journal article
LitStream Collection
Personalized care of obstructive sleep apnea with hypoglossal nerve stimulation
Strollo, Patrick J; Soose, Ryan J
2021 SLEEP
doi: 10.1093/sleep/zsab055pmid: 33903912
Hypoglossal Nerve Stimulation (HNS) is an option for patients with obstructive sleep apnea who cannot accept or adhere to positive pressure therapy (PAP) [1]. Unilateral phasic HNS during sleep has been demonstrated to effectively treat obstructive sleep apnea. The Inspire Medical Systems HNS device is approved by the United States Food and Drug Administration and in the Europe Economic Area by a CE marking. This technology includes a hypoglossal nerve cuff electrode, impulse generator, and a pressure sensor that are surgically implanted. The patient allows for turning on/off, pausing therapy, and adjusting HNS amplitude during the sleep period (Figure 1). Over 10,000 devices have been implanted in over 400 centers in the United States and Europe. The Centers for Medicare and Medicaid Services and most Commercial Insurers cover HNS in all 50 states and the District of Columbia in the United States. Figure 1. Open in new tabDownload slide Hypoglossal nerve stimulation system. Adapted from Strollo et al. [1]. Copyright © 2014, Massachusetts Medical Society Reprinted with Permission. Figure 1. Open in new tabDownload slide Hypoglossal nerve stimulation system. Adapted from Strollo et al. [1]. Copyright © 2014, Massachusetts Medical Society Reprinted with Permission. Research reports to date have focused primarily on the implantation technique and the initial activation of HNS as well as the safety and efficacy of treatment from carefully designed trials and a research registry [1–3]. As this therapeutic option has become more available, strategies to address treatment success on a patient level are necessary. The two papers included in this supplement provide additional insight for clinicians so that longitudinal care can be optimized. In the first paper, Soose and colleagues outline an approach to care that focuses on the post-implant management [4]. An algorithm informed by the experience of five high-performing HNS programs is presented. The timing and the implementation of device activation are reviewed. The insights provided by office-based assessments in conjunction with cloud-based data downloads (like PAP devices) have decreased the need for repeated “in-lab” adjustments of HNS settings. This has allowed in many instances to assess the treatment response with lower cost and more ecologically valid home sleep testing strategy. Using the algorithm presented in the text, well-treated and adherent patients (Green Pathway) can be readily identified, and sub-optimally treated patients (Yellow Pathway) can be categorized based on the nature of the problem- be it suboptimal adherence (Type 1), inadequate control of sleep-disordered breathing / persistent symptoms (Type 2), or both (Type 3). Targeted interventions are discussed based on the type of problems encountered. As with the management of PAP patients, there are device-specific interventions, adjunctive surgical interventions, and medical interventions [5–7]. To fully treat a given patient, it is essential to holistically address a patient’s needs. It is important to troubleshoot and make focused adjustments to the device as well as to be able to provide hypnotics, cognitive behavioral therapy for insomnia, positional therapy, lifestyle modifications, stimulants, and other adjunctive treatments when indicated. Approximately one-third of patients with OSA have comorbid insomnia and approximately 10% have residual daytime sleepiness despite adequate treatment of OSA [8–10]. These data highlight the need for the Sleep Surgeon and the Sleep Physician to work collaboratively to personalize care. In the second paper, Johnson et al. utilize a biophysical computational model to provide insight into how reconfiguring the stimulation settings of the HNS cuff electrode can affect the treatment response [11]. The clinical data from the STAR trial were utilized to develop the model [1]. These data give the scientific rationale for bipolar versus unipolar stimulation configurations. They demonstrate that a unipolar configuration provides more uniform axonal activation resulting in a lower stimulation sensation and functional thresholds with less negative impact if the HNS cuff rotates. The model also provides insight into how unipolar configurations may inadvertently activate tongue retrusor muscles (Styloglossus and/or Hyoglossus) due to the relatively high current densities at the nerve cuff end. This collection of papers gives us practical insights into the personalized management of HNS post-implantation. Ongoing research will further enhance our understanding. Our team is currently collecting qualitative data to better understand why some patients may not use HNS the entire night (START Trial NCT 04768543). These data will help with the development of additional educational interventions, the leveraging of digital health platforms, and the targeted treatment of comorbid sleep problems. Research involving the refinement of selection criteria with imaging (CT/MR) and physiologic phenotyping may also help improve initial and longitudinal response to HNS [12–15]. We still need to understand what constitutes an adequate treatment response. Should measures of cardiovascular risk such as nocturnal blood pressure, hypoxic burden, and/or REM-related sleep-disordered breathing be given more weight than the apnea/hypopnea index? [16–18] Can HNS mitigate cardiovascular risk? [19] There is undoubtedly more work to be done so that we can further optimize this additional tool in our treatment toolbox. References 1. Strollo PJ Jr, et al. ; STAR Trial Group . Upper-airway stimulation for obstructive sleep apnea . N Engl J Med. 2014 ; 370 ( 2 ): 139 – 149 . 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