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.

Should lateral wall collapse be a contraindication for hypoglossal nerve stimulation?

OBJECTIVE: The purpose of this study is to examine how lateral wall collapse affects treatment outcomes for hypoglossal nerve stimulation (HNS) patients. METHODS: Patients (n = 111) queried from a single surgeon's database of HNS cases were divided into groups based on their degree of oropharyngeal lateral wall collapse noted on drug-induced sleep endoscopy (DISE): Complete, Partial, None. For each group, apnea hypopnea index (AHI) reduction, Epworth Sleepiness Scale (ESS) score, stimulation voltage, average nightly usage, need for alternate device configuration/awake sleep endoscopy, and rate of surgical success were collected. Patients with Complete collapse were compared to those with Partial/None via Student's t-tests and Pearson's Chi-square test. RESULTS: Of the 111 eligible patients, 45 had complete, 30 partial, and 36 had no lateral oropharyngeal wall collapse. There were no statistically significant differences found between the Complete and Partial/None groups in terms of age, BMI, sex, AHI (pre and post-op), ESS (pre and post-op), voltage, alternate device configuration, or nightly adherence. Notably, a significantly greater number of the Partial/None group had surgical success (84.84 % vs 66.67 %, p = 0.024). CONCLUSIONS: Patients with Partial/None oropharyngeal collapse were significantly more likely than patients with Complete lateral wall collapse to see surgical success. There are many factors to weigh when assessing a patient's surgical candidacy, it is clear that complete lateral wall collapse at the level of the oropharynx is a negative predictor for success in HNS.

Post-operative Complication Rate Comparison Between Airway Surgery and Upper Airway Stimulation Using NSQIP and ADHERE.

OBJECTIVE: Postoperative complication rates were compared between obstructive sleep apnea surgery (OSAS) and hypoglossal nerve upper airway stimulation (UAS). STUDY DESIGN: Cohort. SETTING: Multi-institutional international databases. METHODS: OSAS data were collected from the NSQIP database (2014; American College of Surgeons National Surgery Quality Improvement Program). UAS data were obtained from the ADHERE registry (Adherence and Outcome of Upper Airway Stimulation for OSA International Registry; 2016-December 2019). ADHERE comorbidities and complications were categorized to match NSQIP definitions. A chi-square test was used for proportion P values. RESULTS: There were 1623 UAS procedures in ADHERE and 310 in NSQIP. The UAS group was older than the OSAS group (mean ± SD, 60 ± 11 vs 42 ± 13 years) but similarly male (75% vs 77%) and overweight (body mass index, 29 ± 4 vs 29 ± 3 kg/m2). There was a higher proportion of hypertension, diabetes, and heart disease in the UAS cohort. Palatopharyngoplasty was the most common surgical procedure (71%), followed by tonsillectomy (25%). UAS operative time was longer (132 ± 47 vs 54 ± 33 minutes). Postoperative length of stay was not normally distributed, as 71% of UAS stays were <1 day as opposed to 40% of OSA stays (P < .0001). Thirty-day return to the operating room related to the procedure was 0.1% for UAS and 4.8% for OSAS (P < .0001). Surgical site infections were 0.13% for UAS and 0.9% for OSAS (P = .046). CONCLUSION: The UAS cohort was older and more likely to have comorbid hypertension, diabetes, and heart disease. Despite baseline differences, the postoperative complication rate was lower with UAS than with OSAS.