Philips is advising clinicians not to use its adaptive servo-ventilation therapy devices to treat sleep apnea and chronic heart failure in light of recent safety risks that were revealed in a Phase 3 study.
In May, ResMed halted its Serve-HF clinical trial after finding that patients who received ASV treatment had a 2.5 percent higher risk of cardiovascular death than patients in the control group. The trial also didn’t show any significant statistical difference in primary endpoints between the treatment and control groups.
The study was designed to assess whether treating moderate to severe predominant central sleep apnea with ASV therapy in addition to optimized medical care could reduce disease and death in patients with symptomatic chronic heart failure.
On Thursday, Philips said it is evaluating the ResMed study to determine the potential impact on patients using its BiPAP, autoSV/BiPAP and auto SV Advanced devices. Pending the outcome of that investigation, clinicians should not use ASV therapy in patients with symptomatic chronic heart failure and moderate to severe sleep apnea, the company said.
The devices displayed no performance issues during the trial, according to ResMed. They are indicated for noninvasive ventilatory support in adult patients with obstructive sleep apnea and respiratory insufficiencies caused by central and/or mixed apneas and periodic breathing. They are not labeled for the treatment of heart failure.