The Angelchik antireflux prosthesis: long-term clinical and technical follow-up.

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.