AGA Institute Technical Review on the Use of Endoscopic Therapy for Gastroesophageal Reflux Disease

The optimal endoscopic antireflux procedure should be effective, easy to apply, and safe. No existing device meets these criteria as currently designed and studied. A variety of endoscopic techniques for the treatment of GERD are currently available, including the delivery of radiofrequency energy to the gastroesophageal junction and suture plication of the proximal fundic folds, but there are no longer any devices that require injection of bulking agents or implantation of a bioprosthesis into the LES zone. Enteryx was voluntarily withdrawn from the market on September 22, 2005, and Gatekeeper was withdrawn in late 2005 before approval and is not expected to be marketed. Each of these techniques involves altering the anatomy of the gastroesophageal junction to decrease reflux. Only limited data are available on the mechanism of action of the various endoscopic techniques. Studies to date of endoscopic therapy have primarily enrolled PPI-dependent patients without severe esophagitis. Each of these techniques results in lessening of GERD symptoms and esophageal acid exposure, while concomitantly decreasing the need for antisecretory medications. Results of a sham-controlled trial of radiofrequency ablation demonstrated decreased heartburn in the active therapy group compared with the sham group but no difference in acid exposure or need for medications in the 2 groups at 6 months. A sham-controlled trial of Enteryx showed decreased PPI use and improved symptoms in the active therapy arm but no difference in esophageal acid exposure between the 2 groups. To understand the role of these novel endoscopic therapies, sham-controlled trials will be required for every new endoscopic device and technique, as well as long-term follow-up of at least 3-5 years. Most studies of endoscopic therapy have only limited follow-up information, and data suggest that some of these techniques, in their current iterations, are not durable. Short-term and long-term safety issues remain unresolved, but a number of life-threatening or fatal adverse events have been reported with these devices. The economics of all techniques for the patient, practitioner, and society are unknown. While newer devices and improvements in endoscopic antireflux techniques may yield better and more durable treatment outcomes, current data suggest that there are no definite indications for endoscopic therapy for GERD at this time. Both practitioners and patients need to be aware of the limitations in the evidence that exist with these devices at present. One further issue that may be relevant to those awaiting further developments in the field of endoscopic antireflux devices is the withdrawal of Enteryx and the suspension of the Gatekeeper clinical development program. Most devices used in gastroenterology are cleared for clinical use by the FDA through what is known as a 510K process, wherein changes in the device and/or its application are relatively simple. However, devices such as Enteryx and Gatekeeper were either approved or in the process of approval via a premarket approval process. Changes to the devices or their application (label) after a premarket approval is granted are tedious and expensive and may require clinical trials supporting such changes. As such, manufacturers are likely to be reluctant to develop such products in the future. This may substantially alter endoscopic antireflux products developed and brought forward in coming years.