Dr. Heather Gornik: Key Points from the New PAD Guidelines

Join us as we welcome back our most popular guest, Dr. Heather Gornik, co-director of the Vascular Center at University Hospitals of Cleveland, as we discuss her role as the lead author of the 2024 ACC/AHA Guideline  for the Management of Lower Extremity Peripheral Artery Disease, including a review of key points from the guidelines.

For more information, see:
2024 ACC/AHA Guideline  for the Management of Lower Extremity Peripheral Artery Disease, including ACC Guideline Hub and Guidelines At-a-Glance with top 10 takeaways.

AHA guideline hub, including slide set  

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Transcript

Kanny: 0:09

So welcome back to the Cardio Ohio podcast. This is Kenny Gral coming to you from Columbus as always. And also as always, I'd like to welcome my co-host from Cleveland, Ellen, SEIC, the current governor of the State of Ohio chapter. Alan, welcome.

Ellen: 0:25

Thank you can. I'm so excited for today because we have an opportunity to speak to Dr. Heather Gornick, who you all probably remember gave us a wonderful discussion of fibromuscular dysplasia and spontaneous coronary artery dissections. She is the co-director of University Hospital's Vascular Center, as well as the Director of Fibromuscular Dysplasia program, a professor of Case, Western Reserve School of Medicine, and now the head of our, women's Heart Center. But today we have her speaking to us about the. Updated guidelines for management of lower extremity, peripheral arterial disease. And we are doing this because she is actually the senior author of this document. So Heather, welcome so much. We're so happy to have you back.

Heather: 1:17

Thank you, Ellen. I'm so glad to be back with you and Ka and I'm really looking forward to this discussion.

Ellen: 1:23

So, before we get into these guidelines, we use guidelines in medical practice all the time, and I think it's important to consider who's involved in creating these types of documents. Can you discuss with us. Who's involved in this process? Is it vascular medicine? Is it surgeons, cardiologists, podiatrists? And, and how does this process actually work?

Heather: 1:46

Sure. Well, I think the PAD guidelines really took a village. I think most guidelines do take a village, but I think this village was very large and robust, and it was actually a four year process to bring these guidelines. Through the whole process from the work with the guideline writing committee, through the peer review, and then endorsement by all the organizations, and I will just say the, the document was spearheaded, of course, by the Joint Guideline Committee of a CC and a HA, but we actually had nine. Partnering organizations with us, and as you alluded to really reflect the, the broad spectrum of multidisciplinary engagement in the field of peripheral vascular disease. So we, among those nine organizations, we have represented not only of course, cardiology. Vascular medicine, interventional cardiology, interventional radiology, vascular surgery with a few organizations cardiovascular rehabilitation, vascular nursing, and podiatry, just to name a few. We also had some patients on the guideline writing committee giving. Their perspectives. And also for the first time on this document, we had two new organizations partnering with us, which I was really excited about. The A PMA, the American Podiatric Medical Association was a partner on this document for the first time. And then we worked with the Association of Black Cardiologists. So it was, it was a lot of fun and very interesting in GE aging, this whole village, reviewing the data together. Coming up with the consensus recommendations, voting, hearing, diverse perspectives. It was a really interesting process and I learned a lot by spearheading the writing committee.

Kanny: 3:39

So Heather, well, one question I have is when you, when you took this process on, you mentioned how you started, you know, several years ago. Are you trying to start from scratch or are you using the previous edition of the guidelines? I think they were, you know, 2016. Are you using them as a, as a framework to move forward, or are you trying to kind of, start from scratch

Heather: 3:59

yeah, I think it was a hybrid of both. And actually this is, I think the fourth time there's been a comprehensive PAD guideline. The first one was actually spearheaded by Dr. The late wonderful Dr. Allen Hirsh. In 2005 was the first time that the. The PAD guidelines came out, although that wasn't just lower extremity PAD, it was also, it was really all vascular disease below the diaphragm. Back in 2005 there was another. Guideline update done in 2011, which is was a brief guideline update that focused on PAD as well as AAA and I believe renal artery disease. And then the, the most comprehensive reboot of just lower extremity, PPAD guideline, as you mentioned, was the 2016 guideline. I had a chance to be involved with. And as we move forward to this 2024 edition, we did look at that prior guideline and what was its scope, but there was a lot of new material and new things and new concepts we wanted to add it in. So it was sort of a springboard. And this document is meant to fully replace the 2016 document.

Kanny: 5:13

Well, that sounds wonderful. Before we kind of get into some of the specific recommendations,, obviously most cardiac practitioners are now very well aware of the crossover between, peripheral arterial disease and coronary arterial disease. But what is the current understanding of the overall, you know, prevalence of PAD? I know your document also talks about specific populations.

Heather: 5:38

For sure. I, in, in our. Document. We talk about the prevalence of PAD in the US estimated to be about 10 to 12 million individuals in the United States, and then the global prevalence is estimated to be as high as 236 million people living with PAD. So this is a really common. Cardiovascular disease. Actually there was some work done many years ago, again led by Dr. Allen Hirsch, a study called the Partners Trial, where they went out in primary care practices. This is one of the first attempts at looking at the prevalence of PAD. So they went to primary care practices and they patients ages 70 or above. Or 50 to 69 who had atherosclerotic risk factors. And in that population they actually found a 29% prevalence of an abnormal a BI estimates of the co prevalence of. PA, D and CAD vary, but it's very clear that patients who have CAD are at greatly increased risk of having PAD. And the flip side is very definitely true. If someone has lower extremity atherosclerotic, PAD, their likelihood of having some coronary disease is extremely high.

Ellen: 6:59

Wonderful. So, so Heather, for cardiac caregivers, who should we think about assessing for PAD? You know, we see a lot of patients with coronary disease, but we see other cardiac conditions as well. What are the red flags or the clues to a problem that we should. Should look at for our patients?

Heather: 7:17

Yeah, and I think if you go into the guideline document, our group made some nice very digestible and helpful tables, and one of the tables is. Who are the patients at increased risk for PAD? Because these are the folks where we give a class one recommendation that they need to have, be asked about claudication. They need to be asked about walking impairment. They need a physical exam, and they, if they have signs or symptoms of PAD, they need an a BI. So the people at increased risk are older patients. This is our Medicare population, ages 65 plus younger patients who have atherosclerotic risk factors. Special of the usual stuff, diabetes, smoking, hyperlipidemia, hypertension, but also CKD and family history of PAD. Anyone who's less than 50 but is a type one diabetic and has another risk factor for atherosclerosis. And then really importantly, people at increased risk for PAD are the people seeing the cardiologist for their CAD. So if you are following a patient who had an MI or. A stent years ago for worsening angina. You need to think about could this patient have PAD Ask them about do they have leg pain with walking that goes away with rest? Are they limited in their walking? And most importantly, this is my soapbox. I get on every time I get a chance to talk to more general cardiologists. You gotta take off their socks and shoes at the office visit. Please and look at the feet for ulcers, assess for perfusion, feel the pulses, and if there's any suspicion for PAD, move on to the next test, which is usually the a BI in the vascular lab.

Kanny: 9:08

I, I assume many ABIs are ordered by general cardiologists. Is there any nuance to when we order arresting a BI versus arresting and exercise? Because I think that's all sometimes a question that comes up from our nurse practitioners and others who are ordering these screening tests.

Heather: 9:23

Yeah, I think for sure. I think if a patient has wounds. So if you take off the socks at the office visit and there's a, a foot ulcer and they're diabetic, that person does not need an exercise. A BII think there you can go right to the resting a BI and not only, I think you wanna do it in a vascular lab where not only they're gonna do a BI. They're gonna do other perfusion assessment. They're gonna do pulse volume recordings, toe brachial index doppler, because sometimes, especially in diabetics, patients with kidney disease, patients with wounds, the a BI doesn't tell the full story. And you can have a normal or slightly elevated a BI due to vascular calcification, but still have PAD. So that's why really sending those folks to the vascular lab for a comprehensive assessment. I think if your patient has any functional limitation. Or leg pain. I think in my practice I would go right away to the exercise a, BI, of course, if they're safely able to walk on a treadmill, if you're at all worried about their cardiac status, I would not do the exercise a, BI, because exercise, ABIs are often performed at a pretty steep incline and in most facilities without cardiac monitoring. So unless there's a cardiac contraindication, if the patient has any. Exertional symptoms, functional impairment, I think you can do the exercise a BI. They'll get the a, BI at rest, they'll get the waveforms and pulse volume recordings, and then they'll do the exercise and repeat the study after exercise.

Kanny: 10:57

That's great. Your document which I was reviewing, really goes very nicely into a summary of the, medical therapy. I think, a lot of clinicians kind of associate PVD with, vascular intervention and we don't always give as much thought to, medical therapy the way we would similarly do for, coronary disease where there's so many outcome trials. But it feels like that's changing. And you now have some excellent trials, given an evidence base for medical therapy. Do you wanna just touch on maybe some of the updated recommendations for medical therapy that you address in, in this document?

Heather: 11:38

Yeah, for sure. I think for most patients with PAD, medical therapy is all they need. And in fact, one of the emphasis. The emphasis of this document is that everybody needs medical therapy across the spectrum of PAD. And as you mentioned, Kenny, there's been a lot of new developments. So we still have the foundational aspects. Patients have to quit smoking. They need lipid lowering therapy. But in addition to high intensity statin, we now have options for more aggressive lipid lowering therapy with either PCSK nine. Or Ezetimibe. There's been a lot of advancement in the field of antithrombotic and anti-platelet therapy for PAD. And in the PAD space, we had two really pivotal RCTs that were published within a few years of this guideline that heavily influenced the guideline recommendation regarding the use of low-dose rivaroxaban, 2.5 milligrams twice daily atop low-dose aspirin. And this is based on two trials. One was called the Compass Trial, patients who were medically managed and one was called the Voyager trial. Patients with PAD who underwent intervention, but the combination of those two medications compared to antiplatelet alone was. Associated with significant reductions in cardiovascular events in patients with PAD and also for one of the first times we have a medical therapy that actually prevented limb events, so prevented repeat revascularization, acute limb ischemia, amputation. So I think in the PAD space. A lot of excitement about low-dose aspirin and rivaroxaban. The guidelines also for the first time include SGLT two inhibitors and GLP one agonists for patients with PAD and diabetes Since. These were published. There's actually been another trial or two that further support especially the GLP ones for patients with PAD to prevent cardiovascular events, but again, to prevent limb events. So that's really exciting for us in the PAD space. One thing that was also new that maybe isn't so sexy is the other things, but ACE inhibitors and ARBs got an upgrade to a Class one recommendation for patients with PAD. Who have hypertension to prevent cardiovascular events. That was previously a Class two A recommendation. And then the other aspect I'm kind of excited about in terms of medical therapy is I think heavily influenced by the engagement of our podiatric colleagues. On this document, we have a section emphasizing the importance of. Preventive foot care for patients with PAD. So a lot of exciting medical therapies.

Ellen: 14:31

So Heather, that is wonderful. One question for you, it's a follow up I guess, regarding medical therapies. There are so many new things coming out, right? So you've got your aspirin, you've got your rivaroxaban, your statin therapy, your other additional lipid lowering therapies. Is this like heart failure, where now we have the four pillars and everybody with any sort of heart failure gets started on all four medications? Or is it a matter of, well, you might start with the basics, aspirin, statins, and a few things, and then if they have future events or further symptoms, you escalate, at what point do you add the rivaroxaban?

Heather: 15:09

Yeah, I think a lot of the implementation science in PAD is forthcoming, so I don't have firm answers for that. I, I do think we need to do a little bit better in, in all of cardiovascular medicine and in PAD with a little bit of treatment inertia, and I'm guilty of this as anyone. I'm the chair of the guidelines. If I have a patient with PAD who's been stable on their aspirin, their high dose. It statin. They're not smoking and they've been stable for many years. I, I think I have been trying to really reboot things and as patients come back to my practice, I say, listen I know you've been doing well and this is just our annual visit, but. There's some new guidelines that came out last year that suggested that the addition of this other medication I'm referring to, rivaroxaban, may prevent events in your case down the road and at least have the conversation with the patient that there's some new data offering them, you know, a new treatment. But I think sometimes I'm curious what you both have to say. I think sometimes there is treatment inertia. When a patient is doing well and new guidelines come out and new therapies and it's hard to know how aggressive to be

Kanny: 16:24

I mean, it's a very similar situation to when you have a patient with stable coronary disease and you at their annual checkup, their lipids are not quite a target, but they're doing so well that you have some inertia to wanting to, advance their statin or add a second agent. you did allude to exercise and I think, it might be a good time to just remind our listeners about the adjunctive benefits of exercise and then maybe even touch on the role of cardiac rehab in some patients.

Heather: 16:50

Sure and actually can to your prior point. The one other thing I will add, and I know there may be some of our Cardiovascular care team members our apps, listening to this podcast, I will say the apps do an amazing job of guideline directed medical therapy and kind of getting patients there incrementally. I'm always really impressed with our A PP colleagues really pushing the cocktail of medicines that are recommended by guidelines and supported by trials. Okay, so onto exercise. So I think for patients with PAD, structured exercise really is a cornerstone of therapy. It is really a wonder treatment for many patients with stable symptomatic PADA, a structured program of exercise, either in a rehab or other structured forms of exercise if done properly. Can result in dramatic improvements in functional capacity, how long patients can walk without having pain, and how long they can walk in total. So exercise has been shown over and over again to work. I think in this document, a couple of new things to highlight. Is that in addition to supervised exercise, which is, has been recognized by CMS and covered for a number of years now for our Medicare patients, but is woefully underutilized. In addition to that supervised exercise, there's now another class one recommended therapy, which is a, a structured community-based exercise program. So that might be a program that is, unfortunately there's not enough of them in the United States, but it's. Maybe not fully conducted in a supervised rehab. There may be a coach, there may be use of trackable wearable devices, accelerometers monitoring and accountability. But that sort of program has been shown to be as effective or nearly as effective as supervised exercise where people come into the medical center. So in this document, it's also given a Class one recommendation. And I think the other nice thing that the document highlights is a recommendation that. Exercise is indicated for patients with chronic symptomatic PAD. Even after they get, if they end up getting revascularization for very limiting symptoms, you can do exercise with that revascularization to get further improvements in a synergistic way on functional outcomes.

Ellen: 19:21

That's wonderful, Heather.'cause. A lot of times the same thing with cardiac rehab, right? We might do an intervention, we might give them medications, but that cardiac rehab, that exercise portion is a real key piece of the puzzle as well. So it's nice that it holds true for PAD as well. So you're talking to a group of cardiovascular caregivers and we obviously can do a lot of this testing and, and medical treatment. But at what point should we refer our patients to a vascular medicine specialist or an interventionalist? At what point do we say, okay, we need some additional expertise in this field.

Heather: 20:01

Yeah, I think general cardiovascular practitioners can do a lot for PAD, and I think that's one of the important reasons why we're excited about this guideline, and we want to broadly disseminate this guideline because we want general cardiovascular practitioners. Internal medicine specialists, other specialists to be able to recognize PAD, diagnose PAD, and manage potentially a lot of the patients. I mean, you're already managing severe coronary disease and heart failure, and you're comfortable with your your, your. Lipid lowering agents and blood pressure lowering agents. And now our new diabetes agents. I, I think throw in some good careful foot inspection and exercise, and I think PAD can be very well managed by the cardiovascular specialist. I think if patients are not responding to usual. Medical therapy if, if they remain functionally limited, if they can't do their job, if their quality of life is poor because they have leg pain with walking and they have PAD and they've tried exercise and they've tried they're on a good medical regimen. Those are people who should be seen by a vascular specialist. And of course any patient with PAD who you think might have what we now call CLTI, chronic limb threatening ischemia, that used to be CLI. It's got a new name. And that would be ischemic rest pain. Ulcers or gangrene. Those are folks who need to see a vascular specialist urgently. But I don't think every patient with PAD needs to see a vascular specialist. I think a lot of them can be managed in cardiovascular medicine practice. And I hope these guidelines give a blueprint for people to feel comfortable doing that.

Ellen: 21:54

I guess since you brought up the difference between chronic. Limb, well, chronic limb threatening ischemia. Can you discuss the hallmarks and the treatment differences between the chronic versus acute limb ischemia?'cause obviously the sort of rapidity with which. Things need to be managed might be a bit different.

Heather: 22:14

Yes, for sure. The CLTI, that's a patient who's generally had symptoms for two weeks or more, and as mentioned it's a chronic wound, it's rest, pain, it's an ulcer. And those people, it is a vascular urgency for limb salvage for them to be evaluated, for revascularization to prevent, potentially manage their wounds. Restore blood flow to the leg and salvage as much of the leg and foot as possible. The acute limb ischemia, that's the six Ps. You know, the pulseless, pale, polar, parasitic I forget my other. I'm laughing and painful. I'm maybe missing one of the PEA's leg That is acute onset symptoms. Those are often embolic events, or they may be. Thrombotic events on top of existing plaque or maybe an occlusion of a revascularization site. Those are the people who need to come to the emergency room, get on IV heparin immediately, and be evaluated for emergency revascularization.

Kanny: 23:26

So on that topic Heather, you know, as a general cardiologist, we're often the first one being called by the emergency room for, for a phone consult. Obviously when we hear that story about the acute ischemic limb, I think, we all understand we have to, get in touch with, with one of our vascular colleagues on an immersion basis and get that patient in. Are there any other situations that you kind of consider red flags for the general practitioner where, rather than just electively getting a consult, we may need to do that emergently or at least discuss a case with you. Is, is the acute ischemia the main one or are there any other clinical scenarios where, the alarm should be getting raised?

Heather: 24:09

I think the CLTI patient is almost at that level. That's, that group has just a very poor natural history with high, Likelihood of moving on to amputation or even death. And I think unfortunately those patients, you would think they would be recognized, but often are not. So there's often a lag in their, in their care. I think the acute limb ischemia, the patients writhing in pain, the foot's white, you know, it's kind of obvious. I think sometimes the CLTI patient that can be more indolent and sometimes people don't put two and two together. I think also sometimes people don't think if you have a diabetic patient with a foot ulcer, that it could be PAD. A lot of diabetic foot ulcers are PAD related and not just related to diabetes. So we actually have, it's been well documented that patients may be. Getting cared for wounds or maybe actually may undergo an amputation without having vascular assessment to see if they have PAD and could potentially be revascularized. So I think that that CLTI group is, is a pretty, is a very high risk group that's often not managed as quickly as they should be because their symptoms are not as dramatic.

Kanny: 25:37

That's very helpful. One other topic I wanted to talk about was kind of you, I think you alluded at the beginning to team-based care and we still have, of course, the more serious cases that do need revascularization. You know, in some settings, they're being done predominantly by vascular surgeons and others by, peripheral vascular cardiology based practitioners as well. And then of course you have so many well-trained vascular medicine specialists like yourself. There's been a move towards team-based care in other areas of cardiology. Valvular disease. We have our heart team conferences every week. Interventional cardiology as well. You have collaboration between surgeons and interventional cardiologists. With the more complicated cases, do you see vascular medicine moving towards a team-based kind of approach? Because I, you know, in my practice, I, I still see especially patients being referred from some outlying hospitals, patients who were maybe saw a vascular surgeon and told that, there was absolutely no option for them. For definitive surgery. And then, once they're assessed by an interventional vascular doc, they actually are a very good candidate to get, percutaneous revascularization. So do you still see some turf battles like that out there, or do you think the vascular communities also kind of moving towards, team-based care, mirroring what's happening in, in the cardiac areas?

Heather: 26:57

Yeah, I think in my 20 years since I left my fellowship, I've seen great progress in this space in terms of partnership. I think in this document we emphasize the tremendous importance of what we call the multi-specialty PAD care team, and that team includes. Expertise in vascular surgery, expertise in endovascular care, expertise in wound care, expertise in risk factor management. You know, a lot of expertise phy people who are experts in orthotics and prosthetics, infectious disease, et cetera. And actually our, especially for our CLTI section, we have a class one recommendation that patients with CLTI. Should be managed by a Multispecialty PAD care team. Just recognizing that there's a lot we can do when we put the patient at the center and have different perspectives putting together a care plan and to build on your other point. We actually have a recommendation in the guideline that for patients with CLTI who require amputation, those patients should be evaluated by the multi-specialty care team to assess for the most distal level of amputation and to make sure there's no. Further revascularization options. So this document strongly endorses Multispecialty, PAD care. I think our multispecialty guideline writing committee, which was very collaborative, really reflects great progress in terms of partnership of all the different groups and less competition because. You know, as I started this conversation, you have 236 million estimated people in the world. With PAD there is plenty of work for everyone to do, and actually a lot of patients don't get any vascular care, so I, I. I do think we need to partner to increase the reach of our all specialties to identify patients with PAD, treat them properly, and then for patients with severe PAD like CLTI really work together, put the patient at the center and come up with the best care plan that optimizes outcome.

Ellen: 29:17

Wow, Heather, this has really been quite an eye-opening discussion and we're learning so much. What are the few most important takeaways that all cardiac caregivers should know about taking care of their patients who may have PAD? Like what are the, the key aspects from the guidelines that we just all need to know as, as a summary.

Heather: 29:38

All right. These may be a combination of the guidelines and Heather Gornick's takeaways, if that's okay. That

Ellen: 29:44

is perfect.

Heather: 29:46

I think number one, you are seeing patients with PAD every day in your cardiovascular medicine practice. You just need to decide if you're gonna recognize it and find it or not. Number two, take off those socks and shoes. Look at the feet, evaluate the pulses. Ask about leg symptoms as part of your office visit. Number three, embrace all of these wonderful medical therapies we now have to prevent limb loss, heart attack, stroke, and death in these patients. And I think probably the most exciting one is the the low-dose rivaroxaban on top of low-dose aspirin. And I think number four is if your patient has. Severe PAD, especially the CLTI. Obviously acute limb ischemia or even just stable, symptomatic PAD that's not responding, and the patient still remains really limited. Get them to your trusted vascular specialist for revascularization and exploration of other options.

Kanny: 30:52

Well, that's, that's a, a concise and awesome summary of a very broad topic. So as we always have, we appreciate your insight. I, I do wanna put one plug, Heather. You know, obviously we're gonna put the link to our guidelines in our podcast notes. But on acc.org there's also a great summary document, guidelines at a glance where they summarize, the 10 takeaway points from your guidelines, but also have a really nice chart comparing the differences. In medical therapy between these guidelines and the prior edition as well as the European guidelines. So it's a very concise way to look at the key differences that, of course, most of which you've outlined in our discussion today. So, thanks again for your service to the cardiovascular community and, and for your clinical work as well, and also for being our most downloaded podcast guests.

Heather: 31:47

Thank you Kenny and Ellen. It's been a lot of fun talking to you.

31:50

Thank you for joining today's podcast. For more information about the speakers or the topics, please go to Ohio acc.org,