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BackTable / ENT / Podcast / Transcript #181
Podcast Transcript: Localized Drug Delivery for CRS
with Dr. Rajiv Pandit
Before bringing a new device into your practice, it’s prudent to understand the science behind, indications for, and insurance coverage of that device. In this episode, Dr. Rajiv Pandit, comprehensive otolaryngologist at Dallas ENT Head & Neck Surgery Center, joins BackTable to discuss his success treating sinusitis with drug-eluting stents. You can read the full transcript below and listen to this episode here on BackTable.com.
Table of Contents
(1) An Introduction to Localized Drug Delivery in Sinus Surgery
(2) Sinus Stents: Choosing the Right Fit for Post-Operative Success
(3) Optimizing Patient Compliance with Nasal Care After Sinus Surgery
(4) Advanced Strategies for Using the PROPEL Contour Stent
(5) SINUVA vs PROPEL
(6) Optimizing Workflow for Sinusitis Management
(7) Sinus Surgery Recovery with Steroid Irrigations
(8) Pre-Op Use of PROPEL: Expanding Options for Challenging Cases
(9) Exploring Off-Label Uses of PROPEL & SINUVA in Challenging Cases
(10) Anesthetic Protocols for In-Office Sinus Procedures
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[Dr. Gopi Shah]
Hello, everybody. Welcome to The Backtable ENT Podcast. My name is Gopi Shah. I'm a pediatric ENT, and I'm across the mic with my partner in crime, Dr. Ashley Agan. How are you today, Ash?
[Dr. Ashley Agan]
Hey, good morning, Gopi. I'm doing wonderful. How are you?
[Dr. Gopi Shah]
I'm doing great. I'm always excited to be here, excited to hang out with you. I'm excited to hang out with our guests, learn a lot.
[Dr. Ashley Agan]
I know. We've got a great lineup today. Dr. Rajiv Pandit is an otolaryngologist practicing at Dallas ENT Head and Neck Surgery Center and Dallas Sinus Institute in Texas, and he's here today to discuss local drug delivery for sinus disease. Welcome to the show, Rajiv.
[Dr. Rajiv Pandit]
Thank you.
[Dr. Ashley Agan]
Before we get into it, can you tell our guests a little bit about yourself for those who don't know you already?
[Dr. Rajiv Pandit]
Sure. I do general otolaryngology, but I specialize in sinus, voice, and head and neck at this point in my practice. I trained in Chicago over 20 years ago at Loyola University with Dr. Jim Stankiewicz and Dr. Jim Chow. We had two great rhinologists, and Dr. Jim Stankiewicz is very well-known in the field. He was our residency director and he was vice chairman. He authored the first paper on complications in sinus surgery, and that was his claim to "Fame." Through him, I learned what not to do from all those complications.
Then when I came down to Dallas, I moved here, like many physicians at the time, wanted some more sunshine and easier place to start a practice with the growth in Texas. My practice naturally included more rhinology just because of the fact that the pollen counts here are through the roof. Eventually, I succumbed to these symptoms, and I ended up having sinus surgery. I had a balloon sinus procedure. I've done localized drug delivery on myself and I had a regular sinus surgery. I've been through the whole thing myself as a patient and as a physician. I've had a unique experience in terms of understanding the pros and cons of various treatments for sinuses.
[Dr. Ashley Agan]
That's awesome. I was just going to say, there's nothing like being a patient to really give you that full-- to be able to really-- I feel like it makes you a better doctor when you've literally walked through those patient's shoes.
[Dr. Rajiv Pandit]
Yes, especially when you wake up in the middle of the night and you have pressure and pain right over your maxillary sinus, and then it just hits you, "Oh, you're having an acute sinus infection," and then apply those principles on yourself. Yes, I know exactly what you mean. [chuckles]
(1) An Introduction to Localized Drug Delivery in Sinus Surgery
[Dr. Gopi Shah]
When we're talking about localized drug delivery for the sinuses, can you just give us a brief overview of exactly what that is? Am I dumbing it down by saying, is this doing a little steroid and some NasoPore? What are we talking about?
[Dr. Rajiv Pandit]
We know that topical delivery of medication is better for the patient because you can get up to actually over 1,000 times the concentration of the drug to the mucosal surface or to the skin than you can from an oral medication. Even eardrops, eye drops, nasal irrigations, mouth rinses, it's the same. There's a huge pro with that because those high concentrations taken early would lead to organ toxicity. The con with localized drug delivery is the fact that you have to get it to that surface area. If you have any blockage, if you have cerumen in the ears, if you have debris or clots or scabbing in the nose, you're not going to get the drug there, and therefore it's completely useless.
What I would describe topicals as localized drug delivery, is it's either all or none. If you use it right, it's very powerful. The other con, besides the fact that you have to have an open pathway there, is patient compliance. It's a lot easier to pop a pill than it is to get a patient to properly apply localized drug delivery. I'll tell you, when I was with Dr. Stankiewicz at Loyola, we would obviously do nasal irrigations, but how do you get nasal irrigations up to the frontal sinus? What he came up with was this great idea of laying the patient flat on the bed and having your head cocked over and then putting these steroid eye drops into the frontal sinus. It worked, but you've got to stay like that in this position for a couple of minutes on either side.
When the patient did, it worked great, but the compliance is the issue with that. Then you move on over to what was in 2011 where I had been in practice about 10 years in dealing with all these complicated sinus issues in Dallas, and I had a vendor who just popped into my office and said to my front desk staff, "I have a product that you can put in the nose after sinus surgery. That's a stent, so you can breathe through it. It releases steroids over the course of a month, and then it dissolves. Would he be interested?" I remember getting that message, and I'm going, "Wait, this is way too good to be true. This is perfect."
This was in August of 2011, and so I was one of the first to try the product after the studies. In fact, it was released at the Academy meeting in September of 2011. I was able to utilize localized drug delivery in the current and the more advanced format that we now had in 2011. I was one of the first, and so I've had over 13 years of experience.
[Dr. Gopi Shah]
Was that PROPEL?
[Dr. Rajiv Pandit]
Yes, that was PROPEL. At that time, it was started by Intersect ENT and was later acquired by Medtronic. PROPEL came out with these absorbable drug-eluted mesh stents that had 370 micrograms of mometasone that dissolved over the course of about 30 days. Then subsequently, they came out with another product called SINUVA, which has over about 1,350 micrograms of mometasone that's released over 90 days. Initially, for a number of years, we had PROPEL product, and then it was a matter of understanding that every sinus isn't identical. We all know that as sinus surgeons. Each sinus cavity has its own space and the way that it opens up.
To get proper apposition, to get the actual-- again, it's all about contact with topicals, to get the right apposition. To get the steroid to actually be released on the right mucosal surface, you would need to have different angles. They came out with different types of PROPELS that all had the same amount of steroids, but would be released over 30 days but in different shapes and sizes.
[Dr. Gopi Shah]
That's like the PROPEL Mini or th-- is that what you're talking about in terms of the different sizes?
[Dr. Rajiv Pandit]
Yes. We came out with the PROPEL Mini. There was the additional PROPEL. There was the PROPEL Mini. Then there is the PROPEL Contour. Those are the three that were developed separate from the SINUVA product.
(2) Sinus Stents: Choosing the Right Fit for Post-Operative Success
[Dr. Gopi Shah]
Is the Mini specifically for the outflow track or the Contour supposed to be going in the ostiomeatal complex? Tell me about the differences between them and how you use each one.
[Dr. Rajiv Pandit]
Sure. Some of what I'm going to say is likely to be off-label, but I'm going to be speaking freely as an otolaryngologist that has been using these products for 13 years. The standard PROPEL was designed to go into the ethmoid cavity. It fits perfectly in the ethmoid cavity. It comes in a straight delivery device. After sinus surgery, after you've opened up the anterior and posterior ethmoid cavities, and that's often an area where you really need to keep that clean for irrigations. It's the pathway often to irrigating to the sphenoid sinus after total ethmoidectomy. The superior ethmoids, polyps there can obstruct the nasofrontal recess.
The standard PROPEL was a fantastic choice post-operatively, especially after polyploid surgery. That would go straight into the standard PROPEL into the ethmoid cavity. The Mini came out for two purposes. For when you're doing anterior ethmoidectomy, so you don't have as much of a distance to cover, for office-based procedures, and then also for the nasofrontal recess when you have one of those long cylindrical nasofrontal recesses, as opposed to the hourglass type where the Contour is actually better designed.
The Contour has more of an hourglass shape to it. It actually has a little bit more tensile strength. It provides great apposition for those openings that are more funnel-shaped in the interior portion of the nasofrontal recess. The Mini, it was used for anterior ethmoidectomy, the nasofrontal recess when you have more of that cylindrical shape, and for in-office procedures. Then the Contour is best put in tight nasofrontal recesses where you need that apposition along the side. Also, I have found it fantastic for those very challenging maxillary sinus disease where you just have a flimsy opening, you're concerned the mucosa will just close back over and you need something to keep that open. The Contour serves a great job there.
I would say in the operating room, I use primarily the standard PROPEL along with the others, but that's where I use that. I rarely use a standard PROPEL in my office for in-office cases, but I do use the Contour probably the most in my in-office cases. Now that's changed because we now are doing more and more in-office as our anesthetic techniques have improved, as products have become more in-office friendly in terms of smaller footprints. For an in-office, it's not just how cool the technology-- how useful it is for the patient, but it's how much space does it take?
As that footprint has come down, we've been able to utilize more and more OR techniques in the office, which therefore means that the OR Propels we now use more in the office.
[Dr. Ashley Agan]
What patients are you using this for? The nasal polyp patients seem to be like the obvious candidates, but beyond that, how do you think of-- in your decision-making of like when you're done with a case and you're deciding whether or not you want to leave a PROPEL?
[Dr. Rajiv Pandit]
That's a great question. Let's look at traditionally what we did. Traditionally after surgery, we would use nasal irrigations. We would put patients on oral steroids, Prednisone primarily, to reduce that post-operative inflammation and give them the chance to stabilize, get back on their regular medications, start immunotherapy, do conservative things like using an ear purifier, saline irrigation, all that kind of stuff. What's really nice is, it's a lot of work after surgery to get patients to learn this entire new regimen that they have to do. Especially when you have younger patients in areas where there's a lot of pollen, like in North Texas, it's just hard to get someone in their 20s or early 30s that's maybe starting a new job, that has a new family to remember to start doing this entire regimen.
Post-operatively PROPELS, continuing to do that for a few months has been extremely helpful in my patients. It's a matter of just compliance and efficacy and convenience. What we do for our patients, as you said, Ashley, the polyploid patients, it's a no-brainer in terms of the benefit that PROPEL has. A number of studies have shown that using PROPELs into the nasofrontal recess, say if you take the average nasofrontal opening is about 7 millimeters, it'll often shrink down to about 5 millimeters or slightly less in about 40% of the patients over the course of 90 to 180 days.
What the post-operative, if you put in-- what I do about 30 days later, I'll put in another PROPEL in the nasofrontal recess. I find that 90 to 180 days later, it's retained the same size. The PROPEL has been proactive in preventing stenosis, especially in the frontal sinus, as we all know, that's our most challenging area. In a way, that's very convenient for the patient. They don't have to worry about it. They don't do irrigations twice a day, they're traveling. You do the surgery in September when we have the highest ragweed in the country here in North Texas, that's when the PROPEL becomes very useful.
I've learned that PROPEL works very good prophylactically in patients that have had surgery, whether or not they've had polyps, and that's been backed up by studies.
[Dr. Gopi Shah]
What about like in the acute setting, acute sinusitis complicated by like an intracranial complication and abscess or a Pott's or something like that. Have you ever used a PROPEL in the frontal in an acute setting for the same reasons that, "Hey, my frontal has a higher chance of scarring if I'm doing surgery on the frontal, and especially while it's acutely inflamed"?
[Dr. Rajiv Pandit]
I have not used it primarily in the acute setting. I would say in those like an orbital decompression or a Pott's situation, I think at that point we're focused on the possible complication that we're dealing with. We're focused on getting as much of the purulence out of there, removing the pressure, culturing the purulence, making sure you're actually covered against the pathogens. In that acute inflammatory setting, I'm a little concerned about how much of that steroid will actually be leaching into the tissues. We know that an acidic environment makes it very difficult to have-- Inflammation is fine in terms of steroid penetration.
An acidic purulent environment is going to make it very difficult for that steroid to effectively work. I think in that case, we have to get rid of the infection. What I'll do is, I will do that PROPEL in the office post-operatively, once we know that we've gotten the purulence out of there. I'm also concerned that PROPEL will-- when the purulence it's coming out, when it'll dry up, it'll coat the PROPEL. I also want to have a clearer view of that area. In that case, you want to delay the use of the PROPEL.
[Dr. Gopi Shah]
Do you leave them in or do you to take them out? My practice is peds, and so I had a lot of pediatric sinus patients. I'm glad you went over the different sizes because I just assumed, and my kids I'd just keep using the Mini because their sinuses are smaller. I knew that at about four to six weeks, that's when it's done delivering the steroid. Sometimes I would see the little mesh, one or two of the legs still there or all of them. A lot of my kids aren't going to tolerate me necessarily pulling it out. Do you always pull it out? Does it depend on the patient? Do you have to pull it out? If I leave it in, is it going to because more scarring?
[Dr. Rajiv Pandit]
Yes, it's a good question. It's very tempting to pull it out, especially when you see a little shard there, it's right there. What I've found is that often if you pull it out after three weeks, it's already pretty dissolved and you're going to see the whole thing there. When you pull it out, the whole thing won't come out. You'll get a little shard and then you'll have another shard and have another shard. I generally tend to leave it in there and I find that they don't even notice it. They may blow out what they will describe as a fishbone, and I've warned them ahead of time that this might happen.
I've rarely had an entire PROPEL come out, and usually that's a technical error where you may have put it in the wrong size into a location, didn't have enough support. That has happened. The patients describe-- their descriptions are often humorous. I find that leaving them in is the best option. I will tell you in terms of-- we often talk about what's the problem? What are the complications that can occur? I have had very few complications, because you're not doing anything permanent. You're putting something that can be removed if it is misplaced when you're concerning it. It's something that dissolves.
The worst thing that can happen most of the time is it may be ineffective for some reason. It's coated in purulence or coated in blood if it's a post-operative case and you haven't achieved hemostasis. I did have one patient in the past 13 years, is very sensitive to migraines. This patient was an attorney who had a very busy workload and had migraines. When I put the PROPEL post-operatively into the nasofrontal recess on one side that was stenosing about 90 days out, the patient developed headaches that were either a triggered a migraine or triggered a regular headache that led to a migraine.
I actually removed the PROPEL about two weeks later and the migraines stopped. Now, was it the patient's workload? Was it psychosomatic? Was it a placebo effect? I don't know, but that was the worst case scenario that I've had with a PROPEL where I could say maybe the PROPEL triggered that migraine. I have not seen any major issues with leaving the PROPEL in until it dissolves.
[Dr. Ashley Agan]
Other than like an acute active infection, like we talked about, any other contraindications, any other patients you would say that you're taking for sinus surgery where you would say, "Oh, I would definitely not recommend it for that"?
[Dr. Rajiv Pandit]
Yes. I think if you have a patient with glaucoma, you always have to confer with the ophthalmologist as far as localized steroid delivery near the eyes. I think that would probably be the only direct contraindication that I can see from a practical perspective. We discussed earlier that an acute purulent state is a relative contraindication. Anyone that might have any any sort of immunocompromised situation where you're concerned, although I really haven't seen topical steroids impact a person's immunocompromised status, but no, if you have someone that's severely immunocompromised, you might need to think about that.
(3) Optimizing Patient Compliance with Nasal Care After Sinus Surgery
[Dr. Ashley Agan]
Because you're using the scent for the local drug delivery. For your patients, what do you tell them for post-op care now? As far as like irrigations and nasal steroids and things, because we're assuming we've got you covered on the steroid because we've put the PROPEL in, so you should be good on that front. Do you still have them doing their rinses or other things?
[Dr. Rajiv Pandit]
That's a good question. I do. The reason I do it it all has to do with compliance. When you tell most patients to do post-op nasal rinses twice a day, you're lucky if you're going to get them to do it once a day, for the most part. I haven't found-- especially with Mometasone, which has. as a very low systemic absorption, I haven't found any issues with having a PROPEL place the nasalfrontal recess when the ethmoid cavity and having the patient continue to irrigate with a steroid rinse twice a day. Most patients don't do it twice a day, and we're not as aggressive about warning them to do it twice a day if they have a propylene.
It's more about what I would call an insurance and it helps give you better success, and it gives them a chance to actually develop those good habits. Think about it, after surgery, you're trying to get your life back in order, dealing with work, dealing with the insurance claims, dealing with this new regimen, maybe dealing with your family, and practically you may forget to do it in the morning before work. It takes them a while. Again, I'm also speaking as a patient. There's a reason I had a balloon sinus procedure and then I had to have sinus surgery.
It's because I wasn't as compliant with my regimen after the balloon procedure because I was feeling so good. I did my nasal steroid spray when I remembered. I was recommended to do allergy immunotherapy and I have that service line in my office. Very easy and I didn't do it. Then next thing you know about a year and a half later, I needed sinus surgery because I developed small polyps in the nasofrontal recess. Then I took it more seriously and I said, "Well, I can just get a shot here in my own office." Ever since I did that, it's been good. I needed two surgeries to, even myself, understand the importance of compliance.
Now, I knew it. Intellectually I know it, academically I know it, as specialists I know it. In terms of behaviors, we have to remember that we often prescribe things to our patients that require change in behavior. I will say things like, "Why don't you put your nasal spray by your toothbrush? Brush your teeth, use your nasal spray." I'll even tell them to put their antihistamines by their toothbrush because I've noticed that taking antihistamines on an empty stomach, most people tolerate that absolutely fine. Especially when I tell teenagers, people in their 20s, things like that, they actually like that. Because like, "Oh, then I don't have to think about it, I just line it up."
We have to remember that compliance is probably our biggest nemesis for chronic sinusitis patients, especially in a region where you're dealing with chronic or constant inflammation like North Texas with the pollen count year round.
(4) Advanced Strategies for Using the PROPEL Contour Stent
[Dr. Gopi Shah]
In terms of the PROPEL stent, I had just two questions. One was for the Contour one. You had mentioned that there's increased tensile strength. When you put that in, does that help you keep that middle turbinate medialized? You had mentioned putting it either the nasofrontal recess or-- I was just wondering, given that tensile strength, does that help you also medialize the middle turbinate at all?
[Dr. Rajiv Pandit]
You're making me share a little pearl, a little trick that I think is wonderful that I learned from actually going to other in-office sinus surgeons and watching them do procedures. I didn't create this. I learned it and implemented it. One of our biggest issues with the ostiomeatal complex is exactly that, it's the lateralization of the middle turbinate. The PROPEL, as you mentioned, the Contour has great tensile strength. That's a great thought. How can we get one to benefit? What I've learned is that the nasofrontal recess, when you have the hourglass opening, the Contour, putting it inside the entire recess and having the apposition go like this inferiorly works great.
However, in the office setting, you often are dealing with patients that don't have as severe disease in the nasofrontal recess, or it doesn't extend all the way into the frontal sinus. It's mostly maybe in the inferior portion of the recess, this peri-ethmoid cavity. What I have learned is that I can actually do three things with one Contour, especially in the in-office setting. In the in-office setting, what I will do is I will put the PROPEL partially into the nasofrontal recess, and I will slant it so that the bottom part is pushing against the middle turbinate. Now we'll put the whole thing behind the uncinate after doing the maxillary sinus dilation.
That way, I am actually keeping the nasofrontal recess open. I'm making sure the uncinate stays medialized, and I'm making sure the turbinate stays medialized. Now, how do I maintain that space, especially since the PROPEL is only there for 30 days and that the middle turbinate may then lateralize again? This is a trick I learned from another surgeon, is that I take the caudal elevator and I make an incision where the middle turbinate comes around. Just where the basal lamella is, just above that, where the middle turbinate comes around and joins the ethmoid bulla. I'll use a caudal to make an incision there.
It's like making a crack to keep that door hinge open, and then that'll get the middle turbinate to medialize, so then when you put the Contour in there, it allows that incision to heal without contracting, and leaves the middle turbinate medialized. I have found this-- I'll do a pre-op photo and then I'll do a post-op photo, and I will show the patients, "Look at what we've done with your middle turbinate. That's why you're breathing better, because you have this entire ostiomeatal complex that's now open. That's where I'm taking full advantage of the tensile strength of the contour.
[Dr. Gopi Shah]
That's neat. It's like releasing incision almost back there.
[Dr. Rajiv Pandit]
Exactly. Exactly.
[Dr. Gopi Shah]
Then, sorry, one other question about the actual stent. You have to remind me, is the delivery of the steroid just at the tips, or is it along the tines as well of the mesh, or is it just at the points of the mesh?
[Dr. Rajiv Pandit]
It's along the entire mesh. That is very useful in-- inflammation is going to be along the entire pathway. It's been very-- I wasn't sure if it was going to be concentrated in the tips, but I have found that it is actually, just in terms of the mucosal surfaces afterwards, they're pretty even afterwards. I can tell you practically, it does look like the steroid is leaching into the mucosal surfaces evenly across the entire PROPEL.
(5) SINUVA vs PROPEL
[Dr. Ashley Agan]
For the PROPELs, they're kind of circular and they expand, but the SINUVA shape differently. Can you talk about that a little bit?
[Dr. Rajiv Pandit]
Yes, so the SINUVA is an interesting product in that it is designed to be 90 days. It looks like a squid. It has a very different shape. There's actually a little plastic button in the center part from where the shards come out. That's what you use to put it in, but that's also the one thing that you do want to remove afterwards. After 90 days, I will go in there, and usually that'll come out with a suction, if not like a Takahashi forcep. Now we'll pull that out.
The SINUVA is much bigger. The SINUVA is-- I do the PROPEL in the post-operative setting just with a topical spray. I'll put a topical spray in. I'm usually able to insert it into the ethmoid cavity or into the ostiomeatal unit. If I have to go up in the nasofrontal recess and it's very tight, then I will put a cotton pledget. It's soaked in lidocaine and oxymetazoline, nasal decongestant, into the middle meatus up by the frontal recess in order to put the Contour up there. This is in a patient that has had an in-office procedure, so the oxidant is still there. Now in a post-op patient in the OR, I just spray them and I'm now able to put it in. I don't usually have to put it in.
The reason I'm mentioning it is because with the SINUVA, you definitely have to put in cotton pledgets. I also actually inject the middle turbinate into your wall, since you have to usually really medialize that just to get the SINUVA in. It's definitely wider. When I first did that-- I'd done many PROPELs when the SINUVA came on, I was thinking, "No big deal," I just spray them up and stick it in. When I put it in, I couldn't get into the nasal cavity. It's wide enough. Then I realized I had to put the cotton pledgets in and then I injected the middle turbinate. There's a little bit more involved.
The wonderful thing about the SINUVA is that it lasts for 90 days. It's a great option for patients that have polyploid disease, that have had recurrent sinus surgery, that likely would need oral steroid regimens afterwards. Prior to SINUVA, there are patients that I would have to, every three to six months, put them on another course of oral steroids. What's nice with the SINUVA is you can avoid that in those patients. Even polyploid patients with people with recurrent polyps, recurrent sinus surgery, I find that they are-- if you can get that-- they obviously have a longer course of post-operative inflammation.
If you can quell that over the first 90 to 120 days, they often can then get on a regimen where they may not need another sinus surgery. I have broken that cycle of revision sinus surgery, usually by doing a PROPEL for 30 days, maybe one more PROPEL and then a SINUVA. Now I have five months pretty much covered. By then, we've been able to get their allergies under control. We've been able to make sure they've incorporated all of their medications. Now we have both steroid and antihistamine nasal sprays. We are able to get-- I would say we've been very successful in my practice in getting people that have had, say, two or more sinus surgeries over the course of-- now looking back over a course of-- we followed patients for five to seven years, more than 50% reduction in people that have had sinus surgery.
Like every five years, 50% of them no longer needed surgery in five years. This is not an actual study. I did not submit this, but this is just something I've done in my practice. I consider myself the Henry Ford of ENT. I'm the one that takes other people's great ideas that have been researched upon and try to find a way to have it available to as many people as possible. That's just based on my own patient population.
(6) Optimizing Workflow for Sinusitis Management
[Dr. Ashley Agan]
I think that's huge. I think it's a good segue into just talking about what your workflow is like in clinic so that you can help determine patients-- identify patients who would have coverage and who would benefit and how that works in your office.
[Dr. Rajiv Pandit]
Yes, that's a great question. I went to private practice when I came down here, I was all excited. We all are when we come out and you'll learn all these things in your residency and you learn these things at conferences and you come out and you try to implement it. I feel like you get roadblocks. You get roadblocks because your staff doesn't understand what you're doing, what you want to do. You're trying to figure out how to get the supply in, how do you order these new products you've learned about. Then even when you figure out how to order it and you get your supply manager to approve it, then you're trying to figure out how to get it reimbursed because your billers aren't thrilled about this new CPT code they have to have, or they're getting reimbursed properly for it.
Even if there's reimbursement, no one got a preauthorization for it. Then you just give up. Then you just give up and you go back your old way. After doing this for numerous conferences, AAO conferences and ARS conferences and Trilogic Society and all that, I hired a PA. When I hired-- I was, I believe, the first person to hire a PA in around 2006 in ENT in North Texas. The reason that I hired a PA was I realized I needed someone that understood clinically what I wanted to do and how I wanted to improve patient care, but that could be my liaison in the office and with patients in getting me to incorporate these new service lines.
With regard to the PROPEL, what I found out was that it's expensive. It's not covered by a reinsurance plan. When it is covered, the amount that the patient pays can be anything from $40 copay to $1,400 for a PROPEL. I found that you can either do very well for your patients and everyone can be happy, or you can end up costing the patient in your practice a lot of money. There's no reason for that. What we did was we decided that we are going to-- for every sinus patient that comes to the office, a potential patient that may need some sinus treatment, we automatically figure out the benefit eligibility for that code as 1091.
That's the other thing about being a specialist in this day and age is you have to know your CPT codes. You have to know your CPT codes, you have to have it memorized. You have to know what the benefit for the S1091 is. You'll either find out it's not covered or it is covered. If it is covered, you'll find out if it needs a pre-authorization and you'll also find out what the out-of-pocket is for the patient. We determine that right off the bat. Every single patient that comes in here, I know before I walk in, what their eligibility for that PROPEL is.
Now, once I know that, that doesn't mean that I'm going to necessarily need it, but I have that option. Now that I've looked at that and I've actually had that discussion with myself and my team and my PAs, then we can separate the financial side with the actual best clinical decision-making process. What's nice now though, is if a patient is eligible, I can naturally incorporate that into the conversation. The last thing I would want to do is incorporate that into a conversation with the patient that has no coverage for it.
I have found that one of the reasons that physicians often don't incorporate new service lines, especially PROPEL, is because it is expensive. They don't want to get stuck with the cost. They don't want the patient to get stuck with the cost. If they don't know, they're not going to want to offer it. Then it's out of your decision-making process. The other thing we've done is that, ones that need a pre-authorization, I have those immediately available. I can click on my computer. I can see the pre-authorization requirements. They may have needed to try oral prednisone. They may have needed to be on steroid irrigation.
I have all that and I can incorporate that into my medical treatment plan and maybe offer it to them on the next.
[Dr. Gopi Shah]
When a new patient makes an appointment and they're coming in for nasal obstruction, chronic sinusitis, any of those types of diagnoses, your front staff knows to, "Hey, let me see. This is one of Dr. Pandit's options. Let me see what his options are or what the patient's getting coverage for, what he might have to try first and pre-op," and that might be flagged for you or a note that says, "Hey, would get coverage, definitely not get coverage or, hey, we got to try some-- you may have to try other things first or send a letter." Is that done upfront?
[Dr. Rajiv Pandit]
Exactly. We have our office, obviously E&M codes. We have our endoscopy codes, like 31231 for nasal endoscopy. We have an in-office CT scanner, so 70486. Then we have our PROPEL, S1091. I know those codes because I see those in every single patient coming in and we get the benefits for that right upfront. That way we have all options open for-- then I can go back to my clinical decision-making. Am I going to do a scope CT? What am I going to offer him? When I have that information available, whether or not I do any of those, I have it available. It's been very liberating. It's more work for the front, but it's very liberating to be able to practice freely, not feeling constrained.
I'm still constrained in the sense that not every patient may be eligible, but I know that upfront and I can then make the best treatment.
[Dr. Ashley Agan]
Could you do something like Gopi was talking about, like the poor man's PROPEL with the NasoPore?
[Dr. Gopi Shah]
Can I do a little NasoPore with a little Kenalog? Is it going to be the same efficacy? Come on. Come on, Rajiv, tell me how to kind of-- [laughs]
[Dr. Rajiv Pandit]
I have found that that works, but it's going to last, what? A week. You're going to get-- Then once the steroid comes off, which is going to come off in less than a week, you get a few days. At that point, I'm going to usually just tell-- I'm going to give him a round of oral prednisone and I'm going to have him do a steroid irrigation. I find that to be more effective, because the other thing with putting up an absorbable pack and you're causing some obstruction, I haven't found that to be-- theoretically, it sounds good, but practically, it hasn't worked out for me. [laughs] I don't know if it's worked out for you.
[Dr. Gopi Shah]
Can we go back to how you partner with your PA? The PA is able to see the patients in terms of new visits, and then you're able to schedule the procedure on the same day or save your clinic time for like a procedure, afternoon? Tell me the workflow when you have your partner, your PA involved to help you navigate these patients.
[Dr. Rajiv Pandit]
Sure. I have three awesome PAs now. They are really the backbone of my practice. It's been so much fun having them. It keeps you on your toes because they will, not only clinically, but in terms of workflow, in terms of the whole decision-making, they will ask questions and you'll have to find a way to answer it. As you're answering it, you're rethinking the process in your head. What I've found wonderful with the PAs is as a specialist, we all want to be involved in the decision-making. We want to make sure we get all the facts. We want to make sure we have a differential diagnosis. We want to make sure we make the right decision for the patient.
That often means spending time getting all the information, especially if they've had previous surgery, you're getting outside medical records and you're reviewing multiple CT scans. You are then having to put this together, spend time explaining it to the patient, review a nasal endoscopy with them or review imaging with them. All that is beyond just your ability to make a decision and then implement, doing a procedure. That's where the PAs are fantastic because they will help me gather the information. They will help review this imaging and the scopes with the nasal endoscopy findings with the patient.
We actually have PROPELs in the office that we show them and we have them hold them, so the patients understand that. Then I can come in and make sure that they get it all. They have many other questions and let them know I'm going to be the one doing the procedure. We tag team this and it's been very effective in getting patients to buy in, because as you know, with sinus surgery, chronic sinusitis, it's a long-term plan and they have to buy in. It's no different than going to a dentist. No one goes to a dentist just to get a cavity filled and then walk away and go, "My toothache is gone." They have to buy into a long-term plan of dental checkups and brushing and flossing.
I often use that exact analogy with patients. I tell them that in Texas, allergies and sinuses are like dealing with your teeth. It's a long-term plan. By explaining this to them in the beginning, what's nice is having the PAs do this education plan with them. Afterwards, if I need to put a propellant, I'm not having that long discussion at that time. I'm saying, "You know what, we need to put another one in," and then they'll go and they'll get their benefits verified, pay any copay. We will get it scheduled the next visit. Since we already have that information upfront with that code, we're ready to just do it at that point if we need to.
The PAs are very helpful to make sure we have the supply, making sure that the patient's benefits cover it. We've had pre-op, they paid for it, explaining to the patient why we need to do it. I'm literally making the decision and putting it in.
(7) Sinus Surgery Recovery with Steroid Irrigations
[Dr. Ashley Agan]
Just to verify, you mentioned earlier, you might still ask patients to go ahead and keep doing your rinses with steroids in your rinses. Do you have them use some Budesonide in their nasal saline, like NeoMed bottle, or what are you usually-- are they just doing spray?
[Dr. Rajiv Pandit]
Yes, I use Mometasone. Budesonide and Mometasone are both very common. I think it depends on which company pharmacy you use and it depends on the patient's insurance, one may be covered more than the other. I think Mometasone has slightly less systemic absorption than Budesonide, but they're both a lot better than dexamethasone, which I think has the highest systemic absorption. I think we're just splitting hairs at that point in terms of which steroid, but I do have them do steroid irrigations afterwards. They may not need to go for six weeks. Maybe we can cut it down to three weeks. They may not need to go for twice a day. We might be able to do once a day.
We usually start with, my typical regimen after the initial post-op visit where we'll do a debridement, make sure that-- initially I just have a new saline spray after surgery. Then after we have them come back for a visit a week later, then we'll go through the instructions again that we did pre-operatively, but we'll go through it again as far as how to actually put the salt in the steroid together and do the irrigations. We'll have them do that and we'll have them follow up three to four weeks later. We'll hopefully get three to four weeks of good use, at least once or twice a day, and then we'll tailor it depending on the patient.
[Dr. Ashley Agan]
With this, but along the same thought line, have you moved towards not prescribing post-op like oral steroids when you've placed a PROPEL?
[Dr. Rajiv Pandit]
That is significantly diminished. Significantly diminished. Yes. We may have to do it pre-operatively, but we rarely have to do it post-operatively at this point. To be honest, I can't remember the last time-- this is something I do every week, and I can't remember the last time we had to give post-op oral steroids in a patient. If we did, it would be probably three to four months out when we're not getting adequate control with PROPEL or SINUVA.
[Dr. Ashley Agan]
Yes. That's huge. That's not a small thing to be able to avoid being on rounds of Prednisone. That's pretty awesome.
[Dr. Rajiv Pandit]
I'm in a campus where there's a number of OB-GYN specialists. I will see women that are under fertility treatment, that are pregnant, that have young babies, that are nursing. Getting a CT or necessarily doing oral steroids is very difficult. A lot of them will come in and they will literally say, "Can you put that PROPEL in? I need to get through the second trimester and third trimester, and then we can reevaluate my sinuses." I'm comfortable doing it in that situation because of the low systemic absorption.
(8) Pre-Op Use of PROPEL: Expanding Options for Challenging Cases
[Dr. Gopi Shah]
That's a great segue. I wanted to ask, we've talked a lot about the use in post-op, but what about pre-op settings? You gave a perfect example of a patient that may have a history of chronic sinusitis or nasal obstruction, especially in a woman that's nursing or pregnancy. In other patients, is there a utility in terms of a PROPEL for a patient that has-- new patient, otherwise not operated on that might have like Grade 2 polyps or something like that? Do you ever do it before you've gotten a surgery?
[Dr. Rajiv Pandit]
I have. That's something that you have to be very careful about. I had a woman who was pregnant, a second trimester, had a history of polyps, had previous surgery and wanted something done. She was desperate. I wasn't going to do a CT because she was pregnant. I did a nasal endoscopy. I made sure that I could have good visualization and made sure I wasn't dealing with encephalocele or something unusual or a neoplasm. At that point I did go ahead and do PROPEL. She was so thrilled. She was so thrilled. She was so thrilled. We saw a whole bunch of other women that were pregnant, and it wasn't from the referring physicians.
What I found out was she had discussed this on a Facebook forum of expecting mothers. I was having-- for a few months, I think for like six to nine months, I had a bunch of women during pregnancy who had the same issue. We're dealing with severe congestion. They didn't all have polyps and just had allergies, but it was just interesting how when you make one person happy-- She was one that a lot of people were concerned about doing something because they couldn't necessarily image her, they weren't comfortable doing a procedure, but the PROPEL was a great, great option, until we could do a more thorough workup after the delivery.
[Dr. Gopi Shah]
Have you used them in your other fragile patients or your cardiac patients or patient granted? I know there's a lot more that we do in the office in terms of sinus work now, but do you do them on a sinus surgery naive patient, with small polyps that you might-- is there a role for PROPEL otherwise, or is it, "No, you really need to have everything opened up and cleaned out," and the real goal is to prevent and cool things down until we get our rinses and it's more effective as opposed to--
[Dr. Rajiv Pandit]
Yes, what I'll do in that case is I will-- a patient that, say, needs a traditional sinus surgery, I will do an in-office balloon dilation just to be able to get the PROPELs into the right area and to make sure that they stay in place. We've had those patients that have small mini polyps in the ostiomeatal complex. It's not huge, but it's definitely enough to obstruct their breathing. They'll get recurrent infections. They probably need a fast of some sort, but they may do fine with just a little plucking of the polyps, a little dilation, putting those PROPELs in and you watch them. You'd be surprised how many of those actually do pretty well. Far fewer of them now need traditional sinus surgery.
I think there's definitely a role for a mid-lane basic procedures in the office in conjunction with a PROPEL. I don't think that I would do the PROPEL alone because it's a little difficult to get it into where you want it unless you dilate that space.
(9) Exploring Off-Label Uses of PROPEL & SINUVA in Challenging Cases
[Dr. Gopi Shah]
Yes. Dilate that space. Then one last question for you. We've talked about placement in nasofrontal recess, maxillary sinus ethmoid. Is there ever a role for the sphenoid sinus?
[Dr. Rajiv Pandit]
There is, but I believe it's still off-label.
[Dr. Gopi Shah]
Okay. [laughs] I know there's a lot of important structures there, but why don't we just put it at the door, or [chuckles] maybe we shouldn't, I don't know.
[Dr. Rajiv Pandit]
No, I have, I have put PROPELs in a number of places. I had a patient, adult patient with nasopharyngeal stenosis. I drill that down, I put a PROPEL there, I put a PROPEL in the sphenoid sinus when you've had those severe polyploid cases. I even did ear canal stenosis and I use a Mini PROPEL and then I put packing inside there to help with that. I've been pretty bold about using it off-label. I'm careful in terms of making sure that it's not going to migrate or go somewhere where it shouldn't. I think it's a great-- the sphenoethmoidal recess is a great place to put it when you have that posterior polyploid disease.
[Dr. Ashley Agan]
Yes, and it's going to break down in a month. It's not like it's going to erode through anything like a foreign body reaction would.
[Dr. Rajiv Pandit]
Exactly.
[Dr. Ashley Agan]
With the SINUVA, that plastic piece that you have to remove, is that basically like the well that's holding that 90 day supply of Mometasone?
[Dr. Rajiv Pandit]
No, it's not. The SINUVA actually has the steroid along the entire framework. Because it's such a long, thicker structure, that's where all the shards come from, where the spokes of the wheel come from. You need that because you need something firm at the base to insert it. That's actually where you put the delivery device and you push it in there and then you release, unhook it from there. That's the purpose it serves, is to actually insert it and for the shards to connect to it. That does have to be removed.
[Dr. Ashley Agan]
Okay. There's no-- you haven't had any problems with that going where it's not supposed to or patients aspirating it or anything weird like that?
[Dr. Rajiv Pandit]
No. The reason is because it doesn't dissolve like the PROPEL where it completely goes away. Usually after 90 days, the actual shards are more like spaghetti. When you're pulling it out, it just comes out literally like spaghetti.
[Dr. Ashley Agan]
Got it. Got it. It's not like there's this plastic piece that's going to be suddenly loose of all the spokes that were holding it in? It's still a form. It's just empty of steroid now and you take the whole thing out.
[Dr. Rajiv Pandit]
If you follow the 90-day guideline now, I have not left one in for six months. I don't know what would happen at that point. I'll see in between 70 and 90 days. I've never let SINUVA go past 100 days. I don't know what would happen if the entire thing would dissolve and you're just left with a plastic button that might further migrate down. I know where you're getting at. That's a scary thought. I've never had one do anything like that if you leave it in for the 90-day time period. We explain that to the patient, that we need to see you back. There's a plastic piece there that we need to identify and remove, and they understand.
(10) Anesthetic Protocols for In-Office Sinus Procedures
[Dr. Gopi Shah]
Rajiv, can you tell us about your anesthetic protocol?
[Dr. Rajiv Pandit]
Sure. The anesthetic protocol varies depending on what I'm doing with PROPEL. If I'm doing it with in-office balloon sinus procedure, then I already have a deep ray anesthetic that I'm incorporating for the balloon sinus dilation, and that'll obviously cover the PROPEL. That often involves the topical medication. Conventionally, I would do oral sedation beforehand. I know Valium is popular. Xanax is something that we prefer now because it has a shorter half-life. Then we'll go to topicals and then we will inject. Then we'll do the procedure and we'll do the PROPEL. If I'm just doing it in a post-op situation, then we just usually use a topical spray.
If I have to go up in the nasofrontal recess, I will do a pledged up in that area. Now we've actually incorporated IV sedation for our in-office balloon, so that makes it a lot easier. I will say, though, there is definitely a benefit to not using IV sedation and that has to do with vasodilation. One of my biggest fears for doing anything in office in the nose was I was concerned about bleeding. Was just the anesthetic, it was-- if there was going to be post-operative bleeding and going down the back of the throat. I have found that there's significantly less bleeding in the office than in the OR, even for significant polyps, because we--
I don't think we as ENT specialists realize how much vasodilation we're dealing with with anesthetics. When you remove inhalational and IV anesthetics, you remove the vast majority of the vasodilation that's going to occur, and they respond so well to, not only local anesthetics, but local decongestion. I have been able to do poly-- even prior to IV sedation, I was doing polypectomies in my office with a shaver and patients that just had oral sedation and topical anesthetic because they were doing so well. They didn't have any bleeding. You can tell. You can tell after you've injected and after you've decongested, how much of those tissues are shriveling, the blanching, and you could tell when you get into it that you've achieved good vasoconstriction.
I think it's both a matter of addressing the anesthesia, but also getting good vasoconstriction. I think that you can achieve both in the office following those protocols.
[Dr. Ashley Agan]
For your topical, are you using 4% lidocaine? Are you using any tetracaine? Is it a gel? Is it a liquid?
[Dr. Rajiv Pandit]
I use just 4% lidocaine spray and then 4% lidocaine with oxymetazoline 50-50 on a cottonwood pledget. Then we just go to injecting. They do not feel the injection after we do those two steps. Some people use a gel. They like to do a gel because they feel that the gel adheres better. I haven't found that to work for me. The protocol that I do works well. If I spray the patient, if I put the pledgets in, I usually put them in for five minutes. This is for if I'm doing an in-office balloon dilation with that, I put the pledgets in for five minutes. Then I readjust the pledgets to get a deeper end of the sphenoethmoid recess or further into the middle meatus for another five minutes.
10 minutes of pledgets is plenty to then inject and they don't feel it. Now, I do one other thing, which is I don't walk in with a needle while they're looking at me. We have our logo on an eye patch that we put on the patient. We just simply explain to them that we're going to have some instruments near your nose, near your eye, and we have a bright light and we want to make it safe for you. That way, when we do the remainder of the anesthesia, they're comfortable and they're not thinking about it because most of the time, the more they think about the anesthesia, the more painful it's going to feel.
With that protocol, I have not had anyone feel the injection and we just tap their shoulder and that seems to work very well.
[Dr. Ashley Agan]
What was the impetus for implementing IV sedation?
[Dr. Rajiv Pandit]
The oral protocol takes about-- initially, it took me about an hour and a half per patient and we brought it down to about an hour and 10 minutes. With IV sedation, we can do the procedure in 10 to 15 minutes.
[Dr. Ashley Agan]
Do you have a sedation nurse that comes that you work with?
[Dr. Rajiv Pandit]
We have an anesthesia team, yes. They bring in-- in Texas and many states, you have to have a license for office-based anesthesia, OBA. We had applied for that license that requires you to work with anesthesia group or you can get trained yourself, but we decided to bring in an anesthesia group. They bring in all the equipment. They bring in the emergency supplies, the endotracheal tube, paralytics. You then have to have a lockbox for these drugs. It's certainly a process. You wouldn't want to necessarily do that until you have enough volume and also you have to look at the liability and you have to look at the additional cost of the patient.
You have to look at multiple factors to see if it's worth it for your practice. It took us a while to get to the point where I would say that it was worth it for our practice to do. I certainly wouldn't start out that way. I think that once you-- there's a certain threshold you get to when you realize, "Okay, now it makes sense." I will tell you in terms of patient comfort, the oral protocol works just as well as the IV. I have had no difference. It's just the speed that you can do it. In fact, the oral protocol from a bleeding perspective is better.
[Dr. Ashley Agan]
The IV, just the patient sedation happens quicker and so you're not spending as much time with all the pledgets and everything?
[Dr. Rajiv Pandit]
Exactly. There's no oral sedation that you have to give. You're not putting in the pledgets. I put the pledgets in for literally 60 seconds because I found out that if I inject and I don't put pledgets in after they've had IV sedation, they still have a cough reflex or sneeze reflex. They will sneeze when you inject the middle turbinate. I actually just put the pledget on the middle turbinate for literally 30 to 45 seconds just enough to inject the area and then they're not sneezing on. That's what I do with this. That's obviously a lot quicker than with oral. Afterwards, once the propofol wears off, they're wide awake and they're ready to go home. It's a lot quicker, but there's definitely a lot of caveats with doing anesthesia in the office.
[Dr. Gopi Shah]
That might be Part 2, Rajiv, because there's a whole slew of questions. [laughs]
[Dr. Rajiv Pandit]
There is. That's a whole different way of thinking because you're now dealing with more vasodilation. You're quicker, but you also have more vasodilation to deal with. I will tell you that when I initially started doing IV, I wanted to go back to oral. [laughs] It took me a while to figure out how to make this work for us. Yes, you're right, that's a Part 2.
[Dr. Gopi Shah]
As we start to round it out, Rajiv, are there any final pearls or tips that you want to leave us and our listeners with?
[Dr. Rajiv Pandit]
Yes, I would say that there's really three parts of incorporating PROPEL into your practice. The first is just understanding the science and looking at the data and being convinced, because if you're convinced, it comes out into the patients. What we do in our office is when I'm convinced of something new, we actually meet with the entire office. Actually, we have it scheduled. Before I go to any conference, we have a meeting scheduled for the entire office, like a show and tell.
That way, if it's scheduled where me and the PAs are required, we know we have to go in front of our office staff, we have to be able to explain it in their language, which helps us explain it to patients. It gets us to recreate our excitement, get them to buy into it. We'll show them some of the slides we've seen at conferences. We'll show them some of the videos. What I find is when a front desk person is making an appointment and they know this, they're talking very differently. They're more confident. "Oh, yes, you're going to want to really learn about that PROPEL." It's very innovative. It's new for any service line. That's part of that buy-in to yourself into the office staff.
The second thing we do, is then we understand the anesthetic protocol. I think that's very, very important. A lot of us are afraid to do things in the office because it's hard to learn. It's a lot easier to learn something in the operating room when patients are asleep and you know they're fully anesthetized and they're not going to be uncomfortable. There's that fear. Then the third part is actually, let's say you got that down. You brought into the service side. You understand how to actually do it. Now you want to actually implement in the workflow. For us, that often required, as I mentioned, understanding the coding and the eligibility and all that.
In the EHR world, it required us to make sure we had that pull up in our outline. When we were pulling up chronic sinusitis and the treatment pathway, those codes were coming up. I was like, "Why aren't we doing them?" Somehow we had an upgrade and that code disappeared from our set. [chuckles] It was no longer being offered. Sometimes we become victims of our own automation. That's my biggest concern with things like AI. They're great. They're useful. They're adjunctive. We have to remember that we have to continue to think and be on our toes when it's easy to get comfortable with these automated processes.
We have to make sure that we remember that there's this three-phase process to implementing a new service line. If you follow it systematically like that, then you're going to find yourself not just doing more PROPELs, but other innovative techniques that have been proven that you've learned about at conferences or elsewhere.
[Dr. Gopi Shah]
I agree. I love it. That's great.
[Dr. Ashley Agan]
Thank you so much. I learned a ton. If any of our audience has any questions or want to reach out to you, do you have social media handles?
[Dr. Rajiv Pandit]
We do. We have Dallas.ENT on TikTok and Instagram. We have a lively TikTok page now. My 20-something Gen Z staff members really wanted a TikTok page. That's surprisingly been pretty effective. I did not realize how many people get their medical information, their news from TikTok these days. That's been effective. Instagram, Dallas.ENT. On Facebook, we're DallasENT. I have found that when you're dealing with something that's lifestyle-affecting and not life-threatening as much, like with typical sinus problems, education is important and making it fun and reminding people that you're going to have more energy and you're going to be happier afterwards, gets them all excited.
That helps with the compliance and gets them through the door. That's what social media is for. We've had our staff-- once I understood the power of social media for a specialty like ENT, and specifically rhinology, we've been able to implement that. Then, of course, my email is the best way to directly communicate with me. That's drpandit@dallasent.com. D-R-P-A-N-D-I-T@dallasent.com.
Podcast Contributors
Dr. Rajiv Pandit
Dr. Rajiv Pandit is a clinical instructor and section chief of otolaryngology at Methodist Dallas Medical Center is Dallas, Texas.
Dr. Gopi Shah
Dr. Gopi Shah is a pediatric otolaryngologist and the co-host of BackTable ENT.
Cite This Podcast
BackTable, LLC (Producer). (2024, July 16). Ep. 181 – Localized Drug Delivery for CRS [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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