Results from the study were published in the American Journal of Respiratory and Critical Care Medicine, the Amsterdam-based company said.
Investigators in the study compared the performance of four different ASV devices, including Philips’ DreamStation BiPap autoSV, as well as an ASV device originally associated with greater mortality during the SERVE-HF trial published in 2015, the company said.
“The pursuit for scientific understanding of various disease and treatment processes is an iterative process where we revisit successes and failures to deepen our understanding of disease processes. It’s imperative we keep this in mind and re-visit previous studies when technological advancements show promise for a certain type of therapy. Today, ASV isn’t used in certain clinical settings due to safety concerns associated with the therapy in patients with congestive heart failure and predominantly central sleep apnea. Now, through devices with smarter algorithms, providers can potentially ensure that patients are getting the right treatment and thereby improve treatment approaches in patients with complex or central sleep apnea,” lead study investigator Dr. Sairam Parthasarathy of the University of Arizona College of Medicine said in a prepared statement.
Data from the new trial suggests that certain physiological performances were different across different devices, and that the mechanisms underlying adverse effects of ASV may be secondary to excessive ventilation due to device-based effect rather than a class-effect, Philips said.
“Philips provides healthcare professionals and patients with innovative treatment solutions and services. The safety of patients who use our devices is our top priority. We also wish to maximize the benefits that patients receive from using our technology. As a science company, we are obligated to understand why and how ASV in the SERVE-HF trial can be associated with increased risk of mortality in patients with central sleep apnea and severe heart failure. Future research is needed to confirm if excessive ventilation during wakefulness and sleep due to device-specific ASV algorithms can result in potentially life-threatening consequences, especially in patients with heart failure,” Philips chief medical liaison Dr. Teofilo Lee-Chiong said in a press release.
Earlier this month, Carestream Health said that it agreed to deal its imaging IT business to Philips for an undisclosed amount.
Registration is open for DeviceTalks Boston! Join us on June 5-6, 2019, as we explore the trends and technology that are shaping the future of the medical device industry.