Abstract 18661: Results of Chronic Phrenic Nerve Stimulation using the RespiCardia(TM) System are Comparable to Acute Results in the Improvement of Central Sleep Apnea: First in Man Experience
Background: Central sleep apnea (CSA) episodes, oxygen desaturation and disruption in sleep architecture are part of the underlying mechanisms associated with periodic beathing (PB) and are responsible for additive detrimental impact on heart failure (HF). Previous acute study of transvenous phrenic nerve stimulation reported overnight improvements in the apnea-hypopnea index (AHI), CSA index (CAI), arousal index, and 5% oxygen desaturation index (ODI5). First-in-man chronic results using a fully implantable system (RespiCardiaTM) are presented here in comparison to the acute results.
Methods: In this chronic study, 3 subjects with a history of PB were implanted with the RespiCardiaTM stimulator and stimulation lead. After a one month healing period, subjects underwent two overnight sleep evaluations to assess breathing pattern, oxygenation and sleep parameters during RespiCardia therapy initiation (T0) as compared to no therapy (BL). Following a month of therapy with the system, the subjects returned for another overnight sleep evaluation (T1).
Results: Acute overnight results comparing Baseline (BL) to therapy (TX) are shown, as are chronic results for BL, T0, and T1. The RespiCardia system improved respiratory parameters (AHI and CAI), sleep architecture (arousal index) and oxygenation (ODI5). Observed changes were similar in magnitude to those achieved during the acute study without reports of adverse events.
Conclusion: Chronic therapy using the RespiCardia system improved the periodic breathing pattern in heart failure patients similar to that achieved under acute stimulation. The acute results appear to be sustained and/or further improved at 1 month. Improvements in oxygenation, sleep architecture and a reduction in CSA episodes are expected to result in improved patient quality of life and functional HF status over time.
- © 2010 by American Heart Association, Inc.