As a journalist and patient advocate, I’ve seen firsthand the devastating impact of poor circulation in the legs, known as Peripheral Artery Disease (PAD), a disease more prevalent and deadlier than most cancers combined, especially when it affects arteries below the knee. For years, this condition has been a challenging one to treat effectively, often leaving patients facing the grim prospect of amputation. But I’m here to tell you that the landscape is changing, and there’s new hope on the horizon.
The Hidden Crisis: Untreated Below-the-Knee PAD
Let me hit you with some shocking numbers. At the Global PAD Association, which I’m proud to lead as CEO, we’ve found that more than 85% of the 1000+ patients we’ve saved from amputation were either not offered a vascular evaluation or had doctors who never even tried to open up blockages in the arteries below the knee before suggesting amputation.
Can you believe that?
It’s mind-boggling, especially when you consider that the Society for Vascular Surgery Guidelines clearly state that doctors should at least attempt to restore inline flow before resorting to amputation.
But it gets worse. Dr. Eric Secemsky and his team conducted a study that really drives home the point. They found that over 60% of patients, according to Medicare data, were never even offered an angiogram before amputation, a whopping 90% of whom weren’t offered any kind of vascular evaluation at all.
These aren’t just numbers.
These are people - our neighbors, friends, and family members - who are losing limbs unnecessarily.
Why?
Here’s the hard truth: many doctors still believe that treating arteries below the knee is a lost cause.
Some simply don’t know how to do it.
Others aren’t aware of the new options available.
And then there are those who wait until tissue is already dying on the patient’s foot or toes before considering intervention - a “Hail Mary” approach that often comes too late because none of the traditional endovascular or surgical approaches have been durable and worth doing early on as they only lead to a revolving door of treatments to maintain the vessels open and leg in tact.
The problem with this wait-and-see attitude is that by the time they intervene, the patient may already have permanent nerve damage. Even if we restore blood flow at this point, the patient might still face chronic foot or toe pain. We’re talking about quality of life here.
Robert’s Story: A Decade of Living with Amputation
Let me tell you about Robert Parant. His story keeps me up at night, but it also fuels my passion for change. Robert’s a long-time Type 1 diabetic who faced a critical situation when a wound became infected and progressed to osteomyelitis. Now, here’s the kicker - the lack of circulation in his leg meant that IV antibiotics and other treatments couldn’t effectively reach the infection site because you need blood flow to carry them to where they’re needed.
And you know what the doctors did?
They moved straight from wound care to amputation.
No attempts to open his arteries.
Nothing.
Robert’s experience happened over a decade ago when we had fewer options for treating below-the-knee arterial blockages. But his story is a stark reminder of how far we’ve come - and how far we still need to go to ensure all patients have access to the latest innovations.
The Dawn of New Hope: Innovations in Below-the-Knee PAD Treatment
Now, let me share some good news. The PAD treatment field is evolving rapidly, and we’re seeing some incredible innovations that are giving hope to patients like Robert. Let me break down some of the game-changers for you:
1. Abbott’s Bioabsorbable Stent
Abbott has come up with this brilliant Esprit BTK Everolimus Eluting Bioresorbable Scaffold System. In plain English? It’s a stent that dissolves over time, supporting the artery and delivering medication to prevent re-narrowing. The results we’re seeing are nothing short of amazing:
In the LIFE-BTK trial, 90.3% of patients treated with this system didn’t need another intervention for two whole years.
Compared to balloon angioplasty, patients treated with this scaffold had a much better chance of avoiding chronic limb-threatening ischemia.
After a year, we’re seeing a 35.2% improvement in reducing vessel re-narrowing compared to balloon angioplasty.
This could be a real game-changer for patients with below-the-knee PAD.
2. Reflow Medical’s Spur Stent System
Now, let me tell you about Reflow Medical’s Spur Stent System. This is some seriously cool tech. It’s designed to give you stent-like results without leaving anything behind in the vessel. How? It uses a temporary stent with these tiny radial spikes that create controlled micro-injuries in the vessel wall. This could enhance drug uptake and modify calcification.
The results from the DEEPER OUS trial are making waves:
86% primary patency rate at six months. That’s huge!
100% of patients were free from major adverse limb events and perioperative death at 30 days.
They saw a significant reduction in vessel recoil compared to standard angioplasty.
At the one-year mark, 79.2% of patients maintained primary patency, and 88.8% didn’t need any further procedures.
This could be a game-changer for treating those tough, calcified lesions below-the-knee that have been giving doctors headaches for years.
3. LimFlow’s Deep Vein Arterialization (DVA) System and Other DVA Approaches
Now, let me introduce you to something that’s giving hope to patients who’ve been told they’re out of all options except amputation because their vessels are shut down below the ankle and the foot as become what’s known clinically as a “Desert Foot.” It’s called Deep Vein Arterialization (DVA), and LimFlow’s system, known as Transcatheter Arterialization of Deep Veins (TADV), is leading the charge.
Here’s the deal: DVA techniques create a connection between arteries and veins, redirecting oxygenated blood from blocked arteries into the veins to feed the foot. It’s like creating a detour when the main road is blocked.
LimFlow’s system has been showing some impressive results:
In the PROMISE I study, 70% of patients avoided amputation for a full year, and 75% of wounds were either fully healed or healing.
The larger PROMISE II study showed a 76% limb salvage rate at 6 months.
In the ALPS study, we saw a 79.8% limb salvage rate at two years, with 72.7% of wounds completely healed.
But here’s the thing - LimFlow isn’t the only player in town. We’re seeing several new entries into the DVA market, all offering similar approaches to reroute blood flow. And get this - some clever doctors have even figured out how to perform DVA using off-the-shelf devices. This means more patients might be able to access this innovative treatment whether in a hospital or office-based lab.
Why These Innovations Matter
Let me break it down for you:
They’re tackling the issues that have made doctors skeptical about treating below-the-knee PAD.
We’re seeing more durable results, which has been a major concern for vascular specialists.
We now have options for patients who were previously told nothing could be done.
These are all minimally invasive approaches, which is crucial for our often fragile patients.
The long-term results we’re seeing are really encouraging, which might help convince skeptical doctors to give these new techniques a shot.
Overcoming Skepticism: The Need for Progressive Thinking
Now, let’s talk about the challenge we still face despite new innovative approaches to treating small arteries below-the-knee and into the foot, physician skepticism. It’s a reality we face in the medical community, but it’s not always rooted in caution. Sometimes, it’s born out of a lack of knowledge or an unwillingness to try new approaches.
Some doctors argue that we need large trials with overwhelming evidence before adopting these new techniques. But let me ask you this: Isn’t medicine a practice? Why should we wait for others to create that evidence when we have patients facing amputation right now?
Let me share a powerful story that really puts this into perspective. Dr. Marta Lobato, a vascular surgeon from Spain and our Global PAD Association’s Global Vascular Surgeon of the Year for 2024, recently told me about a patient who was on deck for amputation. She tried everything in her power to save this patient’s leg, including Deep Vein Arterialization. Despite her best efforts, everything kept failing.
But here’s the kicker - what her patient said to her was a lesson for us all. He told her, “Don’t stop trying new things to save my leg because even if you can’t save my leg, you will have learned something in the process that may help to save that of future generations such as my kids and grandkids.”
Let that sink in for a moment. This patient, facing the loss of his limb, was thinking about how his experience could help others in the future. It’s a powerful reminder of why we do what we do.
So, I ask you: If a patient is on deck for amputation and you don’t do more harm by trying, then why not explore these new options? Why not push the boundaries of what’s possible?
This isn’t about recklessness. It’s about being progressive in our thinking and our approach. It’s about remembering that behind every statistic is a real person, with hopes, dreams, and a life they want to continue living to the fullest.
And let’s talk about what’s at stake here. The mortality rate for people who undergo amputations is alarmingly high. Studies show that more than 60% of patients don’t even get fitted for prosthetics in the year following their amputation. For PAD and diabetic patients, it’s often a constant revolving door of prosthetic fittings due to various factors, unlike someone who lost a leg due to general trauma. We’re not just talking about saving a limb; we’re talking about saving lives and preserving quality of life.
As medical professionals, we have a responsibility to stay informed about the latest innovations and to consider all options before resorting to amputation. And as patients, you have the right to ask about these options and to seek second opinions if you’re told nothing can be done.
A Georgia Patient’s Story: The Power of Persistence
Let me share a story that really drives home why this matters. Just recently, we had a patient from Georgia who was facing a second below-knee amputation. His doctor had told him point-blank that below-the-knee arteries couldn’t be treated effectively.
But this patient?
He wasn’t ready to give up.
He reached out to AVA Vascular in California, who then contacted our Global PAD Association’s Leg Saver Hotline. We were able to connect him with advanced limb salvage specialists right there in Georgia who had experience with these cutting-edge treatments.
The result?
This patient will be more likely to keep his leg as his previous doctor never even tried some of the new advanced approaches to tackling the smaller artery blockages.
Just because one doctor says it can’t be done, doesn’t mean it’s true.
It drives home the crucial point that a second opinion can make the difference between limb and life.
A Call to Action: Awareness and Education
Here’s the bottom line. The story of PAD treatment, especially for below-the-knee blockages, is one of rapid innovation and changing paradigms. We’re seeing hope where there was none a decade ago when patients like Robert faced amputation without alternatives.
If you’re a patient facing PAD, especially with below-the-knee blockages, here’s my advice: Always, always seek a second opinion before consenting to amputation. Ask if blocked arteries are the cause and don’t be afraid to look for specialists with experience in these advanced treatments. You can always call the Global PAD Association’s Leg Saver Hotline at 1-833-PAD-LEGS for assistance or go to PADhelp.org.
But it’s important for all to know that more and more physicians are adopting new, advanced limb salvage tools and techniques across the globe. So, while one doctor in one facility may not have them, it’s becoming more likely another physician nearby may offer additional approaches to give patients one more chance to walk to live another day and live to walk another day.
Still, there is no holy grail treatment yet.
As we move forward, we need continued research, education, and advocacy to ensure all patients have access to these advanced treatments. The innovations we’re seeing today - the Spur Stent System, LimFlow DVA, Abbott’s bioabsorbable stent - they’re just the beginning. We’re entering a new era in PAD treatment, one where losing a limb to below-the-knee arterial blockages could become a thing of the past.
Let’s work together to make that future a reality. Our patients are counting on us.
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