title: Long-term outcomes of endoluminal gastroplication: a U.S. multicenter trial.
abstract: BACKGROUND
  Endoluminal gastroplication has shown promise for the treatment of GERD in short-term studies. Until now, long-term outcome data have been lacking.
  
  
  METHODS
  A prospective, multicenter trial enrolled 85 patients with GERD to be treated with endoluminal gastroplication. Inclusion criteria were 3 or more heartburn or regurgitation episodes per week, >4.2% time in 24 hours with esophageal pH < 4, and dependency on antisecretory medications. Exclusion criteria were the presence of varices, achalasia, aperistalsis, or previous gastric resection. Patients underwent manometry, 24-hour pH monitoring, and symptom severity scoring before and after the procedure. Patient diaries were used to assess medication use and to estimate annual medication cost.
  
  
  RESULTS
  At 1- and 2-year follow-up, patients had significant reductions in median heartburn symptom scores (72 at baseline [interquartile range (IQR) 90-48] vs. 4 at 12 months [IQR 43-0] and 16 at 24 months [IQR 53-3.5]; p < 0.0001 vs. baseline) and median regurgitation symptoms (2 at baseline [IQR 3-1] vs. 0 at 12 months (IQR 1-0) and 1 at 24 months [IQR 1-0]; p < 0.0001 vs. baseline). Of all patients, 59% and 52% showed heartburn symptom resolution at 12 and 24 months, respectively ( p < 0.0001 vs. baseline). Also, 83% and 77% had regurgitation symptom resolution at 12 and 24 months, respectively (p < 0.0001 vs. baseline). Proton pump inhibitor use also was significantly reduced at 12 and 24 months after the procedure. At 2-year follow-up, median annualized medication costs were reduced by 88% (1381 US dollars) (p < 0.0001). Endoluminal gastroplication significantly reduced the duration and the number of episodes of esophageal acid exposure (p < 0.0001 vs. baseline). Only 7 patients experienced adverse events.
  
  
  CONCLUSIONS
  Endoscopic gastroplication is safe and effective, and is associated with symptom reductions in patients with GERD for at least 24 months.
authors.affiliation: University of Colorado Hospital, Denver, USA.
authors.forename: Yang K
authors.initials: YK
authors.lastname: Chen
authors.forename: Isaac
authors.initials: I
authors.lastname: Raijman
authors.forename: Tamir
authors.initials: T
authors.lastname: Ben-Menachem
authors.forename: Anthony A
authors.initials: AA
authors.lastname: Starpoli
authors.forename: Julia
authors.initials: J
authors.lastname: Liu
authors.forename: Haleh
authors.initials: H
authors.lastname: Pazwash
authors.forename: Stacey
authors.initials: S
authors.lastname: Weiland
authors.forename: Mamun
authors.initials: M
authors.lastname: Shahrier
authors.forename: Evelina
authors.initials: E
authors.lastname: Fortajada
authors.forename: John R
authors.initials: JR
authors.lastname: Saltzman
authors.forename: David L
authors.initials: DL
authors.lastname: Carr-Locke
mesh_terms: D002940:Circadian Rhythm / Q000502:physiology; D003362:Cost-Benefit Analysis; D016145:Endoscopy, Digestive System; D004947:Esophagus / Q000378:metabolism / Q000503:physiopathology / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D018662:Fundoplication / Q000191:economics / Q000379:methods*; D005744:Gastric Acid / Q000378:metabolism; D005764:Gastroesophageal Reflux / Q000378:metabolism / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008365:Manometry; D008875:Middle Aged; D010528:Peristalsis / Q000502:physiology; D011312:Pressure; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome