Hypoglossal Nerve Stimulation Respiratory Lead Migration: MAUDE Database Review and Case Report

Area of Science:

• Medical Devices
• Sleep Medicine
• Surgical Complications

Background:

• Obstructive sleep apnea (OSA) is treated with unilateral hypoglossal nerve stimulation (HGNS).
• HGNS involves a pulse generator, respiratory sensing lead, and stimulation lead, with potential complications.
• Previous studies reported overall adverse event incidence for HGNS.

Purpose of the Study:

• To provide an updated report on HGNS complications using the FDA MAUDE database.
• To focus on complications related to the respiratory sensing lead, specifically migration.
• To propose a care algorithm and discuss two cases of sensing lead migration.

Main Methods:

• Retrospective cross-sectional study and case report.
• Querying the MAUDE database for HGNS respiratory sensing lead events (2000-2022).
• Primary outcomes: respiratory lead migration causing pneumothorax or requiring revision/explantation.

Main Results:

• 151 of 765 HGNS adverse events involved the respiratory sensing lead; 75 were lead migrations.
• Seven events involved sensing lead migration into the pleural space, with six requiring revision surgery (<1% of HGNS adverse events).
• Two cases of pneumothorax due to sensing lead migration were noted; two institution-specific cases are detailed.

Conclusions:

• Respiratory sensing lead migration is a rare complication of HGNS for OSA.
• Multidisciplinary surgical planning is essential for managing potential sensing lead migration.
• Consideration for preoperative or intraoperative chest tube placement may be necessary based on migration extent and complexity.