Prakash Chandran (Host): Peripheral artery disease or PAD stems from atherosclerosis of lower extremity arteries. The most severe form of PAD is termed chronic limb threatening ischemia, or CLTI for short and carries a significant risk of limb loss and cardiovascular mortality. Patients with concomitant diabetes mellitus and PAD are at high risk for major complications, such as amputation.

And within this cohort, there's a significant regional, racial, ethnic, and socioeconomic variation in amputation risk. Today we're going to talk about those with elevated health risks, initial treatments, revascularization, and the Limb Salvage Program. And we're joined with Dr. Tejas Shah, a Vascular Surgeon for ASCENSION ILLINOIS and Program Director for the ASCENSION ILLINOIS Vascular Surgery Fellowship. This is “HealthCast,” the podcast from ASCENSION ILLINOIS. I'm your host Prakash Chandran. And so Dr. Shah, really appreciate you joining me today. You know, as I mentioned in the introduction, chronic limb threatening ischemia, or CLTI is the most severe stage of peripheral artery disease or PAD, and it affects more than 230 million adults worldwide. Could you give us an overview of various initial treatment plans for all stages of PAD?

Tejas Shah, MD, FACS, RPVI (Guest): Sure thanks Prakash for having me. Yeah. So PAD and more it's most ominous head, chronic limb threatening ischemia is really essentially, end stages of PAD is I think of it on a spectrum. There could be a very mild PAD, which is asymptomatic, more, more disturbing PAD like claudication and then rest pain. And then on its most severest form, this is where you have limb threatening ischemia, where you either have severe rest pain or wounds with gangrene. Patients with these disease processes have a constant threat to their limb with a potential of a loss of their limb, as the risk of the disease process continues to progress.

We have a very broad encompassing treatment plan for patients with chronic limb threatening ischemia. We understand in this particular disease process, time is of the essence, in terms of revascularization and establishing blood flow back to the, in the leg to be able to get those wounds to heal and to be able to reverse some of the the effects that have occurred over a period of time.

Our treatment strategy is really threefold. Medical management becomes the base of this whole process, making sure we're treating a lot of the underlying disease processes that got to this point. Whether it's diabetes, high cholesterol, hypertension and whatnot, and the atherosclerotic disease itself.

And so we focus on the medical management as a base, as a base layer, if you would, to start the process of getting them, getting their treatment going and to help reverse some of the effects that have occurred for years and years. Then we move on very quickly to evaluating these patients and understanding where the disease is, how much burden of disease there is. And what kind of disease we're talking about. Is this soft plaque, or is this hard calcified disease? And all of this goes hand in hand with the kind of underlying processes the patient has. Are they a long time smoker too? Are they a long time diabetic? Or do they just have elevated cholesterol and high blood pressure?

We evaluate the vast majority of these patients first, with minimally invasive techniques, endovascular with balloons, stents, various catheters and minimally invasive techniques that would help to restore the blood flow if appropriate. However, our tool belt does not stop at just minimally invasive.

Our tool belt is all encompassing with balloons and stents, but also surgery when appropriate, whether it be a bypass or even certain hybrid procedures where we do a little bit of surgery and a little bit of endovascular, ballooning and stenting if needed. But each treatment strategy is really individualized to the patient, based on their underlying comorbidities, the disease location, the disease type. And what would best be served for the patient in terms of long-term durable treatment?

Host: Thank you so much for that comprehensive breakdown. I think it gives us a good sense of the different phases and how each treatment plan is individualized. I'm curious, at what point should patients be referred to a Vascular Surgery Specialist?

Dr. Shah: Yeah, this is a very good point. It's ideal for these patients to really get in early with a Vascular Specialist, because the earlier they are seen and evaluated by Vascular Surgeons in their treatment strategy, the greater options they have available to them. If they have a early disease process with early rest pain, or even if they have claudication, pain in their legs, any element of peripheral vascular disease should start the process to understanding, well, let me understand what my disease burden is. What does it mean for me? And what are my treatment strategies at this point? Peripheral vascular disease or peripheral arterial disease PAD is really a surrogate marker. All their disease processes in the body, too. So, even though patients come to me in my office with leg disease, I often find that there's disease in other parts of their body that also need to be addressed with the same kind of vigor that I'm addressing the lower extremities.

And I often find other disease processes as well in the same breadth of evaluation. So, I think that understanding the fact that you may have this disease and then kind of going in early to a Vascular Specialist really helps to potentially provide multiple treatment options and stave off the disease itself.

Host: So, one of the things that you mentioned there is that oftentimes it's a surrogate marker for other disease processes that patients should be aware of. You know, according to AHA Journals, there are estimated 2 million individuals living with CLTI specifically in the United States. So, could you please talk about the elevated health risks for them or for these individuals specifically?

Dr. Shah: Yeah. So, many of these patients have, as I mentioned earlier, concomitant disease. They have diabetes, they have hypertension, they have hyperlipidemia, they have coronary disease and the same processes that caused a person to have, you know, renal disease, coronary disease, high blood pressure is going to play into the peripheral vascular disease.

And so, although we estimate the number to be about 2 million Americans in the United States with this disease, we actually think that's probably under, an under evaluated number and under, and sort of a low-end estimate at best. And, and there's probably even greater numbers of Americans that are living with peripheral vascular disease that have just gone undetected for various reasons.

And so, I think that once again, the, the critical aspect is those with other concomitant comorbidities, peripheral vascular disease clearly plays a role as part of their disease process.

Host: So, one of the things that I also mentioned in the introduction was the demographic trends. So, I was wondering if you could speak to any demographic trends for greater risks of amputation or more severe outcomes for CLTI?

Dr. Shah: Yeah. So, those that live in you know, have lower access to medical care, those that are of the lower socioeconomic class and we find that African-Americans, Native Americans and Hispanic Americans are really at the highest risk for losing their limb and amputation. The amputation rate in these groups of Americans are really high.

And the single tying thread to all of these groups of patients is late access to care. And because their disease process has become so advanced, their gangrene has spread, their infection has spread; they really have fewer and fewer options and their options become limited to the point where amputation essentially becomes the only option available to them in order to save their life, in order to kind of progress their care.

And so that's why we stress very thoroughly to try to get in early, even if the peripheral vascular disease is not so overbearing at the moment, at least then we have an ability to track it and follow it and be able to treat it early when something does occur as opposed to, as opposed to its late stages.

Host: So, I want to move on now to something that you and your colleagues established, it's the Limb Salvage Program. Could you talk to us a little bit more about what this is?

Dr. Shah: Yeah, we're, we're really proud of this Limb Salvage Center that we have established. It's a multidisciplinary program that includes a series of different disciplines of doctors, including an infectious disease doctor, a wound care specialist, a podiatrist, plastic surgeons, and of course, ourselves as vascular surgeons.

And it essentially involves all different types of physicians who would basically be involved in the patient's care from start to finish. When a patient comes in to our Limb Salvage Program in our Limb Salvage Center, they are thoroughly evaluated on all different fronts, in terms of infectious issues, the wound itself, addressing the wound head-on. And then also other medical comorbidities that may be occurring with them. To help them with their diabetes, we have a endocrinologist on board to be able to control that and hypertension we make sure that they are plugged into our Hypertension Program and we basically help to fix the problem in a, almost like a 360 global point of view so that we're not just hyper-focused on the wound and clearing and healing the wound, but we're also focused on preventing that wound or another wound from forming again. With the Limb Salvage Center, we are able to save a number of patients and their limbs and be able to do it in an expedited fashion because patients are able to see a number of disciplines of doctors in a short period of time.

Host: Yeah, that's truly amazing. One of the things that I wanted you to maybe expand a little bit more detail on is you touched on some of the techniques used for improving that lower extremity blood supply. But what are the latest revascularization techniques and how successful are they in preventing amputations?

Dr. Shah: Yeah, so, in the world of vascular surgery, this is a really exciting time. The technology is ever expanding and growing at a rate of leaps and bounds. We are now able to provide techniques of treatment that are less invasive, more targeted and the therapies are able to fix problems that before were quite burdensome and almost nearly impossible to fix. We have new technological advances in the balloon therapies that we use. We now use lithotripsy in very calcified vessels. We have drug coated balloons, which are specially coated balloons that help to minimize a restenosis rate or narrowing from reoccurring. One of the biggest bugaboos with minimally invasive procedures is that they don't have a great durability. They just don't last a long time. So, now as technology is advancing, we are able to find and offer therapies that will give longer, more durable treatment options. However, we're also not scared or we don't shy away from providing open surgery when appropriate.

We still know that there is a large cohort and subset of population that would do much better with surgery, when appropriate in, in that population. And we're able to provide a very grounded conversation with our patients about all options that are available to them on the table and be able to really give them the best options based on their, their special and unique comorbidities and disease processes. And so I think that this has really, really moved the needle quite a bit in the world of chronic threat limb ischemia.

Host: Yeah, it absolutely sounds like it. You know, just before we close here, I wanted to see if there's anything else that you wanted to share with our audience around CLTI around, or just really the importance of coming in early, anything at all that you'd like to share with the audience.

Dr. Shah: I think you it hit the nail on the head there. The critical, the most important piece of information that I could share is early evaluation is really just critical in, in these patients. This is really a surrogate disease process for other diseases that may be occurring in your body. And by understanding your peripheral vascular disease, we are actually able to help, help better evaluate other beds of vasculature that may also need to be addressed and, or evaluated. Peripheral vascular disease is really, once again, a broad spectrum of disease that can occur and sometimes you know, by not ignoring early signs of pain and wounds that are slow to heal or not healing, will help to allow for a broader range of treatment strategies which are really, which really do benefit the patient.

Host: Well, Dr. Shah, I think that's a great place to end. Thank you so much for your time today.

Dr. Shah: Thank you very much. I appreciate you having me here.

Host: That was Dr. Tejas Shah, a Vascular Surgeon for ASCENSION ILLINOIS and Program Director for the ASCENSION ILLINOIS Vascular Surgery Fellowship. To learn if you are at risk for PAD, abdominal aneurysm or stroke, schedule a vascular screening at Ascension sites of care. No physician order is needed. Visit  ascension.org/ILvascularscreening. Thanks for listening to “HealthCast,” the podcast from ASCENSION ILLINOIS. I’m Prakash Chandran.