Evaluation of Therapeutic Positive Airway Pressure as a Hypoglossal Nerve Stimulation Predictor in Patients With Obstructive Sleep Apnea (original) (raw)

2020, JAMA Otolaryngology–Head & Neck Surgery

bstructive sleep apnea (OSA) is a disorder that involves complete or partial blockage in airflow during sleep. The resulting hypoxia and sympathetic activation place patients at an increased risk for metabolic syndrome, neurocognitive decline, hypertension, stroke, and other cardiovascular sequelae. 1,2 The primary therapy for OSA is positive airway pressure (PAP); however, although PAP treatment is beneficial, recommended adherence to therapy ranges from 17% to 54%. 3 Consequently, there exists a need for treatment alternatives to PAP therapy. One class of alternatives to PAP therapy is upper airway surgery, which includes soft tissue surgery, skeletal surgery, tracheostomy, and hypoglossal nerve stimulation (HGNS). Hypoglossal nerve stimulation, the most recent development in OSA surgery, involves stimulation of select branches of the hypoglossal nerve resulting in tongue protrusion and upper airway dilation during sleep. The HGNS device used consists of 3 implantable components: a respiratory sensor, pulse generator (battery), and an electrode cuff (Inspire; Inspire Medical Systems). Upon inspiration, the respiratory sensor detects changes in the intrathoracic space and signals the pulse generator to stimulate the hypoglossal nerve. Stimulation persists through the end of expiration and then briefly deactivates to avoid overstimulation. Although studies have cited significant improvements in both objective and subjective outcomes following HGNS, 4-6 there exists a need to determine factors predictive of surgical outcomes. A previous study showed that a therapeutic PAP IMPORTANCE Recent retrospective hypoglossal nerve stimulation (HGNS) outcomes data suggest that patients with low therapeutic positive airway pressure (PAP) levels achieve greater success than patients with high therapeutic PAP levels. OBJECTIVE To examine the use of therapeutic nasal PAP levels at the soft palate in predicting the outcomes of HGNS for patients with obstructive sleep apnea. DESIGN, SETTING, AND PARTICIPANTS This prospective cohort study used drug-induced sleep endoscopy (DISE) to evaluate the predictive capacity of therapeutic PAP levels in HGNS outcomes. In an academic sleep surgery center, 27 consecutive patients with obstructive sleep apnea who underwent DISE before implantation of an HGNS device were evaluated. The study was conducted from May 1, 2018, to June 26, 2019. EXPOSURES Positive airway pressure delivered through a nasal mask during DISE. MAIN OUTCOMES AND MEASURES Improvement in apnea-hypopnea index as measured from full-night preoperative and postoperative efficacy studies. RESULTS Twenty-seven patients met all inclusion criteria. The mean (SD) age was 62.0 (14.4) years, 14 participants were men (51.9%), and mean body mass index was 28.1 (4.0). Responders to HGNS therapy (n = 18) had significantly lower mean (SD) palatal opening pressure compared with nonresponders (n = 9) (5.0 [2.8] vs 9.2 [3.7] cm H 2 O, respectively; mean difference, −4.2; 95% CI, −6.8 to −1.6 cm H 2 O). After adjusting for age, sex, and body mass index, the mean palatal opening pressure value for the responders remained 3.5 cm H 2 O lower (95% CI, −6.7 to −0.4 cm H 2 O) than that of nonresponders. A palatal opening pressure cutoff level less than 8 cm H 2 O demonstrated a positive predictive value of 82.4%; sensitivity, 77.8%; and specificity, 66.7%. CONCLUSIONS AND RELEVANCE In this small prospective cohort study, therapeutic nasal PAP levels during DISE differed significantly between responder and nonresponders to HGNS. Because DISE represents a mandatory, relatively standardized diagnostic tool for HGNS candidacy, the use of therapeutic nasal PAP through DISE can be broadly implemented and studied across multiple centers to possibly improve patient selection for HGNS.