title: Four-year follow-up of endoscopic gastroplication for the treatment of gastroesophageal reflux disease.
abstract: OBJECTIVE
  To evaluate the long-term effect of Endocinch treatment for gastroesophageal reflux disease (GERD).
  
  
  METHODS
  After unblinding and crossover, 50 patients (32 males, 18 females; mean age 46 years) with pH-proven chronic GERD were recruited from an initial randomized, placebo-controlled, single-center study, and included in the present prospective open-label follow-up study. Initially, three gastroplications using the Endocinch device were placed under deep sedation in a standardized manner. Optional retreatment was offered in the first year with 1 or 2 extra gastroplications. At baseline, 3 mo after (re) treatment and yearly proton pump inhibitor (PPI) use, GERD symptoms, quality of life (QoL) scores, adverse events and treatment failures (defined as: patients using > 50% of their baseline PPI dose or receiving alternative antireflux therapy) were assessed. Intention-to-treat analysis was performed.
  
  
  RESULTS
  Median follow-up was 48 mo [interquartile range (IQR): 38-52]. Three patients were lost to follow-up. In 44% of patients retreatment was done after a median of 4 mo (IQR: 3-8). No serious adverse events occurred. At the end of follow-up, symptom scores and 4 out of 6 QoL subscales were improved (all P < 0.01 compared to baseline). However, 80% of patients required PPIs for their GERD symptoms. Ultimately, 64% of patients were classified as treatment failures. In 60% a post-procedural endoscopy was carried out, of which in 16% reflux esophagitis was diagnosed.
  
  
  CONCLUSIONS
  In the 4-year follow-up period, the subset of GERD patients that benefit from endoscopic gastroplication kept declining gradually, nearly half opted for retreatment and 80% required PPIs eventually.
authors.affiliation: Matthijs P Schwartz, Department of Gastroenterology, Meander Medical Center, 3800 BM Amersfoort, The Netherlands.
authors.forename: Matthijs P
authors.initials: MP
authors.lastname: Schwartz
authors.forename: J Rieneke C
authors.initials: JR
authors.lastname: Schreinemakers
authors.forename: André J P M
authors.initials: AJ
authors.lastname: Smout
keywords: Endocinch; Endoscopic therapy; Follow-up studies; Gastroesophageal Reflux; Gastroplication