The most significant trends impacting treatment of the #1 killer and who's killing it!

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VATORNEWS Posted on January 14, 2021 - by Kymberlie Mcnicholas · Short URL: https://vator.tv/n/5196

Early diagnosis, less invasive treatments, and remote rehab standout as the most significant areas in which strides are being made in vascular health as we head into 2021. 

Why do we care about vascular health?

For starters, COVID 19 has shed light on the poor vascular health around the world, with the majority of serious complications being experienced by those suffering from vascular diseases such as Cardiovascular Disease, Peripheral Artery Disease (PAD), which is a narrowing of the blood vessels in mainly the legs due to plaque build-up much like it is with CVD in the heart, and diabetes.

YES, diabetes!

More than 50% of people in the U.S have pre-diabetes/diabetes, which is a blood disorder characterized by too much sugar in the blood which ultimately damages the vessel wall triggering the body’s inflammatory response to patch the damage with cholesterol and fats. Those patches build-up and voilà, vascular disease -- the #1 complication of diabetes, which is inevitable if sugar levels are not under control. And researchers don’t expect the problem to get any better with predictions for one in three American adults to have diabetes by 2050. That means innovation in vascular health is critical.

Obviously more needs to be done in prevention, diabetes included.

But do we really need technology innovation for that?

How about purely education and increased access to healthier food options particularly in food deserts where patients are most vulnerable?

What about a more integrative approach to healthcare, with the assignment of a dietitian and covered annual appointments for each patient from the get-go as is a primary care physician – or simply expanding the requirements for each primary care physician to get their medical degree to include advanced dietary and nutritional coursework?

There’s still a lot that can be done from a purely manual and policy standpoint.

Where I see the greatest technological advancements that could be designated as part of the preventative process is in early diagnosis. The right diagnostics sooner rather than later can not only put more tangible risk factors on the radar for the doctor to monitor the patient and provide early treatment, but also help facilitate that critical life-changing conversation between doctor and patient that may inspire someone to eat healthier and exercise, thereby reducing their risk of developing life-threatening complications from diabetes and vascular diseases if they even end up developing them at all. Genetics are no exception.

A big concern I have is that even with these advancements in early diagnostics, will doctors use them? Many won’t even take the time during an annual check-up to grab a simple blood pressure cuff off the wall and place it on their patient’s leg and arm and measure the differential in order to determine a patient’s risk for Peripheral Artery Disease (PAD), one of the most debilitating diseases most have never heard of yet impacts one-in-twenty Americans over the age of 50 and a third of diabetics over age 50. Most don’t know they have it until it’s reached advanced stages, if they ever find out.

Three-in-five people who suffer a heart attack have PAD, but many go undiagnosed. If only their doctor would’ve taken a moment to just check their leg pulses, maybe steps could’ve been taken to reduce their risk of heart attack, even stroke and amputation due to vascular complications not caught or managed soon enough. Standard healthcare system protocols, including questions about cost-effectiveness of early diagnostics such as this, as well as limited training for primary care physicians on various vascular diseases in medical school, impact a physician’s ability to diagnose chronic vascular illnesses before they reach advanced symptomatic changes.

If it’s legislative action that is required to inspire physicians and healthcare systems to do the right thing, well that’s happening. In 2020, Representative Donald Payne introduced the Amputation Reduction and Compassion (ARC) Act which would allow Medicare or Medicaid beneficiaries who are at risk for Peripheral Artery Disease (PAD) to get their PAD screening covered without any cost-sharing requirements. That’s good news for screening technologies such as Dermaflow and Podimetrics who made it on our “Top 10 List of Vascular Innovations To Watch in 2021.” The theory behind this legislation is that early detection will lead to early minimally invasive treatments and ultimately prevent needless amputations, especially in the most vulnerable communities where African Americans have the highest limb loss rates.

The gold standard for restoring blood blood flow whether in the legs or the heart has traditionally been bypass because of its durability lasting five, 10, sometimes even 20 years. But it’s not always the best option for patients because there are a lot of risks that go along with a major surgical procedure. That's why so much effort over the last 20 years has been placed on advancements in technology that can be used to treat artery blockages using less invasive means. The so-called "endovascular" procedures, which are performed through a keyhole entry, typically in the wrist or groin, where doctors can send catheters, wires, balloons, to restore blood flow in a minimally invasive way, are already frontline as treatment for a narrowing of vessels in the coronary region. Thanks to significant advancements in the quality of balloons, stents, and atherectomy devices (plaque removal), these procedures are better, safer, faster, and more cost-effective than bypass for coronary blockages.  If a physician can’t penetrate the blockage using a guidewire, and entering into the vessel wall and creating a new channel using balloons and stents isn’t possible, bypass can still be performed.

When it comes to legs, advances in tools and techniques have lagged that of the heart. Although, I would argue that after observing thousands of hours of procedures to unblock leg arteries in nearly two dozen States and nearly a dozen countries around the world by dozens of doctors, I’ve learned amazing life and limb-saving tools & techniques, that when performed correctly, have proven to be durable life & limb saving options for patients. Knowledge of these newer tools and techniques, however, is what's actually lagging, taking longer than it should to trickle down to the gatekeepers of healthcare. They include primary care physicians who need to think twice whether to send their patient to a traditional surgeon for bypass first or allow an interventional specialist trained in newer techniques with access to newer tools have the first attempt to unblock leg arteries with in a less traumatic way. Also, insurance companies and healthcare administrators who handle the books and create the standard protocols that dictate treatment options that favor more invasive procedures as frontline treatment need to start realizing the value of newer minimally invasive techniques as frontline treatment, taking into consideration:

  • Older patients and those with advanced stage vascular diseases aren’t good candidates for a major surgical procedure with long recovery.

  • Bypass can’t save the feet of patients with the most advanced stage of Peripheral Artery Disease, Critical Limb Threatening Ischemia (CLTI) in which the vessels below-the-knee and into the foot are significantly calcified – a trained interventionalist still must be called in to save a diabetic foot from amputation.

  • If a bypass fails the patient has fewer options long-term to save their life & limb.

  • And don’t get me started on the long incisions, typically three-inches and beyond, sometimes in multiple places that leave patients with extensive areas of numbness along the cut-line for sometimes months!

I’m hoping that newer, more novel bypass approaches (such as ones in our Top 10 list below) that can be performed through a keyhole entry in the leg versus a large incision, will ultimately inspire more vascular surgeons to choose an endovascular approach as frontline treatment for legs as it is in the heart for narrowed vessels.

Wait… let me modify that ‘frontline’ treatment statement to place ‘intervention’ behind what all vascular specialists prescribe, which is “walking as medicine.” That is the best frontline treatment as long as patients have at least some peripheral flow in their legs. When a main artery is narrowed and you continue to walk, it signals the body to form new routes for blood to flow that can keep the leg nourished. Every step someone takes helps the body facilitate the growth of what are called, "Collateral Vessels." It's kind of a 'Do-it-yourself bypass.' For many patients, critical lifestyle changes including exercise and diet can make a huge difference extending the time before an intervention might be required. Getting patients to do it is not always easy, which is why innovation around rehab programs is critical.

Remote rehab with real-time monitoring has proven successful in clinical studies and will remain a big focus of research and innovation in 2021 and beyond.

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DERMAFLOW

Peripheral blood flow is essential to healthcare and wellness, as its vital role is to provide the over a trillion cells in your body with nutrients and oxygen, plus remove cellular wastes.  

Without this, an individual could not survive, as his/her cells and organs would simply collapse and die.  When peripheral blood flow is not sufficient or impacted otherwise negatively, that is the point in which health deterioration sets in.  To be able to monitor the peripheral blood flow and correlate its changes to a specific disease state or health condition provides a HUGE advantage for early detection of deterioration over a broad medical platform. Dermaflow has developed a technology to measure this peripheral in a way that could help reveal the earliest signs of chronic vascular ailments, especially Peripheral Artery Disease.

DermaFlow, though still an early stage, pre-revenue company, has already developed a product line, Perichek™, which includes sensors both disposable and reusable, and devices with one sensor which can be modules for embedding into other devices or a handheld form, or a portable table-top version, Perichek Multi™ with multiple sensors for simultaneous monitoring.  They are working on a patch type of wearable, Perichek Patch™ which will be Blue-Tooth-enabled, and have appropriate software for smart devices (i.e. cell phones) but also for PCs.  These are yet to be commercialized but they’re efforting partnerships this year for the home monitoring product.

Dermflow CEO and BOD member Irene Jaffe, Ph.D. shares the backstory behind Dermaflow, its products, their potential impact, and commercialization plans. VIDEO: https://youtu.be/CyTjS76qPto

Stephen Jacobs