Introduction
Central sleep apnea is a frequent finding in heart failure (HF) and is being increasingly
reported in heart failure patients with preserved ejection fraction (HFpEF). Mechanisms
of CSA occurrence in those with HFpEF may be similar to CSA in HF with reduced ejection
fraction (HFrEF). While treatment of CSA in HFrEF has been reported to be safe and
associated with improved sleep metrics, long-term follow-up in patients with moderately
reduced ejection fraction (HFmrEF - EF 40-50%) or HFpEF (EF > 50%) and CSA is not
well understood. The aim of this analysis was to evaluate changes in LVEF and natriuretic
peptides in patients with HFmrEF or HFpEF and CSA following transvenous phrenic nerve
stimulation (TPNS).
Hypothesis
We hypothesized no meaningful reduction in LVEF or increase in natriuretic peptides
would be observed.
Methods
Patients who participated in the remedē system Pivotal trial had TPNS activated 1-month
post-implant in the treatment group and 6-months post-implant in the control group.
The groups were then pooled for post hoc analysis based on months of active therapy.
Echocardiography was performed at 6, 12, and 18 months with attention to EF%, particularly
in those without permanent atrial fibrillation, as well as measurement of BNP or NT-pro-BNP
at those time points.
Results
: The HFmrEF group had a median EF of 49.5% [interquartile range (IQR) - 47.0, 53.0]
(n=10) at 18 months with a paired change from baseline of 5.0% [2.0, 8.0] (p = 0.031).
The HFpEF group had an EF of 56.0% [54.0, 58.0] (n = 10) at 18 months with a paired
change from baseline of 1.5% [0.0, 4.0] (p = 0.086). Based on pooled data there was
no clinically meaningful change in BNP or NT-pro-BNP over the course of 18 months
of active therapy (Table 1).
Conclusions
This analysis shows no clinically meaningful change in EF based on echocardiographic
changes and no clinically meaningful changes in natriuretic peptides following TPNS
activation in patients with HFmrEF or HFpEF. Future studies in this patient population
should be considered.
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Identification
Copyright
© 2020 Published by Elsevier Inc.
