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Surgical Endoscopy

Published in:

01-03-2007

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

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

Published in: Surgical Endoscopy | Issue 3/2007

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.

Camilleri M, Dubois D, Coulie B, Jones M, Kahrilas PH, Rentz AM, Sonnenberg A, Stanghellini V, Stewart WF, Tack J, Talley NJ, Whitehead W, Revicki DA (2005) Prevalence and socioeconomic impact of upper gastrointestinal disorders in the United States: results of the US upper gastrointestinal study. Clin Gastroenterol Hepatol 3:543–552PubMedCrossRef

Castell DO, Kahrilas PJ, Richter JE, Vakil NB, Johnson DA, Zuckerman S, Skammer W, Levine JG (2002) Esomeprazole (40 mg) compared with lansoprazole (30 mg) in the treatment of erosive esophagitis. Am J Gastroenterol 97:575–583PubMedCrossRef

Chen YK, Raijan I, Ben-Menachem T, Starpoli AA, Liu J, Pazwash H, Weiland S, Shahrier M, Fortajada E, Saltzman JR, Carr-Locke DL (2005) Long-term outcomes of endoluminal gastroplication: a U.S. multicenter trial. Gastrointest Endosc 61:659–667

Chiba N, De Gara CJ, Wilkinson JM, Hunt RH (1997) Speed of healing and symptom relief in grade II to IV gastroesophageal reflux disease: a meta-analysis. Gastroenterology 112:1798–1810PubMedCrossRef

Chuttani R, Sud R, Sachdev G, Puri R, Kozarek R, Haber G (2003) A novel endoscopic full-thickness plicator for the treatment of GERD: a pilot study. Gastrointest Endosc 58:770–776PubMedCrossRef

Cohen LB, Johnson DA, Ganz RA, Aisenberg J, Deviere J, Foley TR, Haber GB, Peters JH, Lehman GA (2005) Enteryx implantation for GERD: expanded multicenter trial results and interim post-approval follow-up to 24 months. Gastrointest Endosc 61:650–658PubMedCrossRef

DeVault KR, Castell DO (2005) Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. Am J Gastroenterol 100:190–200PubMedCrossRef

Haber G, Sakai P, Moura E, Maluf-Filho F, Enns R, Pleskow D, Lembo A (2005) The Plicator procedure for the treatment of GERD: 12-month multicenter study results. Gastrointest Endosc 71:AB17

Johnson DA, Ganz R, Aisenberg J, Cohen LB, Deviere J, Foley TR, Haber B, Peters JH, Lehman GA (2003) Endoscopic implantation of Enteryx for treatment of GERD: 12-month results of a prospective multicenter trial. Am J Gastroenterol 98:1921–1930PubMedCrossRef

10.

Kulig M, Leodolter A, Vieth M, Schulte E, Jaspersen D, Labenz J, Lind T, Meyer-Sabellek W, Malfertheiner P, Stolte M, Willich SM (2003) Quality of life in relation to symptoms in patients with gastro-oesophageal reflux disease—an analysis based on the ProGERD initiative. Aliment Pharmacol Ther 18:767–776PubMedCrossRef

11.

Lagergren J, Bergstrom R, Lindgren A, Nyren O (1990) Symptomatic gastroesophageal reflux as a risk factor for esophageal adenocarcinoma. N Engl J Med 340:825–831CrossRef

12.

Locke GR, 3rd, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ 3rd (1997) Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterology 112:1448–1456PubMedCrossRef

13.

Lundell L (1994) Long-term treatment of gastro-oesophageal reflux disease with omeprazole. Scand J Gastroenterol Suppl 201:74–78PubMed

14.

Mahmood Z, McMahon BP, Arfin Q, Byrne PJ, Reynolds JV, Murphy EM, Weir DG (2003) Endocinch therapy for gastro-oesophageal reflux disease: a one year prospective follow-up. Gut 52:34–39PubMedCrossRef

15.

McHorney CA, Kosinski M, Ware JE Jr (1994) Comparisons of the costs and quality of norms for the SF-36 health survey collected by mail versus telephone interview: results from a national survey. Med Care 32:551–567PubMedCrossRef

16.

Myrvold HE, Lundell L, Miettinen P, Pedersen SA, Liedman B, Hatlebakk J, Julkunen R, Levander K, Lamm M, Mattson C, Carlsson J, Ståhlhammar NO, and the Nordic GORD Study Group (2001) The cost of long-term therapy for gastro-oesophageal reflux disease: a randomized trial comparing omeprazole and open anti-reflux surgery. Gut 49:488–494PubMedCrossRef

17.

Pleskow D, Rothstein R, Lo S, Hawes R, Kozarek R, Haber G, Gostout C, Lembo A (2004) Endoscopic full-thickness plication for the treatment of GERD: a multicenter trial. Gastrointest Endosc 59:163–171PubMedCrossRef

18.

Pleskow D, Rothstein R, Lo S, Hawes R, Kozarek R, Haber G, Gostout C, Lembo A (2005) Endoscopic full-thickness plication for the treatment of GERD: 12-month follow-up for the North American open-label trial. Gastrointest Endosc 61:643–649PubMedCrossRef

19.

Rantanen TK, Salo JA, Sipponen JT (1999) Fatal, life-threatening complications in antireflux surgery: analysis of 5,502 operations. Br J Surg 86:1573–1577PubMedCrossRef

20.

Revicki DA, Wood M, Maton PN, Sorensen S (1998) The impact of gastroesophageal reflux disease on health-related quality of life. Am J Med 104:252–258PubMedCrossRef

21.

Revicki D, Wood M, Wiklund I, Crawley J (1998) Reliability and validity of the Gastrointestinal Symptom Rating Scale in patients with gastroesophageal reflux disease. Qual Life Res 7:75–83PubMedCrossRef

22.

Sandler RS, Everhart JE, Donowitz M, Adams E, Cronin K, Goodman C, Gemmen E, Shah S, Avdic A, Rubin R (2002) The burden of selected digestive diseases in the United States. Gastroenterology 122:1500–1511PubMedCrossRef

23.

Schiefke I, Zabel-Langhennig A, Neumann S, Feisthammel J, Moessner J, Caca K (2005) Long term failure of endoscopic gastroplication (EndoCinch). Gut 54:752–758PubMedCrossRef

24.

Spechler SJ, Lee E, Ahnen D, Goyal RK, Hirano I, Ramirez F, Raufman J-P, Sampliner R, Schnell T, Sontag S, Vlahcevic ZR, Young R, Williford W (2001) Long-term outcome of medical and surgical therapies for gastroesophageal reflux disease: follow-up of a randomized controlled trial. JAMA 2001;285:2331–2338CrossRef

25.

Triadafilopoulos G, DiBaise JK, Nostrant TT, Stollman NH, Anderson PK, Wolfe MM, Rothstein RI, Wo J, Corley DA, Patti MG, Antignano LV, Goff JS, Edmundowicz SA, Castell DO, Rabine JC, Kim MS, Utley DS (2002) The Stretta procedure for the treatment of GERD: 6 and 12 month follow-up of the U.S. open label trial. Gastrointest Endosc 55:149–156

26.

Valanovich V, Wallance S, Gusz J (1996) Quality of life scale for gastroesophageal reflux disease. J Am Coll Surg 183:217–224

Title: Endoscopic full-thickness plication for the treatment of GERD: long-term multicenter results
Authors: D. Pleskow
R. Rothstein
R. Kozarek
G. Haber
C. Gostout
A. Lembo
Publication date: 01-03-2007
Publisher: Springer-Verlag
Published in: Surgical Endoscopy / Issue 3/2007
Print ISSN: 0930-2794
Electronic ISSN: 1432-2218
DOI: https://doi.org/10.1007/s00464-006-9121-8

At a glance: The STEP trials

Springer Medicine

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

Abstract

Background

Methods

Results

Conclusions

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

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