An Anti-Reflux Prosthesis in the Treatment of Gastroesophageal Reflux

Abstract

The Angelchik anti-reflux prosthesis, a C-shaped, silicone filled device surgically secured around the distal esophagus, received premarket approval by the Food and Drug Administration's Bureau of Medical Devices in 1979. Despite its use in over 9000 patients, there are few physiologic data documenting its effectiveness. We studied ten patients before and 3 months after prosthesis implantation with barium meal, endoscopy, esophageal biopsy, standard acid reflux testing, esophageal manometry, gastroesophageal scintigraphy, and symptom scoring. After surgery all patients were able to discontinue cimetidine and elevation of the head of the bed. Two patients had documentation of mild reflux, one of whom needed to have the prosthesis removed because of its herniation into the mediastinum. Eight patients had no reflux. There was statistically significant improvement in endoscopic, symptomatic, and biopsy grading as well as increased lower esophageal sphincter pressure after surgery. Prosthesis implantation is a promising surgical treatment of intractable esophageal reflux, but we believe additional and long-term studies are needed before its general use.

A Prospective Randomized Double‐Blind Study of Gastroesophageal Reflux Surgery in Pediatric‐Sized Developmentally Disabled Patients

“…Posterior padding of the gastroesophageal junction by the prosthesis is suggested to cause changes in the length-tension relationship of the muscle, resulting in increased lower esophageal sphincter pressure (47). Significant increases in human lower esophageal sphincter pressure have been previously reported (34,35). In our study, the lower esophageal sphincter pressure increases, determined from measurements presurgery and 6 months after surgery, were statistically significant.…”

“…As of March 1985, approximately 21,200 such prostheses have been inserted into patients (Mentor Corp., personal communication). Despite reports of the successful use of this prosthesis (34,35), when this study was initiated in 1981, there were no prospective, randomized comparisons of the Angelchik prosthesis with standard antireflux surgery. During the course of this investigation, such a prospective study was published, suggesting the Angelchik prosthesis compares favorably with fundoplication in the surgical treatment of GER in adults (36).…”

Intrathoracic esophageal perforation with the Angelchik antireflux prosthesis: Report of a new complication

“…The main advantage over the standard antireflux operations, especially in obese patients, is the simplicity of the procedure [1][2][3][4][5]7]. Although the short-term control of gastroesophageal reflux and its resultant symptoms is encouraging, long-term follow-up is not yet available.…”

“…This prosthesis consists of a C-shaped silicone shell filled with highly cross-linked silicone gel implanted as a collar around the distal esophagus below the diaphragm, and fixed with radiopaque incorporated tapes that are tied in position. Several series have reported good short-term results [1][2][3][4], but a number of complications have been observed. These consist of migration of the prosthesis into the mediastinum [2][3][4][5], abdomen, or pelvis [2,3], slippage over the stomach with ensuing gastric obstruction [6], and erosion into the stomach [7].…”

Laparoscopic Nissen Fundoplication for the Management of Failed Angelchik Prosthesis

“…2 The early short-term results were promising, and both objective and subjective outcome measures were similar to other accepted surgical anti-reflux procedures available at that time. 3,4 However, by the mid-1980s Angelchik prosthesis was associated with a high incidence of complications and consequently many surgeons discouraged to deploy this device. In 1985, Lancet concluded that ''use of the Angelchik prosthesis is rarely, if ever, justified.''…”