Impact of Body Mass Index and Discomfort on Upper Airway Stimulation: ADHERE Registry 2020 Update

Abstract

ADHERE Registry InvestigatorsObjectives/Hypothesis: To provide the ADHERE registry Upper Airway Stimulation (UAS) outcomes update, including analyses grouped by body mass index (BMI) and therapy discomfort.Study Design: Prospective observational study. Methods: ADHERE captures UAS outcomes including apnea-hypopnea index (AHI), Epworth sleepiness scale (ESS), therapy usage, patient satisfaction, clinician assessment, and safety over a 1-year period. BMI ≤32 kg/m 2 (BMI 32 ) and 32 < BMI ≤35 kg/m 2 (BMI 35 ) group outcomes were examined.Results: One thousand eight hundred forty-nine patients enrolled in ADHERE, 1,019 reached final visit, 843 completed the visit. Significant changes in AHI (À20.9, P < .0001) and ESS (À 4.4, P < .0001) were demonstrated. Mean therapy usage was 5.6 AE 2.2 hr/day. Significant therapy use difference was present in patients with reported discomfort versus no discomfort (4.9 AE 2.5 vs. 5.7 AE 2.1 hr/day, P = .01). Patients with discomfort had higher final visit mean AHI versus without discomfort (18.9 AE 18.5 vs. 13.5 AE 13.7 events/hr, P = .01). Changes in AHI and ESS were not significantly different. Serious adverse events reported in 2.3% of patients. Device revision rate was 1.9%. Surgical success was less likely in BMI 35 versus BMI 32 patients (59.8% vs. 72.2%, P = .02). There was a significant therapy use difference: 5.8 AE 2.0 hr/day in BMI 32 versus 5.2 AE 2.2 hr/day in BMI 35 (P = .028).Conclusions: Data from ADHERE demonstrate high efficacy rates for UAS. Although surgical response rate differs between BMI 32 and BMI 35 patient groups, the AHI and ESS reduction is similar. Discomfort affects therapy adherence and efficacy. Thus, proper therapy settings adjustment to ensure comfort is imperative to improve outcomes.

Hypoglossal Nerve Stimulator Implantation in an Ambulatory Surgery Center Versus Hospital

“…In addition, the vast majority of these pneumothoraces can be conservatively managed and therefore this risk should not preclude HGNS implantation in an ASC. 26 Therefore, our results, in the context of the findings by Szeto et al, suggest that HGNS implantation can be safely performed at an ASC in an appropriately selected cohort. 13 We did find in our study that patients with surgery performed at the ASC had a significantly lower AHI compared to patients whose surgery was performed at the HOPD (31.0 ([IQR 21.0-44.2] vs. 42.0 [27.9-51.0], P = .005).…”

Patienten relevanter Nutzen und Therapieeffekte in der Stimulationstherapie bei schlafbezogenen Atmungsstörungen

“…Publications are mainly available for respiration controlled HNS . On one hand, there are the cohort studies entitled STAR 24 38 39 40 and the German Postmarket study 31 41 42 43 as well as the registry study called ADHERE 44 45 including the prospective comparative study 46 initiated and supported by the manufacturer of Inspire Medical Company. On the other hand, there are independent cohort trials of larger implantation centers with sometimes several years of follow-up examinations 47 48 49 50 51 and the randomized controlled therapy withdrawal study of EFFECT 52 .…”

“…Es gibt zum einen die vom Hersteller Fa. Inspire Medical initiierten und unterstützten prospektiven Kohortenstudien STAR 24 38 39 40 und die German-Postmarket Studie 31 41 42 43 sowie die Registerstudie ADHERE 44 45 inklusive der prospektiven Vergleichsstudie im Wartearmdesign 46 . Zum anderen gibt es unabhängige Kohortenstudien von größeren Implantationszentren mit teilweise mehrjährigen Nachuntersuchungen 47 48 49 50 51 und die randomisierte kontrollierte Therapieentzugsstudie EFFECT 52 .…”

Die Hypoglossus-Stimulation zur Therapie der obstruktiven Schlafapnoe

“…Lag der BMI unter 32 kg/m 2 , erreichten 72 % der Patienten einen AHI < 20 im Vergleich zu 60 % bei einem BMI zwischen 32 und 35 kg/m 2 . 8,6 % nutzten eine ergänzende Behandlung wie eine Lagetherapie [18].…”

“…Mehr als 90 % der Patienten gaben eine hohe Zufriedenheit mit der Therapie an, würden sie sowohl selbst noch einmal wählen und auch anderen empfehlen [18].…”