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Endoscopic Gastric Plication for the Treatment of GERD

6 Year Follow-Up Results with BARD EndoCinch

68

Dukowicz, Andrew C., M.D.; Kelly, Virginia, R.N.; Moriarty, Carol, R.N.; Rothstein, Richard I., M.D., F.A.C.G.

American Journal of Gastroenterology: September 2005 - Volume 100 - Issue - p S46
Supplement Abstracts Submitted for the 70th Annual Scientific Meeting of the American College of Gastroenterology: ESOPHAGUS
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Section of Gastroenterology and Hepatology, Dartmouth Hitchcock Medical Center, Lebanon, NH.

Purpose: The long-term outcomes after endoscopic GERD therapy are not fully known, since these interventions have only been recently introduced. As part of the initial cohort study of the BARD EndoCinch, thirteen patients underwent endoscopic gastric plication between March 1998 and April 1999. At 6 months post-procedure, 9 of 13 were no longer taking any acid suppressive therapy. Mean 2-year follow-up showed 5/13 were on no antisecretories and another 4 were on < 50% of their usual pre-treatment dose. At a follow-up of nearly 2 years later (mean 3.8 yrs post-treatment) these results had not changed. We present further long-term follow-up in this cohort, now a mean of 6.4 years after initial treatment.

Methods: Treated subjects had mild GERD, required daily PPIs, were responsive to the antisecretories and had abnormal pH profiles. No patients had a hiatal hernia >2cm or Barrett's esophagus. They received 2 to 4 linear or circumferential plications during their procedure. Of the original 13 subjects, 12 have agreed to annual questionaires about medication use and to assess GERD symptoms off medications.

Results: At a mean follow-up of 6.4 years (range 6.1 to 7.2 years), only 2/12 patients remain completely off PPIs. One additional subject uses 2 doses of PPI per week, and another takes a PPI every other day. 8 patients are back on their pre-procedure daily PPI doses, and one subject underwent a Nissen fundoplication (still symptomatic). No patient or procedural characteristics appeared predictive of long-term improvement or medication use.

Conclusions: Compared with follow-up at a mean of 24 and 41 months, where 5/13 subjects continued to be off all antisecretory therapy post-procedure, only 2 remained off all PPIs at a mean of 6.4 years after treatment. While there was a durable response for nearly 40% of treated subjects for about 3.5 years, this further follow-up may reflect the natural history of gastric plication treatment. Factors such as the effect of the investigator's learning curve and the role of placebo response should be addressed by further study of endoscopic GERD treatment outcomes in larger cohort series and in randomized controlled trials.

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