Device-related outcomes following hypoglossal nerve stimulator implantation.

Autor:	Moroco AE; Department of Otolaryngology-Head and Neck Surgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania., Wei Z; Department of Neurology and Jefferson Sleep Disorders Center, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania., Byrd I; Inspire Medical, Golden Valley, Minnesota., Rasmussen A; Inspire Medical, Golden Valley, Minnesota., Chio EG; Department of Otolaryngology-Head and Neck Surgery, The Ohio State University Wexner Medical Center, Columbus, Ohio., Soose RJ; Department of Otolaryngology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania., Huyett P; Department of Otolaryngology-Head and Neck Surgery, Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts., Steffen A; Department of Otorhinolaryngology, University of Lübeck, Lübeck, Germany., Heiser C; Department of Otorhinolaryngology/Head and Neck Surgery, Technical University of Munich, Munich, Germany.; Department of Translational Neurosciences, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium., Boon MS; Department of Otolaryngology-Head and Neck Surgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania., Huntley CT; Department of Otolaryngology-Head and Neck Surgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.
Jazyk:	angličtina
Zdroj:	Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine [J Clin Sleep Med] 2024 Sep 01; Vol. 20 (9), pp. 1497-1503.
DOI:	10.5664/jcsm.11176
Abstrakt:	Study Objectives: Hypoglossal nerve stimulation (HGNS) has been widely used to treat obstructive sleep apnea in selected patients. Here we evaluate rates of revision and explant related to HGNS implantation and assess types of adverse events contributing to revision and explant. Methods: Postmarket surveillance data for HGNS implanted between January 1, 2018 and March 31, 2022, were collected. Event rates and risk were calculated using the postmarket surveillance event counts and sales volume over the same period. Indications were categorized for analysis. Descriptive statistics were reported and freedom from explant or revision curves were grouped by year of implantation. Results: Of the 20,881 HGNS implants assessed, rates of explant and revision within the first year were 0.723% and 1.542%, respectively. The most common indication for explant was infection (0.378%) and for revision was surgical correction (0.680%). Of the 5,820 devices with 3-year postimplantation data, the rate of explant was 2.680% and of revision was 3.557%. During this same interval, elective removal (1.478%) was the most common indication, and for revisions, surgical correction (1.134%). Conclusions: The efficacy of HGNS is comparable in the real world setting to published clinical trial data. Rates of explant and revision are low, supporting a satisfactory safety profile for this technology. Citation: Moroco AE, Wei Z, Byrd I, et al. Device-related outcomes following hypoglossal nerve stimulator implantation. J Clin Sleep Med . 2024;20(9):1497-1503. (© 2024 American Academy of Sleep Medicine.)
Databáze:	MEDLINE
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