Endoscopic anti-reflux devices: A year of challenges and change

Current Opinion in Gastroenterology

Volumn 22, Issue 4, 2006, Pages 423-428

  Cassara, Joseph E ^a   Shaheen, Nicholas J ^a,b  

^a IL   (United States)

^b UNIVERSITY OF NORTH CAROLINA   (United States)

Author keywords

Biopolymer injection; Endoscopic antireflux procedures; Endoscopic plication; Endoscopic suturing; Gastroesophageal reflux disease; GERD; Radiofrequency energy

Indexed keywords

BIOPOLYMER; HISTAMINE H2 RECEPTOR ANTAGONIST; POLYACRYLONITRILE; POLYMER; PROTON PUMP INHIBITOR; STOMACH SECRETION INHIBITOR;

ANTIREFLUX OPERATION; BIOCOMPATIBILITY; BIODEGRADABLE IMPLANT; CLINICAL TRIAL; CONFIDENCE INTERVAL; COST BENEFIT ANALYSIS; DATA ANALYSIS; DISEASE SEVERITY; DYSPHAGIA; ENDOSCOPIC GASTROPLICATION; ENDOSCOPIC SURGERY; ESOPHAGITIS; ESOPHAGUS MANOMETRY; FEVER; FOOD AND DRUG ADMINISTRATION; GASTROESOPHAGEAL REFLUX; HUMAN; IMPLANTATION; LEUKOCYTOSIS; META ANALYSIS; PATIENT SATISFACTION; PLEURA EFFUSION; POSTOPERATIVE COMPLICATION; QUALITY OF LIFE; RADIOFREQUENCY; RETROSTERNAL PAIN; REVIEW; RISK ASSESSMENT; SAFETY; SCORING SYSTEM; SHORT FORM 36; STOMACH FUNDOPLICATION; SURGICAL INSTRUMENT; SURGICAL MORTALITY; SURGICAL TECHNIQUE; SUTURE; SYSTEMATIC REVIEW; THORAX PAIN; TREATMENT FAILURE; TREATMENT OUTCOME;

ENDOSCOPES, GASTROINTESTINAL; ENDOSCOPY, GASTROINTESTINAL; EQUIPMENT DESIGN; FUNDOPLICATION; GASTROESOPHAGEAL REFLUX; HUMANS; PROSTHESES AND IMPLANTS; PROSTHESIS IMPLANTATION; TREATMENT OUTCOME;

EID: 33746220200     PISSN: 02671379     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.mog.0000231819.64138.c3     Document Type: Review

References (22)

1. Deviere J, Costamagna G, Neuhaus H, et al. Nonresorbable copolymer implantation for gastroesophageal reflux disease: A randomized sham-controlled multicenter trial. Gastroenterology 2005; 128:532-540. This was the first sham controlled trial for Enteryx. It demonstrated improvements in GERD-HRQL and PPI use compared with sham. It was limited by potential unblinding of patients, short-term follow-up and few available patients for pH data.
2. Shaheen NJ. Raising the bar in studies of endoscopic anti-reflux procedures. Gastroenterology 2005; 128:779-792. This editorial summarizes the limitations of current data in the field of endoscpic antireflux procedures.
3. Cohen LB, Johnson DA, Ganz RA, et al. Enteryx implantation for GERD: expanded multicenter trial results and interim postapproval follw-up to 24 months. Gastrointest Endosc 2005; 61:650-658.
4. Johnson DA, 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.
5. Schumacher G, Neuhaus H, Ortner M, et al. Reduced medication dependency and improved symptoms and quality of life 12 months after Enteryx implantation for gastroesophageal reflux. J Clin Gastroenterol 2005; 39:212-219.
6. Noh KW, Loeb DS, Stockland A, et al. Pneumomediastinum follwing Enteryx™ injection for the treatment of gastroesophageal reflux disease. Am J Gastroenterol 2005; 100:723-726.
7. Schultz, Daniel G. FDA Preliminary Public Health Notification: Recall of Boston Scientific ENTERYX® Procedure Kits and ENTERYX® Injector Single Packs for Treatment of Gastroesophageal Reflux Disease (GERD). US Food and Drug Administration website 2005; http://www.fda.gov/cdrh/safety/101405-enteryx.html. [Accessed 15 January 2006]
8. Tintiller M, Chaput A, Kirch L, et al. Esophageal abscess complicating endoscopic treatment of refractory gastroesophageal reflux disease by Enteryx injection: A first case report. Am J Gastroenterol 2004; 99:1856-1858.
9. Wong RF, Davis TV, Peterson KA. Complications involving the mediastinum after injection of Enteryx of GERD. Gastrointest Endosc 2005; 61:753-756. This is a case report of Enteryx complications.
10. The ENTERYX® Procedure: Boston Scientific Recalls ENTERYX Products. Boston Scientific website; 2005; http://www.bostonscientific.com/ common_templates/procedureOverview.jsp?task=tskProcedureOverview. jsp§ionId=4&relId=7,323,324&procedureId=7004&uniqueId= MPPO1216&clickType=endeca. [Accessed 15 January 2006]
11. Cicala M, Gabbrielli A, Emerenziani S, et al. Effect of endoscopic augmentation of the lower oesophageal sphincter (Gatekeeper reflux repair system) on intraoesophageal dynamic characteristics of acid reflux. Gut 2005; 54:183-186.
12. Shiefke I, Zabel-Ianghennig A, Neumann S, et al. Long term failure of endoscopic gastroplication (EndoCinch). Gut 2005; 54:752-758. A large number of enrolled patients with follow-up endoscopic evaluation demonstrated poor suture retention.
13. Abou-Rebyeh H, Hoepffener N, Rosch T, et al. Long-term failure of endoscopic suturing in the treatment of gastroesophageal reflux: A prosepective follow-up study. Endoscopy 2005; 37:213-216.
14. Arts J, Lerut T, Rutgeerts P, et al. A one-year follow-up study of endoluminal gastroplication (Endocinch) in GERD patients refractory to proton pump inhibitor therapy. Dig Dis Sci 2005; 50:351-356.
15. Chen YK, Raijman I, Ben-Menachem T, et al. Long-term outcomes of endoluminal gastroplication: a U.S. multicenter trial. Gastrointest Endosc 2005; 61:659-667.
16. Pleskow D, Rothstein R, Lo S, et al. Endoscopic full-thickness plication for the treatment of GERD: 12-month follow-up for the North American open-label trial. Gastrointest Endosc 2005; 61:643-649.
17. Schilling D, Kiesslich R, Galle PR, et al. Endoluminal therapy of GERD with a new endoscopic suturing device. Gastrointerst Endosc 2005; 62:27-43.
18. Schiefke I, Neumann S, Zabel-Langhennig A, et al. Use of an endoscopic suturing device: the "ESD" to treat patients with gastroesophageal reflux disease, after unsuccessful EndoCinch endoluminal gastroplication: another failure. Endoscopy 2005; 37:700-705.
19. Lufti ER, Torquati A, Kaiser J, et al. Three year's experience with the Stretta procedure: Did it really make a difference? Surg Endosc 2005; 19:289-295.
20. Cipolletta L, Rotondano G, Dughera L, et al. Delivery of radiofrequency energy to the gastroesophageal junction (Stretta procedure) for the treatment of gastroesophageal reflux disease. Surg Endosc 2005; 19:849-853.
21. Schiefke I, Rogalski C, Zabel-Langhennig A, et al. Are endoscopic antireflux therapies cost-effective compared with laparoscopic fundoplication? Endoscopy 2005; 37:217-222. A cost analysis based on current available short-term data demonstrated endoscopic antireflux therapies to be cost-effective as first line therapy if 30% less expensive.
22. Spechler SJ, 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.