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

Abstract

Objective: Unilateral hypoglossal nerve stimulation (HGNS) to treat obstructive sleep apnea involves implantation of a pulse generator, a respiratory sensing lead, and a stimulation lead. Complications may arise related to all components. Previous studies have presented the overall incidence of reported adverse events. The objective of this study was to provide an updated report of complications from the Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database, with a focus on the respiratory sensing lead, and propose a care algorithm with two cases of sensing lead migration.

Study design: Retrospective cross-sectional study, case report.

Setting: Tertiary care center.

Methods: The MAUDE database was queried for events related to the HGNS respiratory sensing lead from January 1, 2000, to December 1, 2022. Primary outcomes were respiratory lead migration resulting in pneumothorax or need for revision surgery/explantation.

Results: In total, 151 out of 765 HGNS adverse events were related to the respiratory sensing lead, and of those, 75 were related to lead migration. There were seven events related to migration of the sensing lead into the pleural space, of which six cases underwent revision surgery (<1% of adverse events reported related to HGNS). Two cases noted pneumothorax due to sensing lead migration. We report two cases of sensing lead migration at our institution. Migration was demonstrated with serial imaging. These cases highlight the potential need for preoperative or intraoperative chest tube placement, based on the extent of migration, complications, and complexity.

Conclusion: Migration of the respiratory sensing lead is a rare event with multidisciplinary surgical planning considerations.