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 >or= 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.
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 >or= 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.
Authors: H E Myrvold; L Lundell; P Miettinen; S A Pedersen; B Liedman; J Hatlebakk; R Julkunen; K Levander; M Lamm; C Mattson; J Carlsson; N O Ståhlhammar Journal: Gut Date: 2001-10 Impact factor: 23.059
Authors: Donald O Castell; Peter J Kahrilas; Joel E Richter; Nimish B Vakil; David A Johnson; Seth Zuckerman; Wendy Skammer; Jeffrey G Levine Journal: Am J Gastroenterol Date: 2002-03 Impact factor: 10.864
Authors: Douglas Pleskow; Richard Rothstein; Simon Lo; Robert Hawes; Richard Kozarek; Gregory Haber; Christopher Gostout; Anthony Lembo Journal: Gastrointest Endosc Date: 2004-02 Impact factor: 9.427
Authors: D von Renteln; I Schiefke; K H Fuchs; S Raczynski; M Philipper; W Breithaupt; K Caca; H Neuhaus Journal: Surg Endosc Date: 2009-05-14 Impact factor: 4.584
Authors: Brent White; Louis O Jeansonne; Michael Cook; L Felipe Chavarriaga; E Adam Goldenberg; S Scott Davis; C Daniel Smith; Leena Khaitan; Edward Lin Journal: Obes Surg Date: 2008-10-07 Impact factor: 4.129