Long-term efficacy of transoral incisionless fundoplication with Esophyx (Tif 2.0) and factors affecting outcomes in GERD patients followed for up to 6 years: a prospective single-center study

Testoni, Pier Alberto; Testoni, Sabrina Gloria Giulia; Mazzoleni, Giorgia; Vailati, Cristian; Passaretti, Sandro

doi:10.1007/s00464-014-4008-6

Cited by 101 publications

(75 citation statements)

References 41 publications

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“…While we recognize that 11 patients were lost to follow-up for the 3-year evaluation, we believe that an attrition rate of 17 % is acceptable for any 3-year follow-up study. Additionally, as commonly seen in studies evaluating GERD therapies, not all patients were willing to undergo objective evaluation at the study intervals (Table 4); however, the consistent results between 1-, 2-, and 3-year follow-ups from this study, combined with the evidence from double-blind randomized studies [12, 13] and from the long-term European study [32], further support the safety, efficacy, and durability of TF. We conclude that TF offers chronic GERD patients with incomplete symptom control on PPI therapy an effective therapeutic alternative with lasting effect.…”

Section: Discussionmentioning

confidence: 60%

“…Testoni et al [32] had reported that the percentage of patients who either stopped or halved their PPI therapy at 3-year follow-up was unchanged at 6 years (84 %), which portends positively for maintaining even longer-term PPI cessation rates in the same range. Interestingly, in the same study, complete discontinuation of PPIs dropped from 61 % of patients at 6 months to 30 % at 6 years, with the sharpest drop observed between 6 and 12 months post-TF, indicating that resumption of PPIs was most common within the first year after the procedure.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2016

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BackgroundFour 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.MethodsThe TF EsophyX versus Medical PPI Open Label trial was conducted in seven US sites. Between June and August 2012, we enrolled patients with small (<2 cm) or absent hiatal hernias who suffered from troublesome GERD symptoms while on PPI therapy for at least 6 months and had abnormal esophageal acid exposure (EAE). Randomization was to TF group (n = 40) or to PPI group (n = 23). Following evaluation at 6 months, all remaining PPI patients (n = 21) elected to undergo crossover to TF. Fifty-two patients were assessed at 3 years for (1) GERD symptom resolution using three GERD-specific quality of life questionnaires, (2) healing of esophagitis using endoscopy, (3) EAE using 48-h Bravo testing, and (4) discontinuation of PPI use. Two patients who underwent revisional procedures by year 3 were included in the final analysis.ResultsAt 3-year follow-up, elimination of troublesome regurgitation and all atypical symptoms was reported by 90 % (37/41) and 88 % (42/48) of patients, respectively. The mean Reflux Symptom Index score improved from 22.2 (9.2) on PPIs at screening to 4 (7.1) off PPIs 3 years post-TF, p < 0.0001. The mean total % time pH <4 improved from 10.5 (3.5) to 7.8 (5.7), p = 0.0283. Esophagitis was healed in 86 % (19/22) of patients. At the end of study, 71 % (37/52) of patients had discontinued PPI therapy. All outcome measures remained stable between 1-, 2-, and 3-year follow-ups.ConclusionThis study demonstrates that TF can be used to achieve long-term control of chronic GERD symptoms, healing of esophagitis, and improvement in EAE.

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Section: Discussionmentioning

confidence: 60%

Section: Discussionmentioning

confidence: 99%

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

et al. 2016

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“…48 Though the longest follow-up time is 22 months in PPINR, TIF has been shown to be effective in PPI responsive patients at 6 years. 65 Wendling et al reports a dysphagia rate of 0.5% with TIF which is dramatically lower than rates typically reported with LF or MSA; however, this data is all from observation studies rather than head-to-head comparisons. 40 Some investigators have argued TIF may be a valuable treatment for patients at higher risk of developing dysphagia due to esophageal dysmotility, though ineffective esophageal motility is an independent risk factor for TIF failure.…”

Section: Discussionmentioning

confidence: 83%

Review of antireflux procedures for proton pump inhibitor nonresponsive gastroesophageal reflux disease

Hillman

Yadlapati

Whitsett

et al. 2017

Diseases of the Esophagus

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Introduction Up to 40% of patients with gastroesophageal reflux disease (GERD) report persistent symptoms despite proton pump inhibitor (PPI) therapy. This review outlines the evidence for surgical and endoscopic therapies for the treatment of PPI non-responsive GERD. Material and Methods A literature search for GERD therapies from 2005–2015 in PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews identified unique 2928 citations. Of those, 45 unique articles specific to surgical and endoscopic therapies for PPI non-responsive GERD were reviewed. Results Laparoscopic fundoplication (n=19) provides symptomatic and physiologic relief out to 10 years, though efficacy wanes with time. Magnetic sphincter augmentation (n=6) and transoral incisionless fundoplication (n=9) improve symptoms in PPI non-responders, and may offer fewer side effects than fundoplication, though long-term follow-up is lacking. Radiofrequency energy delivery (n=8) has insufficient evidence for routine use in treating PPI non-responsive GERD. Electrical stimulator implantation (n=1) and endoscopic mucosal surgery (n=2) are emerging therapies for the treatment of GERD. Discussion Laparoscopic fundoplication remains the most proven therapeutic approach. Newer anti-reflux procedures such as magnetic sphincter augmentation and transoral incisionless fundoplication offer alternatives with varying degrees of success, durability, and side effect profiles that may better suit individual patients. Larger head-to-head comparison trials are needed to better characterize the difference in symptom response and side effect profiles.

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“…Preprocedure Hill's Grade I-II, hiatal hernia smaller than 2 cm, good esophageal motility, and numbers of fasteners were predictors of good clinical outcome [49]. If these factors are kept in mind TIF 2.0 can offer a powerful tool for symptomatic GERD patients.…”

Section: Endoscopic Antireflux Proceduresmentioning

confidence: 99%

Diagnosis and treatment of benign inflammatory esophageal diseases

Kristo

Schoppmann

2015

Eur Surg

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Long-term efficacy of transoral incisionless fundoplication with Esophyx (Tif 2.0) and factors affecting outcomes in GERD patients followed for up to 6 years: a prospective single-center study

Abstract: TIF by the EsophyX achieved lasting elimination of daily dependence on PPI in 75-80% of patients for up to 6 years. TIF seems an effective therapy for selected symptomatic GERD patients.

Cited by 101 publications

References 41 publications

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

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

Review of antireflux procedures for proton pump inhibitor nonresponsive gastroesophageal reflux disease

Diagnosis and treatment of benign inflammatory esophageal diseases

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