title: Transoral fundoplication offers durable symptom control for chronic GERD: 3-year report from the TEMPO randomized trial with a crossover arm.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  This study demonstrates that TF can be used to achieve long-term control of chronic GERD symptoms, healing of esophagitis, and improvement in EAE.
authors.affiliation: The George Washington University School of Medicine and Health Sciences, Washington, DC, USA. ktrad@mfa.gwu.edu.|The George Washington University Medical Faculty Associates, 1800 Town Center Drive, #218, Reston, VA, 20190, USA. ktrad@mfa.gwu.edu.
authors.forename: Karim S
authors.identifier: 0000-0002-9149-707X
authors.initials: KS
authors.lastname: Trad
authors.affiliation: Crossville Medical Group, Crossville, TN, USA.|Cumberland Medical Center, Crossville, TN, USA.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Fox
authors.affiliation: Advanced Gastroenterology, Inc., Thousand Oaks, CA, USA.
authors.forename: Gilbert
authors.initials: G
authors.lastname: Simoni
authors.affiliation: Saint Mary Medical Center, Hobart, IN, USA.|Internal Medicine Associates, Merrillville, IN, USA.
authors.forename: Ahmad B
authors.initials: AB
authors.lastname: Shughoury
authors.affiliation: Saint Mary Medical Center, Hobart, IN, USA.|Internal Medicine Associates, Merrillville, IN, USA.
authors.forename: Peter G
authors.initials: PG
authors.lastname: Mavrelis
authors.affiliation: Indiana Medical Research, Elkhart, IN, USA.|Unity Surgical Hospital, Mishawaka, IN, USA.
authors.forename: Mamoon
authors.initials: M
authors.lastname: Raza
authors.affiliation: Heartburn Center/Rehabilitation Department, Hancock Regional Hospital, Greenfield, IN, USA.
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Heise
authors.affiliation: Livingston Hospital and Healthcare Services, Inc., Salem, KY, USA.
authors.forename: William E
authors.initials: WE
authors.lastname: Barnes
mesh_terms: D000328:Adult; D000368:Aged; D002908:Chronic Disease; D018592:Cross-Over Studies; D004942:Esophagitis, Peptic / Q000000981:diagnostic imaging / Q000473:pathology; D005260:Female; D018662:Fundoplication / Q000295:instrumentation / Q000379:methods*; D005764:Gastroesophageal Reflux / Q000601:surgery*; D006551:Hernia, Hiatal / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D011788:Quality of Life; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D054328:Proton Pump Inhibitors
keywords: Atypical symptoms; GERD; Heartburn; Regurgitation; TIF; Transoral fundoplication