BY J.L. WEBB

A procedure for ear, nose and throat specialists that takes its technological cue from heart angioplasty may be the most important medical advance in two decades for treating patients who have chronic sinusitis.

A device developed by a California company, Acclarent, Inc., enables ENT surgeons who are trained and certified in the procedure to insert a catheter, with a deflated balloon attached to the tip, into the nostrils. Once the area of blockage is reached, the balloon is inflated and manipulated to open and drain the passageway. It is then deflated before removal.

About 5,000 Balloon Sinuplasty™ surgeries have been performed under general anesthesia as outpatient procedures since October 2005. Most patients are back at work or play in 24 to 48 hours, having been spared the usual week-long recovery period of those who undergo traditional surgery. The traditional method is more invasive and removes tissue and bone, which results in bleeding that requires extensive – and summarily uncomfortable – nasal packing. It is performed on more than 350,000 Americans each year.

The Balloon Sinuplasty device has provided an eye-opening – or more accurately, sinus-opening – option to Dr. Joseph J. Bradfield, one of only about 825 otolaryngologists in the United States, and about a dozen in Central Florida, certified in the procedure.

"There's an ever-increasing number of patients who are candidates for this very promising technology,'' Bradfield said. "I'm not big on jumping on technological bandwagons, but I was convinced very early in the process that this is a very useful addition to our patients and our specialty,'' said Bradfield.

According to an Acclarent spokeswoman, courses are offered across the country for ENT surgeons who wish to be trained in sinus balloon catheter technology. Each course consists of didactic presentations, filmed case studies, hands-on training and surgical observation. The courses are under the direction of Acclarent's professional education group and a leading faculty member from the field of otolaryngology.

Bradfield, 49, who practices at the Barranco Clinic in Winter Haven, has been certified in the balloon procedure for about seven months.

"I've been using (Balloon Sinuplasty) mostly as an adjunct to conventional surgery. So far, half-a dozen surgeries have been completed and everybody is happy, '' he said. "We're moving gradually away from the rip-and-tear (endoscopic) surgery and approaching it from a microsurgical standpoint.''

Bradfield concurs with other otolaryngologists who have recognized that sinus catheter surgery is likely to transform their practices.

"Once you get a feel for how sweet it works, you're hooked,'' he said. "You'd have to go way back to find a more significant step in sinus surgery,'' Bradfield said.

To put it in perspective, Bradfield said he persuaded the local hospital to accommodate this modern procedure by saying that 20 years ago, people started taking out gall bladders endoscopically.

"People then said, "Oh, that'll never catch on,'" he said. "Now it's hard to find someone who won't do it that way.''
Balloon catheters for sinuses are "a big step in the appropriate direction,'' he said.

"This is another weapon to shoot at the frontal sinus area just above the eyes, where traditional surgery (for severe sinus ailments) sometimes fails,'' Bradfield said. "We had a patient who had undergone unsuccessful (traditional) surgery for frontal sinuses. Then we tried Balloon Sinuplasty. We actually connected the dots, working from above, through the frontal sinuses and then below, from where we fed the balloon catheter. Great results. This appears to be a safe, effective and minimally invasive treatment option to relieve sinus ostial obstruction.''

Bradfield acknowledged that, at first, the sinus catheter surgery took him longer to complete than traditional endoscopic surgery, but "each time you do it, you get more and more facile,'' he said. Recently he did "four sinuses in 45 minutes,'' he said.

From a cost standpoint, Bradfield pointed out that the hospital's initial investment is minimal, "which makes it pretty attractive (financially),'' he said. "There's not a lot of capital equipment cost needed. The catheters are kind of dear (monetarily speaking), but that's about it.''

Dr. Trina Espinola, an otolaryngoloist and a member of the Florida Board of Medicine, concurred with Bradfield.

"The cost is only about $1,000 more than traditional surgery," she said. "It's more expensive only because of (the cost of) the balloon.''

Long-term data collection is ongoing, but a research analysis by Acclarent, the CLEAR study, "demonstrated a clinically and statistically significant improvement in patients' symptoms," she said.

Still, those physicians on the front line of diagnosing and treating chronic sinusitis are reserving judgment.

Dr. Steven Rosenberg, 57, is a partner in Allergy and Asthma Associates of Central Florida in Winter Park. The asthma, allergy and immunology specialist said allergies are still the number one cause of sinus infections. "As internists, our job is to find the cause and treat it,'' he said.

Rosenberg estimated 20 to 30 percent of his patients have acute or chronic sinusitis. Of that group, "only about 10 to 15 percent will not respond to medications.''

"We treat by conservative means first,'' which typically involves "antibiotics, nasal steroids and draining methods,'' Rosenberg said. "It's important to stress that most people can be treated successfully.''

Only after a couple of months of failing to correct the problem with those treatments would Rosenberg refer a patient to an ENT for a possible surgical solution.

But for a patient in that category, who probably has been diagnosed with maxillary, sphenoid or frontal ostial obstruction, the Balloon Sinuplasty technology has become a viable intermediate alternative to conventional sinus surgery.

"This technology will make a significant, positive difference in the 'redo rate,''' said Bradfield. "When you're looking at six months out and (tracking studies) show such an impressive patency rate (more than 81 percent), you know you're onto something big."