patients experience non-healing toe ulcers accompanied by gangrene and excruciating pain that disrupts their sleep.

CLI is a formidable adversary, surpassing the combined deadliness of breast cancer, colon cancer, and pancreatic cancer.

Lung cancer is the only condition that surpasses CLI in terms of severity.

At this stage of CLI, approximately 25% of patients face the grim possibility of limb amputation in their first year of diagnosis.

The disease presents immense challenges as plaque accumulates in the arteries to such an extent that it becomes arduous to safely navigate a wire and balloon through the narrowed vessels to open them up, particularly in areas like the calf and foot. It also makes finding a disease-free region to attach a bypass graft and redirect blood flow to the foot exceedingly difficult.

Throughout my personal journey since 2016, traveling across nearly a dozen countries and observing doctors from over 30 states performing thousands of hours of procedures using advanced interventional and invasive techniques, I have encountered hope-inspiring efforts towards preserving both life and limb. These advancements aim to prolong individuals' time with their limbs intact while simultaneously enhancing their overall quality of life.

On the frontlines alongside some of the most advanced limb savers in the world, I have documented on video the invaluable insights shared by physicians as they navigate?the most complex cases.?

The least successful cases I've observed and discussed with physicians performing them, are those in which a physician was in a rush, didn't use additional imaging technologies for proper sizing and placement of stents, relied upon only balloon angioplasty with high barometric pressure to push plaque aside, created a metal jacket groin-to-toe using an abundance of stents, were done without consideration of preserving potential landing zones in case bypass was needed (which is especially important in cases with extensive plaque build-up), and didn't 'complete the case' ensuring blood flow clear to the toes.?

The most successful in limb salvage are those who use more advanced?limb salvage techniques, tiptoeing into the vessels with patience and finesse, preparing the vessels prior to angioplasty when indicated, using the lowest barometric pressure possible, adopting a "leave nothing behind" philosophy with stenting wherever possible, and "completing the case" ensuring adequate flow clear to the toes whenever possible.

While the procedures in question may not provide long-lasting durability, doctors have discovered that by appropriately preparing the vessel and gently "kissing" it with a balloon afterwards, they can restore sufficient blood flow to heal wounds and enable patients to walk. In doing so, patients are able to develop a collateral network of vessels which ultimately enhances their overall prognosis.

But through my experience, I've learned that even if a procedure doesn't last long-term, it's worth giving every patient the best chance of keeping their limb another day.??

The problem is that not every patient knows of advances in medicine and the new innovative limb salvage options which may be available to help them make a more informed decision on next steps in treatment.

Each physician possesses their own philosophy, unique approaches, tools, techniques, and skillset, that ultimately yields different results.

Some continue to practice and advance medicine, while others remain complacent in their practice.

That's why I started?the nonprofit The Way To My Heart , a 501 (c)(3). We provide education, high-touch advocacy and real-time support to more than 10,000 patients globally to help them understand all available options and to navigate the healthcare?system.?Since its inception in 2019, we've been able to save the limbs of nearly 1,000 patients told amputation was the only option by helping to improve healthcare literacy and remove?logistical, financial, and emotional barriers to timely, effective, care.

Our approach to education, advocacy, and support is in line with a growing community of medical professionals, organizations, and industries worldwide who share a common commitment to reach and even surpass the American Heart Association 's (AHA) objective of reducing amputations by 20% before 2030. To address this issue, the American Diabetes Association has established its PAD Alliance, while the AHA has formulated a comprehensive PAD Action Plan. In addition to these initiatives, the CLI Global Society has emerged as an advocate for multidisciplinary collaboration in developing standardized treatment approaches.

Initiatives such as 强生公司 's (Jansen) Save Legs, Change Lives, The Way To My Heart 's Leg Saver Hotline, the African American Male Wellness Agency 's wellness walk, and the LOWER EXTREMITY AMPUTATION PREVENTION LEAP ALLIANCE through its Lions Clubs International foot check initiatives, are helping to bridge gaps between early diagnosis and comprehensive care. And bridging the gap between practices treating PAD, accolades should go to Dr. Jonathan Bonilla and Dr. Zola N'Dandu, for developing the impactful New Orleans CLTI (Critical Limb Threatening Ischemia, another name for CLI), Symposium, which brings together Interventional Radiologists, Interventional Cardiologists, Vascular Surgeons, Podiatrists, Nurses, Wound Care Specialists, Fellow, residents as well as the voice of patients to discuss ideas on improving collaborative care.

Industry leaders are also stepping up their efforts by creating new training facilities where doctors and clinicians can collaborate on pre-clinical imaging techniques. These training centers focus on enhancing quality assurance practices and ensuring patient safety. Notable collaborations include 飞利浦 Healthcare and The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center , led by Philips Director of Evidence Transformation and Medical Safety Officer David A. Chalyan, MD, MSc .

Medical professionals at universities, major medical centers worldwide, as well as outpatient-based clinics (OBL) and ambulatory surgical centers (ASC), are tirelessly innovating limb preservation tools and methods to enable individuals facing amputation to regain mobility and embrace a new lease on life.

• - For example, Dr. Anahita Dua , the 2023 recipient of the prestigious Presidential Scholar of the Year award, is currently dedicated to investigating anticoagulation and biomarkers that can predict thrombosis and hemostasis in patients who have undergone revascularization. The goal is to reduce the occurrence of re-blocking after a procedure aimed at restoring blood flow.
• - Dr. Marco Manzi and Dr. Mariano Palena ( mariano palena ), based in Italy, continue to advance and teach doctors around the world through Cli-Courses , innovative techniques for pedal loop reconstruction, which involves reopening both pedal and plantar arteries along with their anatomical connections. This groundbreaking approach has shown promising results.
• - Institutions like Keck Medicine of USC 's Dr. David Armstrong and Baylor College of Medicine 's Joseph Mills MD have popularized a toe-and-flow model designed to enhance teamwork between vascular specialists and podiatrists when managing patients with non-healing ulcers caused by restricted blood circulation.
• - Dr. Jihad A. Mustapha, MD, FACC, FSCAI has made significant strides in treating chronic total occlusions using cutting-edge methods for successfully crossing these blockages.
• - Another esteemed expert in this field is Dr. Craig Walker, MD from the Cardiovascular Institute of the South , who is a true pioneer in treating blocked arteries throughout the body. He boasts many first-time achievements such as placing a stent in a coronary artery treating a heart attack back in 1989, as well as utilizing laser technology to clear scar tissue within a stent in 2015 - ultimately improving long-term patency rates for those with PAD.
• - Eric A. Secemsky, MD, MSc, RPVI, FACC, FAHA, FSCAI, FSVM ,?Director of Vascular Intervention, BIDMC; Section Head, Interventional Cardiology and Vascular Research, Smith Center for Outcomes Research; Assistant Professor of Medicine, Harvard Medical School, contributes significantly through his impactful comparative outcomes research,?especially with the implementation of structured walking programs,?which provides valuable insights into?patient care.
• - Jaafer Golzar MD FACC FSCAI , was just recognized as a National Limb Salvage Center of Excellence at?Advocate Trinity Hospital ?for their innovative, multidisciplinary Limb Salvage Program, incorporating Vascular Surgeons, Interventional Radiologists, Interventional Cardiologists, podiatry and nursing with a turn-key algorithm and Electronic Medical Record (EMR) order-sets. Since inception in 2014, they've been able to slash amputation rates from a national average of 30% to less than 2%.
• - George Adams , MD, MHS, MBA, FACC, FSCAI, Director of Cardiovascular and Peripheral Vascular Research at Rex-UNC and Associate Professor of Medicine at the University of North Carolina at Chapel Hill is recognized nationally and internationally for his contributions in the care of critical limb ischemic (CLI) patients, especially with antiproliferative devices (i.e. drug coated balloons) to prevent restenosis. He continues to advance the field of vascular care by working with academia and industry, including as Chief Medical Officer of Cordis , to develop and improve devices to treat diseased vessels.
• - Dr. Robert Ferraresi, Dr. Peter Schneider , Dr. Steven Kum , Dan Clair , David H. Deaton, MD FACS , Mehdi H. Shishehbor , are key advisors to Dan Rose and the team at LimFlow , helping to develop a technology that is giving once no-option patients one last 'Hail Mary' to prevent amputation.

These are just a handful of the many exceptional individuals, organizations, and institutions currently revolutionizing medical practices through their unwavering dedication and groundbreaking research endeavors that will undoubtedly shape future treatment approaches across various cardiovascular conditions.

What would we do without physicians who are true to the core of what it means to practice medicine and defy the norm?

As history has taught us, those who defy the norm often propel our society forward.?

Do you remember Barry James Marshall, Australian doctor, a Nobel laureate in physiology or medicine, who disputed the prevailing medical belief that ulcers were mainly due to stress, spicy foods, and excess acid?

His theory that a bacterium called Helicobacter pylori was the cause of ulcers was met with disbelief.?

To persuade the skeptics, who were in the majority, he had to infect himself with the bacteria and then treat it.?

He won the Nobel Prize for his discovery.?

But he was the laughingstock and subject of attacks in physician circles across the globe for years as he pursued proof independently of others.

The ulcer scenario profoundly echoes our present situation, where individuals who risk their lives, enduring radiation for extended periods while working under fluoroscopy, toiling relentlessly to administer treatments that other medical professionals dismiss as futile or ineffective, are under intense scrutiny by competitors.

• Their methods might not be evidence-based yet.
• They may go beyond where other doctors have ever gone before, taking wires, balloons, and controversial atherectomy (plaque removal) devices, clear into the small vessels in the foot to clear blockages and help heal a patient's wound with new nutrient-rich blood flow.
• Their off-label use might be questioned, although any FDA cleared drug or device can be used with caution and care at a physician's discretion with proper documentation and disclosure to the patient.

But with each and every case, their efforts lead to new techniques that offer new hope to each patient, that they might never risk losing a limb.

Five things, however, need to happen in order to ensure progress continues in advancing limb salvage:

1. Physicians who have limitations should collaborate with other doctors to help patients.

Physicians must prioritize the well-being of patients, giving them the best possible chance at preserving their limbs.

• I understand that amputation is much quicker, easier, and safer for physicians who have time constraints and don't want to be exposed to additional radiation for the hours it takes sometimes to tackle complex cases.
• I understand not all physicians have the time to attend advanced seminars and meet with innovators to learn new tools and techniques because so many facilities are short-staffed and overburdened by patients.?
• I understand that not all physicians share the same philosophies on treatments because each chooses the studies and evidence in which they align.?
• I understand that not all physicians can master every tool and technique but feel?pressured by and trust by their facility to treat in the way they feel most comfortable.

But when amputation is on the line, patients should be presented with and encouraged to explore all options, even experimental approaches to limb salvage.

An oncologist would rarely tell a terminal cancer patient their only option is to go home and die.

They would help the patient find whatever options might be available, even if it's elsewhere, to give them even one more day to spend with their children.?

The same respect should be offered to CLI patients.?

Ultimately, it is imperative that healthcare providers prioritize patient care over convenience or personal preferences.

By promoting open discussions about alternative treatments and embracing innovative approaches where appropriate, physicians can ensure that individuals facing limb-threatening situations have access to the best possible outcomes.

2.?A multidisciplinary approach to care will improve patient outcomes.

It is crucial that we end the exclusion of passionate limb savers from various medical practices and instead foster a collaborative and comprehensive approach.?

This entails recognizing the invaluable contributions of vascular surgeons, interventional cardiologists, and interventional radiologists in patient care. In addition to this diverse team, it is essential to include endocrinologists, podiatrists, wound care specialists, dietitians, physical therapists, as well as supporting clinicians and technicians.

During my extensive travels, I have encountered both successful and unsuccessful cases handled by physicians from different specialties.

Based on my experience, the only distinction that needs to be made is between doctors who treat PAD and those who focus on CLI, and do it well.

This differentiation prevents confusion among patients who may not be aware of advanced limb salvage tools or techniques. It also ensures that patients receive appropriate treatment without unnecessary amputations or a lack of vascular assessment.

While some Vascular Surgeons may assert their exclusivity in treating PAD cases due to their ability to perform both interventional and invasive procedures in many instances; it is important for us to embrace an inclusive approach that values collaboration among all healthcare professionals involved in limb preservation. By doing so, we can provide optimal care for our patients while leveraging each specialist's unique expertise.

Analogous to Vascular Surgeons who claim their specialized training makes them best equipped to manage PAD patients due to their comprehensive understanding of vascular systems, Interventional Radiologists assert a similar proficiency. Given that endovascular procedures form the bedrock of their training, and they spend more time under fluoroscopy than others with a special radiation safety certification awarded before graduation, it further solidifies their aptitude for treating these patients.

For Interventional Cardiologists, their core competence lies in maneuvering around complex heart vessels with fluctuating targets - an ideal skillset for treating simpler pathways down the legs. Furthermore, considering three out of five heart attack victims suffer from PAD as well, these cardiac experts are uniquely positioned to offer integrated care solutions for such patients.

Adding to the case for suitability, Interventional Radiologists and Interventional Cardiologists are also pioneers in interventional procedures for treating PAD.

It was Interventional Radiologist Dr. Charles Dotter who took a chance to try something new to save the leg of an 83-year-old woman, which laid the foundation for endovascular procedures to treat PAD, with the invention of angioplasty. Since amputation was on deck and the patient refused that option, her vascular surgeon referred her to Dotter, who experimented with a minimally invasive approach under Xray for the first time in history on January 16, 1964.

Renowned interventional vascular radiologist, Julio Palmaz, holds the distinction for creating the balloon-expandable stent, securing a patent for it back in 1985. This groundbreaking invention has rightfully earned its place in the top 10 list of the most pivotal innovations in history.?

And we can’t ignore the contributions of Interventional Cardiologists, especially legendary Dr. John Simpson, who was credited for commercializing the balloon-over-wire technique, which laid the foundation for today's interventional cardiology and revolutionized the minimally invasive treatment of PAD and coronary artery disease (CAD).?

So, each practice can play a valuable role in PAD care, and we need all hands on deck!

Primary care physicians commonly refer 80% of their patients to Vascular Surgeons, highlighting the significant demand for their expertise. However, there is a pressing shortage of these specialists, leaving us ill-equipped to address not only the current needs but also the growing requirements with the increasing prevalence of diabetes and an aging population.

It's alarming that one-third of hospitals in the United States have unfilled positions for vascular surgeons.

This scarcity was tragically evident when a patient in Atwater, California sought treatment at a local community hospital for blood clots in her legs one month go. Unfortunately, the on-call vascular surgeon failed to respond promptly due to being stretched across multiple facilities located hours apart. This situation forced the patient to be transferred via life flight to a distant tertiary center. Unfortunately, she succumbed to sepsis caused by delays in treatment. The critical importance of time became painfully apparent as her tissue deteriorated rapidly.?

The dire need for more accessible and available PAD and CLI specialists cannot be overstated. Lives depend on swift and efficient medical intervention - something we must strive tirelessly towards achieving.

The issue at hand is particularly prevalent in the South, where the heatmap highlighting the most vulnerable populations for amputation mirrors that of regions associated with slavery during the 1860s.

In these areas, patients lack access to early medical intervention and instead find themselves in emergency rooms with severe infections and gangrene on their feet. Due to advanced stages of disease, and a lack of vascular expertise in the region, orthopedic and general surgeons are left with no choice but to opt for amputation.

Therefore, it is crucial to increase the number of trained practitioners specializing in CLI, especially in underserved areas populated by high-risk ethnic groups such as African Americans, Hispanics, and Indians, who experience amputation rates that are two to four times higher than those among white patients.

Office-based labs (OBL) operated by multiple practices have proven highly effective in reducing amputations in these underserved communities and remain a viable option, but more are needed. A prime example of an impactful limb salvage program in an OBL can be found in Mississippi where Dr. Foluso Fakorede has gained recognition for successfully decreasing statewide amputation rates by 80%. His achievement was made possible through innovative outpatient services introduced specifically for CLI patients within his local area.

3. Supporting the ARC Act and improving physician education is critical to reducing amputation rates.

It's important to not only support the ARC Act, but also encourage it to go further than democratizing early testing and requiring a vascular assessment prior to amputation.?

It should also be required that a patient sees not simply a doctor who treats PAD as part of their practice, but a CLI specialist, to assess whether advanced options might be available to save their limb.?

Would these vascular specialists, who are currently neglecting thorough vascular evaluations prior to amputations, consider employing cutting-edge tools and methods like pedal loop reconstruction or deep vein arterialization to try and save the limb? Well, if not, then they should give up the patient, at the patient's request, to someone who will consider either the former procedure, which involves using wires and balloons to remove blockages in the foot, or the latter technique, which entails diverting blood flow into a vein thereby enhancing circulation in the foot which aids wound healing. These advanced procedures could potentially enhance a CLI patient's life quality by reducing instances of limb loss.

It's simple: If amputation is on the table, physicians treating someone with CLI should be expected to exhaust all efforts to try and save their limb, or give up the patient to someone who can.

It should be the rule, not the exception.

Too often, medical practitioners neglect to address lower leg conditions in CLI patients awaiting amputation. This negligence is especially detrimental for diabetic patients who frequently suffer from obstructed arteries in their calves and feet.?

In a recent social media video discussion regarding former NFL great and current Colorado State University Football Coach Deion Sanders' cardiovascular health, his Vascular Surgeon Max Woehler exhibited a dated mindset that undermines the dedication required to practice medicine effectively. Woehler stated in the video that if they unblocked Coach Prime's arteries, they would simply "close-up" once more; consequently, suggesting amputation as the best solution.?

Consider how challenging it must be for individuals without Sanders' resources and fame seeking specialized limb salvage physicians – particularly within medical deserts such as the South.?

For example, a patient in South Carolina who lost his left leg and was on deck to lose his right leg because his doctor didn't believe it was effective to treat the small vessels below the knee, another patient in California who was?told that she would have to suffer through unconscionable?pain until she was ready for amputations because her vessels in the foot were "too small to treat," and yet another patient in Michigan who had a physician that tried tackling blockages in his calf coming down from the groin and failed but never attempted to come up from the foot to see if it was possible to try a different approach. In all cases, the patients came to The Way To My Heart and we were able to facilitate an introduction to an advanced limb salvage specialist who was able to prevent amputation. Two years later, each one is still has that leg.??

These three patients, along with more than1,500 others, signed a petition supporting the expansion of the ARC Act to give them an even greater chance at keeping their limb and their life (Petition · Limb Loss Prevention · Change.org ).

Let's listen to the voice of the patients.

4. We need to crackdown on preventable amputations (beyond the ARC Act).

Fifty-one percent of all PAD-related amputations are being performed without an attempt to save the limb. What’s more disconcerting is that the The American Diabetes Association reports that, of the more than 154,000 diabetes-related amputations that occur annually in the U.S., 85% of them were preventable.

Medicare is appropriately focusing on cracking down on those administering premature minimally invasive procedures to early-stage PAD patients, known as intermittent claudicants who haven't tried walking as medicine to improve blood flow.

We need similar scrutiny placed on those conducting preventable amputations without an attempt to save the leg, because although there aren't standards, there are guidelines by the Society for Vascular Surgery and AHA that suggest an attempt should be made to restore inline flow prior to amputation.

Amputations are a large cost burden on not only patients, but also insurance companies, and society, although reimbursement to hospitals for cutting off a limb is higher than limb salvage procedures.

“It is commonly believed that amputation costs the hospital less than revascularization procedures. This is incorrect,” explains Sage Group PAD Analyst Mary L. Yost .

“Our analysis, as well as other research, demonstrates that amputation actually costs the hospital more than either surgical bypass or endovascular revascularization. Although initial procedure costs are similar, total amputation costs including the costs of in-hospital mortality, morbidity and revision procedures are higher than those of either bypass or endovascular.”

So, while pioneering limb savers have faced public scrutiny for trying too many times or using experimental methods to try and save a leg "for profit", the greater intensity of focus should be on those who perform amputations "for profit" without an attempt to restore blood flow.

This shift in attention that might inspire more physicians to make an attempt to restore blood flow has the potential to significantly reduce preventable amputations.

5.?We need to create a multidisciplinary patient registry.

The registry needs to be developed through an independent organization in which all practices align in order to start tracking outcomes?from all limb salvage efforts. This is crucial to avoid relying upon biased, flawed, retrospective?studies of Medicare data that don't take into consideration important factors that can determine long-term outcomes. This is helpful for developing more concrete evidence-based standards for treating PAD and CLI so as to establish more consistent limb salvage care that is practice and facility agnostic, resulting in amputation reductions globally.

Conclusion:

We know that the best way to prevent amputations is to prevent PAD and CLI in the first place. Of course, more needs to be done with awareness and advocacy in this area. But until no one ever presents with PAD or CLI again, a collective of passionate CLI Fighters, have the ability to significantly reduce preventable amputations with simply action on those five steps.

The stakes are high when it comes to life and limb.

We must work together by breaking down barriers and fostering collaboration among all stakeholders since there is ample room for improvement in caring for these patients while we strive for a cure.

Be part of the solution rather than contributing to the problem.

Instead of obstructing medical practices that promote innovation—a vital aspect of our healthcare system—join the growing community of medical pioneers, including industry, doctors, non-profits, and other supporting healthcare professionals, striving to enhance PAD and CLI care through innovative approaches.

Just as cancer has been fought with unwavering commitment towards promoting innovation, if we unite efforts in this field, we may succeed in persuading the President to support our cause.

The Recalcitrant Cancer Research Act was signed into law by then President Barack Obama back in year-2013; chartering national strategic action plans targeted towards addressing the deadliest forms of cancers plaguing the nation. These are categorized as ones showcasing mortality rates exceeding half i.e., >50%, thus including fatal varieties such as pancreas, lung, brain, esophagus, and liver cancers.

So, why don’t we have the same type of legislation for CLI when it has a 5-year mortality of >50%??

By collectively dedicating ourselves to advancing limb preservation techniques, I believe it's inevitable. And within a decade, our efforts will be showcased in prominent media outlets as we pay tribute to the medical trailblazers who have made great strides in helping patients with PAD and CLI live a longer, better quality of life.

Let's save life and limb together!