<scp>Two‐Incision</scp> Approach for Hypoglossal Nerve Stimulator Placement: A Single Institution Assessment

Sagalow, Emily S.; Rodin, Julianna; Estephan, Leonard; Jackson, J. Craig; Crippen, Meghan M.; Boon, Maurits; Huntley, Colin

doi:10.1002/lary.30050

Cited by 10 publications

(11 citation statements)

References 19 publications

(49 reference statements)

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“…This finding supports the notion that, with careful dissection and placement, the 2‐incision technique is able to successfully place the sensing electrode within the intercostal space without respiratory signal interference from cardiac artifact. This, along with the other previously described benefits of the 2‐incision approach, 16 , 21 , 22 supports the transition to this technique by sleep surgeons.…”

Section: Discussionsupporting

confidence: 80%

Novel Outcome Analysis Tool for Hypoglossal Nerve Stimulator Sensor Lead Function and Comparison by Incision Type (2 Versus 3)

et al. 2022

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Objective No reported outcome measures have been established to evaluate sensor lead function in the hypoglossal nerve stimulator (HNS). This study describes the development of novel functional outcome measures for intraoperative sensor electrode function and compares 2‐incision and 3‐incision outcomes for HNS. Methods A retrospective cohort study of 100 consecutive patients who underwent HNS between June 2019 and September 2021. Demographic information, intraoperative findings, and immediate postoperative outcomes were recorded. Structured parameters were developed to compare intraoperative waveforms with six outcome measures utilized: waveform syncing, waveform amplitude, sensory current leakage, shark‐fin morphology, cardiac artifact, and overall impression. Two sleep surgeons and two sleep medicine specialists compared all waveforms in a blinded fashion and assigned scores on the Likert Scale. Results The cohort included 50 three‐incision and 50 two‐incision patients. Age, gender, average body mass index, comorbidity profiles, and sleep endoscopy findings did not significantly differ between the two groups. No major complications occurred. The interclass‐correlation‐coefficient was greater than 0.7 for all comparisons (good to very good interrater reliability). There was no difference in waveform amplitude, cardiac artifact, sensory current leakage, or shark‐fin morphology between the two groups. Waveform syncing and overall impression were statistically better in the 2‐incision cohort. Conclusions This study is the first to define a structured method of HNS sensor electrode outcome measurement and showed consistent measures by surgeons and sleep medicine specialists. This article supports the transition to the 2‐incision technique among surgeons for placement of the sensor lead. Consideration should be given to utilizing this novel tool in the clinical/research setting and validating these measures moving forward. Level of Evidence 3 Laryngoscope, 133:423–430, 2023

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Section: Discussionsupporting

confidence: 80%

Novel Outcome Analysis Tool for Hypoglossal Nerve Stimulator Sensor Lead Function and Comparison by Incision Type (2 Versus 3)

et al. 2022

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“…There have been reports of pneumothoraces occurring during both techniques 15,23,24 . In our study, <10 of 486 HNS implantations performed after FDA approval were complicated by a pneumothorax.…”

Section: Discussionmentioning

confidence: 59%

“…23 Kent et al and Sagalow et al found no significant differences in rates of adverse events comparing the 2-and 3-incision approaches. 23,24 There have been reports of pneumothoraces occurring during both techniques. 15,23,24 In our study, \10 of 486 HNS implantations performed after FDA approval were complicated by a pneumothorax.…”

Section: Discussionmentioning

confidence: 99%

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

Lorenz

Goyal

2022

Otolaryngol.--head neck surg.

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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.

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“…A recent retrospective review comparing the 2 techniques showed similar complication rates but a statistically significant decrease in average operation time from 143 to 129 minutes ( P < .001). 46 Upcoming improvements are focused on having the inspiration sensor incorporated within the implantable pulse generator, further decreasing procedure time and risk of complication for the device.…”

Section: Discussionmentioning

confidence: 99%

New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2021

et al. 2022

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Objective To evaluate new medical devices and drugs pertinent to otolaryngology–head and neck surgery that were approved by the Food and Drug Administration (FDA) in 2021. Data Sources Publicly available FDA device and drug approvals from ENT (ear, nose, and throat), anesthesia, neurosurgery, plastic surgery, and general surgery FDA committees. Review Methods FDA device and therapeutic approvals were identified and reviewed by members of the American Academy of Otolaryngology–Head and Neck Surgery’s Medical Devices and Drugs Committee. Two independent reviewers assessed the relevance of devices and drugs to otolaryngologists. Medical devices and drugs were then allocated to their respective subspecialty fields for critical review based on available scientific literature. Conclusions The Medical Devices and Drugs Committee reviewed 1153 devices and 52 novel drugs that received FDA approval in 2021 (67 ENT, 106 anesthesia, 618 general surgery and plastic surgery, 362 neurosurgery). Twenty-three devices and 1 therapeutic agent relevant to otolaryngology were included in the state of the art review. Advances spanned all subspecialties, including over-the-counter hearing aid options in otology, expanding treatment options for rhinitis in rhinology, innovative laser-safe endotracheal tubes in laryngology, novel facial rejuvenation and implant technology in facial plastic surgery, and advances in noninvasive and surgical treatment options for obstructive sleep apnea. Implications for Practice FDA approvals for new technology and pharmaceuticals present new opportunities across subspecialties in otolaryngology. Clinicians’ nuanced understanding of the safety, advantages, and limitations of these innovations ensures ongoing progress in patient care.

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Two‐Incision Approach for Hypoglossal Nerve Stimulator Placement: A Single Institution Assessment

Cited by 10 publications

References 19 publications

Novel Outcome Analysis Tool for Hypoglossal Nerve Stimulator Sensor Lead Function and Comparison by Incision Type (2 Versus 3)

Novel Outcome Analysis Tool for Hypoglossal Nerve Stimulator Sensor Lead Function and Comparison by Incision Type (2 Versus 3)

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

New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2021

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