Evolution and Outcomes of Subglottic Stenosis and the Maddern Procedure Part II
Part II of our discussion on subglottic stenosis with Robert Lorenz, MD centers on the innovative Maddern Procedure. Developed over the past decade, Dr. Lorenz discusses this technique and learnings that have led to improved outcomes.
Evolution and Outcomes of Subglottic Stenosis and the Maddern Procedure Part II
Paul Bryson: Welcome to Head and Neck Innovations, a Cleveland Clinic podcast for medical professionals exploring the latest innovations, discoveries, and surgical advances in otolaryngology head and neck surgery. Thanks for joining us for another episode of Head and Neck Innovations. I'm your host, Paul Bryson, Director of the Cleveland Clinic Voice Center in our Head and Neck Institute. You can follow me on Twitter @PaulCBryson and you can get the latest updates from our institute by following @CleClinicHNI.
I'm joined today by Dr. Robert Lorenz, my colleague in Cleveland Clinic's Head and Neck Institute, to continue our discussion on the history and evolution of subglottic stenosis treatment. If you haven't listened to our previous episode, be sure to give it a listen. Today, we're going to dive further into the Maddern procedure. Let's dive into the Maddern procedure. What are your indications? How has it evolved in your hands? And, what are the lessons learned and future thoughts on the procedure, now that you've got several under your belt?
Robert Lorenz: Yeah, we're over 30. The publication has been conditionally accepted to the Laryngoscope. It was presented at the American Laryngological Association in Dallas in 2022. It's now in the public sphere. I do want to go back to the actual procedure so that those who are not familiar with it just know that we talked about a resection. So, you remove all the scar tissue. Very importantly, you don't do that with a laser. What happens is if you use a laser to do a complete resection, you end up not having vascularized bed of tissue that you resect down to. While the laser may be used in a radial cut to determine the depth of the scar tissue, the actual resection itself is done with a soft tissue shaver. For those of you laryngology surgeons out there thinking about a soft tissue shaver, that's a little bit scary.
There is a learning curve to this, and that's really what my manuscript was about, was about the first 28 patients who underwent the procedure and how you learn to pace the operation, determine the depth of scar tissue, resect safely with the soft tissue in the airway, and then measure the area that needs to be resurfaced with the graft. Then, lastly, this was the important part I was trying to get to is you just can't suture a graft into the subglottis. You have to have it fixed in place with something. So, therefore what we end up using is a T-tube. We of course don't use the whole T-tube, because these patients are not specifically tracheotomized for this. You just cut one of the limbs of the T-tube, usually about 12 millimeters in diameter, usually only about two centimeters long. We do use a Dremel drill to soften the edge, because that's going to be in place for two weeks.
What happens is you wrap the graft around that stent and place the stent with the graft in position. Then, you fix that with a stitch through the entire cricoid. Again, this is Dr. Sandu's technique that I learned. You actually fix that with that suture. I use two just for safety purposes and then wake the patient up and breathing trans-orally for those two weeks. After two weeks, you take the patient back to the operating room, remove that stent, and leave the entire relined mucosa or epithelium of the subglottis. That's scary, right? It's scary to live with a stent in your airway, breathing trans-orally for two weeks. To go back to your question, that's why it's not used as the primary first line therapy. Some people, they read good things about it, or some patients have very good results. They come, and they say, "I want a Maddern procedure."
But, the challenge is you really need to first start with less invasive therapies. They include things like we talked about, which is dilations or steroid injections. Or, we can talk about the Mayo protocol, which uses a little bit more of an aggressive dilation with the CO2 laser resections in those quadrants, followed by triple medication therapy, including an inhaled steroid, an aggressive proton pump inhibitor, an anti-reflux medication, and lastly, Bactrim, once a day Bactrim, probably more for the anti-inflammatory effects than for the anti-microbial effects. That's what we determine we call the Mayo protocol. So, serial steroid injections, dilations, Mayo protocol. Then, patients come and they say, "Doc, unfortunately it's been a dozen. It's been 15. It's been 20 dilations or procedures, and I just am not getting over the hump.This is coming back usually less than every 12 months. I'm not close to my medical professionals, so it's a very scary situation.
We did have several patients who were completely stenosed off, completely stenosed from their disease who underwent Maddern procedure, for example. So, those are really the indications, uncontrolled stenosis after previous regimens of traditional therapy. Then, as I mentioned, we published on the 28 patients. Now, those 28 do include two patients who had what I referred to at the time, I want to make sure I get this out there, the Reacher procedure. Those were the first two patients. I mistakenly thought that you had to approach the subglottis from below, from the tracheal side. I referred to that as the Reacher procedure for retrograde resection of the cricoid epithelium. As it turned out, then I had some learnings from Dr. Sandu where he said, "You know what? You can do this all trans-orally, all through the mouth. You do not have to go from below."
So, it was the first two patients, 26 subsequent patients, all trans-orally. Now, I exclusively do this trans-orally. Now, some patients, you'll actually do some kind of reconstruction. Let's say they have tracheal stenosis or they need a T-tube stent placed in there with a tracheotomy. That's not the Maddern procedure, but for those patients, you're essentially doing the same kind of relining. You're doing it through a laryngofissure, et cetera. Again, not the Maddern procedure, much more invasive disease, but that's the concept here. One of the big learnings of our study and manuscript, Paul, was that I had initially thought that patients with what I'll determine as low disease, that's disease at the bottom of the cricoid, close to the trachea, would be the best candidates. I assumed that they would be able to tolerate the stent in place.
That's why you do a study. You try to figure these things out. As it turned out, the trachea is not a great place to attempt a Maddern procedure. The reason being is the surgeon is going to be quite conservative on the resection once you get out of the cricoid, for good reason, right? Behind the trachealis posteriorly lies the esophagus. With a soft tissue shaver working far away, you do run the risk of going through the trachealis. In general, the patients who did not do well, and that was about a quarter of the patients with the Maddern procedure, didn't end up having long term airway patency. Those were patients who had low disease. Now, the good news is that they did actually respond to a very high resection, usually one or two rings of the trachea and then a primary anastomosis. The surprise here was that patients with quite high disease did tolerate the stent in the graft very well.
So, it's really become my go-to procedure for patients with high subglottic stenosis. Now, I'm not talking about glottic stenosis or inter-retinoid, I'm talking about disease about five to 10 millimeters below the true vocal fold level. I don't have too much my armamentarium for those patients other than a laryngeal split, which is just a huge undertaking. This procedure, as it turned out, works quite well for those patients with high subglottic disease within five to 10 millimeters of the vocal fold. So, it's really my go-to procedure there. For patients with lower disease, I start to think about some kind of tracheal procedure.
Paul Bryson: Now, I appreciate that. I know there can be a fair amount of nuance. Trying to almost customize the approach is important. Are you able to talk a little bit about your graft choices in this, the approach from skin graft to buckle graft?
Robert Lorenz: Yeah, that's another learning. I do believe that I'm actually the only person doing the buckle graft. Now, why is that? So, the way that we had initially described it was to use a split thickness skin graft. Usually, I used it from the thigh, for example. That's indeed the first half of the cohort of patients that I wrote about, was using an epithelial graph from the thigh. The benefit is it's much easier to work with, right? It's relatively thin, usually about 13 one thousandths of an inch thick. It's very firm to work with around the stent and very straightforward. The challenge is that once that lining is vascularized and is alive in the subglottis, it produces keratin. That keratin can drive these patients crazy, because what happens is, as opposed to the keratin on the outside of our body, you take a shower or it sloughs off, that kind of thing.
In the airway, it just collects in the airway. The patients describe almost a peanut butter type of accumulation of the keratin. Now, they can manage that through things like a humidifier, those kind of things. Dr. Sandu's methodology is to then take the patients back after Maddern procedure and use a CO2 laser to literally laser out those keratin producing cells. So, you kind of get a smooth appearance to that part. Now, if you do that in a circumferential 360 degree way, you'll run the risk of actually getting the patients re-stenotic. So, his technique was to do it in two parts, to do it as, let's say a vertical strip of CO2 laser ablation of those keratin producing cells, and then allowing a bridge or a gap where you don't have a circumferential scar, and then taking the patient back maybe a month or six weeks later to then get the intervening keratinocytes, to destroy them.
In that way, you don't create a scar. You get rid of the keratin producing cells, and you get rid of this accumulation of keratin. But, that's four procedures. That's the ablation part of the Maddern, the reconstruction part of the Maddern, a laser procedure, and then another laser procedure. Again, we talked about these patients coming from far away and traveling. We pride ourselves in not saying, "We'll come back next month and we'll do it again." It's challenging for some of these patients. Therefore, the second half of the patient population was being used as the buckle graft. The benefit of the buckle is no keratin producing cells. It can be placed just like a split thickness skin graft can. The downside is that it's much more challenging to work with the buckle. It's kind of like a soft spongy type of material.
Once you place it there under tension, it squishes from out of the stent. But, that being said, after I've worked through that learning process and then trim the graph material after you place the stent, you can then not have excess of grafting material down there. So, that's kind of my go-to procedure now, again avoiding the need for subsequent CO2 laser resection in the future. Now, where are we going with all this? Well, probably somewhere with a different material. Number one, you've got the harvest site in the buckle cavity. I find that patients tolerate this very well.
When I see these patients a year or two later, it's almost as if they did not have a harvest of their almost entire buckle mucosa. It's amazing how well they heal. It's almost as if the inside of the cheek is made for biting your lip and that trauma. I do have patients start to do anti-trismus exercises after about a month. I do have them blow out their cheek to expand the mucosa, but it tolerates it extremely well. But, where we're really probably going is somewhere like a dermal graft, maybe for example, to shave off the superficial layer of skin and then go after the next layer down of dermis, thereby avoiding the keratinocytes, and the same time, using a graft site, harvest site like the thigh, for example. That's probably where we're going.
Then, lastly, possibility of using something like umbilical cord or some kind of pluripotent cell that is able to maybe even take up the respiratory lining of the subglottis. Wouldn't that be great, to create those cilia cells so that patients aren't plagued by mucus collection below the actual area of stenosis? That would be fantastic. A little bit challenging to get that off the ground, right? Because, you'd need to use that knowing that those pluripotential cells may try to heal the subglottis, right? When you heal subglottis, you might heal closed. So, that'll be a step that's going to need some kind of animal model prior to moving forward with, but I think the dermal graph might be the next step.
Paul Bryson: Well, Rob, I really appreciate your time today. I can tell you, I've appreciated working alongside you during my 12 years here. I continue to learn a lot, and I'm grateful for the collaboration, and I'm proud to be a part of the team. As you had mentioned with all the work that you've been doing, we really try to take a patients first attitude. We've tried to be thoughtful about it. We've tried to make the experience good for these patients who are coming with difficult problems, and I look forward to the future with you and continuing to take care of these airway stenosis patients. And, I commend you on your open-mindedness and innovation in this area. It's been great to be a part of and great to learn from you.
Robert Lorenz: Yeah, it's fun, right? Because, we all come at this. You come at it with different training than I do, different experiences. We've got a group that can see these patients. We actually have a conference. Dr. Nelson has started up this conference where we talk about really challenging disease along with interventional pulmonology, thoracic surgery, otolaryngology, speech pathology, et cetera. We all come at this with a different lens. Now that we've got this volume, we can kind of say, "You know what? I think that we might be better managed open, might be managed by interventional pulmonology, et cetera, might be managed better medically, et cetera."
That's really exciting, to have that kind of group of comrades who are talking about the best way to manage patients, and the patients are the beneficiary of it. One last plug I'll put in, this Maddern procedure is new. I've had a number of people come and visit. It does take some finagling and instrumentation to get to know the most efficient way to do it and the safest way to do it. We're always more than welcome to have people come and visit and watch a procedure or two, and so they learn the nuances of it. So, I just welcome anybody to get ahold of us and be happy to have them here in Cleveland, Ohio.
Paul Bryson: For more information on subglottic stenosis treatment at Cleveland Clinic, please visit ClevelandClinic.org/SubglotticStenosis. That's ClevelandClinic.org/SubglotticStenosis, and to speak with a specialist or submit a referral to our Head and Neck Institute, please call 216.444.8500. That's 216.444.8500. Dr. Lorenz, thanks for joining Head and Neck Innovations.
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