The artificial bowel sphincter: a single institution experience over a decade.

OBJECTIVE: A report on the long-term results of a consecutive series of patients implanted with the Acticon Neosphincter. METHOD: Data were reviewed from a prospective database. From May 1996 to Jan 2010, 52 patients (46 women), mean age 51.5 ± 14.8 years, with severe fecal incontinence for a mean of 10.6 ± 10.5 years, were implanted with 85 devices. All patients had failed conservative management, including 13 with unsuccessful prior surgical treatments. Indications for implantation were sphincter destruction (45), pudendal neuropathy (12), congenital malformation (7), and perineal colostomy (4). Preoperative assessment included anal endosonography, anorectal manometry, and electrophysiologic testing. Incontinence (Wexner) and Quality of Life scores were recorded prior to the procedure and at each follow-up visit, together with annual anal physiology assessments. Cumulative risks of device revision and explantation were evaluated using Kaplan-Meier survival curves. RESULTS: Mean follow-up was 64.3 ± 46.5 months (range, 2-169); 26 patients (50%) required revisions after a mean of 57.7 ± 35.0 months, with 73.1% due to a leaking cuff from a microperforation; 14 patients (26.9%) required definitive explantation after a mean of 14.6 ± 7.9 months, with the majority (42.9%) due to infection; and 9 patients were lost to follow-up. In 35 patients (67.3%) with an activated device, there were significant improvements in both median Wexner (P < 0.0001) and Quality-of-life scores (P = 0.0286). There was a significant difference between preoperative resting anal pressures and closed pressures at activation (P < 0.0001) and latest follow-up (P < 0.0001). CONCLUSION: With careful patient selection, meticulous surgical technique, and dedicated surveillance, favorable long-term results can be achieved with acceptable rates of revision and explantation.