0445 Real-world Evaluation of Upper Airway Stimulation system survival using post-market surveillance data

Abstract Introduction Upper airway stimulation (UAS) has become a viable treatment alternative for well selected patients with moderate to severe obstructive sleep apnea (OSA) who struggle to tolerate positive pressure (PAP) therapy. Post-market surveillance is required of medical device manufacturers to assess treatment outcomes, complications, and device failure. We aim to utilize this surveillance data to assess rates of revision and removal of the Inspire (Minneapolis, MN) UAS system in a real-world setting. Methods Post market surveillance data was compiled from manufacturer’s complaint handling system for explants and revisions of the hypoglossal nerve stimulator. Data collection began in January 2018 and was available through September 30 2022 at the time of analysis. Implant procedures from January 2018 through September 2021 were analyzed for events within one year of implant. Events were classified into categories. A subset of these devices implanted before September 30 2019 were analyzed for events between one and three years after implant. Results Between Jan 01 2018 and Sep 30 2021, 15282 devices were implanted. Within one year of the implant, 121 devices (0.8%) were explanted for: infection (66), elective (32), MRI (10), other (10), and twiddler syndrome (3). Surgical revisions were required for 245 patients (1.6%) for: surgical correction (139), device defect (81), other (21), cardioversion (2), twiddler syndrome (1), and MRI (1). A subset of 5080 of these devices were implanted prior to September 30 2019. Between one year and three years following implant 119 devices (2.3%) were explanted for: elective (58), MRI (35), infection (15), Other (9), and twiddler syndrome (2). Surgical revisions were performed for 160 patients (3.1%) for: surgical correction (64), device defect (57), other (32), twiddler syndrome (5), and cardioversion (2). Conclusion As with any implantable medical device, a certain rate of revision and explant is expected for device, patient, and medical indications. The rate of UAS revision and explantation is low at both the 1 year and 3 year time points. UAS implantation is a safe alternative to CPAP for well selected patients with a low rate of unexpected reoperation for either revision or hardware explantation. Support (if any) Inspire Medical