A prospective randomized trial of the cut-and-sew Maze procedure in patients undergoing surgery for rheumatic mitral valve disease.

ABSTRACT

OBJECTIVE: To evaluate the safety and efficacy of the addition of the cut-and-sew Maze III procedure (CSM) for mitral valve replacement (MVR) in patients with atrial fibrillation (AF) associated with rheumatic mitral valve disease (RMVD). METHODS: A total of 130 patients with persistent or long-standing persistent AF associated with RMVD were assigned at random to either the CSM plus MVR (Maze III) group or MVR alone (non-Maze) group. The primary endpoint was a composite of freedom from stroke and death at 1 year. RESULTS: There were no significant differences between the Maze III and non-Maze groups in terms of major complications and in-hospital mortality. One-year freedom from stroke or death was better in the Maze III group compared with the non-Maze group (P = .0028; hazard ratio, 0.2653; 95% confidence interval, 0.1122 to 0.6270). The risk of AF recurrence in the Maze III group was 0.002-fold that in non-Maze group (P = .000). CONCLUSIONS: Addition of the CSM to an MVR procedure can decrease the risk of stroke or death and high sinus rhythm at 1 year without increasing the operative risk. CSM is a safe and effective approach to treating AF associated with RMVD.