title: Endoscopic full-thickness plication for the treatment of GERD: long-term multicenter results.
abstract: BACKGROUND
  The purpose of the present study was to assess the long-term safety and durability of effect for endoscopic full-thickness plication for the treatment of symptomatic gastroesophageal reflux disease (GERD). The Plicator (NDO Surgical, Inc., Mansfield, MA) used delivers a transmural suture through the gastric cardia to restructure the antireflux barrier. Published reports have shown the Plicator procedure to be effective in reducing GERD symptoms and medication use at 1 year post-plication.
  
  
  METHODS
  Twenty-nine patients with chronic heartburn requiring maintenance daily anti-secretory therapy were treated at five sites. Patients received a single full-thickness plication in the gastric cardia 1cm below the gastroesophageal junction (GE) junction. Re-treatments were not permitted. Patients were evaluated at baseline for GERD symptoms and medication use. Intermediate (12 month) and long-term subject follow-up (median follow-up: 36.4 months; range, 31.2-43.9 months) were completed to evaluate procedure safety and durability of effect.
  
  
  RESULTS
  Twenty-nine patients completed the 12-month and 36-month follow-up. All procedure-related adverse events occurred acutely, and no new events were observed during extended follow-up. At 36-months post-procedure, 57% (16/28) of baseline proton pump inhibitor (PPI)-dependent patients remained off daily PPI therapy. Treatment effect remained stable from 12- to 36-months, with 21/29 patients off daily PPI at 12 months compared to 17/29 patients at 36-months. Median GERD- Health Related Quality of Life (HRQL) scores remained significantly improved at 36 months versus baseline off-meds scores (8 versus 19, p < 0.001). In addition, the proportion of patients achieving > or = 50% improvement in GERD-HRQL score was consistent from 12 months (59%) to 36 months (55%).
  
  
  CONCLUSIONS
  Endoscopic full-thickness plication can reduce GERD symptoms and medication use for at least 3-years post-procedure. Treatment effect is stable from 1 to 3 years, and there are no long-term procedural adverse effects.
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, USA.
authors.forename: D
authors.initials: D
authors.lastname: Pleskow
authors.forename: R
authors.initials: R
authors.lastname: Rothstein
authors.forename: R
authors.initials: R
authors.lastname: Kozarek
authors.forename: G
authors.initials: G
authors.lastname: Haber
authors.forename: C
authors.initials: C
authors.lastname: Gostout
authors.forename: A
authors.initials: A
authors.lastname: Lembo
mesh_terms: D015746:Abdominal Pain / Q000209:etiology; D000328:Adult; D000368:Aged; D000863:Antacids / Q000627:therapeutic use; D002637:Chest Pain / Q000209:etiology; D003680:Deglutition Disorders / Q000209:etiology; D004417:Dyspnea / Q000209:etiology; D016099:Endoscopy, Gastrointestinal / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D018662:Fundoplication / Q000009:adverse effects / Q000379:methods*; D005753:Gastric Mucosa / Q000293:injuries; D005764:Gastroesophageal Reflux / Q000188:drug therapy / Q000601:surgery*; D006635:Histamine H2 Antagonists / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D010612:Pharyngitis / Q000209:etiology; D054328:Proton Pump Inhibitors; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D000863:Antacids; D006635:Histamine H2 Antagonists; D054328:Proton Pump Inhibitors