Safety Profile and Complications With Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea: A Systematic Review and Metanalysis

Speaker(s)

Braun M1, Heiser C2, Sommer UJ3, Schoebel C4, Wollny M5
1University Hospital Essen, Bonn, NW, Germany, 2Technical University Munich, Munich, Germany, 3HNO-ZENTRUM Mangfall-Inn, Bad Aibling, BY, Germany, 4University Hospital Duisburg-Essen, Essen, NW, Germany, 5MedImbursement, Tarmstedt, NI, Germany

OBJECTIVES: Hypoglossal nerve stimulation (HNS) is a routine treatment for obstructive sleep apnea (OSA) and leads to significant and constant improvements of OSA control and quality of life. Given the nature of HNS treatment, which involves an implantable neurostimulation system, ensuring patient safety is crucial in evaluating this technology. This review aims to systematically assess adverse events (AEs) and complications associated with HNS therapy.

METHODS: A systematic search was conducted to identify randomized controlled and real-world observational studies, published between January 2000 and October 2023. The search focused on studies reporting outcomes related to HNS therapy for OSA, including procedure-, device-, and treatment-related AEs.

RESULTS: From 418 articles screened, 27 were assessed, and 17 studies with a total of 1,962 patients were included. Over a median follow-up of 17.5 ± 16.9 months, the pooled mortality rate was 0.01% with all reported deaths unrelated to HNS treatment. The 60-month survival probability for the HNS system was 0.9834, with infection and patient request for removal being the most common reasons for system failure. The pooled surgical revision rate was 0.08%. The most frequently reported treatment-related AEs were transient stimulation-related discomfort (0.08%) and tongue abrasions (0.07%). Based on this systematic review, a standardized set of endpoints was proposed to harmonize safety data reporting for HNS.

CONCLUSIONS: This systematic review indicates that HNS therapy for OSA has a favorable patient safety profile. However, the review's generalizability is limited by the underrepresentation of partially implantable HNS systems for which limited evidence is available. Significant heterogeneity was observed in the reporting of adverse events. To enhance comparability of reported data, a standardized framework for reporting HNS outcomes, including AEs and adverse effects, is proposed.

Code

MT66

Topic

Medical Technologies

Topic Subcategory

Medical Devices

Disease

Medical Devices, Neurological Disorders, Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)