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Effects of phrenic nerve stimulation in subjects with central sleep apnoea and heart failure with reduced, mid-range, and preserved ejection fraction: findings from the remede system pivotal trial
Authors : MR Costanzo (Naperville,US), L Goldberg (Philadelphia,US), S Mckane (Minnetonka,US), O Oldenburg (Muenster,DE), A Kao (Kansas City,US), R Kawash (Columbus,US), REG Germany (Oklahoma City,US), P Ponikowski (Wroclaw,PL), C Stellbrink (Bielefeld,DE), WT Abraham (Columbus,US)
1Advocate Heart Institute - Naperville - United States of America
2University of Pennsylvania - Philadelphia - United States of America
3Respicardia, Inc. - Minnetonka - United States of America
4Clemens Hospital Munster - Muenster - Germany
5University of Missouri - Kansas City - Kansas City - United States of America
6Davis Heart & Lung Research Institute - Columbus - United States of America
7University of Oklahoma - Oklahoma City - United States of America
8Wroclaw Medical University, Cardiology - Wroclaw - Poland
9Bielefeld Hospital - Bielefeld - Germany
Background: Patients with heart failure (HF) often have central sleep apnoea (CSA). Treating CSA with phrenic nerve stimulation (PNS) may help improve the prognosis of patients with HF. However, impact of PNS has not been elucidated in patients with HF according to left ventricular ejection fraction (LVEF). Purpose: Investigate the effects of PNS on sleep metrics and quality of life (QoL) in patients with HF and reduced ejection fraction (HFrEF: <40%), mid-range EF (HFmrEF 40-<50%), and preserved EF (HFpEF: >50%). Methods: A PNS system was implanted in patients with CSA and therapy delivered for 6 months. Sleep was assessed at attended in-lab polysomnograms. The Epworth Sleepiness Scale (ESS) and Patient Global Assessment (PGA) were completed by the subjects. Subjects with HF were divided by LVEF into subgroups: HFrEF, HFmrEF, HFpEF. Results: The HFrEF, HFmrEF, and HFpEF subgroups were similar in age (mean 67, 69 and 64 years, respectively) and were primarily male (98%, 85%, 79%) with severe CSA (mean apnoea-hypopnoea index [AHI] of 44, 45 and 51 events/hour). Baseline demographics were similar including hypertension, CAD, and atrial fibrillation. Forty percent, 30% and 29% of patients were NYHA class III. Improvements in sleep metrics, sleep quality and QoL were observed in all subgroups following 6 months of active PNS therapy. A =50% reduction in AHI from baseline was experienced by 48-64% of subjects in each subgroup (table). AHI improved across the subgroups, with much of the reduction driven by improvements in the central apnoea index. Improvements in PGA and ESS were seen in all subgroups. Means or percentages and 95% confidence intervals are provided in the table. Conclusion: Despite small sample sizes in the HFmrEF and HFpEF subgroups, the results from this study suggest the improvements from phrenic nerve stimulation on sleep, daytime sleepiness and quality of life are similar for patients with central sleep apnoea and HF, regardless of LVEF.
6 Month Results
Subjects with 50% reduction in Apnoea Hypopnoea Index (%)
Apnoea Hypopnoea Index (events/hr)
Central Apnoea Index (events/hr)
Arousal Index (events/hr)
% subjects with marked/moderate improved PGA
Epworth Sleepiness Scale (points)
Change from baseline at 6 months and 95% confidence interval for the change.
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