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Identifying and Managing Sensing Lead Malfunction in Upper Airway Stimulation Devices

by Linda Kossoff •

CLINICAL QUESTION

In using the Inspire Medical Systems’ upper airway stimulation (UAS) device to treat patients with moderate to severe obstructive sleep apnea (OSA), what characterizes sensing lead malfunctions that necessitate revision surgery?

BOTTOM LINE

Although the sensing lead component of the UAS device has a low failure rate, it is essential to review past cases and the Food and Drug Administration (FDA) database reports to understand component fail scenarios, event incidents, and appropriate management.

Background: UAS is an effective treatment for patients with OSA. The UAS device includes a respiratory sensing lead, which allows synchronization of stimulation with the most collapse-prone portion of the respiratory cycle. Like any mechanical implant, the sensing lead is susceptible to failure and breakage that can necessitate revision surgery.

STUDY DESIGN: Retrospective cohort and database study.

SETTING: Department of Otolaryngology–Head and Neck Surgery, Virginia Commonwealth University, Richmond, Va.

SYNOPSIS: Researchers identified adult patients implanted with the UAS device at a single tertiary institution between July 2017 and June 2022. Of the 190 patients analyzed, data review found lead malfunction in four patients (2.1%, mean age 70.3 years), all of whom initially underwent a three-incision technique for implantation. After discovery of the abnormality, each patient underwent imaging to ascertain any migration or potential fracture. In two of four patients, sensing lead tip fracture from lead body was noted upon two-incision revision surgery and both tips were retrieved. Review of the FDA Manufacturer and User Facility Device Experience database revealed 122 reports of adverse events associated with the sensing lead component, with 72% requiring revision surgery. The most frequently reported adverse event was sensing lead tip separation from the lead body. Authors stated that routine follow-up is crucial for patients implanted with this device as fractures can migrate into the thoracic cavity and lead malfunction can manifest asymptomatically. Study limitations included its retrospective nature.

CITATION: Islam AS, Pingree G, Chafin A, et al. Respiratory sensing lead malfunction in upper airway stimulation: a single institution report. Laryngoscope. 2024;134:1479–1484.