Sinusitis Solution

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Posted on: August 25th, 2006

Chronic sinusitis is painful and irritating. Having been a sufferer for nearly 10 years, I know about the pain and annoyance of a chronically stuffed nose and having people constantly ask if you’re sick. I’ve written before about treatment strategies for chronic sinusitis, including some prevention strategies, since many of the causes and irritants (allergies, colds, fungi and environmental conditions such as humidity, cold air, smoke, even perfume) can be controlled — at least to some degree.

One danger of chronic sinusitis is that as the sinuses fill with mucus and swell in response to the trigger, the nasal passages that connect them to the nose — the pathway for sinuses to drain and air to reach them — begin to swell and can eventually close off. So this is not a condition to ignore. And, for the 600,000 or so patients each year for whom conventional therapy is no longer enough, there has been much talk about a new treatment that may be helpful. Unfortunately, the talk seems to be better than the reality.

ANGIOPLASTY FOR YOUR NOSE

Each year doctors advise about 600,000 patients for whom their conventional medical therapy is no longer enough that they will need surgery. (Only about half, however, go on to have the surgery.) In the last 20 years or so this has meant endoscopic sinus surgery (ESS), where surgeons put a small tube into the nasal passages and sinuses to view and clear out obstructions and the affected sinuses.

Although the surgery has a high success rate — 80% to 90% — and is much more comfortable than older types of surgery, it still involves bleeding, packing of the area, nasal irrigation and a week or more of recovery. Not surprisingly then, the recent announcement about an easier and pain-free way to fix chronic sinusitis made headlines. Called balloon sinuplasty, it is akin to cardiac angioplasty. Using catheter-based procedures, doctors snake a balloon catheter up the nose of the patient, through the plugged passageway and into the affected sinus. The balloon is inflated and opens the area — including the nasal passage — and allows the sinus to drain at last, clearing the way for it to regain health.

About 150 sinus specialists around the country have been trained in the technique, and some of them are extremely excited about the potential benefits of the procedure, calling it a middle ground between medication therapy and surgery. Testimonies from various patients have also been stirring. Not everyone has been so enthusiastic, however. Some doctors are concerned that — at least for now — there is more hype than promise.

NOT AS GOOD AS IT SOUNDS

James Stankiewicz, MD, chair, department of otolaryngology, head and neck surgery, at Loyola University Health System in Maywood, Illinois, is one of the doctors who has trained in balloon sinuplasty. I called Dr. Stankiewicz to discuss what people can realistically expect from this new procedure. Although he describes the concept as “elegant,” he says that there is no evidence or series of studies that show it’s long-term effectiveness.

The Food and Drug Administration (FDA) does not require manufacturers of “Class I” medical devices to prove them safe or effective before the devices go on the market, and the testing of this procedure was extremely limited — one study on six cadavers and another on 10 living patients, eight of whom had had previous surgery, which could affect the results. In spite of his concern, though, Dr. Stankiewicz anticipates that the balloon might eventually benefit 10% to 20% of patients.

Contrary to what some assume, however, sinuplasty isn’t all that easy. It is surgery, performed in an operating room, and the patient must have anesthesia. Unlike ESS itself, sinuplasty requires fluoroscopy, a technique that uses radioactive material to provide its live imaging of the instruments and anatomy. Some patients are reluctant to have any kind of radioactive material — even minute doses such as this involves — but another issue may be more to the point. Dr. Stankiewicz notes that if the surgeons start replacing many of the 300,000 sinus surgeries a year they are now performing with sinuplasty, they themselves will be in for a heavy dose of radiation exposure as well. Certainly that is a problem that will have to be addressed and resolved.

Additionally, there are patient problems involved. Some types of sinusitis make patients inappropriate candidates for the sinuplasty. Polyps, grape-like structures that develop in the nose and the sinuses, exist in many sinusitis patients. These patients would not benefit from this treatment, says Dr. Stankiewicz. Neither would patients who have fungal sinusitis or large cysts in their sinuses. The problem for many, he says, is that the tissue around the balloon would swell and once again close off the passageway.

For all of the excitement about sinuplasty, at this point its future remains unclear and the gold standard surgery for sinusitis continues to be ESS. Dr. Stankiewicz reports that in fact, many surgeons who are performing sinuplasty actually do it as an add-on to traditional endoscopic surgery.

Dr. Stankiewicz likens sinuplasty to the “introduction of lasers in the 70s and 80s.” Surgeons at that time assumed laser treatments were the future and that they would be doing virtually all of their surgeries with it. While laser treatments have become an invaluable tool, this anticipated use was much greater than the eventual reality. So it will be with sinuplasty, he believes. It will be an important addition to sinusitis treatment — not the answer, but another valuable tool to provide relief to the many who suffer.

Sources:

Sinusitis Solution

* James Stankiewicz, MD, chair, department of otolaryngology, head and neck surgery, Loyola University Health System, Maywood, Illinois.

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