At the recent AAO-HNS meeting, Dr. Catalano presented a study showing that patients with refractory snoring who failed on three Pillar implants were successfully treated with up to five implants. The study included 31 patients; of these, 26 were considered cured and five remained failures. There is no FDA indication for more than three implants yet, he said.
Explore This IssueJanuary 2007
A multicenter prospective study with an investigational device exemption (IDE) has been approved by the FDA to look at the benefit of additional Pillar implants in 50 patients who are snorers without obstructive sleep apnea. After this study is completed, Dr. Catalano and colleagues plan to apply for another IDE study in patients with obstructive sleep apnea.
Patients with sleep apnea often have obstruction at several sites, and surgical procedures used in combination to address the involved sites may provide improved outcomes.
The safety and efficacy of combining Pillar implants with nasal surgery was assessed in a preliminary study reported by Dr. Catalano at the AAO meeting. The study enrolled 11 patients with nasal and palatal obstruction who were treated with combined nasal and Pillar surgery. Six patients were cured, and of the remaining five patients, only two had mild elevations of obstructive sleep apnea.
If those five patients received additional Pillar implants, they might have gotten better, Dr. Catalano said. He noted that concern has been raised that nasal surgery may make some patients worse. In his experience using nasal surgery alone, 50% of 15 patients had cured apnea and only 15% had worsened apnea.
In summary, he said, The potential for the Pillar implant is just beginning to be explored. We are now learning how to use them.
The tongue base, Dr. Friedman said, can be reduced using a new technique called submucosal glossectomy. This procedure, still under development, entails a tiny incision and a radiofrequency device that utilizes cool energy to disrupt the tissue at the tongue base and aspirate out the debris. Thus far, Dr. Friedman has treated more than 50 patients with the glossectomy and says it is a bloodless procedure with minimal pain that should be widely applicable for patients with obstructive sleep apnea.
A larger study of about 90 patients will be initiated to compare the Pillar procedure with submucosal glossectomy and with the combination of both procedures. Although glossectomy can be an outpatient procedure, for the time being, Dr. Friedman admits patients for an overnight stay in the hospital.