Upper Airway Stimulation in Patients With Obstructive Sleep Apnea and an Elevated Body Mass Index: A Multi‐institutional Review

Huntley, Colin; Steffen, Armin; Doghramji, Karl; Hofauer, Benedikt; Heiser, Clemens; Boon, Maurits

doi:10.1002/lary.27426

Cited by 38 publications

(35 citation statements)

References 29 publications

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“…Not surprisingly, improved outcomes are associated with a lower BMI. This has been shown to be true for other OSA surgical procedures, and UAS implantation does not appear to be an exception, despite some prior evidence to the contrary . Although surgical success has been reported at higher BMIs, the BMI cutoff of 32 by STAR criteria remains a useful guide for surgical decision‐making until there are better preoperative assessment tools available to screen out those patients who would not succeed with UAS therapy.…”

Section: Discussionmentioning

confidence: 96%

Results of the ADHERE upper airway stimulation registry and predictors of therapy efficacy

et al. 2019

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Objective/Hypothesis: The ADHERE Registry is a multicenter prospective observational study following outcomes of upper airway stimulation (UAS) therapy in patients who have failed continuous positive airway pressure therapy for obstructive sleep apnea (OSA). The aim of this registry and purpose of this article were to examine the outcomes of patients receiving UAS for treatment of OSA.Study Design: Cohort Study.Methods: Demographic and sleep study data collection occurred at baseline, implantation visit, post-titration (6 months), and final visit (12 months). Patient and physician reported outcomes were also collected. Post hoc univariate and multivariate analysis was used to identify predictors of therapy response, defined as ≥50% decrease in Apnea-Hypopnea Index (AHI) and AHI ≤20 at the 12-month visit.Results: The registry has enrolled 1,017 patients from October 2016 through February 2019. Thus far, 640 patients have completed their 6-month follow-up and 382 have completed the 12-month follow-up. After 12 months, median AHI was reduced from 32.8 (interquartile range [IQR], 23.6-45.0) to 9.5 (IQR, 4.0-18.5); mean, 35.8 AE 15.4 to 14.2 AE 15.0, P < .0001. Epworth Sleepiness Scale was similarly improved from 11.0 (IQR, 7-16) to 7.0 (IQR, 4-11); mean, 11.4 AE 5.6 to 7.2 AE 4.8, P < .0001. Therapy usage was 5.6 AE 2.1 hours per night after 12 months. In a multivariate model, only female sex and lower baseline body mass index remained as significant predictors of therapy response.Conclusions: Across a multi-institutional study, UAS therapy continues to show significant improvement in subjective and objective OSA outcomes. This analysis shows that the therapy effect is durable and adherence is high.

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Section: Discussionmentioning

confidence: 96%

Results of the ADHERE upper airway stimulation registry and predictors of therapy efficacy

et al. 2019

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“…These patients also had significant improvements with all three demonstrating an AHI ≤10 events/hour after implantation. Similarly, a recent study by Huntley et al showed that patients with a BMI ≥32 kg/m 2 experienced similar rates of surgical success and improvements in AHI and ESS score after HGNS compared to patients with a BMI <32 kg/m 2 . Patients with a mean BMI of 34.37 kg/m 2 ± 2.08 (standard deviation) demonstrated surgical success (<50% reduction in AHI and AHI <20 events/hour) in 92.3% of cases compared to 95.4% of patients with a mean BMI of 27.63 ± 2.48 kg/m 2 .…”

Section: Discussionmentioning

confidence: 99%

Hypoglossal Nerve Stimulator Outcomes for Patients Outside the U.S. FDA Recommendations

et al. 2019

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Objectives The hypoglossal nerve stimulator (HGNS) is currently approved for the treatment of obstructive sleep apnea (OSA) in patients with an apnea‐hypopnea index (AHI) of >15 to ≤65 events/hour, and a central apnea index (CAI) <25% of the AHI, no complete concentric collapse on drug‐induced sleep endoscopy, and a recommended body mass index (BMI) <32 kg/m2. We present 18 patients implanted as a salvage procedure despite being outside these guidelines. Methods We included all patients who underwent HGNS but who did not meet all FDA guidelines. Demographic data, previous OSA treatments, polysomnographic (PSG) parameters from baseline and HGNS titration PSG, Epworth sleepiness score (ESS), and BMI were compared before and after surgery. Results Eighteen patients were identified: 94.4% male, median age 63 years. Seven underwent previous sleep surgery. Four had an AHI <15 (mean 10.5 events/hour), four had an AHI >65 (mean 86.9 events/hour), two had an elevated CAI (mean 31.3% of AHI), and 12 had a BMI >32 kg/m2 (range 32.1–39.1). Median AHI decreased from 25.3 to 3.75 events/hour on titration polysomnography (P = .0006), oxyhemoglobin saturation nadir increased from 82% to 88.5% (P = .0001) and median ESS dropped from 11 to 7.5 (P = .0016). Fifteen (83.3%) patients achieved surgical success (decrease in AHI >50% and AHI <20 events/hour) and 12 (66.7%) had an AHI <5 events/hour. Neither patient with CAI >25% was successfully treated. Median adherence = 33.5 hours/week. Conclusion Our success rate for patients outside the Food and Drug Administration guidelines for HGNS (67%) was similar to the 1‐year STAR trial results (66%). Future studies are necessary to consider expansion of these guidelines. Level of Evidence 4 Laryngoscope, 130:866–872, 2020

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“…An elevated BMI is known to be a negative predictor for any kind of OSA treatment, [32][33][34] other than a risk factor for OSA development. 2 A retrospective case-control study 35 of 153 patients analyzed the predictive value of a BMI > 32 Kg/m 2 . It demonstrated that HNS is a safe and effective procedure also for higher-BMI group, obtaining comparable clinical outcome in the two cohorts.…”

Section: Patient Selection and Efficacy Predictorsmentioning

confidence: 99%

<p>Hypoglossal Nerve Stimulation in the Treatment of Obstructive Sleep Apnea: Patient Selection and New Perspectives</p>

Baptista¹,

Costantino²,

Moffa³

et al. 2020

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Hypoglossal nerve stimulation (HNS) is an increasingly widespread OSA treatment. It is a non-anatomical modifying surgery able to achieve an adequate objective and subjective result with a reasonable complication rate. HNS exploits the neurostimulation to reduce upper airway collapsibility providing a multilevel upper airway improvement within a single procedure. Proper patient selection has a fundamental role in determining an adequate long-term clinical outcome. All patient candidates for HNS undergo a standard comprehensive sleep medicine assessment and upper airway surgical examination. Several features should be assessed preoperatively in order to predict patients' response to HNS treatment. In particular, the assessment of OSA severity, BMI > 32 Kg/m 2 , collapse pattern during drug-induced sleep endoscopy (DISE), and many other parameters, is central for a good patient selection and customization of OSA treatment. HNS is indeed one of the most promising tools in the widespread context of personalized sleep medicine. HNS is an adjustable medical device that could be titrated in order to improve HNS effectiveness, maintaining patient comfort. Moreover, HNS provides the opportunity for patients to play an active role in their own care, with a potential improvement in therapy adherence and efficacy. This review summarizes the current evidence in patient selection for HNS, highlighting the reasons behind the optimistic future of this OSA treatment in the context of personalized medicine.

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Upper Airway Stimulation in Patients With Obstructive Sleep Apnea and an Elevated Body Mass Index: A Multi‐institutional Review

Abstract: 3. Laryngoscope, 128:2425-2428, 2018.

Cited by 38 publications

References 29 publications

Results of the ADHERE upper airway stimulation registry and predictors of therapy efficacy

Results of the ADHERE upper airway stimulation registry and predictors of therapy efficacy

Hypoglossal Nerve Stimulator Outcomes for Patients Outside the U.S. FDA Recommendations

<p>Hypoglossal Nerve Stimulation in the Treatment of Obstructive Sleep Apnea: Patient Selection and New Perspectives</p>

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