2015-09-09 17:38:34 UTC

Finding the Sweet Spot: Endoscopic Treatment for GERD is Back

Sept. 14, 2015

Endoscopic GERD treatment should be offered to appropriate patients who have troublesome symptoms, despite optimally dosed PPIs, but who have little interest in laparoscopic fundoplication.

John Hunter

John G. Hunter, MD

Oregon Health & Science University Department of Surgery, Portland, OR

 

Peter Kahrilas

Peter J. Kahrilas, MD

Northwestern University Department of Surgery, Chicago, IL

Read the other half of this AGA Perspectives point-counterpoint debate: Finding the Sweet Spot: Proceed With Caution

You need to understand where we are starting from. Treating gastroesophageal reflux disease (GERD) with a pill that stops acid secretion by the stomach is like treating a flood by removing the trees from the river. Trees in a flood cause some of the downstream damage, but a well-placed dam is generally more effective at minimizing flood damage from both trees and water. Nonetheless, proton pump inhibitor (PPI) administration is the primary treatment for GERD today for two reasons: PPIs work in most people with moderate/severe GERD, and are the least invasive and safest treatment.1 We have no argument with these facts.

From another perspective, optimal GERD treatment utilizes the least invasive method(s) capable of controlling the symptoms and the damage created by gastroesophageal reflux for each individual with this diagnosis. For most patients, PPIs are sufficient, but for the 40 percent of individuals with moderate/severe GERD who are dissatisfied with PPI treatment, another option is desireable.1 This is the niche that laparoscopic fundoplication might have filled, yet, for many individuals, the “invasiveness” jump from a PPI to a laparoscopic fundoplication is, well, just too great a leap. In addition, there is the fear of dysphagia and gas-related side effects.

For over a decade, many hoped that endoscopic techniques and devices would fill the gap between PPI administration and laparoscopic fundoplication. To be successful, endoscopic treatment must be effective at alleviating symptoms poorly controlled by PPI, particularly regurgitation. Additionally, it is important that endoscopic treatments be safe and free of significant side effects. Until recently, endoscopic procedures to address GERD were overpromised and underdelivered.2 None of this is news to any GI doctor, surgeon or device developer who has invested time and/or money in this niche. The landscape is littered with the remains of endoscopic sewing machines, injectables, plicators and thermal coagulators. While many gastroenterologists and surgeons developed and studied the utility of these devices, there was a “fringe” element; these were primarily surgeons who worked on ways to construct a valve (a fundoplication) with the endoscope, hoping to replicate the function of a Nissen fundoplication without the incisions or side effects. While 360 degree fundoplication still requires laparoscopic surgery, we can create an anterior fundoplication with the EsophyX device (EndoGastric Solutions, San Mateo, CA) and probably can accomplish the same with the Medigus device (Medigus, Tel Aviv, Israel). We do not yet know if these endoscopic 180 to 270 degree endo-fundoplications function as well as a laparoscopic fundoplication, but we do know that they work, and in certain circumstances, they provide better reflux symptom control than a properly administered PPI.

How do we know this? Three randomized clinical trials of transoral fundoplication versus PPI for patients with prominent regurgitation symptoms while on PPI were reported in the last 18 months.3-5 While each of these trials offered a slightly different slant, all three showed that symptom control, particularly regurgitation and quality of life, could be better improved with transoral fundoplication, rather than with PPI. The two American trials, TEMPO and RESPECT, were different in one fundamental way; the RESPECT trial included a sham surgery arm, demonstrating the remarkable short-term benefit of a sham procedure. Forty-five percent of those with ‘troublesome’ regurgitation on standard PPI dosing experienced an elimination of their regurgitation symptoms after a 30-to-60 minute endoscopy and esophageal dilation under general anesthesia. Nevertheless, the patients in the fundoplication/placebo group perceived better regurgitation control than patients in the sham/PPI group (67 percent vs. 45 percent, p<0.05). The sham/PPI group had a much higher proportion of early failures than the transoral fundoplication group (36 percent vs. 11 percent, p<0.01). Furthermore, 30 of 42 patients in the sham arm elected to be crossed over to transoral fundoplication once the blind was revealed, independent of their response to sham surgery.The major shortcoming of these randomized clinical trials is the short follow-up period (one year maximum). In the Dutch trial, evidence of valve degradation occurred in 60 percent after one year.5 However, in single-center case series, success rates of 75 to 80 percent were reported three to six years after transoral fundoplication.6-7


Returning to the original question: is endoscopic GERD treatment back? Yes, it certainly is and it should be offered to appropriate patients.


The variability in reported outcomes, like that with laparoscopic fundoplication, could be a result of patient selection or operative technique. Because of tighter study management in the transoral fundoplication trials, patient selection was better controlled than in many trials of laparoscopic fundoplication. The ideal patient for a transoral fundoplication has no hiatal hernia or a very small hernia (<2 cm), a Hill Grade valve of l-II, typical symptoms of heartburn and regurgitation, normal esophageal manometry and at least partial response to PPI therapy. Elements of technique deemed important by the experienced endoscopist include the “rotational” technique, where the device is rotated aggressively into the anterior and posterior cardiophrenic “grooves,” and the liberal application of fasteners. Outcomes are better when more than 16 fasteners are used. These technical “pearls” reveal procedural evolution and increasing surgeon proficiency with transoral fundoplication as the technique is passed along. Additionally, the EsophyX II device is being simplified, with several of the complex steps eliminated in the recently released iteration of the EsophyX Z device. The fasteners are also being improved to increase durability. Transoral fundoplication outcomes are dependent upon operator skill and results may vary.

Returning to the original question: is endoscopic GERD treatment back? Yes, it certainly is and it should be offered to appropriate patients (criteria above) who have troublesome symptoms, despite optimally dosed PPIs, but who have little interest in laparoscopic fundoplication. Recently, AMA assigned a CPT code for the transoral incisionless fundoplication (432XX1) and the appropriate relative value unit (RVU) is under review. The RVU will be established later this year and the new code will take effect in January 2016. It may take a little longer for professional society practice guidelines to catch up and for third-party carriers to include coverage for transoral fundoplication. Most importantly, we need to provide good training for all GI endoscopists and surgeons interested in this technique to assure safety and high-quality outcome

Dr. Hunter serves as a consultant for EndoGastric Solutions.

Dr. Kahrilas serves as a consultant for AstraZeneca and Ironwood, and is on the Pfizer advisory board.

References

1. Fass R. Proton pump inhibitor failure. What are the therapeutic options? Am JGastroenterology 2009;104:Suppl:S33-8.

2. Falk G, Fennerty M, Rothstein R. AGA Institute medical position statement on the use of endoscopic therapy for gastroesophageal reflux disease. Gastroenterology 2006;131:1313-4.

3. Hunter J, Kahrilas PJ, Bell R, et al. Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial. Gastroenterology 2015; 148:324-333.

4. Trad K, Barnes W, Simoni G, et al. Transoral incisionless fundoplication effective in eliminating GERD symptoms in partial responders to proton pump inhibitor therapy at 6 months: The TEMPO randomized clinical trial. Surg Innov. 2015;22:26-40.

5. Witteman BP, Conchillo JM, Rinsma NF, et al. Randomized controlled trial of transoral incisionless fundoplication vs. proton pump inhibitors for treatment of gastroesophageal reflux disease. Am J Gastroenterol 2015;110:531-42.

6. Testoni PA, Testoni S, Mazzoleni G, et al. Long-term efficacy of transoral incisionless fundoplication with Esophyx (Tif 2.0) and factors affecting outcomes in GERD patients followed for up to 6 years: a prospective single-center study. Surg Endosc 2014.

7. Muls V, Eckardt AJ, Marchese M, et al. Three-year results of a multicenter prospective study of transoral incisionless fundoplication. Surg Innov 2013;20:321-30.

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