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BackTable / ENT / Podcast / Transcript #147
Podcast Transcript: Latest Innovations in Rhinitis Treatment: A Comprehensive Guide
with Dr. Omar Ahmed
In this episode, Dr. Gopi Shah and Dr. Ashley Agan invite Dr. Omar Ahmed, rhinologist at Houston Methodist Hospital, to discuss innovative treatments for chronic rhinitis. You can read the full transcript below and listen to this episode here on BackTable.com.
Table of Contents
(1) An Introduction to Chronic Rhinitis
(2) Evaluating Rhinitis: Nasal Endoscopy Techniques & Diagnostic Workup
(3) Managing Chronic Rhinitis: Atrovent vs. RhinAer vs. Neurectomy
(4) In-Office Procedures for Rhinitis: Comparing ClariFix, RhinAer & Neurent
(5) Optimizing Procedures for Allergic vs. Non-Allergic Patients: Advanced RhinAer Use & Patient Counseling
(6) Navigating Challenging Anatomy in Rhinitis Procedures
(7) Post Procedure Care & Potential Complications
(8) Integrating RhinAer With Sinus Surgeries
(9) Anesthesia Protocols for In-Office Procedures
(10) Billing, CPT, & Final Remarks
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[Dr. Gopi Shah]
My name is Gopi Shah. I'm a pediatric ENT. I'm here today with my co-host and life partner. Should I just tell everybody? My life partner, Ashley Agan. How are you doing today, Ash?
[Dr. Ashley Agan]
Hey, good morning, Gopi. I love it when we get to co-host these together. It's always way more fun to be able to get to see you and chat with you.
[Dr. Gopi Shah]
Absolutely.
[Dr. Ashley Agan]
We have a great guest joining us today too. Dr. Omar Ahmed is an otolaryngologist specialized in sinus and skull-based surgery. He practices at Methodist Hospital in Houston, Texas, and he's here today to talk to us about in-office procedures for chronic rhinitis. Welcome to the show, Omar.
[Dr. Omar Ahmed]
Hey, thanks for having me, Gopi, and Ashley. I'm really excited to talk about this topic that I hold true and dear to my heart. It's an area where I've done a lot of research, and I'm very excited to talk about some of the new innovations in this area.
[Dr. Ashley Agan]
Awesome. Can you first just tell us a little bit about yourself and your practice?
[Dr. Omar Ahmed]
Yes. I grew up actually in the Chicagoland area. I grew up in the suburbs of Chicago, lived most of my life there. I did my undergraduate at the University of Illinois in Urbana-Champaign. It's two hours south of Chicago. Then I went to medical school at the University of Chicago where I had two close mentors who were rhinologists, actually. They were my mentors in first-year med school, and I really looked up to them. I found them both very admirable, and I decided to go into ENT. I did my residency training at Baylor College of Medicine in Houston.
I actually couples matched with my wife, who's also a physician, who's a primary care physician, but we couples matched in Houston as we went down, and then I went to Baylor College of Medicine. I did five years of residency there, and then I did a fellowship in rhinology, sinus, and skull-based surgery at Johns Hopkins Hospital. I came back to work with a lot of my mentors at Houston Methodist Hospital, where I get to teach residents, I get to work with a lot of the medical students, actually, and I'm involved in a lot of the innovation. There's actually a Texas A&M engineering medicine program that's new.
I work with a lot of these students to develop new devices and innovations in the field of otolaryngology. It's been great, and I have now been back in Houston for a little over three years.
[Dr. Gopi Shah]
That's really cool.
[Dr. Ashley Agan]
Awesome. What a journey. Today, we're going to talk about chronic rhinitis, specifically in the context of office-based procedures. Can you talk a little bit about how your office-based procedure practice has developed? Did you do much of that in your training, or is that something that you developed when you got out?
[Dr. Omar Ahmed]
I think that's an issue, and I think with a lot of training programs, we're so heavily focused in the operating room. Most of our residency, we are, I'd say, probably three and a half, four days a week in the OR, one day a week in clinic, and very little office-based procedure exposure. I had really very little experience actually coming into being a new attending. What converted me and changed me is that there were so many patients, especially when you're developing a rhinology practice, that really don't want something invasive where you have to go to the operating room. They have also tried tons of different medications.
You're left in this middle ground, this place where you're like you need to offer the patient something that's different and unique. I started getting involved in office-based procedures from the very get-go, from doing things like Clon-1 RF ablation of the turbinates, and then I got involved actually in the randomized clinical trial with Aerin Medical, or RhinAer, and was able to do both placebo and actual treatment groups. I saw what a difference it made in our patients. That helped develop my practice. I also do ClariFix, and I'm actually involved in the new clinical trial for the new RF ablation device with Neurense.
I've been involved in a lot of the research studies regarding these devices. I'm really here to focus on Aerin Medical's RhinAer today, but I do have experience with all the devices. What I've tried to do also is, as I've done these procedures, I have tracked my outcomes, and I've collected all this data. As I was going through it, I tried to figure out ways to continue to improve my outcomes. A lot of my research is focused in this area. Now I'd say I probably do four or five office-based procedures a week. I do about probably five or six FESSs a week in the operating room, or some type of FESS-led skull-based surgery in the operating room. I do have a good balanced practice.
(1) An Introduction to Chronic Rhinitis
[Dr. Ashley Agan]
That's really cool. You talked about your interest with innovation, and a lot of the office-based procedures, that's where our ENT innovation is happening. 10, 15 years ago, I think it was in the operating room. Now, as technology improves and patients value being able to get in and out, how we monetize time or the time that we have, how we want to utilize it, being able to have other options that are as effective and creative is pretty cool as well. Since we're going to talk about chronic rhinitis, and then we can get into some of the in-office procedures, how do chronic rhinitis patients initially present to you? Is your practice a tertiary, quaternary care type, or is it more community, private practice-based?
[Dr. Omar Ahmed]
It is a tertiary, quaternary care-type practice. Even with that, I still get, on average, probably 30 rhinitis patients a week. Part of the reason is a lot of patients have sinus symptoms. Just because they have sinus symptoms doesn't necessarily mean they have sinusitis. Actually, majority of these patients have some form of rhinitis, whether it's allergic, mixed, or non-allergic rhinitis. I actually get a lot of these patients that are referred by PCPs, by allergists, by other ENTs as well. I've developed quite a niche in this area. I also do the surgical treatments for rhinitis, including video neurectomies and posterior nasal neurectomies as well. I get referrals for that.
Again, I see probably 20 to 30 rhinitis patients alone a week, and it's a big portion of my patients. I really get patients both from primary cares, allergists, patients that are self-referred, and other ENTs as well.
[Dr. Ashley Agan]
When you're saying rhinitis, is that specifically the runny nose patient, or are there other symptoms that patients are presenting with? How do you think about that when you're just purely taking the history?
[Dr. Omar Ahmed]
There's one group of patients that have a pure vasomotor rhinitis. Traditionally, that's what we thought these procedures were geared toward. What we realized is that majority of the patients actually have a mixed rhinitis. There's also patients with purely allergic rhinitis. Our research and our understanding of this is changing, and it's dramatically changed over the past 10 years, actually. One of my colleagues and mentors at Johns Hopkins Hospital actually is looking at pollution, environment, temperature, and all these other factors that trigger inflammation.
We know that whatever form of rhinitis a patient has, it's often multifactorial. Our understanding that, "Oh, this is a pure vasomotor, or this is a pure allergic rhinitis patient," I think is changing. I think a majority of patients are actually truly mixed rhinitis. I'm looking at all the different types of rhinitis patients. I think these treatment options actually are beneficial to all these groups of patients.
[Dr. Ashley Agan]
To tease out, for example, your chronic rhinosinusitis from your rhinitis patients, are there surveys or are there specific-- I know there's the SWAT spot 22 and all that, we think, usually for a CRS, but do you use those same surveys for these patients or are there other surveys for the rhinitis patients?
[Dr. Omar Ahmed]
Yes. We have a very sophisticated system to gather patient report outcome measures. We have iPads for all our patients as soon as they walk in. There is a specific question algorithm that they go through to answer your questions. Based on how they answer the questions, they're either given a SWAT 22, TNSS is another very common total nasal symptoms score. There is also some other quality of life measures. We actually have teamed up with a couple of other institutions to collect the same data point. Us, the University of Washington in Seattle, and actually, now I think WashU in St. Louis is also joining, but what we're trying to do is create a big consortium and collaboration between a lot of institutions. We're all collecting the same data points in our patients and every time they visit.
Again, how do you distinguish a rhinitis patient from a sinusitis patient? You can't do it alone from these patient-report outcome measures. You have to evaluate the patient. I think from almost all my patients, I scope them. In some patients, the scope alone is not enough. We actually have an in-office CT scanner, which I think is very beneficial. I'd say about 25%, 30% of patients where you scope them and you don't see any evidence of sinusitis, you pick up on a CT scanner. I think you need some objective evidence. I think it's very easy to miss sinusitis patients. Really, I think either a scope or a scan are needed.
(2) Evaluating Rhinitis: Nasal Endoscopy Techniques & Diagnostic Workup
[Dr. Ashley Agan]
Yes. That brings us to the exam part, the workup for these patients. When you're doing your nasal endoscopy, is there anything in particular that you are doing that would be different than a usual patient that comes in for anything else?
[Dr. Omar Ahmed]
Yes. I actually used to always spray my patients initially with the Lidocaine-Afrin mixture. I see a lot of patients that come in with the primary symptom of post-nasal drip. That's a very difficult symptom to figure out what's the cause. What I've realized is that when you spray them with Lidocaine and Afrin, it doesn't give you the full picture, because a decongestant nose, it causes almost a vasomotor component of rhinitis. We've actually done a study on this right now we've submitted to cause them. We looked at all our patients who have gotten sprayed. Then we looked at 25 patients who got sprayed. Then we scoped them.
Almost, I think, 90% of them had a vasomotor component where there's this streak of drainage that goes along the inferior turbinate and the posterior aspect. It's misleading because you think, "Oh, this patient has obvious drainage coming from their nose," but actually, we're inducing that drainage from sprays. I actually have stopped spraying all my patients to be able to get a sense of what's really happening in the nose. How big are the turbinates really? How big are the septal swell bodies? There's actually another thing called the vestibular swell body, which I'm looking at, which also I'm looking in the anterior aspect of the nose.
I'm really trying to get a sense of what does the natural nose look like. I think it's anything you spray in the nose. I think even if you spray saline, and we haven't done that study yet, but we've always sprayed all our patients with Lidocaine-Afrin. I think it's anything that you spray them with that will cause a component of the drainage.
[Dr. Ashley Agan]
Are you using a rigid scope when you're doing your exam? Is there more patient discomfort if there's not decongested?
[Dr. Omar Ahmed]
Yes, it can be uncomfortable. I think with the pediatric rigid scope, you can really get around a lot of the inflammatory component of the turbinate or the portion of the nose that typically would decongest with the Afrin. You can actually use a pediatric scope. Even if you do press on the turbinate itself, as long as you're not pressing on the bony component, I think patients tolerate it really well. I haven't really had many issues unless there's a severe septal deviation. Yes, I think that the way to go if you really want to assess your patients is without sprays. I think you need to use a pediatric scope.
If you're looking at just the nose, as a rhinologist, I'm just looking at the nose, I'm using a pediatric rigid scope.
[Dr. Ashley Agan]
Do you think that, and it might be because my practice is kids, but just the scope itself is irritating enough to cause a vasomotor rhinitis? It may be because I think of eyes watering and I think of kids and some of them are in tears and that can also cause rhinitis as well. Do you see that as much in adults or is that not as much of an issue?
[Dr. Omar Ahmed]
I don't see as much in adults. The reason is I think you're going pretty quickly. I think it's 10 seconds per side with your scope. I don't think there's enough time to develop that drainage that's as obvious. When we spray our patients, we spray them maybe 15 minutes before I even get in the room with a nurse or MA. I think that's enough time to cause that drainage. I think it's not really an issue with adults.
[Dr. Ashley Agan]
Then with the vestibular swell body, is that swelling on the anterior floor part of the nose where--
[Dr. Omar Ahmed]
Yes. Dr. Nyak out of Stanford actually described this in a nice paper for patients with calcitrant congestion, and he found this vestibular swell body. It's basically just at the very anterior aspect of the nasal vestibule. If you look into-- for example, you're looking at the patient's left nasal cavity, it's on the bottom right-hand side as you're going in when you're looking at the patient. It's a little swell body right in front of the inferior turbinate head on the inferior aspect of that.
[Dr. Ashley Agan]
Then anything else in the office with-- You're doing a rigid nasal endoscopy with a pediatric scope, anything else that you do for exam before we move on?
[Dr. Omar Ahmed]
Yes. When patients complain of post-nasal drip, again, that's a very difficult symptom to assess. We actually just submitted an abstract. We looked at all patients, their primary complaint was post-nasal drip. At the time of the scope, we asked them, "Right now, how much post-nasal drainage do you feel on a Likert scale of 0 to 5? Then we looked at other patients who said they had zero symptoms of post-nasal drip. We scoped both groups and we had them blinded. We recorded it. There's absolutely no difference in the amount of drainage that's actually present.
I think what that made me realize is that there is probably a big reflex component to this like we traditionally thought. For those patients that complain of post-nasal drip, I also get a flexible scope and look at the larynx.
[Dr. Gopi Shah]
I think the post-nasal drainage chief complaint, I agree, can be really challenging. I've seen what you're talking about where you spray them and you see that drainage coming over the soft palate and you're like, "Oh, well, maybe that's it." If they hadn't been reporting that complaint, I also may not have thought about that at all because you can see it in so many normals. It is very interesting that maybe there's a sensory component there that varies patient to patient.
[Dr. Ashley Agan]
Tell us a little bit about your workup. Is allergy testing for any rhinitis patient, are you getting allergy testing if they don't already come in with testing or do you ever repeat it?
[Dr. Omar Ahmed]
Yes. A lot of my patients will have had allergy testing, especially in Houston where the allergen counts have been extremely high compared to other parts of the country. If they have not had allergy testing and they're really complaining of the seasonal component, I will get allergy testing. We actually have a nurse practitioner that does all of our allergy testing and so we do skin testing in our office. I'll refer to him.
Again, I don't think I refer all my patients because I tell my patients, "Hey, the reason to get allergy testing other than to understand what's the cause of your allergen is really to potentially treat it with long-term therapy, which is either an injection that's daily or sublingual immunotherapy that you have to do for years." If patients are like, "Oh no, I'm not doing that," then I don't find it very useful, but I do know other people think differently. Again, it depends on the patient and really what they're trying to achieve, and what they want to do to help with their treatment. If they're like, "I want something done now, I don't want to be on something long-term," then I don't find it to be super useful.
[Dr. Gopi Shah]
With imaging, you mentioned CT scan. I imagine because you are a tertiary referral center, patients are probably coming in with a scan already. When I'm seeing patients like rhinitis patients as the first contact, I don't always feel like they have to have a scan if they're not really reporting any sort of sinusitis symptoms and I don't see sinusitis or inflammation on endoscopy. How do you think of that? Do you feel like a scan is important for a chronic rhinitis patient?
[Dr. Omar Ahmed]
I think again, yes. if you see absolutely no evidence in their main symptom of nasal congestion or drainage, and you've scoped them and you don't see anything, I don't think it's absolutely necessary. For me, I think if I'm going to offer a procedure, it helps me be sure that this is the cause. Especially in the allergic rhinitis patient where it's just very swollen everywhere that part of me is thinking, "Oh, is there a sinusitis component to it?" Again, yes, I don't think it's necessarily economical to basically scan every single patient, especially pure vasomotor. There is absolutely, I don't think, a need for those patients.
[Dr. Ashley Agan]
Going back to the patients that come in super swollen and boggy, on your exam, you will take a look without scoping, but do you ever find yourself like, "Hey, I'm having a hard time seeing everything or it's so boggy that this is a tough exam?" Do you then spray as well? How often do you find yourself in that situation?
[Dr. Omar Ahmed]
I'd say if it's so swollen and I can't get to really look at the posterior aspect of the middle meatus. I'm really looking, is there something coming out of the middle meatus or is it's sphenoethmoidal recess? If I can't see that, then I will go ahead and spray them. I'll spray them and go to see another patient and say, "I'll be back."
(3) Managing Chronic Rhinitis: Atrovent vs. RhinAer vs. Neurectomy
[Dr. Gopi Shah]
For your management, just for the typical rhinitis patient, are you starting with nasal sprays? I feel like Atrovent or Ipertropium sprays-- it's what comes to mind when you think of particularly a vasomotor chronic rhinitis patient.
[Dr. Ashley Agan]
Do you start with nasal steroid sprays and saline, the standard?
[Dr. Gopi Shah]
It depends what type of rhinitis they have. If they have pure vasomotor, then I think Atrovent is the way to go. Drainage is the biggest issue for them, I think Atrovent is the way to go. I'll typically use Atrovent at the higher dose, not only for treatment but for diagnosis. There's actually a great paper with John Craig and P. Batra out of Henry Ford and Rush that they looked at atrophic response and how does that predict success with some of these procedures. They found that an Atrovent response to rhinorrhea specifically helped predict rhinorrhea response or drainage to ClariFix.
I'm sure you can apply that to RhinAer or any of the devices. I think if it's vasomotor or the drainage is the issue, I will spray our ipratropium bromide and I'll go with the 0.06%. The issue is when they complain of post-nasal drip. You can try to use ipratropium bromide as a screening tool. My concern is a lot of patients do not get response. The question is, is it really drainage or is the ipratropium bromide not getting posterior enough to really target the posterior parasympathetic aspects of the nose? It's not as good of a screening tool for that.
We actually looked at our own patients where we did RhinAer for the primary symptom of post-nasal drip. Basically a lot of these are sent by our laryngologist who have said, "We've done everything. They have this post-nasal drip. Just try something." We looked at our outcomes and atrium response was not predictive for the post-nasal drip response to RhinAer. Again, it's used for anterior rhinorrhea, but I don't think it could be used effectively for posterior rhinorrhea.
[Dr. Ashley Agan]
Yes. You're saying that if a patient's primary complaint is post-nasal drainage, that whether or not they respond to Atrovent is not predictive of whether or not they would respond to a posterior nasal nerve ablation.
[Dr. Omar Ahmed]
Especially if they have tight anatomy where the spray is not able to get back to that location. We're doing a study where we're using a different delivery device to see if we can get further back there and see if we can potentially use that to predict post-nasal drip response.
[Dr. Gopi Shah]
Meaning that some of these post-nasal drainage patients may actually benefit from a posterior nasal nerve ablation, even if they didn't respond to Atrovent. Is that what you're saying?
[Dr. Omar Ahmed]
Yes. These are patients where they've been tried on reflux, they've seen GI. Usually, those are patients where they're sent by the laryngologist because they've been tried on some type of reflux gourmet or some type of alginate therapy. They've been tried on PPIs, they've been seeing the GI doctor. They've seen the laryngologist who was like, "I don't know, clearly not--" They don't think it's a sensory phenomenon. Then they've sent those patients to me. At that point, I tell the patients, "Hey, this is an option. I think the success rate-- there's still a good chance for success."
We looked at our patients. There was about 70% of our patients, we had a sample of 70 patients that did report an improvement. I think the primary symptom is post-nasal drip, though some of those patients can still benefit from posterior nasal nerve ablation.
[Dr. Gopi Shah]
What is your Atrovent dosing and how long do you try it for to see if there's a response?
[Dr. Omar Ahmed]
You can do a trial for two weeks, honestly, that's all you need really. I go with the higher doses because I say, "Okay, I could rule out--" It's more of a diagnostic test to rule out, "Okay, are you responding to this at all?" I'll go three times a day. Speaking of post-nasal drip, we just published something looking at all the RhinAer clinical data and looking at post-nasal drip and cough. These are in patients who also had significant rhinitis. Their TNSSs were greater than a six. TNSS is on a scale of zero to 12, anything greater than six is considered moderate to severe.
All those patients were enrolled and we looked at the outcomes and almost, I think, 90% of patients had a significant improvement in chronic cough and post-nasal drip. There is definitely an indication, I think, again, it's tough to tease out when the only symptom is post-nasal drip, but if they're in conjunction with rhinitis, it's shown to help.
[Dr. Gopi Shah]
Prior to these in-office devices to treat the posterior nasal nerve, you had mentioned at the beginning doing surgery, posterior nasal neurectomy. Can you talk a little bit about that before we move on to the office procedures?
[Dr. Omar Ahmed]
I do probably about three or four video neurectomies a year still. I do probably about one or two posterior nasal neurectomies a month. These are patients who have failed. I think in this day and age, you have to try the in-office option first because it's saving time, saving money, saving to the patient, to the hospital system. Since basically if you look at all the data, their responding rate is anywhere from 70% to 95%. Again, leaves anywhere from 5% to 30% of patients that don't get a benefit. Typically I will do these procedures if they have failed other therapies and sometimes even failed two separate treatments.
[Dr. Ashley Agan]
I was going to ask you, do you repeat the in-office procedure before you jump to those?
[Dr. Omar Ahmed]
Definitely. I've had a lot of patients, they've tried ClariFix and it failed. Then I tried RhinAer, had success, and so you don't need to do a procedure. If you've failed everything, then you have to think that we're just not-- at least in my thought process is we're not targeting the posterior nasal nerves. It's much more complicated than we initially thought. We thought all the nerves are right in front of the middle turbine attachment. You hit it there, you're good, but when you look at anatomical data, it's much more intricate. There are branches that come posterior to the middle turbinate right in front of the Eustachian tube opening.
There are branches that go even close to the floor of the nose. There's actually a recent paper that looked at parasympathetic innervation that travel along the anterior ethmoid artery. Again, I think our understanding is going to continue to evolve. I think when we are not successful, we're missing the nerve. A video neurectomy is 100% you're going to get the nerve, but again, almost all my patients have dry eyes.
There are some patients who are so desperate that are just like, "I want something done." Posterior nasal neurectomy is advantageous compared to video neurectomy because it's basically finding all the small parasympathetic branches in the posterior middle meatus, but also further posterior to that, and actually lysing each of the branches. Actually doing a lot of those has helped me understand the anatomy much better because you see all these tiny wispy parasympathetic fibers and you're like, "Oh, I usually--" At least when I first started doing this, I was like, "Oh, I usually don't treat that area with the RhinAer. Maybe I should start treating that area." Our understanding has changed.
(4) In-Office Procedures for Rhinitis: Comparing ClariFix, RhinAer & Neurent
[Dr. Ashley Agan]
Can you give us an overview on the different devices that are out there for the in-office procedures? Then I would like to then get into the more specifics of the RhinAer device.
[Dr. Omar Ahmed]
Yes. Right now there's three devices in the market. The first device that was FDA-approved is ClariFix. I think it was FDA-approved in 2017. It was the first to the market. It uses cryotherapy ablation, so it's almost freezing the posterior nasal nerves. There's great data for it. It's successful. The data rating is anywhere from 65% to I think 90% success rate in terms of responder rate. I think the second one that came out was 2019 that was FDA-approved was the RhinAer. This uses a temperature-controlled radiofrequency ablation of the posterior nasal nerve and it heats it to 60 degrees Celsius.
It's just the right temperature where you're not burning the surrounding tissue and damaging the surrounding tissue. That device, again, great success. A lot of my research has been done using that device. The nice advantage of this device is that it can really target the septal swell bodies, which are very involved in nasal congestion, which we traditionally did not think of. It can be used to treat the vestibular swell body as well. As our understanding of the posterior nasal nerves is changing, there are many more areas that are hard to reach. With this device, you can actually get access to those areas because the tip of the stylus is much narrower and smaller, it's more focused.
You can actually get behind the middle turbinate. You can get in these tight areas, which you couldn't get before. That's the second device. The third device that was just FDA-approved is the Neurent. This uses a radiofrequency ablation, similar to Aerin. What this does is, again, I think a 90-second treatment that basically is a shotgun approach. You basically have these two leaflets and you basically have one leaflet that goes behind the middle turbinate attachment and another leaflet that goes in front of the middle turbinate attachment. The idea is targeting all the posterior nasal nerves.
I've not had as much experience using that. I have performed some and now we're involved in the clinical trial for it. The advantage is it's just like an easy one-time shotgun approach. The disadvantage is you can't treat the septal swell bodies or the turbinates or vestibular swell bodies, which you can with RhinAer. In terms of efficacy, we actually did an indirect comparison paper and we published this in IFAR where we looked at using what's called a butcher coefficient. You can do an indirect comparison if the clinical trials were performed in a very similar manner.
We looked at both ClariFix and RhinAer and we found them to be equally effective. The one thing that at least we've looked at with our own data is the amount of headaches with ClariFix. Actually, one out of two of our patients that we've done ClariFix, we've done about 90 ClariFixes now in our group and one out of two have had a major headache. That lasts at least an hour. It's like an ice cream headache, which you don't get typically with the other devices.
[Dr. Gopi Shah]
I think that's one of the side effects that I think always makes me nervous about using the cryotherapy as well. When you are thinking about who's the best candidate for the procedure, take me through your thought process on that.
[Dr. Omar Ahmed]
I think any patient that has tried medication and it fails, or they just can't tolerate the medication. Sometimes people say with Fluticasone or some Ipertropium, it really burns their nose, they can't do it. Patients who've tried medication that just can't do and they want some type of relief, I think any patient is really a candidate, anyone from 18 and above. I've performed it on patients that were 92 years old and I've performed it on patients who are 25 years old. I have a wide range. Basically, anyone who doesn't necessarily want long-term treatment and wants more of a quick fix.
I think anyone who's interested, I think, is a candidate. Patients who are super anxious and you know it's going to be difficult to do an in-office procedure, those are patients I typically will shy away from or at least say, "Hey, we can do this in the OR in conjunction with another procedure."
(5) Optimizing Procedures for Allergic vs. Non-Allergic Patients: Advanced RhinAer Use & Patient Counseling
[Dr. Ashley Agan]
This includes your allergic rhinitis patients, let's say you have a patient who's maxed out on their Flonase and Azelastine and they're using all the sprays and they're still having symptoms?
[Dr. Omar Ahmed]
Oh yes. I think about 50% of the patients I perform these procedures on are actually allergic or what I call mixed rhinitis because again, there's probably so much more than just allergies. It's pollution, temperature. Those patients as well, I think benefit. I actually have a good relationship with my allergist and even the nurse practitioner in our group as well. They'll say, "Hey, you can either go on immunotherapy or you can try this procedure." I think a lot of patients will actually want to try the procedure. There's outcome data, I think for at least one year for allergic rhinitis.
In terms of mechanism, that's one thing I'm interested in studying, but clearly parasympathetic innervation of the nose and decreasing the parasympathetic innervation of the nose has shown to decrease inflammatory cells, has shown to decrease the number of mucus glands itself, and so clearly there's something happening. I think altering the parasympathetic innervation is really helping these patients. In the '70s and '80s, I think there was a lot of research in parasympathetic innervation, even chronic sinusitis. I think we shied away from that, I think a lot of times because of the big push for bi-pharma, for anti-steroidal medication.
There was a big push away from it. I think the parasympathetic innervation does play a key role in a lot of this.
[Dr. Gopi Shah]
Is it as effective in the allergy patients because you still have that allergy component, or is it about the same between the two groups?
[Dr. Omar Ahmed]
The comparison between the two groups, if you look at the studies show the TNSS score decreases by the same amount. If the trigger is some type of environmental allergen, I do question, in three years, are the symptoms going to be right back to where it is? We just don't have the data. Again, I don't think I've followed my patients long enough to understand that, but at least for one year, probably even two years, there's definitely an improvement. I understand where you're coming from, Gopi. It's like, "Okay, you don't decrease the trigger of the inflammation, then it might just come right back." I understand that.
I think that more research needs to be done, but I do think for one to two years, it is very beneficial. For patients, one to two years is a long time.
[Dr. Gopi Shah]
That's a long time.
[Dr. Ashley Agan]
The other thing, you have patients, and I've personally experienced it, where you do have allergic rhinitis, you're allergic to something, but you have fluctuations throughout the day. I'll have patients say, "Yes, I wake up in the morning and I sneeze, sneeze, sneeze. Then I do a nasal rinse and I go about my day and I'm fine for the rest of the day. There's something about, maybe the parasympathetic tone throughout the day maybe that affects that. Do you ever think about that?
[Dr. Omar Ahmed]
Yes, I agree. Again, there are so many factors, and you're right, I think the tone changes. We know it's regulated hormonally. We know it's regulated. We see that with our rhinitis patients in pregnancy. Clearly, there's a hormonal effect of this. Yes, I think partially regulated by the parasympathetic system.
[Dr. Gopi Shah]
With your counseling patients for their expectations post-procedure, what do you tell them as far as when can they expect to notice improvement? Do you have a different spiel if they're a vasomotor patient versus an allergic rhinitis patient or you have one standard expectation for everybody across the board?
[Dr. Omar Ahmed]
I have different spiels depending on the patient type. I'm always very conservative when I say, "Six weeks, you should expect to see some changes." If you actually look at the data, the responding rate increases with time, which is interesting. You think that at some point it levels off, but even if you look at from three months to one year to two years, somehow the responding rate seems to increase if you look at the clinical trials. I tell my patients, "At least six weeks you should start getting a sense. I would wait before considering another treatment or another treatment option. I would wait at least three to six months before reconsidering any type of procedure."
I usually tell my patients to wait that amount of time. For vasomotor rhinitis patients, I tell them that, "You'll at least have a 30% reduction in symptoms. You probably won't completely get rid of your runny nose. I think part of the issue is there are so many parasympathetics in the nose that I just don't think you can target all of them." They're still going to have some drainage, but again, there's obvious evidence of significant reduction in medication use and also overall symptoms. Again, the number of Kleenexes you use or the number of times you have to spray Atrovent. You have to give them realistic expectation.
[Dr. Gopi Shah]
For your allergic rhinitis?
[Dr. Omar Ahmed]
Allergic rhinitis patients are a little different in a sense. I think majority of the patients are going to get improvement, and I think the reason why is you're also treating the-- For my allergic rhinitis patients, I treat the septal swab bodies, I treat the turbinates and I treat the posterior nasal nerve. Clearly, you're hitting three targets. They're going to get improvement in their congestion. Now the drainage component of it, I think they're still going to 80%, probably get an improvement, but at least the congestion component, almost all of them are going to get improvement.
I have very rarely had a patient say, "That did not help at all." I tell them that, "At six weeks to three months, you're going to see improvement in your symptoms."
[Dr. Gopi Shah]
You can use the same stylus or handpiece for your swell body, your turbinate, and the posterior nasal nerve when you use the RhinAer product.
[Dr. Omar Ahmed]
Yes, you can. They did change. The new stylus for RhinAer has gone actually a little bit skinnier and it's slimmer and easier to access certain regions. Even the tip of the stylus is slimmer. The one thing that you lose with it is some rigidity and stiffness to it. If it's a really medialized inferior turbinate, I will sometimes also use a Goldman Elevator to lateralize the turbinate to help with improving the nasal airflow.
(6) Navigating Challenging Anatomy in Rhinitis Procedures
[Dr. Gopi Shah]
Talk to me a little bit about difficult anatomy. I think of deviated septums, I think of really huge body turbinates. How do you manage some of that anatomy in the clinic, and when are you like, "You now what, we got to go do some other things first before we can get access to where we need to be?"
[Dr. Omar Ahmed]
I think a global deviation that's severe on a septum and that's very challenging to get around, but they're patients-- For those patients, if I see and there's no room to get a scope even into that region, then I will usually try to shy away from an in-office procedure for those patients. There are some patients that have a septal spur. Even if the spur is right at the treatment site, I think for those patients, you can actually do something. I actually have done targeted septoplasty in clinic where I'll actually inject that part of the septum and I'll actually raise little submucosal flaps in those regions.
Then bite off that region and then lay the flaps back on, and then I'll do the procedure. There's also the airway balloon by Clarent, which you can use, which I think is useful. It does cause a deviation to the other side sometimes, but I think you can use that as well.
[Dr. Gopi Shah]
In terms of actual stylet placement, when you're doing the posterior nerve ablation, where exactly and how many-- are you marching down to the floor of the nose posteriorly? Where are you putting everything, and how many of these areas do you ablate?
[Dr. Omar Ahmed]
If you look at our treatment algorithm, it's changed over the years. When I first started doing this, we were doing three, four treatments in the posterior nasal nerve region and basically the middle meatus. We looked at right in front of the middle turbine attachment. We found our success rates were about 60% when we did that. We looked at our data. We actually ended up getting CT scans on a lot of patients. For some of those patients that failed, we did posterior nasal neurectomy, and the video neurectomy. What we found is that some patients had a middle turbinate that was very anterior in relationship to the sphenopalatine foramen.
I know this is complicated, but a lot of the main branches of the posterior nasal nerve were coming out of the sphenopalatine foramen. In some patients, the middle turbinate attachment, the lateral lamella of the middle turbinate is much more anterior. I think in those patients, if you just treat in front of the middle turbinate, you're going to miss a lot of posterior nasal nerves, different branches of the parasympathetics. We actually changed our algorithm and we saw a significant increase in our success rates, our responding rates from 60-something percent to 90%. We actually published that in IFAR as well.
My algorithm is because of this new knowledge, non-overlapping sites, I'll do about four to five treatments. I'll start right in front of the middle turbinate initially and I'll go as high as I can, as superior as I can. Then I'll do at least four to five treatments in that area. Then I march down and I actually go behind the middle turbinate attachment and will do one or two treatments. Then I'll go right in front of the Eustachian tube opening. Right before that towards the Eustachian tube, and there's a lot of parasympathetic nerves in that region, which I will treat, and I'll march my way down just behind the mulberry tip of this of the inferior turbinate and treat that region.
I think that region is really the highest yield area which we traditionally did not think of. Then I'll also do the turbinate, the mulberry because I think the mulberry does play a role in post-nasal drip. We're studying that as well. The turbinate is really large. I'll march along the inferior turbinate as well, all the way to the head of the inferior turbinate. Now if it's pure vasomotor, I don't feel the need to treat the head of the inferior turbinate or even treat the septal swell bodies. I will march along the region. Technically, you're allowed 11 treatments for each side.
I think I actually probably do 13 to 14 treatments. The way I get around it is for some of the treatments along the turbinate, I will actually just stop one-second shy of a lot of time and basically you don't use up a treatment when you do that. Probably 13 to 14 treatments on each side, just to be more comprehensive.
[Dr. Gopi Shah]
That's fascinating. I'm thinking about revisions. If you're doing that comprehensive treatment from the get-go now, do you find that you're doing less revisions because you really treated every possible place where you could have little nerve branches coming from, or if you did a revision, would you just do the same thing?
[Dr. Omar Ahmed]
Yes. I had one patient that, had ClariFix, had RhinAer, failed, and even had a posterior nasal neurectomy. Here I'm like, posterior nasal neurectomy's effectiveness is over 95%. It's really effective, but even in that, the patient failed. The patient was so desperate, I was like, "Okay, my last option is to do a video neurectomy." I did the video neurectomy and the patient has success. Clearly, even if you're as comprehensive as you can be, I think there's just some branches that we don't understand where they're even coming from and we're missing even as comprehensive as you can be.
[Dr. Gopi Shah]
Do we know if any of these nerves re-innervate or regrow? In terms of how long does this procedure last for, we said for the allergy patients, if we can get them a good one to two years, how do these procedures tend to last for and what do we think are the reasons for the return of symptoms?
[Dr. Omar Ahmed]
That's a very good question. We don't have a lot of data in terms of nerve regrowth. Clearly, we're not severing the nerve for these procedures. There's at least two-year data on success. I think there will be three-year data at some point. Clearly, it's beneficial. At least in my mind, I'm thinking we're resetting the nerve for these patients. We're not killing it. We're resetting the nerve. There's no data that's looked at, in live patients two years after what's happened. Ideally, a study where we look at patients that have success three years after and compare the nerve to patients who don't have success, is there a change?
I wanted to do some type of impedance testing, some type of way to test the electrical activity of the nerve. I'm trying to find someone good to collaborate, but we don't have data on it. Clearly, I think we are getting two years. I've had some patients with three years out and four years out that are great success. Clearly, we're resetting something. I don't know the exact mechanism of what's happening. No one does.
(7) Post Procedure Care & Potential Complications
[Dr. Gopi Shah]
More to come on that front. For your patients, after you've done the procedure, what are your post-procedure instructions? What complications are you on the lookout for?
[Dr. Omar Ahmed]
I always tell patients, "You're going to feel really congested like you had a really bad cold for a week. Just expect that you're going to feel miserable," especially if you treat the entire turbinate. It is really swollen. I've actually gotten the chance to see some of my patients two days post-treatment because they were so miserable, especially some of my VIP patients. You look in their nose, and it's pretty impressive how swollen it gets with any of the procedures in the nose. Even if you do a Celon turbinate reduction, it is so crusty and so swollen.
I tell my patient, "Your first week, you're miserable. Do your rinses." I actually tell patients to do their rinses just to help get some of the crusting and mucus out. There's no data on irrigation helps post-op recovery, but it just seems like we do tell all our patients are, "Get started on rinses." I do that. I tell my patients to really not blow their nose hard in that first few two to three weeks. If you look at the complication data from all the clinical trials, really, it's minor bleeding, pain, discomfort, those types of anxiety, things like that.
We have had the opportunity to do over 300 now. I think one of the dreaded complications, which I think can happen with any device that you use, is major epistaxis. I think we are treating the area of the posterior nasal nerve, which is right by the sphenopalatine artery and all its branches. At least in our data, none of our patients had immediate post-op bleeding. It was a small subset of less than 2% of patients, whether it was ClariFix, whether it was Neurent, or whether it was RhinAer, that had a bleed that required some type of surgical intervention.
Again, it's very rare. I've talked to people, though, that have done quite a few of these who have not run into that complication. Again, this is just my data set from doing-- mine and my colleagues from doing over 300 of these, and we did have a bleed rate of less than 2%. It's something to think about. I think the mechanism is probably-- it happens all at three weeks after the procedure. It seems to be, I would assume, probably some type of pseudoaneurysm of the vessels itself, the sphenopalatine branches, that rupture at three weeks. I don't know. Ashley, I know you do these procedures. Have you ever had an epistaxis?
[Dr. Ashley Agan]
No, I haven't. I heard other people talk about potentially having a massive nosebleed. I talk to patients about it and tell them, if something like that were to happen, they need to go to the emergency room, but I haven't experienced it personally.
[Dr. Omar Ahmed]
The thing is, anytime you operate, anytime you do functional endoscopic sinus surgery or any type of procedure in the nose, I think bleeding is a risk. I think as long as patients are aware of that, I have not had a patient turn away this procedure because of bleeding because anything we do can bleed, and even major bleeds, even after functional endoscopic sinus surgery. As long as patients are counseled on it, again, I don't think it'll deter patients away. It's very low risk. It doesn't matter what device you use. Most of the patients do really well. I think this has really changed the way I treat rhinitis patients.
[Dr. Ashley Agan]
Do you have your patients hold their anticoagulation for this procedure? Have them stay on it? What do you like to do?
[Dr. Omar Ahmed]
It depends on what anticoagulation they're on. Because of the bleeding risk, if it's Aspirin 81, I tell them to continue taking it. Anything more than that, I do like them to hold the medication. More so, I'm sure people do this procedure with patients on anticoagulation, and they're fine. For me, I'm just trying to avoid a lot of phone calls. I'm assuming the risk of bleeding increases. I usually have them hold it for a week.
[Dr. Ashley Agan]
Before, and then when do you let them restart it?
[Dr. Omar Ahmed]
Usually about a week.
(8) Integrating RhinAer With Sinus Surgeries
[Dr. Ashley Agan]
Then have you done any of these with other-- combo with a FESS or where you have to maybe do some RhinAer for post-nasal treatment, or you're going to go to or maybe in clinic. You mentioned doing a septoplasty for spurs for access. Do you ever use this for a combination with other sinus procedures?
[Dr. Omar Ahmed]
Yes, that's a good question. For septoplasties and turbinate reductions, a lot of my patients have a rhinitis component. I always give them the option, "Hey, you're going under. Would you want to also do this?" I give them the other option where I say, "Hey, you can see how you do with a septoplasty, turbinate reduction. If your main symptom is just congestion, I'm guessing we can get it better without a procedure." If they have a big drainage component to them, I tell them that it's likely that drainage won't improve significantly with a septoplasty/turbinate reduction.
For those patients, I say, "Hey, you can do a RhinAer in the operating room in tandem with your septoplasty/turbinate reduction." Now FESS is a different story. I never even do a turbinate reduction with FESS. The reason is, if the root cause is inflammation from the sinuses, if you are able to control that inflammation, you can get better and you don't necessarily even need to-- The turbinates actually shrink down. Have you seen a really bad polyp patient that you get them better and the turbinates actually shrink in size? With FESS patients that don't have a vasomotor component, I usually will try FESS first.
If they still have a drainage issue, I would at least offer the treatment after the fact. There is a study going on that's looking at patients with type 1 inflammation, looking at posterior nasal nerve ablation. That's a really interesting concept because type 1 inflammation typically don't have polyps and they have lots of mucoid drainage. Does changing the parasympathetic innervation help those patients? The data's still not out yet. I think it would be very interesting to see.
[Dr. Gopi Shah]
Those are tough patients. They're hard to help get better sometimes, for sure.
(9) Anesthesia Protocols for In-Office Procedures
[Dr. Ashley Agan]
Moving on, I just wanted to-- before we let you go, we would love to hear your anesthesia protocol. I'm just talking about how you get patients comfortable and prepared for the procedure in the office.
[Dr. Omar Ahmed]
It actually works really well on my clinic days to do these procedures. I block off the 30-minute slot. What I do is traditionally, as soon as they walk in, they fill out surveys. They get sprayed with Lidocaine with Afrin. Then I walk into the room right after they've been sprayed. I put two pledgets on each side. I have one pledget that's cut in half, and I actually take that pledget and put it in with a bayonet initially. Then I take a Freer and slide it into the middle meatus. It's 6% tetracaine. It's really hard to actually get it into the middle meatus, but that's the reason that you need to put the pledget in to get a good position. The second pledget goes along the inferior turbinate.
I do it on both sides. Again, really important to put the pledget in that middle meatus region and see it go in. Once I do that, I let them sit for 15 minutes, see my next patient, then walk back and do the procedure. The procedure takes on average less than 10 minutes. In terms of clinic flow, it's just very efficient. Doesn't take up that much time, because while they're getting anesthetized, you are seeing another patient. They're sitting there doing their red cap surveys.
[Dr. Gopi Shah]
That's great. It's just a nasal pledget with Afrin and Lido, and that's it?
[Dr. Omar Ahmed]
No. I spray them first with Afrin and Lido to help decongest their nose, my nurse does that. Then I come in and put pledgets in the nose with 6% tetracaine.
[Dr. Gopi Shah]
You let those sit, but once you remove those, you don't do an injection in that area. It's just all topical.
[Dr. Omar Ahmed]
All topical. I used to. It's interesting. One of the concepts with radiofrequency ablation is it conducts better through liquid. I used to always inject, but I think there's enough edema and fluid in the tissue itself that it doesn't need it. I don't inject. Part of the reason why I don't inject is because sometimes with the injection, the area gets bloody for me. I record my cases, so I like it when it's bloodless.
[Dr. Gopi Shah]
Yes, of course. How long do you leave the pledgets on for?
[Dr. Omar Ahmed]
10 to 15 minutes.
[Dr. Gopi Shah]
Okay. Do you go maybe see a next post-op and then come back in and bounce back and forth?
[Dr. Omar Ahmed]
Yes. Depending on the schedule, if I'm running behind, I'll go see two patients. Anywhere from 10 to 30 minutes is fine.
[Dr. Gopi Shah]
Do you have patients that want to take some sort of benzo, like a Valium or a Triazolam, and do you find that that's necessary?
[Dr. Omar Ahmed]
Very rarely. I'd say maybe three times a year, I'll have some patients that are super anxious that need it, but for the majority of patients, I don't. I just do it, and they're usually fine.
[Dr. Gopi Shah]
One of the advantages of doing it in the office is the ability to just drive yourself in, get it done, and then leave and go on with your day. I usually tell patients if they want to take something, obviously, they have to have a driver and it changes some of that convenience factor, but some people really want it.
(10) Billing, CPT, & Final Remarks
[Dr. Ashley Agan]
Omar, can you tell us a little bit about some of the new billing and CPT? There's approval now? Tell us a little bit about that.
[Dr. Omar Ahmed]
Yes. There's a new code that was approved and it's starting at least with Medicare in January. The new code will allow you-- There's two separate codes, one for radiofrequency ablation of the posterior nasal nerve and ClariFix has their own one where they have cryotherapy ablation. I don't know why they have two separate codes, but they do. It is still economically advantageous. It definitely covers much more than the cost of the device. In January there's a new code with Medicare. I don't know how long it'll take for the other private insurances to approve the new code.
I think it'll be a little bit of an uphill battle in the first six months to a year. The one good thing with especially vasomotor rhinitis is most of your patients are older. A lot of them will have Medicare, so it shouldn't be an issue for those patients. Then the nice thing as well, if you are-- Right now we're using the code 30117, destruction intranasal lesion to bill for these. There are some insurances that have flat-out denied these codes. Basically, I think UHC and a couple of other insurances just did not accept it. For those patients right now, we're offering a cash option.
I think hopefully with the new code, this will all go away. You can also use 30117 in conjunction with the new code if you are treating the septal swell bodies. Again, that gets into an area where I'm just not as familiar with. I usually let our coding billing people do a lot of that. If you have more questions about it, you could always contact your local Aerin rep and they will be very happy to explain to you all the coding and billing. Again, new code, it's going to be great.
[Dr. Ashley Agan]
That's exciting.
[Dr. Gopi Shah]
As we round it out and wrap it up, Omar, any final pearls regarding the device or chronic rhinitis patients?
[Dr. Omar Ahmed]
Yes, I think a lot of people who have traditionally not adopted or adapted to this new technology, I really think it's worth a try. I think as otolaryngologists, this is a huge group of patients that we treat. I think we have to have something that's different than what a primary care physician can get, or an allergist can get, which is sprays. A lot of patients are not looking for spray, they're coming to you for something different because they're tired of trying everything. I think this should be in your algorithm of terms of treatment options.
I really do think if you have not adapted this technology to strongly consider it because times have changed. I think this is going to only get more and more common. I think there's a lot of innovation in this field. My one piece of advice is this is very effective for both non-allergic rhinitis and allergic rhinitis patients and to consider treatment for them.
[Dr. Gopi Shah]
Thank you so much for coming on, Omar. If any of our audience or listeners wanted to reach out to you for questions, are you on any social media?
[Dr. Omar Ahmed]
Yes, I have a Twitter account, Sinus Specialist on Twitter. The Sinus Specialist is my handle. You can tweet me or you can also contact your Aerin rep or a local rep. I'm sure if you have PubMed, you can find my email on there and things like that.
[Dr. Gopi Shah]
Fantastic. Thank you so much for taking the time. This was great.
[Dr. Omar Ahmed]
Yes. Thank you so much for having me, Ashley, and Gopi. I'm also very interested in research in this field. If anyone ever wants to collaborate, I think that's the only way we continue to push this field forward is to look at our own outcomes and think about mechanism, thinking about what's actually happening and how we can continue to treat these patients.
[Dr. Gopi Shah]
Love it. Thank you so much.
Podcast Contributors
Dr. Omar Ahmed
Dr. Omar Ahmed is an Otolaryngologist and ENT Surgeon with Houston Methodist in Texas.
Dr. Ashley Agan
Dr. Ashley Agan is an otolaryngologist in Dallas, TX.
Dr. Gopi Shah
Dr. Gopi Shah is a pediatric otolaryngologist and the co-host of BackTable ENT.
Cite This Podcast
BackTable, LLC (Producer). (2023, December 12). Ep. 147 – Latest Innovations in Rhinitis Treatment: A Comprehensive Guide [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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