GERD WATCHING Dr. Fass and his staff examine a high-resolution esophageal manometry image to determine whether there are abnormalities in a patient's upper esophageal sphincter.

The number of treatment options available to the estimated 50 million Americans suffering with gastroesophageal reflux disease (GERD) is growing. There are now 3 FDA-approved endoscopic therapies and 2 minimally invasive surgical procedures. At least one other new procedure is in the pipeline, awaiting FDA approval. But it's important to note that as promising and potentially effective as some or all of these treatments may end up being, for most patients they shouldn't be the first choice. Instead, they should be considered when medication isn't the most viable option. Still, that leaves a significant subset of patients who may be good candidates for surgery or endoscopic therapy. Which treatment makes the most sense? The answers aren't always black and white, but there are some factors to consider.

Which patients?
The first consideration, of course, is pinpointing which patients we're talking about. Some patients simply aren't interested in medical therapy, which is usually administered in the form of proton pump inhibitors (PPIs). Those patients may not want to deal with having to take pills on a daily basis, or they might not trust themselves to be compliant. There are also a growing number of patients who are concerned about the potential side effects of PPIs. Taken, together, these make up one subset of patients who may be good candidates for endoscopic or surgical therapy.

Some patients have side effects from medical therapy and thus can't take the appropriate medication. For others, PPIs aren't enough to fully control their symptoms, and they have a poor quality of life as a result. Or they may be symptomatic because they also have large hiatal hernias, a condition that definitely requires surgery.

Patients whose predominant symptom is regurgitation or who continue to have an abnormal pH test despite being on the maximum PPI dosage (and who are assessed to be fully compliant) are also candidates for surgical or endoscopic interventions. And patients who have symptoms that correlate with what's called non-acid reflux, despite taking maximum PPI doses, may also benefit from interventions. (The term non-acid reflux is common, but it's really a misnomer. These are the patients who have weakly acidic reflux [pH between 4 and 7], neutral reflux [7] or alkaline reflux [above 7]).

5 Surgical + Endoscopic GERD Options

LINX With the LINX procedure, which involves placing a metal ring with magnetized titanium beads around the lower eshophogeal sphincter, food can pass through the esophagus, but the magnetic force of titanium beads creates a barrier to reflux.

THE TIF PROCEDURE is an endoscopic ?partial fundoplication procedure in which fasteners are used to form a valve and create a barrier to reflux.

MUSE is an endoscopic partial fundoplication procedure that ?uses ultrasound and a stapler at the tip of the scope to reconstruct the dysfunctional lower esophageal sphincter.

STRETTA THERAPY is endoscopic and uses low levels of radiofrequency to modify the structure of the lower esophageal sphincter and strengthen the muscle.

NISSEN FUNDOPLICATION is a laparoscopic procedure that involves wrapping a portion of the stomach completely around the esophagus.

Endoscopic therapies
The approved endoscopic therapies are Stretta, TIF (transoral incisionless fundoplication) and MUSE (Medigus Ultrasonic Surgical Endostapler). All bring about anatomic changes by means of an endoscope.

The obvious advantage is that they require neither surgeons, nor ORs. But they're appropriate only for certain cases — those in which patients have mild (Grade A or B) erosive esophagitis, or non-erosive reflux disease with a clear abnormal pH test on a pH study. Additionally, they're not appropriate for patients with large (more than 3 cm) hiatal hernias.

Stretta therapy, which was approved by the FDA in 2000, uses low levels of non-ablative radiofrequency to modify the structure of the lower esophageal sphincter, strengthening the muscle and enhancing its ability to prevent stomach contents from refluxing back into the esophagus. It's done under conscious sedation and usually takes about 45 minutes.

TIF, approved in 2006, is a non-surgical alternative to Nissen fundoplication. Using the TIF procedure, gastroenterologists and surgeons access the stomach through the mouth with customized instruments and reconstruct the gastroesophageal valve to reestablish a barrier to reflux. It's done under general anesthesia, and usually requires a little more than an hour to do.

MUSE, approved in 2015, is similar to TIF in that it involves transoral fundoplication. It uses ultrasound and a stapler at the tip of the scope and is likely to be comparable to TIF in the results it produces, although comparative studies were not done.

All have the potential to be very effective, and the choice may come down to the preference of both the patient and the practitioner. Of course, the success of every procedure depends in large part on the expertise and experience of the performing physician. The fewer procedures they do on a regular basis, or have done, the greater the risk for some type of adverse event.

Some concerns about adverse effects related to transoral procedures, including mucosal tears, perforations and bleeding, have been raised. But a 2015 study of 39 TIF patients helps drive home the point about the importance of expertise (osmag.net/jzkmz2). No adverse events were reported, an accomplishment the authors attributed to the experience of the practitioners.

Surgical options
For patients who require surgery to control GERD, we have a choice between laparoscopic fundoplication, which is the more traditional anti-reflux surgery, and LINX, a novel and relatively recently approved alternative. Again, there are pros and cons to consider.

Wrapping a portion of the stomach around the esophagus, the essence of 360-degree Nissen fundoplication, can result in future complications, such as rapid emptying of the stomach, difficulty swallowing and excess gas. There's also the possibility that the portion that's wrapped will loosen or slide over time, and that the surgery will fail as a result.

Alternatively, the LINX procedure involves placing a metal ring with magnetized titanium beads around the lower eshophogeal sphincter. Once it's in place, swallowing breaks the magnetic bond, allowing food to pass, but the magnets then pull together again, creating a barrier to reflux.

On the bright side, that means there's no manipulation of the anatomy of the gastroesophageal junction, which is important. But the concept raises questions about the long-term viability and safety of the ring. Is there a risk it will migrate or erode into the esophagus? The procedure hasn't been around long enough to give us 15 or 20 years of follow-up review.

PROTON PUMP INHIBITORS?
Keeping the PPI Scare in Perspective

QUESTIONABLE DATA Concerns about proton pump inhibitors may be overblown.

You've probably heard about the studies linking proton pump inhibitors (PPIs) to a wide variety of adverse events, including kidney disease, dementia, fractures, infection and vitamin or mineral deficiencies. Keep in mind, however, that according to the American Gastroenterological Association, "the quality of evidence supporting these findings is low to very low." Plus, they add, the odds that patients taking PPIs will experience these events are only a tiny bit higher (less than 1% per patient, per year) than they are in patients not taking PPIs.

That doesn't mean there's no risk, of course. We don't know for sure yet. But frankly, I'm not overly concerned. I've been prescribing PPIs for more than 20 years and have yet to see even one of the complications that have been reported in the popular press.

Yes, we should be cautious. We shouldn't prescribe PPIs to people who don't need them, and we should always strive for the lowest dose that controls symptoms and inflammation. But we shouldn't rush toward other interventions when we can use medical therapy to manage GERD.

H2-receptor antagonist blockers can also be effective if patients have mild or low-grade symptoms (and are concerned about the reported potential side effects of PPIs), but there's no question that PPIs control symptoms better, do a better job of healing erosive esophagitis and are better at maintaining healed erosive esophagitis.

— Ronnie Fass

Significant failure rate
Ultimately, there's no magic bullet. A large-scale study (osmag.net/8xjwdh) from Sweden recently published in the Journal of the American Medical Association found an 18% failure rate among patients who'd had fundoplication surgery between 2005 and 2014. Those patients either remained on medication after 6 months or required additional surgery.

Although the numbers don't surprise me, I am surprised that so many surgeries failed so quickly. There may be several explanations, but again, ultimately what I suspect the results reinforce is that the procedure requires expertise and considerable experience. That, I suspect, will lead to increased popularity for the LINX approach, because it reduces failures associated with loosening and other anatomical changes that occur with fundoplication.

Incidentally, for morbidly obese patients who suffer with GERD, I'd typically recommend bariatric surgery over LINX or fundoplication. By bypassing the stomach, you kill 2 birds with 1 stone, reducing the patient's weight and improving reflux. In other words, why just put a finger in the dike when you can fix the dike?

On the horizon?
Still awaiting approval is another promising minimally invasive surgical option, the EndoStim. It's implanted in the abdomen and consists of a stimulator and 2 electrodes. The idea is to restore normal esophageal function by stimulating the lower part of the esophagus. Only about as big as a box of matches, it's looked promising in trials, and the procedure to implant it will likely be the easiest of all to perform. OSM