“A safety and effectiveness evaluation of Refluxstop™ in the treatment of acid reflux comparing large and small hiatal hernia groups: results from 99 patients in Switzerland with up to 4-years follow-up” is a recently published article in Hernia journal. Refluxstop™ is a novel surgical treatment for acid reflux disease. The procedure was developed in Europe, and it is currently not FDA approved for use in Houston, TX. It consists of hiatal hernia repair, partial fundoplication (around 100-degree wrap placed against the left of the esophagus), followed by gastric fundus invagination using a small silicon cube. The silicon cube weighs 9 grams and measures less than one by one inch in dimensions. The silicon cube is imbedded in the top part of the stomach fundus (the stomach dome), just lateral to the partial fundoplication. For the device to work, it must be positioned above the level of the lower esophageal sphincter. In other words, the fundus itself must be invaginated. If the device is placed lower than fundus level, the invagination will involve the gastric body, and the procedure will not control acid reflux.
The purpose of implanting Refluxstop™ according to the manufacturer is to stabilize the partial fundoplication. I am not sure how exactly a silicon cube stabilizes a partial fundoplication. I rather think that Refluxstop™ completes the partial 100-degree fundoplication, by further invaginating the remaining fundus wall, to look more like a Nissen fundoplication (at least from a physiologic point of view).
From this perspective, Refluxstop™ may be as effective as Nissen fundoplication in controlling acid reflux. (a prospective study is currently underway to compare Refluxstop™ to Nissen fundoplication). However, assuming Refluxstop™ is as reliable and durable as a Nissen fundoplication for treatment of GERD, then what is the advantage of Refluxstop™? After all, placing a foreign body near the gastroesophageal junction is always associated with risk of erosion. (Not to mention the increase cost of surgery). Refluxstop™ does not encircle the lower esophageal sphincter, therefore, the risk of postoperative dysphagia (difficulty swallowing) is low. However, unlike LINX ™ surgery, a properly performed Nissen fundoplication by expert acid reflux specialist has a negligible rate of postoperative dysphagia (difficulty swallowing). At Houston heartburn and reflux Center, our Nissen fundoplication dysphagia rate is zero. Hence, I see no advantage in performing a partial fundoplication, then using a foreign body to plicate whatever is left of the gastric fundus to achieve the same therapeutic effect of a Nissen fundoplication.
The second theoretical purpose of placing a silicon ball is to anchor the newly restored anti-reflux barrier below the diaphragm (breathing muscle). The authors of the above-mentioned article expand on this theoretical assumption by comparing small to large hiatal hernia repairs. Large hiatal hernia repair is associated with a higher recurrence rate compared to small hiatal hernia. At one year after surgery, the study showed equally significant improvement in GERD health related quality of life questionnaires in both small and large hiatal hernia repairs with Refluxstop™ implantation. The authors conclude that Refluxstop™ device creates a “mechanical stop” that prevents upward movement of the lower esophageal sphincter into the chest. In other words, as the positive abdominal pressure drives the gastroesophageal junction into the negative chest pressure through the hiatus, the silicon cube will come against the underside of the left side of the hiatus to prevent the lower esophageal sphincter from migrating into the chest through the hiatus.
This assumption, however, holds true, only if hiatal repair remains intact. For if the hiatal repair falls apart, the invaginated fundus and Refluxstop™ device along with the lower esophageal sphincter will slip back into chest. Since, Refluxstop™ does not alter hiatal hernia repair integrity and strength, the claim that Refluxstop™ decreases hiatal hernia recurrence remains to be confirmed