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

Surg Endosc. 2017 Jun;31(6):2498-2508. doi: 10.1007/s00464-016-5252-8. Epub 2016 Sep 21.

Abstract

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 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.

Results: At 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.

Conclusion: This study demonstrates that TF can be used to achieve long-term control of chronic GERD symptoms, healing of esophagitis, and improvement in EAE.

Keywords: Atypical symptoms; GERD; Heartburn; Regurgitation; TIF; Transoral fundoplication.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Chronic Disease
  • Cross-Over Studies
  • Esophagitis, Peptic / diagnostic imaging
  • Esophagitis, Peptic / pathology
  • Female
  • Fundoplication / instrumentation
  • Fundoplication / methods*
  • Gastroesophageal Reflux / surgery*
  • Hernia, Hiatal / surgery
  • Humans
  • Male
  • Middle Aged
  • Proton Pump Inhibitors / therapeutic use
  • Quality of Life
  • Time Factors
  • Treatment Outcome

Substances

  • Proton Pump Inhibitors