Mitigating Infection Risk in Upper Airway Stimulation.

OBJECTIVE: This study aims to define the incidence of infection with upper airway stimulation (UAS) devices requiring explantation in a single academic center and identify factors that may influence the risk of infection. METHODS: A database of patients who underwent UAS at a single tertiary referral academic center from 2017 to 2021 was retrospectively reviewed to identify patients who developed surgical site infections, with and without subsequent explantation. Additional data for cases complicated by infection was extracted from the electronic medical record (EMR) and included: demographic information, medical history, complications and management, and overall outcomes. In March 2021, 2 modifications to infection control protocols were implemented: double skin preparation with Betadine and chlorhexidine, and MRSA decolonization. Statistical analysis was performed to compare infectious risk before and after these protocol changes. RESULTS: In the study period, 215 patients underwent UAS in the specified time period and 3 cases (1.4%) of postoperative infections were identified, all of which required explantation. The infection rate did not significantly change after modifications to the surgical prep protocol (P = .52). CONCLUSIONS: While no significant difference in infection risk was noted after modifying infection control protocols, additional longer-term study is warranted to elucidate effective infection reduction strategies.

Respiratory Sensing Lead Malfunction in Upper Airway Stimulation: A Single Institution Report.

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.

Early effects of very early cochlear implant activation on tinnitus.

BACKGROUND: Cochlear implantation (CI) has long been the standard of care for patients with severe-to-profound hearing impairment. Yet the benefits of CI extend far beyond speech understanding, with mounting recent literature supporting its role in tinnitus abatement. However, those studies have uniformly analyzed the effects of tinnitus after the traditional 3-4 weeks waiting period between CI surgery and device activation. As many clinics are shifting these waiting intervals to become shorter (in some cases within 24 hours, little is known about tinnitus abatement very early in the postoperative period. The aim of this study was to compare preoperative and postoperative tinnitus handicaps in this unique but growing population of very early-activated patients. METHODS: Twenty-seven adults with severe-to-profound hearing impairment with chronic tinnitus (>6 months) were included. Patients with concomitant psychiatric disorders were excluded. All patients were implanted with the same array and were switched on within 24 hours after the surgery. Tinnitus Handicap Inventory (THI) was recorded preoperatively, immediately after activation at 24 hours postoperatively, at 1 week, 2 weeks, and I month after activation. Wilcoxon signed-rank test was used to compare values between preoperative assessment and respective fitting sessions. RESULTS: Mean THI 24 hours after implantation increased in comparison to that assessed preoperatively (77.6 vs 72.5, p = 0.001). By 1 week after surgery, the THI had decreased to 54.9 ( p < 0.001). This trend continued and was statistically significant at 2 weeks (36.0, p < 0.001) and 1 month (28.5, p < 0.001). CONCLUSION: On average, most patients with tinnitus will note a significant improvement in their tinnitus handicap when activated within 24 hours of CI. However, tinnitus does increase between surgery and 24 hours, most likely reflecting not only intracochlear changes, but modulation of the entire auditory pathway. Following this early rise, the tinnitus continues to abate over the following month. Patients with tinnitus may benefit from early activation, although should be counseled that they may experience an exacerbation during the very early postoperative period.