Podcast Transcript: Cryotherapy for Chronic Rhinitis and Nasal Congestion

[Dr. Jeffrey Suh]
Patients that are great candidates, that are excited about doing it in the office, that don't want to miss any work, that don't want to go through the procedure in the operating room, these are the ones we target for office procedures. If they check off all the boxes where every step of the way you don't see any barriers, then you offer them an in-office date for this procedure.

Typically as surgeons, we have to get authorization for the procedure. We have to submit for the codes to be done in the office, and then we have to get the device to the office and then just make sure that we have enough time for the procedure. Usually, I don't do it the same day that I diagnose them. I'll bring them back. Usually, I have an hour blocked off for this patient.

Now, again, I could be doing other things at the same time, but it takes time for the patient to numb the nose adequately. Every doctor has their own anesthesia protocol, and I'll talk about mine, which is different from most, I think, but I can talk about what I think has been effective for me. The biggest thing about this procedure is that there's two phases that need to be addressed with the anesthesia.

The first part is the part that makes sense. It’s that when you put the probe in the nose and you freeze the nose, if the nose is not adequately anesthetized, they can feel coldness or discomfort during the procedure itself. The standard things we do as ENT doctors, to numb the nose for biopsies or balloon dilation of the sinuses tend to work really well for the actual procedure itself to get rid of the discomfort during the freezing.

What I typically start with is the combination of the lidocaine and the Afrin spray that we use for any of our patients to get a nasal endoscopy. Then I'll give that a little bit of time to work. Then I'll put in some pledgets that are soaked with lidocaine into the middle of the meatus specifically, and part of it will cover the inferior turbinate. We call this the landing zone. Anywhere that the cryogen will be touching, I try to put the anesthetic in, which is usually the lateral nasal wall, the middle turbinate, and really the top of the inferior turbinate where the probe will be touching as well. That's the easy stuff. I think it's 3% lidocaine.

I noticed that other doctors have had some phenomenal benefit with tetracaine applied topically. Some compounding pharmacies can provide tetracaine into a goo, and that provides really deep anesthesia into the tissue, more so than lidocaine. I use the lidocaine and the Afrin spray and then lidocaine on the topical half by three pledgets. Then after that's been numbed up for a while, then I'll use some 1 % with 1 to 100,000 epinephrine, like I would do during sinus surgery or a balloon surgery in the area of the middle meatus.

I'll pretty much inject where the sphenopalatine artery is, right where the basal lamella is attached to the lateral nasal wall. That's the direct anesthetic into the area where the procedure is going to be most effective.

[Dr. Gopi Shah]
What needle length and size do you use for your SPA injection?

[Dr. Jeffrey Suh]
In most situations, I use a 25 gauge regular needle we use for local anesthetic for procedures. Sometimes it's not long enough, so I'll have a spinal needle available if I need to. Typically the standard 25 gauge needle would work but for people that it's a difficult area to reach or it's a little bit deeper, then I use a spinal needle.

[Dr. Gopi Shah]
Do you bend your needle, give it a little 45 bend and then just turn your wrist?

[Dr. Jeffrey Suh]
I do bend the needle. You always have to bend it laterally, and it takes a little bit of practice. It's very similar to the way that I think many of us have been doing in-office balloon procedure anesthesia.

[Dr. Gopi Shah]
You're using your 30-degree scope for all this? Is that your preference or do you feel like you can see things better off where you need to see?

[Dr. Jeffrey Suh]
For me, I think I might have one zero-degree endoscope in the office, but I know you could do it with a zero-degree endoscope. I just like to have the ability to look around corners. I'm just used to doing it with the 30, but I would say most otolaryngologists and most anatomy would be favorable to do this with a zero-degree scope. Really, whatever you have in the office. Once the nose is really decongested with the Afrin, you tend to have a really good view unless the septum is in the way.

[Dr. Gopi Shah]
You're just spraying. You're not doing Afrin pledgets. Oh, no, you are. You're doing the lidocaine 3% with Afrin as your pledget?

[Dr. Jeffrey Suh]
Right. The first spray is part Afrin, part lidocaine, and then the pledgets are lidocaine with some Afrin on the pledgets then the local anesthesia. Again, what I've noticed is that some doctors that do quite a bit of these procedures in the office, they'll skip the local anesthesia injection and just use the tetracaine and they've had some great results. I just can't get compounded medications in my academic practice.

[Dr. Gopi Shah]
Then what are you doing in the second part, or are you doing the cryo between the first and second part?

[Dr. Jeffrey Suh]
After the local injection, I'll give that a good 10, 15 minutes to take effect. Usually, by that time, everything is numb in the nose. The patient can't feel anything and they're complaining about some of the lidocaine dripping down the back of their throat. They're like, "This is really uncomfortable." Then you know they're ready. Then again, you do a final assessment to make sure that the patient is calm, they're excited about doing this. Then you have the time and the environment to make sure that this procedure goes well.

[Dr. Gopi Shah]
I assume they're upright, they're not laying down. You do this up right. Is that your preference?

[Dr. Jeffrey Suh]
Yes, sitting upright or maybe slightly tilted back, but definitely not lying on their back. Mostly upright and again, it almost parallels the way that we would do balloon cystoplasty for a lot of our patients in the office. They're sitting upright, they're comfortable, their nose is really numb at this point. There's some things that I do to prepare for the other post-procedural symptoms.

I break it up into the procedural discomfort and then the post-procedural discomfort. You've alluded to this a few times where usually the topical anesthetics works really well to make it so the procedure itself, which is the freezing, is not uncomfortable at all. Then after the procedure is done, which we'll talk about, there's this delayed effect which can hit about 5 to 10 minutes later, where as the frozen mucosa is thawing, they can develop an ice cream headache like we get when we eat something that's too cold, too quickly.

Sometimes it's pretty uncomfortable. Other times it's really not that bad at all. All of us as surgeons that do this in the office have different ways we try to get that post-procedural ice cream headache to be as low as possible.

[Dr. Gopi Shah]
What do you do for that? Does it last for just a few minutes, or is this something that they're going to feel for a couple of hours? Then how do you manage it?

[Dr. Jeffrey Suh]
What I've researched, actually is it's just that very thing. When I was doing the procedure initially in the office, in about 30 minutes, the ice cream headache would resolve. They would walk out of the clinic. They'd be totally comfortable. They'd be happy. They did it. It wasn't that bad. then you just wait for the benefits to kick in a few weeks after the procedure.

For some people, the ice cream headache can be pretty uncomfortable where their head hurts, their palate can hurt, their upper teeth can hurt, and it can be pretty severe. Some people describe it as a 10 out of 10 in terms of discomfort. Some people say it's a 5 out of 10, and it's not too bad. Then we would do all these different things to make it better, whether it's doing more local anesthesia.

I've noticed that if you gargle hot water, then the heart palate discomfort gets better a little bit more quickly but it's always over in about 30 minutes. It just said, how do we get to that 30 minutes without it being too uncomfortable? I would say back in, I think, 2019, I was discussing this post-procedural ice cream headache with one of my colleagues. Tobey Steele is a rhinologist up at UC Davis. We talked about our patients were having the same discomfort.

Then it sounded very nerve-related pain to me, that it must have been the nerve being affected in the way that we wanted to be effective and it was really the nerve pain that was causing the ice cream headache. Then for some of our patients that have nerve-related pain, we give a medication called Gabapentin. Gabapentin, it's a medication that some diabetic patients use for their nerve pain in their feet, tends to be pretty effective, or certain type of headache conditions. This medication is used on label 4.

We decided to give it a shot to give this medication off-label for the sinuses. What we ended up doing in our protocol is giving the Gabapentin 600 milligrams one hour before the procedure. We looked at patients in two different arms. We looked at a group of patients that didn't get the Gabapentin and a group of patients that did get the Gabapentin. We monitored their pain every five minutes and developed these graphs to figure out where the pain was and wanted to see if there was any statistically different level of pain between the two groups of patients.

We found that, yes, with the Gabapentin, at all time points, the pain was no greater than a 5 out of 10. Whereas, again, in the patients without Gabapentin, it could be quite severe in some situations. It really dropped the peak of the pain. It didn't get rid of the pain completely, just limited the amount of the pain that patients were feeling into a way that was quite bearable and much more tolerable.

Now, for all of my patients that get this procedure in the office, I pre-medicate them with a little bit of the Gabapentin before, and I found that it's made a big difference in the amount of discomfort they have in the 10 to 30 minutes after the procedure's done.

[Dr. Gopi Shah]
Have you noticed any risk factors or patient characteristics where you're like, "This person is probably going to get an ice cream headache or this one's probably going to be fine?" Have you noticed anything like that in your data?

[Dr. Jeffrey Suh]
No. I think location is one factor that if you're really burning using the cryogen in the correct spot and you're really getting the nerve where it's supposed to be coming out of, then they tend to get this procedure. I can't really predict which ones won't get it. I just assume that all patients will have an ice cream headache to some extent. Then for some, it's worse than others. For some people, it's really quite debilitating and other people describe it as being just a little bit more discomfort after the procedure, then it wears off pretty quickly.

For that reason, because all patients I feel get it to some extent, even with the anesthetic protocol that I use, I really rely on the Gabapentin to make it more tolerable.

[Dr. Gopi Shah]
In terms of going into the procedure so the balloon's-- it's the size of a small pledget like a square. It's not that small. It's like the one-half-by-half-square pledget size. When you go in, how do you know you're in the right spot? It's going to cover a large area but the area we want to cover is pretty posterior.

[Dr. Jeffrey Suh]
The benefit of this device versus the radiofrequency ablation device which we also use in our hospital is that the horizontal and the vertical segments of the basal lamella, meaning where the middle turbinate turns in the coronal plane and attaches to the lateral nasal wall is a barrier that will stop the tip of the balloon, which is the top the ClariFix device. When you put the ClariFix device, which the tip is the balloon into the middle meatus so we can see the middle turbinate, we can see the lateral nasal wall, and we slide it in the middle meatus.

When it stops, it means that it's hit the basal lamella. That's the endpoint of where the balloon needs to go. In some ways, the ClariFix requires less visibility or less exposure of the middle meatus than the radiofrequency device, which really requires you to see the exact area that the probe is being touched into. The ClariFix balloon will hit the basal lamella, which is the end posterior portion of the middle meatus.

Then you run the balloon for 30 seconds. If you hit that area in the middle meatus, that's the exact area that it needs to be in. Then the cryogen really spreads everywhere in the middle meatus, which is why I feel that even with a little bit less exposure to the area less access, you know it's going to work.

[Dr. Gopi Shah]
Is there a certain setting or is it one of those where you put the wand in and there are settings for you or do you–

[Dr. Jeffrey Suh]
Yes, it's really just an on-and-off. You put in the middle meatus, you flip the trigger, which is the safety and then you squeeze the trigger, and either your nurse or your assistant will look for that 30-second mark, and then they'll let you know that the 30 seconds are done. You turn off the gas, and then you have to wait for a little bit because just like if you touch your tongue on something that's frozen, it'll be stuck. Typically, you have to let it thaw for about 30 to 45 seconds after the freezing.

In that way, when you take out the ClariFix device, it's not stuck to the mucosa because one of the potential or theoretical risks of this procedure is that it can cause bleeding if you damage the mucosa. You want to wait until a good 30 to 45 seconds after you finish the freezing before you gently wiggle the device to pull it out of the nose so you don't damage mucosa on the way out.

[Dr. Gopi Shah]
That's a good tip. I wouldn't have thought about that. Here I am with the full nosebleed or torn mucosa. We've talked about the radiofrequency as well as the cryo and it sounds like you have access to both technologies. How do you know which one you're going to choose for who or do you have a preference at this point in your practice? At the end of the day as surgeons, there are certain things we just like to use better in terms of whether we're more facile with it, more familiar with it and those are our preferences which play a role.

[Dr. Jeffrey Suh]
The literature suggests that cryoablation and radiofrequency ablation if done in the correct area, they can both have a positive effect in terms of symptom management because the postal nasal nerve is being disrupted in both techniques. There's a lot of different factors that will lead a surgeon to choose one device over the other and luckily we're able to use both.

One of the benefits of ClariFix over the radiofrequency ablation device, which is called RhinAer is if the visibility into the middle meatus is restricted because of anatomical issues, again, the septum being deviated just a narrow nasal cavity, the ClariFix device because there are some tactile feedback when you hit the basal lamella, you know you're in the right spot. You don't exactly have to see that it touches the basal lamella.

You just know that what you're touching is the posterior sense of the middle meatus which is where the cryogen probe needs to be. If there's a little bit less visibility, I will say more patients are candidates in the office with the ClariFix procedure than the radiofrequency option. For the radiofrequency, you really need to see where the footplate of the probe is going to touch the lateral nasal wall in order to have the best effect of the nerve being ablated appropriately.

Then hospitals, they will choose one device over the other. Sometimes cost is a factor. The hospital might say to a surgeon, well, of the two devices, we choose one over the other. As a surgeon, just taking comfort in knowing that both are effective, but the hospital might choose one over the other might lead you to say, I believe in the concept of the procedure to treat chronic rhinitis. I'll use one device over the other just because this is just what's available to me.

[Dr. Gopi Shah]
Those are good points. In terms of post-op, do they have to do saline, Flonase? is there any post-op care for these patients, ointments?

[Dr. Jeffrey Suh]
Typically, there'll be some swelling in the mucosa of the middle meatus after the ClariFix, and it can last for about a week or two. I'll put patients on their nasal sprays. I'll say if you were on Flonase before or Atrovent, you might need to use that spray for a few weeks before we really get a sense if the procedure worked. Sinus irrigation will help too. It will help take away any mucus that might be there because of the procedure causing swelling in the middle meatus. Some people feel a little bit of pressure in their sinuses and the rinses and the sprays will often help but also, they do nothing.

It'll eventually recover in a week or two and they'll feel normal. Then typically I say after a few weeks, we'll really get a sense if the procedure worked. In terms of how often the procedure works, typically it's about 80%. If you choose your patients really well, you have a very good chance of the patient benefiting from the procedure in the symptoms that the procedure is meant to address, whether it's congestion or rhinitis. There was a good paper that was published that demonstrated efficacy in this procedure and typically patients that respond to Atrovent before the procedure have over an 80% chance of the procedure working.

If you're an Atrovent nonresponder before surgery, less than a third responded. That's why I really feel that Atrovent preoperatively is a litmus test to the success of the procedure, that if you benefit from Atrovent, I can almost say to the patient, you'll feel like you're living on Atrovent for a year or two after the procedure is done.

[Dr. Gopi Shah]
For the patients that don't respond to Atrovent, what do you do? Are you ever just like, we have nothing else that we should try to do this because there's still a 30% chance or is that silly? Are there other things that you do?

[Dr. Jeffrey Suh]
Those patients, again, I try to temper the expectation because I'm not quite as excited because as a surgeon, I want it to always work in our patients all the time. When something doesn't have the greatest chance of being effective, I don't want to subject a patient to a procedure that might not work for them. Then I think of it as a last resort. In those situations I'll be please try the nasal steroid spray, try the irrigation, see the allergist. Really focus on any other thing that we could possibly treat before we do this procedure.

If none of those things are effective and we're back to square one where you're totally desperate to get something done, and all other medical therapy options and other diagnoses have been eliminated, then we can give it a shot knowing that we've tried everything else first. Whereas the Atrovent responders, I really do feel that this is a phenomenal treatment option for non-allergic rhinitis in this population that are Atrovent responders, and in some ways, it's almost a first resort if they don't want to use the sprays anymore.

[Dr. Gopi Shah]
In terms of success, is this like we did it once and you're good for 5 to 10 years or is this like, listen, this is on average a two-year thing and that's a good outcome? What defines a good outcome?

[Dr. Jeffrey Suh]
Typically, I would say that if they get a year of symptom benefit is what I used to feel was the gold standard, because again, the nerve is not being cut or damaged. It's just being stunned until it can regenerate over the course of a year or so. We would expect that the nerve function would come back, therefore, the rhinitis would come back after the nerve fully regenerates. Recently, studies have shown that the efficacy does extend out to two years, where patients that benefited from the procedure can have sustained benefit for a while.

I've repeated the procedure in my own experience for patients after a year and they've also been able to benefit from the procedure again after the effects started to wane. I've had patients that I've done it on that have never come back afterwards and have done really well for a few years afterwards. It really depends. I tell them going into it that you might have to do this again. The setting situation would be the same or if they handled it well in the office the first time we would do it back in the office the second time.

[Dr. Gopi Shah]
We talked about during the procedure, we can cause bleeding or if we take out the wand too soon we can cause mucosal injury. Any long-term complications with this?

[Dr. Jeffrey Suh]
I've never seen anything past the ice cream headache. Typically, if you remove the probe slowly, the mucosa won't be traumatized and besides a little bit of edema in that area for the next week or so, it recovers totally normal. It's really just how do we make the procedure as comfortable as possible for the patients in the office if you choose to do it in the office. Again, every doctor has their own anesthesia protocols and I found that the use of Gabapentin has been pretty effective. Once you get them past that 30 minutes and they're in their car in the parking lot driving home, they feel pretty good.

[Dr. Gopi Shah]
Then one last question for you. In terms of if you have to do a revision or are there ever scenarios where you may have used one technology and then for-- are there any other reasons or scenarios where you might try again with a different technology?

[Dr. Jeffrey Suh]
There is. Even with the same technology, one of my colleagues at Mass Eye and Ear, Dr. Ben Bleier has done some really phenomenal anatomic studies at where the posterior nerve exits into the sinuses and into the nasal cavity. There are some anatomic variants where the posterior nerve fibers are actually in the inferior meatus as opposed to the middle meatus. I've had some patients initially that didn't fully respond to the procedure and I took them back for an inferior meatus cryoablation.

That also was effective in this small subset of people where maybe the nerve fibers anatomically aren't where we expect them to be. I went back to try again because these patients were still Atrovent responders. They just didn't respond to the procedure itself. I was looking for other answers. My colleagues that do the radiofrequency ablation as their preferred choice, they might do -- typically when I do RhinAer, it's three different locations of the footplate across the lateral nasal wall where we expect the nerve to be.

You might consider doing more ablations than what's typically done to see if we can cover a bigger area. Again, just because anatomically we want to make sure we get the nerve where it exits into the nasal cavity and it might take different sites to actually achieve the effect that we want.

[Dr. Gopi Shah]
With the cryo technology, would you ever do under the middle meatus and the inferior meatus at the same time at the same plate or do you just need to, hey, I'm going to do-- this is where it's most likely where the posterior nasal nerve is coming out, so we're going to start with that as opposed to cryoing the whole nose?

[Dr. Jeffrey Suh]
Right. The downside that are in doing the inferior meatal cryoablation is that they'll tend to get a lot more palate discomfort during the procedure because you're basically on the pterygoid plate right next to the greater palatine nerve. There might be some spread of the cryogen further lateral. They can have a lot of palate discomfort. In addition to the ice cream headache, then now they're going to have a lot of palate discomfort. I really have to choose those patients very carefully that they're ready to do this in the office.

In the operating room, there's very little downside because the patients are asleep. By the time the surgery is over, all the post-procedural discomfort will have already worn off. In the office, it does take a very specific type of patient that you can do both the inferior meatal procedure on and the middle meatal procedure. Again, most anatomic posterior nasal nerves do come out of the middle meatus. You'd capture the vast majority of people into the middle meatus. I wouldn't say you have to do it in both places in the office. I would say most of the time the procedure is very effective in the middle meatus only as the sole site for the procedure.

[Dr. Gopi Shah]
You're using the same wand balloon on both sides.

[Dr. Jeffrey Suh]
Yes. The limiting step for the wand is really the amount of cryogen. You have two cartridges when you do the procedure and it lasts for about a minute per cartridge. The typical cryoablation that we do is for about 30 seconds. If you do it on one side, you have about 20 to 30 seconds left of that cryogen where if it activated without you potentially trying to or if you ran out a little bit faster, what we typically do is we do one cryogen container on one side, we'll burn the extra gas, we'll just empty it and then we'll put the other cartridge in for the other side. You have one minute of gas per each side, but typically we just use 30 seconds of it.

[Dr. Gopi Shah]
In terms of the cryo, is there any special handling of the cartridges, do you have depth special gloves or anything like that?

[Dr. Jeffrey Suh]
No, it's a separate, it's like a paintball cartridge. It's a little CO2 cartridge that you just drop into the back of the device. The whole packaging is sterile. It's usually done on the field if you're doing it in the operating room but in the clinic, the nurses will just put on some gloves and drop the cartridge in on the backside. Yes, it's really simple. It doesn't require any special handling. It doesn't really require very much training. It's very simple to do.

[Dr. Gopi Shah]
It can go in your regular trash bin?

[Dr. Jeffrey Suh]
Yes.

[Dr. Gopi Shah]
Do you see these patients back in a couple of months or what's your follow-up like?

[Dr. Jeffrey Suh]
Usually, what I say is that if there's any concerns after the procedure, just please let me know. I'll give them kind of an open-ended appointment in a month or so, where they can come back to have me take a look to make sure that they've healed well. I used to do that all the time. Now I really just say, just let me know if there's any issues at all. If you have any discomfort or the procedure didn't work, or if you want me to take a look at your nose or your sinuses, then schedule an appointment at that point.

Otherwise, just shoot me a message. Let me know how it worked. Most people at that point say that, again, by the time they got home, they didn't really have any discomfort and they're really happy with the results.

[Dr. Gopi Shah]
Well, thank you so much, Jeff. As we round out, are there any final pearls that you want to leave our audience with?

[Dr. Jeffrey Suh]
Yes. I would say to the otolaryngologists and the people that would treat this disease process, often, for at least ENTs, it's really an afterthought for a lot of the more exciting surgeries that we do, but this disease is pretty common. If you ask our patients that have nasal complaints, it's a lot more than we initially would have expected. When we start asking about it, you realize just how bothersome this is and how much it can really impact their quality of life. There are some phenomenal new treatment options and ClariFix being one of them.

To really provide patients with an alternative to medical therapy that is really effective, really easy to do, and really something that we can add into our practices, where even though we weren't trained in it during residency, it's not very hard to learn how to do it. Our patients really do benefit from it and I've really enjoyed being able to help patients in a different way than what I was able to do before.

[Dr. Gopi Shah]
If anybody in our audience wanted to learn more about cryo or reach out to you, are you on any social media or is there a way they could get in touch with you?

[Dr. Jeffrey Suh]
Yes, so definitely email is the best way. I provide my email to all my patients and any colleagues that would want to reach out to me. I try to hide on social media. I'm not really on social media, but, yes, if anyone wants to reach out, just shoot me an email. You can call the office at any point. I'm really happy to give my anesthesia protocol or any tips that I've had in the last six years of doing the procedure.

[Dr. Gopi Shah]
Awesome. Well, thank you so much, Jeff. I learned a ton. I think it's a wrap.

[Dr. Jeffrey Suh]
Thank you very much.