TY - JOUR
T1 - Endoscopic full-thickness plication for the treatment of GERD
T2 - Five-year long-term multicenter results
AU - Pleskow, Douglas
AU - Rothstein, Richard
AU - Kozarek, Richard
AU - Haber, Gregory
AU - Gostout, Christopher
AU - Lo, Simon
AU - Hawes, Robert
AU - Lembo, Anthony
PY - 2008/2
Y1 - 2008/2
N2 - 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.
AB - 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.
KW - Endoluminal antireflux surgery
KW - Gastroesophageal reflux disease
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U2 - 10.1007/s00464-007-9667-0
DO - 10.1007/s00464-007-9667-0
M3 - Article
C2 - 18027032
AN - SCOPUS:39149099803
SN - 0930-2794
VL - 22
SP - 326
EP - 332
JO - Surgical Endoscopy and Other Interventional Techniques
JF - Surgical Endoscopy and Other Interventional Techniques
IS - 2
ER -