Adverse events associated with device assisted hyoid and tongue base suspension for obstructive sleep apnea

Obstructive sleep apnea (OSA) is a highly prevalent sleep disorder in which partial or complete upper airway collapse is a major contributing factor [1]. It is thought to occur secondary to relaxation and inadequate contraction of the tongue and upper airway dilator muscles during sleep [2]. The prevalence of OSA in the U.S. is estimated to be up to 33.9 % in males and 17.4 % in females [[3], [4], [5]]. Risk factors for OSA include obesity, increasing age, family history, African American race, anthropometric measures such as airway caliber and neck size, as well as behavioral factors [6,7]. Left untreated, OSA is known to increase the risk of hypertension, cerebrovascular accident, and insulin resistance, as well as to cause cognitive impairment which increases the risk for motor vehicle accidents [8,9].

First-line therapy for OSA is positive airway pressure (PAP). While effective, adherence rates have remained low over the last twenty years [10]. As many as 60 % of patients are unable to adhere to continuous PAP therapy due to reasons such as discomfort, inconvenience, claustrophobia, and cost [11]. Oral appliances are an alternative treatment option, but research on their effectiveness is limited and patient adherence is often poor [12].

Surgical treatment of OSA may be offered to patients who fail medical therapy, or as primary treatment in patients with an identifiable anatomical obstruction [13]. Surgical treatment is directed towards the site of obstruction, targeting the nasal, palatal, oropharyngeal, or hypopharyngeal airway. The retrolingual area specifically is a common site of airway collapse, representing the major site of obstruction in up to 50 % of patients with OSA [14].

Two surgical procedures which may be used to address retrolingual collapse in OSA are hyoid suspension and tongue base suspension. Hyoid suspension advances and stabilizes the hyoid bone, which in turn increases the retrolingual space [13,15]. Tongue base suspension involves passing nonabsorbable sutures from the anterior neck to the tongue base, which are then anchored to the mandible, thereby positioning the tongue base anteriorly within the oropharynx. Various manufacturers have developed self-contained surgical kits used for hyoid and tongue base suspension procedures. Medtronic's AIRvance Bone Screw System was first approved by the U.S. Food and Drug Administration (FDA) in 1999, and was subsequently approved for hyoid suspension in 2013; similarly, Siesta Medical's Encore System utilized in the trademarked AIRLIFT procedure first gained FDA approval in 2011, and was later cleared for hyoid suspension in 2014 [16,17]. Both of these kits place two screws in the mandible. Sutures are then looped around the hyoid bone and secured to the screws.

Hyoid and tongue base suspension are options for surgical management of OSA, and previous studies have demonstrated efficacy of these procedures. A study of 33 patients who underwent hyoid suspension using the AIRvance (then called Repose) system reported a 70 % surgical success rate, defined as at least 50 % reduction in apnea hypopnea index (AHI) with final AHI less than 20 [18]. The AIRLIFT procedure has a similar 74 % rate of reduction in AHI. This is based on a study of 39 patients who underwent hyoid suspension, with either concurrent or prior UPPP, in which 74 % of patients achieved a final AHI less than 15 [19].

A prior study queried the Manufacturer and User Facility Device Experience (MAUDE) database for adverse events associated with Hypoglossal Nerve Stimulation (HNS) [20]. Given that prior studies have found that hyoid and tongue base suspension may achieve comparable surgical cure rates in the treatment of OSA in properly selected patients, an understanding of the adverse events associated with these procedures will facilitate better informed decisions when choosing between various surgical procedures in the treatment of OSA.

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