New Implant Surgery for Obstructive Sleep Apnea

There is a continuum of sleep-disordered breathing which ranges from the simple noise of snoring to upper airway resistance syndrome to obstructive sleep apnea. Obstructive sleep apnea is the most worrisome condition since it develops slowly, and many patients wait months or years before even being evaluated.

Key takeaways:
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    The Inspire Upper Airway Stimulation System is an important new addition to the treatment of obstructive sleep apnea in select patients.
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    It is FDA approved with a good track record of cost-effectiveness, safety, and efficacy.
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    It may allow many patients to avoid other more painful surgeries or the use of CPAP or BIPAP.
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    The results of using the device are similar to previous reports of using CPAP or BIPAP after 12 months of use.

It is a condition that can include both nocturnal and daytime symptoms and severely affect one’s overall health.

Many people snore, but not everyone who snores has obstructive sleep apnea. Most people or their spouses or family complain about snoring to their doctor. It is the doctor's responsibility to determine whether that person truly has obstructive sleep apnea.

Upper airway resistance syndrome is an intermediate condition and is unrelated to this article.

There are specific criteria that must be met to establish a diagnosis of obstructive sleep apnea. Most people are familiar with current treatments for obstructive sleep apnea including wearing a mask or having invasive surgery.

There is a new alternative treatment which was become available over the last few years. It is the Inspire Upper Airway Stimulation System, an implantable nerve stimulator.

The main impetus for many patients to consider this option is no longer having to use a mask at night when they sleep. While it has had great success with many patients, it may or may not be suitable for you.

Treatment options for obstructive sleep apnea

Our upper airway is collapsible. It is comprised of various tissues in our throat which can also cause narrowing or obstruction of our palate, tonsils, pharynx, and tongue. Think of these tissues as forming a tube.

If the circumstances are right, the differences in air pressures when we breathe can precipitate a critical and inward collapse of the tissues of the throat. This collapse narrows or completely cuts off the upper airway.

Traditional approaches to relieving this possible obstruction are to open the upper airway surgically. This means removing the tonsils and adenoids, reducing the size of the palate, and possible removal of the uvula or the tissue hanging down from the palate.

There is little that can be done to prevent the lateral walls of the pharynx from collapsing, other than positive air pressure which involves wearing a mask over the nose or continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BIPAP), which involves wearing the mask over the nose and mouth.

Some patients undergo surgery and still need to use CPAP or BIPAP. Others with the most severe obstructive sleep apnea have to have a complete bypass of the upper airway with a tube in the lower part of the throat called a tracheostomy. Fortunately, that circumstance is rare.

How does the Inspire Upper Airway Stimulation work?

As it turns out, the tongue and its movement play a crucial role in patients with moderate to severe sleep apnea. By thrusting our tongue forward, the collapsible upper airway can open up and stop the partial or complete obstruction causing obstructive sleep apnea.

Treating obstructive sleep apnea begins by turning patients on their side to prevent the tongue from falling backward and causing obstructive symptoms. Another option is to use a dental device to aid in getting the patient to thrust their tongue forward or prevent the tongue from falling back into the collapsing throat.

The newest technique is using a hypoglossal nerve stimulator to assist the tongue in moving. The hypoglossal nerve is one of the main cranial nerves (the 12th cranial nerve, to be precise) that controls our tongue movement.

The Inspire Upper Airway Stimulation system is implanted surgically. It includes a small impulse generator implanted beneath the clavicle in the shoulder. Electrodes are then used to detect movement of the muscles of the chest when breathing. Another electrode is tunneled up into the neck and attached to the hypoglossal nerve to produce tongue protrusion.

The surgery for implantation is usually performed as an outpatient procedure. Most patients do not report any pain or discomfort. It has few, if any, reported significant side effects.

It was FDA-approved on April 14, 2020. Patients return to their surgeon about a month after device implantation for activation and patient education and training.

The control unit is handheld, and it takes some time to adjust and optimal use. Patients undergo a repeat sleep study to monitor their progress.

Does the system work and how much does it cost?

Yes, it works.

Its success is based on the pivotal study, which included 126 patients with obstructive sleep apnea who had difficulty with using CPAP.

The cost is usually $30,000 to $40,000, but it is covered by most private insurance companies. The implant is designed to last 10 or more years. If the device fails, it can be replaced with a simple outpatient procedure.

Can anyone with obstructive sleep apnea benefit from the system?

Unfortunately, no.

According to the FDA, the indication for use is only for the treatment of patients over age 18 who have moderate to severe obstructive sleep apnea. It cannot be used in patients with obesity or a body mass index over 33 kg/m.

Candidates for the procedure must have had difficulty using CPAP, and have no other severe illnesses such as severe cardiovascular disease or psychiatric illness.

Other exclusions include large tonsils or other physical characteristics of their upper airway which would preclude a successful outcome. Patients must not have clinically significant central or mixed apnea or complete concentric collapse of their throat on endoscopy during a drug-induced sleep.

As always, a thorough evaluation by an ENT surgeon who is experienced in using the Inspire Upper Airway Stimulation System must be performed to see if you are a candidate for the surgery.

The Inspire Upper Airway Stimulation System is a relatively new treatment for obstructive sleep apnea. An ear-nose-and-throat surgeon will evaluate patients to see if they’re a candidate for the surgery.

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