Percutaneous mitral valvuloplasty has become the technique of choice for mitral stenosis with favorable anatomic features. However, mitral regurgitation is an important complication of this technique that has not reduced with Inoue technique. This study reports the clinical and echocardiographic follow-up (28 +/- 20 months) of 20 patients who developed severe mitral regurgitation after percutaneous mitral valvuloplasty with Inoue technique. The patients were divided into two groups on the basis of the need for mitral valve replacement during follow-up. We analyzed variables before and after percutaneous mitral valvuloplasty using univariate analysis. Multivariate analysis was performed to identify variables as independent predictors of the need for mitral valve replacement. Ten patients needed mitral valve replacement during follow-up. Multivariate analysis showed that suboptimal result of percutaneous mitral valvuloplasty (MVA < 1.5 cm2) was the only independent predictor of the need of mitral valve replacement. We concluded that the need for MVR in patients who develop severe mitral regurgitation after percutaneous mitral valvuloplasty was related to suboptimal result of procedure.