The TEMPO Trial at 5 Years: Transoral Fundoplication (TIF 2.0) Is Safe, Durable, and Cost-effective

Background.  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… Read more »

Transoral fundoplication offers durable symptom control for chronic GERD: 3-year report from the TEMPO randomized trial with a crossover arm

BACKGROUND: Four randomized controlled trials have demonstrated the short-term efficacy and safety of transoral esophagogastric fundoplication (TF) performed with the EsophyX®device in eliminating troublesome gastroesophageal reflux disease (GERD) symptoms in well-selected patient populations. The aim of this study was to assess the durability of these outcomes at 3 years post-procedure. METHODS: The TF EsophyX versus Medical… Read more »

Transoral Incisionless Fundoplication: 2 Year Results from the Prospective Multicenter U.S. study

ABSTRACT The aim of this study was to assess prospectively 2-year outcomes of transoral incisionless fundoplication (TIF) in a multicenter setting. A 14 center U.S. registry was designed to evaluate the effects of the TIF 2.0 procedure on chronic gastroesophageal reflux disease (GERD) in over 100 patients. Primary outcome was symptom assessment. Secondary outcomes were proton pump inhibitor (PPI)… Read more »

Efficacy of Transoral Fundoplication for Treatment of Chronic Gastroesophageal Reflux Disease Incompletely Controlled With High-Dose PPI Therapy: a Randomized, Multicenter, Open Label, Crossover Study

BACKGROUND: The aim of this randomized, crossover study was to determine if transoral fundoplication (TF) could further improve clinical outcomes in partial responders to high-dose (HD) proton-pump inhibitor (PPI) therapy and to evaluate durability of TF. METHODS: In seven United States centers, patients with hiatal hernia ≤ 2 cm and abnormal esophageal acid exposure (EAE)… Read more »

The effects of transoral incisionless fundoplication on chronic GERD patients: 12-month prospective multicenter experience

PURPOSE: This study aimed to assess the impact of transoral incisionless fundoplication (TIF) on patients with chronic gastroesophageal reflux disease (GERD) at 12-month follow-up. METHODS: Clinical outcomes of 100 consecutive patients with chronic GERD who underwent TIF between January 2010 and February 2011 were analyzed. RESULTS: There were no major complications reported. Esophageal acid exposure… Read more »

Impact of transoral incisionless fundoplication (TIF) on subjective and objective GERD indices: a systematic review of the published literature

BACKGROUND: Gastroesophageal reflux disease (GERD) remains a significant problem for the medical community. Many endoluminal treatments for GERD have been developed with little success. Currently, transoral incisionless fundoplication (TIF) attempts to recreate a surgical fundoplication through placement of full-thickness polypropylene H-fasteners. This, the most recent procedure to gain FDA approval, has shown some promise in… Read more »

Transoral Fundoplication vs. Proton Pump Inhibitor Therapy For Treatment of Chronic Gastroesophageal Reflux: Short-term Results From a Multicenter, Randomized, Open Label Clinical Trial

BACKGROUND & AIM:  Transoral fundoplication (TF) has previously been shown to be a safe and effective treatment alternative for a selected gastroesophageal reflux disease (GERD) patient population. The aim of this prospective, multicenter, open-label, randomized study was to compare the safety and efficacy of the TF procedure against maximum dose PPI in controlling the chronic… Read more »

A Prospective Multicenter Registry of Patients with Chronic Gastroesophageal Reflux Disease Receiving Transoral Incisionless Fundoplication

BACKGROUND: This study was undertaken to validate previously reported safety and symptomatic outcomes of transoral incisionless fundoplication (TIF), evaluate the relative benefit of TIF within different gastroesophageal reflux disease (GERD) subgroups, and to determine predictors of success in community settings. STUDY DESIGN: Between January 2010 and February 2011, 100 consecutive patients who underwent TIF procedures… Read more »

Long-term outcomes after transoral incisionless fundoplication in patients with GERD and LPR symptoms

BACKGROUND: A retrospective study evaluated safety, symptom resolution, patient satisfaction, and medication use 1-2 years after transoral incisionless fundoplication (TIF) in patients with gastroesophageal reflux disease (GERD) and/or laryngopharyngeal reflux (LPR) symptoms. METHODS: Thirty-four patients with a confirmed diagnosis of GERD symptoms that were inadequately controlled by antisecretory medications, and who where either dissatisfied with… Read more »