LINX (Reflux Management System)

Can Magnets Cure Heartburn?

How New Technology Can Help Patients With Reflux

Jeffrey S. Mandel, M.D., F.A.C.S.

What Causes Reflux?

Reflux, or Gastroesophageal Reflux Disease (GERD), is a chronic and often progressive condition caused by a weak Lower Esophageal Sphincter (LES) that allows acid and bile to backup, to reflux, from the stomach into the esophagus. The LES is a muscle at the junction of the esophagus and stomach that functions as the body’s natural barrier to reflux. The LES acts like a valve, allowing liquid and food to pass through to the stomach. It is supposed to close immediately after swallowing, however, in people with reflux the LES is weak or closes incompletely, thus allowing the stomach juices to flow backwards up into the esophagus. This can cause both heartburn and regurgitation.

Traditional Therapies

There are three traditional treatment options that are offered to patients: lifestyle modifications, medications and surgery.

Lifestyle modifications include avoiding large meals, avoiding certain foods (citrus, tomato based, alcohol, caffeine, chocolate, onions, garlic, and peppermint), decreasing fat intake, avoiding eating 3-4 hours before bedtime, elevating the head of the bed, weight loss and smoking cessation. Most patients find these modifications difficult or unattractive.

Medications include antacids, H2-blockers (e.g., Pepcid, Tagamet, Zantac) and proton pump inhibitors (PPIs) (e.g., Prilosec, Prevacid, Protonix, Nexium, Dexilant). The PPIs are the most effective, but also most costly. Patients on long term PPIs can expect 85-95% control of esophagitis, but only 60-70% achieve complete symptom control and many patients find that they continue to have breakthrough symptoms. Although PPIs are very effective at blocking acid production, they don’t address the regurgitation that occurs due to an ineffective LES and long term may have unwanted side effects.

The standard surgical therapy has been a laparoscopic Nissen fundoplication, in which the stomach is wrapped around the base of the esophagus in order to augment the LES. Although highly effective in restoring the reflux barrier, many patients are wary of undergoing surgery given the possible side effects of inability to belch or vomit, bloating, increased flatulence, and dysphagia (difficulty swallowing). Patients also have to significantly alter their diet for the first few months post operatively, slowly advancing from a pureed diet back to regular foods, and avoiding carbonated beverages indefinitely.

Alternative endoluminal therapies, meaning treatments performed through an endoscope (a fiberoptic tube placed in the esophagus), have been proposed. These include a variety of treatments such as endoscopic suturing devices (Esophyx), radiofrequency ablation (Stretta), and injection of valve bulking agents (Enteryx) which have been met with initial enthusiasm, but now have been largely abandoned due to safety or efficacy concerns.

New Technology

A new option has now become available, the LINX reflux management system. It is an option that provides a minimally invasive surgical treatment with proven clinical benefits, but without the side effects or anatomic disruption of traditional surgery. The LINX reflux management system is an implantable device consisting of a series of titanium beads, each containing a magnetic core, connected together with independent titanium wires that allow the device to expand. It is placed laparoscopically around the LES and assists, or augments, the LES to maintain a closed position when challenged by gastric reflux. The attractive forces of the magnetic beads provide strength to the LES and restore sphincter competence. In order for reflux to occur, gastric pressure must overcome both the native LES resistance and the magnetic bond between the LINX beads. Upon swallowing, the magnetic bond between the beads is easily overcome by the higher pressures of esophageal peristalsis and the device expands to allow the bolus of food to pass into the stomach.

Clinical studies under FDA oversight showed significant reduction in esophageal acid exposure, immediate and lasting symptom improvement, reduced PPI dependence, and significant improvement in control of regurgitation. This was seen with of minimal side effects and no serious complications. Patients not only do not have to alter their diet, they are encouraged to eat normally from day one to allow the device to function effectively.

The advantages of the LINX reflux management system are: 1) it restores physiologic function with minimal anatomic distortion; 2) it is safe, effective and reproducible; 3) side effects are mild, transient and manageable; and 4) it is reversible and does not preclude other options. The only disadvantage to the LINX reflux management system is that MRIs are contraindicated when the device has been implanted.

Of note, there are several conditions that require special consideration, as they were not included in the trials, and patients with these conditions may be better served by a traditional Nissen fundoplication. These include a hiatal hernia greater than 3cm, severe esophagitis, Barrett’s esophagus, esophageal motility disorders and morbid obesity.

Summary

The LINX reflux management system provides a new and novel opportunity for patients who are dissatisfied with their current anti-reflux regimen. One that combines the benefits of traditional laparoscopic surgery while minimizing the potential risks by taking advantage of cutting edge technology.

In conclusion, Yes, magnets can cure heartburn!

For more information on whether you may be a candidate for the LINX reflux management system, Dr. Mandel may be contacted at SouthCoast Health Surgery, 7001 Hodgson Memorial Dr., Suite 1, Savannah, GA 31406 or at 912.354.6303.

www.toraxmedical.com/linx

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