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.

Elevated Central and Mixed Apnea Index after Upper Airway Stimulation

2020 ◽  
Vol 162 (5) ◽  
pp. 767-772
Author(s):  
Jena Patel ◽  
Kelly Daniels ◽  
Lauren Bogdan ◽  
Colin Huntley ◽  
Maurits Boon
Keyword(s):  
Care Center ◽  
Univariate Analysis ◽  
Tertiary Care ◽  
Upper Airway ◽  
Retrospective Chart Review ◽  
Comorbid Conditions ◽  
Level Of Evidence ◽  
Upper Airway Stimulation ◽  
Obstructive Sleep ◽  
Post Hoc

Objective Upper airway stimulation (UAS) is used to treat patients with moderate to severe obstructive sleep apnea (OSA). The aim of this study is to report the incidence and potential predictors of elevated central and mixed apnea index (CMAI) after UAS. Study Design Retrospective chart review of patients undergoing UAS. Setting Tertiary care center. Subjects and Methods Included patients underwent UAS for OSA at our institution between 2014 and 2018. Data collected included demographic information, implantation records, and pre- and postoperative polysomnography (PSG) results. CMAI ≥5 was considered elevated. Post hoc univariate analysis was performed to evaluate factors associated with elevated CMAI. Results In total, 141 patients underwent UAS at our institution. This included 94 men and 47 women with a mean age of 61.2 ± 11.0 years and a mean body mass index of 29.1 ± 3.9 kg/m2. Five patients had an elevated CMAI after surgery during UAS titration. Demographics, comorbid conditions, and device settings were not associated with an elevated postoperative CMAI ( P > .05). Conclusion The occurrence of an elevated CMAI after surgery may represent treatment-emergent events. Demographics, comorbid conditions, and UAS device settings were not associated with central and mixed apneic events. Level of Evidence 4

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.

Upper Airway Stimulation for Obstructive Sleep Apnea: Results from the ADHERE Registry

2018 ◽  
Vol 159 (2) ◽  
pp. 379-385 ◽  
Author(s):  
Maurits Boon ◽  
Colin Huntley ◽  
Armin Steffen ◽  
Joachim T. Maurer ◽  
J. Ulrich Sommer ◽  
...  
Keyword(s):  
United States ◽  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Upper Airway ◽  
The United States ◽  
Physician Satisfaction ◽  
Upper Airway Stimulation ◽  
Sleep Study ◽  
Obstructive Sleep ◽  
Alternative Treatment Option

Objective Upper airway stimulation (UAS) is an alternative treatment option for patients unable to tolerate continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnea (OSA). Studies support the safety and efficacy of this therapy. The aim of this registry is to collect retrospective and prospective objective and subjective outcome measures across multiple institutions in the United States and Germany. To date, it represents the largest cohort of patients studied with this therapy. Study Design Retrospective and prospective registry study. Setting Ten tertiary care hospitals in the United States and Germany. Subjects and Methods Patients were included who had moderate to severe OSA, were intolerant to CPAP, and were undergoing UAS implantation. Baseline demographic and sleep study data were collected. Objective and subjective treatment outcomes, adverse events, and patient and physician satisfaction were reviewed. Results The registry enrolled 301 patients between October 2016 and September 2017. Mean ± SD AHI decreased from 35.6 ± 15.3 to 10.2 ± 12.9 events per hour ( P < .0001), and Epworth Sleepiness Scale scores decreased from 11.9 ± 5.5 to 7.5 ± 4.7 ( P < .0001) from baseline to the posttitration visit. Patients utilized therapy for 6.5 hours per night. There were low rates of procedure- and device-related complications. Clinical global impression scores demonstrated that the majority of physicians (94%) saw improvement in their patients’ symptoms with therapy. The majority of patients (90%) were more satisfied with UAS than CPAP. Conclusions Across a multi-institutional registry, UAS therapy demonstrates significant improvement in subjective and objective OSA outcomes, good therapy adherence, and high patient satisfaction.

Using Two-Way Fluid-Structure Interaction to Study the Collapse of the Upper Airway of OSA Patients

2014 ◽  
Vol 553 ◽  
pp. 275-280 ◽  
Author(s):  
Mo Yin Zhao ◽  
Tracie J. Barber ◽  
Peter A. Cistulli ◽  
Kate Sutherland ◽  
Gary Rosengarten
Keyword(s):  
Computational Models ◽  
Treatment Success ◽  
Fluid Structure Interaction ◽  
Maximum Velocity ◽  
Upper Airway ◽  
Post Treatment ◽  
Mandibular Advancement ◽  
Fluid Structure ◽  
Structure Interaction ◽  
Obstructive Sleep

Obstructive Sleep Apnea (OSA) is a common sleep disorder characterized by repetitive collapse of the upper airway (UA) during sleep. Treatment options for OSA include mandibular advancement splints (MAS), worn intra-orally to protrude the lower jaw to stabilize the airway. However not all patients will respond to MAS therapy and individual effects on the upper airway are not well understood. Simulations of airway behavior represent a non-invasive means to understand this disorder and treatment responses in individual patients. The aims of this study was to perform analysis of upper airway (UA) occlusion and flow dynamics in OSA using the fluid structure interaction (FSI) method, and secondly to observe changes associated with MAS usage. Magnetic resonance imaging (MRI) scans were obtained with and without mandibular advance splint (MAS) treatment in a patient known to be a treatment responder. Computational models of the anatomically correct UA geometry were reconstructed for both pre-and post-treatment (MAS) conditions. By comparing the simulation results, the treatment success of MAS was demonstrated by smaller UA structure deformation (maximum 2mm) post-treatment relative to the pre-treatment fully collapsed (maximum 6mm) counterpart. The UA collapse was located at the oropharynx and the low oropharyngeal pressure (-51 Pa to-39 Pa) was induced by the velopharyngeal jet flow (maximum 10 m/s). The results support previous OSA computational fluid dynamics (CFD) studies by indicating similar UA pressure drop and maximum velocity values. These findings lay a firm platform for the application of computational models for the study of the biomechanical properties of the upper airway in the pathogenesis and treatment of OSA.

Upper Airway Stimulation Therapy for Obstructive Sleep Apnea

2021 ◽  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Upper Airway ◽  
Novel Therapy ◽  
Upper Airway Stimulation ◽  
Current State ◽  
Obstructive Sleep ◽  
Long Term Follow Up ◽  
Physician Extenders ◽  
Primary Care Practitioners

Upper Airway Stimulation Therapy for Obstructive Sleep Apnea provides the current state of knowledge regarding this novel therapy. It reviews the pathophysiologic basis of sleep apnea and the specific mechanism by which upper airway stimulation provides airway support in this disorder. It also provides practical insights into this therapy related to patient selection, clinical outcomes, surgical technique, long-term follow-up, and adverse events and offers recommendations for those aspiring to develop an upper airway stimulation program. It provides an overview of unique populations and circumstances that may extend the utility of the procedure, and that may provide challenges in management, as well as thoughts on the future of this technology. This textbook is intended for all practitioners who have interest or care for sleep disordered breathing, including sleep medicine physicians, pulmonologists, otolaryngologists, primary care practitioners, as well as physician extenders.

433 Insomnia and Restless Legs Syndrome in Patients with Upper Airway Stimulation Therapy

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A171-A172
Author(s):  
Mohammed Jomha ◽  
Shalini Manchanda ◽  
Stephanie Stahl ◽  
Noah Parker
Keyword(s):  
Restless Legs Syndrome ◽  
Statistical Significance ◽  
Upper Airway ◽  
Post Treatment ◽  
Apnea Hypopnea Index ◽  
Upper Airway Stimulation ◽  
Therapy Adherence ◽  
Restless Legs ◽  
Obstructive Sleep ◽  
Pre Treatment

Abstract Introduction Insomnia and restless legs syndrome (RLS) are common sleep disorders that may impact obstructive sleep apnea (OSA) treatment. To our knowledge, no studies have investigated whether these comorbidities affect upper airway stimulation (UAS) therapy adherence and outcomes. This study aims to explore possible effects of insomnia and RLS in patients using UAS therapy. Methods All patients who underwent UAS system implantation for treatment of OSA at our facility were retrospectively studied. Pre- and post-implant histories and data, including diagnostic sleep testing, otolaryngology evaluation, activation results, and treatment evaluation, were analyzed. Patients with no insomnia or RLS were compared to patients with insomnia, RLS, or both. Apnea-hypopnea index (AHI), Epworth Sleepiness Scale (ESS), and adherence were compared pre- and post-treatment for each group. Results Sixty-four patients who have undergone UAS implantation at our center have completed post-treatment in-lab titration and evaluation of their UAS system. Insomnia was present in 47%, RLS in 28%, and both insomnia and RLS in 14%. In all groups, the overall AHI during in-lab titration was &gt;50% lower than the pre-treatment AHI (16.1+/-14.3/h vs 32.5+/-13.1/h, p&lt;0.001). While the trend in AHI reductions suggested a lower AHI in those without insomnia or RLS, the reduction did not reach statistical significance (no insomnia or RLS 15.7+/-12.9/h, insomnia 16.9+/-16.7/h, RLS 19.0+/-15.5/h, both insomnia and RLS 23.4+/-18.4/h). UAS therapy usage was reduced in patients with RLS (3.9+/-2.6 h/night, p=0.029) and in patients with both insomnia and RLS (3.9+/-1.3 h/night, p=0.046) compared to patients with neither comorbidity (5.9+/-1.9 h/night). Mean reduction in ESS was similar across groups, averaging from 11+/-5 pre-treatment to 7+/-5 post-treatment (p&lt;0.001). Conclusion Insomnia and RLS are common in patients using UAS therapy for OSA. Pre- and post-treatment residual AHI and ESS significantly improved in all patient groups assessed. A decrease in UAS usage was present in patients with RLS and both RLS and insomnia. Our study suggests that identification and treatment of RLS and insomnia may play an important role for UAS therapy adherence and efficacy, thus, optimizing care. Support (if any):

Novel avenues to approach non-CPAP therapy and implement comprehensive OSA care

2021 ◽  
pp. 2101788
Author(s):  
Jean-Louis Pépin ◽  
Peter Eastwood ◽  
Danny J. Eckert
Keyword(s):  
Treatment Success ◽  
Clinical Manifestations ◽  
Upper Airway ◽  
Sleep Apnoea ◽  
Mandibular Advancement ◽  
Individual Risk ◽  
Future Research ◽  
Success Rates ◽  
Recent Advances ◽  
Obstructive Sleep

Recent advances in obstructive sleep apnoea (OSA) pathophysiology and translational research have opened new lines of investigation for OSA treatment and management. Key goals of such investigations are to provide efficacious, alternative treatment and management pathways that are better tailored to individual risk profiles to move beyond the traditional, continuous positive airway pressure (CPAP)-focused, “one size fits all”, trial and error approach which is too frequently inadequate for many patients. Identification of different clinical manifestations of OSA (clinical phenotypes) and underlying pathophysiological phenotypes (endotypes), that contribute to OSA have provided novel insights into underlying mechanisms and have underpinned these efforts. Indeed, this new knowledge has provided the framework for precision medicine for OSA to improve treatment success rates with existing non-CPAP therapies such as mandibular advancement devices and upper airway surgery, and newly developed therapies such as hypoglossal nerve stimulation and emerging therapies such as pharmacotherapies and combination therapy. These concepts have also provided insight into potential physiological barriers to CPAP adherence for certain patients. This review summarises the recent advances in OSA pathogenesis, non-CPAP treatment, clinical management approaches and highlights knowledge gaps for future research. OSA endotyping and clinical phenotyping, risk stratification and personalised treatment allocation approaches are rapidly evolving and will further benefit from the support of recent advances in e-health and artificial intelligence.

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