The Inspire Upper Airway Stimulation System was approved by the FDA in 2014 as a treatment for obstructive sleep apnea in patients who are unable to tolerate or do not receive benefit from positive airway pressure. Studies published in major scientific journals, including the New England Journal of Medicine, showed that 2 out of 3 patients who received the Upper Airway Stimulation system achieved a dramatic improvement or resolution of their sleep apnea. There were major improvements in sleepiness and other effects on daily activities. In addition, 85% of patients had no or soft snoring after treatment.
Dr. Kezirian was the first surgeon in the Western United States to offer Inspire after FDA approval in 2014. Our center has substantial experience with the therapy, managing our own patients and treating patients who come from other sites that may not have achieved ideal results. Based on our commitment to achieving excellent results in all patients, Dr. Kezirian designed the largest study identifying key findings from drug-induced sleep endoscopy (part of the evaluation process) that are associated with associated with outcomes of Inspire Upper Airway Stimulation therapy. A second research study has identified even more findings from the awake office examination before surgery that are associated with results of Inspire Upper Airway Stimulation. This research is based on our goal of determining whether Inspire therapy is the right treatment for an individual patient, and Dr. Kezirian (and many others) uses these studies in making decisions with patients about their care.
This treatment involves a surgical procedure to place the system inside the body, and patients receive a remote control to turn on the device when they go to bed and turn it off in the morning when they wake up. It does not require a mask or anything to wear at night. Dr. Kezirian uses the 2-incision approach approved by the FDA in 2021, which shortens surgery time and reduces the number of scars and healing time.
Dr. Kezirian is one of the world’s leaders in sleep apnea surgery, including Upper Airway Stimulation, and he has worked with this approach to treating sleep apnea for the past 10 years. Dr. Kezirian and the team at UCLA Health have treated many patients who have had tremendous benefit from Upper Airway Stimulation.
Dr. Kezirian has also developed the video below to answer the most common and important questions related to Upper Airway Stimulation.
How does Upper Airway Stimulation work?
The tongue can play a major role in obstructive sleep apnea because during sleep, when the muscles in the body relax, the tongue can fall back to block breathing in the throat. There are 3 components of the Upper Airway Stimulation system that are placed inside the body during a surgical procedure. There is a pulse generator placed on top of the chest (pectoralis) muscle and two leads. When the system is turned on during sleep, the pulse generator sends a gentle stimulation signal through a stimulation lead to move the tongue forward and open the space for breathing in the throat.
How do I know if Upper Airway Stimulation is right for me?
There are 3 steps involved in determining whether you are a good candidate for the Upper Airway Stimulation therapy. First, you must have obstructive sleep apnea and have been unable to tolerate positive airway pressure therapy. Second, you would have an office evaluation with Dr. Kezirian to discuss whether it would be helpful. The third and final step is a short evaluation procedure called drug-induced sleep endoscopy. Dr. Kezirian is an international expert in drug-induced sleep endoscopy and has written on his blog about drug-induced sleep endoscopy and its use in selecting ideal candidates for the Inspire Upper Airway Stimulation System.
Because implanted patients have restrictions on MRIs, if you know you need these examinations in the future, you should discuss these limitations with your doctors. More information can be found in the MRI guidelines posted on the Inspire website.
Why should I come to see Dr. Kezirian for Upper Airway Stimulation?
Dr. Kezirian is acknowledged by other sleep surgeons as an international leader in the field. Dr. Kezirian was the first surgeon in the western United States offering the Inspire Upper Airway Stimulation System after FDA approval in 2014. This is based on Dr. Kezirian’s substantial experience with this approach, his understanding of selection of ideal candidates, and the commitment of the Keck team to achieving the best outcomes. One of the tests required before receiving the Upper Airway Stimulation system is drug-induced sleep endoscopy. Dr. Kezirian is one of the world’s experts in this evaluation technique that is so important to determining whether patients should expect a good outcome from Upper Airway Stimulation. Dr. Kezirian has led an international, multicenter study that enables surgeons to go beyond the standard of care in using drug-induced sleep endoscopy to make better decisions about Inspire Upper Airway Stimulation treatment.
To schedule an appointment with Dr. Kezirian, please call 424-259-6559 (Santa Monica) or 310-205-7310 (Beverly Hills).
Inspire Medical has developed a brochure that provides additional information about the treatment and the published results. Here is another brochure from Inspire Medical that describes the consistent benefits that patients achieved through the first 3 years after receiving the device. Recent results were presented showing consistent outcomes for Upper Airway Stimulation through 5 years after implantation, but there is no specific brochure available. The brochures are slightly more technical and designed for physicians, but many patients can understand these as well as many physicians.
Here is a Zoom presentation from Dr. Kezirian (from his time at USC) to other physicians about Upper Airway Stimulation and his own research:
As with any procedure, there is a risk of bleeding. Bleeding in this area can be serious and life-threatening. Fortunately, this is uncommon, and usually there is only minor bruising. A major factor in preventing serious bleeding is to avoid the use of aspirin, NSAIDs (such as ibuprofen, Advil®, Motrin®, naproxen, or Aleve®), vitamin supplements, or herbal medications for at least two weeks before and after surgery.
To reduce the risk of infection, patients receive intravenous antibiotics prior to the procedure. The risk of infection with this precautions is low, but infections can be serious and require removal of the entire Upper Airway Stimulation system.
Tongue weakness or trouble swallowing
This procedure requires dissection of the nerve responsible for tongue movement: the hypoglossal nerve. The hypoglossal nerve can be injured during the procedure, but there are important precautions taken during the procedure to minimize those risks. Tongue movement is important for swallowing, and nerve injury or the swelling that can occur after this procedure can present some difficulty with swallowing. Damage to the hypoglossal nerve can recover over the course of days or weeks, but the damage can take months to recover or be permanent. Studies have shown that stimulation of this nerve during treatment with Upper Airway Stimulation should not cause damage to this nerve or other nerves.
Tongue numbness or tingling
There is a nerve (lingual nerve) that is responsible for the senses of touch and taste for the tongue. This procedure involves dissection in the general area of this nerve, although it is typically not encountered during the surgery. If nerve damage or these symptoms do occur, usually the damage is temporary with recovery over the course of days or weeks, but the damage can take months to recover or be permanent.
The neck incision can be close to a branch of the nerve that controls facial movement. There are a number of precautions taken to avoid injury to this nerve. If nerve damage or facial weakness does occur, usually the damage is temporary with recovery over the course of days or weeks, but the damage can take months to recover or be permanent.
Change in voice
Damage to the hypoglossal nerve can cause changes in voice. If a change in voice occurs, they will typically resolve soon after surgery. However, permanent changes are possible.
Pneumothorax (collapsed lung)
The sensing lead is placed between muscle layers of the rib cage. There is a low risk of entering the space around the lung or injuring the lung. This can cause a collapsed lung, which requires treatment but should heal without long-term problems.
Limitations on MRI examinations
This is technically not a risk of surgery, but there are limitations of having the Inspire device in the body. Until recently, implanted individuals were not able to have MRI examinations of the chest, abdomen, pelvis, or shoulders, although they could have CT scans of these areas. Testing has now (as of July 2022) shown that it is safe for patients to have MRI examinations (with a magnet strength up to 1.5 Tesla) of their body, although there are important limitations. More information can be found in the MRI guidelines posted on the Inspire website.
It would be extremely rare, but we have had a patient who had some movements of their lower (mandibular) teeth after treatment. This could be related to movement of the tongue forward repeatedly, somewhat similar to tongue thrust seen in children that can push teeth forward.
Need for additional procedures
Upper Airway Stimulation may not be effective in accomplishing the goals of surgery. Another procedure—either performed on the Tongue Region or on another area—may be necessary.
NOTIFY DR. KEZIRIAN IMMEDIATELY IF YOU HAVE ANY TROUBLE BREATHING OR IF ANY BLEEDING DEVELOPS!
Like most surgeries, there is pain in the recovery period. Most patients experience mild to moderate pain for 1-3 days. THe pain should improve after the first 2 days. If there is a second spike up in pain, especially if there is any trouble in breathing or swallowing, contact Dr. Kezirian. You will receive a pain medication to take as you need it. Some people try to “hang in there” or suffer without taking pain medications. Controlling your pain is important for breathing, healing, and being able to swallow enough to maintain your nutrition.
Nutrition and fluids
It is very important to have good nutrition and avoid dehydration after surgery. This procedure has less difficulty with pain and swallowing after surgery than some others that are performed for sleep apnea, but it is possible that you will only be able to tolerate a liquid diet for the first 1-2 days after surgery.
Most patients receive an antibiotic after the procedure. This can be useful for preventing infection and decreasing swelling. Take the antibiotics as directed. If you develop a rash or diarrhea (possible risks of antibiotics and other medications), stop the antibiotics and contact Dr. Kezirian immediately.
Avoid strenuous physical activity for 4 weeks
Most patients will return to normal, non-strenuous activity in 1-2 weeks. However, strenuous physical activity increases heart rate and blood pressure, raising the risk of bleeding. In addition, it is important that all components of the Upper Airway Stimulation system heal in place. Strenuous physical activity can result in movement of the components of the system, resulting in possible additional procedures to place them in the correct position.
Walking and Breathing
Walking and taking deep breaths after surgery is important. Patients should walk at least 3 times a day starting the day after surgery. Taking 10 deep breaths every hour while awake is also very important. Walking helps prevent blood clots from forming in your legs. Taking deep breaths and spending more time out of bed (walking or in a chair) than in bed is helpful because your lungs fill up with air, lowering the risk of fevers and pneumonia. Not walking enough is a major cause of fevers after surgery, so please do remember to walk at least 3 times every day.
Do not use mouthwashes, lozenges, or throat sprays
Patients should not use mouthwashes, lozenges, or throat sprays following surgery because many of these contain alcohol that can irritate the lining of the mouth or numbing medication that can expose you to a serious complication when used for more than a couple of times.
Sleep with head elevated (at 45 degrees) for at least three days
Elevating your head during sleep decreases blood flow to the head and neck regions. Therefore, it decreases swelling and the associated pain. Elevating the head during sleep may also improve breathing patterns in other ways. Therefore, we recommend elevating your head during sleep at 45 degrees for at least three days following the procedure.
Nausea and constipation
Nausea and constipation can occur after any surgery. The anesthetic medications that you receive during surgery and the narcotic pain medication you receive after surgery can cause these. You will receive medications after surgery to decrease nausea and constipation, but please notify Dr. Kezirian if you feel constipated or have not had a bowel movement in any 3 days after surgery.
Dr. Kezirian likes to see his patients about 1 week after surgery. If a postoperative appointment has not been scheduled, please contact the office to schedule this when you return home after your surgery.
For any emergencies, please call 911 or go to the nearest emergency room. For other questions, please call the UCLA Health System page operator at (424) 259-6700 and ask for the Head and Neck Surgery resident on call.