The majority of adult Americans likely experience reflux at least monthly, and several times more often for some, explains Raman Muthusamy, MD, MAS, professor of medicine and medical director of endoscopy at UCLA Health. “It can be quite debilitating, and the management options for reflux have been mostly lifestyle changes, in terms of diet, exercise, timing of meals, and losing weight,” he adds. “Medications are available to treat GERD, including antacids for mild reflux, H2 blockers, and proton pump inhibitors (PPIs), but many patients have concerns about those medications, particularly proton pump inhibitors, in terms of long-term use.”
Data indicate that long-term use of PPIs—medications that reduce stomach acid production by inhibiting the stomach’s H⁺/K⁺ ATPase proton pump—is generally not advised. “We know that PPIs have been associated with certain conditions, such as calcium malabsorption and risk of infection, than can potentially affect patients with GERD,” says Dr. Muthusamy. “And many patients simply don’t like to take a medication over the long term. There are also concerns about drug interactions between PPIs and certain medications that could affect the therapeutic levels of those medications. Additionally, there are occasionally side effects associated with individual drugs that may make some patients reticent to take them or to avoid them altogether. All of these can make patients desire an alternative to taking these medicines over a long period.”
PPI Alternatives
Although FDA approvals for PPIs were for short-term use, based on how the trials supporting their approvals were conducted, data do exist to show they can be used long term, according to Dr. Muthusamy. “In general, they do more good than harm, but I do think we have been very liberal in the use of these medications… Unfortunately, many patients are prescribed these medications and then just seem to stay on them. While I think they’re generally safe, there are some potential concerns of side effects and interactions that should cause clinicians to ensure they precisely choose those patients who would benefit most from their use.”
To that end, Dr. Muthusamy notes that symptoms that do not respond well to medication should be an indication for primary care physicians to order additional testing. “PPIs only block the production of acid. For a patient with a chief complaint focused more on regurgitation—they don’t like the backwash of liquid, which can be irritating—these medications don’t address the mechanical barrier. They just serve to reduce the concentration of acid in the fluid. Patient complaints of hoarseness, perhaps even asthma, or of medicines that worked for a while but seem to be working less well may be reasons to consider additional testing and perhaps alternative therapies.”
Transoral Incisionless Fundoplication
Surgical options are available for GERD, but the most commonly used—Nissen fundoplication—is often associated with significant side effects, explains Dr. Muthusamy, particularly dysphasia or difficulty belching after the procedure, which can lead to gas bloat. Gas bloat can affect between one-quarter and one-half of patients who undergo Nissen fundoplication. “Another alternative is transoral incisionless fundoplication (TIF),” he adds, “meant to provide a middle option, which is a mechanical correction of reflux but perhaps without the side effect of invasiveness of surgery. TIF is a procedure with a few predecessors, but the more modern version started being used in about 2009. The original procedure was FDA approved in 2007 and has undergone some variations, in terms of the technique and in modifications of the device, which is called the EsophyX device, through which the TIF procedure is performed. It is an endoscopic, minimally invasive method to perform a fundoplication. In patients with hiatal hernia (< 2cm in size), we can perform TIF as a direct procedure without the need for hernia repair, so it can be entirely endoscopic in patients who have reflux with larger hernias.”
For a “straight” TIF procedure, the EsophyX device is passed through the endoscope, allowing the clinicians to “essentially wrap the fundus, in the lower esophagus, by grabbing some tissue, essentially pulling down a little bit of the esophagus into the stomach, and then securing that wrap with some fasteners,” explains Dr. Muthusamy. “We typically create a 270-300 degree wrap and typically place 20-30 fasteners during the TIF procedure. It takes, in experienced hands, around 40-60 minutes to perform.”
Experience suggests, according to Dr. Muthusamy, that patients with GERD are opting to try TIF because of promising data in regard to alleviating symptoms, eliminating the need for medication, and avoiding the side effects of traditional fundoplication. “We’ve been trying to provide endoscopic anti-reflux alternatives for 20 years, with a number of technologies that have been proposed and subsequently withdrawn or failed due to lack of adoption of concerns about efficacy or safety,” he says. “There has been a real need for these devices, but like many things, when there are two alternatives—in this case, medications and surgery—that are relatively effective, it becomes difficult to compete with them with the first version of a device. So, it’s really taken about 20 years to come up with some good, tried and true techniques. I’m hopeful that we’ll see additional variations and modifications, because we know there are hundreds of millions of people in our country who suffer from GERD on a regular basis, many of whom are probably looking for alternatives to medicines. As we can provide them with safe, durable, and effective techniques, I suspect that the number of patients who choose to consider these techniques will only grow in the years to come.”
