Endoscopic full-thickness plication for the treatment of GERD: Long-term multicenter results

D. Pleskow, R. Rothstein, R. Kozarek, G. Haber, C. Gostout, A. Lembo

Research output: Contribution to journalArticle

46 Citations (Scopus)

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 ≥ 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.

Original languageEnglish (US)
Pages (from-to)439-444
Number of pages6
JournalSurgical Endoscopy and Other Interventional Techniques
Volume21
Issue number3
DOIs
StatePublished - Mar 2007

Fingerprint

Gastroesophageal Reflux
Proton Pump Inhibitors
Cardia
Therapeutics
Stomach
Quality of Life
Safety
Esophagogastric Junction
Heartburn
Sutures
Maintenance

Keywords

  • Endoluminal anti-reflux surgery
  • Gastroesophageal reflux disease

ASJC Scopus subject areas

  • Surgery

Cite this

Endoscopic full-thickness plication for the treatment of GERD : Long-term multicenter results. / Pleskow, D.; Rothstein, R.; Kozarek, R.; Haber, G.; Gostout, C.; Lembo, A.

In: Surgical Endoscopy and Other Interventional Techniques, Vol. 21, No. 3, 03.2007, p. 439-444.

Research output: Contribution to journalArticle

Pleskow, D. ; Rothstein, R. ; Kozarek, R. ; Haber, G. ; Gostout, C. ; Lembo, A. / Endoscopic full-thickness plication for the treatment of GERD : Long-term multicenter results. In: Surgical Endoscopy and Other Interventional Techniques. 2007 ; Vol. 21, No. 3. pp. 439-444.
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AU - Pleskow, D.

AU - Rothstein, R.

AU - Kozarek, R.

AU - Haber, G.

AU - Gostout, C.

AU - Lembo, A.

PY - 2007/3

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N2 - 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 ≥ 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.

AB - 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 ≥ 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.

KW - Endoluminal anti-reflux surgery

KW - Gastroesophageal reflux disease

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