Background: Endoscopic methods to prevent gastroesophageal reflux (GER) show scarce effectiveness and may narrow the esophageal lumen more or less stiffly, sometimes impairing bolus transit and leading to dysphagia. The aim of this study was to demonstrate the possibility of reinforcing lower esophageal sphincter (LES) tone by implanting endoluminally a magnetic device.
Materials and methods: The device consists of two small magnetic plaques to be implanted in the submucosa close to LES with opposite polarities facing so that they attract one other, closing the esophageal lumen. The magnets were implanted by means of a special endoluminal device in five esophageal-gastric ex vivo specimens taken from swine. Variation in endoluminal pressure at the LES level was measured by means of slow pull-through of a thin side-hole manometric catheter in each specimen, before and after insertion of the magnets.
Results: The new high-pressure zone exhibited a length of about 2 cm and a pressure of 14.2+/-1.27 mmHg [mean +/- standard deviation (SD)], significantly (p<0.001) higher than that measured before insertion of the magnetic valve (1.5+/-0.26 mmHg).
Conclusions: The present research demonstrates that it is possible to create at the LES level a dynamic closure of a value considered sufficient to prevent GER, by implanting in the esophageal submucosa of anatomical specimens a magnetic device by means of a special endoluminal probe. Once effectiveness and tolerability of magnets covered by a biocompatible sheath have been demonstrated in vivo, this device could become a simple and effective nonsurgical solution to GER.