Physicians at the Mount Sinai Health System are among the first in New York State to offer a promising new surgical treatment for people with moderate-to-severe obstructive sleep apnea, a common disorder characterized by the recurrent narrowing and closing of a person’s upper airway during sleep. Moderate-to-severe sleep apnea—defined as 15 or more episodes of disturbed airflow per hour—is often associated with excessive daytime sleepiness and an increased risk for diabetes and heart disease.
The new treatment, which stimulates the hypoglossal nerve, is comprised of three implantable components that sense and monitor a person’s breathing patterns, and deliver mild stimulation to muscles that keep the airway open during sleep.
The device is manufactured by Inspire™ and was approved last year by the U.S. Food and Drug Administration. It is recommended for patients who have trouble using the current therapy, a CPAP (continuous positive airway pressure) machine that is worn over the nose and mouth at night, but is often perceived by patients as intrusive and has a compliance rate of only about 50 percent.
Surgery to implant the Inspire device takes between two to three hours under general anesthesia on an outpatient basis, according to Boris Chernobilsky, MD, Director of the Division of Sleep Surgery at Mount Sinai Beth Israel, who is spearheading the procedure. Fred Lin, MD, Chief of the Division of Sleep Surgery at the Mount Sinai Health System, will perform the surgery as well.
“This is a significant new therapy that stimulates the base of the tongue and offers a wider airway for the patient’s oxygen intake,” says Dr. Chernobilsky. “The patient data has been very favorable, showing great improvement. The procedure is well tolerated and the recovery time is quick. There may be some incisional pain lasting a few days, but no muscles are cut.”
According to Dr. Chernobilsky, this is the first relatively predictable surgical alternative for properly selected patients with sleep apnea. “Other procedures can be quite painful, have a risk of bleeding, two-to-three weeks of healing, and about a 30 percent chance of not working,” he says.
During the procedure, three small incisions are made for the two leads and a pulse generator. Once the incisions are healed, the patient returns to the physician to have the device activated and to receive operating instructions. Patients then return once a year to have the device checked.
The results of a large clinical trial published in the January 9, 2014, issue of The New England Journal of Medicine showed that following the surgical implantation of the Inspire system, the median number of obstructed breathing events—per hour—dropped by 68 percent, to 9 from 29.3.
For more information, please visit www.mountsinai.org/sleepsurgery.