Adverse events associated with device assisted hyoid and tongue base suspension for obstructive sleep apnea.

PURPOSE: Hyoid and tongue base suspension may treat obstructive sleep apnea (OSA). This study summarizes device-related adverse events associated with the AIRvance and AIRLIFT systems used for hyoid and tongue base suspension.

MATERIALS AND

METHODS

The U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports describing adverse events associated with hyoid or tongue base suspension from January 2012 to December 2022.

RESULTS

77 adverse events were identified. When performed separately, adverse events were equally as common with hyoid suspension as with tongue base suspension. More complications occurred postoperatively (51 [66.2 %]) than intraoperatively (26 [33.8 %]). The most reported adverse events were infection (23 [29.9 %]), broken screw (15 [19.5 %]), pain or discomfort (10 [13.0 %]), suture rupture (8 [10.4 %]), and dislodged screw (7 [9.1 %]). 10 infections required drainage or debridement; 12 required device explantation.

CONCLUSIONS

The present study is the largest and most longitudinal review of adverse events associated with hyoid and tongue base suspension. Infection was the most common adverse event, and may require device explantation. While adverse events were most frequently attributed to device malfunction, broken screw, suture rupture, and broken needle were often attributed to operator error due to application of excessive force. Surgeon training to increase familiarity with hyoid and tongue base suspension may reduce adverse events caused by operator error. The MAUDE database is limited as a passive surveillance system. Standardized reporting may improve understanding of associated adverse events, enabling better informed comparisons between surgical treatment options for OSA.