Gastroesophageal reflux disease (GERD) can be treated by bolstering the lower esophageal sphincter with a surgically-implanted bracelet of powerful magnets (NEJM 2013; 368: 719-27).
In a prospective study, 100 patients with GERD were enrolled in this study. The study was conducted in 13 centers in the U.S. and 1 in the Netherlands. It was designed by Torax Medical. There was no control group. The primary outcome was normalization of esophageal acid exposure or a 50% greater reduction in exposure at 1 year.
- Inclusion criteria: 18-75 years with at least 6-month history of GERD and partial response to proton pump inhibitor treatment. All patients had to have abnormal pH probe studies at baseline.
- Exclusion criteria: large hiatal hernia, grade C or D esophagitis (Los Angeles classification), BMI >35, Barrett’s esophagus, motility disorder, dysphagia more than three times a week, or allergy to implant components.
- Primary outcome was achieved in 64% of patients.
- Secondary outcomes: a reduction of proton-pump inhibitor (PPI) use of 50% or more was achieved in 93%. In fact, at 3 years, 87% had completely eliminated the use of PPIs. Quality of life scores improved in 92%.
- Adverse effects: most common was dysphagia (68% postop, 11% at 1 year, 4% at 3 years). This often resolved after esophageal dilatation.
- Six patients had the device removed.
The bracelet of beads contained sealed magnetic neodymium iron boride. Each bead is connected by a small wire to the next. The small wires allow for expansion of the bracelet. It is also designed to avoid compression of the esophagus as the beads can rest against each other. In addition, the beads separate with the transport of food or if increased intragastric pressure (eg. belch or vomit).
The median time for the procedure of laparascopic placement was 36 minutes. This study brings the worldwide clinical experience to 497 magnetic implants. To date, there have been no reported erosions or migrations.
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