Evidence map›Paper›PMID 38656805›Full record

ArticleJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2024

Device-related outcomes following hypoglossal nerve stimulator implantation.

Annie E Moroco, Zhikui Wei, Israel Byrd, Andrea Rasmussen, Eugene G Chio, Ryan J Soose, Phillip Huyett, Armin Steffen, Clemens Heiser, Maurits S Boon and 1 more

Open access · greenAbstract read
In one paragraph

Article in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.0field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
  3. [Content and development of pharyngology and laryngology].Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology head and neck surgery · 2024
    Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 3 countries.

Annie E MorocoDepartment of Otolaryngology-Head and Neck Surgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.
Zhikui WeiDepartment of Neurology and Jefferson Sleep Disorders Center, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.
Israel ByrdInspire Medical, Golden Valley, Minnesota.
Andrea RasmussenInspire Medical, Golden Valley, Minnesota.
Eugene G ChioDepartment of Otolaryngology-Head and Neck Surgery, The Ohio State University Wexner Medical Center, Columbus, Ohio.
Ryan J SooseDepartment of Otolaryngology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
Phillip HuyettDepartment of Otolaryngology-Head and Neck Surgery, Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts.
Armin SteffenDepartment of Otorhinolaryngology, University of Lübeck, Lübeck, Germany.
Clemens HeiserDepartment of Otorhinolaryngology/Head and Neck Surgery, Technical University of Munich, Munich, Germany.
Maurits S BoonDepartment of Otolaryngology-Head and Neck Surgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.
Colin T HuntleyDepartment of Otolaryngology-Head and Neck Surgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.
Thomas Jefferson University Hospital · USInspire Medical Systems (United States) · USMassachusetts Eye and Ear Infirmary · USTechnical University of Munich · DEThe Ohio State University Wexner Medical Center · USUniversity of Lübeck · DEUniversity of Pittsburgh Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectivesHypoglossal 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.

methodsPostmarket 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.

resultsOf 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%).

conclusionsThe 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.

Indexed as

Electric Stimulation TherapyHypoglossal NerveSleep Apnea, ObstructiveAdultDevice RemovalFemaleHumansImplantable NeurostimulatorsMaleMiddle AgedProduct Surveillance, PostmarketingReoperationTreatment Outcomeadverse eventshypoglossal nerve stimulatorobstructive sleep apneaupper airway stimulator

Identifiers

PMID38656805
PMCPMC11367714
OpenAlexW4395446359

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.