“Objective Evidence of Reflux Control After Magnetic Sphincter Augmentation: One Year Results From a Post Approval Study”, is a new multicenter, prospective, study recently published in the Annals of Surgery journal. 200 patients with objective evidence of acid reflux were treated with LINX™ device surgery between 2013 and 2015. At one year after surgery, only 74% of patients had normal esophageal acid exposure. LINX™ device removal rate at one year was 1%. One LINX™ device erosion was reported. The authors conclude that LINX™ device is both safe and effective for treatment of GERD.
Our results at Houston Heartburn Center are much better. On one hand we have a 100% patient satisfaction and 0% surgery failure rate. Since 2015, our redo surgery rate is less than one per one thousand hiatal hernia repair and Nissen fundoplication. Since we don’t use LINX™ device, our erosion and device failure rate are zero. Most importantly, however, is safety and effectiveness of Nissen fundoplication. Our mortality rate is zero and our 30-day complication rate is less than 1%. Nissen fundoplication when properly performed completely eliminates acid reflux. LINX™ device in this study eliminates acid reflux in only 74% of cases. Nissen fundoplication does not impair esophageal motility. LINX™ device is a barrier against esophageal contractions and is contraindicated in patients with weak esophageal peristalsis.
The superiority of a properly performed Nissen fundoplication in controlling GERD is closely associated with its mechanism of action. Nissen fundoplication does not simply augment the lower esophageal sphincter as LINX™ device is assumed to do. Acid reflux is a complex esophago-gastric motility disorder. GERD pathogenesis is not limited to a weak LES. Meticulous hiatal hernia repair restores normal gastro-esophageal junction anatomy and Nissen fundoplication restores a competent reflux barrier without impeding esophageal motility and food emptying from esophagus into stomach. For these reasons, we are hesitant at Houston Heartburn Center to offer LINX™ device for treatment of stage 3 or stage 4 acid reflux disease.