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Safety and effectiveness of phrenic nerve stimulation in male and female patients with central sleep apnoea
Authors : MR Costanzo (Naperville,US), S Mckane (Minnetonka,US), A Hasan (Columbus,US), A Kao (Kansas City,US), H Fox (Bad Oeynhausen,DE), REG Germany (Oklahoma City,US), C Stellbrink (Bielefeld,DE), S Joseph (Dallas,US)
1Advocate Heart Institute - Naperville - United States of America
2Respicardia, Inc. - Minnetonka - United States of America
3Davis Heart & Lung Research Institute - Columbus - United States of America
4University of Missouri - Kansas City - Kansas City - United States of America
5Heart and Diabetes Center NRW - Bad Oeynhausen - Germany
6University of Oklahoma - Oklahoma City - United States of America
7Bielefeld Hospital - Bielefeld - Germany
8Baylor University Medical Center - Dallas - United States of America
Background: Central sleep apnoea (CSA) is more common in men than in women. Phrenic nerve stimulation uses an implanted neurostimulator that has been shown to restore a normal breathing pattern in patients by stimulating the phrenic nerve, but little is known about sex differences in safety and effectiveness. Purpose: The aim of this analysis was to evaluate whether response to phrenic nerve stimulation varies according to sex in patients with CSA. Methods: All patients enrolled in the remede System pivotal trial were included in this analysis. Therapy was activated 1-month post implant in the Treatment group and after 6 months in Control. The randomised groups were pooled based on months of active therapy for analysis. The effects of therapy are reported following 12 months of therapy. Results: In the remede System Pivotal Trial, 11% (16/151) of subjects were female (F) and 89% (135/151) male (M). Mean age was 66 years for F and 65 M, mean BMI was 29.5 and 31.2 kg/m2, and mean ejection fraction was 46.3% and 38.8%. Severe CSA was present at baseline in 81% of subjects for each sex (median apnea hypopnea index [AHI] 38 events/hour F and 44 M). Concomitant diseases included hypertension (69% F, 76% M), CAD (38% F, 59% M) and atrial fibrillation (50% F, 41% M). Also, 56% F had heart failure (NYHA class I/II/III in 25%/13%/19%) compared to 64% M (NYHA I/II/III in 10%/29%/25%). At the 12-month active therapy polysomnogram, 60% (6/10) F and 58% (63/109) M achieved =50% reduction in AHI from baseline. The mean AHI improved at 12-months by approximately 23 events/hour in each sex, driven by a reduction in the central apnoea index. Patient global assessment was markedly/moderately improved in 82% F and 57% M. The Epworth Sleepiness Scale improved by a mean of 3-4 points in each sex. While 10% M experienced a related SAE through 12 months, no F experienced an event (95% CI for the difference [-10%, 16%]). Table 1 shows the results by sex. Conclusion: Despite the lower incidence of CSA in women, both sexes benefit similarly from phrenic nerve stimulation. There was no difference in adverse events between sexes. Women seemed to have greater improvements in quality of life than men.
12 Month results
Difference and 95% CI for Female-Male
Percentage of subjects with a 50% reduction in Apnoea-Hypopnoea Index from baseline
2% (-27%, 27%)
Apnoea-Hypopnoea Index (events/hour)
0.3 (-12.8, 13.3)
Central apnoea index (events/hour)
3.1 (-8.6, 14.8)
Percentage of subjects with Marked/Moderate improved patient global assessment
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