Echocardiographic Changes in Heart Failure Patients Treated with Transvenous Stimulation of the Phrenic Nerve for Central Sleep Apnea

Abstract

Introduction Central sleep apnea (CSA) has been associated with a poor prognosis in patients with heart failure (HF). CSA in HF is associated with fatigue, daytime sleepiness, higher rates of HF-related readmission within 6 months and. Treatment of CSA using transvenous phrenic nerve stimulation (TPNS) with the remedē system has been shown to be safe and effective through 36 months of therapy in those with moderate-to-severe CSA with underlying HF, demonstrating improvement in sleep metrics, daytime sleepiness and quality of life regardless of HF. The aim of this analysis was to evaluate clinically relevant echocardiographic changes seen in patients within all HF subtypes. Hypothesis We hypothesized no adverse change on echocardiography would occur with CSA therapy. Methods Patients with CSA and HF who participated in the remedē system Pivotal trial were implanted with the remedē system with therapy activation 1-month post-implant in the treatment group and 6-months post-implant in the control group. The groups were then pooled for analysis based on months of active therapy. Echocardiography was performed at 6, 12, and 18 months with attention to the right ventricular end-diastolic diameter (RVEDD), tricuspid annular planar systolic excursion (TAPSE) and right ventricular (RV) ejection time. Subjects with permanent atrial fibrillation were excluded. Results Based on pooled data, there was no clinically meaningful change from baseline in RVEDD, TAPSE and RV ejection time in any of the EF subgroups (HFrEF [EF Conclusions This is the first analysis of echocardiographic changes among HF patients with CSA across the EF spectrum receiving TPNS. In concert with prior data, no adverse structural consequences were observed in these echocardiographic parameters of TPNS. These data reveal that transvenous stimulation of the phrenic nerve in patients with HF and CSA may be a therapeutic option for patients regardless of EF.