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Nasal Cryotherapy for Chronic Rhinitis: ClariFix

Author Julia Casazza covers Nasal Cryotherapy for Chronic Rhinitis: ClariFix on BackTable ENT

Julia Casazza • Sep 9, 2023 • 144 hits

Chronic rhinitis affects approximately one in five Americans. Nasal cryotherapy (posterior nasal nerve cryoablation) with the ClariFix device uses liquid nitrogen to target the nerve responsible for non-allergic chronic rhinitis with excellent efficacy and minimal side effects. Success of nasal cryotherapy for rhinitis depends on correct diagnosis, technique, and post-operative management. Traditional therapies for this condition include medical management of allergic contributors and vidian neurectomy for non-allergic symptoms, the latter of which can result in dry eye and sphenopalatine arterial bleeding.

Dr. Jeffrey Suh, rhinologist and professor of otolaryngology at UCLA, shares his thoughts on patient selection and procedural technique in chronic rhinitis on the BackTable ENT Podcast. We’ve provided the highlight reel in this article, and you can listen to the full podcast episode below.

The BackTable ENT Brief

• Nasal cryotherapy targets the posterior nasal nerve, offering a direct treatment for chronic rhinitis symptoms. In contrast, Vidian neurectomy is a less favorable surgical option due to the resulting disruption of lacrimal gland innervation.

• Nasal cryotherapy using the ClariFix device involves inserting a balloon filled with cold liquid nitrogen into the middle meatus to ablate the posterior nasal nerve in less than a minute per side.

• Atrovent spray is used as a litmus test to identify non-allergic rhinitis, and its positive response can indicate the potential benefits of cryotherapy for rhinitis.

• Cryotherapy can be combined with sinus surgery for patients with chronic sinusitis who also experience chronic rhinitis, leading to improved symptom management.

• “Ice cream headache” is the most common complication of cryotherapy for chronic rhinitis. Pre-medication with gabapentin can reduce the incidence of this complication.

An otolaryngologist prepares to preform ClariFix, nasal cryotherapy.

Table of Contents

(1) Nasal Cryotherapy Procedure Technique & Patient Selection

(2) Sinus Surgery Plus Cryotherapy: A One-Two Punch

(3) Anesthesia & Other Procedural Considerations for Cryotherapy

Nasal Cryotherapy Procedure Technique & Patient Selection

Nasal cryotherapy with the ClariFix device can offer lasting relief from chronic rhinitis. This procedure numbs the posterior nasal nerve, whose action underlies rhinitis symptoms. Traditional procedures like vidian neurectomy may lead to undesirable consequences due to permanent disruption of nerve innervation. In contrast, nasal cryotherapy uses a balloon filled with cold liquid nitrogen to numb the posterior nasal nerve. Cryotherapy is considered beneficial for patients with non-allergic rhinitis and those with mixed rhinitis, providing a quick and simple in-office or in-operating room solution. Patients with allergic rhinitis can also benefit from cryotherapy, though the mechanism by which they do isn’t totally clear. When appropriate, cryotherapy can be added to standard sinus surgeries to enhance outcomes.

[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.

Listen to the Full Podcast

Cryotherapy for Chronic Rhinitis and Nasal Congestion with Dr. Jeff Suh on the BackTable ENT Podcast)
Ep 109 Cryotherapy for Chronic Rhinitis and Nasal Congestion with Dr. Jeff Suh
00:00 / 01:04

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Sinus Surgery Plus Cryotherapy: A One-Two Punch

In patients whose chronic rhinitis can be attributed to both allergic and non-allergic causes, a combination of sinus surgery and nasal cryotherapy can provide greater relief than one option alone. For Dr. Suh, response to ipratroprium bromide nasal sprays constitutes an important barometer of whether cryotherapy might be a good add-on to sinus surgery.

[Gopi Shah MD]
For the patients that do have, let's say, chronic sinusitis, let's say they don't have polyps, or let's say they do, how do you know which patients would also benefit from getting the cryo at the same time as their sinus surgery? It makes sense in terms of access for the septoplasty or nasal obstruction, but how do you know which patients like, "Hey, this one actually needs the cryo too."

[Jeffrey Suh MD]
The majority of my practice are for patients that have chronic sinusitis as a rhinologist. The type of patient that clued me in that there might be some benefit for ClariFix in my patient with chronic sinusitis came really after the fact. Patients with a chronic sinusitis have chronic sinus issues for a number of reasons, whether it's allergies or infection or abnormal anatomy or genetics, or any number of causes.

Once you identify that a patient needs to have sinus surgery, you do your sinus surgery and the standard medical therapy is using topical steroids in irrigation long term in the majority of these patients. What I've found in having been in practice now for over a decade is that I will do the best sinus surgery I could possibly do, put them on the correct medical therapy for what I think is the etiology of their sinus issues, and then they'll still have rhinitis after I do my sinus surgery, and for some people that is really bothersome.

They might be very happy with not having infections or not having polyps or getting their sense of smell and taste back, but they could still be very annoyed by the fact that their nose runs all the time. Then what I was doing in those patients is saying, "What did I miss?" Did I miss something in the initial diagnosis because I was so focused on their sinuses? What I found is that there are some patients that have chronic sinusitis that also have chronic rhinitis that would benefit from having ClariFix done during the same operation.

Now I'm very tuned into my patient's symptoms beforehand and I might try them on Atrovent before their sinus surgery if they have some benefit. I'll just add that on to the sinus surgery, and I feel like they're benefiting from that additional procedure to address the symptoms that might not have been addressed only with sinus surgery.


Anesthesia & Other Procedural Considerations for Cryotherapy

When determining the setting of nasal cryotherapy for chronic rhinitis, consider patient preferences and the anesthesia available. If sinus surgery is already scheduled, cryotherapy can be a quick add-on. When working in the office, Dr. Suh uses a combination of lidocaine and Afrin spray for procedural ease and tetracaine for deeper anesthesia. The most common complication of cryotherapy is “ice cream headache,” which is activation of the trigeminal nerve resulting from cold stimuli. Administering gabapentin before surgery can mitigate this consequence. Dr. Suh recommends follow-up with patients one month post-procedure to assess healing and answer lingering questions.

[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.

Podcast Contributors

Dr. Jeffrey Suh discusses Cryotherapy for Chronic Rhinitis and Nasal Congestion on the BackTable 109 Podcast

Dr. Jeffrey Suh

Dr. Jeffrey Suh is an otolaryngologist with UCLA that specializes in rhinology, sinus, and skull base surgery.

Dr. Gopi Shah discusses Cryotherapy for Chronic Rhinitis and Nasal Congestion on the BackTable 109 Podcast

Dr. Gopi Shah

Dr. Gopi Shah is a practicing ENT at UT Southwestern Medical Center in Dallas, TX.

Cite This Podcast

BackTable, LLC (Producer). (2023, May 9). Ep. 109 – Cryotherapy for Chronic Rhinitis and Nasal Congestion [Audio podcast]. Retrieved from https://www.backtable.com

Disclaimer: The Materials available on BackTable.com are for informational and educational purposes only and are not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The opinions expressed by participants of the BackTable Podcast belong solely to the participants, and do not necessarily reflect the views of BackTable.

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