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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

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Abstract

Background

Transoral incisionless fundoplication (TIF) with the EsophyX™ device creates an antireflux valve with good functional results in patients with gastro-esophageal reflux disease (GERD). The aim of this study was to assess the long-term effect of TIF 2.0 on pathological reflux and symptoms in GERD patients with daily dependence on proton pump inhibitors (PPI).

Methods

Fifty patients underwent TIF. All underwent GERD-HRQL and GERD-QUAL questionnaires, upper GI endoscopy, esophageal manometry, and 24-h pH-impedance before and 6, 12, and 24 months after TIF, and subsequent yearly clinical re-evaluation.

Results

Patients were followed for up to six years (mean 52.7 ± 19.7 months). In all, 83.7, 79.6, 87.8, and 84.4 % of patients stopped or halved the PPI therapy 6, 12, 24, and 36 months after TIF. Three-year figure remained stable up to 6 years. Symptom scores off PPI were significantly lower at 6, 12, 24, and 36 months. At 6 months, Hill’s grade I of the newly created valve persisted in all pre-procedure Hill’s grade I patients, in 66.7 % of grade II and 58.3 % of grade III. This figure remained substantially unchanged at 12 and 24 months, too. Impedance monitoring indicated significantly fewer total and acid refluxes after treatment (p = 0.01). Factors predicting good outcomes were pre-procedure Hill’s grade I-II, no hiatal hernia or hernia ≤2 cm (p = 0.03), absence of ineffective esophageal motility (p < 0.0001), and number of fasteners deployed (p = 0.01).

Conclusions

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.

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Disclosures

Drs. Pier Alberto Testoni, Sabrina Testoni, Giorgia Mazzoleni, Cristian Vailati, and Sandro Passaretti have no conflict of interest or financial ties to disclose.

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Authors and Affiliations

  1. Unit of Gastroenterology and Gastrointestinal Endoscopy, Division of Experimental Oncology, IRCCS San Raffaele Scientific Institute - Vita-Salute San Raffaele University, Milan, Italy

    Pier Alberto Testoni, Sabrina Testoni, Giorgia Mazzoleni, Cristian Vailati & Sandro Passaretti

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  1. Pier Alberto Testoni
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  2. Sabrina Testoni
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Correspondence to Pier Alberto Testoni.

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Testoni, P.A., Testoni, S., Mazzoleni, G. et al. 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. Surg Endosc 29, 2770–2780 (2015). https://doi.org/10.1007/s00464-014-4008-6

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