Transvenous phrenic nerve stimulation safe, effective out to 5 years
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Five-year data show sustained safety and efficacy outcomes after implantation of a transvenous phrenic nerve stimulation device in adults with moderate to severe central sleep apnea.
The remed System (Respicardia) was approved by the FDA in 2017 to treat moderate to severe central sleep apnea. The implantable device automatically activates each night to stimulate the right or left phrenic nerve, which sends signals to the diaphragm to help restore a normal breathing pattern. After the initial randomized controlled trial, as a condition of FDA approval, data were collected through 5 years after implant to assess long-term safety, effectiveness and mortality.
Shahrokh Javaheri, MD, with the division of pulmonary critical care and sleep medicine at Bethesda North Hospital at Bethesda North Hospital in Cincinnati and The Ohio State University in Columbia, reported 5-year results during the late-breaking abstract session at the virtual CHEST Annual Meeting.
At 5 years, there was a 96% reduction in central apneas, according to the results. Improvement in sleep-disordered breathing was sustained during follow-up, Javaheri said. At 5 years, overall apnea-hypopnea index was reduced by 22 events per hour of sleep.
Results also demonstrated sustained improvement in arousal, with “paramount changes in the arousal index,” with a decrease in arousal index from 36 events per hour of sleep to 23 events per hours of sleep at 5 years.
The researchers reported a shift from light-stage sleep to more deep-stage sleep at 5 years, with a 14-percentage point increase in deep sleep (N2-REM) and a 19-percentage point decrease in light-stage sleep (N1).
Improvement in daytime sleepiness was sustained during follow-up. At baseline, 45% of patients had an Epworth Sleepiness Scale score greater than 10; at 5 years, 62% of patients with a baseline score greater than 10 shifted to a score of 10 or lower, Javaheri said.
No unanticipated adverse device effects occurred over 5 years, including no deaths related to the implant procedure, device or delivered therapy, according to the results. The majority of related serious adverse events occurred in the first year and the number of the events went down as the physician learned how to implant the device, he said.
Overall survival at 5 years was 78% in all patients and 68% in a subset of patients with heart failure.
The observed improvements from baseline were consistent with previously published 6-, 12-, 24- and 36-month results, according to a company press release.
“These 5-year data provide support for transvenous phrenic nerve stimulation as an effective and safe long-term treatment option for adult patients with moderate to severe central sleep apnea,” Javaheri said.
The data were presented during CHEST and also during the recent Heart Failure Society of America Annual Meeting.
References:
Javaheri S, et al. Chest. 2020;doi:10.1016/j.chest.2020.09.011.