1

Introduction

Treatment for the sleep-disordered breathing disease spectrum ranges from oral appliances, to positive airway pressure ventilation, to operative interventions such as UPPP, but results are mixed. Typically, the goal of surgical intervention is to cause fibrosis and scarring of the vibratory surfaces and to stiffen the soft palate, thus reducing collapsibility and decreasing obstruction.

Interventional treatment options for mild obstructive sleep apnea (OSA) and snoring have expanded in recent years to include less invasive in-office procedures targeted at altering upper airway anatomy. For these patients, the goal is to develop a simple, reproducible, in-office procedure with minimal risk and maximal efficacy. Many procedures have been proposed for this, including implants. The Pillar implant was introduced in 2000 as a potential minimally invasive treatment. The nonabsorbable implant was designed to increase palate stiffness and decrease the vibratory property of the soft palate. Several Pillar studies have shown limited efficacy.

Surgical sutures were first used by the ancient Egyptians. Animal-derived materials (e.g. cat gut) were first used as an alternative to plant-based sutures circa 200 AD by the Roman physician Galen of Pergamon. The next major innovation did not occur until 1860 when Joseph Lister developed a method of sterilizing cat gut sutures using carbonic acid. Another 90 years would pass until, in 1950, modern polyesters and polyglycolic acid resorbable sutures became available. Barbed sutures were introduced in the 1960s but did not gain widespread use until the mid-2000s.

Today, several unidirectional and bidirectional barbed suture varieties have been described in plastic and orthopedic surgical procedures, including fascial closure, tendon repair, suspension of SMAS during facelift surgery, and knotless wound closure, with impressive results. In 2012, barbed sutures made their debut in otolaryngology, when Mario Mantovani described their use to cinch the soft palate in a surgical procedure with encouraging results but that required the use of an operating room. The following year, in 2013, AngioTech’s TranQuill sutures were used in a pilot study to shorten and suspend the soft palate using rectangular or “W” patterns of deployment. These techniques achieved a reasonable degree of postoperative efficacy but fell short of the minimal invasiveness needed to become a popular, quick, in-office procedure. The key limitation remains that the degree of needle manipulation required to create a rectangular or “W” pattern in the soft palate with any suture, barbed or otherwise, necessitates an operating room setting and advanced anesthesia, which reduces its appeal to patients.

By contrast, Elevoplasty is a novel outpatient implant procedure using a resorbable barbed suture implant that not only stiffens but also shortens and suspends the soft palate. It overcomes the limitations of previous barbed suture soft palate procedures because of its simplicity. Only three iterations of a single in-and-out linear suture deployment using a proprietary deployment tool are needed; thus the procedure can be performed in an office setting under local anesthesia. Based on mean efficacy results from the 2017 multicenter SILENCE clinical trial, the Elevoplasty procedure appears to reduce snoring by improving velopharyngeal narrowing during sleep and thereby reducing upper airway obstruction.

2

Patient Selection

Because Elevoplasty shortens and stiffens the soft palate but does not treat the base of the tongue, patient selection should be focused on finding patients whose airway obstruction appears to be mostly or entirely from the soft palate, thus excluding most OSA patients, as they usually have diffuse obstruction. Obese patients are generally not ideal Elevoplasty candidates, for they usually have at least some airway impingement from the base of the tongue inferiorly, lymphoid tissues laterally, and soft palate superiorly. It is the nonobese, non-OSA, simple habitual snorer who makes the best candidate for Elevoplasty.

Patients with primary snoring (Apnea/Hypopnea Index [AHI] <5) or snoring with mild sleep apnea (AHI >5 and ≤14) are ideal candidates. Patients with OSA, defined as AHI ≥15, and patients with tongue base obstruction can undergo Elevoplasty but are less likely to achieve benefit. Preoperative snoring levels, Epworth Sleepiness Scale (ESS), and SF-36v2 Quality of Life questionnaires, as well as preoperative polysomnography, are all helpful tools for assessing the patient’s need for the procedure, and if performed before and after the procedure, tracking efficacy results.

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Outline of Elevoplasty Procedure

Elevoplasty features barbed suture implantation into the submucosal tissue of the soft palate and is performed using a modified curved needle suture passer with a crochet-hook-style tip. The soft palate is anesthetized with 1% lidocaine injection and benzocaine topical anesthetic spray. Three absorbable barbed suture implants are placed in the patient’s soft palate in an anterior-to-posterior submucosal plane. Once the barbed suture implants are deployed, they are gently retracted anteriorly to shorten and stiffen the palate. The proximal end of the barbed suture engages the tissue just deep to the soft palate mucosa due to the distal soft palate exerting its force on the distal suture barbs.

The Elevo suture implant is composed of polyester (p-dioxanone). Polydioxanone (or PDO) has been found to be nonantigenic and to elicit only a slight tissue reaction during absorption. The Elevo suture implant is provided preloaded into the suture delivery needle and handle. The bidirectional barbs allow for effective placement of the suture implant without the need for surgical knots or swaged needles.