HELP ON THE WAY Several promising technologies for treating GERD have either recently been approved by the FDA, or likely will be in the next few years.

Gastroesophageal reflux disease (GERD) leaves a bad taste in millions of mouths every day. The large number of sufferers (estimates range as high as 30% of the U.S. population), combined with growing concerns about the medications traditionally used to treat it (see "Serious Side Effects of Proton Pump Inhibitors"), are creating a huge potential market for minimally invasive surgical and endoscopic procedures. Here's a look at 5 promising new approaches the FDA has either recently approved or is likely to in the next few years.

1Stretta
Approved by the FDA in 2000, Stretta (marketed by Mederi Therapeutics) is indicated for patients who have hiatal hernias smaller than 2 cm, and unlike the others, it's done under conscious sedation. A specialized catheter that you insert through the mouth, into the esophagus, delivers low levels of non-ablative radiofrequency energy to the lower esophageal sphincter and top of the stomach to strengthen the muscle between the stomach and esophagus.

It's time-tested (studies go back 10 years or more) and has been proven to reduce esophageal acid exposure and the need for proton pump inhibitors (PPIs), and improve health-related quality of life. Patients are usually able to go home within a few hours and resume normal activities the next day. Typically they're weaned off their PPIs within about 8 weeks and see significant improvement within 3 months. Many Medicare and private insurers cover the procedure.

2Transoral incisionless fundoplication (TIF)
TIF is a modification of the traditional surgical fundoplication procedure in which the upper portion of the stomach is wrapped around the lower part of the esophagus to reconstruct the anti-reflux barrier. Nissen fundoplication surgeries go back more than 50 years. But with TIF (marketed by EndoGastric Solutions), there's no incision. You insert the company's "EsophyX" through the mouth into the upper part of the esophagus, using visual guidance from an endoscope. Instead of a 360° wrap, it uses fasteners to create a 270° valve that's 2 to 3 centimeters long. Ideally, it corrects the anatomic defect that can cause GERD, recreating the body's natural anti-reflux barrier.

There's considerable data to support the FDA-approved procedure's efficacy, including several years of follow-up data, but most studies have looked primarily at patients who didn't have severe erosive esophagitis or large hiatal hernias. Those can be complicating factors. Still, it's been shown to work on both heartburn and regurgitation symptoms as well. Additionally, patients with refractory GERD — that is, those who continue to have symptoms after being treated with twice daily PPIs — also appear to respond positively to the treatment.

The procedure requires some expertise, and the outcome is likely to depend on the provider's skill and experience. There's a significant learning curve, so patients should go to a surgeon who does it frequently. It's also labor-intensive, and the length of time needed to perform the procedure is likely to be a byproduct of the practitioner's experience — around 90 minutes for a novice, as little as 45 for a veteran.

Recovery is relatively quick. Patients may develop such short-term complications as dysphagia, nausea, vomiting and fever, but those usually resolve within a few days. And most symptoms improve within a few weeks. The majority of patients demonstrate improvement in quality of life, a significant reduction in PPI use — many are able to come off PPI treatment — and significant improvement in esophageal acid exposure. It may be ideal for patients who don't want to take medications on a regular basis, are concerned about the long-term adverse effects of anti-secretory medications and those who have compliance issues.

A new CPT Category 1 code (43210) covering esophagogastric fundoplasty trans-orifice procedures went into effect Jan. 1, but unfortunately, the number of patients with insurance that covers the procedure is still limited, and paying out of pocket is likely to be too expensive (about $6,500) for some others.

3LINX
In this novel minimally invasive surgical approach (marketed by Torax Medical), you place a ring composed from magnetic titanium beads around the lower part of the esophagus. When patients swallow, the beads spread, letting food pass. The magnetic effect then closes the ring, preventing stomach contents from refluxing back into the esophagus.

Several years of follow-up studies show patients are very responsive to the procedure and markedly improve in all relevant parameters. Future studies will focus on whether the ring stays in place or starts to migrate. In 5-year follow-ups, there have been very few adverse events. The hope is that the 10-year picture will look just as good. Another concern is whether the ring will erode over time into the esophagus — there are a few reports of that happening. Dysphagia is a common side effect, and it may last a few months.

Some insurers are paying for the FDA-approved procedure, but many still aren't. At about $20,000, it may be cost-prohibitive for private-pay patients.

4Medigus Ultrasonic Surgical Endostapler (MUSE)
Similar to TIF in that it involves transoral fundoplication, the MUSE system is being performed only on an investigational basis, as Medigus, its manufacturer, seeks FDA approval. MUSE uses ultrasound and a stapler at the tip of the scope and is likely to be comparable to TIF in the results it produces. As with TIF, there's going to be a learning curve, and the quality of the results is likely to correspond with the provider's experience and expertise.

5EndoStim
The hottest new kid on the block is still probably 2 or 3 years away from approval. The EndoStim device, which is similar to a pacemaker, is implanted in the abdomen and consists of a stimulator and 2 electrodes that stimulate the lower part of the esophagus. It's programmed to deliver low-energy personalized neurostimulation, which patients typically can't feel, but which restores normal esophageal function. The device is about as big as a box of matches. EndoStim looks very promising, having been tested in Europe and South America for the last 3 years, and, once approved, is likely to be the easiest of the procedures to perform. OSM