A study conducted at the University of Oklahoma College of Medicine in Oklahoma City, revealed that the use of transvenous phrenic nerve stimulation (TPNS) was associated with a five-fold increase in the likelihood of improved clinical outcomes for patients suffering from central sleep apnea and heart failure. This study, which analyzed the results of the Remedë system pivotal trial, reported that the treatment group had a total of 1,141 winning pairwise comparisons, compared to only 222 for the control group. The win ratio for death, heart failure hospitalization, and a 25% improvement in 4% of the Oxygen Desaturation Index was reported to be 5.14, with a significant P-value of less than 0.0001.
According to Robin Germany, MD, the lead researcher of the study, the findings suggest that the benefits of treating central sleep apnea far outweigh the risks associated with the device. Some of the risks mentioned in the pivotal trial included pocket erosion, hematoma, infection, component failure, lead dislodgment, lead displacement, non-cardiac chest pain, and elevated transaminase levels. Despite these risks, the FDA approved the Remedë device for moderate-to-severe central sleep apnea in 2017, based on the positive results from the pivotal trial.
Central sleep apnea is a condition characterized by the interruption of signals from the respiratory control center of the brain to the body, causing a temporary cessation of muscle activity during sleep. This interruption leads to breathing difficulties while sleeping, as the muscles responsible for respiration fail to function properly. While not as common as obstructive sleep apnea, central sleep apnea is frequently observed in patients with heart failure, affecting approximately 40% of individuals diagnosed with congestive heart failure.
The Remedë System
The Remedë device is a small implantable system designed to stimulate the phrenic nerve, inducing diaphragmatic contraction and creating negative intrathoracic pressure to mimic normal breathing patterns. The device is implanted below the collar bone, with a transvenous stimulator lead that extends to the target nerve. Unlike other stimulation devices for sleep apnea, the Remedë system is implanted by a cardiologist under conscious sedation, rather than by an otolaryngologist.
The retrospective win ratio analysis included patients with heart failure from the original pivotal trial, with 43 participants in the treatment group and 48 in the control group. Participants provided 2,064 pairwise comparisons for three pre-defined components: longest survival, lowest heart failure hospitalization rates through 6 months, and a 25% improvement in the Oxygen Desaturation Index. In order to qualify for the trial, patients had to be considered medically stable 30 days prior to baseline assessments.
The study conducted by Dr. Robin Germany and his team underscores the potential benefits of using transvenous phrenic nerve stimulation for patients with central sleep apnea and heart failure. The findings suggest that this innovative approach to treating sleep apnea could lead to improved clinical outcomes and enhanced quality of life for individuals suffering from these conditions. Further research and long-term studies are needed to fully assess the efficacy and safety of the Remedë system in the management of central sleep apnea and heart failure.
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