Objective: To evaluate the long-term clinical outcome and compare the rupture rate of the two generations of the silicone Angelchik antireflux prosthesis.
Design: A cohort study. Follow-up ranged from 61 to 119 months.
Setting: A university teaching hospital.
Patients: Sixty-three patients: 33 patients received the first generation Angelchik device (group 1) and 30 patients received a second generation design (group 2). The two groups were comparable for sex ratio, mean age and duration of symptoms.
Interventions: Implantation of the Angelchik prosthesis.
Main outcome measures: Comparison of the rupture rate and migration of the prosthesis as assessed by patient questionnaire, telephone interview and radiography of the abdomen.
Results: The prosthesis remained in a good position in 53% of group 1 patients and 93% of group 2 patients. The prosthesis was removed in 40% of group 1 patients, most often for rupture, and in only 7% of patients in group 2, to relieve dysphagia (p < 0.01). Grading on a Visick scale demonstrated a good result in 37% of group 1 patients and 69% of group 2 patients. Long-term dysphagia was the most prevalent adverse effect, seen in 45% of patients whose prosthesis was in a good position, and symptomatic reflux recurred in 8%.
Conclusions: The second generation of the Angelchik prosthesis, resulted in a reduced rupture rate of the prosthesis. Nevertheless the high complication and the failure rates militate against continued implantation of the prosthesis.