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Neurostimulation device shows promise for treatment of central sleep apnea
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A transvenous neurostimulation device was associated with a reduction in the severity of central sleep apnea and was well tolerated, according to the results of a pivotal study published in The Lancet.
In 2013, researchers presented the results of a pilot study of the transvenous phrenic nerve stimulator (remedē system, Respicardia) in patients with HF and central sleep apnea, which showed an improvement in various sleep apnea metrics.
In the present study, William T. Abraham, MD, professor of internal medicine and director of the division of cardiovascular medicine at The Ohio State University Wexner Medical Center, and colleagues evaluated the device in 151 patients with an apnea-hypopnea index of at least 20 events per hour who had been medically stable for at least 30 days. No specific CV conditions were part of the inclusion criteria, but stage D HF and a cerebrovascular event within 12 months were among the exclusion criteria.
William T. Abraham
Concordant results
“This study shows in a definitive fashion that transvenous phrenic nerve stimulation for central sleep apnea improves not only all important measures of sleep ... but also improves oxygenation and, importantly, improves the patient-reported outcomes of quality of life and sleepiness scale,” Abraham said in an interview with Cardiology Today. “The results are concordant across the entire clinical development plan. The pivotal trial extends the findings of the pilot study by studying a larger group of patients, including a parallel control group for a direct comparison and including more data on patient-centered endpoints such as quality of life and sleepiness.”
All patients underwent implantation of the device, after which they were randomly assigned to have neurostimulation activated or not for 6 months. At 6 months, neurostimulation was turned on in the control group. The device is not yet available for commercial use in the United States.
The primary effectiveness endpoint was 50% or greater reduction in apnea-hypopnea index at 6 months. The primary safety endpoint was freedom from serious adverse events related to the procedure, system or therapy at 12 months.
In an intention-to-treat analysis, Abraham and colleagues found 51% of the neurostimulation group achieved the primary effectiveness endpoint at 6 months vs. 11% of the control group (between-group difference, 41%; 95% CI, 25-54).
Serious adverse events related to the procedure, system or therapy occurred in 8% of the neurostimulation group and 9% of the control group, according to the researchers. There were two deaths in each group at 6 months and three deaths between 6 months and 12 months when all patients received neurostimulation; all deaths were ruled unrelated to the procedure, system or therapy.
In the neurostimulation group, 37% of patients reported therapy-related discomfort that was not serious, and it was resolved via reprogramming in all patients but one, Abraham and colleagues wrote.
Markedly positive
The study “is markedly positive in hitting all primary and secondary endpoints which were designed to serve as the basis for FDA regulatory approval,” Abraham told Cardiology Today. “I am hopeful that ... we will be able to get this therapy to more patients. That being said, we are interested in seeing additional studies done in the postmarketing setting. It is important to note that ... we have studied patients with HF, atrial fibrillation, other CV disorders and non-CV disorders ... as a cardiologist and HF specialist, I would like to see more studies done focusing on patients with HF and the effect on HF clinical outcomes.” – by Erik Swain
For more information:
William T. Abraham, MD, can be reached at The Ohio State University, 473 W. 12th Ave., Columbus, OH 43210; email: william.abraham@osumc.edu.
Disclosure: The study was funded by Respicardia. Abraham reports receiving institutional research grants and personal fees from Respicardia. Please see the full study for a list of the other researchers’ relevant financial disclosures.
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