Walker RP et al. Otolaryngology-Head and Neck Surgery (2006) 135,549-554
My take:
This is the first study to look at the Pillar Implant System as a method to treat sleep apnea. The study shows there is improvement in snoring and roughly 75% patient satisfaction and bed partner satisfaction.
There is one group of patients who did not improve with the implant system. This was the group with a Mallampatti or Freidman Tongue Position score of 3 or 4 (when looking in the mouth, the uvula cannot be seen without depressing the tongue). In this group, the base of tongue is playing too much of a role and likely needs to be addressed as well to obtain good results.
This study shows the Pillar Implant System can be used to treat snoring, but I do not believe it can be used to treat sleep apnea on its own. There may be a role for the use of this system when combined with other treatment methods but this was not addressed in this study.
Summary
This was the first article investigating the ability of palatal implants to treat mild to moderate sleep apnea. There were 5 centers involved across the United States. In total, 53 patients were accepted into the study. To be included, patients had to have an AHI between 10 and 30, the doctors involved had to believe the palate was the primary source of obstruction without any nasal obstruction. Patients could not be significantly overweight (BMI <32) and could not have had any other procedure done for snoring during the study.
Patients had a sleep study done, filled out the Epworth Sleepiness Scale (ESS) and bed partners filled out a snoring survey before the procedure and another 3 months after the study.
Results:
- 75 % of patients had improvement in their sleep apnea (AHI)
- This went from an average of 25 to 22.
- Average snoring score improved from 7.9/10 to 4/10
- Average daytime sleepiness using the ESS improved from 11 to 4.5.
- Three out of four patients would recommend the procedure.
Complications:
- The extrusion rate (implant came out) was 4 to 9 %.
- Four patients had some persistent irritation at the implant site. One of these required antibiotics.
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