Nasal Cryotherapy for Chronic Rhinitis: ClariFix

[Jeffrey Suh MD]
There are some old-school surgical techniques that we all learn in residency and what cryotherapy is, it's typically what I use. I find it to be the most effective and it covers kind of a wide treatment area and we'll kind of discuss this, whereas radio frequency is a newer option that also kind of targets this nerve called the posterior nasal nerve. The earlier branch of this nerve, and I love talking about the anatomy of the sinuses.

The posterior nasal nerve is the end nerve that we focus on for our surgical treatments for rhinitis, and it's kind of the area that the Atrovent spray also works on. The earlier part of this nerve is called the Vidian nerve. When we are residents, we learn about this surgery, which is basically cutting the Vidian nerve, so a Vidian neurectomy. That surgery works because you're basically cutting off the nerve that's responsible for drip inside the nose, but unfortunately, the Vidian nerve also innervates the lacrimal gland. If you disrupt the innervation of the lacrimal gland, then the patients can't cry or they can't tear so they get dry eyes. It's not a very good surgical procedure because of the consequences of the surgery itself. This is a much more direct treatment just for the rhinitis that our patients have.

[Gopi Shah MD]
Yes, and the Vidian neurectomy, it can bleed a lot, the dry eye. There's a lot more to it than just we're going to go in and you have to do a real FESS [laughs]

[Jeffrey Suh MD]
Right.

[Gopi Shah MD]
-to get your exposure at an easy, quick little in and out. In terms of nasal cryotherapy, what happens?

[Jeffrey Suh MD]
This procedure, I think I first heard about it in 2017 and again, I was fascinated by the idea that there's a new treatment option for patients that have rhinitis. The procedure is quite simple. The area of the middle meatus. It's area that all of us when we do sinus surgery, we enter to do our maxillary antrostomies and our ethmoidectomies. Specifically, it's where the middle turbinate attaches to the lateral nasal wall.

There is a structure called the basal lamella where the basal lamella attaches to the lateral wall behind them mucosa a nerve comes out called the posterior nasal nerve. What nasal cryotherapy for rhinitis is, it's in the form that we use it for ClariFix. It's a balloon that you insert inside the middle meatus, and then when you activate the cryogen, it fills the balloon with cold liquid nitrogen essentially that will have the effect on the mucosa and the nerve underneath the mucosa, which is the posterior nasal nerve.

You just repeat it on the left and the right side on these patients that have rhinitis, when the cryogen acts for about 30 seconds before you turn it off and then you pull out the device, it's quite simple, and typically the actual procedure component itself is less than a minute per side.

[Gopi Shah MD]
In terms of patients who benefit, is this going to be a zero difference in outcomes for allergic versus non-allergic rhinitis? Is it better for a certain subgroup of the rhinitis patient? Who's this for?

[Jeffrey Suh MD]
In my experience, I use it in all of my patients that have non-allergic rhinitis that are either candidates for the surgery because of a positive Atrovent response, or in patients that have a mixed rhinitis. They might have allergic rhinitis, which is pretty common, and there's some component that I suspect is a non-allergic rhinitis. I would say the majority of otolaryngologists that I know do it in patients with non-allergic rhinitis and patients with mixed rhinitis, but the literature suggests that patients with allergic rhinitis also have some benefit.

[Jeffrey Suh MD]
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 than 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, is 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 is with the combination of the lidocaine and the Afrin spray that we use for any of our patients to get 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 amyloid attached to the lateral nasal wall. That's the direct anesthetic into the area where the procedure is going to be most effective.

…

[Gopi Shah MD]
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?

[Jeffrey Suh MD]
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.