Ryan S. Nord

Objectives Upper airway stimulation (UAS) is an effective treatment for patients with obstructive sleep apnea. The device consists of a stimulating electrode, an internal pulse generator, and a respiratory sensing lead. The purpose of this study is to characterize the incidence of sensing lead malfunction necessitating revision surgery in a high‐volume center in conjunction with a review of the FDA Manufacturer and User Facility Device Experience (MAUDE) database reports on adverse events associated with the sensing lead component. Methods Patients age ≥18 implanted with the device were reviewed between July 2017 and June 2022. Those determined to have sensing lead malfunction were analyzed. The FDA MAUDE database was reviewed for reports associated with “Inspire Model 4323 Respiratory” and “Inspire Model 4340 Respiratory” between January 2014 and September 2022. Results One hundred ninety patients underwent UAS at our institution during the study period and four (2.1%) patients were found to have sensing lead malfunction. Analysis of the MAUDE database revealed 122 reports of adverse events associated with the sensing lead component, with 72% (88/122) of these requiring revision surgery. The most frequently reported adverse event was sensing lead tip separation from lead body, noted in 46% of these reports (56/122). Conclusion The functionality of the sensing lead component is vital to the integrity of the UAS device and is measurable through waveform analysis. To provide optimal care after device implantation, it is essential to have a comprehensive understanding of the scenarios in which this component fails, the incidence of such events, and appropriate management. Level of Evidence 4 Laryngoscope , 134:1479–1484, 2024

Objective This study aims to compare readmission and complication rates between hypoglossal nerve stimulation (HNS) and traditional sleep surgery (TSS) in the 90‐day postoperative period using a federated electronic health record (EHR) database. Methods We queried TriNetX, a global federated health research network providing access to EHR data from approximately 70 million patients in 49 large health care organizations to identify individuals who underwent either HNS or TSS for obstructive sleep apnea (OSA) from April 2014 to March 2021. Propensity scores based on demographics and obesity were used to balance groups. We compared the frequency of readmission/representation and surgical‐related complication rates between cohorts. Results After propensity score matching of HNS versus palatal surgery ( n = 1014 in each cohort) and HNS versus multilevel surgery ( n = 374 in each cohort), we found palatal and multilevel surgery had a significantly higher risk of readmission versus HNS. (12% vs. 4%, p < .0001). Palatal surgery complication rate was also higher than HNS (21% vs. 2%, p < .0001). Multi‐level surgery results were similarly higher (22% vs. 3%, p < .001). The most common diagnoses at ER readmission for TSS were procedural complications and pain, while common diagnoses for HNS readmission were general complaints such as malaise and headache. Conclusions Hypoglossal nerve stimulation has lower risk of readmission and postoperative complications than traditional sleep surgery as demonstrated in a large research network database analysis. Level of Evidence: 3.