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What is Peripheral Artery Disease and Standard Treatment Protocols?

An explanation inspired by Deion Sanders' revelation that he has a circulation issue putting him at-risk of amputation.

· Heart of Innovation

Deion Sanders courageously shared his struggles with a circulation issue that puts him at-risk of losing his foot in a video posted on social media. It may have been left on the editing room floor, but critical information about this circulation issue and treatment options to prevent amputation were not shared in the video or across other media covering this story.

That's why in this episode of The Heart of Innovation, hosts Emmy Award-winning Journalist Kym McNicholas and Interventional Cardiologist Dr. John Phillips are joined by specialists trained in advanced treatment of this circulation issue known as peripheral artery disease (PAD) and its advanced stage critical limb ischemia CLI), a circulation issue characterized by narrowed or blocked arteries due to plaque such as blood clots and/or calcium, which can cause leg pain, leg cramps, non-healing wounds, and more.   

Vascular Surgeons Dr. James Antezana, M.D., FSVS, RPVI and Dr. William Shutze, who’s also a Society for Vascular Surgery Board Member, talk about what you need to know about this circulation issue, which is one of the most debilitating diseases most have never heard of, yet impacts 3-in-5 heart attack sufferers, 1-in-5 over age 60, and 1-in-3 diabetics (Type 1 and Type 2 diabetics) over the age of 50. Importantly, they share advances in treatment and amputation prevention as well as the standards of care patients should expect from their physicians treating it. 

Definition of PAD

In the first hour, one key discussion was around the definition of peripheral artery disease and whether it is only characterized by atherosclerosis, the buildup of fatty plaque in the arteries, or whether it includes anything that can cause a narrowing of the vessels that restricts blood flow, including blood clots.

The question arose as Deion Sanders' Vascular Surgeons only discussed a 'circulation issue' or 'blood clot' that is putting the college football coach and former NFL star at-risk for amputation. Physicians, clinicians, industry and advocates have expressed concern as to why it wasn't called peripheral artery disease (PAD) or critical limb ischemia (CLI).

It's likely due to the technical definition of each.

The Society for Vascular Surgery (SVS) offers this definition on its website:

Peripheral arterial disease (PAD) occurs when atherosclerosis, or hardening of the arteries, causes a buildup of plaque in the blood vessels.

The American Heart Association (AHA) defines Peripheral artery disease as: A narrowing of the peripheral arteries that carry blood away from the heart to other parts of the body. It goes on to say that it's, 'caused by atherosclerosis.'

The specificity of 'atherosclerosis' in the definition is likely why Deion Sanders' vascular surgeons did not call his circulation issue PAD, as it wouldn't be technically correct by definition.

Same goes for CLI, which is defined by the SVS as a clinical syndrome defined by the presence of peripheral artery disease (PAD) in combination with rest pain, gangrene, or a lower limb ulceration >2 weeks duration.

Vascular Surgeons and PAD/CLI Patient advocate Kym McNicholas talk about expanding the definition to officially include anything that might cause a narrowing or blockage in the peripheral arteries, mainly the legs, whether acute or chronic, so as to reduce confusion with patients and healthcare teams. It's how PAD/CLI are referred to and addressed on a grander scale across the industry anyway, especially since symptoms, testing, managing physician, and treatment options are similar. 

Patient Experiences with PAD

Another key discussion (Hour 2) during the show involved nearly half-a-dozen patients who share their experiences with PAD and challenge current standards as not going far enough to reduce amputation risk. Two patients shared powerful instances where, what they viewed as sub-standard care, especially wound care, led to a revolving door of amputations. This led to Dr. William Schutze, Secretary for the Society for Vascular Surgery, sharing a new proposed project aimed at improving wound care for patients, and unexpectedly attracting volunteers to help in this potentially impactful effort.

How Prevalent is PAD?

Why does The Heart of Innovation dedicate so much time to talking about PAD? PAD is one of the most debilitating diseases most have never heard of but impacts millions:

  • 3-in-5 heart attack sufferers have PAD
  • 1-in-5 Americans over age 60 have PAD
  • 1-in-10 Americans age 50 have PAD
  • 1-in-3 Americans with diabetes have PAD

Most don’t know they have it until it reaches advanced stages and heart attack, stroke, and/or amputation are imminent. Doctors may dismiss symptoms as indicative of sciatica, diabetic neuropathy, restless leg syndrome, electrolyte deficiency, or simply old age.

What are the risk factors for PAD/CLI?

  • Diabetes
  • Genetics such as hereditary clotting disorders (as with Deion)
  • Smoking
  • Obesity
  • High Cholesterol
  • High Blood Pressure
  • Autoimmune diseases
  • Chronic Kidney Disease
  • COVID-19

What Are Symptoms of PAD?

  • Leg cramps (intermittent claudication) while walking
  • Leg pain
  • Leg fatigue
  • Leg discoloration
  • Numbness
  • Temperature differences between legs
  • Lack of leg hair growth

Advanced stage PAD is known as critical limb ischemia (CLI) or critical limb threatening ischemia (CLTI) and is defined by the presence of PAD symptoms combined with:

  • Rest pain
  • Foot/toe ulceration
  • Gangrene

The CLI Global Society is a great resource for learning more about this advanced stage of PAD. They recently issued a press release in response to public discussions around Deion Sanders' circulation issue that has him presenting with CLI symptoms.

How do physicians test for PAD/CLI?

In the video, a vascular surgeon tells Sanders he determined Sanders has poor circulation by using blood pressure cuffs placed on his arm and leg. That test is known as an Ankle-Brachial Index (ABI) test. It's used specifically to diagnose PAD. Doctors may also use advanced imaging such as a leg artery ultrasound and CT Angiogram, where contrast fluid is pumped into the arteries intravenously to obtain high resolution 3D images of the vessels. An arterial duplex ultrasound, computed tomography angiography, magnetic resonance angiography, and invasive angiography) are recommended diagnostic tools for PAD as per the Society for Vascular Surgery (SVS) guidelines.

How serious is PAD/CLI?

If left undiagnosed and untreated for too long, it can lead to heart attack, stroke, and amputation.

PAD in-and-of-itself is not life threatening in its early stages. But if plaque is building up in the leg arteries, it's likely building up elsewhere in the body, such as in the heart and the carotids (neck), which can pose a more serious threat. If someone is diagnosed with PAD, it's important to C.H.A.T. with their physicians annually. C.H.A.T. stands for, check my:

C - Carotids

H - Heart

A - Abdomen (aneurysm)

T - Toes (peripheral artery disease)

CLI is of greater concern. This is limb AND life-threatening

More patients die within five years of CLI diagnosis than with any type of cancer except for lung cancer.

The mortality rate is significantly higher after primary lower limb amputation. It is crucial to consider this when deciding whether to save the limb or not. The increased mortality is not primarily due to post-operative complications, but rather the decrease in mobility that follows. This decrease in mobility leads to a higher risk of plaque build-up throughout the body, particularly in the heart. Although advancements in medical care have improved patient prognosis, mortality remains a serious concern. If possible, it is important to address any pre-existing health conditions that increase the risk of mortality before proceeding with surgery.

How Do Doctors Treat PAD/CLI?

If diagnosed in the early stages where a patient is either asymptomatic or experiences intermittent claudication while walking, frontline treatment is:

  • Medical management such as blood thinners, anticoagulants, and statins. SVS guidelines suggest also pharmacologic quality of life treatments which may include cilostazole (100 mg twice daily in patients without a history of heart failure), pentoxifylline (400 mg three times daily in patients with a contraindication to cilostazole), and ramipril (10 mg daily).
  • Lifestyle modifications such as diet, smoking cessation, and exercise in the form of a regimented walking program. The walking program is critical because the body is miraculous in its ability to create a 'natural bypass' around narrowed or blocked vessels with proper technique and frequency.

Most diagnosed with PAD, under appropriate medical management and compliance, never progress to advanced stages to where they experience lifestyle-limiting claudication or CLI.

According to SVS and European Society for Vascular Surgery guidelines, If medicine and lifestyle modifications don't improve symptoms and daily life activity is severely compromised, revascularization (manually restoring blood flow) can be proposed, along with exercise therapy. If a patient presents with CLI symptoms such as tissue loss, infection, and/or gangrene, guidelines mandate urgent revascularization. Two types of revascularization options are available:

  • Endovascular: A medical intervention tends to be minimally invasive and does not usually need a cut into the skin. It is performed using x-ray and ultrasound guidance and entails catheters, wires, balloons, plaque removal devices, and stents being placed directly into the artery through tiny holes, rather than through large external incisions.
  • Surgical: Surgery is a more invasive medical intervention, and it does require a cut into the skin. A physician may offer a bypass using your veins, a donor's veins or a synthetic graft to re-route blood flow around blockages. They might also offer an endarterectomy, which entails a smaller incision allowing the physician to manually scrape out the plaque from the blocked vessel.

SVS guidelines indicate endovascular interventions are preferred over open surgery whenever possible for most presentations of PAD.

What if treatment fails? Amputation!

Amputation should be a last resort ONLY if ALL minimally invasive treatment options are exhausted, yet an estimated 200,000 PAD related limb amputations are performed every year.

Fortunately, with recent advancements in techniques, tools, and approaches, amputation is now rarely necessary when under the care of the right physician trained in advanced limb salvage.

In fact, more than 80% of all limb amputations caused by PAD can now be prevented with early and medically appropriate diagnosis and treatment.

As mentioned earlier, the decision to undergo amputation should not be taken lightly, as mortality rates following PAD-related amputations are alarmingly high.

Unless a patient presents with a limb that is life-threatening (e.g., necrotizing fasciitis, sepsis, acute limb ischemia), an amputation should not be performed:

  • Without a multidisciplinary discussion between the vascular specialist, cardiologist, podiatrist, primary care physician, and even endocrinologist.
  • Without a second opinion by an advanced skilled limb salvage specialist.
  • Until an assessment of other comorbidities is done. According to SVS guidelines

When assessing patients who need a major amputation, it is important to understand the risk of postoperative morbidity and mortality. Myocardial infarction, pulmonary complications, and renal failure are frequent after lower extremity amputations. 

  • an attempt to restore inline flow using either endovascular or surgical approaches. This is crucial. SVS and American Heart Association guidelines state

Revascularization should be performed to minimize tissue loss prior to amputation.

Amputations rarely end with just one when they are linked to PAD/CLI.

It is important for Deion and his healthcare team, as well as all individuals with PAD/CLI and their care teams, to prioritize revascularization as the first course of action. This approach aims to restore sufficient blood flow to promote wound healing, prevent tissue loss, and minimize the chances of further limb amputations. Even if there is a risk of the reopened blood vessels closing again, it is crucial to still attempt to restore blood flow before considering amputation.

Who Treats PAD/CLI?

Four different practices directly treat PAD/CLI.

Vascular Surgeon: May have the ability to treat P.A.D. and other vascular issues using endovascular (minimally invasive tools & techniques), bypass, and amputation.

Interventional Cardiologist: May have the ability to treat P.A.D. and Coronary Artery Disease (C.A.D.) using endovascular tools & techniques.

Interventional Radiologist: May have the ability to treat P.A.D. using minimally invasive tools & techniques as well as provide other image guided diagnostics and therapy such as cancer treatments

Vascular Medicine: Always treat P.A.D. patients who do not require surgery, but instead only medical therapy, which may include walking program. A patient may have a vascular medicine doctor along with a vascular surgeon, Interventional Cardiologist, or Interventional Radiologist for long-term disease management.

Title is not as important as skillset.

Different doctors have different approaches, different tools, different philosophies, and different skillsets when it comes to treating PAD/CLI.

Each one is likely to tell you that if they can't open up your arteries, no one else can either and their way is the best way.

It may be true.

It may not be true, even at the most prestigious hospitals and with doctors who have the highest pedigree.

The greatest success in preventing amputation, are those vascular specialists known by their peers as CLI Fighters.

These CLI Fighters go beyond medical school education and fellowship to continuously pursue learning new, advanced limb salvage techniques.

CLI Fighters have a high volume of the most complex cases in which other physicians have told a patient there's no option but amputation and have a high success rate in limb salvage.

You won't find these CLI Fighters through a general referral by your primary care physician or by simply looking at their title, practice, publications, podium, or online reviews.

You must do your research and learn their practical limb salvage skillset.

What questions should I ask in vetting a vascular specialist?

Here are the questions The Way To My Heart suggests patients ask before selecting a vascular specialist to lead their PAD/CLI team:

  • Tell me a story about a case similar to mine and how you helped them live a better quality of life, longer.
  • What is your volume of complex cases and success rate for limb salvage?
  • What is your standard approach during endovascular procedures and do you have the ability to not only enter into the arteries at the groin, but also through the wrist, foot, or calf in case you need to tackle a blocked artery from multiple directions?
  • Do you use additional imaging during procedures such as intravascular ultrasound (IVUS)?
  • What are your go-to tools? They may include plain old balloons, drug-coated balloons, vessel preparation devices (plaque removal, audio waves), and stents. (I look up these tools on the FDA's MAUDE, (Manufacturer and User Facility Device Experience) website, which collects reports on complications that come in from patients, attorneys, hospitals, and device users like hospitals.)
  • What are the typical complications you face during your endovascular procedures and how do you mitigate those risks?
  • How do you minimize trauma to the vessel during a revascularization procedure to ensure the vessels have the best chance at staying open, longer? (Do you try to dilate the vessels using balloon angioplasty at a lower barometric pressure with slow inflation?)
  • Do you have experience and are you willing to use minimally invasive tools and techniques to revascularize the small vessels below-the-knee and into the pedal-plantar loop of arteries, especially in a diabetic's foot?
  • Have you performed a deep vein arterialization (DVA) or have the ability to refer me to someone who does in case it is deemed medically appropriate as a last effort to prevent amputation?
  • Do you have the ability to perform a bypass or endarterectomy or have someone whom you can refer me to if an endovascular approach fails or surgery is preferred or indicated to restore blood flow?
  • What is your threshold before sending a patient for amputation?

Many of these questions are deep and technical, but they're critical to know if your vascular specialist is going to be your long-term partner in care with the best chance of keeping your limbs in-tact.

How do I get help finding a specialist and learn more about PAD/CLI?

The Way To My Heart's PAD Navigators are connected already to some of the most advanced limb salvage specialists in the world and they are available FREE to help you:

  • Find a physician that meets your needs.
  • Answer any questions you might have about PAD/CLI.
  • Prepare you for your appointments with critical questions to ask your vascular specialist, endocrinologist, podiatrist, primary care physician, cardiologist, and more.
  • Be with you virtually or in-person to help facilitate a productive conversation with your vascular specialist and take notes.
  • Follow-up with you and your select family members/friends after appointments to ensure a comprehensive understanding of diagnostic and treatment options, as well as to help you find a second opinion if desired.
  • Provide compliance support for lifestyle modifications including smoking cessation, diet, and exercise.
  • Offer emotional support as PAD/CLI are chronic and not only physically but also mentally debilitating.
  • Help remove any financial barriers to timely, effective care, including co-pay relief and transportation.

Call The Way To My Heart's Leg Saver Hotline at 415-320-7138, which is also available through the American Diabetes Association’s website, or go to our website www.TheWayToMyHeart.org

We are here to help.

If given the opportunity, The Way To My Heart is committed to saving the limbs of Deion Sanders and the millions of others who are suffering with PAD/CLI.

Don't hesitate to reach out! Your life and limb may depend on it!

 

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