We recently spoke with Raman Muthusamy, MD, MAS, professor of medicine and medical director of endoscopy at UCLA Health, about current treatment alternatives for patients with GERD who are either failing medical treatment or prefer non-pharmaceutical approaches to manage their disease.


 

PW: Can you explain why long-term use of proton pump inhibitors (PPIs) to treat GERD is generally not advised?

RM: 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. 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.

Do data exist to support the long-term use of PPIs?

The FDA approvals for these drugs were in the short term, but simply because that’s how the trials were conducted. Data clearly exists to show that they can be used. In generally, they do more good than harm, but I do think we have been very liberal in the use of these medications. In fact, patients can now get them over the counter, such that they have become the default treatment for abdominal pain. 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.

What signs should physicians recognize as indicators that alternatives to medication may be needed in managing patients with GERD?

Symptoms that are not responding well to a medication certainly are an indication for additional testing, which could include pH testing to confirm that the patient is, in fact, complaining of acid reflux. Some patients will have other symptoms, such as functional heartburn, which can mimic the symptoms of GERD by may not be associated with true GERD evidence of acid reflux. 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.

Why do you feel endoscopic and minimally invasive surgical approaches to GERD are being increasingly employed?

We are starting to get increasing data. Several, randomized control trials for these technologies have shown their benefits. We’ve also seen refinements in these techniques, as well as more physicians who are comfortable in performing them. Based on a more solid body of evidence with some longer-term data on durability and the accessibility and availability, these devices seem to be more incorporated into the GERD management algorithm. And, as I said, sometimes patients prefer a solution that allows them to come off their medications or avoid them to begin with. If you want to fundamentally solve the problem, you can suggest that either a minimally invasive surgical or endoscopic approach would be a truer solution to that problem.
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Which endoscopic and minimally invasive surgical approaches to GERD appear to obtain the best durable results?

Traditional surgeries like laparoscopic Nissen fundoplication, and several variations of that procedure, can perhaps be performed in patients with impaired motility in moving food across the junction if it’s too tight. They may use a warp that’s not as tight or not as complete in these variations, such as Toupet fundoplication. Another option is magnetic sphincter augmentation, in which a magnetic ring is surgically placed around the lower esophageal sphincter.

A newer option is transoral incisionless fundoplication (TIF), which is an endoscopic technique for patients with a 2 cm or smaller hiatal hernia—if it’s larger, surgery is needed to repair the hernia, but if it’s small hernia, repair can be achieve entirely endoscopically in a 45-minute procedure. TIF can serve to mimic a surgical wrap, and that procedure, in particular, has gained popularity. While the traditional Nissen fundoplication provides the tightest wrap around the lower esophageal sphincter, like many things in life, you want it tight enough be maybe not too tight. Nissen fundoplication has been associated with trouble swallowing or burping (gas bloat), which are the two most common side effects are many anti-reflux procedures. It appears, both from the literature and my own personal experience as someone who performs TIF, that those side effects are significantly reduced in patients undergoing TIF. That’s one reason that many times, now, clinicians and patients are more inclined to seek the TIF procedure.

How do you feel TIF compares with some of the other endoscopic of minimally invasive approaches?

In full disclosure, I’m a gastroenterologist, not a surgeon, so I do not perform laparoscopic Nissen fundoplication, the variant fundoplications, or magnetic sphincter augmentation. I feel that patients should be given the pros and cons of each of these approaches. I usually see patients who are interested in a mechanical solution to their GERD in conjunction with a surgeon, and we discuss their goals and have an honest discussion about the pros and cons of each approach before letting the patient decide, based on that information, how they would like to proceed. Our experience now in that setting is that many patients are opting to try TIF because the data seem to be quite promising in terms of alleviating symptoms, eliminating the need for medications, 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. 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 fist 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.