Outcomes of transoral incisionless fundoplication (TIF 2.0): a prospective multicenter cohort study in academic and community gastroenterology and surgery practices (with video).

Background and Aims: Transoral incisionless fundoplication (TIF) is an established safe endoscopic technique for the management of GERD but with variable efficacy. In the past decade, the TIF technology and technique have been optimized and more widely accepted, but data on outcomes outside clinical trials are limited. We tracked patient-reported and clinical outcomes of GERD patients after TIF 2.0.
Methods: Patients with body mass index <35 kg/m ² , hiatal hernia <2 cm, and confirmed GERD with typical or atypical symptoms from 9 academic and community medical centers were enrolled in a prospective registry and underwent TIF 2.0 performed by gastroenterologists and surgeons. The primary outcomes were safety and clinical success (response in 1 subjective and at least 1 of 3 objective secondary end points). Secondary end points were symptom improvement, acid exposure time (AET), esophagitis healing, proton pump inhibitor (PPI) use, and satisfaction. Outcomes were assessed at last follow-up within 12 months.
Results: A total of 85 patients underwent TIF 2.0, and 81 were included in the outcomes analysis. Clinical success was achieved in 94%, GERD Health-Related Quality of Life scores improved in 89%, and elevated Reflux Symptom Index score normalized in 85% of patients with elevated baseline. Patient satisfaction improved from 8% to 79% (P < .0001). At baseline, 81% were taking at least daily PPI, and after TIF 2.0, 80% were on no or occasional PPI (P < .0001). Esophageal AET was normal in 72%, greater with an optimized TIF 2.0 valve (defined as >300-degree circumference and >3-cm length; 94% vs 57%; P = .007). There were no TIF 2.0-related serious adverse events.
Conclusions: TIF 2.0 is a safe and effective endoscopic outpatient treatment option for selected patients with GERD.
Competing Interests: Disclosure The following authors disclosed financial relationships: M. I. Canto: research grant to Johns Hopkins University from EndoGastric Solutions for this investigator-initiated prospective TIF Registry (the sponsor had no influence on the design, conduct, data collection, analysis, interpretation of results, and manuscript preparation), research grants from Pentax Medical Corporation, royalties from UpToDate, and consultant for Castle Biosciences and BlueStar Genomics; P. Janu: consultant for EndoGastric Solutions, Ethicon, Johnson and Johnson, and Olympus; D. L. Diehl: speaker for EndoGastric Solutions; B. Parker: consultant for EndoGastric Solutions; B. K. Abu-Dayyeh: research support from EndoGastric Solutions, Spatz Medical, and ERBE, speaker for Endogastric Solutions, and consultant for Boston Scientific, Olympus, and Medtronic; J. Kolb: consultant for Castle Biosciences and research support from Exact Sciences; M. Murray: consultant for EndoGastric Solutions; R. Sharaiha: consultant for Olympus, Boston Scientific, Cook Medical and Surgical Intuitive and research grants from Boston Scientific and Cook Medical; O. I. Brewer Gutierrez: consultant for EndoGastric Solutions; K. Chang: consultant for and educational grants from Apollo Endosurgery, Cook, Creo, EndoGastric Solutions, Erbe, Medtronic, and Olympus, and member of the EndoGastric Solutions scientific advisory board. All other authors disclosed no financial relationships.
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