A Retrospective on Anterolateral Thigh Fascia Lata Rescue Flap for Osteoradionecrosis

Podcast Transcript

Dale Shepard, MD, PhD: Cancer Advances, a Cleveland Clinic podcast for medical professionals, exploring the latest innovative research in clinical advances in the field of oncology. Thank you for joining us for another episode of Cancer Advances. I'm your host, Dr. Dale Shepard, a medical oncologist here at Cleveland Clinic overseeing our Taussig Phase I and Sarcoma programs. Today, I'm happy to be joined by Dr. Michael Fritz, director of the section of Facial, Plastic, and Microvascular surgery at Cleveland Clinic. Dr. Fritz was previously a guest on this podcast to discuss salvage operations for post-treatment complications. He's here today to talk to us about anterolateral thigh fascia lata rescue flap for osteoradionecrosis. So welcome, Michael.

Michael Fritz, MD: Thank you. Happy to be here.

Dale Shepard, MD, PhD: So remind us about your role here at Cleveland Clinic.

Michael Fritz, MD: So I am primarily a clinician, a surgeon here. I'm the head of facial plastics. We have a section of four people, which is part of the broader Head & Neck Institute effort. My main role at the clinic is in complex facial reconstruction, and most of that involves free flaps or microvascular free tissue transfer, where we transplant other parts of the body to fix faces and necks and heads and whatnot. I also do cosmetics once a week just to kind of balance everything out.

Dale Shepard, MD, PhD: All right. So today we're going to talk about this anterolateral thigh fascia lata rescue flap. And this is for a condition, osteoradionecrosis. And we have a fairly broad group that might be listening in. So let's start basic. What is osteoradionecrosis?

Michael Fritz, MD: So osteoradionecrosis, often termed ORN because it's a big word, is basically death of bone related to radiation therapy. The actual mechanism is still debated, but it's essentially the bone gets treated very hard with radiation like the cancer gets treated and it's never the same. And sometimes it can't recover from a minor infection or an injury. And then it sets off this cascade of bone exposure infection and then bone destruction. And that obviously causes big problems. The big kick in the pants for folks is it usually happens when their cancer is cured and they're 10 years out and they just have a, for instance, a bad tooth and they need to get that treated. But that tooth exists in an area of poor healing substrate, and so you can't just pull the tooth. The dentist know to do everything they can not to take it out because if you expose that bone, you open Pandora's box. And that's kind of how often ORN starts.

Dale Shepard, MD, PhD: What are the current treatments? What's the most common way this is treated right now?

Michael Fritz, MD: It varies around the country and when there hasn't been an ideal treatment in the past, then you get a lot of opinions because nothing is definite. The two most popular treatments that exist are hyperbaric oxygen, which usually involves about 30 trips to the dive chamber where you've got pressurized air, high concentration oxygen you're breathing. And the theory behind that is you're increasing the delivery of oxygen and nutrients to the tissue by increasing that amount that's dissolved in your bloodstream, through the atmospheric pressure. It's a good theory, and it does help with some wound healing issues. For sure it has value, but with ORN, the randomized controlled studies, the really good studies, have never shown that it's super effective. But yet around the country, in most places, this remains kind of the first standard of care. So it's 30 days, a lot of time out of people's lives, and often significant copay, at least in the state of Ohio for a lot of our patients.

Dale Shepard, MD, PhD: I suspected you were going to say it didn't work that well when you said it's a good theory.

Michael Fritz, MD: Right. And then the other option is medical management. Pentoxifylline, vitamin E, clodronate, which is a bisphosphonate medication, those have all been looked at. And there is some reported efficacy with those, probably a little bit more convincing than with hyperbaric oxygen. Which interestingly, hyperbaric oxygen is still more popular. But what they've shown in the quality studies is if you have very minor disease, you have about a 50% rate of control. And then the question is, is well, you have control, it heals over, but then what happens five years later down the road? And nobody really knows the answer to that because those studies have never been done. So between those two, you don't really have an awesome solution.

Dale Shepard, MD, PhD: And so interestingly, bisphosphonates can be a therapy in this situation, even though they can cause osteonecrosis.

Michael Fritz, MD: And some of the studies have shown that... Because that doesn't make sense to people who see the damage in bone from bisphosphonate some time. But the theory behind it is there's an imbalance that somehow is created by the effects of radiation therapy. And then that strikes the balance better in terms of osteoclasts and osteoblasts, the cells that are destroying and putting down bone. But when they've looked at those two medical managements together, they've shown that the medical management without the bisphosphonate's better. Again, it's all kind of a little bit nebulous data. There's no perfect study that's been done. So everyone's kind of got their own witches brew that they give folks. But at least from my standpoint, where they come to me with continued problems, none of those seem to be super effective.

Dale Shepard, MD, PhD: So tell me about the surgical options.

Michael Fritz, MD: So not so long ago, this is kind of when I was a resident and early staff, we only had one surgical option. So we told the patients, "Yes, go through the debridement, the cleaning up of the bone, go through hyperbaric oxygen or whatever medical management." And if the problem continues to smolder, which is actually most of the folks that get to us already have gone through that stuff and the problem has continued to smolder, we've kind of given them the talk about having a roof that leaks, but to fix it's a tear off. And so it's a very big operation to fix it. So traditionally what we did was take a segment out of the jaw or the maxilla or whatever bone was the problem, cut it down all the way through to good bone, and then we take a bone from somewhere else in the body, like the fibula most commonly, with the blood supply, and we put it in there.

Now, that works really well, but it's a very big operation. Usually people are in the hospital for about seven to 10 days. They often have a trach. They always have a feeding tube. I mean, a fibula is a good spare part. You do recover very well from taking it out because it's not a weight-bearing bone, but you're talking in the order of six weeks to a few months before you're walking comfortably. So that's a high-cost item. And so basically we told people, "Let's just watch this and when it breaks and when it gets bad enough, then we'll do something about it." That always seemed to be a very imperfect solution in my mind.

And so at the influence of one of our former oral surgeons who was very bright, our first patient, we did this rescue operation on that we're going to talk about. And he was a very good candidate because he was in hyperbaric oxygen and he had retinal detachment in the chamber. And that's an absolute contraindication to going back in the chamber. You can go blind. So he had pretty good looking jaw bone for the inferior two-thirds of his jaw, but the upper part, with two of his big molar teeth in it, was clearly very, very dead. And she said, "Look, I need to pull these teeth. It's going to leave a hole. And the traditional management would be to do this fibula free flap and a resection. But look at all this good bone. Isn't there any way we can put something on this bone to stop the process?"

And she had had some experience with big, way more antiquated flaps that they were doing at other institutions. But we had been getting very good with these tiny little perforator flaps from the thigh. And I was like, "Well, why don't we put a perforator flap on that? Give it a whole new blood supply, cover it up. It won't have any bulk. So the patient certainly won't have any discomfort or swelling from it. And let's see how that goes." And with the patient's permission, we went ahead and did that. And he left post-op day one, less than 23 hours after his operation, which was four hours long. And now he's 14 years out and has never had another problem. Actually, I saw him not too long ago. And he said he never looked back from that operation.

So that was the first one. And it seemed to be very, very compelling. And so here and there, we found candidates for this, and we've done it through the years. But it was very, very slow to take... As you know as well as I do, doctors are probably the slowest people to accept change in innovation. So it was hard to get people in that weren't so far along that their bone was all the way broken through. This operation doesn't fix that. You have to have enough healthy bone so that when you stop the process, it's going to stay stable. It's going to give them jaw stability.

So now we do one or two of these a week. It's become a very popular operation. We've published on it a couple times. And our experiences in the candidates that are good, the candidates that have enough healthy bone, that we can maintain the stability, after we clean up all the bad stuff, 95% of them have not gone on to need that bigger operation with a fibula. And the difference is for our operation, people typically stay one to two days. We let them start drinking right away, keep them on soft food for a while because we don't want to traumatize that reconstruction.

And the other reason why we thought this was a really good idea is the anterolateral thigh flap, which is where we take this tissue from, the upper thigh, the lateral aspect, it's almost free spare parts. People walk the next day. Anybody who's had a skin graft says that this operation hurts way, way less than a simple skin graft. And it doesn't weaken the muscle. It doesn't change anything. It's a non-named vessel. It's the descending branch to the lateral circumflex femoral artery.

And I tell my residents when it's that long of a name, it's not like your radial artery. It's not a critical vessel. It's spare parts. So this is a very effective operation, but it's also so low cost to the patients. Simply if you told them, "You're going to take 30 days out of your life and go in a chamber, even if it was equally as effective, or we can do a four hour operation, you'd go home the next day and then go on with your life," many of them just choose that just out of that, regardless of the fact that one of them's 95% effective and the other one doesn't have statistically significant improvement. We think it's the answer.

Dale Shepard, MD, PhD: Has there been any difficulty getting sort of an awareness of the procedure as terms of getting people to you I guess? It sounds like it'd be an easy sell if somebody's in front of you and you describe it as you just have. But in a situation where surgery was usually kind of a last option and you say, "Well, I'll do something if I absolutely have to," to now saying, "Hey, if you've got a good bone, come in and I'll do this." Has there been difficulty getting people to sort of get... a consideration to get people to you early enough?

Michael Fritz, MD: Yeah, I think there's two roadblocks in this. One we mentioned before that doctors are slow to accept change. So we're still essentially the only facility doing this operation. A couple of the folks I trained around the country are starting to embrace it and believe in it and are performing it, but not on a regular basis. So it's an education issue among oral surgeons, radiation oncologists, reconstructive surgeons, that this is truly a really effective, low morbidity procedure.

The other is, is I think every patient that's been through all of the pain and tribulations of cancer, the operation, chemotherapy, the radiation, I think in their mind, anything they can do that keeps them out of the hospital and keeps them out of surgery is probably a good option before they consider that. It's definitely a barrier to jump over to say, "Okay, I'm going to go ahead and have another operation now," because it's scary for them to go back in again. I think a lot of them are worried that there might be cancer there again, or something like that. So they'd much rather go down the route of anything that doesn't involve being the hospital, medical management or hyperbaric or whatnot.

Dale Shepard, MD, PhD: Are there things that are being done sort of on the front end during the procedures themselves that are minimizing the risk for this developing or different radiation techniques, hyperfractionation, things like that are going to decrease the likelihood that people get this in the first place?

Michael Fritz, MD: I think certainly with our modern radiation techniques, the incidence of osteoradionecrosis has gone down, and the amount of peripheral damage to the tissues around that bone have gone down. But we're still seeing it regularly. It's still a relatively common problem. But the degree and the extent of ORN that we saw say 20 years ago, when I was a resident starting practice, you don't see a jaw that's just destroyed along its entire length. Which again, it actually lends itself more to this operation than in needing replacement, because the damage isn't quite as global. There are still some centers that are quite aggressive, even with oral cavity cancers, where they're doing chemotherapy and radiation as a primary mode of treatment. And so their instance of ORN is up along the lines of 20% still. So that's really high. I'd say in general, ours is probably three to 5%, but that's still a meaningful number.

Dale Shepard, MD, PhD: So you've had successes. What's the next step? Anything in the works to improve the process?

Michael Fritz, MD: There's a lot of questions that still need to be answered. I think really right now is getting the education, the word out. Most of the patients that see me, a lot of them see me from around the country. It's more of a word of mouth based on patient stories that are published on the internet. And they're googling and they're finding, hey, there's an alternative to the big operation or waiting until I have the big operation. So I think gaining more acceptance, and I think that's going to come through more publications, stronger pure data. Because some of the stuff we publish on this, this is applicable to osteoradionecrosis everywhere. It's not just in the mandible.

So some of our data includes skull-based patients, which actually those are even harder to manage because we do those with just endoscopes through the nose. And to reconstruct that area, it used to be getting there was worse than the reconstruction itself because you'd have to go through the neck, through the jaw to get to the back of the skull. Now we can even do that just endoscopically. But we mix those in with our maxillary ones and our mandibular ones. So we are now in the process of writing a pure mandibular study with more robust controls and data.

One of the journals asked me if we had a control for this, and they wanted us to do a randomized controlled study. And I just don't think that's ethical. When you have something that treats someone 95% of the time and something else doesn't have any efficacy, it doesn't seem right to randomize folks to that. So we're not going down that road, but we're going to have a lot more careful and robust data. So I think that will help.

But I think just going around and lecturing on this. I mean, I give talks on this probably two, three times a year at certain national forums. And folks are now really starting to talk about it and it's catching on. Making the patients understand that how low morbidity this is too, is really important. We're not even going into their neck that's radiated. We're actually doing a facelift incision using their superficial temporal vessels, the ones in front of their ear. So they really don't have a visible, external scar.

The amount of surgery done in their mouth is essentially the equivalent of a wisdom tooth extraction or whatever it takes to get the bad bone out. But the key to this operation is we don't lift any of the lining of the bone where the bone is in good shape. So we leave the periosteum on the bone. We only debris down to healthy stuff. And so it's as little as we need to do to get the problem fixed, almost the equivalent of like Mohs surgery, where they're only following what's bad and not taking any more tissue out. Same with us. Because you want to preserve all that good tissue. So getting that education out there and convincing people that yes, it's a surgery, but it's not the same operation that was done in the past is going to be really important.

Dale Shepard, MD, PhD: From an awareness standpoint, a podcast might be a good idea.

Michael Fritz, MD: That's great idea. We should do that. The other question is, and patients ask me this is, can I get dental implants in this bone? And my answer is I have no idea. We just don't know yet. We've put an incredibly healthy blood supply on there. And there's a lot of studies out there that show when you transfer this tissue, it's essentially transferring a vascular pedicle and artery and veins flowing into that area. We've just re-routed tremendous blood supply, like a heart bypass on the jaw. So when we do that, what happens to that bone? Will that bone tolerate us putting implants in like normal bone would? I don't know. And so we're going to have to go down there [inaudible 00:17:56] some folks that are very motivated and see how it goes.

In all the folks that have two legs, we have another option if something goes wrong. We can always do it again. And some of my patients have really said, "Well, it wasn't that bad. I'd rather try and get dental implants then. If you have to salvage it, I accepted a scar on my other thigh that's covered by shorts." So we've got to figure that out. We've also, in patients that are borderline, that don't have the full thickness disease, but I want them to have enough that I'm very confident about stability... So that's at least a centimeter on the tongue side and the cheek side, the lingual and the buccal cortex of the bone on the mandible. If they don't have that height, I'll actually supplement them with a little bit of graft from their hip bone, which is tiny little incision. We put this long-term numbing medicine in. They hardly know that's even been done.

But that's been growing great bone when we put it in there, because we're wrapping this kind of like a burrito with this healthy blood supply. And can that bone accept implants in patients that are motivated to do so? Or is the next step getting scaffolds with our own progenitor bone cells and then wrapping that with this tissue and really building a stable jaw for them? I think the sky's limit on what we can do when we've got thin vascularized tissue that we can transfer, that can separate spit or snot from everything else and keep it clean, give it an amazing blood supply, keep it healthy. And I think this is kind of opening new doors in reconstruction that we have to we have to go down and figure out.

Dale Shepard, MD, PhD: So if people happen to be listening in, and they're thinking about this as a potential option for a patient, you've certainly mentioned the quality of the bone, the amount of bone that might be present as a factor in terms of whether someone would be a good candidate. Are there other things that would make a patient particularly a good or bad candidate for this?

Michael Fritz, MD: Well, I mean, if their disease is recognized early, they're a good candidate for it almost always. It's very rare that someone presents with full thickness destruction of the jaw. It's usually a story that they've been observed for even years and gone through hyperbaric oxygen and IV antibiotics and debridement. And that's when it's too far gone. So the early candidates are the better candidates. And everyone doesn't look like a nail to us. So if you have very minor disease and we don't think it's big enough that it needs this operation, certainly we go down the lines of a simple debridement and medical management and see if we can get someone better, but with a very close eye on them. I think anyone that fails aggressive management or hyperbaric oxygen should strongly consider this.

Because at some point you're going to go beyond the simple operation. You're going to need the big operation. And again, the big operation works, but it's an order of magnitude different. And a lot of excellent centers have reported complications with the fibula operation, the segmental resection, that approach 60% in terms of post-op complications. And a lot of that is related to, to get the exposure of the jaw, you're going through a whole lot of very irradiated, damaged tissue, and it just can't close and heal. We don't go through any of that. And I think that's the key, is we're staying in the mouth and we're tunneling blood vessels in front of the ear.

Dale Shepard, MD, PhD: That's some great work you're doing. I appreciate your insights and look forward to hearing about even more exciting developments. Thanks for being with us.

Michael Fritz, MD: Thank you. It's been a pleasure.

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