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Reflux and Barrett's disease.

In this prospective cohort study, Ganz et al. evaluated a new magnetic device for augmentation of the lower esophageal sphincter in 100 patients with gastroesophageal reflux disease (GERD). The sphincter device consisted of adjacent magnetic beads arranged in a ring. Each bead contained a magnetic core surrounded by a titanium case. The beads were connected to adjacent beads by small wires. The beads were designed to be separated by a bolus of food, belching, or vomiting. In this study, the magnetic esophageal sphincter device was placed around the lower esophageal sphincter using laparoscopic techniques. Patients included in this study had a history of reflux disease of at least 6 months, with a partial response to daily proton pump inhibitor (PPI) treatment and pathological pH-metry. Patients with severe reflux (Los Angeles grade C and D), large hiatal hernia, Barrett’s esophagus, or a body mass index of over 35 were excluded. The primary end point was the number of patients whose pH returned to normal or who had at least a 50% reduction of the time that the pH was less than 4 compared with the baseline measurement. The primary end point was achieved in 64% of patients. A significant improvement in quality of life was achieved in 92% of patients (≥50% reduction in the quality-of-life score); after 1 year, however, the rate decreased to 73%. A complete cessation of PPI treatment was possible in 87% after 3 years. Adverse events were dysphagia in 68% of patients after surgery and 11% at 1 year, requiring esophageal dilation in 19% and device removal in 3%. Device migration or erosion was not noted during follow-up. The study describes an interesting new treatment method for patients with GERD and reports promising results. Compared with other large trials investigating treatment for GERD (e.g. the LOTUS trial), the authors included only patients without or with only partial response to PPI treatment [2]. This might be an explanation for the moderate results regarding the median percentage of time in a 24-hour pH-metry in which the pH was less than 4; in this study it was 3.3% compared with 0.4% after 6 months and 0.7% after 5 years following laparoscopic fundoplication in the LOTUS trial [2]. However, there are several limitations of the study. Patients with severe GERD (Los Angeles grade C and D), Barrett’s esophagus, or large hiatal hernias were excluded. The rate of adverse events requiring device removal due to dysphagia was relatively high in this study (3%). In comparison, only 1 out of 248 patients in the LOTUS study required more than one dilation for dysphagia after fundoplication [2]. A prospective randomized trial comparing the magnetic sphincter device with laparoscopic fundoplication is required before the new device can be used routinely in clinical practice. In addition, long-term results and safety data with a followup of at least 5 years are needed.