Abnormal Milan Score and Compromised Esophageal Mucosal Integrity Stratify Gastroesophageal Reflux Disease Severity

Objective: To explore the manometric characteristics of patients with severe GERD. To assess the role of HRM features in patients with adjunctive diagnostic Lyon 2.0 criteria and to create a GERD severity prediction model. Summary Background Data: GERD is a complex disorder with diagnostic challenges, as symptoms may not reflect disease severity. High-resolution manometry and the Milan Score numerically quantify the degree of anti-reflux barrier disruption in patients with GERD symptoms. Methods: An international prospective database of patients undergoing HRM and pH-impedance (MII-pH) for persistent GERD symptoms was queried. GERD was defined according to Lyon 2.0. Severe GERD was defined as either acid exposure time (AET)>12%, DeMeester score>50, grade C-D esophagitis or Barrett's esophagus. Demographic, HRM and pH data were compared between groups (no GERD, non-severe GERD, severe GERD). The ability of the HRM and MII-pH variables in stratifying GERD severity was assessed using ordinal logistic regression. Results: Among 603 patients enrolled (median age 49.9 y, median body mass index 25.3 kg/m2, 49.5% females), 124 (20.6%) had non-severe and 142 (23.5%) had severe GERD. On ordinal logistic regression, hiatal hernia size and Milan Score category were independent predictors of GERD severity (OR 1.28 and 2.92). Patients with adjunctive Lyon 2.0 GERD evidence and those fulfilling any severe GERD criteria had significantly higher Milan Score (P<0.001). In the comprehensive HRM-MII-pH model, mean nocturnal baseline impedance (MNBI) and Milan Score category remained independent predictors of severe GERD (OR 4.17 and 1.61, P<0.001). Conclusions: MNBI and Milan Score are independently associated with severe GERD. The Milan Score is significantly higher in patients with pathologic adjunctive pH-impedance metrics.