Radiofrequency Volumetric Tissue Reduction of the Palate in Subjects With Sleep-Disordered Breathing: Conclusion

30 May
2014

Our study showed a mean Sa02 nadir on posttreatment (48 to 72 h) of 86.5 ±6.3%, which was similar to the Terris et al report of 87.7±6.2%. The importance of these findings is the substantial change in the airway after treatment with both LAUP and RF (our study). A worsening trend in the RDI and Sa02 is noted in our group and in the RDI in the Terris et al group. In subjects with more substantial SDB, development of edema with the risk of upper airway compromise is of concern. However, the clarification of patient groups that would safely benefit from this treatment is not yet defined, and until this is accomplished, it is suggested that subjects who have moderate or severe SDB who undergo RFe treatments as outpatients be carefully monitored and treated. canadian health and care mall

It is well established that controversy exists concerning how to define snoring, let alone how to measure this variable in a valid subjective or objective reproducible manner. The confounds are many and the electronic equipment and software are confusing. The reports of snoring by Hoffstein et al over the years are by far the most comprehensive and define the problems associated with evaluation of this symptom or complaint. We agree with their report that suggests that snoring is in the ear of the beholder. A snoring microphone was used during the polysomnogram on all of our subjects but only to assist in polysomnographic scoring purposes. Since this system was not quantitatively accurate to use as an objective tool to assess snoring levels, we elected to use a VAS scale. Both the subject and bed partner participated in this subjective assessment, as suggested by Wiggins et al. Although all of these issues on snoring are germane to this study, the simple fact is that this variable was only a secondary objective and used to assist in establishing the end point of treatment. Fortuitously, the decrement in this variable during treatment coincided with the goals of the subject and the protocol. Snoring levels by VAS score decreased from baseline 77%, which was a sufficient decrement to satisfy the study group.
Conclusion
The primary and secondary goals of this investigation have been carefully evaluated. The results suggest that in this defined group of subjects, using the formulated RFe parameters, safety was established and concerns of adverse effects or worsening of SDB were not seen. The limited statistical power and small sample size in this study make it difficult to fully correlate these findings with risk or final outcomes. Until this technology can be evaluated in patients with more advanced SDB with primary retropalatal obstruction, caution is advised.

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