Elevoplasty®: An Innovative, Minimally Invasive Procedure for the Treatment of Snoring

According to the National Sleep Foundation, snoring affects as many as 90 million adults in the United States. Its prevalence is greater in males (35% to 45%) than in females (18% to 28%) and in those who are overweight.¹ Snoring commonly becomes more serious with age, and it can cause disruptions in both an individual's sleep and their bed partner's sleep. Snoring can lead to fragmented and unrefreshing sleep, which can translate into poor daytime function (tiredness and sleepiness) for all those affected.^2,3 Reduced energy and vitality, increased daytime anxiety, and higher risk of depression, stress, and fatigue have been implicated in snorers.⁴

Snoring is breathing loudly while asleep. While people sleep, the muscles in the throat relax, the tongue falls backwards, and the throat becomes narrower and "floppy." Snoring is caused by air vibrating the tissues in the throat, nose, and mouth. These vibrations produce the snoring noises with which most people are familiar.

Snoring can be a symptom of obstructive sleep apnea (OSA), a sleep-related breathing disorder that is characterized by multiple episodes of total or partial upper airway obstructions while sleeping, leading to repeated reductions in blood oxygen saturation despite efforts to breathe. This can lead to fatigue, excessive daytime sleepiness, decreased cognitive function, and multiple metabolic, inflammatory, and cardiovascular manifestations, with significant public health implications. Although it is thought that well over 50% of people diagnosed with OSA exhibit snoring, 20% to 25% of patients with central sleep apnea do not snore. It is estimated that 20% to 40% of the adult population that snore may have OSA, leaving 60% to 80% of snorers categorized as habitual, non-OSA snorers.⁵

Diagnosing OSA requires polysomnography, an in-depth analysis of a patient's breathing during sleep. This study is traditionally performed in an overnight sleep center. Recently, improved monitors for at-home sleep analysis have been developed and are being used.

Snoring in combination with any of the following symptoms and signs should lead to a consult with a physician to evaluate the patient for the possibility of OSA: excessive daytime sleepiness; morning headaches; recent weight gain; not feeling rested when awaking in the morning; awaking at night feeling confused; changes in the patient's level of attention, concentration, or memory; and observed pauses in breathing during sleep.¹

Commonly, the first recommendations to treat snoring involve lifestyle changes, such as losing weight, avoiding alcohol and sedatives close to bedtime, treating nasal congestion or obstruction, avoiding sleep deprivation, raising the head of the bed, sleeping on one's side and avoiding sleeping on the back, and quitting smoking. Other snoring reduction aids include nasal strips or external nasal dilators and conservative oral appliances. Elevoplasty^® (Zelegent, Inc., zelegent.com) is a minimally invasive procedure indicated for the treatment of non-OSA diagnosed patients with predominantly palatal snoring.

For snoring accompanied by OSA, common recommendations include:

Oral appliances. Appliances made to fit on the upper jaw, lower jaw, or both jaws are designed to advance the position of the lower jaw and tongue to open the upper airway. Some of the problems patients may encounter from the use of oral appliances include excessive salivation, dry mouth, jaw and temporomandibular joint pain, facial muscle discomfort, and occlusal changes.^6,7

Continuous positive airway pressure (CPAP). This approach involves wearing a mask over the nose and/or mouth while sleeping. The mask directs pressurized air from a small bedside pump to the airway to keep it open during sleep. CPAP eliminates snoring and is most often used to treat snoring when associated with OSA. Although CPAP is a reliable and effective method of treating OSA, many people find it uncomfortable, have difficulty adjusting to the noise or feel of the mask, and have difficulty sleeping with the mask and machine.^8,9

Surgery. There are several procedures designed to open the upper airway and prevent narrowing during sleep. A uvulopalatopharyngoplasty is a procedure performed under general anesthesia and can be done conventionally or with a carbon dioxide (CO₂) laser. The procedure involves trimming or sculpting excess tissues in the area of the soft palate and uvula.¹⁰ Radiofrequency tissue ablation uses a low-intensity radiofrequency signal to shrink tissue in the soft palate, tongue, or nose.¹¹ In some patient cases that are refractory to other treatments, upper and/or lower jaw orthognathic surgery (maxillomandibular advancement) can be used to advance the upper and/or lower jaw(s) to open the upper airway.¹² A newer surgical technique called hypoglossal nerve stimulation uses an electric stimulus applied to the nerve that controls the forward movement of the tongue to advance the tongue so it does not block the airway during breathing.^13,14

Elevoplasty is typically performed in an office setting. The minimally invasive procedure can be carried out under local anesthesia with or without light sedation. The treatment involves the placement of three to four small resorbable polydioxanone barbed sutures, which are buried in the tissues of the soft palate. Immediately after placement, these sutures are "activated" by a gentle pull, which provides a "lift" of the soft palatal tissues and uvula. This moves the soft palate off of the posterior pharyngeal tissues at the back of the throat, opening the posterior pharyngeal airway a small amount.

Over months, as the sutures resorb, the soft palatal tissues internally stiffen and scar. The embedded material fully resorbs in less than 1 year. (See Figure 1 through Figure 12 for sequential illustrations of the placement and activation of the resorbable barbed suture; sagittal and oblique views of the procedure are shown.) Future material versions with advanced proprietary materials may last a year or more, potentially allowing for a longer period of time for scarring. Postoperatively, patients can typically expect a mild sore throat and a small amount of pain when swallowing for 2 to 3 days. Pain is usually well managed with over-the-counter medications.

In a recent US-based, multicenter, prospective study treating 52 non-OSA adults with chronic disruptive snoring (snoring that impacted a patient's life and caused the patient or bed partner to seek medical intervention), after treating the patients with Elevoplasty, statistically significant reductions in bed/sleep partners' visual analog scale for subjects' snoring severity were found. Three out of four patients' bed partners reported a reduction in snoring at 30, 90, and 180 days post-procedure. Patients correlated this with increased sleep quality and decreased daytime sleepiness. All procedures were performed under local anesthesia in an office setting, and no material adverse events occurred in the treatment of the 52 subject patients. Three minor reported events consisted of one uvular hematoma, which resolved, and two extruded barbed suture implants that were treated by trimming the protruding portion of the implants.¹⁵

Elevoplasty is an innovative, minimally invasive procedure performed in an office setting under local anesthesia indicated for the treatment of non-OSA diagnosed patients with predominantly palatal snoring. It has proven to reduce snoring severity in most of the patients treated, which may be correlated with increased sleep quality and decreased daytime sleepiness. The procedure is associated with minimal adverse complications.

The images shown in Figure 1 through Figure 12 are courtesy of Zelegent, Inc.

Gary Orentlicher, DMD
Section Chief, Oral and Maxillofacial Surgery, White Plains Hospital, White Plains, New York; Attending Oral and Maxillofacial Surgeon, Manhattan Veterans Administration Hospital, New York, New York; Private Practice, New York Oral, Maxillofacial, and Implant Surgery, Scarsdale, New York; Diplomate, American Board of Oral and Maxillofacial Surgery