Long‐Term Generator Replacement Experience in Hypoglossal Nerve Stimulator Therapy Recipients With CPAP‐Intolerant Obstructive Sleep Apnea

Abstract

AbstractObjectiveIn the last decade, hypoglossal nerve stimulation (HNS) has emerged as a therapeutic alternative for patients with obstructive sleep apnea. The original clinical trial cohorts are entering the phase of expected battery depletion (8‐12 years). This study aimed to examine the surgical experience with implantable pulse generator (IPG) replacements and the associated long‐term therapy outcomes.Study DesignRetrospective analysis of patients from the original clinical trial databases (STAR, German post‐market) who were followed in the ongoing ADHERE registry.SettingInternational multicenter HNS registry.MethodsThe ADHERE registry and clinical trial databases were cross‐referenced to identify the serial numbers of IPGs that were replaced. Data collection included demographics, apnea‐hypopnea index (AHI), therapy use, operative times, and adverse events.ResultsFourteen patients underwent IPG replacement 8.3 ± 1.1 years after their initial implantation. Body mass index was unchanged between the original implant and IPG replacement (29 ± 4 vs 28 ± 2 kg/m2, p = .50). The mean IPG replacement operative time was shorter than the original implant (63 ± 50 vs 154 ± 58 minutes, p < .002); however, 2 patients required stimulation lead replacement which significantly increased operative time. For patients with available AHI and adherence data, the mean change in AHI from baseline to latest follow‐up (8.7 ± 1.1 years after de novo implant) was −50.06%, and the mean therapy use was 7.2 hours/night.ConclusionIPG replacement surgery was associated with low complications and shorter operative time. For patients with available outcomes data, adherence and efficacy remained stable after 9 years of follow‐up.