Program Profile

The Nonsurgical Sleep Medicine Physician Role in the Development of an Upper Airway Stimulation Program

Fed Pract. 2020 April;37(4):177- 181

Author(s):

Background: Obstructive sleep apnea (OSA) is a common disorder in the US and other industrialized countries. Untreated OSA is associated with increased risk of coronary artery disease, cerebrovascular accidents, uncontrolled diabetes mellitus, poor workplace productivity, increased health care utilization, and higher risk of motor vehicle accidents. Continuous positive airway pressure (CPAP) is a commonly used treatment for OSA. CPAP nonadherence continues to be a major problem in clinical practice.

Methods: Upper airway stimulation (UAS) is an alternative option for management of OSA and has been shown to be safe and effective. This therapy involves electrical stimulation of the hypoglossal nerve to facilitate airway opening in the oropharynx.

Results: Although the UAS device is implanted by a surgeon in the operating room, the nonsurgical sleep medicine provider can play an important role in this type of therapy.

Conclusions: This article outlines opportunities for a nonsurgical physician to become a leader in development of an institutional UAS program.

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References

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Obstructive sleep apnea (OSA) is a common disorder in the US and other industrialized countries. The Wisconsin Sleep Cohort Study reported prevalence rates as high as 20% to 30% in men and 10% to 15% in women.^1,2 Several studies have shown high prevalence of OSA among veterans. Ancoli-Israel and colleagues reported a OSA rate of 36% in a cohort of elderly patients at a US Department of Veterans Affairs (VA) medical center.³ A study by Kreis and colleagues showed that OSA was present in 27% of patients hospitalized on the medical ward at a VA hospital.⁴ Incidence of sleep apnea among veterans in the US will likely increase over time as obesity is becoming more prevalent. Rates of obesity have increased from 14% in 2000 to 18% in 2010 among both male and female veterans.⁵

Untreated OSA is associated with increased risk of coronary artery disease, cerebrovascular accidents, uncontrolled diabetes mellitus, and other complications. Patients with OSA are less productive, have increased health care utilization, and have a higher risk of motor vehicle accidents.⁶ Continuous positive airway pressure (CPAP) is the main form of treatment of OSA. However, despite the adverse outcomes of untreated sleep apnea, suboptimal CPAP adherence remains a major problem in clinical practice. When adherence is defined as > 4 hours of nightly use, 29% to 83% of patients with OSA have been reported to be nonadherent to treatment.⁷Stepnowsky and colleagues estimated that 50% of patients with OSA for whom CPAP was recommended were no longer using it 1 year later.⁸ CPAP adherence among veterans also has been poor. Wallace and colleagues reported that about one-third of patients with OSA at a VA Miami Healthcare System had mean daily use ≥ 4 hours.⁹ Typical reasons for poor CPAP adherence include pressure intolerance, mask discomfort, nasal and oropharyngeal dryness and irritation.¹⁰ Development and implementation of alternate treatment strategies for OSA is important to reduce disease burden of this widespread and debilitating condition.

Upper airway stimulation (UAS) is a novel therapy for management of OSA that has been gaining popularity and acceptance within the sleep medicine community in the past few years. This treatment option involves implantation of a neurostimulator with a sensing lead and a stimulation lead. The device is similar to a pacemaker and is surgically implanted in chest wall. The sensing lead is placed close to the diaphragm for monitoring of pleural pressure to help assess ventilation. The stimulation lead is placed under the tongue in proximity to the hypoglossal nerve (cranial nerve XII). The neurostimulator delivers electrical pulses to the hypoglossal nerve through the stimulation lead. These stimulating pulses are synchronized with the ventilation detected by the sensing lead. This electrical stimulation results in anterior displacement of the tongue via action of the genioglossus and geniohyoid muscles. Mechanical coupling with the palate also is common and leads to additional airway opening within the oropharynx to prevent apneic episodes. The patient turns on the stimulation through the use of a portable remote control and is turned off in the morning. The patient is able to operate the UAS device by placing the remote control on the skin in proximity of the device. The patient also is able to adjust device voltage within a range set by their physician. The effective voltage range is determined via an overnight sleep study titration performed 1 month after device activation. UAS therapy is not considered first-line treatment for OSA as it requires surgical implantation under general anesthesia; however, it provides an alternative to patients with OSA who are unable to tolerate traditional therapy with CPAP.

The landmark Stimulation Therapy for Apnea Reduction (STAR) trial showed effectiveness of UAS therapy at 12 months postimplantation.¹¹ Follow-up of these participants has proven the sustainability of this effect at 18, 24, 36, and 48 months of therapy.^12-15 Inclusion criteria of the study was moderate-to-severe sleep apnea with predominantly obstructive events. Subjects were excluded if there were anatomical abnormalities of the upper airway or if the pattern of airway collapse was not conducive to UAS on sedated endoscopy evaluation. Participants in the trial were predominantly white males, the average age was 54.5 years, and the average body mass index (BMI) was 28.4. The outcomes measured included Functional Outcomes of Sleep Questionnaire, Epworth Sleepiness Scale (ESS), percentage of sleep time with oxygen saturation < 90%, and subjective snoring. All of these objective and subjective markers of sleep improved significantly with UAS therapy at 12 months and were maintained at improved levels at 48 months of therapy.

The adverse effects (AEs) associated with device implantation and subsequent UAS therapy have been infrequent and mostly transient. Out of 126 device implantations, there were 2 participants who had serious AEs due to implantation and required repositioning and fixation of the neurostimulator to resolve discomfort. Other AEs related to the procedure, including sore throat and muscle soreness, were considered nonserious and resolved with supportive care. AEs related to subsequent UAS therapy included temporary tongue weakness and tongue soreness/abrasion. These complications also have either resolved spontaneously or with use of supportive strategies such as a mouth guard. Due to the sustained clinical benefit and acceptable AE profile as demonstrated by the STAR trial, UAS has emerged as a realistic alternative for management of OSA.

Development of a successful program that provides and supports all aspects of UAS, including device implantation and follow-up, necessitates a multispecialty team approach. Ideally surgical and nonsurgical sleep physicians as well as clinical and administrative support staff should be part of this group.

This study is based on the experience of the development of the UAS program at the Clement J. Zablocki VA Medical Center (CJZ VAMC) in Milwaukee. Currently, there are 25 patients who are part of this UAS program. The inclusion and exclusion criteria were adopted from the STAR trial. The patient population is similar to the population in that trial. They are all white males with average age of 57.2 years and BMI of 31.3. The CJZVAMC UAS Program consists of multidisciplinary group of health care professionals. This article describes the role of a nonsurgical sleep medicine physician that was crucial in the development of this UAS program.