Merit Medical announces ASGE updated guidelines for management of GERD

Merit Medical (MMSI) Systems announced that the American Society for Gastrointestinal Endoscopy updated its guideline on the diagnosis and management of gastroesophageal reflux disease to include Transoral Incisionless Fundoplication and TIF 2.0 Consecutive Transoral Incisionless Fundoplication procedures as evidence-based approaches to care. A minimally invasive therapy, the TIF 2.0 procedure reconstructs the gastroesophageal valve and restores its function as a reflux barrier. TIF 2.0 can also be combined consecutively with a surgical hiatal hernia repair, in a procedure referred to as cTIF. To diagnose and manage GERD, the ASGE developed an evidence-based guideline using the Grading of Recommendations Assessment, Development, and Evaluation framework. Updated from the 2014 ASGE guideline, the revised guideline addresses the role endoscopic anti-reflux therapy plays in the management and treatment of GERD, including TIF 2.0 and cTIF procedures. “In patients with confirmed GERD with small hiatal hernias and Hill grade I or II who meet specific criteria, the ASGE suggests evaluation for TIF as an alternative to chronic medical management,” the ASGE Standards of Practice Committee and co-authors wrote. “In patients with persistent GERD with large hiatal hernias and Hill grade III or IV, the ASGE suggests either cTIF or surgical therapy based on multidisciplinary review.” “The recent update to the ASGE practice guidelines is a significant milestone for patients suffering with GERD. We have learned that TIF 2.0 and cTIF are both safe and efficacious and we now have level 1 evidence to prove it, which has led to societal endorsement,” said Kenneth Chang, Executive Medical Director and Gastroenterologist at Hoag Digestive Health Institute in Newport Beach, CA, and founding faculty member of Merit’s TIF physician education course. “The clinical evidence continues to build with a recent prospective multicenter cohort study4 of 85 patients examined patient-reported and clinical outcomes of GERD patients assessed at last follow-up within 12 months after TIF 2.0. Results showed a clinical success rate of 94%; GERD Health-Related Quality of Life scores improved in 89% of patients; elevated Reflux Symptom Index score normalized in 85% of patients with elevated baseline; and patient satisfaction improved from 8% to 79%. There were no TIF 2.0-related serious adverse events. The expectation is that with this evolution, more patients that qualify for TIF 2.0 or cTIF will have access to the procedure.”