Palatal Implants Offer Long-Term Benefits in Obstructive Sleep Apnea

From the American Academy of Otolaryngology?Head and Neck Surgery

TORONTO—Implanting tiny polyester rods in the soft palate provides long-lasting symptom relief for patients with obstructive sleep apnea (OSA), researchers reported at the 110th Annual Meeting of the American Academy of Otolaryngology—Head and Neck Surgery.

Treatment for the 12 million Americans with OSA has traditionally begun with continuous positive airway pressure (CPAP). For patients who do not respond to CPAP, various surgical techniques have been tried, including removal or reduction of portions of the soft palate and part or all of the uvula.

Early results from short-term trials showed that the palatal implants reduced nighttime snoring and apneic episodes, as well as daytime sleepiness. The new results suggest that these benefits persist in the long-term.

The same researchers who conducted the extended follow-up study participated in an earlier trial of 53 adults with mild-to-moderate OSA who were recruited from 5 clinical sites and met the criteria for implantation.

The criteria for using the palatal implants included: age >18 years; apnea-hypopnea index 10 to 30 episodes/hour; body mass index ≤32 kg/ m²; soft palate length >25 mm; no significant nasal obstruction; and no previous pharyngeal surgery.

The procedure involves inserting 3 tiny Pillar (Restore Medical) palatal inserts (Photo) into the soft palate under local anesthesia during a brief office procedure. The implants stiffen the soft palate, reducing the likelihood of airway obstruction and lessening the vibration that causes snoring.

At 90 days postprocedure, the apnea-hypopnea index decreased from 25.0 to 14.8 events/hour, Epworth Sleepiness Scale scores (a measure of daytime sleepiness) decreased from 11.0 to 6.9, and snore scores (based on a visual analog scale) decreased from 7.9 to 4.0.

The extended follow-up study included 16 men and 6 women (average age, 53 years; mean body mass index, ≤27.8 kg/m²) who participated in the original study and were stratified according to their response at 90 days (indicated by a decrease or increase in the apnea index).

Results showed that almost 77% of the patients who had shown a favorable response at 90 days continued to reap benefits. On average, apnea-hypopnea index decreased from 19.5 events/hour at baseline to 13.0 at 90 days and to 12.8 at 15 months.

In this group, daytime sleepiness scores, based on the Epworth Sleepiness Scale, decreased by 43%, and snoring scores decreased by 56% at the end of 15 months. In contrast, patients who were classified as nonresponders at 3 months did not improve at 15 months.

Despite this and the small study size, the researchers, led by Regina P. Walker, MD, Hinsdale Medical Center, Hinsdale, Ill, said the results were encouraging, showing “prolonged objective and subjective improvements in treatment outcomes of OSA and snoring.”

The researchers noted that this simple office procedure should be considered as an initial treatment for patients with OSA who meet the criteria for this minimally invasive implantation.