Additional Information
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MiVu™ Mucosal Integrity Testing System
Primary diagnostic tools used in practice today for suspected GERD include endoscopy and ambulatory reflux monitoring. These commonly used tools have significant limitations, resulting in many tested patients having a vague, questionable diagnosis that is not a practical guide for therapy.
Oesophageal mucosal injury detected by endoscopic evaluation is present in less than 30% of patients¹. Currently, available pH technology only measures the acidity of refluxed material at a single point along the oesophagus. Furthermore, these tests fail to account for day-to-day variability of reflux, as they only provide a 24- to 48-hour snapshot of a disease process that is chronic in nature². Thus, current diagnostic testing in GERD is suboptimal and can have false-negative rates of nearly 30% in patients that have endoscopic oesophagitis.
Why MiVu?
Using oesophageal mucosal integrity measurements, clinicians can easily differentiate certain esophageal disorders and monitor treatment response in GERD.
In those patients with non-erosive disease who had abnormal reflux by pH monitoring, MI values were similar to those with erosive esophagitis. MI was more effective than pH monitoring in predicting erosive reflux, with a specificity of 95% and a positive predictive value of 96%, compared to 64% and 40%, respectively⁵. Despite the absence of noticeable mucosal changes on endoscopy, MI can distinguish individuals with abnormal reflux patterns from those with normal reflux parameters.
MI also accurately predicted EoE during endoscopy with a sensitivity of 100% and specificity of 96% without the need for histology⁶.
Findings support the possibility that in vivo measurement of oesophageal mucosal impedance may be an accurate means of assessing activity in a patient with EoE without the need for obtaining oesophageal biopsy specimens.
References
1 Dent J. Gastro-oesophageal reflux disease. Digestion 1998;59: 433–445.
2 Patel DA, Vaezi MF. Utility of esophageal mucosal impedance as a diagnostic test for esophageal disease. Curr Opin Gastroenterol 2017;33:277–284.
3 Wenner J, Johansson J, Johnsson F, et al. Optimal thresholds and discriminatory power of 48-h wireless esophageal pH monitoring in the diagnosis of GERD. Am J Gastroenterol 2007;102:1862–1869.
4 Kessels SJM, Newton SS, Morona JK, et al. Safety and efficacy of wireless pH monitoring in patients suspected of gastroesophageal reflux disease: a systematic review. J Clin Gastroenterol 2017;51:777–788.
5 Caroline Barrett & Yash Choksi & Michael F. Vaezi, Mucosal Impedance: a New Approach to Diagnosing Gastroesophageal Current Gastroenterology Reports (2018) 20:33 Reflux Disease and Eosinophilic Esophagitis.
6 Choksi Y, Lal P, Slaughter JC, et al. Esophageal mucosal impedance patterns discriminate patients with eosinophilic esophagitis from patients with GERD. Clin Gastroenterol Hepatol 2018;16:664–671 e1.
7 Dhyanesh A. Patel, Tina Higginbotham, James C. Slaughter, Muhammad Aslam, Elif Yuksel, David Katzka, C. Prakash Gyawali, Melina Mashi, John Pandolfino, and Michael F. Vaezi, Development and Validation of a Mucosal Impedance Contour Analysis System to Distinguish Esophageal Disorders, Gastroenterology 2019;156:1617–1626.
MiVu™ Mucosal Integrity Testing System is covered by one or more of the following patents: US 11,291,382, US 10,321,867 and US 9,814,408.
