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New Study Findings on Extended Follow-Up of Palatal Implants for Obstructive Sleep Apnea

ALEXANDRIA, VA -- September 19, 2006 -- Sleep apnea is a disorder afflicting some 12 million Americans. It causes a sleeping person to literally stop breathing for one or more breaths. Obstructive sleep apnea (OSA) is the most common form of the disorder, frequently associated with disruptive snoring, and being viewed as a potential cardiovascular disease risk.

Background
For decades, treatment for OSA began with (CPAP), or Continuous Positive Airway Pressure, in which a controlled air compressor generates an airstream at a constant pressure. Removal or reduction of parts of the soft palate and some or all of the uvula, such as uvulopalatopharyngoplasty (UPPP) or laser-assisted uvulopalatoplasty (LAUP) are surgical options that are considered for patients that fail CPAP. For children, and some adults, removal of enlarged tonsils often provides relief from this sleep disorder.

At the turn of the century, a new treatment for mild to moderate obstructive sleep was introduced to the public. The Pillar® procedure involves palatal implants, small polyester rods, that are surgically inserted into the soft palate. The rods are each 3/4" long and are injected under local anesthetic. Most patients receive three such implants necessary to stiffen the soft tissue of the palate. This goal is to prevent the roof of the mouth from fluttering and collapsing during sleep.

Previously published reports on palatal (upper roof of the mouth) implants to treat the disease using the Pillar® procedure have indicated both short-term and long-term successes for mild to moderate OSA. A new study involving four clinical sites in the United States finds that this implant approach to treatment is beneficial in carefully chosen patients. The study was intended to evaluate the safety and effectiveness of permanent palatal implants for the treatment of patients with mild to moderate OSA after an extended follow-up period in a US study population

A New Study
The study, entitled Extended Follow-up of Palatal Implants for OSA Treatment, is the work of Regina P. Walker MD, Hinsdale Medical Center; Howard L. Levine MD, Director, Cleveland Nasal Sinus & Sleep Center; Cleveland, OH; Martin L. Hopp MD PhD, Cedars-Sinai Medical Center, Los Angeles, CA; and David Greene MD, FACS, Chief of Otolaryngology, Medical Surgical Specialists Adjunct Staff, Cleveland Clinic Head and Neck Institute, Naples, FL.

Dr. Walker and her colleagues will be presenting their findings at the 110th Annual Meeting & OTO EXPO of the American Academy of Otolaryngology—Head and Neck Surgery Foundation, being held September 17-20, 2006, at the Metro Toronto Convention Centre, Toronto, Canada.

Methodology
Patients with mild to moderate OSA were implanted under local anesthesia with three implants into the soft palate during a short office procedure. The implants, cylindrical and measure 18 mm by 1.8 mm are made of porous and braided polyethylene terephthalate (PET), a material common in many medical applications.

Polysomnography (sleep study) AHI, daytime sleepiness (Epworth Sleepiness Scale), and snoring intensity (Visual Analog Scale) data were measured at the start of the follow-up period, 90 days, and approximately 15 months post-procedure. The primary outcome measure for this study was AHI, which provides objective evidence of sleep-related apneas and hypopneas. Secondary outcomes included the Epworth Sleepiness Scale (ESS), a validated measure of daytime sleepiness, and a Visual Analog Scale (VAS) to measure the degree of snoring intensity. The ESS is a series of eight questions that determine the level of sleepiness encountered in various activities (watching TV, reading, etc.).

Results
Extended follow-up data was obtained for 22 (16 males, 6 females) of the patients originally enrolled in the initial study. These patients met the original inclusion criteria and had no other treatment for OSA rendered during the extended follow-up period. Patients had a mean age of 53.3 ± 11.9 years (range of 32-76) and a mean body mass index of 27.8 ± 2.8 kg/m2. Mean follow-up time was 446 ± 85 days (approximately 15 months). Patients were stratified by an increase or decrease in AHI at 90 days.

Mean AHI for patients responding to treatment at 90 days decreased from 19.5 ±
4.9 events per hour at baseline to 13.0 ± 8.3 at 90 days, and 12.8 ± 8.6 at fifteen
months. Significant decreases for daytime sleepiness and snoring intensity were also maintained. No adverse events were reported.

This suggests that soft palate implants produce prolonged objective and subjective improvements in treatment outcomes of OSA and snoring. A significant long-term reduction of AHI, daytime sleepiness, and snoring was maintained in 76.9% of the patients who had a favorable result noted at the 90-day follow-up. The extended follow-up of approximately 15 months demonstrated a lasting improvement in the patients that originally responded to the implants, which are designed to have a permanent effect providing rigidity to the soft palate.

Conclusions
The palatal implant treatment should be considered as an initial, minimally invasive, surgical treatment option for patients with OSA. This study found that most patients who initially responded to minimally invasive palatal implant treatment for mild to moderate OSA at 90 days maintained favorable treatment responses over an extended follow-up period. Improvements in OSA related events; daytime sleepiness and snoring symptoms were maintained long-term. These data add to the continuing evidence supporting the effectiveness of palatal implants for patients with OSA. When considering the low morbidity and simplicity of this office procedure, palatal implants can be considered as an initial, minimally invasive, surgical treatment option for properly selected patients.


SOURCE: American Academy of Otolaryngology Head and Neck Surgery

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