Assessing the Upper Esophageal Sphincter Assist Device for Reflux-Associated Laryngeal Symptoms

Abstract

Introduction: It is challenging to manage patients with reflux associated laryngeal symptoms. The Upper Esophageal Sphincter Assist Device (UESAD) is a novel device which applies external cricoid pressure to augment intraluminal UES pressure, and is postulated to restrict proximal passage of esophageal refluxate (Figure 1). We aimed to measure the effectiveness of the UESAD in patient with laryngeal symptoms.Figure 1Table 1: Comparison of symptom questionnaires and mean pepsin concentration in subjects at baseline and after 2-week UESAD useMethods: This is an interim assessment of an ongoing prospective pilot study at a single tertiary care center. We recruited adult subjects with laryngeal symptoms (Reflux Symptom Index (RSI) score ≥ 13). Proton pump inhibitors (PPI) were not withheld during study period. The UESAD was worn at nighttime for 2 weeks. We collected symptom questionnaire (GerdQ, RSI, and Nocturnal GERD Symptom Severity & Impact Questionnaire (N-GSSIQ)) data and 3 morning salivary samples for pepsin analysis (using Peptest) at baseline and after 2 weeks of UESAD use. The primary outcomes are symptom response and change in salivary pepsin concentration. Results: Of 10 subjects recruited to date, 2 withdrew and 8 have successfully completed the study. Baseline characteristics are as follows: 5 (60%) female, mean age 47.1 years (15.6), mean BMI 30.4 kg/m2 (8.6), 4 (50%) on PPI. All symptom scores (GerdQ, RSI, and N-GSSIQ) significantly decreased following 2 weeks of UESAD use (p < 0.01 for all, Table). There was a non-significant reduction in mean salivary pepsin concentrations (p =0.8). In linear regression, controlling for baseline RSI, subjects with a higher baseline mean salivary pepsin concentration were more likely to have a reduction in RSI scores (p < 0.01, Figure 2). Symptom response did not differ between PPI users and non-users. 7 subjects intend to continue UESAD use and 8 would recommend the UESAD to others.Figure 2Conclusion: In this pilot study, nocturnal UESAD use in patients with laryngeal symptoms was associated with reductions in laryngeal, overall GERD, and nocturnal GERD symptoms. Although salivary pepsin concentrations did not significantly decrease with UESAD use, baseline salivary pepsin was predictive of symptom response following UESAD use. The UESAD may have a therapeutic role for patients with reflux associated laryngeal symptoms.