Embracing Innovation: A Path to Limb Salvage and Improved Quality of Life for Peripheral Artery Disease Patients

Jason, a 41-year-old African American gentleman residing in North Carolina, who is battling type 2 diabetes, sought assistance from a podiatrist for a persistent foot wound and unfortunately fell prey to a disconcerting pattern. 

The podiatrist, upon diagnosing a blood circulation issue known as peripheral artery disease (PAD), recommended toe amputation as the remedy. When the wound at the surgical site showed no signs of improving, and nocturnal leg cramps causing him to dangle his legs for relief began, his podiatrist deemed it necessary to hand him over to a vascular surgeon. 

The suggested standard treatment from the vascular surgeon was to amputate below the knee. 

This suggestion was given regardless of established guidelines from the Society for Vascular Surgery and presence of nearby experts proficient in modern limb preservation techniques that could have potentially saved Jason's limbs. The vascular surgeon didn't make any efforts to clear blocked arteries to improve blood circulation or refer Jason to another expert who might have attempted this. 

Through seeking out a second opinion from innovative medical professionals who specialize in cutting-edge limb preservation methods using wires, balloons, atherectomy (plaque removal devices), and stents, Jason astonishingly avoided the scheduled leg amputation.

However these alternative solutions may not be available much longer for others facing similar situations.

SOME SURGEONS REJECT NEW INNOVATION DESPITE AMPUTATION DECLINE

Even though there was a substantial drop of 45% in amputations from 1996 to 2011 due to the advent of new, less invasive surgical techniques, some vascular specialists are still manipulating unreliable and prejudiced information to obstruct life-saving innovations. 

This could have consequences for life and limb-saving advances that could reverberate across all areas of healthcare. 

It’s a handful of Vascular Specialists who prefer quick-fix amputations without exhausting all possible advanced limb-saving options first, who are arguing for their own limitations, fighting to remain complacent in care by resorting to unprincipled and immoral tactics for safeguarding their ego, monetary gain, and territory. 

They are manipulating medical boards, legislators, and journalists through defamation campaigns against anyone who poses a threat to their comfort zone, self-esteem, profits, or domain.

Their target is a small group of forward-thinking pioneering vascular doctors, whom I’d liken to a modern-day Galileo, who went against popular belief, advocating that the Earth revolves around the sun, which defied the Church’s authority, and was consequently placed under house arrest and accused of heresy.

Clearly, Galileo was correct, but he tragically lost his life due to the ignorance of his era. 

Do we desire a similar destiny for medical trailblazers who exhaust all efforts for limb salvage, and whose complication and amputation rates are lower than their accusing counterparts who label their limb-saving efforts as profit-driven and unnecessary? 

When will we stop disregarding those who challenge the established norms with innovative ideas in medicine?

HOW INNOVATION DRIVES MEDICAL ADVANCES FORWARD

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 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 laughing stock 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 to 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 limb preservation techniques that give new hope for each patient, similar to Jason, that they might have the opportunity of retaining their limb.

Those who criticize doctors for executing a substantial amount of intricate limb salvage procedures through innovative methods, which sometimes involve off-label device usage, should also consider their own cardiology colleagues within their hospital systems who may not always adhere to conventional paths in order to increase a patient’s survival odds. 

Wouldn't our progress in treating coronary artery disease be significantly hindered if not for physicians willing to deploy eluting stents beyond the FDA's approved application?

In hospitals across the United States, over one-third of the drug-eluting stents implanted during the initial nine months post-market approval of the Cypher stent were utilized for off-label purposes, as per the American College of Cardiology-National Cardiovascular Data Registry. 

Doctors saw their value in complex lesions they couldn’t previously treat which would have gone unaddressed or scheduled for bypass. The rate of in-hospital fatalities and unexpected coronary artery bypass surgeries linked with the off-label usage of the Cypher stent were both significantly less than 1% (similar to those innovating with leg treatments). So many lives were saved with those cardiologists who took a measured risk to help their patients who might've lost their life or would've had to undergo a massive bypass procedure.

But to do so, they had to be unconventional and become pioneers in their space to advance medicine.

MEDICINE IS EVER-CHANGING SCIENCE

The advancement of medical science hinges on the continuous evolution and invention of new treatment methods and therapies for illnesses. 

Imagine if Werner Theodor Otto Forssmann, a German researcher and doctor, had followed the traditional path laid out by his superiors and not ventured into performing the very first self-heart catheterization. In 1929, under local anesthesia, he daringly inserted a catheter into one of his own arm veins. He took an enormous risk without any certainty if the vein would withstand such an intrusion.

Despite this uncertainty, Forssmann successfully navigated the catheter into his heart. This groundbreaking discovery earned him a Nobel Prize later and has since significantly contributed to saving millions of lives worldwide.

Without such forward-thinking, the medical industry would hit a standstill, unable to make any progress. 

Who would want that?

Certainly not the patient.

In 1964 An 83-year-old patient with a gangrenous foot was told her only option was amputation.

She refused.

She would’ve lost her limb if it weren’t for her Vascular Surgeon allowing another practice to attempt the first endovascular limb salvage attempt.

Interventional Radiologist Dr. Charles Dotter, took a chance to try something new since amputation was on deck and already the limb was at-risk of loss. 

He sized-up multiple catheters to push plaque aside and restore blood flow in a minimally invasive way under x-ray for the first time in history.

Today, this sort of collaborative, innovative mindset across practices in the treatment of PAD is falling by the wayside, which has the potential to undo the progress achieved in the past ten years in minimizing amputations using novel, minimally invasive, interventional approaches for limb salvage.

This could have a disastrous effect on those who were not diagnosed with PAD in its early stages where medicine and lifestyle modifications, especially walking are frontline therapy, are now suffering with the most advanced stage of PAD, Critical Limb Ischemia (CLI).

THE VICTIMS OF AN INNOVATION CRACKDOWN

Critical Limb Ischemia (CLI) or Critical Limb Threatening Ischemia (CLTI), the progressed stage of PAD. Symptoms include excruciating nocturnal leg pain and cramps, non-healing wounds on toes or feet, and even gangrene that, if untreated, can threaten not only limbs but also lives. In the US, PAD affects 11% of the population, which equates to about 1 in 5 individuals over the age of 60, 1 in 3 diabetics over the age of 50, and 3 in 5 heart attack victims. The estimated prevalence of CLI is around 2 million, with more than 1.3% of adults affected, slightly more men than women. CLI affects approximately 500 to 1000 per million per year.

The condition is becoming more common with an increase in diabetes and an aging population. 

It’s a very sick population of patients with multiple comorbidities that may also include coronary artery disease and chronic kidney disease that contribute to one of the highest morbidity and mortality rates of any medical condition.

Even breast cancer, prostate cancer, and colon cancer don’t come close to killing as many people as CLI.

In fact CLI has a higher mortality rate than all cancers combined except for lung cancer. 

Published online 2020 Mar 24. doi: 10.1186/s13047-020-00383-2 Southwestern Academic Limb Salvage Alliance (SALSA), Department of Surgery, Keck School of Medicine of University of Southern California, Los Angeles, USA David G. Armstrong

It’s even higher after an amputation.

That’s why it’s imperative for these patients to keep their legs as long as possible. 

But 25% of CLI patients undergo an amputation in the first year after diagnosis.

If the potential loss of a limb is a possibility, shouldn't a doctor consider innovative approaches to limb preservation, even if it means offering a patient just one additional day of walking on their own two feet?

But that's not the case.

COMPLACENCY STALLS ADVANCEMENT FOR A CURE

I firmly believe that the only reason College Football Coach Deion Sander's vascular specialists attempted a revascularization is because of public and peer pressure as Max Woehler clearly said in a video posted on social media that it wasn't worth trying to open up his blocked arteries because they would only block back up again.

That's a sentiment I hear a lot from patients told no-option and I have facilitated a limb-saving introduction to a second opinion elsewhere.

While critics of so-called CLI Fighters are arguing that these medical trailblazers are doing too many unnecessary procedures leading to amputation, in actuality the more widespread problem is that too few limb preservation attempts are being performed in favor of easy, more profitable, invasive methods.

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 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 and eliminating those administering unnecessary minimally invasive procedures to early-stage PAD patients, known as claudicants.

So, why isn’t similar scrutiny placed on those conducting unnecessary amputations such as with the preventable 85% including Derrick Six?

Six, a 56-year-old Type 2 diabetic, was told by a large University Hospital in Chicago that amputation was his only option for his circulation issue which they explained as being caused by diabetes. 

“I was being amputated toe by toe by toe for two years before I found Dr. M and the amputations finally stopped,” explains Six. 

Six had lost multiple toes on one leg and half his foot on the other prior to his wife Toni discovering through internet research his circulation issue had a name, peripheral artery disease, and other limb saving options may be available to treat it. So, when the vascular surgeon suggested taking half Derrick’s leg as the next step, Toni packed their car and drove Derrick to see an advanced skilled doctor in a Michigan office-based lab. After four revascularization procedures that included balloons as well as laser atherectomy, and orbital atherectomy devices, he was able to heal his wounds and has not been back for another procedure in more than two years.

Atherectomy, when used in medically appropriate procedures such as in Derrick’s case, for indications that include calcium and a build-up of scar tissue in a stent, plays an important role in reducing trauma to the vessels By. removing some of the plaque build-up the doctor is able to use lower barometric balloon pressure to ease more plaque aside, resulting in fewer stent usage by physicians. A systematic review of seven studies conducted by the Cochrane Vascular Group, found that atherectomy led to lower rates of bailout stenting during the procedure and reduced balloon inflation pressures when compared to balloon angioplasty alone.

Mike P is another success story.

He was told by multiple prestigious facilities in Cleveland, Ohio and Indianapolis, Indiana that amputation was the only option. He and his wife drove five hours to Michigan where an advanced limb saver saved his leg using the endovascular procedure portrayed as a leading cause of amputation in media, known as atherectomy, which is a device that removes plaque.

“I may need another one but I’m willing to do everything I can so I can walk with my wife,” explains Potts.

As if Mike, or any other patient would ever say their limb is not worth as many attempts as necessary to save.

There are no rules written that specifically say how many procedures a patient can have if a physician believes there’s still hope to save the limb.

But that’s not stopping some critics from shamelessly reporting these physicians, who expand limb salvage options, to medical boards, getting their hospital privileges revoked, and driving them out of business simply to deflect from their own desire to maintain the status quo.

CLI patients deserve better.

You don’t hear of a Cancer doctor under scrutiny for going the extra mile to help a patient knocking on death’s doorstep to live a longer, better quality of life of their choice.

It's unimaginable to find a doctor who would deny a cancer-stricken woman a potential life-extending experimental treatment that might afford her an additional day to witness her children's growth.

Doctors are incentivized to do everything possible to do everything in their power to extend the life and improve the quality of life for patients with terminal cancer. 

Take HIPEC, for instance, a heated chemotherapy bath used for specific abdominal and gastrointestinal cancers. This treatment, sometimes referred to as 'shake and bake,' involves distributing warmed chemotherapy drugs throughout the abdomen. It's invasive, costly, and time-consuming (around 8-10 hours).

Yet, institutions like Johns Hopkins offer it to eligible patients, stating that this experimental option such as this one can enhance long-term results and provide additional treatment avenues for patients diagnosed with advanced or inoperable cancer.

A significant number of these patients eventually succumb to their cancers, akin to CLI cases. However, people seldom doubt that the experimental treatment, such as what Johns Hopkins provides, that’s aimed at enhancing and prolonging their lives caused their demise, unlike the skepticism surrounding those with CLI.

So, if new endovascular methods to treat CLI are considered experimental, like HIPEC for cancer patients, then why shouldn't they be utilized to potentially extend a patient's life when medically appropriate and preferred by the patient?

Just like Cancer patients, CLI patients have no time to waste.

What do they have to do to get the best chance of life and limb they deserve?

Wrap a tourniquet around the legs of the naysaying doctors and make them experience their daily and nightly suffering by walking around and sleeping with the tie cutting off their circulation, causing their muscles, tissue and nerves to scream for oxygen and other nutrients?

Must they experience firsthand the challenges of living limbless, confined to a wheelchair and bed in their last days, with over 60% of amputees lacking access to prosthetic limbs currently?

The increased disability brought about by a Lower Extremity Amputation (LEA) is only part of the problem. Research indicates that one-third may not survive beyond their first year post-amputation.

Let’s give these patients the best chance at living a better quality of life with their limbs in tact.

They call it the “practice of medicine’ for a reason. 

If you have been granted the title to practice medicine, practice it.

What you learned in medical school is only a foundation for you to build upon.

I joke sometimes that everything I needed to learn about practicing law was in my first year in law school, because it's then that they teach you the fundamentals of learning and practicing law that you could apply in cases never tried before - it's about giving you the tools and teaching you how to think about tackling future problems no one has seen before.

It's the same idea with medicine, especially with vascular problems as no two sets of human super highways ever present exactly the same.

Inari Medical Chief Medical Officer and Interventional Cardiologist Dr. Thomas Tu told Dr. John Phillips and I during our interview on The Heart of Innovation, that his 'ahha moment' was during a call he received about 3am one morning from a surgeon colleague in charge of care for a patient with a pulmonary embolism, who said, "I need you to come in and do something with your catheters to at least try and save this patient." It wasn't anything Dr. Tu had ever done before, but since he understood the human anatomy, and he was skilled with minimally invasive tools, he gave it a shot. It wasn't successful in that case, but it was enough to spark Dr. Tu's interest in pursuing newer, innovative approaches that could improve the prognosis for P/E patients. That's why he joined Inari Medical, to further advance medicine and find solutions he needed to bring more hope to patients with blood clots.

The vascular area of medicine is ripe for innovation.

And there's no time like the present to see the light.

Dr. John Simpson, a renowned interventional cardiologist, initially dismissed Dr. Andreas Gruentzig's groundbreaking work in improving cardiovascular healthcare through less invasive methods of restoring blood flow to the heart.

Reflecting on this in an interview with Mass Device, Dr. Simpson recalled, "Gruentzig proposed inserting a balloon into a patient's coronary arteries, inflating it, and allowing the patient to recover. I thought, 'This sounds incredibly risky.'"

On that day, Dr. Simpson confided in his wife, saying, "He will either revolutionize the treatment of vascular disease or end up in prison." He further expressed his skepticism to the reporter, stating, "I was leaning more towards the latter as the most likely outcome for Andreas."

Eventually, Dr. Simpson received recognition for commercializing the balloon-over-wire technique, which served as the foundation for modern interventional cardiology and transformed the minimally invasive treatment of peripheral artery disease (PAD) and coronary artery disease (CAD). His inventions over the past decade have greatly advanced efforts in preserving limbs.

However, further advancements are still required in the field of limb preservation.

Let's keep the spirit of what it means to truly practice medicine, alive, and therefore our patients.

As long as we don’t have a cure for PAD and unnecessary premature amputations are occurring globally, we must unite to find safe, moral, and ethical ways for the evolution of treatment for blocked arteries to continue.

Innovation in limb salvage is not a solitary endeavor but relies on collaborations and partnerships between medical professionals, engineers, researchers, and patients themselves. By working together, we can leverage collective expertise and insights to develop groundbreaking solutions that address the unique needs of each individual presentation of PAD.

It's time to put a stop to the unconscionable suffering of these patients!

Let's not let ignorance, as in the loss of Galileo, sacrifice life and limb in our era.

Let’s save life and limb together.