The most important goals of any GERD treatment are symptom control, prevention of GERD-related complications, and healing of esophagitis [34
]. Although PPIs are very effective in healing esophagitis, a significant proportion of patients continue to be symptomatic. Frequently, these symptoms are laryngopharyngeal in nature. In addition, PPIs do not prevent nonacid reflux, which has been imputed as the cause of GERD-related complications such as asthma, aspiration pneumonia, or cough [35
]. Traditional surgical therapy for GERD, whether laparoscopic or open, has been demonstrated to be effective in the treatment of GERD refractory to medical therapy [37
]. However, traditional fundoplication creates a super-competent valve, which limits the ability to vent air and to vomit and leads to side effects of dysphagia, bloating, nausea, and meteorism in some patients. The super-competent nature of the valve and concomitant side effects have been a major limiting factor in the acceptance of fundoplication by many patients and gastroenterologists. Consider the following American Gastroenterological Association medical position statement on the management of GERD regarding antireflux surgery [2
]: “The potential benefits of antireflux surgery should be weighed against the deleterious effect of new symptoms consequent from surgery, particularly dysphagia, flatulence, an inability to belch, and postsurgery bowel symptoms.” With failures of both current medication regimens and traditional antireflux surgery, there is need for a therapy that would treat medically refractory GERD symptoms without the risks and side effects of traditional surgery. Such a therapy could be acceptable, even if it had a more limited success rate than the current modalities. Because no single-treatment regimen is completely successful, GERD should be considered a chronic condition that requires chronic management and multimodality therapy, much like cardiac disease [38
With the hope of improving GERD-related quality of life by controlling reflux without creating side effects, various transoral methods of restoring gastroesophageal valve competence have been tried with varying degrees of success [39
]. Until recently, transoral procedures were limited to gastrogastric plication or attempts to decrease the compliance of the gastroesophageal valve. The EsophyX device enables creation of full-thickness esophagogastric plication transorally and is currently the only device commercially available that does so.
With our technique the device was used to create not merely a longitudinal esophagogastric fundoplication (the so-called TIF 2), but a rotational and longitudinal esophagogastric fundoplication. The phrenoesophageal membranes are left intact and small hiatal hernias are reduced. Based on limited experience, performance of a laparoscopic fundoplication in the case of failure is not significantly more complicated than performance of a primary laparoscopic fundoplication. This retrospective study of our first 37 patients represents the results of our initial learning curve both with the device and with the development of this technique. Despite these potential limitations, our results are significant in terms of symptom improvement and objective reflux control. Perhaps just as important, we have not observed any of the side effects seen with traditional fundoplications.
The utilization of postoperative pH-metry as an end point in this study should be understood in the context of the treatment goals mentioned above, which do not
include normalization of acid exposure [43
]. Most acid reflux events in GERD patients are asymptomatic [45
]. Eighteen to 30% of patients who have met treatment goals of symptom control and healing of esophagitis with PPI therapy have abnormal amounts of esophageal acid exposure [46
]. We chose to measure reflux postoperatively with the intent to demonstrate that the TIF procedure produces objectively identifiable changes in the amount of esophageal acid exposure that correlate with symptom improvement. Utilization of a telemetry capsule pH probe was favored over transnasal impedance testing because of patient acceptance, even though it did not provide us with information on nonacid reflux events [47
]. In our research protocol we defined pH-metric success by normalization of one or more of the acid reflux characteristics such as acid exposure, number of refluxates, or DeMeester score. By these protocol-specific pH-metric standards, the TIF procedure was successful in up to 89% of patients.
Limitations of this study include its retrospective nature of baseline data collection, with associated incomplete data set for all patients, and the 6-month duration of follow-up. In addition, this study represents our initial learning curve not only with the device but with the evolution of the rotational-longitudinal esophagogastric fundoplication technique. We are currently conducting a prospective study to address these limitations; but we believe this current study’s results to be significant enough to report. This technique should not be considered experimental, a position supported by position statements from the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) [49
] and the American Society of General Surgeons (ASGS) [50