Prospective study of the Angelchik anti-reflux prosthesis.

Fifty patients with medically refractory gastro-oesophageal reflux were treated by the insertion of an Angelchik anti-reflux prosthesis. All patients had a pre-operative upper gastrointestinal endoscopy, 32 were investigated with 15 h overnight oesophageal pH studies combined with oesophageal bile sampling and 20 underwent oesophageal manometric studies. At pre-operative endoscopy 45 patients had evidence of oesophagitis and the 5 who did not had pathological reflux demonstrated on overnight pH testing. Postoperatively the main clinical problem was dysphagia which appeared to settle with time but left one-third of patients with mild dysphagia at the end of 12 months. A further 12 per cent had residual moderate to severe dysphagia which required the removal of the prosthesis in five patients (10 per cent). In only one patient was the dysphagia due to prosthetic migration and this was the first patient in the series. Subsequently, we have had no problems with prosthetic migration, disruption, or erosion into the oesophagus. The overnight pH studies confirmed the efficacy of the prosthesis in preventing reflux which correlated with symptomatic improvement. We conclude that, while the Angelchik anti-reflux prosthesis is an effective device, it has a disturbingly high incidence of postoperative dysphagia though this appears to settle with time, leaving around 10 per cent of patients with severe dysphagia which will necessitate removal of the prosthesis and one-third with mild dysphagia which may settle with the further passage of time.