Advancing the GERD Care Pathway With Targeted and Timely Referrals
Gastroenterology & Endoscopy News, April 2025
A Transformative Approach to GERD: TIF 2.0
Transoral incisionless fundoplication (TIF) 2.0 is a minimally invasive endoscopic outpatient procedure that addresses the root cause of gastroesophageal reflux disease. In this article, V. Raman Muthusamy, MD, MAS and IL Joon Paik, MD, discuss the importance of increasing awareness of the clinical benefits of TIF 2.0 and consecutive TIF 2.0 to overcome referral resistance and improve the health and quality of life of more patients.
“A straightforward TIF 2.0 without surgery is an option for patients who have very small hiatal hernias—2 cm or less and a Hill grade classification of 2 or less—especially when they have reflux symptoms and proper esophageal peristalsis,” Dr Paik said.1
1.Bazerbachi F, et al. Gastrointest Endosc. 2019;90(3):370-383.
The TIF 2.0 procedure addresses the root cause of GERD by reconstructing the gastroesophageal flap valve with up to a 3-cm, 270-degree esophagogastric fundoplication, depending on patient anatomy.
Clinical Research Articles
Marcia et al. 2025. “Outcomes of transoral incisionless fundoplication (TIF 2.0): a prospective multicenter cohort study in academic and community gastroenterology and surgery practices (with video).” Gastrointestinal Endoscopy 101, no. 1 (Jan):90-102.
“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.”
Brewer et al. 2023. “American Foregut Society White Paper on Transoral Incisionless Fundoplication.” Foregut 3, no. 3:242-254.
“Gastroesophageal reflux disease (GERD) is a chronic disease on a spectrum that has an array of management options ranging from lifestyle changes, acid suppressive therapy to laparoscopic anti-reflux surgery (LARS). Transoral incisionless fundoplication (TIF) is an endoscopic procedure in the management of GERD that re-establishes and augments the gastroesophageal flap valve (GEFV). TIF is appropriate for patients that do not have a hiatal hernia greater than 2 cm. Patients with a hiatal hernia greater than 2 cm have the option to have either a conventional LARS (laparoscopic hiatal hernia repair with complete or partial fundoplication) or a concomitant laparoscopic hiatal hernia repair with TIF, known as concomitant TIF (cTIF). This white paper summarizes the published outcome data for TIF 2.0 and cTIF to date and outline the best practice approaches including patient assessment, selection, and management for TIF and cTIF.”
Nguyen et al. 2022. “The American Foregut Society White Paper on the Endoscopic Classification of Esophagogastric Junction Integrity.” Foregut 2, no. 4:339-348. doi:10.1177/26345161221126961.
“One of the most common and debilitating esophageal conditions is gastroesophageal reflux disease (GERD). The Hill grade is an endoscopic classification of the esophagogastric junction (EGJ) based on the appearance of the gastroesophageal flap valve from a retroflexed view of the hiatus. This endoscopic classification provides insight into the anatomic disruption of the EGJ which has been shown to correlate with GERD. However, clinical utilization of this classification by endoscopists has been limited due to the perceived relevance and subjectivity of the classification. With the advent of endoscopic treatment options for GERD, there is renewed enthusiasm to develop a grading system of the EGJ that can objectively define anatomical impairment and reduce interobserver grading variability.”
Choi et al. 2021. “Novel Interdisciplinary Approach to GERD: Concomitant Laparoscopic Hiatal Hernia Repair with Transoral Incisionless Fundoplication.” Journal of the American College of Surgeons 232, no.3 (Mar):309-318. doi: 10.1016/j.jamcollsurg.2020.11.021.
“Transoral incisionless fundoplication (TIF) is an endoscopic alternative for the treatment of GERD. However, TIF does not address the hiatal hernia (HH). We present a novel approach with a laparoscopic HH repair followed by same-session TIF, coined concomitant transoral incisionless fundoplication (cTIF). The aim of this study was to assess the efficacy, safety, and feasibility of cTIF in a collaborative approach between Gastroenterology and surgery.”
Jaruvongvanich et al. 2020. “881 Multicenter Comparative Study of Hiatal Hernia Repair with Transoral Incisionless Fundoplication versus Nissen Fundoplication for the Treatment of Gastroesophageal Reflux Disease.” Gastrointestinal Endoscopy 91, no. 6. https://doi.org/10.1016/j.gie.2020.03.609.
“Transoral incisionless fundoplication (TIF) is a lesser invasive endoscopic procedure for gastroesophageal reflux disease (GERD) alternative to laparoscopic Nissen fundoplication (LNF). Many patients with GERD require hiatal hernia (HH) repair. The US Food and Drug Administration expanded the indication of TIF for patients with hiatal hernia > 2 cm with concomitant HH repair. Recent studies demonstrated favorable outcomes of TIF with HH repair. Data comparing this modality with conventional LNF is lacking.”
Ihde et al. 2019. “pH Scores in Hiatal Repair with Transoral Incisionless Fundoplication.” JSLS 23, no. 1 (Jan-Mar). doi: 10.4293/JSLS.2018.00087.
“Transoral incisionless fundoplication is an alternative to traditional laparoscopic fundoplications. Recently, hiatal hernia repair combined with transoral incisionless fundoplication has become an accepted modification of the original procedure; however, outcomes information, particularly objective pH monitoring, has been sparse. We retrospectively review the subjective and objective outcomes of transoral incisionless fundoplication combined with hiatal hernia repair.”
Janu et al. 2019. “Laparoscopic Hiatal Hernia Repair Followed by Transoral Incisionless Fundoplication With EsophyX Device (HH + TIF): Efficacy and Safety in Two Community Hospitals.” Surgical Innovation 26, no.6 (Dec):675-686. doi: 10.1177/1553350619869449.
“The TIF (transoral incisionless fundoplication) 2.0 procedure is indicated for patients with a hiatal hernia less than 2 cm. Many patients with gastroesophageal reflux disease (GERD) require hiatal hernia repair. This study examined the safety and efficacy when repairing defects in 2 anatomical structures (hiatus and lower esophageal sphincter) in a concomitant set of procedures in patients with hiatal hernias between 2 and 5 cm. Methods. Prospective data were collected from 99 patients who underwent hiatal hernia repair followed immediately by the TIF procedure (HH + -TIF). GERD-HRQL (Health-Related Quality of Life), RSI (Reflux Symptom Index), and GERSS (Gastroesophageal Reflux Symptom Score) questionnaires were administered before the procedure and mailed at 6 and 12 months.”
Trad et al. 2018. “The TEMPO Trial at 5 Years: Transoral Fundoplication (TIF 2.0) Is Safe, Durable, and Cost-effective.” Surgical Innovation 25, no. 2:149-157.
“Questions remain about the therapeutic durability of transoral incisionless fundoplication (TIF). In this study, clinical outcomes were evaluated at 5 years post-TIF 2.0.
Methods: A total of 63 chronic gastroesophageal reflux disease (GERD) sufferers with troublesome symptoms refractory to proton pump inhibitor (PPI) therapy, absent or ≤2 cm hiatal hernia, and abnormal esophageal acid exposure were randomized to the TIF group or PPI group. Following the 6-month evaluation, all patients in the PPI group elected for crossover to TIF; therefore, all 63 patients underwent TIF 2.0 with EsophyX2 device. Primary outcome was elimination of daily troublesome regurgitation and atypical symptoms at the 5-year follow-up. Secondary outcomes were improvement in symptom scores, PPI use, reoperations, and patient health satisfaction. The cost-effectiveness of TIF 2.0 was also estimated.”
Hunter et al. 2015. “Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial.” Gastroenterology 148, no. 2 (Feb):324-333.e5. doi: 10.1053/j.gastro.2014.10.009.
“Transoral esophagogastric fundoplication (TF) can decrease or eliminate features of gastroesophageal reflux disease (GERD) in some patients whose symptoms persist despite proton pump inhibitor (PPI) therapy. We performed a prospective, sham-controlled trial to determine if TF reduced troublesome regurgitation to a greater extent than PPIs in patients with GERD.”
REFERENCES
*Janu P, Shughoury AB, Venkat K, et al. Laparoscopic Hiatal Hernia Repair Followed by Transoral Incisionless Fundoplication With EsophyX Device (HH + TIF): Efficacy and Safety in Two Community Hospitals. Surgical Innovation. 2019;26(6):675-686. doi:10.1177/1553350619869449.