Phrenic Nerve Stimulation is Safe and Improves Sleep and QOL in Patients with Central Sleep Apnea and Atrial Fibrillation Regardless of Heart Failure Status

Introduction Central sleep apnea (CSA) is common in patients with atrial fibrillation (AF) with or without heart failure (HF). CSA is also a known trigger of new onset AF. Phrenic nerve stimulation (PNS) is an approved technology implanted by electrophysiologists shown to treat CSA effectively and safely. Hypothesis Phrenic nerve stimulation is safe and effective in a cohort of patients with CSA and AF. Methods Sleep metrics and quality of life (QOL) were analyzed for change from baseline to 6 months in patients with AF from the remedē System Pivotal Trial. Related serious adverse events (SAE) through 12 months are also reported. Results Baseline AF was reported in 42% (64/151) patients (32 Treatment [TX] and 32 Control [CL]). The mean age was 72, 88% were male, 78% had HF and 55% had an implanted cardiac device. Median ejection fraction was 38%. Baseline mean values for TX vs CL included: apnea hypopnea index (AHI) 46 vs 40 events/hr, central apnea index (CAI) 29 vs 21 events/hr, oxygen desaturation (ODI4) 39 vs 36 events/hr, arousal index (Arl) 50 vs 39 events/hr, Epworth Sleepiness Scale (ESS) 8 vs 9 and % of sleep in rapid eye movement (REM) 8 vs 12. Following 6 months of PNS therapy, 56% of patients in the TX group achieved ≥50% improvement in the AHI compared to 3% in CL (mean difference 53%, p Conclusions Phrenic nerve stimulation is safe and improves sleep and QOL in CSA patients with AF regardless of HF status. These findings underscore the need to evaluate changes in AF burden with PNS in future studies.