Adverse Events in Hypoglossal Nerve Stimulator Implantation: 5-Year Analysis of the FDA MAUDE Database

2020 ◽  
pp. 019459982096006
Author(s):  
Nikhil Bellamkonda ◽  
Travis Shiba ◽  
Abie H. Mendelsohn
Keyword(s):  
Adverse Events ◽  
Large Scale ◽  
Hypoglossal Nerve ◽  
Upper Airway ◽  
Perioperative Period ◽  
Nerve Stimulator ◽  
Upper Airway Stimulation ◽  
Patient Reports ◽  
Obstructive Sleep ◽  
National Patient

Objective Use of hypoglossal nerve stimulator implantation has dramatically improved the surgical treatment of multilevel airway collapse during obstructive sleep apnea (OSA). Understanding causes of adverse events and their impact on patients undergoing stimulator implantation will help improve patient preparation and surgical practices to avoid future complications. Study Design This study is a retrospective review of the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database, a publicly available voluntary reporting system. Setting National patient event database. Methods The MAUDE database was searched for reports associated with the terms “hypoglossal nerve stimulator” and “Inspire,” being the only currently FDA-approved system for upper airway stimulation for OSA. All records were searched with the events limited in dates between May 2014 and September 2019. Results A total of 132 patient reports were identified over the 5-year inclusion period, containing 134 adverse events. The reported adverse events resulted in 32 device revision procedures as well as 17 explantations. Device migration and infection were 2 of the most commonly reported adverse events. Complications not witnessed in previous large-scale clinical trials included pneumothorax, pleural effusion, and lead migration into the pleural space. Conclusion Previous data have demonstrated hypoglossal nerve stimulator implantation results in reliable OSA improvement. However, a number of technical difficulties and complications still exist during the perioperative period, which should be communicated to patients during the surgical consent process.

scholarly journals 0645 The Association of Hypoglossal Nerve Stimulator Adherence and Insomnia

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A246-A246
Author(s):  
M Sharma ◽  
A Chacko ◽  
M Rosenthal ◽  
M Khan
Keyword(s):  
Hypoglossal Nerve ◽  
Sleep Problems ◽  
Medical Center ◽  
Eligible Patient ◽  
Upper Airway ◽  
Severity Index ◽  
Nerve Stimulator ◽  
Obstructive Sleep ◽  
Significant Difference ◽  
The Ohio State University

Abstract Introduction The gold standard for treatment of Obstructive sleep apnea (OSA) is continuous positive airway pressure (CPAP). However, CPAP adherence is less than 50%. An alternative treatment is the hypoglossal nerve stimulator (HNS) which displaces the tongue anteriorly to treat upper airway obstruction. Difficulties tolerating HNS are related to stimulation discomfort. In this study, we investigated insomnia as a barrier to adherence. Methods Patients implanted and activated with HNS at The Ohio State University Wexner Medical Center between 2015 and 2019 were eligible. Patient usage data from the previous six months was obtained and subjects were asked to complete an Insomnia Severity Index (ISI). Participants were divided into adherent (defined as use ≥28 hours/week) and non-adherent (use <28 hours/week). Results 32 subjects were enrolled, 22 in the adherent group and 10 in the non-adherent group. There was a significant decrease in mean treatment AHI in both groups: 36.25 to 11.14 in the adherent group and 36.30 to 15.69 in the non-adherent group (p<0.0001). The mean ISI score in the adherent group was 6.84 which is consistent with no clinically significant insomnia and 8.67 in the non-adherent group consistent with subthreshold insomnia. However, there was not a statistically significant difference between the two groups (p=0.441). There was a statistically significant higher score for the question “Do you worry about your sleep problems?” in the non-adherent group (1.78, SD1.39 vs 0.74. SD 0.81) (p =0.018). Conclusion This study suggests that patients who have difficulty with sleep may have more difficulty with HNS adherence than those who do not. In particular the question stating “Do you worry about your sleep problems” had a statistically higher score in the non-adherent group. Prospective studies are needed to further explore a possible relationship between insomnia and HNS adherence. Support N/A

Successful Hypoglossal Nerve Upper Airway Stimulator Implantation After Chemoradiotherapy for Oropharynx Malignancy Complicated by Mandibular Osteoradionecrosis

2021 ◽  
pp. 014556132098602
Author(s):  
Steven G. Hoshal ◽  
Scott C. Fuller
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Successful Treatment ◽  
Hypoglossal Nerve ◽  
Upper Airway ◽  
Upper Airway Stimulation ◽  
Oropharynx Cancer ◽  
Obstructive Sleep

This case demonstrates the first successful treatment of obstructive sleep apnea with hypoglossal nerve upper airway stimulation in a patient with prior radiation for oropharynx cancer complicated by osteoradionecrosis of the mandible.

Safety and Effectiveness of Upper Airway Stimulation via the Hypoglossal Nerve for Obstructive Sleep Apnea

2013 ◽  
Vol 149 (2_suppl) ◽  
pp. P140-P140
Author(s):  
David L. Steward ◽  
Nico de Vries ◽  
Oleg Froymovich ◽  
Ryan J. Soose ◽  
Marion B. Gillespie ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Hypoglossal Nerve ◽  
Upper Airway ◽  
Upper Airway Stimulation ◽  
Obstructive Sleep

Randomized Controlled Withdrawal Study of Upper Airway Stimulation on OSA

2014 ◽  
Vol 151 (5) ◽  
pp. 880-887 ◽  
Author(s):  
B. Tucker Woodson ◽  
M. Boyd Gillespie ◽  
Ryan J. Soose ◽  
Joachim T. Maurer ◽  
Nico de Vries ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Outcome Measures ◽  
Hypoglossal Nerve ◽  
Upper Airway ◽  
Oxygen Desaturation ◽  
Upper Airway Stimulation ◽  
Randomized Controlled ◽  
Obstructive Sleep ◽  
Therapy Withdrawal

Objective To assess the efficacy and durability of upper airway stimulation via the hypoglossal nerve on obstructive sleep apnea (OSA) severity including objective and subjective clinical outcome measures. Study Design A randomized controlled therapy withdrawal study. Setting Industry-supported multicenter academic and clinical setting. Subjects A consecutive cohort of 46 responders at 12 months from a prospective phase III trial of 126 implanted participants. Methods Participants were randomized to either therapy maintenance (“ON”) group or therapy withdrawal (“OFF”) group for a minimum of 1 week. Short-term withdrawal effect as well as durability at 18 months of primary (apnea hypopnea index and oxygen desaturation index) and secondary outcomes (arousal index, oxygen desaturation metrics, Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, snoring, and blood pressure) were assessed. Results Both therapy withdrawal group and maintenance group demonstrated significant improvements in outcomes at 12 months compared to study baseline. In the randomized assessment, therapy withdrawal group returned to baseline, and therapy maintenance group demonstrated no change. At 18 months with therapy on in both groups, all objective respiratory and subjective outcome measures showed sustained improvement similar to those observed at 12 months. Conclusion Withdrawal of therapeutic upper airway stimulation results in worsening of both objective and subjective measures of sleep and breathing, which when resumed results in sustained effect at 18 months. Reduction of obstructive sleep apnea severity and improvement of quality of life were attributed directly to the effects of the electrical stimulation of the hypoglossal nerve.

scholarly journals Effect of upper-airway stimulation for obstructive sleep apnoea on airway dimensions

2014 ◽  
Vol 45 (1) ◽  
pp. 129-138 ◽  
Author(s):  
Faiza Safiruddin ◽  
Olivier M. Vanderveken ◽  
Nico de Vries ◽  
Joachim T. Maurer ◽  
Kent Lee ◽  
...  
Keyword(s):  
Obstructive Sleep Apnoea ◽  
Hypoglossal Nerve ◽  
Upper Airway ◽  
Sleep Apnoea ◽  
Therapeutic Level ◽  
Drug Induced ◽  
Upper Airway Stimulation ◽  
Cross Sectional ◽  
Obstructive Sleep ◽  
Anterior Posterior

Upper-airway stimulation (UAS) using a unilateral implantable neurostimulator for the hypoglossal nerve is an effective therapy for obstructive sleep apnoea patients with continuous positive airway pressure intolerance. This study evaluated stimulation effects on retropalatal and retrolingual dimensions during drug-induced sedation compared with wakefulness to assess mechanistic relationships in response to UAS.Patients with an implanted stimulator underwent nasal video endoscopy while awake and/or during drug-induced sedation in the supine position. The cross-sectional area, anterior–posterior and lateral dimensions of the retropalatal and retrolingual regions were measured during baseline and stimulation.15 patients underwent endoscopy while awake and 12 underwent drug-induced sedation endoscopy. Increased levels of stimulation were associated with increased area of both the retropalatal and retrolingual regions. During wakefulness, a therapeutic level of stimulation increased the retropalatal area by 56.4% (p=0.002) and retrolingual area by 184.1% (p=0.006). During stimulation, the retropalatal area enlarged in the anterior–posterior dimension while retrolingual area enlarged in both anterior–posterior and lateral dimensions. During drug-induced sedation endoscopy, the same stimulation increased the retropalatal area by 180.0% (p=0.002) and retrolingual area by 130.1% (p=0.008). Therapy responders had larger retropalatal enlargement with stimulation than nonresponders.UAS increases both the retropalatal and retrolingual areas. This multilevel enlargement may explain reductions of the apnoea–hypopnoea index in selected patients receiving this therapy.

scholarly journals Upper Airway Stimulation/Hypoglossal Nerve Stimulator

2020 ◽  
Vol 202 (8) ◽  
pp. P23-P24
Author(s):  
Shalini Manchanda ◽  
Pritam Neupane ◽  
Ninotchka L. Sigua
Keyword(s):  
Hypoglossal Nerve ◽  
Upper Airway ◽  
Nerve Stimulator ◽  
Upper Airway Stimulation

The Future in Upper Airway Stimulation Therapy

2021 ◽  
pp. 223-238
Author(s):  
David T. Kent
Keyword(s):  
Patient Selection ◽  
Nerve Stimulation ◽  
Hypoglossal Nerve ◽  
Upper Airway ◽  
Upper Airway Stimulation ◽  
Hypoglossal Nerve Stimulation ◽  
Obstructive Sleep ◽  
To Come ◽  
Research Initiatives ◽  
Future Work

Hypoglossal nerve stimulation therapy for obstructive sleep apnea was first approved by the U.S. Food and Drug Administration in 2014, but it has been under development through various research initiatives for the better part of the last three decades. Currently, multiple lines of research are directed toward optimizing patient selection and device adjustment with available neurostimulation therapies. Additional hypoglossal nerve stimulation devices are in trial or under active development. Future work will focus on iterative improvement of these devices and appropriate patient selection. Additional pharmacological and neurostimulation targets beyond the hypoglossal nerve in the upper airway exist, and current publications provide hints of what is yet to come.

scholarly journals Post-approval upper airway stimulation predictors of treatment effectiveness in the ADHERE registry

2018 ◽  
Vol 53 (1) ◽  
pp. 1801405 ◽  
Author(s):  
Clemens Heiser ◽  
Armin Steffen ◽  
Maurits Boon ◽  
Benedikt Hofauer ◽  
Karl Doghramji ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Adverse Events ◽  
Treatment Success ◽  
Upper Airway ◽  
The United States ◽  
Final Visit ◽  
Effective Treatment Option ◽  
Upper Airway Stimulation ◽  
Obstructive Sleep ◽  
Post Hoc

Upper airway stimulation (UAS) has been shown to reduce severity of obstructive sleep apnoea. The aim of this study was to identify predictors of UAS therapy response in an international multicentre registry.Patients who underwent UAS implantation in the United States and Germany were enrolled in an observational registry. Data collected included patient characteristics, apnoea/hypopnoea index (AHI), Epworth sleepiness scale (ESS), objective adherence, adverse events and patient satisfaction measures.Post hocunivariate and multiple logistic regression were performed to evaluate factors associated with treatment success.Between October 2016 and January 2018, 508 participants were enrolled from 14 centres. Median AHI was reduced from 34 to 7 events·h−1, median ESS reduced from 12 to 7 from baseline to final visit at 12-month post-implant. Inpost hocanalyses, for each 1-year increase in age, there was a 4% increase in odds of treatment success. For each 1-unit increase in body mass index (BMI), there was 9% reduced odds of treatment success. In the multivariable model, age persisted in serving as statistically significant predictor of treatment success.In a large multicentre international registry, UAS is an effective treatment option with high patient satisfaction and low adverse events. Increasing age and reduced BMI are predictors of treatment response.

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