A Novel Endoesophageal Magnetic Device to Prevent Gastroesophageal Reflux

Abstract

Purpose: The endoscopic methods to prevent gastroesophageal reflux (GER) show a scarce effectiveness and may narrow the esophageal lumen, sometimes leading to dysphagia (Clin Gastro Hepatol 2005;3:831). The aim of this study was to demonstrate the possibility of implanting by endoesophageal way a magnetic valve in the esophageal submucosa, close to lower esophageal sphincter (LES), to strengthen the incompetent LES. Methods: The device consists in a couple of small magnetic plaques of about 5 × 20 × 1.5 mm destined to be implanted by means of a special endoluminal device in the esophageal submucosa close to LES in 5 esophago-gastric specimens taken from swines. The delivery device serves to make two pockets in the submucosa one in front of the other, where the magnets are deployed, first in one side and after in the opposite one, with the contrary polarities face to face, so that they can attract themselves, closing the lumen. A series of 5 slow pull-throughs with a thin side-hole manometric catheter was carried out in each specimen before and after the insertion of the magnets and the mean pressure values were compared by means of Student t test for paired data. Results: The new HPZ showed a length of about 2 cm and a pressure of 14.2 ± 1.27 mmHg (mean ± SD), significantly (P < 0.001) higher than that measured before the insertion of the magnetic valve (1.5 ± 0.26 mmHg). Conclusion: The present research demonstrated that it is possible to create at LES level a new HPZ that is considered sufficient to prevent GER (N Engl J Med 1982;307:151), by implanting in the esophageal submucosa of swine gastroesophageal specimens, close to LES, a magnetic device by means of a special endoluminal delivery probe. The main advantage of this system, beside its reversibility and the possibility of tailoring the HPZ for each patient by choosing magnets with different magnetic force, shape and size, lies in the fact that the magnetic valve does not give a rigid lumen closure, as that obtained with other endoscopic methods, but creates a “dynamic closure”, that may allow an easy content transit, when the magnetic plaques are detached by the endoesophageal pressure. As a matter of course, before considering this magnetic valve a simple and effective non-surgical solution of the GER problem, it is necessary to perform“in vivo”experiments in animals by using magnets covered with bio-compatible materials and with a proper attraction force, that does not damage the tissues, but is able to strengthen LES to prevent GER.