Carotid Artery Disease Patient Care Update

Podcast Transcript

Announcer:

Welcome to Cleveland Clinic Cardiac Consult, brought to you by the Sydell and Arnold Miller Family Heart, Vascular and Thoracic Institute at Cleveland Clinic.

Sean Lyden, MD:

Welcome, everybody. My name is Sean Lyden. I'm the chairman of vascular surgery at the Cleveland Clinic. And with me today, I have Dr. Scott Cameron, who is the head of vascular medicine at Cleveland Clinic, and Dr. Christopher Bajzer, who is one of our intervention cardiologists at the Cleveland Clinic. And we're going to talk to you guys a little bit about carotid artery disease, and where it stands today in 2021, both from medical management and then the options for treatment, from either a surgical or an interventional standpoint.

Sean Lyden, MD:

And so maybe Dr. Cameron, there's been a couple of really interesting studies that have come out in the last couple of years, that have talked about risk factor reduction and also about the risks of stroke. And so where do we stand today, in terms of what the risk of carotid disease is? And what are the new medicines out there that we might see our patients on, that might reduce those ongoing risks of either stroke or other problems, or progression of the carotid disease, or progression of vascular disease outside of the carotid arteries, in their both legs and in their heart?

Scott Cameron, MD, PhD:

Sure. It's a great question. I mean, one of the things that we know is that patients who've got narrowing in another blood vessel somewhere in their body, whether it's the heart or the legs, statistically have a much higher risk of a narrowing in the carotid arteries. Maybe a one in three chance, if it's found elsewhere. Medications that lower cholesterol, medications that lower blood pressure are the mainstay and always have been.

Scott Cameron, MD, PhD:

But some of the exciting developments we've had, at least in the last five or six years, involve medications that thin the bloods. And so we call those antithrombotic medications. Two types of classes. There are those that block platelets, the cells that float around in your body, and can stick together and form blood clots. And then there are those called anticoagulants. Those are things that sometimes you would associate a patient needing if they'd had a blood clot in their body.

Scott Cameron, MD, PhD:

Some of the newer studies showing that combinations of certain antiplatelet medicines and other blood thinners may be more beneficial than just giving aspirin, for example, which is what we always did. And so what I find myself doing when I see patients is I look at the medications they're on. I look at the data, I look at certain things the patient may have going on in other parts of their body. And we can actually individualize the medicine regimen based on what that patient is, and what other diseases they have, if they've already had a stroke, for example, or if they've also got narrowed arteries in the leg. We know that by changing the combinations in medicine, we can decrease that stroke risk in someone with carotid disease.

Sean Lyden, MD:

Dr. Bajzer, when we're all medical students, we're taught how to do physical exam, to listen for carotid bruits. We know that a carotid bruit means your turbulence can be narrowing into those patients to get a carotid ultrasound, to see if they have carotid disease. Who else, for patients with both cardiovascular, cerebrovascular, peripheral vascular disease, should we think about screening or looking for the risk of having carotid disease, because it's so prevalent in some of those other populations? So when you see a patient with cardiac disease or vascular disease who's in your office, and you don't hear a carotid bruit, who else might you think about getting a screening ultrasound on, to see if there's carotid disease?

Christopher Bajzer, MD:

You bring up an excellent point. And for my practice, if anyone has vascular disease or atherosclerosis anywhere in their body, I personally believe that they're deserving of at least one carotid duplex screen, to check to see if they have disease in the carotid artery. If it is then found, then a surveillance map for the upcoming years can be made to keep tabs on that.

Christopher Bajzer, MD:

Likewise, I also believe that anybody with vascular disease is in a good position to have at least a screening ABI, or a pulse volume recording, to check if there's actually disease in the lower extremities. So I think that anybody with vascular disease, anywhere in the body, is deserving of these screens.

Christopher Bajzer, MD:

And that being said, I think that if you have a number of risk factors, even if you are asymptomatic or you don't hear a brewery, which is not always indicative of an open artery, I still think that with a number of risk factors that could contribute to the development and progression of vascular disease, you're deserving of at least once in your life having a screening study.

Sean Lyden, MD:

I think that's important. And I think the other question many times, I think we get from physicians who don't manage these patients every day, is how often then if we do find some disease, should we recheck it? Should it be every six months, every three months, every couple of years? And so maybe, Dr. Cameron, you can comment about, depending on the degree of narrowing of how often, the carotid disease should get rechecked. And then when should they be sent to someone who would actually be able to figure out when to manage it?

Sean Lyden, MD:

And so if they get a screening ultrasound and there's some disease, at what point should it get checked again? And then when should they send it to someone here in the Heart and Vascular Institute, to be evaluated for the options for management?

Scott Cameron, MD, PhD:

That's an excellent question. I think the easiest decision-making for patients are those that have got extremely narrowed arteries in the neck, or those that really don't have very much narrowing. They may just have some hardening. We know what to do with those patients at one extreme, someone with severe narrowing, even without symptoms. There's a lot of data to say that they would benefit from a procedure. We know this. This is very clear in terms of reducing the risk of stroke, even without symptoms.

Scott Cameron, MD, PhD:

Those that are at the other end of the spectrum, they have some narrowing or maybe what we call soft plaque, those are patients that I may do it again in a year, just to see if it's progressing, and if the medicine regimen I'm giving them is appropriate for them. Now, somebody who's in the moderate range, that's completely different, because we know that those patients are at higher risk of stroke. And those patients, I would say if you're moderately narrowed, it would be more appropriate that the imaging is done more frequently than once annually. So that may be at least once every six months. And occasionally, depending on other risk factors the patient has, I may do it three months later, just to see if anything's happened.

Scott Cameron, MD, PhD:

But I think most people would tell you in the moderate range, you should check one more time in around six months, just to see if your medicines are doing what they're supposed to. That is that they're preventing further narrowing. And even sometimes regressing some of that soft plaque, which we do sometimes see.

Sean Lyden, MD:

And I think that's a question people ask us all the time is can we do anything to have Liquid Drano to get rid of the plaque? And I remind patients and doctors, we don't have Liquid Drano, but we do know with aggressive pharmacologic therapy of cholesterol, that we can get that down.

Sean Lyden, MD:

Dr. Bajzer, maybe you want to talk about what are the goals we use for driving LDL, and if they're not tolerant of a statin, what are the other things we do here at the Clinic to try and get patients so they get to an appropriate LDL? And then what are the options we have for them here?

Christopher Bajzer, MD:

All very good questions. Obviously, there's a huge family of drugs that are in the statin class. Cardiologists, vascular surgeons, vascular medicine specialists, we really like just a few of those medications, specifically because studies have shown their ability to either halt the progression of disease, or potentially cause that Drano effect, as you pointed out. So I tend to gravitate towards either Lipitor or Crestor, if the patient can tolerate it.

Christopher Bajzer, MD:

And the current guidelines would say that people with vascular disease, they're deserving of what is termed to be a high intensity statin, which is really only one of a couple of options. It's usually Lipitor at its highest dose of 80 milligrams a day, or Crestor, either its intermediate dose of 20, or its highest dose of 40 milligrams a day.

Christopher Bajzer, MD:

If a person is on one of these agents and is not able to achieve what I call the Drano threshold, which is an LDL usually less than 70 milligrams per deciliter, I would often add a little ezetimibe, Zetia, to the regimen. If on that combination, we're still not able to get a person to that goal of less than 70 milligrams per deciliter for LDL, I usually would refer to my colleagues in preventive cardiology, to see if they could potentially be placed on a PCSK9 inhibitor, such as Praluent or Repatha.

Christopher Bajzer, MD:

There are obviously some obstacles to those medications. One, that they're not a tablet. They require injection. And the second, sometimes is actually costs becomes an obstacle. But our preventive cardiology group is very adept and has a lot of good relationships with insurance companies, as well as the companies that manufacture the drug, to be able to get this to be at an affordable cost.

Sean Lyden, MD:

In the last couple of years, we've seen five-year results from the ACT 1 trial, which looked at asymptomatic patients having carotid stenting versus surgery. We've seen the CREST trial, and the CREST trial's now ongoing. Where do we sit in terms of what we know about our knowledge about stenting versus surgery, and who may be best for surgery? Who may be it for stenting? And how we try and think of it here as a group of both vascular medicine, interventional cardiology, and vascular surgery, to make sure we offer the best therapy for our patients.

Sean Lyden, MD:

And so maybe Dr. Cameron, if you want to comment a little bit about the data. Then Chris, what are the factors that you look at of who you think might be best for one therapy over another?

Scott Cameron, MD, PhD:

I think one of the biggest things that drives the decision-making is other things a patient might have going on in their body. So if you have somebody who's perhaps a lot older, they're frail, they have disease in the arteries and they have disease in the legs. We know that those are patients that are higher risk for doing certain procedures. We also know that patients that may have certain, what we call anatomic constraints. And so the big blood vessel, the aorta, if you're trying to stent and move beyond the aorta on the way to the neck, depending on the angle of that blood vessel, it can be a bit more risky in terms of stroke risk for a patient. And those are patients that we know would probably do better with an open surgical technique.

Scott Cameron, MD, PhD:

Part of it is just knowing the imaging of the patient, what's going on in their body, and then also having a great collaborative relationship with colleagues who either perform the surgical procedures, or also can do percutaneous stenting.

Christopher Bajzer, MD:

Yeah. To Scott's point, I think that's where really the strength of the Cleveland Clinic lies, is that we have the depth and breadth of specialties, both non-invasive, invasive endovascular, and as well as invasive surgical, to be able to act as a team, such that we have a team approach. So we try to really find the best possible option for an individual patient, because all patients are not alike.

Christopher Bajzer, MD:

And to Scott's point, every person may have some certain nuance of how they're put together inside of the body, how much other disease may be present in other parts of the body. And this will factor into the risk of undergoing either a surgical procedure versus an endovascular procedure. And although again, a patient may have a certain particular bias, ultimately, there is usually some component of health or non-health or disease that would sway a doctor into choosing one or the other option.

Sean Lyden, MD:

Maybe I can ask you guys both a comment. A lot of times, we see patients from all over the place. And many times, it may be from a primary care physician or internal medicine physician, or it may be from another specialist. It may be an intervention cardiologist, a vascular medicine doctor, a vascular surgeon. And one of the things we try and do to work with them, so that we provide good care here, but also make sure the patient goes home and continues to have good care. So I know when I do a procedure on a patient, where it's a carotid-centered surgery, I usually want to see them for their first postoperative visit.

Sean Lyden, MD:

But one of the things I try to do is figure out how much expertise the person who sent them to me had. And really, a lot of times, we're really, really open to having those discussions on the phone, to make sure that if they're comfortable having it at home, that patient, if they had good care, we can do apart, but then we can work together. So maybe you guys want to comment of some things we try and do in our practices here, to engage so that when people come from afar, that they're not having to come back here for everything. But we want to be there for as much as we need to be, depending on the expertise that they have locally, before they come to us.

Scott Cameron, MD, PhD:

That's a little more challenging, depending on what the patient has done and where they come from. This is how I do it. I have a personal policy that if a consultation is requested as a new patient, the person requesting that consultation will have a full and thorough documentation within 24 hours. It's the very least we can do. We'll communicate with them.

Scott Cameron, MD, PhD:

If there's a particularly sensitive issue, and it might be one where I'm recommending a procedure, I do actually try and talk with them. And what I find patients find reassuring is me telling them, the person that referred you here, the physician referred you, they had a very specific question. I want to make sure the answer that question. But I also want to be able to relay certain feelings that you have. So that if I recommend something, it's also going to be managing your expectations and not just a procedure that we can offer. And I find that keeping communication open only helps.

Scott Cameron, MD, PhD:

But in terms of handling remotely, I think that the MyChart option that Cleveland Clinic offers is excellent. I tell patients I check that twice, daily. So even though you might live in California, you have a local physician and they'll be able to manage sometimes the imaging, if they've had a stent, for example, or surgery. If you have any questions or anything that warrants clarification, feel free to just send that to me. And sometimes I set up the MyChart for them, right in the office. And it it'll go to their cellphone. And they quite like that comfort, knowing that when they leave, they still have access.

Sean Lyden, MD:

Dr. Bajzer, you see people from all over the world, all over the country. How have you tried to incorporate that in your practice? To make sure that we're providing the expertise as needed, but also making sure that what is appropriate local can be done locally.

Christopher Bajzer, MD:

Very similar to your practice. If I do do a procedure, I feel a certain responsibility and ownership of the patient, for that short period of time after the procedure is performed, to make sure that there's no complications that are directly related to the procedure. After the procedure though, I do like to communicate with the referring doctor and say, "Look, thank you very much for the referral to the Cleveland Clinic. I'm happy to be available as much as you feel would be necessary." Oftentimes, the referring doctor would say, "This is a problem. I feel more comfortable having the Cleveland Clinic manage. Please do the appropriate follow-up." Sometimes they say, "Thank you very much for the repair and taking care of my patient. I believe that we can do the surveillance locally, at home."

Christopher Bajzer, MD:

And to Scott's point, I do leverage our electronic medical record, which has the ability not only of the MyChart for the patient, but DrConnect, which is the physician side, where the physician, again, no cost to the practice, they're allowed to have access to every bit of the medical record that's at the Cleveland Clinic, through a web portal that's secure, and they can get all the information of what happened to their patient, while they were at the Cleveland Clinic. Even if they don't share our particular platform for an electronic medical record, which I think is a very handy thing for people that are coming from out of state, or if they're even out of country.

Sean Lyden, MD:

And with carotid disease, we've had stenting for now 20 years, and really in the last five to seven, we've not had much development outside of the United States. I know there's been a lot of trials and interest in stents that are lined with membranes or fabrics. There was one trial in the United States, but it seems that it's still evolving in Europe, but it really hasn't come to mainstream in the United States.

Sean Lyden, MD:

Dr. Bajzer, can you comment on where those trials stand, and what sort of expectations and road bumps those have had, and where we might see the stenting technology maybe evolve over the next five years, for things we might have available for patients here to be cared for?

Christopher Bajzer, MD:

Well, to your point, when stenting first came into being, there was a large cohort of companies that were making various different types of stents, different designs of stents, different designs of filters. As the technology matured, a number of these companies have gone by the wayside for various different business decisions, decided that this was not going to be something that they were going to pursue. Such that today, we have just a few companies that actually have FDA approval for use in the United States.

Christopher Bajzer, MD:

Do I think that there'll be continued improvement? There will be and there has been to some degree, in terms of efficacy of filters, reversal of flow. Stents that have medication coatings on them have some tremendous improvements with regards to coronary disease, in that they've taken an in-stent restenosis rate of almost 50%, down to less than 7%.

Christopher Bajzer, MD:

It becomes a little bit more challenging with carotid disease, because the carotid stents with an un-medicated or non-medicated stents, were still in a range of about one to 2% chance of restenosis. So it's really very challenging to say that putting a membrane coding or medication is going to move the dial tremendously, that'll make the difference in terms of outcomes.

Sean Lyden, MD:

And I think the one thing we've really struggled with for the last 20 years is when CMS put out a non-coverage determination, or the national coverage determination of carotid disease, a lot of our patients are Medicare/Medicaid, and there's very specific guidance on who can be treated. I think the one thing that we've done well at the clinic is really work together, whether it's cardiology, vascular surgery, vascular medicine, as a team.

Sean Lyden, MD:

And I think the really one thing that resounded when that came out, was the fact that all the different specialties held very ideas of the best way to treat patients. And we've seen in other platforms, like TAVR, where you're treating now valves percutaneously, when everybody's on the same page, it's very difficult for our Medicare to have coverage policies that don't make sense. I know I've been on panels with some people from CMS, and they say the one thing that they hope they could walk back would be that.

Sean Lyden, MD:

And I think the really things physicians need to realize is that the data, in my opinion, supports that both therapies are really well. They have equivalent outcomes and skilled hands. And we hope that someday that we can get all the societies, like we have at the Cleveland Clinic, on one page to do the best thing for the patient, so that we can roll back that NCD, so that you really talk about a technology and a platform, and where each works best, as opposed to a therapy does someone need carotid disease or not. Because I think there's good five-year data from CREST and ACT 2, and hopefully, eventually from CREST 2, that really shows that both therapies work. And really, we need to understand who each one works better in.

Sean Lyden, MD:

And so I think we really have a good model here, where it's about how we work together, do the best thing for the patient to get all their risk factors controlled. But I really think one of the things we all struggle with is, at least from a stenting platform, there are limitations depending on payers, of what we can offer patients. And what are the things you try and talk to the referring doctors about? Because they may send someone who's Medicare, who is asymptomatic and 70% and high risk, but they haven't had symptoms. And by Medicare standards, we can't get those people treated. And it's a struggle, where a private payer may say yes for this person, and the governmental payer says no.

Christopher Bajzer, MD:

Yeah. Excellent question. And oftentimes, actually indeed more recently, I've had a younger patient that will come in and previously, commercial insurance would pretty much agree and say that this option of carotid stenting is very reasonable. But of late, I've been having a number of denials. And then really, the option to the patient is just the surgery. Not that it's actually a wrong decision, but it does take away some options for the patient, and options for the doctor to really steer the patient, perhaps in the right therapy for that particular patient.

Christopher Bajzer, MD:

I wish that things were a little bit different. And hopefully, in the future, they will be a bit different. But I think the more collaboratively we can work as physicians to actually show that, yes, we can work together, just like surgeons can with cardiologists, with regards to valvular heart disease. I think we could actually move the needle on that.

Sean Lyden, MD:

What other ideas or topics, Dr. Cameron, that we haven't addressed yet, that are common things that you get asked by the internal medicine people, the other people referring patients from carotid disease, or things that we'd want to let them know, that are new updates in parts of carotid management that we've really seen in the last three to four years, since we last talked about this?

Scott Cameron, MD, PhD:

Well, that's an easy question to answer. The thing that comes up from both patients and referring physicians, or providers, is can the patient be enrolled in any studies while they're there? And that's something that I think is fairly organic at Cleveland Clinic, because research and clinical care, they go hand-in-hand. Clinical care is number one. The patient is number one when they're here. But what I often find, at least in clinic, is that the patients will ask, "Are there any studies? Can you use my blood?" I studied blood clotting and coming up with guidelines for stents, the only way that we'll be able to progress guidelines, and positively impact reimbursability and cover care for patients, is by data. And the only way you can get data is to get data. And that's doing research.

Scott Cameron, MD, PhD:

If this is a new procedure, a new stent, how about the risk of restenosis? Is it less? How is the blood interfacing with the surface of the stent? And so while the patient's here for clinical care, quite often, they'll give a blood sample. And then the same day, we have a team that can take that sample to the lab and get real-time data. And so for each of those patient encounters, after several of them, we can then be the people that can show the data and write the guidelines. And that's how policy changes.

Sean Lyden, MD:

I think one really cool technology we're looking at is we know from the coronary data, that when you put a ultrasound within the blood vessel, an intravascular ultrasound, you can determine what type of plaque it is. And then we know what are the best treatments of the plaque, what are the likelihood that it could progress. And one of the really interesting things is the person who developed that technology was a physician at the clinic. He left for industry. He's now back. And he's now working with us, and we're giving him specimens from when we clean out arteries. And they're getting ultrasounds ahead of time to try and correlate how, from an external ultrasound, you might define the type of plaque.

Sean Lyden, MD:

And if we then could define it routinely, whether it was calcified, whether it was fibrotic, whether it had fatty infiltrates, we can actually then correlate that with the risk of ongoing events. And so one of the really cool things we're doing now is trying to understand how an external probe might tell us the same information when we're inside the blood vessel, without the interventional therapy. And I think that's the really interesting thing here, is we continue to try and evolve, to try and understand how we're doing things, as Dr. Bajzer pointed out.

Sean Lyden, MD:

When the national coverage determination came out, a lot of the bigger companies fell out of supporting carotid stents. But there are some new technologies out there with covered stents, and pairing the stents with the protection systems. We actually just got invited last week for a new trial. So we hopefully have some new endovascular therapies or stenting therapies to offer patients. But really, unless we critically look at all their aspects of their care, I don't think we're going to better define who is best with what therapy, and what's their best ongoing long-term management. So it's not just that one single episode of treatment. It's really how they're going to do over the rest of their lifetime.

Scott Cameron, MD, PhD:

I think collaborative care is key. And I like how you say the guideline statements. Quite often, they're written with American Heart Association, American College of Cardiology, Society of Vascular Surgery, Society of Vascular Medicine. And I think that by continuing to stay on the same page and capitalizing on each other's expertise, that's how we'll progress the field.

Sean Lyden, MD:

So with that, I want to thank Dr. Bajzer and Dr. Cameron for working with us. For those physicians, we do have a Cardiac Consult that comes out with the new and evolving therapies we're doing here. If you're not on Cardiac Consult, our information will be attached. Please reach out to us. We'll be happy to make sure you get that. If not information, reaching out to us directly or through the Cleveland Clinic website. And with that, I want to thank everybody for attending or listening.

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