title: Endoscopic full-thickness plication for the treatment of GERD: 12-month follow-up for the North American open-label trial.
abstract: BACKGROUND
  The aim of this study was to assess the intermediate-term (12-month) safety and efficacy of endoscopic full-thickness plication in patients with symptomatic GERD.
  
  
  METHODS
  Sixty-four patients with chronic heartburn that required maintenance antisecretory therapy received a single, endoscopically placed, full-thickness plication in the gastric cardia 1 cm distal to the gastroesophageal junction. At baseline and 12 months after plication, patients completed the GERD Health Related Quality of Life questionnaire, Gastrointestinal Symptom Rating Scale, and SF-36 Health Survey, as well as a medication use diary. Ambulatory 24-hour pH monitoring and esophageal manometry were obtained at baseline and 3 months after plication. At 6 months after plication, the 24-hour pH study was repeated.
  
  
  RESULTS
  Of the 57 patients who completed the 12-month follow-up, 40 (70%) were no longer taking a proton pump inhibitor. Median GERD Health Related Quality of Life scores were improved compared with baseline while taking medication (19.0 vs. 5.0; p < 0.0001) and while not taking medication (13.0 vs. 5.0; p < 0.002). At 6 months after the procedure, an improvement in distal esophageal acid exposure was demonstrated in 40 of 51 patients (80%), with a decrease of 39% in the median percentage of time the pH was less than 4 (p < 0.0001). Normal pH scores were observed in 30% of patients. All procedure-related adverse events occurred acutely, as previously reported, and no new adverse event was observed during extended follow-up.
  
  
  CONCLUSIONS
  Full-thickness plication at the gastroesophageal junction is an effective endoscopic procedure for treatment of patients with symptoms caused by GERD. It reduces reflux symptoms and antisecretory medication use over at least a 1-year period.
authors.affiliation: Division of Gastroenterology, Department of Medicne, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA.
authors.forename: Douglas
authors.initials: D
authors.lastname: Pleskow
authors.forename: Richard
authors.initials: R
authors.lastname: Rothstein
authors.forename: Simon
authors.initials: S
authors.lastname: Lo
authors.forename: Robert
authors.initials: R
authors.lastname: Hawes
authors.forename: Richard
authors.initials: R
authors.lastname: Kozarek
authors.forename: Gregory
authors.initials: G
authors.lastname: Haber
authors.forename: Christopher
authors.initials: C
authors.lastname: Gostout
authors.forename: Anthony
authors.initials: A
authors.lastname: Lembo
mesh_terms: D000328:Adult; D000368:Aged; D002940:Circadian Rhythm / Q000502:physiology; D016145:Endoscopy, Digestive System; D005260:Female; D005500:Follow-Up Studies; D018662:Fundoplication / Q000379:methods* / Q000523:psychology; D005744:Gastric Acid / Q000378:metabolism; D005764:Gastroesophageal Reflux / Q000378:metabolism / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008875:Middle Aged; D009656:North America; D017060:Patient Satisfaction; D010528:Peristalsis / Q000502:physiology; D011446:Prospective Studies; D011788:Quality of Life; D012449:Safety; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome