0590 Hypoglossal Nerve Stimulation for OSA – a Systematic Review of Adverse Events in Clinical Trials & Real-world-data

Abstract Introduction Hypoglossal Nerve Stimulation (HNS) has been recognized as a novel therapeutic approach for individuals suffering from Obstructive Sleep Apnea (OSA). Extensive clinical trials and accumulated real-world data have consistently demonstrated that HNS offers significant, enduring enhancements in managing OSA symptoms and improving overall quality of life for patients. Given the nature of HNS treatment, with the requirement of using an implantable neurostimulation system, patient safety is a critical domain in the assessment of this technology. The objective of this review was to evaluate adverse events (AE) and complications with HNS therapy in a systematic review of published evidence. Methods MEDLINE, Cochrane, and Web of Science were systematically searched to identify randomized controlled and real-world observational studies reporting relevant outcomes with HNS therapy for treatment of OSA, which included procedure-, device- and treatment-related AE. Risk of bias assessment was conducted using the ROBINS-I tool. Results Out of 499 articles screened, 27 were reviewed for eligibility, and seventeen studies, the majority found having low to moderate risk of bias, and totaling data of 2,095 patients were included for further analysis. Across included studies, reporting of AE was heterogenous with regards to used classifications as well as extent of reporting. Over an average follow-up duration of 17.5 ± 16.9 months, the pooled mortality rate was 0.01% (95% CI = 0.0 to 0.2%), with all reported deaths being unrelated to HNS treatment. The pooled HNS device explant rate was 0.03% (95% CI = 1.0 to 2.1%), with infections and request for removal by patient being the most common indications. The pooled surgical revision rate was 0.08% (95% CI 0.0 to 0.2%). Most reported treatment-related side-effects were transient stimulation-related discomfort (0.08%, 95% CI = 0.0 to 0.2%) and tongue-abrasions (0.07%, 95% CI = 0.0 to 0.2%). Conclusion In this systematic review, HNS therapy for treatment of OSA is associated with a positive patient safety profile. AE occur mainly at device implantation and during the treatment acclimatization period. Significant heterogeneity was found for adverse event reporting. Implementation of a harmonized framework for reporting HNS outcomes that includes AE and side-effects is warranted to ensure comparability of results. Support (if any)