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New Hope for Patients with Medication-Refractory GERD

MUSC First in State to Implant LINX® Device for Gastroesophageal Reflux Disease

LINX DeviceIn September 2012, David B. Adams, M.D., Co-Medical Director of MUSC’s Digestive Disease Center, began implanting the LINX® reflux management system (Torax Medical, Minneapolis- St. Paul, MN), a device for managing medication-refractory gastroesophageal reflux disease (GERD), in select patients. MUSC is one of fewer than 20 centers in the country and one of only three in the Southeast chosen by the device’s manufacturer to  roll out LINX, which was approved as a safe and effective treatment for medication-refractory GERD in March of 2012. MUSC was chosen in part because of the repu- tation, clinical expertise and leadership of Donald O. Castell, M.D., Director of the Esophageal Disorders Program, in treating GERD and the top-flight program he has built.

In patients with GERD, the lower esophageal sphincter, which typically controls the passage of material between the esophagus and stomach, is weakened, allowing the contents of the stomach (stomach acid, bile, ingested food) to flow backward into the esophagus, causing irritation. Heartburn, regurgitation, and difficulty lying flat are among the hallmark symptoms of GERD. If the reflux reaches the bronchial tubes, it can provoke other symptoms, including wheezing, coughing, choking and hoarseness.

The LINX device consists of a “necklace” of magnetized titanium beads that can be placed around the lower esophageal sphincter to provide better closure and to prevent reflux from the stomach into the esophagus (Figure 1, middle). The dynamic device is “beautifully engineered,” according to Dr. Adams, in that the “necklace” of magnets tightens when the esophagus is at rest but loosens upon swallowing to allow passage of food (Figure 1, right). Its dynamic nature helps ensure its durability. It is not likely to erode into the stomach (a problem with an earlier plastic prosthesis called the Angelchick) because the tension of the neck- lace is continually adjusting to the pressure placed on the esophagus (ie, by swallowing); a collagen sheath that naturally develops around it renders it almost biologic and helps protect against dam- age to any surrounding tissue.

The device is inserted laparoscopically, meaning that five ¼-inch slits are cut into the abdomen through which a telescope is inserted; the images recorded by the telescope can then be seen on a television monitor. Surgeons use sutures on the device to position it into place (Figure 2). The procedure typically takes less than an hour. Once in place, the device prevents or minimizes reflux and minimizes both esophageal and bronchial symptoms.

Patient Selection

Nonsurgical treatments for GERD should be exhausted before considering LINX. Patients who still experience symptoms after 6 months of daily treatment with proton pump inhibitors (PPIs) are potential candidates. Although effectively controlling symptoms in most patients, PPIs will provide little benefit to patients with nonacid reflux because they act by reducing the acidity of the reflux and not by addressing the cause of the reflux itself (ie, a weak lower esophageal sphincter). Before discussing LINX with a patient, physicians should question them closely to ensure that the inadequate treatment response is not a result of the patient’s nonadherence to the daily regimen of PPIs. Potential candidates undergo a thorough evaluation, including a barium x-ray of the esophagus, an endoscopic procedure to examine the esophagus and stomach, an esophageal manometry study to measure the strength of the esophageal contraction, and a 24-hour pH study, all of which are offered by MUSC.

Illustration of esphageal sphincter with LINX device
FIGURE 1. In GERD, a weak esophageal sphincter permits reflux of stomach contents into the esophagus (left). LINX, a necklace of magnets, prevents reflux into the esophagus (middle). The necklace of magnets loosens to allow for swallowing (right).

The LINX device is not currently recommended for patients with large hiatal hernias (>3 cm), a body mass index greater than 35, a history of trouble swallowing, or Barrett’s esophagus (a some- times precancerous condition characterized by a damaged lining of the esophagus). Because of the device’s metallic composition, patients with known allergies to titanium, stainless steel, nickel and ferrous materials are not candidates for this procedure.

Once implanted with the titanium-bead implant, patients should avoid magnetic resonance imaging (MRI) because the beads could cause it to malfunction and cause harm. If an MRI becomes necessary in a patient implanted with a LINX device, the device can be removed laparoscopically.

Fewer Side Effects Than Nissen Fundoplication

Side effects with the LINX device are less severe and less frequent than with the most widely used treatment for medication-resistant GERD, Nissen fundoplication, a procedure in which the top of the stomach is essentially tied around the bottom part of the esophagus to improve closure. Instead of the typical one- to two-day hospitalization after Nissen fundoplication, patients implanted with a LINX device can typically go home the same day because they have less pronounced symptoms (ie, less trouble swallowing and less pain). Also, unlike the Nissen fundoplication, which cannot be reversed, the LINX device can be removed should the need arise.

Recent Study Results in Patients Implanted With LINX

A recent article by Lipham et al¹ reported significant improvements in esophageal acid exposure, GERD quality of life as deter- mined by a patient’s score on the GERD-HRQL questionnaire, and use of proton pump inhibitors at (up to) 4-year follow-up vs baseline in 44 patients who were implanted with the LINX reflux management system to treat chronic medication-refractory GERD. At 3 years, the mean percentage of time that pH was less than 4 (acidic) was 3.8% compared with 11.9% at baseline (P<.001).

In addition to these marked reductions in acid exposure, qual- ity of life significantly improved, as evidenced by a mean total GERD-HRQL score at four years of 3.3±3.7 vs 25.7±6.4 (P<.001) at baseline for patients off of PPIs. Of the 25 patients who were four or more years postimplantation, 20 (80%) had completely stopped using PPIs. There were no reports of death or erosion or migration of the device.


FIGURE 2. Surgical implantation of LINX device

A total of three study patients opted to have the device removed, one because of dysphagia, one so that a Nissen fundoplication could be performed, and one because of the need for an MRI. The relative ease with which the LINX device can be removed is one of its advantages. Because the LINX reflux management system, unlike Nissen fundoplication, does not change the anatomy of the esophagus, it can be reversed easily by removing the device laparoscopically and thus does not limit the patient’s subsequent treatment options. Another encouraging finding was that less than 5% of patients complained of being unable to belch or vomit after implantation of the LINX reflux management system; the inability to do so can lead to gas bloat syndrome in patients undergoing Nissen fundoplication.

For more information on LINX, call MEDULINE at 1-800- 922-5250 or 843-792-2200 and ask to be connected to Mary John- son, RN, the clinical coordintor for LINX.

Reference

¹ Lipham JC, DeMeester TR, Ganz RA, et al. The LINX® reflux management system: confirmed safety and efficacy now at 4 years. Surg Endosc. 2012;26:2944-2949. doi:10.1007/s00464-012-2289-1.

This article originally appeared in the January/February 2013 issue of Progressnotes.

View Highlights

Dr. David Adams discusses LINX® in this video interview