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Title: New Palatal Implant Shows Promise in Sleep Apnea: Presented at AAO-HNSF

"New Palatal Implant Shows Promise in Sleep Apnea: Presented at AAO-HNSF"

By Jill Stein NEW YORK, NY -- September 20, 2004 -- Investigators are reporting early favorable results using the Pillar Palatal Implant System for the management of obstructive sleep apnea. Initial results in 24 patients followed for 30 days revealed no significant complications during the procedure or at any time point during follow-up, said Regina P. Walker, MD, Clinical Associate Professor of Otolaryngology, Hinsdale Medical Center/Loyola University of Chicago, Chicago, Illinois. She presented the data here on September 19[^th at the American Academy of Otolaryngology - Head and Neck Surgery Foundation Annual Meeting.

"Pillar soft palate implants are a new and effective treatment for snoring, and patient and bed partner satisfaction remain high 1 year following the implant," Dr. Walker pointed out. "Clinically significant decreases in the apnea-hypopnea index and daytime somnolence have recently been reported in patients with obstructive sleep apnea in European studies."

The present study assessed the morbidity and efficacy of the palatal implants in mild to mild-to-moderate sleep apnea. Patients were 18 years of age or older, had an apnea-hypopnea index (AHI) of 10 to 30 episodes per hour, a body mass index of 32 kg/m² or less, a soft palate length greater than 25 mm, no significant nasal obstruction, and no prior history of pharyngeal surgery.

For each patient, three implants were placed in the patient's soft palate under local anesthesia during a single-stage office procedure.

Minimal pain and swallowing difficulty were noted at 24 to 72 hours but diminished quickly. Speech quality was unchanged by the procedure.

Mean daytime somnolence, as measured by a visual analog scale, was significantly reduced from 8.4 to 5.2 (P =.001). Among bed partners questioned, 82% noted improvement in the patient's snoring at 30 days; 20% of bed partners reported episodes of apnea compared to 71% at baseline.

A small number of patients had partial extrusion of the implant, which were removed and replaced without incident. Dr. Walker said that extrusions may result from superficial placement and added that implants need to be placed deep within the palatal muscle to minimize the potential for this complication.

"Overall, our early results suggest that the new Pillar Palatal Implant System is associated with minimal morbidity and provides improvements in quality of life measures including daytime somnolence, snoring intensity, and the number of observed apneas," she said.

Ninety-day polysomnography testing is needed for all patients, to evaluate the treatment's effectiveness in AHI reduction, she added.

Active recruitment for the trial is ongoing.

[Presentation title: "Soft Palate Implants: A New Treatment for Obstructive Sleep Apnea." Abstract R072]

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