Minimally Invasive Procedure Offers Chronic Sinusitis Sufferers New Hope

Today, more than 39 million Americans experience sinusitis, making it one of the most common health problems in the U.S. Sinusitis can block the sinus passages--the air filled cavities around the nose and eyes, and women are affected in slightly greater numbers than men. Of those with sinusitis, more than half have symptoms severe enough to seek medical treatment. As a result, Americans spend well over $8 billion on healthcare related to sinus troubles and lose more than 73 million days of activity each year.

Patients suffer debilitating headaches, facial pain and nasal congestion. Until recently, severe suffers had few options for relief. Now a new low-risk, minimally invasive procedure that uses a balloon-tipped catheter device is allowing many sinus sufferers to breathe easy.

Sinus sufferers often are treated with antibiotics, decongestants, or steroid-containing nasal sprays. However, antibiotics and other medications do little, if anything, for many of them. Indeed, a British study, published in the Journal of the American Medical Association (JAMA) in December 2007, found that antibiotics and other medicines are ineffective in treating most sinusitis. Ian G. Williamson, MD, of the University of Southampton, England, and his colleagues conducted a double-blind study of 240 adults with sinus infections and found their symptoms cleared up no faster with an antibiotic, a topical steroid alone, or the two in combination than with a placebo. Also, physicians worry that continual use of antibiotics poses the risk of becoming resistant to them.

Surgery is an option for those who have symptoms that last longer than two months, that repeatedly recur, or that don't respond to medication. Since the mid-1980s, nasal surgery has been done with fiberoptic endoscopes, very thin flexible tubes, that allow ear nose and throat (ENT) surgeons to see directly into the patient's nasal passages. However, surgery to open nasal passageways involves the removal of bone and tissue, often an extremely painful process with a long recovery period. It also can result in scarring and other complications. Because conventional surgery is perceived to be so miserable and risky, most regard it as a last resort and then only in the most severe cases

Fortunately, a new evolution in sinus surgery offers an appealing and effective alternative to the old. Joshua Makower, MD, a physician/engineer and chronic sinusitis sufferer, developed the balloon procedure for Acclarent, Inc., of Menlo Park, California, receiving FDA clearance for his technology in 2004. The procedure is called Balloon Sinuplasty (TM), and it works to clear sinuses the same way angioplasty does to clear blocked arteries in the heart.

With the aid of a tiny camera, the physician guides a wire catheter that is thinner than a human hair through the patient's nostrils into the clogged area. The flexible catheter is equipped with a tiny sausage-shaped balloon that is inflated about a quarter-inch once it is in place. As the balloon expands, it puts gentle pressure on the bones of the nasal passages, spreading them apart and allowing mucous to drain.

Because the bones in the nasal passages are thin and malleable, they open easily. Once the passageways are widened, the balloon is deflated and withdrawn. Because no tissue or bone is removed, patients bleed less than with conventional surgery.

The balloon procedure is done as an out-patient. Surgery usually takes less time than traditional sinus surgery, depending on the number of sinus blockages, and patients usually can go home a few hours later.

Balloon Sinuplasty (TM) doesn't entirely eliminate the need for conventional sinus surgery. The balloon will not fit all passageways and may not work for patients with large cysts, severe bone disease, or previous sinus surgery. Also, because the nasal passages are in close proximity to the brain, the procedure poses a potential risk of injury--as there is with any nasal surgery.

However, the tens of thousands of chronic sinusitis sufferers who have undergone Balloon Sinuplasty (TM) since it was approved by the U.S. Food and Drug Administration say that it has helped them tremendously. Today, thousands of surgeons have been trained to perform the procedure, and the number continues to increase.

Studies have found that in 90% of cases patients have significant improvement and that their nasal passages stay widened. If they do not, the sinuplasty can be repeated.

Fred Kuhn, MD, founder of the Georgia Nasal & Sinus Institute in Savannah and a past president of the American Rhinologic Society, says he considers balloon dilation of the sinus openings "a major advancement" in the treatment of chronic sinusitis.

American Rhinologic Society.

Antibiotics and Topical Nasal Steroid for Treatment of Acute Maxillary Sinusitis - A Randomized Controlled Trial" Ian G. Williamson, MD; Kate Rumsby, BA; Sarah Benge, PhD; Michael Moore, FRCGP; Peter W. Smith, PhD; Martine Cross, BA; Paul Little, MD JAMA. 2007;298(21):2487-2496.

Balloon Sinuplasty (TM) by Acclarent.

National Institute of Allergy and Infectious Diseases.

Beth W. Orenstein of Northampton, Pennsylvania, is a freelance medical writer. She writes for national professional health magazines. A magna cum laude graduate of Tufts University, she majored in English.