PAD Care at OhioHealth

A conversation with John A. Phillips, MD

CLD 's managing editor Rebecca Kapur talks with John A. Phillips, MD, a cardiovascular and peripheral vascular interventionalist, about what he is seeing in his practice regarding the treatment and care of peripheral arterial disease patients (transcript available below video).

The transcript below has been lightly edited for clarity.

What are some of the trends that you are seeing in your practice?

Dr. Phillips: At least maybe in Central Ohio, we're seeing less and less claudicants. I know I'm taking fewer claudicants to the cath lab, and I'm doing that only the after they've failed medical therapy with typically cilostazol and a walking program. I'm in Columbus; we have 11-12 hospitals or so. And I think in general, we as a group are treating less and less claudicants, reserving those that we treat to only the severest cases and those that have vocational- or lifestyle-limiting claudication. We participate in the Society for Vascular Surgeons Vascular Quality Initiative (VQI) and I review our data. And in our region, OhioHealth does the majority of peripheral endovascular cases in that registry. We’re still doing a lot, but I think the numbers are a little bit less for claudicants, if you had to ask me a trend in our area. Now having said that, the critical limb or the chronic limb-threatening ischemia folks are the bulk of what we do. I would say over 70% of our endovascular peripheral procedures are critical limb. And unfortunately, I'm just starting to get into our data, they still have a high mortality rate and they undergo amputation. So we're trying to figure out, okay, what can we do differently here? Is everybody practicing with the same playbook? That's what we're trying to figure out in our health system. And we're just starting to uncover this, so it's a lot of work. But that's what that's thinking about right now in our group.

For your interventional patients, are there any concerns that still remain regarding paclitaxel-coated devices?

Dr. Phillips: We have not shied away from the use of paclitaxel at all. In fact, I don't think we even have that conversation anymore. All that data has moved that hazard ratio a lot closer to one, and so it doesn't even really cross my mind anymore, frankly. I was disappointed by the SAVAL trial data with respect to Boston Scientific’s paclitaxel stent below the knee. We were involved in that trial, it was very hard to enroll. If nothing else, that shows us that prolonged balloon angioplasty, at least in the tibial vessel, still works. I think that's probably it, for the foreseeable future, until limus or something else comes out, which I know some companies are working on. Plain old balloon angioplasty in the tibials seems to be where we're at for critical limb.

Have you noticed any other changes or trends in your own treatment patterns?

Dr. Phillips: I don't stent as much as I used to. I think we're getting better at vessel prep with respect to whatever modality you use. And I'm using more intravascular ultrasound (IVUS) than I have in the past, just to help with sizing and plaque morphology, dissections, things of that nature. I've really gotten away from doing full metal jackets, superficial femoral artery (SFA)/popliteals (pop). We published some data a few years ago that was okay; but certainly if you need to do it, you do it. But I think there's better ways to skin that cat, so to speak.

You mentioned vessel prep. Can you talk more about that?

Dr. Phillips: So in folks with heavy dense calcification, SFA pop, I have taken on this concept of sandblasting, which I talked about a few years ago at Leipzig Interventional Course (LINC). And I'd be the first one to tell you, it's not the most cost effective, but at least it works for me. And in fact, I'm in the process of writing an IRB to look at our patients that we've done it on. So in these kind of coral reef popcorn like calcification, particularly popliteal and no stent zones, I'm doing CSI and then treating that also with intravascular lithotripsy (IVL), and then drug-coated balloon (DCB). And I've got at least 10 cases, at least, that we've had really good short-term results with. So that's kind of the new thing that I'm doing. Otherwise, we're still doing a fair amount of atherectomy, whether it's directional or front cutting. And then trying to use long balloon inflations with the drug-coated system and then seeing what we have. I think the TACKs (Philips) are nice for focal dissections. I don't think people use them as much as they should. And obviously the stents work well, right? Whether it's Eluvia (Boston Scientific) or Zilver PTX (Cook Medical). The other thing is, I know that Medtronic is coming out with a longer shaft DCB that you might be able to, or you should be able to, get some fem-pop from the radial approach. And so along with that and the R2P system, radial to peripheral, from Terumo, they have, sheaths and balloons themselves and stents that make that an option. So I kind of was a naysayer of that and poo-pooed it. I mean, I still don't know where it's going to land in my algorithm, but at least now that there's a longer drug-coated balloon, I'm more apt to explore the radial approach, because I do all my coronaries radial, and so it's a nice transition. But there are some nuances still using radial. And so people need to be cautious, I guess, or at least thoughtful when they're doing it.

You mentioned using IVL and then a DCB. What's the value in using a drug-coated balloon in a very heavily calcified vessel?

Dr. Phillips: That's a fantastic question. I think if you can really prep that vessel... This is my theory; I think with orbital atherectomy, you create micro fissures and then IVL, you create more macro fissures. And the combination of those two really, in the way I describe it to patients and physicians sometimes, is you've got a piece of uncooked spaghetti that you're trying to cook, basically, right? Because those vessels are so rigid. And you cannot make it completely malleable, but I think that preparation allows for those vessels to become a little more al dente, then completely uncooked, if you will. And then I think that allows you to penetrate with the drug. But I agree, if you don't prep that vessel well, there is that data that shows the more calcification, the less likely you're going to get a benefit from the DCB. So I think you have to be very aggressive when you prep those vessels if you're going to use any type of definitive treatment, whether it's a stent or a balloon.

Can you talk about the current status of PAD care?

Dr. Phillips: I came across some data, Johnson & Johnson and Janssen, because they have low-dose Xarelto, rivaroxaban for PAD, they have an indication for PAD. They are looking at underserved patient populations with peripheral arterial disease. And this is kind of a long-winded answer, so forgive me, but they're working on a heat map of the United States that you can zone into your state and then you can zone into your counties. And again, the one that I saw was pretty rudimentary. You maybe have, I don't know, 25% of the counties in Ohio accounted for. But they basically color-code the amputation rate for African Americans. And not that this is acceptable — so you're doing pretty well if you have a population of African Americans who only have an amputation rate, that's 2.1 times that of whites. And then you're not doing well if you're above that, and then it kind of tells you what it is. But we have some counties where it's six, seven, eight times that of whites, which is unacceptable, and so to get back to your question, we have to do a better job of educating our patients to be proactive. We have to do a better job of having patients understand what this disease process is. I've always said that PAD and CLI doesn't really have a “face”. I mean, yes, September is PAD Awareness Month, but it doesn't register to a patient, somebody at risk, a diabetic who has a black spot on their toe, that it could be the start of something really bad. It doesn't click for them. Whereas a woman, for example, finds a lump in her breast, that triggers something. Lumps everywhere trigger things. We need to be better at that. So it's not only raising awareness to patients, but it's raising awareness to primary care doctors and endocrinologists and people that are touching these folks that are at risk. Because it's not going to get any better. The statistics show that there's going to be triple the amount of people with PAD in the next 10 or 15 years. And so we have to get better, because everyone's living longer, but their disease processes are getting a little bit worse, I think.