“Long-term outcomes of patients receiving a magnetic sphincter augmentation device for gastroesophageal reflux” is a recent article published in the current issue of Clinical gastroenterology and Hepatology. The study is prospective in nature and includes 100 patients with GERD for at least 6 months and who are partially responsive to proton pump inhibitors with evidence of prolonged esophageal acid exposure on ambulatory pH testing. 14 centers in the United States and Netherlands participated in this study. Patients with a hiatal hernia with more than 3 cm in axial displacement or with Barrett’s esophagus were excluded. 85 patients were followed up 5 years after LINX™ procedure with 82 patients completing endoscopy at the 5-year mark.
70 out of 84 patients had greater than 50% reduction in GERD health related quality of life score. 15% of patients continued using proton pump inhibitors at 5 years. 7 patients had the LINX™ device removed, 8 patients had ongoing esophagitis, 5 patients developed de novo esophagitis, and 5 patients reported dysphagia. Overall, the complication rate and presence of esophagitis at 5 years is around 25% for LINX™ procedure. Assuming of course that those patients who were lost to follow up did well.
Esophageal pH monitoring or manometric studies were not performed at 5 years according to FDA protocol. I am not sure why would the protocol eliminate such important information for a new device like LINX™. Manometric data is extremely important to analyze at 5 years. We need to make sure there is no damage to esophageal motility in the setting of a constricting device like LINX™ continuously applied to the distal esophagus. pH analysis is equally important as it offers important insight on the long-term efficacy of a LINX™ device in controlling acid reflux. These important studies were surprisingly eliminated from the FDA protocol.
The authors continue with their analysis and conclude that LINX™ was not associated with any erosion because the magnets are specifically made in such a way not to cause erosion. They expand with each swallow rather than being a non-movable object constricting the esophagus and hence the risk of erosion is low. Most importantly for the authors of this study is the ability of LINX™ patients to vomit and belch contrary to Nissen fundoplication cases. LINX™ is described as a natural sphincter that mimics the Lower esophageal sphincter whereas the Nissen wrap completely eliminates acid reflux making it an “un-natural” solution for GERD. Suffice to say, these outrageous assumptions cannot be part of a peer-reviewed article published in a decent scientific journal.
I may be partial towards Nissen surgery because I am used to it and I have witnessed its efficacy hundreds of times. However, the obvious question regarding LINX™ procedure remains the same: what is the advantage of LINX™ over Nissen? What is the advantage of placing a foreign body with limited efficacy in controlling reflux compare to a Nissen wrap? What is the advantage of a device that is associated with higher complication rate and higher failure rate than a safe, reliable and time-tested procedure? Finally, shouldn’t we be concerned about the long-term effect of a constricting band on causing irreversible esophageal dysmotility? After all esophageal dysmotility itself is an important cause of GERD. Gastric secretion pooling in the esophagus causes cough, sore throat, aspiration, and hoarseness. Is LINX™ a solution for GERD or a cause of GERD? The answer could have been easily obtained by including esophageal motility studies in the FDA protocol for LINX™ patients 5 years after procedure implantation. We could have at least tested those patients whose symptoms did not improve or those patients who developed de novo esophagitis. The data was conveniently or inadvertently ignored. The question is why and who is responsible for these decisions? So far, the evidence in support of LINX™ is not that encouraging and the FDA ought to do a better job designing theses studies rather than rushing in approving these devices.