There are only anecdotal reports of use of endoscopic anti-reflux procedures as an adjunct to therapy in patients who have failed anti-reflux surgery. Although it is intuitive that some or all of these devices could augment the effect of an ineffective anti-reflux surgical procedure based on their anatomic and physiological effects at the LES, there are still no reliable data documenting efficacy in this specific situation. Nonetheless, we are aware of at least three of the endoscopic devices being used to augment a less than optimal anti-reflux surgical outcome with at least verbal reports of success in some cases. Hopefully, we will see more reliable data from clinical trials become available in the near future regarding the use of these devices as augmentation of either an initial suboptimal surgical outcome or later with relapse of symptoms. Until then, one needs to make sure that the patient and referring physician are aware that we do not know what the magnitude of treatment success, if any, is with endoscopic antireflux procedures used in the postoperative state and that patients being treated with these devices may fail this therapy as well (Figure 10.6).
THE MEDICAL AND ENDOSCOPIC MANAGEMENT OF FAILED SURGICAL PROCEDURES
One other consideration regarding endoscopic anti-reflux therapy versus other management approaches after failed surgery includes the issue of cost of therapy. In this era of health care, the issue of cost-effectiveness of a therapy will always remain a critical question. Payers not only are demanding efficacy be proven before paying for new therapies, they often require proof that new therapies are as, or more, cost-effective than currently used therapies. All of the endoscopic anti-reflux devices have high initial cost, related in part to the need for endoscopy to apply or direct therapy, but also related to the device itself and/or its associated equipment costs (radiofrequency generators, etc.) as well. If repeat applications of these techniques are required to maintain remission or co-therapy with drugs are still needed once these devices have been applied (e.g., they downgrade the severity of GERD but do not eliminate symptoms), these costs will have to be taken into consideration as well, along with indirect costs (lost work time, etc.). However, given the enormous upfront cost of repeat laparoscopic anti-reflux surgery, if efficacy and durability with these endoscopic techniques similar to surgery can be demonstrated, it is intuitive that these devices would then be cost-effective alternatives to repeat surgery. Whether cost-effectiveness of endoscopic anti-reflux devices can be demonstrated versus medical therapy for treatment of failed anti-reflux surgery will be more difficult to prove.70-73
The availability of over-the-counter and generic histamine-2-receptor antagonists (H2RAs) and PPIs, make the comparable cost-effectiveness of these endoscopic techniques less likely to be achievable. However, if one-time applications of endoscopic anti-reflux procedures results in substantial efficacy and prove to be durable in the postoperative patient, it is at least likely that these therapies would be competitive from a cost standpoint, even with the availability of inexpensive generic pharmacological therapies. Formal cost studies will be required to definitively answer these important clinical questions.
We believe that endoscopic therapies for GERD are promising technologies that likely will find clinical application in at least a subset of patients with persistent or recurrent GERD after anti-reflux surgery. But integration of these new endoscopic GERD therapies into clinical practice will require more information from carefully performed and analyzed trials. Issues that still need to be addressed include the efficacy of these devices compared with repeat surgery or PPI therapy and which, if any, endo-scopic technique works best in this clinical situation. Once efficacy has been established, durability of response also needs to be clearly determined. Intensive postmarketing surveillance, device registries, and long-term clinical follow-up studies should be able to document durability. The impact of the learning curve for endoscopic anti-reflux procedures on outcomes including efficacy and safety should also be studied.
Despite these seemingly large hurdles that still have to be surmounted, we are confident that one, if not more, of these technologies will prove to be an effective, durable, safe, and cost-effective treatment option(s) for patients with recurrent or persistent GERD after a surgical anti-reflux procedure.
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Gastroesophageal reflux disease is the medical term for what we know as acid reflux. Acid reflux occurs when the stomach releases its liquid back into the esophagus, causing inflammation and damage to the esophageal lining. The regurgitated acid most often consists of a few compoundsbr acid, bile, and pepsin.