Sleep medicine · 2026
Changes in quality of life in patients with atrial fibrillation and central sleep apnea treated with transvenous phrenic nerve stimulation.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Javaheri Shahrokh, McKane Scott W, Germany Robin E
Аннотация
BACKGROUND: It is well-known patients with atrial fibrillation (AF) have significant fatigue and impaired quality of life (QoL). Because central sleep apnea (CSA) could be associated with AF, CSA could be a contributory but treatable comorbidity.
OBJECTIVES: Retrospective assessment of the impact of CSA treatment with transvenous phrenic nerve stimulation (TPNS) on sleep and QoL in a subgroup of patients with CSA and AF from the remedē® System pivotal trial.
METHODS: Patients were implanted with a TPNS device and randomized to treatment or control. Therapy was activated in the treatment arm and remained off in control for 6 months, when TPNS was also activated. Patients were followed through 12 months.
RESULTS: Sixty-four of 151 implanted participants had AF, including 32 per arm. The apnea hypopnea index and central apnea index decreased significantly from medians of 49 and 20 events/hour of sleep at baseline to 21 and 1/hour after 6 months of TPNS therapy (p < 0.001 for each), respectively. In parallel, changes in arousal index (48 at baseline vs. 25/hour of sleep at 6 months, p < 0.001) and percent of sleep time with oxygen saturation less than 90% (8% vs. 4%, p = 0.071) improved. Compared to the control group, Patient Global Assessment and Epworth Sleepiness Scale improved significantly with treatment. Improvements were sustained for 12 months and results were similar in the control group after therapy activation.
CONCLUSIONS: AF was highly prevalent in patients with CSA. TPNS therapy may significantly improve sleep metrics, QoL, and daytime sleepiness in patients with CSA and AF.
REGISTRATION: ClinicalTrials.gov identifier NCT01816776.
OBJECTIVES: Retrospective assessment of the impact of CSA treatment with transvenous phrenic nerve stimulation (TPNS) on sleep and QoL in a subgroup of patients with CSA and AF from the remedē® System pivotal trial.
METHODS: Patients were implanted with a TPNS device and randomized to treatment or control. Therapy was activated in the treatment arm and remained off in control for 6 months, when TPNS was also activated. Patients were followed through 12 months.
RESULTS: Sixty-four of 151 implanted participants had AF, including 32 per arm. The apnea hypopnea index and central apnea index decreased significantly from medians of 49 and 20 events/hour of sleep at baseline to 21 and 1/hour after 6 months of TPNS therapy (p < 0.001 for each), respectively. In parallel, changes in arousal index (48 at baseline vs. 25/hour of sleep at 6 months, p < 0.001) and percent of sleep time with oxygen saturation less than 90% (8% vs. 4%, p = 0.071) improved. Compared to the control group, Patient Global Assessment and Epworth Sleepiness Scale improved significantly with treatment. Improvements were sustained for 12 months and results were similar in the control group after therapy activation.
CONCLUSIONS: AF was highly prevalent in patients with CSA. TPNS therapy may significantly improve sleep metrics, QoL, and daytime sleepiness in patients with CSA and AF.
REGISTRATION: ClinicalTrials.gov identifier NCT01816776.