The Solution To Atherectomy

Innovation is moving at the speed of light around the treatment of a limb-threatening circulation issue, known as peripheral artery disease (P.A.D), which occurs mainly in the legs. Because of that, the development of best practice standards is lagging behind leading to public debates over the value of specific devices, especially those categorized as 'atherectomy,' which are designed to remove plaque and prepare vessels for balloon angioplasty and stent.

Researchers from Johns Hopkins Medicine are at the forefront of the debate, expressing concern that a handful of physicians may be overusing these devices due to higher rates of reimbursement and that it may be leading to amputation. But it's not clear in their recent study if patients selected to review using Medicare data were on deck for amputation anyway and whether atherectomy was part of a "Hail Mary" limb salvage attempt for a patient with advanced stage P.A.D. known as Critical Limb Threatening Ischemia (CLTI). Twenty-five percent of patients with CLTI are on deck for amputation within the first year of diagnosis regardless of treatment.

Nevertheless, some doctors are using that limited data to call for federal regulators to intervene and lower atherectomy reimbursement as well as restrict atherectomy use.

Federal Regulators have acknowledged a handful of physicians may be taking advantage of a financial incentive that the Centers for Medicare and Medicaid Services (CMS) implemented 15 years ago for limb salvage procedures in an attempt to decrease spending on complications from P.A.D.

So, they are cracking down on those whom they believe haven't filed proper documentation to justify the use of atherectomy and other minimally invasive tools. They're also reviewing the potential for reimbursement adjustments to address this issue.

But some physicians and societies believe they're not doing enough to deter the abuse of this well-intentioned incentive and so they've turned the media such as Pro Publica and The NY Times for support in their plight to raise awareness and urge lawmakers to take action.

It's important to address any overuse of devices, but it's equally important to maintain perspective so as to not create unnecessary fear in the patient and referring physician community by demonizing atherectomy devices and all who use them. The overtreatment of patients is the exception to the rule across practices and most physicians performing minimally invasive limb salvage procedures using tools such as atherectomy, are trying to do the right thing.

The problem is not the device.

If it's FDA cleared, it comes down to the operator, their ethics, and their skillset. All of which can be mitigated and measured by the development a set of best practices and better training.

In this article, I will discuss why as I share my understanding of atherectomy, its proper use, benefits, complications, and limitations, through what I've observed in my travels to nearly a dozen countries and more than thirty states, watching hundreds of doctors perform thousands of hours of procedures to treat blocked leg arteries.

What is atherectomy?

The process of atherectomy involves the removal of plaque, which could be composed of fat, cholesterol or tissue deposits, from the artery to improve blood flow. This procedure is also known as debulking and is sometimes referred to as "roto-rooting". Atherectomy devices, including rotational, orbital, directional, and laser technologies, have different mechanisms of action to create channels for blood flow through methods such as sanding, cutting, or ablation. These devices are considered adjunctive therapy and are not intended to be used alone, as their benefits compared to standard balloon therapy are not well supported by evidence.

Balloons are used in the affected artery to push plaque aside and then typically a stent is placed to maintain the vessel open. Atherectomy devices are used to prepare the vessel for balloon angioplasty and stent placement. The objective is to remove some of the plaque so physicians don't have to resort to high balloon pressure, which may cause dissections or vascular trauma, lowering long term patency and increasing the need for stenting.

The concept of vessel preparation has been the main cause of the increased interest in atherectomy device.

Why is atherectomy important?

Even though traditional methods of using balloons to prepare the lesion before placing a stent aim to reduce the risk of in-stent restenosis and stent thrombosis, some lesions do not respond well to these methods because of the extent of calcification. A balloon requires higher barometric pressure to push calcium aside to make room for a stent to be placed. As it's pushing the plaque aside, the vessel is stretching, increasing the risk of recoil and dissection, which could impact long-term outcomes. In recent years, significant advancements have been made in the methods used for modifying calcium, such as with atherectomy devices, resulting in improved procedural success rates and minimal complications during the procedure.

I observed a doctor treating a patient with a heavily calcified superficial femoral artery using angioplasty, dilating the balloon to 19 atmospheres of barometric pressure. He inserted intravascular ultrasound (IVUS) afterward to review his work and he spotted a dissection. He commented to the tech that he should've 'prepped the vessel first' with orbital atherectomy.

An atherectomy device can change the compliance of the plaque and allow the balloon to be used with a less traumatic "low and slow" angioplasty technique, reducing the chance of dissections and reducing the need for a stent.

It makes sense logically.

We had a patient who presented to The Way To My Heart, a 501(c)(3) nonprofit focused on patient education, advocacy, and support, after a revolving door of more than a dozen angioplasty and stenting procedures. She could barely make it to the kitchen without resting due to intense claudication. We coordinated a second opinion from an advanced trained limb salvage specialist. He reviewed case notes from every previous procedure and discovered "excessively high" barometric pressure was used for this patient's vessels, with multiple dissections reported following each procedure. She returned for a re-do about every six months, one within weeks. This new physician performed the 13th intervention, using atherectomy to remove some calcium and scar tissue, followed by lower balloon pressure. No additional stents were placed. It's now been 14 months since and the patients is walking 3.5 miles per day without claudication.

In my travels around the world since 2016, observing hundreds of doctors performing thousands of hours of procedures for treating P.A.D., I have noticed that atherectomy devices, when used correctly and in medically suitable situations, result in fewer stents and lower barometric balloon pressure usage by physicians. This observation is supported by a systemic review of seven studies conducted by the Cochrane Vascular Group, which also found that atherectomy led to lower rates of bailout stenting during the procedure and reduced balloon inflation pressures when compared to balloon angioplasty alone.

Italy is one of the countries in which I have spent a lot of time observing advanced limb salvage specialists. Two of which are Dr. Marco Manzi and Dr. mariano palena, who are considered pioneers, continuously advancing the treatment of P.A.D. Dr. Manzi and Dr. Palena tell me that they use atherectomy sparingly because it's expensive and there's not a dedicated reimbursement as with angioplasty in Italy as there is in America. But they don't hold back when it comes to cases in which they believe it will improve outcomes. They believe atherectomy is essential in cases in which physicians find the presence of diffuse and severe calcifications (MAC = Media Artery Calcification) or eccentric rough plaque both in the superficial femoral artery (SFA), popliteal, (POP), and below-the-knee (BTK) arteries. They have also found it to be valuable in preparing severely calcified vessels for therapeutical options such as the application of Drug Eluting Balloons (DEB).

DEBs were developed to improve the durability of angioplasty without the use of stents. They are coated with chemotherapy drugs that are thought to calm the vessel and prevent spasming that could lead to quick recoil and/or an inflammatory response in the body which leads to scar tissue developing (neointimal hyperplasia) in the area of treatment, which could cause further obstruction and a revolving door of treatments sooner.

"The amount of calcium represents an obstacle for drug's absorption in the vessel wall and it is responsible for acute and early recoiling of the lesion," explains Dr. Palena.

The key to the use of DEB is that the drugs have to act on real live cells versus just inner calcium. That's where an atherectomy device or a newer lithotripsy device, which uses sonic waves to create cracks in the calcium, comes in, because they aid in the drugs getting to the vessel wall for better penetration.

Laser atherectomy is also indicated prior to DEB for in-stent restenosis, where scar tissue builds up in a vessel scaffolding and limits blood flow.

So, the value in atherectomy is such that it assists physicians in:

• Debulking calcium
• Plaque remodeling
• Balloon compliance
• Drug delivery
• Less trauma
• Less recoil
• Avoiding dissection
• Reducing stent use

Atherectomy Limitations

While atherectomy has measurable benefits, Dr. Manzi warns that just as with any device, it has its limitations. It's not a fit for all types of plaque, all vessels, and all people. And precautions must be taken to mitigate risk of complications for all patients.

"Atherectomy is contraindicated when calcified lesions are not present and there is not enough room to deploy an embolic protection system."

What Dr. Manzi is referring to is the potential for larger pieces of plaque, or emboli, to break off or be removed and flow downstream, resulting in flow obstruction, which would increase risk of complications including compartment syndrome and amputation. Most particles removed by atherectomy devices are found to be smaller than red blood cells, but the use of filters are highly recommended to reduce risk of complications.

Distal embolization is one of the biggest concerns with atherectomy because if larger plaque is dislodged, it can not only travel along the blood vessel and block another blood vessel in the leg, but also in the lungs, heart, and brain leading to stroke and heart attacks.

Retrospective studies of atherectomy use have shown this is a legitimate concern.

Another major concern is the risk of vessel tearing, or perforation.

So, proper usage of these devices is critical.

That comes down to a Standarization of use and training.

The Problem With Atherectomy

In my opinion, two key issues exist: Lack of training and lack of standardization of best practices. This leads to the misuse of devices, even overuse of devices, which can impact patient outcomes.

According to Johns Hopkins researchers, the high utilization of atherectomy is causing a rise in the number of amputations and deaths.

Some atherectomy critics argue that higher reimbursement for atherectomy in America is leading to this high utilization. That can be easily investigated and resolved through analyzing Medicare numbers and comparing its use volume across physicians and facilities. But that still points to a lack of proper training because you have to assume that a physician has a patient's best interest at heart and wouldn't knowingly 'harm' a patient for the sake of financial gain.

The principle of?nonmaleficence?directs physicians to “do no harm” to patients.?And there are serious repercussions for negligence.

Suffice to say, that harm might happen inadvertently if a physician is not properly trained on a specific device. That includes knowing 'best practices' by renowned limb salvage specialists. Real world experience goes well beyond the training manual provided by a device-maker and Federal Guidelines, which could make the difference in life and limb.

Every tool developed has the potential to impact the quality of life for patients with P.A.D., and if a tool is used improperly used such as on the wrong class of patient, in the wrong vessel, or on the wrong type of plaque, a patient might be compromised.

A patient supported by The Way To My Heart was brought to the emergency room with a foot ulcer that wouldn't heal. To treat the heavy calcium in her superficial femoral artery, an interventional specialist used lithotripsy, which is not an atherectomy device, although it is used for vessel preparation prior to deployment of especially a drug coated balloon. Lithotripsy generates sonic shockwaves in a balloon-based delivery system to induce calcium fractures, which facilitate stent expansion and luminal gain. The specialist informed the patient's family that the patient's blood vessels were fragile, and as a result of the procedure, debris from the lithotripsy caused blockages in the distal blood flow, causing compartment syndrome because of a decrease in the local tissue's blood supply. Unfortunately, the patient's heart was not strong enough to undergo the amputation procedure, and she passed away within a few weeks.

If this physician would've attended a seminar where best practices were shared by renowned physicians, he would've known that a 90-year-old individual with friable vessels might not be the best candidate for lithotripsy.

Another case I observed while visiting labs in Germany, was that of a 94-year-old woman with a non-healing ulcer. The woman required sufficient blood flow to promote wound healing, not run marathons. The physician used a laser atherectomy device to create a pathway for blood to flow into her foot, which he believed would be sufficient to promote healing. However, another physician who was visiting recommended using a different device to achieve even greater luminal gain. The physician used this device for the first time, and I observed as the artery was damaged by it. The physician later admitted that providing the right amount of blood flow would have been enough to save the woman's foot, but unfortunately, amputation became necessary due to the improper use of the device.

If both of the physicians would have watched a seminar where best practices for these devices were shared, they would've known that atherectomy and lithotripsy are not about attaining maximum luminal gain, it's more about vessel preparation to reduce trauma and improve outcomes.

Patients don't need what I would describe as a doctor going 'zero to hero' trying to clear out as much plaque as possible, potentially increasing the risk of complications and the body's healing response that least to quick vessel closure. They just need enough blood flow to decrease pain and cramping to get them back on their feet to start walking and try to grow their own natural bypasses by maximizing their collateral network of vessels.

The Answer To Atherectomy

The solution to the overuse of atherectomy is not demonizing these devices. Atherectomy devices, when used as indicated and in medically appropriate situations, offer significant value for reducing trauma and improving outcomes.

The solution is better training and the development and dissemination of best practices and standards.

Five minutes with a clinical specialist for the device maker to go through instructions for proper use, its indications, benefits, drawbacks, and limitations is not enough to master a device.

I was in a case in Belgium where a physician refused to spend more than five minutes with a clinical specialist to learn not only a new tool but along with it, and entirely new approach to handling the tool and navigating the vessel with that tool. The result was she ended up kinking the catheter multiple times and within moments giving up the patient to another surgeon for amputation without even entertaining additional support to improve her technique.

In another case in Germany, the surgeon refused any instruction beyond how to pull the device out of its package, set-up, and basic handling. He told the clinical specialist he was not to provide further support or correct him during the procedure as he didn't want the patient, who happened to be a good friend of his, to hear someone else telling him "how to do his job."

This case was also a failure.

A successful case using a new device is one in which the clinical specialist is able to spend enough time prior to device-use going through all relevant safety information and supporting the physician throughout the procedure.

But learning can't stop there.

The treatment of PAD and CLI is constantly evolving...and fast.

Physicians with high volumes of CLI patients tell me they learn something new every day as PAD and CLI don't have completely consistent patterns so each patient presents a new puzzle to piece together.

"Make science, not war," says Interventional Radiologist Dr. Lorenzo Patrone

Interdisciplinary collaborations abound where doctors share best practices based on their experiece in both publications and at seminars. One of the latest examples of best practices being shared, not atherectomy specific, is in the Journal of Endovascular Therapy where Interventional Cardiologist Hady Lichaa, MD, FACC, FSCAI, FSVM, RPVI , Interventional Radiologist Lorenzo Patrone , Vascular Surgeon August Ysa , and Cardiologist Resident Marco Covani, MD share "Antegrade Crossing Techniques for Hard Proximal Occlusion Caps Without The use of Dedicated Chronic Total Occlusion Devices: A Pictorial Review."

At physician training seminars and LIVE events, such as CLI-C Global in Venice, Italy, New Cardiovascular Horizons , AMP, Veith, ISET, FYA, and more, renowned limb salvage specialists across practices such as Dr. Manzi and Dr. Palena, and Dr. Roberto Ferraresi, and Bruno Migliara demonstrate best practices for all aspects of treating the most advanced stage of P.A.D., Critical Limb Ischemia (CLI), from angioplasty and stenting to lithotripsy and atherectomy, including appropriate:

• Indications
• Patient selection
• Vessel selection
• Plaque selection
• Device selection
• Proper risk mitigation techniques
• And ultimately the most effective ways to use atherectomy for vessel preparation.

This is information that can only be learned and mastered through participating in physician education forums.

These gatherings are critical to improving patient outcomes.

The next step beyond that is to standardize these best practices discussed in highly regarded forums and found in peer-reviewed publications in order to make it easier and more accessible for all physicians to stay on the cutting-edge of life and limb-saving information.

Best practices and better training, coupled with a review and appropriate adjustment of reimbursement by Federal Regulators will help ensure the treatment of PAD and CLI continues to evolve and be used across practices and facilities in a safe, effective manner.

Let's work together to take a proactive approach to resolving concerns about atherectomy devices so as to not cause any further unnecessary fear for patients in critical need of limb salvage procedures.

We can't afford to have more patients avoid seeking timely treatment.

The reality is that the majority of unnecessary amputations is not due to too many procedures, it's from too few procedures with more than 50% of amputations being performed without even an attempt at limb salvage.

So, while it's important for Federal Regulators, researchers, and journalists raise red flags on the handful who may be overusing limb salvage devices...

1. They should proceed with caution so as to not encompass those physicians who are performing limb salvage procedures on CLI patients who would lose their legs otherwise, and although they may still lose their legs, have them longer than they would've if no one had even attempted.
2. They should also devote more time to cracking down on and raising awareness of the overtreatment of blocked leg arteries using amputation as frontline treatment as it's a larger issue that is especially prevalent in the most vulnerable African American and Hispanic communities.

Every patient deserves the same respect as a Cancer patient for this disease that's deadlier than all Cancers combined except Lung Cancer, exhausting every option available to give them the best chance of walking to live and living to walk longer.

Let's save life and limb together.

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