Appeal type: Experimental/Investigational
Decision: Overturned

This case involves a male with a long history of reflux that is not effectively managed with maximal medical therapy, nor with a prior endoscopic (incisionless) fundoplication that he underwent. His current pH testing is markedly abnormal demonstrating gastroesophageal reflux disease (GERD) with a DeMeester score that was markedly elevated with good symptom correlation to acid GER events. His upper gastrointestinal (UGI) contrast study shows normal anatomy with the exception of a small hiatal hernia and gastric mucosal thickening suggestive of gastritis. High resolution manometry shows weak lower esophageal sphincter (LES) and reflux. Weak esophageal peristalsis and bolus progression. Esophagogastroduodenoscopy (EGD) showed normal stomach, normal mid third esophagus with some duodenitis.
The subject under review is whether the LINX treatment is likely to be more beneficial for this patient than other treatments.

The health plan's determination is overturned.

Yes, the LINX procedure is likely to be more beneficial than standard surgical therapy due to the equivalent effectiveness of these two approaches to GERD treatment and the documented lower risk of adverse events after LINX compared with standard surgical therapy (fundoplication).
Until 2012, the surgical options for management of GERD had been limited to Nissen fundoplication or, in some patient populations (morbidly obese), roux en Y gastric bypass. This patient does not have a body mass index that would indicate gastric bypass. Magnetic sphincter augmentation using the LINX device is a newer anti-reflux surgical technique which reinforces the lower esophageal sphincter using a ring of spaced magnetic beads that is placed around the sphincter. Research showing the efficacy and safety of this device led to approval by the Food and Drug Administration (FDA) in 2012 by unanimous vote of the expert panel.
Currently, numerous published clinical studies have confirmed that the LINX device reinforces the lower esophageal sphincter, effectively reduces the percent time of esophageal acid exposure, and improves GERD health-related quality of life similar to that of fundoplication. However, the question at hand is whether the LINX device is "more beneficial" than fundoplication. In experienced hands, the operation time for LINX placement is shorter than that of Nissen fundoplication, primarily due to the fact that an extensive dissection of the fundus and re-creation of the angle of His and anti-reflux barrier is not necessary. Postoperative dysphagia has been reported, as with fundoplication, and for the majority of patients, these symptoms appear to be short-lived and resolve with observation or with dilation of the gastroesophageal junction.
When outcomes of patients who underwent LINX were compared with another group undergoing fundoplication, the number of patients reporting mild gas-bloat was similar between the two groups, but there were no patients with severe gas and bloating in the LINX group compared with significantly more (11%) in the fundoplication group. Nearly 3x more fundoplication patients were unable to belch and about 5x more fundoplication patients were unable to vomit. These findings of superiority, along with the similar anti-reflux efficacy between the device and standard fundoplication, form the justification for LINX being the better surgical option in modern times.
Thus, the plurality of the evidence demonstrates that the device is more beneficial than the alternative surgical option of fundoplication. Data shows that the procedure is similarly effective against reflux but with lower risks of surgical trauma, bleeding risk, risk of postoperative complications such as gas-bloat and inability to vomit. These data are well described by Telem et al. in the most recent 2017 Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) TAVAC report. The peer reviewed, published outcome data now very clearly show that patients who have undergone device placement have benefited from this treatment.