Mitral balloon valvulotomy (MBV) has proved to be an effective method in the treatment of patients with mitral stenosis. Although several factors determining an optimal immediate result have been described, there is little information regarding long-term follow-up, as well as factors influencing late success after MBV. This study analyzes 350 patients (mean age 46 +/- 12 years) treated by MBV who were clinically followed up between 6 months and 6 years. At least 1 echo-Doppler follow-up study was obtained in 298 patients 28 +/- 14 months after MBV; hemodynamic reevaluations were performed in 66 patients after 23 +/- months. Late success was considered if the patient was in functional class I to II and free of major events (death, restenosis and valve surgery). Restenosis was defined as a 50% loss of initial gain with regard to valve area by echocardiography, which was confirmed hemodynamically. After a mean follow-up of 38 +/- 15 months, 296 patients (84%) remained in functional class I to II, without surgery or the need for an increase in medical treatment. The 5-year Kaplan-Meier survival rate was 94 +/- 1%, whereas restenosis, valve surgery and major event-free probability were 90 +/- 3%, 91 +/- 2% and 85 +/- 2%, respectively. Multivariate study (Cox regression model) identified the presence of sinus rhythm (p < 0.001) and the absence of calcium at fluoroscopy (p < 0.003) as the only independent factors of late success.(ABSTRACT TRUNCATED AT 250 WORDS)