Dr Regina P. Walker of the Hinsdale Medical Center in Hinsdale, Ill., and colleagues tested the Pillar procedure in 22 middle-aged patients, including 16 men and six women, with mild-to-moderate sleep apnoea. Although some of the patients had previously tried a treatment called continuous positive airway pressure (CPAP), none had undergone any earlier surgery for their sleep apnoea.
After 90 days, 17 of the subjects showed significant improvements in their snoring intensity, daytime sleepiness and apnoea hypopnea index, a measure of breathing interruptions that occur during sleep. Most significantly, these results were sustained after 15 months, indicating that the improvements could be permanent, according to Walker.
Overall, the patients' apnoea hypopnoea index decreased from a mean of 19.5 to 13 events per hour after 90 days, and to 12.8 events per hour after 15 months.
Walker was expected to present the study at the 110th annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery Foundation, being held Sept. 17-20 in Toronto, Canada.
An important study
"This is an important study," said Dr Michael Friedman, chairman of head and neck surgery at Rush-Presbyterian-St. Luke's Medical Center in Chicago. "Sleep apnoea is a huge problem affecting millions. If you count very mild forms of sleep apnoea, the number just goes up."
In sleep apnoea, breathing stops or gets very shallow during sleep. Each pause in breathing typically lasts 10 to 20 seconds or more. These pauses can occur 20 to 30 times or more an hour. The most common type of sleep apnoea is obstructive sleep apnoea, according to the US National Institutes of Health.
Even mild forms of sleep apnoea can increase a person's risk of cardiovascular disease by five times, Friedman said. The condition is also associated with an increased risk of high blood pressure, weight gain, memory problems, depression and impotence.
Until the Pillar procedure was introduced about six years ago, patients with sleep apnoea only had two treatment options: CPAP, a machine that keeps the airways open during sleep; and invasive surgery to remove excess tissue in the mouth and throat.
Old treatments have drawbacks
"Although both treatments are effective, they have drawbacks," Friedman said. "Because many patients are unwilling or unable to use a CPAP machine, compliance is only about 40%. And the results of invasive surgery tend to diminish after a year as tissues loosen and symptoms return," he said.
During the in-office Pillar procedure, patients receive a local anesthetic before several polyester rods are inserted into their soft palate. Pain is usually minimal and can be managed with over-the-counter medications.
Most patients can resume full activity the same day and return to their usual diets after a day or two. They usually can't even feel the implants after a week or two. "Rarely, implants work their way to the surface and must be re-implanted," Friedman said.
It's not the rods themselves that tighten loose tissue and reduce symptoms of sleep apnoea, but the scar tissue that forms around them. "Scar tissue tends to become more effective over time," Friedman said. "That's why this study is important, because it shows that the results are stable or even better after 15 months, whereas the results of invasive surgery drop off after a year."
Not for morbidly obese
Although most of the patients in Walker's study were overweight or mildly obese, the Pillar procedure isn't recommended for patients who are morbidly obese. Friedman estimated that up to 50% of sleep-apnoea patients are candidates for the procedure, but said it probably would be a stand-alone treatment for only about half of them.
"The nice thing about this procedure is it doesn't eliminate the possibility of other procedures," Walker said. "Quite often, we can combine many treatments. Studies are now being done on implant patients who use CPAP machines to see if it's possible to reduce CPAP pressure."
The Pillar procedure costs about $1 500, which insurance may cover in patients with diagnosed sleep apnoea but not in patients who simply have snoring problems. "It's still a fairly new procedure that doesn't have a specific CPT code," Walker said. "I would say that about 25 to 30% of procedures in sleep-apnoea patients are being paid for, although the number appears to be increasing."
Some doctors are using the Pillar procedure to treat severe sleep apnoea. "But this hasn't been well-studied," Walker said. "So, it's too early to say if the implants will be of benefit to such patients." -(HealthDayNews, September 2006)