Evaluation of Angelchik antireflux prosthesis. Long-term results.

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.