Newer Endoscopic Therapies for GERD: Help or Hype?

For the last 55 years, anti-reflux surgery (Nissen or Toupet fundoplication) has had excellent outcomes, few side effects and commendable durability for a functional repair. The procedure is a true anti-reflux operation, increasing lower esophageal sphincter pressure and eliminating acid reflux in 90 percent of patients. Thirty-day mortality is less than 1 percent (and 0 percent in many centers), perioperative morbidity usually due to co-morbid illnesses, and the durability measured by revisional surgery is less than 10 percent over more than 10 years of follow up.1 Yes, “heartburn” returns in many patients and some require PPIs, but only a fraction have abnormal pH tests and most are back on PPIs for non-specific dyspeptic symptoms.

Why then is there an interest in alternative endoscopic and surgical treatments for GERD? I believe because of the potential financial gains and the misrepresentation of expected post-operative complications after fundoplication, including dysphagia, gas-bloat syndrome and diarrhea. Some dysphagia occurs in everyone, occasionally requires esophageal dilation and is a troubling problem in fewer than 5 percent of patients after one year. The best predictors of post-operative dysphagia are dysphagia before surgery and the same can be said about gas-bloat syndrome. Over the last 30 years, my experience at four academic centers with four surgeons find these side effects are minimal by proper patient selection. My “golden rules” are:

1. Esophageal manometry in all and pH testing off PPIs in most patients preoperatively.

2. Do not allow an abnormal pH test to be the sole criteria for surgery, especially in anxious patients — all the “pieces of the puzzle” should fit together.

3. Avoid the “intractable patient,” especially with anxiety/depression or irritable bowel driving their complaints.


Therefore, new alternative treatments must be measured against the “gold standard” of fundoplication with respect to symptoms and pH control, safety and durability. Let’s see who are the “pretenders” for the royal kingdom of the Nissen fundoplication.


Therefore, new alternative treatments must be measured against the “gold standard” of fundoplication with respect to symptoms and pH control, safety and durability. Let’s see who are the “pretenders” for the royal kingdom of the Nissen fundoplication.

The first is the Stretta procedure (Mederi Therapeutics), first approved by FDA in 2000, which reappeared again in 2005 after bankruptcy and at least four procedure-related deaths. The device uses radiofrequency ablation to decrease lower esophageal sphincter (LES) compliance and reduce transient LES relaxation, but tissue neurolysis also contributes to symptom improvement. Advocates, including SAGES, boast about the more than 15,000 patients treated with this device and over 80 publications, all uncontrolled observational studies, attesting to Stretta’s efficacy. We recently reported a meta-analysis on the four published randomized controlled trials (three vs. shams and one vs. PPIs) involving 165 patients.2 The overall quality of evidence was poor. Pooled results showed no difference between Stretta and sham/PPIs for an increase in LES pressure, decrease in acid reflux, ability to stop PPIs or health-related quality of life. Furthermore, the reported 10-year durability of Stretta therapy is compromised by an enthusiastic single operator’s publication in a selected group of patients representing fewer than 40 percent of his Stretta practice. So, tell me again, why do I want to burn the esophagus to improve symptoms, while not increasing LES pressure orreducing acid reflux at a patient charge of $2,000 to $3,500? Seems like a very expensive antacid.

The second available procedure is transoral incisionless fundoplication (TIF) (EndoGastric Solutions) which attempts to create serosa-to-serosa plications in a circumferential pattern around the cardia. Two similar procedures, EndoCinch and Endoscopic plication system, previously failed due to poor pH control and lack of durability. Most studies to date have been small with less than 6 month follow-up and variable results. Recently, two randomized, controlled trials were reported.3-4 The U.S. study found good control of regurgitation superior to sham and PPIs, but 11 percent failed endoscopic treatment in the first six months going back on PPIs.3The European experience was similar at six months, with excellent heartburn and pH control, similar to PPIs, but at one year less than 30 percent had acid pH normalization and 60 percent were back on PPIs.4 Here again complications are not rare. The database maintained by the FDA reported over 40 complications with TIF of which 35 percent were esophageal perforations often requiring hospitalization and sometimes surgical repair.5 So again, despite the enthusiasm, how do I “sell” this operation to a patient with lifelong GERD generally better on inexpensive PPIs, when the durability at one year is poor, with most back on PPIs? Maybe the surgeon can offer a “money-back guarantee” to the customer if he or she is unhappy with the results.

I do want to clarify that this esophagologist is not against all new surgical innovations. I have enthusiasm for the magnetic sphincter augmentation device (LINX, Thorax Medical) because it normalizes acid reflux in most patients, complications are few and reversible, and most importantly the operation is durable for up to five years.6 Unfortunately, insurance companies are reluctant to pay for this procedure. Until reimbursement changes, this esophageal expert wants to offer my patients only the best — and that’s a Nissen fundoplication by an experienced surgeon after careful esophageal testing.

Dr. Richter has served as a consultant to EndoStim.

References

1. Richter JE. Gastroesophageal reflux disease treatments: Side effects and complications of fundoplication. Clin Gastroenterol and Hepatol 2013; 11:465-71.
2. Lipka S, Kumar A, Richter JE. No evidence for efficacy of radiofrequency ablation for treatment of gastroesophageal reflux disease: A systemic review and meta-analysis. Clin Gastroenterol and Hepatology 2015; 13: 1058-67.
3. Hunter JG, Kahrilas PJ, Bell RCW, et al. Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial. Gastroenterology 2015; 148:324-33.
4. Witteman BPL, 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.
5. US Food and Drug Administration. MAUDE – Manufacturer and User Facility Device Experience. 2016 available from: “http://www.accessdata.fda. gov/scripts/cdrh/cfdocs/cfmaude/search.cfm” www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfmaude/search.cfm
6.Ganz RA, Peters JH, Horgan S, et al. Esophageal sphincter device for gastroesophageal reflux disease. N Engl J Med 2013; 368:719-27.

One comment

  • “Why then is there an interest in alternative endoscopic and surgical treatments for GERD? I believe because of the potential financial gains…”. I am not interested in “financial gains”; I just want to help my patients. This is a rather jaundiced view of the field, unfortunately.

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