Endoscopic Augmentation of the Lower Esophageal Sphincter for the Treatment of Gastroesophageal Reflux Disease: Multicenter Study of the Gatekeeper Reflux Repair System

Background and Study Aims: The safety and effectiveness of the Gatekeeper Reflux Repair System (Medtronic Europe, Tolochenaz, Switzerland) in the treatment of gastroesophageal reflux disease (GERD) was evaluated. This new, reversible treatment modality involves the endoscopic introduction of expandable polyacrylonitrile-based hydrogel prostheses into the esophageal submucosa to augment the lower esophageal sphincter (LES).
Patients and Methods: For this study, data from two prospective, nonrandomized European multicenter trials were pooled. Sixty-nine GERD patients with heartburn and regurgitation and abnormal esophageal acid exposure (24-h pH < 4.0 for > 4 % of the total time) who had responded to proton-pump inhibitor (PPI) therapy were recruited, and 68 were treated with up to six prostheses placed at the gastroesophageal junction. Patients underwent esophageal manometry, endoscopy, 24-h pH-metry, and symptom scoring at intake and 1, 3, and 6 months after the procedure.
Results: A total of 77 procedures were performed in 67 patients, and a total of 270 prostheses were placed (mean 4.3 per procedure). At 1 and 6 months, 80.4 % and 70.4 % of the prostheses were retained, respectively. At 6 months, 24-h pH-metry outcomes with pH < 4.0 for > 4.0 % of the time decreased from 9.1 % to 6.1 % (n = 45; P < 0.05). Median LES pressure increased significantly from 8.8 mmHg at baseline to 13.8 mmHg at 6 months (n = 42, P < 0.01). Median GERD heartburn-related quality-of-life scores improved significantly from 24.0 to 5.0 (n = 53, P < 0.01) in patients no longer receiving PPI therapy. Two serious adverse events (3.0 %) occurred. Both patients recovered uneventfully. Prostheses were endoscopically removed from one patient without any adverse events.
Conclusions: The Gatekeeper Reflux Repair System is a safe endoscopic treatment modality that significantly improves GERD symptoms and has objective effects on acid reflux.

References

• 1 Gallup Organization .A Gallup Organization national survey: heartburn across America. Princeton, NJ; The Gallup Organization 1988
• 2 Locke G R, Talley N J, Fett S L. et al . Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota.  Gastroenterology. 1997;  112 1448-1456
• 3 Nebel O T, Fornes M F, Castell D O. Symptomatic gastroesophageal reflux: incidence and precipitating factors.  Am J Dig Dis. 1976;  21 953-956
• 4 Faru P C, Kleinman L, Sloan S. et al . The impact of nocturnal symptoms associated with gastroesophageal reflux disease on health-related quality of life.  Arch Intern Med. 2001;  161 45-52
• 5 Fennerty M B, Castell D, Fendrick A M. et al . The diagnosis and treatment of GERD in a managed care environment; suggested disease management guidelines.  Arch Intern Med. 1994;  156 477-484
• 6 Revicki D A, Wood M, Matoon P N, Sorensen S. The impact of gastroesophageal reflux disease on health-related quality of life.  Am J Med. 1998;  104 252-258
• 7 Ramage J I, Feitoza A B, Gostout C J. Future opportunities and developments for endoscopic gastroesophageal reflux disease therapy.  Gastrointest Endosc Clin N Am. 2003;  13 211-221
• 8 Fass R, Ofman J J. Gastroesophageal reflux disease: should we adopt a new conceptual framework?.  Am J Gastroenterol. 2002;  97 1901-1909
• 9 Fitzgerald R C, Onwuegbusi B A, Bajaj-Elliott M. et al . Diversity in the esophageal phenotypic response to gastroesophageal reflux: immunological determinants.  Gut. 2002;  50 451-459
• 10 Boeckxstaens G E, Tytgat G N. More pathophysiologically oriented treatment of GORD?.  Lancet. 2002;  359 1267-1268
• 11 Hirsch D P, Tytgat G N, Boeckxstaens G E. Transient lower esophageal sphincter relaxations: a pharmacological target for gastroesophageal reflux disease.  Aliment Pharmacol Ther. 2002;  16 17-26
• 12 Fennerty M B. Endoscopic therapy for gastroesophageal reflux disease: what have we learned and what needs to be done?.  Gastrointest Endosc Clin N Am. 2003;  13 201-209
• 13 Edwards S J, Lind T, Lundell L. Systematic review of proton-pump inhibitors for the acute treatment of reflux oesophagitis.  Aliment Pharmacol Ther. 2001;  15 1729-1736
• 14 Kaitan L, Ray W A, Holzman M D, Smalley W E. Health care utilization after medical and surgical therapy for gastroesophageal reflux disease: a population-based study, 1996-2000.  Arch Surg. 2003;  138 1356-1361
• 15 Spechler S J, Lee E, Ahnen D. et al . Long-term outcome of medical and surgical therapies for gastroesophageal reflux disease: follow-up of a randomized controlled trial.  JAMA. 2001;  285 2331-2338
• 16 Velanovich V, Vallance S R, Gusz J R. et al . Quality of life scale for gastroesophageal reflux disease.  J Am Coll Surg. 1996;  183 217-224
• 17 Pleskow D, Rothstein R, Lo S. et al . Endoscopic full-thickness plication for the treatment of GERD: a multicenter trial.  Gastrointest Endosc. 2004;  59 163-171
• 18 Johnson D A, Ganz R, Aisenberg J. et al . Endoscopic implantation of Enteryx for treatment of GERD: 12-month results of a prospective, multicenter trial.  Am J Gastroenterol. 2003;  98 1921-1930
• 19 Richards W O, Houston H L, Torquati A. Paradigm shift in the management of gastroesophageal reflux disease.  Ann Surg. 2003;  237 638-647; discussion 648-649
• 20 DiBaise J K, Brand R E, Quigley E M. Endoluminal delivery of radiofrequency energy to the gastroesophageal junction in uncomplicated GERD: efficacy and potential mechanism of action.  Am J Gastroenterol. 2002;  97 833-842
• 21 Triadafilopoulos G, DiBaise J K, Nostrant T T. et al . The Stretta procedure for the treatment of GERD: 6 and 12 month follow-up of the U.S. open label trial.  Gastrointest Endosc. 2002;  55 149-156
• 22 Filipi C J, Lehman G A, Rothstein R I. et al . Transoral, flexible endoscopic suturing for treatment of GERD: a multicenter trial.  Gastrointest Endosc. 2001;  53 416-422
• 23 Devière J, Pastorelli A, Louis H. et al . Endoscopic implantation of a biopolymer in the lower esophageal sphincter for gastroesophageal reflux: a pilot study.  Gastrointest Endosc. 2002;  55 335-341
• 24 Johnson D A, Ganz R, Aisenberg J. et al . Endoscopic, deePmural implantation of Enteryx for the treatment of GERD: 6-month follow-up of a multicenter trial.  Am J Gastroenterol. 2003;  98 250-258
• 25 Carlson M A, Frantzides C T. Complications and results of primary minimally invasive antireflux procedures: a review of 10,735 reported cases.  J Am Coll Surg. 2001;  193 428-439