Comprehensive Analysis of Adverse Events Associated with Gastric Peroral Endoscopic Myotomy: An International Multicenter Study.

BACKGROUND: Gastric peroral endoscopic myotomy (G-POEM) has emerged as an effective management approach for patients with refractory gastroparesis. This study aims to comprehensively study the safety of G-POEM and describe the predictive factors of adverse events (AEs) occurrence. METHODS: This study is a retrospective study involving 13 tertiary care centers (7 USA, 1 South America, 4 Europe, and 1 Asia). Patients who underwent G-POEM for refractory gastroparesis were included. Cases were identified by the occurrence of AEs. For each case, two controls were randomly selected and matched for age (± 10 years), gender, and etiology of gastroparesis. RESULTS: A total of 216 patients underwent G-POEM for gastroparesis. Overall, 31 (14%) AEs were encountered [mild 24 (77%), moderate 5 (16%), and severe 2 (6%)] during the duration of the study. The most common AE was abdominal pain (n = 16), followed by mucosotomy (n = 5) and capnoperitoneum (n = 4), and AEs were most commonly identified within the first 48-h post-procedure 18 (58%). The risk of adverse event occurrence was significantly higher for endoscopists with experience of < 20 G-POEM procedures (OR 3.03 [1.03-8.94], p < 0.05). CONCLUSION: G-POEM seems to be a safe intervention for refractory gastroparesis. AEs are most commonly mild and managed conservatively. Longitudinal mucosal incision, use of hook knife, use of clips for mucosal closure and endoscopist's experience with > 20 G-POEM procedures is significantly associated with decreased incidence of AEs.

Validation of the oesophageal hypervigilance and anxiety scale for chronic oesophageal disease.

BACKGROUND: Oesophageal hypervigilance and anxiety can drive symptom experience in chronic oesophageal conditions, including gastro-oesophageal reflux disease, achalasia and functional oesophageal disorders. To date, no validated self-report measure exists to evaluate oesophageal hypervigilance and anxiety. AIMS: This study aims to develop a brief and reliable questionnaire assessing these constructs, the oesophageal hypervigilance and anxiety scale (EHAS). METHODS: Questions for the EHAS were drawn from 4 existing validated measures that assessed hypervigilance and anxiety adapted for the oesophagus. Patients who previously underwent high-resolution manometry testing at a university-based oesophageal motility clinic were retrospectively identified. Patients were included in the analysis if they completed the EHAS as well as questionnaires assessing symptom severity and health-related quality of life at the time of the high-resolution manometry. RESULTS: Nine hundred and eighty-two patients aged 18-85 completed the study. The EHAS demonstrates excellent internal consistency (α = 0.93) and split-half reliability (Guttman = 0.87). Inter-item correlations indicated multicollinearity was not achieved; thus, no items were removed from the original 15-item scale. Principal components factor analysis revealed two subscales measuring symptom-specific anxiety and symptom-specific hypervigilance. Construct validity for total and subscale scores was supported by positive correlations with symptom severity and negative correlations with health-related quality of life. CONCLUSIONS: The EHAS is a 15-item scale assessing oesophageal hypervigilance and symptom-specfic anxiety. The EHAS could be useful in evaluating the role of these constructs in several oesophageal conditions in which hypersensitivity, hypervigilance and anxiety may contribute to symptoms and impact treatment outcomes.

Evaluating the reliability and construct validity of the Eckardt symptom score as a measure of achalasia severity.

BACKGROUND: Achalasia is a disease of mechanical esophageal dysfunction characterized by dysphagia, chest pain, regurgitation, and malnutrition. The Eckardt symptom score (ESS) is the gold standard self-report assessment tool. Current guidelines outline a three-step approach to patient reported outcomes measure design. Developed prior to these policies, the ESS has not undergone rigorous testing of its reliability and validity. METHODS: Adult achalasia patients retrospectively identified via a patient registry were grouped based on treatment history. Patients were grouped PREPOST (completed ESS, GERDQ, brief esophageal dysphagia questionnaire, NIH PROMIS Global Health, high resolution manometry, timed barium esophagram prior to treatment and after) and POST (completed measures only after treatment). Clinical characteristics, treatment type and date were obtained via medical record. Standardized psychometric analyses for reliability and construct validity were performed. KEY RESULTS: 107 patients identified; 83 POST and 24 PREPOST. The ESS has fair internal consistency and split-half reliability with a single factor structure. Dysphagia accounts for half the variance in ESS, while chest pain and weight loss account for 10% each. Pre-post-surgical assessment demonstrates improvements in ESS, except for weight loss. Effect sizes range from 0.24 to 2.53, with greatest change in regurgitation. Validity of the ESS is supported by modest correlations with GERDQ, HRQOL, and physiological data. CONCLUSIONS & INFERENCES: The ESS demonstrates fair reliability and validity, with a single factor structure mostly explained by dysphagia. Based on psychometric findings, weight loss and chest pain items may be decreasing ESS reliability and validity. Further assessment of the ESS under FDA guidelines is warranted.