Post-Approval Results Confirm Surgical Intervention for Sleep Apnea Safe and Effective

Sleep apnea, characterized by patients who temporarily stop breathing in their sleep, is common in the United States, with 25 million adults diagnosed, according to the American Sleep Association. Although the continuous positive airway pressure, or CPAP, device is a remarkable advance in the field, the large tubed mask can be cumbersome. Many patients, even those with serious conditions like heart disease or stroke linked to their sleep apnea, stop wearing the device.

A surgical intervention, called Upper Airway Stimulation (UAS), which uses an implanted device to prevent airway blockage, was introduced in the last few years as an alternative for patients whose sleep apnea does not improve with the CPAP machine. In the largest study since the device was approved, and one that compared patient outcomes across two academic medical centers, Thomas Jefferson University researchers confirmed that the implanted UAS device is effective in improving sleep and quality of life.

“With new but complex surgical procedures such as this one, it’s important to validate that they can be effectively performed by different experienced surgeons at different institutions,” says senior author and surgeon Maurits Boon, M.D., Associate Professor in the Department of Otolaryngology at the Sidney Kimmel Medical College at Thomas Jefferson University. In addition, whereas the studies that led to this therapy’s approval were performed under strictly-controlled experimental settings, this study includes patients that were treated in real-life circumstances.”

The research, published in the Journal of Clinical Sleep Medicine examines outcomes of 48 patients who underwent the UAS procedure at Jefferson and 49 patients at the University of Pittsburgh, School of Medicine. Both institutions showed effectiveness and safety results that were comparable to original research that led to the government approval of the device.

“Using outcome data to affirm that this procedure is effective gives us more confidence in exploring it as an alternative option for our patients with sleep apnea,” says co-author Karl Doghramji, Director of the Jefferson Sleep Disorders Center and Professor of Psychiatry and Human Behavior at Sidney Kimmel Medical College.

 

For more information on sleep apnea, visit the Jefferson Sleep Disorders website.

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