Michael Bergstein, MD, ENT and Allergy Associates, talks about nasal polyps and how a new option is revolutionizing treatment.
Interview conducted by Ivanhoe Broadcast News in August 2019.
Let’s start with Sinuva. If you could describe for me what it is and what it’s designed to do.
BERGSTEIN: Sinuva is a revolutionary new procedure that we can perform for our chronic sinus patients who have nasal polyps. In some patients who have chronic sinusitis, they can grow these nasal polyps. Nasal polyps are like a water balloon. And they grow these things out of the sinus itself. And previously, up until now, we’ve only had the ability to bring them to the operating room under general anesthesia and remove them. The issue with nasal polyps is that they can block the sinus, which then can block your ability to smell. And as a consequence of not smelling, you have issues with taste as well. Anyone who doesn’t smell is unable to taste. In addition, patients could be experiencing chronic nasal obstruction, difficulty sleeping, fatigue. So approximately 50 percent of patients will regrow their polyps after their initial surgery. And in fact, of those patients who have polyp surgery or sinus surgery, at least 50 percent of them will go on to have more than two surgeries.
Wow. With those surgeries and with everything coming back, is there a concern that people could permanently lose the sense of smell?
BERGSTEIN: Absolutely. As a result of having multiple surgeries, it is possible that you could lose your smell permanently. In addition, with every surgery that you have, the risk of the surgery itself goes up, not to mention that you have to go to sleep for it and then there’s a recovery period – a time off from work as well. Polyps, up until now, that have recurred after surgery have been treated with steroids. And what the steroids do is they decrease the size of the polyps. Problem is is that it only works temporarily, and there are systemic effects as a result of repeated courses of steroids, and those can be thinning of the bone, anxiousness as well, in addition to weight gain. So now, as a result of the Sinuva and with the advent of Sinuva, we now are able to treat locally in the office without the need for further surgery. Regarding placement of this implant, which is an anti-inflammatory, patients don’t know they’re in there. We use a little topical anesthesia and the procedure takes about 10 minutes.
How does it work?
BERGSTEIN: Sinuva is an implant that we place into the sinus – looks like a very small eggshell. What we do is we bring the patient into the office, we apply some topical anesthesia – nothing intravenous. They’re completely awake. And in fact, I put it on the screen so that they’re able to watch their procedure being performed. There’s no associated pain or discomfort whatsoever. The procedure takes approximately 10 minutes to perform. There’s virtually no bleeding whatsoever. The implant itself lasts approximately three months. During that period of time, what the Sinuva does is, with its anti-inflammatory properties, we’re able to locally treat the polyps – again, without giving any systemic steroids. Over the course of the three months, the polyps melt away. In the first month, patient begins to breathe better naturally on their own. They begin to smell better. The smell nerves sit at the base of the skull. The polyps inhibit the aroma of your food to get to the nerves. So we need to open that up so that now the aroma can get to where it needs to go. So over the course of the three months, the polyps melt away, patient gets their smell back. They get their life back. And in Eric’s case, they get the ability to both breathe, smell and taste again, which was obviously critical for his line of work.
If the polyps come back, can you retreat with Sinuva?
BERGSTEIN: Absolutely. So once again, the difficulty with giving systemic steroids is that there are all sorts of side effects. And you can’t keep giving prednisone – steroids – because of all the bad effects that it has for the patient. And that’s why those patients require repeated surgeries. Sinuva can be repeated as many times as is necessary. Fortunately, up until now, I haven’t had to repeat any Sinuva procedures because it’s done such a wonderful job of completely melting away and evaporating the polyps. And thus far, I don’t have any patients who’ve had a recurrence of their polyps.
Tell me a little bit about Eric. He had been coming to you for a while. Talk to me about what kind of difficulty he was having, the frustration he was going through.
BERGSTEIN: Eric is an executive chef at a major restaurant here in the area. And Eric was unable to breathe and was unable to smell and, consequently, was unable to taste. And clearly, he was distressed by that. He had issues with regards to what he might do in terms of his career. So initially what I recommended – after trying to get him better with medicines, we brought him to the operating room and we then removed his polyps, opened up his sinuses. Initially, he did very well. He was able to smell again. He was able to taste again. He returned to work breathing better and feeling better. But a short time thereafter, as happens with many chronic polyp patients, there’s something in their DNA – either in terms of allergies or whatever the case may be – that the polyps return. And, again, the only treatment up until now has been to either repeat the surgery or to give them Prednisone, which is a steroid. I mentioned to Eric that there was this new revolutionary procedure that we can perform in the office without any anesthesia and they will melt his polyps away and give him the ability to smell and taste again. Eric’s eyes lit up. And he said, where do I sign? And so we did this procedure for Eric rather than performing another surgery.
Would you consider this a game-changer?
BERGSTEIN: The procedure itself avoids the necessity for further surgeries. It completely changes the landscape of our treatment for patients who have chronic, recurring polyps and chronic sinusitis. So clearly this is a game-changer in terms of how we treat our patients. Eric came in approximately two months later and he said, “Dr. Bernstein, I have just cooked the best meal of my life thanks to you and thanks to Sinuva.” He says, “my ability to smell has gotten better and better.” And I just spoke to him not long ago once again, and he says it just continues to get better. His meals are getting better and he practically had tears in his eyes, he’s just so ecstatic that I gave him his life back, again, with this new revolutionary procedure that is non-surgical.
Is there anyone for whom this is not an option?
BERGSTEIN: No. It’s specifically wonderful for patients who are unable to tolerate oral steroids. Those would be patients who are anxious, patients who are diabetic with steroids used to increase their sugars. Thus far, this is a local placement of an implant that does not affect, systemically, a patient’s sugars to any degree. And you can, thus far, keep repeating the procedure as is necessary. So everyone, potentially, is a candidate for this.
What’s the cost of surgery versus this treatment?
BERGSTEIN: There is a surgical cost that is significant with operating on the sinuses, both in terms of the operating room and in terms of the surgeon’s fee and the cost to the insurance. Here, there’s none of that. In other words, because it’s an in-office local procedure, essentially, it’s just the cost of the implant and, essentially, that’s all.
Covered by insurance for most patients?
BERGSTEIN: Covered by insurance for most patients. Because it’s a new procedure, insurances are catching up to the idea that this works. This was FDA approved back in December of 2017, so the insurance companies are just being enlightened as to the efficacy of this procedure and the benefit that it provides to the patient, but also to the insurance company because we’re now saving the insurance company a significant amount of money because they’re not having to pay for an anesthesiologist, a surgeon’s time, and the operating room itself.
How many treatments do you think you’ve done?
BERGSTEIN: I would say multiple. Eight to ten.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
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