Phrenic Nerve Stimulation for the Treatment of Central Sleep Apnea: A Pooled Cohort Analysis
Central sleep apnea treatment has been limited mostly to various PAP therapies despite conflicting data regarding their use. In the last decade several trials of the remedē System phrenic nerve stimulator have been conducted to evaluate its safety and efficacy. An analysis by Fudim et al published December 15th, 2019 in the Journal of Clinical Sleep Medicine pooled data from both pilot and pivotal trials using the remedē System phrenic nerve stimulator. Of the 208 participants, 197 underwent successful implantation of the remedē System and 170 had data available for analysis at 6 months. HF was present in 68% of these patients, the majority of whom had EF ≤40%. Median AHI and CAI on baseline PSG were 44.6 and 24.2, respectively. At 6 months there were significant reductions in median AHI and CAI compared to baseline (58% and 92% reduction, respectively). Furthermore, there was a significant reduction in the median Epworth Sleepiness Scale score from 9 to 6 at 6 months compared to baseline. Safety events at 12 months were reported in 30% of participants in the pilot study but only 9% in the pivotal after development of new device leads.
(Post by: Oren Cohen)
