Pillar Procedure Safe, Effective for Snoring, and Bed Partner Recommended

Newswise — Habitual snoring affects approximately one in five of all Americans. In the past decade, there has been a significant increase in treatment options for snoring, ranging from herbal remedies to mechanical devices to a variety of new surgical outpatient procedures.

Snoring and obstructive sleep apnea (OSA) comprises a continuum from partial airway collapse with vibration of the upper airway to complete airway obstruction. Airway collapse in OSA can occur at a variety and multiplicity of sites, while most vibration of the soft tissues in snoring is thought to occur at the level of the soft palate. A variety of outpatient surgical procedures have undergone evaluation for the treatment of snoring, including laser assisted uvulopalatopharyngoplasty (LAUP), radiofrequency treatment to the soft palate, injection snoreplasty, and the newest treatment, polyethylene terephthalate (PET) palatal implants or Pillar® Procedure, produced by Restore Medical Inc., St. Paul, Minnesota.

Two otolaryngologists—head and neck surgeons set out to report on their experience and patient outcome data with Pillar palatal implants. With a grant from Restore Medical, Inc., St. Paul, Minnesota, they have provided their findings in a study, "Efficacy and Safety of Palatal Implants for the Treatment of Socially Significant Snoring." The authors are John H. Romanow MD FACS, and Peter. J. Catalano MD FACS, from the Otolaryngology Department, Lahey Clinic, Burlington, MA. Their findings are to be presented at the 109th Annual Meeting & OTO EXPO of the American Academy of Otolaryngology—Head and Neck Surgery Foundation, being held September 25-28, 2005, at the Los Angeles Convention Center, Los Angeles, CA.

In this study, researchers evaluated the safety and efficacy of palatal implants for the treatment of socially significant snoring. Palatal implants are made of braided material measuring 18 mm by 1.6 mm and are inserted transmucosally in a passage created by an introducer needle. The implants are placed in the central portion of the soft palate muscle, which serves to stiffen the tissues of the soft palate and reduce dynamic flutter. Once in place, the implants induce a foreign body response (scarring) that further stiffens the soft palate. The palatal implants have received FDA clearance for treating both snoring and mild to moderate OSA. PET is a stable, biologically inert compound that has a long history of human implantation in other areas of the body.

Methodology: A prospective trial of 25 patients who presented at an otolaryngology department was conducted. All patients had a primary complaint of socially unacceptable snoring. All patients underwent a medical evaluation, and patients who were deemed at risk for OSA were excluded from the study unless polysomnography, or sleep study, demonstrated the absence of OSA. Patients were considered primary snorers if their complaints were socially unacceptable snoring in the absence of witnessed apnea and hypersomnulence. Polysomnography was not routinely performed.

Prior to enrollment in the study, patients and their bed partners were asked to fill out pre-procedure questionnaires. These questionnaires used a 10 centimeter visual analogue scale (VAS) to identify the severity of the snoring, as well as its ramifications in the home. Patients were also asked to assess their sleepiness using both a VAS as well as the Epworth Sleepiness Scale (ESS). On the day of the procedure, physical measurements were made including the Body Mass Index (BMI), an assessment of the nasal airway, tonsil size, uvular dimensions, Mallampati score, laryngoscopy grade, as well as the size of the base of tongue in relationship to the larynx.

Under topical and local anesthesia, three separate palatal implants were placed. The first was placed in the midline of the muscle of the soft palate, the others two mm to each side of the midline. They were placed so that the insertion point of the implant was near the junction of the hard and soft palate. Post-procedure flexible nasopharyngoscopy was done to ensure the implant was not placed posteriorly through the soft palate. All patients were given a five-day course of antibiotics post-procedure, and were offered analgesics as needed. No steroids were used before the procedure.

The patient's outcomes were assessed at one and three months post-procedure. Patient and bed partner questionnaires were assessed and evaluations were made by an otolaryngologist for complications. Questionnaires included evaluations of the effectiveness of treatment.

Results: Some 25 patients were enrolled in the study, 20 males and five females. The mean age was 52 years (range 27 to 70). The mean BMI on presentation was 29.4 (range 22.0 to 40.7).

All patients tolerated the procedure well. No changes were noted in pain, speech, and swallowing at 30 and 90 days, in comparison to pre-procedure values. Three implants partially extruded within the 90 days, for a partial extrusion rate of four percent. There were no complications as a result of the partial extrusions. Additionally, there weren't any immediate post-procedure complications from implant insertion, such as bleeding, infection, or other airway issues.

Assessment of the loudness of snoring by the bed partner using a 10 cm VAS showed a pre-procedure average value of 8.5, which decreased to 5.0 at 30 days, and then to 4.4 at 90 days. This was statistically significant at p<0.0001. The change in the subjects sleepiness was statistically significant on the VAS but not on the ESS. At 90 days, 75 percent of patients and 90 percent of bed partners recommended the procedure.

Conclusions: The researchers found the implantation of the PET palatal implants to be safe. No complications were noted during the implant placement, or post-procedure. There were no airway issues. Immediate post-procedure discomfort was minimal and managed easily. All patients had peri-procedure antibiotics and no infections occurred. No implants were noted to extrude at the time of placement, and the total 90-day extrusion rate was four percent.

The findings demonstrated to the researchers that palatal implants are an effective mechanism of significantly reducing the loudness of snoring. They interpret the results to state the procedure is safe, quick, easy to perform, and recommended by patients and their bed partners. Further work needs to be done to determine the optimal patient population and the emerging role of palatal implants in the treatment of obstructive sleep apnea.