Armin Steffen1, Ulrich J Sommer2, Joachim T Maurer3, Nils Abrams4, Benedikt Hofauer5, Clemens Heiser6. 1. Department of Otorhinolaryngology, University of Lübeck, Klinik für HNO-Heilkunde, Ratzeburger Allee 160, 23538, Lübeck, Germany. armin.steffen@uksh.de. 2. Department of Otorhinolaryngology, Head and Neck Surgery, Helios University Hospital Wuppertal, University Witten/Herdecke, Wuppertal, Germany. 3. Department of Otorhinolaryngology, Head and Neck Surgery, University-Hospital Mannheim, Mannheim, Germany. 4. Department of Otorhinolaryngology, University of Lübeck, Klinik für HNO-Heilkunde, Ratzeburger Allee 160, 23538, Lübeck, Germany. 5. Department of Otorhinolaryngology, University of Freiburg, Kilianstraße 5, 79106, Freiburg, Germany. 6. Department of Otorhinolaryngology, Head and Neck Surgery, Technische Universität München, Munich, Germany.
Abstract
PURPOSE: Upper airway stimulation (UAS) is an effective treatment for obstructive sleep apnea (OSA) in positive airway pressure (PAP) failure. Most reports have presented short-term data, so long-term safety and efficacy reports are rare. The German post-market study (G-PMS) has followed approximately 60 patients from three implanting centers for several years. METHODS: Patients with OSA and PAP failure qualified for the G-PMS by the absence of obesity class 2 an AHI between 15 and 65 events/h and absence of complete concentric collapse at the velum during drug-induced sleep endoscopy. Optional 2- and 3-year follow-ups after implantation were collected during routine clinical practice. We measured respiratory parameters such as apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) and daytime sleepiness using the Epworth sleepiness scale (ESS) in a per protocol analysis. Usage was calculated from device-downloaded reports. Device-related complications were documented. RESULTS: Of the 60 original patients, 41 returned for 2-year follow-up, and 38 for 3 years. About 76% at 2 years and 68% at 3 years met the criterion of therapy success defined as an AHI below 15/h. The median AHI was reduced from 28.6/h (baseline) to 9.0/h (2 years) and 10.0/h (3 years); whereas median ODI decreased from 27.0 to 6.3/h (2 years), and 8.3/h (3 years). Median ESS improved from baseline 13 points to 4 (2 years) and 6 (3 years). Usage was stable at approximately 45 h per week at 2 and 3 years. Serious device-related adverse events were rare, with two-device explantation between 12 to 36 months postoperatively. CONCLUSIONS: The German multi-center long-term outcomes compare favorably with previously published studies. Respiratory and sleepiness efficacy outcomes were sustained over 2 and 3 years, with a favorable safety profile, supporting the safety and efficacy of a chronic implantable therapy.
PURPOSE: Upper airway stimulation (UAS) is an effective treatment for obstructive sleep apnea (OSA) in positive airway pressure (PAP) failure. Most reports have presented short-term data, so long-term safety and efficacy reports are rare. The German post-market study (G-PMS) has followed approximately 60 patients from three implanting centers for several years. METHODS:Patients with OSA and PAP failure qualified for the G-PMS by the absence of obesity class 2 an AHI between 15 and 65 events/h and absence of complete concentric collapse at the velum during drug-induced sleep endoscopy. Optional 2- and 3-year follow-ups after implantation were collected during routine clinical practice. We measured respiratory parameters such as apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) and daytime sleepiness using the Epworth sleepiness scale (ESS) in a per protocol analysis. Usage was calculated from device-downloaded reports. Device-related complications were documented. RESULTS: Of the 60 original patients, 41 returned for 2-year follow-up, and 38 for 3 years. About 76% at 2 years and 68% at 3 years met the criterion of therapy success defined as an AHI below 15/h. The median AHI was reduced from 28.6/h (baseline) to 9.0/h (2 years) and 10.0/h (3 years); whereas median ODI decreased from 27.0 to 6.3/h (2 years), and 8.3/h (3 years). Median ESS improved from baseline 13 points to 4 (2 years) and 6 (3 years). Usage was stable at approximately 45 h per week at 2 and 3 years. Serious device-related adverse events were rare, with two-device explantation between 12 to 36 months postoperatively. CONCLUSIONS: The German multi-center long-term outcomes compare favorably with previously published studies. Respiratory and sleepiness efficacy outcomes were sustained over 2 and 3 years, with a favorable safety profile, supporting the safety and efficacy of a chronic implantable therapy.
Entities:
Keywords:
Device; Hypoglossal nerve stimulation; Long term; Obstructive sleep apnea; PAP failure; Surgery; Upper airway stimulation
Authors: Peter Michael Baptista; Carlos Prieto-Matos; Manuel Alegre-Esteban; Elena Urrestarazu-Bolumburu; Juan Alcade Navarrete Journal: Indian J Otolaryngol Head Neck Surg Date: 2021-03-14
Authors: Armin Steffen; Clemens Heiser; Wolfgang Galetke; Simon-Dominik Herkenrath; Joachim T Maurer; Eck Günther; Boris A Stuck; Holger Woehrle; Jan Löhler; Winfried Randerath Journal: Eur Arch Otorhinolaryngol Date: 2021-06-21 Impact factor: 2.503