C Prakash Gyawali1, Radu Tutuian2, Frank Zerbib3, Benjamin D Rogers4, Marzio Frazzoni5, Sabine Roman6, Edoardo Savarino7, Nicola de Bortoli8, Marcelo F Vela9, Daniel Sifrim10. 1. Division of Gastroenterology, Washington University School of Medicine, St Louis, Missouri. Electronic address: cprakash@wustl.edu. 2. Division of Gastroenterology, University Clinics for Visceral Surgery and Medicine, Bern University Hospital, Bern, Switzerland. 3. Centre Hospitalier Universitaire de Bordeaux, Centre Medico-chirurgical Magellan, Hôpital Haut-Lévêque, Gastroenterology Department, Université de Bordeaux, Institut National de la Santé et de la Recherche Médicale CIC 1401, Bordeaux, France. 4. Division of Gastroenterology, Washington University School of Medicine, St Louis, Missouri; Division of Gastroenterology, Hepatology, and Nutrition, University of Louisville School of Medicine, Louisville, Kentucky. 5. Department of Specialized Medicine, Digestive Pathophysiology Unit, Baggiovara Hospital, Modena, Italy. 6. Digestive Physiology, Hospices Civils de Lyon, Hôpital Edouard Herriot, Université de Lyon, Lyon, France; Laboratory of Therapeutic Applications of Ultrasound, Institut National de la Santé et de la Recherche Médicale U1032, Université de Lyon, Lyon, France. 7. Division of Gastroenterology, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy. 8. Gastroenterology Unit, Department of Translational Research and New Technology in Medicine and Surgery. University of Pisa, Pisa, Italy. 9. Division of Gastroenterology, Mayo Clinic, Scottsdale, Arizona. 10. Barts and The London School of Medicine and Dentistry Queen Mary, University of London, London, United Kingdom.
Abstract
BACKGROUND AND AIMS: Acid exposure time (AET) and reflux episode thresholds from the Lyon Consensus may not apply for pH impedance studies performed while on proton pump inhibitor (PPI) therapy. We aimed to determine metrics from "on PPI" pH impedance studies predicting need for escalation of therapy. METHODS: De-identified pH impedance studies performed while on twice-daily PPI (Diversatek, Boulder, CO) in healthy volunteers (n = 66, median age 37.5 years, 43.9% female), and patients with proven gastroesophageal reflux disease (GERD) (European heartburn-predominant cohort: n = 43, median age 57.0 years, 55.8% female; North American regurgitation-predominant cohort: n = 42, median age 41.6 years, 42.9% female) were analyzed. Median values and interquartile ranges for pH impedance metrics in healthy volunteers were compared with proven GERD patients with and without 50% symptom improvement on validated measures. Receiver operating characteristic (ROC) analyses identified optimal thresholds predicting symptom response. RESULTS: Both conventional and novel reflux metrics were similar between PPI responders and nonresponders (P ≥ .1 for each) despite differences from healthy volunteers. Combinations of metrics associated with conclusively abnormal reflux burden (AET >4%, >80 reflux episodes) were seen in 32.6% and 40.5% of heartburn and regurgitation-predominant patients, respectively, 57.1% and 82.4% of whom reported nonresponse; and 85% with these metrics improved with invasive GERD management. On ROC analysis, AET threshold of 0.5% modestly predicted nonresponse (sensitivity, 0.62; specificity, 0.51; P = .22), and 40 reflux episodes had better performance characteristics (sensitivity, 0.80; specificity, 0.51; P = .002); 79% with these metrics improved with invasive GERD management. CONCLUSION: Combinations of abnormal "on PPI" pH impedance metrics are associated with PPI nonresponse in proven GERD patients, and can be targeted for treatment escalation, including surgery, particularly in regurgitation-predominant GERD.
BACKGROUND AND AIMS: Acid exposure time (AET) and reflux episode thresholds from the Lyon Consensus may not apply for pH impedance studies performed while on proton pump inhibitor (PPI) therapy. We aimed to determine metrics from "on PPI" pH impedance studies predicting need for escalation of therapy. METHODS: De-identified pH impedance studies performed while on twice-daily PPI (Diversatek, Boulder, CO) in healthy volunteers (n = 66, median age 37.5 years, 43.9% female), and patients with proven gastroesophageal reflux disease (GERD) (European heartburn-predominant cohort: n = 43, median age 57.0 years, 55.8% female; North American regurgitation-predominant cohort: n = 42, median age 41.6 years, 42.9% female) were analyzed. Median values and interquartile ranges for pH impedance metrics in healthy volunteers were compared with proven GERD patients with and without 50% symptom improvement on validated measures. Receiver operating characteristic (ROC) analyses identified optimal thresholds predicting symptom response. RESULTS: Both conventional and novel reflux metrics were similar between PPI responders and nonresponders (P ≥ .1 for each) despite differences from healthy volunteers. Combinations of metrics associated with conclusively abnormal reflux burden (AET >4%, >80 reflux episodes) were seen in 32.6% and 40.5% of heartburn and regurgitation-predominant patients, respectively, 57.1% and 82.4% of whom reported nonresponse; and 85% with these metrics improved with invasive GERD management. On ROC analysis, AET threshold of 0.5% modestly predicted nonresponse (sensitivity, 0.62; specificity, 0.51; P = .22), and 40 reflux episodes had better performance characteristics (sensitivity, 0.80; specificity, 0.51; P = .002); 79% with these metrics improved with invasive GERD management. CONCLUSION: Combinations of abnormal "on PPI" pH impedance metrics are associated with PPI nonresponse in proven GERD patients, and can be targeted for treatment escalation, including surgery, particularly in regurgitation-predominant GERD.
Authors: Rena Yadlapati; C Prakash Gyawali; Melina Masihi; Dustin A Carlson; Peter J Kahrilas; Billy Darren Nix; Anand Jain; Joseph R Triggs; Michael F Vaezi; Leila Kia; Alexander Kaizer; John E Pandolfino Journal: Am J Gastroenterol Date: 2022-06-10 Impact factor: 12.045