Upper Airway Stimulation for Obstructive Sleep Apnea: 5‐Year Outcomes

Abstract

Objective To present 5-year outcomes from a prospective cohort of patients with obstructive sleep apnea (OSA) who were treated with upper airway stimulation (UAS) via a unilateral hypoglossal nerve implant. Study Design A multicenter prospective cohort study. Setting Industry-supported multicenter academic and clinical trial. Methods From a cohort of 126 patients, 97 completed protocol, and 71 consented to a voluntary polysomnogram. Those having continuous positive airway pressure failure with moderate to severe OSA, body mass index <32 kg/m, and no unfavorable collapse on drug-induced sleep endoscopy were enrolled in a phase 3 trial. Prospective outcomes included apnea-hypopnea index (AHI), oxygen desaturation index, and adverse events, as well as measures of sleepiness, quality of life, and snoring. Results Patients who did and did not complete the protocol differed in baseline AHI, oxygen desaturation index, and Functional Outcomes of Sleep Questionnaire scores but not in any other demographics or treatment response measures. Improvement in sleepiness (Epworth Sleepiness Scale) and quality of life was observed, with normalization of scores increasing from 33% to 78% and 15% to 67%, respectively. AHI response rate (AHI <20 events per hour and >50% reduction) was 75% (n = 71). When a last observation carried forward analysis was applied, the responder rate was 63% at 5 years. Serious device-related events all related to lead/device adjustments were reported in 6% of patients. Conclusions Improvements in sleepiness, quality of life, and respiratory outcomes are observed with 5 years of UAS. Serious adverse events are uncommon. UAS is a nonanatomic surgical treatment with long-term benefit for individuals with moderate to severe OSA who have failed nasal continuous positive airway pressure.

Comparing Upper Airway Stimulation to Transoral Robotic Base of Tongue Resection for Treatment of Obstructive Sleep Apnea

“…The median ESS was 6, within the normal range, at 5-year follow-up with use of therapy. [18][19][20][21][22] These findings have been confirmed by numerous single and multi-institutional outcomes articles. Kent et al conducted a case series evaluating 20 patients.…”

“…Similarly, there was continuation of benefit with ESS and FOSQ scores. The median ESS was 6, within the normal range, at 5‐year follow‐up with use of therapy …”

Contemporary Concise Review 2019: Sleep and ventilation

“…Woodson et al . recently reported 5‐year follow‐up from the original Stimulation Therapy for Apnea Reduction (STAR) study showing persistent improvement in sleepiness, quality of life and apnoea–hypopnoea index (AHI) among the 97 patients who were available for follow‐up . Moreover, based on the data from a large multicentre registry, older age and lower body mass index (BMI) are predictive of HGNS response .…”

CPAP Effect on Cardiopulmonary Exercise Testing Performance in Patients with Moderate-Severe OSA and Cardiometabolic Comorbidities

“…Treatment is recommended in all cases of moderate-severe OSA (AHI ≥ 15 events/h), as well as in patients with mild OSA who associate symptoms or cerebrovascular comorbidities [8]. Current therapy options include continuous positive airway pressure (CPAP), mandibular advancement devices, maxillo-facial surgery and nocturnal hypoglossal nerve stimulation [9,10]. Although CPAP remains the gold-standard treatment option for moderate-severe OSA, its use is limited by poor treatment adherence, especially among children.…”