FDAnews Device Daily Bulletin


Dec. 19, 2005

Using a pacemaker to accelerate the heart rate during sleep has no significant effect in the treatment of obstructive sleep apnea-hypopnea syndrome, according to a new study that contradicts earlier findings on the role of atrial overdrive pacing (AOP) in treating this common condition.

By contrast, nasal continuous positive airway pressure (CPAP) therapy is highly effective for the treatment of the sleep apnea disorder, according to the study published in the New England Journal of Medicine (NEJM).

These findings differ from a study four years ago that demonstrated substantial improvement in sleep apnea with AOP, according to an editorial the NEJM. In the 2002 study, a mean 57 percent decrease in the apnea-hypopnea index (the frequency of episodes of apnea or hypopnea per hour of sleep) was observed during a single night of pacing at a rate 15 beats per minute above the baseline nocturnal heart rate. That study also showed a 40 percent improvement in each subject.

In stark contrast, the current study found the pacing had no meaningful effect on any measure of severity of the sleep apnea disorder. The current study compared AOP to CPAP therapy. "At the same time, the use of CPAP resulted in dramatic and sustained improvement in the apnea-hypopnea index, sleep quality on the basis of polysomnography and self-reported daytime sleepiness," the editorial said. The editorial attributed the differences in the studies to the types of patients selected.

Treatments that primarily modify airway anatomy during sleep, including CPAP, surgery and oral appliances, "will probably remain the most important tools in the treatment of sleep apnea," the editorial concludes.

()a href="http://www.fdanews.com/ddl" target=_blank>