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.
Fifteen patients with intractable reflux or its complications were sequentially studied after the placement of the Angelchik antireflux prosthesis. In all, 16 devices were inserted. Parameters were measured before and 3, 12, 24, and 36 months after prosthesis placement and included symptom scoring, esophageal manometry with Tuttle test, endoscopy, suction biopsy, barium swallow, and gastroesophageal scintigraphy. In addition, a subset of patients underwent stimulation/inhibition of the lower esophageal sphincter (LES) with pentagastrin, metoclopramide, edrophonium, and atropine. At a mean time of 16 months postsurgery, 10 of 16 (63%) patients were reflux-free and there was significant improvement in endoscopic, biopsy, and symptom scoring. Post-insertion, there were statistically significant increments in LES pressure with intravenous boluses of pentagastrin, metoclopramide, and edrophonium, and a significant decrease with atropine. Two patients who developed prosthesis herniation into the chest required removal because of ongoing reflux and dysphagia. An additional patient had prosthesis disruption and migration, which also required removal. Four patients with previously failed antireflux procedures had five prostheses placed. All continued to reflux postoperatively. No patient who was initially reflux-free subsequently developed reflux, despite a tendency for LES pressure to decline with time. Although this procedure proved effective for up to 36 months in patients who had had no previous antireflux procedure, the displacement rate (3/16 = 19%), reoperation rate (3/16 = 19%), and the progressive decline in LES pressure over time should make one cautious about its routine use in the surgical treatment of reflux esophagitis.
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