Can TADV Help No-Option CLI Patients?

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My name is Dr. Brian Lepow. I'm a practicing podiatrist in Houston, Texas at Hope Vascular and Podiatry. We focus on a comprehensive limb preservation program where we have really podiatry and vascular surgery paired together in the quintessential toe and flow type programming. We have a wound care hyperbaric and then an vascular practice. So this is where we're at today.
 
What is TADV and what are its applications?
 
TADV is another term for deep vein arterialization and basically its indications currently are for the no-option CLTI patient population or critical limb-threatening ischemia patient.
 
There is a subset or population of patients that we deal with really sort of in our communities that have kind of the no option, where they've been told that there's no option for vascular reconstruction and an amputation is the only option that they have. So there's a device that came out by a company called LimFlow and basically what that device does is creates sort of in a nutshell, takes a vein in turns and sort of recreate the arterial system via a sort of fistula that's created in the lower extremity. All done endovascular, which is really cool.
 
What should DPMs know about this procedure?
 
So the TADV is a really interesting and I think sort of career changing type technique and procedure that's being done for that no-option CLTI patient population. From the podiatrist's perspective, there are a lot of nuances when it comes to wound healing and wound management. It's not your typical revascularization and then you go and operate on the foot.
 
This particular patient population has sort of on the front in a bit of a longer of a time towards healing and the reason for that is that circuit that's created in the foot does need time to mature and once that maturation point has hit then we can do surgery on the foot. That maturation period goes anywhere from 4 to 6 weeks. So it's very atraditional to what we're used to. Really telling people not to touch the foot for the initial 4 to 6 weeks. Really, two drivers or indications for early foot surgery include pain and infection. Pain may include the need for sort of a decompression of the forefoot in order to sort of like create somewhat of a fasciotomy.
 
And then the infection come under. Certainly if there's some concern that infection may arise, certainly doing an early procedure is helpful. Any reconstructive work is done typically 4 to 6 weeks after.
 
That's sort of not what we're used to. We're used to a few things. Number one, we're used to using tourniquets in most of our patients, and this is a no-no in this particular population. You can close down the circuit by doing that. And certainly that sort of 4 to 6 week waiting time period is definitely unique in the fact that, again, usually we're used to being, hey, you know, a standard arterial revasc takes place or a bypass and you can operate on the foot, you know, maybe two to three days later. This is a much different type procedure.
 
The other thing to consider and that I think is one thing that we have to do a better job educating the community is that with those patients that undergo these arterializations, most of these wounds are not able to be closed. So it's being comfortable, I tell a lot of people, it's being comfortable with the uncomfortable and that's wort of working outside the parameters of what we’re used to doing and that’s leaving wounds open, meaning open first rays, open digital, open transmets. These are all how these patients heal the fastest. There are a few I think through the PROMISE 1, PROMISE 2 studies, which are the studies driven by LimFlow and now Anari, have brought the commercialization of this to the forefront, but with that again comes these various nuances that I think the podiatry teams need to come to terms with and really again it's stuff that you know you're not going to open a textbook and read about currently and so I think it's hard for us to get a little uncomfortable doing these procedures where you're taking somebody's forefoot off and you're leaving it open but the studies have told us that that's and sort of driven to the idea that that's what works best in this population.
 
What role can TADV play in PAD treatment?
 
Oh, I think it's a, I think it's a career changing opportunity for not only the vascular in IR and the IIC population but also for the podiatric component. I think, you know, more and more podiatrists are seeking limb preservation practices to work in and I think this just is one more way to really provide options to a fairly significant subset of population of patients that before this never really had an option. You know, they faced a major amputation and I think as we continue to uncover that population we're going to realize that that population is much higher than most of us ever thought and so I think what this is going to do is going to provide an option for those patients to keep their leg and ultimately we know the mortality rates are quite high for somebody who's had an amputation. And so if we can reduce that amputation risk for these patients, then we're going to be a lot more successful.
 
And we're going to not only change the lives of our patients, but really sort of with their families. You know, a lot of the patients that see us, I think with limb preservation, it's a really unique environment where, you know, I think people don't want to talk about your grandmother at home with the dead toe or the dead foot. It's just not something that people want to talk about. So we have to bring that to the forefront, talk about it more, but also be able to offer people alternative options.
 
It's no longer good enough to say, well, the doctor told me I don't have an option, so I just have to cut my leg. And I think families are comfortable with that because they've seen a husband, a father, a grandparent, an uncle lose a limb, so they feel that that's sort of just the natural progression of life. But this technology really is game changing.
 
And speaking with my vascular colleagues, they really say that this is something, It's not just another atherectomy device or catheter, this is a completely paradigm shift towards treatment for that no-option CLTI patient.