H.4 Finding the middle ground between PPI and fundoplication: an endoscopic antireflux device
Gastroesophageal reflux disease (GERD) is a condition that develops when the reflux of stomach contents into the esophagus causes troublesome symptoms and mucosal injury. It has an estimated prevalence of over 20% of individuals in the western world (El-Serag et al., 2014) and impacts millions worldwide. In the United States, over half of adults will report symptoms of heartburn at some time (Locke et al., 1997).
The symptoms of GERD can be severe and functionally debilitating or relatively minimal, however untreated disease leads to devastating complications including erosions, ulcerations, strictures, painful esophagitis, and upper gastrointestinal bleeding. Most notably, long-standing erosive disease leads to intestinal metaplasia of the esophagus with the potential to progress to esophageal adenocarcinoma.
Despite the high burden of disease and significant morbidity and mortality, almost no novel treatment modalities have come to market. Proton pump inhibitors (PPIs) continue to be the mainstay of treatment and are among the most widely prescribed medications worldwide, yet long-term use is associated with a range of adverse effects including high risk of fractures, pneumonia, clostridium difficile diarrhea, hypomagnesemia, vitamin B12 deficiency, chronic kidney disease, and dementia (Nehra et al., 2018). The only other option for refractory disease is laparoscopic fundoplication, during which the antireflux barrier is surgically restored. Surgical repair is not only expensive but carries a wealth of risks and has fallen out of favor due to poor durability. Studies demonstrate the operation controls symptoms for just over a decade (Kellokumpu, 2017).
Upper endoscopy is already routinely used to screen patients with refractory GERD for intestinal metaplasia. What if a device existed that could be endoscopically implanted to repair the antireflux barrier? This would provide an affordable middle-ground between pharmacotherapy and surgical repair, and more importantly, alleviate the primary risk factor for the development of esophageal adenocarcinoma for millions.