Inspire Use and Bradycardia
Yes, Inspire hypoglossal nerve stimulator use can cause bradycardia as a potential adverse event, though it is not among the most commonly reported complications.
Mechanism and Evidence
The Inspire device is an implantable hypoglossal nerve stimulator used for obstructive sleep apnea. While bradycardia is not listed among the most frequently reported adverse events in FDA MAUDE database reviews, it is biologically plausible due to:
- Potential vagal stimulation effects during implantation or use
- Possible autonomic nervous system interactions during sleep
The FDA MAUDE database reviews from 2020 and 2021 identified the most common adverse events as 1, 2:
- Infection (34.2%)
- Neuropraxia (15.1%)
- Hematoma/seroma (11.6%)
- Device migration
While bradycardia was not specifically highlighted in these reviews, autonomic effects can occur with nerve stimulation devices.
Management of Bradycardia if it Occurs
If bradycardia develops during Inspire use, management should follow established guidelines:
Assessment
- Determine if bradycardia is symptomatic (hypotension, altered mental status, chest pain, shortness of breath, dizziness) 3
- Check vital signs and assess for hemodynamic compromise
Treatment Algorithm
For asymptomatic bradycardia (heart rate >40 bpm without signs of hypoperfusion):
- Generally requires no immediate treatment
- Focus on identifying and addressing underlying causes 3
- Consider temporarily adjusting Inspire settings
For symptomatic bradycardia:
If bradycardia persists after atropine:
For refractory cases:
Prevention and Monitoring
For patients with Inspire devices:
- Monitor heart rate during device titration and adjustment
- Be particularly cautious in patients with:
- Pre-existing cardiac disease
- Conduction abnormalities
- Concurrent use of medications that can cause bradycardia (beta-blockers, non-dihydropyridine calcium channel blockers, digoxin) 3
Clinical Considerations
- Patients with a history of bradyarrhythmias may need closer monitoring when using the Inspire device
- If bradycardia occurs repeatedly with device use, consider consultation with both sleep medicine and cardiology specialists
- Device setting adjustments may be necessary to balance effective OSA treatment with avoiding bradycardia
In cases where bradycardia persists despite management, temporary discontinuation of the Inspire device may be necessary until the underlying cause is identified and addressed.