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Page 2 of 9 Kitamura et al. Mini-invasive Surg 2022;6:44 https://dx.doi.org/10.20517/2574-1225.2022.27

rates are also growing in younger populations and are concerning with the concomitant increase of reflux-
related complications, including erosive esophagitis, peptic strictures, related respiratory illnesses, Barrett’s
[3-5]
esophagus (BE), and esophageal adenocarcinoma .

Proton-pump inhibitor (PPI) use, however, is significant in all age groups, and treatment failure occurs in
40% of patients and is not without risk. Chronic PPI use has been linked retrospectively to increased risk of
enteric infections (i.e., Clostridium Difficile colitis), pneumonia, osteoporosis, nutritional deficiencies, and
interference of anti-platelet medications metabolism elevating cardiac risk . Even maximally dosed PPIs
[3,6]
may be inadequate to prevent clinically significant reflux in the presence of a mechanically defective lower
esophageal sphincter .
[2,5]

Despite this, rates of anti-reflux surgery have been in decline. This is at least in part due to apprehension of
variable outcomes associated with laparoscopic fundoplication (LF). Generally, LF is associated with
excellent long-term heartburn relief with > 90% patient satisfaction more than 20 years after surgery .
[7]
[2,4]
However, the surgical technique is not standardized and outcomes, including adverse effects, often vary .
The LINX® Reflux Management System uses magnetic sphincter augmentation (MSA) and has been
[5,8]
proposed as a solution for those that fall into this “treatment gap” . Proponents of MSA state that
implantation will decrease surgical technique variation, avoid significant hiatal and gastric dissection, and
expands to allow normal physiologic passage of gas or gastric contest when needed. These characteristics
address the general concerns of laparoscopic fundoplication and provide patients with a reasonable and
[5,9]
viable intermediary treatment option .
The LINX® device was approved by the U.S. Food and Drug Administration (FDA) in 2012 for
uncomplicated cases of GERD. Several single-arm safety and efficacy studies followed, and subsequently,
comparative studies between MSA and LF. Results thus far have been encouraging and recent studies are
looking to extend indications for MSA use. Feasibility studies for MSA in severe or complicated reflux are
now emerging, specifically in the setting of large hiatal hernias, severe esophagitis, and in bariatric
patients [10,11] .

INDICATIONS AND TECHNIQUE
LINX® reflux management system
The LINX® device was approved in 2012 for the treatment of reflux in patients aged 21-75 with abnormal
pH testing who continued to have symptoms despite maximal medical therapy .
[12]

At that time, it had not been evaluated for those with hiatal hernia larger than 3 cm, BE, Los Angeles grade
C or D esophagitis, esophageal stricture, esophageal or gastric varices, body mass index over 35 kg/m ,
2
major motility disorders [i.e., known achalasia, nutcracker esophagus, diffuse esophageal spasm,
hypertensive lower esophageal sphincter (LES), or distal esophageal motility less than 35 mm Hg in
peristaltic amplitude on wet swallows or less than 70% peristaltic sequences], scleroderma, malignancy, or in
the setting of prior anti-reflux surgery.

The MSA device consists of biocompatible titanium beads with magnetic cords linked with titanium wires
to form an expandable ring. The device is placed around the LES and augments the intraluminal pressure.
The ring will expand when challenged by a food bolus or physiologic passage of gas or gastric contents (i.e.,
belching or vomiting) [4,13] . In 2015, the FDA approved the next generation of the device, which is compatible
and safe with 1.5 Tesla magnetic resonance imaging (MRI), whereas previously, it was limited to 0.7 Tesla.