Endoscopic full-thickness plication for the treatment of GERD: Five-year long-term multicenter results

Douglas Pleskow, Richard Rothstein, Richard Kozarek, Gregory Haber, Christopher Gostout, Simon Lo, Robert Hawes, Anthony Lembo

Research output: Contribution to journalArticle

39 Citations (Scopus)

Abstract

Background: The Plicator™ (NDO Surgical, Inc., Mansfield, MA) endoscopically places a full-thickness permanent suture to augment the antireflux barrier. At 3-years post-treatment, published results demonstrated a reduction in subjects' gastroesophageal reflux disease (GERD) symptoms and related medication use. Aim: To evaluate the Plicator's safety and durability of effect at improving GERD symptoms at 5-years post-treatment. Methods: A total of 33 chronic GERD sufferers across seven sites were followed for approximately 5 years (median follow-up: 59 months, range 50-65 months) after receiving a single full-thickness plication approximately 1 cm below the gastroesophageal (GE) junction in the anterior gastric cardia. At baseline, 30 out of 33 subjects required daily proton-pump inhibitor (PPI) therapy. Results: Of the subjects who were PPI dependent prior to treatment 67% (20/30) remained off daily PPI therapy at 60 months and 5-year median GERD health-related quality-of-life (HRQL) scores show significant improvement from baseline off-meds scores (10 versus 19, p < 0.001). Additionally, 50% (16/32) of subjects achieved ≥ 50% score improvement in GERD-HRQL. No new adverse events were identified and all device-related events occurred acutely. These results were comparable to the results seen at 36 months follow-up. Conclusions: Endoscopic full-thickness plication can reduce GERD symptoms and medication use for at least 5-years post procedure with no long-term adverse events post treatment.

Original languageEnglish (US)
Pages (from-to)326-332
Number of pages7
JournalSurgical Endoscopy and Other Interventional Techniques
Volume22
Issue number2
DOIs
StatePublished - Feb 2008

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Gastroesophageal Reflux
Proton Pump Inhibitors
Quality of Life
Esophagogastric Junction
Cardia
Sutures
Stomach
Safety
Equipment and Supplies
Therapeutics

Keywords

  • Endoluminal antireflux surgery
  • Gastroesophageal reflux disease

ASJC Scopus subject areas

  • Surgery

Cite this

Endoscopic full-thickness plication for the treatment of GERD : Five-year long-term multicenter results. / Pleskow, Douglas; Rothstein, Richard; Kozarek, Richard; Haber, Gregory; Gostout, Christopher; Lo, Simon; Hawes, Robert; Lembo, Anthony.

In: Surgical Endoscopy and Other Interventional Techniques, Vol. 22, No. 2, 02.2008, p. 326-332.

Research output: Contribution to journalArticle

Pleskow, Douglas ; Rothstein, Richard ; Kozarek, Richard ; Haber, Gregory ; Gostout, Christopher ; Lo, Simon ; Hawes, Robert ; Lembo, Anthony. / Endoscopic full-thickness plication for the treatment of GERD : Five-year long-term multicenter results. In: Surgical Endoscopy and Other Interventional Techniques. 2008 ; Vol. 22, No. 2. pp. 326-332.
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