Many GERD sufferers have had it up to their esophagus with the burning backwash of stomach acid. They're ready to get off Prilosec and Prevacid and get on an OR table. Are you ready for them? Laparoscopic Nissen fundoplication — which involves wrapping the upper stomach around the bottom of the esophagus to assist it in closing and prevent reflux — remains the standard surgical therapy, but several other minimally invasive treatments for gastroesophageal reflux disease are also gaining traction.

? Laparoscopic magnetic sphincter augmentation. Surgeons apply a necklace of magnetic beads made of lightweight and durable titanium around the lower esophageal sphincter. The patient's swallowing action causes the beads to separate and lets food pass; the magnets then rejoin to prevent regurgitation.

"Clinical trials, although limited, show the device is especially good at restricting reflux, which is the Achilles' heel of proton pump inhibitors," says Peter Kahrilas, MD, a professor of gastroenterology and hepatology at Northwestern University of Feinberg School of Medicine in Chicago, Ill. "Patients who have the device implanted do quite well. They're able to get off proton pump inhibitors and have shown marked reductions in regurgitation and heartburn."

The procedure came under criticism over concerns of the device eroding into the esophagus. That issue was primarily associated with a previous generation that had smaller magnetic rings and has since been taken off the market; the manufacturer of the latest magnetic sphincter augmentation device is optimistic that the issue of erosion into the esophagus has been lessened, according to Steven Schwaitzberg, MD, professor and chairman of the department of surgery at the University of Buffalo Jacobs School of Medicine and Biomedical Sciences. Dr. Schwaitzberg, who's also the chair of the FDA's GI panel, says this treatment option has received its own CPT code and there has been movement among large commercial payers to pay for the procedure.

? Transoral fundoplication (TIF). This endoluminal plication technique employs an endoscope and proprietary device to reconstruct the angle of His — the normally acute angle between the abdominal esophagus and the fundus of the stomach at the esophagogastric junction, which is a key component of the natural anti-reflux barrier.

"You're constructing something that looks like laparoscopic Nissen fundoplication using a tool that fits around an endoscope," says Dr. Kahrilas. He was involved in a study that tested the ability of the device to prevent problematic regurgitation, which was the primary endpoint to achieve therapeutic efficacy. The 6-month trial had a statistically significant result, but was limited by its duration.

Dr. Schwaitzberg says the TIF procedure has enjoyed a recent resurgence because the treatment option now has its own CPT code, the proprietary device used to perform the procedure has undergone design improvements and longer-term outcomes data show a persistence of anti-reflux effect.

? Radiofrequency ablation. A balloon catheter device is introduced through the mouth to deliver low levels of radiofrequency energy to multiple locations at the lower esophageal sphincter, where the energy changes the tissue's mechanical properties through shrinking and scarring, which results in less reflux. However, according to Dr. Kahrilas, there is no significant clinical evidence to show the device achieves that goal.

? Ultrasonic surgical endoscopic stapling. Surgeons employ a flexible endoscopic stapling device to perform a transoral partial fundoplication. The device is inserted into the stomach, where it's retroflexed before surgeons fire staples into the stomach under ultrasound guidance. Dr. Kahrilas says the device provides a strong fixation and the ultrasound imaging acts as a safety mechanism that lets surgeons know that the folds of tissue they grab with the endoscopic stapler do not contain unseen blood vessels or the crural diaphragm.

Slow growth

Both laparoscopic magnetic sphincter augmentation and fundoplication can be performed safely in the surgery center setting as long as surgeons have the necessary laparoscopic skills to work safely and effectively around the esophagus and diaphragm, notes Dr. Schwaitzberg. Surgeons must also be more aggressive in managing the post-op diet of patients to ensure the durability of the surgical interventions.

Endoscopic treatments are largely effective in patients with mild to moderate disease, but require slightly different approaches to managing the post-op diet of patients and are not generally indicated for patients with a large hiatal hernia, according to Dr. Schwaitzberg. "You have to be much more aggressive in limiting or altering the foods patients might ordinarily eat," he explains.

The more minimally invasive endoscopic procedures are less invasive and are associated with faster recoveries and fewer adverse events than laparoscopic techniques. Limited clinical data suggest endoscopic treatments provide durable solutions to reflux disease, but the procedures have been trialed primarily in patients with minimal esophageal inflammation and small hiatus hernias, according to recent research (osmag.net/cJA9Td).

The report says endoscopic interventions have been proven to reduce esophageal acid exposure, but don't solve the condition, which over the time can cause Barrett's esophagus and esophageal adenocarcino. Many patients who undergo the procedures don't require as many proton pump inhibitors to manage their disease, but they also can't get off the medications entirely.

That might be why some of the endoscopic therapies have not emerged as widespread treatment options, but part of that slow growth can also be blamed on hesitant insurers that are pumping the brakes on paying for the promising procedures.

"They're basing reimbursement policies on the subpar performances of devices that are no longer on the market," says Dr. Schwaitzberg. "Payers lump these therapies, regardless of whether or not they have CPT codes, into experimental status."

Approval from insurance carriers for endoscopic therapies remains spotty and varies by state and even by region, adds Dr. Schwaitzberg. "Just because a procedure has a CPT code doesn't mean insurers are going to pay for it," he says. "Payment barriers have impeded more widespread adoption of endoscopic treatments even though they're effective interventions for patients with mild to moderate reflux disease."

Though endoscopic therapies are less expensive to perform, payers are faced with the conundrum of paying for the care of patients in which the interventions might fail, according to Dr. Schwaitzberg. "Payers must decide if paying once for a more significant laparoscopic procedure makes more sense than paying for a smaller endoscopic intervention that might not work as well," he says.

Concerns persist about how well surgical interventions provide durable and long-lasting esophageal protection. "Surgical treatment options will not beat proton pump inhibitors for controlling heartburn or healing esophagitis," says Dr. Kahrilas. "Proton pump inhibitors aren't effective in preventing regurgitation, which these surgical and endoscopic interventions are designed to limit the reflux.

"For it to reach mouth, a large volume would have to distend the esophagus," he explains. "Preventing that is an important goal, and surgical intervention appears to work well, but data supporting it is somewhat limited." OSM