The Pillar Palatal Implant, approved by the FDA for sleep apnea and snoring, was shown to be effective for both conditions in two new studies to be presented in Los Angeles next week at the annual meeting of the American Academy of Otolaryngology -- Head and Neck Surgery.
"This is one of the more promising new treatments out there," says Dallas sleep medicine specialist Craig Schwimmer, MD, who did not participate in either of the studies.
"To me the biggest attraction to this is that it is an effective alternative to standard surgery," he tells WebMD.
The standard surgery involves removal of excess tissue at the back of the throat and soft palate, a procedure known as uvulopalatopharyngoplasty (UPPP). Patients who get the surgery face weeks of painful recovery and they don't always improve.
"This isn't a surgery that it is easy for patients to get excited about," Schwimmer says.
The New Sleep Apnea Treatment
Sleep apnea and loud persistent snoring are two of the most common sleep complaints. If left untreated sleep apnea can lead to major health problems such as heart disease, high blood pressure, and stroke. People with the disorder often snore, but not all snorers have sleep apnea.
Both conditions are caused by partial airway collapse, often due to weakening of the muscles of the soft palate. Palate movement, or "palatal flutter," causes the vibration, which results in snoring.
The new treatment reduces the movement or vibration of the soft palate with implants designed to stiffen it. Using a special needle, three pieces of braided, polyester string about three-quarters of an inch long each are inserted into the soft palate near the point where it meets the hard palate.
Although considered a surgical procedure, implantation takes only about 10 minutes and it is done under local anesthesia in the physician's office.
"People with sleep apnea have no trouble breathing during the day," Loyola University Medical Center associate professor of otolaryngology Regina P. Walker, MD, tells WebMD.
"They have very good airway flow when they are sitting up and standing, and terrible airway when they are lying flat. What we do with this procedure is try to recreate the muscle tone that is compromised when patients lie down. Like when you suck something through a straw, the stiffer the straw, the less likely it is to collapse."
Patients and Partners See Improvement
In the sleep apnea study, Walker and colleagues followed 53 patients treated with the palatal implants at five centers around the country. At evaluation three months after implantation, roughly three-fourths of the patients' bed partners reported witnessing no evidence of sleep apnea.
Nearly 75% of patients and bed partners said they would recommend the procedure to a friend or family member.
"The implants were as effective as other surgical treatments, but there was much less pain and recovery time involved," Walker says. "From the patient standpoint, it was easy."
The second study involved 25 patients who snored loudly night after night but did not have sleep apnea. All the patients were treated at the Lahey Clinic in Burlington, Mass.
Three months after getting the implants, 75% of the patients and 90% of their bed partners reported that they would recommend the procedure. Independent testing showed that snoring loudness declined significantly following the surgery.
Researcher John Romanow, MD, FACS, tells WebMD that even though the implants are rarely covered by insurance, patients often consider the $1,500 to $2,500 out-of-pocket costs well worth it.
Restore Medical, Inc., of St. Paul, Minn., the manufacturer of the palatal implant, funded both studies.
Just as with standard surgery, all patients with sleep apnea and snoring are not good candidates for palatal implants. Surgical treatments do not work well in patients who are extremely obese, and implants are also not recommended for people with very large tonsils.
Implants may be an effective option, however, for patients who are still having problems after having traditional surgery, Walker says.
"I tell my patients that they don't have a lot to lose with this procedure, other than some money," she says. "If it doesn't work, we still have the other treatment options available to us."