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Stents For Sinusitis

Stents For Sinusitis

CREATED Jan 22, 2014

CHICAGO, Ill. (Ivanhoe Newswire) – Thirty one million Americans suffer from chronic sinusitis.  When medications fail, seeking relief can often lead to surgery. Now, there's a new device that can help guarantee permanent results.

Nurse Jillian Giertuga had to undergo a CAT scan.

"I had constant pressure in my cheeks and forehead," Jillian told Ivanhoe.

She was suffering from chronic sinusitis.

"Chronic sinusitis is an inflammation of the tissues that line the air filled cavities within the skull," Jordan Pritikin, MD, Physician-Director, Chicago Nasal & Sinus Center, told Ivanhoe.

When steroids, decongestants, and antibiotics fail surgery becomes an option.

"We are opening up this space to allow air to flow, allow mucus to drain, and to get rid of as much diseased tissue as possible," Dr. Pritikin said.

Up to 20 percent of nasal surgeries fail due to scarring or recurrent inflammation.  Now, Dr. Pritikin is using a stent that holds the sinuses open.

"It doesn't interfere with the drainage, doesn't interfere with airflow, but more importantly it's coated with a steroid that slowly releases into the tissues to decrease inflammation," Dr. Pritikin said.

The stent is absorbed by the body, patients find long term relief.

"Things are much better. There is no pressure and no headaches," Jillian said.

Half a million patients each year undergo surgery to treat sinusitis. Studies show the PROPEL implant has provided a 29 percent reduction in the need for postoperative interventions.

RESEARCH SUMMARY

BACKGROUND: Sinusitis is an inflammation, or swelling, of tissue lining the sinuses. This happens when the sinuses become clogged and are filled with fluid. Sinuses should be filled with air, but when they are blocked and filled with fluid, germs can grow and cause an infection. There are different types of sinusitis: chronic sinusitis, acute sinusitis, recurrent sinusitis, and sub-acute sinusitis. Almost 37 million people in the U.S. suffer from at least one episode of sinusitis a year. (Source: http://www.webmd.com/allergies/guide/allergies-sinusitis)

CAUSES: Sinusitis may be caused by a number of things, but those who have a common cold, swelling of the nose, nasal polyps, or a deviated septum have a larger risk of developing the infection. Fungal infections, especially in people with impaired immune systems, can develop the infection and it may be more difficult to treat because sinusitis is viral, not bacterial. (Source:http://www.webmd.com/allergies/guide/allergies-sinusitis

PROPEL STEROID-RELEASING IMPLANT:  The newest treatment for sinusitis is the PROPEL dissolvable implant for chronic sinusitis patients undergoing sinus surgery.  PROPEL is the first of a new category of products offering localized, controlled drug delivery directly to the sinus tissue.  It is inserted by a physician to maintain the surgical opening, the spring-like implant expands to prop open the ethmoid sinus and gradually delivers an advanced corticosteroid with anti-inflammatory properties directly to the sinus lining as the implant dissolves.  Safety and efficacy of the PROPEL implant has been studied in three prospective clinical trials in the U.S., with a total of 205 patients enrolled.

  • A randomized, controlled, double-blind Pilot study, recognized with the 2010 Maurice Cottle Research Award honoring best clinical or basic science by the American Rhinologic Society (ARS).
  • The ADVANCE single-cohort study that assessed safety, endoscopic outcomes and patient symptoms to 6 months.
  • The ADVANCE II randomized, controlled, double-blind clinical trial, which included review by an independent panel of surgeons. (Source: http://www.intersectent.com/advantage-clinical_data.html

INTERVIEW

Jordan Pritikin, MD, Physician-Director, Chicago Nasal & Sinus Center, talks about a new treatment option for patients with sinusitis.

Can you talk about what chronic sinusitis is?

Dr. Pritikin:  Chronic sinusitis is inflammation of the tissues that line the air filled cavities within the skull and, by definition, which goes on for more than twelve weeks. That's what makes it "chronic." The symptoms can include facial pain, facial pressure, discolored nasal discharge, pain in the teeth, nasal congestion, bad breath, and post nasal drainage.  All may occur, or some of these may occur. Patients will typically have some underlying anatomic obstruction. They may have some underlying allergic inflammation. There may be some environmental triggers, but taken together they lead to this inflammation within the sinuses.

How is it diagnosed?

Dr. Pritikin: A combination of examination and imaging studies. There may be some blood tests that are done as well to determine whether someone has immune issues. There may be allergy testing.

In the past has there been a way to treat and eliminate it completely?

Dr. Pritikin: We're still exploring the reasons that sinus problems develop and there may be something in an individual's immune system that predisposes to the development of sinus disease. There may be some genetic factor. There may be something in terms of their anatomy. So we're still exploring why sinus disease develops in the first place and we treat accordingly. There are a number of medications and treatments available. But we're not at the point where we can guarantee a cure in every situation.

Why don't we talk about first this new breakthrough?

Dr. Pritikin:  When medical therapy for sinusitis fails…and that's antibiotics and decongestants and oral steroids and steroid nasal sprays…then we look to surgery. Surgery is intended to improve airflow within the nose and sinuses, improve drainage of the sinuses and to eliminate as much of the diseased tissue within the sinuses as possible. There are two major reasons for sinus surgery to fail, to not give us adequate results. Number one is scarring that closes off the openings that we create, and number two recurrent inflammation which again closes off these openings. For years we've been trying to find some way of keeping the sinuses open after surgery. A piece of foam or packing can be put in to the sinus space which will hold everything open but it then blocks the drainage pathway of the sinus and it doesn't allow the sinus to drain properly. A new alternative is this stent…this Propel implant…that is a spring like device that holds the sinuses open, doesn't interfere with the drainage, and doesn't interfere with airflow. But more importantly it's coated with a steroid that slowly releases in to the tissues to decrease inflammation and prevent scarring.

So you still do the surgery. Is it just an implant?

Dr. Pritikin: It's placed as an adjunct to the surgery.  It's an added measure to increase the effectiveness, of surgery, slowly releasing medication into the tissues while the tissues are healing. We are starting to think of sinus surgery as a means of improving delivery of medications into the sinuses to control chronic disease rather than a means of completely eliminating that disease. The implant is a way to treat inflammation without relying on pills or sprays and its potential as an ongoing treatment for chronic sinusitis is promising.

How do you know how much medication somebody needs?

Dr. Pritikin:  The implant comes in two sizes, each with a fixed dose of the steroid medication. The biomechanics of polymers is beyond my understanding, but this medication is slowly released from the implant as it dissolves over a three week period. There have been three randomized controlled studies looking at the efficacy of this device and there is no significant systemic absorption, there have been no complications associated with its use and there have been significant improvements in post-op outcomes.

Are there any side effects?

Dr. Pritikin:  There are no side effects and no adverse reactions reported to date.

So, why only three weeks and what happens after that?

Dr. Pritikin: The material that this device is made out of is broken down by the body, and on average it lasts for about three weeks. There may be some patients where it lasts a little longer, and there may be some people where it breaks down sooner but that seems to be the average. We find that the initial three week period following surgery is a critical period for healing.

Can you just pick it up at the three week period?

Dr. Pritikin: That first three week period after surgery is critical; that's when most of the healing after sinus surgery occurs. That's when new tissue is growing in to the operated areas of the sinuses, that's when the bony structures are healing are solidifying again. That seems to be the critical period of healing.

Did you come up with this invention for lack of a better term and can you explain how this came about?

Dr. Pritikin: The thought process behind this this stent is borrowed from cardiology. For years they have been using balloon catheters and stents to hold open diseased arteries, but now, we're starting to see that same technology applied elsewhere in the body including the sinuses. This is a carryover of technology from another field that seems to be appropriate within the sinuses.

Were you instrumental in discovering this?

Dr. Pritikin: No, I did not create it nor did I discover it, but I was an early adopter of this technology. The company that manufacturers this product rolled out the product in a very controlled fashion. They selected one or two physicians in each major metropolitan area of the country to begin using this this product and we've been reporting back on our results. There are a few multi-center studies that are looking at long term effect, but they have been very slow in rolling this product out because they want to be able to show some effectiveness of the implant over the course of time and they want physicians that are skilled in performing sinus surgery using the implant appropriately.

Is there anybody who would not be a candidate for this surgery?

Dr. Pritikin: There are two parts to that question: Are there people who are not candidates for surgery? Certainly. And not everyone who undergoes sinus surgery necessarily needs this implant. The implant is used when there is polypoid disease that needs to be addressed but it is physically impossible to remove all inflamed tissue and surgery does not address the root cause of that inflammation. The implant is also used when there is the potential for scarring or inflammation to close down the openings that have been created in the sinuses. So the implant provides structural support during the healing process.

In which cases would they need the implant?

D. Pritikin: The implant intended to be used in to the ethmoid sinus cavity, which is the space between the eyes. When we do surgery on this area, we are potentially destabilizing the structures that surround the sinus opening and so the stent holds these structures apart and holds the sinus open. If we don't enter that sinus we generally don't need to use the implant. When we perform sinus surgery, we are balancing removal of inflamed and diseased tissue with preservation of normal tissue and structures. Sometimes it is not possible to remove all diseased tissue without putting healthy tissue at risk. In this instance, the implant can be placed to address whatever inflamed tissue remains.

About how many of those people, I mean it's hard to say but do you think that's chronic? Would say all those people would need some sort of surgery or are there other routes?

Dr. Pritikin: More than 35 million people in the United States suffer from chronic sinusitis. The vast majority of people with chronic sinusitis can either be treated with medication or with surgery. When medical therapy fails, surgery is a consideration., but again  Roughly 600,000 sinus procedure are performed each year in the United States, so we're looking at a relatively small subset of patients with sinusitis. We need to make sure that the surgery is appropriate and there are criteria that we use to determine whether surgery is the appropriate next step.

Can you talk a little bit about what she came in with and what surgery you performed and what that process was?

Dr. Pritikin: Sure, Jillian came to us with complaints of nasal congestion, sinus pressure and recurring sinus infections that would lay her up for weeks at a time, where she could function but not at one hundred percent capacity. She was taking antibiotics over and over again and being treated with nasal sprays and decongestants, and she would get temporary relief but not satisfactory relief. So on examination we saw that she had some curvature of the septum…the cartilage and bone that divide the two sides of the nose was crooked…and on CT scan we saw that septal deviation as well as blockages to the openings to the sinuses in cheeks and between the eyes. Based on her history, based on her continued symptoms despite medical therapy, and based on her CT findings we gave her the option of surgery. She decided to undergo thesurgery. We straightened out the septum, we opened up the sinuses, and we found that there was polypoid tissue within the sinuses that needed to be addressed. And so she was a candidate for this PROPEL implant.

How has she been doing since?

Dr. Pritikin: She's done very well. She is breathing clearly through her nose, she has no sinus pain or pressure and she's had no further sinusitis symptoms since her surgery.

How long has this stent been around?

Dr. Pritikin: The product was patented in 2006 and investigational studies began shortly thereafter. FDA approval was issued in September 2011 but it has only been available for clinical use since November 2011 and only in limited distribution. I was among the first in the United States to use the device.

Does sinusitis ever get misdiagnosed as a sinus infection? Do you hear that term a lot?

Dr. Pritikin: I have a number of patients who come in complaining of "sinus problems," but what does that mean? Well, for some people it means a runny nose or a stuffy nose which may be due to allergies. For other people it means headaches, and a fair number of people with headaches actually have some kind of migraine condition. There are some subtle differences between sinus problems and allergy problems, between sinus headaches and migraine headaches, and those need to be sorted out.

Who is a good candidate for the propel implant?

Dr. Pritikin: Anyone who is undergoing ethmoid sinus surgery that potentially de-stabilizes the structures in the sinuses would be a candidate for the stent placement. Anyone with polyps…with inflamed tissue within the sinuses…is an excellent candidate for the PROPEL implant.

And you said there wasn't a cause, like a known cause?

Dr. Pritikin:  We're still exploring the basis of polyp formation, and we're still exploring why some people develop sinus problems and other people don't. Is it something about their anatomy, is it their nasal physiology, or is it something about their immune function? It is an allergy issue? Is it something in their diet? Is it something they've been exposed to? We're still trying to figure those things out.

FOR MORE INFORMATION, PLEASE CONTACT:

Jordan Pritikin, MD
Physician-Director
Chicago Nasal & Sinus Center
(312) 372-9355
jpritikinmd@gmail.com