Dataset Information

Iatrogenic Pneumothorax During Hypoglossal Nerve Stimulator Implantation: A Large Database Analysis.

ABSTRACT:

Objective

There have been case reports of adverse events of hypoglossal nerve stimulator (HNS) implantation not seen in previous clinical trials, including pneumothorax and pleural effusion. The purpose of this study was to determine the rates of these complications and potential risk factors.

Study design

Retrospective case-control study during 2014 to 2021.

Setting

Twenty-five health care organizations across the United States.

Methods

The TriNetX Research Network was queried by using disease codes to retrospectively identify patients with obstructive sleep apnea who underwent HNS implantation. Rates of pneumothorax, pleural effusion, other complications, and need for revision/replacement or explant were determined.

Results

We identified 1813 patients from 25 health care organizations who underwent HNS implantation. The average age was 60 years, and there were 68% males and 32% females. Of the cohort, 2.4% (n = 44 from 7 implant centers) experienced a pneumothorax, and 0.6% (n = 11) were diagnosed with a pleural effusion on the day of surgery. Patients who experienced pneumothorax were more likely to have a history of chronic lower respiratory diseases when compared with those who did not (odds ratio, 2.2; 95% CI, 1.1-4.1; P = .02).

Conclusion

The incidence of intraoperative pneumothorax and pleural effusion during HNS implantation may be greater than initially thought. Patients with chronic lower respiratory diseases may be at increased risk. This should be communicated with patients during the informed consent process.

SUBMITTER: Lorenz FJ

PROVIDER: S-EPMC10474953 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Publications

Iatrogenic Pneumothorax During Hypoglossal Nerve Stimulator Implantation: A Large Database Analysis.

Lorenz F Jeffrey FJ Goyal Neerav N

Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery 20230129 4

<h4>Objective</h4>There have been case reports of adverse events of hypoglossal nerve stimulator (HNS) implantation not seen in previous clinical trials, including pneumothorax and pleural effusion. The purpose of this study was to determine the rates of these complications and potential risk factors.<h4>Study design</h4>Retrospective case-control study during 2014 to 2021.<h4>Setting</h4>Twenty-five health care organizations across the United States.<h4>Methods</h4>The TriNetX Research Network ...[more]

PMID: 36066978

Similar Datasets

Project description:BackgroundHypoglossal nerve stimulator (HGNS) is a therapeutic option for moderate to severe obstructive sleep apnea (OSA). Improved patient selection criteria are needed to target those most likely to benefit. We hypothesized that the pattern of negative effort dependence (NED) on inspiratory flow limited waveforms recorded during sleep, which has been correlated with the site of upper airway collapse, would contribute to the prediction of HGNS outcome. We developed a machine learning (ML) algorithm to identify NED patterns in pre-treatment sleep studies. We hypothesized that the predominant NED pattern would differ between HGNS responders and non-responders.MethodsAn ML algorithm to identify NED patterns on the inspiratory portion of the nasal pressure waveform was derived from 5 development set polysomnograms. The algorithm was applied to pre-treatment sleep studies of subjects who underwent HGNS implantation to determine the percentage of each NED pattern. HGNS response was defined by STAR trial criteria for success (apnea-hypopnea index (AHI) reduced by > 50% and < 20/h) as well as by a change in AHI and oxygenation metrics. The predominant NED pattern in HGNS responders and non-responders was determined. Other variables including demographics and oxygenation metrics were also assessed between responders and non-responders.ResultsOf 45 subjects, 4 were excluded due to technically inadequate polysomnograms. In the remaining 41 subjects, ML accurately distinguished three NED patterns (minimal, non-discontinuous, and discontinuous). The percentage of NED minimal breaths was significantly greater in responders compared with non-responders (p = 0.01) when the response was defined based on STAR trial criteria, change in AHI, and oxygenation metrics.ConclusionML can accurately identify NED patterns in pre-treatment sleep studies. There was a statistically significant difference in the predominant NED pattern between HGNS responders and non-responders with a greater NED minimal pattern in responders. Prospective studies incorporating NED patterns into predictive modeling of factors determining HGNS outcomes are needed.

Dataset Information

Iatrogenic Pneumothorax During Hypoglossal Nerve Stimulator Implantation: A Large Database Analysis.

Objective

Study design

Setting

Methods

Results

Conclusion

Publications

Iatrogenic Pneumothorax During Hypoglossal Nerve Stimulator Implantation: A Large Database Analysis.

Similar Datasets

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