GERD is one of the most common conditions seen in the adult population. Nearly 10% of the population experiences reflux symptoms at least once a week and Proton Pump Inhibitors top the list of most prescribed drugs. Most patients are quite satisfied with medical therapy of their reflux symptoms and more aggressive treatment is only needed in a small percentage of GERD patients. For a patient with GERD who is not fully controlled with PPI’s or who wants to discontinue taking medication there are very few options. While laparoscopic anti-reflux surgery is efficacious, the long term success rate has been called into question and the side effects can be troubling. If one attempts to match the treatment to the spectrum of the severity of the disease there is a glaring gap in the therapeutic armamentarium between PPI’s and laparoscopic fundoplication. It is this void which is most likely to be filled by endoluminal therapies. The first significant attempt to treat GERD endoluminally was the Bard EndoCinch. This device created mucosal plications at the GE Junction. It was cumbersome to use and had poor long term results- in part because of the shallow depth of the sutures. A different approach was tried by the Stretta Procedure. This device attempted to stop pathological reflux by using RF energy to create multiple lesions in the muscular layer of the esophagus near the lower esophageal sphincter. The device was easy to use and appeared
to have some efficacy though the exact mechanism by which reflux was prevented was unclear. Several devices were tried that “bulked up” the lower esophageal region with submucosal injections. Both Gatekeeper and Enteryx showed some promise in short term studies, but extra-esophageal injections while placing Enteryx lead to several fatalities and the device was withdrawn from the market. The NDO plicator was the first endoluminal device to be able to place full thickness sutures at the GE Junction and as such appealed to many surgical providers. Like the other endoluminal therapies, it showed some efficacy in early trials. The endoluminal therapies mentioned above all are either off the market or headed for bankruptcy. The factors responsible for the uniform demise of previous endoluminal therapy are multiple:
1) Success was claimed based on improvement in QOL instruments such as GERD-HRQL or decrease PPI consumption.
a. When physiologic testing was performed on the patients, none of these therapies consistently normalized acid exposure.
b. Patients who seemed to be treated successfully had a high relapse rate on longer term follow up
c. Esophagitis, if present prior to the procedure, did not heal
2) Patients that seemed to benefit were the same as those who did well on medical therapy. Patients with hiatal hernias, erosive esophagitis, or other complications of GERD were not candidates for endoluminal therapy.
3) The payer community refused to pay for endoluminal therapies because they were relatively expensive and did not seem to provide benefit for most patients beyond what they were getting from PPI’s
In reviewing many years of experience with endoluminal therapies, it seems clear that some patients benefited from treatment and hence interest remains in creating an effective device to treat patients who are not completely satisfied with medical therapy. There are currently several devices on the market that seem capable of replicating a surgical fundoplication. Both Esophyx and Medigus are trans-oral devices that fire multiple rows of full thickness plicators and can create competent valves at the GE Junction. These procedures require that the patient be intubated and under general
anesthesia and at the moment require an overnight stay in the hospital. The Payers remain reluctant to reimburse for these procedures ( Medigus is not yet FDA approved) and hence the future of these devices is uncertain. At the moment the necessary and compelling data that these are efficacious is lacking but clinical trials are underway. As many as 10% of patients requiring surgery for GERD will have Barrett’s Esophagus(BE). Patients with BE are typically concerned about cancer risk and often ask if BE can be treated. Patients with short segment BE may see regression in up to 30% of cases following fundoplication and in 10-15% of cases with adequate medical therapy. There are new devices that effectively ablate Barrett’s mucosa, such as BARRX and cryo-ablation, and should be considered for BE patients with low grade dysplasia and GERD. Ablation of BE in the absence of dysplasia is of uncertain benefit and should probably be undertaken within the context of a clinical trial.
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