Endoscopic Treatment of Reflux
In the last three years, the United States has seen introduction of two FDA devices allowing the endoscopist to treat reflux in patients who previously only lifestyle modification, proton pump inhibitors and surgical approaches had been available. These minimally invasive gastrointestinal procedures are divided into two basic approaches. The first approach is the technique of using an endoscope, which has a suturing apparatus attached to its tip, which when placed just below the Gastroesophageal (GE) junction, multiple small fundoplications are made, essentially forming a speed bump that reduces refluxant into the distal esophagus. The second new technology is a catheter balloon probe, which is placed blindly at the level of the GE junction, which emits a radiofrequency that subsequently causes scar tissue to form, which increases the lower esophageal sphincter. As such, this increases the reflux barrier to refluxant in the lower esophagus.
With respect to the first technology described, the suturing device was introduced into the Jacksonville market approximately a year ago. It is essentially a small suturing machine that is attached to the endoscope. The endoscope is then brought just below the GE junction and multiple plications of gastric mucosa are brought together, forming a barrier that effectively reduces refluxant into the lower esophageal sphincter (Images 1-5 Below). Early preliminary data that lead to FDA approval suggested a reduction of proton pump inhibitor use in patients undergoing this procedure. Unfortunately, the follow-up 24 hour esophageal acidification data was limited at the time of FDA approval, as were long-term studies with respect to efficacy.
Recently, at this year’s Digestive Disease Week (DDW) in San Francisco, Dr. Chen et al. presented follow up of 183 patients who had undergone endoluminal fundoplication. Pre-annual cost with respect to pharmacotherapy, hospital visits and medical management of these patients was $2379.00. This was compared to $351.00 at twelve months follow-up after gastric fundoplication, suggesting an overall average cost savings of $2208.00 per patient per year for those undergoing fundoplication versus controls. Certain patients required a second procedure to be performed for improved clinical efficacy and complications were minor with four patients described as having minor mucosal injury, five patients who had bleeding that was managed endoscopically and two patients who developed transient dysphagia. The conclusion of this study suggested that after 12 months after fundoplication, patients continued to report good symptomatic control of heartburn and regurgitation. In addition, the authors suggested substantial cost savings benefit because of complete or partial elimination of pharmacologic intake.
Another paper presented at this year’s DDW by Dr. Abou-Rebyeh described 16 patients who had undergone endoscopic fundoplication for reflux symptoms. In this study, esophageal reflux scores were measured pre and post treatment with a significant reduction in symptomatology. In addition, proton pump inhibitor requirements declined significantly after fundoplication.
As is the case with most new technologies, early clinical series usually lack head to head comparisons to more traditional therapies. In the case of the endosuturing procedure little is known about how it compares to Laparoscopic Nissen Fundoplications. In a very preliminary study by Zahid Mahmood et al. presented at this years DDW, 18 patients where randomized to undergo endoscopic suturing and 16 Laparoscopic Fundoplication. Both groups had reduced usage of post intervention use of pharmacotherapy to treat reflux, but by physiologic testing, the Laparoscopic group had better outcomes as measured by 24hr pH probes.
Endoscopic fundoplication is a technology that is now available. Dr. Joseph performs this procedure at our clinic. Its technical requirements are somewhat laborious and specialized training is required. In time, with perfection of this technology and more importantly with long-term trials, this may very well become a reasonable approach to treating patients with reflux symptoms and may very well diminish the need for long-term pharmacotherapy. What is required are long-term clinical trials comparing issues of cost compared to other forms such as traditional Nissen fundoplication, and other new technologies as described below.
Radiofrequency ablation is another new technology that has become available in the Jacksonville community. In essence, this technology enables the physician to use radiofrequency technology to form scar tissue within the muscular layer surrounding the lower esophageal sphincter (Images 6 and 7 below). Preliminary results that led to FDA approval showed both decreased utilization of pharmacotherapy in the treatment of reflux after radiofrequency therapy and, in addition, increases in lower esophageal sphincter pressures and, post treatment 24-hour pH monitoring improvement.
Several papers were presented at this year’s Digestive Disease Week in San Francisco on this new technology. A paper presented by Dr. Corley et al. looked at 54 patients who had enrolled at eight centers of which 34 patients underwent active radiofrequency and 30 patients underwent Sham radiofrequency therapy. At six months, the radiofrequency procedure significantly improved the primary end-point, being the resolution of gastroesophageal reflux symptoms versus the Sham procedures. There was no evidence for a placebo effect on symptom scores with respect to the Sham patients. In addition, patients who underwent radiofrequency as compared to Sham procedure had diminished utilization of PPIs after treatment. Interestingly, esophageal pH scores by 24-hour pH monitoring was not significantly significant between the group who underwent radiofrequency treatment versus those compared to Sham procedure.
Another paper at this years DDW on the radio frequency procedure was presented by Dr. Wolfsen who studied 33 centers in which 590 patients had undergone the radiofrequency procedure. In his paper, Dr. Wolfsen concluded that the procedure significantly improved gastroesophageal reflux symptoms both with respect to control and patient satisfaction and that this was superior to that therapy previously derived from drug therapy. In addition, most patients were off of all antisecretory therapy at follow-up.
The radiofrequency procedure, as is the case with the fundoplication procedure, is new. As such, long-term follow-up is still needed before we can conclusively suggest that one procedure is superior to the other. As stated above, head to head multicenter studies between these two new technologies is needed. In addition, a further arm comparing and contracting efficacy with surgical techniques such as fundoplication both laparoscopically and open are required. Dr. Peterson of our clinic performs this procedure.
The last area being investigated in the treatment of endoscopic and gastrointestinal medical therapeutic management of reflux is the use of injecting different types of substances at the level of the LES. Several papers again were presented on different varieties of technologies at this year’s DDW and, as of yet, there has been no FDA approval of any specific infusion. Of note though, approximately 10 years ago, attempts at sclerosing the musculature at the LES were described by Donnelley et al. in a paper presented at DDW in 1992. In this technique, the authors injected a sclerosant at the level of the LES but, unfortunately, they found results inferior and concluded that this form of therapy would not avail to therapeutic and clinical response. As such, the development of injectable forms of therapy into the lower esophageal sphincter need to be patiently studied before any conclusion can be made with respect to their efficacy and appropriateness for FDA approval.
How endo-suturing is done
The endoscope is advanced to the junction of the stomach and esophagus.
At the tip of the endoscope is a needle which is advance thru tissue that has been sucked into a capsule.
The needle is then deployed down into the sucked up tissue.
Next, a second suture is made next to the first, and a knot is formed.
Finally, complete, a plication is formed, and several more are done.
Radio Frequency Ablation Technique
This is an alternative new procedure in which a catheter is placed to the level of the junction between the esophagus and stomach, and a balloon is blown up with small spikes which emit a radio frequency which then causes the formation of scar tissue to form a circumferential tightness to prevent reflux.