DEVELOPMENT OF AN ADJUSTABLE PROSTHESIS FOR THE TREATMENT OF GASTROESOPHAGEAL REFLUX - PRELIMINARY-RESULTS IN A PORCINE MODEL

Dysphagia and recurrent gastroesophageal reflux complicate use of the Angelchik prosthesis. The authors developed an inflatable silicone dev ice, similar to the Angelchik prosthesis, that may allow for the adjus tment of the total pressure exerted around the gastroesophageal juncti on after implantation. To estimate its potential to prevent gastroesop hageal reflux in humans, we used a short-term porcine model in which w e measured the effective lower esophageal sphincter pressure in 10 ane sthetized pigs using a computerized, three dimensional pressure vector volume analysis. Anesthesia and mobilization of the gastroesophageal junction did not modify the three dimensional pressure vector volume a t the lower esophageal sphincter. Implantation of the deflated device significantly increased effective lower esophageal sphincter three dim ensional pressure vector volume compared with baseline. Inflation of t he device with 30 mi of saline further increased lower esophageal sphi ncter pressure significantly. Deflation of the device returned the pre ssure to the pre-inflation value. Using an animal model and short-term implantation, this new antireflux device appeared to offer the potent ial ability to adjust the pressure selectively at the gastroesophageal junction postoperatively. An added future feature of this device may be the ease of insertion using laparoscopic techniques. Longterm anima l implantation studies and clinical trials are required to help establ ish the safety and efficacy of this device in humans.