Central sleep apnea is a serious condition that affects many patients with heart failure, leading to interrupted signals from the brain to the body and causing breathing difficulties during sleep. The use of transvenous phrenic nerve stimulation (TPNS) has been associated with a significant improvement in clinical outcomes for these patients, according to a recent study conducted by Robin Germany, MD. This groundbreaking research sheds light on a potential treatment option that could help alleviate symptoms and improve the quality of life for those suffering from central sleep apnea and heart failure.
Germany’s study revealed that patients who received TPNS had a five-fold higher chance of better clinical outcomes compared to those in the control group. With over 1,100 winning pairwise comparisons for the treatment group, the results were statistically significant. The win ratio for death, heart failure hospitalization, and a 25% improvement in the Oxygen Desaturation Index was reported to be 5.14 with a confidence interval of 95%. These findings suggest that TPNS could be a promising treatment option for patients with central sleep apnea and heart failure.
The Remedē system, which was approved by the FDA in 2017, is an implantable device that stimulates the phrenic nerve to induce diaphragmatic contraction. This stimulation creates negative intrathoracic pressure similar to normal breathing, helping patients with central sleep apnea maintain adequate breathing while sleeping. The device is small and implanted below the collar bone, with a transvenous stimulator lead extending to the target nerve. Unlike other stimulation devices for sleep apnea, the Remedē system is implanted by a cardiologist under conscious sedation, making it a unique and innovative treatment option.
The study included patients with heart failure from the original pivotal trial, with 43 participants in the treatment group and 48 in the control group. Patients in the TPNS group had a median age of 67 and were predominantly men, with a median left ventricular ejection fraction of 34%. In contrast, patients in the control group had a slightly higher median age of 69, with similar demographics. The results of the study demonstrated the potential benefits of TPNS for patients with heart failure and central sleep apnea.
The use of transvenous phrenic nerve stimulation has shown promising results in improving clinical outcomes for patients with central sleep apnea and heart failure. The Remedē system offers a unique and effective treatment option for those struggling with this challenging condition. As additional research continues to support the long-term safety and effectiveness of the device, more patients may benefit from this innovative therapy. Overall, this study provides valuable insights into the potential of TPNS to enhance the quality of life for individuals with central sleep apnea and heart failure.