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CC BY-NC-ND 4.0 · Pneumologie 2024; 78(09): 634-648
DOI: 10.1055/a-2331-8978
Übersicht

Zehn Jahre Hypoglossusnerv-Stimulation bei obstruktiver Schlafapnoe – ein systematischer Literaturreview

Ten years of hypoglossal nerve stimulation in obstructive sleep apnea: a systematic literature review
Susanne Habetha
1   Healthcare Heads GmbH, Kiel, Deutschland
,
Sven Sauermann
1   Healthcare Heads GmbH, Kiel, Deutschland
,
Stefanie Müller
1   Healthcare Heads GmbH, Kiel, Deutschland
,
Gerd Gottschalk
2   GERD Consulting, Kreuzau, Deutschland
› Author AffiliationsSupported by: Nyxoah S.A., Mont-Saint-Guibert, Belgium Dieser Artikel wurde nicht öffentlich gefördert.
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Zusammenfassung

Zielsetzung Es soll die Bedeutung der Hypoglossusnerv-Stimulation (HGNS) als Behandlungsmethode der obstruktiven Schlafapnoe (OSA) im deutschen Versorgungskontext dargestellt werden, um im Ergebnis eine bessere Einschätzung darüber zu erhalten, in welcher Weise Patienten, die bisher nicht ausreichend versorgt sind, von der HGNS profitieren können.

Methoden Anhand einer systematischen Literaturauswertung in den Literaturdatenbanken Medline und Cochrane Library, in die unterschiedliche Stimulationstechnologien eingeschlossen wurden, wurde die Wirksamkeit der HGNS mithilfe patientenrelevanter Endpunkte (Tagesschläfrigkeit, Lebensqualität), die Therapieadhärenz sowie der Apnoe-Hypopnoe-Index (AHI) und Oxygen Desaturation Index (ODI) eingeschätzt. Die Sicherheit der Behandlungsmethode wurde anhand der unerwünschten Ereignisse (UE) überprüft.

Ergebnisse Einschluss und Auswertung von 33 Publikationen: 2 randomisierte kontrollierte Studien (RCTs, Level Ib), 1 Studie Level IIb (n = 1) und 30 Studien Level IV mit einer Studiendauer von bis zu 60 Monaten. In den RCTs zeigten sich für die Tagesschläfrigkeit und Lebensqualität unter Anwendung der HGNS bessere Werte als in der Kontrollgruppe. AHI und ODI wiesen unter Placebostimulation bzw. Therapieentzug in den RCTs eine Verschlechterung auf. Zur Adhärenz wurden auch im Langzeitverlauf konsistent hohe Werte berichtet. Schwere UE unter HGNS waren selten und konnten meist durch eine Repositionierung von Elektroden oder einen Austausch von Geräteteilen beseitigt werden. Andere UE waren überwiegend vorübergehend oder konnten durch nicht-invasive Maßnahmen behoben werden. Alle untersuchten Parameter zeigten gleichgerichtete Ergebnisse in den ausgewerteten Studien. Die Ergebnisse von unterschiedlichen Stimulationssystemen sind in Art und Ausmaß vergleichbar.

Schlussfolgerung Basierend auf einer umfangreichen Literaturauswertung unterstreichen konsistente Daten die Bedeutung der HGNS als wirksame und sichere Behandlung der OSA nach erfolgloser CPAP-Behandlung. Die Auswertung lässt darüber hinaus erkennen, dass die unterschiedlichen Stimulationssysteme eine an den patientenindividuellen Erfordernissen ausgerichtete Therapie ermöglichen. Eine zukünftige systematische Auswertung von Real-World-Daten zur Anwendung der HGNS erscheint notwendig, um zusätzliche Erkenntnisse über die Relevanz der Methode in der klinischen Routine zu erhalten.

Abstract

Objective To show the importance of hypoglossal nerve stimulation (HGNS) as a treatment method for obstructive sleep apnea (OSA) in the German healthcare context and to better assess the way patients who do not receive adequate care could benefit from HGNS.

Methods A systematic literature review in the Medline and Cochrane Library literature database was conducted, including publications using different stimulation technologies for HGNS. The efficacy of HGNS was assessed based on patient-relevant outcomes (daytime sleepiness, quality of life), treatment adherence and the apnea-hypopnea index (AHI) and oxygen desaturation index (ODI). The safety of the treatment method was assessed based on adverse events (AEs).

Results Inclusion and analysis of 33 publications: 2 randomized controlled trials (RCTs, level Ib), 1 level IIb trial (n = 1) and 30 level IV trials with a study duration of up to 60 months. The RCTs showed better values for daytime sleepiness and quality of life when using HGNS than in the control group. AHI and ODI showed a deterioration under placebo stimulation or therapy withdrawal in the RCTs. Consistently high adherence was also reported in the long-term course. Severe AEs under HGNS were rare and could usually be resolved by repositioning electrodes or replacing device components. Other AEs were mostly transient or could be resolved by non-invasive measures. All investigated parameters showed similar results in the evaluated studies. The results of different stimulation systems are comparable in type and extent.

Conclusion The comprehensive review of the literature shows consistent data that highlight the importance of HGNS as an effective and safe treatment for OSA after unsuccessful CPAP treatment. The evaluation also shows that the different stimulation systems make it possible to better tailor the therapy to the patientʼs individual requirements. A future systematic evaluation of real-world data on the use of HGNS would help gain additional insights into the relevance of the method in routine clinical practice.

Schlüsselwörter

schlafbezogene Atmungsstörung - obstruktive Schlafapnoe - Nervus hypoglossus - Neurostimulation - Stimulation der oberen Atemwege

Keywords

sleep-disordered breathing - obstructive sleep apnoea - hypoglossal nerve - neurostimulation - upper airway stimulation


Publication History

Received: 18 January 2024

Accepted after revision: 05 May 2024

Article published online:
24 June 2024

© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

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