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Complications with the Hypoglossal Nerve Stimulator: An Analysis of Nationally Reported Adverse Events

Hypoglossal Nerve Stimulation Therapy Surgery

On-Demand Session – Best of Scientific Oral Presentation

 

The hypoglossal nerve stimulator (HGNS) was approved by the U.S. Food and Drug Administration in 2014 for the treatment of obstructive sleep apnea in eligible patients—but no studies had examined HGNS on a national scale until now.

Elisa Berson

In order to investigate this, Elisa Berson, Rema Shah, and Yan H. Lee, MD, of Yale University School of Medicine in New Haven, Connecticut, and Harold G. Moore, of Weill Cornell Medicine Medical College in New York City, New York, completed a retrospective analysis of the Manufacturer and User Facility Device Experience database from January 2015 to December 2019 to identify—and consequently learn from—adverse events involving the HGNS. Of all cases logged, 180 met inclusion criteria for adverse events.

“These cases and the associated complications represent all adverse events and vary in severity and outcome,” said Berson. “As this study does not focus on the many cases with a hypoglossal nerve stimulator without an adverse event, it cannot make judgments or statements about the overall safety.”

The benefit of the study, then, is to study the adverse events in order to minimize a patient’s odds of an adverse event with the HGNS—not to insinuate that an adverse event is likely. In fact, Berson says it’s the opposite.

“Because complications are so rare, the use of a nationwide database and the examination of narrative descriptions can help to obtain a broad overview of the potential complications throughout the past few years,” she said. “Moreover, knowledge of the potential complications helps shape additional research questions to identify any susceptible patient populations. We are all working to keep patients safe. If we understand the pattern of adverse events, we can find better solutions to bring the number of adverse events closer to zero.”

Based on the data, Berson said that, as with any procedure, it’s important to be aware of infection risk.

“Surgeons should have a plan for treatment in case an infection or another adverse event happens following the placement of a hypoglossal nerve stimulator,” she said. “Of note in addition to infections, some other rarer complications occurred including Twiddler’s syndrome, a complication most frequently attributed to patients with pacemakers, and vascular injury intraoperatively while tunneling the leads, which occurred in four cases. It is important to increase awareness about the possibility of these complications as well as have a plan for alternative treatment of obstructive sleep apnea if device explantation is warranted.”

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