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Respiratory Sensing Lead Malfunction in Upper Airway Stimulation: A Single Institution Report
Albina S Islam1, Graham Pingree2, Andrew Chafin2
1Department of Otolaryngology-Head and Neck Surgery, Virginia Commonwealth University, Richmond, Virginia, USA.
The Laryngoscope
|September 21, 2023
Summary
Sensing lead malfunction occurred in 2.1% of patients receiving upper airway stimulation (UAS) for obstructive sleep apnea. Lead tip separation was the most common issue, often requiring revision surgery.
Area of Science:
- Medical Devices
- Sleep Medicine
- Surgical Technology
Background:
- Upper airway stimulation (UAS) is an effective obstructive sleep apnea treatment.
- The UAS device relies on a sensing lead for proper function.
- Sensing lead malfunction can compromise treatment efficacy.
Purpose of the Study:
- To determine the incidence of sensing lead malfunction in UAS patients.
- To analyze adverse event reports related to UAS sensing leads.
- To identify common causes and management strategies for lead failure.
Main Methods:
- Retrospective review of 190 UAS patients (July 2017-June 2022).
- Analysis of FDA MAUDE database for specific device models (Jan 2014-Sep 2022).
- Characterization of sensing lead malfunction types and revision surgery rates.
Main Results:
- Four patients (2.1%) experienced sensing lead malfunction.
- 122 MAUDE reports identified, with 72% requiring revision surgery.
- Sensing lead tip separation from the lead body was the most frequent issue (46% of reports).
Conclusions:
- Sensing lead integrity is crucial for UAS device function.
- Understanding lead failure modes is essential for optimal patient care.
- Waveform analysis can monitor sensing lead performance.
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