Discussing Deep Vein Arterialization

Key Takeaways

1. Deep vein arterialization (DVA) offers a limb-salvage option for “no-option” CLTI patients
DVA fundamentally changes the treatment landscape for patients with chronic limb-threatening ischemia who are not candidates for traditional endovascular or bypass revascularization. By rerouting arterial blood into the venous system of the foot, DVA provides oxygenated blood flow where none previously existed, helping avoid major amputations that are associated with alarmingly high 3- and 5-year mortality rates.

2. Podiatrists play a critical gatekeeping and post-procedure role in DVA success
Patient identification, referral, wound stability, and post-procedure management are central to achieving favorable outcomes. Proper patient selection—particularly those with distal wounds and salvageable foot architecture—combined with meticulous, tension-free, open surgical management and conservative wound care protocols, makes podiatry indispensable to the multidisciplinary DVA team.

3. Early outcomes data show promising limb preservation rates, with future growth on the horizon
Clinical trials such as PROMISE-1 and PROMISE-2 demonstrate high technical success rates (~99%) and meaningful limb salvage outcomes at 6 and 12 months. With ongoing studies like PROMISE-3 and increasing awareness among podiatry and vascular specialists, DVA is poised to become a more widely adopted strategy for patients with end-stage PAD, CLTI, and complex comorbidities such as renal disease.

Transcript

Jennifer Spector, DPM:

Welcome back to Podiatry Today Podcasts, where we bring you the latest in foot and ankle medicine and surgery from leaders in the field. Today, we are thrilled to have Dr. Brett Chatman with us, who specializes in foot and ankle surgery and serves as an associate professor of surgery at the Hospital of the University of Pennsylvania, where he also acts as an assistant fellowship director and the residency liaison. In addition to his teaching responsibilities, he's an integral part of a growing limb preservation center in Philadelphia, which is dedicated to advancing care for patients at risk for limb loss in the local community. We're really excited today to be speaking to him about deep vein arterialization and a lot of important concepts surrounding this that contribute to limb preservation. I'm Dr. Jennifer Spector, the Associate Editorial Director for Podiatry Today, and we're so glad to have the audience with us as well.

Dr. Chatman, welcome to the podcast.

Brett Chatman, DPM:

Thank you. Thank you. Excited to be here.

Jennifer Spector, DPM:

Could you start out for us by just explaining for folks that may not be as familiar with this? What is deep vein arterialization and maybe a little bit about why it's so important for patients with CLTI?

Brett Chatman, DPM:

Deep venous arterialization in the very core of this is turning the venous system of the foot into the arterial system. And this is really a procedure that's done by our vascular surgery colleagues, our interventional cardiologists, and it's really done in the no option patient. So these are patients where they're not a candidate for an endovascular revascularization or they're not a bypass candidate at all. And up until a few years ago, if they were no longer a candidate for either of these revascularization procedures, oftentimes they would go on for a major amputation, which would be a below the knee or above the knee amputation. However, with deep venous arterialization, this is now the option for the no option patient. In a little bit more, I guess, technical specificity of the procedure itself, the operator normally starts by accessing the lateral plantar vein in the foot. And by stimming a wire up through the lateral plantar vein, they go up through the posterior tibial vein, just proximal to where the posterior tibial artery is occluded.

We know that the blood flow is coming down to the large extremity and coming through the posterior tibial artery into the foot. And so by going just proximal in the venous system to where the occlusion is of the arterial system, they leave the wire there. And then the operator will also access through the groin the posterior tibial artery and go to the level of the blockage. So if we can imagine that the two wires, one in the vein and one in the artery is just proximal to where that blockage is, the operator is then going to send a crossing wire and they do a stenting over a stent per se from the venous system into the arterial system. And by stenting from the posterior tibial artery into the posterior tibial vein, the oxygenated blood flow can now go from the posterior tibial artery into the vein and through the venous system into the foot, thereby now bringing oxygenated blood flow to the foot, which is a really cool new treatment.

I think to answer the question as to why this has emerged as a treatment for patients is a really, really meaningful answer when we think about it. And why would we go through all this hassle to get this oxygenated blood flow to the foot? And it's kind of what I was talking about earlier where I said, up until this point, if they weren't a candidate, if a patient wasn't a candidate for an endovascular revascularization or for a bypass, they would've had a major amputation. And I always tell all of our residents and our fellows at Penn bringing up previous studies, if you look in the Journal of Plastic Surgery published in 2021 out of Georgetown, they looked at mortality rates after major amputation, and they looked at three-year and five-year mortality rates. And at three year, it was a 50% mortality rate after a major amputation, and the mortality rate at five years was 70%.

And in a separate study of the Journal of Foot and Ankle Surgery, they looked at 36,000 non-traumatic lower extremity amputations and had very similar statistics at the three-year mortality rate being 53% and the five-year mortality rate was 64.4%, so close to that 70% mark. And so 70% of these patients, unfortunately, are dead at five years after a major amputation. So by offering patients who were once no option, now offering them or having an option to offer them, I think is pretty remarkable.

Jennifer Spector, DPM:

No, it definitely is. And I think so many podiatrists find themselves in the situation where they've invested a significant multidisciplinary approach into limb preservation, but then you reach that roadblock of the blood flow. And too many times we've all had that experience of there being no option. So we do know when options exist though, that proper patient selection is key. From your experience, what are some key clinical and anatomical criteria that might go into determining if a patient is an eligible candidate for DVA?

Brett Chatman, DPM:

Yeah, great question. I think from a clinical standpoint, I think podiatrists in general are the gatekeepers for patients for DVA, because oftentimes we are the individuals out there who are referring these patients to see a vascular surgeon. I'm very lucky in the sense that I work at an academic institution where I can call vascular and have them evaluate our patient in two minutes. But oftentimes with my colleagues in private practice, they are the referral source to the vascular surgeons. And so just knowing that there is an option out there, I think is key. From a clinical standpoint, obviously as a podiatrist, you're going to do a full evaluation and a full vascular evaluation of this patient where we're feeling pulses or we're ordering non-invasive vascular studies and just knowing that there's any clinical signs of tissue loss for these patients or there's any signs of poor perfusion for these patients of the lower extremity, I think warrants a vascular surgery evaluation.

A DVA is going to be done by the vascular surgeon. And oftentimes I found that at Penn, if that patient is a candidate for an endovascular revascularization or bypass, they'll go for it, but they will do a further workup and do a diagnostic angiogram to really evaluate if that person is or is not a candidate for those interventions or if they should go on for a deep venous arterialization. So I think in any patient where we notice that there's any sort of tissue loss or poor perfusion, warranting them vascular surgery evaluation is key. And I think from an anatomical standpoint and looking at these patients for a DVA, let's say we know that the patient is going to undergo a DVA or is considered a no option patient. The ideal candidate for a DVA is one where the wound is distal to the metatarsal phalangeal joint.

It's not a contraindication by any means if that wound is more proximal. But having that wound distal to the MPJ is key. Also, part of the procedure of the deep venous arterialization is after that procedure is done, we have to wait around six to eight weeks for the circuit to mature, i.e.,further blood formation or for the overall, I guess, circuit of the lower extremity to mature to have the blood flow reach the toes. And in that waiting process, the key is to keep that foot alive and keep those wounds healthy. And so having a dry, stable wound is going to be key. Again, if it's wet or infected, it's not a contraindication. We know that infection trumps ischemia every time and we'll just have to mitigate that infection first before they undergo the arterialization. But the most ideal wound, if we could target would be from the MPJ distal.

I think extending into that midfoot area is also going to be okay. We've had several patients undergo a DVA where there was a midfoot wound. I think that from an anatomical standpoint, the patients that are not the best candidates are where the entire surface of the entire weightbearing surface of the foot is necrotic or all that tissue loss and that's not going to be a functional lower extremity post-revascularization and post-reconstruction, those are the patients where it's really not ideal. And I think the last one I'm thinking about is really that dreaded heel wound. Now, we've had some very stable heel wounds progress and do just spine, but I think when the extent of the soft tissue loss is so extensive and we now have calcaneal osteomyelitis, I think those candidates maybe don't do as well or maybe aren't the best candidate for a DVA.

Jennifer Spector, DPM:

Well, that makes sense. And just like any procedure that any surgeon undertakes, there are a couple different approaches. For instance, with DVA, there could be a more open versus a percutaneous approach. Are there any new devices or imaging guidance or ways of looking at the surgical approach that our colleagues are taking with these, our vascular colleagues? And are they shaping how the procedure is performed?

Brett Chatman, DPM:

Yes. I think that this is an ever-changing procedure from start to finish, from the actual procedure to how, as a podiatrist, we're managing these patients postoperatively and our post-procedure management protocols. I think our protocols are ever changing. There has been a lot of talk about open versus percutaneous approach for the DVA, and I think it's really up to the operator. I think when evaluating the patient, some of the patients with really, if they have really complex occlusions or heavy calcifications, or there's really poor distal targets, sometimes the surgeon may favor a more open surgical approach for direct visualization or for bypass creation. However, I think nine times out of 10, the operator is really targeting more of a percutaneous approach for the deep venous arterialization. But I do think it, again, depends on that quality and accessibility of the target veins that they're in processing.

Jennifer Spector, DPM:

You mentioned a little bit about the post-procedure protocols and how they have evolved. Can you talk a little bit about what that might look like in some of the patients that you've observed and how podiatry might contribute at that stage?

Brett Chatman, DPM:

Absolutely. I think the post-procedure management is critical, and I think podiatrists are the key to success of this procedure. I think this procedure itself from an operator standpoint is a technically advanced procedure, but I think they could do an amazing deep venous arterialization, but without a podiatrist on board that specializes in wound care and post-procedure management, the chance of success is very minimal. I think we should look at post-procedure management in a few different ways. I think there's the surgical approach, the immediate surgical approach, and then what that looks like shortly thereafter. So again, I mentioned this earlier, after the deep enough arterialization is performed, we normally wait around six to eight weeks for the revascularization of the lower extremity. Again, we refer to this as the circuit maturing, but once that circuit's matured or we notice that there's now clinical oxygenation of the lower extremity as done by a wound evaluation or a duplex ultrasound, now that we know that there is adequate flow to the foot, the podiatrist will then go on for whatever surgical intervention is needed.

And this is where it gets interesting. The surgical approach for us is a little bit different than what we've been used to or what we've been trained to. What we've created at our post-procedure management protocol at Penn is we do a strictly open amputation. In fact, if it's a toe amputation, it's just an open guillotine amputation, or if it's a midfoot amputation, it's relatively the same where hopefully we're doing a disarticulation on day one and removing any of the dead tissue day one, and then I stage everybody. So 48 hours later, we go back and I'll bluntly push the dorsal fastener cutaneous flap off the metatarsal shafts, make my osteotomies, and then let that soft tissue herniate back over the metatarsal shafts. And then at that point, I now have a little bit of fascial covering over the resected metatarsals. I'm then going to apply my biologic graft over the entire guillotine open amputation site, and I always utilize a wound Vac for these patients.

I think if it's just a toe amputation, I'll still do the same procedure where I bluntly push back that dorsal fasciocutaneous flap and then let the soft tissue herniate back over and tack a little graft on and I'll do a bolster dressing. But if we're a midfoot or any weird wound resection at all, I'm always going for a wound vac. It's really key. I think from a podiatrist and a surgical standpoint, the biggest key takeaway is a no closure whatsoever. Any tension on a closure site is going to cause soft tissue necrosis. And I like to think about this from an anatomical standpoint, and if we look at the anatomy of an artery, it's firm, it's pliable, but if we look at and we compare that though to the anatomy of a vein that is very, very loose per se or very soft to touch, if I had any tension in and around the vein that we now is the newly created artery for the foot, that's going to cause the vein to close off.

So unlike a normal post revascularized patient, so say post bypass where I do a TMA and I would suture it closed, the deep venous arterialization surgical management is really an open amputation with a biologic graft and a wound VAC. And then at that point, I see these patients either weekly or biweekly for continued grafting in the clinic and just making sure that the wounds are staying alive, staying healthy, and that there's no infection setting in. I think another key takeaway that I teach our residents, our fellows about the wound care for this is really no debridement whatsoever. So if it was a post-revascularized patient, post-bypass or post angio with stent placement, whatever, sometimes I'll debride the wounds. We want to see that healthy wound blush and bleeding in the clinic, but with the DVA patient, we don't do any debriding at all. Very minimal. And the only debridement I'm going to perform is on anything that's questionably infected to make sure there is no infection setting in because trauma to that tissue will cause the soft tissue to necrose.

So it's a little bit of a different management in comparison to our normal post-revascularized patients.

Jennifer Spector, DPM:

Well, that's so interesting to hear because we've had such a strong algorithm for years on how to handle those patients that have had some blood flow restored. So this is really interesting to learn more about.

Brett Chatman, DPM:

I'd say one other thing that's a little different from my standpoint is if I close a TMA, they're normally non-weightbearing for two to three weeks until we know that there's healing or healing involved and then we get them up and get them walking. With our DVA patients, we have everybody walking post-op day one in a protected CAM boot or a surgical shoe. And it was a little bit of a learning curve for me to be comfortable doing a guillotine amputation with a graft and a vac and saying, "Hey, all right, let's go walking." But when you look at it, there's no vascular contraindications, there's no real podiatric contraindications. We desensitize those lower extremities quicker, and it also helps with the swelling that occurs postoperatively from a DVA. So everybody is weightbearing day one.

Jennifer Spector, DPM:

Wow. Do you build in any forefoot offloading to that or is it just sturdy enough and hardy enough to handle it?

Brett Chatman, DPM:

Yeah. Well, I guess it depends on what the surgery that was actually done. I think if it's a toe, I do have them really maybe in a more forefoot offloading shoe if they feel stable in the forefoot offloading shoe. Otherwise, nine times out of 10, I'm putting everybody in just a standard diabetic CAM boot. And again, my TMAs are staged. There are two trips to the OR normally staged 48 hours apart. So on day one, when I just do the open disarticulation and just remove the toes and just remove anything necrotic or dead, we do see postoperative oozing, right? But over that 48 hours, I changed the dressing postop day one. At that time, we have really just clot hemostasis appreciated. Obviously, hemostasis is created in the OR, but any superficial oozing that we have is really at that point coagulated. So on my post-op or my return to the OR day two trip, and I'm bluntly pushing that fascia back, making my cuts, I'm just flushing it with cystotubing in a three-liter bag and tacking my graft on.

There's not a lot of soft tissue manipulation happening, so we don't really experience a lot of bleeding on that second trip to the OR, and that's when I put my wound Vac on. And so at that point, I have them walking that day or the following morning, and they do great. And I'm not really worried about that first step down hemostasis issue or the bleeding through the bandage whatsoever, because at this point, it's really been clotted off because that second trip to the OR is just flushing it with my graft.

Jennifer Spector, DPM:

You talked a lot about your personal experience with this, and it's just fascinating to hear about, but do we know what the data is showing us about limb salvage rates and longer term outcomes after DVA?

Brett Chatman, DPM:

Yes, absolutely. So the PROMISE-1 study, looking at the PROMISE-1 data that was published. Now, PROMISE-1 was only, I believe, 32 patients, so a US cohort of 32 patients for the PROMISE-1 trial, and they had amputation-free survival rate at 70% with the limb salvage rate at 76%. But again, that was a lower cohort. So that after PROMISE-1 came the PROMISE-2 trial, and the six-month data was recently published in the New England Journal of Medicine, and they had a technical success rate of 99%, a functional limb preservation rate at six months of 76%. And it was also noted that at six months, 76% of the wounds were either healed or were healing at that point. The 12-month data was also recently released and had an overall reported outcome of 69% from PROMISE, from the PROMISE-2 data. And I also think that's really interesting because if you look at the technical success of anything on the market, or a new bunion procedure or a new flatfoot procedure, normally the technical success there, there are noted failures here or failures there.

So to have a technical success at 99% is pretty remarkable, but we're at 76% limb salvage rate at the six-month mark and around a 69% limb salvage rate at 12-month mark. And that's even striking if you think about the patients who would've went on for an amputation, knowing that there's a 70% mortality at five years, having at almost 70% limb salvage rate at the one-year mark, I think is pretty great because this is procedure and post-procedure is really reserved for patients that unfortunately would've had an amputation otherwise.

Jennifer Spector, DPM:

So it seems like DVA is really just such a great option for folks that otherwise literally had no options and no choices. Can you talk a little bit about how this plays into the statistics that go along with CLTI, with PAD and with amputations?

Brett Chatman, DPM:

And in fact, if we're looking at the studies that I referenced earlier from General Plastics and Reconstructive Surgery and the Journal of Foot and Ankle Surgery, looking at mortality rates, at three years, it was 50% and at five years it was 70%. And I think it's actually really important to note that those are patients who oftentimes have diabetes along with peripheral arterial disease. Well, we know that the end stage of peripheral arterial disease is CLTI, and unfortunately, CLTI mortality rates are even higher than 50% and 70%. In fact, one study looked at approximately up to 10% of patients with the diagnosis of CLTI die before they're discharged from the hospital, and up to 70% of patients die before the three-year mark. So diabetes and PAD, we're a 50% mortality rate at three years and 70% at five years, but when the PAD reaches CLTI, that mortality rate's up to 70% at three-year mark, which is strikingly high.

So knowing that those patients who would've had an amputation because of their diabetes and their PAD or CLTI, now knowing that in the mortalities are so high, knowing that there is another procedure out there or another option that the patient might be able to have, which is the TADV procedure, transcatheter arterialization of the deep veins, and knowing that there's a 99% technical success rate and a 70% limb salvage rate at six months, or a 69% limb salvage rate at 12 months is game changing. And from a podiatry standpoint, oftentimes I see this time and time again where someone comes into my office and they have maybe soft tissue necrosis of the toe, but they say, "Hey, Dr. Chapman, I was recommended a below the knee amputation at an outside hospital. I'm just here for a second opinion." And just even knowing that the procedure exists and knowing who I can contact to plug them in to see if they are a candidate for a DVA, I think is key and game changing for my practice, but more so game changing for that patient.

Jennifer Spector, DPM:

Well, to start to wrap up our conversation today, I know there's so much more that we could say about this, but to kind of put the bow on this episode, let's look ahead a little bit. When we do that, where do you see the field of deep vein arterialization going? And are there any upcoming trials or potential techniques or patient populations that you're particularly inspired by?

Brett Chatman, DPM:

Absolutely. So looking at the new trials that are coming out, we're currently enrolled in part of the PROMISE-3 trial, which PROMISE-1, again, was 32 patients, PROMISE two was 105 patients. So PROMISE three will hopefully be a lot more patients enrolled in this trial. And I think in looking at the field of DVA and where is it going, I just think that the knowledge as to how to do a DVA from a operator standpoint, as well as the knowledge from a podiatric standpoint on post-procedure management, and that it's really about that relationship between podiatry and vascular surgery or podiatry and interventional cardiology growing and just becoming more aware and more out there. I think spreading the word about DVA and that knowing that there's another option for the no-option patient is key. I'm really excited to see the results of the PROMISE-3 study when that does come out.

And I think that in terms of where I see the field going, to me, it's just getting the word out there and knowing that there's another option to really help these patients. I think we see time and time again in these specific patient populations where those who have end-stage renal disease or those who you take an x-ray of their foot and you can see their whole arterial system because it's so calcified on the x-ray, we know that from a post-revascularized standpoint, these patients oftentimes don't do well, but those are the patients who are key ... Those patients are a key candidate for a deep venous arterialization procedure. So I'm really excited to see further studies and how the further outcomes come for these patients, specifically those that are, again, end-stage PAD or those who have CLTI, as well as those who have renal disease.

Jennifer Spector, DPM:

Dr. Chapman, thank you so much for sharing all of your insights with us today. And I think we just need to have you back another time in the future so that we can talk more about this.

Brett Chatman, DPM:

I would absolutely love that. And thank you for having me today.

Jennifer Spector, DPM:

Of course. And we also want to thank our audience for joining us today for this episode. You can look under podcasts to find those in case you're finding us through our other podcast platforms, SoundCloud, Spotify, or Apple Podcasts. Be sure to tune into this and any other episodes on any of those platforms, and we hope you'll join us next time.